SCCS on 4-MBC, formaldehyde and homosalate releasers in cosmetics

In May 2025, the European Commission's Scientific Committee on Consumer Safety (SCCS) published new preliminary opinions that could mark significant changes in the regulation of certain widely used cosmetic ingredients. The opinions, now open for public consultation, focus on 4-methylbenzylidene camphor (4-MBC), several formaldehyde-releasing substances, and the UV filter homosalate.

Table of contents

1. 4-MBC: Limited presence, but with persistent concerns

2. Formaldehyde releasers: closer to a severe restriction

3. Homosalate: green light only with conditions

4. What's next?

5. Conclusion

   
   

SCCS on 4-MBC, formaldehyde and homosalate releasers in cosmetics

4-MBC: Limited presence, but with persistent concerns

4-MBC, a UV filter with restricted use in Europe , has come under scrutiny for its potential endocrine activity. Although its use in the EU is very limited and in many cases has been replaced by safer alternatives, the SCCS has re-evaluated its safety in light of new toxicological data.

According to the preliminary opinion, the use of 4-MBC in leave-in products cannot be considered safe under current conditions. This recommendation reinforces the regulatory trend toward eliminating ingredients suspected of disrupting the endocrine system, even if their commercial use is marginal.

Formaldehyde releasers: closer to a severe restriction

Another focus of the SCCS is formaldehyde-releasing preservatives, such as DMDM Hydantoin, Imidazolidinyl Urea, and Quaternium-15. These ingredients, used for decades for their antimicrobial efficacy, have been questioned due to the risk of sensitization and cumulative exposure to formaldehyde, a known carcinogen.

The preliminary opinion suggests that even when the 0.05% formaldehyde release threshold (currently required by the Cosmetics Regulation) is respected, adequate safety may not be guaranteed, especially in products intended for people with sensitive skin or for frequent use.

This position could herald a gradual withdrawal of this type of preservative from the European market.

Homosalate: green light only with conditions

Regarding homosalate sunscreen, the SCCS maintains the assessment previously published in 2023, confirming that its use is safe up to a maximum concentration of 0.5% in leave-in facial products, when strict purity measures and specifications are applied.

Although homosalate can still be found at much higher concentrations in some markets, such as the US, Europe continues to apply a more restrictive approach, in line with the precautionary principle governing EU cosmetics legislation.

What's next?

These opinions are currently open to public comment and could lead to amendments to Annex II (prohibited substances) and Annex V (permitted preservatives) of Regulation (EC) No 1223/2009. Following final adoption, economic operators are expected to have a transitional period to reformulate affected products and adapt to the new requirements.

Conclusion

The SCCS's ongoing evaluation of ingredients highlights the constant evolution of the EU cosmetic safety framework. Beyond compliance, these decisions also provide a roadmap for innovation: opting for cleaner, safer, and more sustainable formulas is not only an obligation, but a growing competitive advantage.