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ABA And B&C Announce Release Of “Chemical Product Law and Supply Chain Stewardship” Book: The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®) are pleased to announce the release by American Bar Association (ABA) Publishing of Chemical Product Law and Supply Chain Stewardship: A Guide to New TSCA, edited by Acta President Lynn L. Bergeson and authored by Ms. Bergeson and members of Acta and B&C’s highly experienced Toxic Substances Control Act (TSCA) practice...

Bergeson & Campbell, P.C. (B&C®), its global consulting affiliate The Acta Group (Acta®), and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to share with you our 2025 Forecast. For all the reasons you might imagine, our seasoned team was especially challenged this year in speculating on what to expect in 2025 regarding global industrial, agricultural, and biocidal chemical regulatory and policy initiatives. Given the European Parliamentary...

The May 2, 2024, ECHA Weekly includes an item on the June 3-6, 2024, meeting of the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) and June 4-7, 2024, meeting of ECHA’s Committee for Socio-Economic Analysis (SEAC). ECHA states that the plenary meetings will address the following topics concerning the universal per- and polyfluoroalkyl substances  (PFAS) restriction proposal: ECHA notes that additionally, RAC and SEAC will discuss pending issues from the previous...

On April 22, 2024, the European Commission (EC) announced that it adopted a “Communication from the Commission: Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals.” The press release states that “[t]he overall aim of this concept is to achieve higher regulatory efficiency and predictability for authorities, investors and industry for a faster phase-out of the most harmful substances in non-essential uses, while allowing more time for the...

The European Chemicals Agency (ECHA) announced on February 27, 2024, that between 2009 and 2023, it performed compliance checks of approximately 15,000 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations, representing 21 percent of full registrations. ECHA states that it met its legal target for dossier evaluation, which increased from five percent to 20 percent in 2019. ECHA notes that for substances registered at quantities of 100 metric tons or more per...

The European Chemicals Agency (ECHA) announced on February 7, 2024, that it is considering recommending the following substances for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Authorization List: ECHA states that it is looking for further information on the uses of these substances in scope of authorization, their possible exemptions from the authorization requirement, and on the structure and complexity of the supply chains. ECHA encourages REACH...

The European Chemicals Agency (ECHA) has released a draft Community Rolling Action Plan (CoRAP) update for 2024-2026. The draft CoRAP contains 28 substances, including 11 new substances compared to the current CoRAP for 2023-2025; ten substances are planned for evaluation in 2024, including evaluation of four substances as a group, and 18 are divided for evaluation in 2025 and 2026. The draft update states that from the 24 substances included in the CoRAP update published...

The European Chemicals Agency (ECHA) announced on September 13, 2023, that to improve transparency of the legislative process, its Enforcement Forum has decided to make its advice on the enforceability of Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation restriction proposals public. According to ECHA, Forum advice will from now on be available on ECHA’s website. The first published advice is on the proposal to restrict creosote and related substances in...

The European Chemicals Agency (ECHA) has begun a public consultation on six proposals to identify new substances of very high concern (SVHC). The substances, including examples of their uses, are: Comments are due October 16, 2023. If a substance is identified as an SVHC, it will be added to the Candidate List for eventual inclusion in Annex XIV of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (the authorization list)....

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...

WEBINAR — Product Stewardship Practices For Effective Supply Chain Interaction, August 1, 2023, 11:00 a.m. – 12:00 p.m. (EDT), Via Webinar: International compliance in today’s evolving regulatory arena presents challenges to organizations. This webinar, presented by Catherine M. Croke, DBA, Director of Product Stewardship and Regulatory Affairs, The Acta Group (Acta®); Lee A. Bowers, Vice President, Environmental Health & Safety, RPM International Inc. (RPM);...

10:00 a.m. – 11:00 a.m. (EDT)4:00 p.m. – 5:00 p.m. (CEST) REGISTER NOW 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...

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...

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)...

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)...

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...

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: 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...

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...

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...

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....

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...

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...

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...

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 Name Reason for Inclusion Examples of Use(s) 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] Very persistent and very...

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...

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...

On October 14, 2020, the European Commission adopted the Chemicals Strategy for Sustainability. The Strategy set into motion a series of remarkable actions by the European Chemicals Agency (ECHA) intended to transform the European Union (EU) into a sustainable and carbon neutral economy while improving protection of its people and the environment. The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and the Classification, Labeling and Packaging (CLP) regulations...

The European Chemicals Agency (ECHA) announced on November 16, 2022, that the Enforcement Forum agreed that the next Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) enforcement project will investigate how companies fulfill the registration, authorization, and restriction obligations for products and chemicals they import from outside the European Union (EU). According to ECHA, the project will be done in 2023-2025 and “will require close cooperation between REACH...

The European Chemicals Agency (ECHA) has opened a call for evidence on polyvinyl chloride (PVC) and its additives related to: Uses; European Union (EU) volumes per use sector and end-use; End-of-life information per use; and Experimental/measured release and exposure information. ECHA states that with this call, it seeks to obtain an understanding on the use volumes at the EU level per sector and for as many end-uses as feasible, but company-specific information is also welcome....

The European Chemicals Agency (ECHA) has received restriction proposals for: 4,4′-isopropylidenediphenol (bisphenol A) and other bisphenols and bisphenol derivatives with endocrine disrupting properties for the environment, prepared by the German authority. The proposal would restrict the use as an additive and the content in articles (0.02 percent by weight); restrict content of residues (unreacted monomer) in articles and for imported goods (0.02 percent by weight); restrict the use of...

