The European Chemicals Agency (ECHA) announced in the August 16, 2023, issue of ECHA Weekly that to support substitution toward safer chemicals, it has published information on the main alternatives to substances requiring authorization under Annex XIV of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. ECHA notes that companies applying for an authorization under REACH must provide information on potential alternatives to the Annex XIV substance(s) they use. This information is presented in the Analysis of Alternatives (AoA) submitted as part of their authorization application. ECHA publishes the public version of the AoA on its website. ECHA states that it extracted the main information on these alternatives from AoAs, and the information is available in the Shortlisted Alternatives Table. ECHA states that if a field is left blank, either the applicant has claimed the information as confidential or it has not identified corresponding information. The file contains data available as of June 30, 2023.
During the United Kingdom (UK) Chemicals Stakeholder Forum’s (UKCSF) July 20, 2023, meeting, UKCSF received updates from the Department for Environment, Food and Rural Affairs (Defra) and the Health and Safety Executive (HSE) on UK REACH. According to the UKCSF Chemicals policy and regulation update, Defra, along with Welsh and Scottish governments, worked with HSE, the Environment Agency, and a wide range of stakeholders, including non-governmental organizations (NGO) and trade associations, to identify priorities for the UK REACH Work Programme in 2023-2024. The update states that since UK REACH came into force, the Work Programme has prioritized the issues that are most effectively addressed through UK REACH and where action would have the greatest impact for human health and the environment. The UK REACH Work Programme 2023-2024 “will be published in due course and will be accompanied by an updated rationale setting how we identified priorities for this financial year.”
As reported in our April 12, 2023, blog item, on April 4, 2023, HSE published a regulatory management option analysis (RMOA) for per- and polyfluoroalkyl substances (PFAS). The update states that Defra ministers have accepted the RMOA’s recommendations, which include reducing PFAS emissions by developing UK REACH restrictions, beginning with a restriction on PFAS in firefighting foams and exploring further restrictions covering a wide range of industrial and consumer uses. The RMOA “took a grouping approach, to prevent regrettable substitution.” According to the update, Defra will share further details in upcoming UK REACH Work Programmes and the UK Chemicals Strategy. It will continue to work with stakeholders as this work develops and build on the constructive dialogue initiated through the PFAS UKCSF Working Group.
HSE has published a rolling action plan (RAP) of substances to be evaluated. The update notes that substance evaluation under UK REACH aims to clarify concerns that the manufacture and/or use of the substances could pose a risk to human health or the environment. In line with its obligations under UK REACH Article 44 and as stated within the 2022-2023 Work Programme, HSE has published a RAP of substances that will be evaluated. HSE has one year from the date of publication of the RAP to evaluate substance(s) added to the RAP that year and, where necessary, to prepare a draft decision requesting further information from the registrants to clarify the identified concern. In 2023 and 2024, HSE, working with the Environment Agency, will evaluate one substance, N-butylbenzenesulphonamide. According to the update, as part of this process, HSE has worked with the appropriate authorities to develop and agree on criteria for prioritizing substances for substance evaluation.
On June 28, 2023, Rebecca Pow, Parliamentary Under Secretary of State, Department for Environment, Food and Rural Affairs (Defra), signed the REACH (Amendment) Regulations 2023, extending the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registration deadlines. The Explanatory Memorandum states that the amendment extends the current legislative deadlines for registrants to submit information to the Health and Safety Executive (HSE) under UK REACH. It also extends the period in which downstream users and distributors who were importing before the end of the EU Exit Implementation Period (pre-IP completion) can continue to import chemicals from the European Union (EU) without submitting a full registration. The Explanatory Memorandum notes that extending these timelines “will provide sufficient time for the government to develop and introduce a new transitional registration model.” This amendment also extends the dates by which HSE is required to carry out compliance checks so that these dates now align with the extended submission deadlines. The amendment will take effect July 19, 2023.
