Cooley's Productwise Bitesize brings you a short introduction to the REACH Regulation.
What is it called?
Regulation (EC) 1907/2006 on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (more commonly known as "REACH").
What is it about?
REACH is the key EU Regulation regulating chemicals in the EU. It applies to the manufacture, placing on the market and use of chemical substances in the EU. REACH applies to chemical substances on their own (for example, lead), in mixtures (for example, paint) and in finished products (for example, a smartphone).
After Brexit, EU REACH is no longer directly applicable in the UK, where the EU regulation has been replaced by UK REACH, which largely follows the same approach embedded in EU REACH. Businesses that manufacture, place on the marker or use chemical substances in the EU and the UK must now comply with both regulatory regimes. In Northern Ireland, however, EU REACH will continue to operate under the Northern Ireland Protocol.
The key requirements of REACH and UK REACH are as follows:
- Registration: the overarching principle of REACH is "no data, no market", meaning that no substance can be manufactured or placed on the market unless it is registered with the European Chemicals Agency ("ECHA") for the EU or the Health and Safety Executive ("HSE") for Great Britain. Registration is based on the principle "one substance, one registration", meaning that manufacturers and importers of the same substance will have to submit their registration dossier jointly and, consequently, share both the data generated for the purposes of registration and the costs associated with the generation of data and the registration of the substance.
- Evaluation: ECHA and HSE evaluate whether registration dossiers are in compliance with the information requirements set out in REACH. If they find that the registration dossiers are not compliant, they can require the manufacturer or the importer to bring the dossier into compliance by generating the required information and update the registration dossier. Risks posed by registered substances are also screened by Member States in the EU and HSE in the UK on the basis of the information included in the registration dossier. If it is concluded that the substance may pose a risk to human health or the environment that needs to be clarified, they can request registrants to generate additional data.
- Authorisation: substances (on their own, in mixtures or in articles) that are identified as "substances of very high concern" ("SVHC") and included in Annex XIV to REACH ("the Authorisation List") cannot be placed on the market for a use or be used (including in finished products manufactured in the EU/UK), unless a specific authorisation is granted. The authorisation requirements do not apply to imported articles, meaning that articles manufactured outside the EU/the UK and incorporating a substance subject to authorisation in the EU/UK can be placed on the EU/UK market.
- Restrictions: When the manufacture, use or placing on the market of a substance, on its own, in a mixture or in an article, poses an unacceptable risk to human health or the environment, it can be restricted by the European Commission. A restriction can be any measure necessary to address the "unacceptable risk". Most REACH restrictions ban the manufacture, placing on the market and use of substances (above specific tolerance levels). However, in some instances restrictions impose training or labelling/information requirements.
Who and what does it apply to?
REACH applies to all chemical substances that are manufactured, placed on the market or used in the EU, whether on their own, in mixtures (e.g. cosmetics) or finished products (e.g. a laptop, a bike or a piece of furniture).
Certain exemptions apply. For example:
- REACH does not apply to radioactive substances, substances under customs supervision, the transport of substances, non-isolated intermediates, waste and some naturally-occurring low hazard substances.
- Substances subject to more specific legislation, such as human and veterinary medicines, food and feed, plant protection products and biocides, have tailored provisions under REACH.
Why does it matter?
REACH is largely seen as one of the most comprehensive and protective chemicals legislation worldwide. It is taken as a model by many other countries and has been retained by the UK post-Brexit.
However, 2023 will be a year of major changes in how chemicals are regulated on both sides of the Channel.
In the EU, the European Commission is currently drafting a proposal for the "targeted" revision of EU REACH and is expected to adopt the proposal at the end of 2023 (see Commission's 2023 Work Programme). The proposal was originally scheduled for the end of 2022 and has been pushed back. It is one of the fundamental pillars of the Chemicals Strategy for Sustainability ("CSS"), whose objective is to achieve a toxic-free environment, and its delay is attracting criticism from Member States, the European Parliament and certain voices in civil society.
In the UK, the Government has recently introduced to Parliament the so-called Freedom Bill. If adopted, all retained direct EU legislation will be revoked by the end of 2023. Retained direct EU legislation also includes UK REACH. So far, EU REACH has guided the UK's post-Brexit approach to the regulation of chemicals. It is too early to anticipate whether UK REACH will be revoked, but it is possible that, in the near future, the UK and EU chemicals regulatory framework will grow further apart, with the consequence that companies wishing to do business both in the EU and the UK might be confronted with different regimes to comply with and, consequently, bear increased regulatory costs.
Where can I find it?
The EU REACH regulation can be found here.
The REACH etc. (Amendment) Regulations 2021 can be found here. The consolidated version of REACH incorporating the amendments made by the UK can be found here.
Is there any guidance?
Yes, guidance on different aspects of EU REACH can be found here, here and here.
Guidance on UK REACH can be found here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.