Sorbic Acid

The Food and Drug Administration (FDA) reviewed the safety of Sorbic Acid and Potassium Sorbate and determined that they were 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.) as preservatives for direct addition to food. Sorbic Acid and Potassium Sorbate are effective for the control of mold and yeast in cheese products, baked goods, fruit juices, fresh fruits and vegetables, wines, soft drinks, pickles, sauerkraut, and certain fish and meat products. The safety of Sorbic Acid and Potassium Sorbate 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 Sorbic Acid and Potassium Sorbate were safe for use in cosmetics and personal care products. In 2006, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on these ingredients and reaffirmed the above conclusion.

CIR Safety Review: Sorbic Acid and Potassium Sorbate were practically nontoxic in acute oral toxicity studies. In subchronic studies, no significant adverse effects were observed when 10% Sorbic Acid was included in the diet. Sorbic Acid and Potassium Sorbate, at concentrations up to 10%, were practically nonirritating to the eye. Both ingredients at concentrations up to 10% were at most only slightly irritating to skin. Sorbic Acid and Potassium Sorbate have been tested for mutagenic effects using bacterial tests, genetic recombination tests, reversion assays, tests for chromosomal aberrations, sister chromatid exchanges and gene mutations. The weight of evidence of these tests indicates that these ingredients were not mutagenic. Potassium Sorbate at 0.1% in the diet or 0.3% in drinking water for up to 100 weeks was not carcinogenic. In other chronic studies, no carcinogenic effect was demonstrated by Sorbic Acid in diets containing up to 10% Sorbic Acid. No developmental effects have been observed with Potassium Sorbate. Formulations containing up to 0.5% Sorbic Acid and or Potassium Sorbate were not significant primary or cumulative irritants and not sensitizers.

Link to FDA Code of Federal Regulations for Sorbic Acid and Potassium Sorbate

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Sorbic Acid (Hexa-2-4-Dienoic Acid) and its salts may be used as preservatives at a maximum concentration of 0.6% in cosmetics and personal care products marketed in the European Union (see Annex VI).

Link to the EU Cosmetic Regulation: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-25 mg/kg body weight for the sum of Sorbic Acid and Calcium, Potassium and Sodium Sorbates.
http://www.inchem.org/documents/jecfa/jeceval/jec_2181.htm