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EU SCCS Issued Preliminary Opinion on Acetophenone, Safe Up to 100 ppm in Cosmetics

May 15, 2026
EU
Cosmetics
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On May 4, 2026, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued preliminary opinion (SCCS/1689/26) open for comments regarding the safety of Acetophenone (CAS No. 98-86-2). The deadline for submitting comments is set for July 6, 2026.

Preliminary Opinion on Acetophenone

In light of the data provided and taking into consideration the possible classification as ‘Repr.1B’ under Regulation (EC) No 1272/2008 (CLP Regulation), the SCCS considers Acetophenone safe when present up to a maximum concentration of 100 ppm (0.01%) in cosmetic products, taking also into account sources of exposure other than cosmetics (food, tobacco smoking).

Natural complex substances (NCS) as such were not assessed, so the conclusion on safety only relates to Acetophenone as part of NCS, and not to NCS as such.

Assessment Background

In March 2025, the European Risk Assessment Committee (RAC) of ECHA issued an opinion recommending classification of Acetophenone as 'Reprotoxic Category 1B (H360FD)'. Under Article 15(2) of the Cosmetics Regulation, CMR 1A/1B substances are prohibited in cosmetic products. In view of this, regulatory measures must be adopted by the Commission services of the classification as CMR 1A or 1B of the substance(s) concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

However, the EU Cosmetics Regulation provides an exemption pathway for CMR 1B substances: if all four conditions below are met simultaneously, application may be made for continued use in cosmetic products:

  • Compliance with relevant food safety requirements;
  • No suitable alternative ingredients are available;
  • The product is intended for a specific use with known exposure levels;
  • The SCCS considers the use in cosmetic products to be safe, with particular attention to cosmetic exposure levels and cumulative exposure from other sources, especially for vulnerable populations.

In September 2025, the European Commission requested SCCS to conduct a safety assessment on Acetophenone in view of the potential classification.

Interpretation of Acetophenone

Acetophenone (CAS No. 98-86-2, EC No. 202-708-7), is an aromatic compound commonly used in cosmetics primarily as a perfuming agent, valued for its sweet and floral scent. It occurs naturally in various plant extracts (also called ‘NCS’ for Natural Complex Substances), such as essential oils,concretes, absolutes, gums and resinoids. In addition, Acetophenone is also listed as a food additive in Implementing Regulation (EU) No 872/2012. In particular, the Joint FAO/WHO 10 Expert Committee on Food Additives (JECFA) concluded that the substance does not present 11 a safety concern at current low levels of intake when used as a flavouring agent.

The Global Cosmetic Ingredient Regulatory Database-Global CosIng, independently developed by CIRS Group indicates that Acetophenone (CAS No. 98-86-2) is included in the following key lists globally. 

Implications for Enterprises

Enterprises using acetophenone or NCS ingredients containing acetophenone should take note of the following:

  • Review product formulations and calculate NCS-derived amounts: Conduct a systematic review to determine whether acetophenone is present in the formulation, whether added as an individual fragrance ingredient or introduced through NCS raw materials such as essential oils;
  • Preliminary assessment against the threshold: Referencing the 100 ppm concentration recommended in the SCCS preliminary opinion, conduct a preliminary assessment of whether the actual acetophenone concentration in current formulations may meet the threshold, and prepare for compliance in advance;
  • Monitor subsequent developments: As the SCCS opinion is currently open for public comment, enterprises are advised to track the publication of the final opinion and subsequent regulatory measures by the European Commission. CIRS Group will continue to monitor the SCCS assessment opinion and changes to EU cosmetics regulations, and provide timely updates.

For more detailed information about Global CosIng or if you need any assistance or have any questions, please get in touch with us via cosmetic@cirs-group.com.

Our Services

  • EU Cosmetic Product Formula and Label Review
  • EU Cosmetic Responsible Person
  • Product Information File (PIF)
  • EU Cosmetic Safety Assessment (CPSR)

Further Information:
SCCS- Preliminary Opinion-Acetophenone

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