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.

The European Chemicals Agency (ECHA) announced on March 8, 2023, the results of the Enforcement Forum’s European Union (EU)-wide project on inspections of Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) authorization duties. During the project, the enforcement authorities of 28 countries carried out 690 inspections at 516 companies. According to ECHA, the most commonly controlled substances of very high concern (SVHC) were chromium trioxide and strontium chromate. The inspections primarily focused on downstream users, specifically small- and medium-sized enterprises (SME), who are the final users of the SVHCs.

ECHA states that in one of four inspections (26 percent) of downstream users, inspectors found that the substance was not used in compliance with conditions set out in the European Commission’s (EC) authorization decision granted to their supplier. Consequently, in these companies, workers or the environment were not being adequately protected from possible adverse effects of the SVHCs. According to ECHA, inspectors also discovered that for 20 percent of the checked authorized substances, downstream users did not notify ECHA of their use. In addition, for 35 percent of the checked substances, suppliers failed to communicate information about operational conditions, risk management, or monitoring arrangements specified in the authorization decision to the rest of the supply chain.

ECHA states that while there is “clear room for improvement in the levels of compliance” with specific authorization requirements, the results show that most downstream users adhere to the fundamental authorization duties. In three percent of the inspections, instances were uncovered where companies used or marketed substances without obtaining or applying for an authorization or being covered by an applicable exemption.

Enforcement Measures

According to ECHA, when finding non-compliance, inspectors took 254 enforcement measures to bring all companies into compliance. The measures included mainly written advice and administrative orders, as well as fines and, in some cases, criminal complaints.

Recommendations

The project report outlines recommendations for industry, the Enforcement Forum, national authorities, ECHA, and the EC. For example, suppliers of authorized substances should improve the quality of safety data sheets (SDS) while downstream users should ensure that the authorized substance is used in accordance with the conditions in the authorization decision.

To improve the implementation by duty holders and the enforceability of REACH authorizations, a number of recommendations are provided for the EC on the content and clarity of future authorization decisions.

On February 28, 2023, the European Chemicals Agency (ECHA) announced that it updated its recommendations to improve Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations. According to ECHA, the recommendations are based on ECHA’s findings from registration dossier compliance checks and take recent changes to REACH information requirements into account. The recommendations focus on the rules for using adaptations to assess the safety of chemicals without animal testing. ECHA states that they provide advice on read-across, covering considerations on structural similarity, defining substance groups, and predicting target substance properties. ECHA also provided information on adaptations based on exposure scenarios outlined in chemical safety reports. According to ECHA, further advice addresses the requirements for mutagenicity information and chronic aquatic toxicity studies for poorly soluble substances. ECHA recommends that companies review the recommendations to make sure their dossiers comply with REACH and ensure the safe use of their chemicals.

ECHA also released statistics on its progress evaluating registered substances. In 2022, ECHA conducted 330 compliance checks covering more than 2,300 registration dossiers and addressing 295 substances. According to ECHA, 302 checks were full compliance checks, addressing all relevant endpoints of substances of potential concern. They resulted in 277 draft decisions being sent to companies, requesting more data to clarify long-term effects on human health or the environment. ECHA adopted 252 compliance check decisions together with European Union (EU) member states. ECHA states that these decisions addressed data gaps remaining after draft decisions and dossier updates. ECHA also adopted 169 testing proposal decisions addressing 347 information requirements for which testing was originally proposed by industry.

ECHA follows up on information requests sent to companies to check whether the information provided by companies complies with REACH requirements. According to ECHA, in 2022, this was concluded for 249 substances. In about 60 percent of the cases, companies provided the requested information. ECHA notified the remaining 40 percent to EU member states for enforcement. ECHA notes that it also adopted nine substance evaluation decisions, requesting further information to assess the safety of substances of potential concern.

On June 29, 2021, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) issued a decision on a compliance check case (A-001-2020) regarding registration obligations for polymer importers. ECHA rejected the adaptations by which the Appellant had sought to fulfill the standard information requirements for a sub-chronic toxicity study (Section 8.6.2. of Annex IX to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation), a pre-natal developmental toxicity (PNDT) study on one species (Section 8.7.2. of REACH Annex IX), and a simulation of ultimate degradation in surface water (Section 9.2.1.2. of REACH Annex IX). In its decision, BoA dismissed the appeal in regard to the sub-chronic toxicity study and the PNDT study, but annulled the contested decision insofar as it required the Appellant to submit information on the simulation of ultimate degradation.

