NANOFORCE

NANOFORCE
Nanotechnology for Chemical enterprises –
how to link scientific knowledge to the business in the Central Europe
REGULATION AND SAFETY IMPLEMENTATION OF NANOTECHNOLOGY FOR
CHEMICAL ENTERPRISES IN THE CENTRAL EUROPE SPACE
A. Falk1, S. Hartl1, F. Sinner1,2
1
BioNanoNet Forschungsgesellschaft mbH, Graz, Austria
JOANNEUM RESEARCH- HEALTH, Graz, Austria
Contact: andreas.falk@bionanonet.at Tel.: +43 (0)664 602 876 2115
2
Co-Financed by:
Agenda
Why are we speaking about nanomaterials and safety? Why Central
Europe Region? What are we speaking about?
Which regulations already exist and which needs are still there
(identified within NANOFORCE-project)?
Some (Austrian) efforts to ensure success of nanotechnological
developments
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
http://www.nsf.gov/crssprgm/nano/reports/NNI_11-1031_Roco_AVS_NanoManu_62sl.pdf
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Nanotechnology – potential market
segments
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Source: Allianz; AT Kearney; DIGITIP; Helmut Kaiser Consultancy; ISTAT; Lux Research; NANOFORCE; Nanoposts; Nanotechwire; OECD; SEMI
Why
Central
Europe
Region?
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Why
Central
Europe
Region?
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
NANOFORCE-consortium
LP SC - Sviluppo Chimica spa (IT)
PP2 Veneto Nanotech S.C.p.A. (IT)
PP3 Association of Chemical Industry of the
Czech Republic – SCHP (CZ)
PP4 Chemie Cluster Bayern (DE)
PP5 Polish Chamber Of Chemical Industry
- PIPC (PL)
PP6 University of Nova Gorica (SI)
PP7 BioNanoNet Forschungs GmbH (AT)
PP8 Association of Chemical & Pharmaceutical
Industry of the Slovak Republic (SK)
PP9 Institute of High Pressure Physics, Polish
Academy of Sciences (PL)
www.nanoforceproject.eu
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Concerns on Nanosafety
• Potential for human toxicity
• Lack of knowledge (transfer)
• Put the development of nanotechnology in Europe at risk
Needs
•
•
•
•
Enable safe implementation of nanotechnologies
Assess potential risks for humans in a transparent manner
Assure proper dissemination of reviewed nano-safety knowledge
Setting up of an international (communication) framework
(science&research/authorities/market) based on “high quality
science”
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
What we are speaking about…
Definition (ref. EC):
• A natural, incidental or manufactured material containing particles, in
an unbound state or as an aggregate or as an agglomerate and where, for
50 % or more of the particles in the number size distribution, one or more
external dimensions is in the size range 1 nm - 100 nm
•
In specific cases and where warranted by concerns for the environment,
health, safety or competitiveness the number size distribution threshold of
50 % may be replaced by a threshold between 1 and 50 %
•
By derogation from the above, fullerenes, graphene flakes and single wall
carbon nanotubes with one or more external dimensions below 1 nm should
be considered as nanomaterials
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Definition of nanomaterial
• The definition will be used to identify materials for which special
provisions might apply (e.g. for risk assessment or ingredient
labelling)
• The safety assessment of the substances must be done on a caseby-case basis
• Only the results of the risk assessment will determine whether the
nanomaterial is hazardous and whether or not further action is
justified
• Definition is intended to be used by Member States, European
Union and companies
• Provisions will be adapted in order to ensure a consistent approach
• Review of the definition by the European Commission in 2014
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
2nd Regulatory Review on
Nanomaterials
Some aspects…
– current legislation covers in principle the relevant risks
relating to nano-materials, and
– that the protection of health, safety and the environment
needs mostly be enhanced by improving implementation of
current legislation, when due to the lack of appropriate
data (and methods to assess the risks relating to
nanomaterials) it is effectively unable to address their risks
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Chemicals - REACH (1/2)
REACH - Registration, Evaluation, Authorisation and Restriction of Chemical
substances
• Main Aim:
“… to produce fewer industrial chemicals,
to understand the possible human and ecological
hazards of those that are produced, and
to insure that any major threat is anticipated, as well as
prevented…”
• Broadest coverage of nanomaterials of any European
legislation
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Chemicals – REACH
(2/2)
• Commission remains convinced that REACH sets the best possible
framework for the risk management of nanomaterials when they
occur as substances or mixtures but…
• …more specific requirements for nanomaterials within the
framework have proven necessary
• …Commission envisages modifications in some of the REACH
Annexes
• ...encourages ECHA to further develop guidance for registrations
after 2013
Source: http://ec.europa.eu/nanotechnology/pdf/second_regulatory_review_on_nanomaterials_-_com(2012)_572.pdf
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
EU regulations with relevance for
nanomaterials (1/4)
•
Cosmetics
–
•
Food
–
•
Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on Food additives
Biocidal material
–
•
Commission Regulation (EU) No. 10/2011 on plastics materials and articles intended to come into contact
with food
Food additives
–
•
Regulation (EU) No. 1169/2011 of the European Parliament and the Council on the provision of food
information to consumers …
Food contact materials
–
•
Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products
Regulation (EU) No. 528/2012 of the European Parliament and of the Council concerning the making
available on the market and use of biocidal products
