Potassium Sorbate

What Is It?

Sorbic Acid is a white, free-flowing, crystalline powder. Potassium Sorbate, the potassium salt of Sorbic Acid, occurs as a white crystalline powder, white granules, or pellets. In cosmetics and personal care products, Sorbic Acid and Potassium Sorbate are used primarily in the formulation of facial and eye makeup and skin care and hair products.

Why Is It Used?

Sorbic Acid and Potassium Sorbate kill microorganisms, or prevent or retard their growth and reproduction, and thus protect cosmetics and personal care products from spoilage.

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

Scientific Facts

Sorbic Acid occurs naturally as para-sorbic acid in berries of the mountain ash tree, Sorbus aucuparia, Rosaceae. It can also be synthesized by various processes. Sorbic Acid and Potassium Sorbate have a broad spectrum of fungistatic activity but are less active against bacteria. Optimum antimicrobial activity is attained at pH values up to 6.5.

Safety Information

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) 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 Review (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

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

More Scientific Information

Sorbic Acid is a straight-chain monocarboxylic acid also known as 2,4-hexadienoic acid. Potassium Sorbate is the potassium salt of Sorbic Acid. In cosmetics and personal care products, Sorbic Acid and Potassium Sorbate function as preservatives and antimicrobial agents. The use of preservatives is required to prevent product damage caused by microorganisms and to protect the product from inadvertent contamination by the consumer during use.

Resources

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

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/