Revision of the addendum to the opinion of Climbazole (P64) (Preservatives)

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, G. Degen, W. Lilienblum, E. Nielsen, V. Rogiers (rapporteur), T. Sanner, S. Ch. Rastogi (chairman), J. van Engelen, R. Waring, I.R. White, Th. Platzek, Ch. Rousselle, J. van Benthem, A. Luch, P.-J. Coenraads, D. Gawkrodger
Contact:SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1506/13
Doi: 10.2772/49340
Adopted on: 18 June 2013

Conclusion of the opinion:

Does the SCCS consider that Climbazole is safe for the consumers, when used as a preservative in cosmetic products up to a maximum concentration of 0.5% if the product categories face and hair products, as recommended by the former SCCP opinion (SCCP/1204/08) are extended to include foot care products?
The SCCS is of the opinion that the use of Climbazole as a preservative at a maximum concentration of 0.5% either in a foot care cosmetic and used alone, or in combination with a face cream (at a maximum concentration of 0.5%) or hair lotion (at a maximum concentration of 0.5%) does not pose a risk to the health of the consumer. In the case of combination of the 3 products (foot care cosmetic, face cream and hair lotion), each containing Climbazole at the maximum requested concentration (0.5%, safe when used separately) applied simultaneously, this combination cannot be considered safe for the consumer. As Climbazole can also be used in cosmetics as an anti-dandruff agent in shampoo (rinseoff) up to a maximum concentration of 2%, the use of shampoo alone or in combination with face cream or hair lotion or foot care cosmetic does not pose any risk. However, when anti-dandruff shampoo is used together with hair lotion and foot care cosmetic this combined use cannot be considered safe for the consumer. When the 4 different types of products (shampoo, hair lotion, foot care cosmetic and face care cosmetic), all containing Climbazole at the maximum allowed concentration, are simultaneously topically applied, this combination cannot be considered safe for the consumer. This opinion does not address the possible environmental concerns of the use of Climbazole in cosmetic products.

Keywords:

SCCS, scientific opinion, Climbazole, preservative, P64, directive 76/768/ECC, CAS 38083-17-9, EC 253-775-4

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), addendum to the opinion on climbazole (SCCP/1204/08), 26 February 2013, revision of 18 June 2013.