Zinc Citrate
Safety Information
Expert Panel for Cometic Ingredient Safety
The safety of citric acid and its salts and esters was assessed by the Expert Panel in 2014. Given that the FDA determined citric acid, calcium citrate, potassium citrate, sodium citrate and triethyl citrate as GRAS for use in food, in addition to the fact that citric acid is essential for the production of energy in cells in both plants and animals, the Expert Panel focused on the potential for citric acid and its salts and esters to cause adverse effects when placed on the skin.
The Expert Panel reviewed scientific literature and data which indicated that at concentrations used in cosmetics and personal care products, citric acid and its salts and esters were not eye irritants, nor did they cause skin irritation or allergic skin reactions. Thus, Expert Panel concluded that the available scientific data showed that citric acid, its salts, and esters were safe under current conditions of use in cosmetics and personal care products.
The Expert Panel did note that although citric acid could be considered an alpha-hydroxy acid, it is also a beta-hydroxy acid making it distinct from the other alpha-hydroxy acids previously reviewed by the Expert Panel (for example lactic acid and glycolic acid). The Expert Panel concluded that the concern about increased sun sensitivity resulting from the use of alpha-hydroxy acid containing products was not relevant to products containing citric acid and its salts and esters because of the difference in chemical structure.
U.S. Food and Drug Administration (FDA)
Citric acid, calcium citrate, potassium citrate, sodium citrate and triethyl citrate are on the FDA’s list of direct food substances affirmed as Generally Recognized as Safe (GRAS). FDA permits tributyl citrate and triethyl citrate to be used as indirect food additives in some food packaging materials.
Learn more about FDA Code of Federal Regulations for citric acid and its calcium, potassium and sodium salts, and tributyl and triethyl citrates:
- Substances for Use as Components of Coatings: Sec. 175.300 Resinous and polymeric coatings
- Substances for Use as Components of Coatings: Sec. 175.320 Resinous and polymeric coatings for polyolefin films
- Specific Prior-Sanctioned Food Ingredients Sec. 181.27 Plasticizers
- Substances for Use Only as Components of Adhesives Sec. 175.105 Adhesives
All of the ingredients reviewed by the Expert Panel are listed in the European Union inventory of cosmetic ingredients and 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.
The safety of citric acid and its calcium, potassium and sodium salts has been assessed by the Joint FAO/WHO Expert Committee on Food Additives. The most recent review concluded that these additives ‘do not constitute a significant toxicological hazard’ and it was therefore not necessary to set an Acceptable Daily Intake limit. As such, the amount in food is limited only by the amount needed to achieve the technical function within the product.