▪︎ CLP, REACH
Heliotropin in cosmetic products: SCCS allows exception
The evaluation of fragrances is increasingly caught between scientific risk assessment and regulatory precaution. Against this backdrop, the European Commission has presented a well-founded assessment of the safety of heliotropin in a recent opinion from the Scientific Committee on Consumer Safety (SCCS).
Scientific Safety Assessment by the SCCS
In its opinions, the SCCS evaluates the health and safety risks of non-food consumer products and services. In the case of the fragrance substance heliotropin (1,3-benzodioxole-5-carbaldehyde; piperonal), the Committee concludes in its preliminary opinion that heliotropin can be used safely as a fragrance ingredient in perfumes for adults at concentrations of up to 1.8 %. This assessment is based on a margin-of-safety approach using reproductive toxicological data from a standardized animal study. A value of 300 mg/kg body weight per day from an oral reproductive toxicity study in rats was used as the so-called point of departure. In addition, the Committee took into account overall consumer exposure to heliotropin from various sources, including not only cosmetics but also food, household products, and e-cigarettes. This comprehensive exposure assessment ensured that a sufficient margin of safety for consumers could be maintained.
Harmonised Classification Would Lead to a Use Ban
In June 2024, the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) recommended a harmonised classification of heliotropin as toxic to reproduction, category 1B, as well as a skin sensitiser, category 1. If the European Commission were to follow this recommendation, it would have far-reaching consequences for the use of the substance in cosmetic products. Under the Cosmetics Regulation, such a classification would generally result in a prohibition of use unless the SCCS explicitly establishes that the substance can be used safely. This is precisely where the current opinion gains regulatory relevance, as it provides a scientific basis for allowing exemptions under defined conditions.
Relevance for Industry and Consumers
Due to its sweet, floral fragrance profile, heliotropin is a valued component of numerous cosmetic formulations, including creams, lotions, shampoos, and deodorants. In addition to its role as a fragrance ingredient, it is used to stabilise fragrance compositions or to mask less pleasant inherent odours of other ingredients. The positive safety evaluation by the SCCS allows manufacturers to retain established formulations or make only minor adjustments, without compromising product safety or consumer protection. Regarding the preliminary SCCS opinion, comments can still be submitted until 15 June 2026.
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