B thuringiensis ssp aizawai GC-91 final RR 1107 Part B Section 7

Transcription

Part A
National Assessment –
Germany
Agree 50 WG
Page 1 of 30
Registration Report – Central Zone
REGISTRATION REPORT
Part A
Risk Management
Product code:
Agree 50 WG
Active Substance: Bacillus thuringiensis
ssp. aizawai GC-91 500 g/kg
COUNTRY: Germany
Central Zone
Zonal Rapporteur Member State: Germany
NATIONAL ASSESSMENT
Applicant: Mitsui AgriScience International SA
Date:
November 2015
Evaluator: DE
Date: November 2015
Part A
National Assessment - Germany
Agree 50 WG
Page 2 of 30
Registration Report –Central Zone
Table of Contents
PART A – Risk Management
4
1
Details of the application
4
1.1
Application background
4
1.2
Annex I inclusion
4
1.3
Regulatory approach
5
1.4
Data protection claims
5
1.5
Letters of Access
5
2
Details of the authorisation.
6
2.1
Product identity
6
2.2
Classification and labelling
6
2.2.1
Classification and labelling under Directive 99/45/EC
6
2.2.2
Classification and labelling under Regulation (EC) No 1272/2008
6
2.2.3
R and S phrases under Regulation (EC) No 547/2011
7
2.2.4
Other phrases
7
2.3
Product uses
10
3
Risk management
16
3.1
Reasoned statement of the overall conclusions taken in accordance with the Uniform
Principles
16
3.1.1
Physical and chemical properties (Part B, Section 1, Points 2 and 4)
16
3.1.2
Methods of analysis (Part B, Section 2, Point 5)
16
3.1.2.1
Analytical method for the formulation (Part B, Section 2, Point 5.2)
16
3.1.2.2
Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
16
3.1.3
Mammalian Toxicology (Part B, Section 3, Point 7)
17
3.1.3.1
Acute Toxicity (Part B, Section 3, Point 7.1)
17
3.1.3.2
Operator Exposure (Part B, Section 3, Point 7.3)
17
3.1.3.3
Bystander Exposure (Part B, Section 3, Point 7.4)
17
3.1.3.4
Worker Exposure (Part B, Section 3, Point 7.5)
18
Evaluator: DE
Date: November 2015
Part A
Agree 50 WG
Page 3 of 30
3.1.4
Residues and Consumer Exposure (Part B, Section 4, Point 8)
19
3.1.4.1
Residues (Part B, Section 4, Points 8.3 and 8.7)
19
3.1.4.2
Consumer exposure (Part B, Section 4, Point 8.10)
19
3.1.5
Environmental fate and behaviour (Part B, Section 5, Point 9)
20
3.1.6
Ecotoxicology (Part B, Section 6, Point 10)
21
3.1.6.1
Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
21
3.1.6.2
Effects on Aquatic Species (Part B, Section 6, Point 10.2)
22
3.1.6.3
Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)
23
3.1.6.4
Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6)
24
3.1.6.5
Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
25
3.1.6.6
Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
25
3.1.6.7
Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna)
(Part B, Section 6, Point 10.8)
25
3.1.7
Efficacy (Part B, Section 7, Point 8)
3.3
Further information to permit a decision to be made or to support a review of the
conditions and restrictions associated with the authorisation
29
25
Appendix 1 – Copy of the product authorisation
30
Appendix 2 – Copy of the product label
30
Appendix 3 – Letter of Access
30
Evaluator: DE
Date: November 2015
Part A
National Assessment –
Germany
Agree 50 WG
Page 4 of 30
PART A – Risk Management
This document describes the acceptable use conditions required for the registration of Agree 50 WG
containing Bacillus thuringiensis ssp. aizawai GC-91 in Germany. This evaluation is required subsequent
to the inclusion of Bacillus thuringiensis ssp. aizawai GC-91 on Annex 1.
The risk assessment conclusions are based on the information, data and assessments provided in
Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for Germany.
The information, data and assessments provided in Registration Report, Parts B includes assessment of
further data or information as required at national registration by the EU review. It also includes
assessment of data and information relating to Agree 50 WG where that data has not been considered in
the EU review. Otherwise assessments for the safe use of Agree 50 WG have been made using endpoints
agreed in the EU review of Bacillus thuringiensis ssp. aizawai GC-91.
This document describes the specific conditions of use and labelling required for Germany for the
registration of Agree 50 WG.
Appendix 1 of this document provides a copy of the final product authorisation Germany.
Appendix 2: The submitted draft product label has been checked by the competent authority. The
applicant is requested to amend the product label in accordance with the decisions drawn by the
competent authority. The final version of the label is not available, because the layout is the sole
responsibility of the applicant and will not be checked again.
Appendix 3 of this document contains copies of the letters of access to the protected data / third party data
that was needed for evaluation of the formulation.
Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
1
Details of the application
1.1
Application background
This application was submitted by Mitsui AgriScience International in April 2012.
The application was for approval of Agree 50 WG, an insecticide formulated as water dispersible
granules containing 500 g/kg of Bacillus thuringiensis ssp. aizawai strain GC-91. Agree 50 WG is based
on naturally occurring bacteria and has highly specific insecticidal efficacy.
1.2
Annex I inclusion
Bacillus thuringiensis ssp. aizawai GC-91 was included on Annex I of the EU Directive 91/414/EEC on 1
May 2009 under Inclusion Directive 2008/113/EC and implemented under Regulation (EU) No 540/2011.
The approval of Bacillus thuringiensis ssp. aizawai GC-91 (Inclusion Directive 2008/113/EC from 8
December 2008) provides specific provisions under Part B which need to be considered by the applicant
in the preparation of their submission and by the MS prior to granting an authorisation.
Evaluator: DE
Date: November 2015
Part A
Agree 50 WG
Page 5 of 30
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No
1107/2009, the conclusions of the review report on GC-91 (SANCO/1538/2008) and in particular
Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
These concerns were all addressed in the submission.
Expiration of approval: 30/04/2019.
1.3
Regulatory approach
To obtain approval the product Agree 50 WG must meet the conditions of Annex I inclusion and be
supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to
Uniform Principles, using Annex I agreed end-points.
This application was submitted in order to allow the first approval of this product/use in Germany in
accordance with the above.
1.4
Data protection claims
The applicant, Mitsui AgriScience International S.A./B.V. (Boulevard de la Woluwe 60, Brussels,
Belgium), is holder of all proprietary data used in the dossier. The data owner is Certis U.S.A. (9145
Guilford Road, Columbia, USA). The same applies to all studies assessing the physical-chemical
properties and the storage stability of Agree 50 WG for which Certis Europe (Safariweg 55, 3605
Maarssen, Netherlands) was the sponsor. Data protection claims are indicated in the reference list
included in the Registration Report, Part B section 1-7.
1.5
Letters of Access
On behalf of Certis U.S.A., Mitsui AgriScience International S.A./B.V. submitted data for approval of
Bacillus thuringiensis ssp. aizawai GC-91 and has full access to the data. The same applies for all data for
Agree 50 WG. A Letter of Access from Certis Europe is provided.
Evaluator: DE
Date: November 2015
Part A
Agree 50 WG
Page 6 of 30
2
Details of the authorisation.
2.1
Product identity
Product Name
Authorization Number
Function
Applicant
Composition
Formulation type
Packaging
Agree 50 WG
007638-00
Biological insecticide
Mitsui AgriScience International SA/BV
Bacillus thuringiensis ssp. aizawai strain GC-91 (Bta
GC-91): 500 g/kg; biopotency: 25,000 IU/mg product;
δ-endotoxin: 3.8%; spores: 3 x 1013 CFU/kg
Water dispersible granules [Code: WG]
1 kg primary packaging (polyethylene bag),
1 secondary packaging containing 10 pieces of primary
packaging
2.2
Classification and labelling
2.2.1
Classification and labelling under Directive 99/45/EC
In accordance with Directives 67/548/EEC and 1999/45/EC the following classification / labelling with
regard to toxicological data is proposed for the preparation.
Hazard Symbol:
Indication of danger:
Risk Phrases:
Safety Phrases:
Labelling texts and restrictions:
2.2.2
Xi
Irritant
43
2-24-36-37-46
To avoid risks to man and the environment, comply with the instructions
for use.
Micro-organisms may have the potential to provoke sensitising reaction.
Classification and labelling under Regulation (EC) No 1272/2008
According to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008, the following classification for toxicological hazards of the preparation
according to GHS is proposed:
Evaluator: DE
Date: November 2015
Part A
Pictograms, code:
Signal word:
Hazard code:
GHS07
Warning
H317
EUH401
Agree 50 WG
Page 7 of 30
May cause an allergic skin reaction.
To avoid risks to human health and the environment, comply
with the instructions for use.
Micro-organisms may have the potential to provoke sensitising
reactions.
18 percent of the mixture consists of ingredients of unknown
oral, dermal and inhalation toxicity.
2.2.3
R and S phrases under Regulation (EC) No 547/2011
SF1891 Re-entering the treated areas/crops is only possible on the day of application wearing
personal protective equipment which is specified for applying the particular product.
Successive work on/in treated areas/crops may fundamentally not be carried out until 24
hours after applying the product. Within the first 48 hours, protective suits against pesticides
and standard protective gloves (plant protection) are to be worn.
2.2.4
Other phrases
The authorization of the PPP is linked to the following conditions (mandatory labelling):
•
Operator protection
Safety instructions (codes according to BVL 1))
SB001 Avoid any unnecessary contact with the
product. Misuse can lead to health
damage.
SB110 The directive concerning requirements for
personal protective gear in plant
protection, "Personal protective gear for
handling plant protection products" of the
Federal Office of Consumer Protection
and Food Safety must be observed.
SS110 Wear standard protective gloves (plant
protection) when handling the undiluted
product.
SS2101 Wear a protective suit against pesticides
Justification
Mandatory for plant protection products.
Mandatory for plant protection products.
Based on BBA-Guideline Part I, 3-3 (1993) with
regard to the dangerous substance directive
(Biologische Bundesanstalt für Land- und
Forstwirtschaft, Richtlinen für die Prüfung von
Pflanzenschutzmitteln - Kennzeichnung von
Pflanzenschutzmitteln (Gesundheitsschutz)
(Federal Biological Research Centre for
Agriculture and Forestry, Guidelines for
Evaluation of Plant Protection Products –
Labelling of Plant Protection Products (Human
Health)).
Evaluator: DE
Date: November 2015
Part A
Agree 50 WG
Page 8 of 30
and sturdy shoes (e.g. rubber boots) when
handling the undiluted product.
SS2202 Wear a protective suit against pesticides
and sturdy shoes (e.g. rubber boots) when
applying/handling the product ready for
application.
VH650 The packaging must be provided with the
wording "micro-organisms may have the
potential to provoke sensitising
reactions".
VA269
The product must be applied using loss
reducing equipment which is registered in
the index of 'Loss Reducing Equipment'
of 14 October 1993 (Federal Gazette No
205, p. 9780) as amended, and be
registered in at least drift reducing class
75 %.
Health)).
With regard to preventive health protection and
good agricultural practice.
Health)).
With regard to preventive health protection and
good agricultural practice.
http://www.bvl.bund.de/SharedDocs/Downloads/04_Pflanzenschutzmittel/eAntrag-CodelistenEN.pdf?__blob=publicationFile&v=6
1)
Environment
EB001-2
Do not contaminate water with the product or its container (Do not clean application
equipment near surface water./Avoid contamination via drains from farmyards and roads).
NW642-1
The product may not be applied in or in the immediate vicinity of surface or coastal
waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by
state law must be observed. Violations may be punished by fines of up to 50 000 EUR.
Evaluator: DE
Date: November 2015
Part A
Agree 50 WG
Page 9 of 30
Labelling phrases for efficacy and sustainable use
WMI11
Mode of action (IRAC-group): 11 (bacillus thuringiensis)
NB6641
The product is classified as non-hazardous to bees, even when the maximum application rate,
or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4)
NN1001
The product is classified as not harmful for populations of relevant beneficial insects.
NN1002
The product is classified as not harmful for populations of relevant beneficial predatory mites
and spiders.
Evaluator: DE
Date: November 2015
Part A
National Assessment Germany
Agree 50 WG
Page 10 of 30
2.3
Product uses
PPP (product name/code)
active substance
Agree 50 WG
Bacillus thuringiensis ssp. aizawai GC-91
Formulation type:
Conc. of as :
WG
500 g/kg
Applicant:
Zone(s):
Mitsui AgriSciences International S.A./B.V.
central EU
professional use
non professional use
x
x
Verified by MS: yes
1
UseNo.
001
2
Member
state(s)
DE
3
4
Crop
or
5
6
7
and/ F
situation G
or
(crop
destination
/ I
purpose of crop)
Pests or Group of pests
controlled
Method /
Kind
(additionally:
developmental stages of
the pest or pest group)
Application
Timing / Growth
stage of crop &
season
grape vine (VITVI)
F
(use as table and wine
grape)
grape berry moth
1.generation (L1-L2)
from emergence of
first larvae after
beginning of
infestation or
warning service
appeal / from
BBCH 53
spraying or
fine
spraying
(low
volume
spraying)
8
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
3 (at least
days apart)
10
11
12
13
Application rate
PHI
Water
L/ha (days)
g, kg as/ha
kg, product / ha
a) max. rate per
a) max. rate
appl.
min / max
b) max. total rate per appl.
b) max. total
per crop/season
rate per
crop/season
7 a) – base dose:
a) 0,125 -0,375 – base dose:
0,25 kg/ha
b) 1,125
400 l/ha
- BBCH 61:
- BBCH 61:
0,5 kg/ha
800 l/ha
- BBCH 71:
- BBCH 71:
0,75 kg/ha
1200 l/ha
b) 2,25
Evaluator: DE
Date: November 2015
14
Remarks:
e.g. safener/synergist per ha
e.g. recommended or
mandatory tank mixtures
NW642-1
Use cannot be authorised due
to insufficient number of
efficacy trails to allow
efficacy assessment (EPPO
PP 1/226 (1) and PP 1/225
(1))
Use cannot be authorised
because no final conclusion
on possible health risks for
consumers through residues
of B. t is possible.
Part A
Product code
Page 11 of 30
002
DE
grape vine (VITVI)
F
grape)
grape berry moth
spraying or
2. and 3. generation (L1- fine
L2)
spraying
(low
volume
spraying)
from emergence of
first larvae after
beginning of
infestation or
warning service
appeal / from
BBCH53
003
DE
berries (NNNOB)
except for strawberry
F
free biting caterpillars
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 11
004
DE
berries (NNNOB)
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 11
3 (at least 7 a) – base dose:
days apart)
0,25 kg/ha
- BBCH 61:
0,5 kg/ha
- BBCH 71:
0,75 kg/ha
-BBCH 75:
1 kg/ha
b) 2,25
3 (at least 7 a) 1
days apart)
b) 3
a) 0,125 – 0,5
b) 1,5
– base dose:
400 l/ha
- BBCH 61:
800 l/ha
- BBCH 71:
1200 l/ha
- BBCH 75:
1600 l/ha
NW642-1
a) 0,5
b) 1,5
max. 1000
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
max. 1000
NW642-1
PP 1/226 (1) and PP 1/225
(1))
PP 1/226 (1) and PP 1/225
(1))
Evaluator: DE
Date: November 2015
Part A
Product code
Page 12 of 30
005
DE
strawberry (FRAAN)
F
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 13
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
1000 - 2000
006
DE
strawberry (FRAAN)
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 13
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
1000 - 2000
007
DE
fruit vegetables (NNNVF) G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
a) 0,25 – 0,5
b) 3
008
DE
leafy and stem vegetables F
(NNNVL)
except for
vegetable
cabbage
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
a) < 50 cm:
min 600 l/ha
50 – 125cm:
min 900 l/ha
> 125 cm:
min 1200 l/ha
b) 6
200 - 800
009
DE
leafy and stem vegetables G
(NNNVL)
except
for
vegetable
cabbage
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
(low
6 (at least 7 a) < 50 cm:
days apart)
0,5 kg/ha
50 – 125 cm:
0,75 kg/ha
> 125 cm:
1 kg/ha
b) 6
3 (at least 7 a) 1
days apart)
b) 3
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
after beginning of
infestation; from
emergence of first
larvae /
Evaluator: DE
Date: November 2015
a) 0,5
b) 1,5
200 - 1000
NW642-1
PP 1/226 (1) and PP 1/225
(1))
PP 1/226 (1) and PP 1/225
(1))
NW642-1
Part A
Product code
Page 13 of 30
010
DE
vegetable
(BRSOX)
cabbage F
011
DE
vegetable
(BRSOX)
cabbage G
012
DE
root and tuber vegetables F
(NNNVW)
013
DE
root and tuber vegetables G
(NNNVW)
014
DE
bulb crops (NNNSZ)
F
015
DE
herbs (NNNKR)
F
016
DE
herbs (NNNKR)
G
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 1000
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 1000
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
3 (at least 7
days apart)
a) 1
b) 3
a) 0,5
b) 1,5
200 - 800
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
after beginning of
infestation; from
emergence of first
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
Evaluator: DE
Date: November 2015
NW642-1
NW642-1
NW642-1
NW642-1
Part A
Product code
Page 14 of 30
(low
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
larvae /
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
017
DE
pulse crops (NNNLG)
except: runner beans
F
018
DE
pulse crops (NNNLG)
except: runner beans
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
019
DE
ornamentals (NNNZZ)
F
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
6 (at least 7 a) 1
days apart)
b) 6
a) 0,5
b) 3,0
min 1000 l/ha
Evaluator: DE
Date: November 2015
NW642-1
Plant height is restricted to
max. 50 cm
max. 50 cm.
NW642-1
max. 50 cm.
Part A
020
DE
ornamentals (NNNZZ)
021
DE
woody
(NNNZG)
Remarks:
Product code
Page 15 of 30
G
ornamentals G
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
6 (at least 7 a) 1
days apart)
b) 6
after beginning of
infestation; from
emergence of first
larvae
a) 0,25 – 0,5
days apart)
0,5 kg/ha
b) 1,5
50 – 125 cm:
0,75 kg/ha
> 125 cm: 1 kg/ha
b) 3
(a) In case of group of crops the Codex classification should be used
(b) Outdoor or field use (F), glasshouse application (G) or
indoor application (I)
(c) e.g. biting and sucking insects, soil born insects, foliar fungi
(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
(e) Use CIPAC/FAO Codes where appropriate
(f) All abbreviations used must be explained
a) 0,5
b) 3,0
min 1000 l/ha
max. 50 cm.
a) < 50 cm:
min 600 l/ha
50 – 125cm:
min 900 l/ha
> 125 cm:
min 1200 l/ha
NW642-1
This use is included in GAP
020.
(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants
(i)
(j)
(k)
(l)
g/kg or g/l
Growth stage at last treatment
PHI = Pre-harvest interval
Remarks may include: Extent of use/economic importance/restrictions
(e.g. feeding,grazing)/minimal intervals between applications
Evaluator: DE
Date: November 2015
Part A
National Assessment Germany
Product code
Page 16 of 30
3
Risk management
3.1
Reasoned statement of the overall conclusions taken in accordance with the
Uniform Principles
3.1.1
Physical and chemical properties (Part B, Section 1, Points 2 and 4)
Overall Summary:
All studies have been performed in accordance with the current requirements and the results are deemed
to be acceptable. The appearance of the product is that of a pale brown, water dispersible granules-based
formulation with a fish meal odour. It is not explosive, has no oxidising properties. It has a self ignition
temperature of 392 °C. In aqueous solution, it has a pH value around 6.4. The stability data indicate a
shelf life of 6 month at ambient temperature based on content of cfu, but based on biopotency a shelf life
of 24 month is observed.
The technical characteristics are acceptable for a water dispersible granules (WG) formulation.
Implications for labelling: None
Compliance with FAO specifications:
There is no FAO specification for bacillus thuringiensis ssp. aizawai GC-91.
Compliance with FAO guidelines:
The product Agree 50 WG complies with the general requirements according to the FAO/WHO manual
(2010).
Compatibility of mixtures:
There are no tank mixtures recommended for Agree 50 WG.
Nature and characteristics of the packaging:
Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,
leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents
of the packaging, have been submitted, evaluated and is considered to be acceptable.
Nature and characteristics of the protective clothing and equipment:
Information regarding the required protective clothing and equipment for the safe handling of Agree 50
WG has been provided and is considered to be acceptable.
3.1.2
Methods of analysis (Part B, Section 2, Point 5)
3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)
The submitted analytical method is suitable and reliable for the determination of concentration of the
number of spores of Bacillus thuringiensis aizawai strain GC-91 in the product Agree WG and in aqueous
dilutions. The method was validated by definition of the linearity, the precision and the accuracy
according to the criteria set by SANCO/3030/99 rev. 4.
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
Evaluator: DE
Date: November 2015
Part A
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Page 17 of 30
For the time being, analytical methods for residues of bacillus thuringiensis ssp. aizawai strain GC-91 are
not required.
3.1.3
Mammalian Toxicology (Part B, Section 3, Point 7)
Inclusion of Bacillus thuringiensis ssp. aizawai strain GC-91 into Annex I entered into force in May 2009
(Commission Directive 2008/113/EC). The relevant review information are summarized in the review
report for the active substance Bacillus thuringiensis ssp. aizawai strain GC-91 (SANCO/1538/2008) and
EFSA conclusion on the peer review of the pesticide risk assessment of the active substance Bacillus
thuringiensis ssp. aizawai (strains ABTS 1857, GC-91) (EFSA Journal 2013, 11(1):3063).
If the product is used properly and according to the intended conditions of use, adverse health effects for
operators, workers, bystanders and residents will not be expected.
3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1)
Acute toxicity studies for Agree 50 WG were not evaluated as part of the EU review of Bacillus
thuringiensis ssp. aizawai strain GC-91.
In the EU review of Bacillus thuringiensis ssp. aizawai strain GC-91 Agree 50 WP was a representative
formulation. The acute toxicity studies for the Agree 50 WP were evaluated during the review and were
considered adequate. In general, WP formulations are toxicologically considered more critical than WG
formulations due to the higher potential risk for dust to be inhaled. Therefore, it is considered acceptable
to use the study results on Agree 50 WP for the assessment of Agree 50 WG, too.
Agree 50 WG, containing 500 g/L Bacillus thuringiensis ssp. aizawai strain GC-91, has a low potential of
toxicity following acute oral, dermal or inhalation exposure. It is not irritating to the rabbit eye or skin. It
has been found to be classifiable as a skin sensitiser to the guinea pig. Taking into account all submitted
data Agree 50 WG should be labelled as irritating, with phrase R 43 - May cause sensitisation by skin
contact.
3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3)
The safety of the application of Agree 50 WG was not evaluated as part of the EU review of Bacillus
thuringiensis subspecies aizawai strain GC-91. Therefore, the risk was assessed for all intended uses here
and is considered to be adequate.
Data on dermal absorption of Agree 50 WG was not provided and considered not relevant for
microorganisms. Operator exposure was modelled using the German model and the exposure study by
Mich, qualitative considerations as well as weight of evidence.
According to the model calculations, it can be concluded that the risk for the operator using Agree 50 WG
on the intended uses in greenhouses and outdoor is acceptable with the use of personal protective
equipment. Given the sensitising potential of Delfin WG impermeable gloves and a protective suit against
pesticides and sturdy shoes should be worn when handling the concentrate. A protective suit against
pesticides and sturdy shoes (e.g. rubber boots) should also be used when applying/handling the product
ready for application. Hence, phrase S36/37 should be added to the national standard phrases S2, S24 and
S46.
3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4)
In the case of greenhouse applications no bystander or resident exposure is expected.
Evaluator: DE
Date: November 2015
Part A
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Bystanders of outdoor applications may be potentially exposed towards spray mist during the application
of Agree 50 WG, whereas residents could be exposed towards spray deposits on surfaces after
application. Since micro-organisms may have the potential for sensitisation, this has to be taken into
account in risk assessment for bystanders and residents. But, there is no reference value for this
toxicological property. In this particular case the plant protection product is applied at a maximum
concentration of 0.5 % (w/v). Therefore, from a formal point of view the spray solution is not considered
sensitising (< 1 % w/w) so that most likely there will be no risk for bystanders and residents.
But in order to further minimise the potential exposure of bystanders and residents and thus further reduce
the probability of sensitisation the use of drift-reducing nozzles (tractor-mounted equipment) or spraying
shields (hand-held equipment) is recommended mandatorily.
3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5)
Since workers are normally potentially exposed towards dry foliar residues on plant surfaces, intensive
dermal exposure might occur. This might be enhanced by multiple applications. In this case max. 6
applications of Agree 50 WG are intended. Although no systemic effects are to be expected by dermal
contact because no penetration of Bacillus thuringiensis through intact skin is considered likely, the use of
gloves and protective garment is necessary for workers during re-entry tasks due to the sensitising
potential of Agree 50 WG.
Implications for labelling resulting from operator, worker, bystander assessments:
Hazard Symbol:
Risk Phrases:
Safety Phrases:
Xi
Irritant
43
2-24-36-37-46
R and S phrases under Regulation (EC) No 547/2011:
SF1891 Re-entering the treated areas/crops is only possible on the day of application wearing
personal protective equipment which is specified for applying the particular product.
Successive work on/in treated areas/crops may fundamentally not be carried out until 24
hours after applying the product. Within the first 48 hours, protective suits against pesticides
and standard protective gloves (plant protection) are to be worn.
Other phrases:
Safety instructions
SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage.
SB110 The directive concerning requirements for personal protective gear in plant protection,
"Personal protective gear for handling plant protection products" of the Federal Office of
Consumer Protection and Food Safety must be observed.
SS110 Wear standard protective gloves (plant protection) when handling the undiluted product.
SS2101 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling
the undiluted product.
SS2202 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when
applying/handling the product ready for application.
VH650 The packaging must be provided with the wording "micro-organisms may have the potential
to provoke sensitising reactions".
VA269 The product must be applied using loss reducing equipment which is registered in the index
of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as
amended, and be registered in at least drift reducing class 75 %.
Evaluator: DE
Date: November 2015
Part A
3.1.4
Product code
Page 19 of 30
Residues and Consumer Exposure (Part B, Section 4, Point 8)
No MRLs for Bacillus thuringiensis ssp. aizawai, strain GC-91 are established. Inclusion into Annex IV
of Reg. (EC) No 396/2005 is currently discussed but not recommended by Germany due to the following
reasons (see below).
3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7)
No supervised residue trials were submitted for the assessment of Bacillus thuringiensis ssp. aizawai,
strain GC-91 on any of the crops for which approval is sought. The applicant provided rationales for
waiving such studies, noting particularly the ubiquitous occurrence of the strain, its very specific action
against lepidoptera larvae and the insignificant amount of toxin production. However, the potential of
Bacillus thuringiensis ssp. aizawai, strain GC-91 for the formation of toxins after application is unclear.
Bacillus thuringiensis ssp. aizawai, strain GC-91 proved positive for the genetic sequences coding the
Bacillus cereus toxins, but the rate of formation is expected to be lower.
In a scientific opinion by EFSA (2005, Opinion of the Scientific Panel on Biological Hazards on Bacillus
cereus and other Bacillus spp. in foodstuffs, The EFSA Journal 175, 1-48, ASB2012-9549), an amount of
105 CFU/g food was identified as a point of departure for B. cereus, which, in view of the limited
information available, seems also sufficiently protective for Bacillus thuringiensis ssp. aizawai, strain
GC-91.
For estimating the potential amount of CFUs after application of Agree 50 WG, an approach was
developed based on harvest yields (Statistisches Bundesamt: Wachstum und Ernte – Fachserie 3, Reihe
3.2.1 – Gemüse 2011) or empirical residues after foliar treatment as described by MacLachlan and
Hamilton in 2009 (see Part B, Section 4). From these calculations it is obvious that based on the intended
application rates an exceeding of 105 CFU/g food cannot be excluded for the uses on grape vine, berries
(except strawberries), strawberries, fruiting vegetables, leaf, stem and bulb vegetables, brassica
vegetables, fresh herbs and legume vegetables. Further information is required to confirm that these uses
can be considered safe with respect to consumer health.
For root and tuber vegetables only the aerial part is sprayed. A significant contamination of roots and
tubers with the microorganism is not expected. Therefore these uses are considered to be safe (uses 12
and 13).
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)
The Bacillus thuringiensis ssp. aizawai, strain GC-91 contains the genetic information to produce B.
cereus like toxins. Nevertheless, since no further information is available for a quantitative risk
assessment, it is proposed to apply the suggested value of 105 CFU/g food (EFSA 2005) also to Bacillus
thuringiensis ssp. aizawai, strain GC-91. The data provided for the application of Bacillus thuringiensis
ssp. aizawai, strain GC-91 to food crops is insufficient to estimate the amount of CFU per g food.
Therefore, the consumer risk assessment for the intended uses on grape vine, berries (except
strawberries), strawberries, fruiting vegetables, leaf, stem and bulb vegetables, brassica vegetables, fresh
herbs and legume vegetables can not be finalized at the moment.
No dietary risk to consumers is assumed to arise from non-food crops (ornamentals).
Evaluator: DE
Date: November 2015
Part A
3.1.5
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Page 20 of 30
Environmental fate and behaviour (Part B, Section 5, Point 9)
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points
9.4 and 9.5)
A natural breakdown of the endospores of Bta in soil begins after application onto the fields and gradually
reduces the numbers of spores remaining. Any vegetative cells or crystal proteins are likely to be far more
rapidly degraded. This reduction in numbers will be greatly augmented by the photo degradation effects
of sunlight. It is very unlikely that Bta endospores will germinate and grow into vegetative cells, unless
appropriate conditions exist, meaning favourable soil pH, soil moisture content, sufficient nutrient
availability and lack of competition/predation from other soil micro-organisms. The good persistence of
Bt spores in soil after the first two weeks seems to be a result of their inability to germinate in soil.
Survival and viability of parasporal crystal proteins associated with the application of Agree 50 WG is
expected to be short-term as effects of other soil micro-organisms and natural sunlight, in combination
with the natural degradation of the proteins, occurs. The survival of Bta in the soil is a dynamic process
involving sporostasis, germination and sporulation in specific habitats and will be influenced by changing
conditions regarding soil type, native microflora, nutrient availability and fertilization.
According to the PEC calculation (in compliance with country specific requirements in Germany), the
highest load of Agree 50 WG in soil is expected upon field application in flowers (sun flower as
representative crop). The value of 40.0 mg Agree 50 WG/kg dry weight soil corresponds to 20 mg Bta/kg
dry weight soil. of CFU and IU, this is equivalent to 1.2 × 109 CFU or 1,000,000 IU/kg dry weight soil,
respectively.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,
Section 5, Point 9.6)
Various experiments examining the movement of Bt in soils following spraying of commercial products
containing Bt showed little or no movement. Thus movement of Bta through the soil by leaching is
unlikely to occur. Additionally, adsorption and binding of protoxins and toxins from Bt have been
demonstrated to occur readily, rapidly and strongly onto the clay fraction and clay humic acid complexes
of soils. Desorption occurs far less readily.
It is thus concluded that no threat of contamination of groundwater exists following applications of Agree
50 WG according to GAP.
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section
5, Points 9.7 and 9.8)
Under natural conditions, residues of Bta in water are not considered to be able to persist for very long
periods due to a combination of natural physical and chemical degradation factors such as solar radiation
and predation from resident bacteriophages, protozoans and other lower animal forms. It may be stated
that Bta GC-91 is inactivated under natural conditions, including water.
The highest predicted environmental concentration of Agree 50 WG and its active ingredient Bta GC-91
in surface waters is 128.07 µg/L (64.04 µg Bta/L) corresponding to 3.84 × 106 CFU or 3202 IU/L.
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point
9.9)
Due to solar inactivation Bt spores and δ-endotoxin crystals are rapidly degraded in air. Furthermore,
unlike chemical products, evaporation and volatility of bacteria is not expected to be a factor to consider
in assessing the fate in air. Hence volatilisation from plant surfaces and from soil can be excluded. Spray
drift, however, can occur following an application of Bta which may lead to temporary concentrations in
Evaluator: DE
Date: November 2015
Part A
Product code
Page 21 of 30
the atmosphere which are capable of drifting with wind currents before the spores and crystals in finer
spray droplets settle out. The overall half-life determined during the nine-day monitoring period was 2.4
days. This gives an indication of the rapid disappearance of spray droplets containing Bta and parasporal
crystals from air.
Implications for labelling resulting from environmental fate assessment:
None
3.1.6
Ecotoxicology (Part B, Section 6, Point 10)
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
Birds
Effects on birds for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91. However
further data on Agree 50 WG are not relevant as active substance data on toxicity to birds are used and
the ingredients in the formulation are not expected to pose a risk to birds. Therefore all relevant data were
assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided
here and are considered adequate.
•
The risk assessment for effects on birds is carried out according to the latest draft of the
‘European Food Safety Authority Guidance Document on Risk Assessment for Birds and
Mammals (EFSA Journal 2009)1
•
The risk of Agree 50 WG to birds was assessed from toxicity exposure ratios between toxicity
endpoints, estimated from studies with the active substance Bta GC-91 and maximum residues
occurring on food items following applications according to the proposed use pattern.
Acute risk assessment
The TERA values exceed the Annex VI trigger value of 10, indicating that Agree 50 WG poses no risk to
birds following application according to the proposed use patterns.
Table 3.1.6.1-1
Screening assessment for birds following GAP directed application of Agree
50 WG.
Indicator
species
Crop
Small
omnivorous bird
Vegetables
Small
insectivorous
birds
Test
item
Bta
Orchards and GC-91
ornamentals/
nursery
Toxicit
Application MAF2
y
)
rate1)
LD50
Short
cut
value3)
DDD
TER
(10)
0.5 kg/ha
1.9
158.8
150.86
> 22.1
0.5 kg/ha
1.9
46.8
44.46
> 75.0
> 3333
mg/kg
b.w.
1)
Refers to Bta GC-91 (corresponding to 1 kg Agree 50 WG/ha)
MAF according to 6 successive applications at intervals of 7 days provided in EFSA Guidance document 20092
3)
Short cut value based on the 90th percentile of residues provided in EFSA Guidance document 20092
2)
1
European Food Safety Authority; Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA.
EFSA Journal 2009; 7(12): 1438. [139 pp.].
Evaluator: DE
Date: November 2015
Part A
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Page 22 of 30
Long-term risk assessment
As the acute TER value indicates no risk to birds and no adverse effects were observed in short-term
toxicity studies, no long-term effects are to be expected upon field application of Agree 50 WG according
to GAP.
Terrestrial vertebrates (other than birds)
Effects on mammals for Agree 50 Wg were not evaluated as part of the EU review of Bta GC-91.
However further data on Agree 50 WG are not relevant as active substance data on toxicity are used and
the ingredients in the formulation do not pose a risk to mammals. Therefore, all relevant data were
assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided
• The risk assessment for effects on mammals is carried out according to the latest draft of the
‘European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals
(EFSA Journal 2009)2
• The risk of Agree 50 WG to mammals was assessed from toxicity exposure ratios between toxicity
endpoints, estimated from studies with CGA-237218 technical and maximum residues occurring on
food items following applications according to the proposed use pattern.
Acute risk assessment
The TERA values exceed the Annex VI trigger value of 10, indicating that Agree 50 WG poses no risk to
mammals following application according to the proposed use patterns.
Table 3.1.6.1-2
Indicator
species
Screening assessment for mammals following application of Agree 50 WG.
Crop
Small herbi- Vegetables/
ornamentals
vorous
mammals and nursery
Test item
Toxicity
LD50
CGA237218
technical
> 5050
mg/kg b.w.
Applicatio MAF
2)
n rate1)
0.5 kg/ha
1.9
Short
cut
value3)
DDD
136.4
129.58 > 39.0
TER
(10)
1)
MAF according to 6 successive applications provided in EFSA Guidance document 20092
3)
2)
Long-term risk assessment
Due to the absence of toxicity in the acute study and the highly specific mode of action of Bta GC-91, no
adverse effects in mammals are to be expected upon prolonged exposure to Agree 50 WG.
3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)
Effects on aquatic non-target organisms for Agree 50 WG were not evaluated as part of the EU review of
Bta GC-91. However, further data on Agree 50 WG are not relevant as active substance data on toxicity
are used and the ingredients in the formulation do not pose a risk to aquatic species. Therefore all relevant
data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern
are provided here and are considered adequate. A new study assessing the acute toxicity of the formulated
product Agree 50 WG on daphnids has been performed and as a result there are new end-points which are
used in the risk assessment.
Evaluator: DE
Date: November 2015
Part A
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For the risk assessment the maximum (initial) PECSW was compared with the acute ecotoxicological
endpoints of aquatic organisms. The toxicity exposure ratios (TER) are given only for worst case
scenarios, for which the relevant trigger value is passed. Only drift entries were considered in the PECSW
calculation since this is the only suitable exposure pathway for the use of Agree 50 WG.
Table 3.1.6.2-1 TER values for Agree 50 WG/Bta GC-91 with exposure via spray drift
Compound
CGA237218a
Agree 50
WG
CGA237218a
CGA237218a)
Organism
Fish
Endpoint
Exposure
(PECSW)
LC50 > 2.0 × 1010 CFU/L
3.84 × 106 CFU/L
Daphnids
(acute)
Daphnids
(chronic)
LC50 > 100 mg/L
128.07 µg/L
NOEC = 1.57 × 108
CFU/L
3.84 × 106 CFU/L
Algae
EbC50 > 3.6 × 109 CFU/L
3.84 × 106 CFU/L
TER
(trigger)
> 5208
(100)
> 781
(100)
40.9
(10)
> 938
(10)
a) Synonym for Bta GC-91 technical material contained in Agree 50 WG
The TER values exceed the trigger values indicating that Agree 50 WG poses no risk to aquatic
organisms following application according to the proposed use patterns.
Implications for labelling
EB001-2
NW642-1
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and
10.5)
Bees
The risks of Agree 50 WG to honey-bees was assessed from hazard quotients between toxicity endpoints,
estimated from acute oral and contact studies with active ingredient and formulated product. The
recommended use pattern for Agree 50 WG includes application in grape vine, berries, vegetables, herbs,
ornamentals and other crops at a maximum application rate of up to 1 kg product/ha.
All the hazard quotients are considerably less than 50, indicating that the active ingredient(s) poses a low
risk to bees. It is concluded that Agree 50 WG will not adversely affect bees or bee colonies when used as
recommended.
The product is classified as non-hazardous to bees, even when the maximum application rate, or
concentration if no application rate is stipulated, as stated for authorisation is applied (B4).
Other non-target arthropods
Evaluator: DE
Date: November 2015
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Page 24 of 30
Studies on the effects of the Bta GC-91-based product TUREX 50 WP (= Agree 50 WP) on non-target
arthropods were conducted and evaluated as part of the EU review of Bta GC-91. Due to the absence of
toxicity in laboratory glass plate tests with Typhlodromus pyri and Aphidius rhopalosiphi at 4.5-fold the
maximum intended application rate of Agree 50 WG in Germany, no unacceptable risk for non-target
arthropods is expected upon GAP directed use. The risk for non-target arthropods in off-crop habitats was
assessed according to country specific requirements in Germany following the TER (toxicity exposure
ratio) approach. From the calculated TER value no unacceptable risk for non-target arthropods in off-field
areas is indicated.
Table 3.1.6.3-2 Off-field TER values for non-target arthropods
Species
LR50
(kg/ha)
Off-field foliar
PER
Off-field foliar
Trigger value
TER
(kg/ha)
Typhlodromus pyri
> 4.5
0.072
> 62.5
Aphidius rhopalosiphi
PER: predicted environmental rate depending on application rate and drift
TER: toxicity exposure ratio
10
Lepidoptera species in off-crop habitats
In this section no new study on the toxicity of Bta on Lepidopteran species is submitted. Additionally,
field studies revealed that Macrolepidoptera caterpillars may be affected by the use of Btk products, but
severe effects on populations were not recorded because populations recovered after applications.
Regarding the the risks to non-target-arthropods, including lepidopteran species, the following is stated in
the EFSA Conlusion on Bacillus thuringiensis subsp. aizawai (strains ABTS 1857, GC-91):
Several laboratory studies on non-target arthropods for both strains were available. These studies
indicated a low risk from pathogenicity and infectivity for non-target arthopods following exposure to
Bacillus thuringiensis aizawai strain ABTS 1857 and strain CG-91. The only potentially significant area
of concern for non-target arthropods is in relation to the specific species showing susceptibility to
particular subspecies of Bacillus thuringiensis. In the case of Bacillus thuringiensis aizawai, this relates to
a restricted group of Lepidopteran families and it is important that this selectivity is considered within the
context of the wide scale impact of broad-spectrum insecticides on non-target arthropods. Clearly for the
in-crop area where application occurs there will be an impact on Lepidopteran species i.e. the intended
effect on the target pest species. However, the published information shows that recovery occurs within a
relatively short period of time (depending on application timing, life history of affected species, dispersal
ability etc). Recovery of any affected populations is therefore likely to be rapid. Therefore the risk for
non-target arthropods was indicated as low. The risk for non-target arthropods for the strain GC-91 was
indicated as low by the HQ calculation.
3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point
10.6)
Earthworms
Effects on earthworms for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91.
However, further data on Agree 50 WG are not required as data of Agree 50 WP, containing the same
active ingredient as Agree 50 WG, on toxicity are used and the ingredients in Agree 50 WG are not
expected to pose a risk to earthworms.
The presented risk assessment performed according to country specific requirements in Germany and
calculating the relation between the expected environmental concentration of Agree 50 WG in soil and
Evaluator: DE
Date: November 2015
Part A
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Page 25 of 30
the endpoint from the acute study is considered adequate. The obtained TER value indicates no risk for
earthworms upon field application of Agree 50 WG.
Table 3.1.6.4-1 Acute TER value for earthworms
Compound
LC50
Maximum PECS for Agree 50
WG
TERA
Limit
Agree 50 WP
> 1000 mg/kg d.w. soil
40 mg/kg. d.w. soil
> 25
10
Effects on other soil non-target macro-organisms
No EU data requirement for MPCP.
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
No EU data requirement for MPCP.
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
Effects on the soil microflora for Agree 50 WG were not evaluated as part of the EU review of Bta GC91. However, further data on Agree 50 WG are not required as data of Agree 50 WP, containing the same
active ingredient and similar co-formulants as Agree 50 WG, on toxicity are used which have been
already evaluated in the EU review. The study demonstrated the absence of adverse effects on nitrogen
turnover and dehydrogenase activity at application rates of up to 20 kg/ha. This is 3.3-fold the maximum
accumulated application rate intended for Agree 50 WG and it can be concluded that GAP directed use of
Agree 50 WG poses no risk for the soil microflora.
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and
Fauna) (Part B, Section 6, Point 10.8)
Non-Target Plants
Tests on non-target plants are not required.
Other non-target species (Flora and Fauna)
Tests on other non-target species are not required.
Implications for labelling resulting from ecotoxicological assessment:
Other phrases:
EB001-2
NW642-1
3.1.7
Efficacy (Part B, Section 7, Point 8)
Uses in viticulture (001 and 002):
Evaluator: DE
Date: November 2015
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From a formal point of view the applicant did not deliver the complete set of data necessary for the
registration in viticulture (e.g. trials on the impact of the product on the fermentation and the quality of
the wine). The evaluation is based therefore additionally on the long term experience with other products
containing the same active ingredient.
The trials are exclusively done during the second generation. Consequently risk assessment could be
finalised only for the maritime zone and only for the 2nd and 3rd generation (use -002) of Eupoecilia
ambiguella and Lobesia botrana and not for their first generation (use -001).
Uses in soft-berries (003 and 004):
An assessment was not possible, because no data were submitted for this uses (EPPO standard PP 1/226).
An extrapolation form other uses is not possible due to the specific conditions in berry crops and the time
of pest occurrence during spring time.
Uses in strawberries (005 and 006):
An assessment was not possible, because no data were submitted for this uses (EPPO standard PP 1/226).
An extrapolation form other uses is not possible due to the specific application techniques conditions in
strawberry crops.
Use in fruit vegetables (007):
The application rates used in the presented trials are very different and only little information is given if
higher dose rates correspond with crop size (fruit vegetables in the greenhouse can grow up to 5 m). Only
in few trials the dose rate corresponds with the proposed GAP for cucurbits and solanaceous fruits. In all
trials efficacy was sufficient. The area of use is in the greenhouse. Therefore, results from greenhouse
trials conducted the Mediterranean can be included. Furthermore, it is possible to extrapolate from the
submitted data to larvae of other Noctuid moths. According to the EPPO extrapolation table 09/15092
efficacy in Solanaceae, data on Autographa gamma and Mamestra oleracea in brassica crops can be used
for extrapolation to Solanaceous vegetables.
Fruit vegetables are defined in Germany as a grouping of cucurbits, solanaceous fruits and pulse crops.
Use 007 includes fruit vegetables, whereas uses 017 and 018 include pulse crops. The target crops in use
007 should be changed to: fruit vegetables (except pulse crops).
Uses in leafy and stem vegetables (008 and 009):
No data submitted. Efficacy can be extrapolated from other uses (see reports for fruit vegetables and
vegetable cabbages).
Uses in vegetable cabbage (010 and 011):
The majority of submitted data are not rateable. The efficacy for:
• Plutella xylostella is proven for the maritime zone;
• Mamestra brassicae is not finally evaluable;
• Pieris sp. is not finally evaluable;
• Spodoptera littoralis is proven for the Mediterranean zone.
Efficacy can be extrapolated from other uses (see report for fruit vegetables) and from experience with
respect to the former authorisation.
Uses in root and tuber vegetables (012 and 013):
Use in allium bulb crops (014):
Evaluator: DE
Date: November 2015
Part A
Product code
Page 27 of 30
Uses in fresh herbs (015 and 016):
Fresh herbs are a minor use. This group is consisting of crops from many plant families and susceptible to
many different species of lepidopteran larvae. Efficacy for fresh herbs can be extrapolated from other
crops.
Uses in pulse crops (017 and 018):
Pulse crops except from runner beans, build dense crop stands already at lower heights; therefore no
vertical separation is necessary. Application rates with vertical separation is only relevant for runner
beans, thus uses 017 and 018 are amended to grant authorisation with respect to efficacy:
Pulse crops except from runner beans: 1 kg/ha in 200 to 800 l water/ha
The plant height is restricted to max. 50 cm.
Efficacy can be extrapolated from other uses (see report for fruit vegetables) and from experience with
respect to the former authorisation.
Uses in (woody) ornamentals (019 - 021):
The application rates used in the presented trials are very different and often higher than applied for, just
as the number of application was higher. Little information is given if higher dose rates correspond with
crop size (ornamentals in the greenhouse can grow up to 2 m for instance). Regarding small crops, in
most trials efficacy was sufficient concerning number of attacked leaves, damaged plants, and larvae
control and the reference product acted similar or only slightly better. For higher and dense crops the
doses applied for may not be sufficient. Efficacy can be extrapolated for small plants, thus uses 019 and
0208 are amended to grant authorisation with respect to efficacy:
Ornamentals: 1 kg/ha in at least 1.000 l water/ha
Use 021 (woody ornamentals) is per definition included in use 020 (ornamentals).
In general:
Agree 50 WG is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The
product is not expected to exhibit herbicidal activity. Agree 50 WG is, therefore, not expected to cause
phytotoxic effects. In addition, products based on Bacillus thuringiensis have already been authorised for
a considerable time in many countries within Europe. From these years of experience no negative
influences on yield or transformation processes are known.
Agree 50 WG is classified as not harmful for populations of relevant beneficial insects or beneficial
predatory mites and spiders.
It is concluded that the proposed use of Agree 50 WP will not pose an unacceptable risk to populations of
earthworms or other soil macro-organisms, when applied according to the recommended use pattern.
There is no indication of any unacceptable adverse effects on soil macro- or soil micro-organisms relevant
for the maintenance of soil quality.
The application of Bta products is considered to have a low potential of causing resistance or crossresistance within the target pest organism. Decreased sensitivity or resistance has been reported for
Bacillus thuringiensis in some countries including France (for Spodoptera littoralis only). Therefore, it is
precautionary recommended to alternate with products based on different active substances after three
applications outdoors.
Evaluator: DE
Date: November 2015
Part A
3.2
Product code
Page 28 of 30
Conclusions
Concerning the physical, chemical and technical properties of the formulation as well as the analytical
methods (formulation and residue) an authorisation can be granted.
Concerning effects on the environment an authorisation can be granted.
Exposure assessment:
With respect to mammalian toxicology an authorisation can be granted.
The exposure towards Bacillus thuringiensis spp.aizawai strain GC-91 in Agree 50 WG is not considered
to give rise to concern for operators, workers, bystanders or residents in the greenhouse or in the case of
outdoor applications. Due to potential sensitisation by microorganisms personal protective equipment, i.e.
gloves and protective garment for operators and workers is necessary. The exposure will be reduced
further due to necessary PPE allocated according to dangerous substances regulations. If the product is
used properly and according to the intended conditions of use, adverse health effects for operators,
workers, bystanders and residents will not be expected.
Residues:
Authorization of the uses 1 - 11 and 14 - 18 is not possible due to the reasons outlined below.
For the time being no final conclusion on possible health risks for consumers through residues of B. t.
resulting from applications of Agree 50 WG on grape vine, berries (except strawberries), strawberries,
fruiting vegetables, leaf, stem and bulb vegetables, brassica vegetables, fresh herbs and legume vegetables
can be drawn. The genetic potential for enterotoxin formation has been shown for several B. t. strains
(Beattie et al., 19992; Damgaard, 19953; Helgason et al., 20004). Even though in lab testing the potential
of B. t. to produce enterotoxins was less than e.g. that of Bacillus cereus, enterotoxin formation cannot be
excluded based on currently available data, since both species belong to the Bacillus cereus group due to
their close genetic match. The concentration of Bacillus thuringiensis ssp. aizawai, strain GC-91 which is
required to induce enterotoxin formation is not known yet. On the other hand it is not clear, which B. t.
concentrations really have to be envisaged in the varieties of agricultural commodities treated with Agree
50 WG. Based on the available information and the calculations performed so far, an exceeding of 105
CFU/g food cannot be excluded for uses on grape vine, berries (except strawberries), strawberries,
fruiting vegetables, leaf, stem and bulb vegetables, brassica vegetables, fresh herbs and legume vegetables
(uses 1 – 11 and 14 - 18) and thus the uses can not be considered as safe. For a more realistic estimation
of the potential CFUs per g food after treatment with Agree 50 WG and to derive appropriate withholding
periods (based on degradation rates/ spore half-lives on the plant surface), supervised residue trials are
required on grapes (outdoor), strawberries (outdoor and indoor), tomatoes (indoor), lettuce (open headed
varieties, outdoor and indoor), beans with pods (outdoor and indoor) conducted in accordance with the
data requirements laid down in Reg. (EC) No 1107/2009 and consecutive regulations.
Beattie, S. H. et al. (1999). Detection of toxigenic strains of Bacillus cereus and other Bacillus spp. with
an improved cytotoxicity assay. Letters Appl. Microbiol. 28, 221-225.
2
3 Damgaard, P.H. (1995). Diarrhoeal enterotoxin in production by strains of Bacillus thuringiensis
isolated from commercial Bacillus thuringiensis-based insecticides. FEMS Immun. Med. Microbiol. 12,
245-250.
4
Helgason, E., Okstad, O.A., Caugant, D.A., Johansen, H.A., Fouet, A., Mock, M., Hegna, I. and Kolsto,
A.B. (2000). Bacillus anthracis, Bacillus cereus, and Bacillus thuringiensis - one species on the basis of
genetic evidence. Appl Environ Microbiol 66, 2627-2630.
Evaluator: DE
Date: November 2015
Part A
Product code
Page 29 of 30
The use of Bacillus thuringiensis ssp. aizawai, strain GC-91 on ornamentals (uses 19 - 21) is not
considered relevant in terms of consumer health protection. For root and tuber vegetables (uses 12 and
13) only the aerial part is sprayed. A significant contamination of roots and tubers with the
microorganism is not expected. Therefore, as far as consumer health protection is concerned, the intended
uses 12 and 13 and 19 - 21 can be authorized.
Efficacy:
The following uses are duly substantiated and can be authorised from the perspective of the efficacy
assessment: -002, -007, -008, -009, -010, -011, -012, -013, -014, -015 and -016
Pulse crops except from runner beans, build dense crop stands already at lower heights; therefore no
vertical separation is necessary. Application rates with vertical separation is only relevant for runner
beans, thus uses 017 and 018 are amended to grant authorisation with respect to efficacy:
Pulse crops except from runner beans: 1 kg/ha in 200 to 800 l water/ha
Uses 019 and 020 are amended to grant authorisation with respect to efficacy:
Ornamentals: 1 kg/ha in at least 1.000 l water/ha
Use 021 (woody ornamentals) is per definition included in use 020 (ornamentals).
The following uses can not be authorised:
001: trials were presented exclusively for the second generation of the pest insects. There are no
conclusive test results for the control of the first generation of pest insects. According to the assessment
authority an extrapolation is not possible. An efficacy assessment of the product against the applied
organisms is therefore not possible.
