Polyglycerol Esters of Fatty Acids

About

What it is and where it shows up.

Polyglycerol esters of fatty acids (PEFA) are a group of food emulsifiers produced by esterifying polyglycerols with food fats, oils, or fatty acids; the polyglycerol moiety is predominantly di-, tri-, and tetraglycerol. They are widely used in baked goods, confectionery, margarines, and other foods to improve texture, fat distribution, volume, and shelf life.

Safety summary

The regulatory and scientific consensus.

EFSA's 2017 re-evaluation concluded that PEFA is not of safety concern at reported use levels and that no numerical ADI is required; no adverse effects were observed at any dose in short-term, subchronic, or chronic toxicity studies, and no genotoxic potential was identified. However, manufacturing processes can introduce trace contaminants—glycidol and epichlorohydrin—both classified as IARC Group 2A probable human carcinogens, prompting the EU to mandate stricter specification limits for these and other impurities via Regulation (EU) 2023/1329 effective 20 July 2023. Children represent the highest-exposure subgroup (up to 6.4 mg/kg bw/day at the 95th percentile), though this remains well within the historical JECFA ADI of 25 mg/kg bw/day.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	EFSA ANS Panel 2017 scientific re-evaluation concluded no safety concern at current use levels and no need for a numerical ADI; flagged glycidol and epichlorohydrin manufacturing contaminants as requiring further specification controls.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Permitted as an emulsifier under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations; specific conditions of use align with Codex/FAO-WHO standards. Confirm current schedule for product-specific maximum levels.source
FDA (Food and Drug Administration) (United States)	Approved	Listed as a permitted food substance in the FDA food substances database; regulated as a direct food additive under 21 CFR 172.854 for use as an emulsifier in food.source

Who should approach with care

Whose guidance would steer them away.

Infants — Glycidol, an IARC Group 2A genotoxic and carcinogenic manufacturing contaminant in E475 (EFSA CONTAM Panel 2016), may pose a proportionally higher risk to infants due to lower body weight and higher relative dietary exposure; EU has mandated stricter residual limits from July 2023.

Children — EFSA estimated the highest dietary exposure to E475 occurs in children (up to 6.4 mg/kg bw/day at the 95th percentile in the non-brand-loyal scenario), warranting attention to cumulative intake relative to the historical JECFA ADI of 25 mg/kg bw/day.

Research citations

The sources behind this verdict.

1WHO. POLYGLYCEROL ESTERS OF FATTY ACIDS – JECFA Chemical Assessment. apps.who.int
2EFSA. Follow-up of the re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive, 2022. efsa.europa.eu
3PubMed. Follow-up of the re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive, 2022. pubmed.ncbi.nlm.nih.gov
4EFSA. Re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive, 2017. efsa.europa.eu
5PubMed. Re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive, 2017. pubmed.ncbi.nlm.nih.gov

Independently researched5 citations