Safety of the proposed extension of use of sucralose (E 955) in foods for special medical purposes in young children

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Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2016;14(1):4361 [11 pp.].
doi
10.2903/j.efsa.2016.4361
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Applications: Maria Jose Frutos, David Gott, Lieve Herman, Claude Lambré, Jean-Charles Leblanc, Peter Moldeus, Alicja Mortensen, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright for the preparatory work on this scientific output and EFSA staff members: Paolo Colombo and Camilla Smeraldi for the support provided to this scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2015-00135
Adopted
9 décembre 2015
Published
19 janvier 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion regarding the safety of the extension of use of the food additive sucralose (E 955) when added to dietary food for special medical purpose (FSMP) intended for young children aged from 1 to 3 years. Sucralose was evaluated by the EU Scientific Committee on Food (SCF) who established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw). Sucralose is authorised in the EU for food use with exception for foods for young children. According to the applicant, the use of sweeteners is required to ensure palatable foods for the dietary management of patients whose compliance with the dietary regime (prescribed by healthcare professionals) is a key factor to their health. The exposure scenarios based on the proposed use by the applicant on the FSMP indicated that the total daily protein requirement (3 g protein/kg bw) could be covered by the product containing 400 mg sucralose/kg without exceeding the ADI. Also, exposure in other scenarios based on different assumptions was always below the ADI. Therefore, the ANS Panel concluded that the proposed extension of use of sucralose (E 955) in FSMP in young children aged from 1 to 3 years would not be of safety concern. 

Summary

Following a request from the European Commission, the European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion regarding the safety of the extension of use of the food additive sucralose (E 955) when added to dietary food for special medical purposes (FSMP) intended for young children aged from 1 to 3 years.

According to the applicant, the use of sweeteners is required to ensure palatable foods for the dietary management of patients whose compliance with the dietary regimen (prescribed by health care professionals) is a key factor to their health. Their diet is based on FSMPs, which either fulfil their daily nutrient requirements or supplement an inadequate dietary intake. The applicant stated that the FSMPs-added sucralose (E 955) were designed to cover or supplement dietary protein requirement in order to maintain physiological growth and development of the target population.

Although sucralose was previously evaluated by the European Union (EU) Scientific Committee on Food (SCF) and an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) established in 1991 and 2000 by the joint FAO/WHO Expert Committee on Food Additives (JECFA) and by the SCF, respectively, the acceptability of the use of sucralose and any sweetener in dietary foods for young children for special medical purposes was not assessed.

The Panel considered that the available toxicological assessments of sucralose by SCF establishing an ADI would remain valid and in principle there would be no need to reconsider this to address the Terms of Reference.

In consideration of the medical condition of the recipient of the FSMPs, a different dietary pattern compared to their counterparts from the general population should be considered. These specific aspects were taken into account by the Panel when estimating exposure to sucralose (E 955) by different scenarios. With this aim, the applicant has proposed to assess two exposure scenarios with a specific product example: a liquid product containing 10 g protein per 100 mL and sweetened with 40 mg of sucralose, corresponding to 4 mg sucralose/g of protein. A first scenario would be closed to the original standard recommendations of 14.5 g/day for protein in children across the range of 1–3 years, whereas the second scenario would require the patients to meet their daily protein need set up by the applicant to 3 g/kg bw/day solely from the sweetened products.

According to this last maximum scenario, the protein intake can be fully ensured (3 g protein/kg body weight) by the sweetened product resulting in an approximate intake of sucralose of 12 mg/kg without exceeding the ADI of 15 mg/kg bw. Also, other exposure scenarios based on different assumptions were below the ADI.

The ANS Panel concluded that the proposed extension of use of sucralose (E 955) in FSMP in young children aged from 1 to 3 years would not be of safety concern. 

Keywords
food additive, sweetener, sucralose, E 955, extension of use, FSMP, children
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Number of Pages
11