Formic Acid

What Is It?

Formic Acid is a colorless liquid. In cosmetics and personal care products, Formic Acid is used in the formulation of face, neck, and other skin care products, foot powders and sprays, and hair care products.

Why Is It Used?

Formic Acid is used as a preservative and to control the pH of cosmetics and personal care products.

Follow this link for more information about how preservatives protect cosmetics and personal care products.

Scientific Facts

Formic Acid is a simple carboxylic acid consisting of one carbon atom, two oxygen atoms and two hydrogen atoms. Formic Acid occurs naturally in some unripened fruit; in the venom of ants, wasps, and bees; and in mammalian muscle tissue.

Safety Information

The Food and Drug Administration (FDA) includes Formic Acid on its list of indirect food additives considered Generally Recognized As Safe (GRAS). 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 Review (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 adjuster 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

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 agent.

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…

More Scientific Information

Formic Acid is a simple organic acid. In cosmetics and personal care products, Formic Acid functions as a preservative and a pH adjustor.

Resources

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/