The European Commission has published its long-awaited Communication on Regulatory Aspects of Nanomaterials. The review covers nanomaterials currently in production and/or placed on the market and was conducted in order to support a claim in the previous EC Communication Nanosciences and nanotechnologies: an Action Plan for Europe 2005 – 2009 that ‘all applications and use of nanosciences and nanotechnologies must comply with the high level of public health, safety, consumers and workers protection, and environmental protection chosen by the Community’.
Overall the regulatory review concludes that ‘current legislation covers to a large extent risks in relation to nanomaterials and that risks can be dealt with under the current legislative framework’. It notes, however, that‘current legislation 'may have to be modified in the light of new information becoming available, for example as regards thresholds used in some legislation'.
The elements of the European legislative framework and actions that cover nanomaterials are:
- for Chemicals: REACH Regulation
- for Worker Protection: Framework Directive 89/391/EEC
- for Products: Product legislation lays down requirements regarding specific products, such as medicinal products, plant protection products (PPP), cosmetics, food and feed additives, etc.. Consumer products that are not governed by specific legislation have to meet the requirements of the General Product Safety Directive
- for Environmental protection: several environmental regulations are relevant to nanomaterials, including the Integrated Pollution Prevention and Control (IPPC), the control of major accident hazards involving dangerous substances (Seveso II), and the Water Framework Directive and a number of Waste Directives
The EC concludes that, ‘whilst the Community legislative framework generally covers nanomaterials, implementation of legislation needs further elaboration…the Commission and EU Agencies will therefore in the first place review current documents that support implementation, such as implementing legislation, standards and technical guidance with regard to their applicability and appropriateness to nanomaterials…Important elements are the test methods and the risk assessment methods that serve as a basis for implementing legislation, administrative decisions, manufacturer’s obligations or employer’s obligations’.
The following Community actions are recommended, in relation to managing the risks in order to meet regulatory requirements:
- Improving the knowledge base
- Improving the implementation of legislation (Examples are the setting of thresholds, authorisation of substances and ingredients, qualifying waste as hazardous, reinforcing conformity assessment by reclassification, introducing restrictions on the marketing and use of chemical substances and preparations, etc. In most cases, implementing legislation can be adopted through “Comitology” procedures.)
- Information to users
- Market surveillance and intervention mechanisms
Follow these links to download the full EC Communication on Regulatory Aspects of Nanomaterials.