Propane

The Food and Drug Administration (FDA) has reviewed the safety of Butane, Isobutane and Propane and has placed these ingredients on the list of direct food substances affirmed as 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.). Isopentane has been approved as an 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 use in the manufacture of foamed plastics. The safety of Butane, Isobutane, Propane and Isopentane 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. Expert (CIR) Panel. The CIR Expert Panel evaluated scientific data and concluded that Butane, Isobutane, Isopentane and Propane were safe as a cosmetic ingredients under present practices of concentration and use. In 2002, the CIR Expert Panel considered available new data on these ingredients and reaffirmed the above conclusion.

CIR Safety Review: Since Butane, Isobutane, Propane and Isopentane are used predominantly as aerosol propellants, inhalation toxicity testing rather than dermal toxicity has been emphasized. Many studies have been conducted on the anesthetic effects of these ingredients. It is believed, however, that these observations have little relevance to the use of these ingredients in cosmetics and personal care products, because of the brief and low level exposures involved in their use.

As aerosols, Butane, Isobutane, Propane and Isopentane are greatly diluted in air when discharged and it is estimated that, as propellants, they would remain on the skin no longer than 10 seconds. Because they evaporate quickly, these ingredients, even in foam products would not remain in contact with the skin longer than 10 seconds. Such a short period of contact makes the absence of sensitization, phototoxicity, and photosensitization studies unimportant. Furthermore, exposure standards have already been set by the National Institute for Occupational Safety and Health (NIOSH) and most of the substance is volatilized before it can come in contact with the skin.

FDA Code of Federal Regulations for n-Butane and Isobutane

Code of Federal Regulations for Propane

Code of Federal Regulations for Isopentane

Butane, Isobutane, Propane and Isopentane 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..

EU Cosmetic Regulation