Climbazole opinion has been published on the SCCS website

An Addendum to the opinion on Climbazole has been recently published by the Scientific Committee on Consumer Safety (SCCS) of the European Commission.

What is Climbazole?

Climbazole is a common ingredient used in cosmetics as preservative, also know by its chemical name 1-(4- chlorophenoxy)-1-imidazol-1-yl-3,3-dimethyl-2-butanone.

The use of Climbazole is currently restricted in the European Union up to a maximum authorized concentration of 0.5% in a finished product. However, the previous opinions of the SCCS had assessed its presence in different cosmetic product categories combined -as shampoo, hair lotion, etc.- up to 0.5 % for leave on cosmetics and up to 2% as anti-dandruff agent in rinse-off hair products.

Presence in cosmetic product categories:

The combined presence of Climbazole in different cosmetic product categories has been subject of debate as it can trespass the maximum allowed concentration by too high overall exposure.

To address the current objective of decreasing the authorised palette of preservatives and considering that less than 1% of products launched in the EU contain this substance, the SCCS has re-evaluated the maximum limits of Climbazole by performing a new risk assessment, considering a more realistic application frequency.

Conclusion

The maximum concentrations of Climbazole considered as safe under an aggregate exposure scenario are as follows:

2% as anti-dandruff agent in rinse-off shampoos and 0.2% as cosmetic preservative in leave on formulations (face cream, hair lotion, foot care) except for cosmetics applied on a full body area (body lotion).

With more than 25 years of regulatory experience, it will be our pleasure to help and advice you on EU cosmetics regulatory updates, SCCS opinions and restricted or banned cosmetic ingredients in the EU. If you would like to know more on cosmetics products regulatory compliance, please contact us.

Victor Pastor Martin

in News