003/004/005/006:
According to EPPO standard PP 1/226 (1) and the EPPO standard PP 1/225 (1), 6-15 efficacy trails
including minimum effective dose trails shall be provided over at least 2 years. No efficacy results
according to EPPO Standard PP were submitted. An efficacy assessment of the product against the
applied organisms is therefore not possible.
Beneficials:
The product is classified as not harmful for populations of relevant beneficial insects, predatory mites and
spiders.
An authorisation can only be granted for the uses -012, -013, -019 and -020.
3.3
Further information to permit a decision to be made or to support a review of the
conditions and restrictions associated with the authorisation
No further information is required.
Evaluator: DE
Date: November 2015
Part A
Product code
Page 30 of 30
Appendix 1 – Copy of the product authorisation
•
See below.
Appendix 2 – Copy of the product label
The submitted draft product label has been checked by the competent authority. The applicant is
requested to amend the product label in accordance with the decisions drawn by the competent
authority. The final version of the label is not available, because the layout is the sole
responsibility of the applicant and will not be checked again.
Appendix 3 – Letter of Access
Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
Evaluator: DE
Date: November 2015
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig
Dr. Susanne Luttmann
Referentin
TELEFON +49 (0)531 299-3612
TELEFAX +49 (0)531 299-3002
E-MAIL susanne.luttmann@bvl.bund.de
Mitsui AgriScience
International S.A./B.V.
Bouleward de la Woluwe
1200 Brussels
BELGIEN
IHR ZEICHEN
IHRE NACHRICHT VOM
AKTENZEICHEN 200.22100.007638-00/00.66658
(bitte bei Antwort angeben)
DATUM 11. November 2015
ZV1 007638-00/00
Agree 50 WG
Zulassungsverfahren für Pflanzenschutzmittel
Bescheid
Das oben genannte Pflanzenschutzmittel
mit dem Wirkstoff:
500 g/kg
Bacillus thuringiensis subspecies aizawai
Stamm GC-91 (25000 IU/mg)
Zulassungsnummer:
007638-00
Versuchsbezeichnungen:
MTA-11111-I-0-WG
Antrag vom:
30. April 2012
wird auf der Grundlage von Art. 29 der Verordnung (EG) Nr. 1107/2009 des Europäischen
Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzenschutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates
(ABl. L 309 vom 24.11.2009, S. 1), wie folgt zugelassen:
Zulassungsende
BVL_FO_05_2437_200_V1.7
Die Zulassung endet am 30. April 2020.
Festgesetzte Anwendungsgebiete bzw. Anwendungen
Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1):
Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de
SEITE 2 VON 35
Anwendungs-
Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck
nummer
Zweckbestimmung Objekte
007638-00/00-012, Freifressende
Wurzel- und Knollenge-
007638-00/00-013 Schmetterlingsrau-
müse
pen
Zierpflanzen
007638-00/00-020 Schmetterlingsraupen
Festgesetzte Anwendungsbestimmungen
Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum
Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I
S. 148, 1281), zuletzt geändert durch Artikel 375 der Verordnung vom 31. August 2015
(BGBl. I S. 1474), festgesetzt:
Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3.
Verpackungen
Gemäß § 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend
näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen:
Verpackungs-
Verpackungs-
Anzahl
art
material
von
Beutel
HDPE
1
Inhalt
bis
von
bis
1,00
Einheit
kg
Die Verpackungen für den beruflichen Anwender sind wie folgt zu kennzeichnen:
Anwendung nur durch berufliche Anwender zulässig.
Auflagen
Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden:
Kennzeichnungsauflagen:
(EB001-2)
SP 1: Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen. (Ausbringungsgeräte nicht in unmittelbarer Nähe von Oberflächengewässern reinigen./Indirekte Einträge über
BVL_FO_05_2437_200_V1.7
Hof- und Straßenabläufe verhindern.)
(SB001)
Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschäden führen.
SEITE 3 VON 35
(SB012)
Mikroorganismen können ein Potential zur Auslösung von Sensibilisierungsreaktionen
haben.
(SB110)
Die Richtlinie für die Anforderungen an die persönliche Schutzausrüstung im Pflanzenschutz
"Persönliche Schutzausrüstung beim Umgang mit Pflanzenschutzmitteln" des Bundesamtes
für Verbraucherschutz und Lebensmittelsicherheit ist zu beachten.
(SF1891)
Das Wiederbetreten der behandelten Flächen/Kulturen ist am Tage der Applikation nur mit
der persönlichen Schutzausrüstung möglich, die für das Ausbringen des Mittels vorgegeben
ist. Nachfolgearbeiten auf/in behandelten Flächen/Kulturen dürfen grundsätzlich erst 24
Stunden nach der Ausbringung des Mittels durchgeführt werden. Innerhalb 48 Stunden sind
dabei der Schutzanzug gegen Pflanzenschutzmittel und Universal-Schutzhandschuhe (Pflanzenschutz) zu tragen.
(SS110)
Universal-Schutzhandschuhe (Pflanzenschutz) tragen beim Umgang mit dem unverdünnten
Mittel.
(SS2101)
Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.B. Gummistiefel) tragen
beim Umgang mit dem unverdünnten Mittel.
(SS2202)
Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.B. Gummistiefel) tragen
bei der Ausbringung/Handhabung des anwendungsfertigen Mittels.
(VA269)
Die Anwendung des Mittels muss mit einem verlustmindernden Gerät erfolgen, das in das
Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S.
9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 75 %
BVL_FO_05_2437_200_V1.7
eingetragen ist.
(WMI11)
Wirkungsmechanismus (IRAC-Gruppe): 11
SEITE 4 VON 35
Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2.
Sonstige Auflagen:
(VH650)
Die Verpackung ist mit der Aufschrift "Mikroorganismen können ein Potential zur Auslösung
von Sensibilisierungsreaktionen enthalten" zu versehen.
Vorbehalt
Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder
Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.
Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG)
Nr. 1272/2008
Signalwort:
(S1)
Achtung
Gefahrenpiktogramme:
(GHS07)
Ausrufezeichen
Gefahrenhinweise (H-Sätze):
(EUH 401)
Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten.
(H317)
Kann allergische Hautreaktionen verursachen.
Sicherheitshinweise (P-Sätze):
BVL_FO_05_2437_200_V1.7
- keine -
SEITE 5 VON 35
Abgelehnte Anwendungsgebiete bzw. Anwendungen
Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe
Anlage 2):
Anwendungs-
nummer
007638-00/00-001 Einbindiger Trauben- Weinrebe
wickler (Heuwurm),
Bekreuzter Traubenwickler (Heuwurm)
007638-00/00-002 Einbindiger Trauben- Weinrebe
wickler (Sauerwurm),
Bekreuzter Traubenwickler (Sauerwurm)
Beerenobst (ausgenom-
men: Erdbeere)
pen
Blatt- und Stielgemüse
(ausgenommen: Kohl-
pen
gemüse)
Erdbeere
007638-00/00-007 Freifressende
Fruchtgemüse
Schmetterlingsraupen
Hülsengemüse (ausge-
nommen: Stangen-
pen
bohne)
Kohlgemüse
Kräuter (trocken)
BVL_FO_05_2437_200_V1.7
Ziergehölze
SEITE 6 VON 35
Anwendungs-
nummer
Zwiebelgemüse
Hinweise
Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden:
(NB6641)
Das Mittel wird bis zu der höchsten durch die Zulassung festgelegten Aufwandmenge oder
Anwendungskonzentration, falls eine Aufwandmenge nicht vorgesehen ist, als nicht bienengefährlich eingestuft (B4).
(NN1001)
Das Mittel wird als nicht schädigend für Populationen relevanter Nutzinsekten eingestuft.
(NN1002)
Das Mittel wird als nicht schädigend für Populationen relevanter Raubmilben und Spinnen
eingestuft.
Weitere Hinweise und Bemerkungen
Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben,
soweit sie noch nicht erfüllt sind.
Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu
schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulassungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen.
BVL_FO_05_2437_200_V1.7
Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid.
SEITE 7 VON 35
Rechtsbehelfsbelehrung
Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch
erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und
Lebensmittelsicherheit, Messeweg 11/12, 38104 Braunschweig, schriftlich oder zur
Niederschrift einzulegen.
Mit freundlichen Grüßen
im Auftrag
gez. Dr. Martin Streloke
Abteilungsleiter
Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.
BVL_FO_05_2437_200_V1.7
Anlage
SEITE 8 VON 35
Anlage 1 zugelassene Anwendung: 007638-00/00-012
1
Anwendungsgebiet
Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen
Pflanzen/-erzeugnisse/Objekte:
Wurzel- und Knollengemüse
Verwendungszweck:
2
Kennzeichnungsauflagen
2.1
Angaben zur sachgerechten Anwendung
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Freiland
Anwendung im Haus- und
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
Anwendungszeitpunkt:
Nach Befallsbeginn; ab Schlüpfen der ersten Larven
Maximale Zahl der Behandlungen
- in dieser Anwendung:
3
- für die Kultur bzw. je Jahr:
3
- Erläuterungen Anzahl
Behandlungen:
Anwendungstechnik:
zeitlicher Abstand der Behandlungen mindestens 7
Tage
spritzen oder sprühen
Aufwand:
2.2
1 kg/ha in 200 bis 800 l Wasser/ha
Sonstige Kennzeichnungsauflagen
(NW642-1)
Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstengewässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorgegebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können
mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.
2.3
BVL_FO_05_2437_200_V1.7
(F)
Wartezeiten
Freiland: Wurzel- und Knollengemüse
Die Wartezeit ist durch die Anwendungsbedingungen
und/oder die Vegetationszeit abgedeckt, die zwischen
Anwendung und Nutzung (z. B. Ernte) verbleibt bzw.
die Festsetzung einer Wartezeit in Tagen ist nicht
erforderlich.
3
Anwendungsbezogene Anwendungsbestimmungen
- keine -
SEITE 9 VON 35
1
Anwendungsgebiet
Wurzel- und Knollengemüse
Verwendungszweck:
2
2.1
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Gewächshaus
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
2.2
- keine 2.3
(F)
Wartezeiten
Gewächshaus: Wurzel- und Knollengemüse
Die Wartezeit ist durch die Anwendungsbedingungen
und/oder die Vegetationszeit abgedeckt, die zwischen
Anwendung und Nutzung (z. B. Ernte) verbleibt bzw.
die Festsetzung einer Wartezeit in Tagen ist nicht
erforderlich.
BVL_FO_05_2437_200_V1.7
3
- keine -
SEITE 10 VON 35
1
Anwendungsgebiet
Zierpflanzen
Verwendungszweck:
2
2.1
Einsatzgebiet:
Zierpflanzenbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
6
6
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
- Pflanzengröße bis 50 cm
2.2
1 kg/ha in mindestens 1000 l Wasser/ha
(NW642-1)
Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstengewässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorgegebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können
mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.
(WH915)
In die Gebrauchsanleitung ist eine Arten- und/oder Sortenliste der Kulturpflanzen aufzunehmen, für die der vorgesehene Mittelaufwand verträglich ist (Positivliste).
2.3
BVL_FO_05_2437_200_V1.7
(N)
Wartezeiten
Freiland: Zierpflanzen
Die Festsetzung einer Wartezeit ist ohne Bedeutung.
3
- keine -
SEITE 11 VON 35
1
Anwendungsgebiet
Zierpflanzen
Verwendungszweck:
2
2.1
Einsatzgebiet:
Zierpflanzenbau
Anwendungsbereich:
Gewächshaus
Kleingartenbereich:
Nein
6
6
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
2.2
(WH915)
In die Gebrauchsanleitung ist eine Arten- und/oder Sortenliste der Kulturpflanzen aufzunehmen, für die der vorgesehene Mittelaufwand verträglich ist (Positivliste).
2.3
(N)
Wartezeiten
Gewächshaus: Zierpflanzen
Die Festsetzung einer Wartezeit ist ohne Bedeutung.
BVL_FO_05_2437_200_V1.7
3
- keine -
SEITE 12 VON 35
Anlage 2 nicht zugelassene Anwendung: 007638-00/00-001
1
Anwendungsgebiet
Schadorganismus/Zweckbestimmung: Einbindiger Traubenwickler (Heuwurm), Bekreuzter
Traubenwickler (Heuwurm)
Weinrebe
Verwendungszweck:
2
Einsatzgebiet:
Weinbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Erläuterung zum Schadorganismus:
1. Generation
Stadium des Schadorganismus:
Larvenstadium L1 bis Larvenstadium L2
Erläuterung zur Kultur:
Nutzung als Tafel- und Keltertraube
Stadium der Kultur:
ab 53
Ab Schlüpfen der ersten Larven nach Befallsbeginn
oder ab Warndienstaufruf
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
- Basisaufwand:
0,25 kg/ha in 400 l Wasser/ha
- ES 61:
- ES 71:
BVL_FO_05_2437_200_V1.7
3
Begründung
Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu
Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus
bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der
Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für
Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom der-
SEITE 13 VON 35
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zeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei
der Ernte unterschritten wird.
Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann.
Wirksamkeit
Die vorgelegten Versuche wurden ausschließlich zum Zeitpunkt der 2. Generation der
Schadinsekten durchgeführt. Es fehlen aussagekräftige Versuchsergebnisse zur Bekämpfung der 1. Schädlingsgeneration. Ein Extrapolation ist nach Aussage der Bewertungsbehörde nicht möglich.
SEITE 14 VON 35
1
Anwendungsgebiet
Schadorganismus/Zweckbestimmung: Einbindiger Traubenwickler (Sauerwurm), Bekreuzter
Traubenwickler (Sauerwurm)
Weinrebe
Verwendungszweck:
2
Einsatzgebiet:
Weinbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Erläuterung zum Schadorganismus:
2. und 3. Generation
Stadium des Schadorganismus:
Larvenstadium L1 bis Larvenstadium L2
Erläuterung zur Kultur:
Nutzung als Tafel- und Keltertraube
Stadium der Kultur:
ab 53
Ab Schlüpfen der ersten Larven nach Befallsbeginn
oder ab Warndienstaufruf
3
3
Anwendungstechnik:
Aufwand:
- Basisaufwand:
- ES 61:
- ES 71:
- ES 75:
1 kg/ha in 1600 l Wasser/ha
BVL_FO_05_2437_200_V1.7
3
Begründung
Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei
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1
Anwendungsgebiet
Beerenobst (ausgenommen: Erdbeere)
Verwendungszweck:
2
Einsatzgebiet:
Obstbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 11
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
1 kg/ha in maximal 1000 l Wasser/ha
Begründung
Wirksamkeit
Nach EPPO PP 1 /226 (1) und der EPPO PP 1/225 (1) sind 6 - 15 Wirkungsversuche inkl.
Grenzaufwandversuche aus möglichst 2 Versuchsjahren vorzulegen. Es wurde keine ausrei-
SEITE 17 VON 35
BVL_FO_05_2437_200_V1.7
chende Anzahl an Wirksamkeitsergebnissen gemäß EPPO Standard PP 1/226 "Number of
efficacy trials" eingereicht. Die Wirksamkeit des Mittels gegenüber den beantragten Schadorganismen ist somit nicht belegt.
SEITE 18 VON 35
1
Anwendungsgebiet
Beerenobst (ausgenommen: Erdbeere)
Verwendungszweck:
2
Einsatzgebiet:
Obstbau
Anwendungsbereich:
Gewächshaus
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 11
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
1 kg/ha in maximal 1000 l Wasser/ha
Begründung
Wirksamkeit
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1
Anwendungsgebiet
Erdbeere
Verwendungszweck:
2
Einsatzgebiet:
Obstbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 13
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
Begründung
Wirksamkeit
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SEITE 22 VON 35
1
Anwendungsgebiet
Erdbeere
Verwendungszweck:
2
Einsatzgebiet:
Obstbau
Anwendungsbereich:
Gewächshaus
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 13
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
Begründung
Wirksamkeit
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SEITE 24 VON 35
1
Anwendungsgebiet
Fruchtgemüse
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Gewächshaus
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
6
6
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
0,5 kg/ha in mindestens 600 l Wasser/ha
- Pflanzengröße 50 bis 125 cm
- Pflanzengröße über 125 cm
BVL_FO_05_2437_200_V1.7
3
Begründung
BVL_FO_05_2437_200_V1.7
SEITE 25 VON 35
SEITE 26 VON 35
1
Anwendungsgebiet
Blatt- und Stielgemüse (ausgenommen: Kohlgemüse)
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
Begründung
SEITE 27 VON 35
1
Anwendungsgebiet
Blatt- und Stielgemüse (ausgenommen: Kohlgemüse)
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Gewächshaus
Kleingartenbereich:
Nein
Stadium der Kultur:
ab dem Auflaufen
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
Begründung
SEITE 28 VON 35
1
Anwendungsgebiet
Kohlgemüse
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
Begründung
SEITE 29 VON 35
1
Anwendungsgebiet
Kohlgemüse
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Gewächshaus
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
Begründung
SEITE 30 VON 35
1
Anwendungsgebiet
Zwiebelgemüse
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
Begründung
SEITE 31 VON 35
1
Anwendungsgebiet
Kräuter (trocken)
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
Begründung
SEITE 32 VON 35
1
Anwendungsgebiet
Kräuter (trocken)
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Gewächshaus
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
-
BVL_FO_05_2437_200_V1.7
3
Begründung
SEITE 33 VON 35
1
Anwendungsgebiet
Hülsengemüse (ausgenommen: Stangenbohne)
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
BVL_FO_05_2437_200_V1.7
3
Begründung
SEITE 34 VON 35
1
Anwendungsgebiet
Hülsengemüse (ausgenommen: Stangenbohne)
Verwendungszweck:
2
Einsatzgebiet:
Gemüsebau
Anwendungsbereich:
Gewächshaus
Kleingartenbereich:
Nein
Stadium der Kultur:
ab 09
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
BVL_FO_05_2437_200_V1.7
3
Begründung
SEITE 35 VON 35
1
Anwendungsgebiet
Ziergehölze
Verwendungszweck:
2
Einsatzgebiet:
Zierpflanzenbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
3
3
Behandlungen:
Anwendungstechnik:
Tage
Aufwand:
- Pflanzengröße 50 bis 125 cm
- Pflanzengröße über 125 cm
3
Begründung
BVL_FO_05_2437_200_V1.7
Wirksamkeit
Die Ziergehölze stellen eine Untergruppe der Kulturgruppe "Zierpflanzen" dar. Die Anwendung 021 wird negativ bewertet, da sie als solche bereits in den Anwendungen 019 bzw. 020
miterfasst und mitbewertet ist.
Agree 50 WG
Part B – Section 1
Core Assessment –
Germany
Page 1 of 26
REGISTRATION REPORT
Part B
Section 1: Identity, physical and chemical
properties, other information
Detailed summary of the risk assessment
Product code:
Agree 50 WG
Active Substance:
Bacillus thuringiensis
Central Zone
Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant:
Mitsui AgriScience International SA
Date:
November 2015
Applicant Mitsui AgriScience International SA
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
Agree 50 WG
Page 2 of 26
Table of Contents
IIIM1 1
IDENTITY OF THE PLANT PROTECTION PRODUCT .............................. 6
IIIM1 1.1
Applicant ................................................................................................................ 6
IIIM1 1.3
Trade Names and Manufacturer’s Code Numbers for the Preparation.......... 6
IIIM1 1.5
Type of Preparation and Code ............................................................................. 6
IIIM1 1.6
Function.................................................................................................................. 6
IIIM1 1.6.1 Biological sphere of action and arear of application ............................................. 6
IIIM1 1.7
Other/Special Studies ............................................................................................ 6
IIIM 1.7.4 Quality control data from 3-5 production batches, including product stored
for duration of shelf life if it is metabolically active ........................................... 6
IIIM 1.7.5 The formation, presence and/or impact of unintentional ingredients ................... 6
IIIM1 2
PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE
PLANT PROTECTION PRODUCT ................................................................... 7
IIIM1 2.7
Summary and evaluation of of data on properties of MPCP presented
under points 2.1 to 2.6 ......................................................................................... 15
IIIM1 3
DATA ON APPLICATION OF THE PLANT PROTECTION
PRODUCT ........................................................................................................... 15
IIIM1 3.1
Field of Use ........................................................................................................... 15
IIIM1 3.2
Nature of the Effects on Harmful Organisms ................................................... 15
IIIM1 3.3
Details of Intended Use ....................................................................................... 15
IIIM1 3.3.1
Details of existing and intended uses ................................................................. 15
IIIM1 3.3.2
Details of harmful organisms against which protection is afforded ............... 15
IIIM1 3.3.3
Effects achieved ................................................................................................... 15
IIIM1 3.4
Proposed Application Rates (Active Substance and Preparation) ................. 16
IIIM1 3.5
Concentration of the Active Substance in the Material Used ......................... 16
IIIM1 3.6
Method of Application, Type of Equipment Used and Volume of Diluent .... 16
IIIM1 3.7
Number and Timings of Applications, Timing, Growth Stages (of Crop
and Harmful Organism) and Duration of Protection ...................................... 16
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
Agree 50 WG
Page 3 of 26
IIIM1 3.7.1
Maximum number of applications and their timings ...................................... 16
IIIM1 3.7.2
Growth stages of crops or plants to be protected ............................................. 16
IIIM1 3.7.3
Development stages of the harmful organism concerned ................................ 16
IIIM1 3.7.4
Duration of protection afforded by each application ....................................... 16
IIIM1 3.7.5
Duration of protection afforded by the maximum number of applications .. 16
IIIM1 3.8
Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic
Effects on Succeeding Crops .............................................................................. 16
IIIM1 3.8.1
Minimum waiting periods or other precautions between last application
and sowing or planting succeeding crops .......................................................... 16
IIIM1 3.8.2
Limitations on choice of succeeding crops ........................................................ 16
IIIM1 3.8.3
Description of damage to rotational crops ........................................................ 16
IIIM1 4
FURTHER INFORMATION ON THE MPCP................................................ 17
IIIM1 4.1
Packaging: description ........................................................................................ 17
IIIM1 4.2
Specifications of the packaging and mesasures of its suitability..................... 17
IIIM1 4.3
Label instructions regarding cleaning equipment and protective clothing ... 17
IIIM1 4.4
Procedures for cleaning application equipment and protective clothing;
measures of their effectiveness ........................................................................... 17
IIIM1 4.5
Nessessary waiting period (in days) for re-entry; recommended
protective measures to reduce occupational exposure ..................................... 18
IIIM1 4.6
Label instructions (safe handling and storage)................................................. 18
IIIM1 4.7
Recommendations (handlimg, storage, transport, fire: specific risks,
specify procedures to minimise hazards and the generation of waste............ 18
IIIM1 4.8
Label instructions (clean up of spills) ................................................................ 19
IIIM1 4.9
Detailed procedures in case of accident to: contain a spillag,
decontaminate an area or vehicle, disposal of packaging and adsorbents,
protect workers and bystanders, first aid. ........................................................ 19
IIIM1 4.10
Procedures for destruction/ disposal of MPCP and its package ..................... 20
IIIM1 4.10.1 Controlled incineration ....................................................................................... 20
IIIM1 4.10.2 Methods other than controlled incineration ..................................................... 20
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
IIIM1 11
Agree 50 WG
Page 4 of 26
SUMMARY AND ASSESSMENT OF IMPACT ON THE
ENVIRONMENT AND THE ENVIRONMENTAL RISK............................. 21
Appendix 1: List of data used in support of the evaluation .................................................... 22
Appendix 2: Critical Uses – justification and GAP tables ....................................................... 25
Appendix 3: Experimental testing of the product's physico-chemical and technical
characteristics: ..................................................................................................... 26
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
Agree 50 WG
Page 5 of 26
Introduction
This document summarises the information related to the identity, the physical and chemical properties, the
data on application, further information and the classification for the product Agree 50 WG containing the
active substance Bacillus thuringiensis subspecies aizawai strain GC-91 which was approved according to
Regulation (EC) No 1107/2009.
Agree 50 WG was not the representative formulation.
Appendix 1 of this document contains the list of references included in this document for support of the
evaluation. Appendix 1 of this document is the table of intended uses for Agree 50 WG.
Information on the detailed composition of Agree 50 WG can be found in the confidential dossier of this
submission (Registration Report - Part C).
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
Agree 50 WG
Page 6 of 26
IIIM1 1
IDENTITY OF THE PLANT PROTECTION PRODUCT
IIIM1 1.1
Applicant
Boulevard de la Woluwe, 60
Woluwedal 60
1200 Brussels, Belgium
IIIM1 1.3
Trade Names and Manufacturer’s Code Numbers for the Preparation
Trade name:
Agree 50 WG, Agree WG, Turex 50 WG, Turex WG
Company code number:
None
IIIM1 1.5
Type of Preparation and Code
Type : Water dispersible granules
IIIM1 1.6
Code : WG
Function
The product will be used as a biological insecticide.
IIIM1 1.6.1 Biological sphere of action and arear of application
Function: Agree 50 WG acts as insecticide, for biological control of the species of the order Lepidoptera.
Field of use: Agriculture, viniculture, horticulture, orcharding, forestry and amenity areas (grass land),
professional use.
IIIM1 1.7
Other/Special Studies
Confidential information - data provided separately (Part C).
IIIM 1.7.4 Quality control data from 3-5 production batches, including product stored for
duration of shelf life if it is metabolically active
No EC data requirement.
IIIM 1.7.5 The formation, presence and/or impact of unintentional ingredients
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
IIIM1 2
Agree 50 WG
Page 7 of 26
PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT
All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is
that of a pale brown, water dispersible granules-based formulation with a fish meal odour. It is not explosive, has no oxidising properties. It has a self
ignition temperature of 392 °C. In aqueous solution, it has a pH value around 6.4. The stability data indicate a shelf life of 24 month at ambient
temperature. The technical characteristics are acceptable for a water dispersible granules (WG) formulation.
Tabelle 1: Summary of the physical, chemical and technical properties of the plant protection product
Test or study &
Annex point
Method used /
deviations
Test material purity
and specification
Findings
GLP
Reference
Acceptability /
comments
Y/N
Colour, odour and
physical state
(IIIM1 2.1)
Visual assessment and
organoleptic
determination
Batch no. 4093650
The preparation consists of small
granules with a pale brown color
(RAL 8025) and a fish meal like
odour.
Y
Aversa, S., 2011a,
BT066/11
acceptable
Storage stability after
18 weeks at 30 °C
(IIIM1 2.2.1)
Visual control of the
test item container.
Batch no. 4093650
Storage material: aluminium sachet.
Y
Aversa, S., 2011a,
BT066/11
acceptable
Weight change of the
Control of activity by
bioassay.
Method no. R&D
0011; Validation
No damage of the test item
containers was observed. No loss in
weight was found after storage. The
activity of the test item was not
significantly changed after the
storage.
The changes of the physical and
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
Test or study &
Annex point
Agree 50 WG
Page 8 of 26
Method used /
deviations
and specification
Findings
GLP
Reference
Acceptability /
comments
Aversa, S., 2013,
BT067/11
acceptable
Y/N
according to
SANCO/3030/99 rev.
4 (11/07/00)
chemical properties are negligible.
Content of Bta GC-91:
Before storage: 2.80 x 1010 CFU/g
After storage: 2.38 x 1010 CFU/g
degradation:
15 %
Agree 50 WG is stable when stored
at 30 °C for 18 weeks.
Storage stability after
24 months at 20 °C
(IIIM1 2.2.1)
Visual control of the
Weight change of the
Control of activity by
bioassay.
Method no. R&D
0011; Validation
according to
SANCO/3030/99 rev.
4 (11/07/00)
Batch no. 4093650
Storage material: aluminium sachet.
No damage of the test item
containers was observed. No loss in
weight was found after storage. The
changes of the physical and
chemical properties are negligible.
Content of Bta GC-91:
before storage: 2.80 x 1010 CFU/g
after 6 month: 2.74 x 1010 CFU/g
after 12 month: 1.26 x 109 CFU/g
Evaluator: DE
Date: November 2015
Y
The formulation is
stable for 6 month at
20 °C (with respect to
content of CFU)
According to the
instruction for use the
product should be
stored in a cool and
dry place, but no data
were submitted for
storage stability at
temperatures < 20 °C.
Core Assessment –
Germany
Test or study &
Annex point
Agree 50 WG
Page 9 of 26
Method used /
deviations
and specification
Findings
GLP
Reference
Acceptability /
comments
Aversa, S., 2013,
BT067/11
acceptable
Chen, C.-Y. (2012)
acceptable, based on
biopotency
formulation is stable
for 24 month at 20
°C.
Y/N
After 24 month: 1.16 x 10 9 CFU/g
degradation: 95.9 % after 24 month
applicant: The decrease in CFU
counts is likely due to a loss in
culturability and is not expected to
have any negative influence on the
efficacy of the product.
Microbial
conaminants methods:
MFLP-44 April 1998,
NF EN ISO
4832:2006,
NF EN ISO 68883:2003,
NF EN ISO
21567:2005,
Nf EN ISO
6579:2002,
NF EN ISO 112901/A1:2005
Batch no. 4093650
After storage:
Anaerobic spore formers:
<10 CFU/g,
Coliforms: <10 CFU/g,
Staphylococcus aureus: absent in
1g,
Shigella sp.: absent in 25 g,
Salmonella sp.: absent in 25 g,
Listeria monocytogenes: absent in
10 g
Lot # 99-98
Potencies at 20 ° C after storage:
t=0
15.0 BIU/LB
3 month:
16.1 BIU/LB
6 month:
12.6 BIU/LB
12 month:
14.7 BIU/LB
Evaluator: DE
Date: November 2015
Y
Core Assessment –
Germany
Test or study &
Annex point
Agree 50 WG
Page 10 of 26
Method used /
deviations
and specification
Findings
GLP
Reference
Acceptability /
comments
Ahrens, A., 2011a,
acceptable.
Y/N
24 month:
11.2 BIU/LB
Degradation after 24 month: 25 %
Explosive properties
(IIIM1 2.3.1)
EEC A.14,
OECD 113 (1981),
OPPTS 830.6316
(1995)
Batch no. 4093650
Oxidizing properties
(IIIM1 2.3.1)
EEC A.17
Batch no. 4093650
Flammability
(IIIM1 2.3.2)
EEC A 10
Auto-flammability
(IIIM1 2.3.2)
EEC A 16
Acidity or alkalinity
and pH
(IIIM1 2.3.3)
-
-
Since the pH was < 10 and > 4, the
acidity/alkalinity test was not
performed
-
-
acceptable
pH of a 1% aqueous
dilution, emulsion or
dispersion
(IIIM1 2.3.3)
CIPAC MT 75.3
Batch no. 4093650
Before storage:
6.40
Y
Aversa, S., 2011a,
BT066/11
acceptable.
After 18 weeks, 30°C:
6.28
After 2 years, 20°C:
6.33
Batch no. 4093650
The test item has no explosive
properties.
Y
The test item has no oxidizing
properties.
Y
no ignition during preliminary test
Y
20110112.02
Ahrens, A., 2011b,
acceptable.
20110112.04
Ahrens, A., 2011c,
acceptable
20110112.01
Batch no. 4093650
Auto-ignition at 392 °C.
Y
Ahrens, A., 2011d,
acceptable.
20110112.03
Evaluator: DE
Date: November 2015
Aversa, S., 2013,
BT067/11
Core Assessment –
Germany
Test or study &
Annex point
Agree 50 WG
Page 11 of 26
Method used /
deviations
and specification
Findings
GLP
Reference
Acceptability /
comments
Y/N
(demineralised water, 20°C)
Viscosity
(IIIM1 2.3.4)
-
-
not required for solid formulations
-
-
acceptable
Surface tension
(IIIM1 2.3.4)
-
-
not required for solid formulations
-
-
acceptable
Wettability
(IIIM1 2.4.1)
CIPAC MT 53.3.1
Batch no. 4093650
Before storage:
Static:
2s
Dynamic: 1 s
Y
Aversa, S., 2011a,
BT066/11
acceptable.
MT 53.3.2
Aversa, S., 2013,
BT067/11
Static:
2s
Dynamic: 1 s
After storage:
Static:
2s
Dynamic: 1 s
Persistence of
foaming
(IIIM1 2.4.2)
CIPAC MT 47.2
Batch no. 4093650
CIPAC water D, 0.05 %:
10 s:
49 mL
1 min: 11 mL
3 min:
5 mL
12 min: 2 mL
Evaluator: DE
Date: November 2015
Y
Aversa, S., 2011c,
BT065/11
acceptable.
highest use concentration is 0.5 %, but
based on results at
0.05 % and 0.2 % no
problems are
expected
Core Assessment –
Germany
Test or study &
Annex point
Agree 50 WG
Page 12 of 26
Method used /
deviations
and specification
Findings
GLP
Reference
Acceptability /
comments
Y/N
Suspensibility
(IIIM1 2.4.3)
CIPAC MT 47.2
TUREX WP
10 s:
31 mL
1 min: 23 mL
3 min: 20 mL
12 min: 15 mL
Y
Fifi, 2006
additional
information
(Turex 50 WP and
Agree 50 WG differ
slightly in
composition)
CIPAC MT 184
Batch no. 4093650
Before storage:
82 %
After 18 weeks, 30 °C: 84 %
After 2 years, 20 °C:
78 %
Y
Aversa, S., 2011a,
BT066/11
acceptable.
Aversa, S., 2013,
BT067/11
Before storage:
75 %
After 18 weeks, 30 °C: 68 %
93 %
Spontaneity and
degree of dispersion
(IIIM1 2.4.3)
Dry and wet sieve test
(IIIM1 2.4.4)
CIPAC MT 174
CIPAC MT 185
Batch no. 4093650
Batch no. 4093650
CIPAC water D, 1 %:
Before storage:
After 18 weeks, 30 °C:
Y
93 %
101 %
94 %
Before storage:
1.97 % on 75 µm sieve
Evaluator: DE
Date: November 2015
Aversa, S., 2011a,
BT066/11
acceptable.
Aversa, S., 2013,
BT067/11
Y
Aversa, S., 2011a,
BT066/11
Aversa, S., 2013,
BT067/11
acceptable.
Core Assessment –
Germany
Test or study &
Annex point
Agree 50 WG
Page 13 of 26
Method used /
deviations
and specification
Findings
GLP
Reference
Acceptability /
comments
Aversa, S., 2011a,
BT066/11
acceptable.
Y/N
Particle size
distribution
(IIIM1 2.4.5)
CIPAC MT 170
Batch no. 4093650
Before storage:
< 10 %: 500 µm
> 90 %: 125 µm
Y
Aversa, S., 2013,
BT067/11
< 10 %: 500 µm
> 90 %: 125 µm
< 10 %: 500 µm
> 90 %: 125 µm
Dust content
(IIIM1 2.4.5)
Friability and attrition
(IIIM1 2.4.5)
CIPAC MT 171
CIPAC MT 178.2
Batch no. 4093650
Batch no. 4093650
nearly dust free
Y
Before storage:
2.99 mg
3.71 mg
3.60 mg
Before storage:
99.96 %
99.92 %
After 2 years, 20°C:
99.84 %
Evaluator: DE
Date: November 2015
Aversa, S., 2011a,
BT066/11
acceptable.
Aversa, S., 2013,
BT067/11
Y
Aversa, S., 2011a,
BT066/11
Aversa, S., 2013,
BT067/11
acceptable.
Core Assessment –
Germany
Test or study &
Annex point
Agree 50 WG
Page 14 of 26
Method used /
deviations
and specification
Findings
GLP
Reference
Acceptability /
comments
Y/N
Emulsifiability,
emulsion stability and
re-emulsifiability
(IIIM1 2.4.6)
-
-
not required for WG formulations
-
-
acceptable
Flowability,
pourability
(rinsability) and
dustability
(IIIM1 2.4.7)
CIPAC MT 172
Batch no. 4093650
Spontanious flow without any
residue.
Y
Aversa, S., 2011c,
BT065/11
acceptable.
Density
(IIIM1 2.5)
CIPAC MT 186
Batch no. 4093650
pour density:
0.477 g/mL
Y
Aversa, S., 2011c,
BT065/11
acceptable.
tap density:
0.526 g/mL
-
-
acceptable
Adherence and
distribution to seeds,
for seed treatment
products
(IIIM1 2.6)
-
-
not intended for seed treatment
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
IIIM1 2.7
Page 15 of 26
Summary and evaluation of of data on properties of MPCP presented under
points 2.1 to 2.6
All studies have been performed in accordance with the current requirements and the results are deemed
to be acceptable. The appearance of the product is that of a pale brown, water dispersible granules-based
formulation with a fish meal odour. It is not explosive, has no oxidising properties. It has a self ignition
temperature of 392 °C. In aqueous solution, it has a pH value around 6.4. The stability data indicate a
shelf life of 6 month at ambient temperature based on the content of cfu/g, based on biopotency a shelf
life of 24 month is observed.
The technical characteristics are acceptable for a water dispersible granules (WG) formulation.
Experimental testing of the product's physico-chemical and technical characteristics:
See Appendix 3
Implications for labelling: None
IIIM1 3
DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT
IIIM1 3.1
Field of Use
Agree 50 WG is a biological insecticide formulated as a water dispersible granule, containing 3 × 1013
colony forming units (CFU) or 500 g of Bta GC-91 in 1 kg product..
IIIM1 3.2
Nature of the Effects on Harmful Organisms
Agree 50 WG is non-systemic and poisons the caterpillars. Therefore, it is used to control leaf consuming
caterpillars on various crops. Upon ingestion, the crystal proteins dissolve in the stomach and damage the
tissue. The caterpillars stop eating and die after a few days. Mostly young caterpillars are more sensitive
than old ones. For an adequate effectiveness all plant parts should be sufficiently sprayed. Applications
are performed at pest occurrence, independ-ently from the crop growth stage.
IIIM1 3.3
Details of Intended Use
IIIM1 3.3.1
Details of existing and intended uses
Please refer Part B Section 7.
IIIM1 3.3.2
Details of harmful organisms against which protection is afforded
Please refer Part B Section 7.
IIIM1 3.3.3
Effects achieved
Please refer to Part B Section 7.
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
IIIM1 3.4
Page 16 of 26
Proposed Application Rates (Active Substance and Preparation)
IIIM1 3.5
Concentration of the Active Substance in the Material Used
IIIM1 3.6
Method of Application, Type of Equipment Used and Volume of Diluent
IIIM1 3.7
Number and Timings of Applications, Timing, Growth Stages (of Crop and
Harmful Organism) and Duration of Protection
IIIM1 3.7.1
Maximum number of applications and their timings
IIIM1 3.7.2
Growth stages of crops or plants to be protected
IIIM1 3.7.3
Development stages of the harmful organism concerned
IIIM1 3.7.4
Duration of protection afforded by each application
IIIM1 3.7.5
Duration of protection afforded by the maximum number of applications
IIIM1 3.8
Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects
on Succeeding Crops
IIIM1 3.8.1
Minimum waiting periods or other precautions between last application and
sowing or planting succeeding crops
IIIM1 3.8.2
Limitations on choice of succeeding crops
IIIM1 3.8.3
Description of damage to rotational crops
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 17 of 26
IIIM1 4
FURTHER INFORMATION ON THE MPCP
IIIM1 4.1
Packaging: description
Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,
leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents
of the packaging, have been submitted, evaluated and is considered to be acceptable.
IIIM1 4.2
Specifications of the packaging and mesasures of its suitability
Taking into account the composition of the product and its anticipated physical properties, Agree 50 WG
is characterized as non-reactive and non-hazardous; no further investigations and tests were conducted.
The chemically inert product does not require special stability or resistance properties of the packaging or
the material used in packaging.
Professional use:
Primary packaging:
1.0 kg bag:
material:
48 gauge polyester/0.003 PE laminated
shape/size:
approx. 16.5 cm x 7.6 cm x 33.0 cm
material:
28 gauge solid unbleached sulphate (SUS)
shape/size:
Secondary packaging:
1.0 kg box:
Master shipping package:
10.0 kg box:
IIIM1 4.3
material:
ECT (edge crush test) 48 double wall fibreboard
shape/size:
Label instructions regarding cleaning equipment and protective clothing
Please refer to Point IIIM 4.4.
IIIM1 4.4
Procedures for cleaning application equipment and protective clothing;
measures of their effectiveness
Equipment cleaning procedure:
Rinse the application equipment thoroughly with water. Distribute the cleaning water on the treated area.
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 18 of 26
Protective clothing cleaning procedure:
Protective clothing shall be washed according to manufacturer’s instruction. If no such instructions for
washables exist, use detergent and hot water. Keep and wash protective clothing separately from other
laundry.
IIIM1 4.5
Nessessary waiting period (in days) for re-entry; recommended protective
measures to reduce occupational exposure
Pre-harvest interval for each relevant crop:
Agree 50 WG is not supposed to produce any relevant residues on the crop. B. thuringiensis ssp. aizawai
does not produce toxins or secondary metabolites of toxic concern to non-arthropods, including man and
domestic animals. Fixing a pre-harvest interval is therefore not relevant.
Re-entry period for livestock, to areas to be grazed:
Not relevant (see above). Agree 50 WG is not intended for use on pastures.
Re-entry period for man to crops, buildings or spaces treated:
Not relevant (see above).
Withholding periods for animal feeding stuffs:
Waiting period between application and handling treated products:
Waiting period between last application and sowing or planting succeeding crops:
B. thuringiensis ssp. aizawai does not cause injuries to plants. Due to restricted field persistence and
absence of toxicity, waiting periods for planting or sowing of succeeding crops are not required.
IIIM1 4.6
Label instructions (safe handling and storage)
IIIM1 4.7
Recommendations (handlimg, storage, transport, fire: specific risks, specify
procedures to minimise hazards and the generation of waste
Handling and storage precautions:
Keep away from food, drink and animal feeding stuffs. When using, do not eat, drink or smoke. Wash
hands and face before eating, drinking or smoking. Do not breathe dust or spray. Avoid contact with skin
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 19 of 26
and eyes. Wear suitable protective clothing, gloves, eye/face protection and respiratory protection.
(minimal A2, P3 filter).
Store in a cool, dry and a well-ventilated place, secure area out of the reach of children and domestic
animals. Do not store food, beverages or tobacco products in the storage area. Prevent eating, drinking,
tobacco usage, and cosmetic application in areas where there is a potential for exposure to the material.
Always wash thoroughly after handling, high humidity and temperatures over 30ºC decrease the activity
of the product. Do not contaminate waters with this product or its container.
Transport:
Transport of Agree 50 WG does not require special precautions.
Procedures to minimize the generation of waste:
Remainder of spray shall be diluted and sprayed over already treated areas. Totally cleaned packages can
be given to the waste disposal or recycling system.
Hazardous combustion products:
Not known at the indicated conditions of use.
Please, for any further information refer to the Material Safety Data Sheet submitted in KIIIM 4.7/01
IIIM1 4.8
Label instructions (clean up of spills)
IIIM1 4.9
Detailed procedures in case of accident to:
contain a spillag, decontaminate an area or vehicle, disposal of packaging
and adsorbents, protect workers and bystanders, first aid.
Containment of spillages:
Wear chemical safety glasses with side shields or chemical goggles, rubber gloves, rubber boots, longsleeved shirt, long pants, head covering, and a NIOSH-approved dust or pesticide respirator with dust
prefilters. For small spills, sweep up, keeping dust to a minimum and place in an approved chemical
container. Wash the spill with water containing a strong detergent, absorb with pet litter or other
absorbent material, sweep up and place in a chemical container. Seal the container and handle in a
approved manner. Flush the area with water to remove any residue. Do not allow wash water to
decontaminate water supplies.
Decontamination of areas, vehicles and buildings:
Refer to the above statement on spillages.
Disposal of damaged packaging, adsorbents and other materials:
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 20 of 26
Protection of emergency workers:
First aid measures:
Eye contact:
Immediately wash eyes with a large amount of running water. Hold eyelids apart
to rinse the entire surface of the eyes and lids. Do not apply any medicating agent except on the advice of
a physician.
Skin contact: Wash with plenty of soap and water, including hair and under fingernails. Do not apply
any medicating agent except on the advice of a physician. Remove contaminated clothing and
decontaminate prior to use.
Inhalation:
necessary.
Move victim from contaminated area to fresh air. Apply artificial respiration if
Ingestion:
If victim is fully conscious, immediately give large amounts of water to drink
and induce vomiting. Never give anything by mouth to a unconscious person.
Please, for any further information refer to the Material Safety Data Sheet submitted in KIIIM 4.9/01.
IIIM1 4.10
Procedures for destruction/ disposal of MPCP and its package
The disposal of product has to be performed in accordance with all applicable federal, state and local
environmental regulations. Wastes resulting from the use of Agree 50 WG, i.e. residual water dispersions
can be disposed of at an approved waste disposal facility. Remainder of spray can also be diluted and
sprayed over already treated areas.
The same procedure is applicable to larger quantities, which may occur very rarely only.
Totally cleaned packages can be given to the regular waste disposal.
Please, for any further information refer to the Material Safety Data Sheet submitted in KIIIM 4.10/01.
IIIM1 4.10.1 Controlled incineration
Incineration should be made in authorized and specialized plant.
IIIM1 4.10.2 Methods other than controlled incineration
Not applicable.
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
IIIM1 11
Page 21 of 26
SUMMARY AND ASSESSMENT OF IMPACT ON THE ENVIRONMENT
AND THE ENVIRONMENTAL RISK
See Part B, Section 6.
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 22 of 26
Appendix 1: List of data used in support of the evaluation
Annex point/
Author(s)
Year
reference No
Owner
How considered in
Title
Data
Source (where different from
protection
dRR
company)
claimed
Study-Status /
Usage*
Report-No.
GLP or GEP status (where relevant),
Published or not
KIIIM1 2.1
2.2
2.3.3
2.4.1
2.4.3.1
2.4.3.2
2.4.4
2.4.5.1
2.4.5.2
2.4.5.3
KIIIM1 2.2.1
KIIIM1 2.1
Aversa, S. 2011
Physical-chemical properties
of product Agree WG before
and after accelerated storage
at 30 ± 2 ºC for 18 weeks
BT066/11
GLP: Y, published: N
Y
Mitsui
1
Chen, C.Y.
Anonymo
us
Storage stability of Agree
WG
Material safety data sheet
Agree 50 WP
Certis, USA
GLP: N, published: N
Interim report of study
BT067/10 6 months check
point. Physical-chemical
properties of product Agree
WG after 2 years shelf life
BT067/11
Physical, chemical, technical
properties and accelerated
storage of TUREX WP 50
(Bacillus thuringiensis).
BT033/05
2294298 /
Physical, chemical,technical
properties and shelf life of
Turex WP 50 (Bacillus
thuringiensis) at room
temperature for two years
BT034/05
Y
Mitsui
1
Y
Mitsui
3
Y
Mitsui
3
Y
Mitsui
5
Y
Mitsui
5
2012
2001
KIIIM1 2.2
Aversa, S. 2011
KIIIM1 2.2
Fifi, A.P.
2006
KIIIM1 2.2
Fifi, A.P.
2008
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Annex point/
Page 23 of 26
Author(s)
Year
reference No
Title
Data
protection
dRR
company)
claimed
Study-Status /
Owner
How considered in
Usage*
Report-No.
Published or not
KIIIM1 2.2
2.3.3
2.4.1
2.4.3.1
2.4.3.2
2.4.4
2.4.5.1
2.4.5.2
2.4.5.3
KIIIM1 2.2
Aversa, S. 2013
Physical-chemical properties
of product Agree WG after 2
years shelf life
BT067/11
Y
Mitsui
1
Coranelli,
S.
Analytical method validation Y
for the determination of the
active ingredient content in
the formulated product Agree
WG and in aqueous dilutions
Mitsui
1
Y
Mitsui
1
Y
Mitsui
1
Y
Mitsui
1
Y
Mitsui
1
Y
Mitsui
3
2011
BT064/11
KIIIM1
2.3.1.1
KIIIM1
2.3.1.2
KIIIM1 2.3.2
KIIIM1 2.3.2
KIIIM1 2.3.2
Ahrens, A. 2011a Agree WG Explosive
properties A.14
20110112.02
Ahrens, A. 2011b Agree WG Oxidizing
Properties A.17
20110112.04
Ahrens, A. 2011 Agree WG Flammability
(solids) A.10
20110112.01
Ahrens, A. 2011 Agree WG Auto-flammability
(solids-determination of
relative self-ignition
temperature) A.16
20110112.03
Smeykal, 2006 Turex 50 WP - AutoH.
flammability (BowesCameron-Cage test)
20060301.01
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Annex point/
Page 24 of 26
Author(s)
Year
reference No
Title
Data
protection
dRR
company)
claimed
Study-Status /
Owner
How considered in
Usage*
Report-No.
Published or not
KIIIM1 2.4.2
2.4.3
2.4.7
2.5
KIIIM1 4.7
4.9
KIIIM1 4.7
KIIIM1 4.10
* 1
2
3
4
5
Aversa, S. 2011c Physical-chemical properties:
flowability, bulk density and
persistent foaming of product
Agree WG
BT065/11
Anonymo 2012 Safety data sheet Agree WG
us
Anonymo 2001 Safety data sheet - Agree 50
us
WP
Anonymo 2012 Safety data sheet Agree WG
us
2012
Y
Mitsui
1
Y
Mitsui
1
Y
Mitsui
3
Y
Mitsui
1
accepted (study valid and considered for evaluation)
not accepted (study not valid and not considered for evaluation)
not considered (study not relevant for evaluation)
not submitted but necessary (study not submitted by applicant but necessary for evaluation)
supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
Agree 50 WG
Page 25 of 26
APPENDIX 2: CRITICAL USES – JUSTIFICATION AND GAP TABLES
Product use for professional
Please refer to Appendix 2 of Part B Section 7
Product use for amateur
Please refer to Appendix 2 of Part B Section 7
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
Agree 50 WG
Page 26 of 26
Appendix 3: Experimental testing of the product's physico-chemical and technical
characteristics:
The following physical, chemical and technical properties of the plant protection product were
experimentally tested:
pour and tap density, colour, pH, storage stability at high temperatures (18 weeks at 30 °C), wettability,
persistent foaming, suspensibility, particle size distribution (laser diffraction), content of dust/fines,
attrition and flowability.
A significant higher attrition was detected compared to the data submitted by the applicant.
The formulation complies with the chemical, physical and technical criteria which are stated for this type
of formulation in the FAO/WHO manual (2010).
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 1 of 10
REGISTRATION REPORT
Part B
Section 2: Analytical Methods
Product code:
Agree 50 WG
Active Substance:
Bacillus thuringiensis
Central Zone
Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant:
Date:
November 2015
Evaluator: DE
Date: November 2015
Core Assessment –
Germany
Agree 50 WG
Page 2 of 10
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 3 of 10
III 5
Methods for Analysis, Manufacturing, Quality Control and Postregistration Monitoring of MPCP ..................................................................... 4
IIIA 5.1
Quality control and post-registration monitoring methods .............................. 4
IIIA 5.1.1
Methods to differentiate a mutant or genetically-modified microorganism from the parent strain .......................................................................... 4
IIIA 5.1.2
Methods to detect spontaneous change in major characteristics of
microorganism.................................................................................................... 4
IIIA 5.1.3
Methods to define contents of micro-organism in appropriate terms .............. 4
IIIA 5.1.4
Methods to identify contaminant micro-organisms in MPCP .......................... 5
IIIA 5.1.5
Methods to show control to a specified and acceptable level, of
microbial impurities and of any other impurities of toxicological
concern ................................................................................................................... 5
IIIA 5.2
Storage stability test and determination of shelf life (methods of
analysis) .................................................................................................................. 6
IIIA 5.3
Production process for MPCP, describing techniques used to ensure a
uniform product .................................................................................................... 6
IIIA 5.4
Description of Analytical Methods for the Determination of Residues............ 6
Appendix 1 – List of data submitted in support of the evaluation ........................................... 9
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
III 5
Page 4 of 10
Methods for Analysis, Manufacturing, Quality Control and Post-registration
Monitoring of MPCP
This document reviews the analytical methods for the product Agree 50 WG containing the Bacillus
thuringiensis ssp. aizawai strain GC-91 (Bta GC-91) which was included into Annex I of Directive
91/414 EC by directive 2008/113/EC. It is approved under Regulation (EC) 1107/2009 as listed in
implementing Regulation (EU) 540/2011 of 25 May 2011
IIIA 5.1
Quality control and post-registration monitoring methods
IIIA 5.1.1
Methods to differentiate a mutant or genetically-modified micro-organism
from the parent strain
Not required, because the strain Bacillus thuringiensis ssp. aizawai GC-91 is of natural origin, not a
mutant and or genetically modified.
IIIA 5.1.2
Methods to detect spontaneous change in major characteristics of microorganism
Confidential information, please refer to Part C.
IIIA 5.1.3
Methods to define contents of micro-organism in appropriate terms
An analytical method has been developed and validated for the determination of the content of active
ingredient Bacillus thuringiensis ssp. aizawai CG-91 in the formulated product Agree 50 WG and in
aqueous dilutions obtained after suspensibility and dispersibility tests.
The following analytical method for the determination of the active substance has not previously been
reviewed and is provided in support of this assessment.
Report:
Title:
Document No:
Guidelines:
GLP
KIIIM 5.1.3/01, Coranelli, S. (2011)
Analytical method for the determination of the active ingredient content in the
formulated product Agree WG and in aqueous dilutions
Study BT064/11
SANCO/3030/99 rev.4.
