Navigation path
Page navigation
Additional tools
REACH is the over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. Nanomaterials are covered by the definition of a "substance" in REACH, even though there is no explicit reference to nanomaterials. The general obligations in REACH, such as registration of substances manufactured at 1 tonne or more and providing information in the supply chain apply as for any other substance.
Information on the implementation of REACH for nanomaterials, including identification of registered substances in nanoform, applicable guidance and the application of the REACH evaluation processes, can be found on the ECHA website.
On 3 December 2018 the Commission adopted Commission Regulation (EU) 2018/1881 to modify REACH Annexes I, III and VI-XII, introducing nano-specific clarifications and new provisions in the chemical safety assessment (Annex I), registration information requirements (Annex III and VI-XI) and downstream user obligations (Annex XII).
The proposed amendments that entered into mandatory application on 1/1/2020 for the new as well as the existing registrations. Provisions include:
Qualification of existing adaptation possibilities to ensure their responsible application to nanoforms and modification of information requirement where the test method is not applicable/informative for nanoforms (e.g. KoW partition coefficient, genotoxicity AMES test).
In a separate process, the Commission has also updated Annex II of REACH with Commission Regulation (EU) 2020/878. New provisions on Safety Data Sheets are complementing the new registration requirements for nanomaterials (see above) and ensuring that this same information is reflected also in the Safety Data Sheets.
Provisions came into force on 1 January 2021, with a transition period for the update of existing Safety Data Sheets extended to 31 December 2022.
There are no nanomaterial-specific provisions in CLP. Nanomaterials that fulfil the criteria for classification as hazardous under Regulation 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures must be classified and labelled. This applies to nanomaterials as substances in their own right, or nanomaterials as special forms of the substance. Many of the related provisions, including safety data sheets and classification and labelling apply already today, independently of the tonnage in which the substances are manufactured or imported. Substances, including nanomaterials, meeting the classification criteria as hazardous should have been notified to ECHA by 3 January 2011. Any further update to the classification must also be notified without undue delay. It is perfectly possible that the classification is applied only to specific form(s) including nanoforms of the substance.