nanomaterials under reach - europa · 2012. 10. 4. · dec 2008 oct 2009 ripon1, spring 2011...
TRANSCRIPT
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Nanomaterials underREACH
ECHA Workshop on nanomaterials, 30-31 May 2012, Helsinki
Maila Puolamaa and Andrej Kobe
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Overview
• REACH – aims and legal basis• CA/59/2008 : Nanomaterials in REACH
• Activities at EU level• CARACAL and CASG Nano
• EU Recommendation on the definition
• RIPoN 1,2&3
• Regulatory review of nanomaterials
• REACH Review 2012
• Conclusions and next steps
Slide 2
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EU Approach to Nanotechnologies
- Safe: ensure a high level of protection of human health and the environment
- Integrated: simultaneous development of competitiveness and safety aspects in nanotechnologies
- Responsible: managing the evolving development of nanotechnologies in a scientifically sound manner
Slide 3
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REACH – aims (Article 1.1)
- - to ensure a high level of protection of human health and the environment
- - including the promotion of alternative methods for assessment of hazards of substances
- - as well as the free circulation of substances on the internal market
- - while enhancing competitiveness and innovation
Slide 4
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REACH Coverage of nanomaterials• REACH requirements apply to nanomaterials (NMs),
even though there are no specific provisions for NMs.
• Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
• This covers in principle (CA/59/2008):• Nanomaterial, substance at the nanoscale• Nano form vs. bulk form• Agglomerates and aggregates
Slide 5
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REACH applicability to nanomaterialsREACH implementation issues such as
• Substance identification• Registration of nanomaterials• Chemicals Safety Assessment• Risk management measures• Communication in the supply chain• Current and evolving nanoapplications • Information needs
Other issues of relevance• Test methods and test guidelines (JRC, FPs, OECD-WPMN)• Member State activities• Other
CASG Nano Mandate, March 2008
Slide 6
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Tbd
RIPoN 2, Spring 2011
Nov 2011
June 2012
June 2012
June 2012
14. Advice on REACH guidance
15. Advice on testing strategies for NM
16. Recommendations for further research
Open (ES in RIP-oN3)
Dec 2010
Dec 2010
Dec 2010
12. Risk management measures
13. Alternative testing methods for NM
RIPoN 2, Spring 2011
RIPoN 2, Spring 2011
Dec 2010
Dec 2010
10. Testing – Ecotoxicity Environment
11. Testing – Fate, Degradation, Aq. Env.
RIPoN 3, Spring 2011
RIPoN 2, Spring 2011
open
Dec 2010
Dec 2010
open
7. CSA of NM
8. Testing – Human health toxicity
9. ?Annex XIV - Authorisation of NM-SVHC
Dec 2011
RIPoN 2, Spring 2011
Dec 2010
Dec 2010
5. Communication in the supply chain
6. Testing – Physico-chemical properties
Dec 2008
Oct 2009
RIPoN1, Spring 2011
Dec 2011
Nov 2009
Dec 2008
Jan 2009
Jan 2009
Dec 2010
Dec 2010
0. Nanomaterials in REACH
1. Carbon and graphite in Annex IV and V
2. Substance Identification
3. Registration of NM
4. Advice on C&L of NM
4th CASG-Nano
Dec 2009, Rev 1
1st CASG-Nano,
July 2008
CASG Nano Advice
CASG Nano WP 2008-2012
Slide 7
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Substance ID (RIPoN 1)
• Characterizer or identifier?
• Common agreement that phys-chem parameters such as size and surface treatment of a nanomaterial affect intrinsic properties of a substance
• No agreement on whether they are characterisers or identifiers (or may trigger new identifiers)
• Agreement found on approach to carbon nanotubes (CNT)
Insufficient evidence to create general solutions at present, indication thatsome flexibility may be required.
• CA/58/2011• Further practice needs to be developed on developing rules on how size should
be used as a characterizer and when it could be used as an identifier. If specific substance identification rules for nanomaterials will be developed they must be consistent with practices for substances in general.
• Registrants can should adequately motivate their approach to ID of the registered nanomaterials either as a substance or a nanoform of a substance.
• Data sharing should be considered as important driver for these decisions.
Slide 8
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Information Requirements and Chemical Safety Assessment (RIPoN 2&3)
• Principal findings• REACH approach overall suitable
Recall: all identified uses, registered substance may be present in several forms
• No new endpoints identified at present• Test methods generally applicable, adaptations may be
required (e.g. sampling)Read-across possible if scientifically justifiedLack of validated alternative methods
• Importance of phys-chem characterisation (granulometry)• Still scarce evidence base, field in development
• Broad support on RIPoN 2&3 findings from stakeholders
• ECHA has already taken the recommendations in an update to the Guidance on IR and CSA
Slide 9
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European Parliament resolution on NMs
• No regulatory void, further actions on guidance and implementation as well as R&D needed
• EP Resolution on Regulatory aspects of NMs, 2009• Disagrees with Commission that « current legislation covers
risks of nanomaterials »• Lack of NM definition and information about NMs on market• Special evaluations needed in core legislative areas, incl. REACH
• Commission Response to the Parliament, July 2009• 2nd Regulatory review of nanomaterials, including information
on nanomaterial types and uses, including safety aspects in 2011
1st NM Regulatory Review, June 2008
Slide 10
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Definition of nanomaterial
• Commission Recommendation 2011/696/EU• science-based, broadly applicable
• Default : 1-100nm, >50% (constituent) particle number size distribution
• Facilitate coherent approach across different regulatory regimes; application to be considered individually
• REACH: COM asked ECHA to consider how to best take the EU recommendation into account
Slide 11
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REACH Review 2012• Different aspects of REACH will be looked at to inform
the 2012 review process
• Several thematic studies address issues which may provide inputs to the Commission services in the review
• Inputs to the Commission analysis will also emerge from other review activities going on independently from the REACH exercise but almost in parallel from a time prospective such as:
• Review of regulatory aspects of nanomaterials
• Review of EU legislation addressing risks from exposure to
multiple chemicals from different sources and pathways
Slide 12
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Conclusions and next steps
• Competitiveness, innovation and high level of protection fundamental for the EU• Uncertainties influence consumer trust and investment decisions • Key to increase certainty on sustainability and safety
• Legislative reviews on nanomaterials and REACH to steer towards the above
• REACH and CLP regulations cover in principle nanomaterials• Present task : effective implementation
• NM issues addressed in CASG Nano and in the new ECHA Nano-WG
• Close cooperation with the Member States, Industry and NGOs.
• Efficient use of results from OECD-WPMN & ISO/CEN and R&D
Slide 13
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Thank you!
• Further info:
http://ec.europa.eu/enterprise/sectors/chemicals/index_en.htm
• http://ec.europa.eu/environment/chemicals/nanotech/index.htm