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Public Health
Expert opinion

Addendum to the Opinion on Climbazole (P64) ref. SCCS/1506/13

Final Opinion

Details

Publication date
25 October 2017
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), 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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1590/17
Adopted on: 24-25 October 2017

Conclusion of the opinion:

1. In light of the new margin of safety data provided, does the SCCS consider safe the use of Climbazole (CAS 38083-17-9) as a cosmetic preservative in hair lotion and foot care with a maximum concentration of 0.31 % and in face cream with a maximum concentration of 0.5% and as anti-dandruff agent in shampoo with a maximum concentration of 2.0% under an aggregate exposure scenario for cosmetics?

The use of Climbazole (CAS 38083-17-9) as a cosmetic preservative in hair lotion and foot care with a maximum concentration of 0.31 % and in face cream with a maximum concentration of 0.5% and as anti-dandruff agent in shampoo with a maximum concentration of 2.0% are, when individually used, safe for human health. Combinations of 3- or 4- products, however, cannot be considered as safe. Most combinations of 2 products can be considered as safe, the combinations of ‘hair lotion and face cream’ and ‘face cream and foot care’ give, using the conservative “adding on calculation”, a MoS below 100 (83 and 90, respectively).

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 in hair lotion, foot care and face cream as well as anti-dandruff agent in rinse-off shampoos under an aggregate exposure scenario for cosmetics?

The maximum concentrations of Climbazole considered as safe for human health 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) with the exception of cosmetics applied on a full body area (body lotion).

Based on the considerations by ECHA, the SCCS will closely follow up the outcome of further studies to be conducted in the context of the REACH legislation and, if necessary, will reassess the safety of Climbazole.

Keywords:

SCCS, addendum, scientific opinion, Climbazole, preservative, P64, Regulation 1223/2009, 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 (P64) ref. SCCS/1506/13, 24-25 October 2017, SCCS/1590/17.

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