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Nanomaterials

REACH

In the federal government, the BMU has lead responsibility for the European Chemicals Regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). 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. Manufacturers and importers are obliged to obtain registration for their substances before placing them on the market. According to the EU, REACH is generally suited for regulating the use of nanomaterials.

The EU Commission considered the REACH Regulation as suitable for the regulation of nanomaterials as early as 2008. However, a comprehensive review of the regulation and its annexes identified a need for further adjustments of the annexes. In October 2017, the EU Commission presented an official proposal comprising specific amendments to Annexes I, II, VI and XII of the REACH regulation, in order to obtain registrant data relevant for the assessment of potential risks nanomaterials might present to human health and the environment. The Commission will also amend Annex II with the requirements for safety data sheets soon. The amendments are being made at the request of the Member States.

On 26 April 2018, the REACH Regulatory Committee of the European Commission voted on the amendments to the Annexes of the European Chemicals Regulation concerning adaptation to nanomaterials. Thus, the REACH regulation now provides EU-wide uniform testing requirements for nanomaterials.

With all Member States voting, the result was unanimous approval. Germany had proposed four 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 characterise the nanomaterials and their nanoforms and more detailed toxicological and eco-toxicological data requirements for the registrants of nanomaterials. The European Chemicals Agency (ECHA) will adjust the relevant guidelines in line with the new REACH amendments soon.

Engineered nanomaterials might have additional properties which make them different to the usual manufactured substances. The REACH Annexes had to be amended to obtain data which facilitate a factual assessment of the safety of nanomaterials for human health and the environment at the substance registration stage.

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.

The recommended definition was to be reviewed in 2014. This task was commissioned by the Commission to the Joint Research Centre (JRC). As part of the review, the JRC compiled a report analysing current definitions, for example those of the ISO/OECD. In addition, the three parts of the JRC review “Towards a review of the EC Recommendation for a definition of the term ‘nanomaterial’” suggest additional improvements for the term.

Currently, the Commission plans to hold a public consultation on the recommended definition. It remains to be seen whether the recommended definition of nanomaterial will be amended.