What’s the UK’s new approach to evaluating chemicals? 

July, 2023 - Shoosmiths LLP

UK REACH (Registration, Authorisation, Evaluation and Restriction of Chemicals) is the UK’s post-Brexit chemicals regulatory framework for the Great Britain (GB) market. It is regulated by the Health and Safety Executive (HSE) and has the overall aim of ensuring the protection of human health and the environment from the use of chemicals.

UK REACH places responsibility for understanding and managing the risks associated with the use of chemicals on those who place them on the market (i.e. importers and manufacturers). It also seeks to promote the use of alternative methods for the assessment of any hazardous properties of substances.

The prioritisation of substances for evaluation is done on a risk-based approach, coupled with the exposure potential of specific hazards. Prioritised hazards include substances that are known or suspected to be Carcinogenic, Mutagenic and Reprotoxic (CMRs). The HSE must consult with the ‘Appropriate Authorities’ – i.e. the Secretary of State for Environment, Food and Rural Affairs, alongside the equivalent Scottish and Welsh Ministers, to develop criteria for evaluation. 

Rolling Action Plans

If a particular substance identified constitutes a risk to human health or the environment, it will be prioritised with a view to further evaluation. The criteria for prioritising it are then used to compile a rolling action plan (RAP). 

The first RAP was published in March 2022. If the HSE is unable to draw conclusions about a particular substance once it has conducted initial evaluations, it will then seek further information from registrants of the identified substance.

The substances to be evaluated are selected through collaboration and stimulus from bodies such as the Environment Agency and the European Chemicals Agency (ECHA). The UK Chemicals Strategy, which forms part of Defra’s 25-year Environment Plan, provides guidance to inform the HSE’s input into substance evaluation. Additionally, the HSE will undertake both domestic and international horizon scanning, including but not limited to the GB Classification, Labelling and Packaging (CLP) Regulation and the EU REACH Regulation. The EU REACH Regulation is likely to play a large part in the HSE’s decision making.

PFAS

The most recent substance the HSE announced (in June 2023) to be included in the RAP are poly- and perfluoroalkyl substances (PFAS), which will be the focus for 2024/25. PFAS are colloquially referred to as ‘forever chemicals’, given their inability to break down naturally, meaning they stay in the environment for many years. The HSE is seeking to analyse these substances (of which there are over 9,000) to ensure better human health and environmental protection, especially given their everyday use in products such as non-stick pans, water-repellent clothing, food packaging, and stain-resistant carpeting. The HSE outlined particular concerns about PFAS in its non-binding Regulatory Management Options Analysis (RMOA), which was published in March 2023. The RMOA offered a clear view of the risks of PFAS, which primarily concern the environment (driven by extreme persistence). Current scientific research also suggests that exposure to high levels of PFAS can lead to adverse health outcomes, such as liver damage and fertility issues.

What happens next?

The HSE is expected to select the next substance of concern (to be examined in 2025/26) and place it in the RAP by 31 May 2025. As the RAP’s name suggests, more substances will continue to be added to it over time. In contrast, the ECHA’s Community Rolling Action Plan (CoRAP) currently has 23 substances, 6 of which have been added in 2023.

Given the economic importance of the chemical industry in the UK (it accounts for 9% of total UK exports), businesses which manufacture or import chemicals included in the RAP into GB in quantities greater than 1 tonne annually should first identify whether they have placed any of those substances on the GB market. If so, then correspondence from the HSE requesting an explanation of what steps the business has taken to ensure the aims of UK REACH are being met can be expected. The HSE will also impose deadlines for the provision of information.

 



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