Butyl Acetate

The Food and Drug Administration (FDA) includes Ethyl Acetate 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.) for use as a synthetic flavoring substance and adjuvant. It is also permitted to be used as a secondary food additive as a solventSubstances, usually liquids, that are used to dissolve other substances., lubricant or release agent. FDA allows Butyl Acetate to be added to food as a synthetic flavoring substance and adjuvant. The safety of Ethyl Acetate and Butyl Acetate 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 Ethyl Acetate and Butyl Acetate were safe as cosmetic ingredients in the present practices of use and concentration. In 2006, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Ethyl Acetate and Butyl Acetate and reaffirmed the above conclusion.

CIR Review: Doses of Ethyl Acetate and Butyl Acetate much larger than those resulting from normal use of nail products containing these ingredients were needed to result in effects following oral, dermal or inhalation exposure. Ethyl Acetate and Butyl Acetate were nonmutagenic when tested in bacteria, yeast and mammalian cells. Butyl Acetate did not cause developmental effects when inhaled. Ethyl Acetate and Butyl Acetate were mild skin irritants but not sensitizers to humans. Ethyl Acetate was neither phototoxic or photoallergenic in human tests.

FDA: Link to Code of Federal Regulations for Ethyl Acetate

• Synthetic Flavoring Substances and Adjuvants 
• Ethyl Acetate 

FDA: Code of Federal Regulations for Butyl Acetate

Ethyl Acetate and Butyl Acetate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union. 

The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake for Ethyl Acetate of 0-25 mg/kg body weight.

For Butyl Acetate the Joint FAO/WHO Expert Committee on Food Additives concluded that there was no safety concern at current levels of intake when used as a flavouring agent.