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23 May 2014

Public consultation on a European nanomaterials registry

In mid-May, the European Commission set going a public consultation on possible measures to increase the transparency of nanomaterials on the European market. The consultation outcome will help inform an impact assessment of a possible future Commission proposal.

DG Enterprise and Industry has commissioned a study from two consultancy firms - Risk & Policy Analysts Ltd. (RPA) and BiPRO GmbH - to support the Commission’s preparation of that impact assessment.

The Commission has already produced a Draft Impact Assessment setting out five different policy options:

1) do nothing; 2) a Commission Recommendation on a “best practice model” for Member States wishing to establish national nano-registries, 3) the establishment of an EU Nanomaterials Observatory collecting relevant information on nanomaterials and presenting it in a clear way to the public; 4) an EU Regulation on a nanomaterials registry with one annual registration per substance per manufacturer/importer/downstream user/distributor; 5) an EU Regulation on a nanomaterials registry with one annual registration per use (including substances, mixtures, and articles).

The fourth option would require manufacturers and importers to submit substance identity information and annual production figures for nanomaterials produced in quantities over 100 grams a year and say how they are used.

With the fifth option, operators would also be required to submit a separate declaration for each use of a nano-substance, mixture or article. This means that downstream users of nanomaterials would have to submit a new declaration every time they put a new nanomaterial-containing mixture or article on the market.

The consultation will run until 5 August. The final impact assessment is expected to be completed by October.

The European Trade Union Confederation (ETUC) first called on the Commission to set up an EU-wide registry in its resolution on nanotechnologies and nanomaterials adopted in 2008, then again in a second resolution in 2010.

“The information generated will facilitate monitoring of any human or environmental contamination, and identification of liability for any harmful effects. In terms of policy, such information will be helpful to update existing regulations”, wrote Aida Ponce, head of the ETUI Working Conditions, Health & Safety unit, in a Policy Brief published in 2011.

National initiatives are already underway in some Member States. France has already put in place a national nano-registry, while Belgium is poised to pass legislation establishing a Belgian registry, and Denmark has announced plans to do likewise.

In a report released on 15 May, the French Food Safety, Environment and Labour Agency (Anses) claims that some nanomaterials are "toxic to humans" and may be harmful to natural environments, calling for "a strengthened European regulatory framework to be introduced without delay" and for "an assessment of the usefulness" of their being placed on the market. The Agency recommends that nanomaterials be included in the European CLP (classification, labelling and packaging) Regulation on hazardous chemicals

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