SCCS publishes final opinions on Acetophenone and Heliotropin
Two fragrance ingredients avoided an EU-wide ban this October, acetophenone and heliotropin. Both were headed toward classification as Reproductive Toxicity Category 1B, which under Article 15 of the Cosmetics Regulation generally means an automatic prohibition unless the SCCS can establish safe conditions of use first. That’s exactly what’s happened here, for both substances.
Why these ingredients were at risk
Spain first proposed the Repr. 1B classification for acetophenone back in 2023, and ECHA’s Committee for Risk Assessment (RAC) went on to recommend it. Heliotropin followed a similar path: in 2024, RAC recommended classifying it as both Repr. 1B and a skin sensitiser. Once a classification like that lands, a fragrance ingredient is presumed banned in cosmetics by default. An SCCS opinion carving out a safe concentration is what keeps it usable at all.
Acetophenone: safe up to 100 ppm, and only as a trace in natural materials
Acetophenone (CAS 98-86-2, EC 202-708-7) has a sweet, floral scent. Worth noting how narrow the industry’s own submission was here: nobody defended acetophenone as an intentionally added cosmetic ingredient. The dossier covered only its presence as an unavoidable trace constituent of Natural Complex Substances (NCS), things like essential oils, absolutes, concretes and resinoids.
The SCCS concluded it’s safe up to 100 ppm (0.01%) in the finished product, for adults and children from age 3, when it occurs this way. The exposure assessment accounted for other sources too, including food and tobacco smoke, not just cosmetics. The SCCS was explicit that it did not evaluate the NCS itself, only the acetophenone content within it, so a natural ingredient can clear this limit and still carry other unassessed substances. It’s also worth being clear this isn’t a green light for acetophenone as a standalone added ingredient, since that was never what was assessed.
Heliotropin: a narrow safe-use window
Heliotropin (CAS 120-57-0, EC 204-409-7), also known as piperonal, is mostly synthetic and used in perfumes, lotions, creams, shampoos and deodorants, both as a fragrance note and to stabilise fragrance blends or mask off-notes from other ingredients.
The SCCS set the safe concentration at 1.8%, using a margin-of-safety approach based on a reproductive toxicity study in rats, but limited the finding to fine fragrances for adults only. The applicant also submitted margin-of-safety figures for other product types, including products for children, which looked acceptable too, but the SCCS hasn’t formally assessed or endorsed that wider use. Extending the finding would need its own mandate from the Commission.
What this means for brands
Neither opinion is cosmetics law yet, but this is the groundwork for the next Omnibus Act on CMR substances, so expect these limits to get written into the Cosmetics Regulation. If you use either ingredient:
- Check formulas against the limits, especially heliotropin outside fine fragrance.
- For acetophenone, confirm whether it’s present via an NCS, not as an added ingredient, and check the finished-product concentration against supplier data or testing.
- Flag anything over these levels for reformulation ahead of the binding deadline.
CE.way can check your fragrance formulas against both limits and flag anything that needs attention. Get in touch if you’d like us to run that review.
Sources
SCCS, opinion on the safety of Acetophenone (CAS No. 98-86-2, EC No. 202-708-7), final version of 14 October 2026, SCCS/1689/26.
SCCS, opinion on the safety of Heliotropin (CAS No. 120-57-0, EC No. 204-409-7) used in cosmetic products, final version of 12 October 2026, SCCS/1688/26.
ECHA, Committee for Risk Assessment (RAC) opinion on the harmonised classification and labelling of Acetophenone.
ECHA, Committee for Risk Assessment (RAC) opinion on the harmonised classification and labelling of Heliotropin, June 2024.
Article 15, Regulation (EC) No 1223/2009 on cosmetic products.
