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...
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...
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...
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...
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...