ANEXO I: Relación de productos no notificados al CPNP, o que no

Transcription

ANEXO I: Relación de productos no notificados al CPNP, o que no están registrados en esta Agencia (en el caso de productos de
higiene personal). La AEMPS no ha realizado actuaciones.
Número de
notificación
RAPEX
UE-A12-0603/13
UE-A12-0657/13
Denominación
Producto
Coppola Keratin
Complex Repair
Therapy- Intense RX
Plastica Dos Fios
Selagem Termica
CORREO ELECTRÓNICO
controlcosmeticos@aemps.es
Pág. 1 de 33
Finalidad
Producto
Cosméticos para
el cabello
Cosméticos para
el cabello
Responsable
Producto
Tipo Incumplimiento
European Beauty
Distribution S.r.L.
Italia
Presencia de sustancia
regulada en condiciones
distintas de las
establecidas:
0,8 % de Formaldehído
(producto 1)
(producto 2)
B Team S.r.L.
Italia
distintas de las
establecidas:
total
libre
Código
AEMPS
CM-435/2013
CM-455/2013
C/ CAMPEZO, 1 – EDIFICIO 8
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Número de
notificación
RAPEX
UE-A12-0670/13
UE-A12-0683/13
UE-A12-0684/13
CORREO ELECTRÓNICO
Pág. 2 de 33
Denominación
Producto
Whitesmile Home
whitening 35%
Carbamide Peroxide
Inecto Superblack guaranteed permanent
hair colour creme
Electric Ink 4011 Light
Brown
Finalidad
Producto
Blanqueante
dental
Cosméticos para
el cabello
Productos de
estética:
Tintas para
tatuaje
Responsable
Producto
Tipo Incumplimiento
Código
AEMPS
Whitesmile GmbH
Alemania
Presencia de sustancias
reguladas en condiciones
distintas de las
CM-466/2013
establecidas:
hasta 13,2 % de Peróxido
de hidrógeno
Mahd
Bélgica
prohibida en productos
cosméticos:
m-Fenilendiamina
Anexo II / 1204
Magic Moon Tattoing
GmbH
Alemania
Riesgo químico de
acuerdo a la resolución
ResAP(2008)1 del
Consejo de Europa:
710 µg/Kg de
3,3'-Diclorobencidina
CM-468/2013
CM-469/2013
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Número de
notificación
RAPEX
Denominación
Producto
Finalidad
Producto
UE-A12-0704/13
Paul Mitchell XG
Processing Cream
UE-A12-0724/13
Productos de
estética:
Dragonhawk Tattoo ink
Tintas para
tatuaje
UE-A12-0725/13
Productos de
estética:
Tintas para
tatuaje
CORREO ELECTRÓNICO
Pág. 3 de 33
Classical Tattoo ink
Red (Peach)
Cosméticos para
el cabello
Responsable
Producto
Tipo Incumplimiento
Se han detectado casos
de intolerancia y de
Mitchell Europe SRL Unip
alergias a este producto
Italia
en relación a la
introducción de nuevas
fragancias.
Código
AEMPS
CM-472/2013
Jochen Hirsch GmbH
Alemania
Riesgo químico de
ResAP(2008)1 del
Consejo de Europa:
1577 mg/Kg de
4-metil-m-fenilendiamina
CM-473/2013
Simone Firsch GmbH
Alemania
Riesgo químico de
ResAP(2008)1 del
Consejo de Europa:
1331 mg/Kg de
4-metil-m-fenilendiamina
CM-474/2013
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Número de
notificación
RAPEX
Denominación
Producto
Finalidad
Producto
Responsable
Producto
Tipo Incumplimiento
Código
AEMPS
UE-A12-0777/13
Cosmético:
Larissa Lait de Beaute
Blanqueante para Desconocido
Carotte
la piel
prohibida:
Hidroquinona
Anexo II / 1339
CM-480/2013
UE-A12-0778/13
Clairmen Lightening
Program For MenCream Formula
Cosmético:
Blanqueante para Desconocido
la piel
prohibida:
Hidroquinona
Anexo II / 1339
CM-481/2013
UE-A12-0779/13
Lulanjina Skin
lightening product
Cosmético para
el cuidado de la
cara
Desconocido
prohibida:
24000 mg/Kg de Mercurio CM-482/2013
Anexo II / 221
UE-A12-0780/13
E`Yôute Whitening
spot removing cream
Cosmético para
el cuidado de la
cara
Desconocido
prohibida:
6900 mg/Kg de Mercurio
Anexo II / 221
CORREO ELECTRÓNICO
Pág. 4 de 33
CM-483/2013
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Número de
notificación
RAPEX
UE-A12-0782/13
UE-A12-0789/13
UE-A12-0790/13
CORREO ELECTRÓNICO
Pág. 5 de 33
Denominación
Producto
Finalidad
Producto
Responsable
Producto
Tipo Incumplimiento
Código
AEMPS
CM-484/2013
Speckle Doctor White
Cosmético para
Skin Care - Skin Magic
el cuidado de la
Power Instauration
cara
Desconocido
prohibida:
Anexo II / 221
Yimei Whitening spotremoving suit
Durdur Shop
Noruega
prohibida:
Anexo II / 221
CM-485/2013
Riesgo químico de
ResAP(2008)1 del
Consejo de Europa:
1151 µg/kg de
Hidrocarburos
aromáticos, policíclicos
(PAH)
CM-486/2013
Universal Black
Sumi Black
Cosmético para
el cuidado de la
cara
Productos de
I Max International S.r.l.
