SKIP TO CONTENT
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...
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...
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...
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;...
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...