HSE elicits input to support restriction proposal on PFAS in firefighting foams


Apr. 15, 2024

The Health and Safety Executive (HSE) has launched a call for evidence to invite stakeholders to provide information on the UK REACH Annex XV dossier. The British regulator is currently working on a proposal to restrict per- and polyfluoroalkyl substances in firefighting foams.

  • Background: U.K. chemicals regulatory framework after Brexit

    • The U.K.’s official withdrawal from the European Union on February 1, 2020, started a year-long transition period. E.U. laws on chemicals officially ceased to apply to the U.K. as of January 1, 2021. The U.K.’s Health and Safety Executive (HSE), the Environment Agency (EA), and the Department for the Environment, Food and Rural Affairs (Defra) – along with the Welsh, Scottish, and Northern Irish governments’ devolved agencies – have now replaced the EU’s chemical regulators (i.e., ECHA, EFSA, Member State competent authorities, and the Commission).
    • The U.K. encompasses England, Scotland, Wales and Northern Ireland, but not the Republic of Ireland. Great Britain includes England, Scotland and Wales, but not Northern Ireland. The Protocol on Ireland and Northern Ireland preserves the integrity of the E.U.’s single market. This agreement also aims to prevent the establishment of a “hard border” between the Republic and Northern Ireland, while ensuring the integrity of the single market, including protection of public health and consumers.
    • In short, the arrangement has meant that Northern Ireland, effectively, follows E.U. chemical rules, while Great Britain – England, Scotland and Wales – is subject to what the U.K. regulators have begun to characterize as “GB regulations.”
    • The U.K. has incorporated much of the chemicals legislation that existed in the E.U. at the time of Brexit into its own framework, as so-called “retained legislation.” This includes EU REACH (now referred to as UK REACH) and the E.U.’s CLP (now referred to as89 GB CLP), as well as the regulations on prior informed consent (now GB PIC), persistent organic pollutants (now GB POPs) and biocidal products (now GB BPR).
    • The post-Brexit approach to chemicals management is broadly based on England’s Environmental Improvement Plan and the U.K.’s 25 Year Environment Plan. It aims to ensure the safe use of chemicals and to advance efforts to replace the most harmful and persistent pollutants with safer and more sustainable alternatives.

    Restrictions under U.K. REACH

    • The provisions for restricting chemicals in Great Britain are laid out in UK REACH under Title 8, which addresses restrictions on the manufacture, placement on the market and use of certain dangerous substances, mixtures and articles. These rules are based on EU REACH’s restriction procedure, including the process by which chemicals are singled out, assessed, and added to the list of restricted substances, Annex 17.
    • As of today, the biggest differences between the U.K. and EU frameworks for restricting substances are the authorities carrying out the different elements of the process. The HSE has been assigned the main tasks to administer UK REACH-related regulatory risk management procedures, including restriction. The EA may also support HSE with input for certain processes.
    • The restriction procedure can be initiated by request from the so-called Appropriate Authorities, that is, Defra or the equivalent competent authorities from Scotland or Wales. The Defra secretary of state has taken on the functions carried out by the European Commission under EU REACH, including the decision-making role on restrictions.
    • The UK’s opinion-making phase of the restriction procedure differs from that of the EU in that HSE engages with experts on the so-called REACH Independent Scientific Expert Pool (RISEP). Following the six-month consultation after a restriction proposal has been published, RISEP’s input in the form of “Challenge Panel” meetings informs HSE’s opinion. This differs from the EU’s procedure, which uses ECHA’s committees on risk assessment and socio-economic analysis (RAC and SEAC) for opinion development stage.

    Now, HSE is calling on stakeholders as it prepares to draft the restriction dossier proposal addressing PFAS-containing firefighting foams (FFFs)