estética:
Italia
Tinta para tatuaje
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Número de
notificación
RAPEX
UE-A12-0801/13
UE-A12-0807/13
Denominación
Producto
Finalidad
Producto
Orient Pearl Whitening
Cosmético para
pearl beauty & spot
el cuidado de la
removing suite
cara
Paint Glow Products
Neon Body Paint
Cosmético:
Pigmentos no
permanentes
Responsable
Producto
Tipo Incumplimiento
Código
AEMPS
Garihaween
Noruega
prohibida:
12000 mg/Kg de Mercurio CM-509/2013
Anexo II / 221
Dance Factory Ltd t/a
Extreme FX
Reino Unido
Contaminación
microbiológica:
CM-510/2013
Pseudomonas aeruginosa
4
(1,5 x 10 ufc/g)
UE-A12-0811/13
E`Yôuth Skin-lightening Cosmético para
Durdur Shop
product
el cuidado y la
Noruega
limpieza de la piel
prohibida:
CM-511/2013
Anexo II / 221
UE-A12-0812/13
CPHL Seven Herbal
Wrinkle De Crease
prohibida:
CM-512/2013
Anexo II / 221
CORREO ELECTRÓNICO
Pág. 6 de 33
Cosmético:
Crema antiedad
Garihaween
Noruega
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Número de
notificación
RAPEX
Denominación
Producto
Finalidad
Producto
Responsable
Producto
Eternal ink Tangerine
UE-A12-0826/13
Tattoosafe/TS Trading
Productos de
B.V.
Eternal ink Lime Green estética:
Holanda
Tinta para tatuaje
Eternal ink Old Orchid
UE-A12-0867/13
UE-A12-0874/13
CORREO ELECTRÓNICO
Pág. 7 de 33
Traditionelle
Bierkosmetik Bierbad
Silverback Tattoo ink
Cosmético:
Aceite de baño
Bohemia Cosmetics
República Checa
Productos de
Tattoo Goods
estética:
Alemania
Tinta para tatuaje
Tipo Incumplimiento
Riesgo químico de
ResAP(2008)1 del
Consejo de Europa:
Poseen las aminas
aromáticas:
o-toluidina
5-nitro-o-toluidina
Código
AEMPS
CM-539/2013
CM-540/2013
CM-541/2013
El producto puede
confundirse con un
alimento y posee un alto
riesgo si se ingiere por
qué contiene alta
concentración de
surfactantes
CM-535/2013
Riesgo químico de
ResAP(2008)1 del
Consejo de Europa:
25,03 mg/kg de
Hidrocarburos
(PAH)
CM-542/2013
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Número de
notificación
RAPEX
Denominación
Producto
Finalidad
Producto
Responsable
Producto
Eternal ink Bright
orange
Lev. Medische
Productos de
Groothandel V.O.F
estética:
Holanda
Tinta para tatuaje
UE-A12-0903/13
Eternal ink Caramel
UE-A12-0908/13
UE-A12-0943/13
CORREO ELECTRÓNICO
Pág. 8 de 33
Alla Prima Prima Black
Biotek Bioprogram
Newgex
Productos de
Tattoo Goods
estética:
Alemania
Tinta para tatuaje
Cosméticos para
el cabello
Biotek srl
Italia
Tipo Incumplimiento
Riesgo químico de
ResAP(2008)1 del
Consejo de Europa:
Poseen las aminas
aromáticas:
156 mg/kg de o-toluidina
135 mg/kg de 2,4toluenediamina
972 mg/kg de o-anisidina
Código
AEMPS
CM-543/2013
CM-544/2013
Riesgo químico de
ResAP(2008)1 del
Consejo de Europa:
2,2 mg/kg de
Hidrocarburos
(PAH)
CM-545/2013
distintas de las
establecidas:
1% de Cetrimida
CM-572/2013
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
ANEXO II: Relación de productos de los que se ha encontrado IETM o notificación al CPNP, la AEMPS ha realizado actuaciones.
