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 pH 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). 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 Review (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 adjuster, 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 Union.

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/