Rating: Caution

Purpose / Use

Propylparaben is used as an antimicrobial agent (preservative), flavoring agent and adjuvant¹ (aids the function or performance of other chemical ingredients) in food products. It is part of a group of chemicals called parabens, which are also widely used in cosmetics and other personal care products.

Products

Propylparaben is used in some food products including tortillas, icing, and baked goods. According to the USDA FoodData Central - Branded Foods Database, which lists over 400,000 products, the use of propylparaben appears to be limited to a few hundred products in the US.

Safety assessment

A 2002 study reported that propylparaben reduced testosterone levels, sperm production, and sperm count in young rats.² Due to this study, the European Food Safety Authority (EFSA) could not recommend a safe level of use for propylparaben, and it did not recommend the use of propylparaben as a food additive.³ In effect, propylparaben is banned from foods in the EU. In 2007, the World Health Authority (WHO) reached the same conclusion as EFSA that propylparaben had adverse effects on the male reproductive system in animals.⁴  

However, recent evaluations from other authoritative bodies have questioned the data from the early reproductive toxicity studies. In 2019, Health Canada’s Food Directorate did not agree with EFSA’s or WHO’s conclusions and lists propylparaben as a permitted preservative.⁵ In a 2021 report, the EU Scientific Committee on Consumer Safety (SCCS)—which is separate from EFSA and assesses safety of cosmetics, textiles, toys, and other non-food goods—investigated use of propylparaben in cosmetics. In that opinion, SCCS dismissed the concern for male reproductive toxicity raised by the 2002 study because newer studies, which SCCS considered to be of higher quality, reported no effects on male reproduction. Further, unlike earlier SCCS assessments, which expressed major concerns that parabens were endocrine disruptors, the 2021 SCCS concluded that while studies indicated a potential for endocrine effects, there was insufficient data to conclusively consider propylparaben an “endocrine disrupting substance.”⁶ EFSA has not reevaluated the safety of propylparaben as a food additive in light of the new evidence.

Propylparaben was banned from foods in California in 2023 and has been banned from school foods in several other states since. It is currently listed on FDA’s list of chemicals under review. It was added to the list in 2024, and it is unclear if and when FDA will complete that evaluation.

Due to concerns for potential endocrine effects, CSPI rates propylparaben as Caution.

References

1. US Food and Drug Administration. 21 CFR 184.1670. Propylparaben.
2. Oishi, S. Effects of Propyl Paraben on the Male Reproductive System. Food Chem Toxicol. Dec 2002; 40(12):1807-13.
3. EFSA. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a Request from the Commission related to para hydroxybenzoates (E 214-219): Question number EFSA-Q-2004-063 EFSA Journal. 2004; 83, 1-26.
4. Joint FAO/WHO Expert Committee on Food Additives. WHO Food Additives Series 58. World Health Organization. International Programme on Chemical Safety. 2007.
5. Health Canada. Health Canada's Proposal to Revise Permitted Uses of the food additives Methyl Paraben, Propyl Paraben and their Sodium Salts in Various Foods [NOP/ADP-0033]. November 15, 2019.
6. European Commission: Scientific Committee on Consumer Safety (SCCS). Opinion on Propylparaben. March 2021. Available at: https://health.ec.europa.eu/system/files/2022-08/sccs_o_243.pdf

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