Número de
notificación
RAPEX
UE-A12-0631/13
UE-A12-0632/13
Denominación
Producto
Finalidad
Producto
BioNaza Cosmetics
Choco Hair Brazilian
Keratin Chocolate
UE-A12-0672/13
BioNaza Cosmetics
KeraHair Premiere
Brazilian Keratin System
Pág. 9 de 33
Código
AEMPS
CM-441-2013
BioNaza Cosmetics
Diamond Premiere
UE-A12-0636/13
Tipo Incumplimiento
BioNaza Cosmetics
KeraVino Premiere
Cosméticos para
el cabello
CORREO ELECTRÓNICO
Responsable
Producto
Ferrer & Winter Import
S.L.
C/ Diego de León 292ªdcha
28006 Madrid
distintas de las
establecidas:
Más del 0,2% de
Formaldehído libre
CM-442-2013
CM-443-2013
CM-467-2013
Respuesta a las
actuaciones de la
AEMPS
El responsable ha
informado que los
productos que se
comercializan en España
son de lotes diferentes a
los notificados en el
Rapex.
A solicitud de la AEMPS
la empresa ha enviado
un análisis del contenido
de formaldehído libre
para cada uno de estos
productos en el que se
indica que todos ellos
están muy por debajo del
0,2% permitido.
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
ANEXO II: Relación de productos de los que se ha encontrado IETM o notificación al CPNP, la AEMPS ha realizado actuaciones.
Número de
notificación
RAPEX
UE-A12-0637/13
CORREO ELECTRÓNICO
Pág. 10 de 33
Denominación
Producto
Pazzini Spazzola
Progressiva Fluido Gel
Extra
Finalidad
Producto
Cosméticos para
el cabello
Responsable
Producto
Tipo Incumplimiento
Pluinca S.L.
distintas de las
C/ Beato Diego de Cádiz establecidas:
8-10
03009 Alicante
total
libre
Código
AEMPS
CM-444-2013
Respuesta a las
actuaciones de la
AEMPS
El responsable ha
informado que el
producto no se
comercializa en España
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
ANEXO III: Notificación sólo para información (no se reflejan en la lista del Anexo V).
Número de
notificación
RAPEX
INFO-0106/13
A11/0036/13
INFO-0115/13
CORREO ELECTRÓNICO
Pág. 11 de 33
Denominación
Producto
Tattoo Ink Lining black
SC Johnson Nixoderm
Teeth Whitenning Gel
(pen) Type TT-P01
Finalidad
Producto
Responsable
Producto
Micky Sharpz Supplies
Productos de estética:
LTD
Tintas para tatuaje
Reino Unido
Tipo Incumplimiento
Riesgo químico de acuerdo a
la resolución ResAP(2008)1
del Consejo de Europa:
79 µg/Kg de a-Benzopireno
Código
AEMPS
CM-436/2013
Cosméticos para el
cuidado de la piel
Haz Afro Cosmetics Ltd distintas de las establecidas:
Reino Unido
6,0 % de Acido benzoico
2,5 % de Acido salicílico
CM-456/2013
Blanqueante dental
distintas de las establecidas:
10,0 % de Peróxido de
carbamida
CM-457/2013
Royalestic OU
Estonia
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
ANEXO IV: Notificación sólo para información (no se reflejan en la lista del Anexo V).
Número de
notificación
RAPEX
Denominación
Producto
A11/0045/13
Black Rose Kali
Mehaude
INFO-0148/13
Ultradent Products Teth
Whitening set
“Opalescemce – Tooth
Whitening System”
INFO-0149/13
CORREO ELECTRÓNICO
Pág. 12 de 33
Eternal Ink triple Black ”
Finalidad
Producto
Responsable
Producto
Tipo Incumplimiento
Cosméticos para el
cabello
S.K. Mathon B.V.