Yes
Material:
Agree WG, Batch No. 4093650, containing Bacillus thuringiensis aizawai strain GC-91, content: 11
BIU/lb, 2.75 × 1010 CFU/g
Reference item: Agree technical powder, Batch No. 041211, containing Bacillus thuringiensis aizawai
strain GC-91, content: 22 BIU/lb, 5.6 × 1010 CFU/g
Blank Formulation: Agree WG inert, Batch No. 106-48
Demineralized water and Standard Water D.
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 5 of 10
Principle of the method
The active ingredient content was determined by colonies counting and reported as spore concentration.
After a first dilution of the sample (100 times) the suspension was heat shocked for 45 min at 65 °C for
killing of vegetative cells. Then sufficient dilutions were prepared to obtain 30 - 300 colonies. Namely,
0.1 mL of the already diluted dispersions were plated on nutrient agar (15 - 20 mL of agar were added).
Finally, the Petri dishes were incubated at 30 ± 1°C for 24 hours and the colonies were counted.
The calculation of spore/g was performed according to the following formula:
[spore] = (dilution) × (mean number of colonies counted)/(weight or volume of sample)
The method was validated with regard to specificity, linearity, precision and accuracy.
For the validation of the method in aqueous dilutions (dispersions), the samples were prepared using
Standard Water D.
Validation
Table 5.1.3-1: Summary of validation of the method for the determination of Bacillus thuringiensis
aizawai strain CG-91.
Reference
Linearity
Accuracy
Repeatability
n=5
(Recoveries)
(Precision)
n=5
KIIIA 5.1.3/01
concentration 0.1 - 4 g/L:
formulated product:
r = 0.9945
aqueous dilutions:
r = 0.9965
The accuracy was evaluated
by a recovery determination
on two fortification levels.
formulated product:
100.11 %
aqueous dilutions:
101.76 %
formulated product:
RSD = 2.28 %
aqueous dilutions:
RSD = 2.13 %
acceptable according
modified Horwitz eqn.:
2.68 % (for 1 %)
Conclusion:
The analytical method is suitable and reliable for the determination of concentration of the number of
spores of Bacillus thuringiensis aizawai strain GC-91 in the product Agree WG and in aqueous dilutions.
The method was validated by definition of the linearity, the precision and the accuracy according to the
criteria set by SANCO/3030/99 rev. 4.
IIIA 5.1.4
Methods to identify contaminant micro-organisms in MPCP
Please refer to dRR Part C.
IIIA 5.1.5
Methods to show control to a specified and acceptable level, of microbial
impurities and of any other impurities of toxicological concern
Please refer to Part C.
IIIA 5.1.6
Methods to show presence of any human and mammalian pathogens
Confidential information, please refer to Part C.
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
IIIA 5.2
Page 6 of 10
Storage stability test and determination of shelf life (methods of analysis)
The analytical method described under IIIA 5.1.3 has been used in the storage stability tests to determine
the content of Bacillus thuringiensis aizawai strain GC-91.
IIIA 5.3
Production process for MPCP, describing techniques used to ensure a
uniform product
IIIA 5.4
Description of Analytical Methods for the Determination of Residues
IIIA 5.4.1
Evaluation of Bacillus thuringiensis ssp. aizawai GC-91
The conclusions regarding the peer review of the analytical methods for residues of Bacillus thuringiensis
ssp. aizawai GC-91 are summarized in SANCO/1538/08 – rev. 4. An EFSA Conclusion on the peer
review of the pesticide risk assessment of the active substance Bacillus thuringiensis ssp. aizawai (strains
ABTS 1857, GC-91) is available (EFSA 2012, ASB2013-1005).
IIIA 5.4.1.1
Overview of residue definitions and levels for which compliance is required
In Regulation (EC) No 396/2005 no MRLs and thus no residue definition are regulated for B. thuringiensis ssp. aizawai GC-91.
The active components of commercial B. thuringiensis ssp. aizawai preparations, spores and crystal
proteins, are not toxic or pathogenic to humans, plants, and most animals. The remaining issue for
consumer exposure is that B. thuringiensis ssp. carries the genetic material that encodes for the Bacillus
cereus enterotoxin, however at a lower level. It is proposed to apply the suggested value of 105 CFU/g
food as a trigger for safe uses (EFSA 2005, ASB2012-9549). Consequently, the level of 105 CFU/g food
is considered here as the maximum acceptable level for B. thuringiensis ssp. aizawai GC-91 in food.
A residue definition for soil and water was not defined in the Draft Assessment Report (ASB2010-10682)
and was not considered necessary because of low risks for terrestrial vertebrates, aquatic organisms or
bees.
IIIA 5.4.1.2
Description of Analytical Methods for the Determination of Residues of
Bacillus thuringiensis ssp. aizawai GC-91 in Plant Matrices (OECD KIII A
5.3.1)
EFSA concluded that validated analytical methods for all representative uses have to be generated.
However, due to several data gaps, the risk assessment could not be finalized (EFSA 2012, ASB20131005) and a residue definition for monitoring was not proposed. It is not clear if MRLs and a
corresponding residue definition will be established in future or if B. thuringiensis ssp. aizawai GC-91
will be included in Annex IV (meaning that no MRLs are required). For the time being it is therefore not
feasible to develop or evaluate appropriate analytical methods.
Only such intended uses are currently foreseen for authorization, which result in < 105 CFU/g food. In
that case the risk to consumers is low and analytical methods for the determination of residues in plant
matrices are not required.
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
IIIA 5.4.1.3
Page 7 of 10
Description of Analytical Methods for the Determination of Residues of
Bacillus thuringiensis ssp. aizawai GC-91 in Animal Matrices (OECD KIII A
5.3.1)
EFSA concluded that validated analytical methods for all representative uses have to be generated.
However, due to several data gaps, the risk assessment could not be finalized (EFSA 2012, ASB20131005) and a residue definition for monitoring was not proposed. It is not clear if MRLs and a
corresponding residue definition will be established in future or if B. thuringiensis ssp. aizawai GC-91
will be included in Annex IV (meaning that no MRLs are required). For the time being it is therefore not
feasible to develop or evaluate appropriate analytical methods.
Only such intended uses are currently foreseen for authorization, which result in < 105 CFU/g food. In
that case the risk to consumers is low and analytical methods for the determination of residues in animal
matrices are not required.
IIIA 5.4.1.4
Description of Methods for the Analysis of Bacillus thuringiensis ssp. aizawai
GC-91 in Soil (OECD KIII A 5.4)
B. thuringiensis ssp. aizawai GC-91 is an ubiquitously occurring microorganism with low risk for soil
microflora, earthworms and other non-target organisms. Due to its ubiquitous occurrence, a detection of
B. thuringiensis ssp. aizawai GC-91 cannot be directly traced back to the application of a plant protection
product. Analytical methods for the determination of residues of B. thuringiensis ssp. aizawai GC-91 in
soil are not feasible and therefore not required.
IIIA 5.4.1.5
GC-91 in Water (OECD KIII A 5.6)
Bacterial cells and especially spores may survive in water, but are not expected to cause any
environmental impact and are not expected to occur in concentrations which could be potentially harmful
to humans. Therefore, analytical methods for the determination of residues of B. thuringiensis ssp.
aizawai GC-91 in water are not required.
IIIA 5.4.1.6
GC-91 in Air (OECD KIII A 5.7)
B. thuringiensis ssp. aizawai GC-91 is not expected to occur in concentrations in air which could be
potentially harmful to humans. Analytical methods for the determination of residues in air are therefore
not required.
IIIA 5.4.1.7
GC-91 in Body Fluids and Tissues (OECD KIII A 5.8)
The registration of plant protection products which contain microorganisms is not allowed, if these
microorganisms or their toxins are harmful to humans. Therefore, it is concluded that analytical methods
for body fluids and tissues are generally not required.
IIIA 5.4.1.8
Other Studies/ Information
Other studies are not required.
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
IIIA 5.4.2
Page 8 of 10
Conclusion on the availability of analytical methods for the determination of
residues
For the time being, analytical methods for residues of B. thuringiensis ssp. aizawai GC-91 are not
required.
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 9 of 10
Appendix 1 – List of data submitted in support of the evaluation
Annex
point/ Author(s)
Year
reference No
Data
Title
Source
(where
different
Owner
How considered in
dRR
from protection
Study-Status
claimed
company)
/
Usage*
Report-No.
Published or not
KIIIM1 5.1.3
* 1
2
3
4
5
Coranelli,
S.
2011
Analytical method for the Y
determination of the active
ingredient content in the
formulated product Agree 50
WG
and
in
aqueous
dilutions,
Biotecnologie BT Srl, Fraz.
Pantalla, Italy,
Certis Europe B.V., NL,
BT064/11,
GLP: yes, Published: no
MTA
1
accepted (study valid and considered for evaluation)
not accepted (study not valid and not considered for evaluation)
not considered (study not relevant for evaluation)
not submitted but necessary (study not submitted by applicant but necessary for evaluation)
supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)
Annex point/
reference No
Author(s)
Year
Italy
2007
EFSA
2005
EFSA
2012
Title
Report-No.
Authority registration No
Bacillus thuringiensis subspecies
aizawai strain GC-91 (Draft Assessment
Report)
GLP: Open Published: Yes
ASB2010-10682
Opinion of the scientific panel of
biological hazards on Bacillus cereus
and other Bacillus spp in foodstuffs
EFSA Journal (2005) 175, 1-48 ! EFSAQ-2004-010
The EFSA Journal, 175, 1-48
GLP: No Published: Yes
BVL-2294154, ASB2012-9549
Conclusion on the peer review of the
pesticide risk assessment of the active
substance Bacillus thuringiensis subsp.
aizawai (strains ABTS 1857, GC-91)
EFSA Journal 2013;11(1):3063 ! EFSAQ-2009-00247
EFSA Journal (2013) 11 (1), 3063
ASB2013-1005
Data
protection
claimed
Open
No
Owner
LIT
How
considered in
dRR *
Add
Y
Add
Evaluator: DE
Date: November 2015
Agree 50 WG
Core Assessment –
Germany
Page 10 of 10
Annex point/
reference No
Author(s)
Year
KIIM 4.3.1, KIIM
4.5, KIIM 4.5.1,
KIIM 4.5.3, KIIM
4.5.4, KIIM 4.5.5,
KIIM 4.5.6
Hill, K. K.; Ticknor, L. O.;
Okinaka, R. T. et al.
2003
KIIM 4.5.1
Kim, Y.-R.; Czajka, J.;
Batt, C. A.
2000
KIIM 4.5.1, KIIM
4.5.4
Bernhard, K.; Jarrett, P.;
Meadows, M. et al.
1997
KIIM 4.5.3, KIIM
5.3.7.1
Hadley, W. H.; Burchiel, S.
W.; McDowell, Th. D. et
al.
1987
KIIM 4.5.5, KIIM
4.5.6
Valadares de Amorim, G.;
Whittome, B.; Shore, B. et
al.
2001
Title
Report-No.
Fluorescent amplified fragment length
polymorphism analysis of Bacillus
anthracis, Bacillus cereus, and Bacillus
thuringiensis isolates
0099-2240/04 !
10.1128/AEM.70.2.1068-1080.2004
Appl Environ Microbiol, 70 (2), 10681080
BVL-2294132, BVL-2294140, BVL2294143, BVL-2294145, BVL2294147, BVL-2294149, BVL2294151, ASB2012-9391
Development of a fluorogenic probebased PCR assay for detection of
Bacillus cereus in nonfat dry milk
0099-2240/00
BVL-2294142, ASB2012-9394
Natural isolates of Bacillus
thuringiensis: Worldwide distribution,
characterization, and activity against
insect pests
IN974669 ! 0022-2011/97
J Invertebr Pathol, 70, 59-68
BVL-2294141, BVL-2294146,
ASB2012-9393
Five-month oral (diet)
toxicity/infectivity study of Bacillus
thuringiensis insecticides in sheep
0272-0590/87
Fundam Appl Toxicol, 8, 236-242
BVL-2294144, BVL-2294192, BVL2294204, TOX2006-1566
Identification of Bacillus thuringiensis
subsp. kurstaki strain HD1-like bacteria
from environmental and human samples
after aerial spraying of Victoria, British
Columbia, Canada, with Foray 48B
LIT
How
considered in
dRR *
N
No
LIT
N
No
LIT
N
No
LIT
N
No
LIT
N
Data
protection
claimed
No
Owner
BVL-2294148, BVL-2294150,
TOX2006-1561
* Y:
N:
Add:
Yes, relied on
No, not relied on
Relied on, study not submitted by applicant but necessary for evaluation
Evaluator: DE
Date: November 2015
Agree 50 WG – ZV1 007638-00/00
Part B – Section 3 - Core Assessment
zRMS version
REGISTRATION REPORT
Part B
Section 3: Mammalian Toxicology
Product code: Agree 50 WG
Active Substance:
500 g/kg Bacillus thuringiensis ssp. Aizawai GC-91
(3 x 1013 CFU/kg)
Central Zone
CORE ASSESSMENT
Applicant: Mitsui AgriScience International
S.A./B.V
Date:
November 2015
Page 1 / 23
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Table of Contents
3
Mammalian Toxicology ...................................................................................................... 3
3.1
Toxicological Evaluation of Active Substance.................................................................... 3
3.1.1
Bacillus thuringiensis subspecies aizawai strain GC-91...................................................... 3
3.2
Toxicological Evaluation of Pesticide ................................................................................. 3
3.3
Dermal Absorption .............................................................................................................. 5
3.4
Safety Assessment of Pesticide Application........................................................................ 6
3.4.1
Selection of critical uses and justification ........................................................................... 6
3.4.2
Evaluation of the Active Substance Bacillus thuringiensis ssp. aizawai strain GC91 ....................................................................................................................................... 10
3.4.2.1
Operator exposure and risk assessment ............................................................................. 10
3.4.2.2
Worker exposure and risk assessment ............................................................................... 12
3.4.2.3
Bystander and resident exposure and risk assessment ....................................................... 12
3.4.3
Conclusion of Exposure Estimation and Risk Assessment ............................................... 13
3.5
Justified Proposals for Classification and Labelling and Safety Instructions ................... 13
Appendix 1
List of Data Submitted in Support of the Evaluation......................................................... 15
Appendix 2
Exposure Calculations ....................................................................................................... 17
A 2.1
Exposure Calculations for Bacillus thuringiensis ssp. aizawai strain GC-91 ................... 17
A 2.1.1
Operator exposure calculations.......................................................................................... 17
Appendix 3
Detailed Evaluation of the Exposure Studies Relied upon ................................................ 22
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3
Mammalian Toxicology
3.1
Toxicological Evaluation of Active Substance
3.1.1
Bacillus thuringiensis subspecies aizawai strain GC-91
Table 3.1-1:
General information on Bacillus thuringiensis subspecies aizawai strain GC-91
Common Name
Bacillus thuringiensis ssp. aizawai
CAS-No.
Not applicable
Chemical substance class
Not applicable
Table 3.1-2:
Agreed EU endpoints
Value
Reference
ADI
Not applicable based on the lack
of pathogenicity and infectivity
in the available data.
EFSA Conclusion 2013
(ASB2013-1005)
AOEL systemic
EFSA Conclusion 2013
(ASB2013-1005)
ARfD (acute reference dose)
Table 3.1-3:
Classification and proposed labelling for Bacillus thuringiensis subspecies
aizawai strain GC-91
with regard to toxicological data
(according to the criteria in Dir. 67/548/EEC)
with regard to toxicological data
(according to the criteria in Reg. (EC) No
1272/2008)
3.2
Not applicable
Not applicable
Toxicological Evaluation of Pesticide
Table 3.2-1:
General information on Agree 50 WG
Product name and code
Agree 50 WS (MRA-11111-I-0-WG)
Formulation type
Water dispersible granules
Active substance (incl. content)
Bacillus thuringiensis subspecies aizawai strain GC-91;
500 g/kg, 25000 IU/mg, 3 x 1013 CFU/kg
Category
Insecticide
Statement as to whether the product was already
evaluated as the ‘representative formulation’ during the
Annex I inclusion or has been previously evaluated in
an other MS according to Uniform Principles
No, but the previous formulation Agree 50 WP
containing also 500 g/kg Bacillus thuringiensis
subspecies aizawai strain GC-91 was the representative
formulations during Annex I inclusion, Rapporteur MS:
IT (May 2007). For the detailed composition of Agree 50
Page 3 / 23
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WP it is referred to Vol. 4 of the DAR.
In general, WP formulations are toxicologically
considered more critical than WG formulations due to the
higher potential risk for dust to be inhaled. Moreover,
Xxx
in all) of Agree 50 WP were replaced by one Xxx
.Taken all together, it is considered acceptable to use the
study results on Agree 50 WP for this evaluation.of
Agree 50 WG.
A summary of the toxicological evaluation for Agree 50 WG on the basis of studies conducted using
Agree 50 WP is given in Table 3.2-2. For full summaries of studies on the product Agree 50 WP it is
referred to the DAR by IT (May 2007).
Table 3.2-2:
Type of test, species
(Guideline)
Summary of evaluation of the studies on acute toxicity including irritancy and
skin sensitisation for Agree 50 WP
Result
Acceptability
Classification
(acc. to the
criteria in Dir.
67/548/EEC)
Classification
(acc. to the
criteria in Reg.
(EC) No
1272/2008)
Reference
LD50 oral, rat
(EPA FIFRA 81-1)
> 5050 mg/kg
bw corresponding to 3.23 ×
1010 CFU
Bta/kg bw 1), 2)
Yes
None
None
Xxx
1991
LD50 oral, rat
(EPA FIFRA 81-1)
> 5050 mg/kg
1011 CFU
Bta/kg bw 1), 3)
Yes
None
None
Xxx
1992
LD50 dermal, rabbit
(EPA 152A-11)
> 2020 mg/kg
109 CFU Bta/kg
bw 1)
Yes
None
None
Xxx
1991
LC50 inhalation, rat
(EPA 81-3)
> 5.78 mg/L air
corresponding to
1.8 × 108 CFU
Bta/L air 1), 4)
Yes
None
None
Xxx
1991
LC50 inhalation, rat
(EPA 81-3)
> 0.651 mg/L
air corresponding
to 3.4 × 108 CFU
Bta/L air 1), 5)
Yes
None
None
Xxx
1993
Skin irritation, rabbit
(EPA 152A-11)
Non-irritant 1)
Yes
None
None
Xxx
1991
Eye irritation, rabbit
(EPA 152A-14)
Non-irritant 1)
Yes
None
None
Xxx
1991
Skin sensitisation,
Sensitising 6)
Yes 7)
R43
H317
Xxx
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1999
guinea pig
(design comparable to
M&K; no statement,
but OECD 406
mentioned in the
bibliography)
Supplementary studies No data – not
required
for combinations of
plant protection
products
1)
2)
3)
4)
5)
6)
7)
test using ‘technical material’
2/5 females but 0/5 males died
1/5 females but 0/5 males died
no mortality at this powder concentration containing an average of 14.8 % of particles < 1 µm; study with shortcomings in
generation of test atmosphere: substantial fluctuations of MMAD during 4h-test period (3.911 µm – 11.332 µm)
no mortality at this powder concentration containing an average of 10.8 % of particles < 1 µm; MMAD constant during 4htest period (3.228 µm – 3.612 µm)
test on formulated product
no GLP statement, no positive controls even though not compulsory from a scientific point of view in this case
Table 3.2-3:
Additional relevant toxicological information
Type of test, species
(Guideline)
Classification of the
Substance
substance
(Concentration
(acc. to the criteria in Dir.
in product,
67/548/EEC and/or in
% w/w)
Reg. (EC) No 1272/2008)
Short-term toxicity
studies
No data – not
required
Toxicological data on
active substance (not
tested with the
preparation)
Bacillus
thuringiensis
subspecies
aizawai strain
GC-91
(50 % (w/w))
Toxicological data on
non-active substances
(not tested with the
preparation)
Reference
Classification of Agree
50 WG
(acc. to the criteria in
Dir. 67/548/EEC, in
Dir. 1999/45/EC and/or
in Reg. (EC) No
1272/2008)
Considering that all
microbials should be
regarded as potential
sensitizers, the agreed
warning phrase is
“Micro-organisms may
have the potential to
provoke sensitising
reactions”. 1)
Considering that all
microbials should be
regarded as potential
sensitizers, the agreed
warning phrase is
“Micro-organisms may
have the potential to
provoke sensitising
reactions”. 1)
None
None
Further relevant
No data – not
toxicological
required
information
1)
In accordance with EFSA Conclusion 2013 Bacillus thuringiensis subsp. aizawai (strains ABTS 1857, GC-91)
(ASB2013-1005)
An overview on the classification and labelling of the preparation is given in paragraph 3.5.
3.3
Dermal Absorption
Not applicable.
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3.4
Safety Assessment of Pesticide Application
Table 3.4-1:
Product information and toxicological reference values used for safety
assessment of pesticide application
Product name and code
Agree 50 WS (MRA-11111-I-0-WG)
Formulation type
Water dispersible granules
Active substance
(incl. content)
Bacillus thuringiensis subspecies aizawai strain GC-91; 500 g/kg, 25000 IU/mg,
3 x 1013 CFU/kg
Category
Insecticide
Container size, short
description
Bags, composite material, 1 kg
Statement as to whether the The safety of the application of Agree 50 WG was not evaluated as part of the EU
product was already
review of Bacillus thuringiensis subspecies aizawai strain GC-91.
evaluated as the
‘representative
formulation’ during the
Annex I inclusion
AOEL systemic
Not derived
Oral absorption
100 %
Inhalative absorption
Considered non-relevant for micro-organisms
Dermal absorption
Considered non-relevant for micro-organisms
3.4.1
Selection of critical uses and justification
The critical GAPs used for the safety assessment of pesticide application are presented in Table 3.4-2. A
list of all intended uses within the zone is given in Appendix 2 of Part B, Section 1.
Page 6 / 23
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Table 3.4-2:
1
UseNo.
2
Zone
Critical uses according to Reg. 1107/2009 (worst case) for safety assessment of pesticide application (Agree 50 WG, 500 g a.s./kg,
3 x 1013 CFU/kg)
3
Crop and/
or situation
(crop destination /
purpose of crop)
1*
2 */#
3 **
4 **/°
5**/°
6**/°
4
F
G
or
I
5
controlled
6
Method /
Kind
(additionally:
(a)
Central Grape vine (VITVI)
grape)
(b)
F
(c)
Grape berry moth
2nd and 3rd generation
(L1-L2)
(d-f)
Spraying or
fine spraying
(low volume
spraying)
Central Berries (NNNOB)
except for strawberries
F
Free biting caterpillars
Spraying or
fine spraying
(low volume
spraying)
Central Strawberries (FRAAN)
F
Central Leafy and stem
vegetables (/NNNVL)
except for vegetable
cabage
F
Central Vegetable cabage
(BRSOX)
F
Central Root and tuber
vegetables
F
Spraying or
fine spraying
(low volume
spraying)
Spraying or
fine spraying
(low volume
spraying)
Spraying or
fine spraying
(low volume
spraying)
Spraying or
fine spraying
(low volume
spraying)
7
Application
Timing / Growth
stage of crop &
season
8
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
(h)
(g)
From emergence of
3;3
first larvae after
beginning of
(at least 7 days)
infestation or
warning service
appeal / from
BBCH 53
After beginning of
3;3
infestation; from
emergence of first (at least 7 days)
larvae / from
BBCH 11
3;3
After beginning of
infestation; from
larvae / from
BBCH 13
After beginning of
3;3
infestation; from
larvae / from
BBCH 09
After beginning of
3;3
infestation; from
larvae / from
BBCH 09
After beginning of
3;3
infestation; from
larvae / from
BBCH 09
Page 7 / 23
10
11
12
Application rate
Water L/ha
kg product / ha kg as/ha
a) max. rate
min / max
a) max. rate
per appl.
per appl.
b) max. total
b) max. total
rate per
rate per
crop/season
crop/season
a) 0.125 – 0.5
a)
- base dose: 0.25
- BBCH 61: 0.5
- BBCH 71: 0.75
- BBCH75: 1
b) 3
a) 1
b) 1.5
a) 0.5
b) 3
b) 1.5
a) 1
a) 0.5
b) 3
b) 1.5
a) 1
a) 0.5
b) 3
b) 1.5
a) 1
a) 0.5
b) 3
b) 1.5
a) 1
a) 0.5
b) 3
b) 1.5
- base dose: 400
- BBCH 61: 800
- BBCH 71: 1200
- BBCH 75: 1600
max. 1000
1000 - 2000
200 - 800
200 - 800
200 - 800
13
PHI
(days)
(i)
14
Remarks:
safener/synergist
per ha
recommended or
mandatory tank
mixtures
(j)
Agree 50 WG – ZV1 007638-00/00
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7**/°
8**/°
9*
10 *
Central Bulb crops (NNNSZ)
Central Herbs (NNNKR)
Central Pulse crops (NNNLG)
Central Ornamentals (NNNZZ)
F
F
F
F
Spraying or
fine spraying
(low volume
spraying)
Spraying or
fine spraying
(low volume
spraying)
Spraying or
fine spraying
(low volume
spraying)
Spraying or
fine spraying
(low volume
spraying)
After beginning of
infestation; from
emergence of first
larvae / from
BBCH 09
After beginning of
infestation; from
emergence of first
larvae / from
BBCH 09
After beginning of
infestation; from
emergence of first
larvae / from
BBCH 09
After beginning of
infestation; from
emergence of first
larvae
3;3
a) 1
a) 0.5
(at least 7 days)
b) 3
b) 1.5
3;3
a) 1
a) 0.5
(at least 7 days)
b) 3
b) 1.5
3;3
a) < 50 cm: 0.5
a) 0.25 – 0.5
(at least 7 days) 50-125 cm: 0.75
> 125 cm: 1
6;6
b) 3
a) < 50 cm: 0.5
b) 1.5
a) 0.25 – 0.5
(at least 7 days) 50-125 cm: 0.75
> 125 cm: 1
11**** Central Berries (NNNOB)
except for strawberries
12**** Central Fruit vegetables
13**** Central Pulse crops (NNNLG)
14**** Central Ornamentals (NNNZZ)
G
G
G
G
Spraying or
fine spraying
(low volume
spraying)
Spraying or
fine spraying
(low volume
spraying)
Spraying or
fine spraying
(low volume
spraying)
Spraying or
fine spraying
(low volume
spraying)
After beginning of
infestation; from
emergence of first
larvae / from
BBCH 11
After beginning of
infestation; from
emergence of first
larvae / from
BBCH 09
After beginning of
infestation; from
emergence of first
larvae / from
BBCH 09
After beginning of
infestation; from
emergence of first
larvae
Page 8 / 23
3;3
b) 6
a) 1
b) 3
a) 0.5
(at least 7 days)
b) 3
b) 1.5
6;6
a) < 50 cm: 0.5
a) 0.25 – 0.5
(at least 7 days) 50-125 cm: 0.75
> 125 cm: 1
3;3
b) 6
a) < 50 cm: 0.5
b) 3
a) 0.25 – 0.5
(at least 7 days) 50-125 cm: 0.75
> 125 cm: 1
6;6
b) 3
a) < 50 cm: 0.5
(at least 7 days) 50-125 cm: 0.75
b) 1.5
a) 0.25 – 0.5
200 - 800
200 - 800
< 50 cm: min
600
50-125 cm: min
900
> 125 cm: min
1200
< 50 cm: min
600
50-125 cm: min
900
> 125 cm: min
1200
max. 1000
< 50 cm: min
600
50-125 cm: min
900
> 125 cm: min
1200
< 50 cm: min
600
50-125 cm: min
900
> 125 cm: min
1200
< 50 cm: min
600
50-125 cm: min
900
Agree 50 WG – ZV1 007638-00/00
zRMS version
> 125 cm: min
1200
> 125 cm: 1
b) 6
*
**
***
****
b) 3
Critical GAPs for operators in high crops outdoors, German model
Critical GAPs for operators in low crops outdoors, German model
has to be clarified
Critical GAPs for operators in high crops in the greenhouse, German model and exposure data by Mich (1996); all intended uses on low crops in the greenhouse are covered by these
critical GAPs on high crops
#
Critical GAPs for operators in high crops outdoors, UK POEM
°
Critical GAPs for operators in low crops outdoors, UK POEM
(g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants,
Remarks:
(a) For crops, the EU and Codex classifications (both) should be used; where relevant,
1997, Blackwell, ISBN 3-8263-3152-4), including where relevant,
the use situation should be described (e.g. fumigation of a structure)
information on season at time of application
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(h) The minimum and maximum number of application possible under practical
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
conditions of use must be provided
(d) All abbreviations used must be explained
(i) PHI - minimum pre-harvest interval
(e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting,
(j) Remarks may include: Extent of use/economic importance/restrictions
drench
(f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the
plants - type of equipment used must be indicated
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3.4.2
Evaluation of the Active Substance Bacillus thuringiensis ssp.
GC-91
3.4.2.1
Operator exposure and risk assessment
aizawai strain
Estimation of operator exposure and risk assessment
Even if this approach using the below mentioned German model is not suitable for exposure estimation in
the case of micro-organisms (cf. EFSA conclusion on B.thuringiensis ssp. kurstaki), it may provide a
rough overview of operator exposure. Estimations according to the UK POEM are not deemed necessary.
Table 3.4-3:
Critical uses
Models
Table 3.4-4:
Model data
Exposure models for intended uses
Ornamentals, grape vine, strawberries and various others
(max. 6 x 1 kg Agree 50 WG/ha)
German model (available on
http://www.bfr.bund.de/cm/343/anwendersicherheit_deutsches_modell_v1.xls)
[Uniform Principles for Safeguarding the Health of Applicators of Plant Protection
Products (Uniform Principles for Operator Protection), Mitteilungen aus der
Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277,
1992]
Estimated operator exposure towards Bacillus thuringiensis subspecies aizawai
strain GC-91
External exposure
(mg/kg bw/day)
Level of PPE
Total external exposure
(mg/kg bw/day)
Tractor mounted boom spray application outdoors to low crops
Application rate: 0.5 kg a.s./ha
German Model
Body weight: 70 kg
no PPE 1)
inhalative: 0.001286
dermal: 0.577143
0.57843
with PPE 2)
dermal: 0.294286
0.29557
no PPE 1)
dermal: 0.771426
0.77291
with PPE 2)
dermal: 0.658286
0.65977
no PPE 1)
inhalative: 0.002286 3)
dermal: 0.438571
0.44086
with PPE 2)
inhalative: 0.002286 3)
dermal: 0.290071
0.29236
Air assisted spray application outdoors to high crops
German Model
Body weight: 70 kg
Hand-held spray application outdoors to high crops
German Model
Body weight: 70 kg
1)
2)
no PPE: Operator wearing T-shirt and shorts
with PPE: gloves during mixing/loading (PPE acc. to the Federal Office of Consumer Protection and Food Safety (BVL);
2006; Personal protective equipment for handling plant protection products - Guidelines for requirements concerning
personal protective equipment in plant protection)
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3)
scenario resulting in the worst predicted exposure via inhalation
For the detailed calculations it is referred to Appendix 2.
Estimation of operator exposure based on measured values and risk assessment
Operator exposure was estimated using a GLP study performed for the generic assessment of products
applied in greenhouses. Even if this approach is not suitable for exposure estimation in the case of microorganisms (cf. EFSA conclusion on B.thuringiensis ssp. kurstaki), it may provide a rough overview of
operator exposure.
Detailed considerations and calculations as well as a summary of the greenhouse study it is referred to
Appendices 3.
Estimation of operator exposure based on measured values after greenhouse applications and risk
assessment
Table 3.4-5:
Exposure models for intended uses
Critical uses
Fruit vegetables, ornamentals and others (max. 6 x 1 kg Agree 50 WG/ha)
Model
German model (available on
http://www.bfr.bund.de/cm/343/anwendersicherheit_deutsches_modell_v1.xls)
[Uniform Principles for Safeguarding the Health of Applicators of Plant Protection
Products (Uniform Principles for Operator Protection), Mitteilungen aus der
Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277,
1992] and
Exposure study according to Mich (1996)
Table 3.4-6:
Model data
Estimated operator exposure towards Bacillus thuringiensis subspecies aizawai
strain GC-91
External exposure
(mg/kg bw/day)
Level of PPE
(mg/kg bw/day)
Knapsack spray applications in greenhouses to high crops
German Model and
Exposure study
Body weight: 70 kg
1)
2)
no PPE 1)
dermal: 0.844467
0.84538
with PPE 2)
dermal: 0.695967
0.69688
no PPE: Operator wearing T-shirt and shorts
with PPE: gloves during mixing/loading (PPE acc. to the Federal Office of Consumer Protection and Food Safety (BVL);
2006; Personal protective equipment for handling plant protection products - Guidelines for requirements concerning
personal protective equipment in plant protection
For the detailed calculations it is referred to Appendix 2.
Up to now (cf. DAR by Italy, LoEP 2007) no dose-effect relationship, no specific target organ or NOAEL
could be determined for Bacillus thuringiensis ssp.aizawai strain GC-91.
Since no dermal uptake of micro-organisms is anticipated through the intact skin, no systemic exposure
will result from this path of entry.
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Exposure towards Bacillus thuringiensis ssp.aizawai strain GC-91 via inhalation will normally be cleared
by mucociliary clearance mechanisms. Even if this clearance is delayed and/or slow, as was figured out
during the EU review process for Bacillus thuringiensis ssp. kurstaki strain SA-11, it can be assumed that
at least part of the primarily inhaled micro-organisms can be ingested. As a worst case assumption all
inhaled bacilli might be ingested.
In order to address that Bacillus species (other than B. cereus) might cause food poisoning the following
considerations are taken as a basis: The minimum dose reported for potentially pathogenic microorganisms involved in foodborne illness is 106 CFU/g food according to the opinion of the EFSA Panel
on Biological Hazards on Bacillus cereus and other Bacillus ssp in food stuffs (EFSA Journal 2005, 175).
If ingestion of 100 g contaminated food is assumed, 108 CFU of such pathogenic Bacillus species could
cause diarrhea. Although Bacillus thuringiensis ssp. aizawai GC-91 is not pathogenic, the respective
estimated inhalation exposure is compared with this reference value of 108 CFU/day. On the basis of
70 kg body weight for operators this corresponds to 1.43 x 106 CFU/kg bw/day.
According to the German model (‘worst case’: hand-held equipment, outdoor application on high crops)
2.286 µg/kg bw/day of bacilli are inhaled during application of Agree 50 WG without RPE (see above).
This corresponds to 1.37 x 105 CFU/mg bw/day. Thus, there is a margin of safety of 10.4 between the
estimated operator exposure via inhalation and the assumed reference value (1.43 x 106 CFU/kg bw/day /
1.37 x 105 CFU/mg bw/day).
Therefore and probably due to the sensitising potential of micro-organisms, the applicant recommends the
use of adequate PPE (including RPE) during mixing/loading and application by the operator.
Since the above mentioned assumptions seem to overestimate exposure significantly and hence represent
unrealistic worst case conditions, the use of RPE by the operator is not deemed required for the use of
Agree 50 WG in the greenhouse or outdoor under the actual described conditions of use (e.g. handling of
nearly dustfree WG (approximately 0.01% w/w, attrition resistance approximately 99.96 %, cf. dRR
Part B – section 1 by the applicant, ASB2012-9812) during mixing/loading and 0.5 % (w/v)
Agree 50 WG in the spray dilution at the most).
3.4.2.2
Worker exposure and risk assessment
Estimation of worker exposure and risk assessment
Since workers are normally potentially exposed towards dry foliar residues on plant surfaces, intensive
dermally exposure might occur. This might be enhanced by multiple applications. In this case max. 6
applications of Agree 50 WG are intended. Although no systemic effects are to be expected by dermal
contact because no penetration of Bacillus thuringiensis through intact skin is considered likely, the use
of gloves and protective garment is necessary for workers during re-entry tasks due to the sensitising
potential of Agree 50 WG.
3.4.2.3
Bystander and resident exposure and risk assessment
In the case of greenhouse applications no bystander or resident exposure is expected.
Bystanders of outdoor applications may be potentially exposed towards spray mist during the application
of Agree 50 WG, whereas residents could be exposed towards spray deposits on surfaces after
application.
Since micro-organisms may have the potential for sensitisation, this has to be taken into account in risk
assessment for bystanders and residents. But, there is no reference value for this toxicological property.
In this particular case the plant protection product is applied at a maximum concentration of 0.5 % (w/v).
Therefore, from a formal point of view the spray solution is not considered sensitising (< 1 % w/w) so
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that most likely there will be no risk for bystanders and residents.
But, in order to further minimise the potential exposure of bystanders and residents and thus further
reduce the probability of sensitisation the use of drift-reducing nozzles (tractor-mounted equipment) or
spraying shields (hand-held equipment) is recommended mandatorily.
3.4.3
Conclusion of Exposure Estimation and Risk Assessment
The risk assessment according to the German model and the exposure study by Mich as well as
qualitative considerations have shown that exposure towards Bacillus thuringiensis subspecies aizawai
strain GC-91 in Agree 50 WG is not considered to give rise to concern for operators, workers, bystanders
or residents in the greenhouse or in the case of outdoor applications. Due to potential sensitisation by
micro-organisms the need of personal protective equipment, i.e. gloves and protective garment is
highlighted for operators and workers.
Notwithstanding the recommendation by the applicant, where respiratory protection is explicitly included
into the protection equipment for operators, this is not deemed necessary in this particular case due to
intended uses and the formulation of the product.
Further reduction of exposure is to be expected due to necessary PPE allocated according to dangerous
substances regulations.
If the product is used properly and according to the intended conditions of use, adverse health effects for
operators, workers, bystanders and residents will not be expected.
3.5
Justified Proposals for Classification and Labelling and Safety Instructions
Justified proposals for classification and labelling
In accordance with Directives 67/548/EEC and 1999/45/EC the following classification and labelling
with regard to toxicological data is proposed for the preparation:
Table 3.5-1:
Classification and labelling according to Directives 67/548/EEC and
1999/45/EC
Hazard symbol:
Xi
Irritating
Risk phrases:
R43
Safety phrases:
2-24-36-37-46
To avoid risks to man and the environment, comply with the instructions for
use.
‘Micro-organisms may have the potential to provoke sensitising reactions.’
According to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008, the following classification for toxicological hazards of the preparation
according to GHS would be proposed:
Table 3.5-2:
Hazard class, category:
Classification and labelling according to Regulation (EC) No 1272/2008
Skin Sens. 1
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Signal word:
Warning
Hazard statement:
H317
To avoid risks to man and the environment, comply with the instructions for
use.
‘Micro-organisms may have the potential to provoke sensitising reactions.’
'30 to 50 percent of the mixture consist of ingredients of unknown oral, dermal
and inhalation toxicity.' 1)
1)
Depending on individual composition of test substance which is not exactly known in every particular case.
Safety instructions
Table 3.5-3:
Safety phrases for instructions for use
Safety instructions (codes according to BVL 1))
1)
2)
1
2
3
4
Justification 2)
SB001
Avoid any unnecessary contact with the product. Misuse can lead to health
damage.
1
SB110
The directive concerning requirements for personal protective gear in plant
protection, "Personal protective gear for handling plant protection products" of
the Federal Office of Consumer Protection and Food Safety must be observed.
1
SF1891
Re-entering the treated areas/crops is only possible on the day of application
wearing personal protective equipment which is specified for applying the
particular product. Successive work on/in treated areas/crops may
fundamentally not be carried out until 24 hours after applying the product.
Within the first 48 hours, protective suits against pesticides and standard
protective gloves (plant protection) are to be worn.
2
SS110
Wear standard protective gloves (plant protection) when handling the undiluted
product.
3
SS2101
Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots)
when handling the undiluted product.
3
SS2202
Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots)
when applying/handling the product ready for application.
2
VH650
The packaging must be provided with the wording "micro-organisms may have
the potential to provoke sensitising reactions".
3
The product must be applied using loss reducing equipment which is registered
in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette
No 205, p. 9780) as amended, and be registered in at least drift reducing class
75 %.
2
http://www.bvl.bund.de/SharedDocs/Downloads/04_Pflanzenschutzmittel/eAntrag-CodelistenEN.pdf?__blob=publicationFile&v=6
Justification:
Mandatory for plant protection products
With regard to preventive health protection and good agricultural practice
Based on BBA-Guideline Part I, 3-3 (1993) with regard to the dangerous substance directive
(Biologische Bundesanstalt für Land- und Forstwirtschaft, Richtlinen für die Prüfung von Pflanzenschutzmitteln –
Kennzeichnung von Pflanzenschutzmitteln (Gesundheitsschutz) (Federal Biological Research Centre for Agriculture and
Forestry, Guidelines for Evaluation of Plant Protection Products – Labelling of Plant Protection Products (Human Health))
Based on the exposure estimation according to the German model and exposure data by Mich (1996) for the operator and
the uniform principles for the protection of workers: None
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Appendix 1 List of Data Submitted in Support of the Evaluation
Table A 1:
List of data submitted in support of the evaluatio
Annex point/
reference No
Author
Year
All
EFSA
2013
Mich, G.
1996
OECD: KIIIM1
7.1.1
Xxx
1991
OECD: KIIIM1
7.1.1
Xxx
1992
OECD: KIIIM1
7.1.2, OECD:
KIIIM1 7.1.4
Xxx
1991
OECD: KIIIM1
7.1.3
Xxx
1991
OECD: KIIIM1
7.1.3
Xxx
1993
OECD: KIIIM1
7.1.5
Xxx
1991
OECD: KIIIM1
7.1.6
Xxx
1999
Title
Report-No.
Aizawai (strains ABTS 1857, GC-91)
EFSA Journal 2013;aa(1):3063
ASB2013-1005
Operator exposure in greenhouses
during practical use of plant protection
products
EF 94-02-03 ! MO-00-002686 ! M024096-01-1
BVL-1752398, BVL-1760625, BVL1771380, BVL-1771381, BVL1937458,
TOX2000-2081
CGA-237218 WP FL-910959: Acute
oral toxicity study in rats with a
microbial pest control agent (MPCA)
8188-91
BVL-2294311,
ASB2012-9779
Agree FL-920303 (CGA-237218 WP):
Acute oral toxicity study in rats with a
microbial pest control agent (MCPA)
8938-92
BVL-2294312,
Z48651
Agree (CGA-237218 WP) FL-911716:
Acute dermal toxicity/irritation study in
rabbits with a microbial pest control
agent (MPCA)
8373-91
BVL-2294313, BVL-2294316,
ASB2012-9780
CGA-237218 WP FL-910986: Acute
inhalation toxicity study in rats with a
8200-91
BVL-2294314,
Z48652
Agree FL-921616: Acute inhalation
toxicity study in rats with a microbial
pest control agent
9398-92
BVL-2294315,
ASB2012-9781
CGA-237218 WP FL-910959: Primary
eye irritation study in rabbits with a
8189-91,
BVL-2294317,
ASB2012-9782
AGREE 50WP: Skin sensitization test
99/1054-1A ! B99/0036.A,
BVL-2294318,
ASB2012-9783
Page 15 / 23
Data
protection
claimed
Owner
How
considered in
dRR *
Add
Add
CEU
Y
CEU
Y
CEU
Y
CEU
Y
CEU
Y
CEU
Y
CEU
Y
Agree 50 WG – ZV1 007638-00/00
zRMS version
Annex point/
reference No
Author
Year
OECD: MIIIM1
Sec 1
Applicant
2012
* Y:
N:
Add:
Data
Title
protection
Report-No.
claimed
Bacillus thuringiensis ssp. aizawai GC91 / Agree 50 WG: Identity, physical,
chemical and technical properties, data
on application, further information,
classification and labelling on the plant
protection product - Tier 2, IIIA-1,2,3,4
- Draft registration report - Part B - Core
assessment MIII / Sec. 1,
BVL-2288427, BVL-2298152,
ASB2012-9812
Yes, relied on
No, not relied on
Page 16 / 23
Owner
How
considered in
dRR *
Y
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Appendix 2 Exposure Calculations
A 2.1
Exposure Calculations for Bacillus thuringiensis ssp. aizawai strain GC-91
A 2.1.1
Operator exposure calculations
Table A 2:
Formulation type:
Application rate (AR):
Area treated per day (A):
Dermal absorption (DA):
Inhalation absorption (IA):
Body weight (BW):
AOEL
Estimation of operator exposure towards Bacillus thuringiensis subspecies
aizawai strain GC-91 using the German model (FCTM)
WG
0.5
20
0
0
100
70
Not derived
Application technique:
kg a.s./ha
ha
% (concentr.)
% (dilution)
%
kg/person
mg/kg bw/d
Dermal hands m/l (DM(H)):
Dermal hands appl. (DA(H)):
Dermal body appl. (DA(B)):
Dermal head appl. (DA(C)):
Inhalation m/l (IM):
Inhalation appl. (IA):
Field crop tractor mounted
2
0.38
1.6
0.06
0.008
0.001
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
Operator exposure towards Bacillus thuringiensis ssp. aizawai strain GC-91
Without PPE
Operators: External dermal exposure after application in
strawberries, cabbage
Dermal exposure during mixing/loading
Hands
EDEOM(H) = (DM(H) x AR x A) / BW
(2 x 0.5 x 20) / 70
External dermal exposure
20 mg/person
0.285714 mg/kg bw/d
Dermal exposure during application
Hands
EDEOA(H) = (DA(H) x AR x A) / BW
(0.38 x 0.5 x 20) / 70
3.8 mg/person
0.054286 mg/kg bw/d
Body
EDEOA(B) = (DA(B) x AR x A) / BW
(1.6 x 0.5 x 20) / 70
16 mg/person
0.228571 mg/kg bw/d
Head
EDEOA(C) = (DA(C) x AR x A) / BW
(0.06 x 0.5 x 20) / 70
0.6 mg/person
0.008571 mg/kg bw/d
Total external dermal exposure: EDEO = EDEOM(H) + EDEOA(H) +
EDEOA(B) + EDEOA(C)
Total external dermal exposure
40.4 mg/person
0.577143 mg/kg bw/d
Operators: External inhalation exposure after application in
strawberries, cabbage
Inhalation exposure during mixing/loading
EIEOM = (IM x AR x A) / BW
(0.008 x 0.5 x 20) / 70
External inhalation exposure
0.08 mg/person
0.001143 mg/kg bw/d
Inhalation exposure during application
EIEOA = (IA x AR x A) / BW
(0.001 x 0.5 x 20) / 70
With PPE
Hands
EDEOM(H) = (DM(H) x AR x A x PPE 1)) / BW
(2 x 0.5 x 20 x 0.01) / 70
0.2 mg/person
0.002857 mg/kg bw/d
Hands
EDEOA(H) = (DA(H) x AR x A x PPE) / BW
(0.38 x 0.5 x 20 x 1) / 70
3.8 mg/person
0.054286 mg/kg bw/d
Body
EDEOA(B) = (DA(B) x AR x A x PPE) / BW
(1.6 x 0.5 x 20 x 1) / 70
16 mg/person
0.228571 mg/kg bw/d
Head
EDEOA(C) = (DA(C) x AR x A x PPE) / BW
(0.06 x 0.5 x 20 x 1) / 70
0.6 mg/person
0.008571 mg/kg bw/d
EDEOA(B) + EDEOA(C)
20.6 mg/person
0.294286 mg/kg bw/d
EIEOM = (IM x AR x A x PPE) / BW
(0.008 x 0.5 x 20 x 1) / 70
EIEOA = (IA x AR x A x PPE) / BW
(0.001 x 0.5 x 20 x 1) / 70
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0.001143 mg/kg bw/d
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0.01 mg/person
0.000143 mg/kg bw/d
Total external inhalation exposure: EIEO = EIEOM + EIEOA
Total external inhalation exposure
0.09 mg/person
Total external inhalation exposure 0.0012857 mg/kg bw/d
0.01 mg/person
0.000143 mg/kg bw/d
0.09 mg/person
Total external inhalation exposure 0.0012857 mg/kg bw/d
Total external exposure: EEO = EDEO + EIEO
0.57843 mg/kg bw/d
0.29557 mg/kg bw/d
1)
reduction factor for gloves is 0.01 (professional appl.)
Table A 3:
Formulation type:
Body weight (BW):
AOEL
aizawai strain GC-91 using the German model (HCTM)
WG
0.5
20
0
0
100
70
Not derived
kg a.s./ha
ha
% (concentr.)
% (dilution)
%
kg/person
mg/kg bw/d
High crop tractor mounted
2
0.7
9.6
1.2
0.008
0.018
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
Without PPE
ornamentals
Hands
(2 x 0.5 x 8) / 70
8 mg/person
0.114286 mg/kg bw/d
Hands
(0.7 x 0.5 x 8) / 70
2.8 mg/person
0.04 mg/kg bw/d
Body
(9.6 x 0.5 x 8) / 70
38.4 mg/person
0.548571 mg/kg bw/d
Head
(1.2 x 0.5 x 8) / 70
4.8 mg/person
0.068571 mg/kg bw/d
EDEOA(B) + EDEOA(C)
54 mg/person
0.771429 mg/kg bw/d
ornamentals
(0.008 x 0.5 x 8) / 70
0.032 mg/person
0.000457 mg/kg bw/d
With PPE
Hands
(2 x 0.5 x 8 x 0.01) / 70
0.08 mg/person
0.001143 mg/kg bw/d
Hands
(0.7 x 0.5 x 8 x 1) / 70
2.8 mg/person
0.04 mg/kg bw/d
Body
(9.6 x 0.5 x 8 x 1) / 70
38.4 mg/person
0.548571 mg/kg bw/d
Head
(1.2 x 0.5 x 8 x 1) / 70
4.8 mg/person
0.068571 mg/kg bw/d
EDEOA(B) + EDEOA(C)
46.08 mg/person
0.658286 mg/kg bw/d
(0.008 x 0.5 x 8 x 1) / 70
Page 18 / 23
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0.000457 mg/kg bw/d
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(0.018 x 0.5 x 8) / 70
0.072 mg/person
0.001029 mg/kg bw/d
0.104 mg/person
0.001486 mg/kg bw/d
(0.018 x 0.5 x 8 x 1) / 70
0.072 mg/person
0.001029 mg/kg bw/d
0.104 mg/person
0.001486 mg/kg bw/d
0.77291 mg/kg bw/d
0.65977 mg/kg bw/d
1)
Table A 4:
Formulation type:
Body weight (BW):
AOEL
aizawai strain GC-91 using the German model (HCHH)
WG
0.5
1
0
0
100
70
Not derived
kg a.s./ha
ha
% (concentr.)
% (dilution)
%
kg/person
mg/kg bw/d
High crop hand held
21
10.6
25
4.8
0.02
0.3
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
Without PPE
ornamentals
Hands
(21 x 0.5 x 1) / 70
10.5 mg/person
0.15 mg/kg bw/d
Hands
(10.6 x 0.5 x 1) / 70
5.3 mg/person
0.075714 mg/kg bw/d
Body
(25 x 0.5 x 1) / 70
12.5 mg/person
0.178571 mg/kg bw/d
Head
(4.8 x 0.5 x 1) / 70
2.4 mg/person
0.034286 mg/kg bw/d
EDEOA(B) + EDEOA(C)
30.7 mg/person
0.438571 mg/kg bw/d
ornamentals
With PPE
Hands
(21 x 0.5 x 1 x 0.01) / 70
0.105 mg/person
0.0015 mg/kg bw/d
Hands
(10.6 x 0.5 x 1 x 1) / 70
5.3 mg/person
0.075714 mg/kg bw/d
Body
(25 x 0.5 x 1 x 1) / 70
12.5 mg/person
0.178571 mg/kg bw/d
Head
(4.8 x 0.5 x 1 x 1) / 70
2.4 mg/person
0.034286 mg/kg bw/d
EDEOA(B) + EDEOA(C)
20.305 mg/person
0.290071 mg/kg bw/d
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(0.02 x 0.5 x 1) / 70
0.01 mg/person
0.000143 mg/kg bw/d
(0.3 x 0.5 x 1) / 70
0.15 mg/person
0.002143 mg/kg bw/d
0.16 mg/person
0.002286 mg/kg bw/d
(0.3 x 0.5 x 1 x 1) / 70
0.15 mg/person
0.002143 mg/kg bw/d
0.16 mg/person
0.002286 mg/kg bw/d
0.44086 mg/kg bw/d
0.29236 mg/kg bw/d
1)
(0.02 x 0.5 x 1 x 1) / 70
0.01 mg/person
0.000143 mg/kg bw/d
Table A 5:
Formulation type:
Body weight (BW):
AOEL
aizawai strain GC-91 using the German model and the exposure data by
Mich (1996)
WG
0.5
1
0
0
100
70
Not derived
kg a.s./ha
ha
% (concentr.)