Restriction of hazardous substances in electrical and electronic equipment
–
Directive 2001/65/EU of the European Parliament and of the Council on the restriction of the use of …
hazardous substances in electrical & electronic equipment
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
EU regulations with relevance for
nanomaterials (2/4)
• Cosmetics (Regulation (EC) No. 1223/2009 of the European Parliament and of the
Council on cosmetic products)
cosmetic products containing nanomaterials have to be notified to the
Commission
need of a "a catalogue of all nanomaterials used in cosmetic products placed on
the market, including colorants, preservatives and UV filters”
labelling obligations to “list the relevant materials with the word 'nano' in
brackets"
• Food (Regulation (EU) No. 1169/2011 of the European Parliament and the Council on
the provision of food information to consumers)
clearly indicating the nanomaterial in the list of ingredients and labelling such
ingredient with the word ‘nano’ in brackets
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
EU regulations with relevance for
nanomaterials (3/4)
• Food contact materials (Commission Regulation (EU) No. 10/2011 on plastics
materials and articles intended to come into contact with food)
nanoparticles used in food contact materials only be used prior to an
explicit authorization
• Food additives (Regulation (EC) No. 1333/2008 of the European Parliament and
of the Council on Food additives)
additives produced by new methods (nanotechnology) leading to
alterations in particle size need to be considered as different agents
requiring a new entry in the community list or change in the specification
prior to market placement
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
EU regulations with relevance for
nanomaterials (4/4)
• Biocidal material (Regulation (EU) No. 528/2012 of the European Parliament and of the
Council concerning the making available on the market and use of biocidal products)
labelling of the product with ‘nano’ in brackets
Sept. 2015 Member States have to report to the Commission the correct
implementation of the regulation (providing information on the use of
nanomaterials in biocidal products including risks)
• Restriction of hazardous substances in electrical and electronic
equipment (Directive 2001/65/EU of the European Parliament and of the Council on the
restriction of the use of … hazardous substances in electrical & electronic equipment)
precautionary principle, EEE produced with or using nanotechnology and
nanomaterials have to be notified to the Commission
substituted by environmentally friendly alternatives to ensure the safe use
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Summary - Regulatory Needs
• simplified registration for nanomaterials manufactured or imported
< 1 tonne/year
• reporting requirements for all nanomaterials on the market
• harmonized labeling of nanomaterials
• safety reports with exposure assessment for registered nanomaterials
• Adoption of the precautionary principle at all levels of the production
cycle
– business infrastructure, human resource management, technology development
and procurement, inbound logistics, production, outbound logistics, marketing &
sales and customer service)
• Waste management and recycling schemes-LCA (Life Cycle
Assessment)
• Communication…
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
EURO-NANOTOX –
Austrian hub in Nanotox
• Consolidation of knowledge
• Standardization of nanotox. Methods and strategies
• Critically review of results
EURO-NanoTox was founded and serves as Austrian
national research hub to:
pool nanotoxic expertise in Austria
standardize nanotoxic methods in Austria
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
NANOFORCE & EURO-NANOTOX
international service
hub for nanotechnology
– expertise database
nanotechnology
responsible management
tangible sources for
nanotechnology & nanotoxioclogy
data transfer
– communication and dissemination
development of standardized
testing and evaluation methods
safety data sheets and
exposure scenarios
information pool for governmental bodies –
recommendations on safe use of
nanotechnology to the European Commission
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
EURO-NANOTOX - Activities
international
cooperation in
research projects
European Center for Nanotoxicology
Standardized nano-toxic
methods
helping to establish
international standards
ONLINE-Journal
www.euro-nanotox-letters.com
provision of centralized
nanotoxicology scientific
information with emphasis on
human toxicology
comparative studies and
interlaboratory tests
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
BioNanoNet
Your Key to the Austrian Research Community
focus areas:
1)
2)
3)
4)
nanotoxicology – EURO-NanoTox, NANOFORCE
nanomedicine – EHS, nano-health
sensor technologies – Medical Sensor Solutions
regulatory expertise, communication and management
– NANoREG, SPIDIMAN
offers scientific expertise and …
• regulatory aspects of nanotechnology
• coordination, management, communication and dissemination
activities
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Conclusion
Findings of the project NANOFORCE
• significant needs in standardization of the regulatory body for
nanomaterials
• better implementation and development of simple and
standardized testing methods
• a uniform data collection,
• harmonization tools for a better knowledge dissemination
and transparency for data to be available for stakeholders
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
Thank You …
Sonja Hartl,
Frank Sinner
And to the BioNanoNet-team:
Gabriele Katz,
Patricia Junk,
Birgit Krassnitzer,
Nikolaus Ladenhauf,
Simone Jagersbacher-Uhl
This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.
picture © piCHEM
www.bionanonet.at
Contact: andreas.falk@bionanonet.at
Tel.: +43 (0) 664 602 876 2115
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This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.