The European Commission has launched a public consultation on possible EU measures to increase the transparency of nanomaterials on the European market. The consultation is the first step of a Commission drafting procedure that is likely to end in a proposal for a Regulation on an EU Nano-Registry that the Commission could formally present by Spring 2015.
The Commission’s consultation aims at gathering the views of the public on the currently available information on nanomaterials on the market, whether the information available is sufficient to guarantee the safe use of nanomaterials and products containing them and informed consumer choice, and the different options to address any lack of information. The consultation will contribute to the preparation of an impact assessment of a possible future Commission proposal.
A Draft Impact Assessment prepared by the Commission takes the position that the current level of available information on nanomaterials and products containing them on the market is insufficient to guarantee an adequate response to health and environmental risks and to ensure informed consumer choice. The Draft identifies five different policy options for the EU to address this concern: (i) do nothing; (ii) a Commission Recommendation on a “best practice model” for Member States wishing to establish national nano-registries, (iii) the establishment of a EU Nanomaterials Observatory collecting relevant information on nanomaterials and presenting it in a clear way to the public; (iv) a EU Regulation on a nanomaterials registry with one annual registration per substance per manufacturer/importer/downstream user/distributor; or (v) a EU Regulation on a nanomaterials registry with one annual registration per use (including substances, mixtures, and articles).
The former EU nanomaterials registry Regulation (option iv) would require manufacturers and importers of nanomaterials to submit information on the identity and annual product volume for nanomaterials produced in quantities above 100 grams per year. In addition, manufacturers, importers and distributors of nanomaterials, mixtures containing nanomaterials as well as articles that are intended to release nanomaterials would be required to submit, per each nanomaterial substance, an annual declaration specifying the total quantity of the substance per year and its uses.
The latter nanomaterial registry Regulation (option v) would be identical to the former, but would require operators 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.
Importantly, France has already put in place a national nano-registry, while Belgium is about to adopt a Decree establishing a Belgian registry, and Denmark has also announced its intention of doing the same. Moreover, 11 Member States have asked the Commission to propose legislation on the “registration or market surveillance of nanomaterials or products containing nanomaterials.”
The public consultation and impact assessment on whether and how to gather additional information on nanomaterials that are on the market runs in parallel to an expected Commission proposal to amend the Annexes to the REACH Regulation on chemicals, which is intended to improve the risk assessment and management of nanomaterials. In practice, a possible EU Regulation on a EU nano-registry could target nanomaterials in volumes between 100 grams and one ton per year, whereas the amended REACH Regulation would require improved registration dossiers for nanomaterials in volumes above one ton per year. The Commission is expected to present its proposal to amend the Annexes to the REACH Regulation by October-November 2014.
Stakeholders may submit their comments to the Commission’s consultation until August 5, 2014.