By Lynn L. Bergeson and Carla N. Hutton The European Chemicals Agency (ECHA) recently reminded only representatives (OR) that they must identify the non-European Union (EU) manufacturers that they represent and provide their contact information in REACH-IT by October 14, 2022. According to an April 24, 2022, news item, ORs must have a separate REACH-IT account for each non-EU manufacturer they represent and have the necessary registrations for each. The contact information that must be...

By Lynn L. Bergeson and Carla N. Hutton The European Chemicals Agency (ECHA) has begun public consultations on nine proposals to identify new substances of very high concern (SVHC). The substances and examples of their uses are: 4,4′-sulphonyldiphenol (bisphenol S; BPS): The substance is used for the manufacture of pulp, paper, and paper products; textile, leather, or fur; and chemicals. Perfluoroheptanoic acid and its salts: The substances are not registered under the Registration,...

According to an item in the August 10, 2022, ECHA Weekly, France, Ireland, and Germany are requesting interested parties to submit information related to skin sensitizing substances in consumer mixtures. The European Chemicals Agency (ECHA) website states that this is an opportunity for all sectors to provide information on the presence of skin sensitizing substances in mixtures with consumer uses, including information on known safe uses. The call for evidence is issued to assess whether...

By Lynn L. Bergeson and Carla N. Hutton The European Chemicals Agency (ECHA) recently reminded registrants of substances with a harmonized classification to update their dossiers. According to an item in the July 13, 2022, ECHA Weekly, ECHA will soon begin a second screening project to check that companies are keeping their registrations updated. The project will focus on substances with a harmonized classification and labeling and will examine registrations where this information is not...

The European Chemicals Agency (ECHA) announced on June 10, 2022, that n-(hydroxymethyl)acrylamide has been added to the Candidate List as it may cause cancer or genetic defects. According to ECHA, it is mostly used in polymers and when manufacturing other chemicals, textiles, leather, or fur. Candidate List substances may be placed on the Authorization List in the future. If a substance is on that list, its use will be prohibited unless companies apply for authorization...

The European Chemicals Agency (ECHA) published an item in its May 11, 2022, ECHA Weekly announcing that it is launching consultations to support the Member State Committee (MSC) in adopting an opinion on whether 4,4’-methylenediphenol (BPF), 4,4’-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (BPAF), and eight BPAF salts meet the criteria for endocrine disrupting substances for the environment, as defined by the World Health Organization (WHO)/International Program on Chemical...

The European Chemicals Agency (ECHA) implemented new checks on Chemical Safety Reports (CSR) submitted via European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registration dossiers since March 1, 2021, so that it can “better fulfil” its obligation to ensure that registrations meet the information requirements. ECHA’s CSR manual completeness check includes the following elements: The CSR must contain an exposure assessment and risk...

The European Chemicals Agency (ECHA) reports on the effectiveness of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) authorization process. TCE was added to the authorization list (Annex XIV) in 2013 because of its carcinogenic properties. The substance cannot be placed on the market, or used, unless an authorization is granted by the European Commission (EC) or an exemption applies. REACH registration data show that 50,000 metric tons of trichloroethylene (TCE)...

The European Chemical Agency’s (ECHA) Socio Economic Assessment Committee (SEAC) has reviewed Norway’s restriction proposal for 1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (Dechlorane Plus™) and requests further information from stakeholders. Norway has identified several restriction options and each affects the manufacture, use, and placing the substance on the market in concentrations >0.1 percent, with possible derogations....

The European Chemical Agency’s (ECHA) Community Rolling Action Plan (CoRAP) update for the years 2022–2024 lists 27 substances suspected of posing a risk to human health or the environment. Two of the substances are new to the evaluation process and the other 25 are existing. The two new substances are: Substance name Initial grounds of concern 1,3,4,6,7,8- hexahydro4,6,6,7,8,8- hexamethylindeno[5 ,6-c]pyran Potential endocrine disruptor, suspected persistent, bioaccumulative, and toxic...

By Lynn L. Bergeson The European Commission (EC) updated the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation on April 11, 2022, to add five new substances to Annex XIV (the authorization list). Companies cannot use or place these substances on the market after the Sunset Date unless an authorization has been granted by the EC or an exemption applies. Substance Name Latest Application Date Sunset Date Intrinsic property Tetraethyllead...

By Lynn L. Bergeson The European Chemicals Agency (ECHA) announced on April 6, 2022, that together with European Union (EU) member states, it has assessed a group of 148 bisphenols for risks to human health and the environment. Of these, more than 30 have been identified to have the potential for hormonal or reprotoxic effects. Some uses of these bisphenols include: Anti-oxidant for processing polyvinyl chloride (PVC); Epoxy resin hardeners; Textile, leather, paper and board;...

ECHA announced on February 2, 2022, that it is considering recommending eight new substances for the EC to include in the Authorization List (REACH Annex XIV). The substances include: Substances SVHC-Relevant Intrinsic Property Examples of Use(s) in the Scope of Authorization Ethylenediamine Respiratory sensitizing properties Use as processing aid, scavenging agent in refinery streams, corrosion inhibitors, process additive, use in control of odor emission 2-(4-Tert-butylbenzyl)propionaldehyde...