Although acetophenone is not among the most widely discussed cosmetic ingredients, its recent toxicological classification and subsequent SCCS evaluation make it an important case study for understanding how the European Union manages substances of concern in cosmetic products.
The preliminary opinion is currently open for comments until 6 July 2026, after which the SCCS will consider any scientific feedback before adopting its final position.
Why Is Acetophenone Under Review?
Acetophenone is an aromatic compound that can be found naturally in certain plant-derived materials and may occur as a constituent of Natural Complex Substances (NCS), such as some fragrance ingredients and essential oils.
The regulatory attention surrounding acetophenone originates from a recommendation by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) to classify the substance as toxic for reproduction Category 1B under the Classification, Labelling and Packaging (CLP) Regulation. Such classifications are highly relevant for cosmetics because Article 15 of the EU Cosmetics Regulation generally prohibits the use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), unless specific conditions for a derogation are met.
This triggered a request for the SCCS to evaluate whether acetophenone could still be considered safe under certain restricted conditions of use in cosmetic products.
An Important Distinction: Not a Defence of Acetophenone as an Ingredient
One of the most noteworthy aspects of the SCCS assessment is its limited scope.
The cosmetics industry did not submit a dossier seeking to defend acetophenone as an intentionally added cosmetic ingredient. Instead, the submission focused exclusively on acetophenone as a trace constituent of Natural Complex Substances. In practical terms, the question before the SCCS was not whether acetophenone should remain available as a cosmetic ingredient in its own right, but whether the unavoidable presence of small amounts of the substance in natural ingredients could be considered safe.
This distinction is critical because it reflects a broader trend in cosmetic regulation: regulators are increasingly required to evaluate not only intentionally added substances but also impurities, by-products and naturally occurring constituents.
The SCCS Conclusion
Based on the data submitted, the SCCS concluded in its preliminary opinion that acetophenone can be considered safe when present in cosmetic products at a maximum concentration of 100 ppm (0.01%), provided that it occurs as a constituent of Natural Complex Substances.
The Committee’s assessment also considered aggregate exposure from sources beyond cosmetics, including food and tobacco smoke. After evaluating the available toxicological information and estimated exposure levels, the SCCS concluded that the proposed maximum concentration does not raise a safety concern for consumers.
However, the opinion does not constitute a general safety endorsement of acetophenone in all cosmetic applications. The conclusion is specifically restricted to the conditions assessed by the SCCS and should not be interpreted as approval for broader use levels or different exposure scenarios.
What Does This Mean for Manufacturers?
For manufacturers using natural fragrance materials or other Natural Complex Substances, the preliminary opinion offers a degree of regulatory clarity.
If the SCCS final opinion remains unchanged, the presence of acetophenone at trace levels up to 100 ppm in cosmetic products may be considered acceptable from a safety perspective. This could help preserve the use of certain natural raw materials that naturally contain acetophenone without requiring extensive reformulation efforts.
At the same time, the opinion highlights the increasing importance of detailed compositional knowledge for natural ingredients. Companies may need robust analytical data to demonstrate that acetophenone levels remain within the concentrations considered safe by the SCCS.
The case also reinforces a broader regulatory reality: natural origin does not exempt a substance from toxicological scrutiny. Even constituents present at very low concentrations can become subject to extensive evaluation when hazard classifications evolve.
What Happens Next?
The current document is a preliminary opinion and remains open for scientific comments until 6 July 2026. Stakeholders may submit observations or additional data during this consultation period. The SCCS will then review the feedback before publishing its final opinion.
While significant changes are not always introduced between preliminary and final opinions, the consultation phase remains an important part of the EU scientific assessment process and can lead to clarifications, refinements or additional considerations.
For now, the key message is clear: according to the SCCS preliminary assessment, acetophenone does not present a safety concern when present as a constituent of Natural Complex Substances in cosmetic products at concentrations up to 100 ppm. Whether this conclusion remains unchanged in the final opinion will be closely watched by both industry and regulators in the months ahead.
