Aspects of Risk Assessment (Status of nanomaterial in EU-regulation)

Transcription

1 Aspects of Risk Assessment (Status of nanomaterial in EU-regulation) Gregory Moore Nanomaterials possibilities, issues and risk assessment Svensk Förening för Toxikologi 15 April 2016

2 Content About KemI Regulation EU Commission s activities NM definition Transparency Modification of EU regulation for NM (REACH) ECHA activities Synergies Questions (ECHA = European Chemicals Agency)

3 About KemI Established ca 270 personnel (2016) Environment and Energy Ministry National, EU and international Competent authority in EU for Plant Protection and Biocide Products, REACH and CLP Human Health and Environment Approvals, Risk Assessment/Management, Enforcement, Development of regulations A Non-Toxic Environment - Action plan: Non-toxic everyday environment

4 Basic regulation Definition What to regulate How to Information detect/identify/ characterise How to translate Criteria (assessment) information into regulation

5 Brief overview on development of regulation (squaring the circle) Actors: Commission, Member States, stakeholders. Regulation proposal Impact Assessment (IA: Cost vs Benefit) Public Consultation Regulatory Scrutiny Board (IA) EU Inter-Service Consultation (proposal) Final proposal WTO Approval by EU committees Adoption Implementation Application Guidance

6 Nanomaterial - definition Cosmetic Regulation (EC 1223/2009) Commissions recommendation (EU 969/2011) Biocide regulation (EU 528/2012) New Novel foods regulation (EC 2283/2015 active 2017)

7 Commissions Recommendation on the Definition of Nanomaterial (2011/696/EU) 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 nm. Ad hoc: may be replaced by 1 and 50 % Ad hoc: inclusion : fullerene, graphene flakes and carbon nanotubes Add-on: potential use of specific surface area volume Information om definitionen: tech/faq/definition_en.htm

8 Revision of Commission s recommended definition Reviewed by December 2014 Review divided into Scientific and Policy parts. 3 Joint Research Centre reports, April 2015 Background, Assessment, Recommendation Policy analysis and Public Consultation, spring 2016 Conclusion, potential revision, mid 2016 Implementation immediately thereafter Food, Cosmetics, REACH Case-by-case transition arrangements where existing definitions already in place.

9 Transparency, Traceability of NM on the market National NM-databases, e. g. FR, DK ( ) COM believes that 90% of NM will be registered on REACH by 2018 ECHA at present only has 9 NM registered 319 NM are notified in FR-database Prioritise NM for assessment EU-COM evaluates need for harmonized EU-registry 2014 ECHA = European Chemicals Agency

10 Transparency & Tractability.. COM rejects idea of EU nano register, April 2016 Expensive, less targeted, lacks link to hazard/risk Recommend public Website listing existing information Less complete, cannot be use for enforcement, politician & consumer friendly Nano Observatory ECHA is responsible Work Shop, 25 April 2016 Complete by 2018 NB, Swedish NM-registry operational by 2019

11 Modification of REACH for NM 2006, REACH Drafting COM would provide robust provisions for NM requirements 2010, 1 st REACH registration COM: need to wait for guidance 2012 German CA proposal to amend REACH KemI proposal to develop a specific NM-legislation CIEL et al., Nanopatch CIEL = Centre for International Environmental Law

12 Modification of REACH Annexes In October 2012 the European Commission published its second Regulatory Review on Nanomaterials. It was concluded that Overall the 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. The Commission envisages modifications in some of the REACH Annexes..

13 Modification of REACH Annexes 2013, 2 nd REACH registration COM: REACH Annexes must first be modified 2013 Hague conference German CA proposal to amend REACH Annexes Danish informal WS MS agree to amend REACH Annexes as first step 2013, 2014 {delay} 2016 EU COM meetings (CASG Nano*) DG-ENV & DG-(ENT)-GROW Non-paper *CASG Nano = Competant Authority SubGroup on NM

14 Modification of REACH Annexes Denmark, , (Miljøsyrelsen) Better Control of NM 24 mil DKKr 30 reports e.g. Information requirements for NM IRNANO Dutch 2013 (RIVM) Building Block for amending EU Regulation.. German CA, 2014 (UBA) Commentary on NM in regulation Swedish CA, 2015 (KEMI) Impact Assessment of Further regulation

15 Modification of REACH Annexes 2016 Changes in REACH Annexes will not apply for REACH registration 2018 Non-paper Impact Assessment rejected, Feb 2016 High costs but no benefits included in IA Ambiguous: Nanoform Applicability date 2008 Definitions legality

16 ECHA activities Scientific and Technical guidance Best practices for REACH registration ( ) Registration: Compliance Checks of NM Board of Appeal Guidance (2018) {different cf. food* & cosmetics**) Registration issues Read across, grouping, sameness Health assessment Environmental assessment *EFSA = European Food Safety Authority **SCCS = Scientific Committee on Consumer Safety

17 Synergies OECD Test methods & Guidance (Health & Env)(ca 5 + 7) Test Method regulation (EU 440/2008) Nordic Chemicals Gruop (NKG) Test methods, classification of NM in GHS/CLP UN Globally Harmonized System Classification, Labelling & Packaging regulation EU projects/networks NANoREG, Horizon 2020, 7 th Research Framework Programme) SE-Nanosafety Nanoplatform at Swetox

18 Questions.. Thank you