Methyl Alcohol

What Is It?

Methyl AlcoholAlcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages., also called methanol, is a clear, colorless liquid. In cosmetics and personal care products, Methyl Alcohol is used in the formulation of bath products.

Why Is It Used?

Methyl Alcohol is used as an alcohol denaturantIngredients added to ethyl alcohol (grain alcohol) to make it unsuitable for drinking, usually by imparting an intensely bitter taste. In the United States, the use of denaturants are controlled by the Alcohol and Tobacco Tax and Trade Bureau in the Department of Treasury..

Scientific Facts

Methyl Alcohol, or methanol, has historically been produced from the distillation of wood and is also known as wood alcohol.

It can also be produced synthetically from fossil fuels, as well as from other starting materials.

Safety Information

The Food and Drug Administration (FDA) permits Methyl Alcohol residues not to exceed specified limits in spice oleoresins and extracts of hops used for beer production.

FDA also includes Methyl Alcohol on its list of indirect food additives for use in adhesives and as a defoaming agent in the maufacture of paper and paperboard used for food packaging.

The safety of Methyl Alcohol 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 Methyl Alcohol was safe as used to denature alcohol used in cosmetics and personal care products.

CIR Safety Review:

Methyl Alcohol was readily absorbed through the skin and from the gastrointestinal and respiratory tracts, was distributed throughout all organs and tissues (in direct relation to the body’s water distribution), and was eliminated primarily via the lungs. Undiluted Methyl Alcohol was an ocular and skin irritant.

Inhalation studies showed a no-effect level for maternal effects of 10,000 ppm and for developmental effects of 5,000 ppm.

Overall, Methyl Alcohol was not considered mutagenic. Carcinogenicity data were unavailable.

The toxicity of Methyl Alcohol in humans results from the metabolism of the alcohol to formate and formic acid through a formaldehyde intermediate. Formate accumulation causes metabolic acidosis and inhibits cellular respiration. Methyl Alcohol toxicity is time and concentration dependent, and its toxic effect is competitively inhibited with ethyl alcohol (ethanol).

Because of the moderating effect of ethyl alcohol, it was concluded that Methyl Alcohol was safe as used to denature ethyl alcohol used is cosmetics and personal care products. No conclusion was reached regarding any other use of Methyl Alcohol.

More information about formaldehyde.

Link to FDA Code of Federal Regulations for Methyl Alcohol

The Joint FAO/WHO Expert Committee on Food Additives indicated that the daily intake of Methyl Alcohol is only limited to that determined by good manufacturing practice which is expected to result in minimal residues.

http://www.inchem.org/documents/jecfa/jeceval/jec_1374.htm

Health Canada permits the use of Methyl Alcohol in cosmetics and personal care products. When a product contains more than 5 ml Methyl Alcohol, it must be labeled appropriately.

http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…

Methanol is listed in the Cosmetics Directive of the European Union (see Annex III) and may be used only as a denaturant for ethanol and isopropyl alcohol at a maximum concentration of 5%, calculated as a percentage of ethanol and isopropyl alcohol.

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm

More Scientific Information

Methyl Alcohol is an aliphatic alcohol that is metabolized to formaldehyde and formic acid. In cosmetics and personal care products, Methyl Alcohol functions a denaturant

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/default.htm

Substances 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.): 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/