About
Polyglycerol polyricinoleate (PGPR) is a mixture of products formed by the esterification of polyglycerols with condensed castor oil fatty acids, primarily ricinoleic acid (80–90%). It functions as a water-in-oil emulsifier widely used in chocolate, emulsified sauces, and edible ices to stabilise emulsions, reduce viscosity, and improve texture.
Safety summary
EFSA re-evaluated PGPR in 2017 and revised its ADI upward to 25 mg/kg body weight per day, concluding it raises no genotoxicity or carcinogenicity concerns and that acute oral toxicity is low; human studies demonstrated no indication of significant adverse effects. The single available reproductive toxicity study was judged by EFSA to be limited and insufficient for deriving a health-based guidance value, leaving some residual uncertainty. A 2022 EFSA follow-up opinion confirmed proposed extensions of use would not give rise to safety concerns but recommended tightening specification limits for heavy metals (arsenic, lead, mercury, cadmium) and processing contaminants (glycidyl esters, 3-MCPD).
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | PGPR (INS 476) is already approved for food use in Australia and New Zealand for multiple food categories. Application A1322 (December 2024) seeks additional permission in sauces and toppings (Schedule 15-20.2.0.4) at up to 8,000 mg/kg to enable reduced-oil product formulations.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised under Regulation (EC) No 1333/2008, Annex II and III. ADI revised from 7.5 to 25 mg/kg bw/day by EFSA ANS Panel in 2017. Permitted in cocoa- and chocolate-based products, emulsified sauces, and liquid vegetable oil emulsions (fat ≤70%). Specifications defined in Commission Regulation (EU) No 231/2012. EFSA 2022 follow-up (pub/7294) recommended amendments to lower heavy-metal limits and add glycidyl ester/3-MCPD limits in the official specifications.source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Approved | UK retains EU-derived specifications under retained Regulation (EC) No 231/2012 post-Brexit. Extension of use in edible ices (up to 4,000 mg/kg) and revised maximum level in emulsified sauces (up to 8,000 mg/kg) were under active safety assessment by AEJEG as of September 2023. Exposure estimates at proposed new levels did not exceed the ADI.source |
| FDA (Food and Drug Administration) (United States) |
Who should approach with care
Research citations
- 1FDA. GRAS Notice GRN 1105 Agency Response Letter – Polyglycerol Polyricinoleic Acid (PGPR), 2023. fda.gov
- 2EFSA. Follow-up of the re-evaluation of polyglycerol polyricinoleate (E 476) as a food additive, 2022. efsa.europa.eu
- 3PubMed. Follow-up of the re-evaluation of polyglycerol polyricinoleate (E 476) as a food additive, 2022. pubmed.ncbi.nlm.nih.gov
- 4EFSA. Scientific Opinion on re-evaluation of polyglycerol polyricinoleate (E 476) as a food additive, 2017. efsa.europa.eu
- 5PubMed. Re-evaluation of polyglycerol polyricinoleate (E 476) as a food additive, 2017. pubmed.ncbi.nlm.nih.gov
