PROPYLPARABEN - 94-13-3

Key Functions: Cosmetics & Personal Care, Food Contact & Additives, Pharmaceuticals

Propylparaben is an ester of p-hydroxybenzoate that is used as an antimicrobial preservative in foods, drugs and cosmetics for over 50 years. It is produced by the n-propanol esterification of phydroxybenzoic acid in the presence of sulfuric acid followed by distillation (HSDB 2017). Propylparaben is Generally Recognized as Safe (GRAS) as a food ingredient in the United States, and is acceptable for use as an antimicrobial agent (21 CFR §184.1670). It is also permitted as an antimycotic in food-packaging materials (21 CFR § 181.23) and a food flavoring agent (21 CFR § 172.515) (U.S. FDA 2022). In 2004, the European Food Safety Authority (EFSA) Scientific Panel on Food Additives, Flavorings, Processing Aids and Materials in Contact with Food evaluated the safety of parabens in food and concluded that the Acceptable Daily Intake (ADI) for methylparaben and ethylparaben should not extend to propylparaben due to concerns for reproductive toxicity and lack of a clear NOAEL (EFSA 2004). Although the EFSA opinion has not been updated, the SCCS who previously shared EFSA’s opinion (SCCS 2013) recently concluded, based on new data, that propyl paraben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14% (SCCS 2021).

Chemical Synonyms Propyl 4-hydroxybenzoate; 4-hydroxybenzoic acid propyl ester; propyl phydroxybenzoate; propyl parahydroxybenzoate; n-propyl 4-hydroxybenzoate; n-propyl phydroxybenzoate; p-hydroxypropyl benzoate; p-hydroxybenzoic acid propyl ester; n-propylparaben; phydroxybenzoic propyl ester; propyl-4-hydroxybenzoate; 4-hydroxybenzoic acid, propyl ester; propyl 4- oxidanylbenzoate (SCCS 2021).

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