On May 16, the Department for Environment, Food and Rural Affairs (Defra) launched a public consultation on UK REACH, which remained open until July 25.
The Alternative Transitional Registration model (ATRm) for UK REACH has been devised in response to the UK government’s impact assessment, which was published in 2023 and estimated that registering substances under UK REACH would cost industry £2 billion by 2030.
The consultation sets out proposals to reduce costs for businesses moving from EU to UK REACH with reductions to duplication of data. It also contains proposals to introduce further protections against unnecessary animal testing.
The ATRm specifically focuses on the submission of data for transitional substances – this covers substances that were “grandfathered”, New Registration for Existing Substances (NRES), or included in a downstream user import notification (DUIN).
Hazard data
The proposal sets out to “significantly reduce hazard information provided in registrations for transitional substances” with a greater focus on use and exposure information. This applies to all substances registered and on the market before the end of the exit implementation period (December 31, 2020).
Full hazard information will still be required for substances entering the market after that date.
The consultation notes that in general the hazard information would lead to the same hazard conclusions for EU REACH as for UK REACH, and so this aspect of the risk assessment would remain the same. Therefore, it is proposed because there is no need to fully replicate ECHA’S database of hazard information, the required hazard data can be reduced.
This would possibly result in a 70% reduction in costs associated with submitting a registration dossier under UK REACH, against current UK REACH baselines [includes buying and accessing data].
However, this does not remove the requirement for industry to update hazard conclusions and risk assessments, where necessary.
Chemical safety reports
Under UK REACH all registrants of a substance over 10 tons must undertake a Chemical Safety Assessment (CSA) and produce a Chemical Safety Report (CSR). This has not changed, however, under the ATRm, it is proposed that registrants who submit a CSR for a transitional substance are not required to include full details of the hazard assessment under UK REACH (unless the details differ from that provided under EU REACH).
The CSR must contain the key hazard data such as classification under classification, labelling and packaging (CLP). Persistent, bioaccumulative, and toxic (PBT) assessment conclusions and Derived No Effect Level (DNEL) and Predicted No Effect Concentration (PNEC) will still be required and some other data may be needed if an exposure and risk assessment is triggered.
Use and exposure in GB
The UK government would like to use the ATRm to understand use and exposure of substances in Great Britain (GB).
The consultation notes that the UK government would like to learn and develop from EU REACH, by placing a greater focus on the clarity of the information available about how the substance is used and how humans and the environment may be exposed in Great Britain.
The goal of incorporating enhanced information on use and exposure into the existing hazard conclusion is to improve the quality of risk assessment, management, and control. This helps industry meet its responsibility to ensure the safe use of chemicals throughout the supply chain.
It notes that the clarity of information is often hidden within EU REACH dossiers.
Regulatory powers
The proposal aims to support regulatory needs by giving the Health and Safety Executive (HSE) – the Agency for UK REACH – the authority to request and obtain data from registrants. This will allow the HSE to assess risks more effectively and respond promptly to new or emerging hazards, ensuring better prioritization of regulatory and safety measures.
Due to the proposed changes to hazard data requirements for transitional substances, Defra will review what data will be included in the Public Register.
Animal testing
The consultation stresses that in accordance with UK REACH testing on vertebrate animals shall be undertaken only as a last resort. The approach set out by the ATRm reduces the need to repeat animal tests that were conducted to meet the information requirements of EU REACH.
Next step
A summary of the responses to the consultation and the Government response will be published on Defra’s website.
Source from CIRS
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