July 28, 2022

DEFRA Calls for Evidence on Amending UK REACH Authorization List

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)...
July 12, 2022

Defra Publishes Rationale for UK REACH Work Programme Priorities in 2022/23

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...
June 29, 2022

ECHA Adds Chemical to Candidate List

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...
June 9, 2022

High Level Roundtable on the CSS Holds Third Meeting in May 2022

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...
May 24, 2022

ECHA Begins Consultation Identifying BPF, BPAF, and Eight BPAF Salts as Endocrine Disruptors

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...
May 10, 2022

HSE Begins Public Consultations on First Restriction Dossiers under UK REACH

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...
May 3, 2022

27 Percent of CSRs Fail in First Year of Manual Completeness Checks

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...
May 3, 2022

Trichloroethylene Use Reduces by 95 Percent Due to REACH Authorization Requirements

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)...
May 3, 2022

ECHA Begins Consultation on Proposed EU REACH Restriction for Dechlorane Plus™

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....
May 3, 2022

ECHA Adds 27 Substances to the Community Rolling Action Plan

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...
May 3, 2022

EC Adds Five Substances to EU REACH Authorization List

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...
May 2, 2022

HSE Produces a Final Opinion on the First New REACH Application for Authorization

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...
May 2, 2022

HSE Publishes the First Rolling Action Plan under UK REACH

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...
May 2, 2022

EC Publishes Restrictions Roadmap, Prioritizing Group Restrictions for the Most Harmful Chemical Substances

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...
May 1, 2022

EC Updates EU REACH Information Requirements

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...
May 1, 2022

ECHA and EU Member States Conclude Assessment of Regulatory Needs on Group Assessment of Bisphenols

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;...
April 28, 2022

Sweden Proposes N-(Hydroxymethyl)acrylamide as a New SHVC

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....
April 20, 2022

EP Committee Approves Corporate Sustainability Reporting Directive

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...
April 5, 2022

Recording Available: “UK REACH, What’s Happened and What’s Next?”

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...
March 8, 2022

UK HSE Opens Call For Evidence For Four Substances

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) derivs....
March 8, 2022

EC Begins Public Consultation On Reducing The Release Of Microplastics Into The Environment

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...
March 8, 2022

ECHA Seeks Comment On Proposal To Add Eight SVHCs To Authorization List

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...
March 8, 2022

EU Opens Consultation On Changes To REACH

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...
March 8, 2022

Register Now For “UK REACH, What’s Happened And What’s Next?,” On March 23, 2022

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...