REACHblog®

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...

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...

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...

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...

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...

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,...

On December 21, 2022, the European Chemicals Agency (ECHA) began two public consultations: Bisphenol A (BPA) and other bisphenols: Germany has submitted a proposal to restrict the placing on the market of mixtures and articles containing bisphenol A, other bisphenols, and bisphenol derivatives with endocrine-disrupting properties for the environment. The proposed restriction would apply to mixtures and articles where the concentration is equal to or greater than ten parts per million (ppm)...

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 period....

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...

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...

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. To facilitate...

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...

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:...

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...

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...

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 2023. In...

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 and the European...

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 in...

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...

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 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...

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...

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...

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...

The Health and Safety Executive (HSE), the agency for the United Kingdom (UK) REACH, has created a Rolling Action Plan (RAP) to increase understanding of the hazard and risk profile of two substances on the Great Britain (GB) market. HSE states that “we have sought to complement rather than replicate evaluation work that has been or will be performed by other regulatory regimes (such as via EU REACH).” The two substances that have been added to the RAP are: Year...

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)....

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...

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; (Intermediate in)...

The Swedish Member State Competent Authority (MSCA) proposed that N-(Hydroxymethyl)acrylamide is a substance of very high concern (SVHC) due to its carcinogenic and mutagenic properties. There are 14 active registrations of the substance and it is imported or manufactured in the European Economic Area (EEA) in volumes of 1,000 to 10,000 metric tons per year. N-(Hydroxymethyl)acrylamide is used as a monomer for polymerization, as a fluoroalkyl acrylate copolymer, and in paints or coatings....

The European Parliament (EP) Legal Affairs Committee announced on March 15, 2022, that it voted 22-1 in favor of the Corporate Sustainability Reporting Directive. According to the Committee, if agreed with European Union (EU) governments, the bill would “make businesses more accountable for their impact on people and the planet, while giving investors and the public access to comparable, reliable and easily accessible information on sustainability.” The European Financial Reporting Advisory...

The Acta Group’s (Acta®) March 23, 2022, webinar “UK REACH, What's Happened and What's Next?” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/815913916012295937. During this 1-hour webinar, Lynn L. Bergeson, President, Acta; Steven P. Brennan, Ph.D., Senior Manager, REACH, Acta; and Jane S. Vergnes, Ph.D., DABT®, Vice President, Scientific Affairs and Director of Toxicology, Acta discussed the significant implications for chemical regulatory...

The Health and Safety Executive (HSE), in conjunction with the Environment Agency, has assessed 11 substances and substance groups that were added to the EU REACH Candidate List. As a result, the agencies have identified the following four substances, or substance groups, that require regulatory management options analysis (RMOA): Substance Name Identified Uses Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy)...

The EC announced on February 22, 2022, the launch of a public consultation on how best to reduce the amount of unintentionally released microplastics into the environment. According to the EC, the public consultation will support its initiative on Microplastics pollution – measures to reduce impacts on the environment, “a key deliverable of the Circular Economy Action Plan and the Zero Pollution Action Plan.” According to the EC, the consultation focuses on plastic pellets, synthetic...

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...

On January 20, 2022, the European Commission (EC) launched a public consultation seeking comment on a proposed revision of the REACH regulation (No. 1907/2006). The consultation is the most extensive to date; it covers many elements of the legislation and, once changes are implemented, will have a significant impact on industry for the future. The consultation topics include: Revision of the registration requirements, including increased information requirements and establishing the obligation...

Companies worldwide must be aware of the significant implications for chemical regulatory compliance under the United Kingdom (UK) REACH regulation as the UK has completed its first year of complete separation from the European Union (EU). Companies should act quickly to understand their rights and obligations under UK REACH to maintain continuity of their supply chains and market access. “UK REACH, What’s Happened and What’s Next?” will delve into these important issues with The Acta...