Sodium Malate
What Is It?
Malic acid is a tart-tasting organic dicarboxylic acid that contributes to the taste of many sour or tart foods such as apples. Sodium Malate is the sodium salt of Malic Acid. Malic Acid and Sodium Malate can be found in a wide range of cosmetics and personal care products.
Why Is It Used?
Malic Acid and Sodium Malate are used primarily to control the pHA measurement of the acidity or basicity of a substance. pH is the negative logarithm (base 10) of the concentration of hydrogen ions in solution. Water has a concentration of hydrogen ions of 1.0 x 10-7, and thus has a pH of 7. A pH of 7 is considered neutral, a pH lower than 7 is considered acidic, and a pH higher than 7 is considered basic. of cosmetic products.
Scientific Facts
Malic Acid is an organic acid which can be prepared by fermentation from natural sugars. The naturally occurring form of Malic Acid can be found in unripe apples and other fruits. Malic acid can make a wine taste tart, although the amount decreases with increasing fruit ripeness. The process of malolactic fermentation converts Malic Acid to much milder lactic acid.
Safety Information
Malic Acid is included on the Food and Drug Administration’s (FDA) list of direct food substances that are 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.). Malic Acid is not considered GRAS for use in baby food. The safety of Malic Acid, and Sodium Malate, 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 Malic Acid and Sodium Malate were safe for use as pH adjusters in cosmetic formulations. The CIR Expert Panel determined that the data were insufficient to determine safety of these ingredients for other functions.
CIR Safety Review: The CIR Expert Panel considered separately the ways in which Malic Acid and Sodium Malate are used. As a pH adjusterIngredients that are used to control the pH of cosmetic products., Malic Acid historically has been used at concentrations less than 1%. The available data demonstrate that the toxicity that has been demonstrated for Malic Acid and Sodium Malate is related to concentration. Accordingly, the CIR Expert Panel concluded that Malic Acid and Sodium Malate are safe for use as pH adjusters. Data included in the report, however, were insufficient to determine the safety of these ingredients when used in cosmetics as anything other than a pH adjuster.
FDA: Link to the Code of Federal Regulations for Malic Acid
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Malic Acid may be used in cosmetics and personal care products marketed in 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..
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
The Joint FAO/WHO Expert Committee on Food Additives has not restricted the daily intake of L-Malic Acid. The Committee has established a daily intake of 0-100 mg D-Malic Acid/kg body weight. Neither D- nor DL-Malic Acid should be added to food for very young infants except for therapeutic purposes.
http://www.inchem.org/documents/jecfa/jecmono/40abcj45.htm
More Scientific Information
Malic Acid is a colorless, crystalline aliphatic dicarboxylic acid that occurs naturally in a wide variety of unripe fruit, including apples, cherries, and tomatoes. Malic Acid is also used to flavor wine and is produced in the aging of wine. Malic Acid is an intermediate in the Kreb’s cycle and functions as a pH adjuster when used in cosmetic formulations. Sodium Malate is the sodium salt of Malic Acid.
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/