Holanda
distintas de las establecidas:
0,9 ±,0,5 % de
p-Fenilendiamina
Blanqueante dental
U.P. Dental GmbH
Alemania
Por la concentración de H2O2
presente en el producto no
puede utilizarse en menores
de 18 años
Units 2-4 Parliament
Business Centre
Tintas para tatuaje
Reino Unido
Código
AEMPS
CM-513/2013
CM-514/2013
CM-546/2013
5,6 mg/Kg de Hidrocarburos
aromáticos, policíclicos (PAH)
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
ANEXO IV: Notificación sólo para información (no se reflejan en la lista del Anexo V).
Número de
notificación
RAPEX
INFO/0173/13
CORREO ELECTRÓNICO
Pág. 13 de 33
Denominación
Producto
Kuro Sumi Tattoo
Outlining Ink
Finalidad
Producto
Responsable
Producto
Fine Line Tattoo &
Piercing
Tintas para tatuaje
Alemania
Tipo Incumplimiento
Código
AEMPS
CM-578/2013
2,7 mg/Kg de Hidrocarburos
aromáticos, policíclicos (PAH)
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
ANEXO IV: Alertas europeas transmitidas a través del Sistema RAPEX recibidas en la AEMPS
(tal y como se publican en la página Web de la Comisión Europea)
No. Ref.
A12/0603/13
Notifying
country
Italy
CORREO ELECTRÓNICO
Pág. 14 de 33
Product
Category: Cosmetics
Product: Hair treatment products
Brand: Coppola
Name: Keratin Complex Repair
Therapy – Intense RX
Type/number of model: Ionic keratin
protein restructuring serum
Batch number/Barcode: 1. 9492248912
(50ml) – 2. 9492249984 (473ml)
OECD Portal Category: 53000000 Beauty / Personal Care / Hygiene
Description: The product is sold in two
formats: 1. Rigid, metal-coloured 50 ml
bottle with pump cap and dispenser.
The liquid is clear with a fruity scent.
Enclosed in a black box with
fluorescent pink and white lettering; 2.
Black plastic 473 ml bottle with pump
cap.
Country of origin: Brazil
Danger
Chemical
The product poses a chemical risk due to the
presence of 0.8% (product 1) and 0.5% (product 2)
free and liberated formaldehyde, above the
permitted levels. The product does not comply with
the Cosmetics Directive 76/768/EEC.
Measures adopted by notifying
country
Compulsory measures: Withdrawal of the
product from the market
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
A12/0631/13
Italy
Category: Cosmetics
Brand: BioNaza Cosmetics
Name: KeraVino – Premiere Brazilian
Keratin System
Type/number of model: Unknown
Batch number/Barcode: 1.
5248700201 (236 ml) ,
2. 5248700213 (473 ml),
3. 5248700207 (976 ml)
Description: The product is sold in
three formats: 1. plastic bottle with
pump cap (236 ml); 2. plastic bottle
with pump cap (473 ml); 3. plastic
bottle with screw cap and brown label
(976 ml).
Chemical
The products pose a chemical risk because they
contain 0.9% (Product 1.), 1.7% (Product 2.) and
1.5% (Product 3.) of free and liberated
formaldehyde and 0.9% (Product 1.), 1.7% (Product
2.) and 1.6% (Product 3.) of free formaldehyde,
above the permitted levels (0.2%). The products do
not comply with the Cosmetics Directive.
A12/0632/13
Italy
Category: Cosmetics
Name: Diamond – Premiere Brazilian
Keratin System
5248700224 (119 ml),
2. 5248700211 (236 ml),
Chemical
contain 1.3% (Product 1. and 3.), 1.0% (Product 2.
and 4.) of free and liberated formaldehyde, and
1.7% (Product 1.), 1.0% (Product 2. and 4.), 0.8%
(Product 3.) free formaldehyde, above the permitted
levels (0.2%). The products do not comply with the
Cosmetics Directive.
CORREO ELECTRÓNICO
Pág. 15 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
3. 3600029145 (354 ml),
4. 5248700220 (946 ml)
four formats: 1. plastic bottle with spray
cap and black label (119 ml); 2. plastic
bottle with pump cap (236 ml); 3.
plastic bottle with pump cap (354 ml);
4. plastic bottle with screw cap and
black label (946 ml).
