Archives

April 25, 2024

Germany Posts Information on Dossier Submitter’s Ongoing Role in Proposed REACH Restriction for PFAS

On April 15, 2024, Germany’s Federal Institute for Occupational Safety and Health (BAuA) REACH-CLP-Biozid Helpdesk published an item entitled “Dossier Submitter’s ongoing role in the PFAS restriction proposal.” While the European Chemicals Agency’s (ECHA) Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) evaluate the restriction proposal, the five national authorities that prepared the proposal (the Netherlands, Germany, Denmark, Sweden, and Norway) are...
March 29, 2024

ECHA Checks More than 20 Percent of REACH Registration Dossiers for Compliance

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...
March 18, 2024

ECHA Clarifies Next Steps for PFAS Restriction Proposal

The European Chemicals Agency (ECHA) issued a press release on March 13, 2024, to outline how the Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will progress in evaluating the proposal to restrict per- and polyfluoroalkyl substances (PFAS) in Europe. As reported in our February 13, 2023, memorandum, the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted a proposal to restrict more than 10,000 PFAS under the...
February 23, 2024

ECHA Begins Public Consultation on Recommending Authorization for Five SVHCs and Adding a New Hazard to DBP

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...
February 9, 2024

ECHA’s New Database for Chemicals Includes Information from all REACH Registrations

The European Chemicals Agency (ECHA) announced on January 30, 2024, the launch of ECHA CHEM, its “new solution for publishing information on chemicals.” According to ECHA, the first version of ECHA CHEM includes information from the more than 100,000 Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (REACH) registrations that companies have submitted to ECHA. On the support page for ECHA CHEM, ECHA notes that as it gradually transfers the data it makes publicly...
January 23, 2024

ECHA Adds Five Chemicals to Candidate List of SVHCs for Authorization

The European Chemicals Agency (ECHA) announced on January 23, 2024, that it added five chemicals to the Candidate List of substances of very high concern (SVHC) for authorization and updated the existing entry for dibutyl phthalate to include its endocrine-disrupting properties for the environment: Substance Name Reason for Inclusion Examples of Uses 2,4,6-Tri-tert-butylphenol Toxic for reproduction (Article 57(c))   Persistent, bioaccumulative, and toxic (PBT) (Article 57(d)) Manufacture...
December 14, 2023

ECHA Calls for Evidence on Certain Chromium (VI) Substances

According to an item in the December 13, 2023, issue of the ECHA Weekly, the European Chemicals Agency (ECHA) is looking for information for a potential restriction of certain chromium (VI) substances under the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (REACH). ECHA has opened a call for evidence targeting companies using chromium (VI) substances. ECHA seeks information on: The call for evidence is intended for interested parties, such as private companies...
October 26, 2023

ECHA Finds REACH Registrations in Breach of Update Requirement

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...
September 22, 2023

ECHA Enforcement Forum Publishes Advice on Enforceability on Restricting Creosote

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...
August 22, 2023

ECHA Publishes Main Alternatives to Substances Subject to REACH Authorization

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...
June 30, 2023

ECHA Accepting Comment on Draft SEAC Opinion on Proposed MCCP Restriction Proposal

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...
June 28, 2023

Registration Now Open for “Preparing a PFAS Game Plan in the U.S., the UK, and the EU” Webinar

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...
June 12, 2023

HSE Recommends Restricting Hazardous Substances in Tattoo and Permanent Makeup Inks

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...
June 6, 2023

HSE Proposes to Include Substances in UK REACH Substance Evaluation Rolling Action Plan

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...
May 26, 2023

ECHA Publishes Annual Report on Helpdesk Activities

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)...
May 16, 2023

ECHA Calls for Evidence on Analytical Methods to Measure CMR Substances in Childcare Articles

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)...
May 4, 2023

ECHA Publishes Q&A Document Following the April 5, 2023, PFAS Restriction Proposal Online Information Session

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...
May 3, 2023

ECHA Recommends Eight Substances for REACH Authorization

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...
March 23, 2023

Public Consultation Begins on PFAS Restriction Proposal; ECHA Will Hold Information Session on April 5

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...
March 14, 2023

ECHA Enforcement Forum Project Finds Most Downstream Users Adhere to “Fundamental” Authorization Duties

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....
March 1, 2023

ECHA Updates Recommendations to Improve REACH Registrations

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...
February 8, 2023

ECHA Announces Changes to Completeness Checks

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...
January 26, 2023

Recording Available For “Two Years Later: How Has the Chemicals Strategy for Sustainability Changed REACH and CLP Regulations?”

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...
January 17, 2023

ECHA Receives “One of the Broadest” Proposals to Restrict PFAS under REACH

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...
December 16, 2022

Register Now — Webinar: “Two Years Later: How Has the Chemicals Strategy for Sustainability Changed REACH and CLP Regulations?”

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...
November 16, 2022

ECHA Announces EU-Wide REACH Enforcement Project Will Focus on Imported Products

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...
October 14, 2022

ECHA Announces Receipt of Restriction Proposals for Bisphenols and Creosote

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...
September 8, 2022

ECHA Proposes to Identify Nine Substances as SVHCs

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,...
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

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

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...