Polyglycerol esters of fatty acids (E 475) and its impurities
What it found
The Panel assessed impurities in commercial samples of E 475 and found that limits for arsenic, lead, mercury and cadmium should be lowered, and limits for erucic acid, 3-MCPD and glycidyl esters should be added.
The assessment was based on data from commercial samples, not studies in people or animals.
What they found
Toxic elements in samples
Levels of arsenic, lead, mercury and cadmium in commercial samples of E 475 were substantially lower than the current EU specification limits. For lead, four samples had 0.29 mg/kg and the rest were below the limit of quantification; for mercury, cadmium and arsenic, all samples were below their limits of quantification.
Arsenic risk assessment
The Panel concluded that for arsenic, the lower end of the range of calculated margin of exposure values was insufficient. This means the safety margin for arsenic was not large enough at the proposed limit.
Other toxic elements
For cadmium, mercury and lead, the limit values proposed by the interested business operator do not give rise to safety concerns, based on the Panel's risk assessment.
Glycidyl esters
Glycidyl esters were measured in eight commercial samples of E 475, with concentrations ranging from below 0.1 mg/kg to 6.45 mg/kg. The Panel concluded that the proposed limit of 5 mg/kg does not give rise to a health concern.
3-MCPD and its esters
The sum of 3-MCPD and 3-MCPD fatty acid esters was measured in nine commercial samples of E 475, with concentrations ranging from below 0.1 to below 0.3 mg/kg. The Panel concluded that the proposed maximum limit of 2.5 mg/kg does not give rise to a health concern.
Erucic acid
No analytical data on erucic acid levels in E 475 were provided because manufacturers stated they do not use oils from the Brassicaceae family. The Panel concluded that the proposed limit of 20 g/kg does not give rise to a health concern.
Trans-fatty acids
Levels of trans-fatty acids in commercial samples of E 475 ranged from 0.05% to less than 1% for samples from fully hardened fats and oils, and from 0.43% to 2.19% for samples from non-hardened fats and oils. The Panel concluded there is no need for a specification limit because a limit already exists in Regulation (EU) No 2019/649.
Acrolein and butanetriol
Acrolein and butanetriol were not detected in the limited number of analysed samples of E 475. The Panel recommends that polyglycerol used to make E 475 should be produced from glycerol meeting the specifications for E 422, in which case limits for these impurities would not be needed.
What the authors conclude
“The Panel concluded that the maximum limits in the EU specifications for the 4 toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 475.”
Also in their conclusions
- They concluded that the maximum limits in the EU specifications for the 4 toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 475.
- They also concluded that maximum limits for erucic acid, 3-monochloropropanediol and glycidyl esters should be included in the EU specifications for E 475.
- They recommend an amendment of the definition of E 475 to include a requirement that the fats and oils used in the manufacturing of E 475 comply with the respective EU legislation regarding suitability for human consumption.
How it was done
The Panel did this work as a follow-up to the 2017 re-evaluation of E 475, which identified data gaps and recommended updating the EU specifications for this food additive.
The Panel assessed analytical data on impurities and undesirable constituents in commercial samples of E 475, submitted by one interested business operator. They calculated potential exposure to these impurities from the use of E 475 and compared it with health-based guidance values or reference points.
What it can’t tell you
- This assessment is based on analytical data from commercial samples and calculated exposure, not on studies in people or animals. It cannot show what health effects might occur in people from eating E 475.
- The risk assessment compares potential exposure to impurities against health-based guidance values, but it does not measure actual health outcomes in any population.
The paper
- Title
- Follow-up of the re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive
- Type
- Scientific opinion of the European Food Safety Authority
- Summarised from
- Full text
- Licence
- CC BY-ND. Words in quotation marks are the authors’; the rest is our summary.
- Cite
- EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, et al (2022). Follow-up of the re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2022.7308Free full textPubMed 35600272DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error