Wheat Germ Glycerides
Safety Information
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) includes wheat glutenA mixture of proteins obtained from wheat and other cereal grains; usually adhesive. on the list of ingredients 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.) for direct addition to food.
Expert Panel for Cosmetic Ingredient Safety
The safety of wheat germThe embryonic form of a grain from which a new organism is developed. glycerides and triticum vulgare (wheat) gluten has been assessed by the Expert Panel for Cosmetic Ingredient Safety.
The Expert Panel evaluated the scientific data and concluded that wheat germ glycerides and triticum vulgare (wheat) gluten were safe for use in cosmetics and personal care products. In 2001, as part of the scheduled re-evaluation of ingredients, the Expert Panel considered available new data on wheat germ glycerides and wheat gluten and reaffirmed the above conclusion.
The Expert Panel reviewed the results of laboratory tests on the safety of wheat germ glycerides, triticum vulgare (wheat) gluten, and of numerous cosmetics and personal care products containing these materials as presently used. These data supported the conclusion that wheat germ glycerides (0.25-2%) and wheat gluten (1%), in low concentrations in specific product formulations are non-sensitizing and nonirritating to human skin. Limited photopatch testing of wheat germ glycerides in lipstick bases (1-2%) was also negative.
Link to FDA Code of Federal Regulations for wheat gluten
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Because some people are allergic to wheat, the FDA Food Allergen Labeling and Consumer Protection Act requires that all food containing wheat be clearly labeled. Information about the FDA Food Allergen Labeling and Consumer Protection Act http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/Guidance…
Wheat germThe embryonic form of a grain from which a new organism is developed. glycerides and wheat glutenA mixture of proteins obtained from wheat and other cereal grains; usually adhesive. may be used in cosmetics and personal care products marketed in Europe according to 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…