Addendum to the scientific Opinions on Climbazole (P64) ref. SCCS/1506/13 and SCCS/1590/17

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
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/1600/18
Adopted on: 21-22 June 2018

Conclusion of the opinion:

1. In light of the SCCS addendum (SCCS/1590/17), does the SCCS consider safe the use of Climbazole (CAS 38083-17-9) when used in cosmetic products in the following specified concentrations under an aggregate exposure scenario for cosmetics:

- As a cosmetic preservative in face cream up to a concentration of 0.2%;
- As a cosmetic preservative in hair lotion up to a concentration of 0.2%;
- As a cosmetic preservative in foot care up to a concentration of 0.2%;
- As a cosmetic preservative in rinse-off shampoo up to a concentration of 0.5%;
- As an anti-dandruff agent in rinse-off shampoo up to a concentration of 2.0%.

o The SCCS considers the specified concentrations when used as preservative, for the individual cosmetic products as well as for their combinations under aggregate exposure scenario as safe

o When Climbazole is used as an anti-dandruff agent up to 2%, the 4-cosmetic products combination (with hair lotion, face cream and foot care) is also considered as safe

o The SCCS therefore considers that the use of climbazole up to a concenration of 2% in shampoos is safe for the consumer, either as anti-dandruff agent or as a preservative agent in combination with other uses and at concentrations as listed above.

2. If not, what is according to the SCCS, the maximum concentration considered safe for use of Climbazole (CAS 38083-17-9) as a cosmetic preservative respectively in face cream, hair lotion, foot care and rinse-off shampoo as well as anti-dandruff agent in rinse-off shampoo under an aggregate exposure scenario for cosmetics?

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Keywords:

SCCS, addendum, scientific opinion, Climbazole, preservative, P64, CAS 38083-17-9, EC 253-775-4, SCCS/1600/18, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Addendum to the scientific Opinions on climbazole (P64) ref. SCCS/1506/13 and SCCS/1590/17, final version adopted on 21-22 June 2018, SCCS/1600/18.