Potassium Benzoate

What Is It?

Benzyl AlcoholAlcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages. is an organic alcohol found in many fruits and teas. Benzyl Alcohol has a hydroxyl group (-OH), while the related compound, Benzoic Acid has a carboxyl group (-COOH). Sodium Benzoate, Calcium Benzoate and Potassium Benzoate are salts of Benzoic Acid. Benzyl Benzoate is an esterAn organic compound formed by the reaction of an acid with an alcohol. of Benzyl Alcohol and Benzoic Acid.

Benzyl Alcohol, Benzoic Acid and its salts, and Benzyl Benzoate are used in a wide variety of cosmetics and personal care products, including baby products, bath products, soaps and detergents, eye makeup, blushers, cleansing products, make up products, as well as hair, nail and skin care products.

Why Is It Used?

The following functions have been reported for these ingredients.

Corrosion inhibitorIngredients that prevent the corrosion (rust) of metallic materials used in cosmetic packaging. – Sodium Benzoate
Fragrance ingredientSubstances that impart an odor to a product. – Benzyl Alcohol, Benzoic Acid, Sodium Benzoate, Benzyl Benzoate
pH adjusterIngredients that are used to control the pH of cosmetic products. – Benzoic Acid
PreservativeIngredients that prevent or retard bacterial growth, and thus protect cosmetic products from spoilage. – Benzyl Alcohol, Benzoic Acid, Sodium Benzoate, Calcium Benzoate, Potassium Benzoate
SolventSubstances, usually liquids, that are used to dissolve other substances. – Benzyl Alcohol, Benzyl Benzoate Viscosity decreasing agentSubstances that decrease the thickness of liquid cosmetic products – Benzyl Alcohol

Follow this link for more information about how preservatives protect cosmetics and personal care products.

Scientific Facts

Benzyl Alcohol and Benzoic Acid are found naturally in many foods such as apricots, snap beans, cocoa, cranberries, mushrooms and honey. Benzyl Alcohol is also found in the essential oilA concentrated liquid containing volatile aroma compounds from plants. of many plants, including jasmine, hyacinth and ylang-ylang.

Safety Information

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“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.). 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 Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel.

The CIR 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.

IFRA Standards

CIR Safety Review:

The CIR 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 CIR Expert Panel was not concerned about potential reproductive and developmental effects.

The CIR 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 Benzaote 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.

The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-5 mg/kg for the sum of Benzoic Acid, Potassium and Sodium Benzoate.

More information about the safety of fragrances.

Resources

Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration

Find out more about the regulation of Food Additives by the Food and Drug Administration