Propyl paraben E216
antimicrobial — Primarily synthetic.
Propyl 4-hydroxybenzoate
CAS: 94-13-3
Factual Regulatory Reference
This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.
What Is Propyl paraben?
Propyl paraben is a propyl ester of para-hydroxybenzoic acid, used as a preservative against molds and yeasts in baked goods, confectionery, and some beverages. It was once widely used alongside methyl paraben (E218), but regulatory re-evaluations raised concerns. EFSA's 2004 scientific panel concluded that propyl paraben at high doses affected testosterone levels and sperm production in male rats. Consequently, the EU banned propyl paraben as a food additive in 2006 (no longer on the EU permitted list), while it remains permitted under strict limits in some other jurisdictions.
? Did You Know?
Beyond food, Propyl paraben is also used in cosmetics, medicine, industrial applications. Its versatility makes it one of the most multi-purpose chemical compounds in everyday life.
To reach the Acceptable Daily Intake limit, a 60kg adult would need to consume approximately ~2000 grams of food with propyl paraben (300ppm) in a single day. (This is a mathematical illustration, not a safety recommendation.)
Regulatory Analysis
Propyl paraben's (E216) regulatory divergence between the EU and other jurisdictions reflects a precautionary response to endocrine-active properties, rather than a documented harm at food-use levels. EFSA's Scientific Committee on Food evaluated parabens in 2004 and noted that high-dose propyl paraben reduced testosterone levels and sperm counts in male rats. Acting on the precautionary principle, the EU subsequently revoked E216's authorization for food use — it is no longer included in Regulation (EC) No 1333/2008's permitted list. Separately, the EU restricted longer-chain parabens in cosmetics under Commission Regulation (EU) No 358/2014. The FDA retains propyl paraben under GRAS status (21 CFR 184.1670) at ≤0.1%, having concluded that food-use exposure is insufficient to produce endocrine effects. JECFA's 1973 group ADI of 10 mg/kg body weight was set before endocrine endpoints were routinely evaluated and has not been superseded.
Detailed Regulatory Assessment
European Union (EFSA)
Permitted in limited food categories
United States (FDA)
Maximum 0.1% in food
Japan (MHLW)
Permitted preservative
Acceptable Daily Intake (ADI)
International Standard (JECFA)
mg/kg body weight per day
European Standard (EFSA)
Everyday Perspective
For a 60kg adult, this limit is roughly equivalent to consuming:
Natural Occurrence
This additive is not known to occur naturally in significant quantities.
Manufacturing
Synthesized by esterifying p-hydroxybenzoic acid with propanol.
Applications Beyond Food
Widely used in cosmetics and personal care products
Used in oral and topical medications
Preservative in pharmaceuticals