Statement on the exposure assessment of sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate including exposure resulting from extension of the authorisation of sodium stearoyl-2-lactylates

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Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2013;11(3):3125 [15 pp.].
doi
10.2903/j.efsa.2013.3125
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright
Acknowledgements

The Panel wishes to thank the members of the Working Group B on Food Additives and Nutrient Sources added to Food: Fernando Aguilar, Martine Bakker (until February 2013), Riccardo Crebelli, Birgit Dusemund, David Gott, Torben Hallas-Møller, Jürgen König, Oliver Lindtner, Daniel Marzin, Inge Meyland, Alicja Mortensen, Iona Pratt, Paul Tobback, Ine Waalkens-Berendsen and Rudolf Antonius Woutersen for the preparatory work on this scientific opinion.

Contact
Type
Statement of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00698
Adopted
20 February 2013
Published
12 March 2013
Last Updated
6 May 2013. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following a request by the European Commission, the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) carried out an exposure assessment of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as a food additive, including an extension of the uses to use the additives in emulsified cooked meat products (e.g. mortadella, paté). Reflecting the data on actual use levels provided by food industry, the combined exposure to sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate is in the range of 29-92 mg/kg bw/day for toddlers, 28-81 mg/kg bw/day for children, 13-32 mg/kg bw/day for adolescents, 8-21 mg/kg bw/day for adults, and 5-15 mg/kg bw/day for the elderly at the mean level. For exposure at high levels, ranges of 69-223 mg/kg bw/day for toddlers, 44-190 mg/kg bw/day for children, 21-59 mg/kg bw/day for adolescents, 19-53 mg/kg bw/day for adults, and 16-31 mg/kg bw/day were calculated for the elderly. The extension of the authorisation for the use of sodium stearoyl-2-lactylate in emulsified cooked meat products (e.g. mortadella, paté) would not lead to an increase of exposure based on the approach taken for the exposure assessment for the two food additives.

Summary

Following a request by the European Commission, the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) carried out an exposure assessment of sodium stearoyl-2-lactylate (E 481) (SSL) and calcium stearoyl-2-lactylate (E 482) (CSL) as a food additive including extension of the uses to  use in emulsified cooked meat products (e.g. mortadella, paté).

In April 2011 the application for the extension of the use of sodium stearoyl-2-lactylate (E 481) was limited to emulsified cooked meat products (e.g. mortadella, paté) by proposing a maximum limit of 3 g/kg food in combination with iota carrageenan (stabilizer E 407, which belongs to group I of food additives used at quantum satis), that is 2.2 g/kg food of E 481 and 0.8 g/kg food of iota carrageenan. The applicant has indicated that sodium stearoyl-2-lactylate is one of the emulsifiers with the highest hydrophilic-lipophylic balance and is therefore an excellent emulsifier for fat in water emulsions. An important synergy between sodium stearoyl-2-lactylate emulsifier and the stabilizer iota carrageenan (E 407) has recently been discovered and has been patented (European Patent No. 1488 701 A1). As sodium stearoyl-2-lactylate is authorised to be used individually or in combination with calcium stearoyl-2-lactylate it does not seem justified to make the exposure assessment only to sodium stearoyl-2-lactylate and it is therefore preferable to perform exposure assessments for both substances included in the group of lactylates.

On 13 April 2012, the European Commission requested EFSA to perform an exposure assessment of the food additives SSL (E 481) and CSL (E 482) due to the request for an extension of use of this substance.

Currently, SSL/CSL is an authorised emulsifier in the EU with MPLs ranging from 2000 to 10 000 mg/kg in foods. An extension of authorisation to the use of SSL has been requested for the use in emulsified cooked meat products (e.g. mortadella, paté) within food category 08.2.2 Heat-treated processed meat at a proposed use level of 2200 mg/kg food in combination with iota carrageenan (E 407) at a level of 0.8 g/kg food.

Information about the actual levels in use has been provided by the European Food Emulsifier Manufacturers’ Association (EFEMA) and from a data collection by the Confederation of the Food and Drink Industries of the EU (CIAA, now FoodDrinkEurope). For calculation of chronic exposure, intake statistics have been calculated based on individual average consumption over the total survey period excluding surveys with only one day per subject. High level consumption was only calculated for those foods and population groups where the sample size was sufficiently large to allow calculation of the 95th percentile. The Panel estimated chronic exposure for the following population groups: toddlers, children, adolescents, adults and the elderly. Calculations were performed using individual body weights. Exposure to SSL and CSL from its use as food additive has been calculated by using MPLs combined with national consumption data for the five population groups.

The exposure estimates based on reported use levels are in a range of 29-92 mg/kg bw/day for toddlers, 28-81 mg/kg bw/day for children, 13-32 mg/kg bw/day for adolescents, 8-21 mg/kg bw/day for adults, and 5-15 mg/kg bw/day for the elderly at the mean level.

To perform a preliminary evaluation on the impact of impurities, an exposure estimation was performed on the basis of a daily ingestion of 20 mg/kg bw SSL or CSL (the current ADI value) and the maximum permitted levels of the impurities. The comparison with the tolerable daily intake of these impurities showed no toxicological concern after ingestion of the current ADI of 20 mg/kg bw/day of SSL or CSL (individually or in combination).The extension of the authorisation of sodium stearoyl-2-lactylate to the use in emulsified cooked meat products would not result in a substantial increase of exposure based on the scenario of exposure assessment in this opinion. At present, sodium stearoyl-2-lactylate is authorised in the food category “heat-treated processed meat” (08.2.2) for minced and diced canned meat products. The EFSA Comprehensive Food Consumption Database however does not provide data specifically on the consumption of these foods. Therefore, the data on the consumption of the top level category 08.2.2 had to be used for the exposure assessment. The exposure resulting from the extension of use to emulsified cooked meat products is already included in this conservative approach.

The Panel concluded that an extension of the authorisation for the use of sodium stearoyl-2-lactylate in emulsified cooked meat products (e.g. mortadella, paté) would not lead to an increase of exposure based on the approach taken for the exposure assessment for the two food additives.

Keywords
Sodium stearoyl-2-lactylate, calcium stearoyl-2-lactylate, E 481, E 482, exposure
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Number of Pages
15