Nanomaterials under REACH

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1 Nanomaterials under REACH ECHA Workshop on nanomaterials, May 2012, Helsinki Maila Puolamaa and Andrej Kobe

2 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

3 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

4 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

5 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

6 CASG Nano Mandate, March 2008 REACH applicability to nanomaterials REACH 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 Slide 6

7 CASG Nano WP CASG Nano Advice 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 5. Communication in the supply chain 6. Testing Physico-chemical properties 7. CSA of NM 8. Testing Human health toxicity 9.?Annex XIV - Authorisation of NM-SVHC 1 st CASG-Nano, July 2008 Dec 2008 Jan 2009 Jan 2009 open 4 th CASG-Nano Dec 2009, Rev 1 Dec 2008 Oct 2009 RIPoN1, Spring 2011 Dec 2011 Nov 2009 Dec 2011 RIPoN 2, Spring 2011 RIPoN 3, Spring 2011 RIPoN 2, Spring 2011 open 10. Testing Ecotoxicity Environment 11. Testing Fate, Degradation, Aq. Env. 12. Risk management measures 13. Alternative testing methods for NM 14. Advice on REACH guidance 15. Advice on testing strategies for NM 16. Recommendations for further research June 2012 June 2012 June 2012 RIPoN 2, Spring 2011 RIPoN 2, Spring 2011 Open (ES in RIP-oN3) Tbd RIPoN 2, Spring 2011 Nov 2011 Slide 7

8 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 that some 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

9 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 justified Lack 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

10 European Parliament resolution on NMs 1st NM Regulatory Review, June 2008 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 nd Regulatory review of nanomaterials, including information on nanomaterial types and uses, including safety aspects in 2011 Slide 10

11 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

12 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

13 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

14 Thank you! Further info: tm htm

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