According to the Explanatory Memorandum, in response to concerns by industry about the costs of obtaining the information needed to comply with these transitional provisions, Defra, working with HSE and the Environment Agency, is exploring an alternative model for transitional registrations that aims to reduce the need for replicating EU REACH hazard information by placing a greater emphasis on improving understanding of the uses and exposures of chemicals in the context of Great Britain (GB). The Explanatory Memorandum notes that the government needs sufficient time to develop and then legislate for this model, however, and that it will take until late 2024 to develop, legislate, and implement an alternative traditional registration model, including changes to the information technology (IT) system.
The legislation amends the current UK REACH information submission deadlines by three years to:
- October 27, 2026, for substances included on the candidate list on or before December 31, 2023; substances that are carcinogenic, mutagenic, or toxic for reproduction (CMR) and manufactured or imported in quantities of one metric ton a year or more; substances that are very toxic to aquatic life and manufactured or imported in quantities of 100 metric tons or more a year; and all substances manufactured or imported in quantities of 1,000 metric tons or more a year;
- October 27, 2028, for substances added to the UK REACH candidate list before the above submission deadline; and all substances manufactured or imported in quantities of 100 metric tons or more a year; and
- October 27, 2030, for all substances manufactured or imported in quantities of one metric ton or more a year.
The legislation also amends the dates by which HSE must carry out 20 percent of compliance checks to October 27, 2027, October 27, 2030, and October 27, 2035.
The European Chemicals Agency (ECHA) is seeking comment on the draft opinion of its Committee for Socio-Economic Analysis (SEAC) concerning the restriction proposal for medium-chain chlorinated paraffins (MCCP) and other substances that contain chloroalkanes with carbon chain lengths within the range of C14 to C17. According to the Information Note on SEAC’s draft opinion, substances containing chloroalkanes with carbon chain lengths from C14 to C17 are used in various sectors and in a broad range of applications, such as polyvinyl chloride (PVC), adhesives and sealants, rubber, metalworking fluids, paints, and coatings. The Information Note states that they are mainly used as plasticizers, flame retardants, or extreme pressure additives. Comments on SEAC’s draft opinion are due August 14, 2023. Comments received will be taken into account before the adoption of the SEAC final opinion in September 2023. ECHA will send the Committee for Risk Assessment (RAC) and SEAC final opinions to the European Commission (EC), which will make the decision whether to include the proposed restriction in Annex XVII of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.
The Information Note states that the consultation includes four specific questions intended to obtain information considered to be particularly relevant to the evaluation of the proposal:
- SEAC’s view is that a transition period of seven years for the entry into force of the ban on the use of the substances in metalworking fluids is required since alternatives may not be readily available for all extreme pressure metalworking fluid applications. SEAC also notes that several respondents who contributed to the third-party consultation of the Annex XV restriction report requested a transition period longer than seven years. SEAC’s view is that these requests were not sufficiently substantiated, however.
SEAC is therefore looking for additional information on the use of the substances in metalworking fluids that would allow SEAC to assess further whether a longer transition period for these applications is needed. In the absence of concrete and well-substantiated comments, SEAC will consider that the conclusion reached on the transition period required for the use in metalworking fluids is adequate.
- The third-party consultation of the Annex XV restriction report confirmed that substances containing chloroalkanes with carbon chain lengths from C14 to C17 that are used as extreme pressure additives in metalworking fluids for heavy-duty metalworking operations (such as fine blanking, broaching, and deep drawing) are challenging to replace with alternatives and that it seems that the type of fluids concerned are oil-based fluids. Based on this, the Dossier Submitter has refined the wording of the derogation for metalworking fluids under restriction option B in the Background Document to specify the type of fluids that should be covered by MCCP and other substances that contain chloroalkanes with carbon chain lengths within the range from C14 to C17 derogation, namely oil-based metalworking fluids as defined under the German Institute for Standardization (DIN) 51385 standard.
