REACHblog®

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...

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,...

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...

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 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...

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...

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...

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)...

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,...

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...

By Lynn L. Bergeson and Carla N. Hutton 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...

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...

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 December 21, 2022, the European Chemicals Agency (ECHA) began two public consultations: Comments on the proposals are due June 22, 2023. ECHA states that comments submitted by January 25, 2023, will be used by the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) in their first discussions of the proposals in March 2023....

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...

As reported in our July 18, 2022, memorandum, in July 2022, the Department for Environment, Food and Rural Affairs (Defra) began a public consultation on extending the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) submission deadlines for transitional registrations — the registrations under UK REACH of substances that were registered in the European Union (EU) in accordance with EU REACH on or before December 31, 2020, the end of the Brexit transition...

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 Environmental Audit Committee of the United Kingdom (UK) Parliament announced on November 1, 2022, that it is planning an oral evidence session later in 2022 to examine progress in implementing UK REACH, which governs the registration, evaluation, and authorization of chemical products in England, Scotland, and Wales. The Committee plans to take evidence from representatives of the Department of Environment, Food and Rural Affairs (DEFRA) and the Health and Safety Executive (HSE). In advance...

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...

On September 20, 2022, the European Commission (EC) began a public consultation on a draft delegated regulation that would amend Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) to add new hazard classes and their criteria. CLP would be amended to include hazard classes and criteria for: Endocrine disruptors; Substances and mixtures with persistent, bioaccumulative, and toxic (PBT) properties; Substances and mixtures with very persistent,...

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 Department for Environment, Food and Rural Affairs (Defra) has published two calls for evidence on amending Annex 14 of UK REACH to include the following substances: Dicyclohexyl phthalate (DCHP); and Disodium octaborate. In December 2021, the Health and Safety Executive (HSE) recommended which substances of very high concern (SVHC) are a priority for inclusion in Annex 14. Following HSE’s recommendation, the appropriate authorities (Defra Secretary of State, Scottish and Welsh ministers)...

The Health and Safety Executive (HSE) recently published the UK REACH Work Programme 2022/23. The work programme sets out the activity that HSE, supported by the Environment Agency and other relevant agencies, will carry out to operate UK REACH. To complement the publication of the work programme, the Department for Environment, Food and Rural Affairs (Defra) has published the rationale used for identifying particular substances for potential regulatory action under UK REACH in 2022 to...

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...

On May 18, 2022, the High Level Roundtable on the Implementation of the Chemicals Strategy for Sustainability (CSS) held its third meeting. During the meeting, the European Commission (EC) provided an update on the state of implementation of the CSS. According to the written report, main achievements since the last meeting of the High Level Roundtable include: Promoting Safe and Sustainable-by-Design Chemicals: The EC proposal for an update of the Industrial Emission Directive was adopted...

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...

By Lynn L. Bergeson and Carla N. Hutton The United Kingdom (UK) Health and Safety Executive (HSE) announced on May 6, 2022, the beginning of a six-month public consultation on restriction proposals on lead in ammunition and substances in tattoo inks and permanent make-up (PMU). According to its press release, HSE proposed the restriction on lead in ammunition after identifying there is an unacceptable risk to human health and the environment that is not adequately...

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...