Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk.

Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) have prepared this 20-page memorandum for your consideration. It offers a high-level outline of issues, focusing on the most significant bans and restrictions, the most impactful potential legal developments regarding PFAS, and the most important steps chemical product manufacturers should be taking now to identify, diminish, and supplant, as appropriate, PFAS in their supply chains.

We hope this information is helpful. We would be pleased to provide additional information and assist with PFAS-related scientific, regulatory, or legal questions that you may have.

Download a PDF of this memorandum

The Health and Safety Executive (HSE) has proposed to include three substances in the rolling action plan (RAP) for 2023 to 2025. HSE states that it has “sought to complement rather than replicate evaluation work that has been or will be performed by other regulatory regimes” (such as via the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation). According to HSE, its intention is to increase its overall understanding of the hazard and risk profile of the priority substances and their relevance to Great Britain (GB). HSE selects substances for inclusion in the RAP based on the hazard profile of substances and their exposure potential, including the quantities that are supplied. HSE will consider information from a number of sources to identify priorities:

  • The GB specific data within the United Kingdom’s (UK) database (Comply with UK REACH-IT);
  • UK REACH processes (such as dossier evaluation), which will also develop with the embedding of the UK REACH system past the first year of operation; and
  • Other intelligence, such as horizon scanning of other regimes, both domestic (like the GB Classification, Labelling and Packaging (CLP) Regulation) and international (such as EU REACH and other regulatory systems from other countries).

HSE will evaluate substances where it identifies a potential concern. The evaluation will determine if a conclusion on the concern can be drawn from the available data. If a conclusion cannot be drawn, HSE can, as the agency for UK REACH, require registrants to provide additional information to clarify the concern. HSE states that in such cases, if they arise, it will set deadlines by which information shall be provided.

The RAP briefly describes the initial grounds for concern and provides further detail in the specific justification document for each substance. HSE notes that the indication of the initial grounds for concern does not limit the scope of the evaluation and states that it may address other areas of concern identified during an assessment.

HSE identified one substance for evaluation in 2023. In 2024/25, HSE will focus on per- and polyfluoroalkyl substances (PFAS) and consider recommendations from broader scoping activities, regulatory management options analyses (RMOA), and the Environment Agency’s updated report on flame retardants when published.

YearSubstanceInitial Grounds for Concern
2023N-butylbenzenesulphonamideEnvironment: Suspected PMT (a substance with characteristics of persistence, mobility, and toxicity (PMT) in the environment)   Exposure: Widespread detection in environmental monitoring
2024PFAS, subject to further assessmentRecommendation from the UK REACH RMOA for PFAS   View the PFAS RMOA Annexes
2025To be agreed (by May 31, 2025) 

The European Chemicals Agency (ECHA) has published its annual report on helpdesk activities. According to the annual report, in 2022, the national helpdesks (NHD) replied to almost 43,000 enquiries, and the ECHA Helpdesk to almost 9,500 questions. The annual report states that responses provided through the survey reflect the activities of the Biocidal Products Regulation (BPR), Classification, Labeling, and Packaging (CLP), and Registration, Evaluation, Authorisation and Chemicals (REACH) helpdesks across 34 countries. Helpdesks of three candidate and one third country also reported on their 2022 activities.

According to the annual report, the overall trend shows that the number of queries addressed to the NHDs and ECHA decreased after peaking in 2020, returning to pre-pandemic levels. BPR remains the regulation with the highest number of enquiries received by NHDs in the past eight years. The annual report states that the most popular topics were topics that fall within the remit of national authorities, i.e., “National procedures and laws governing the transitional period,” “National fees,” and “National authorisations of biocidal products or families.” For ECHA, REACH continues to be the regulation prompting the highest number of enquiries, in particular in the areas of “Registration” and “Communication along the supply chain.” For all helpdesks, the number of CLP enquiries decreased, although questions related to Annex VIII and poison center notification (PCN) duties “continued to require quite some support.”

