In the federal government, the BMUB has lead responsibility for the European Chemicals Regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). The REACH Regulation aims to secure a high level of protection for humans and the environment. The regulation introduced what is called a reversal of the burden of proof, making manufacturers and importers responsible for registering their chemicals before placing them on the market. According to the EU, REACH is the appropriate instrument for regulating the use of nanomaterials. However, REACH and its annexes have not yet been adapted to take adequate account of nanomaterial issues. Only the European Commission has the right to initiate such a revision. It is planning amendments to the REACH annexes and further clarification in guidance documents.
In October 2017, an official proposal from the European Commission to amend the REACH annexes regarding nanomaterials was presented for discussion. The new regulations are planned to enter into force in January 2020.
A vote on the official Commission proposal will take place in the REACH Regulatory Committee once a definition of nanomaterial has been incorporated. This will likely happen following the conclusion of public consultation on the recommended definition. The BMUB reckons with the vote on the Commission proposal during the summer break.
Commission recommendation on the definition of nanomaterial
In 2011, the European Commission recommended a definition of nanomaterial, which has since been taken up in specific definitions in various regulatory areas.
A review of this definition was conducted in 2014 by the Commission’s in-house science service the Joint Research Centre (JRC). The JRC compiled a number of reports in the course of the review. Currently, the Commission plans to hold a public consultation on the recommended definition. It remains to be seen whether the definition of nanomaterial will be amended.