The European Commission Directorate-General on Enterprise and Industry (DG ENTR) has announced that, ‘as part of the Communication on the Second Regulatory Review on Nanomaterials, the European Commission […will develop] an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight on nanomaterials’. In order to support the development of this assessment, a public consultation is being run ‘to obtain stakeholder views on the currently available information on nanomaterials on the market, the problem definition that forms the basis of the impact assessment, as well as the positive and/or negative impacts of […] policy options’. NIA will be replying to the assessment on behalf of its Members.
The consultation is aimed at ‘companies, public authorities, academia, associations, consumers and all other interested stakeholders’. A draft working document has been made available that highlights the first chapters of the Impact Assessment report. The consultation is being carried out by external organisations on behalf of DG ENTR, who have created two separate one: one for industrial stakeholders, and one for all other stakeholders. DG ENTR also informs readers that it will be running a validation workshop on the topic on 30 June 2014, and that there are several documents already available that can act as reference points.
The draft working document that will make up the beginning of the eventual Impact Assessment report consists of:
- The regulatory and political context of the assessment
- The ‘problem definition’ around the topic
- Objectives of the assessment (including general, specific and operational policy objectives)
Policy Options, that consist of:
- ‘Baseline scenario
- Recommendation on how to implement a "best practice model" for Member States wishing to establish a national system (soft law approach)
- Structured approach to collect information ("Nanomaterials Observatory")
- Regulation creating an EU nanomaterial registry with one annual registration per substance for each manufacturer/importer/downstream user/distributor
- Regulation creating an EU nanomaterial registry with one annual registration per use (including substances, mixtures and articles with intended release)’
Submissions are due by 5 Aug 2014, and the final opinion is set to be unveiled in December 2014.
Follow this link for more information on the consultation, and this for the draft working document. Follow this link to read NIA’s announcement that it will be replying on behalf of NIA Members.