ECHA announced on February 21, 2023, that it has revised its Guidance for monomers and polymers to align with BoA’s June 2021 decision and includes changes to the description of registration obligations for those importing and manufacturing polymers and monomers. ECHA states that the key changes relate to:

  • The monomer that needs to be registered by the manufacturer or importer of a polymer;
  • The calculation of registration tonnages of monomers ending up in the final polymer as a reacted substance; and
  • The information that registrants of monomers must include in a registration chemical safety report.

ECHA states that it “encourages all importers and manufacturers of polymers and monomers to examine the updated guidance and review their registrations to make sure they are complying with these minimum requirements.”

The European Chemicals Agency (ECHA) carries out a completeness check on each incoming registration, as set out in Article 20(2) of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. In 2021 and 2022, the European Commission (EC) amended some of the information requirements for registering chemicals under REACH. In its January 23, 2023, press release, ECHA states that, beginning May 1, 2023, it will start checking both new registrations and updates to existing ones against the amended requirements, which will also take effect May 1, 2023, and will apply to both new registrations and updates of existing ones. ECHA states that registrants should prepare for the changes, as registrations submitted before may no longer pass the completeness check.

The new and amended checks concern:

  • Substance identity: Ensuring correct and consistent identification of a substance’s boundary composition and its constituents and additives based on clarifications made to REACH Annex VI; and
  • Standard information requirements based on REACH Annexes VII-XI: Supporting registrants in reporting information for endpoints concerning mutagenicity, degradation, and aquatic toxicity based on REACH Annex VII-XI information requirements. Registrants adding a new weight-of-evidence adaptation will be prompted to provide arguments for the approach in a more structured format.

According to ECHA, in parallel, it has made limited revisions to the completeness check in other areas, such as use information. ECHA notes that the IUCLID validation assistant will also be updated with the amended completeness check rules when the new version of IUCLID is released at the end of April 2023. ECHA encourages registrants to use the validation assistant to check their registrations before submitting them to ECHA.

ECHA held a webinar on February 8, 2023, for stakeholders to learn more about the changes. A recording is available.

The European Chemicals Agency (ECHA) announced on January 17, 2023, that it has added nine chemicals to the Candidate List because of their hazardous properties. According to ECHA, the chemicals are used in flame retardants, paints and coatings, inks and toners, coating products, and plasticizers, and in the manufacture of pulp and paper. The chemicals are:

Substance NameReason for InclusionExamples of Use(s)
1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]Very persistent and very bioaccumulative (vPvB) (Article 57(e) of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation)While the substance itself is not registered under REACH, identification as a substance of very high concern (SVHC) can be seen as a measure to avoid future regrettable substitution.
2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenolCarcinogenic (REACH Article 57(a))As a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles.
4,4′-sulphonyldiphenolToxic for reproduction (REACH Article 57(c));   Endocrine disrupting properties (REACH Article 57(f) — environment);   Endocrine disrupting properties (REACH Article 57(f) — human health)In the manufacture of pulp, paper, and paper products, textile, leather or fur, and chemicals.
Barium diboron tetraoxideToxic for reproduction (REACH Article 57(c))In paints and coatings.
Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereofvPvB (REACH Article 57(e))As a flame retardant and as a plasticizer for flexible polyvinyl chloride (PVC) and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings, and adhesives.
Isobutyl 4-hydroxybenzoateEndocrine disrupting properties (REACH Article 57(f) — human health)In the manufacture of substances and in the following products: coating products, fillers, putties, plasters, modeling clay, and inks and toners.
MelamineEquivalent level of concern having probable serious effects to human health (REACH Article 57(f) — human health);   Equivalent level of concern having probable serious effects to the environment (REACH Article 57(f) — environment)In polymers and resins, coating products, adhesives and sealants, leather treatment products, laboratory chemicals.
Perfluoroheptanoic acid and its saltsToxic for reproduction (REACH Article 57(c));   Persistent, bioaccumulative, and toxic (PBT) (REACH Article 57(d));   vPvB (REACH Article 57(e));   Equivalent level of concern having probable serious effects to human health (REACH Article 57(f) — human health);   Equivalent level of concern having probable serious effects to the environment (REACH Article 57(f) — environment)While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution.
Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholinevPvB (REACH Article 57(e))Used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.

