Harmonised rules will apply to nanomaterials in future in the EU. The REACH Regulatory Committee amended the EU REACH Regulation on chemicals. Starting in 2020, detailed data will be required during substance registration.
Harmonised rules will apply to nanomaterials in future in the EU. Yesterday, the REACH Regulatory Committee amended the EU REACH Regulation on chemicals accordingly.
Federal Environment Minister Svenja Schulze commented: "We will finally have clear rules for nanomaterials in the EU. This will make it easier to assess potential risks and minimise them. This is important for environmental and consumer protection."
In future, manufacturers, importers and downstream users of nanomaterials will have to provide detailed data on the materials and their nanoforms during registration with the European Chemicals Agency (ECHA). The amended Regulation enters into force in January 2020. Systematic data collection enables a risk assessment of the REACH-registered nanoscale substances.
Engineered nanomaterials may have additional properties that make them different to the usual manufactured substances. The REACH Annexes had to be amended in order to obtain data during the substance registration stage that facilitates proper assessment of the safety of nanomaterials for human health and the environment.
A final vote on the changes to REACH Annexes I and III through XII, which were coordinated with all member states, took place this week. Germany proposed four main changes that were accepted by the Commission. These changes were related to selection of testing methods, obligation to collect a base set of data on the characteristics of nanomaterials and their nanoforms, and more detailed toxicological and eco-toxicological data requirements for the registrants of nanomaterials.
This Regulation is based on the principle – derived from the precautionary principle – that manufacturers, importers and downstream users must ensure that the substances they manufacture, place on the market or use do not adversely affect human health or the environment. REACH thus delegates authoritative responsibility to industry with regard to generating safety data and, to an extent, evaluating it, in order to guarantee safe use of their substances, mixtures and articles. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals within the EU.