SEAC is concerned that the wording of the scope may be too narrow, however, as other categories of metalworking fluids (not covered by the definition of oil-based fluids under this DIN standard) might also be relevant and should be included under paragraph 8 of the restriction entry text.
Please provide detailed information on whether other categories of metalworking fluids used for heavy-duty applications and not covered by DIN 51385 would also require a longer transition period than two years. Please refer to any relevant industry standards applicable to the type of metalworking fluids concerned.
- According to the SEAC draft opinion, a ban on the manufacture of the substances within the scope of the restriction proposal should enter into force after the seven-year transition period for metalworking fluids has ended. Please provide further information on the potential impacts of a ban on manufacturing once the ban on the placing on the market and use of the substance in the European Union (EU) has entered into force.
- During the third-party consultation on the Annex XV report, some stakeholders have indicated the presence of substances containing chloroalkanes with carbon chain lengths from C14 to C17 in concentrations above 0.1 percent (and up to 15 percent) in PVC recyclates (e.g., from PVC cables) and PVC articles made of these PVC recyclates. According to the recently published restriction on lead (Pb) in PVC, flexible PVC containing Pb above 0.1 percent by weight will no longer be allowed to be recycled in Europe by May 28, 2025. In this context, SEAC would like to understand how the restriction on Pb in PVC would affect the recycling of PVC containing chloroalkanes with carbon chain lengths from C14 to C17. Please estimate the quantity/volume of recycled PVC that would not contain Pb but could still contain chloroalkanes in the scope of the restriction proposal.
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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 these global legal developments and take steps now to minimize legal, regulatory, and commercial risk.
In the United States and globally, the number of bans, restrictions, and reporting requirements for PFAS increases seemingly daily. The European Union (EU) is currently considering a proposal to restrict more than 10,000 PFAS under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. This would be the most extensive regulatory restriction on PFAS to date, in one of the world’s largest markets.
The stakes are high. Companies must ascertain which legal requirements apply in the jurisdictions in which they operate and determine how each may impact business operations and risk profiles. The need to balance commercial imperatives with legal, commercial, and stewardship sensitivities is not easy, and companies need all the help they can get to make sound, informed decisions.
The Acta Group (Acta®) and EPPA are pleased to offer this one-hour complimentary webinar providing companies with the information needed to develop a PFAS game plan. Register now to join Meglena Mihova, Managing Partner, EPPA; Richard E. Engler, Ph.D., Director of Chemistry, Acta; and Lynn L. Bergeson, President, Acta, as they present how best to respond to U.S., UK, and EU PFAS developments influencing market access, supplier continuity, product sustainability, and reputation management.
- Overview of PFAS regulation in the United States
- Overview of PFAS regulation in the UK
- Overview of the EU restriction proposal and the listed (potential) derogations
- Identifying PFAS in the supply chain
- Identifying PFAS alternatives; developing justifications where alternatives are not currently an option
- Effective stakeholder input to agency processes
Meglena Mihova, Managing Partner of EPPA, a Brussels-based regulatory and public affairs consultancy. She brings deep insight into the role and functioning of the EU Member States, the deal making among them, and the resulting challenges and opportunities for business. Ms. Mihova has over 20 years of experience in EU chemicals and environmental legislation. She served as a Member of the Board and prior to that as a Chair of the Environment Committee of the American Chamber of Commerce to the EU.
Richard E. Engler, Ph.D., Director of Chemistry, Acta, a chemical regulatory consultancy with offices in Washington, D.C., Manchester, England, and Brussels, Belgium. He is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and one of the most widely recognized experts in the field of green chemistry. Dr. Engler has participated in thousands of Toxic Substances Control Act (TSCA) substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist clients as they develop and commercialize sustainable products.
