The first details of the Alternative Transitional Registration model (ATRm) for UK REACH recently released by the Department for Environment, Food and Rural Affairs (Defra) suggest a shift in the regulatory approach in Great Britain (GB) and further divergence from the EU. Notably the proposals, which remain under development, include reducing the essential minimum ‘hazard’ information required for transitional registrations which is expected to significantly reduce the financial burden on the chemical industry. One of the most significant take-home messages has been Defra’s view that replicas of EU datasets for substances are generally not required to be held for the purpose of UK REACH registrations. Instead, an increased focus will be placed on ensuring ‘use and exposure’ information for chemicals in GB is available to support effective risk management. The proposals also indicate regulators will be equipped with the powers and flexibility needed to enable a more targeted regulatory approach that allows for prioritisation of regulatory actions and responsiveness to new and emerging risks. The proposals to aim to help reduce the costs to industry in making the transition to UK REACH whilst ensuring high levels of protection to health and the environment are maintained under the domestic regime.
The establishment of an independent ‘UK REACH’ regulatory framework in January 2021 prompted the need for registrants to transfer EU REACH registrations to UK REACH for continued access to market in GB. This ‘grandfathering’ process for registrations initially required only basic information about the substances to be notified to the Health and Safety Executive (HSE) by registrants.* However, to complete transitional registrations into UK REACH, data packages meeting UK REACH requirements would need to be submitted before a subsequent statutory deadline. The deadlines were originally staggered from 27th October 2023 to 27th October 2027 depending upon the associated tonnage band and hazards of the substance.
Given UK REACH data requirements largely mirrored those of EU REACH, the chemical industry faced the prospect of needing to replicate or purchase access to data packages held by EU industry consortia to complete transitional registrations. The industry has expressed significant concerns over the financial burden of acquiring access to EU data packages, with a 2022 impact assessment by Defra estimating the potential costs to the industry to be in the region of £2 billion and potentially even larger.
In response to industry feedback, Defra, in December 2021, committed to exploring an alternative transitional registration model for UK REACH, which would aim to reduce the financial costs for businesses transitioning to the domestic regime whilst also ensuring high standards of protection for health and the environment are maintained. Recognizing the time needed to develop and implement an alternative model, Defra, following consultation on various options, agreed to extend the statutory deadlines for completing transitional registrations by a further three years. These deadlines are now staggered from 27th October 2026 through to 27th October 2030.
The policy paper released by Defra in November 2023 marks the first information released on proposals for the ATRm.
What has Defra said about the ATRm?
Significantly, Defra’s proposal for the ATRm outline that UK REACH registrants will generally not be required to hold replicas of EU datasets for substances for the purpose of transitional registrations under UK REACH. Early indications suggest the ATRm will adopt a more targeted regulatory strategy, focussed on the availability of information about the uses and exposure of chemicals within GB to enhance understanding and management of risks posed. By maintaining use and exposure information specific to GB, the ATRm aims to enable regulators to prioritise regulatory actions more effectively. Defra cite the Risk Management Option Analysis (RMOA) published in April 2023 for the so-called “forever chemicals”, poly- and perfluoroalkyl substances (PFAS) as an example of how this proposed approach can be implemented in practice.
The full list of proposals outlined as under development in the Defra policy paper on the ATRm cover:
- Refining the ‘use and exposure’ information registrants need to provide for GB, covering essential information necessary for industry to understand and manage risks, and enabling regulators to prioritise regulatory actions.
- Reducing the ‘hazard’ information needed for transitional registrations and intermediates to the essential minimum, removing the general need for UK REACH registrants to access and pay for EU industry consortia data packages.
- Significantly reducing the estimated £2 billion industry cost of purchasing access to EU hazard information.
- Enhancing regulatory powers to require and receive data quickly from registrants for regulatory or risk prioritisation purposes and for prompt response to new or emerging risks.
- Reviewing UK REACH fees structures to establish a more sustainable funding model, including exploring reducing current registration fees.
- Revising the UK REACH restriction procedures to ensure regulators have flexibility to act quickly where risks are identified, building on work by UK regulators and other sources.
Potential implications of the ATRm proposals
While more information on the proposal is still needed for industry to fully assess and understand the implications of the ATRm, based upon the information released by Defra so far suggest potential implications for the chemicals industry include:
- REDUCTION OF COSTS FOR INDUSTRY: The ATRm aims to significantly cut the costs associated with transitioning from EU REACH to UK REACH, primarily by removing the need for registrants to purchase access to EU datasets. In addition, a review of fee structures could also lead to a reduction of registration fees for UK REACH.
- FOCUS ON ESTABLISHING A COMPREHENSIVE PICTURE OF USE AND EXPOSURE IN GREAT BRITAIN: Defra aims to establish a detailed understanding of how and where chemicals are used in GB. This approach aligns with indications of a more targeted and pragmatic regulatory approach that will increase focus on understanding exposure and risk, underpinned by a detailed understanding of how chemicals are being used in GB.
- LEVERAGING GLOBAL CHEMICAL KNOWLEDGE: Defra’s policy paper indicates regulators will consider global information on emerging chemical risks to help identify priority areas of focus for regulatory action in GB.
- FLEXIBLE AND RESPONSIVE REGULATION: Defra’s policy paper also suggests an adaptable approach to chemical regulation will be adopted, with regulators having powers to request additional information from registrants when necessary for regulatory and risk prioritization. Could such a flexible approach also support more effective regulatory response to new and emerging risks as the landscape for the chemical industry and chemical safety evolves?
While the information released by Defra gives an indication of the future direction for UK REACH, information on how the new policy direction will be implemented remain limited. A more comprehensive understanding of the how the ATRm will function in practice, and its implications for industry, is still required. The next steps are expected to include the release of further details of the plans along with a public consultation on the proposals which Defra has outlined will be launched in 2024. At the time of release of the Defra policy document (9th November 2023), no further updates on the current state-of-play regarding on the overall timelines for legislating and implementing the plans – which the government have previously stated would take until late 2024 to complete – were made, nor on any potential further extensions to the transitional registrations deadlines, the first of which is currently set for 27thOctober 2026.
* According to information published by Defra, approximately 4000 substances were notified to HSE as of 1st July 2021in line with the process for grandfathering EU registrations into UK REACH. In comparison over 22500 substances are registered under EU REACH.