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Freshfields Risk & Compliance

| 3 minutes read

Long-awaited announcement on reforms to the UK chemical regulations landscape

The Government has recently published a long-awaited consultation on reforms to several aspects of the UK Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (“UK REACH”). The consultation covers proposals on the Alternative Transitional Registration model for transitional substances (“ATRm”), the required information on use and exposure of chemicals, the regulatory powers of the Health and Safety Executive (“HSE”), the restriction consultation process and further protections against unnecessary animal testing. The consultation will be followed by a second consultation featuring a draft statutory instrument and a final impact assessment. Stakeholders can respond to the consultation here by 11.45pm on 11 July 2024, or alternatively by email to ATRmConsultation@defra.gov.uk or post to the Department for Environment, Food and Rural Affairs (“Defra”). 

The Proposals 

Registration 

The Government is proposing to reduce the hazard information provided in registrations for transitional substances previously covered by EU REACH. The aim is to avoid duplication given that this information has previously been submitted to the European Chemicals Agency. This will be achieved by removing the requirements to provide certain information at the second stage of the data-registration process, including study summaries and testing proposals.  Instead, businesses will now only need to provide the hazard classifications of the substance in question to fulfil the hazard information requirements. This will apply to all registrations of substances that were on the market before the end of the exit implementation period. However, the full hazard information requirements will continue to apply to registrations of new substances that enter the market after that date. In light of the reduced registration requirements for transitional substances, the consultation confirms that the Chemicals Safety Report submitted with a ATRm registration will not need to provide detailed hazard information (unless the details differ from that provided under EU REACH). 

Whilst reducing the registration information for transitional substances, the consultation also looks to enhance the information on ‘use and exposure’ that will need to be submitted. The consultation states that official analyses shows that existing EU REACH registrations frequently have incomplete sections or contain insufficient detail. To address these gaps, registrants would be expected to provide enhanced information (at three different levels determined by the hazard profile of the substance) relating specifically to the use and exposure of chemicals. The aim is to improve the sector’s understanding of risks and the HSE’s ability to prioritise regulatory actions. These additional requirements will also apply to new substances, and it is suggested that this will help ensure a consistent approach to risk management for all substances in the future.

Regulatory powers

The HSE is set to receive additional powers to request data from registrants in response to new or emerging risks as part of transitional evaluations. The HSE will also be required to complete compliance checks on no less than 20% of registrations and to publish revised hazard data in the Public Register for substances.

Enhanced information sharing 

To facilitate information-sharing across the chemicals sector, the consultation proposes to organise UK REACH registrants of the same substance into Substance Groups to enable data sharing and joint submission of data on the intrinsic properties of substances. 

Reforms to the restriction process 

The UK REACH restrictions process allows the HSE to introduce legislation proposing a restriction on the supply or use of a chemical following a risk assessment, independent scientific advice, and stakeholder consultation. The HSE is proposing to truncate the process by (amongst other steps) reducing the period for consultation, consolidating the publication of the HSE’s final risk assessment and socioeconomic analysis, and removing the requirement for a second consultation as part of the stakeholder engagement exercise. The revised process would be 24 months compared to the current 27 months. 

Animal testing

The consultation also proposes that testing on vertebrate animals is to be minimised. This will be achieved via reinforcing the last resort principle on animal testing by either a legislative (extending the testing proposal requirements in UK REACH) or non-legislative (support through guidance) approach.

Trade impact

The consultation also seeks views on how the proposals may impact international trade.

Devil in the detail

Businesses which manufacture or import chemicals will likely welcome the streamlining of information for transitional substances as a sensible way forward to avoid unnecessary duplication. Nonetheless, the proposals may not have reduced the extent of information that needs to be provided as far as the industry had hoped. In addition, the enhanced use and exposure information requirements could impose additional burdens on the sector. 

The Government’s Impact Assessment claims that the enhanced requirements will help improve the industry’s understanding of risks. However, it is unclear how this will be achieved in practice, particularly when the mechanisms for sharing of information also proposed have not been fully articulated in the consultation. 

Ultimately, how these changes will affect industry will become clearer only when we see the final proposals, expected later this year. In the meantime, stakeholders should share their views by submitting a consultation response and working collectively with relevant trade associations to ensure their voice is heard. 

 

Tags

chemicals, regulatory, product liability