% (dilution)
%
kg/person
mg/kg bw/d
High crops hand held, greenhouse
21
13.1884
82.47509
1.56194
0.02
0.10841
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
Without PPE
fruit vegetables
Hands
(21 x 0.5 x 1) / 70
10.5 mg/person
0.15 mg/kg bw/d
Hands
(13.1884 x 0.5 x 1) / 70
6.5942 mg/person
0.094203 mg/kg bw/d
Body
(82.47509 x 0.5 x 1) / 70
41.237545 mg/person
0.589108 mg/kg bw/d
Head
(1.56194 x 0.5 x 1) / 70
0.78097 mg/person
0.011157 mg/kg bw/d
EDEOA(B) + EDEOA(C)
59.112715 mg/person
0.844467 mg/kg bw/d
With PPE
Hands
(21 x 0.5 x 1 x 0.01) / 70
0.105 mg/person
0.0015 mg/kg bw/d
Hands
(13.1884 x 0.5 x 1 x 1) / 70
6.5942 mg/person
0.094203 mg/kg bw/d
Body
(82.47509 x 0.5 x 1 x 1) / 70
41.237545 mg/person
0.589108 mg/kg bw/d
Head
(1.56194 x 0.5 x 1 x 1) / 70
0.78097 mg/person
0.011157 mg/kg bw/d
EDEOA(B) + EDEOA(C)
48.717715 mg/person
0.695967 mg/kg bw/d
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fruit vegetables
(0.02 x 0.5 x 1) / 70
0.01 mg/person
0.000143 mg/kg bw/d
(0.10841 x 0.5 x 1) / 70
0.054205 mg/person
0.000774 mg/kg bw/d
0.064205 mg/person
0.000917 mg/kg bw/d
(0.10841 x 0.5 x 1 x 1) / 70
0.054205 mg/person
0.000774 mg/kg bw/d
0.064205 mg/person
0.000917 mg/kg bw/d
0.84538 mg/kg bw/d
0.69688 mg/kg bw/d
1)
(0.02 x 0.5 x 1 x 1) / 70
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0.01 mg/person
0.000143 mg/kg bw/d
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Appendix 3 Detailed Evaluation of the Exposure Studies Relied upon
Reference:
KIIIM1 7.3.3, Measurement of operator exposure
Report
Mich, G.; 1996; Operator exposure in greenhouses during practical use of
plant protection products. Report No. EF 94-02-03, Doc. No. M-02409601, June 6, 1996; ECON GmbH Ingelheim, conducted in Germany, Dates
of work July, 1994 – June, 1996, TOX2000-2081
Guideline(s):
Following the OECD guidance document for the conduct of studies of
occupational exposure to pesticides during agricultural application, Series
on Testing and Assessment No. 9, 1997
GLP:
Yes (certified laboratory)
Acceptability:
The study is considered to be acceptable.
Materials and methods
To elucidate the potential of operator’s exposure by application of plant protection products in
greenhouses an exposure study was performed. Dermal and inhalation exposure were measured using the
patch technique (passive dosimetry technique), by analysis of whole body underwear, glove and hand
rinsing and absorbent air filters during mixing/loading. The following plant protection products were
applied on ornamentals at 2 sites in Germany: the wettable powder fungicide Euparen WP 50 (a.s.
dichlofluanid), the insecticide Rody (a.s. fenpropathrin) and the fungicide Saprol Neu (a.s. triforine)
(both emulsifiable concentrates). Twelve experienced operators were monitored. The products were
applied with conventionally used knapsack sprayers at recommended rates. All analytical methods were
validated for the various matrixes in a wide range of concentrations.
Samples were extracted for analysis followed by gas chromatographic determination. The results of the
measurements are reported as determined (i.e. µg active substance per sample) and as specific exposure
values, i.e. as mg of exposure per kg of active substance handled. The latter facilitates the use of the data
for generic purposes. Samples were analysed for each of the 3 active substances.
The following scenarios were investigated:
a) mixing and loading Euparen WP 50 for hydraulic knapsack sprayers,
b) application using knapsack sprayers to low cultures on tables,
c) application using knapsack sprayers to high cultures,
d) airborne concentrations after application.
The test substances Euparen WP 50, Rody and Saprol Neu were applied in 4 greenhouses in the low
crop scenario. 4 trials were performed in each house. The treated plants (hibiscus, cyclamen, anturium
and scutelarium) had a height of 10-25 cm (+ 1.15 m table height). In the high crop scenario the test
substances Euparen WP 50, Rody and Saprol Neu were applied in 3 greenhouses. Again 4 trials were
performed in each house. In this scenario roses were treated. They covered a height from 1.2-1.75 metres.
Results and discussion
All data were evaluated according to Lundehn et al., 1992 (TOX2003-430, German Model). For the
calculation of exposure recorded values below limit of quantification were calculated as half the limit of
quantification. Results of geometric mean exposure during application for the three scenarios are given
below.
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Table 3.5-4:
Specific exposure during knapsack application in greenhouse low crops
Route of exposure during application in low crops
Exposure [mg/kg a.s. handled]
Actual
Potential
0.43926
0.43926
0.00894
0.7357
0.22265
6.31994
0.39849
0.39849
Dermal (head)
Dermal (hands)
Dermal (body)
Inhalation
Table 3.5-5:
Specific exposure during knapsack application in greenhouse high crops
Route of exposure during application in high crops
Exposure (mg/kg a.s. handled)
Actual
Potential
1.56194
1.56194
0.00746
13.1884
0.22789
82.47509
0.10841
0.10841
Dermal (head)
Dermal (hands)
Dermal (body)
Inhalation
Conclusions
The study provides appropriate data for hand held scenarios in greenhouses. Application data may be
used for generic purposes. Mixing/loading data are available for one wettable powder preparation (WP)
only. However, it should be considered that the process of mixing/loading for both indoor and outdoor
applications is comparable. Therefore, generic exposure estimates for mixing/loading can be taken from
other models.
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REGISTRATION REPORT
Part B
Section 4: Metabolism and Residues
Product code: Agree 50 WG
Active Substance:
500 g/kg Bacillus thuringiensis ssp. Aizawai GC-91
(3 x 1013 CFU/kg)
Central Zone
CORE ASSESSMENT
Applicant: Mitsui AgriScience International S.A./B.V.
Date:
November 2015
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Table of Contents
4
METABOLISM AND RESIDUES DATA ......................................................................... 3
4.1
Evaluation of the active substances ..................................................................................... 3
4.1.1
Bacillus thuringiensis aizawai strain GC-91 ....................................................................... 3
4.1.1.1
Storage stability ................................................................................................................... 3
4.1.1.2
Metabolism in plants and plant residue definition(s)........................................................... 3
4.1.1.3
Metabolism in livestock and animal residue definition(s) ................................................... 3
4.1.1.4
Residues in rotational crops ................................................................................................. 4
4.1.1.5
Residues in livestock ........................................................................................................... 4
4.2
Evaluation of the intended uses ........................................................................................... 4
4.2.1
Selection of critical use and justification ............................................................................. 4
4.2.2
Fruit and vegetables as compiled in table 8.2-1 (uses 1-18) ................................................ 9
4.2.2.1
Residues in primary crops ................................................................................................... 9
4.2.2.2
Distribution of the residue in peel/pulp ............................................................................. 11
4.2.2.3
Residues in processed commodities .................................................................................. 11
4.2.2.4
Proposed pre-harvest intervals, withholding periods......................................................... 11
4.2.3
Ornamentals (uses 19-21) .................................................................................................. 11
4.2.3.1
Residues in primary crops ................................................................................................. 11
4.2.3.2
Distribution of the residue in peel/pulp ............................................................................. 11
4.2.3.3
Residues in processed commodities .................................................................................. 11
4.2.3.4
Proposed pre-harvest intervals, withholding periods......................................................... 12
4.3
Consumer intake and risk assessment................................................................................ 12
4.3.1
Bacillus thuringiensis ssp. aizawai, strain GC-91 ............................................................. 12
4.4
Proposed maximum residue levels (MRLs) ...................................................................... 12
4.5
Conclusion ......................................................................................................................... 12
Appendix 1
List of data submitted in support of the evaluation ........................................................... 13
Appendix 2
Detailed evaluation of the additional studies relied upon .................................................. 15
Appendix 3
Pesticide Residue Intake Model (PRIMo) ......................................................................... 15
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4
METABOLISM AND RESIDUES DATA
4.1
Evaluation of the active substances
4.1.1
Bacillus thuringiensis aizawai strain GC-91
Table 4.1-1:
Identity of the active substance
Structural formula
not applicable
Common Name
Bacillus thuringiensis aizawai strain GC-91
CAS number
not applicable
4.1.1.1
Storage stability
Table 4.1-2:
Stability of residues (Annex IIA, point 6.1)
Stability of Bacillus thuringiensis aizawai strain
GC-91
4.1.1.2
not applicable
Metabolism in plants and plant residue definition(s)
Metabolism studies were not considered of relevance for viable residues (DAR, IT 2007; ASB201010682).
Table 4.1-3:
Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, 6.6.2 and 6.7.1)
Plant groups covered
none
Rotational crops
none
Metabolism in rotational crops similar to metabolism not applicable
in primary crops? (yes/no)
Distribution of the residue in peel/ pulp
not applicable
Processed commodities (nature of residue)
not necessary
Residue pattern in raw and processed commodities
similar? (yes/no)
not applicable
Plant residue definition for monitoring
None
discussed candidate for Annex IV of Reg. (EC) No
396/2005 (which is currently not supported by DE)
Plant residue definition for risk assessment
none
Conversion factor(s) (monitoring to risk assessment) not applicable
4.1.1.3
Metabolism in livestock and animal residue definition(s)
Metabolism studies in livestock animals were not considered of relevance (DAR, IT 2007; ASB201010682).
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Table 4.1-4:
Metabolism in livestock (Annex IIA, point 6.2.2 to 6.2.5 and 6.7.1)
Animals covered
none
Time needed to reach a plateau concentration in milk not applicable
and eggs
Animal residue definition for monitoring
None
discussed candidate for Annex IV of Reg. (EC) No
396/2005 (which is currently not supported by DE)
Animal residue definition for risk assessment
not applicable
Conversion factor(s) (monitoring to risk assessment) not applicable
Metabolism in rat and ruminant similar (yes/no)
not applicable
Fat soluble residue: (yes/no)
not applicable
4.1.1.4
Residues in rotational crops
No field residue studies in rotational crops were conducted, nor were they deemed necessary due to the
ubiquitous occurrence of Bacillus thuringiensis aizawai strain GC-91 in agricultural environments.
However, in soil the spores of Bacillus thuringiensis spp. are relatively persistent, showing half-live times
above 100 days.
4.1.1.5
Residues in livestock
No calculation of the dietary burden is necessary and livestock feeding studies are not required.
4.2
Evaluation of the intended uses
4.2.1
Selection of critical use and justification
The critical GAPs used for consumer intake and risk assessment are presented in Table 4.2-1.
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Table 4.2-1:
1
2
Critical Use (worst case) used for consumer intake and risk assessment
3
4
5
6
7
8
9
Application
Crop and/
or situation
UseNo.
Member
state(s)
(crop destination /
purpose of crop)
(a)
F
G
or
I
12
13
Remarks:
Method /
Kind
(d-f)
(b)
11
Application rate
controlled
(additionally:
10
(c)
Timing / Growth
stage of crop &
season
(g)
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
(h)
kg product / ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
kg as/ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
Water
L/ha
PHI
(days)
(i)
e.g. recommended or
min / max
(j)
1
grape vine (use as
table and wine grape)
F
Grape berry moth,
European grape vine moth
spraying or
fine spraying (low
volume
spraying)
from BBCH 53;
From emergence of
first larvae after
beginning of
infestation or
warning service
appeal
a)
b)
3
3
a)
b)
0.75
2.3
a)
b)
0.38
1.1
400 / 1200
F
2
grape vine (use as
table and wine grape)
F
Grape berry moth,
European grape vine moth
spraying or
fine spraying (low
volume
spraying)
from BBCH 53;
From emergence of
first larvae after
beginning of
infestation or
warning service
appeal
a)
b)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
400 / 1600
F
3
berries (except
strawberry)
F
spraying or
fine spraying (low
volume
spraying)
from BBCH 11;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
1000
F
4
berries (except
strawberry)
G
spraying or
fine spraying (low
volume
spraying)
from BBCH 11;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
1000
F
5
strawberry
F
spraying or
fine spraying (low
volume
spraying)
from BBCH 13;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
1000 / 2000 F
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1
2
3
4
5
6
7
8
9
Application
Crop and/
or situation
UseNo.
Member
state(s)
(crop destination /
purpose of crop)
(a)
F
G
or
I
12
13
Remarks:
Method /
Kind
(d-f)
(b)
11
Application rate
controlled
(additionally:
10
(c)
Timing / Growth
stage of crop &
season
(g)
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
(h)
kg product / ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
kg as/ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
Water
L/ha
PHI
(days)
(i)
e.g. recommended or
min / max
(j)
6
strawberry
G
spraying or
fine spraying (low
volume
spraying)
from BBCH 13;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
1000 / 2000 F
7
fruiting vegetables
G
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
6
6
a)
b)
1.0
6.0
a)
b)
0.50
3.0
600 / 1200
F
8
Leaf, stem and bulb
vegetables
F
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
200 / 800
F
9
Leaf, stem and bulb
vegetables
G
spraying or
fine spraying (low
volume
spraying)
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
200 / 1000
F
10
Brassica vegetables
F
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
200 / 800
F
11
Brassica vegetables
G
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
200 / 1000
F
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1
2
3
4
5
6
7
8
9
Application
Crop and/
or situation
UseNo.
Member
state(s)
(crop destination /
purpose of crop)
(a)
F
G
or
I
12
13
Remarks:
Method /
Kind
(d-f)
(b)
11
Application rate
controlled
(additionally:
10
(c)
Timing / Growth
stage of crop &
season
(g)
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
(h)
kg product / ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
kg as/ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
Water
L/ha
PHI
(days)
(i)
e.g. recommended or
min / max
(j)
12
root and tuber
vegetables
F
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
200 / 800
F
13
root and tuber
vegetables
G
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
200 / 1000
F
14
bulb vegetables
F
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
200 / 800
F
15
Fresh herbs
F
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
200 / 800
F
16
Fresh herbs
G
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
200 / 800
F
17
Legume vegetables
F
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
600 / 1200
F
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1
2
3
4
5
6
7
8
9
Application
Crop and/
or situation
UseNo.
Member
state(s)
(crop destination /
purpose of crop)
(a)
F
G
or
I
12
Method /
Kind
(c)
Timing / Growth
stage of crop &
season
(g)
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
(h)
kg product / ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
kg as/ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
Water
L/ha
PHI
(days)
(i)
G
spraying or
fine spraying (low
volume
spraying)
from BBCH 09;
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
600 / 1200
F
19
ornamentals
F
spraying or
fine spraying (low
volume
spraying)
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
6
6
a)
b)
1.0
6.0
a)
b)
0.50
3.0
600 / 1200
N
20
ornamentals
G
spraying or
fine spraying (low
volume
spraying)
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
6
6
a)
b)
1.0
6.0
a)
b)
0.50
3.0
600 / 1200
N
21
ornamentals
F
spraying or
fine spraying (low
volume
spraying)
After beginning of
infestation; from
emergence of first
larvae
a)
b)
(7 days)
3
3
a)
b)
1.0
3.0
a)
b)
0.50
1.5
600 / 1200
N
(b)
(c)
(d)
(e)
(f)
For crops, the EU and Codex classifications (both) should be used; where relevant,
the use situation should be described (e.g. fumigation of a structure)
Outdoor or field use (F), glasshouse application (G) or indoor application (I)
e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
All abbreviations used must be explained
Method, e.g. high volume spraying, low volume spraying, spreading, dusting,
drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the
plants - type of equipment used must be indicated
Page 8 / 15
(g)
(h)
(i)
(j)
e.g. recommended or
(j)
Legume vegetables
(a)
min / max
18
Remarks:
13
Remarks:
(d-f)
(b)
11
Application rate
controlled
(additionally:
10
Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season
at time of application
The minimum and maximum number of application possible under practical
conditions of use must be provided
PHI - minimum pre-harvest interval
Remarks may include: Extent of use/economic importance/restrictions
Agree 50 WG – ZV1 007638-00/00
zRMS version
4.2.2
Fruit and vegetables as compiled in table 8.2-1 (uses 1-18)
4.2.2.1
Residues in primary crops
No supervised residue trials were submitted for the assessment of Bacillus thuringiensis ssp. aizawai,
strain GC-91 on any of the crops for which approval is sought. The applicant provided rationales for
waiving such studies, noting particularly the ubiquitous occurrence of the strain, its very specific action
against lepidoptera larvae and the insignificant amount of toxin production.
However, the potential of Bacillus thuringiensis ssp. aizawai, strain GC-91 for the formation of toxins
after application is unclear. Bacillus thuringiensis ssp. aizawai, strain GC-91 proved positive for the
genetic sequences coding the Bacillus cereus toxins, but the rate of formation is expected to be lower.
In a scientific opinion by EFSA (2005, Opinion of the Scientific Panel on Biological Hazards on Bacillus
cereus and other Bacillus spp. in foodstuffs, The EFSA Journal 175, 1-48, ASB2012-9549), an amount of
105 CFU/g food was identified as a point of departure for B. cereus, which, in view of the limited
information available, seems also sufficiently protective for Bacillus thuringiensis ssp. aizawai, strain
GC-91. For estimating the potential amount of CFUs after application of “Agree 50 WG”, an approach
was developed based on harvest yields (Statistisches Bundesamt: Wachstum und Ernte – Fachserie 3,
Reihe 3.2.1 – Gemüse 2011) or empirical residues after foliar treatment as described by MacLachlan and
Hamilton in 2009.
The approach is as follows:
− For all commodities, which are harvested once a year and where the harvested commodity represents
the major part of the whole plant (e.g. brassica vegetables, leafy vegetables), maximum residues are
estimated by correlating the total amount of CFUs applied per hectare to the yield of the crop per
hectare. In case of crop groups, the span between the highest and lowest yield is taken into account.
The degradation rate of Bacillus thuringiensis ssp. aizawai, strain GC-91 is unknown and therefore not
considered.
− For other plants, which contain large percentages of inedible parts (fruit trees, berry bushes etc.) or
which may be harvested continuously (e.g. fruiting vegetables in glasshouse), potential residue levels
can not be calculated in the same way. In these cases the empirical residue values derived by
MacLachlan and Hamilton are used. These values describe typical residue concentrations directly after
application of 1 kg active substance per hectare or within one hectoliter. Based on these values, the
amount of active substance remaining on crops after treatment according to the intended uses can be
estimated and translated into the maximum amount of CFU per g food.
Amount of CFU in the active substance: 3 x 1013 CFU/kg
Use No. 1: Grape vine
Maximum rate per season: 1.1 kg as/ha
Residues according to MacLachlan & Hamilton after application of 1 kg as/ha: Median = 1.5 mg as/kg,
P95 = 6.6 mg as/kg
Calculation according to current GAP:
Median residue:
0.0000015 kg as/kg food × 1.1 kg as/ha → 0.00000165 kg as/kg food = 4.95 x
104 CFU/g food (0.00000165 kg as/kg food × 3 x 1013 CFU/kg = 4.95 x 107
CFU/kg food = 4.95 x 104 CFU/g food)
P95 residue:
0.0000066 kg as/kg food × 1.1 kg as/ha → 0.0000073 kg as/kg food = 2.2 x 105
CFU/g food (0.0000073 kg as/kg food × 3 x 1013 CFU/kg = 2.2 x 108 CFU/kg
food = 2.2 x 105 CFU/g food)
Page 9 / 15
Agree 50 WG – ZV1 007638-00/00
zRMS version
Use No. 2: Grape vine (calculation see use no. 1)
P95 = 6.6 mg as/kg
Median residue:
6.8 x 104 CFU/g food
P95 residue:
Uses No. 3 & 4: Berries, except strawberries (calculation see use no. 1)
Median residues according to MacLachlan & Hamilton after application of 1 kg as/ha: 2.7 mg as/kg
(based on currants)
Median residue:
(P95 not sufficiently reported)
Uses No. 5 & 6: Strawberries (calculation see use no. 1)
P95 = 24 mg as/kg
Median residue:
P95 residue:
Use No. 7: Fruiting vegetables (calculation see use no. 1)
Maximum rate per season: 3 kg as/ha
P95 = 4.3 mg as/kg (based on peppers)
Median residue:
P95 residue:
4 x 105 CFU/g food
Uses No. 8, 9 & 14: Leaf, stem and bulb vegetables
Minimum and maximum yield for leafy vegetables per season: 76.4 dT/ha (Lamb´s lettuce) – 277.4 dT/ha
(head lettuce)
Calculation based on total annual yield:
Minimum residue: 1.5 kg as/ha ÷ 227400 kg yield/ha = 0.0000066 kg as/kg food = 2 x 105 CFU/g food
(0.0000066 kg/kg food × 3 x 1013 CFU/kg = 2 x 108 CFU/kg food = 2 x 105 CFU/g food)
Maximum residue: 1.5 kg as/ha ÷ 76400 kg yield/ha = 0.00002 kg as/kg food = 6 x 105 CFU/g food
(0.00002 kg/kg food × 3 x 1013 CFU/kg = 6 x 108 CFU/kg food = 6 x 105 CFU/g food)
Minimum and maximum yield for stem vegetables per season: 201.8 dT/ha (rhubarb) – 430.3 dT/ha
(celery)
Calculation based on total annual yield (method see use on leafy vegetables):
Minimum residue:
Maximum residue:
Minimum and maximum yield for bulb vegetables per season: 388.5 dT/ha (green onions) – 535.4 dT/ha
(bulb onions)
Minimum residue:
Maximum residue:
Page 10 / 15
Agree 50 WG – ZV1 007638-00/00
zRMS version
Uses No. 10 & 11: Brassica vegetables
Minimum and maximum yield for brassica vegetables per season: 122.2 dT/ha (broccoli) – 772.3 dT/ha
(head cabbage)
Minimum residue:
Maximum residue:
Uses No. 12 & 13: Root and tuber vegetables
For root and tuber vegetables only the aerial part is sprayed. A significant contamination of roots and
tubers with Bacillus thuringiensis ssp. aizawai, strain GC-91 is not expected.
Uses No. 15 & 16: Fresh herbs (calculation see use no. 1)
Residues according to MacLachlan & Hamilton after application of 1 kg as/ha: Median = 19 mg as/kg,
P95 = 104 mg as/kg (based on lettuce)
Median residue:
P95 residue:
Uses No. 15 & 16: Legume vegetables (calculation see use no. 1)
P95 = 8.5 mg as/kg (based on beans with pods)
Median residue:
P95 residue:
From these calculations it is obvious that based on the intended application rates an exceedance of 105
CFU/g food can not be excluded. Further information is required to confirm that the uses applied for can
be considered as safe uses with respect to consumer health (data gap, see Conclusions).
4.2.2.2
Distribution of the residue in peel/pulp
Not applicable.
4.2.2.3
Residues in processed commodities
No data available.
4.2.2.4
Proposed pre-harvest intervals, withholding periods
Currently no proposal for a withholding period is possible, because no residue studies are available.
4.2.3
Ornamentals (uses 19-21)
4.2.3.1
Residues in primary crops
The intended uses are not relevant in terms of consumer health protection. The submission of supervised
residue trials is not necessary.
4.2.3.2
Distribution of the residue in peel/pulp
Not applicable.
4.2.3.3
Residues in processed commodities
Not applicable.
Page 11 / 15
Agree 50 WG – ZV1 007638-00/00
zRMS version
4.2.3.4
Proposed pre-harvest intervals, withholding periods
Not applicable.
4.3
Consumer intake and risk assessment
4.3.1
Bacillus thuringiensis ssp. aizawai, strain GC-91
The Bacillus thuringiensis ssp. aizawai, strain GC-91 contains the genetic information to produce
B.cereus like toxins, however at a lower level. Nevertheless, since no further information is available for
a quantitative risk assessment, it is proposed to apply the suggest value of 105 CFU/g food (EFSA 2005)
also to Bacillus thuringiensis ssp. aizawai, strain GC-91.
The data provided for the application of Bacillus thuringiensis ssp. aizawai, strain GC-91 to food crops is
insufficient to estimate the amount of CFU per g food. The consumer risk assessment for the intended
uses 1-11 and 14-18 can not be finalized at the moment.
The uses 19-21 involve treatment of non-food crops. No dietary risk to consumers is assumed to arise
from these uses.
4.4
Proposed maximum residue levels (MRLs)
No MRLs for Bacillus thuringiensis ssp. aizawai, strain GC-91 are established. Inclusion into Annex IV
of Reg. (EC) No 396/2005 is currently discussed. For the time being Germany is not in favour of this
proposal.
4.5
Conclusion
The available data are considered insufficient for an evaluation of the intended uses on food crops (apart
from root and tuber vegetables, in which no residues are expected). Based on the available information
and the calculations performed so far, an exceedance of 105 CFU/g food can not be excluded for uses
1-11 and 14-18 and thus the uses cannot be considered safe.
For a more realistic estimation of the potential CFUs per g food after treatment with “Agree 50 WG” and
in order to derive appropriate withholding periods (based on degradation rates/ spore half-lives on the
plant surface), supervised residue trials are required. They should be conducted in accordance with the
data requirements laid down in Reg. (EC) No 1107/2009 and consecutive regulations. The following
studies should be provided to fill the data gaps:
− Grapes: 8 trials on grapes are required (outdoor treatment under conditions of the critical GAP with at
least 4 trials conducted as decline trials). Extrapolation to other small fruit and berries grown outdoors
is considered appropriate, though this is not in full compliance with the data requirements. It is noted,
that berries except strawberries are also intended to be treated in glasshouse. However, since this is not
an important use in Germany and both outdoor trials on grapes and indoor trials on strawberries are
required, the overall data package is considered sufficient.
− Strawberries: 8 trials on strawberries are required each for the outdoor and the glasshouse situation
(treatment under conditions of the critical GAP with at least 4 trials each conducted as decline trials)
− Fruiting vegetables: 8 trials on tomatoes are required (indoor treatment under conditions of the critical
GAP with at least 4 trials conducted as decline trials). Extrapolation to other fruiting vegetables grown
indoors is considered appropriate, though this is not in full compliance with the data requirements.
− Brassica, leafy, bulb and stem vegetables: 8 trials on lettuce (open headed varieties) are required each
for the outdoor and the glasshouse situation (treatment under conditions of the critical GAP with at
least 4 trials each conducted as decline trials). Extrapolation to brassica vegetables, other leafy
Page 12 / 15
Agree 50 WG – ZV1 007638-00/00
zRMS version
vegetables (including fresh herbs), stem and bulb vegetables is considered appropriate, though this is
not in full compliance with the data requirements.
− Legume vegetables: 4 trials on beans with pods are required each for the outdoor and the glasshouse
situation (treatment under conditions of the critical GAP with at least 2 trials each conducted as
decline trials). Extrapolation to other legume vegetables is possible.
The use of Bacillus thuringiensis ssp. aizawai, strain GC-91 on ornamentals is not considered relevant in
terms of consumer health protection. The chronic and the short-term intake is unlikely to present a public
health concern.
As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the
intended uses 12-13 and 19-21. It does not agree with the authorization of uses 1-11 and 14-18 for the
reasons outlined above.
Appendix 1
Annex point/
reference No
KIIA 6.3
List of data submitted in support of the evaluation
Author(s)
Year
Italy
2007
EFSA
2005
EFSA
2012
Akiba, Y.
1985
KIIA 6.3
Bae, S.; Fleet, G. H.;
Heard, G. M.
2004
KIIA 6.3
Beegle, C. C.; Dulmage, H.
T.; Wolfenbarger, D. A. et
al.
1981
Title
Report-No.
Bacillus thuringiensis subspecies
aizawai strain GC-91 (Draft Assessment
Report)
GLP: Open Published: Yes
ASB2010-10682
Opinion of the scientific panel of
biological hazards on Bacillus cereus
and other Bacillus spp in foodstuffs
EFSA Journal (2005) 175, 1-48 ! EFSAQ-2004-010
The EFSA Journal, 175, 1-48
BVL-2294154, ASB2012-9549
aizawai (strains ABTS 1857, GC-91)
EFSA Journal 2013;11(1):3063 ! EFSAQ-2009-00247
EFSA Journal (2013) 11 (1), 3063
ASB2013-1005
Microbial ecology of Bacillus
thuringiensis - VI. Germination of
Bacillus thuringiensis spores in the soil
Jpn J Appl Entomol Zool, 21, 76-80
BVL-2294216, ASB2012-9598
Occurrence and significance of Bacillus
thuringiensis on wine grapes
0168-1605 !
10.1016/j.ijfoodmicro.2004.01.013
Int J Food Microbiol, 94, 301-312
BVL-2294218, ASB2012-9600
Persistence of Bacillus thuringiensis
Berliner insecticidal activity on cotton
foliage
Environ Entomol, 10, 400-401
BVL-2294224, ASB2012-9603
Page 13 / 15
Data
protection
claimed
Open
No
Owner
LIT
How
considered in
dRR *
Add
Y
Add
No
LIT
Y
No
LIT
Y
No
LIT
Y
Agree 50 WG – ZV1 007638-00/00
zRMS version
Annex point/
reference No
Author(s)
Year
KIIA 6.3
Benoit, T. G .; Wilson, G.
R.; Bull, D. L. et al.
1990
KIIA 6.3
Damgaard, P. H.; Hansen,
B. M.; Pedersen, J. C. et al.
1996
KIIA 6.3
Hendriksen, N. B.; Hansen,
B. M.
KIIA 6.3
Hostetter, D. L.; Ignoffo, C. 1975
M.; Kearby, W. H.
KIIA 6.3
Ignoffo, C. M.; Hostetter,
D. L.; Pinnell, R. E.
2002
1974
KIIA 6.3
MacLachlan D.J. and
Hamilton, D.
2009
KIIA 6.3
Martin, Ph. A. W.
1994
KIIA 6.3
Pedersen, J. C.; Damgaard,
P. H.; Eilenberg, J. et al.
1994
KIIA 6.3
Pinnock, D. E.; Brand, R.
J.; Jackson, K. L. et al.
1973
KIIA 6.3
Pusztai, M.; Fast, P.;
Gringorten, L. et al.
1991
Title
Report-No.
Plasmid-associated sensitivity of
Bacillus thuringiensis to UV light
0099-2240/90/082282-05
BVL-2294220, RIP9300149
Natural occurrence of Bacillus
thuringiensis on cabbage foliage and in
insects associated with cabbage crops
J Appl Microbiol, 82, 253-258
BVL-2294222, ASB2012-9602
Long-term survival and germination of
Bacillus thuringiensis var. kurstaki in a
field trial
10.1139/W02-009
Can J Microbiol, 48, 256-261
BVL-2294217, ASB2012-9599
Persistence of formulations of Bacillus
thuringiensis spores and crystals on
eastern red cedar foliage in Missouri
J Kansas Entomol Soc, 48, 189-193
BVL-2294213, ASB2012-9595
Stability of Bacillus thuringiensis and
Baculovirus heliothis on soybean foliage
Environ Entomol, 3 (4), 117-119
BVL-2294211, ASB2012-9593
A new tool for the evaluation of crop
residue trial data (day-zero-plus
decline), Food Additives and
Contaminants 2009, 1-18
An iconoclastic view of Bacillus
thuringiensis ecology
Am Entomol, Sommer 1994, 85-90
BVL-2294214, ASB2012-9596
Dispersal of Bacillus thuringiensis var.
kurstaki in an experimental cabbage
field
07019901
Can J Microbiol, 41, 118-125
BVL-2294212, ASB2012-9594
The field persistence of Bacillus
thuringiensis spores on cercis
occidentalis leaves
BVL-2294210, ASB2012-9592
The mechanism of sunlight-mediated
inactivation of Bacillus thuringiensis
crystals
Biochem J, 273, 43-47
BVL-2294209, BVL-2294225,
RIP9300151
Page 14 / 15
LIT
How
considered in
dRR *
Y
No
LIT
Y
No
LIT
Y
No
LIT
Y
No
LIT
Y
no
publ
Add
No
LIT
Y
No
LIT
Y
No
LIT
Y
No
LIT
Y
Data
protection
claimed
No
Owner
Agree 50 WG – ZV1 007638-00/00
zRMS version
Annex point/
reference No
Author(s)
Year
KIIA 6.3
Rosenquist, H.; Smidt, L.;
Andersen, S. R. et al.
2005
KIIA 6.3
Sánchez-Yánez, J. M.;
Pena-Cabriales, J. J.
2000
KIIA 6.3
Smith, R. A.; Barry, J. W.
1997
KIIA 6.3
Smith, R. A.; Couche, G.
A.
1990
KIIA 6.3
Statistisches Bundesamt
2011
* Y:
N:
Add:
Title
Report-No.
Occurrence and significance of Bacillus
cereus and Bacillus thuringiensis in
ready-to-eat food
page 129-136 ! 0378-1097 !
10.1016/j.femsle.2005.06.054
FEMS Microbiol Lett, 250, 129-136
BVL-2294223, ASB2011-60
Persistencia de esporas de Bacillus
thuringiensis en hojas de maiz, de frijol
y en suelo - Persistence of Bacillus
thuringiensis spores on soil and maize
and bean leaves (in Spanish with
English abstract)
LIT
How
considered in
dRR *
Y
No
LIT
Y
No
LIT
Y
No
LIT
Y
no
publ.
Add
Data
protection
claimed
No
Terra, 18 (4), 325-331
BVL-2294219, ASB2012-9601
Environmental persistence of Bacillus
thuringiensis spores following aerial
application
IN974738 ! 0022-2011/98
BVL-2294215, ASB2012-9597
The phylloplane as a source of Bacillus
thuringiensis variants
0099-2240/91/010311-05
BVL-2294221, Z39235
Wachstum und Ernte – Fachserie 3,
Reihe 3.2.1 – Gemüse 2011
Owner
Yes, relied on
No, not relied on
Appendix 2
Detailed evaluation of the additional studies relied upon
Not applicable.
Appendix 3
Pesticide Residue Intake Model (PRIMo)
Not applicable.
Page 15 / 15
Core Assessment
Agree 50 WG
Page 1 of 12
REGISTRATION REPORT
Part B
Section 5: Fate and Behavior in the environment
Product code:
Agree 50 WG
Active Substance:
50% Bacillus thuringiensis
ssp. aizawai GC-91
Central Zone
CORE ASSESSMENT
Applicant:
Mitsui AgriScience International
S.A./B.V.
Date:
November 2015
Applicant Mitsui AgriScience International S.A./B.V.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 2 of 12
Table of Contents
IIIM 9
Fate and behaviour in the environment for the Microbial Pest Control
Product (Rationale to waive testing, based on adequacy of information
provided for MPCA, to permit an assessment of the fate and behaviour
of MPCP in the environment) .............................................................................. 3
General note 3
Summary on environmental behaviour of Bta GC-91 ............................................................... 4
Fate and behaviour in soil ............................................................................................................ 4
Fate and behaviour in water ........................................................................................................ 4
Fate and behaviour in air ............................................................................................................. 5
Predicted Environmental Concentration in Soil (PECS) .......................................................... 7
Predicted Environmental Concentration in Surface Water (PECSW) .................................... 7
Appendix 1: List of data submitted in support of the evaluation ........................................... 8
Appendix 2: Table of Intended Uses justification and GAP tables ........................................ 9
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 3 of 12
IIIM 9
provided for MPCA, to permit an assessment of the fate and behaviour of
MPCP in the environment)
General note
This document reviews data on the environmental behaviour of the microbial plant protection product Agree 50 WG
containing Bacillus thuringiensis ssp. aizawai strain GC-91 (Bta GC-91). Inclusion of Bta GC-91 into Annex I entered
into force in May 2009 (Commission Directive 2008/113/EC1). Bta GC-91 was notified and defended by Mitsui
AgriScience International S.A./B.V. Agree 50 WG was not the representative formulation, and has not been previously
evaluated in the EU according to Uniform Principles. Nonetheless, Agree 50 WG contains the same active substance
(Bta GC-91), in the same proportions, which can be found in the representative formulation Agree 50 WP. It appears
therefore feasible to lean on the data of Agree 50 WP for the evaluation of Agree 50 WG.
This document refers to the conclusions of the EU review of Bta GC-91. The active substance data is relied upon in
the risk assessment of the formulation Agree 50 WG.
Note: this Part B document only reviews data (Annex II or Annex III) and additional information that has not
previously been considered within the EU review process, as part of the Annex I inclusion decision.
The review report for Bta GC-91 (SANCO/1538/08 - rev. 3 final – 06/05/2008) is considered to provide the relevant
review information or a reference to where such information can be found. The data presented in the present dossier
comply with the agreed end points in the Review Report.
The Annex I Inclusion Directive for Bta GC-91 (Commission Directive 2008/113/EC1) provides specific provisions
under Part B, which need to be considered by the applicant in the preparation of their submission and by the MS prior
to granting an authorisation:
-
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the
active substance Bta GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised
in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of
use shall include, where appropriate, risk mitigation measures.
Appendix 1 of this document would contain the list of references included in this document for support of the
evaluation. However, no references are submitted.
Appendix 2 of this document presents the uses of Agree 50 WG. Information on the detailed composition of Agree 50
WG can be found in the confidential dossier of this submission (Registration Report - Part C).
Agree 50 WG is a biological insecticide formulated as water dispersible granules, containing 3 x 1013 colony forming
units (CFU) or 500 g of Bta GC-91 in 1 kg product. The potency of Agree 50 WG is 25,000 IU/mg.
With regard to safety issues, it is important to note that Bta and all other members of the species of Bacillus
thuringiensis are naturally present in our environment. Therefore, their application in pest control means only a
fluctuation of the bacterium population in the biotope of the pest insect. The experience that Bta presents no risk for
the environment has been confirmed by numerous studies. The inclusion of results of other subspecies of Bacillus
thuringiensis or products containing them is justifiable due to close family relationship resulting in much conformity.
1
OJ L 330, 09.12.2008, p.6
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 4 of 12
Summary on environmental behaviour of Bta GC-91
Fate and behaviour in soil
Based on available information derived from studies and published literature on Bacillus thuringiensis bacteria, the
environmental fate and population dynamics of Bta upon field application of Agree 50 WG can be summarized as
follows:
A natural breakdown of the endospores of Bta in soil begins after application onto the fields and gradually reduces the
numbers of spores remaining. Any vegetative cells or crystal proteins are likely to be far more rapidly degraded. This
reduction in numbers will be greatly augmented by the photo degradation effects of sunlight. It is very unlikely that
Bta endospores will germinate and grow into vegetative cells, unless encouraging conditions exist, meaning favourable
soil pH, soil moisture content, sufficient nutrient availability and lack of competition / predation from other soil microorganisms. The good persistence of Bt spores in soil after the first two weeks seems to be a result of their inability to
germinate in soil. Survival and viability of parasporal crystal proteins associated with the application of Agree 50 WG
is expected to be short-term as effects of other soil micro-organisms and natural sunlight, in combination with the
natural degradation of the proteins, occurs. The survival of Bta in the soil is a dynamic process involving sporostasis,
germination and sporulation in specific habitats and will be influenced by changing conditions regarding soil type,
native micro flora, nutrient availability and fertilization.
Fate and behaviour in water
Surface water
Under natural conditions, residues of Bta in water are not considered to be able to persist for very long periods due to
a combination of natural physical and chemical degradation factors such as solar radiation and predation from resident
bacteriophages, protozoans and other lower animal forms. It may be stated that Bta GC-91 is inactivated under natural
conditions, including water.
Ground water
Various experiments examining the movement of Bt in soils following spraying of commercial products containing
Bt showed little or no movement. Even 1 year following an application onto a sandy clay loam soil in a cabbage field
in Denmark, 77% of recovered Btk remained in the 0 to 2 cm topsoil layer (Pedersen et al., 1995, please refer to DAR,
B.8.1.2, 2007). In experiments in Japan, Akiba (1991) (please refer to DAR, B.8.1.2, 2007) found that under artificially
and naturally irrigated conditions, there was no translocation of sprayed Bt into the soil down to a depth of 10 cm.
Artificial irrigation with 450 mm simulated rainfall in a soil column showed no movement through 6 cm of volcanic
ash and only a few bacteria were detected in the flow through water from movement through a 6 cm column of
alluvium sand. Under natural rainfall conditions, a reduction of Bt numbers in the top 0 to 1 cm of surface soil of 71
to 99% occurred in the first week of a 34-day post-application observation period. No dispersion of Bt was detected
in the field soils below 1 cm to investigated depths of 9-10, 19-20 and 29-30 cm. It can thus be concluded that
movement of Bta through the soil by leaching is unlikely to occur.
Additionally, adsorption and binding of protoxins and toxins from Btk have been demonstrated to occur readily,
rapidly and strongly onto the clay fraction and clay humic acid complexes of soils. Desorption occurs far less readily
(Venkateswerlu & Stotzky, 1992; Tapp & Stotzky, 1995; Crecchio & Stotzky, 1998; Crecchio & Stotzky, 2001, please
refer to DAR, B.8.1.2, 2007).
It is thus concluded that no threat of contamination of groundwater exists following applications of Agree 50 WG
according to GAP.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 5 of 12
Fate and behaviour in air
A rapid degradation of Bta in air is assumed since inactivation by solar radiation is a very important factor causing
loss of activity and degradation of bacteria spores and δ-endotoxin crystals in the field environment. Furthermore,
unlike chemical products, evaporation and volatility of bacteria is not expected to be a factor to consider in assessing
the fate in air. Hence volatilisation from plant surfaces and from soil can be excluded. An investigation of
photochemical-oxidative degradation in air is of no relevance in view of the volatility characteristics of the bacteria.
Spray drift, however, can occur following an application of Bta which may lead to temporary concentrations in the
atmosphere which are capable of drifting with wind currents before the spores and crystals in finer spray droplets
settle out. Following an aerial spray program at 4 L product/ha (2.1% Btk concentration), measurements of Btk
concentrations in the air demonstrated an initial half-life (10-hour period from start of spraying) of 3.3 hours. The
overall half-life determined during the nine-day monitoring period was 2.4 days, (Teschke et al., 2001, please refer to
DAR, B.8.1.3, 2007). This gives an indication of the rapid disappearance of spray droplets containing Bta and
parasporal crystals from air.
Concentrations of Agree 50 WG in various environmental compartments are predicted following the proposed use
pattern. The predicted environmental concentrations (PEC values) in soil and surface water are provided.
Full details of all proposed uses pattern that will be assessed is included in Appendix 2. A summary is provided in
Table 9-1.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 6 of 12
Table 9-1
Summary of critical Good Agricultural Practice for Agree 50 WG (50% Bta GC-91), Professional use,
Central Europe
F,
Application
Application rate per treatment
G, Growth stage Number
Interval kg MPCA./hL water
kg
or
(k)
between (g MPCP/hL)
MPCA./ha
L/ha
I
applications
(MPCP
(a)
kg/ha)
(b)
min...max
(min.)
(j)
min...max min...max min...max
Grapes
F BBCH 53-89
1-3
7 days
0.025
2000
0.5
(0.05)
(1.0)
G BBCH 00-99
Red, black/white currant, blueberry, F BBCH 00-79
1-3
7 days
0.025
2000
0.5
goosberry, blackberry, raspberry
(0.05)
(1.0)
G BBCH 00-99
Strawberry
F BBCH 13-89
1-3
7 days
0.083 - 0.167 300 - 600
0.5
(0.167 – 0.333)
(1.0)
G BBCH 13-89
0.025
2000
(0.05)
Tomato, pepper (sweet and chilli), G BBCH 09-89
1-6
7 days
0.025
2000
0.5
eggplant
(0.05)
(1.0)
Cucumber, gherkin, courgette,
F/ BBCH 09-89
1-6
7 days
0.025
2000
0.5
melon, patisson
G
(0.05)
(1.0)
Lettuce, endive, curled endive,
F BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
lamb´s lettuce, spinach
(0.125 – 0.5)
(1.0)
G BBCH 09-99
0.05 – 0.25 200 - 1000
(0.1 – 0.5)
Red cabbage, savoy cabbage,
F BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
pointed head cabbage, white
(0.125 – 0.5)
(1.0)
cabbage, Brussel sprouts, kale
Chinese cabbage, choi cabbage,
F BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
cauliflower, broccoli, Indian
(0.125 – 0.5)
(1.0)
mustard, kohlrabi
0.05 – 0.25 200 - 1000
G BBCH 09-99
(0.1 – 0.5)
Swede
F BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
(0.125 – 0.5)
(1.0)
F BBCH 09-99
Beetroot, raddish, black raddish,
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
carrot, celery, celery leaves,
(0.125 – 0.5)
(1.0)
celeriac, parsley
G BBCH 09-99
0.05 – 0.25 200 - 1000
(0.1 – 0.5)
Onions, shallots, pickles, garlic, leek F BBCH 07-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
(0.125 – 0.5)
(1.0)
Witloof, Chicory
F BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
(0.125 – 0.5)
(1.0)
Herbs
F/ BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
G
(0.125 – 0.5)
(1.0)
F/ BBCH 09-99
Dwarf snap and slicing bean, pole
1-3
7 days
0.025
2000
0.5
G
snap and slicing bean, yard long
(0.05)
(1.0)
bean
Ornamentals and flowers
F/ BBCH 09-99
1-6
7 days
0.025
2000
0.5
G
(0.05)
(1.0)
Nursery crops and perennials
F/ BBCH 09-99
1-6
7 days
0.025
2000
0.5
G
(0.05)
(1.0)
Forestry
F BBCH 09-99
1-3
7 days
0.025
2000
0.5
(0.05)
(1.0)
Public green
F BBCH 09-99
1-3
7 days
0.025
2000
0.5
(0.05)
(1.0)
n.r.: not relevant
Crop and/or situation
PHI
(days)
(l)
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 7 of 12
Predicted Environmental Concentration in Soil (PECS)
In order to perform a risk assessment for non-target organisms, the actual concentration of Agree 50 WG upon six
applications in ornamentals and flowers (sunflower as representative crop) is calculated as here the highest exposure
is expected according to the intended uses. The calculation bases on a maximum application rate of 1 kg Agree 50
WG/ha, assuming as a worst case that no degradation occurs between applications. For the risk assessment the
resultant load of Agree 50 WG will be related to the top 5 cm of soil to achieve the highest theoretical soil
concentration.
Assumptions:
Accumulated dose rate, considering 6 applications in vegetables: 6 kg Agree 50 WG /ha (= 3 kg Bta/ha = 1.8 x 1014
CFU/ha)
Incorporation into the top 5 cm layer (= 50 L soil/m2)
Soil density of 1.5 g/ cm³ (= 75 kg soil/ m2)
Plant interception was not considered for the PEC calculation, as this is the worst case and covers all uses.
According to the PEC calculation the expected initial concentration is 8.0 mg Agree 50 WG/kg dry weight soil (4 mg
Bta/kg dry weight soil). In terms of CFU, this is equivalent to 2.4 × 108 CFU or 200,000 IU/kg dry weight soil.
Predicted Environmental Concentration in Surface Water (PECSW)
Aquatic organisms may be exposed to Agree 50 WG through spray drift from the application site into adjacent water
bodies. The present PEC calculation was performed on the basis of six applications in flowers and ornamentals, as
here the highest exposure of aquatic non-target organisms is to be expected. Following the Guidance Document on
Aquatic Ecotoxicology (SANCO/3268/2001), the maximum drift rate is 6.41% (considering six applications) of the
applied amount at a distance of 3 m to surface waters. As a worst case, no degradation between the applications is
assumed. Drift was considered according to Rautmann et al.2, 2001.
Table 9-1
Calculation of the predicted environmental concentration of Agree 50 WG in lentic
water bodies (PECsw)
Applic. rate kg/ha
Rate
mg/m2
Distance
(m)
Drift
(%)2)
Amount of drift
g/ha
mg/m2
Initial PECSW (µg/L)
1m
30 cm
6.01)
600.0
3
6.41
384.6
38.46
38.46
128.073)
1)
accumulated application rate of Agree 50 WG for GAP directed use in flowers (6 x 1 kg/ha)
according to Rautmann et al. 2001 (flowers/ornamentals > 50 cm)
3)
equivalent to 3.84 x 106 CFU/L or 3202 IU/L
2)
Due to the PECSW calculation, the initial concentration of Agree 50 WG in 30 cm depth in surface waters is 128.07
µg/L (64.04 µg Bta/L) corresponding to 3.84 × 106 CFU or 3202 IU/L.
2
Rautmann et al. (2001), New basic drift values in the authorisation procedure for plant protection. In Forster, R. & Streloke, M.
Workshop on Risk Assessment and Risk Mitigation Measures in the Context of the Authorisation of Plant Protection Products
(WORMM). Mitt. Biol. Bundesanst. Land-Forstwirtsch. Berlin-Dahlem, Heft 381.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 8 of 12
Appendix 1: List of data submitted in support of the evaluation
No references are submitted in this section.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 9 of 12
Appendix 2: Table of Intended Uses justification and GAP tables
Table of Good Agricultural Practice for Agree 50 WG (also called Turex WG) containing Bacillus thuringiensis ssp. aizawai GC-91 (50%, 25,000 IU/mg, 3.8% δ-endotoxins).
Application rates are the same throughout the Central zone.
Crop and/or Member- Product F,
state or
situation
name G,
country
or
I
(a)
(b)
Pests or Groups of pests
controlled
(c)
Formulation
Type Conc. of
MPCA
PHI Remarks
kg MPCA./hL water L/ha kg MPCA./ha (days)
Interval
(kg MPCP/ha)
between (kg MPCP/hL)
applications
(l)
(m)
min-max
min-max
min-max
min-max
(min.)
Application
Method Growth stage Number
(k)
kind
(f - h)
(j)
Grapes
Central
Europe
Agree 50
WG
F Tortricidae (Lobesia botrana,
Eupoecilia ambiguella)
WG
50%
Foliar
spraying
BBCH 53-89
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
Red, black and
white currant,
blueberry,
goosberry,
blackberry,
raspberry
Strawberry
Central
Europe
Agree 50
WG
F Geometridae (Operophtera
brumata)
WG
50%
Foliar
spraying
April - May
BBCH 00-79
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-3
7 days
0.083 - 0.167
(0.167 – 0.333)
300 - 600
0.5
(1.0)
Not
relevant
-
0.025
(0.05)
2000
Tomato,
pepper (sweet
and chilli),
eggplant
Cucumber,
gherkin,
courgette,
melon,
patisson
(d - f)
G
Central
Europe
Agree 50
WG
F Plutellidae (Plutella xylostella), WG
Noctuidae (Autographa gamma,
Plusia spp.)
G
50%
Foliar
spraying
Central
Europe
Agree 50 G Noctuidae (Chrysodeixis
WG
chalcites, Autographa gamma,
Polia oleracea, Plusia spp.)
WG
50%
Foliar
spraying
Central
Europe
WG
WG
50%
Foliar
spraying
January –
December
BBCH 00-99
April –
September
BBCH 13-89
January –
December
BBCH 13-89
January December
BBCH 09-89
January –
December
BBCH 09-89
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 10 of 12
state or
situation
name G,
or
country
I
(b)
(a)
controlled
(c)
Formulation
Type Conc. of
MPCA
(d - f)
PHI Remarks
Interval
(kg MPCP/ha)
applications
(l)
(m)
min-max
min-max
min-max
min-max
(min.)
Application
kind
(k)
(f - h)
(j)
High volume
spraying
April –
September
BBCH 09-99
Pieridae (Pieris spp.), Noctuidae
(Polia oleracea, Autographa
gamma, Plusia spp.)
G
50%
Agree 50
WG
F Plutellidae (Plutella xylostella),
Crambidae (Evergestis
forficalis), Pieridae (Pieris
spp.), Noctuidae (Autographa
gamma, Mamestra brassicae,
Plusia spp.)
WG
50%
Foliar
spraying
Agree 50
WG
G gamma, Mamestra brassicae,
Plusia spp.)
WG
50%
Foliar
spraying
forvicalis), Pieridae (Pieris
Plusia spp.)
F Plutellidae (Plutella xylostella)
WG
50%
Foliar
spraying
AprilSeptember
BBCH 09-99
1-3
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
January –
December
BBCH 09-99
1-3
Lettuce,
endive, curled
endive, lamb´s
lettuce,
spinach
Central
Europe
Red cabbage,
savoy
cabbage,
pointed head
cabbage, white
cabbage,
Brussel
sprouts, kale
Chinese
cabbage, choi
cabbage,
cauliflower,
broccoli,
Indian
mustard,
kohlrabi
Swede
Central
Europe
Central
Europe
Central
Europe
Agree 50
WG
Beetroot,
raddish, black
raddish,
carrot, celery,
celery leaves,
celeriac,
parsley
Central
Europe
Agree 50
WG
Agree 50
WG
G
January –
December
BBCH 09-99
April –
September
BBCH 09-99
April –
September
BBCH 09-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
0.5
(1.0)
Not
relevant
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
January –
December
BBCH 09-99
Evaluator: Germany
Date: November 2015
-
-
Core Assessment
Agree 50 WG
Page 11 of 12
state or
situation
name G,
or
country
I
(b)
(a)
controlled
(c)
Formulation
Type Conc. of
MPCA
PHI Remarks
Interval
(kg MPCP/ha)
applications
(l)
(m)
min-max
min-max
min-max
min-max
(min.)
Application
kind
(k)
(f - h)
(j)
Onions,
shallots,
pickles, garlic,
leek
Witloof,
Chicory
Central
Europe
Agree 50
WG
F Plutellidae (Acrolepiopsis
assectella)
WG
50%
Foliar
spraying
April –
September
BBCH 07-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
-
Central
Europe
Agree 50
WG
F Noctuidae (Autographa gamma, WG
Plusia spp.)