ECHA states that its Member State Committee confirmed the addition of these substances to the Candidate List, which now has 233 entries. ECHA notes that some entries are groups of chemicals so the overall number of impacted chemicals is higher. These nine chemicals may be placed 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.

Under REACH, 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) must 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. Importers and producers of articles must notify ECHA if their article contains a Candidate List substance within six months from the date it has been included on the list (January 17, 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 will publish this notification in its database of substances of concern in products (SCIP).

The Acta Group’s (Acta®) January 17, 2023, webinar, “Two Years Later: How Has the Chemicals Strategy for Sustainability Changed REACH and CLP Regulations?,” is now available for on-demand viewing. During this one-hour webinar Meglena Mihova, Managing Partner, EPPA; Thomas Petry, Ph.D., Managing Director, ToxMinds; Jane S. Vergnes, Ph.D., DABT®, Vice President, Scientific Affairs, Director of Toxicology, Acta; and Lynn L. Bergeson, President, Acta, explore exactly how the Chemicals Strategy for Sustainability is fundamentally reshaping the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and the Classification, Labeling and Packaging (CLP) regulations in ways that are resetting the global stage in terms of identifying new hazard classes and New Approach Methodologies (NAM) for identifying them.

By Lynn L. Bergeson and Carla N. Hutton

The European Chemicals Agency (ECHA) is holding a public consultation on a harmonized classification and labeling (CLH) proposal for a biocidal active substance, 3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate (IPBC) (European Community Number (EC No.) 259-627-5, Chemical Abstracts Service Registry Number® (CAS RN®) 55406-53-6). ECHA used a combined format, including the competent authority (renewal) assessment report prepared according to Commission Delegated Regulation (EU 1062/2014) and the proposal for an updated CLH according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. The hazard classes open for commenting are “acute toxicity — inhalation” and “hazardous to the aquatic environment (acute and chronic).” Comments are due February 17, 2023.

The Great Britain Mandatory Classification and Labelling (GB MCL) process includes the consideration of information gathered from public consultations, conducted by the United Kingdom (UK) Health and Safety Executive (HSE) or international bodies such as ECHA. HSE encourages UK-based businesses with an interest in the proposal to share any relevant information directly with ECHA. HSE suggests that if a business is affected by the Great Britain Classification, Labelling and Packaging (GB CLP) Regulation, it should consider whether it is likely to be affected by the classification and labeling proposal and let HSE know at an early stage if it anticipates any significant impacts or benefits. Information on wider policy and impact considerations can be submitted to HSE at GBCLP.GBMCL@hse.gov.uk. Under the GB CLP Regulation, HSE will consider all published opinions of ECHA’s Committee for Risk Assessment (RAC) before publishing its own Agency Technical Reports and Agency Opinions, so any information provided will be important in any final GB MCL decision.

The European Chemicals Agency (ECHA) announced on January 13, 2023, that the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden have submitted a proposal to restrict per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. ECHA will publish the detailed proposal, “one of the broadest in the [European Union’s (EU)] history,” on February 7, 2023. According to ECHA, the national authorities found risks in the manufacture, placement on the market, and use of PFASs that are not adequately controlled and need to be addressed throughout the EU and the European Economic Area (EEA). ECHA states that it will run the required administrative checks before the proposed restriction and supporting documents are made available on February 7, 2023. On the same day, the national authorities will host a hybrid media event in Brussels from 11:00 to 12:30 (CET).

ECHA’s Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will check that the proposed restriction meets the legal requirements of REACH in their March 2023 meetings. If it does, RAC and SEAC will begin their scientific evaluation of the proposal. ECHA plans to begin a six-month consultation on March 22, 2023. ECHA states that it will hold an online information session on April 5, 2023, to explain the restriction process and help those interested in participating in the consultation.

ECHA notes that the opinions of RAC and SEAC are typically ready within 12 months of the start of the scientific evaluation, in accordance with REACH. In view of the complexity of the proposal and the extent of information that is expected from the consultation, however, RAC and SEAC “may need more time to finalise their opinions.” Once the opinions are adopted, they will be sent to the European Commission (EC), who together with the EU member states will then decide on a potential restriction.