In the federal government, the BMU has lead responsibility for the European Chemicals Regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). The REACH-Regulation applies to all industrial chemicals and is based on the precautionary principle: All manufacturers, importers and downstream users must ensure that they produce, place on the market or use only such substances that do not adversely affect human health or the environment. Manufacturers and importers are obliged to register their substances before placing them on the market. They must provide various information (inter alia on the properties of the specific substance and various toxicological issues) for the registration.
Amendments for nanomaterials
Engineered nanomaterials may have additional properties that make them different to the usual manufactured substances. Therefore, the REACH Annexes had to be amended in order to obtain all relevant data at registration that are needed for a proper assessment of the safety of nanomaterials for human health and the environment.
Following lengthy negotiations, many proposals and modifications, the REACH regulatory committee of the European Commission voted on the amendments to Annexes I, II, VI and XII of the REACH Regulation to cover nanomaterials as well. Germany had proposed essential modifications that were accepted by the Commission. These relate to the choice of testing methods, the requirement to collect a set of basic data to clearly characterise nanomaterials and nanoforms, as well as more detailed toxicological and eco-toxicological data requirements for the registrants of nanomaterials. In a vote of all member states, the amendments were approved unanimously. The EU-wide uniform testing requirements for nanomaterials under REACH entered into force on 1 January 2020.
Upon request of the member states, the Commission will also amend Annex II, which specifies the requirements for the Safety Data Sheet.
In a next step, the European Chemicals Agency ECHA will adjust the guidance documents for registrants to the new amendments.