Revision of the opinion on Cetylpyridinium chloride - Submission II (P97)

WG on Cosmetic ingredients
SCCS members:U. Bernauer, P. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, S. C. Rastogi, Ch. Rousselle, Ja. van Benthem
Former SCCS members:A. Luch
External experts: A. Bernard A. Giménez-Arnau, 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/1548/15
Adopted on: 15 December 2015

Conclusion of the opinion:

1. On the basis of the data provided, does the SCCS consider that cetylpyridinium chloride is safe for consumers, when used as a preservative in cosmetic products in the following specified concentrations:

• mouthwashes cosmetic products up to a concentration of 0.1 %
• all other oral hygiene cosmetic products up to a concentration of 0.5 %
• skin lotions and creams up to a concentration of 0.2 %
• anti-perspirant deodorants up to a concentration of 2.0 %

Except for potential skin, eye and oral mucosal irritation, the SCCS considers that the use of cetylpyridinium chloride in a single cosmetic product for oral or dermal application is safe for the consumer. Aggregate exposure (based on worst case default assumptions for dermal and oral absorption) to cetylpyridinium chloride via cosmetic products and other consumer products (denture adhesive and cleanser) for the oral and dermal applications may be of concern for some consumers; however, it is considered unlikely that all the oral and dermal applications mentioned above will be used simultaneously.

2. Does the SCCS have any further scientific concerns with regard to the use of cetylpyridinium chloride in cosmetic products?

Oral exposure to cetylpyridinium chloride can also occur due to use of cetylpyridinium chloride containing solutions for the removal of microbial surface contamination of raw poultry products, as described in the EFSA Opinion (Ref.: 24). Aggregate exposure (based on worst case default assumptions for dermal and oral absorption) to cetylpyridinium chloride via cosmetic products and via treated poultry is of concern for consumers.

This Opinion covers only the use of cetylpyridinium chloride in non-spray cosmetic products.

Keywords:

SCCS, scientific opinion, cosmetic ingredient, preservative, P97, Cetylpyridinium chloride, directive 76/768/ECC

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Cetylpyridinium chloride - submission II (P97), SCCS/1548/15, 25 March 2015, revision of 15 December 2015.