Nanomaterials and environmental legislation regulatory strategies under reach framework
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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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