Regulation 2019/698: New restrictions for Climbazole
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Regulation 2019/698 of 30 April 2019, published in the Official Journal of the European Union on 7 May 2019, amends Annexes III (Restricted substances) and V (Preservatives) of Cosmetics Regulation 1223/2009, to tighten the restrictions of use of the preservative and anti-dandruff agent Climbazole. The ban will come into force as from 27 November 2019.
The whereas of Regulation 2019/698
The substance 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one, which has been assigned the name Climbazole under the International Nomenclature of Cosmetic Ingredients (INCI), is currently allowed as a preservative in cosmetic products at a maximum concentration of 0.5% in ready for use preparation. It is listed in entry 32 of Annex V to Regulation (EC) No.1223/2009. In accordance with Article 14(1)(d)(ii) of Regulation (EC) No.1223/2009, Climbazole may also be contained in cosmetic products for an intended use other than as preservative, only within the concentration limit laid down in entry 32 of Annex V.
The Scientific Committee on Consumer Safety (SCCS) concluded at its plenary meeting on 21-22 June 2018, in an addendum to its earlier opinions on Climbazole, that, under an aggregate exposure scenario, Climbazole is safe when used as a preservative in face cream, hair lotion and foot care products at a maximum concentration of 0.2% and when used as a preservative in rinse-off shampoo at a maximum concentration of 0.5%.
The SCCS also concluded that, under an aggregate exposure scenario, Climbazole is safe when used as an anti-dandruff agent in rinse-off shampoo at a maximum concentration of 2%.
In light of the addendum, there is ...