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REACH

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. According to the EU, it is the appropriate instrument for regulating nanomaterials. REACH and its annexes have not yet been adapted to take account of nanomaterials. 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. The European Commission has not yet submitted an official proposal.

The higher federal authorities as the Federal Institute for Occupational Safety and Health (BAuA), the Federal Environment Agency (UBA) and the Federal Institute for Risk Assessment (BfR) drafted a concrete text proposal for amending the REACH annexes in 2013. They introduced it into the relevant EU bodies in order to launch the debate. A background paper was compiled by the competent federal authorities and can be downloaded in German and English from the webpages of the BAuA, BfR and UBA.

Due to this delay it can be assumed that, based on the law, no data on nanomaterials and their diverse forms will be published before the final deadline for the registration of chemicals with the European Chemicals Agency (ECHA) in 2018.

Commission recommendation on the definition of nanomaterial

In 2011 the Commission submitted a recommendation on the definition of a nanomaterial, which has since been taken up in various areas of legislation.

A review of this definition was planned for 2014 by the Commission's in-house science service, the Joint Research Centre (JRC). The JRC is compiling a number of reports in the course of the review. It remains to be seen whether the definition of nanomaterials will be amended.

Furthermore, the European Commission has not yet submitted an official proposal on how future recommendations for a definition of nanomaterials and their forms can be incorporated into the REACH regulation. This also depends on regulatory procedures and how they will enable the recommendations for definitions to be adapted to technical progress in future.

Last update: 19.07.2017