The deletion of “magnesium salts of fatty acids” from the Codex International Numbering System (INS) had been proposed at the 42nd Session of the Codex Committee on Food Additives, 2010. The International Alliance of Dietary/Food Supplement Associations (IADSA) offered technological justification for not deleting this additive, which was endorsed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and assigned the INS number 470(iii) (IADSA, April 2011).
Magnesium stearate is a salt containing stearate (the anion of stearic acid) and magnesium. Stearic acid or octadecanoic acid is a common fatty acid found in both animal and vegetable sources. It has a long history of use in nutritional supplements as it has been generally recognized as safe since 1979 (U.S. Food and Drug Administration, Database of Select Committee on GRAS Substances, 2006).
Magnesium stearate functions as a colorant, moisturizing agent, anticaking and bulking agent in cosmetic products (EU Cosmetics CosIng Database, 2012). Furthermore, it is listed as being allowed for use without conditions, as a white colorant acceptable in products applied to all body parts (EU Cosmetic directive, Annex IV, List of Colorants Allowed in Cosmetic Products).
The U.S. Food and Drug Administration’s (FDA) Code of Federal Regulations (CFR) Title 21, 2011, cites that food additives of salts of fatty acids (including magnesium stearate) may be safely used in food and in the manufacture of food components if the additive consists of one or any mixture of two or more of the aluminum, calcium, magnesium, potassium, and sodium salts of the fatty acids. The food additive must be used as a binder, emulsifier, or anticaking agent in food in accordance with good manufacturing practice and with compliant labeling (U.S. FDA CFR 21, 2011).
The 44th Session of the Codex Committee on Food Additives was held in March 2012. Magnesium stearate can be found listed in an Inventory of Substances Used as Processing Aids, specifically as an antifoam agent, an anticaking agent and a lubricant. An Acceptable Daily Intake for its use in food has not been allocated.
Does this mean Magnesium salts of fatty acids are off the danger list? We will bring you further information once it is made available.
U.S. Food and Drug Administration, Database of Select Committee on GRAS Substances, 2006. Available at: http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing&id=198, October 31, 2006. Accessed June 11, 2012
EU Health and Consumers, Cosmetics – CosIng [EC Regulation (v.2)], 2012.
EU Cosmetic directive, Annex IV, List of Colorants Allowed in Cosmetic Products. Available at: http://ec.europa.eu/consumers/cosmetics/cosing/. Accessed June 12, 2012
International Alliance of Dietary/Food Supplement Associations, April 20, 2011. IADSA saves key additives from deletion at Codex. News Centre. Available at: http://www.iadsa.org/news_view.php?key=key=news,f98b75cc96783bd9acca63ecd221ce092694e8e4,0,1&id=843fc5f097e55155862bffb44acf9941f859e1a5. Accessed June 12, 2012
Joint FAO/WHO Food Standards Programme Codex Committee on Food Additives, 44th Session, Hangzhou, China, 12 – 16 March 2012 Inventory of Substances Used As Processing Aids (IPA), Updated List (Information Document).
U.S. Food and Drug Administration (FDA) – Code of Federal Regulations (CFR) Title 21, Food Additives Permitted for Direct Addition to Food for Human Consumption: Multipurpose Additives; Salts of Fatty Acids, April 1, 2011. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=172.863&SearchTerm=salts%20of%20fatty%20acids Accessed June 12, 2012
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