Sodium Propyl Paraben

About

What it is and where it shows up.

Sodium propyl paraben is the sodium salt of propyl p-hydroxybenzoate, a synthetic antimicrobial preservative belonging to the paraben family derived from p-hydroxybenzoic acid. It is used in foods, pharmaceuticals, and cosmetics to inhibit the growth of bacteria, yeasts, and moulds, thereby extending product shelf life.

Safety summary

The regulatory and scientific consensus.

EFSA's 2004 AFC Panel re-evaluation found that dietary administration of propyl paraben reduced daily sperm production in juvenile male rats at the lowest dose tested (10 mg/kg bw/day), and concluded that no clear NOAEL and no safe ADI could be established, leading to suspension of E216/E217 in EU food use. Propyl paraben also exhibits weak estrogenic activity in vitro, and ongoing scientific debate exists regarding its endocrine-disrupting potential and possible links to breast cancer, though subsequent GLP studies in rodents using doses up to 1000 mg/kg bw/day did not replicate the original adverse reproductive findings. The US FDA continues to permit propylparaben in food under 21 CFR, and no IARC carcinogenicity classification has been assigned.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Banned	E217 (sodium propyl p-hydroxybenzoate) and E216 (propyl p-hydroxybenzoate) were suspended as permitted food additives in the EU following EFSA's AFC Panel opinion (2004), which found propyl paraben caused adverse effects on sex hormones and male reproductive organs in juvenile rats and could not establish a safe NOAEL or group ADI. The E-numbers were formally removed under subsequent EU food additive regulations (linked to Regulation 37/2010). Only methyl and ethyl parabens (E218/E214 and their sodium salts E219/E215) retained a group ADI of 0–10 mg/kg bw.source
FDA (Food and Drug Administration) (United States)	Approved	Propylparaben and its sodium salt are permitted in foods under 21 CFR 184.1670 (GRAS) and appear in the FDA Food Additive Status List with approved uses as antimicrobial preservatives. The FDA has not issued any ban or restriction on propylparaben in food and continues to evaluate new safety data.source

Who should approach with care

Whose guidance would steer them away.

Children — EFSA's 2004 evaluation specifically identified adverse effects on sex hormones and male reproductive organ development in juvenile rats at the lowest dose tested (10 mg/kg bw/day), raising heightened concern for children, particularly during developmental stages.

Infants — The EU regulatory ban was driven by reproductive and hormonal developmental concerns observed in juvenile animals; the immature endocrine system of infants makes precautionary avoidance appropriate.

Pregnancy — Propyl paraben's demonstrated weak estrogenic and potential endocrine-disrupting activity, as reviewed in multiple studies, warrants precautionary avoidance during pregnancy given sensitivity of fetal hormonal development.

Lactation — Given the unresolved controversy around propyl paraben's estrogenic activity and endocrine disruption potential, precautionary limitation during lactation is prudent to minimise infant exposure via breast milk.

Research citations

The sources behind this verdict.

1EMA. European Public MRL Assessment Report (EPMAR) for propyl 4-hydroxybenzoate and its sodium salt (all food producing species). ema.europa.eu
2FDA. Parabens in Cosmetics — FDA. fda.gov
3PubMed. Assessing the Public Health Implications of the Food Preservative Propylparaben: Has This Chemical Been Safely Used for Decades, 2021. pubmed.ncbi.nlm.nih.gov
4PubMed. Regulatory risk assessments: Is there a need to reduce uncertainty and enhance robustness? Update on propylparaben in relation to its EU regulatory status, 2017. pubmed.ncbi.nlm.nih.gov
5EFSA. EFSA advises on the safety of paraben usage in food — Opinion of the AFC Panel on para-hydroxybenzoates (E 214–219), 2004. efsa.europa.eu

Independently researched5 citations