Elaine Campling, Chair of ESMA’s Health, Safety and Environment Protection Committee, reports on an expected UK REACH Public Consultation. The anticipated discussion follows a statement issued towards the end of 2023 by the Department for Environment, Food and Rural Affairs (DEFRA)
UK REACH was brought into UK law on 1 January, 2021. Under the European Union (EU) Withdrawal Act, it encompasses Regulation (EC) 1907/2006 on the registration, evaluation, authorisation and restriction of chemicals. However, as Northern Ireland continues to be governed by EU REACH – under the terms of the Northern Ireland Protocol – UK REACH only applies in Great Britain, despite the title.
“As Northern Ireland continues to be governed by EU REACH, UK REACH only applies in Great Britain”
The chemical industry and trade bodies have put pressure on the UK Government to re-think registration under UK REACH. The Policy Statement from DEFRA, outlines the direction in which the UK Government is moving on the proposals for an Alternative Transitional Registration model (ATRm).
Companies were particularly concerned with the costs associated with accessing EU REACH data packages to support GB REACH registration. This is also considered to be resource intensive and involve unnecessary duplication.
TRANSITIONAL ARRANGEMENTS
Qualifying substances, manufactured or imported into Great Britain in quantities of one tonne or more per year, are subject to immediate registration under UK REACH.
However, existing EU REACH registrations, held by UK-based entities at the time of BREXIT, could be grandfathered into UK REACH. Initially, information on the registration(s) needed to be submitted to the regulator within defined timescales. Once this was completed, registrants could benefit from transitional arrangements and defer full registration.
Transitional arrangements were also put in place to defer registration of imported substances by entities previously considered downstream users and distributors under EU REACH. To qualify, a notification termed a Downstream User Import Notification (DUIN) was required for submission to the regulator by 27 October, 2021.1
Full registration was originally expected to be submitted for both groups of substances within phased time periods – two, four or six years – from 28 October, 2021, depending on the tonnage band/hazard profile of the substance.
However, following agreement that an ATRm would be progressed, it was realised that regulators needed time to comply with obligations imposed by GB REACH and develop the new model.
DEADLINES FOR REGISTRATION
A public consultation was issued with three options including proposals to extend the UK REACH submission deadlines by up to three years and a do-nothing option. Following the outcome of the consultation, the deadlines were all extended by three years. Deadlines now apply to registration of substances subject to transitional registration arrangements:
Firstly, October, 2026 – Candidate List substances of very high concern (as at 31 December, 2023), classified as carcinogenic, mutagenic or toxic to reproduction (one tonne or more per year), classified as very toxic to aquatic organisms (100 tonnes or more per year) and in the 1,000 tonnes or more per year tonnage category.
Secondly, October, 2028 – Candidate List substances of very high concern (as at 27 October, 2026) and in the 100 tonnes or more per year tonnage category.
Thirdly, October, 2030 – all other substances in the one tonne or more per year tonnage category.2
It is important to note that the 2021 deadlines to submit a DUIN – and notifications for substances permitted to be ‘grandfathered’ into UK REACH – have not been enforced by the regulator and currently remain open.
POLICY OBJECTIVES
DEFRA, alongside the Health and Safety Executive (as the Agency for REACH) and the Environment Agency associated with UK REACH, have been exploring options for the ATRm.
These regulators acknowledge that a lot more information is now available on thousands of chemicals and associated hazards. However, detailed knowledge on the uses and exposures of chemicals, within the domestic market, is considered critical to managing risks within Great Britain.
DEFRA has therefore set out the policy objectives in preparation for a consultation on the new model that is expected in 2024. The following measures are expected to reduce the estimated £2 billion costs to industry associated with buying or accessing EU data under the previous arrangements3:
Firstly, encompassing provision for refining information on uses and exposures within Great Britain – expected to be provided by registrants.
Secondly, reduction of hazard information to ‘essential minimum’ required for transitional registrations and intermediates. This will mean that UK REACH registrants will not generally need to access and pay for data packages held by EU industry consortia.
Thirdly, empowerment of regulators to request and receive data quickly from registrants for regulatory or risk prioritisation purposes.
Lastly, reviewing the existing fee structure, to ensure a more sustainable funding model, including the possible reduction of the current fee levels for UK REACH registrations.
DIVERGENCE FROM EU POLICY
A new approach to REACH registration for application within Great Britain, will result in further divergence from the EU on regulatory governance.
The UK regulator has already stated that there are no plans to implement the new hazard classes introduced to the EU Classification, Label and Packaging (CLP) Regulation (EC) No.1272/2008 on the CLP of substances and mixtures, unless established at United Nations (UN) level.
These new hazard classes were implemented into the EU CLP Regulation under Delegated Regulation (EU) 2023/707, outside the UN’s Globally Harmonised System, upon which CLP and other worldwide systems are based.
“Following the outcome of the consultation, the deadlines were all extended by three years”
Furthermore, the UK government does not have any immediate plans to revise the GB CLP Regulation to include other changes being made to the EU CLP Regulation. These changes are in motion and have been provisionally agreed by the European Parliament and Council.
These alterations include measures to regulate online sales and trade in refill products, introduce changes in hazard communication and include provisions on digital labelling.4
The agreement is now subject to endorsement and formal adoption by both institutions, which will further divide the regulatory landscapes of the EU and Great Britain.
- UK REACH: Notification of status as a GB-based downstream user or distributor under EU REACH (hse.gov.uk)
- www.legislation.gov.uk/uksi/2023/722/contents/made
- www.gov.uk/government/publications/uk-reach-alternative-transitional-registration-model-atrm/uk-reach-alternative-transitional-registration-model-atrm
- Safer chemicals: Council and Parliament strike deal on the regulation for classification, labelling and packaging of chemical substances – Consilium (europa.eu)