A12/0636/13
Italy
CORREO ELECTRÓNICO
Pág. 16 de 33
Category: Cosmetics
Name: Choco Hair – Brazilian Keratin
Chocolate
Batch number/Barcode: 5248700206
four formats: 1. plastic screw-cap
bottle, brown label, spray (119 ml); 2.
plastic screw-cap bottle, brown label
(473 ml); 3. plastic screw-cap bottle,
brown label (946 ml).
Chemical
contain 1.8% (Product 1. and 2.), 1.4% (Product 3.)
of free and liberated formaldehyde and 1.7%
(Product 1.), 1.4% (Product 2.) and 1.2% (Product
3.) of free formaldehyde, above the permitted levels
(0.2%). The products do not comply with the
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
A12/0637/13
Italy
Category: Cosmetics
Product: Hair treatment product
Brand: PAZZINI Spazzola progressiva
Name: Fluido Gel Extra
Batch number/Barcode:
8010820012376
Description: Grey plastic bottle with
screw cap (1 000 ml).
Chemical
The product poses a chemical risk because it
contains 1.4% of free and liberated formaldehyde
and 1.3 % of free formaldehyde, both above the
permitted levels of 0.2%. The product does not
comply with the Cosmetics Directive.
A12/0657/13
Italy
Category: Cosmetics
Brand: Plastica Dos Fios
Name: Selagem Termica
7898927206871
OECD Portal Category: 53000000 -
Chemical
contains 7.7% free and liberated formaldehyde and
7.4% free formaldehyde, above the permitted levels
(0.2%). The product does not comply with the
CORREO ELECTRÓNICO
Pág. 17 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Beauty / Personal Care / Hygiene
Description: Pink plastic bottle with a
screw cap (1000 ml).
A12/0670/13
Germany
CORREO ELECTRÓNICO
Pág. 18 de 33
Category: Cosmetics
Product: Teeth whitening product
Brand: Whitesmile
Name: Home whitening 35%
Carbamide Peroxide
Batch number/Barcode: Batch 12070
Description: Colourless teeth
whitening gel with air bubbles. It has a
light, fresh and aromatic fragrance. The
composition shown on the packaging is
35% carbamide peroxide, and ~12.2%
hydrogen peroxide.The product comes
in a transparent plastic syringe with
black application tip in white and blue
collapsible box.
Country of origin: Germany
Chemical
contains up to 13,2 % of hydrogen peroxide, which
exceeds the permitted level. The product does not
comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Ban on the
marketing of the product and any
accompanying measures
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
A12/0672/13
Italy
Category: Cosmetics
Name: KeraHair – Premiere Brazilian
Keratin System
5248700202 (946 ml),
2. 5248700210 (473 ml),
3. 5248700201 (236 ml),
4. Unknown (119 ml)
four formats: 1. plastic bottle with
screw cap and blue label (946 ml); 2.
plastic bottle with screw cap and
blue label (473 ml); 3. plastic bottle
with pump cap (236 ml); 4. plastic
bottle with spray cap and blue label
(119 ml).
Chemical
contain 2.3% (Product 1.), 2.4% (Product 2.), 0.7%
(Product 3.) and 2.6% (Product 4.) of free and
liberated formaldehyde and 2.5% (Product 1. and
2.), 0.9% (Product 3.) and 2.5% (Product 4.) of free
formaldehyde, above the permitted level (0.2%).
The products do not comply with the Cosmetics
Directive.
Compulsory measures: Withdrawal of
the product from the market
A12/0683/13
Belgium
Category: Cosmetics
Product: Hair dye
Brand: Inecto
Name: Superblack - guaranteed
permanent hair colour creme - 28ml
Type/number of model: 1/32633 BB
01 2015
Chemical
The product poses a chemical risk because,
according to the label, it contains mphenylenediamine which is classified as strongly
sensitising, and must not be present in hair dyes.
The product does not comply with the Cosmetics
Directive 76/768/EEC.
CORREO ELECTRÓNICO
Pág. 19 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
6002058000036
Description: Black hair dye consisting
of a 28 ml tube with hair colour creme
and a 23 ml brown bottle with solution.
The product, which is packed in a black
cardboard box with white and pale
orange lettering, includes plastic gloves
and a leaflet with instructions in
English, French and Portuguese.
Country of origin: South Africa
A12/0684/13
Germany
CORREO ELECTRÓNICO
Pág. 20 de 33
Category: Chemical products
Product: Tattoo ink
Brand: Electric Ink
Name: 4011 Light Brown
Type/number of model: Article No
401130
Batch number/Barcode: Batch: 2161
Description: Opaque brown liquid in
small brown bottle with colour printing.
