SALICYLIC ACID

Salicylic Acid is an aromatic acid consisting of a benzene ring substituted with a hydroxyl group and a carboxyl group in adjacent positions. In cosmetic formulation it is used under multiple declared technical functions: anti-seborrheic, hair conditioning, keratolytic, fragrance, preservative and skin conditioning. It is identified in pharmacopoeial nomenclature as acidum salicylicum and in the international nonproprietary name as salicylic acid.

From a regulatory standpoint, the ingredient appears in Annex III of Regulation (EC) No 1223/2009 under reference 98, with restrictions differentiated by product type. The maximum authorized concentrations are "(a) 3.0%" in rinse-off hair products, "(b) 2.0%" in other products except body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant, and "(c) 0.5%" in the latter category of products. The following literal conditions apply: "Not to be used in preparations for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Not to be used in oral products. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. These levels are inclusive of any use of salicylic acid." The mandatory labelling warning is: "Not to be used for children under 3 years of age", exclusively in products that may be used by that population. The ingredient is classified as Reprotoxic Cat. 2. In addition, it appears under reference V/3 of Annex V.

The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.

Salicylic Acid and its salts are named Benzoic acid, 2-hydroxy-, Calcium salicylate, Magnesium salicylate, MEA-salicylate, Potassium salicylate, Sodium salicylate and TEA-salicylate.

The ingredient and its salts are listed in Annex V, reference 3, with a maximum authorized concentration of "0,5 % (acid)" for both salicylic acid and its salts expressed as acid. For salicylic acid, the following literal conditions apply: "Not to be used in products for children under 3 years of age", "Not to be used in oral products" and "Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation". For the salts: "Not to be used in products for children under 3 years of age, except for shampoos". The mandatory labelling warning for salicylic acid is "Not to be used for children under 3 years of age", applicable only to products that may be used on children under three years of age. For the salts, the equivalent warning applies only to products that may be used on children under three years of age and that remain in prolonged contact with the skin. Entry V/3 has no CMR classification, although salicylic acid is classified as Reprotoxic Cat. 2 in Annex III, reference 98.

Preservatives authorized in Annex V are incorporated into cosmetic formulations to preserve the microbiological stability of the product throughout its shelf life and after opening. Their use complies with the literal conditions of the corresponding annex. The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.