The Food and Drug Administration (FDA) includes benzoic acid and sodium benzoate on its list of direct food substances affirmed as Generally Recognized As Safe (GRAS). Benzyl alcohol and benzyl benzoate are also approved as a synthetic flavoring agents for direct addition to food. Benzyl alcohol is approved as an anesthetic ingredient in Over-the-Counter (OTC) anorectal, oral healthcare and topical analgesic drug products.
The safety of benzyl alcohol, benzoic acid, sodium benzoate, calcium benzoate, potassium benzoate and benzyl benzoate has been assessed by the Expert Panel on Ingredient Safety.
The Expert Panel evaluated the scientific data and concluded that these ingredients were safe for use in cosmetic products. The safety of benzyl alcohol and benzyl benzoate has been evaluated by the Research Institute for Fragrance Materials Expert Panel (REXPAN).
Based on these evaluations, International Fragrance Association (IFRA) Standards have been established. The IFRA standards restrict the use of benzyl alcohol and benzyl benzoate in fragrances because of potential sensitization.
The Expert Panel noted that no adverse effects of benzyl alcohol were seen in chronic oral exposure studies. Effects of benzoic acid and sodium benzoate in chronic oral exposure studies were limited to reduced feed intake and reduced growth. At doses used in cosmetics and personal care products, the Expert Panel was not concerned about potential reproductive and developmental effects.
The Expert Panel reviewed data that indicated that inhalation exposure to benzyl alcohol and benzoic acid did not result in adverse effects. Although, genotoxicity tests for these ingredients were mostly negative, there were some assays that were positive. Carcinogenicity studies, however, were negative.
Clinical data indicated that in a few individuals these ingredients produced non-immunologic contact urticaria and non-immunologic immediate contact reactions, characterized by the appearance of wheals, erythema, and pruritis. In one study, 5% benzyl alcohol elicited a reaction, and in another study, 2% benzoic acid did likewise. Benzyl alcohol, however, was not a sensitizer at 10%, nor was benzoic acid a sensitizer at 2%.
Recognizing that the non-immunologic reactions were strictly cutaneous, likely involve a cholinergic mechanism, it was concluded that these ingredients could be used safely at concentrations up to 5%. Additionally, benzyl alcohol was considered safe at up to 10% for use in hair dyes.
The limited body exposure, the duration of use, and the frequency of use were considered in concluding that the non-immunologic reactions would not be a concern.
Link to FDA Code of Federal Regulations and the Federal Register for benzoic acid, sodium benzoate, benzyl alcohol and benzyl benzoate
Benzyl alcohol may be used as a preservative in cosmetics and personal care products marketed in the European Union at a maximum concentration of 1%. Benzoic acid and its salts and esters are also permitted for use as preservatives in cosmetics and personal care products at a maximum concentration (expressed as the acid) of 2.5% in rinse-off products (except oral care products), 1.7% in oral care products and 0.5% in leave on products (see Annex VI). Benzyl alcohol and benzyl benzoate are also listed in in Annex III of the European Union Cosmetics Directive. When benzyl alcohol or benzyl benzoate are used as fragrance ingredients, Annex III requires that the presence of these fragrance ingredients be indicated on the label of the product when used at greater than 0.001% in leave-on products, and greater than 0.01% in rinse-off products.
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