Ethylparaben (CAS 120-47-8) is a widely used antimicrobial preservative in the food, pharmaceutical, and personal care industries. Chemically known as ethyl 4-hydroxybenzoate, it is an ethyl ester of 4-hydroxybenzoic acid that prevents the growth of mold, fungi, and certain bacteria. For kosher food and pharmaceutical manufacturers, verifying the kosher status of ethylparaben is an important part of ingredient qualification.
As a member of the paraben family of preservatives, ethylparaben has a long safety track record in regulated applications. The FDA lists it as an authorized food contact substance under 21 CFR 175.105, and it meets NF (National Formulary) standards for pharmaceutical use.
Kosher Considerations for Ethylparaben
Ethylparaben is produced by esterification of 4-hydroxybenzoic acid with ethanol. Both starting materials are typically derived from petrochemical or plant-based sources, neither of which presents inherent kosher concerns. The kosher evaluation focuses on the manufacturing process, including catalysts, solvents, and shared production equipment that might introduce non-kosher contamination.
Their operations comply with current Good Manufacturing Practices under 21 CFR Parts 210 and 211, with original manufacturers adhering to ICH Q7 standards. Kosher certification documentation is available as part of their standard document package alongside safety data sheets and certificates of analysis.
Regulatory Status in Food Applications
Ethylparaben appears in the FDA Inventory of Food Contact Substances Listed in 21 CFR. Its primary regulatory listing under 21 CFR 175.105 covers its use as a component of adhesives, and it functions as an antimicrobial agent in certain food-related applications. The compound is recognized for its preservative effectiveness at relatively low concentrations.
PubChem identifies ethylparaben as having roles as an antifungal agent, an antimicrobial food preservative, and a plant metabolite. The CIR Expert Panel has reviewed ethylparaben multiple times (1984, 2008, 2020) and concluded it is safe in current practices of use when the combined concentration of parabens does not exceed 0.8% in any formulation.
Pharmaceutical and Supplement Considerations
Ethylparaben frequently appears as an excipient in pharmaceutical tablets, capsules, and liquid formulations. For kosher consumers, the cRc and STAR-K provide guidelines on medications and supplements that may contain preservatives like ethylparaben. Solid tablets that are swallowed are generally considered acceptable even without kosher certification, but liquid and chewable forms require closer evaluation.
Supplement manufacturers should note that products classified as food supplements rather than medicine typically require full kosher certification. Ethylparaben used as a preservative in these products falls under the same requirement.
Quality Specifications to Request
When sourcing kosher ethylparaben, request NF or FCC grade product with a current kosher certificate. Key quality parameters include color of solution testing, elemental impurity analysis, residual solvent levels, and FTIR identification matching reference spectra. A complete document package should include a safety data sheet, certificate of analysis, cGMP certification, and the kosher certificate.
Confirm that the kosher certificate is current and issued by a recognized agency. Maintain documentation for each lot received to support audits and regulatory submissions.
Kosher Ethylparaben Supplier
We supply bulk food-grade ethylparaben from top manufacturers in China. We help you handle the entire bulk ingredients sourcing process in China: manufacturer selection (top Chinese food ingredients manufacturers), price negotiation, quality verification, and logistics coordination.
View our Ethylparaben product page and request a free sample