Chemical
Voluntary measures: Withdrawal of the
contains a concentration of 710 mg/kg of 3.3'-ddichlorobenzidine (aromatic amine). According to
the Council of Europe Resolution ResAP (2008)1 on
requirements and criteria for the safety of tattoos
and permanent make-up, aromatic amines such as
3.3'-d-dichlorobenzidine should not be present in
tattoo ink.
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
A12/0704/13
Germany
Category: Cosmetics
Product: Hair traitment product
Brand: Paul Mitchell
Name: XG Processing Cream
Type/number of model: XG
Processing Cream 5 Volume 1.5 %
1000 ml; XG Processing Cream 10
Volume 3.0 % 1000 ml; XG Processing
Cream 20 Volume 6.0 % 1000 ml; XG
Processing Cream 30 Volume 9.0 %
1000 ml; XG Processing Cream 40
Volume 12.0 % 1000 ml
Batch number/Barcode: Unknown
OECD Portal Category: 53000000 Beauty/Personal Care/Hygiene
Description: Hair traitment product in
white plastic bottles with coloured
labelling.
Country of origin: Italy
Voluntary measures: Warning consumers
Chemical
The products pose a chemical risk because
of the risks
intolerance and alergic reactions have arisen in
connection with the introduction of new fragrances.
Cases of intolerance and allergic reactions reported.
The product does not comply with the Cosmetics
A12/0724/13
Germany
Product: Tattoo ink
Brand: Dragonhawk Tattoo
Name: Unknown
Type/number of model: 1. True
Magenta 2. Dark Red
Description: Tattoo ink in a 1/4 oz.
plastic bottle with dropper and
protective caps.
Chemical
contains up to 1577 mg/kg of 4-methyl-mphenylendiamine. According to the Council of
Europe Resolution ResAP (2008) on requirements
and criteria for the safety of tattoos and permanent
make-up, the aromatic amines as 4-methyl-mphenylendiamine with carcinogenic effects, should
neither be present in tattoos and PMU products nor
released from azo-colorants.
CORREO ELECTRÓNICO
Pág. 21 de 33
Compulsory measures: Import rejected at
border
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Country of origin: China
A12/0725/13
Germany
Product: Tattoo ink
Brand: Classical Tattoo
Name: Unknown
Type/number of model: Red (Peach),
5 ml
Description: Tattoo ink in a opaque
transparent plastic bottle with attached
lid and spray nozzle with cap.
Chemical
contains up to 1331 mg/kg of 4-methyl-mphenylendiamine. According to the Council of
make-up, the aromatic amines as 4-methyl-mphenylendiamine with carcinogenic effects, should
neither be present in tattoos and PMU products nor
released from azo-colorants.
border
A12/0777/13
Portugal
Category: Cosmetics
Product: Body milk
Brand: Larissa
Name: Lait de Beaute Carotte
Type/number of model: Action rapide
Chemical
contains the ingredient hydroquinone (1,4-dihydroxy
benzene), the use of which is prohibited in
cosmetics and personal hygiene products. The
product does not comply with the Cosmetics
border
CORREO ELECTRÓNICO
Pág. 22 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Description: Moisturizing body milk in
an orange plastic bottle with gold,
green, white and black characters and
orange cap. Volume 250 ml.
Country of origin: Ivory Coast
A12/0778/13
Portugal
CORREO ELECTRÓNICO
Pág. 23 de 33
Category: Cosmetics
Product: Skin lightening product
Brand: Clairmen
Name: Lightening Program For MenCream Formula
Description: Cream in a plastic
container of 300 ml with a black cap.
The labelling on the back part bears
the list of ingredients and the
indications " Contains Hydroquinone.
Keep out of reach of children. Do not
expose yourself to sunshine. Product
colour change does not affect product
quality in any way" in French and
English.
Country of origin: Democratic
Republic Of Congo
Chemical
border
contains the ingredient hydroquinone, the use of
which is prohibited in cosmetics and personal
hygiene products. The product does not comply with
the Cosmetics Directive 76/768/EEC.
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
A12/0779/13
Norway
Category: Cosmetics
Brand: Lulanjina
Name: Unknown
Batch number/Barcode: Barcode:
69362177100256 Batch: AE0622A06
Description: The product is packed in
a red cardboard box with a picture of a
Chinese woman and print in Chinese.
