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Chemical consultation: proposed changes to UK REACH

20 May 2024

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Last week, the UK Government’s Department for Environment, Food and & Rural Affairs (Defra) launched its consultation period on An alternative transitional registration model (ATRm) for UK REACH. The opportunity presented by the consultation provides stakeholders opinions to be fully considered through the policy development phase before legislative changes are introduced. 

As one of the main pieces of legislation overseeing chemical manufacture, supply and use in Great Britain, the implications of any changes made are far reaching, with the effects felt throughout the chemical sector and its supply chain. The consultation period enables invested parties to provide feedback on the proposed changes aiming to reduce costs to businesses moving from the EU REACH regime to UK REACH, whilst maintaining existing human health and environmental protections. The potential changes following the consultation period would look to reduce duplication and speed up decision-making, with additional proposals to introduce further protections against unnecessary animal testing.

This long-awaited consultation also includes the detail that the chemical industry has been waiting for, allowing them to start planning their registrations for the 2026, 2028 and 2030 UK REACH deadlines. 


Key points from the proposals

The ATRm has previously been framed as applying only to those UK based registrants who held EU REACH registrations prior to the end of the Exit Implementation Period and claimed free ‘Grandfathered’ registrations under UK REACH. This was to avoid UK REACH registrants having to pay again for hazard data they had already bought access to under EU REACH. The new proposals expand on this scope and, rather than giving reduced requirements only to Grandfathered UK REACH registrants, seem to roll out the reduced data requirements to all registrants of ‘transitional substances’, which are substances capable of being subject to a grandfathered or NRES registration or included in a DUIN, i.e., those registered under EU REACH before the end of the Exit Implementation Period.

“This reduction in hazard data has been proposed in light of a greater focus on use and exposure information. These revised hazard requirements will apply to all registrations of substances that were on the market before the end of the Exit Implementation Period. The full hazard information requirements will continue to apply to registrations of new substances that enter the market after that date.” The proposals describe the reduced data requirements as consisting of “the hazard classifications of the substance in question to fulfil the hazard information requirements when submitting their chemical dossiers to register their substances under UK REACH. PBT assessment conclusions, DNEL (Derived No Effect Level) and PNEC (Predicted No Effect Concentration) will continue to be required at >10tpa and some physicochemical and fate hazard data will be needed if an exposure and risk assessment is triggered.” The HSE could, under these proposals, still request that data be supplied to them if they require it for ‘transitional evaluation’ purposes. These ‘transitional evaluations’ reflect the intent behind ATRm and other changes envisioned to UK REACH to more away from a hazard based system to a risk based system.

The other key part of the changes proposed under the ATRm centres around the provision of information on uses and exposure. The HSE and EA have previously identified a need for improved information in this area to fill what they see as data gaps that prevent registrants and regulators from adequately addressing risk assessments and prioritising regulatory action. Under the proposed changes registrants will be required to improve compliance with existing use and exposure requirements, and build on this to provide additional information on uses and exposure related to environmental hazards. 

A new 3 level scheme is proposed that would see these additional requirements for environmental use and exposure data imposed on registrants of substances > 10 tons per year and classified as hazardous to health. Registrants in the 1-10 tons per year band for substances that meet the “T” criteria under Annex  XIII (i,e. those classified as Muta. Cat. 1A or 1B, Carc. Cat. 1A or 1B, Repr. Cat. 1A, 1B or 2, or STOT RE Cat. 1 or 2, and additionally, those classified as skin or respiratory sensitisers), would also find themselves subject to new requirements to generate exposure scenarios and communicate risk management measures to customers. 

This news will likely be received well by industry as the uncertainty around costs and the number of other registrants has been delaying companies making decisions on whether to continue supplying the UK market past the applicable UK REACH deadline. The proposals echo questions being asked in the EU regarding global competition and the weight of regulation on EU companies to produce the same goods as other countries. A barrier to supplying both the EU and UK markets for many international companies is the high initial outlay to obtain a REACH registration number.  While this cost can be justified when supplying to twenty-seven EU countries (plus Norway, Iceland and Lichtenstein) it is much harder to justify for the UK market alone.


Sector wide impact

The consultation closes 11 July 2024 and will attract a large number of responses.  The first UK REACH transitional deadline is 27 October 2026 and it is expected that these proposals will be put into law before this deadline. The forthcoming general election in the UK is not expected to have a major impact on the timetable at this stage. 
While the removal of study costs will be welcomed by industry, the lower cost of UK REACH registration for these ‘transitional substances’ will remove the barrier to market for many international sellers who have not previously supplied the UK market due to the initial cost outlay to obtain a registration.  What effect this will have on competition and the UK chemicals industry remains to be seen.

It is imperative that organisations in the chemical sector respond to the consultation prior to the deadline of 11 July 2024, to enable all viewpoints to be considered and the outcome to be one that supports the continued growth of the chemicals sector within the UK – a necessity for the global response to the climate crisis.
Ricardo’s team of chemical regulatory experts can support your organisation in understanding the implications of the proposed changes to UK REACH and how these may affect your organisation, its products and what steps you can take to prepare for the outcomes of the consultation. 


Contact us today to discuss the implications for your business.

 

 

Learn more about maintaining chemical regulatory compliance in the EU.

 

Contact our chemical regulatory team to understand how the proposed changes may impact your organisation.