Salicylic acid (CAS 69-72-7) - Submission I

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: A. Simonnard, A. Koutsodimou, W. Uter
Acknowledgements: N. von Goetz
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/1601/18
Adopted on: 21 December 2018

Conclusion of the opinion:

1. In light of the new data provided, does the SCCS still consider Salicylic acid (CAS 69-72-7) safe when used as a preservative in all cosmetic products up to a maximum concentration of 0.5% (acid) considering its current restriction as reported above?

The SCCS considers salicylic acid (CAS 69-72-7) safe when used as preservative at a concentration of 0.5 % in cosmetic products considering its current restrictions in place.
This Opinion is not applicable to any oral product (such as toothpaste and mouthwash) with the exception of lipsticks. Sprayable products that could lead to exposure of the consumer’s lung by inhalation are also excluded. The provided information shows that salicylic acid is an eye irritant with the potential to cause serious damage to the eye.

2. In addition, does the SCCS still consider Salicylic acid (CAS 69-72-7) safe when used for purposes other than inhibiting the development of micro-organisms at a concentration up to 3.0 % for the cosmetic rinse-off hair products and up to 2.0 % for other products considering its current restrictions as reported above?

Based on the data provided and available literature, the SCCS considers salicylic acid (CAS 69-72-7) safe when used for purposes other than preservative at a concentration up to 3.0 % for the cosmetic rinse-off hair products and up to 2.0 % for other products, considering its current restrictions in place. However, in body lotion, eye shadow, mascara, eyeliner, lipstick and roll on deodorant applications, salicylic acid is considered safe up to 0.5 %. The SCCS position is that these levels are inclusive of any use of salicylic acid, i.e. should not exceed the stated levels with additional use as a preservative.
This Opinion is not applicable to any oral product (such as toothpaste and mouthwash) with the exception of lipsticks. Sprayable products that could lead to exposure of the consumer’s lung by inhalation are also excluded.

3. Does the SCCS have any further scientific concerns with regard to the use of Salicylic acid (CAS 69-72-7) in cosmetic products?

Salicylic acid is also used as a preservative in food and as a biocide in some consumer products (see section 3.2.3) or in various pharmaceutical formulations such as anti-acne products. As no specific exposure data were made available to SCCS to assess exposure following these non-cosmetic uses, it was not possible to include them in the aggregated exposure scenarios. Therefore, the actual total exposure of the consumer may be higher than exposure from cosmetic products alone. The conclusions of this Opinion refer only to Salicylic Acid and should not be applied to other salicylates or salicylic acid salts.

Keywords:

SCCS, scientific opinion, salicylic acid, Regulation 1223/2009, CAS 69-72-7, EC 200-712-3, SCCS/1601/18

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on salicylic acid (CAS 69-72-7) - Submission I, SCCS/1601/18, preliminary version of 10 September 2018, final version of 21 December 2018, CORRIGENDUM on 20-21 June 2019.