    • The HSE kicked off a call for evidence on April 4, targeting stakeholders to submit relevant information in support of the agency’s data gathering task to prepare an Annex XV dossier restriction report to address per- and polyfluoroalkyl substances (PFAS) – forever chemicals – used in firefighting foams (FFFs) in Great Britain. The HSE’s proposal, like those ECHA and EU member-state authorities produce in the EU, is expected to contain hazard and risk information related to PFAS in FFFs, as well as an assessment of available information on potential alternatives and measures to be taken to manage risks from PFAS-containing FFFs. Like calls for evidence under EU REACH, this consultation early in the restriction process serves to provide more information and context concerning a potential restriction of PFAS-containing FFFs, including assessment of suitable alternatives, possible unintended consequences of restriction, consideration of exemptions, and further prioritization of areas of concern and exposure. The HSE also pointed out that this exercise is aimed at building a network of stakeholders that the agency can engage with as it develops the restriction.
    • On March 5, the Defra secretary of state, with consent from Scottish and Welsh governments, requested that HSE initiate the restriction process by producing this Annex XV dossier proposal. The request was based on the findings of HSE’s regulatory management options analysis (RMOA) on PFAS published in April 2023. That report concluded that the consideration of a restriction was warranted for PFAS, specifically prioritizing a restriction for firefighting foams, given the evidence and significant amount of information available, as well as the “likely direct emissions to the environment.” Specifically, the RMOA found that PFAS’ properties pose a concern to the environment and human health due to their persistence and degradation products in the environment, their capacity to travel over long distances resulting in widespread dispersal and risk of contamination (e.g., through water), and uncertainties concerning forever chemicals’ long-term adverse effects on the environment and people. The secretary of state concluded that these substances in FFFs represent a “reasonably foreseeable risk to the environment which is not adequately controlled” and thus require commensurate regulatory risk management action.
    • The HSE defines PFAS for the purposes of the RMOA 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–).” The agency notes that this delineation limits the number of in-scope substances to “hundreds, maintaining focus on substances that are persistent degradation products of PFAS.” Notably, it differs from that of the EU, which piggybacks off the OECD’s definition. According to the latter definition, the EU’s PFAS restrictions could affect roughly 10,000 substances.
    • The HSE has launched this call for evidence with the objective of targeting stakeholders possessing information on PFAS-containing FFFs in Great Britain. The agency says it would like to hear from relevant manufacturers, importers, distributors, formulators, retailers, and professional users of firefighting foams, among others. HSE is specifically seeking information related to the manufacture of firefighting foams, including substances used, processes, and quantities; import of firefighting foam products; their uses including quantities, sectors of use, frequency, storage on site, products used; alternatives to PFAS-containing FFFs; hazardous properties of PFAS-containing FFFs as documented in SDSs, new studies on intrinsic properties and exposure, and recommended risk management measures; insights into environmental fate; information on waste disposal requirements, recycling, and other remediation opportunities; and any standards available, including product specific legislation, performance, certification.

    Analysis and next steps

    • This call for evidence represents the first restriction undertaken under UK REACH since 2021 when two restrictions were initiated on lead ammunition and harmful substances in tattoo ink. By contrast, by the end of January 2024, the EU had already restricted eight substances. POLITICO Pro EU reported earlier this year that although the EU had added 31 chemicals to its list of substances of very high concern (SVHC), the U.K. added none. [See AgencyIQ’s February 21 article for more on the UK’s chemicals framework, including the apparent growing distance between the EU and Great Britain in regulating chemicals.]
    • Britain and the EU might also wind up with significant differences in how forever chemicals are ultimately regulated, based on the two jurisdictions’ diverging definitions of PFAS. As the HSE’s RMOA for PFAS pointed out, “hundreds” of chemicals may be within scope, while the EU’s broader definition could result in fluorinated chemicals numbering into the thousands being restricted or regulated in some other way in the bloc.
    • The agency has highlighted that it intends to hold “one or more meetings” in the future for stakeholders to better understand the potential restriction and the type of information that HSE is interested in obtaining in support of the restriction proposal. HSE stated that it would “try to group stakeholders together by interest” for the upcoming meetings. As of this writing, HSE had not announced any specific dates when these meetings would take place.
    • The HSE also noted that stakeholders can become accredited stakeholder organizations (ASOs). This status, the HSE explained, will enable entities to participate, for example, in the Challenge Panel meetings to be held during the opinion-making process.
    • Stakeholders must respond before midnight BST on June 3 to respond to the call for evidence by submitting relevant information and comments to HSE.

    Featuring previous research by Kirsten Messmer.

    To contact the author of this analysis, please email Scott Stephens ( [email protected]).
    To contact the editor of this analysis, please email Kari Oakes ( [email protected]).

    Key Documents and Dates

Get an insider’s view on regulatory movements.

Sign up for AgencyIQ’s newsletters to receive exclusive regulatory updates and analysis impacting the life sciences or chemical industry.

Copy link
Powered by Social Snap