50%
Foliar
spraying
April –
September
BBCH 09-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
-
Herbs
Central
Europe
Agree 50
WG
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
January –
December
BBCH 09-99
April –
September
BBCH 09-99
January –
December
BBCH 09-99
April –
September
BBCH 09-99
January –
December
BBCH 09-99
April –
September
BBCH 09-99
January –
December
BBCH 09-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
-
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
(d - f)
G
Dwarf snap
and slicing
bean, pole
snap and
slicing bean,
yard long bean
Ornamentals
and flowers
Central
Europe
Agree 50
WG
F Noctuidae (Polia oleracea,
Autographa gamma, Plusia
spp.)
G
WG
50%
Foliar
spraying
Central
Europe
Agree 50
WG
F Pieridae (Pieris spp.), Noctuidae WG
(Plusia spp., Mamestra spp.)
50%
Foliar
spraying
50%
Foliar
spraying
G
Nursery crops
and perennials
Central
Europe
Agree 50
WG
(Plusia spp., Mamestra spp.),
Lymantriidae (Euproctis
G chrysorrhoea, Leucoma salicis,
Lymantria dispar),
Lasiocampidae (Malacosoma
neustria), Yponomeutidae
(Yponomeuta spp.)
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 12 of 12
state or
situation
name G,
or
country
I
(b)
(a)
Forestry
Central
Europe
Agree 50
WG
Public green
Central
Europe
Agree 50
WG
controlled
(c)
F Pieridae (Pieris spp.),
Geometridae (Operopthera
brumata), Lymantriidae
(Euproctis chrysorrhoea,
Lymantria dispar, Leucoma
salicis), Lasiocampidae
(Malacosoma neustria),
Yponomeutidae (Yponomeuta
spp.)
Geometridae (Operophtera
spp.)
Formulation
Type Conc. of
MPCA
(f - h)
(j)
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
not
relevant
(yes)
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
not
relevant
-
(d - f)
Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where
relevant, the use situation should be described (e.g. fumigation of a structure)
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (latin names pests)
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989
PHI Remarks
Interval
(kg MPCP/ha)
applications
(l)
(m)
min-max
min-max
min-max
min-max
(min.)
Application
kind
(k)
(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant - type of
equipment used must be indicated
(i) g/kg or g/l (or potency, or % Cry-toxins)
(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell,
ISBN 3-8263-3152-4), including where relevant, information on season at time of application
(k) Indicate the minimum and maximum number of application possible under practical conditions of use
(l) PHI - minimum pre-harvest interval
(m) Remarks may include: Extent of use/economic importance/restrictions (relative importance crop and
pest)
Evaluator: Germany
Date: November 2015
National addendum - Germany
Agree 50 WG
Page 1 of 11
REGISTRATION REPORT
Part B
Section 5: Fate and Behavior in the environment
Detailed summary and risk assessment
Product code:
Agree 50 WG
Active Substance:
ssp. aizawai GC-91
Central Zone
National addendum for Germany
S.A./B.V.
Date:
November 2015
Applicant: Mitsui AgriScience International S.A./B.V. Evaluator: Germany
November 2015
Agree 50 WG
Page 2 of 11
Table of Contents
IIIM 9
provided for MPCA, to permit an assessment of the fate and behaviour
of MPCP in the environment) .............................................................................. 3
Appendix 1: List of data submitted in support of the evaluation ........................................... 4
Appendix 2: Table of Intended Uses justification and GAP tables ........................................ 5
November 2015
Agree 50 WG
Page 3 of 11
IIIM 9
Fate and behaviour in the environment for the Microbial Pest Control Product
(Rationale to waive testing, based on adequacy of information provided for
MPCA, to permit an assessment of the fate and behaviour of MPCP in the
environment)
This document usually describes only those chapters where national exposure assessment approaches differ
from those given in the core assessment due to specific national assessment requirements. In the present
case, no specific national assessment requirements are identified and accordingly, additional calculations
are not necessary for the exposure assessment (reference should be made to the core assessment for more
information).
November 2015
Agree 50 WG
Page 4 of 11
No references are submitted in this section.
November 2015
Agree 50 WG
Page 5 of 11
Table of Good Agricultural Practice for Agree 50 WG (also called Turex WG) containing Bacillus thuringiensis ssp. aizawai GC-91 (50%, 25,000 IU/mg, 3.8% δ-endotoxins)
in Germany.
Date:
active substance
Applicant:
Zone(s):
Verified by MS:
1
UseNo.
2
Member
state(s)
2012-06-12
Agree 50 WG
Bacillus thuringiensis subsecies aizawai strain GC- 91
central EU
yes
3
Crop and/
or situation
(crop destination /
purpose of crop)
4
F
G
or
I
5
controlled
(additionally:
6
7
Formulation type:
Conc. of as :
professional use:
non professional use:
8
Application
Method /
Kind
Timing / Growth
stage of crop &
season
DE
grape vine (VITVI)
F
002
DE
grape vine (VITVI)
grape)
grape berry moth
grape)
F
grape berry moth
2. and 3. generation (L1L2)
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
from emergence of
first larvae after
beginning of
infestation or
warning service
appeal / from
BBCH 53
from emergence of
first larvae after
beginning of
infestation or
warning service
11
12
Application rate
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
001
10
WG
500 g/kg
x
3 (at least 7
days apart)
3 (at least 7
days apart)
kg, product / ha
g, kg as/ha
a) max. rate per
appl.
a) max. rate
per crop/season b) max. total
rate per
crop/season
a) – base dose:
a) 0,125 -0,375
0,25 kg/ha
b) 1,125
Water L/ha
min / max
– base
dose:
- BBCH 61:
400 l/ha
0,5 kg/ha
- BBCH 61:
- BBCH 71:
800 l/ha
0,75 kg/ha
- BBCH 71:
b) 2,25
1200 l/ha
a) – base dose:
a) 0,125 – 0,5
– base dose:
0,25 kg/ha
b) 1,5
400 l/ha
- BBCH 61:
- BBCH 61:
0,5 kg/ha
800 l/ha
- BBCH 71:
- BBCH 71:
Evaluator: Germany
Date: November 2015
13
14
Remarks:
PHI
(days)
e.g. recommended or mandatory tank
mixtures
Agree 50 WG
Page 6 of 11
appeal / from
BBCH53
0,75 kg/ha
1200 l/ha
-BBCH 75:
- BBCH 75:
1 kg/ha
1600 l/ha
b) 2,25
003
DE
berries (NNNOB)
F
004
DE
berries (NNNOB)
G
005
006
DE
DE
strawberry (FRAAN)
strawberry (FRAAN)
F
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
max. 1000
from BBCH 11
max. 1000
from BBCH 11
1000 - 2000
from BBCH 13
from BBCH 13
Evaluator: Germany
Date: November 2015
1000 - 2000
Agree 50 WG
Page 7 of 11
007
008
DE
DE
leafy and stem vegetables
(NNNVL)
F
cabbage
009
DE
(NNNVL)
G
cabbage
010
011
012
013
DE
DE
DE
DE
vegetable cabbage
(BRSOX)
vegetable cabbage
(BRSOX)
root and tuber vegetables
(NNNVW)
(NNNVW)
F
G
F
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
6 (at least 7
days apart)
from BBCH 09
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
after beginning of
infestation; from
a) < 50 cm:
a) 0,25 – 0,5
a) < 50 cm:
0,5 kg/ha
b) 3
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 6
b) 6
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
200 - 800
from BBCH 09
200 - 1000
from BBCH 09
200 - 800
from BBCH 09
200 - 1000
from BBCH 09
200 - 800
from BBCH 09
Evaluator: Germany
Date: November 2015
200 - 1000
Agree 50 WG
Page 8 of 11
spraying
(low
volume
spraying)
014
015
016
017
DE
DE
DE
DE
bulb crops (NNNSZ)
herbs (NNNKR)
herbs (NNNKR)
pulse crops (NNNLG)
F
F
G
F
emergence of first
larvae /
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) < 50 cm:
a) 0,25 – 0,5
< 50 cm:
0,5 kg/ha
b) 1,5
min 600 l/ha
from BBCH 09
spraying or
fine
spraying
(low
volume
spraying)
spraying or
fine
spraying
(low
volume
spraying)
b) 3
from BBCH 09
200 - 800
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
200 - 800
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 3
200 - 800
Evaluator: Germany
Date: November 2015
Agree 50 WG
Page 9 of 11
018
DE
pulse crops (NNNLG)
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
3 (at least 7
days apart)
from BBCH 09
a) < 50 cm:
a) 0,25 – 0,5
< 50 cm:
0,5 kg/ha
b) 1,5
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 3
019
DE
ornamentals (NNNZZ)
F
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
6 (at least 7
days apart)
a) < 50 cm:
a) 0,25 – 0,5
a) < 50 cm:
0,5 kg/ha
b) 3
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 6
020
DE
ornamentals (NNNZZ)
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
6 (at least 7
days apart)
a) < 50 cm:
a) 0,25 – 0,5
a) < 50 cm:
0,5 kg/ha
b) 3
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 6
Evaluator: Germany
Date: November 2015
Agree 50 WG
Page 10 of 11
021
DE
woody ornamentals
(NNNZG)
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
3 (at least 7
days apart)
a) < 50 cm:
a) 0,25 – 0,5
a) < 50 cm:
0,5 kg/ha
b) 1,5
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 3
Evaluator: Germany
Date: November 2015
Agree 50 WG
Germany
Evaluator:
Date: November
2015
Core Assessment
Agree 50 WG
Page 1 of 37
REGISTRATION REPORT
Part B
Section 6 Impact on Non-Target Organisms
Product code:
Agree 50 WG
Active Substance:
ssp. aizawai GC-91
Central Zone
CORE ASSESSMENT
S.A./B.V.
Date:
Applicant Document ID dRR Part B Section 6
Applicant Author Dr. Jacqueline Süß
November 2015
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 2 of 37
Table of Contents
IIIM 10
Rationale to waive additional testing, based on adequacy of
information provided for MPCA, to permit an assessment of the
impact of the MPCP on non-target organisms. ....................................................... 3
IIIM 10.1
Effects on Birds........................................................................................................... 6
IIIM 10.2
Effects on Aquatic Organisms ................................................................................. 10
IIIM 10.3
Effects on Bees .......................................................................................................... 17
IIIM 10.4
Effects on Arthropods Other Than Bees ................................................................ 19
IIIM 10.5
Effects on Earthworms ............................................................................................ 24
IIIM 10.6
Effects on Soil Micro-organisms ............................................................................. 25
IIIM 10.7
Additional Studies .................................................................................................... 27
IIIM 11
Summary and evaluation of environmental impact .............................................. 27
IIIM 11.1
Distribution and fate of the MPCA ........................................................................ 27
IIIM 11.2
Identification of non-target species at risk and extent of their
exposure..................................................................................................................... 28
IIIM 11.3
Precautions necessary to minimise environmental contamination and
to protect non-target species.................................................................................... 29
Appendix 1a: List of data submitted in support of the evaluation .............................................. 30
Appendix 1b: References cited but not included ........................................................................... 31
Appendix 2: Table of Intended Uses justification and GAP tables ........................................... 34
Evaluator: Germany
Date: November 2015
Core Assessment
IIIM 10
Agree 50 WG
Page 3 of 37
Rationale to waive additional testing, based on adequacy of information
provided for MPCA, to permit an assessment of the impact of the MPCP
on non-target organisms.
General note
This document reviews data of ecotoxicological studies for the microbial plant protection product Agree 50 WG
containing Bacillus thuringiensis ssp. aizawai strain GC-91 (Bta GC-91). Inclusion of Bta GC-91 into Annex I
entered into force in May 2009 (Commission Directive 2008/113/EC1). Bta GC-91 was notified and defended by
Mitsui AgriScience International S.A./B.V. Agree 50 WG was not the representative formulation, and has not
been previously evaluated in the EU according to Uniform Principles. Nonetheless, Agree 50 WG contains the
same active substance (Bta GC-91), in the same proportions, which can be found in the representative
formulation Agree 50 WP. It appears therefore feasible to lean on the data of Agree 50 WP for the evaluation of
Agree 50 WG.
This document refers to the conclusions of the EU review of Bta GC-91. The active substance data is relied upon
in the risk assessment of the formulation Agree 50 WG.
Note: this Part B document only reviews data (Annex II or Annex III) and additional information that has not
previously been considered within the EU review process, as part of the Annex I inclusion decision.
The review report for Bta GC-91 (SANCO/1538/08 - rev. 3 final – 06/05/2008) is considered to provide the
relevant review information or a reference to where such information can be found. The data presented in this
dRR dossier comply with the agreed end points in the Review Report.
The Annex I Inclusion Directive for Bta GC-91 (Commission Directive 2008/113/EC1) provides specific
provisions under Part B, which need to be considered by the applicant in the preparation of their submission and
by the MS prior to granting an authorisation:
-
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on
the active substance Bta GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Appendix 1 of this document contains the list of references included in this document for support of the
evaluation.
Appendix 2 of this document presents the uses of Agree 50 WG.
Agree 50 WG is a biological insecticide formulated as water dispersible granules, containing 3 x 1013 colony
forming units (CFU) or 500 g of Bta GC-91 in 1 kg product. The potency of Agree 50 WG is 25,000 IU/mg.
1
OJ L 330, 09.12.2008, p.6
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 4 of 37
With regard to safety issues, it is important to note that Bta and all other members of the species of Bacillus
thuringiensis are naturally present in our environment. Therefore, their application in pest control means only a
fluctuation of the bacterium population in the biotope of the pest insect. The experience that Bta presents no risk
for the environment has been confirmed by numerous studies. The inclusion of results of other subspecies of
Bacillus thuringiensis or products containing them is justifiable due to close family relationship resulting in
much conformity.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 5 of 37
Introduction
This section of the submission summarises the ecotoxicological effects of the formulation Agree 50 WG and
evaluates the potential risk to various representatives of terrestrial, aquatic and soil organisms. Full details or the
proposed use pattern that will be assessed are shown in Appendix 2. A summary is presented in Table 10-1.
Table 10-1:
Proposed use pattern of Agree 50 WG in Central Europe (professional use)
F,
Application
G, Growth stage Number
Interval kg MPCA./hL water
kg
or
(k)
L/ha
between (g MPCP/hL)
MPCA./ha
I
applications
(MPCP
(a)
kg/ha)
(b)
min...max
(j)
min...max min...max min...max
(min.)
Grapes
F BBCH 53-89
1-3
7 days
0.025
2000
0.5
(0.05)
(1.0)
G BBCH 00-99
Red, black/white currant, blueberry, F BBCH 00-79
1-3
7 days
0.025
2000
0.5
goosberry, blackberry, raspberry
(0.05)
(1.0)
G BBCH 00-99
Strawberry
F BBCH 13-89
1-3
7 days
0.083 - 0.167 300 - 600
0.5
(0.167 – 0.333)
(1.0)
G BBCH 13-89
0.025
2000
(0.05)
Tomato, pepper (sweet and chilli), G BBCH 09-89
1-6
7 days
0.025
2000
0.5
eggplant
(0.05)
(1.0)
Cucumber, gherkin, courgette,
F/ BBCH 09-89
1-6
7 days
0.025
2000
0.5
melon, patisson
G
(0.05)
(1.0)
Lettuce, endive, curled endive,
F BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
lamb´s lettuce, spinach
(1.0)
(0.125 – 0.5)
G BBCH 09-99
0.05 – 0.25 200 - 1000
(0.1 – 0.5)
F BBCH 09-99
Red cabbage, savoy cabbage,
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
pointed head cabbage, white
(1.0)
(0.125 – 0.5)
cabbage, Brussel sprouts, kale
F BBCH 09-99
Chinese cabbage, choi cabbage,
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
cauliflower, broccoli, Indian
(1.0)
(0.125 – 0.5)
mustard, kohlrabi
G BBCH 09-99
0.05 – 0.25 200 - 1000
(0.1 – 0.5)
Swede
F BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
(1.0)
(0.125 – 0.5)
F BBCH 09-99
Beetroot, raddish, black raddish,
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
(0.125 – 0.5)
carrot, celery, celery leaves,
(1.0)
celeriac, parsley
G BBCH 09-99
0.05 – 0.25 200 - 1000
(0.1 – 0.5)
Onions, shallots, pickles, garlic, leek F BBCH 07-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
(0.125 – 0.5)
(1.0)
Witloof, Chicory
F BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
(1.0)
(0.125 – 0.5)
Herbs
F/ BBCH 09-99
1-3
7 days
0.0625 – 0.25 200 - 800
0.5
G
(1.0)
(0.125 – 0.5)
Dwarf snap and slicing bean, pole
F/ BBCH 09-99
1-3
7 days
0.025
2000
0.5
snap and slicing bean, yard long
G
(0.05)
(1.0)
bean
Ornamentals and flowers
F/ BBCH 09-99
1-6
7 days
0.025
2000
0.5
G
(0.05)
(1.0)
Nursery crops and perennials
F/ BBCH 09-99
1-6
7 days
0.025
2000
0.5
G
(0.05)
(1.0)
Forestry
F BBCH 09-99
1-3
7 days
0.025
2000
0.5
(0.05)
(1.0)
Public green
F BBCH 09-99
1-3
7 days
0.025
2000
0.5
(0.05)
(1.0)
n.r.: not relevant
Crop and/or situation
PHI
(days)
Evaluator: Germany
Date: November 2015
(l)
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
n.r.
Core Assessment
Agree 50 WG
Page 6 of 37
Please note:
As worst case, the maximum number of applications were considered for the risk assessment within the frame of
the risk envelope approach.
IIIM 10.1
Effects on Birds
In this section, no new studies are submitted assessing the effect of Agree 50 WG. Instead data from the
assessment with the active ingredient Bta GC-91 are presented.
Overview and summary
Table 10.1-1
Study
Short-term
dietary
toxicity
EU Endpoints: Toxicity of Bta GC-91 to birds
EU agreed endpoints
Test
substance
Test species
Bta GC-91
Colinus
virginianus /
Anas
platyrhynchos
(SANCO/1538/08 - rev. 3
final – 06/05/2008)
LD50 > 3333 mg/kg b.w.
Endpoints used in risk
assessment
LD50 > 3333 mg/kg b.w.
Effects on birds for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91. However further
data on Agree 50 WG are not relevant as active substance data on the toxicity to birds are used and the
ingredients in the formulation Agree 50 WG are not expected to pose a risk to birds. Therefore all relevant data
were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided
Risk Assessment
Toxicity
The short-term toxicity of Bta GC-91 to Colinus virginianus and Anas platyrhynchos was evaluated (refer to
Annex IIM, Section 6, Point IIM 8.1/01 and 02). The test substance was administered at a daily dose of 3333
mg/kg b.w./day for five days in both studies. No treatment related mortalities or effects of Bta occurred in both
test organisms. The acute LD50 can be determined to lie above the tested concentration of 3333 mg/kg b.w./day.
Table 10.1-2
Summary of avian toxicity endpoint for Bta GC-91
Study type
Short-term dietary
toxicity
Test substance
Bta GC-91
Species
Colinus virginianus
(Northern bobwhite)
Anas platyrhynchos
(mallard)
Endpoint
Reference
XXXXX, 1990a
LD50 > 3333 mg/kg b.w.
XXXXX, 1990b
Exposure
Birds are typically exposed to dry residues on their food items following the dilution and spraying of the
formulated product. During these processes, much of the formulation constituents are likely to be lost by
volatilisation. Therefore, where oral exposure is the main route of exposure, toxicity data for the active substance
are used in preference to data from tests with the formulated material. Exposure to Agree 50 WG via dermal and
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 7 of 37
inhalation routes is considered unlikely, since at the time of application and for a short period thereafter, most
wild mammals will leave the immediate vicinity of spray operations in response to the human disturbance.
The potential exposure of birds to Agree 50 WG was estimated following GAP directed applications of the
product in the different uses at maximum application rates. The risk assessment for effects on birds is carried out
according to the latest draft of the ‘European Food Safety Authority Guidance Document on Risk Assessment
for Birds and Mammals’ (EFSA Journal 2009)2.
Toxicity exposure ratios
Acute toxicity exposure ratio (TERA)
Birds may be exposed to Agree 50 WG as a result of feeding on contaminated vegetation, seeds or insects.
Standard exposure scenarios for the intended uses are described in the EFSA Journal2 (please refer to Table
10.1-3 for details). The risk for indicator species of each scenario was assessed in a screening assessment. Data
on short-term toxicity are used as they cover acute toxicity to birds.
According to the EFSA Journal (2009)2 the daily dietary dose (DDD) was calculated for the active substance
with the following formulae:
DDD (multiple) = application rate (kg/ha) × shortcut value × MAF
With:
Shortcut value = default parameter combining food intake rate, body weight, concentration of the substance in
the diet (based on the 90th percentile residues) and the fraction of diet obtained in the treated area for the bird
indicator species/crop combination in question. In case of multiple applications a corresponding MAF (multiple
application factor) is considered. The TER value was calculated by dividing the acute endpoint by the daily
dietary dose (DDD) for each application rate. The screening assessment was performed for the uses with the
maximum number of applications (6) which are vegetables, flowers and ornamentals and nursery crops and
perennials. As here the highest exposure is expected all other uses should be covered by the assessment. The
screening assessment is shown in Table 10.1-3.
Table 10.1-3
Screening assessment for birds following GAP directed application of Agree 50 WG.
Indicator species
Crop
Small omnivorous
bird
Vegetables
Small insectivorous
birds
Orchards and
ornamentals/
nursery
Test item
Bta
GC-91
Toxicity Application
Short cut
MAF2)
value3)
rate1)
LD50
> 3333
mg/kg
b.w.
DDD
TER
(10)
0.5 kg/ha
1.9
158.8
150.86
> 22.1
0.5 kg/ha
1.9
46.8
44.46
> 75.0
1)
MAF according to 6 successive applications at intervals of 7 days provided in EFSA Guidance document 20092
3)
2)
The TERA value exceeds the Annex VI trigger value of 10, indicating that Agree 50 WG poses no risk to birds
following application according to the proposed use patterns.
2
EFSA Journal 2009; 7(12): 1438. [139 pp.].
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 8 of 37
Risk mitigation
No risk mitigation measures are required.
Review Comments:
IIIM 10.1 Birds
None
Agreed endpoints:
IIIM 10.1. Birds
LD50 > 3333 mg MPCA/kg bw (Colinus virginianus / Anas
platyrhynchos)
Short-term and long-term toxicity exposure ratio (TERST/LT)
As the acute TER value indicates no risk to birds and no adverse effects were observed in short-term toxicity
studies, no long-term effects are to be expected upon field application of Agree 50 WG according to GAP.
Effects on Terrestrial Vertebrates Other Than Birds
assessment with the active ingredient Bta GC-91 are presented.
Table 10.1-4
a)
Ecotoxicological endpoints of Bta GC-91 for mammals
Test substance
Test
species
EU agreed endpoints
(SANCO/1538/08 - rev. 3 final –
06/05/2008)
assessment
CGA-237218 technical
material a)
Rat
LD50 > 5050 mg/kg b.w.
LD50 > 5050 mg/kg b.w.
Synonym for Bta GC-91 technical material contained in Agree 50 WG
Effects on mammals for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91. However
further data on Agree 50 WG are not relevant as active substance data on toxicity are used and the ingredients in
the formulation do not pose a risk to mammals. Therefore all relevant data were assessed in the EU review. Risk
assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate.
Toxicity
An acute oral toxicity study has been conducted with CGA-237218 technical on rats (refer to Annex IIM, Sec. 3,
P. IIM 5.3.2/01). No test substance related signs of infectivity were observed in the study, so that the acute oral
LD50 was estimated to be > 5050 mg/kg b.w.
Table 10.1-5: Acute oral toxicity to mammals
Substance
Species
Endpoint
CGA-237218
technical material
Rat
LD50
Value
(mg/kg bodyweight)
> 5050 mg/kg b.w.
a)
b)
Report
XXXXX, 1991 (please
refer to Point IIIM 7.1.1)
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 9 of 37
Exposure
Mammals are typically exposed to dry residues on their food items following the dilution and spraying of the
formulated product. During these processes, much of the formulation constituents are likely to be lost by
volatilisation. Therefore, where oral exposure is the main route of exposure, toxicity data for the active substance
are used in preference to data from tests with the formulated material. Exposure to Agree 50 WG via dermal and
inhalation routes is considered unlikely, since at the time of application and for a short period thereafter, most
wild mammals will leave the immediate vicinity of spray operations in response to the human disturbance.
The potential exposure of mammals to Agree 50 WG was estimated following GAP directed applications of the
product in the different uses at maximum application rates. The risk assessment for effects on mammals is
carried out according to the latest draft of the ‘European Food Safety Authority Guidance Document on Risk
Assessment for Birds and Mammals’ (EFSA Journal 2009)2.
Acute toxicity exposure ratio (TERA)
Mammals may be exposed to Agree 50 WG as a result of feeding on contaminated vegetation, seeds or insects.
Standard exposure scenarios for the intended uses are described in the EFSA Journal2 (please refer to Table
10.1-3 for details). The risk for indicator species of each scenario was assessed in a screening assessment.
According to the (EFSA Journal 2009)2 the daily dietary dose (DDD) was calculated for the active substance
with the following formulae:
DDD (multiple) = application rate (kg/ha) × shortcut value × MAF
With:
Shortcut value = default parameter combining food intake rate, body weight, concentration of the substance in
the diet (based on the 90th percentile residues) and the fraction of diet obtained in the treated area for the
mammal indicator species/crop combination in question. In case of multiple applications a corresponding MAF
(multiple application factor) is considered. The TER value was calculated by dividing the acute endpoint by the
daily dietary dose (DDD) for each application rate. The screening assessment was performed for use in
vegetables, ornamentals and flowers and nursery crops/ and perennials. As here the highest exposure is expected
due to the highest number of successive treatments all other uses are covered by the presented risk assessment.
Details are shown in Table 10.1-6.
Table 10.1-6
Screening assessment for mammals following application of Agree 50 WG.
Indicator
species
Crop
Test item
Toxicity
LD50
Application
rate1)
MAF2)
Short cut
value3)
DDD
TER
(10)
Small
herbivorous
mammals
Vegetables/
ornamentals and
nursery
CGA237218
technical
> 5050
mg/kg b.w.
0.5 kg/ha
1.9
136.4
129.58
> 39.0
1)
MAF according to 6 successive applications provided in EFSA Guidance document 20092
3)
2)
2
EFSA Journal 2009; 7(12): 1438. [139 pp.].
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 10 of 37
The TERA values exceed the Annex VI trigger of 10, indicating that Agree 50 WG poses no acute risk to
mammals following application according to the proposed use patterns.
Risk mitigation
Review Comments:
IIIM 10.3
None
Agreed endpoints:
IIIM 10.3
LD50 >5050 mg CGA-237218 (GC-91)/kg bw (rat)
Short-term and long-term toxicity exposure ratio (TERST/LT)
No data on the short- or long-term toxicity of Bta GC-91 or Agree 50 WG are presented here. Due to the absence
of toxicity in the acute study and the highly specific mode of action of Bta GC-91, no adverse effects in
mammals are to be expected upon prolonged exposure to Agree 50 WG.
IIIM 10.2
Effects on Aquatic Organisms
In this section, one new study is submitted assessing the effect of Agree 50 WG on the aquatic invertebrate
Daphnia magna. For all other aquatic non-target species assessment data the active ingredient Bta GC-91 or
products containing it are presented.
Evaluator: Germany
Date: November 2015
Core Assessment
Table 10.2-1
Test
item
Agree 50 WG
Page 11 of 37
Ecotoxicological endpoints for aquatic organisms
Test species
Fish
CGAOncorhynchus
237218a) mykiss
CGACyprinodon
237218a) variegatus
Aquatic invertebrates
CGA237218a)
Daphnia magna
CGA237218a)
Daphnia magna
CGA237218a)
Palaemonetes
vulgaris
Agree 50
WG
Daphnia magna
Single cell algae
Desmodesmus
CGAsubspicatus
237218a) (=Scenedesmus
subspicatus)
EU agreed endpoints
(SANCO/1538/08 - rev.
3 final – 06/05/2008)
Endpoints used in
risk assessment
32-day (static renewal)
LC50 > 2.0 × 1010 CFU/L
LC50 > 2.1 × 109 CFU/L
LC50 > 2.0 × 1010
CFU/L
EC50 > 3.24 × 108
CFU/L
NOEC = 1.57 × 108
CFU/L
EC50 > 6.2 × 108 CFU/L
NOEC ≥ 6.2 × 108
CFU/L
EC50 > 1.9 × 109 CFU/g
food
Reference
XXXXX, 1991a
XXXXX, 1991b
Christensen, 1991c
Long term toxicity:
NOEC = 1.57 × 108
CFU/L
Collins, 1993
Christensen, 1991d
(study was not submitted
in the EU dossier)
Acute toxicity:
EC50 (48 hours)
> 100 mg Agree 50
WG/L (nominal)c)
> 25 mgb) Agree 50
WG/L (actual)
Dengler, 2010 (please
refer to point IIIM 10.2
Acute toxicity of the
formulation)
72-hour
EbC50 > 56.5 mg/L
corresponding to 3.6 ×
109 CFU/L
EbC50 > 3.6 × 109
CFU/L
Grade, 1993
a) Synonym for Bta GC-91 technical material contained in Agree 50 WG
b) Actual content based on CFU counts
c) A new study on the formulated product Agree 50 WG has been performed and as a result there are new end-points which are used in the
risk assessment.
Effects on aquatic non-target organisms for Agree 50 WG were not evaluated as part of the EU review of Bta
GC-91. However further data on Agree 50 WG are not relevant as active substance data on toxicity are used and
the ingredients in the formulation do not pose a risk to aquatic species. Therefore all relevant data were assessed
in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are
considered adequate.
Toxicity
Fish
Static renewal tests on rainbow trout and sheephead minnow were conducted with the technical material CGA237218 over a period of 32 days and 30 days, respectively (XXXXX, 1991a and b). Exposure through aqueous
and dietary routes caused no adverse effects to both fish species based on parameters of survival, infectivity
and/or pathogenicity. The LC50 value was estimated to be > 2.0 x 1010 CFU/L as worst-case scenario.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 12 of 37
Daphnia
Three studies on the effect of the technical material CGA-237218 on aquatic invertebrates were conducted (refer
to Table 10.2-2). As a conclusion, a CGA-237218 content of 6.2 x 108 CFU/L was regarded as threshold value
for toxicity of Bta GC-91 to daphnids (Daphnia magna). The lowest no-observed-effect-concentration (NOEC)
was determined to be 1.57 x 108 CFU/L (Christensen, 1991c).
In addition, an aquatic invertebrate toxicity study performed on Agree 50 WG is provided in support of the
assessment (please refer to Point “Toxicity of the preparation” below)
Algae
An acute toxicity study on Scenedesmus subspicatus was conducted with the technical material CGA-237218
(refer to Annex IIM, Sec. 6, P. IIM 8.4/01). No significant effects were detected at any concentration. Therefore,
the EbC50 was estimated to be > 56.5 mg CGA 237218 technical/L (equivalent to 3.6 x 109 CFU/L).
Exposure
Aquatic organisms may be exposed to Agree 50 WG and Bta GC-91 through spray drift. Exposure of aquatic
organisms from this route was estimated by calculating Predicted Environmental Concentration in surface water
(PECSW) (see Part B, Section 5).
For 6 applications in flowers and vegetables (drift value of 6.41% for plant heights > 50 cm) assuming worst
case conditions of no degradation of Bta GC-91 between the spraying resulting in an accumulated application
rate of 6 kg Agree 50 WG/ha, the initial concentration of Agree 50 WG and Bta GC-91 in 30 cm depth in surface
waters is as follows:
Table 10.2-2
PECSW values for Agree 50 WG
Test substance
PECSW
Agree 50 WG
128.07 µg/L
Bta GC-91
64.04 µg/L or 3.84 x 106 CFU/L
The initial risk assessments were carried out by comparing the PECSW values with the acute and long-term
toxicity endpoints. Acute toxicity exposure ratios (TERA) were calculated using the following equations:
TER =
LC50 or EC50 [CFU/L]
PECSW [CFU/L]
TERA for fish
The highest short-term toxicity endpoint for rainbow trout was used as it covers the acute risk assessment. The
resulting acute TER value for Bta GC-91, based on the maximum PECSW value following six applications in
flowers and vegetables x 3 m from the application site is shown below.
Table 10.2-3
Test organism
Fish acute TER value for Agree 50 WG (Bta GC-91)
Test substance
32-day LC50
(static renewal)
PECSW
TERA
Trigger
value
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 13 of 37
CGA-237218a)
Oncorhynchus mykiss
> 2.0
CFU/L
×
1010
3.84 x 106 CFU/L
> 5208
100
d) Synonym for Bta GC-91 technical material contained in Agree 50 WG
The TER for Bta GC-91 is above the Annex VI trigger value of 100, indicating that GAP directed use of Agree
50 WG poses no risk to fish.
Review Comments:
IIIM 10.2 TERA for fish
None.
Agreed endpoints:
32-day LC50 > 2.0 x 1010 CFU/L
IIIM 10.2 TERA for fish
TERLT for fish
Due to the absence of toxicity in the semi static studies conducted over a period of 30 and 32 days, respectively,
no risk for fish is expected even upon prolonged exposure to Agree 50 WG.
TERA for Daphnia
The acute Agree 50 WG TER for Daphnia magna was calculated using the calculated PECSW at 3 m from the
application site following based on the maximum PECSW value following six applications in flowers x 3 m from
the application site. The resulting TERA is presented below:
Table 10.2-4
Acute TER value for D. magna for Agree 50 WG
Test organism
Test substance
Daphnia magna
Agree 50 WGa)
48-hour LC50
(static)
PECSW
TERA
Trigger
value
> 100 mg/L (nominal)
128.07 µg/L
> 781
100
> 25 mg/L (actual)
128.07 µg/L
> 195
100
The TERA values calculated with the nominal concentration as well as with the mean measured (actual)
concentration are above the Annex VI trigger of 100, indicating a low acute risk to D. magna following GAP
directed application of Agree 50 WG.
TERLT for Daphnia
The TERLT of Agree 50 WG for Daphnia magna was calculated using the calculated PECSW at 3 m from the
application site following based on the maximum PECSW value following 3 applications in orchards x 3 m from
the application site and the lowest NOEC obtained in the 21-day static renewal tests with the active ingredient
(1.57 × 108 CFU/L). The resulting TERLT is presented below:
Table 10.2-5
a)
Daphnia TERLT value for Agree 50 WG
Test
organism
Test substance
21- day NOEC
(static renewal)
PECSW
TERLT
Trigger
value
Daphnia
magna
CGA-237218a)
1.57 × 108 CFU/L
3.84 × 106 CFU/L
40.9
10
From the TERLT value exceeding the trigger of 10 no long-term risk for daphnids is indicated. Prolonged
exposure, however, is not likely to occur due to the restricted persistence of Bta in water.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 14 of 37
Risk mitigation
Review Comments:
IIIM 10.2 TERLT for Daphnia
During the peer review process it was noted that data on growth and
reproduction had not been presented in the original DAR, for no apparent
reason. Indeed, sublethal endpoints have been investigated in the chronic
daphnid study by Christensen (1991c) and the results can be summarised
as follows:
Survival: At test termination, survival in the control group was 100%,
which exceeded the minimum standard criterion (≥70% survival)
established by the U.S. EPA in 1985. Survival in the test concentrations
ranged from 0% in the highest concentration tested (5.71 x 109 CFU/L) to
90% in the 1.57 x 108 CFU/L test concentration. Statistical analysis
indicated that the survival rate among daphnids in the three highest mean
measured concentrations (5.71 x 109, 1.77 x 109 and 6.24 x 108 CFU/L)
was significantly different (α=0.05) when compared to control survival.
Growth: Daphnid growth, as determined by body length, in the control
group averaged 4.6 mm. The average length of daphnids in the test
concentrations ranged from 4.7 mm in the highest concentration in which
growth was evaluated (1.57 x 108 CFU/L) to 4.8 mm in the 4.86 x 107
CFU/L test concentration. Daphnid growth was not significantly decreased
in the two concentrations evaluated when compared to the control.
Reproduction: Reproduction in the control group averaged 107
offspring/female which exceeded the minimum standard criterion
established by the U.S. EPA (≥40 offspring/female). Reproductive
capacity among daphnids in the test concentrations ranged from 0
offspring/female in the two highest concentrations tested (5.71x109 and
1.77 x 109 CFU/L) to 163 offspring/female in the 6.24 x 108 CFU/L test
concentration; however, this last group exhibited significant mortality
from the control and so was excluded from reproductive analysis.
Statsitical analysis of reproduction revealed no difference between the
number of offspring produced by the treatment groups in which survival
was not affected (1.57 x 108 and 4.86 x 107 CFU/L) and the control
daphnids.
Agreed endpoints:
IIIM 10.2 TERLT for Daphnia
Based on the results given above, survival of daphnids (Daphnia magna)
represents the most sensitive endpoint. Therefore, the 21-day NOEC was
determined to be 1.57 x 108 CFU/L (mean measured concentration).
TERLT for algae
The long-term risk for algae from exposure to Agree 50 WG was assessed using the EbC50value for Bta GC-91
(Table 10.2-2). The resulting TER, calculated on the basis of the PECSW value for six applications in flowers at 3
m from the application site, is given in the Table 10.2-6.
Table 10.2-5
Algae TERLT value for Agree 50 WG
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 15 of 37
Test organism
Test substance
72-hour EbC50
(static)
PECSW
TERLT
Trigger
value
Desmodesmus subspicatus
(=Scenedesmus subspicatus)
CGA-237218a)
> 3.6 x 109 CFU/L
3.84 x 106 CFU/L
> 938
10
e) Synonym for Bta GC-91 technical material contained in Agree 50 WG
The TER value is above the Annex VI trigger value of 10, indicating that application of Agree 50 WG according
to the proposed label uses poses no risk to algae.
Risk mitigation
Review Comments:
IIIM 10.2 TERLT for algae
None.
Agreed endpoints:
IIIM 10.2 TERLT for algae
72-hours EC50 > 3.6 x 109 CFU/L (Desmodesmus subspicatus)
Acute toxicity of the formulation
For an overview on toxicity of Bta GC-91 and Agree 50 WG to aquatic non-target species please refer to Table
10.2-2.
The following Daphnia acute toxicity study performed on Agree 50 WG is provided in support of the assessment
and has not been previously evaluated.
Report:
KIIIM 10.2/01, Dengler, 2010
Title:
Assessment of toxic effects of Agree WG on Daphnia magna using the 48 h acute
immobilisation test
Document No:
S10-02545
Guidelines:
OECD 202 (2004)
GLP
Yes
Executive Summary
Under the conditions of the study, Agree WG was found to be not toxic to Daphnia magna. The EC50 (48h) of
the test item was determined to be > 100 mg/L (nominal) or > 25 mg/L (actual).
I. MATERIALS AND METHODS
Test Item
Designation
Characteristics
Batch no.
Agree WG
Granular, light brown
1000990
Evaluator: Germany
Date: November 2015
Core Assessment
Active ingredient(s)/Content
Storage conditions
Stability (expiry date)
Agree 50 WG
Page 16 of 37
Bta CG-91, conc. of a.i.: 8.5 x 1012 CFU/kg (nominal), 1.02 x 1012 CFU/kg
(actual)
Max 40°C
Not available
Test System
Species
Age
Weight
Supplier
Acclimatisation period
Diet
Daphnia magna
6 - 24 hours (at start of treatment)
Not provided
Certis USA, Colombia
Not provided
Single cell green algae
Test Conditions
Housing
Temperature
Oxygen concentration
Photoperiod
pH value
Hardness (CaCO3)
The daphnids were held in 100 mL glass beakers filled with 50 mL test
solution (loading: 10 mL/animal)
21.0 ± 0.1°C
97 ± 0.5%.
16 hours daily (~1250 lux)
8.16 ± 0.21
10°dH
Study Design and Methods
Conducted at
In-life dates
Treatment
Observations
Statistics
Eurofins Agroscience Services GmbH, Eutinger Straße 24, NiefernÖschelbronn, Germany
07.07.2010 to 12.10.2010
During the 48-hour static limit tests the daphnids were exposed to Agree 50
WG at a nominal concentration of 100 mg/L. Test media were prepared by
dilution of the test item in test water and application of defined volumes of
the stock solutions to the test vessels. Two concentrations of the reference
item potassium dichromate (1.0 mg/L and 2.0 mg/L) were tested in addition.
Each test item and an untreated control (test water) were set up in four
replicates with 5 individuals each.
Assessment of immobilisation of the daphnids was carried out after 24 and
48 hours. Temperature and pH as well as oxygen saturation were measured
at test start, after 24 and after 48 hours. Hardness of the test water was
measured at test start only. To determine the content of viable spores of Bta
CG-91 in the test item, CFU counts were performed at the start of the test
The data did not warrant statistical analysis.
II. RESULTS AND DISCUSSION
CFU counts
The content of CFU in the test item was 12% of the nominal, corresponding to 1.02 x 109 CFU/g. Therefore, the
average content of Agree WG in the sample at test start was considered to be 25% of the nominal.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 17 of 37
Mortality
After 24 and 48 hours no immobilisation was observed in the test groups exposed to Agree WG, in the untreated
control and in the group exposed to 1.0 mg/L of the toxic reference. Immobilisation in the second control group
exposed to 2.0 mg/L potassium dichromate was 50% after 24 hours and 95% upon 48 hour exposure. These data
fell well within the range previously obtained with the toxic reference in the laboratory indicating a suitable
sensitivity of the test animals.
III. CONCLUSIONS.
The EC50 (48h) of the test item was determined to be > 25 mg/L (actual content based on CFU counts)
(Dengler, 2010)
Implications for labelling
The product has to be labelled according to the following:
• Do not contaminate water with the product or its container (EB001-2)
• The product may not be applied in or in the immediate vicinity of surface or coastal waters.
Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be
observed. Violations may be punished by fines of up to 50 000 EUR (NW 642-1).
IIIM 10.3
Effects on Bees
Effects on bees for Agree 50 WG were not evaluated as part of the EU review of Bt aizawai GC-91. However,
the comparable formulation CGD 97220 I and the active substance were tested. Therefore all relevant data were
assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here
and are considered adequate.
Toxicity
Table 10.3-1 presents the results of laboratory bee toxicity studies with the active substance and the formulation.
Further details regarding the tests with the formulation are provided in section 10.3.2.
Table 10.3 - 1: Results of laboratory bee toxicity studies
Test substance
Exposure route
LD50
Reference
CGD 97220 I
(= Agree 50 WG)
oral, 48 h
> 197 µg product/bee *
Kleiner, 1992;
con, 72 h
> 77 µg product/bee **
oral, 10 days
= 91 µg/bee *
CGA-237218
technical
(=Bt aizawai GC91)
92 10 48 068
Parrish and Yeager, 1994
* EU agreed endpoint (SANCO/1538/08 - rev. 3 final – 06/05/2008)
** no EU agreed endpoint (see remark below)
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 18 of 37
Remark on the contact endpoint with CGD 97220 I (Kleiner, 1992):
According to the test guideline (BBA-Guideline VI, 23-1) in the contact toxicity test 1 mL test solution has to be
applied to ten bees through the gauze of each test cage by a hand sprayer. Mortality is compared to a water
control. However, no LD50 calculation is required. In this test 1 mL test solution containing 0.4 % CGD 97220 I
was applied on an area of 8 x 6.5 cm (backside of test cages), corresponding to a dose of 77 µg CGD 97220
I/cm2. Taking into account that a bee has a surface of approximately 1 cm2, the applied dose is equivalent to 77
µg CGD 97220 I/bee.
Exposure
The recommended use pattern for Agree 50 WG includes application in grape vine, berries, vegetables, herbs,
ornamentals and other crops at a maximum application rate of up to 1 kg product/ha.
Bees may be exposed to Agree 50 WG by direct spraying while bees are foraging on flowers and weeds, through
contact with fresh or dried residues or by oral uptake of contaminated pollen, nectar and honey dew.
Hazard quotients for bees
Hazard quotients for oral and contact exposure according to EPPO (2003) Environmental risk assessment
scheme for plant protection products (Chapter 10: Honeybees (PP 3/10(2)). Bulletin OEPP/EPPO Bulletin 33:
141-145) were calculated as follows:
Hazard Quotient =
Maximum application rate (g formulation/ha)
Acute LD50 (µg formulation/bee)
Table 10.3 - 2 Hazard quotients for honeybees
Test substance
Max. single
application rate
Exposure
route
[µg product/ha]
oral
Agree 50 WG
Bt aizawai GC-91
technical
LD50
[µg product/Biene]
> 197
Hazard
quotient (HQ)
<6
1000
500
HQ
trigger
50
con
> 77
< 13
oral
= 91
<6
50
Risk assessment
Due to the results of laboratory tests Agree 50 WG is considered to be practically non-toxic to bees. All hazard
quotients are clearly below the trigger of 50, indicating that the intended use poses a low risk to bees in the field.
Due to the findings of the EU review of Bacillus thuringien-sis ssp. aizawai strain GC-91 no signs of
infectiveness or pathogenicity have been observed in laboratory chronic toxicity feeding tests. Bee brood testing
is not required since the test item is not an IGR.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 19 of 37
Overall conclusion:
It is concluded that Agree 50 WG will not adversely affect bees or bee colonies when used as recommended.
Risk mitigation:
NB6641:
The product is classified as non-hazardous to bees, even when the maximum application rate,
or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4)
IIIM 10.4
Effects on Arthropods Other Than Bees
assessment with another Bta-GC-91 product are presented.
Table 10.4-1
Ecotoxicological endpoints for arthropods other than bees
Test item
EU agreed endpoints
(SANCO/1538/08 - rev. 3
final – 06/05/2008)
TUREX 50 WPa)
LR50 > 4.5 kg/ha
Test species
Endpoints used in
risk assessment
LR50 > 4.5 kg/ha
Typhlodromus pyri
a)
Other trade name of Agree 50 WP, contains the same content of Bta-GC-91 as Agree 50 WG
Effects of Agree 50 WG on arthropods were not evaluated as part of the EU review of Bta GC-91. However
the formulation do not pose a risk to arthropods. Therefore all relevant data were assessed in the EU review. Risk
assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate.
Toxicity
The toxicity of the Bta GC-91-based product TUREX 50 WP (= Agree 50 WP) to non-target arthropods has been
investigated. The testing and risk assessment strategy used here follow the approach recommended in the
ESCORT 2 guidance document (Candolfi et al. 2001)3 and the EC Guidance Document on Terrestrial
Ecotoxicology4.
The toxicity of the formulation to non-target arthropods has been investigated by carrying out Tier I test on
Aphidius rhopalosiphi and Typhlodromus pyri. These two species are tested, in accordance with ESCORT 2, as
representative non-target arthropods since they have been found to be particularly sensitive species, and
therefore can be considered as indicators of potential effects to the most sensitive arthropods in the field. Both
studies confirmed the absence of toxicity of the test item to non-target arthropods. The results of the studies were
submitted with the EU dossier in Annex IIIM, Section 6, Point 10.4/01-02). An overview on the obtained data is
provided in Table 10.4-2. The data can be directly used for the risk assessment of Agree 50 WG as both
products contain the same content of Bta GC-91.
3
Candolfi MP, Barrett KL, Campbell PJ, Forster R, Grandy N, Huet M-C, Lewis G, Oomen PA, Schmuck R, Vogt H (2000)
‘Guidance Document on regulatory testing procedures for plant protection products with non-target arthropods’ From the
workshop, European Standard Characteristics of Non-target Arthropod Regulatory Testing (ESCORT 2) 21-23 March
2000.
4 EC Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC, SANCO/10329, 17 October
2002.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 20 of 37
Table 10.4-2
Agree 50 WG- Toxicity to non-target arthropods
Test
substance
TUREX 50
WPa)
a)
Species
Exposed
life stage
Study type
LR50
(kg product/ha)
Reference
Aphidius
rhopalosiphi
Typhlodromus
pyri
Adult
Acute laboratory (glass plate)
> 4.5
Warmers, 2005a
Adult
Acute laboratory (glass plate)
> 4.5
Warmers, 2005a
Containing the same content of Bta GC-91 as Agree 50 WG
Exposure
In-field
Non-target arthropods living in the crop can be exposed to residues from Agree 50 WG by direct contact either
as a result of overspray or through contact with residues on plants and soil or in food items. The maximum
number of successive treatments for Agree 50 WG is 6 and the maximum application rate are 1.0 kg/ha. The infield exposure is calculated according to ESCORT 2 (2000)4 using the following equation:
PERIn-field =
Maximum application rate [g product/ha] × MAF
Due to six applications a default MAF (leaf) of 3.2 was adopted.
Table 10.4-3
In-field PER values for application of Agree 50 WG
Compound
referred to
Application rate
MAF
PER (foliar)
Agree 50 WG
1000 g/ha
3.2
3200 g/ha
Off-field
Risk assessment of areas immediately surrounding the crop is considered important since these areas represent a
natural reservoir for immigration, emigration and reproduction of arthropod populations and provide increased
species diversity. Exposure of non-target arthropods living in off-field areas to Agree 50 WG will mainly be due
to spray drift. Off-field areas are assumed to be densely vegetated and thus spray drift is unlikely to reach bare
ground. Therefore, evaluation of exposure via soil residues in off-field areas was not considered. The off-field
exposure value was calculated from in-field exposure in conjunction with drift values published by the JKI
(2006)5 as shown in the following equation:
PEROff-field =
5
Maximum in-field exposure × (% drift/100)
Vegetation distribution factor
Julius Kühn Institute spray drift data from 27. March 2006, http://www.jki.bund.de/fileadmin/dam_uploads/_AT/abdrifteckwerte/Abdrifteckwerte.xls
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 21 of 37
Vegetation distribution factor: The model used to estimate spray drift was developed for drift onto a twodimensional water surface and, as such, does not account for interception and dilution by three-dimensional
vegetation in off-crop areas. Therefore, a vegetation distribution or dilution factor is incorporated into the
equation when calculating off-field exposure, to be used in conjunction with toxicity endpoints derived from
two-dimensional (glass plate or leaf disc) studies. A dilution factor of 10 is recommended by ESCORT 2.
The PERoff-field was calculated for use of Agree 50 WG in flowers/ornamentals and vegetables because here the
highest exposure is expected due to the highest number of successive treatments. For six applications the drift
value at 1 m distance is 6.41% of the application rate (90th percentile drift). The drift factor (% drift/100) is
therefore 6.41/100 = 0.06.
The resulting PERoff-field value is shown in Table 10.4-4.
Table 10.4-4
Off-field foliar Predicted Environmental Rates (PER) for Agree 50 WG
Study type
Maximum in-field foliar
PER a
Drift factor
(% drift/100)
a
Vegetation
distribution factor
Off-field foliar PER
10
19.2
(g formulation/ha)
(g formulation/ha)
Glass plate
a
3200
0.06
for flowers/vegetables, plant height > 50 cm
Risk assessment
The risk to non-target arthropods is assessed using the approach recommended in the published ESCORT 2
document (Candolfi et al. 2001) 4 and the EC Guidance Document on Terrestrial Ecotoxicology5.
In-field
The potential risk of Agree 50 WG to in-field non-target arthropods was assessed by calculation of the hazard
quotient (HQ = exposure/toxicity) with the predicted environmental rate (PER) and the lowest lethal rate (LR50)
values according to the following formula:
In field HQ =
In - field PER
LR 50
The HQ trigger for Tier I laboratory is 2. The resulting HQin-field values are presented in Table 10.4-5.
Table 10.4-5
In-field HQs for non-target arthropods
Species
Typhlodromus pyri
LR50
(g/ha)
> 4500
In-field foliar
PER
(g/ha)
HQ
3200
< 0.71
Trigger
value
2
4
Candolfi MP, Barrett KL, Campbell PJ, Forster R, Grandy N, Huet M-C, Lewis G, Oomen PA, Schmuck R, Vogt H (2000)
‘Guidance Document on regulatory testing procedures for plant protection products with non-target arthropods’ From the
workshop, European Standard Characteristics of Non-target Arthropod Regulatory Testing (ESCORT 2) 21-23 March
2000.
5
EC Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC, SANCO/10329, 17 October
2002.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 22 of 37
The in-field HQ values indicate that GAP directed application of Agree 50 WG poses no risk to in-field nontarget arthropods.
Off-field
In order to assess the potential risk of Agree 50 WG to off-field non-target arthropods, the predicted
environmental rate (Table 10.4-4) is compared with the toxicity endpoints according to the following formula:
Off - field HQ =
PER off −field (g/ha)
× Correction factor
LR 50 (g/ha)
The HQ trigger for Tier I laboratory studies is 2.
Correction factor: ESCORT 2 recommends that a correction factor of 5 is used when assessing Tier II data, or 10
for Tier I data, to account for extrapolation from testing just 2 representative species, to the species diversity
expected in off-crop areas.
HQoff-field values are given in Table 10.4-6.
Table 10.4-6
Off-field HQ values for non-target arthropods
Species
LR50
(g product/ha)
Off-field foliar
PER
Correction
factor
Off-field foliar
HQ
Trigger
value
10
< 0.004
2
(g product/ha)
Typhlodromus pyri
Aphidius
rhopalosiphi
> 4500
19.2
The off-field HQ value for the tested non-target arthropods fall below the trigger value of 2, indicating that GAP
directed application of Agree 50 WG does not pose an unacceptable risk to non-target arthropods in off-field
areas.
