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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

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nanomaterials and environmental legislation regulatory strategies under reach framework

Nanomaterials and environmental legislation“Regulatory strategies under REACH framework”

Andrej Kobe

EP Brussels, 21 November 2011

  • 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
Key deliverables in 2011/12


  • 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


  • 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
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
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
    • ECHA invited to immediately use as appropriate
    • Extended role might require changes to REACH provisions
  • Review in 2014
environmental regulatory review
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 – 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
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
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
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 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
in conclusion
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
    • Major (the only regulatory) generator of data
    • Additional ‘responsibility’ as upstream legislation
    • Follow-up required on identified implementation issues




Thank you for your attention

Email: [email protected]

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