What Is It?
Ammonium Alum is a white crystalline solid. It is the aluminum salt of ammonium sulfate. In cosmetics and personal care products, Ammonium Alum is used in the formulation of aftershave lotions, body and hand products and douches.
Why Is It Used?
Ammonium Alum can be applied topically for use in caring for the oral cavity. It is also used to induce a tightening or tingling sensation of the skin. Ammonium Alum draws together or constricts body tissues which are effective in stopping the flow of blood or other secretions.
Ammonium Alum, or aluminum ammonium sulfate, has bacteriostatic properties. This means that Ammonium Alum inhibits the growth of microorganisms but does not kill them. Ammonium Alum is an inorganic salt.
Ammonium Alum is on the list of substances Generally Recognized As Safe (“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 multipurpose food substance. The Food and Drug Administration (FDA) adds ingredients to this list after review by the Select Committee on GRAS Substances. FDA also allows its use in over-the-counter (OTC) oral health care products. When used in an OTC product it must be listed on the label as Alum, Aluminum. The The 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) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.
The FDA’s Select Committee on GRAS Substances (SCOGS) concluded that there was no evidence in the available information on Ammonium Alum that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when it is used at levels that are now current or might reasonably be expected in the future. http://www.cfsan.fda.gov/~dms/opascogc.html
Alum, including Ammonium Alum is allowed to be used as an astringent in OTC oral health care products.
Link to FDA Code of Federal Regulations for Ammonium Alum (aluminum ammonium sulfate)
More information about aluminum.
Ammonium Alum may be used in cosmetics and personal care products marketed in Europe according to the Under 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..
Link to the EU Cosmetic Regulation:
More Scientific Information
Ammonium Alum is an inorganic salt. In cosmetics and personal care products, Ammonium Alum functions as an astringent.
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
Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration
OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…
Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process
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/