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. 2023 Apr 21;21(4):e07961. doi: 10.2903/j.efsa.2023.7961
Kind of data Data requested in the call for data Responses from interested parties Comment
A. Information regarding the follow‐up of the conclusions and the recommendations of the EFSA ANS Panel opinion on the safety of sucrose esters of fatty acids (E 473) as food additive
1.Technical data
  • analytical data on current levels of lead, mercury, cadmium and arsenic in commercial samples of the food additive;

  • the lowest technologically achievable level for lead, mercury, cadmium and arsenic in order to adequately define their maximum limits in the specifications;

  • the lowest technologically achievable level for impurities currently included in the EU specifications for sucrose esters of fatty acids (E 473);

  • the lowest technologically achievable level for vinyl esters of fatty acids when sucrose esters of fatty acids (E 473) are manufactured from sucrose and the vinyl esters of food fatty acids.

Provided Assessed, no further follow‐up
2.Toxicological data The risk characterisation at the lowest technologically achievable level of any residual of toxicological concern included in the EU specifications of sucrose esters of fatty acids (E 473) as food additive. Provided Assessed, no further follow‐up
3. Literature searches Literature searches should be conducted relevant for the safety evaluation of sucrose esters of fatty acids (E 473) for all uses in foods for all population groups from 9 January 2017 up to the date of the data submission, as described in the Guidance for submission for food additive evaluations (Section 5.3) Provided Assessed, no further follow‐up
B. Information required for the risk assessment of sucrose esters of fatty acids (E 473) as food additive for use in foods for infants below 16 weeks of age
1. Technical data
  • For the uses of sucrose esters of fatty acids (E 473), in foods for infants below 16 weeks (food categories 13.1.1 and 13.1.5.1) EFSA seeks;

  • information and justification on the concentration of sucrose esters of fatty acids (E 473) alone or in combination with food additives E 322, E 471 and E 472c;

  • information on the fate and the reaction products of sucrose esters of fatty acids (E 473) in these foods;

  • proposals for particular specification requirements for identity and purity of sucrose esters of fatty acids (E 473) when used in these food categories. In particular, the absence of residuals such as vinyl esters of fatty acids, acetaldehyde and p‐Methoxyphenol.

Provided Assessed, no further follow‐up
2. Toxicological data Within the frame of the EFSA Guidance of the Scientific Committee on the risk assessment of substances present in food intended for infants below 16 weeks of age the following information on the toxicological properties of sucrose esters of fatty acids (E 473) and its adverse effects relevant for its use in food categories for infants below 16 weeks of age 13.1.1 and 13.1.5.1 is required:
  • clinical data to assess the safety of sucrose esters of fatty acids (E 473);

  • post‐marketing surveillance reports on undesired and adverse reactions, indicating the ages and other relevant data of the exposed infants and young children and the use levels in the marketed products;

  • published and unpublished case reports (e.g. available nutrivigilance data) on undesired and adverse effects, associated with the oral administration of sucrose esters of fatty acids in any form, to infants and young children;

Provided Assessed, no further follow‐up
3. Literature searches Literature searches relevant for the safety evaluation of sucrose esters of fatty acids (E 473) when used in foods for infants below 16 weeks of age, should be conducted as described in the Guidance for submission for food additive evaluations (Section 5.3) Provided Assessed, no further follow‐up