REACH etc (Amendment) Regulations 2021 – Draft


Who does this apply to?

These Regulations will apply to companies that are manufacturing, importing, selling, distributing or using chemical substances or mixtures.


When did it change?

The Regulations will come into force on 30 September 2021.


What does it mean?

The EU REACH Regulation forms part of retained EU law by virtue of the European Union (Withdrawal) Act 2018. The retained version of the EU REACH Regulation is referred to as the UK REACH Regulation.


This Statutory Instrument amends the UK REACH Regulation and related legislation that also forms part of retained EU law. It:

  • Corrects deficiencies to ensure that the legislation operates effectively in the domestic context.

  • Makes some related minor amendments to ensure consistency in respect of references to medical devices, to ensure that medical devices are referred to consistently throughout the UK REACH Regulation, and with the Medicines and Medical Devices Act 2021.

The changes made by this Statutory Instrument are needed in order to address deficiencies in retained EU law, to ensure that it operates effectively in the domestic context. Those deficiencies relate to EU legislation that came into effect shortly before, or during, the transition period.


This Instrument amends several Commission Implementing Decisions which authorise the use of a number of substances in Great Britain as retained EU law. It will also amend two Commission Implementation Regulations made under the EU REACH Regulation relating to data sharing and registrants’ duties to keep their registrations up to date.


The EU REACH Regulation places an authorisation requirement on the use of certain substances of very high concern. This means that the substance cannot generally be used unless the Commission has authorised its use. The Commission grants authorisations through making Implementing Decisions. Any such Implementing Decisions made before the end of the transition period form part of retained EU law to the extent that they grant authorisations to anyone established in GB.


What’s changed?

REACH legislation adopted in the EU before the end of the transition period became part of the UK’s domestic legal framework, as retained EU law. Where those measures operate by reference to EU concepts, they need to be amended so that they operate effectively in the domestic context. The legislation also needs to be internally consistent in the terminology it uses, and to use terminology consistently with other relevant domestic legislation.

The draft Statutory Instrument is available here. An explanatory memorandum can be found here. Parliament June 2021



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