The European Chemicals Agency (ECHA) has begun a call for evidence on analytical methods to measure carcinogenic, mutagenic, or reprotoxic substances (CMR) in childcare articles. ECHA states that the European Commission (EC) has requested that ECHA prepare a report on CMRs in childcare articles. According to ECHA, this work will support the EC in the preparation of a restriction proposal for CMR 1A or 1B substances in childcare articles on the basis of Article 68(2) of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. Responses are due June 7, 2023.

According to the EC’s mandate, the scope of ECHA’s report should cover:

  • Articles under the definitions in entry 51 of Annex XVII of REACH: Any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children; and/or
  • Articles within the remit of European Committee for Standardization (CEN) Technical Committee (TC) 252: Any product “designed or obviously intended to safely ensure and facilitate seating, bathing, changing and general body care, feeding, sleeping, transportation and protection of young children.”

The substances within the scope are all CMRs with harmonized classification category 1A or 1B under Regulation 1272/2008 on the classification, labeling, and packaging of substances and mixtures (CLP). The mandate notes that consideration should also be given to future updates of the restriction when additional substances will get harmonized classifications. For enforcement purposes and to help with implementation of the restriction, the mandate states that ECHA’s report “should gather data on whether the substances are present in childcare articles, to establish a list of most relevant substances per group of articles, and the materials typically used in the articles and where possible, if they either can be released from articles or lead to exposure of children.”

The mandate states that the deliverable is a report that should include:

  • A list of CMRs with harmonized classification 1A or 1B that may be present in childcare articles (grouped per article types/material types, intentional vs unintentional if possible);
  • Where available, information on tonnage, concentration ranges, frequency of finding in articles to be used as estimation of likelihood of exposure for further prioritization;
  • Where available, information on release/exposure potential;
  • An inventory of existing Generic Concentration Limits (GCL)/Specific Concentration Limits (SCL) per substance or per groups of substances and further existing regulatory measures;
  • Identification if deviation from GCL/SCL (content) limits is needed;
  • Summary of information on availability of analytical methods; and
  • An overview and summary of the stakeholder consultations.

ECHA states that the call for evidence is intended for testing laboratories (e.g., enforcement, customs, independent, and industry laboratories). ECHA encourages both European Union (EU)/European Economic Area (EEA) and non-EU stakeholders to participate. ECHA notes that information can be submitted confidentially.

The European Chemicals Agency (ECHA) published on May 3, 2023, the Question and Answer (Q&A) document following the April 5, 2023, online information session on the proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. As reported in our April 7, 2023, memorandum, national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted the proposal after finding risks in the manufacture, placement on the market, and use of PFAS that are not, in their view, adequately controlled and need to be addressed throughout the European Union (EU) and the European Economic Area (EEA). The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks. A six-month consultation on the proposal started on March 22, 2023. The April 5, 2023, online information session explained the restriction proposal, how the REACH restriction process works, and how to participate in the consultation.

ECHA will publish the Q&A document in two parts. The first part, published on May 3, 2023, focuses on questions regarding the consultation, the evaluation, and the opinion-making process by ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC), and the REACH restriction process. The responses to these questions come from ECHA experts. The second part of the Q&A document, which ECHA expects to publish later in May or in June 2023, will focus on questions regarding the content of the proposed restriction and will include replies from the five national authorities that have prepared the proposal.

In this first Q&A document, readers can find responses to practical questions regarding the consultation and submitting information, such as where to find certain information or documents, how to submit comments, or how to claim information as confidential. Other questions relate to the opinion-making process by ECHA’s scientific committees, for example, how the committees will manage the expected flood of derogation requests received during the consultation. Lastly, the Q&A document provides responses to miscellaneous questions relating to the provisions of the restriction proposal, such as what types of PFAS would be covered, how the restrictions would apply in practice, or how the proposed restrictions would relate to existing restrictions on PFAS.

