1. Andrej Kobe EP Brussels, 21 November 2011
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 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 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

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 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

12. 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

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