All Knowledge & Insights By Date

The European Chemicals Agency (ECHA) announced on September 27, 2023, that it carried out two campaigns during 2021-2023 to remind companies of their obligation to keep their Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations up to date. According to ECHA, 57 of the 689 screened registrations, from 50 companies in 11 European Union (EU) member states, are still in breach of the update requirements under REACH Article 22. ECHA states that it reported...

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) 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...

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...

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 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 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...

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...

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...

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 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...

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...

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 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) 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,...

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)...

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...

The Health and Safety Executive (HSE) recommends that MeiraGTx UK II Limited receive a 12-year review period for its use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO). The applicant uses the substance as a manufacturing aid in the production of gene therapy products at its manufacturing facility in London, UK. 4-ter-OPnEO is known to have endocrine-disrupting properties in the environment. The use applied for may result in <100 grams per year releases of the substance to...

On April 25, 2022, the European Commission (EC) published a Restrictions Roadmap under the Chemicals Strategy for Sustainability (Restrictions Roadmap) that provides detailed information on all ongoing work on future restrictions under the European Union (EU) chemical legislation. The Restrictions Roadmap prioritizes group restrictions for the most harmful substances to human health and the environment, as set out in the Chemicals Strategy for Sustainability (Strategy). According to the EC’s...

By Lynn L. Bergeson The EC updated the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation on March 25, 2022, to clarify the information required by registrants of substances. Major changes include: Requirements and specific rules for adaptation of: In vitro and in vivo mutagenicity studies, specifying when further studies are needed based on mutagenicity concerns; Reproductive toxicity studies, specifying the preferred animal species and...