In a move that could affect US manufacturers and chemical companies that do business in Europe, the European Chemicals Agency is moving forward with nanomaterial guidance regulations.
These substances are regulated under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), the primary chemical law in the European Union.
It follows the first-ever federal nanoscale chemical rule in the US, finalized last month, that will require manufacturers and companies that import or process nanomaterials, now and in the future, to report certain information to the EPA. These nano-sized versions of chemicals and are now subject to EPA regulation under the Toxic Substances Control Act.
The European Chemicals Agency recently moved several REACH guidance documents concerning nanomaterials to the next step in the consultation process. The draft guidance is intended to provide an approach on how to justify the use of hazard data between nanoforms, and the non-nanoforms, and within groups of nanoforms of the same substance, according to attorneys at Bergeson & Campbell.
- Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance;
- Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7b Endpoint specific guidance; and
- Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance.
Although REACH is an EU law, it’s worth paying attention to for companies in the US as its reach extends beyond far Europe.
REACH affects a wide range of producers, importers, exporters and downstream users of chemicals in industries from automotive to textiles manufacturing. If the European Chemicals Agency deems a chemical to be unsafe to human health or the environment, it places it on the REACH restricted substances list.
Although REACH applies only to products sold in the EU, US and other global businesses are affected, because REACH compliance throughout the supply chain is required to do business in Europe.