ANSES proposes classifying galaxolide as toxic for reproduction in the European CLP Regulation
ANSES is proposing a harmonised classification for galaxolide, sometimes referred to as HHCB, as a Category 1B reproductive toxicant under the CLP Regulation (for Classification, Labelling and Packaging of products). This substance, which is widely used in everyday products such as perfumes, cosmetics and air fresheners, can cause damage to human fertility and development, according to the conclusions of ANSES’s expert appraisal work. Since 27 January 2025, the scientific dossier has been available for public consultation on the website of the European Chemicals Agency (ECHA), for comments or provision of additional information on this substance.
A substance used in everyday products
Galaxolide is a synthetic musk used for its fragrance and masking properties. It is found in perfumes, cosmetics (soaps, shower gels, deodorants, creams, lotions, shampoos, hair conditioners, etc.), washing and cleaning products (detergents, softeners, washing-up liquids, ironing aids, etc.), air treatment products, polishes and waxes.
Residues of this substance have been found in human biological samples, particularly in breast milk and adipose tissue, suggesting chronic exposure via the environment or the use of products containing galaxolide.
Extending the current classification to human reproductive toxicity
Galaxolide is already classified at European level under the CLP Regulation because of its acute and chronic toxicity to aquatic life. It is currently being assessed by ANSES for its effects on the environment, in particular for its potential endocrine-disrupting properties and its suspected persistent, bioaccumulative and toxic (PBT) properties.
At the same time, ANSES has also carried out assessment work on this substance in the area of human health, concluding that it has suspected effects on fertility and presumed effects on development, which means that its current classification needs to be extended. This is because toxicological data show an impact on the rat as an animal model when exposed to the substance, for both male and female reproductive organs, and for subsequent generations.
The Agency is therefore proposing that galaxolide be classified and labelled as follows under the CLP Regulation: Reproductive toxicity; Category 1B (H360Df: May damage the unborn child. Suspected of damaging fertility.)
If this classification proposal is accepted at European level, galaxolide would therefore be identified as a CMR (carcinogenic, mutagenic, toxic for reproduction) substance for its reprotoxic impact.
Harmonised classification proposal submitted for public consultation
The harmonised classification proposal for galaxolide has been submitted for public consultation on ECHA's website until 28 March 2025. The aim of this consultation is to give all stakeholders the opportunity to comment on these proposals, by providing any additional scientific arguments and information they may have. Comments can be sent via a dedicated form on the ECHA website.
Following this consultation stage, ANSES will be asked to respond to the comments received. The initial proposal, comments and ANSES's responses to them will then be placed before ECHA’s Committee for Risk Assessment, which will issue an opinion on the classification of galaxolide.
Based on this opinion, the European Commission will draft regulatory texts allowing the proposed classifications to be included in the CLP Regulation.