Classification proposal for a fragrance

The substance hexyl salicylate, used in cosmetics and household cleaners, can have various effects on health, ranging from allergic skin reactions to abnormal foetal development. In order to better inform and protect consumers, ANSES has submitted a classification proposal to the European Chemicals Agency (ECHA) under the CLP Regulation on product classification, labelling and packaging. If validated, this classification will have direct consequences on the labelling of products containing this substance at European level. The classification proposal was submitted for public consultation on 8 February 2021, for a period of two months, to allow stakeholders to comment or provide any additional information at their disposal.

Hexyl salicylate is a fragrance used in many products such as cosmetics (mainly shampoos, soaps and other toiletries), household cleaners and detergents.

This substance is not currently subject to any regulatory measures at European level, but has been identified as potentially toxic to humans. In order to protect consumer health, therefore, ANSES assessed the effects associated with exposure to this substance, with a view to classifying it under the CLP Regulation.

Following its assessment, the Agency confirmed the substance's ability to cause allergic skin reactions, as well as toxic effects on foetal development (malformations, delayed development, etc.). For the latter, data are available on structurally similar substances – salicylic acid and methyl salicylate – which have already been classified for their toxicity for foetal development. ANSES has therefore proposed classifying the substance hexyl salicylate in the same way in the European Regulation.

If this proposal is validated, hexyl salicylate will have to be labelled as follows:

  • "May cause an allergic skin reaction; Category 1 (H317)";
  • "Suspected of damaging the unborn child; Category 2 (H361d)".

This proposal was submitted for public consultation on the ECHA website on 8 February 2021, for a two-month period, to give all stakeholders the opportunity to present their positions, scientific arguments or any additional information at their disposal.

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 hexyl salicylate. On the basis of this opinion, the European Commission will make its final decision.

Regulation on Classification, Labelling and Packaging (CLP)          

Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, known as the CLP Regulation, is the legislation in force in the European Union to ensure the protection of workers, consumers and the environment. In particular, it aims to identify any hazards posed by a substance or substance mixture due to its physico-chemical properties and its effects on health and the environment. This Regulation defines how these substances and mixtures must be classified, labelled and packaged. It also has impacts on other European regulations, possibly leading to the prohibition or substitution of highly hazardous substances or mixtures. Once the substance or mixture has been classified with regard to the identified hazards, appropriate labelling informs the user about these hazards through pictograms and safety data sheets. The European Chemicals Agency is responsible for its implementation