In the following paragraphs, a quantitative risk assessment is presented using the toxicity/exposure ratio
(TER) approach:
The PERoff-field was calculated for use of Agree 50 WG in flowers/ornamentals and vegetables , as here the
highest exposure is expected. For six successive treatments the drift value at 1 m distance is 6.41% of the
application rate (90th percentile drift). The drift factor (% drift/100) is therefore 6.41/100 = 0.06. The maximum
in-field exposure is calculated as the maximum application rate x the maximum number of treatments. The
resulting PERoff-field value is shown in the following Table.
Off-field foliar Predicted Environmental Rates (PER) for Agree 50 WG
a
Maximum
application rate
(kg/ha)
Maximum number
of treatments
1.0
6
Drift factor
(% drift/100)
Vegetation
distribution
factor
0.06
5
0.072
(kg/ha)
For flowers/ornamentals and vegetables
Risk assessment
Off-field
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 23 of 37
In order to assess the potential risk of Agree 50 WG to off-field non-target arthropods, the predicted
environmental rate (Table 10.4-4) is compared with the toxicity endpoints according to the following formula:
LR50
PERoff-field
TERoff-field =
The TER trigger for Tier I laboratory studies is 10. The calculated TER value for non-target arthropods in offfield areas is given in following table:
Off-field TER values for non-target arthropods
Species
Typhlodromus pyri
LR50
Off-field foliar
(kg/ha)
(kg/ha)
TER
> 4.5
0.072
> 62.5
Trigger value
10
The off-field TER value for the tested non-target arthropods exceeds the trigger value of 10, indicating that GAP
directed application of Agree 50 WG does not pose an unacceptable risk to non-target arthropods in off-field
areas.
Risk mitigation measures
Not required.
Comments:
IIIM 10.4
Agreed endpoint/s:
IIIM 10.4
a)
In general, the test method used is not considered suitable for testing MPCAs because test
organisms were only exposed to fresh dry product residues on glass plates (contact
exposure). However, Bacillus thuringiensis is basically a proteinaceous insecticide that
must be ingested by susceptible species to be effective. Nevertheless, on the basis of
available information submitted in the EU review of Bt subspecies aizawai, the use of
Agree 50 WG is considered unlikely to cause any adverse effects on predatory mites and
predatory wasps. For the non-target arthropod risk assessment, more attention should be
paid to the effects of Btk on non-target lepidopteran species. It should be noted that
expected concentrations are likely to be below the levels calculated in the worst case
scenario in Tier I since the MPCA is very susceptible to UV light and rainfall. Therefore, a
qualitative risk assessment based on an overall view of all available information is regarded
as the most relevant evaluation. In the case of large-scale (aerial) applications of Bta in
forestry, further risk mitigation measures should be considered at Member States level.
LR50 > 4.5 kg TUREX 50 WPa)/ha
Other trade name of Agree 50 WP, contains the same content of Bta-GC-91 as Agree 50 WG
Effects of Bta on Lepidoptera species in off-crop habitats
In this section no new study on the toxicity of Bta on Lepidopteran species is submitted. Additionally, field
studies revealed that Macrolepidoptera caterpillars may be affected by the use of Btk products, but severe effects
on populations were not recorded. Populations recovered after applications (Glare & O’Callaghan, 2000).
Regarding the the risks to non-target-arthropods, including lepidopteran species, the following is stated in the
EFSA Conlusion on Bacillus thuringiensis subsp. aizawai (strains ABTS 1857, GC-91):
Several laboratory studies on non-target arthropods for both strains were available. These studies indicated a low
risk from pathogenicity and infectivity for non-target arthopods following exposure to Bacillus thuringiensis
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 24 of 37
aizawai strain ABTS 1857 and strain CG-91. The only potentially significant area of concern for non-target
arthropods is in relation to the specific species showing susceptibility to particular subspecies of Bacillus
thuringiensis. In the case of Bacillus thuringiensis aizawai, this relates to a restricted group of Lepidopteran
families and it is important that this selectivity is considered within the context of the wide scale impact of
broad-spectrum insecticides on non-target arthropods. Clearly for the in-crop area where application occurs there
will be an impact on Lepidopteran species i.e. the intended effect on the target pest species. However, the
published information shows that recovery occurs within a relatively short period of time (depending on
application timing, life history of affected species, dispersal ability etc). Recovery of any affected populations is
therefore likely to be rapid. Therefore the risk for non-target arthropods was indicated as low. The risk for nontarget arthropods for the strain GC-91 was indicated as low by the HQ calculation.
IIIM 10.5
Effects on Earthworms
assessment with another Bta GC-91-based product are presented.
Table 10.5-1
Test item
CGD 97220
Ia)
a)
Ecotoxicological endpoints for earthworms
EU agreed endpoints
(SANCO/1538/08 - rev. 3 final – 06/05/2008)
Endpoints used in risk assessment
LC50 > 1000 mg/kg artificial soil
Synonym for Agree 50 WP containing the same content of Bta GC-91 as Agree 50 WG
Effects of Agree 50 WG on earthworms were not evaluated as part of the EU review of Bta GC-91. However
the formulation do not pose a risk to earthworms. Therefore all relevant data were assessed in the EU review.
Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate.
Toxicity
The acute toxicity of the formulation CGD 97220 I (equivalent to Agree 50 WP) to the earthworm Eisenia
foetida was determined in a laboratory study (refer to Annex IIIM, Sec. 6, P. IIIM 10.5). The median lethal
concentration LC50 of the test item to Eisenia foetida determined after 14 days exposure was shown to be greater
than 1000 mg/kg artificial soil. As the content of Bta GC-91 in Agree 50 WP and Agree 50 WG is the same the
obtained data can be directly used to assess the risk of Agree 50 WG.
Earthworm toxicity endpoints are summarised in Table 10.5-2.
Table 10.5-2
a)
Acute earthworm toxicity endpoint for Agree 50 WG
Test substance
Endpoint
Value
Reference
CGD 97220 Ia)
LC50
> 1000 mg/kg artificial soil
Winkler, 1992a
Exposure
The exposure to soil organisms was estimated by calculating the maximum predicted environmental
concentrations in soil (PECS) (please refer to Part B, Section 5). The PECS value was calculated for 6
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 25 of 37
applications of 1.0 kg Agree 50 WG/ha in vegetables assuming as a worst case that no degradation of the product
and the active ingredient occurs between the treatments. Under these conditions and based on standard
assumptions for the soil density and the incorporation depth, the PECS was determined to be 8 mg Agree 50
WG/kg dry weight soil.
Toxicity exposure ratios: TERA and TERLT
Acute risk
The potential acute risk of Agree 50 WG to earthworms was assessed by comparing the maximum instantaneous
PECS with the 14-day LC50 value to generate the acute TER value. The TERA was calculated as follows:
TER A =
LC 50 (mg/kg)
PEC S (mg/kg)
The resulting TERA value is shown in Table 10.5-3.
Table 10.5-3
Acute TER value for earthworms
Compound referred to
LC50
Maximum PECS for Agree 50 WG
TERA
Limit
Agree 50 WG
8.0 mg/kg. d.w. soil
> 125
10
The acute TER value is much higher than the Annex VI acute trigger value of 10, indicating that GAP directed
application of Agree 50 WG poses no acute risk to earthworms.
Long-tern risk
Due to the absence of acute toxicity no adverse effects on earthworms are to be expected even upon prolonged
exposure to Agree 50 WG or Bta GC-91.
Risk mitigation
No risk mitigation measures are considered necessary.
Comments:
IIIM 10.5
None.
Agreed endpoint/s:
IIIM 10.5
LC50 > 1000 mg/kg d.w. soil
IIIM 10.6
Effects on Soil Micro-organisms
assessment with another Bta GC-91-based product are presented.
Evaluator: Germany
Date: November 2015
Core Assessment
Table 10.6-1
Agree 50 WG
Page 26 of 37
Ecotoxicological endpoints for soil micro-organisms
Test substance
Test design
b)
EU agreed endpoints
06/05/2008)
assessment
NOEC = 20 kg/ha
NOEC = 20 kg/ha
C
N
CGD 97220 Ia)
a)
b)
C:carbon transformation, N: nitrogen turnover
Effects of Agree 50 WG on the activity of the soil microflora were not evaluated as part of the EU review of Bta
GC-91. However further data on Agree 50 WG are not relevant as active substance data on toxicity are used and
the ingredients in the formulation do not pose a risk to soil microorganisms. Therefore all relevant data were
assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here
and are considered adequate.
Toxicity
Side effects of CGD 97220 I (synonym for Agree 50 WP) on the activity of the soil microflora were assessed in
two soils over a period of 28 days at 2.0 L/ha and 20.0 L/ha (corresponding to 2 and 20 kg/ha; refer to Annex
IIIM, Sec. 6, P. IIIM 10.6). Even at the higher concentration, the test item had no negative influence on the
nitrogen turnover or the dehydrogenase activity in the two test soils. In conclusion, the test substance represents
no hazard to soil microflora at a concentration of 20.0 kg/ha.
Table 10.6-2
a)
Toxicity of Agree 50 WG to soil micro-organisms
Test substance
Endpoint
Reference
CGD 97220 Ia)
NOEC = 20 kg/ha
Winkler, 1992b
Exposure
The maximum predicted environmental concentrations of Agree 50 WG in soil (PECS) was calculated for use in
vegetables (6 x 1 kg/ha) as here the highest exposure is to be expected. For details please refer to Part B, Section
5.
Table 10.6-3
Predicted Environmental Concentrations in soil (PECS) of Agree 50 WG
Compound referred
to
Maximum accumulated application rate
Maximum PECS
Agree 50 WG
6.0 kg/ha
8.0 mg/kg dry weight soil
Risk assessment
CGD 97220 I had no significant effect on soil micro-organisms at 20 kg/ha. This value is more than 3-fold the
maximum accumulated application rate intended for Agree 50 WG. Due to the assumption of the worst case that
no degradation of Agree 50 WG occurs between the treatments and the absence of adverse effects observed in
the laboratory study with CGD 97220 I containing the same amount of Bta GC-91 as Agree 50 WG, it can be
concluded that GAP directed use of Agree 50 WG poses no risk for the soil microflora.
Risk mitigation
No risk mitigation measures are considered necessary.
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 27 of 37
Study Comments:
IIIM 10.6
None.
Agreed endpoint/s:
IIIM 10.6
NOEC = 20 kg/ha
IIIM 10.7
Additional Studies
No additional studies are required
IIIM 11
Summary and evaluation of environmental impact
IIIM 11.1
Distribution and fate of the MPCA
Fate and behaviour in soil
Based on available information derived from studies and published literature on Bacillus thuringiensis bacteria,
the environmental fate and population dynamics of Bta upon field application of Agree 50 WG can be
summarized as follows:
A natural breakdown of the endospores of Bta in soil begins after application onto the fields and gradually
reduces the numbers of spores remaining. Any vegetative cells or crystal proteins are likely to be far more
rapidly degraded by the photo degradation effects of sunlight. The better persistence of Bt spores in soil after the
first two weeks seems to be a result of their inability to germinate in soil. Survival and viability of parasporal
crystal proteins associated with the application of Agree 50 WG is expected to be short-term as effects of other
soil micro-organisms and natural sunlight, in combination with the natural degradation of the proteins, occurs.
The highest predicted environmental concentration of Agree 50 WG and its active ingredient Bta GC-91 in soil
was calculated as 8 mg/kg dry weight soil (4 mg Bta/kg dry weight soil). In terms of CFU, this is equivalent to
2.4 × 108 CFU or 200,000 IU/kg dry weight soil.
Fate and behaviour in water
Surface water
Under natural conditions, residues of Bta in water are not considered to be able to persist for very long periods
due to a combination of natural physical and chemical degradation factors such as solar radiation and predation
from resident bacteriophages, protozoans and other lower animal forms. It may be stated that Bta GC-91 is
inactivated under natural conditions, including water.
The highest predicted environmental concentration of Agree 50 WG and its active ingredient Bta GC-91 in
surface waters is 128.07 µg/L (64.04 µg Bta/L) corresponding to 3.84 × 106 CFU or 3202 IU/L.
Ground water
Various experiments examining the movement of Bt in soils following spraying of commercial products
containing Bt showed little or no movement neither in laboratory columns nor in the field under natural irrigation
conditions. Additionally, adsorption and binding of protoxins and toxins from Btk have been demonstrated to
occur readily, rapidly and strongly onto the clay fraction and clay humic acid complexes of soils while
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 28 of 37
desorption occurs far less readily. It is thus concluded that no threat of contamination of groundwater exists
following applications of Agree 50 WG according to GAP.
Fate and behaviour in air
Unlike chemical products, evaporation and volatility of bacteria is not expected to be a factor to consider in
assessing the fate in air. Hence volatilisation from plant surfaces and from soil can be excluded. An investigation
of photochemical-oxidative degradation in air is of no relevance in view of the volatility characteristics of the
bacteria.
Spray drift, however, can occur following an application of Bta which may lead to temporary concentrations in
the atmosphere which are capable of drifting with wind currents before the spores and crystals in finer spray
droplets settle out. However, rapid degradation of Bta in air or in these droplets mainly due to inactivation by
solar radiation is assumed and confirmed by literature reports.
IIIM 11.2
Identification of non-target species at risk and extent of their exposure
According to the presented risk assessment, the use of Agree 50 WG at the proposed label rates according to
good agricultural practice poses no risk to any of the non-target species.
Terrestrial vertebrates
Birds and mammals
Due to the highly specific mode of action of Bta and its low field persistence birds and mammals are not
considered to be at risk upon application of Agree 50 WG. This was confirmed by the absence of toxicity upon
oral administration in birds and rats and TER values exceeding the Annex IV trigger of 10 for all indicator
species considered in screening assessments for these two vertebrate groups, respectively.
Aquatic organisms
Fish
The acute TER value of fish for Agree 50 WG exceeds the Annex VI trigger value of 100 indicating that no
adverse effects are to be expected upon field application at recommended use levels. Due to the absence of
toxicity in the semi static studies conducted over a period of 30 and 32 days, respectively, no risk for fish is
expected even upon prolonged exposure to Agree 50 WG. Furthermore, prolonged exposure is not likely to
occur due to the restricted persistence of Bta in water.
Daphnids
The acute TER value of aquatic invertebrates for Agree 50 WG is above the Annex VI trigger value of 10.
Therefore, no risk is expected for aquatic invertebrates following GAP directed use. Considering the absence of
acute toxicity and the NOEC obtained in the 21-day static renewal tests (1.57 × 108 CFU/L) that is more than 10fold higher than the PECSW (1.44 × 107 CFU/L) no adverse effects on daphnids are to be expected even upon
prolonged exposure to Agree 50 WG. Prolonged exposure, however, is not likely to occur due to the restricted
persistence of Bta in water.
Algae
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 29 of 37
The long-term TER value of algae for Agree 50 WG strongly exceeds the Annex VI trigger value of 10
suggesting that no negative side effect is expected following field application according to GAP.
Bees
Application of Agree 50 WG at intended use levels represents no risk for honey bees as the calculated Hazardous
Quotient is far below the trigger value of 50.
Other arthropods
Following the result of the non-target arthropod risk assessment the HQ values are below the trigger value of 2
indicating that no unacceptable risk is to be expected upon field application of Agree 50 WG according to GAP.
The risk for non-target Lepidopteran species in off-crop habitats was assessed using data from open peer
reviewed literature. Following the results the HQ values for 4 out of 5 species (Vanessa cardui, Manduca sexta,
Pieris rapae and Heliothis virescens) are below the trigger of 2, although the worst case was assumed. Hence, no
negative side effects are expected following field application according to GAP.
Assuming the same conditions, the HQ value for Lymantria dispar exceeds the trigger of two. However, due to
the fast inactivation of Bta spores and the behaviour of L. dispar to feed in crowns of broadleaf trees, where a
lower exposure rate is expected, no unacceptable risk is expected upon field application of Agree 50 WG.
Earthworms
The acute TER value of earthworms for Agree 50 WG exceeds the Annex VI trigger value of 10 indicating that
no adverse effects are to be expected upon field application at recommended use levels.
Soil microbial activity
No effects > 25% on short-term respiration and nitrogen turnover were observed at the tested rates with other Bta
GC-91 containing products. Therefore, no unacceptable risk to the soil microflora and their activity is expected
at recommended application rates of Agree 50 WG.
IIIM 11.3
Precautions necessary to minimise environmental contamination and to
protect non-target species
The above risk assessment proves that Agree 50 WG is not toxic to the tested aquatic and terrestrial species, and
considering the expected environmental concentration will not be hazardous to natural populations upon
applications according to Good Agricultural Practice. No hazard classification or specific labelling according to
EC Directive 67/548/EEC is required for Agree 50 WG.
Evaluator: Germany
Date: November 2015
Core Assessment
Appendix 1a:
Agree 50 WG
Page 30 of 37
List of data submitted in support of the evaluation
Annex point/
reference
number
Author(s)
Year
KIIIM 10.2/01
Dengler, D.
2010
KIIIM 10.4/01
Broderick, N.A., 2006
Raffa, K.F.,
Handelsman,J.
KIIIM 10.4/02
Broderick, N.A., 2009
Robinson, C.J.,
McMahon, M.D.,
Holt, J.,
Handelsman, J.,
Raffa, K.F.
Title
Testing Facility
Owner / Source (where different from owner)
Report No
GLP or GEP status (where relevant)
Published or not
ASSESSMENT OF TOXIC EFFECTS OF
AGREE WG ON DAPHNIA MAGNA USING
48H ACUTE IMMOBILISATION TEST
Eurofins Agroscience Service GmbH
Certis USA LLC
Report-no. S10-02545
GLP: yes
Published: no
MIDGUT BACTERIA REQUIRED FOR
BACILLUS THURINGIENSIS INSECTICIDAL
ACTIVITY
Proc Natl Acad Sci USA, 103, 15196-15199
Report-no. not applicable
GLP/GEP: no
Published: yes
CONTRIBUTIONS OF GUT BACTERIA TO
BACILLUS THURINGIENSIS-INDUCED
MORTALITY VARY ACROSS A RANGE OF
LEPIDOPTERA
BMC Biology, 7, 1-9
GLP/GEP: no
Published: yes
Data
protection
claimed
Owner
yes/no
yes
CEB
no
LIT
no
LIT
Evaluator: Germany
Date: November 2015
Core Assessment
Appendix 1b:
Agree 50 WG
Page 31 of 37
References cited but not included
Author(s)
Annex point
XXXXX
IIIM 10.2
XXXXX
IIIM 10.2
Christensen, K.P. IIIM 10.2
Christensen, K.P. IIIM 10.2
Collins, M.K.
IIIM 10.2
Glare, T.R.,
O'Callaghan, M.
IIIM 10.4
Title
Testing Facility
Report No
Published or not
1991a (CGA-237218 TECHNICAL MATERIAL) INFECTIVITY AN PATHOGENICITY TO
RAINBOW TROUT (ONCORHYNCHUS
MYKISS) DURING A 32-DAY STATIC
RENEWAL TEST
Springborn Laboratories Inc., Massachusetts, USA
Certis USA LLC
Report-no. 90-6-3363
GLP: yes
Published: no
1991b (CGA-237218) - INFECTIVITY AND
PATHOGENICITY TO SHEEPSHEAD
MINNOW (CYPRINODON VARIEGATUS)
DURING A 30-DAY STATIC RENEWAL TEST
Spingborn Lab. Inc., Wareham, Massachusetts
02571, USA
Certis Europe B.V., NL
Report-no. 1781.0889.6230.160, 154-21
GLP: yes
Published: no
1991c CGA-237218 CHRONIC TOXICITY TO
DAPHNIDS (DAPHNIA MAGNA) UNDER
STATIC RENEWAL CONDITIONS
Certis USA LLC
Report-no. 1781.0889.6229.130, 90-7-3385
GLP: yes
Published: no
1991d CGA-237218 TECHNICAL MATERIAL INFECTIVITY AND PATHOGENICITY TO
GRASS SHRIMP (PALAEMONETES
VULGARIS) DURING A 30-DAY STATIC
RENEWAL TEST
Certis USA LLC
Report-no. 90-6-3445
GLP: yes
Published: no
1993 INFECTIVITY AND PATHOGENICITY TO
DAPHNIDS (DAPHNIA MAGNA) DURING A
21-DAY STATIC RENEWAL TEST
Certis USA LLC
Report-no. 93-10-4968
GLP: yes
Published: no
2000 BACILLUS THURINGIENSIS: BIOLOGY,
ECOLOGY AND SAFETY
not applicable
John Wiley and Sons Inc New York
Year
Data
protec- Owner
tion
claimed
yes/no
yes
CEB
yes
CEB
yes
CEB
yes
CEB
yes
CEB
no
LIT
Evaluator: Germany
Date: November 2015
Core Assessment
Author(s)
Agree 50 WG
Page 32 of 37
Annex point
Grade, R.
IIIM 10.2
Kleiner, R.
IIIM 10.3
XXXXX
IIIM 10.1
XXXXX
IIIM 10.1
Parrish, J.R,
Yeager, B.
IIIM 10.3
Warmers, C.
IIIM 10.4
Title
Testing Facility
Report No
Published or not
GLP/GEP: no
Published: yes
1993 REPORT ON THE GROWTH INHIBITATION
TEST OF CGA 237218 TECH. TO GREEN
ALGAE (SCENEDESMUS SUBSPICATUS)
CIBA-GEIGY Ltd., CH-4002 Basel, Switzerland
Certis USA LLC
Report-no. 938007
GLP: yes
Published: no
1992 TESTING TOXICITY TO HONEYBEE - APIS
MELLIFERA L. (LABORATORY) ACCORDING
TO BBA GUIDELINE VI, 23-1 (1991)
BioChem Agrar, Cunnersdorf, Germany
Certis USA LLC
Report-no. 92 10 48 068
GLP: yes
Published: no
1990a CGA-237218 TECHNICAL (GC-91) - AN AVIAN
ORAL PATHOGENICITY AND TOXICITY
STUDY IN THE BOBWHITE
Wildlife International, Ltd., Easton, Maryland,
USA
Certis USA LLC
Report-no. 108-308
GLP: yes
Published: no
1990b CGA-237218 TECHNICAL (GC-91) - AN AVIAN
ORAL PATHOGENICITY AND TOXICITY
STUDY IN THE MALLARD
Wildlife International, Ltd., Easton, Maryland,
USA
Certis USA LLC
Report-no. 108-309
GLP: yes
Published: no
1994 HONEY BEE TOXICITY FEEDING
TEST/CHRONIC- CGA-237218
BIO/WEST, INC., Utah 84321, USA
Certis USA LLC
Report-no. HB419
GLP: yes
Published: no
2005a TUREX 50 WP: ACUTE TOXICITY TO THE
APHID PARASITOID, APHIDIUS
RHOPALOSIPHI DE STEFANI PEREZ
(HYMENOPTERA, BRACONIDAE) IN THE
LABORATORY (LIMIT TEST)
GAB Biotechn. GmbH & GAB Analytik GmbH,
Niefern-Öschelbronn
Certis USA LLC
Year
Data
protec- Owner
tion
claimed
yes/no
yes
CEB
yes
CEB
yes
CEB
yes
CEB
yes
CEB
yes
CEB
Evaluator: Germany
Date: November 2015
Core Assessment
Author(s)
Agree 50 WG
Page 33 of 37
Annex point
Warmers, C.
IIIM 10.4
Winkler, J.
IIIM 10.5
Winkler, J.
IIIM 10.6
Title
Testing Facility
Report No
Published or not
Report-no. 20051317/01-NLAp
GLP: yes
Published: no
2005b TUREX 50 WP: TOXICITY TO THE
PREDATORY MITE, TYPHLODROMUS PYRI
SCHEUTEN (ACARI, PHYTOSEIIDAE) IN THE
LABORATORY (LIMIT TEST)
GAB Biotechn. GmbH & GAB Analytik GmbH,
Niefern-Öschelbronn
Certis USA LLC
Report-no. 20051317/01-NLTp
GLP: yes
Published: no
1992a ACUTE TOXICITY EARTHWORM TEST EISENIA FOETIDA ACCORDING TO THE
OECD GUIDELINE 207
BioChem GmbH, Cunnersdorf, Germany
Certis USA LLC
Report-no. 921049014
GLP: yes
Published: no
1992b EFFECTS ON THE ACTIVITY OF SOIL
MICROFLORA ACCORDING TO THE BBA
GUIDELINE VI, 1-1 (1990)
BioChem GmbH, Cunnersdorf, Germany
Certis USA LLC
Report-no. 921049013
GLP: yes
Published: no
Year
Data
protec- Owner
tion
claimed
yes/no
yes
CEB
yes
CEB
yes
CEB
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 34 of 37
Table of Good Agricultural Practice for Agree 50 WG (also called Turex WG) containing Bacillus thuringiensis ssp. aizawai GC-91 (50%, 25,000 IU/mg, 3.8% δendotoxins). Application rates are the same throughout the Central zone.
state or
name G,
situation
country
or
I
(a)
(b)
controlled
(c)
Formulation
Type Conc. of
MPCA
Application
kind
(k)
kg MPCA./hL water L/ha kg MPCA./ha
Interval
(kg MPCP/ha)
applications
min-max
min-max
min-max
min-max
(min.)
PHI Remarks
(days)
(f - h)
(j)
(l)
(m)
Grapes
Central
Europe
Agree 50
WG
WG
50%
Foliar
spraying
BBCH 53-89
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
Red, black and
white currant,
blueberry,
goosberry,
blackberry,
raspberry
Strawberry
Central
Europe
Agree 50
WG
brumata)
WG
50%
Foliar
spraying
April - May
BBCH 00-79
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-3
7 days
0.083 - 0.167
(0.167 – 0.333)
300 - 600
0.5
(1.0)
Not
relevant
-
0.025
(0.05)
2000
Tomato,
pepper (sweet
and chilli),
eggplant
Cucumber,
gherkin,
courgette,
melon,
patisson
(d - f)
G
Central
Europe
Agree 50
WG
Noctuidae (Autographa gamma,
Plusia spp.)
G
50%
Foliar
spraying
Central
Europe
WG
WG
50%
Foliar
spraying
Central
Europe
WG
WG
50%
Foliar
spraying
January –
December
BBCH 00-99
April –
September
BBCH 13-89
January –
December
BBCH 13-89
January December
BBCH 09-89
January –
December
BBCH 09-89
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 35 of 37
state or
situation
name G,
country
or
I
(a)
(b)
Lettuce,
endive, curled
endive, lamb´s
lettuce,
spinach
Central
Europe
Red cabbage,
savoy
cabbage,
pointed head
cabbage, white
cabbage,
Brussel
sprouts, kale
Chinese
cabbage, choi
cabbage,
cauliflower,
broccoli,
Indian
mustard,
kohlrabi
Swede
Central
Europe
Central
Europe
Beetroot,
raddish, black
raddish,
carrot, celery,
celery leaves,
celeriac,
parsley
controlled
(c)
Formulation
Type Conc. of
MPCA
(d - f)
Application
(k)
kind
(f - h)
(j)
High volume
spraying
April –
September
BBCH 09-99
Interval
(kg MPCP/ha)
applications
min-max
min-max
min-max
min-max
(min.)
Pieridae (Pieris spp.), Noctuidae
(Polia oleracea, Autographa
gamma, Plusia spp.)
G
50%
Agree 50
WG
Plusia spp.)
WG
50%
Foliar
spraying
Agree 50
WG
G gamma, Mamestra brassicae,
Plusia spp.)
WG
50%
Foliar
spraying
forvicalis), Pieridae (Pieris
Plusia spp.)
WG
50%
Foliar
spraying
AprilSeptember
BBCH 09-99
1-3
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
January –
December
BBCH 09-99
1-3
Agree 50
WG
Central
Europe
Agree 50
WG
Central
Europe
Agree 50
WG
G
January –
December
BBCH 09-99
April –
September
BBCH 09-99
April –
September
BBCH 09-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
PHI Remarks
(days)
(l)
(m)
0.5
(1.0)
Not
relevant
-
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
January –
December
BBCH 09-99
-
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 36 of 37
state or
situation
name G,
country
or
I
(a)
(b)
controlled
Formulation
Type Conc. of
MPCA
Application
(k)
kind
Interval
(kg MPCP/ha)
applications
min-max
min-max
min-max
min-max
(min.)
PHI Remarks
(days)
(f - h)
(j)
(l)
(m)
Onions,
shallots,
pickles, garlic,
leek
Witloof,
Chicory
Central
Europe
Agree 50
WG
assectella)
WG
50%
Foliar
spraying
April –
September
BBCH 07-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
-
Central
Europe
Agree 50
WG
F Noctuidae (Autographa gamma, WG
Plusia spp.)
50%
Foliar
spraying
April –
September
BBCH 09-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
-
Herbs
Central
Europe
Agree 50
WG
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
January –
December
BBCH 09-99
April –
September
BBCH 09-99
January –
December
BBCH 09-99
April –
September
BBCH 09-99
January –
December
BBCH 09-99
April –
September
BBCH 09-99
January –
December
BBCH 09-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
-
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
(c)
(d - f)
G
Dwarf snap
and slicing
bean, pole
snap and
slicing bean,
yard long bean
Ornamentals
and flowers
Central
Europe
Agree 50
WG
F Noctuidae (Polia oleracea,
spp.)
G
WG
50%
Foliar
spraying
Central
Europe
Agree 50
WG
50%
Foliar
spraying
50%
Foliar
spraying
G
Nursery crops
and perennials
Central
Europe
Agree 50
WG
Lymantria dispar),
Lasiocampidae (Malacosoma
neustria), Yponomeutidae
(Yponomeuta spp.)
Evaluator: Germany
Date: November 2015
Core Assessment
Agree 50 WG
Page 37 of 37
state or
situation
name G,
country
or
I
(a)
(b)
Forestry
Central
Europe
Agree 50
WG
Public green
Central
Europe
Agree 50
WG
controlled
(c)
Geometridae (Operopthera
spp.)
spp.)
Formulation
Type Conc. of
MPCA
Application
(k)
kind
PHI Remarks
(days)
(f - h)
(j)
(l)
(m)
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
not
relevant
(yes)
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
not
relevant
-
(d - f)
Interval
(kg MPCP/ha)
applications
min-max
min-max
min-max
min-max
(min.)
pest)
Evaluator: Germany
Date: November 2015
National addendum Germany
Delfin WG
Registration Report – Central
Zone
Page 1 of 9
REGISTRATION REPORT
Part B
Section 6: Impact on Non-Target Organisms
Product code:
Agree 50 WG
Active Substance:
ssp. aizawai GC-91
Central Zone
National addendum for Germany
S.A./B.V.
Date:
November 2015
Applicant
Mitsui AgriScience International S.A./B.V. Evaluator: Germany
Applicant Document ID dRR Part B Section 6Date: November 2015
Applicant Author Dr. Sabine Asser-Kaiser
Delfin WG
Zone
Page 1 of 9
Table of Contents
IIIM 10
provided for MPCA, to permit an assessment of the impact of the
MPCP on non-target organisms.................................................................. 2
IIIM 10.4
Effects on Arthropods Other Than Bees ............... Fehler! Textmarke nicht
definiert.
IIIM 10.5
Effects on Earthworms ........................... Fehler! Textmarke nicht definiert.
IIIM 10.6
Effects on Soil Micro-organisms ............ Fehler! Textmarke nicht definiert.
IIIM 11
Summary and evaluation of environmental impact ...... Fehler! Textmarke
nicht definiert.
IIIM 11.1
Distribution and fate of the MPCA ....... Fehler! Textmarke nicht definiert.
IIIM 11.2
Identification of non-target species at risk and extent of their
exposure.................................................... Fehler! Textmarke nicht definiert.
Applicant
IIIM 10
Delfin WG
Zone
Page 2 of 9
provided for MPCA, to permit an assessment of the impact of the MPCP on
non-target organisms.
This document usually describes only those chapters in which national exposure assessment
approaches differ from those given in the core assessment due to specific national assessment
requirements. In the present case, no specific national assessment requirements are identified and
accordingly, additional calculations are not necessary for the risk assessment (reference should
be made to the core assessment for more information)
Applicant
2.3
Zone
Page 3 of 9
Delfin WG
Product uses
GAP rev.
Agree 50 WG
Formulation type:
WG
active substance
Bacillus thuringiensis subsecies aizawai
Conc. of as :
500 g/kg
professional use
x
, date: 2012-06-12
Stamm GC- 91
Applicant:
Zone(s): central EU
Verified by MS: yes
1
UseNo.
2
Member
state(s)
3
Crop and/
or situation
(crop destination /
purpose of crop)
4
F
G
or
I
5
controlled
(additionally:
6
7
8
Application
Method /
Kind
Timing / Growth
stage of crop &
season
DE
grape vine (VITVI)
grape)
F
grape berry moth
spraying or
fine
spraying
(low
volume
spraying)
from emergence of
first larvae after
beginning of
infestation or
warning service
appeal / from
BBCH 53
Applicant
Mitsui AgriScience International S.A./B.V.
11
12
Application rate
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
001
10
3 (at least 7
days apart)
kg, product / ha
g, kg as/ha
a) max. rate per
appl.
a) max. rate
per crop/season b) max. total
rate per
crop/season
a) – base dose:
a) 0,125 -0,375
0,25 kg/ha
b) 1,125
Water L/ha
min / max
– base
dose:
- BBCH 61:
400 l/ha
0,5 kg/ha
- BBCH 61:
- BBCH 71:
800 l/ha
0,75 kg/ha
- BBCH 71:
b) 2,25
1200 l/ha
Evaluator: Germany
13
14
Remarks:
PHI
(days)
e.g. recommended or mandatory tank
mixtures
002
DE
grape vine (VITVI)
F
grape berry moth
2. and 3. generation (L1L2)
grape)
Zone
Page 4 of 9
Delfin WG
spraying or
fine
spraying
(low
volume
spraying)
from emergence of
first larvae after
beginning of
infestation or
warning service
appeal / from
BBCH53
3 (at least 7
days apart)
a) – base dose:
a) 0,125 – 0,5
– base dose:
0,25 kg/ha
b) 1,5
400 l/ha
- BBCH 61:
- BBCH 61:
0,5 kg/ha
800 l/ha
- BBCH 71:
- BBCH 71:
0,75 kg/ha
1200 l/ha
-BBCH 75:
- BBCH 75:
1 kg/ha
1600 l/ha
b) 2,25
003
DE
berries (NNNOB)
F
004
DE
berries (NNNOB)
G
005
006
DE
DE
strawberry (FRAAN)
strawberry (FRAAN)
F
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
max. 1000
from BBCH 11
max. 1000
from BBCH 11
1000 - 2000
from BBCH 13
from BBCH 13
Applicant
Evaluator: Germany
1000 - 2000
007
008
DE
DE
(NNNVL)
F
cabbage
009
DE
(NNNVL)
G
cabbage
010
011
012
DE
DE
DE
vegetable cabbage
(BRSOX)
vegetable cabbage
(BRSOX)
(NNNVW)
F
G
F
Zone
Page 5 of 9
Delfin WG
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
6 (at least 7
days apart)
from BBCH 09
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
a) < 50 cm:
a) 0,25 – 0,5
a) < 50 cm:
0,5 kg/ha
b) 3
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 6
b) 6
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
200 - 800
from BBCH 09
200 - 1000
from BBCH 09
200 - 800
from BBCH 09
200 - 1000
from BBCH 09
from BBCH 09
Applicant
Evaluator: Germany
200 - 800
013
014
015
016
017
DE
DE
DE
DE
DE
(NNNVW)
bulb crops (NNNSZ)
herbs (NNNKR)
herbs (NNNKR)
pulse crops (NNNLG)
G
F
F
G
F
Zone
Page 6 of 9
Delfin WG
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
200 - 1000
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) 1
a) 0,5
b) 3
b) 1,5
3 (at least 7
days apart)
a) < 50 cm:
a) 0,25 – 0,5
< 50 cm:
0,5 kg/ha
b) 1,5
min 600 l/ha
from BBCH 09
200 - 800
from BBCH 09
200 - 800
from BBCH 09
200 - 800
from BBCH 09
from BBCH 09
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 3
Applicant
Evaluator: Germany
018
DE
pulse crops (NNNLG)
G
Zone
Page 7 of 9
Delfin WG
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
3 (at least 7
days apart)
from BBCH 09
a) < 50 cm:
a) 0,25 – 0,5
< 50 cm:
0,5 kg/ha
b) 1,5
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 3
019
DE
ornamentals (NNNZZ)
F
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
6 (at least 7
days apart)
a) < 50 cm:
a) 0,25 – 0,5
a) < 50 cm:
0,5 kg/ha
b) 3
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 6
020
DE
ornamentals (NNNZZ)
G
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
6 (at least 7
days apart)
a) < 50 cm:
a) 0,25 – 0,5
a) < 50 cm:
0,5 kg/ha
b) 3
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 6
Applicant
Evaluator: Germany
021
DE
woody ornamentals
(NNNZG)
G
Zone
Page 8 of 9
Delfin WG
spraying or
fine
spraying
(low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
3 (at least 7
days apart)
a) < 50 cm:
a) 0,25 – 0,5
a) < 50 cm:
0,5 kg/ha
b) 1,5
min 600 l/ha
50 – 125 cm:
50 – 125cm:
0,75 kg/ha
min 900 l/ha
> 125 cm:
> 125 cm:
1 kg/ha
min 1200
l/ha
b) 3
Applicant
Evaluator: Germany
Core Assessment
Agree 50 WG
ZV1 007638-00-00
Registration Report
Central Zone
Page 1 of 55
REGISTRATION REPORT
Part B
Section 7: Efficacy Data and Information
Detailed Summary
Product Code: Agree 50 WG
Reg. No.: ZV1 007638-00-00
Active Substance: Bacillus thuringiensis ssp.aizawai
GC-91 500g/kg
Central Zone
CORE ASSESSMENT
Applicant: Mitsui AgriScience International S.A./B.V
Date: 2012-04-27
Evaluator: Julius Kühn-Institut
Date: 2015-11-12
Julius Kühn-Institut
2015-11-12
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ZV1 007638-00-00
Core Assessment
Registration Report
Central Zone
Page 2 of 55
Table of Contents
IIIA1 6
Efficacy Data and Information on the Plant Protection Product ............................ 4
General information ............................................................................................. 4
Recent registration situation/history of the PPP ................................................... 4
Information on the active ingredients (Uptake and mode of action) ..................... 5
Information on crops and pests ........................................................................... 5
Information on the intended uses ........................................................................ 6
Further Information .............................................................................................. 6
IIIA1 6.1
Efficacy data........................................................................................................ 8
IIIA1 6.1.1
Preliminary range-finding tests ............................................................................ 8
IIIA1 6.1
Efficacy data for caterpillars infesting grape vine ................................................. 8
IIIA1 6.1.2
Minimum effective dose tests .............................................................................. 8
IIIA1 6.1.3
Efficacy tests ....................................................................................................... 9
IIIA1 6.1.4
Effects on yield and quality ................................................................................ 10
IIIA1 6.1.4.1
Impact on the quality of plants and plant products ............................................. 10
IIIA1 6.1.4.2
Effects on the processing procedure ................................................................. 10
IIIA1 6.1.4.3
Effects on the yield of treated plants and plant products .................................... 10
IIIA1 6.1
Efficacy data for free biting caterpillars infesting soft berries ............................. 10
IIIA1 6.1.2
Minimum effective dose tests ............................................................................ 11
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 11
IIIA1 6.1
Efficacy data for free biting caterpillars infesting strawberries ............................ 11
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 12
IIIA1 6.1
Efficacy data for free biting caterpillars infesting fruit vegetables ....................... 12
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 13
IIIA1 6.1.4
IIIA1 6.1
Efficacy data for free biting caterpillars infesting leafy and stem vegetables ...... 17
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 17
IIIA1 6.1
Efficacy data for free biting caterpillars infesting vegetable cabbage ................. 17
IIIA1 6.1.2
IIIA IIIA1 6.1.3 Efficacy tests ..................................................................................................... 18
1 6.1.4
IIIA1 6.1
Efficacy data for free biting caterpillars infesting root and tuber vegetables ....... 22
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 22
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IIIA1 6.1
Efficacy data for free biting caterpillars infesting allium bulb crops .................... 23
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 23
IIIA1 6.1
Efficacy data for free biting caterpillars infesting fresh herbs ............................. 23
IIIA1 6.1
Efficacy data for free biting caterpillars infesting pulse crops ............................. 24
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 24
IIIA1 6.1
Efficacy data for free biting caterpillars infesting ornamentals ........................... 26
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 26
IIIA1 6.1
Efficacy data for free biting caterpillars infesting forests .................................... 27
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 27
IIIA1 6.1
Efficacy data for free biting caterpillars in the public green ................................ 28
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 28
IIIA1 6.1.4
Effects on yield and quality for all crops............................................................. 28
IIIA1 6.2
Adverse effects ................................................................................................. 29
IIIA1 6.2.1
Phytotoxicity to host crop................................................................................... 29
IIIA1 6.2.2
Adverse effects on health of host animals ......................................................... 29
IIIA1 6.2.3
Adverse effects on site of application ................................................................ 29
IIIA1 6.2.4
Adverse effects on beneficial organisms (other than bees)................................ 29
IIIA1 6.2.5
Adverse effects on parts of plant used for propagating purposes ...................... 33
IIIA1 6.2.6
Impact on succeeding crops .............................................................................. 33
IIIA1 6.2.7
Impact on other plants including adjacent crops ................................................ 33
IIIA1 6.2.8
Possible development of resistance or cross-resistance ................................... 33
IIIA1 6.3
Economics ........................................................................................................ 34
IIIA1 6.4
Benefits ............................................................................................................. 34
IIIA1 6.4.1
Survey of alternative pest control measures ...................................................... 34
IIIA1 6.4.2
Compatibility with current management practices including IPM........................ 34
IIIA1 6.4.3
Contribution to risk reduction ............................................................................. 34
IIIA1 6.5
Other/special studies ......................................................................................... 34
IIIA1 6.6
Summary and assessment of data according to points 6.1 to 6.5 ...................... 34
IIIA1 6.7
List of test facilities including the corresponding certificates .............................. 38
Appendix 1:
List of data submitted in support of the evaluation ............................................. 39
Appendix 2:
GAP tables ........................................................................................................ 47
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IIIA1 6
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Page 4 of 55
Efficacy Data and Information on the Plant Protection Product
General information
This document reviews efficacy data for the microbial plant protection product Agree 50 WG
(also called Turex WG or Turex 50 WG) containing Bacillus thuringiensis ssp. aizawai strain
GC-91 (Bta GC-91). Inclusion of Bta GC-91 into Annex I entered into force in May 2009 (Commission Directive 2008/113/EC). Bta GC-91 was notified and defended by Mitsui AgriScience
International S.A./B.V.
Agree 50 WG was not the representative formulation, and has not been previously evaluated in
the EU according to Uniform Principles. Nonetheless, Agree 50 WG contains the same active
substance (Bta GC-91), in the same proportions, which can be found in the representative formulation Agree 50 WP.
Agree 50 WG consists of spores and crystal proteins (δ-endotoxins) from the bacteria B. thuringiensis subsp. aizawai GC-91 and contains 25,000 i.u./mg. It is a biological insecticide formulated as a water dispersible granule, containing 3 × 1013 colony forming units (CFU) or 500 g of
Bta GC-91 in 1 kg product. Agree 50 WG is to be applied at a dose rate of 0.05-0.1% up to 1
kg/ha.
Agree 50 WG is non-systemic and poisons the caterpillars. Therefore, it is used to control leaf
consuming caterpillars on various crops. Upon ingestion, the crystal proteins dissolve in the
stomach and damage the tissue. The caterpillars stop eating and die after a few days. Mostly
young caterpillars are more sensitive than old ones. For an adequate effectiveness all plant
parts should be sufficiently sprayed. Applications are performed at pest occurrence, independently from the crop growth stage.
This document refers to the conclusions of the EU review of Bta GC-91. The active substance
data is relied upon in the risk assessment of the formulation Agree 50 WG. The representative
formulation in the EU review was Agree 50 WP.
The Annex I Inclusion Directive for Bta GC-91 (Commission Directive 2008/113/EC) provides
specific provisions under Part B, which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation:
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the active substance Bta GC-91 (SANCO/1538/2008) and in particular Appendices I and
II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be
taken into account. Conditions of use shall include, where appropriate, risk mitigation measures.
Recent registration situation/history of the PPP
Some Bacillus thuringiensis subsp. aizawai containing products are registered in Europe for the
control of lepidopteran larvae in various crops such as vegetables, ornamentals, fruits, grape
vine, other arable crops and forests, in greenhouses and in the field. Some of these products
contain combinations of B. thuringiensis subsp. aizawai and B. thuringiensis subsp. kurstaki.
Table 6-1: A list of countries and products can be found in the following
Country
products
Belgium
XenTari WG (15,000 IU/mg)
Finland
Turex 50 WP (500 g/kg)
Germany
Turex (500 g/kg); XenTari (540 g/kg)
Greece
Italy
Xentari WG (3%)
Flobac (100 g/kg); Xentari (100 g/kg); Turex (500 g/kg Bt kurstaki & aizawai); Agree (500 g/kg Bt kurstaki & aizawai)
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Luxembourg
The Netherlands
Portugal
Spain
Sweden
France
Registration Report
Central Zone
Page 5 of 55
XenTari WG (3%)
Turex 50 WP (50%); XenTari WG (15,000 IU/mg)
Turex (380 g/kg)
XenTari GD (150 g/kg); Turex (250 g/kg)
Turex 50 WP (50% Bt kurstaki & aizawai strain GC 91)
Turex 50 WP (50% Bt kurstaki & aizawai strain GC 91)
Table 6-2: Existing approval of products containing Bta GC-91 in the European zone
Country
Registration number
Country
Registration number
Italy
9477
Netherlands
11702 N
Spain
19430/13
Germany
04143-00 (until 2005)
Portugal
3234
Switzerland
W-6882
Greece
1661
Sweden
4492
Cyprus
2189
Finland
1735
Information on the active ingredients (Uptake and mode of action)
Bacillus thuringiensis (Bt) is an ubiquitous bacterium occurring worldwide, mainly in soils as well
as on insects and on plant surfaces. B. thuringiensis belongs to the spore forming bacteria of
the family Bacilliacea. Dormant spores of B. thuringiensis can persist for long in the environment
and contribute to the transmission of the species in the environment, but are metabolically inactive. During sporulation B. thuringiensis produces inclusion bodies which are composed of insecticidal crystal proteins (ICP, also called Cry proteins or δ-endotoxins). These Cry toxins are
highly toxic to a wide variety of important agricultural and health related insect pests of the order
Lepidoptera.
The crystal proteins of B. thuringiensis must be ingested to be effective against the target insect.
Upon ingestion of B. thuringiensis by the larvae, the crystalline inclusions dissolve in the larval
midgut, releasing the insecticidal crystal proteins (δ-endotoxins). Most of the crystal proteins are
protoxins, converted proteolytically into smaller toxic polypeptides under the alkaline conditions
in the insect midgut. The activated Cry toxins interact with the midgut epithelium cells of susceptible insects.
After binding to specific midgut receptors, they insert into the apical membrane to create ion
channels, or pores, disturbing the osmotic balance, permeability and the regulation of the transmembrane electric potential. This can result in colloid-osmotic lysis of the cells, which is the
main cytotytic mechanism common to all ICPs. Spore germination and proliferation of the cells
into the haemocoel may result in septicaemia, contributing to mortality of the insect larvae. Each
B. thuringiensis strain has a unique Cry protoxin pattern varying in number and amount of the
single proteins produced. Each type of Cry toxins has a unique spectrum of activity and targets
only a small range of Lepidopteran species. Within the small target ranges there are dramatic
differences in potency in species that are often closely related.
Information on crops and pests
Lepidoptera (moths and butterflies) are the second most diverse pest insect order outnumbered
only by the beetles. There is hardly any cultivated plant that is not attacked by at least one lepidopteron pest. As pollinators of many plants, adult moths and butterflies are usually beneficial
insects that feed on nectar using their siphoning proboscis. The larvae (caterpillars) however
almost always have chewing mouthparts that are suitable for feeding on various parts of a plant.
Most caterpillars are defoliators or miners of succulent plant tissues.
Tomato looper
The tomato looper (Chrysodeixis chalcites) is a moth of the family Noctuidae. It is endemic to
southern Europe, the Levant and tropical Africa, but can be found in great parts of Europe as a
migratory species. The tomato lopper feeds on different herbaceous plants including tomato,
strawberries or tobacco and can cause damages in greenhouse crops.
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Registration Report
Central Zone
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Cabbage moth
The Cabbage Moth (Mamestra brassicae) is a common European moth of the family Noctuidae.
The larvae of the cabbage moth damage many different cabbage species.
Winter moth
Winter moth (Operophtera brumata) larvae hatch and feed ravenously on leaves and fruit beginning in early spring. Larvae feed on the inside of buds and leaf clusters during the day, inching their way to the outside of leaves at night. In June, larvae drop to the ground under the trees
where they bury themselves in the soil until fall. November through January, adults come out
and mate. Having no wings, females have a gruelling climb up tree trunks where they lay eggs.
Information on the intended uses
The intended dose rate for all uses is 1 kg/ha. Use of Agree 50 WG is applied for different pests
in soft berry fruits, grapes, fruit and other vegetables including fresh herbs and ornamentals.
Table 6-3: Overview of included pests species
Pests
Acrolepiopsis assectella
ACROAS
Autographa gamma
PHYTOGA
Chrysodeixis chalcites
PLUSCH
Eupoecilia ambiguella
CLYSAM
Euproctis chrysorrhoea
EUPRCH
Evergestis forficalis
EVERFO
Leucoma salicis
LEUOSA
Lymantria dispar
LYMADI
Lobesia botrana
POLIBO
Malacosoma neustria
MALANE
Mamestra sp.
1MAMEG
Mamestra brassicae
BARABR
Operophtera brumata
CHEIBR
Pieris sp.
PIERSP
Plusia sp.
PLUSSP
Plutella xylostella
PLUTMA
Polia oleracea
Thaumetopoea processionea
Yponomeura sp.,
HYPNSP
leek moth
silver Y moth
tomato looper
European grape berry moth
brown-tail moth
garden pebble moth
white satin moth
gypsy moth
grape berry moth
European lackey moth
e.g. glasshouse tomato moth
cabbage moth
common winter moth
e.g. small white
e.g. silver Y moth or tomato looper
cabbage moth
glasshouse tomato moth
oak processionary caterpillar
e.g. spindle ermine moth
Apart from Germany, authorisation is applied for different uses in the European central zone
(Austria, Belgium, Czech Republic, Hungary, Ireland, Luxembourg, the Netherlands, Poland,
Romania, Slovenia, Slovak Republic, and the United Kingdom).
Further Information
Another WP formulation of Turex is already authorised in the Netherlands (trade name: Turex
Spuitpoeder). In this document and trials it is abbreviated to Turex SP, but the formulation is
WP. Besides the new WP formulation (Agree 50 WP/Turex WP) also a WG formulation of Turex
(Agree 50 WG) has been developed to be marketed in Europe. The bridging trials presented
here, were undertaken by the applicant to demonstrate that all three products (Turex SP, Turex/Agree WP and Turex/Agree 50 WG) are similarly effective in pest control when applied in
the same crops against the same pests to justify registration of Agree 50 WG in the Central European zone.
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Registration Report
Central Zone
Page 7 of 55
Data to support the label claims dossier were generated in a total of 53 trials. The majority of
these trials (48) were carried out in testing facilities officially recognized in accordance with the
Principles of Good Experimental Practice (GEP). Of these trials only a minority was conducted
in one of the three concerned EPPO zones (maritime, north-east, south-east), mainly in the
maritime zone. Many of the submitted trials were conducted in the Mediterranean zone.
The applicant claims that inclusion of data obtained in the Mediterranean EPPO zone for the
evaluation of Agree 50 WG in the Central European zone would be justified as under the conditions occurring in the South, pest pressure is usually higher than under the temperate climate
occurring in great parts of Central Europe and are thus, at least or even more challenging than
in the Central European zone (Bouma, 2005). Conditions in the Mediterranean EPPO zone
might be comparable to those occurring in the South-East EPPO zone, at least with regard to
temperatures during the time period which is of relevance for cropping. Moreover, available trials in vegetables from the Netherlands and Switzerland, in grapes conducted in the Northern
Part of France and in Switzerland and the orchard trials from Poland confirm the efficacy of
Agree 50 WG also under the conditions in the Central European zone.
A serious problem which appeared during the evaluation process was that the product Agree
WG used in some trials was not the one applied for. The content of the test product Agree 50
WG applied for is 25,000 i.u./mg Bt aizawai but in these trials it was a combination of Bt kurstaki
& aizawai (Turex 50 WP). In table 6-1 it is described that products named Turex 50 WP and
Agree can have different active ingredients. Information for the use of products containing such
combinations is given for some trials with Chrysodeixis chalcites and Mamestra brassicae.
