Tallow

The Food and Drug Administration (FDA) includes Tallow and Hydrogenated Tallow 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 substances migrating from cotton and cotton fabrics used in dry food packaging. The polyglycerol esters of Tallow are also approved as multipurpose direct food additives. The safety of Tallow and the Tallow Glyceride ingredients 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 Tallow, Tallow Glyceride, Tallow Glyerides, Hydrogenated Tallow Glyceride and Hydrogenated Tallow Glycerides were safe as cosmetic ingredients in the present practices of use. In 2006, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Tallow and the Tallow Glyceride ingredients and reaffirmed the above conclusion. During the re-review, the CIR Expert Panel considered concerns about bovine spongiform encephalopathy (BSE). They noted that these ingredients were processed and purified sufficiently so that there was no free proteinA naturally occurring complex organic substance present in relatively high amounts in meats, fish, eggs, cheese, legumes. Made of carbon, hydrogen, oxygen, and nitrogen, and sometimes sulfur and phosphorus.. It was also noted that FDA regulations that establish source and processing controls help to assure that these ingredients present no risk of BSE.

CIR Safety Review: The CIR Expert Panel noted that they previously reviewed the safety of the fatty acidA natural organic compound that consists of a carboxyl group (oxygen, carbon and hydrogen) attached to a chain of carbon atoms with their associated hydrogen atoms. The chain of carbon atoms may be connected with single bonds, making a ‘saturated’ fat; or it may contain some double bonds, making an ‘unsaturated’ fat. The number of carbon and hydrogen atoms in the chain is what determines the qualities of that particular fatty acid. Animal and vegetable fats are made up of various combinations of fatty acids (in sets of three) connected to a glycerol molecule, making them triglycerides. constituents of Tallow, and some of the corresponding fatty acid alcohols. These components have also been evaluated for safety by the Federation of American Societies of Experimental Biology and the FDA. In all cases, the ingredients were found safe in present practices of use. None of these constituents of Tallow was toxic through oral or dermal exposure, they were not ocular or dermal irritants, and they were neither dermal sensitizers nor photosensitizers. The same was true for other oils that contain varying concentrations of the constituents of Tallow. Based on the CIR safety evaluations of the individual constituents of Tallow and of cosmetic ingredients containing the constituents of Tallow, and on the approval of Tallow for use in foods and other consumer products, it was concluded that Tallow, Tallow Glyceride, Tallow Glycerides, Hydrogenated Tallow Glyceride and Hydrogenated Tallow Glycerides were safe as cosmetic ingredients.

Link to the FDA Code of Federal Regulations for Tallow

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

The use of Tallow and Tallow derived ingredients used in cosmetics and personal care products marketed in the United States is subject to sourcing limitation and record-keeping requirements described in the Code of Federal Regulations as described in several Federal Register publications.

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

Federal Register Publications:

July 14, 2004:

• http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15880.pdf
• http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15881.pdf
• http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15979.pdf

October 11, 2006:

• http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-16830.pdf

More information about bovine spongiform encephalopathy (BSE).

When used in cosmetics and personal care products in Europe, Tallow and Tallow Glyceride ingredients must conform to European Union animal by-products legislation, and the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

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