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

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]

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)

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.

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

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

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.

NANO SUPPORT JRC (+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

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).

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

2nd Regulatory Review of nanomaterials Information 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

REACH/CLP case-by-case read-accross 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

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