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SCCS Says Heliotropin Is Safe at 1.8%. That Number Covers One Product Type.

2 days ago
5 min read

In October 2026, the EU's Scientific Committee on Consumer Safety (SCCS) closed two files that fragrance users have been watching since spring. Heliotropin (also sold as piperonal, CAS 120-57-0) and acetophenone (CAS 98-86-2) both went through preliminary opinions, heliotropin in April and acetophenone in May, and both received final opinions after the comment period. The SCCS adopted the heliotropin opinion (SCCS/1688/26) on 12 October and the acetophenone opinion (SCCS/1689/26) on 14 October. The Commission published both on 15 October.


Read quickly, the headline is reassuring: both substances are "safe". Read properly, it is much narrower. Each opinion answers a specific question, under a specific mandate, for specific products, and anything outside that scope has no SCCS backing at all. This article explains what was actually decided, why it matters even though no new legal limit exists yet, and what to check in your fragrance blends.


Why the SCCS was asked in the first place

The trigger was a recommendation by the European Chemicals Agency's Committee for Risk Assessment (RAC) to classify both substances as toxic to reproduction, Category 1B (Repr. 1B), under Regulation (EC) No 1272/2008 (CLP). A RAC recommendation is not the same as a legally adopted harmonised classification. The classification only has legal effect once it is adopted into Annex VI of CLP and an application date is set.


That distinction matters because of Article 15 of Regulation (EC) No 1223/2009. Substances classified as CMR 1A or 1B in Part 3 of Annex VI to CLP are, in principle, prohibited in cosmetics. A derogation is possible only if all conditions are met: compliance with the applicable food-safety requirements, no suitable alternative (documented in an analysis of alternatives), an application for a defined product category with known exposure, and a favourable SCCS opinion that considers overall exposure and vulnerable groups. The October opinions speak to that last condition and nothing else. They do not grant a derogation, create a binding concentration limit or set an application date.


What the two opinions actually say

Heliotropin. The SCCS considers it safe at up to 1.8% in fine fragrances intended for adults, and only there. The opinion is limited to that use because that is what the mandate covered. The applicant also submitted margin-of-safety calculations for other products, including products for children, and the SCCS noted that those calculations stay within acceptable margins. But noting is not concluding: to obtain an opinion on other categories, the Commission would need to issue a new mandate. In the final opinion the SCCS also recalculated exposure from non-spray fine fragrances using the 95th-percentile use amount rather than the applicant's arithmetic mean, and left tobacco and e-cigarette sources out of the final margin-of-safety calculation.


Acetophenone. The SCCS considers it safe at up to 100 ppm (0.01%) in the finished cosmetic product, for adults and children aged three and over, taking exposure from non-cosmetic sources into account. The conclusion applies to acetophenone as a constituent of natural complex substances (NCS), such as essential oils, absolutes and resinoids. It does not support acetophenone added as a stand-alone ingredient, and it does not assess the NCS themselves.




What this means for your formulations

The practical effect is that your safety assessor now has a benchmark that did not exist in the spring. Two worked examples show why scope matters. The numbers below are illustrative only.


Suppose a leave-on cream contains 0.5% of an essential oil whose supplier specification shows 2% acetophenone. The contribution is 0.5% × 2% = 0.01%, exactly the 100 ppm ceiling, before counting any other acetophenone-containing raw material in the formula. Because the acetophenone content of natural materials can vary from batch to batch, a specification that sits at the limit leaves no margin.


Now suppose a fragrance compound used at 5% in a body lotion contains 10% heliotropin. The lotion carries 0.5% heliotropin, well under 1.8%. The number looks comfortable, but a body lotion is not an adult fine fragrance, so the SCCS conclusion does not apply to it. The figure is safe on paper; the opinion simply does not cover that product.


Three mistakes we keep seeing

"1.8% is the heliotropin limit." It is not a limit. It is the highest concentration the SCCS found safe in one use, adult fine fragrance. Applying it to creams, shampoos, deodorants or children's products borrows a conclusion the SCCS did not reach.


"Natural means out of scope." The acetophenone conclusion exists precisely because the substance occurs in plant-derived materials. If your formula relies on essential oils, absolutes or resinoids, acetophenone from those sources counts towards the 100 ppm, and the SCCS did not assess the natural material as a whole.


"15 October was either a deadline or a clearance." It was neither. The publication date is not a reformulation deadline, and a favourable opinion does not establish that every derogation condition has been met. It is a scientific input to a decision the Commission has not yet taken.


What comes next, and why the sequence outlasts these two substances

Coslaw reports that the Commission is expected to take the two opinions into account in the future Omnibus Act on CMR substances in cosmetics. In the sources we reviewed, no date has been made public. What is durable here is the sequence, and it applies well beyond these two substances: the RAC recommends a classification, the SCCS tests whether specific cosmetic uses remain safe, and the Commission decides whether to ban the substance or allow a derogation. It is the same pathway that made Galaxolide a live issue after ECHA's RAC opinion in March 2026.


Omnibus VI has already compressed the time brands have once a CMR ban is adopted, so the time to map exposure is before the legal text appears. A brand that knows which of its raw materials carry a RAC recommendation, and which uses an SCCS opinion really covers, can plan reformulation or a derogation case on its own timetable instead of its supplier's.


Checklist: what to do this month


  • Ask suppliers for the heliotropin (CAS 120-57-0) and acetophenone (CAS 98-86-2) content of every fragrance compound, including constituents of essential oils and absolutes.


  • Calculate finished-product concentrations across every raw material that contributes, not only the fragrance.


  • Match each product to the assessed use: adult fine fragrance for heliotropin; adults and children aged three and over, as an NCS constituent, for acetophenone.


  • Flag what falls outside: children's products, products for under-threes, heliotropin in anything other than adult fine fragrance, and acetophenone added as a stand-alone ingredient.


  • Ask your safety assessor whether the exposure assessment in the CPSR and PIF needs updating in light of the final opinions.


  • Track CLP and Omnibus publications. Any legally binding restriction, derogation or application date will come from there, not from the SCCS.


Not sure whether your fragrance blends and natural extracts fall inside what the SCCS actually assessed? Cláritas Regulatory can review your formulations and supplier documentation against these opinions before the Commission's next move. Get in touch.





 
 
 

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