Chemical
contains a mercury compound (24000 mg/kg) as a
skin-lightening substance. The product does not
A12/0780/13
Norway
Category: Cosmetics
Brand: E`Yôute
Name: Whitening spot removing cream
6932511250213
Chemical
CORREO ELECTRÓNICO
Pág. 24 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Description: Whitening spot removing
cream packed in a red cardboard box
with a picture of a woman's face.
A12/0782/13
Norway
CORREO ELECTRÓNICO
Pág. 25 de 33
Category: Cosmetics
Brand: Speckle Doctor
Name: White Skin Care - Skin Magic
Power Instauration
Batch number/Barcode: Batch
number: CM1183
OECD Portal Category: 75000000 Household / Office Furniture /
Furnishings
Description: Whitening spot removing
cream in a red and orange cardboard
box with a picture of a woman's face.
Chemical
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
A12/0789/13
Norway
Category: Cosmetics
Brand: Yimei
Name: Whitening spot-removing suit
Type/number of model: CM-1068
6928286400120
Description: Green cardboard box
with white label.
Chemical
contains mercury compound (5.800 mg/kg). The
product does not comply with the Cosmetics
A12/0790/13
Germany
Product: Tattoo ink
Brand: Universal Black
Name: Sumi Black
Type/number of model: Item Code
13296
Batch number/Barcode: Use-by date:
12/2015
Description: Small glass bottle with
screw cap; black liquid
Country of origin: Unknown
Chemical
contains polycyclic aromatic hydrocarbons (PAH),
with a benzo[a]pyrene content of 1151 µg/kg, which
is classified as carcinogenic. According to the
Council of Europe Resolution ResAP (2008) on
and permanent make-up, polycyclic aromatic
hydrocarbons may not exceed a certain
concentration. The level of PAH detected in the
sample exceeded that level.
Compulsory measures: Recall of the
product from end users
CORREO ELECTRÓNICO
Pág. 26 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
No pictures are available
A12/0801/13
Norway
Category: Cosmetics
Product: Skin-lightening product
Brand: Orient Pearl
Name: Whitening pearl beauty & spot
removing suite
4710589601968
Description: Skin-lightening product in
pink and white cardboard box.
Country of origin: Taiwan
Chemical
contains a mercury compound (12000 mg/kg) as
skin whitening substance. The product does not
A12/0807/13
The
Netherlan
ds
Category: Cosmetics
Product: Body paint powder
Brand: Paint Glow Products
Name: Neon Body Paint
Batch number/Barcode: Batch 1:
000002 ,
Batch 2: 000003,
Barcode: 5036567 022044
Description: Plastic bottle of 200 ml,
containing body paint powder in 6
different glowing colours.
Microbiological
The product poses a microbiological risk because it
is contaminated by Pseudomonas aeruginosa, a
pathogenic organism. The level of pseudomonas
aeruginosa detected is 15000 cfu/g, above the
guidance value (1000 cfu/g). The product does not
CORREO ELECTRÓNICO
Pág. 27 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Country of origin: United Kingdom
A12/0811/13
Norway
CORREO ELECTRÓNICO
Pág. 28 de 33
Category: Cosmetics
Brand: E`Yôuth
Name: Unknown
Type/number of model: QB/T 18572004
6932511250206
Description: The whitening spotremoving and cleansing set contains
two products in red plastic tube,
packaged in a cardboard box.
Chemical
contains a mercury compound (2000mg/kg) as a
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
A12/0812/13
Norway
Category: Cosmetics
Brand: CPHL - Seven Herbal
Name: Wrinkle De Crease
Description: The anti-aging cream is
sold in a green cardboard box.
Country of origin: Pakistan
Chemical
contains a mercury compound (820mg/kg) as a
A12/0826/13
The
Netherlan
ds
Product: Tattoo Ink
Brand: Eternal
Name: Tangerine - Lime Green - Old
Orchid
Type/number of model: Tangerine:
Lot 07/19/12 Lime Green: Lot 01/03/13
Old Orchid: lot 12/07/12
Description: Plastic bottle (30 ml) in
red, black and green colours with
yellow label and black top.
Chemical
contains azo dyes releasing aromatic amine otoluidine and 5-nitro-o-toluidine classified as
carcinogenic, mutagenic, toxic and sensitising.
According to the Council of Europe Resolution
ResAP (2008)1 on requirements and criteria for the
safety of tattoos and permanent make-up' otoluidine and 5-nitro-o-toluidine should not be
present in tattoo ink.