Therefore these results are not rateable. Information about the de facto content is not given for
all trails as in some report the test product is only declared as Bacillus thuringiensis; this is particularly true for non GEP trials.
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IIIA1 6.1
Efficacy data
IIIA1 6.1.1
Preliminary range-finding tests
Registration Report
Central Zone
Page 8 of 55
Data was not included by the applicant due to a large number of GEP trials for registration.
IIIA1 6.1
Efficacy data for caterpillars infesting grape vine
Authorization is applied for DE. See use-no. 001 and 002 in appendix 2, table 1.
Use-No.
Area of application
Crop(s)/object(s)
Crop stage(s) (BBCH)
Notes on crop
Pest(s)/target(s)/aim(s)
Pest stage(s) (BBCH)
Area of use
Time of treatment
Max. number of treatments for the use
Max. number of treatments per crop or season
Application technique/type of treatment
Dose rate(s) in amount of water to be used
Use-No.
Pest stage(s) (BBCH)
007638-00/00-001
Viticulture
grape vine (VITVI)
from 53
use as table and wine grape
grape berry moth (CLYSAM_2), European grape vine moth
(POLYBO_2)
1st generation (Larval stage L1 to L2)
Outdoors
After beginning of infestation or warning service appeal; from
emergence of first larvae
3
3
spraying or fine spraying (low volume spraying)
basic application rate: 0.25 kg/ha in 400 l water/ha
growth stage (BBCH scale) 61: 0.5 kg/ha in 800 l water/ha
007638-00/00-002
grape berry moth (CLYSAM_3), European grape vine moth
(POLYBO_3)
2nd and 3rd generation (Larval stage L1 to L2)
basic application rate: 0.25 kg/ha in 400 l water/ha
growth stage (BBCH scale) 75: 1 kg/ha in 1600 l water/ha
Authorization is applied for the central zone also. See use-no. 001 in appendix 2, table 2.
Crop and/or
situation
(a)
Grapes
F, Pests or Groups of pests
G, controlled
or
I (c)
(b)
Application*
Growth stage
(j)
BBCH 53-89
kg MPCA./hL
water
(kg MPCP/hL)
L/ha
min-max
min-max
0.025
(0.05)
kg MPCA./ha
(kg MPCP/ha)
min-max
2000
0.5
(1.0)
Foliar application with 1-3 applications and an interval of 7 days between applications.
From a formal point of view the applicant did not deliver the complete set of data necessary for
the registration in viticulture (e.g. trials on the impact of the product on the fermentation and the
quality of the wine). The evaluation based therefore additionally on the long term experience we
have with this and with other products containing the same active ingredient.
IIIA1 6.1.2
Minimum effective dose tests
No information delivered for viticulture.
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IIIA1 6.1.3
Registration Report
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Page 9 of 55
Efficacy tests
The effectiveness trials testing the efficacy against vine moth were carried out in 1999, 2007,
2010 and 2012 in France (Northern and Southern part), Italy and Spain. The trials were conducted in compliance with the CEB guideline 100 or 222: Vine tortrix as well as EPPO guideline
PP 1/11(3) Eupoecilia ambiguella and Lobesia botrana. The target pests were Eupoecilia ambiguella (9 trials) and Lobesia botrana (10 trials). All trials were set up in a randomised complete
block design with 4 replicates. The plots contained between 5 and 30 plants with plot sizes between 8 and 46 m². The grapevine varieties ‘Chardonnay’, ‘Gamay’ and ‘Pinot noir’, ‘Melon de
Bourgogne’, ‘Muscated’, ‘Carignan’ (Noir), ‘Syrah’, ‘Bobal’, ‘Fridularo’, ‘Trebbiano’, and ‘Montepulciano’ were used in the trials. Normal crop maintenance applications were applied. No insecticides with the same spectrum of activity were applied during the trial.
Additional non GEP-trials (see table W-1) were not considered for the efficacy evaluation as
they are badly documented and cryptic. They deliver no information about the design of the trials and about the circumstances under which they took place.
Tabel W-1 shows a summary and overview of the trials delivered for the registration of Agree
against Eupoecilia ambiguella and Lobesia botrana. Table W-2 gives information about the efficacy against Eupoecilia and Lobesia of the product Agree within the efficacy trials conducted in
the maritime and in the Mediterranean zone.
Table W-1: Summary of the efficacy trials delivered by the applicant for the registration of Agree
against the first to third generation of Lobesia botrana and Eupoecilia ambiguella
Trial code
FAGS 99 4094
FAGS 99 4299
FAGS 99 4327
FAGS 99 5987
FAGS 99 6006
FAGS 99 6026
FCER129901
FCER102102
S10-2129-01
FCER127062
FCER128065
FCER103660
Bari 2. Generation
Bari 3. Generation
AOOSVIRIS 3409
01992EIVI
CAI 14010
SRS10-045-10IE
SRS10-044-10IE
*Trial No. 219
*Trial No. 212
*Trial No. 130
*Trial No. 301
*Trial No. 131
*93502
*Trial No. 134
*Trial No. 131.2
*Trial No. 133
Location
Civray
Cars
St. Paul
Athée
Cercié
Villé sur Jarnioux
Maisdon sur Sevre
Maisdon sur Sevre
St. Georges sur Layon
Redessan
Toulouges
Bages
Bari
Bari
Calosso
Tribano
Ravenna
Valencia
Valencia
country
France
France
France
France
France
France
France
France
France
France
France
France
Italy
Italy
Italy
Italy
Italy
Spain
Spain
climatic zone Eppo
PP 1/241(1)
maritim
maritim
maritim
maritim
maritim
maritim
maritim
maritim
maritim
mediterranean
mediterranean
mediterranean
mediterranean
mediterranean
mediterranean
mediterranean
mediterranean
mediterranean
mediterranean
Yvorne
Yvorne
Saillon
Mont sur Rolle
Leytron
Leytron
Leytron
Leytron
Saillon
Switzerland
Switzerland
Switzerland
Switzerland
Switzerland
Switzerland
Switzerland
Switzerland
Switzerland
maritim
maritim
maritim
maritim
maritim
maritim
maritim
maritim
maritim
year
1999
1999
1999
1999
1999
1999
2012
2010
2010
2012
2012
2010
2007
2007
2010
1999
2010
2010
2010
Eppo guideline
no
no
no
no
no
no
PP 1/11(3)
CEB No 222
PP 1/11(3)
PP 1/11(3)
PP 1/11(3)
PP 1/11(3)
no
no
PP 1/11(3)
PP 1/11(3)
PP 1/11(3)
PP 1/11(3)
PP 1/11(3)
BBCH
79
75-77
77
79
79
79
77-79
79
75
75-79
75-79
75
?
?
75-79
77
77
79-81
73-81
Pest species
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
No. of
applications
1
1
1
1
1
1
3
2
2
3
2
2
2
2
2
2
2
3
4
1993
1993
1993
1993
1993
1994
1994
1993
1994
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
Lobesia botrana
3
2
4
3
4
1
4
4
4
infestation untreated [%,
no. of perforations/100
bunches]
13
20,5
7,3
40,5
44,8
20,3
171
44,6
328
29,25
203
395
26,7
11,4
239
477
446
67,5
85
2,1
63 and 115
107
0,5
64
27
6,5
64
8
*: Trial not considered as the applying company only delivered a result overview and no trial
protocol. Material and Methods of these trials are not clear.
Table W-2: Mean efficacy (Abbot) of Agree in the efficacy trials against Lobesia botrana and
mean
efficacy [%]
(Abbot)
75.3
SD
20.4
Min efficacy Max efficacy
[%] (Abbot) [%] (Abbot)
17.9
97.87
Conclusion:
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Agree 50 WG
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Registration Report
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Page 10 of 55
Viticulture in Germany is a major use (100,000 ha). 9 trials together with the additional
information from the Mediterranean area are enough for a registration within the maritime climate zone of the central registration zone. We do not recommend the registration
within the south east EPPO-zone as no trials have been conducted there at all.
• Not all considered trials where conducted according to an EPPO-guideline. We do not
know the French guideline they used, but apparently both guidelines are comparable.
We would expect to get trial results according to the EPPO guideline which was first approved in 1977.
• The trials are exclusively done during the second generation. As we expect a higher UVdegradation of the Bt-product during the first generation of both moth species than during the second generation, when pea-shaped berries are shadowed by the canopy, we
expect a lower efficacy in the first generation than in the second. No trials show the contrary.
Consequently we recommend the registration only for the maritime zone and only for the 2nd
and 3rd generation of Eupoecilia ambiguella and Lobesia botrana and not for their first generation.
•
IIIA1 6.1.4
Effects on yield and quality
IIIA1 6.1.4.1 Impact on the quality of plants and plant products
The applicant delivered only little information on this topic for viticulture. The product had been
registered in many European countries until now. During all those years there were no reports
about phytotoxicity on grape of this product and we do not expect any.
IIIA1 6.1.4.2 Effects on the processing procedure
The applicant delivered no information on this topic for viticulture for viticulture except a publication about the effect of Bt.-toxin on yeasts (There was no yeast inhibiting effect). The product
had been registered in many European countries until now. During all those years there were no
reports about an effect of this product on the fermentation kinetics or the quality of the wine.
With regard to the practical experience we have with this product for a lot of years, we do not
request more fermentation trials.
IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products
The applicant delivered no information on this topic for viticulture. The product had been registered in many European countries until now. During all those years there were no reports of
negative effects on the yield and quality of the grapes harvested.
IIIA1 6.1
Efficacy data for free biting caterpillars infesting soft berries
Authorization is applied for DE. See use-no. 003 (field) and 004 (greenhouse) in appendix 2,
table 1.
Use-No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
007638-00/00-003
Fruit growing
Berries (NNNOB) (except: strawberry (FRAAN))
from 11
free biting caterpillars (LEPISF)
Outdoors
After beginning of infestation; from emergence of first larvae
3
3
1 kg/ha in max. 1000 l water/ha
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Rate App. comment
Registration Report
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Page 11 of 55
treatments must be at least 7 days apart
Authorization is applied for the central zone also. See uses-no. 002-003 in appendix 2, table 2.
Crop and/or
situation
(a)
Red, black and white
currant, blueberry,
goosberry, blackberry,
raspberry
G, controlled
or
I
(b) (c)
Application*
Growth stage
brumata)
April - May
BBCH 00-79
(j)
G
January – December
BBCH 00-99
kg MPCA./hL
water kg MPCA./ha
(kg MPCP/hL)
(kg
L/ha
MPCP/ha)
min-max
min-max
min-max
0.025
(0.05)
0.5
(1.0)
2000
IIIA1 6.1.2
No data submitted for this use.
IIIA1 6.1.3
Efficacy tests
No data was submitted for the control of winter moth (Operophtera brumata) in red, black and
white currant, blueberry, gooseberry, blackberry or raspberry. Due to the specific conditions in
berry crops and the time of pest occurrence in spring an extrapolation form other uses is not
possible.
Conclusion:
The registration of the use against winter moth (Operophtera brumata) in red, black and white
currant, blueberry, gooseberry, blackberry or raspberry will not be supported because no data
were submitted for this use (EPPO standard PP 1/226). An extrapolation form other uses is not
possible due to the specific conditions in berry crops and the time of pest occurrence during
spring time.
IIIA1 6.1
Efficacy data for free biting caterpillars infesting strawberries
table 1.
Use-No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
Rate App. comment
007638-00/00-005
Fruit growing
Strawberry (FRAAN)
from 13
Outdoors
3
3
1 kg/ha in 1000 to 2000 l water/ha
Crop and/or
situation
(a)
Strawberry
G, controlled
or
I
(b) (c)
Noctuidae (Autographa gamG ma, Plusia spp.)
Application*
Growth stage
(j)
April – September
BBCH 13-89
BBCH 13-89
water kg MPCA./ha
kg MPCA./hL
L/ha
(kg MPCP/hL)
(kg
MPCP/ha)
min-max
min-max
min-max
0.083 - 0.167
(0.167 – 0.333)
0.025
(0.05)
300 - 600
2000
0.5
(1.0)
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IIIA1 6.1.2
No data submitted for this use.
IIIA1 6.1.3
Efficacy tests
No data was submitted for the control of lepidopteran pests in strawberry. Due to the specific
application techniques in strawberry crops a minimum of GEP trails are necessary for a regular
registration. Furthermore Plutella xylostella is not a pest of strawberries.
Conclusion:
The registration of the use against lepidopteran pests in strawberry will not be supported because no data were submitted for this use (EPPO standard PP 1/226). An extrapolation form
other uses is not possible due to the specific application techniques conditions in strawberry
crops.
IIIA1 6.1
Efficacy data for free biting caterpillars infesting fruit vegetables
Authorization is applied for DE. See use-no. 007 in appendix 2, table 1.
Use-No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
Rate App. comment
007638-00/00-007
Vegetable growing
fruit vegetables (NNNVF)
from 09
Greenhouse
6
6
plant height up to 50 cm 0.5 kg/ha in at least 600 l water/ha
plant height 50 up to 125 cm 0.75 kg/ha in at least 900 l water/ha
plant height more than 125 cm 1 kg/ha in at least 1200 l water/ha
Authorization is applied for the central zone also. See uses-no. 005 in appendix 2, table 2.
Crop and/or
situation
(a)
Tomato, pepper
(sweet and chilli),
eggplant
Cucumber, gherkin,
courgette, melon,
patisson
G, controlled
or
I
(b) (c)
G Noctuidae (Chrysodeixis chalcites, Autographa gamma,
G Noctuidae (Chrysodeixis chalcites, Autographa gamma,
Application*
Growth stage
(j)
water kg MPCA./ha
kg MPCA./hL
L/ha
(kg
(kg MPCP/hL)
MPCP/ha)
min-max
min-max
min-max
January - December
BBCH 09-89
0.025
(0.05)
2000
0.5
(1.0)
BBCH 09-89
0.025
(0.05)
2000
0.5
(1.0)
*Foliar application with 6 applications at most and an interval between applications of 7 days.
IIIA1 6.1.2
Beet armyworm and silver Y moth:In all trials the intended does rate of 1 kg/ha or higher doses were tested. A clear dose response with the higher rate being more effective was not observed.
Tomato looper: In all trials the intended dose (1.0 kg/ha) and a reduced dose (0.5 kg/ha) was
tested. In most cases Turex WG (similar to Agree 50 WG) was used, in two trials a product a
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WP formulation was used. Not in all trials a clear and significant dose response of Turex WG
applications with 1 and 0.5 kg/ha was found. Nevertheless, the number of living larvae, the leaf
area damaged and the number of damaged leaves was nearly always higher with 0.5 kg/ha
than with 1.0 kg/ha proving that 1 kg/ha gives better control than 0.5 kg/ha. Therefore and because of the long history of use of BT products, it seems not to be advisable to reduce the intended dose of 1.0 kg/ha.
In all trials evaluated for this use, a dose of 1 kg/ha was applied at crops not higher than 50 cm,
and thereby a double dose of the intended one (for Germany). For higher crops (sweet pepper)
a higher dose (2 kg/ha) was used by keeping a concentration of 0.1%. For fruit vegetables the
intended dose in this use may be sufficient, because fruit vegetables have only little leaf area at
a height beneath 125 cm in contrast to other crops such as pulse crops or ornamentals which
build dense crop stands even below 50 cm.
Regarding these results, it seems not advisable to reduce the intended dose of 1 kg/ha.
IIIA1 6.1.3
Efficacy tests
Data available to evaluate this use are
(a) Tomato looper(Chrysodeixis chalcites):
(b) Beet armyworm (Spodoptera littoralis):
(c) Silver Y moth (Autographa gamma):
8 trials conducted in the greenhouse, maritime
zone; 1 fruit vegetable, 7 ornamental trials
7 additional trials, Mediterranean zone; 2 greenhouse, 5 field trials; 3 fruit vegetable, 4 vegetables trials
1 additional field trial, Mediterranean zone;
(a) Tomato looper (Chrysodeixis chalcites, Noctuidae)
Material and methods:
Eight efficacy trials against tomato looper were carried out in 2003 to 2011 in The Netherlands
(Table 1). The trials from 2010 and 2011 were conducted in compliance with the EPPO guidelines pp 1/150(2): ‘Spodoptera exigua on cotton’. All trials were set up in a randomised complete
block design with 3 or 4 replicates. In 8 trials the WG and WP formulations were used, in 2 trials
the WP formulation only.
Agree 50 WG (in the following Agree) was tested at dose rates of 0.05 and 0.1%, resulting in
0.5 and 1 kg/ha, in two trials of 1.5 and 2 kg/ha. The product and the reference products are
listed in table 3. Assessments were carried out just before each application and one and two
weeks after the last application. The number of living and dead caterpillars was counted per
plot. Furthermore, the percentage of leaf surface damaged by C. chalcites was assessed and
the number of damaged leaves was counted. The control of larvae of C. chalcites was calculated according to the Henderson & Tilton formula.
Results:
Treatments with Agree (1% or 1 kg/ha) gave high, increasing levels of control until 14 days after
the 2nd applications (85-100%). The levels of control were slow in the beginning but in the comparable for all Bta containing products not depending on the formulation. Similarly comparable
were the reference products Xentari and Nomolt, whereas the efficacy of Nomolt was slightly
weaker.
The percentage of leaf area damaged decreased and was in most trials significantly lower than
that recorded for the untreated control at the last assessment. Results were comparable to
those found for the reference treatments. Additionally, the number of damaged leaves was significantly lower than those recorded for the untreated control at the last two assessments. The
number of damaged leaves found was comparable to those found for the reference treatments.
Phytotoxic symptoms were not found.
Table F-1: Efficacy trials submitted for Agree 50 WG evaluated against tomato looper
2015-11-12
Agree 50 WG
ZV1 007638-00-00
Core Assessment
No. Year
1
crop
g/f
2003 sweet pepper greenhouse
‘express’
4 m high
2005 pot gerbera
greenhouse
no.
appl.
dose
32)
Registration Report
Central Zone
Page 14 of 55
L/ha
water
GEP
Products1)
0.1 % = 2000 l/ha
Yes
3/4/7/8/9
2 kg /ha
2
22)
0.1 % = 1000 l/ha
Yes
3/4/7/8/9/10
1 kg /ha
3 2008 pot gerbera
greenhouse
2
0.1 % = 1500 l/ha
Yes
35 cm high
1/3/7/8
1.5 kg /ha
4 2010 hibiscus ‘Sunny greenhouse
2
0.1 % = 1000 l/ha
Yes;
Red’
1/2/4/5/7
1 kg /ha
5 2010 hibiscus ‘Athe- greenhouse
2
0.1 % = 1000 l/ha
Yes;
na’
1/2/4/5/6/7
1 kg /ha
6 2010 hibiscus
greenhouse
2
0.1 % = 1000 l/ha
Yes;
‘S. Zaragoza’
1/2/4/5/6/7
1 kg /ha
7 2011 hibiscus ‘Bor- greenhouse
2
0.1 % = 1000 l/ha
Yes
deaux’
1/2/3/4/5/6/7
1 kg /ha
8 2011 hibiscus ‘Can- greenhouse
2
0.1 % = 1000 l/ha
Yes
cun’
1/2/3/4/5/6/7
1 kg /ha
1)
For a description of the reference products see table 3
2)
Turex WP as a combination of BT subsp. kurstaki and BT subsp. aizawai
3)
0 = not sufficiently effective (up to about 70 %); + = sufficiently effective (70 to 90%);
++ = good efficacy (> 90%)
Efficacy
3)
+
not
specified
+
++
++
+
++
++
(b) Beet armyworm (Spodoptera littoralis, Noctuidae)
Seven efficacy trials against beet armyworm were carried out in the Mediterranean zone (Table
2). The trials were conducted in compliance with the EPPO guidelines pp 1/150(2): ‘Spodoptera
exigua on cotton’. All trials were set up in a randomised complete block design with 4 replicates.
Agree 50 WG (in the following Agree) was tested at dose rates of 1, 1.2, 1.5 and 2 kg/ha. The
test and the reference products are listed in table 4. In some trials the number of living and dead
caterpillars was counted per plot. Furthermore, the percentage of leaf surface damaged was
assessed and the number of damaged leaves was counted. The efficacy was calculated according to the Henderson & Tilton formula.
Results:
In all but one trials a sufficient (+) or good (++, > 90%) efficacy of the test product was shown.
Treatments with Agree gave high, increasing levels of control until to 7 days after the last applications (70-96%). The levels of control were slow in the beginning but in the comparable for all
Bta containing products not depending on the formulation. Also, there was no difference in efficacy between the different doses. In mean, the reference products Xentari, Delfin, Laser, and
Steward were similarly comparable.
The percentage of leaf area damaged decreased and the number of damaged leaves was significantly lower than those recorded for the untreated control at the last assessments. Results
were comparable to those found for the reference treatments. In the last trial the number of
damaged fruits (F) was recorded. All BT products reduced the number of damaged fruits to
about 60-75%. Only Redan performed better with 90% sound fruits (trial 15). Phytotoxic symptoms were not found.
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Page 15 of 55
Table F-2: Efficacy trials submitted for Agree 50 WG evaluated against Beet armyworm
No. Year
Crop & cultivar
F/G
no.
dose rate
ProdGEP
country
appl.
L/ha water
ucts1)
9
1999, IT pepper ‘Soldi‘
G
3
1.5 & 2 kg/ha in 13
No
900 L/ha
10 2005, ES* brokkoli **
F
2
1.5 & 2 kg/ha
7, 9, 12
Yes
11 2006, IT* cauliflower ‘PaF
6
1.2 kg/ha in 900 - 1,7
miros‘
1200 l/ha
12 2008, IT pepper ‘Quadrato
F
3
1 & 1.5 kg/ha in 9, 7, 15
rosso‘
1000 L/ha
13 2010, IT lettuce ‘Mafalda‘
F
3
1.5 kg/ha in 1000 13, 14
L/ha
14 2010, IT lettuce ‘Ballerina’
G
4
1, 1.5 & 2 kg/ha in 9, 13, 15
800 L/ha
15 2010, IT pepper ‘Corino‘
F
4
1.5 kg/ha in 1000 9, 13, 16
L/ha
* low infestation level in untreated; ** original trial document not submitted (AS 6204 I 03)
**)
F) In this trail, the number of damaged fruits (F) was recorded.
EF
**)
++
++
+
++
0
+
+F)
(c) Silver Y moth (Autographa gamma, Noctuidae)
See table 3. Three different formulations of Agree were tested: Agree WP (new), Agree WP
(old) and Agree WG.
Results:
The degree in pest incidence increased throughout the trial with 70% of fruits infested at the last
assessment. Under the conditions of the study, efficacy with regard to the reduction in fruit
damage was generally low for all Bt products. Best results were obtained with the chemical
standard treatment. Efficacy with regard to the reduction of leaf damage was very similar for all
products with best results achieved with the highest rate of Agree WP and the chemical treatment; however, not significant. Applied at the same rate, the results for the Agree formulations
were very similar confirming that data on Agree WP (old or new formulation) can be used to
support the label claims of Agree 50 WG.
There was no clear dose-response observed for Agree WP.
Table F-3: Efficacy trials submitted for Agree 50 WG evaluated against silver Y moth
No. Year
Crop & cultivar
F/G
no.
dose rate
ProdGEP
country
appl.
L/ha water
ucts1)
16
2010, water melon ‘Pata
F
3
1.0, 1.5 and 2.0 9, 13, 17 Yes
ES
negra’
kg/ha in 1000 L/ha
*)
+ = sufficiently effective (70 to 90%)
Table F-4: Reference products used in the efficacy trials
Product
active substance
content
1 Turex SP (WP) B. t. subsp. aizawai
25.000 i.u./mg
2 Turex SP (WP) B. t. Subsp. aizawai 25.000 i.u./mg
3 Turex WP
B. t. subsp. aizawai
25.000 i.u./mg
4 Turex WP
25.000 i.u./mg
5 Turex WG
25.000 i.u./mg
EF
*)
+
application rate per ha
1.0 kg/ha
25x109 i.u./ha
0.5 kg/ha
12.5x109 i.u./ha
1.0 kg/ha
25x109 i.u./ha
0.5 kg/ha
12.5x109 i.u./ha
1.0 kg/ha
25x109 i.u./ha
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6 Turex WG
7 XenTari WG
8 Nomolt
Product
teflubenzuron
active substance
25.000 i.u./mg
15.000 i.u./mg
150 g/L
content
0.5 kg/ha
12.5x109 i.u./ha
1 kg/ha
15x109 i.u./ha
0.4 L/ha
9
10
11
12
13
14
15
16
17
diflubenzuon
tebufenozid
B. t. subsp. kurstaki
indoxacarb
spinosad
clorpirifos methyl
cypermethrin
25.000 i.u./mg
25 g/kg
25.000 i.u./mg
240 g/L
32.000 i.u./mg
300 g/kg
42 g/L
220 g/L
no information
1.5 kg/ha
0.5 kg/ha
2 kg/ha
0.75 L/ha
1 kg/ha
0.125 kg/ha
0.2-0.25 L/ha
1.5 L/ha
1.0 L/ha
Turex WP
Dimilin
Turex WP
Mimic
Delfin WG
Steward
Laser SC
Reldan 22
Cipert
IIIA1 6.1.4
37x109 i.u./ha
50x109 i.u./ha
32x109 i.u./ha
In only one efficacy trial (15) effects on the yield were recorded, resulting in a reduced the number of damaged fruits of about 60-75%.
In all other efficacy trials the percentage of leaf area damaged and the number of leaves damaged was recorded. Both parameters are relevant to the plant quality of ornamentals. In the
trials 1-7 the leaf area consumed by lepidopteran larvae in hibiscus and gerbera was significantly reduced. Hence, the quality and depending on the severity of the damage, the number of
marketable plants and yield resp. was improved.
The yield has been recorded quantitatively in 4 phytotoxicity trials in cucumber (see IIIA1 6.2.1.).
The number of fruits was counted after 4 applications with Agree/Turex WG at the proposed
dose rate of 0.1% and the double dose rate. No negative influences of Agree/Turex WG on the
yield were observed.
No tests on transformation processes have been submitted. However, Agree is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The product it is not expected to exhibit herbicidal activity. Agree is therefore not expected to cause adverse effects on
the yield of treated plants or plant products. In contrary, the protection given by Agree against
the various caterpillars will prevent the crops from feeding damages and consequential yield
loss. In addition, products based on Bacillus thuringiensis have already been authorised for a
considerable time in many countries within Europe. From these years of experience no negative
influences on yield or transformation processes are known or expected.
Conclusion:
In all trials besides one a sufficient (+) or good (++) efficacy of the test product was shown. The
trials cover a wide range of different crop morphologies, botanical families and cropping systems. Therefore, it can be concluded that the effectiveness of Agree 50 WG is independent of
the crop. The application rates used in the presented trials are very different and only little information is given if higher dose rates correspond with crop size (fruit vegetables in the greenhouse can grow up to 5 m). Only in few trials the dose rate corresponds with the proposed GAP
for cucurbits and Solanaceous fruits. In all trials efficacy was sufficient concerning number of
attacked leaves, living larvae and damaged fruits. In all trials the reference product acted similar
or slightly better.
The area of use is in the greenhouse. Therefore, results from greenhouse trials conducted the
Mediterranean can be included. In 4 additionally submitted trials cucurbits and Solanaceous
fruits were included. In the other 11 trails relevant pest species were included.
Furthermore, it is possible to extrapolate from the submitted data to larvae of other Noctuid
moths. According to the EPPO extrapolation table 09/15092 efficacy in Solanaceae, data on
Autographa gamma and Mamestra oleracea in brassica crops can be used for extrapolation to
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Solanaceous vegetables. Thus, together with data on other pests (Mamestra brassicae, Plutella
xylostella, Spodoptera spp., and Pieris sp.) in brassica crops, the claim is support for lepidopteran larvae in Solanaceous fruits and cucurbits.
Therefore, authorization is supported.
IIIA1 6.1
Efficacy data for free biting caterpillars infesting leafy and stem vegetables
table 1.
Use-No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
Rate App. comment
007638-00/00-008
Vegetable growing
leafy and stem vegetables (NNNVL) (except: vegetable cabbage
(BRSOX))
from 09
Outdoors
3
3
Use-No.
Area of use
007638-00/00-009
Greenhouse
Authorization is applied for the central zone also. See uses-no. 008 and 9 in appendix 2, table 2.
Crop and/or
situation
(a)
G, controlled
or
I
(b) (c)
Application*
Growth stage
(j)
Lettuce, endive, curled F Plutellidae (Plutella xylostella),
Pieridae (Pieris spp.), Noctuendive, lamb´s lettuce,
idae (Polia oleracea, Autograspinach
G pha gamma, Plusia spp.)
water kg MPCA./ha
kg MPCA./hL
L/ha
(kg MPCP/hL)
(kg
MPCP/ha)
min-max
min-max
min-max
April – September
BBCH 09-99
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
BBCH 09-99
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
0.5
(1.0)
*Foliar application with 3 applications at most and an interval between applications of 7 days.
IIIA1 6.1.2
No data submitted, see the uses for fruit vegetables and vegetable cabbages.
IIIA1 6.1.3
Efficacy tests
No data submitted.
Conclusion:
Efficacy can be extrapolated from other uses (see reports for fruit vegetables and vegetable
cabbages).
IIIA1 6.1
Efficacy data for free biting caterpillars infesting vegetable cabbage
table 1.
Use-No.
007638-00/00-010
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Area of application
Crop(s)/object(s)
Area of use
Time of treatment
Rate App. comment
Vegetable growing
vegetable cabbage (BRSOX)
from 09
Outdoors
3
3
Use-No.
Area of use
007638-00/00-011
Greenhouse
Authorization is applied for the central zone also. See uses-no. 010, 011 and 012 in appendix 2,
table 2.
Crop and/or
situation
G, controlled
or
I
(b) (c)
(a)
Application*
Growth stage
(j)
Red cabbage, savoy
cabbage, pointed head
Crambidae (Evergestis forficalApril – September
cabbage, white
is), Pieridae (Pieris spp.),
BBCH 09-99
cabbage, Brussel
Noctuidae (Autographa gamsprouts, kale
ma, Mamestra brassicae,
Plusia spp.)
Chinese cabbage, choi F Plutellidae (Plutella xylostella),
April – September BBCH
Crambidae (Evergestis forficalcabbage, cauliflower,
09-99
is), Pieridae (Pieris spp.),
broccoli, Indian
mustard, kohlrabi
G Noctuidae (Autographa gamJanuary – December
ma, Mamestra brassicae,
BBCH 09-99
Plusia spp.)
kg MPCA./hL
water kg MPCA./ha
(kg MPCP/hL)
(kg
L/ha
MPCP/ha)
min-max
min-max
min-max
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
0.5
(1.0)
0.5
(1.0)
Foliar application with 3 applications at most and an interval of 7 days between applications.
IIIA1 6.1.2
(a) Diamondback moth:
2 trails with only a minor dose (0.5 kg/ha) and sufficient efficacy;
(b) Cabbage moth:
a minor doses was included in 1 trial (2004 BE) without a clear
dose response; in 2 trials higher doses (1.5 & 2 kg/ha) were used
with a clear dose response in 1 trial;
(c) Cabbage white:
minor doses not included but in both trials higher doses (1.5 & 2
kg/ha) with a clear doses response in both trials;
Regarding these results, it seems not advisable to reduce the intended dose of 1 kg/ha.
IIIA IIIA1 6.1.3
Efficacy tests
(a) Diamondback moth:
6 trials conducted in the maritime zone;
(b) Cabbage moth:
1 trails maritime zone, 4 additional trials, Mediterranean zone;
(c) Cabbage white:
2 additional field trial, Mediterranean zone.
(a) The diamondback moth Plutella xylostella (Plutellidae)
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The Diamondback Moth Plutella xylostella is a common European moth. Six trials testing the
efficacy of Agree/Turex WG against P. xylostella were carried out in 2002 and 2010 in the Netherlands. The trials 1-3 from 2010 were conducted in compliance with the EPPO guideline PP
1/83(2): Caterpillars on leaf brassicas.
While counting the caterpillars a division was made between live caterpillars and pupae. Before
the applications as well as one, two and about three weeks after the last application the number
of caterpillars per plant was counted. Additionally, at each sampling date the percentage infested plants was determined. The percentage of caterpillar control compared with the untreated
treatment was calculated according to Henderson & Tilton. In the trials 3 and 4 only the percentage of damaged sprouts/cabbages was calculated.
Results:
In the mean of the 2010 trials the efficacy of all Bta containing products was similar and good
(Table 1). The feeding damage by the caterpillars was significantly reduced compared to the
untreated control. Treated plants showed better plant vigour. In trials 2 and 3 the infestation
level was low, but still sufficient for evaluation. In all trials infestation with the cabbage white
(Pieris rapae) occurred although infestation level was very low. Larvae of P. rapae were controlled with the Bta product likewise. In trial 3, the percentage of damaged sprouts in the untreated control was 17%. After the application of Turex WP it was significantly lower (8%). This
was comparable to the reference product (3%). In trial 4 the number of damaged sprouts and in
the trials 5 and 6 the number of damaged heads was significantly reduced (The latter are trial
reports of Dutch research stations with unclear intention).
Conclusion:
Efficacy to control Plutella xylostella is proven for the maritime zone.
Table C-1: Efficacy trials submitted for Agree 50 WG evaluated against diamondback moths
Year
crop
g/f
no.
dose/ for- L/ha waGEP
Efficacy
3)
Country
ap.
mulation
ter
Products1)
2010, NL cauliflower
field
3
1 kg/ha, WG 400 l/ha Yes; 1/2/3/5 +
‘Fremont’
2010, NL cauliflower ‘Cleobis’ field
3
1 kg/ha, WG 400 l/ha Yes; 1/2/3/5 ++
2010, NL cauliflower ‘Kornalu’ field
3
1 kg/ha, WG 400 l/ha Yes; 1/2/3/5 ++
2002, NL Brussels sprouts
field
5
1 kg/ha, WP not specino; 2/6
+
‘Cyrus’
fied
field
5
0.5 kg/ha
2002, NL white cabbage ‘Li500 L/ha
no; 7 2)
++
3)
not specified 500 L/ha
2002, NL on’
field
4
no; 4, 5
+
1)
For a description of the products see the table 4
2)
Turex + adjuvant Designer or Silwet; 3) low infestation level
3)
(b) The cabbage moth Mamestra brassicae (Noctuidae)
The Cabbage Moth Mamestra brassicae is a common European moth of the family Noctuidae.
All trials were set up in a randomised complete block design with 4 replicates. Normal crop
maintenance applications were applied. No insecticides with the same spectrum of activity were
applied during the trial.
Results:
In Trial 1 the dose per ha of all products is not mentioned and the evaluation method is unclear;
therefore the trial is not rateable. In trial 2, the percentage of damaged cabbage heads and the
damaged leaf area were significantly reduced after application of Turex WP. This was comparaJulius Kühn-Institut
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ble to the reference products. No phytotoxic symptoms occurred. In trial 3-5 the test product
Agree WG is described as a combination of BT aizawai and kurstaki. Therefore the product applied for is not included and these trials are not rateable.
Conclusion:
The efficacy is not finally evaluable.
TableC- 2: Efficacy trials submitted for Agree 50 WG evaluated against cabbage moths
Year
crop
g/f
no.
dose
L/ha waGEP
Country
ap.
ter
Products1)
1993, CH Brussels sprouts field
3
200 g/hL ai
no
2004, BE cauliflower
field
6
0.5 & 1 kg/ha 600 l/ha not specified;
‘Amerigo’
2/4/5
2010, IT cauliflower
field
5
1, 1.5 & 2
not
Yes; 8, 9, 11
‘Freedom’
kg/ha
specified
2010, IT broccoli ‘Switch’ field
4
1.5 kg/ha
800 l/ha Yes; 8, 10, 12
2010, IT broccoli ‘Marafield
5
1, 1.5 & 2
700 l/ha Yes; 8, 10, 12
thon’
kg/ha
1)
For a description of the products see the table 4
2)
Efficacy
2)
0
+
+
++
++
(c) The cabbage white Pieris sp. (Pieridae)
Both trials were set up in a randomised complete block design with 4 replicates. Normal crop
maintenance applications were applied. No insecticides with the same spectrum of activity were
applied during the trial. In both trials a higher as applied dose rate was used. Given that infestation occurred at the end of the trial period, only the last three applications were responsible for
control. The efficacy in controlling larvae was sufficient. There was a clear dose response in
both trials (1: 94% vs. 100% and 2: 84% vs. 97% efficacy).
Conclusion:
The efficacy is not finally evaluable.
Table C-3: Efficacy trials submitted for Agree 50 WG evaluated against cabbage white
Year
crop
g/f
no.
Dose
L/ha waGEP
Efficacy
**)
Country
ap.
ter
Products*
2005, ES savoy cabbage
field
8
1.5 & 2 kg/ha 250 L/ha Yes / 5, 8, 9 ++
‘Hercules’
(0.75 kg), 14
2005, ES cauliflower ‘Casfield
8
1.5 & 2 kg/ha 600 l/ha
Yes / 5, 8, 9 +
per’
(0.75 kg), 14
* For a description of the products see the table 4
**)
+ = sufficiently effective (70 to 90%); ++ = good efficacy (> 90%)
Table C-4: Reference products used in efficacy trials
Product
active substance
content
1 Turex SP (WP) B. t. subsp. aizawai
25.000 i.u./mg
2 Turex WP
25.000 i.u./mg
3 Turex WG
25.000 i.u./mg
4 Delfin
32.000 i.u./mg
5 XenTari WG
15.000 i.u./mg
6 Nomolt
teflubenzuron
150 g/L
7 Decis
deltamethrin
25 g/L
1.0 kg/ha
25x109 i.u./ha
1.0 kg/ha
25x109 i.u./ha
1.0 kg/ha
25x109 i.u./ha
0.5 kg/ha
16x109 i.u./ha
1 kg/ha
15x109 i.u./ha
0.4 L/ha
0.3 L/ha
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8
9
10
11
12
13
14
Turex WP
Delfin
Delfin
Steward
Reldan 22
Karate Zeon
Mimic
indoxacarb
clorpirifos methyl
lambda-cyhalothrin
tebufenozid
25.000 i.u./mg
32.000 i.u./mg
32.000 i.u./mg
300 g/kg
220 g/L
100 g/L
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1.5 kg/ha
1 kg/ha
1.5 kg/ha
0.125 kg/ha
1.5 L/ha
20 g/L
0.75 kg/ha
37.5x109 i.u./ha
32x109 i.u./ha
48x109 i.u./ha
(d) Beet armyworm Spodoptera littoralis (Noctuidae)
Efficacy was tested in altogether 7 trails in the Mediterranean; in 2 trials cauliflower and broccoli
were included with 1.2 and 1.5 kg/ha and sufficient efficacy (see chapter fruit vegetables).
(e) Additional data
In four field experiments set up in 1995 at ADAS, United Kingdom, the effectiveness of Agree,
Bactospein and two chemical standards was tested against Plutella xylostella, Pieris rapae, Evergestis forficalis and Mamestra brassicae in Brussels sprouts. Spray treatments were applied
with 1.125 kg/ha in a water volume of 1000 L/ha. Efficacy for reducing infestation with larvae
was sufficient.
Within the frame of product development several effectiveness trials were carried out in the USA
in 1998, 1999 and 2002. All experiments were set up in complete randomised block design with
four replicates. Rated was either the damage score or the number of dead/living larvae or both.
The applicant submitted six trials to support the Northern GAP for use in brassica crops although they were conducted in southern states of the USA (Florida, South Carolina). Additionally, it needs to be noted that the number of applications, ranging between three and seven, was
in most cases higher than the number of treatments intended for the Central European zone.
The dose was approx. 1.1 to 1.4 kg/ha. The obtained results confirm the good effectiveness of
Turex WG against Plutella xylostella, Pieris rapae and Evergestis sp.
1 6.1.4
In some trials the percentage of damaged cabbage heads (2002 NL, 2004 BE) or sprouts (2002
NL) was counted. In all trials these parameter were significantly improved compared to the untreated control.
Overall conclusion:
Drawing a resilient conclusion is difficult. Of all 13 trials only 3 trials were conducted in the central (maritime) zone including GEP and EPPO guidelines proving sufficient efficacy. 4 trials of
the maritime zone were unspecified trial records showing sufficient efficacy as well. One old trial
was not rateable (1993 CH). For the south east zone 5 trials from the Mediterranean zone were
submitted instead with two trials including higher doses only and 3 trails using a product with
another formulation (containing a combination of BT aizawa and kurstaki).
Concerning the efficacy on different lepidopteran species efficacy for:
• Plutella xylostella is proven for the maritime zone;
• Mamestra brassicae is not finally evaluable;
• Pieris sp. is not finally evaluable;
• Spodoptera littoralis is proven for the Mediterranean zone.
Note:
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In existing and former authorisations of Turex or products containing a similar a.s. in Germany,
a minor dose rate of 500 and 600 g/ha, respectively, was sufficient to control lepidopteran larvae
(e.g. pierid moth or Evergestis sp.) in cabbage except from noctuids. Such a differentiation is
not possible considering the submitted results. Hence, the applied amount of product in practice
may in some cases and regions be higher than needed.
Conclusion:
Efficacy can be extrapolated from other uses (see report for fruit vegetables) and from experience with respect to the former authorisation.
IIIA1 6.1
Efficacy data for free biting caterpillars infesting root and tuber vegetables
table 1.
Use-No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
Rate App. comment
007638-00/00-012
Vegetable growing
root and tuber vegetables (NNNVW)
from 09
Outdoors
3
3
Authorization is applied for the central zone also. See uses-no. 013-015 and 017 in appendix 2,
table 2.
G, controlled
or
I
(b) (c)
Crop and/or
situation
(a)
Swede
Beetroot, raddish,
black raddish, carrot,
celery, celery leaves,
celeriac, parsley
Witloof, Chicory
Crambidae (Evergestis forvicalis), Pieridae (Pieris spp.),
Noctuidae (Autographa gamma, Mamestra brassicae,
Plusia spp.)
G
F Noctuidae (Autographa gamma, Plusia spp.)
Application*
Growth stage
(j)
kg MPCA./hL
water kg MPCA./ha
(kg MPCP/hL)
L/ha
(kg
MPCP/ha)
min-max
min-max
min-max
April-September
BBCH 09-99
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
April – September
BBCH 09-99
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
BBCH 09-99
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
April – September
BBCH 09-99
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
0.5
(1.0)
0.5
(1.0)
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests
No data submitted.
Conclusion:
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cabbages).
IIIA1 6.1
Efficacy data for free biting caterpillars infesting allium bulb crops
Authorization is applied for DE. See use-no. 014 in appendix 2, table 1.
Use-No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
Rate App. comment
007638-00/00-014
Vegetable growing
bulb crops (NNNSZ)
from 09
Outdoors
3
3
Authorization is applied for the central zone also. See uses-no. 016 in appendix 2, table 2.
Crop and/or
situation
(a)
Onions, shallots,
pickles, garlic, leek
G, controlled
or
I
(b) (c)
assectella)
Application*
Growth stage
(j)
April – September
BBCH 07-99
kg MPCA./hL
water kg MPCA./ha
(kg MPCP/hL)
L/ha
(kg
MPCP/ha)
min-max
min-max
min-max
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests
No data submitted.
Conclusion:
cabbages).
IIIA1 6.1
Efficacy data for free biting caterpillars infesting fresh herbs
table 1.
Use-No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
Rate App. comment
007638-00/00-015
Vegetable growing
Herbs (NNNKR)
from 09
Outdoors
3
3
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G, controlled
or
I
(b) (c)
Crop and/or
situation
(a)
Herbs
Application*
Growth stage
(j)
G
April – September
BBCH 09-99
BBCH 09-99
water kg MPCA./ha
kg MPCA./hL
L/ha
(kg
(kg MPCP/hL)
MPCP/ha)
min-max
min-max
min-max
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Conclusion:
Fresh herbs are a minor use. This group is consisting of crops from many plant families and
susceptible to many different species of lepidopteran larvae. Efficacy for fresh herbs can be
extrapolated from other crops.
For authorisation in the central zone: It should be taken into account that Plutella xylostella only
plays a minor role in a very limited number of herb species.
IIIA1 6.1
Efficacy data for free biting caterpillars infesting pulse crops
table 1.
Use-No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
Rate App. comment
007638-00/00-017
Vegetable growing
pulse crops (NNNLG)
from 09
Outdoors
3
3
Crop and/or
situation
(a)
G, controlled
or
I
(b) (c)
Dwarf snap and slicing F Noctuidae (Polia oleracea,
bean, pole snap and
spp.)
slicing bean, yard long
bean
Application*
Growth stage
(j)
April – September
BBCH 09-99
kg MPCA./hL
water kg MPCA./ha
(kg MPCP/hL)
L/ha
(kg
MPCP/ha)
min-max
min-max
min-max
0.025
(0.05)
2000
0.5
(1.0)
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests
No data submitted.
Conclusion:
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(a) For Germany: The use in this version is only suitable for runner beans. For pulse crops except from runner beans, which build dense crop stands already at lower heights, no vertical
separation is necessary. The use should therefore be separated and the application rate for
pulse crops apart from runner beans should be:
Dose rate(s) in amount of water to be used: 1 kg/ha in 200 to 800 l water/ha
(b) For the central zone: Efficacy can be extrapolated from other uses (see reports for fruit vegetables and vegetable cabbages).
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Efficacy data for free biting caterpillars infesting ornamentals
Authorization is applied for DE. See use-no. 019 (field) and 020 (greenhouse) for ornamentals
and use 021 for woody ornamentals in the greenhouse (3 applications) in appendix 2, table 1.
Use-No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
Rate App. comment
007638-00/00-019
Ornamental growing
Ornamentals (NNNZZ)
Outdoors
6
6
Crop and/or
situation
(a)
G, controlled
or
I
(b) (c)
Ornamentals and
flowers
F Pieridae (Pieris spp.), Noctuidae
G
Nursery crops and
perennials
F Pieridae (Pieris spp.), Noctuidae
Lymantria dispar), Lasiocampidae (Malacosoma neustria),
spp.)
Application*
Growth stage
(j)
April – September
BBCH 09-99
BBCH 09-99
water kg MPCA./ha
kg MPCA./hL
(kg MPCP/hL)
L/ha
(kg
MPCP/ha)
min-max
min-max
min-max
0.025
(0.05)
2000
0.5
(1.0)
0.025
(0.05)
2000
0.5
(1.0)
April – September
BBCH 09-99
BBCH 09-99
IIIA1 6.1.2
IIIA1 6.1.3
Efficacy tests
For this application a total of 53 trial reports have been submitted. In these trials a wide range of
caterpillar species and their respective families were included in. In most trials a sufficient (+) or
good (++, > 90%) efficacy of the test product was shown. The following species were included:
• Noctuidae: Chrysodeixis chalcites (tomato looper), Spodoptera littoralis (Beet armyworm),
Autographa gamma (Silver Y moth), Mamestra brassicae (Cabbage Moth),
• Plutellidae: Plutella xylostella (Diamondback Moth),
• Pieridae: Pieris sp. (cabbage white),
• Tortricidae: Pandemis cerasana (barred fruit-tree tortrix), Cydia pomonella (codling moth),
Adoxophyes orana (summer fruit tortrix), Eupoecilia ambiguella (vine moth) Lobesia botrana
(European grapevine moth)
Seven of these trials have been conducted with the ornamentals hibiscus (5) and gerbera (2) in
the greenhouse to test the efficacy against the tomato looper (Chrysodeixis chalcites) (see use
for fruit vegetables).
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Though most of the included species does not occur or play a minor role in ornamentals, efficacy can be extensively extrapolated. Nevertheless, in many of the submitted trials a higher dose
than intended was used (1.5 to 2 kg/ha). It is therefore not clear if a maximum amount of 1
kg/ha is adequate for a sufficient control particularly for high and dense crop stands.
Typical species damaging woody ornamentals in Germany for instance would include also
members of the family Yponomeutidae (e.g. Yponomeuta cagnella, Y. malinellus.) and other
members of the tortrix and the geometridae family.
Conclusion:
Considering all trials submitted for this application a wide range of different crop morphologies,
botanical families and cropping systems is covered. In most of these trials a sufficient (+) or
good (++) efficacy of the test product was shown. Therefore, it can be concluded that the effectiveness of Agree is independent of the crop. Hence, results from other crops are included in
this evaluation. If the area of use is in the greenhouse, results from greenhouse trials conducted
the Mediterranean can also be included.
However, the application rates used in the presented trials are very different and often higher
than applied for, just as the number of application was higher. Little information is given if higher
dose rates correspond with crop size (ornamentals in the greenhouse can grow up to 2 m for
instance). Regarding small crops, in most trials efficacy was sufficient concerning number of
attacked leaves, damaged plants, and larvae control and the reference product acted similar or
only slightly better. For higher and dense crops the doses applied for may not be sufficient. This
agrees with the former authorisation in Germany with dose rates from 1 to 2 kg/ha depending on
the crop height.
(a) For Germany: Efficacy cannot be supported with the recommended dose rate.
(b) For the central European zone: Efficacy can be extrapolated from other uses; dose rates
have to be evaluated according to the local production systems.
IIIA1 6.1
Efficacy data for free biting caterpillars infesting forests
Authorisation is applied for the central zone. See use-no. 026 and 027 in appendix 2, table 2.
Crop and/ or
situation
Country/
F
Member G or
state
I
Pests or
Group of pests controlled
(c)
(a)
Forestry
(b)
Central
Europe
F
Pieridae (Pieris spp.); Geometridae
(Operophtera brumata); Lymantriidae
(Euproctis chrysorrhoea, Lymantria
dispar, Leucoma salicis); Lasiocampidae (Malacosoma neustria); Yponomeutidae (Yponomeuta spp.)
Application*
Growth
stage &
season
(j)
kg
MPCA/hL
(MPCP/hL)
min max
BBCH 09-99
(April - September)
0.025
(0.05)
Water kg MPCA/ha
(MPCP/ha)
L/ha
min
max min max
2,000
0.5
(1.0)
IIIA1 6.1.2
The applicant did not present any tests which were created in accordance with the EPPO guideline PP1/225 (2) “Minimum effective dose”.
IIIA1 6.1.3
Efficacy tests
The applicant did not present any tests which were created in accordance with the EPPO guideline PP1/210 (1) “Defoliators of forest trees” and the EPPO guideline PP1/226 (1) “Number of
efficacy trials”. For Germany, the presented examinations were not made with the relevant
harmful organisms and the application technology appropriate for forests. The amount of water
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applied for the application with aircraft (helicopter) is too high in the GAP-table. The water effort
varies between 30 and 150 L/ha depending on aircraft type. Studies of plant damages are missing with the less middle amount of 30-150 L/ha.
Conclusion:
Authorisation cannot be supported.
IIIA1 6.1
Efficacy data for free biting caterpillars in the public green
Authorisation is applied for the central zone. See use-no. 026 and 027 in appendix 2, table 2.
Crop and/ or
situation
Country/
F
Member G or
I
state
Pests or
Group of pests controlled
(c)
(b)
(a)
Public Green
Central
Europe
F
Pieridae (Pieris spp.); Geometridae
(Operophtera brumata); Lymantriidae
(Euproctis chrysorrhoea, Lymantria
dispar, Leucoma salicis); Lasiocampidae (Malacosoma neustria); Yponomeutidae (Yponomeuta spp.)
Application*
Growth
stage &
season
(j)
kg
MPCA/hL
(MPCP/hL)
min ax
BBCH 09-99
(April - September)
0.025
(0.05)
Water kg MPCA/ha
(MPCP/ha)
L/ha
min
max min max
2,000
0.5
(1.0)
IIIA1 6.1.2
The applicant did not present any tests which were created in accordance with the EPPO guideline PP1/225 (2) “Minimum effective dose”.
IIIA1 6.1.3
Efficacy tests
For more detailed information to harmful organisms in the urban green: See use no. 019 and
021. For the EU zone B the applicant derives the adequate effectiveness of his means from the
submission of studies to the following harmful organisms: gypsy moth (Lymantria dispar), winter
moth (Operopthera brumata), brown-tail moth (Euproctis chrysorrhoea), Satin moth (Leucoma
salicis), lackey moth (Malacosoma neustria) and spindle ermine moth (Yponomeura sp.).
Conclusion:
According to the use in ornamentals, efficacy is extrapolated and authorisation supported.
IIIA1 6.1.4
Effects on yield and quality for all crops
Information or trial results on the effect on yield and quality were only delivered in some trail
results on fruit crops, ornamentals, and vegetable cabbages. In these cases results are located
at the corresponding uses.
In none of the effectiveness trials and selectivity trials unacceptable phytotoxicity or other adverse effects were observed. Agree WG is not expected to cause adverse effects. In contrary,
the protection given by Agree WG against the various caterpillars will prevent the crop from eating damage and consequential yield loss. In addition, products based on Bacillus thuringiensis
have already been authorised for a considerable time in many countries within Europe. From
these years of experience no negative influences on yield or transformation processes are
known.
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IIIA1 6.2
Adverse effects
IIIA1 6.2.1
Phytotoxicity to host crop
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(a) Grapes
No phytotoxicity was observed during the trials mentioned.