A similar blog post will be published here and on The Acta Group’s (Acta®) PFAS Resource Center upon publication by ECHA of the second part of the Q&A document.

The scientists, regulatory specialists, business consultants, and attorneys of Acta and our affiliated law firm Bergeson & Campbell, P.C. (B&C®) relentlessly participate in and track developments regarding the global regulatory approach to PFAS. We offer a PFAS Resource Center, a constantly updated library of PFAS resources, to help those in the chemical and chemical products industry understand what they need to know and what it means to their business.

The European Chemicals Agency (ECHA) announced on April 12, 2023, that it has recommended that the EC add the following substances to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Authorisation List:

  • Ethylenediamine;
  • 2-(4-Tertbutylbenzyl)propionaldehyde and its individual stereoisomers;
  • Lead;
  • Glutaral;
  • 2-Methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one;
  • 2-Benzyl-2-dimethylamino-4′-morpholinobutyrophenone;
  • Diisohexyl phthalate; and
  • Orthoboric acid, sodium salt.

ECHA states that it prioritized these substances from the Candidate List of Substances of Very High Concern (SVHC) for this recommendation “as they are of the highest priority, following the agreed approach of 2014.” The European Commission (EC) will determine which substances are added to the Authorisation List and what conditions apply for each substance. If a substance is included on the Authorisation List, it can only be placed on the European Economic Area (EEA) market or used after a given date, if an authorization is granted for a specific use.

By Lynn L. Bergeson and Carla N. Hutton

The European Commission (EC) has published a report entitled Supporting the Commission in Developing an Essential Use Concept. The report presents the outcome of a project to support the EC to define further the essential use concept and associated criteria to help phase out the most harmful chemicals. According to the abstract, the report investigates how the essential use concept could be implemented in European Union (EU) legislation, including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, the Restriction of Hazardous Substances Directive, food contact materials legislation, the Cosmetic Products Regulation, the Taxonomy Regulation, and the End-of-life Vehicles Directive. For REACH, the report identifies “sub-options” for the essential use concept that could apply within options for the reform of authorization and restriction, as considered in the targeted revision of REACH. The report includes a qualitative assessment of expected impacts from the introduction of the essential use concept in REACH. The abstract states that the evidence base was built up through a review of legislation and literature; a targeted survey; interviews; and a workshop.

On April 4, 2023, the Health and Safety Executive (HSE) published a regulatory management options analysis (RMOA) for per- and polyfluoroalkyl substances (PFAS). The RMOA is a preliminary step used within the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) framework. The RMOA collates, combines, and analyzes information on the nature and extent of exposure to chemical substances, and it considers existing laws and also how PFAS are being managed around the world, including Europe, Asia, and the United States. The RMOA defines PFAS as “[f]luorinated 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 RMOA states that this “reduces the number of PFAS in scope to hundreds, maintaining focus on substances that are persistent degradation products of PFAS.” The RMOA acknowledges that the Organization for Economic Cooperation and Development (OECD) defines PFAS more broadly as “fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any hydrogen, chlorine, bromine or iodine atom attached to it).” As reported in our February 13, 2023, memorandum, the European Chemicals Agency (ECHA) is accepting comments on a proposal to restrict more than 10,000 PFAS under REACH. The chemical scope of the restriction proposal is defined as “[a]ny substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it),” and this definition is aligned with OECD’s.

The RMOA states that based on initial considerations of likely effectiveness and efficiency of options — and considering the Precautionary Principle — HSE concludes that it would be appropriate to consider initiating some or all of the following risk management measures with regard to certain uses of PFAS:

  • Preparation of background dossiers to support potentially one or more UK REACH restrictions of PFAS, including:
  • The use and disposal of fire-fighting foams (FFF) where non-PFAS alternatives are available;
  • Other wide dispersive uses such as the application of coatings or use of cleaning agents; and
  • 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, and 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;
  • UK REACH authorization of PFAS used in processing aids in the manufacture and processing of fluorinated polymers;
  • Further evaluation and investigation of substances that have been highlighted to be of concern; and
  • Continued collaborative work across government and with external stakeholders to bring together work on PFAS strategically.

