Formic Acid

The Food and Drug Administration (FDA) includes Formic Acid on its list of indirect food additives 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.). Formic Acid is approved for use as a consituent of paper and paperboard used for food packaging. Formic Acid is also an approved direct food additive. It may be used as as a synthetic flavoring substance or adjuvant.

The safety of Formic Acid 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 Formic Acid was safe when used in cosmetic formulations as a pH adjusterIngredients that are used to control the pH of cosmetic products. with a 64 ppm limit for the free acid.

CIR Safety Review: Formic Acid is a common metabolic intermediate that can be oxidized to carbon dioxide. The available data suggested that Formic Acid was an ocular and skin irritant and can be especially irritating to lung tissue. Both positive and negative results were noted in various mutagenicity studies (acidic experimental conditions were indicated in most cases of positive mutagenicity). In cosmetic formulations, Formic Acid is expected to be used at low concentrations and neutralized into various formate salts.

Thus, the free Formic Acid level is expected to be very low. Using data from an inhalation toxicity study in which 64 ppm was found to be nonirritating, it was extrapolated that such a level of free Formic Acid in a cosmetic formulation should not produce adverse effects. Accordingly, it was concluded that Formic Acid was safe for use in cosmetics and personal care products as a pH adjuster with a limit of 64 ppm for the free acid.

Link to FDA Code of Federal Regulations for Formic Acid

• 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 Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-3 mg/kg body weight for Formic Acid. No safety concern at current levels of intake were noted when Formic Acid was used as a flavoring agentIngredients that impart a flavor or a taste to a product..

http://www.inchem.org/documents/jecfa/jeceval/jec_867.htm

Formic Acid and its sodium salt are listed as preservatives in the Cosmetics Directive of the European Union (see Annex VI) and may be used at a maximum authorized concentration of 0.5% (expressed as acid).

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