(b) Vegetables and ornamentals
In all effectiveness trials in hibiscus (5 trials), gerbera (2 trials), sweet pepper (1 trial), Brussels
sprouts (1 trial) and cauliflower (4 trials) assessments were conducted on phytotoxicity, crop
vigour and/or visible residue. In none of the effectiveness trials phytotoxic effects were observed. In 2 trials with hibiscus some visible residue was recorded shortly after the first application but this always disappeared at the end of the trial period.
Specific phytotoxicity trials have been performed in 2010 in the floriculture crops cyclamen (1
trial), Saintpaulia (1 trial), begonia (1 trial) and Ficus (1 trial) and 2011 in cucumber (4 trials).
Trials were conducted according to the EPPO guideline PP 1/135(3): Phytotoxicity assessment.
In these trials Turex was applied 4 times at the proposed dose rate of 1.0 kg/ha or 0.1% and the
double dose rate. Assessments were made on phytotoxicity, crop vigour, leaf deformation, necrosis and visible residue. In none of these trials unacceptable permanent phytotoxic symptoms
were observed. Residue was visible in the trials on the floriculture crops. However, these were
only slight and were also seen at the treatments with the reference product.
Conclusion:
Agree 50 WG is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The product is not expected to exhibit herbicidal activity. Agree 50 WG is, therefore, not expected to cause phytotoxic effects. In addition, products based on Bacillus thuringiensis have
already been authorised for a considerable time in many countries within Europe. From these
years of experience no negative influences on yield or transformation processes are known.
IIIA1 6.2.2
Adverse effects on health of host animals
This is not an EU requirement.
IIIA1 6.2.3
Adverse effects on site of application
IIIA1 6.2.4
Adverse effects on beneficial organisms (other than bees)
Effects on relevant beneficial organisms
The toxicity of Agree 50 WG (also labeled Turex 50 WP) on beneficial organisms has been investigated by carrying out tests under laboratory conditions on Aphidius rhopalosiphi and Typhlodromus pyri.
With Aphidius rhopalosiphi, unacceptable effects (≥ 30%) on survival were not observed, when
Turex 50 WP was applied at 4.5 times the maximal recommended field rate/ha and application
(Table 6.2.4-1). However, the parasitation rate of the exposed test animals was reduced by
55.1%. The indicator test species Aphidius rhopalosiphi is not relevant antagonist in vineyards,
fields with soft fruits, vegetables and ornamentals. In greenhouses Aphidius rhopalosiphi is not
a relevant beneficial insect too. But, the results for Aphidius rhopalosiphi indicate that applications of Agree 50 WG to vineyards, fields with soft fruits, vegetables and ornamentals might
reduce the population of relevant parasitoids > 25%.
In Table 6.2.4-2.the results of the test on the predatory mite Typhlodromus pyri are shown. An
application rate of 4.5 kg/ha (corresponding to 4.5 times the maximal recommended rate/ha and
application) is not harmful (effects < 8%) for these beneficial arthropod species. On the basis of
these results no effects ≥ 25% are expected for populations of Typhlodromus pyri, when Agree
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50 WG is applied according to the recommended use pattern, i.e. 3 applications of maximal 1.0
kg/ha to vineyards and fields with soft fruits.
Table 6.2.4-1: Effects of Turex 50 WP on Aphidius rhopalosiphi (exposed stage: male and female) in a laboratory test (substrate: glass)
Application rate Corrected mortality Effect on parasitisation rate
Reference
[kg/ha]
[%]
[%]
4.5
7.5
55.1
Warmers, C., 2005a
20051317/01-NLAp
Table 6.2.4-2: Effects of Turex 50 WP on Typhlodromus pyri (exposed stage: protonym) in a
laboratory test (substrate: glass)
Application rate
Corrected mortality
Effect on reproduction
Reference
[kg/ha]
[%]
[%]
4.5
7.1
-33.9
Warmers, C., 2005b
20051317/01-NLAp
Conclusions:
Agree 50 WG is classified as not harmful for populations of Typhlodromus pyri.
Effects on soil quality
Effects on soil macro-organisms being used as indicators of soil quality
Effects on earthworms
Active substances
No data available.
Metabolites
No data available.
Products
In this section, no new studies are submitted assessing the effect of Agree 50 WG. Agree 50
WG was not the representative formulation, and has not been previously evaluated in the EU
according to Uniform Principles.
Instead data from the assessment with another Bta GC-91-based product are presented by the
applicant. Nonetheless, the applicant declares that Agree 50 WG (synomym for CGD 97220 I)
contains the same active substance (Bta GC-91), in the same proportions, which can be found
in the representative formulation Agree 50 WP. It appears therefore feasible to lean on the data
of Agree 50 WP for the evaluation of Agree 50 WG
Table 6.2.4-3: Ecotoxicological endpoints for earthworms
EU agreed endpoints
Test item
06/05/2008)
CGD 97220
Ia)
Endpoints used in risk assessment
a) Synonym for Agree 50 WP containing the same content of Bta GC-91 as Agree 50 WG
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As the content of Bta GC-91 in Agree 50 WP and Agree 50 WG is the same the obtained data
can be directly used to assess the risk of Agree 50 WG.
Table 6.2.4-4: Acute earthworm toxicity endpoint for Agree 50 WG
Duration,
Test product
Endpoint
Value
Dimension
organism
14 d, mortality
1000
LC50
Eisenia fetida
mg/kg soil
CGD 97220 Ia)
56 d, reproducNOEC
_
tion
Reference
Winkler,
1992a
a) Synonym for Agree 50 WP containing the same content of Bta GC-91 as Agree 50 WG
Proposed use pattern
See GAP table – list of intended uses for the central zone, Part A
Exposure
The exposure to soil organisms was estimated by calculating the maximum predicted environmental concentrations in soil (PECS) (please refer to Part B, Section 5). The PECS value was
calculated for 6 applications of 1.0 kg Agree 50 WG/ha in vegetables assuming as a worst case
that no degradation of the product and the active ingredient occurs between the treatments.
Under these conditions and based on standard assumptions for the soil density and the incorporation depth, the PECS was determined to be 8 mg Agree 50 WG/kg dry weight soil.
The PECs for Agree 50 WP (used in the DAR, Vol 3, Annex B, Part 7, B9., Aug. 2009) was calculated as 2.56 Agree 50 WP mg/kg dry weight soil (1.28 mg Bta/ kg dry weight soil) for multiple
applications and worst case situation.
Table 6.2.4-5: Maximum soil PEC values for Agree 50 WP and Agree 50 WG
Test substance
Maximum PECsoil [mg/kg]
Agree 50 WP
Agree 50 WG
2.56
8
Risk assessment (Toxicity exposure ratios, TERA and TERLT)
Acute risk
The potential acute risk TERA of Agree 50 WG to earthworms was assessed by comparing the
maximum instantaneous PECS with the 14-day LC50 value to generate the acute TER value.
The TERA was calculated as follows:
TER A =
LC50 (mg/kg)
PECS (mg/kg)
Table 6.2.4-6: Acute TER value for earthworms
Compound referred
LC50
to
Maximum PECS
TERA
Trigger
Agree 50 WP
2.56 mg/ kg. d.w. soil
> 390
10
Agree 50 WG
8.0 mg/ kg. d.w. soil
> 125
10
The acute TER value is much higher than the Annex VI acute trigger value of 10, indicating that
GAP directed application of Agree 50 WG poses no acute risk to earthworms.
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Long-term risk
Due to the absence of acute toxicity no adverse effects on earthworms are to be expected due
to the recommended application of Agree 50 WG or Bta GC-91. Bacillus thuringiensis subsp.
aizawai (Bta GC 91) and its ∂–endotoxins are rapidly degraded by UV light and the activities of
other microorganisms. The persistence of active vegetative cells is short, but spores are viable
for longer periods.
Thus, all TER are above the relevant trigger value of 10 indicating a low and acceptable acute
risk to earthworms of the plant protection products following treatment with Agree 50 WP in accordance with the intended worst-case use pattern.
Conclusion:
Thus, the TERA is above the relevant trigger value of 10 indicating a low and acceptable chronic
risk for earthworms to the active substance Bta GC 91 as well as to Agree 50 WP, following
treatment with the product in accordance with the intended worst-case use pattern and good
agricultural practice.
Field tests
Not required as an acceptable risk to earthworms was identified, based on the laboratory studies available.
Effects on other non-target macro-organisms
Tests on other soil non-target organisms are triggered by breaching the soil persistence criteria
(DT90 > 365 days).
For Bta GC 91 and Agree 50 WP no field DT90 values are available, but both were considered
not to be persistent and to bio-accumulate in the field (EU DAR).
Effects on organic matter breakdown
No data required.
Overall conclusion with respect to effects on soil macro-organisms
It is concluded that the proposed use of Agree 50 WP will not pose an unacceptable risk to populations of earthworms or other soil macro-organisms, when applied according to the recommended use pattern.
Instructions and information: None
Overall conclusion with respect to effects on soil quality
There is no indication of any unacceptable adverse effects on soil macro- or soil microorganisms relevant for the maintenance of soil quality.
Effects on soil non-target micro-organisms exposed to Agree 50 WP
Table 6.2.4-7: Ecotoxicological endpoints for soil micro-organisms
Test item
EU agreed endpoints
No significant effect > 25% at day 28 at
2.0 L or 20 L product/ha
No significant effect > 25% at day 28 at
N
2.0 L or 20 L product/ha
DHA = Dehydrogenase activity, N = Nitrogen transformation.
CGD 97220 I
(3 + 1013 CFU/kg)
1
Test
design1
DHA
Reference
Winkler, J. (1992)
Report No. 921049013
Risk assessment for soil microflora functions
Based on the results of these studies, Agree 50 WP showed no effects of > ± 25% compared to
the control on soil microbial activity up to a maximum tested concentration of 20.0 L product/ha,
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after 28 days. As the proposed use of Agree 50 WP an acceptable risk to soil microbial activity
can be concluded.
IIIA1 6.2.5
Adverse effects on parts of plant used for propagating purposes
Impact on propagation of plants is not expected. Agree 50 WG is based on naturally occurring
bacteria and has highly specific insecticidal efficacy. The product is not expected to exhibit herbicidal activity. Agree is therefore not expected to cause adverse effects.
In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no negative influences on yield or propagation processes are known.
IIIA1 6.2.6
Impact on succeeding crops
No assessments on following crops were made in any of the trials. Besides, an impact on succeeding crops is not expected. Agree 50 WG is based on naturally occurring bacteria and has
highly specific insecticidal efficacy. The product it is not expected to exhibit herbicidal activity.
Agree 50 WG is therefore not expected to cause adverse effects.
In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no unacceptable
effects on succeeding crops are known.
IIIA1 6.2.7
Impact on other plants including adjacent crops
Agree 50 WG is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The product it is not expected to exhibit herbicidal activity. In the effectiveness and phytotoxicity trials crop safety has been demonstrated in both protected floriculture crops and protected
cucumber; cultivations known to be very sensitive. Agree is therefore not expected to cause
adverse effects.
In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no unacceptable
effects on adjacent crops are known.
IIIA1 6.2.8
Possible development of resistance or cross-resistance
Active ingredients based on Bacillus thuringiensis subspecies belong to the IRAC main group
11: Microbial disruptors of insect midgut membranes. To control lepidopteran larvae, the subspecies aizawai and kurstaki are used. Resistance to Bacillus thuringiensis subspecies aizawai
is reported from different species belonging to the noctuidae, pyralidae and plutelidae family,
such as Plodia interpunctella, Plutella xylostella, and Spodoptera littoralis (for further information
see: Arthropod Pesticide Resistance Database (APRD)). Resistance to B. thuringiensis can be
associated with reduced binding of ICP to the brush border membranes of midgut epithelium. In
addition, selection pressure can lead to changes in the mean population response levels. The
complex mode of action of B. thuringiensis, involving multiple toxins and B. thuringiensis spores,
is supposed to provide protection against resistance because a single mutation in the insect
would be unlikely to affect susceptibility. It was, however, suggested that at high levels of selection, the multi-component-toxicity pathway merely expands behavioural and /or physiological
opportunities for adaptation to B. thuringiensis. The general lack of cross resistance between
conventional insecticides and B. thuringiensis is not surprising because these two types of pesticides have different modes of action and they engender different mechanisms of resistance.
The application of Bta products is not considered to have a high potential of causing resistance
or cross-resistance within the target pest organism.
Hence, only one of report of resistance (Spodoptera littoralis in France) is related to European
populations, the applicant therefore recommends alternating with products based on different
active substances after three applications as a contribution to risk reduction and integrated pest
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management strategies. Additionally, the intended number of application is limited to three in
most uses or in special cases to six (ornamentals and fruit vegetables).
IIIA1 6.3
Economics
IIIA1 6.4
Benefits
IIIA1 6.4.1
Survey of alternative pest control measures
IIIA1 6.4.2
Compatibility with current management practices including IPM
IIIA1 6.4.3
Contribution to risk reduction
Decreased sensitivity or resistance has been reported. It is therefore recommended to alternate
with another product based on a different active substance after three applications (see 6.2.8).
IIIA1 6.5
Other/special studies
No additional studies are included to support this application.
IIIA1 6.6
Summary and assessment of data according to points 6.1 to 6.5
Agree 50 WG (also called Turex WG or Turex 50 WG) consists of spores and crystal proteins
(δ-endotoxins) from the bacteria B. thuringiensis subsp. aizawai GC-91 and contains 25,000
i.u./mg. It is a biological insecticide formulated as a water dispersible granule, containing 3 ×
1013 colony forming units (CFU) or 500 g of Bta GC-91 in 1 kg product. Agree 50 WG is to be
applied at a dose rate of 0.05-0.1% up to 1 kg/ha.
Agree 50 WG is non-systemic and poisons the caterpillars. Therefore, it is used for the control
of leaf consuming caterpillars on various crops. Upon ingestion the crystal proteins dissolve in
the stomach and damage the tissue. The caterpillars stop eating and die after a few days. Mostly young caterpillars are more sensitive than old ones. For an adequate effectiveness all plant
parts should be sufficiently sprayed.
Agree 50 WG is intended to control pests in soft fruits, grape vines and vegetables, as well as
ornamentals. Agree 50 WG and other products containing B. thuringiensis subsp. aizawai are
registered in a large number of European countries.
Due to the applicant, data for preliminary range finding tests were not included because of a
sufficient number of GEP trials for registration. Because of the long period of registered products in Europe, a dose rate of 0.05-0.1% and 1.0 kg/ha has turned out to be suitable.
However, in many trials the tested rates ranged between 1.0 and 2.0 kg/ha. The inclusion of
trials with higher dose rates is partly justified as available trial data suggest that the differences
between 1.0 and 1.5 kg/ha are usually not significant and often no clear dose-response correlation can be observed when different rates of Turex WG are tested simultaneously. However, the
application rates used in the presented trials are very different and often higher than applied for,
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just as the number of application was higher. Little information is given if higher dose rates correspond with crop size (ornamentals in the greenhouse can grow up to 2 m for instance, fruit
vegetable considerably higher even if not so dense). Regarding all results a dose rates of 2
kg/ha seem to provide better control for higher and dense crops
On the other hand: In existing and former authorisations of Turex or products containing a similar a.s. in Germany, a minor dose rate of 500 and 600 g/ha, respectively, was sufficient to control lepidopteran larvae (e.g. pierid moth or Evergestis sp.) in cabbage except from noctuids.
Such a differentiation is not possible considering the submitted results and the lack of trials for
the evaluation of the minimum effective dose. Hence, the applied amount of product in practice
may in some cases and regions be higher than needed.
This report presents a summary of the trials performed in The Netherlands, Belgium, France,
Poland, Italy and Spain. Data to support the label claims were generated in a total of 48 GEP
trials which have been carried out in vegetables or assessing the effect against typical vegetable moths (24 GEP trials), in grapes (16 GEP trials) and orchards (8 GEP trials). In addition,
data from 28 non-GEP trials are presented which have been carried out in vegetables (18 trials)
and grapes (10 trials). The trials were carried out between 1993 and 2012 in the Maritime EPPO
zone, the North-East EPPO zone and the Mediterranean EPPO zone.
The applicant describes that data obtained in the Mediterranean EPPO zone should be used for
extrapolation to the South-East EPPO zone assuming that temperature regimes and the resulting pest pressure are comparable and considering that several countries of the Central European zone belong to the Mediterranean EPPO zone, e.g. all Adriatic states. In addition, data from
six trials carried out in the USA are presented.
The pests considered in the trials were Chrysodeixis chalcites (8 GEP trials), Plutella xylostella
(3 GEP trials, 3 non-GEP trials, 8 other reports), Spodoptera littoralis (6 GEP trials, 1 non GEP
trial), Mamestra brassicae (3 GEP trials, 2 non-GEP trials; GEP trials not rateable ), Autographa
sp. (1 GEP trial), Pieris sp. (2 GEP trials, 4 other reports) all representing typical vegetables
moths which also occur in ornamentals and flowers, herbs, berries etc. In addition, data on Evergestis forficalis are presented (2 non-GEP trials). In some trials mixed populations of different
pests occurred. However, the results always refer only to the main target pest. In grapes, the
efficacy of Turex WG against Eupoecilia ambiguella (7 GEP trials, 2 non-GEP trials) and
Lobesia botrana (9 GEP trials, 8 non-GEP trials) was tested and in orchards control of Cydia
pomonella (2 GEP trials), Adoxophyes orana (2 GEP trials) and Pandemis cerasana (4 GEP
trials).
In the GAP table for the central zone (appendix 2, table 2) individual pest species are mentioned
for the respective uses. An evaluation regarding these species is difficult as the applicant has
for instance listed pest species which does not occur in or which cover only a small part of the
crops within a crop group. This involves for instance the Pieridae in ornamentals or the species
Plutella xylostella (Plutellidae) in the uses 004, 005, 008, 009, 014, 015, 018 and 019. However,
this species does not occur in strawberries (uses 004, 005) or lettuce (008, 009) and infests only
some members in the groups root and tuber vegetables or herbs.
A serious problem which appeared during the evaluation process was that in some trials Agree
containing a combination of Bt kurstaki & aizawai (Turex 50 WP) was used (see also table 6-1),
in some trials with Chrysodeixis chalcites and Mamestra brassicae for instance. Therefore,
these results are not rateable. Information about the de facto content is not given in many trials
as in some report the a.i. of the test product is only declared as Bacillus thuringiensis. This is
particularly true for non GEP trials.
The trials performed in Europe on a wide range of different crops species and plant families
showed that Agree 50 WG is selective towards most crops. Moreover, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within
Europe. From these years of experience no negative influences on plants are known.
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The application of Bta products is considered to have a low potential of causing resistance or
cross-resistance within the target pest organism. Decreased sensitivity or resistance has been
reported for Bacillus thuringiensis in some countries including France (for Spodoptera littoralis
only). Therefore, it is precautionary recommended to alternate with products based on different
active substances after three applications outdoors.
Under these conditions, the applicant proposes the authorisation of Agree 50 WG to control
lepidopteran larvae in soft fruits, grapes, vegetables and ornamentals at a dose rate of 0.050.1% but not more than 1.0 kg/ha by foliar application at a maximum number of three and six
applications in ornamentals resp., at an interval of seven days. Applications are performed at
pest occurrence, independently from the crop growth stage. In the following table the recommended evaluations are listed.
Table S-1: Efficacy evaluation for the applied uses of Agree 50 WG in Germany:
Crops
Pest
Evaluation
DE
grape berry moth, European
authorisation is not supported
grape vine
grape vine moth (1. generation)
grape berry moth, European
authorisation is supported for
grape vine
grape vine moth (2.and 3.
the maritime zone only
generation)
soft berries
free feeding caterpillars
strawberries
fruit vegetables
leaf and stem
vegetables
vegetable cabbage
root and tuber
vegetables
allium bulb crops
fresh herbs
pulse crops
ornamentals
woody ornamentals
efficacy is proven, authorisation
is supported
extrapolation of efficacy is
possible; authorisation is
supported
authorisation is supported
possible; authorisation is
supported
authorisation is not supported,
a final evaluation is not
possible; the dose rate has to
be adapted
Table S-2: Efficacy evaluation for the applied uses of Agree 50 WG in the central European
zone (except Germany):
Uses / Crops
Pest*
Evaluation
Central European zone except for DE
001;
Tortricidae (Lobesia botrana,
authorisation is supported for
grape vine
the maritime zone only
002 & 003;
soft berries
brumata)
004 & 005;
strawberries
006 & 007;
Solanaceae and
authorisation can be supported
cucurbitaceae
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Uses / Crops
Pest*
Central European zone except for DE
008 & 009;
leaf and stem
vegetables
010, 011 & 012;
vegetable cabbage
0013, 014, 015 & 017;
root and tuber
vegetables
016;
allium bulb crops
018 & 019;
fresh herbs
020 & 021;
pulse crops
022 & 023;
ornamentals
Registration Report
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Evaluation
possible; authorisation can be
supported
authorisation can be supported
possible; authorisation can be
supported
possible; the dose rates has to
be checked particularly for
greenhouse use
extrapolation of efficacy might
be possible
024 & 025;
nursery crops and
perennials
026; forestry
027; public green
extrapolation of efficacy might
be possible
2015-11-12
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IIIA1 6.7
Country
NL
NL
NL
BE
FR
FR
FR
FR
FR
CH
ES
ES
IT
IT
IT
IT
IT
IT
IT
IT
IT
IT
IT
PO
Agree 50 WG
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List of test facilities including the corresponding certificates
Facility
De Bredelaar B.V.
Proeftuin Zwaagdijk
PPO, Westmaas
PCBT, Rumbeke
Prestagro
Anadiag
Eurofins Agroscience Services
Agrolis Consulting
Novex
Ciba Plant Protection
AgroSoler C.I.F.
Recerca Agricola/ SynTech Research Spain
Centro di Saggio Metaponum Agrobios
Centro di Saggio CAA Giorgio Nicoli S.r.l.
A.S.T.R.A - Innovazione e sviluppo
Consiglio per la Ricerca e la Sperimentazione in Agricoltura
CORAGRO S.r.l.
DST
ARA Spermentazioni i Agricoltura
Vit. En.
Sperimentazione fitofarmaci S.P.F. S.n.c.
Consorcio Agrario di Ravenna
Regional Plant Health Monitoring Centre Plugia Region in
cooperation with AGROLAB s.r.l.
Fertico Sp. z o.o., Agricultural Research Service
GEP
yes
yes
no
no
Yes
yes
yes
yes
yes
no
yes
yes
yes
yes
yes
yes
yes
yes
no
Yes
yes
yes
yes
yes
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Annex
Point
Author
Title
Year
Document
C
Anonymous
Draft label Agree 50 WG Central zone 2011
2011
KIIIM1 6.2
Rinsma, S.
Ref. App.
Ref. JKI
268413
Biological Assessment Dossier of Turex WG
2012
268427
KIIIM1 6.2
Jansen, E.
Control of Chrysodeixis chalcites in glasshouse
grown Hibiscus
2011
I-10-3215
268430
KIIIM1 6.2
De Lange,
J.
Control of Plutella xylostella with Turex in cauliflower
2011
I10.468.VE
G-1.ZWA
268433
KIIIM1 6.2
Jansen, E.
Control of Chrysodeixis chalcites in glasshouse
grown Hibiscus
2012
I-11-3214
268436
KIIIM1 6.2
Oostingh,
C.
Control of Chrysodeixis chalcites in ornamentals
2011
I11.468.OR
N-2.ZWA
268439
KIIIM1 6.2
Temmerma
n,
F.,
Rapol, J.,
Delanote,
L.
Rupsenbestrijding in de najaarsteelt van bloemkool
2004
PCBT
BT04BLK_I
NS01
268442
KIIIM1 6.2
Vlaswinkel,
M.,
Kruistum,
G.
Beheersing koolmotje in spuitkool
2003
PPO
12
35330
268445
KIIIM1 6.2
Waalkens,
W.
Control of Chrysodeixis chalcites in sweet pepper
2004
I-03-321
268448
KIIIM1 6.2
Rinsma, S.
Control of Chrysodeixis chalcites in ornamentals
2008
I08.468.OR
N-1.401
268451
KIIIM1 6.2
Waalkens,
W.
Control of Chrysodeixis chalcites in pot gerbera.
2005
I-04-320-1
268454
KIIIM1 6.2
Prevotat,
M.
Final report of field study Biocillis Vine Tortrix
2000
PRE99102
268458
KIIIM1 6.7
Jansen, E.
Crop safety of PAF97 001, PAI 08 002 and PAI 10
009 in protected fruiting vegetables
2012
F-11-3202
268461
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Annex
Point
Author
Title
Year
Ref. App.
Ref. JKI
KIIIM1 6.7
Jansen, E.
Crop safety of PAF97 001, PAI 08 002, PAI 10 008
and PAI 10 009 in protected fruiting vegetables
2012
F-11-3201
268466
KIIIM1 6.7
Jansen, E.
Crop safety of Turex SP in ornamentals
2012
I-10-3225
268469
MIIIM1 Sec
6
MTA
Draft Registration Report - Part B - Agree 50 WG DE -Section 6 - Ecotoxicology -- Core assessment
2012
MIIIM1 Sec
6
268503
MIIIM1 Sec
6
MTA
Draft Registration Report - Part B - Agree 50 WG DE -Section 6 - Ecotoxicology -- Core assessment
2012
MIIIM1 Sec
6
268506
MIIIM1 Sec
7
MTA
Draft Registration Report - Part B - Agree 50 WG DE -Section 7 - Efficacy Data an information -- Core
assessment
2012
MIIIM1 Sec
7
268508
Document
C
Anonymous
Document C
2005
k.A.
268523
MIIM Sec 6
BarlettaBergman
Document MIIM Sec. 6
2006
k.A.
269332
KIIIM1 10.5
Winkler, J.
Acute toxicity earthworm test - Eisenia foetida
according to the OECD Guideline 207
1992
92 10 49
014
269360
KIIIM1 10.6
Winkler, J.
Effects on the activity of soil microflora according to
the BBA Guideline VI, 1-1 (1990)
1992
92 10 49
013
269362
MIIIM1 Sec
6
BarlettaBergan, A.
Document MIIIM1 Sec. 6
2006
k.A.
269370
MIIM Sec 6
BarlettaBergman,
A.
Document MIIM Sec. 6
1900
k.A.
269405
MIIIM1 Sec
6
Süß, J.
Document MIIIM1 Sec. 6
2009
k.A.
269407
MIIIA1 Sec
6
MTA
Draft Registration Report - Part B - Agree 50 WG DE - Section 6 ¿ Ecotoxicology - Core assessment
(word)
2012
MIIIA1 Sec
7
MTA
Draft Registration Report - Part B - Agree 50 WG DE - Section 7 ¿ Efficacy Data and Information Core assessment (word)
2012
270449
270450
2015-11-12
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ZV1 007638-00-00
Core Assessment
Registration Report
Central Zone
Page 41 of 55
Annex
Point
Author
Title
Year
Ref. App.
Ref. JKI
KIIIM1 6.1
Nolting, H.G.
Zulassung des Pflanzenschuzmittels "Turex"
2000
AP-ZA
004143-00
316614
KIIIM1 6.1
Kohsiek, H.
Zulassung des Pflanzenschutzmittels Turex mit dem
Wirkstoff: 500 g/kg Bacillus thuringiensis
2000
AP-ZA
004143-00
316615
KIIIM1 6.1
Nolting, H.G.
Genehmigungsverfahren
für
Pflanzenschutzmittel "Turex", Zul.Nr.: 4143-00
das
2002
APG1800414
300/02WR/V
d
316616
KIIIM1 6.1
Stridh, H.
Supportive letter for Turex 50 WP from orchard
grower
2013
Rosenberg,
O.
Supportive letter for Turex 50 WP from Skogforsk
1900
KIIIM1 6.1
Anonymous
Adaptive sampling and control of caterpillar pests of
horticultural brassica crops
1997
BtAGR
1997
Brussels
UK
316619
KIIIM1 6.1
Anonymous
Effectiveness of various insecticides in controlling
Diamondback moth, cabbage looper and striped
armyworm on cabbage, Spring 1998
1998
TTC-1998001
316620
KIIIM1 6.1
Anonymous
Control of diamondback moth with biological
pesticides in Homestead, FL, Spring 1999
1999
TTC-1999018
316621
KIIIM1 6.1
Anonymous
Control of insect pests of collard with biological
pesticides in charleston, SC, spring 1999
1999
TTC-1999021
316622
KIIIM1 6.1
Anonymous
Control of diamondback moth with biological
pesticides in Homestead, FL, Spring 1999
1999
TTc-1999023
316623
KIIIM1 6.1
Anonymous
Effectiveness of Bioinsecticides for control of collard
insect pests in Clemson, SC, Spring 1999
1999
TTC-1999031
316624
KIIIM1 6.1
Anonymous
Efficacy of Evaluation of Bioinsecticide formulations
for control of the insect pests on Cole crops
2002
CER-2002016
316625
KIIIA1 6.1
316617
316618
2015-11-12
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Page 42 of 55
Annex
Point
Author
Title
Year
Ref. App.
Ref. JKI
KIIIM1 6.1
Anonymous
Ciba Crop protection Trial Report
1993
93420Atrial212
316626
KIIIM1 6.1
Anonymous
Ciba Plant Protection Trial Report
1993
93781trial219
316627
KIIIM1 6.1
Anonymous
1993
93682trial3
01
316628
KIIIM1 6.1
Anonymous
1993
93859trial93502
316629
KIIIM1 6.1
Anonymous
1993
93417trial131
316630
KIIIM1 6.1
Anonymous
1993
93679trial131
316631
KIIIM1 6.1
Anonymous
1993
93680trial1
30
316632
KIIIM1 6.1
Anonymous
1993
93418trial1
30
316633
KIIIM1 6.1
Anonymous
1994
94578
316634
KIIIM1 6.1
Anonymous
1994
94579trial134
316635
KIIIM1
6.2.1
Anonymous
Control of Cabbage moth by Turex
2002
Bt
TUR2002
Cabbage
NL
316636
KIIIM1
6.2.1
Leocata, S.
Experimental field evaluation of agree and TTC 1502 against noctuids lepidoptera on protected
peppers in Italy
1999
99SL05
316637
2015-11-12
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Page 43 of 55
Annex
Point
Author
Title
Year
Ref. App.
Ref. JKI
KIIIM1
6.2.1
Bouma, E.
Development of comparable agro-climatic zones for
the international exchange of data on the efficacy
and crop safety of plant protection products
2005
KIIIM1
6.2.1
Lacertosa,
G.
Efficacy evaluation of Bacillus thuringiensis subsp.
Kurstaki and aizawai (Agree) against Spodoptera
littoralis Koch on cauliflower in Basilicata (Southern
Italy)
2006
019_MA_0
6
316639
KIIIM1
6.2.1
Sánchez
Rosales,
J.L.
Activity of Turex (B. thuringiensis) for caterpillars
control by foliar application at prefixed intervals on
lettuces
2005
AS610410
3
316640
KIIIM1
6.2.1
Gengotti, S.
Experimental field evaluation of Costar (Bacillus
thuringiensis) against Spodoptera spp. in open field
lettuce
2010
PCE10CE
RLACSAP
HYTOGA
316641
KIIIM1
6.2.1
Sannino, L.
Efficacia di Bacillus thuringiensis ssp. kurstaki contro
Spodoptera littoralis su lattuga in serra -Experimental
field trial to evaluate the efficacy of Bacillus
thuringiensis ssp. kurstaki against Spodoptera
littoralis on lettuce (green ho
2010
CRA-CdSBt-SI-1-272010-Ce
316642
KIIIM1
6.2.1
Tornello, G.
Experimental field trial evaluation of BT against
Spodoptera sp on open field Peppers - Italy - Sicily Year 2010
2010
ICO10CE4
-CO1
316643
KIIIM1
6.2.1
Biffara, G.
Studio sperimentale per la valutazione dell
2008
E02PH08
316644
KIIIM1
6.2.1
Gengotti, S.
Experimental field evaluation of Costar (Bacillus
thuringiensis) against Mamestra spp. on cabbage
2010
PCE10CE
RBRSOXB
ARBR
316645
KIIIM1
6.2.1
Tornello, G.
Experimental field evaluation of Bt against Mamestra
brassica on open field cabbage Italy-Sicily-Year 2010
2010
ICO10CE3
-CO1
316646
KIIIM1
6.2.1
Tornello, G.
Experimental field evaluation of Bt against Mamestra
brassicae on open field cabbage - italy - sicily - year
2010
2010
ICO10CE3
-CO1
316647
KIIIM1
6.2.1
Anonymous
1993
CIB1993137
316648
KIIIM1
6.2.1
Torres, I.
Efficacy and selectivity of TUREX against Plusia sp
on WATERMELON in Spain 2010
2011
SRS10041-10IE
316649
316638
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Page 44 of 55
Annex
Point
Author
Title
Year
Ref. App.
Ref. JKI
KIIIM1
6.2.1
Sánchez
Rosales,
J.L.
Determine the activity of TUREX (B. thuringiensis)
against caterpillars in Brassicae through prefixed
interval of foliar applications
2005
AS6204I02
316650
KIIIM1
6.2.1
Sánchez
Rosales,
J.L.
Determine the activity of TUREX (B. thuringiensis)
against caterpillars in Brassicae through prefixed
interval of foliar applications
2005
AS6204I01
316651
KIIIM1
6.2.1
Guario, A.
Strategie di contenimento della tignoletta a della vite
(Lobesia botrana) con formulati a base di Bacillus
thuringiensis su vite da vino - Control of Lobesia
botrana in grape (Original report and translation)
2007
KIIIM1
6.2.1/7/01
316652
KIIIM1
6.2.1
Bouma, E.
Development of comparable agro-climatic zones for
the international exchange of data on the efficacy
and crop safety of plant protection products
2005
KIIIM1
6.2.1
Bersegeay,
A.
Insecticide - Vine Grape berry moth - Efficacy
2013
EFF01
316654
KIIIM1
6.2.1
Chatelier,
B.
Campagne 2010,
Insecticide - Vigne Efficacité
Eupocilia ambiguella
2010
S10CE113
8BC73
316655
KIIIM1
6.2.1
Imbert,
C.
Study the efficacy of CER.I1003 at 0,75 - 1 and 1,5
Kg/ha on the second generation of grape berry moth
(Lobesia botrana) - Comparison with different
standards
2012
EFF01
316656
KIIIM1
6.2.1
Novoa, D.
To assess CER.I10003 efficacy in grape for Lobesia
botrana control
2012
dn12-43Cer-LB2Ba1
316657
KIIIM1
6.2.1
Nova, D.
Efficay test against grape berry moth, lobesia
botrana, in grape vines in France with
ACETAMIPRIDE and CER.I 1003
2010
dn10-68ce-Lb3-Pr5
316658
KIIIM1
6.2.1
Lopez, F.
Efficacy and selectivity of TUREX for the control of
Lobesia botrana on GRAPEVINES
2010
SRS10045-10IE
316659
KIIIM1
6.2.1
Lopez, F.
Efficacy and selectivity of TUREX for the control of
Lobesia botrana on GRAPEVINES
2010
SRS10044-10IE
316660
KIIIM1
6.2.1
Morando,
A.
Moths control with indecticides application
2010
053/10_Ce
rtis
316661
KIIIM1
6.2.1
Chianella,
M.
Determination of efficacy for control of grape moth
(Lobesia botrana) on grapevine in Italy
1999
01992EIVI
316662
J.-
316653
2015-11-12
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Page 45 of 55
Annex
Point
Author
Title
Year
Ref. App.
Ref. JKI
KIIIM1
6.2.1
Allegri, A.
Efficacy of COSTAR WG to control Lobesia botrana
2010
CAI14010
316663
KIIIM1
6.2.1
Dimon, C.
Determination of efficacy of acetamipride against
Eupoecilia ambiguella and Lobesia botrana in vine, 2
sites in France 2010
2011
S1002129-01
316664
KIIIM1
6.2.1
Gajek, D.
Efficacy of Delfin WG and Agree WG in the control of
codling moth Cydia pomonella in apple, Poland 2012
2012
78_PROT_
F12
316665
KIIIM1
6.2.1
Gajek, D.
colding moth Cydia pomonella in apple, Poland 2012
2012
78_PROT_
F12
316666
KIIIM1
6.2.1
Gajek, D.
summer fruit tortrix moth Adoxophyes orana in apple,
Poland 2012
2012
79_PROT_
F12
316667
KIIIM1
6.2.1
Gajek, D.
summer fruit tortrix moth Adoxophyes orana in apple,
Poland 2012
2012
79_PROT_
F12
316668
KIIIM1
6.2.1
Ferrari, R.
Efficacia di formulati a base di Bacillus thuringiensis
nei confronti di Pandemis cerasana Hübner
(Tortricide ricamatore)- Control of Pandemis
cerasana on apple
2010
6_1_3_1_2
_B.doc
316669
KIIIM1
6.2.1
Ferrari, R.
Efficacy evaluation of formulations based on Bacillus
thuringiensis against Pandemis cerasana Hübner on
pear fruit
2010
6_1_3_1_2
_C.doc
316670
KIIIM1
6.2.1
Ferrari, R.
Efficacy evaluation of formulated products based on
Bacillus thuringiensis against Pandemis cerasana
Hübner on pear
2011
6_1_3_1_2
_E.doc
316671
KIIIM1
6.2.1
Chianella,
M.
Determination of efficacy for control of leaflorells
(Pandemis spp.) in apples in Italy
1999
01991E1A
P
316672
KIIIM1
6.6.2
Bae,
S.,
Fleet, G.H.,
Heard,
G.M.
Occurrence and significance of Bacillus thuringiensis
on wine grapes
2004
MIIIM1 Sec
7
MTA
Registration Report - Part B - Agree 50 WG - DE Section 7 - Efficacy Data and Information - Core
assessment
2013
KIIIM1 6
Rinsma, S.,
Süß, J.
Biological Assessment Dossier
2013
316673
MIIIM1 Sec
7
316674
316676
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Page 46 of 55
2015-11-12
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Central Zone
Page 47 of 55
Appendix 2: GAP tables
Table 1: List of intended uses for Germany
AGAP rev.
SUMMARY OF GOOD AGRICULTURAL PRACTICES FOR PESTICIDE USES
active substance
Applicant:
Zone(s):
Verified by MS:
1
UseNo.
2
Member
state(s)
3
Agree 50 WG
Bacillus thuringiensis subsecies aizawai
Stamm GC- 91
central EU
yes
4
Crop
or
5
6
Formulation type:
Conc. of as :
WG
500 g/kg
professional use
x
7
and/ F
situation G
or
(crop destination / pur- I
pose of crop)
controlled
Method /
Kind
(additionally: developmental stages of the pest or
pest group)
Application
Timing / Growth
stage of crop &
season
from emergence of
first larvae after
beginning of
infestation or
warning service
appeal / from
BBCH 53
from emergence of
first larvae after
beginning of
infestation or
warning service
appeal / from
001
DE
F
grape vine (VITVI)
grape)
grape berry moth
002
DE
grape vine (VITVI)
F
grape)
spraying or
grape berry moth
2. and 3. generation (L1- fine sprayL2)
ing (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
, date: 2012-06-12
8
Max. number
(min. interval
between applications)
a) per use
b) per crop/
season
3 (at least 7
days apart)
10
kg, product / ha
a) max. rate per
appl.
b) max. total rate
per crop/season
a) – base dose:
0,25 kg/ha
- BBCH 61:
0,5 kg/ha
- BBCH 71:
0,75 kg/ha
b) 2,25
3 (at least 7 a) – base dose:
days apart)
0,25 kg/ha
- BBCH 61:
0,5 kg/ha
- BBCH 71:
0,75 kg/ha
11
12
Application rate
g, kg as/ha
Water
13
PHI
Remarks:
L/ha (days)
min / max
a) max. rate
per appl.
b) max. total
rate per
crop/season
a) 0,125 -0,375 – base dose:
b) 1,125
400 l/ha
- BBCH 61:
800 l/ha
- BBCH 71:
1200 l/ha
a) 0,125 – 0,5
b) 1,5
14
e.g. recommended or mandatory tank mixtures
– base dose:
400 l/ha
- BBCH 61:
800 l/ha
- BBCH 71:
1200 l/ha
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BBCH53
003
DE
berries (NNNOB)
F
004
DE
berries (NNNOB)
G
005
DE
strawberry (FRAAN)
F
006
DE
strawberry (FRAAN)
G
007
DE
008
DE
leafy and stem vegetables F
(NNNVL)
except for
vegetable
cabbage
009
DE
leafy and stem vegetables G
(NNNVL)
except
for
vegetable
cabbage
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 11
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 11
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 13
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 13
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
Registration Report
Central Zone
Page 48 of 55
- BBCH 75:
1600 l/ha
-BBCH 75:
1 kg/ha
b) 2,25
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
max. 1000
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
max. 1000
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
1000 - 2000
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
1000 - 2000
days apart)
0,5 kg/ha
50 – 125 cm:
0,75 kg/ha
> 125 cm:
1 kg/ha
b) 6
3 (at least 7 a) 1
days apart)
b) 3
a) 0,25 – 0,5
b) 3
a) < 50 cm:
min 600 l/ha
50 – 125cm:
min 900 l/ha
> 125 cm:
min 1200 l/ha
b) 6
200 - 800
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
a) 0,5
b) 1,5
200 - 1000
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Agree 50 WG
ZV1 007638-00-00
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010
DE
vegetable
(BRSOX)
cabbage F
011
DE
vegetable
(BRSOX)
cabbage G
012
DE
root and tuber vegetables F
(NNNVW)
013
DE
root and tuber vegetables G
(NNNVW)
014
DE
bulb crops (NNNSZ)
F
015
DE
herbs (NNNKR)
F
016
DE
herbs (NNNKR)
G
017
DE
pulse crops (NNNLG)
F
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
volume
spraying)
spraying or
fine spraying (low
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
after beginning of
infestation; from
emergence of first
Registration Report
Central Zone
Page 49 of 55
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
3 (at least 7 a) 1
b) 3
days apart)
a) 0,5
b) 1,5
200 - 1000
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 1000
3 (at least 7 a) 1
b) 3
days apart)
a) 0,5
b) 1,5
200 - 800
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
3 (at least 7 a) 1
days apart)
b) 3
a) 0,5
b) 1,5
200 - 800
0,5 kg/ha
days apart)
50 – 125 cm:
a) 0,25 – 0,5
b) 1,5
< 50 cm:
min 600 l/ha
50 – 125cm:
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volume
spraying)
larvae /
from BBCH 09
Registration Report
Central Zone
Page 50 of 55
018
DE
pulse crops (NNNLG)
G
spraying or
fine spraying (low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae /
from BBCH 09
3 (at least 7
days apart)
019
DE
ornamentals (NNNZZ)
F
spraying or
fine spraying (low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
6 (at least 7
days apart)
020
DE
ornamentals (NNNZZ)
G
spraying or
fine spraying (low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
6 (at least 7
days apart)
021
DE
woody
(NNNZG)
ornamentals G
spraying or
fine spraying (low
volume
spraying)
after beginning of
infestation; from
emergence of first
larvae
3 (at least 7
days apart)
Remarks: (a) In case of group of crops the Codex classification should be used
(b) Outdoor or field use (F), glasshouse application (G) or
indoor application (I)
(c) e.g. biting and sucking insects, soil born insects, foliar fungi
(e) Use CIPAC/FAO Codes where appropriate
0,75 kg/ha
> 125 cm: 1 kg/ha
b) 3
a) < 50 cm:
0,5 kg/ha
50 – 125 cm:
0,75 kg/ha
> 125 cm: 1 kg/ha
b) 3
a) < 50 cm:
0,5 kg/ha
50 – 125 cm:
0,75 kg/ha
> 125 cm: 1 kg/ha
b) 6
a) < 50 cm:
0,5 kg/ha
50 – 125 cm:
0,75 kg/ha
> 125 cm: 1 kg/ha
b) 6
a) < 50 cm:
0,5 kg/ha
50 – 125 cm:
0,75 kg/ha
> 125 cm: 1 kg/ha
b) 3
a) 0,25 – 0,5
b) 1,5
a) 0,25 – 0,5
b) 3
a) 0,25 – 0,5
b) 3
a) 0,25 – 0,5
b) 1,5
min 900 l/ha
> 125 cm:
min 1200 l/ha
< 50 cm:
min 600 l/ha
50 – 125cm:
min 900 l/ha
> 125 cm:
min 1200 l/ha
a) < 50 cm:
min 600 l/ha
50 – 125cm:
min 900 l/ha
> 125 cm:
min 1200 l/ha
a) < 50 cm:
min 600 l/ha
50 – 125cm:
min 900 l/ha
> 125 cm:
min 1200 l/ha
a) < 50 cm:
min 600 l/ha
50 – 125cm:
min 900 l/ha
> 125 cm:
min 1200 l/ha
(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting,
drench
(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the
plants
(i) g/kg or g/l
(j) Growth stage at last treatment
(k) PHI = Pre-harvest interval
(l) Remarks may include: Extent of use/economic importance/restrictions
(e.g. feeding,grazing)/minimal intervals between applications
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Page 51 of 55
Table 2: List of intended uses for other Member States of Central Zone except for Germany * (not verified)
Table of Good Agricultural Practice for Agree 50 WG (also called Turex WG) containing Bacillus thuringiensis ssp. aizawai GC-91 (50%, 25,000
IU/mg, 3.8% δ-endotoxins). Application rates are the same throughout the Central zone.
Member- Product F, Pests or Groups of Formulation
pests controlled
state or name G,
Type Conc. of Method
country
or
MPCA
kind
I
(c)
(b)
(d - f)
(f - h)
Application
Growth Number
(k)
stage
(j)
0001 Grapes
002
003
004
005
Central
Europe
Red, black and Central
white
currant, Europe
blueberry,
goosberry,
blackberry,
raspberry
Strawberry
Central
Europe
006
Tomato, pepper Central
(sweet
and Europe
chilli), eggplant
007
Cucumber,
Central
gherkin, cour- Europe
gette,
melon,
patisson
Agree 50 F Tortricidae (Lobesia
WG
botrana, Eupoecilia
ambiguella)
Agree 50 F Geometridae (OperWG
ophtera brumata)
WG
50%
Foliar
BBCH 53-89
spraying
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
WG
50%
Foliar
April - May
spraying BBCH 00-79
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-3
7 days
0.5
(1.0)
Not
relevant
-
G
Agree 50 F Plutellidae (Plutella
WG
xylostella), Noctuidae
(Autographa gamma,
G Plusia spp.)
minmax
PHI Remark
s
Interval kg MPCA./hL water kg MPCA./ha (days)
between
L/ha
(kg
(kg
MPCP/ha)
applications MPCP/hL)
(l)
(min.)
(m)
min-max
min-max
min-max
WG
Agree 50 G Noctuidae (Chrysodeix- WG
is chalcites, AutograWG
pha gamma, Polia
oleracea, Plusia spp.)
Agree 50 G Noctuidae (Chrysodeix- WG
is chalcites, AutograWG
pha gamma, Polia
oleracea, Plusia spp.)
50%
50%
50%
January –
December
BBCH 00-99
Foliar
April –
spraying September
BBCH 13-89
January –
December
BBCH 13-89
Foliar
January spraying December
BBCH 09-89
Foliar
spraying
January –
December
BBCH 09-89
0.083 - 0.167 300 - 600
(0.167 – 0.333)
0.025
(0.05)
2000
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
2015-11-12
Agree 50 WG
ZV1 007638-00-00
Core Assessment
pests controlled
state or name G,
or
country
kind
MPCA
I
(b)
(c)
(f - h)
(d - f)
Registration Report
Central Zone
Page 52 of 55
Application
Growth Number
stage
(k)
(j)
April –
High
September
volume
spraying BBCH 09-99
minmax
Lettuce, endive, Central
curled endive, Europe
lamb´s lettuce,
spinach
WG
WG
xylostella), Pieridae
(Pieris spp.), Noctuidae
(Polia oleracea, AutogG
rapha gamma, Plusia
spp.)
50%
Red cabbage,
savoy cabbage,
pointed
head
cabbage, white
cabbage, Brussel
sprouts,
kale
Chinese
cabbage,
choi
cabbage, cauliflower, broccoli,
Indian mustard,
kohlrabi
Central
Europe
WG
WG
xylostella), Crambidae
(Evergestis forficalis),
Pieridae (Pieris spp.),
Noctuidae (Autographa
gamma, Mamestra
brassicae, Plusia spp.)
WG
WG
(Evergestis forficalis),
G Noctuidae (Autographa
gamma, Mamestra
50%
013
Swede
Central
Europe
50%
Foliar
spraying
AprilSeptember
BBCH 09-99
1-3
014
015
Beetroot, rad- Central
dish,
black Europe
raddish, carrot,
celery,
celery
leaves, celeriac,
parsley
WG
WG
(Evergestis forvicalis),
Noctuidae (Autographa
gamma, Mamestra
WG
WG
xylostella)
50%
Foliar
spraying
April –
September
BBCH 09-99
January –
December
BBCH 09-99
1-3
008
009
010
011
012
Central
Europe
G
50%
January –
December
BBCH 09-99
Foliar
April –
spraying September
BBCH 09-99
Foliar
spraying
April –
September
BBCH 09-99
1-3
PHI Remark
s
between
L/ha
(kg
(kg
MPCP/ha)
(l)
(min.)
(m)
min-max
min-max
min-max
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
0.5
(1.0)
Not
relevant
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
0.05 – 0.25
(0.1 – 0.5)
200 - 1000
January –
December
BBCH 09-99
-
-
2015-11-12
Agree 50 WG
ZV1 007638-00-00
Core Assessment
pests controlled
state or name G,
or
country
kind
MPCA
I
(b)
(c)
(f - h)
(d - f)
Registration Report
Central Zone
Page 53 of 55
Application
Growth Number
stage
(k)
(j)
minmax
PHI Remark
s
between
L/ha
(kg
(kg
MPCP/ha)
(l)
(min.)
(m)
min-max
min-max
min-max
016
Onions,
shal- Central
lots,
pickles, Europe
garlic, leek
Agree 50 F Plutellidae (AcrolepiWG
opsis assectella)
WG
50%
Foliar
spraying
April –
September
BBCH 07-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
-
017
Witloof, Chicory
Central
Europe
Agree 50 F Noctuidae (Autographa WG
WG
gamma, Plusia spp.)
50%
Foliar
spraying
April –
September
BBCH 09-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
-
018
019
Herbs
Central
Europe
WG
xylostella)
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
January –
December
BBCH 09-99
Foliar
April –
spraying September
BBCH 09-99
January –
December
BBCH 09-99
Foliar
April –
spraying September
BBCH 09-99
January –
December
BBCH 09-99
Foliar
April –
spraying September
BBCH 09-99
January –
December
BBCH 09-99
1-3
7 days
0.0625 – 0.25
(0.125 – 0.5)
200 - 800
0.5
(1.0)
Not
relevant
-
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
1-6
7 days
0.025
(0.05)
2000
0.5
(1.0)
Not
relevant
-
G
020
021
Dwarf snap and Central
slicing
bean, Europe
pole snap and
slicing
bean,
yard long bean
Agree 50 F Noctuidae (Polia
WG
oleracea, Autographa
gamma, Plusia spp.)
G
WG
50%
022
023
Ornamentals
and flowers
Central
Europe
WG
Agree 50 F Pieridae (Pieris spp.),
WG
Noctuidae (Plusia spp.,
Mamestra spp.)
G
50%
024
025
Nursery crops Central
and perennials
Europe
WG
WG
Noctuidae (Plusia spp.,
Mamestra spp.),
G Lymantriidae
(Euproctis
chrysorrhoea, Leucoma salicis, Lymantria
dispar), Lasiocampidae
Yponomeutidae
(Yponomeuta spp.)
50%
2015-11-12
Agree 50 WG
ZV1 007638-00-00
Core Assessment
pests controlled
state or name G,
or
country
kind
MPCA
I
(b)
(c)
(f - h)
(d - f)
Registration Report
Central Zone
Page 54 of 55
Application
Growth Number
stage
(k)
(j)
026
Forestry
Central
Europe
027
Public green
Central
Europe
WG
Geometridae (Operopthera brumata),
Lymantriidae
(Euproctis
chrysorrhoea,
Lymantria dispar,
Leucoma salicis),
Lasiocampidae (Malacosoma neustria),
Yponomeutidae
(Yponomeuta spp.)
WG
Geometridae (Operophtera brumata),
Lymantriidae
(Euproctis
chrysorrhoea,
Lymantria dispar,
Leucoma salicis),
Lasiocampidae (Malacosoma neustria),
Yponomeutidae
(Yponomeuta spp.)
minmax
PHI Remark
s
between
L/ha
(kg
(kg
MPCP/ha)
(l)
(min.)
(m)
min-max
min-max
min-max
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
not
relevant
(yes)
WG
50%
Foliar
spraying
April –
September
BBCH 09-99
1-3
7 days
0.025
(0.05)
2000
0.5
(1.0)
not
relevant
-
pest)
* Austria, Belgium, Czech Republic, Hungary, Ireland, Luxembourg, Netherlands, Poland, Romania, Slovenia, Slovak Republic, United Kingdom
2015-11-12
Core Assessment
Agree 50 WG
ZV1 007638-00-00
Registration Report
Central Zone
Page 55 of 55
2015-11-12

B thuringiensis ssp aizawai GC-91 final RR 1107 Part B Section 7

Transcription

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