According to its April 4, 2023, press release, the recommendation to prioritize FFFs for action will be founded on scoping work with stakeholders including industry, firefighters, and those with expert knowledge of alternative foams. The press release states that similar exercises will take place for other commercial uses of PFAS. HSE will work with the Environment Agency and the appropriate authorities (Department for Environment, Food and Rural Affairs (Defra), Scotland, and Wales) to consider the recommendations and how action on these recommendations will be set out in the forthcoming UK REACH Work Programme for 2023-24.

The European Chemicals Agency (ECHA) announced on March 22, 2023, the beginning of a six-month consultation on the proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. As reported in our February 13, 2023, memorandum, the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted the proposal after finding risks in the manufacture, placement on the market, and use of PFAS that are not, in their view, adequately controlled and need to be addressed throughout the European Union (EU) and the European Economic Area (EEA). The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks. According to ECHA, the public consultation is to give anyone with information on PFAS the opportunity to have their say. ECHA states that of particular interest is information relevant to the risks, socio-economic aspects, and alternative substances. Comments are due September 25, 2023.

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will use the consultation input to evaluate the proposed restriction and to form an opinion on it. ECHA will hold an online information session on April 5, 2023, from 11:00 to 13:00 Helsinki time. During the session, experts from ECHA and the five national authorities will explain the restriction process, the content of the proposal, and how to participate in the consultation. They will also respond to questions from the participants. Questions can be sent to the expert panel in advance of the session through this link. A memorandum summarizing the information session will be posted on The Acta Group’s (Acta®) website.

The scientists, regulatory specialists, business consultants, and attorneys of Acta and our affiliated law firm Bergeson & Campbell, P.C. (B&C®) relentlessly participate in and track developments regarding the global regulatory approach to PFAS. We offer a PFAS Resource Center, a constantly updated library of PFAS resources, to help those in the chemical and chemical products industry understand what they need to know and what it means to their business. B&C will hold a webinar on May 17, 2023, on “PFAS Reporting, PBTs, and Other TSCA Hot Topics.” Panelists will discuss expected PFAS reporting rules, U.S. Environmental Protection Agency (EPA) actions on persistent, bioaccumulative, and toxic (PBT) chemicals, and other timely Toxic Substances Control Act (TSCA) issues. More details will be added as they are announced. Registration is open.

By Lynn L. Bergeson and Carla N. Hutton

The European Chemicals Agency (ECHA) announced on March 15, 2023, that it released its Regulatory Strategy for Flame Retardants, identifying aromatic brominated flame retardants as candidates for a European Union (EU)-wide restriction. ECHA states that aromatic brominated flame retardants, such as polybrominated diphenyl ethers, are generally persistent in the environment, and that many, like decabromodiphenylether, are also known or suspected of being toxic and accumulating in people and animals. ECHA notes that their release could be minimized through an EU-wide restriction.

According to ECHA, before a potential restriction proposal, some preparatory work is required. ECHA states that this work could include an assessment of the waste stage to find out if hazardous substances are released when products containing flame retardants are dismantled, recycled, or disposed of. It could also include an assessment of the availability of suitable alternative substances or materials.

The restriction scope could cover all aromatic brominated flame retardants confirmed to be persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) through harmonized classification or identification as substances of very high concern (SVHC).

According to ECHA, for many aliphatic brominated and some organophosphorus-based flame retardants, more data are needed to determine if a restriction is necessary. ECHA states that it expects these data to be available from 2024 onward, and ECHA suggests reassessing the situation for those groups in 2025.

ECHA is not recommending regulatory action for several non-halogenated subgroups of flame retardants, including certain organophosphorus-based flame retardants, since it identified no or low hazard at this time. ECHA notes that for chlorinated flame retardants, regulatory measures are already in place or initiated.