The European Union (EU) has issued new restriction the use of Climbazole, 1-(4-Chlorophenoxy)-1-(imidazole-1-yl)-3,3-dimethylbutan-2-one, in cosmetic products.
Published by the European Commission (EC) on April 30, 2019, Regulation (EU) 2019/698 amends the current rules concerning Climbazole. Currently, ready to use preparations can contain Climbazole to a maximum concentration of 0.5%, when used as a preservative.
The EC has now considered the opinion of the Scientific Committee on Consumer Safety (SCCS) – SCCS/1600/18 – which considered an aggregate exposure scenario. In light of this, Climbazole is now considered safe for use at a maximum concentration of:
- Face cream, hair lotion & foot cream – 0.2%
- Rinse-off shampoo – 0.5%
- Anti-dandruff rinse-off shampoo – 2%
Climbazole is a topical antifungal agent commonly used in the treatment of human fungal skin infections such as dandruff and eczema but can also be used to inhibit the development of micro-organisms in the product. Known side-effects include localized irritation of the skin, such as redness and itching.
The new regulation came into force on May 22, 2019. The important dates for stakeholders to remember are:
- From November 27, 2019 – products not complying with the new rules shall not be placed onto the market in the EU
- From February 27, 2020 – shall not be made available in EU markets
Cosmetic manufacturers are now advised to check their products comply with the latest regulations for Climbazole.
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