nanomaterials and environmental legislation regulatory strategies under reach framework andrej kobe...
TRANSCRIPT
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]
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)
Key deliverables in 2011/12
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 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
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
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