Lynn L. Bergeson, President, Acta. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters pertinent to conventional, biobased, and nanoscale chemicals. Ms. Bergeson is Chair of the International Bar Association (IBA) Agriculture and Food Section, Immediate Past President of the Product Stewardship Society (PSS), and a past Chair of the American Bar Association Section of Environment, Energy, and Natural Resources.
The European Chemicals Agency (ECHA) announced on June 14, 2023, that it has added two new chemicals to the Candidate List of substances of very high concern (SVHC). One is toxic for reproduction, and the other has very persistent and very bioaccumulative (vPvB) hazardous properties. According to ECHA, their uses include in inks and toners and in the production of plastic products. ECHA provides the following information regarding the chemicals:
|Substance Name||Reason for Inclusion||Examples of Use(s)|
|Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide||Toxic for reproduction (Article 57(c))||Inks and toners, coating products, photo-chemicals, polymers, adhesives and sealants and fillers, putties, plasters, modeling clay|
|Bis(4-chlorophenyl) sulphone||vPvB (Article 57 (e))||Manufacture of chemicals, plastic products, and rubber products|
According to ECHA, the Candidate List now has 235 entries, although some are groups of chemicals, so the overall number of impacted chemicals is higher. ECHA may place these substances on the Authorisation List in the future. If a substance is on that list, its use will be prohibited unless companies apply for authorization and the European Commission (EC) authorizes them to continue its use.
Consequences of the Candidate List
ECHA notes that under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, companies have legal obligations when their substance is included — either on its own, in mixtures, or in articles — on the Candidate List.
Suppliers of articles containing a Candidate List substance above a concentration of 0.1 percent (weight by weight) have to provide their customers and consumers information to be able to use them safely. ECHA states that consumers have the right to ask suppliers whether the products they buy contain SVHCs.
ECHA states that importers and producers of articles “will have to notify ECHA if their article contains a Candidate List substance within six months from the date it has been included” on the list (June 14, 2023). Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a safety data sheet (SDS).
Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain SVHCs in a concentration above 0.1 percent (weight by weight). ECHA publishes this notification in its database of substances of concern in products (SCIP).
The Health and Safety Executive (HSE) announced on June 8, 2023, that it is recommending the restriction of hazardous substances in ink used for tattooing and permanent makeup (PMU) in Great Britain (GB). HSE states that the proposed restriction would target substances classified for carcinogenicity, mutagenicity, reproductive toxicity, skin sensitization, skin corrosion, and serious eye damage. HSE proposes concentration limits of substances in tattoo ink and PMU based on those established in the GB Classification, Labelling and Packaging (CLP) Regulation: a concentration limit of 0.1 percent for substances that are prohibited for use in cosmetics because they are listed in Annex II or Annex VI of the Cosmetic Products Regulation (CPR). HSE proposes a derogation for 19 pigments (including Pigment Blue 15:3 and Pigment Green 7) that are prohibited for use in hair dyes but permitted for use in other types of cosmetics (such as lipsticks). According to HSE, its review of the available hazard information for these 19 pigments did not identify evidence indicating they are unsafe if used in tattoo or PMU ink. The proposed restriction is intended to protect people from any potential harmful effects that may be caused by tattoo and PMU ink.
HSE notes that this is the first time it has recommended a restriction of a substance in its role as the agency for the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) framework, the chemicals regime established in GB after the United Kingdom (UK) left the European Union (EU). According to HSE, the Secretary of State for the Department for Environment, Food and Rural Affairs (Defra), in consultation with Welsh and Scottish ministers, will now decide if the restriction should be brought into law.
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.
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.
|Year||Substance||Initial Grounds for Concern|
|2023||N-butylbenzenesulphonamide||Environment: Suspected PMT (a substance with characteristics of persistence, mobility, and toxicity (PMT) in the environment) Exposure: Widespread detection in environmental monitoring|
|2024||PFAS, subject to further assessment||Recommendation from the UK REACH RMOA for PFAS View the PFAS RMOA Annexes|
|2025||To 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.”