Hazard List, Harmonization, Toxicity Tests and O'Malley Appointment: ECHA Updates

The European Chemicals Agency (ECHA) has made several moves in recent months relevant to cosmetics, personal care and fragrance chemicals safety, testing, labeling and more, as well as added a new acting executive director. Following is a brief roundup.

Hazardous Candidate Chemical Addition

1,7,7-Trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one and any of its individual isomers and/or combinations was added to the ECHA's candidate list of substances of very high concern due to potential endocrine-disrupting properties. While it is unclear how prevalent these materials are in cosmetics, the Personal Care Products Council (PCPC) INCI Dictionary currently indicates three suppliers offering its technical equivalent, 4-methylbenzylidene camphor, and one supplier providing a blend containing it, all of which relate to sunscreen applications.

See archived: EU Draws the Line on Endocrine Disruptors

Harmonized Classification and Labeling

Eugenol (CAS: 97-53-0) and tetrahydrofurfuryl methacrylate (CAS: 2455-24-5) are among recent proposals from Denmark and Austria, respectively, to the ECHA for harmonized classification and labeling. The proposals are submitted by Member State competent authorities, manufacturers, importers or downstream users. Interested parties can follow the progress of a proposal through the CLH process, from the notification of the intention to the adoption of the opinion of the Committee for Risk Assessment (RAC).

The advance notice aims to enable interested parties to plan and prepare for later comment. Anyone with relevant information on the identity or hazard properties of a substance is encouraged to provide this information to the dossier submitter during the early stages of the process, or at the latest during the consultation.

See related: Toxicological Evaluation of Cosmetics; A Primer

Toxicity Testing Dosing

The ECHA highlighted new advice for determining dose levels in toxicity testing to ensure reliable results while avoiding repeated animal tests. The agency notes this is clarified in the amended REACH annexes, which apply as of January 2022.

"We need to ensure that any test results can reliably show whether a chemical causes severe health effects or not. In doing so, we avoid companies having to redo inconclusive tests and causing more suffering to animals.

Briefly, the annexes state that toxicity tests should be performed at an appropriately high dose level, in line with the corresponding OECD test guideline. Also, the ECHA’s advice on how to apply dose selection for repeated dose toxicity and reproductive toxicity is aligned with OECD guidelines and guidance documents.

The ECHA’s Director for Hazard Assessment, Mike Rasenberg, said “The amended REACH annexes and our instructions guide companies to do toxicity tests using the correct dose level. We need to ensure that any test results can reliably show whether a chemical causes severe health effects or not. In doing so, we avoid companies having to redo inconclusive tests and causing more suffering to animals.”

The agency notes its guidance document on Information Requirements and Chemical Safety Assessment–Chapter R.7a will be revised to take the amended REACH annexes into account. It will be published later in 2022.

O'Malley Named Acting Executive Director

Finally, Shay O’Malley, director of resources, has been named ECHA’s Acting Executive Director as of April 1, 2022, until the new Head of the Agency starts in the role. In relation, Bjorn Hansen will retire on March 31, 2022.

Shay O’Malley, director of resources, has been named ECHA’s Acting Executive Director as of April 1, 2022.

O’Malley became ECHA’s Director of Resources in January 2015, and he holds the responsibility for ECHA’s finance, human resources and corporate service functions. He joined ECHA in March 2011 as Head of Unit—Human Resources. Prior to joining ECHA, Shay worked in a number of senior management positions with the Irish communications regulator (ComReg) and he also served as an officer in the Irish Defense Forces.