Nanomaterials and environmental legislation “Regulatory strategies under REACH framework”

1. Nanomaterials and environmental legislation“Regulatory strategies under REACH framework” Andrej Kobe EP Brussels, 21 November 2011

2. Content • Past and curent activities • Definition and its role • Environmental legislation • Inter-dependence, data and uncertainty • Some basic paradigms and their application • Same treatment as all chemicals, case-by-case approach, read-accross • Precautionary principle • Conclusions [Pivotal role of research ‘taken for granted’ in presentation]

3. Key deliverables in 2011/12 2011 • Definition of a nanomaterial • RIPoN : REACH Implementation projects on Nanomaterials • JRC (+ECHA) REACH nano-adequacy review (ongoing) • Studies: Env regulatory review, Industrial emissions of NM and ultrafines 2012 • 2nd regulatory review of nanomaterials • Report on nanomaterial types and uses on the market and safety • REACH review • Other activities (ECHA, COM)

4. Definition of a nanomaterial • "Nanomaterial" means 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 point 2 (1 on this slide), fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

5. Definition – role in env legislation • Based solely on size – exact scope of application will be defined for individual legislation • e.g. restrict action to manufactured NM, include additional materials • Potential application • Special risk assessment considerations, data generation and reporting, labeling • Biocides, Ecolabel • Already applied to information requirement and risk assessment • REACH/CLP • ECHA invited to immediately use as appropriate • Extended role might require changes to REACH provisions • Review in 2014

6. Environmental regulatory review • Covers NM in principle, but no NM (as yet) identified as pollutant • Classification under CLP often required which unlocks impl. tools • Knowledge gaps: chronic toxicity, eco-toxicity, exposure • In some cases (e.g. WFD) recognized the identification method not appropriate • With exception of (implicitly) REACH, env. legislation generates data only for specifically identified pollutants • Challenges: monitoring techniques, quantification of effectiveness of measures • Information expectation high if to apply env. leg. RMM • (e.g. emission limits, env. quality standards, separate treatment of waste) • Upstream & downstream legislation • Downstream much less timely and effective, if at all feasible Ensure effective REACH/CLP implementation for NM Apply in precautionary manner

7. RIPoN – REACH Implementation Projects • RIPoN 1 – Substance identification • Top-down solution: no consensus between stakeholders. • COM: substance ID driven by data sharing, registrant responsible for management of risks for all forms under scope of registration • ECHA: bottom-up development of experience. • RIPoN 2 – Information requirements • Recommendations to ECHA and COM (guidance + Annexes) • RIPoN 3 – Chemical Safety Assessment • Risk assessment paradigm applicable, case-by-case required • No new endpoints identified, but specific considerations: tests might require modification, appropriate metrics, limited alternatives to testing • Read across only when scientifically justified • Recommendations to ECHA (guidance) and research • RIPoN2&3 avoided discussion on forms as throughout related only to single (nano)form.

8. NANO SUPPORTJRC (+ECHA) nano adequacy review • Identification and assessment (45 dossiers) • Detailed assessment (25 dossiers). Not a compliance check! • Generally not possible to identify the scope of registration and/or verify whether nanomaterial and/or nanoforms were addressed • Little detailed information on characterisation of forms • Typically one set of data for all forms covered by all registrants • Options to adapt REACH + their impacts(ongoing - draft proposals) • Characterisation, then specific treatment of form throughout the dossier • Scientifically justify read-across between forms • Address nano-specific uses and form/state of NM

9. Implementing paradigms #1 • NM is just another chemical, assessment case-by-case • Example: functional group vs. functionalized surface • RIPoN1 – characterizer vs. identifier – unfinished debate • If properties differ shouldn’t the assessment be separate if all forms are to be covered? • Read-across • Well developed concept between chemicals: argumentation required • RIPoN conclusion : for NM possible when scientifically justified • Categorization, grouping, QSAR etc. : not yet available for NM • Priority for development! • Current practice and lack of provisions ‘allow’ implicit read-across by not differentiating between forms in the dossier or in communication (Safety Data Sheet).

10. Implementing paradigms #2 • Precautionary principle • Treaty, single law (e.g. “underpins REACH”) and inter-legislation • Identification and application of most effective tools • Ensuring effectiveness (and application) of upstream regulation • Improving knowledge base • Promoting safety by design, addressing societal needs • Developing tools that support implementation & enforcement

11. 2nd Regulatory Review of nanomaterialsInformation on nanomaterial types and uses, including safety aspects • Communication and associated Staff Working Document • Principal inputs identified but interpretation still in internal discussion • Including views on EU database, product register • Adoption planned in January 2012

12. In conclusion • Need “integrated, safe and responsible” strategy • Env legislation covers NM in principle • Proof in practice is still ongoing • Risk assessment paradigm and most implementation tools applicable, may often require adaptation • case by case approach • Important knowledge gaps impede implementation • Inter-dependence between legislation: Risk & Opportunity • e.g. CLP: Supports consistency but will introduce time delay and negative ripple effect when inadequate upstream • REACH • Major (the only regulatory) generator of data • Additional ‘responsibility’ as upstream legislation • Follow-up required on identified implementation issues REACH/CLP case-by-case read-accross

13. Thank you for your attention Email: andrej.kobe@ec.europa.eu Photo : unknown (internet)