BHT

BHT is included on the Food and Drug Administration’s (FDA) 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.) for use in food. It is permitted to be used in food as a preservativeIngredients that prevent or retard bacterial growth, and thus protect cosmetic products from spoilage. limited to concentrations of 0.02%. BHT is also an FDA approved indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage.. For example, BHT is permitted to be used in adhesives that come in contact with food.

The safety of BHT 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 BHT was safe for use in cosmetics and personal care products.

CIR Safety Review: The CIR Expert Panel recognized that there is extensive literature examining the safety of antioxidants, including BHT. Although dermal application of BHT results in some skin absorption, BHT appears to remain primarily in the skin or passes through the skin only slowly, and dermal application does not produce systemic exposures to BHT or its metabolites of the magnitude seen in oral studies.

The CIR Expert Panel noted that only limited tests evaluated the effects of BHT on skin but studies in which topical application of BHT was used to moderate the effect of ultraviolet radiation were considered. These studies clearly demonstrated the absence of a photosensitization effect and no sensitization or significant irritation was reported.

Oral exposure to relatively large doses of BHT has resulted in liver and kidney effects. BHT was not a reproductive or developmenta toxicant. It was not genotoxic, nor was it carcinogenic. The CIR Expert Panel was not concerned with the liver and kidney effects reported after oral exposure because of the limited dermal penetration of BHT, and the low concentrations of use (0.01 to 0.1%) of this compound in cosmetics and personal care products.

FDA: Link to the Code of Federal Regulations for BHT (Butylated Hydroxytoluene)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

BHT 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…

The Joint FAO/WHO Expert Committee on Food Additives has established a temporary Acceptable Daily Intake of 0-0.125 mg/kg body weight for BHT.

http://www.inchem.org/documents/jecfa/jecmono/v21je03.htm