Sodium Ascorbate

The Food and Drug Administration (FDA) includes Ascorbic Acid, Calcium Ascorbate and Sodium Ascorbate on its list of substances considered 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. Ascorbic Acid is also on the list of GRAS nutrients. The safety of Ascorbic Acid, Calcium Ascorbate, Magnesium Ascorbate, Magnesium Ascorbyl Phosphate, Sodium Ascorbate and Sodium Ascorbyl Phosphate 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 reveiwed the sceintific data and concluded that Ascorbic Acid and its salts were safe for use in cosmetic and personal care products.

CIR Safety Review: The CIR Expert Panel noted that Ascorbic Acid was not genotoxic in most of the assay systems, but did yield a positive response in a few assay systems. When acting as an antioxidantIngredients that prevent or slow deterioration due to chemical reaction with oxygen., the CIR Expert Panel concluded that Ascorbic Acid was not genotoxic. Ascorbic acid was not carcinogenic in studies conducted by the National ToxicologyToxicology is the study of the adverse effects of chemical and physical agents on living organisms. Program. Because of the possibility that certain metal ions that could combine with Ascorbic Acid and related ingredients producing pro-oxidative activity, the CIR Expert Panel cautioned formulators to be certain that these ingredients are acting as antioxidants in cosmetic formulations. The CIR Expert Panel also considered clinical experience and data from a study using 5% Ascorbic Acid, coupled with an absence of reports in the clinical literature of sensitization, as strong support for the safety of Ascorbic Acid and related ingredients.

FDA: Link to the Code of Federal Regulations for Ascorbic Acid and its Calcium and Sodium Salts

• Ascorbic Acid 
• Chemical Preservatives 
• Calcium Ascorbate 
• Sodium Ascorbate 

Ascorbic Acid and the salts of Ascorbic Acid may be used in Europe according to the general provisions of the Cosmetics Regulation of the European Union. The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-15 mg/kg body weight for Ascorbic Acid and its Potassium and Sodium salts.