Revision of the opinion on HC Blue 18 (Colipa No. B122) - Submission I

SCCS members: Qasim Chaudhry, P. Coenraads, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, S. C. Rastogi, Ch. Rousselle, Ja. van Benthem
External experts: A. Bernard, L. Bodin, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, E. Mirkova,E. Panteri, T. Vanhaecke
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/1560/15
Adopted on: 15 December 2015

Conclusion of the opinion:

(1) In light of the data provided, does the SCCS consider HC Blue 18 (B122) safe when used as a direct hair colouring agent at an on-head concentration up to 0.35% in non-oxidative as well as in oxidative hair dye formulations?

In light of the data provided, SCCS considers that the use of HC Blue 18 (B122) as an ingredient in non-oxidative as well as in oxidative hair dye formulations at a maximum concentration of 0.35% on the head is safe.

Concerning oxidative conditions, the safety cannot be assessed because stability assessment was not adequately performed.

(2) Does the SCCS have any further scientific concerns with regard to the use of HC Blue 18 (B122) in cosmetic products?

The purity of HC Blue 18 and impurities in it are not adequately quantified. Details on impurities will be submitted at a later date by the applicant.
SCCS considers HC Blue 18 as a moderate sensitiser.

Keywords:

SCCS, scientific opinion, hair dye, HC Blue 18, Colipa B122, Regulation 1223/2009, CAS 1166834-57-6

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on HC Blue 18, Colipa no. B122, 25 June 2015, SCCS/1560/15, revision of 15 December 2015.