EFSA opinion · EFSA journal. European Food Safety Authority · 2023

Sucrose esters of fatty acids (E 473) intake and safety review

What it found

In many groups, the estimated intake of sucrose esters of fatty acids (E 473) went above the group acceptable daily intake of 40 mg/kg body weight per day.

The additive was not used in infant formula or foods for infants under 16 weeks, so no safety assessment was done for that age group.

What they found

Intake above the ADI

Using updated use levels, the estimated intake of E 473 went above the group acceptable daily intake of 40 mg/kg body weight per day for many population groups. This confirms what the earlier 2018 evaluation found.

Not used in infant formula

According to the information available, E 473 is not used in infant formulae or in foods for infants below 16 weeks of age. Because of this, the panel did not assess its safety for that age group.

Toxic elements in E 473

Companies sent data on lead, cadmium, mercury and arsenic in E 473. The levels found were in almost all cases much lower than the current limits in the EU specifications.

Exposure to arsenic

The panel calculated that, under the current specifications, exposure to arsenic from eating E 473 could be substantial. For mercury and cadmium, the potential exposure was also high, keeping in mind that E 473 is only one source.

Missing data on impurities

No information was sent on erucic acid, 3-MCPD and glycidyl esters in commercial samples of E 473, and very little on trans fatty acids. The panel could not propose maximum limits for these impurities.

Specifications need updating

The technical data provided by companies support changing the specifications for E 473. The panel recommended lowering the maximum limits for toxic elements based on the actual levels found.

What the authors conclude

“When the updated exposure estimates considering the provided use levels for some food categories are taken into account the estimates of exposure to sucrose esters of fatty acids (E 473) exceeded the group acceptable daily intake (ADI) of 40 mg/kg body weight (bw) per day for many population groups.”
EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, et al, 2023

Also in their conclusions

  • They concluded that the technical data provided by the interested business operators support an amendment of the specifications for sucrose esters of fatty acids (E 473) laid down in Commission Regulation (EU) No 231/2012.
  • They recommended that the maximum limits for toxic elements in the EU specifications should be lowered on the basis of the information provided by the IBOs and on the considerations of the Panel.
  • They recommended that the fats and oils used for the manufacturing process of E 473 should comply with Regulations (EC) No 1881/2006 and (EC) No 1925/2006, or that limit values for these impurities could be introduced in Commission Regulation (EU) No 231/2012 for E 473.

How it was done

The European Commission asked EFSA to check the safety of sucrose esters of fatty acids (E 473) for use in food for infants below 16 weeks of age and to follow up on issues from earlier evaluations for the general population.

The panel asked companies for data on how much E 473 is used in foods, on impurities, and on manufacturing. Five companies provided use levels for six food categories, and two provided data on toxic elements like lead, cadmium, mercury and arsenic. The panel then estimated how much people of different ages might take in.

What it can’t tell you

  • The intake estimates are based on food consumption data and reported use levels, not on actual measurements in people. They cannot show what health effects, if any, might occur from eating E 473.
  • No safety assessment was done for infants below 16 weeks of age because the additive is not used in their foods. So this paper cannot say anything about safety for that age group.
  • The data on impurities were not complete, so the panel could not set limits for some impurities or fully assess exposure to them.

The paper

Title
Re-evaluation of sucrose esters of fatty acids (E 473) as a food additive in foods for infants below 16 weeks of age and follow-up of its previous evaluations as food additive for uses in foods for all population groups
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 (2023). Re-evaluation of sucrose esters of fatty acids (E 473) as a food additive in foods for infants below 16 weeks of age and follow-up of its previous evaluations as food additive for uses in foods for all population groups. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2023.7961Free full textPubMed 37089185DOI

Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error