SCCS Final Opinions on Heliotropin and Acetophenone Clarify Safe Use in Cosmetics

SCCS Final Opinions: Safety Conclusions and Scope

Heliotropin: Up to 1.8% in Fine Fragrances for Adults Only

The Scientific Committee on Consumer Safety (SCCS) adopted its final opinion on Heliotropin, SCCS/1688/26, on 12 October 2026.

Taking into account concerns associated with its possible classification as toxic to reproduction, Category 1B (Repr. 1B), the SCCS concluded that Heliotropin (CAS No. 120-57-0) is safe at a maximum concentration of 1.8%, only in fine fragrances for adults.

The assessment covers this specific use. Although the applicant submitted margin-of-safety calculations for other cosmetic products, including products for children, these calculations do not extend the scope of the SCCS assessment or establish an equivalent safety conclusion for those uses.

Acetophenone: Up to 100 ppm as a Constituent of Natural Complex Substances

The SCCS adopted its final opinion on Acetophenone, SCCS/1689/26, on 14 October 2026.

The assessment addresses Acetophenone (CAS No. 98-86-2) present as a constituent of natural complex substances (NCS) used in cosmetic products. The SCCS concluded that it is safe at a maximum concentration of 100 ppm (0.01%) in the finished cosmetic product, for adults and children aged three years and above, including exposure from sources other than cosmetics.

The conclusion has two important boundaries:

• It relates to Acetophenone as part of NCS, rather than supporting its use as a separately added cosmetic ingredient.

• The NCS themselves were not assessed. Meeting the assessed Acetophenone concentration does not establish the safety of the complete natural material.

Regulatory Context: A Favourable Opinion Is One Condition for a CMR Derogation

Both opinions were prepared following recommendations by the European Chemicals Agency's Committee for Risk Assessment (RAC) to classify the substances as Repr. 1B under Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP Regulation). A RAC recommendation must be distinguished from a legally adopted harmonised classification and its application date.

Under Article 15(2) of Regulation (EC) No 1223/2009 on cosmetic products, substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) of Category 1A or 1B in Part 3 of Annex VI to the CLP Regulation are generally prohibited in cosmetics. Their use may be permitted by way of derogation where all applicable conditions are met, including:

• Compliance with the specified food-safety requirements;

• The absence of suitable alternative substances, documented through an analysis of alternatives;

• An application for a particular product-category use with known exposure; and

• A favourable SCCS assessment that considers overall exposure and vulnerable population groups.

A favourable SCCS opinion does not, on its own, establish that all derogation conditions have been fulfilled. Businesses must assess the applicable legislation separately from the scientific conclusions.

Final Assessments Refine Exposure Calculations

For Heliotropin, the SCCS used the 95th-percentile product-use amount rather than the applicant's arithmetic mean when recalculating exposure from non-spray fine fragrances. It also excluded tobacco and nicotine-containing e-cigarette sources from the final margin-of-safety calculation, while documenting the relevant exposure information in the annexes. These methodological decisions do not broaden the assessed cosmetic use.

For Acetophenone, the final opinion explicitly identifies the covered age groups and confirms consideration of non-cosmetic exposure. The SCCS recalculated children's cosmetic exposure using measured product-use data because it considered the applicant's body-surface-area extrapolation to underestimate use.

Impact and Recommended Actions for Businesses

The principal challenge for manufacturers, brands and importers is to determine whether their actual formulations, intended users and exposure conditions fall within the assessments. Fragrance and natural-ingredient suppliers should be prepared to provide composition information sufficient to support that review.

REACH24H recommends that affected businesses:

• Identify relevant ingredients and sources. Review formulations, fragrance blends and natural raw materials for Heliotropin and Acetophenone, including constituents introduced through NCS.

• Verify finished-product concentrations. Account for contributions from all relevant raw materials. Where natural-material composition varies, review supplier specifications and supporting analytical information.

• Check product categories and age groups. Do not extrapolate the Heliotropin conclusion beyond adult fine fragrances or the Acetophenone conclusion to children under three.

• Review safety documentation. Have the safety assessor evaluate whether the final opinions require changes to the exposure assessment, safety reasoning or supporting data in the Cosmetic Product Safety Report (CPSR) and Product Information File (PIF).

• Monitor regulatory implementation. Track relevant CLP amendments and subsequent cosmetic regulatory measures, including any legally established restrictions, derogations and application dates.

These are recommended review actions arising from the scientific opinions. The publication date of 15 October 2026 is not a reformulation deadline.

How REACH24H Can Help

REACH24H supports manufacturers, brands and importers through EU cosmetic compliance services, including ingredient and formula review, safety-data gap assessment, CPSR preparation and review, and PIF maintenance.

For products containing Heliotropin or Acetophenone, our team can review formulation and supplier information against the assessed conditions, identify documentation gaps and support the evaluation of relevant regulatory developments.