The UK\’s Health and Safety Executive (HSE) has recently published a regulatory management options analysis (RMOA) that examines the risks associated with the use, import, and manufacture of poly- and perfluoroalkyl substances (PFAS) and recommends appropriate management options.

Definition of PFAS Under RMOA

PFAS are a group of man-made chemicals widely used in various industrial and consumer products due to their unique properties, but they are also known to persist in the environment and pose potential risks to human health and the ecosystem.

Under this RMOA, PFAS are defined as fluorinated substances that contain at least one fully fluorinated methyl carbon atom (without any hydrogen, chlorine, bromine, or iodine atom attached to it), or two or more contiguous perfluorinated methylene groups (–CF₂–). This reduces the number of PFAS in scope to hundreds, maintaining focus on substances that are persistent degradation products of PFAS.

Risk Management Measures to Be Considered

The HSE concludes that it would be appropriate, considering the Precautionary Principle, to initiate some or all of the following risk management measures with regard to certain uses of PFAS:

1. Preparation of Annex XV dossiers to potentially support one or more restrictions of PFAS under UK REACH, including:

• the use and disposal of FFF where non-PFAS alternatives are available,
• other wide dispersive uses such as the application of coatings or use of cleaning agents,
• the manufacture and placing on the market of consumer articles from which PFAS are likely to be released into air, water or soil, or directly transferred to humans. This includes textiles, upholstery, leather, apparel, rugs and carpets, paints, varnishes, waxes and polishes, cleaning products. Consideration may be given to other consumer articles if other gaps are identified in consultation with other legislative regimes such as food contact materials.

2. UK REACH authorization of PFAS used in processing aids in the manufacture and processing of fluorinated polymers

There are no PFAS on the UK REACH Authorisation List (Annex 14), but the following are identified as SVHCs on the UK REACH Candidate List:

• Perfluorooctanoic acid (PFOA) and its ammonium salt – persistent, bioaccumulative and toxic (PBT), reprotoxic;
• C₉-C₁₀ PFCAs and their ammonium and sodium salts – PBT, reprotoxic;
• C₁₁-C₁₄ PFCAs – very persistent, very bioaccumulative (vPvB);
• PFHxS and its salts – vPvB;
• 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts, and its acyl halides (HFPO-DA) (the ammonium salt is commonly known as GenX®); and
• perfluorobutane sulfonic acid (PFBS) and its salts.

HFPO-DA and PFBS could be considered for inclusion on the UK Authorisation List, but neither is UK REACH registered and there are no current known uses in GB, but should more information become available on using this could be considered in the future. PFBS may be present in surface coatings on imported articles, but these uses are not within the scope of the authorization regime. In addition, both are listed on the basis of “Equivalent Level of Concern” and it is currently unclear whether an authorization application could be made using the adequate control route for this type of concern.

Furthermore, the RMOA recommends that formal evaluation according to UK REACH should be undertaken for some other PFAS, with the aim of better understanding the risks they may pose.

HSE, acting as the Agency for UK REACH, supported by specialists in the Environment Agency, concluded that the proposed risk management measures would help manage the significant risks associated with PFAS use. The RMOA serves as a technical document that provides preliminary recommendations for additional measures within UK REACH to manage PFAS risks.

This RMOA represents a significant step towards better regulating the use of PFAS in the UK and reducing their potential risks to human health and the environment.

How REACH24H Can Help

As a compliance service provider, REACH24H can help businesses navigate the complex regulatory landscape, including the recent proposal by the UK Health and Safety Executive (HSE) to regulate the use of poly- and perfluoroalkyl substances (PFAS).

Our regulatory expertise and knowledge can help companies understand and comply with these measures, including the preparation of Annex XV dossiers to potentially support one or more restrictions of PFAS under UK REACH.

Reprinted from: HSE

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