On 16 May 2024, the UK Government launched an open consultation seeking stakeholders' views on various government proposals and policy options aimed at facilitating the transition of companies from EU REACH to UK REACH, and improving UK REACH operations. The consultation closes on 11 July 2024.
The consultation provides information which will allow the chemical industry to start planning registrations. This will be welcome. It is also intended that the changes to the registration regime will reduce costs. The main driver of cost reductions is removing the need to purchase access to full EU REACH datasets in respect of hazard information for transitional substances. However, there will be some increased burdens, including a requirement to provide more detailed, Great Britain-specific information on the use and exposure of chemicals.
The consultation will be followed by a second follow-up consultation, based on a Statutory Instrument and a final impact assessment.
The policy proposals can be divided into three main blocks: (i) amendment of transitional provisions under UK REACH; (ii) improvement of the UK REACH restriction and reporting processes; and (iii) further protections against unnecessary animal testing.
AMENDMENT OF TRANSITIONAL PROVISIONS UNDER UK REACH
The UK Government is considering changes to reduce the burden on businesses moving from EU REACH regime to UK REACH.
To facilitate the shift to UK REACH, businesses were afforded a transitional period to submit (register) data concerning substances manufactured in or imported into Great Britain at a level of at least 1 tonne per year to the Health and Safety Executive (HSE).
However, an impact assessment published by the UK Government in 2023 concluded that industry would expend too many resources on buying or accessing EU hazard data to complete the registrations of their transitional substances in the UK (~£2 billion by 2030).
In this context, the UK Government has devised an Alternative Transitional Registration model (“ATRm”) for UK REACH, which intends to make registration of transitional substances in the UK less burdensome.
The proposals in this regard mainly relate to:
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REDUCTION OF HAZARD INFORMATION TO BE PROVIDED IN REGISTRATION FOR TRANSITIONAL SUBSTANCES
For substances that were on the market before the end of the Exit Implementation Period, the UK Government proposes to waive the registrants' duty to supply in their UK REACH registration dossiers the hazard data that was previously submitted to ECHA.
The UK Government considers that the UK does not need to completely replicate ECHA’s database of hazard information. Therefore, registrants will be released from having to submit the more detailed elements of hazard information, which would largely reduce the costs associated with buying or transferring hazard information for UK REACH purposes.
Under the ATRm, registrants of transitional substances will only have to submit information on hazard conclusions and hazard classification and labelling. Industry will continue to be required to update their hazard conclusions and risk assessments where necessary.
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ENHANCED INFORMATION ON USE AND EXPOSURE
The UK Government wants to use the ATRm to gather more targeted and enhanced information on the use of and exposure to chemicals in Great Britain, allowing for a clearer identification of associated risks in a national context and helping the regulator develop the UK REACH risk management further.
Under the ATRm, registrants will be required to provide information on use and exposure related to human health across three different levels. The level of information required will depend on the hazard profile of the substance, with each level adding to the information required by lower levels.
For data relating to exposure of the environment to a substance, level 2 will be the standard information requirement. For instance, for a substance used in manufacture, formulation and industrial uses, the information to be provided would include the maximum daily (and the annual) use amount at site for each use, the release fraction to air/water/soil, the risk management measures used as standard on large sites, etc.
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TRANSITIONAL EVALUATIONS
Alongside the reduced hazard data requirements under the ATRm, the UK Government will provide new powers to the regulator to require the submission of supporting hazard information in certain circumstances for regulatory or risk prioritisation purposes (referred to as “transitional evaluations”).
The introduction of transitional evaluations will enable the regulator to receive more detail if the reasoning behind a submitted hazard conclusion is not clear. The information requirements will encompass those elements which would have applied if the registration had followed the standard approach for new substances rather than the ATRm.
Regulatory decisions on transitional evaluations will be enforceable and appealable in the same way as dossier evaluation and substance evaluation decisions are.
IMPROVEMENT OF THE UK REACH RESTRICTIONS AND REPORTING PROCESSES
- The UK Government identifies changes to the statutory consultation requirements which could streamline the restrictions process and speed up decision-making.
The recommended approach:
- Consolidates the two consultations inherited from EU REACH into a single one, on the restriction dossier. Currently, there is a first 6-month consultation on the restriction dossier, on which basis the HSE finalises the RA opinion and prepares a draft SEA opinion within 3 additional months; and a second 60-day consultation on the draft SEA opinion, on which basis the HSE issues its final SEA opinion within 1 additional month.
- Reduces the period of the single consultation to a 3-month public consultation.
Therefore, if and when these amendments come into effect, the final RA and SEA opinions will be formulated at the same time, 6 months after the end of the single consultation and 9 months after the restriction dossier is adopted.
- The UK Government also proposes amendments to UK REACH to streamline reporting requirements and reduce the administrative burden on the HSE to provide duplicative reports to the UK Government.
FURTHER PROTECTIONS AGAINST UNNECESSARY ANIMAL TESTING
The UK Government proposes potential legislative and non-legislative measures in relation to substances falling under Annexes 7 and 8 of UK REACH. These Annexes set out the requirements in respect of substances manufactured or imported in quantities of 1 tonne or more per year per registrant and 10 tonnes or more per year per registrant, respectively. The intention is to further reinforce the 'last resort' principle regarding animal testing.
Currently, there is no requirement for testing proposals to be made for new tests conducted to meet the requirements set out in Annexes 7 and 8, and registrants may freely resort to animal testing to fulfil some of the information needs at those tonnage levels.
Proposed legislative measures include:
- Extending the testing proposal requirement that currently exists for higher tonnages to Annexes 7 and 8, so that the HSE would have to issue a formal decision to permit (or modify) any proposed tests involving vertebrate animals.
- Requiring registrants to ensure that there is no appropriate alternative approach to vertebrate testing available before submitting a testing proposal, and to accompany any testing proposal with a justification as to why alternative approaches are not suitable and vertebrate testing is proposed.
The UK Government proposes to adopt further guidance on alternative methods/approaches, in order to support registrants towards their responsibilities for minimising vertebrate tests. This would put the onus on registrants themselves, as opposed to the testing proposal requirement where the HSE makes the decision.
Further detailed information about the policy proposals is available at https://consult.defra.gov.uk/reach-policy/atrm-consultation/consultation/subpage.2024-04-05.2944378255/.
The public consultation is available online at https://consult.defra.gov.uk/reach-policy/atrm-consultation/.
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