CORREO ELECTRÓNICO
Pág. 29 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Country of origin: United States
A12/0867/13
Germany
CORREO ELECTRÓNICO
Pág. 30 de 33
Category: Food-imitating products
Product: Beer bath oil
Brand: Traditionelle Bierkosmetik
Name: Bierbad
Type/number of model:
Manufactured: 11/2012 Use by:
05/2015
Batch number/Barcode: L502
Description: Twin-component foaming
bath oil with brewer's yeast and hop
extracts. Packaging: colourless PET
bottle shaped like a disposable beer
bottle. The bottle neck is covered with
gold-coloured metallic foil and a band
(which must be removed when first
opened) and has a white plastic screw
top. Diameter of bottle neck opening:
approx. 2.0 cm. No dosage aperture.
Country of origin: Czech Republic
Chemical
The product poses a chemical risk because the
liquid contains high content of surfactants which, if
swallowed, can be toxic. Due to its characteristic
form, appearance and packaging, consumers may
mistake the product for foodstuffs and therefore
swallow the liquid. The product does not comply
with the Directive 87/357/EEC on products which,
appearing to be other than they are, endanger the
health or safety of consumers.
Compulsory measures: Ban on the
marketing of the product and any
accompanying measures
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
A12/0874/13
Germany
Product: Tattoo ink
Brand: Silverback Ink
Name: Unknown
Type/number of model: Black 11
Batch number/Barcode: Lot:
B498103012 Batch: B498103012S
Description: Black tattoo ink in a
plastic bottle of 120 ml with screw top
and dispensing nozzle.
Chemical
contains 7 polycyclic aromatic hydrocarbons (PAH)
(25.03 mg/kg), which is classified as carcinogenic.
According to the Council of Europe Resolution
ResAP (2008) on requirements and criteria for the
safety of tattoos and permanent make-up, polycyclic
aromatic hydrocarbons may not exceed a certain
concentration. The level of PAH detected in the
sample exceeded the level of 0.5 ppm
recommended in Resolution ResAP (2008).
A12/0903/13
The
Netherlan
ds
Product: Tattoo Ink
Brand: Eternal
Name: 1.Eternal ink Bright orange 2.
Eternal ink Caramel
Type/number of model: Eternal ink
Bright orange: lot 09/18/12 exp
09/18/2014; Eternal ink Caramel: lot
12/18/12 exp 12/18/2014;
Description: Transparent bottle with
yellow label and black top. Contains 30
ml.
Chemical
contain azo dyes releasing 156 mg/kg of the
aromatic amine o-toluidine, 135 mg/kg 2,4toluenediamine and 972 mg/kg o-anisidine which
are substances classified as carcinogenic,
mutagenic, toxic and sensitizing. According to the
Council of Europe Resolution ResAP (2008)1 on
and permanent make-up o-toluidine, 2,4toluenediamine and o-anisidine should not be
released from azo dyes in tattoo inks. The products
do not comply with the national legislation
CORREO ELECTRÓNICO
Pág. 31 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
A12/0908/13
Germany
Product: Tattoo ink
Brand: Alla Prima
Name: Prima Black
Batch number/Barcode: LOT 1010
Batch: 0820821016
Description: Black tattoo ink in a
plastic bottle with screw top and
dispensing nozzle – 60 ml.
Chemical
contains 2.2 ppm of polycyclic aromatic
hydrocarbons (PAHs). According to the Council of
make-up, the level of PAH may not exceed 0.5 ppm.
A12/0943/13
The
Netherlan
ds
Category: Cosmetics
Product: Skin regenerator cream for
permanent make-up and tattoo
Brand: Biotek
Name: Bioprogram Newgex
Batch number/Barcode: Lot IB05401
exp. Date 2015-08
Chemical
contains 1% cetrimide (mytrimonium bromide), as
declared in the list of ingredients, which exceeds the
permitted limit in cosmetics (0.1%). The product
does not comply with the Cosmetics Directive
76/768/EEC.
CORREO ELECTRÓNICO
Pág. 32 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89
Description: Skin regenerator cream
for permanent make-up and tattoo in
white sachet samples containing 4 ml.
50 pieces contained in a white box.
Country of origin: Italy
CORREO ELECTRÓNICO
Pág. 33 de 33
28022 MADRID
TEL: 91 822 54 90
FAX: 91 822 52 89

ANEXO I: Relación de productos no notificados al CPNP, o que no

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