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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > EC Publishes Inception Impact Assessment Concerning Possible REACH Annex Amendments for Registration of Nanomaterials

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
On February 2, 2016, the European Commission (EC) published an inception impact assessment concerning ˇ§Possible amendments of Annexes to REACH for registration of nanomaterials.ˇ¨

February 9th, 2016

EC Publishes Inception Impact Assessment Concerning Possible REACH Annex Amendments for Registration of Nanomaterials

On February 2, 2016, the European Commission (EC) published an inception impact assessment concerning ˇ§Possible amendments of Annexes to REACH for registration of nanomaterials.ˇ¨ See http://ec.europa.eu/smart-regulation/roadmaps/docs/2014_env_013_nanomaterials_en.pdf According to the inception impact assessment, the EC identified a need for more specific requirements for nanomaterials to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers to attain the aims of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. This initiative intends to solve how nanomaterials should be addressed and safety demonstrated in REACH registration dossiers. The inception impact assessment identifies the following options:

- Baseline scenario -- no European Union (EU) policy change;
- Option 1: No change;
- Options of improving implementation and enforcement of existing legislation or doing less/simplifying existing legislation:
„«- Option 2: Clarifying the existing information requirements;
„«- Option 3: Soft law measures;
„«- Option 4: Scientific-technical recommendations tailoring information requirements;
„«- Option 5: Reduced information requirements; and
„«- Option 6: Exhaustive information requirements.

The chosen option, if different to the baseline scenario, will take the form of a draft EC implementing regulation amending certain REACH Annexes, and the EC will submit it to the REACH Committee for opinion in accordance with REACH Article 133(4) before its adoption by the EC. The inception impact assessment states that work on the impact assessment was expected to conclude by the end of 2015.

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