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 * REACH


REACH

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In the federal government, the Federal Ministry for the Environment 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. 


LINKS

 * Proposal for amending the REACH annexes external website


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. This means that uniform testing
requirements for nanomaterials in the REACH Regulation applies in the EU since 1
January 2020.

At the request of the Member States, the Commission has also adapted Annex II of
the REACH Regulation. It contains the requirements for the safety data sheet.
Such a safety data sheet must be prepared for all hazardous substances covered
by REACH or the Chemicals Act. It contains information on the identity of the
substance, on hazards that may occur, on safe handling and measures for
prevention as well as in case of danger. With the adaptation of the safety data
sheets to nanomaterials, it must now be stated in each relevant section whether
the information also applies to nanoforms and, if so, to which. The relevant
safety information must also be assigned to the respective nanoforms. The
amended Annex II has been in force without restriction since 01 January 2023.


LINKS

 * Amended REACH Regulation and Annexes external website
 * Harmonised EU rules for nanomaterials in future press release of 27 April
   2018

The European Chemicals Agency ECHA is continuously adapting the guidance
documents, which provide guidance to registrants, to these innovations.


LINKS

 * Guidance on Information Requirements and Chemical Safety Assessment external
   website

Last updated: 23.01.2023


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