In October, the EU Scientific Committee on Consumer Safety (SCCS) published final opinions on acetophenone and heliotropin, following indications provided in the minutes of the SCCS Working Group meeting released earlier in the month. The SCCS evaluation was triggered by concerns related to the potential classification of both substances as Reproductive Toxicity Category 1B (Repr. 1B) under Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging (CLP).
Aromatic compounds commonly used for their fragrance properties
Both substances are aromatic compounds commonly used in cosmetic products, particularly for their fragrance properties. Acetophenone occurs naturally in various plant-derived materials and natural complex substances (NCS), such as essential oils, concretes, absolutes, gums, and resinoids. Heliotropin (also known as piperonal) is naturally present in some essential oils but is predominantly produced synthetically and widely used as a fragrance ingredient in perfumes, lotions, creams, shampoos, and deodorants.
Safety of Acetophenone
Acetophenone (CAS No. 98-86-2, EC No. 202-708-7) is chemically known as 1-phenylethanone. It is primarily used in cosmetics as a fragrance ingredient due to its sweet, floral scent.
Based on the data submitted and considering the concerns associated with its potential classification as Repr. 1B, the SCCS concluded that acetophenone is safe when present in cosmetic products at concentrations up to 100 ppm (001%) for both adults and children aged three years and above. This conclusion takes into account aggregate exposure, including exposure from sources other than cosmetic products.
The SCCS clarified that natural complex substances (NCS) were not assessed as part of this opinion. Consequently, the safety conclusion applies only to the presence of acetophenone within such substances and does not constitute a safety assessment of the NCS themselves.
Safety of Heliotropin
Heliotropin (CAS No. 120-57-0, EC No. 204-409-7) was assessed by the SCCS in light of the same concerns regarding its potential classification as Repr. 1B under the CLP Regulation.
Based on the available data, the SCCS concluded that heliotropin is safe when used at concentrations up to 1.8% in only fine fragrances intended for adults. The opinion is limited to this specific use, as defined by the mandate received by the SCCS.
Nevertheless, the Committee noted that the applicant – the stakeholder who submitted the scientifical evidence – also submitted margin of safety (MoS) calculations for a wider range of cosmetic products, including products intended for children. According to these calculations, the combined exposure from such uses would remain within acceptable safety margins.
To assess the safety of heliotropin in other cosmetic product categories, the European Commission would need to request a separate SCCS assessment through a new mandate.
What happens next?
The European Commission is expected to take these SCCS conclusions into account in the future Omnibus Act addressing CMR substances in cosmetic products. Companies using acetophenone or heliotropin should therefore continue to monitor regulatory developments closely and verify, where relevant, whether their fragrance ingredients or botanical extracts contain these substances, based on supplier documentation and analytical testing.
Do you have questions on compliance of cosmetics in the EU, UK, USA, and Canada? Contact us here or at coslaw@obelis.net.
References
SCCS. (2026). Opinion on the safety of Acetophenone. Retrieved on 16 October 2026.
SCCS. (2026). Opinion on the safety of Heliotropin used in cosmetic products. Retrieved on 16 October 2026.
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