Potassium Hydroxide

The Food and Drug Administration (FDA) includes Sodium Hydroxide, Magnesium Hydroxide and Potassium Hydroxide on its list of substances affirmed as 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 direct addition to food. All three ingredients, as well as Calcium Hydroxide are also approved as indirect food additives for use as defoaming agents in the manufacture of paper and paperboard used as food packaging. Sodium and Potassium Hydroxide can be used for the production of cacao products. The FDA has approved Magnesium Hydroxide for use in Over-the-Counter (OTC) antacid drug products.

Concentrated Sodium Hydroxide, Calcium Hydroxide, Magnesium Hydroxide and Potassium Hydroxide are strong irritants and corrosive to the skin, eyes, respiratory tract and gastrointestinal system if ingested. The severity of effects caused by Sodium, Magnesium and Potassium Hydroxide is a function of the concentration, the pH, the length of tissue contact time, and local conditions and skin type.

The Joint FAO/WHO Expert Committee on Food Additives has not limited the Acceptable Daily Intake of Sodium Hydroxide, Magnesium Hydroxide or Potassium Hydroxide.

• Sodium Hydroxide
• Magnesium Hydroxide
• Potassium Hydroxide

FDA Code of Federal Regulations for

Sodium Hydroxide

Magnesium Hydroxide

• Magnesium Hydroxide 
• Listing of Specific Active Ingredients 

Potassium Hydroxide

• Potassium Hydroxide 
• Acrylate Ester Copolymer Coating 

Potassium and Sodium Hydroxide

Sodium, Calcium, Magnesium and Potassium Hydroxide 

Sodium Hydroxide and Potassium Hydroxide are listed in the Cosmetics Directive of the European Union (see Annex III) and may be used at the following concentrations and pH values: 5% by weight in nail cuticle solvents, 2% by weight in hair straighteners for general use, 4.5% by weight in hair straighteners for professional use, up to a pH 12.7 in depilatories, and up to pH 11 in other uses as a pH adjuster. The nail cuticle solvents and the general use hair straighteners containing these ingredients must be labeled “contains alkali, avoid contact with eyes, can cause blindness, keep out of reach of children.” The professional hair straighters must be labeled “for professional use only, avoid contact with eyes, can cause blindness.” Depilatories containing these ingredients must include the following on the label: “Keep out of reach of children, avoid contact with eyes.” Calcium Hydroxide may be used at a maximum of 7% in hair straighteners that also contain a guanidine salt. It is also permited in depilatories as a pH adjuster if the pH does not exceed 12.7, and in other products if the pH does not exceed 11. Hair straighteners and depilatory products containing this ingredient must be labeled “Contains alkali, avoid contact with eyes, keep out of reach of children”, hair straighteners must also be labeled “can cause blindness” (see Annex III). Magnesium Hydroxide may be used in cosmetics and personal care products marketed in the Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder 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..

EU Cosmetic Regulation