Scientific Opinion on the exposure assessment of sucrose esters of fatty acids (E 473) from its use as food additive 1

EFSA Journal 2012;10(5):2658 SCIENTIFIC OPINION Scientific Opinion on the exposure assessment of sucrose esters of fatty acids (E 473) from its use as food additive 1 ABSTRACT EFSA Panel on Food additives and Nutrient Sources added to Food (ANS) 2, 3 European Food Safety Authority (EFSA), Parma, Italy The ANS provides a scientific opinion on the exposure assessment of sucrose esters of fatty acids (E 473) taking into account the additional information on its use as surface treatment agent for food and the additional proposed use in flavourings. The Panel previously adopted a scientific opinion (2010) on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings. In that opinion the Panel concluded that, based on the data available, the additional use of the sucrose esters of fatty acids may lead to exposures in excess of the ADI of 40 mg/kg bw/day for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) established by EFSA in 2004. The Panel further noted that the main contribution to total dietary exposure to sucrose esters of fatty acids was from its use as surface treatment for fruits (on average 40-50%) and suggested that for a more refined estimate of intake, actual data on this use would need to be known. Following this conclusion new data were submitted to EFSA providing actual use levels of sucrose esters of fatty acids as a surface treatment for fresh fruits and the resulting residual levels in fruit. A new exposure assessment was based on this information and taking into account an additional proposed use in flavourings. The Panel noted that the current intake of sucrose esters of fatty acids is considerably lower than previously estimated, but is still above the ADI for children high level consumers. However, an intake resulting from its use as a surface treatment for fruits and the additional proposed use in clear flavoured soft drinks contributes to 0.25% and 0.1% of the ADI, respectively. European Food Safety Authority, 2012 KEY WORDS Sucrose monoesters of fatty acids, E 473, food additive, emulsifier, stabiliser, surface treatment of fruit 1 On request from the European Commission, Question No EFSA-Q-2011-00935, adopted on 18 April 2012. 2 Panel members: F. Aguilar, R. Crebelli, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, U. Gundert-Remy, J. König, C. Lambré, J-C. Leblanc, A. Mortensen, P. Mosesso, D. Parent-Massin, I. Stankovic, P. Tobback, I. Waalkens-Berendsen, R.A. Woutersen, M.C. Wright. Correspondence: ans@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group A on Food Additives and Nutrient Sources of the ANS Panel for the preparation of this opinion: N. Bemrah, P. Galtier, U. Gundert-Remy, R. Guertler, C. Lambré, J.C. Larsen, J-C. Leblanc, P. Mosesso, D. Parent-Massin, Ch. Tlustos, I. Stankovic, P. Tobback and M.C.Wright. Suggested citation: EFSA Panel on Food additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the exposure assessment of sucrose esters of fatty acids (E 473) from its use as food additive. EFSA Journal 2012;10(5):2658. [11 pp.] doi:10.2903/j.efsa.2012.2658. Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2012

SUMMARY Following a request from the European Commission to the European Food Safety Authority (EFSA), the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the exposure assessment of sucrose esters of fatty acids (E 473) resulting from its use as a food additive, taking into account the additional information on the proposed use of sucrose esters of fatty acids as a surface treatment agent for food and its proposed additional use in flavourings. In this opinion possible exposure from processed fruit the peel of which is usually not consumed as part of the fruit (i.e. citrus peel, etc ) is not taken into consideration because the Panel considered this exposure negligible. Sucrose esters of fatty acids (E 473) are authorised for use in a number of foods according to the European Parliament and Council Directive 95/2/EC on food additives other than colours and sweeteners. In February 2010, the Panel adopted a scientific opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings (EFSA, 2010). The Panel concluded that, based on the data available, it was possible that the additional use of the sucrose esters of fatty acids may lead to exposures in excess of the acceptable daily intake (ADI) of 40 mg/kg bw/day for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) established by EFSA in 2004. The Panel further noted that the main contribution to the total dietary exposure to sucrose esters of fatty acids was from fruit (36% and 46% for adults and children, respectively), due to the use of sucrose esters of fatty acids as a surface glazing agent. As no actual data had been provided by the applicant on the use of sucrose esters of fatty acids as a surface treatment for fruits, and as its use is regulated quantum satis, a residual level of 18 g/kg was estimated by the Panel in the original opinion and this value was used in the refined exposure assessment, resulting in high exposure estimates. The Panel suggested that for a more refined estimate of intake, actual data on the use of sucrose esters of fatty acids as a surface treatment for fruits would need to be known. In the absence of data on the use of sucrose esters of fatty acids in fruit, information would need to be provided on the exact depth of the application layer, the types of fruit which are treated with the glazing agent and the market share of the glazing agent in comparison to other glazing agents/waxes. Following these conclusions in the EFSA opinion (EFSA, 2010), new data were submitted to EFSA on the actual use of sucrose esters of fatty acids as a surface treatment for fresh fruits and on the resulting residual levels in fruit (Tennant, 2010). The present opinion makes a revised assessment of exposure based on these new data and takes into account the proposed extension of use in flavourings used in clear soft drinks. The results of the current exposure assessment for sucrose esters of fatty acids, are considerably lower than those of the original opinion (EFSA, 2010), with population-group-dependent reductions ranging from 55-65%. The current mean and high (95 th percentile) total intake of sucrose esters of fatty acids were 13.1 and 22.6 mg/kg bw/day for adults and 19.6 and 42.8 mg/kg bw/day for children, respectively, while in the original opinion of the Panel, the estimated total mean and high (95 th percentile) intake of sucrose esters of fatty acids were 29.1 and 64.2 mg/kg bw/day in adults and 51.6 and 117.3 mg/kg bw/day in children, respectively. However, for children high level consumers the current estimated intake exceeds the ADI by 7%. The Panel concluded that the exposure to sucrose esters of fatty acids resulting from its use as a surface treatment for fruits represents less than 0.25% of the ADI. The Panel additionally concluded that the exposure resulting from an additional use of sucrose esters of fatty acids in clear flavoured soft drinks would only represent less than 0.1% of the ADI.. EFSA Journal 2012;10(5):2658 2

TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by the European Commission... 4 Terms of reference as provided by the European Commission... 4 Assessment... 5 1. Introduction... 5 2. New additional information on the use of sucrose esters of fatty acids as a surface treatment agent for fruits... 5 3. Revised exposure assessment... 6 3.1. Refined estimates... 7 4. Discussion... 9 Conclusions... 9 Documentation provided to EFSA... 10 References... 10 Glossary and/or abbreviation... 11 EFSA Journal 2012;10(5):2658 3

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION The European Food Safety Authority s Scientific Panel on Food Additives and Nutrient Sources Added to Food (ANS) adopted a Scientific Opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings in February 2010. The Panel concluded that based on the data available it is possible that the additional use of the sucrose ester may lead to exposures in excess of the ADI. The Panel suggested furthermore that for a more refined estimate of intake, actual data on the use of sucrose esters of fatty acids in fruit would have to be known, or in the absence of the former, information on the exact depth of the application layer, the types of fruit which are treated with the glazing agent and the market share of the glazing agent in comparison to other glazing agents/waxes would have to be provided. The applicant has now requested to reconsider the use of the sucrose esters in flavourings in order to improve solubility of the flavouring in water based beverages, taking into account the additional information on the actual use of sucrose esters of fatty acids as a surface treatment agent for fresh fruits, the resulting residual levels in fruit and their potential impact on estimates of intake of sucrose esters of fatty acids by EU consumers. TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION In accordance with Article 29 (1) (a) of Regulation (EC) No 178/2002, the European Commission asks the European Food Safety Authority to provide an exposure assessment of sucrose esters of fatty acids taking into account new additional information on the use of sucrose esters of fatty acids as surface treatment agent for food and the additional proposed use in flavourings EFSA Journal 2012;10(5):2658 4

ASSESSMENT 1. Introduction Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) carried out an exposure assessment of sucrose esters of fatty acids (E 473) resulting from its use as a food additive, taking into account the additional information on the proposed use of sucrose esters of fatty acids as a surface treatment agent for food and its proposed additional use in flavourings. In this opinion possible exposure from processed fruit the peel of which is usually not consumed as part of the fruit (i.e. citrus peel, etc ) is not taken into consideration because the Panel considered this exposure negligible. In its opinion of 10 th February 2010, the Panel adopted a scientific opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings (EFSA, 2010). The Panel concluded that based on the data available it was possible that the additional use of the sucrose esters of fatty acids may lead to exposures in excess of the acceptable daily intake (ADI) of 40 mg/kg bw/day for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) established by EFSA in 2004. The Panel further noted that the main contribution to total dietary exposure to sucrose esters of fatty acids was from the use as surface treatment agent for fruits (on average 40-50%). As no actual usage data for sucrose esters of fatty acids used as a surface treatment for fruits had been provided by the applicant, and its use is regulated as quantum satis, a residual level of 18 g/kg was estimated by the Panel in the original opinion and used in the exposure assessment. The Panel therefore suggested that for a more refined estimate of intake, actual data on the use of sucrose esters of fatty acids as a surface treatment for fruit would need to be known. In absence of data on the use of sucrose esters of fatty acids in fruit, information would need to be provided on the exact depth of the application layer, the types of fruit which are treated with the glazing agent and the market share of the glazing agent in comparison to other glazing agents/waxes. Following the conclusions in the EFSA opinion (EFSA, 2010), new data were submitted to EFSA on the actual use of sucrose esters of fatty acids as a surface treatment for fresh fruits and the resulting residual levels in fruit (Tennant, 2010). The present opinion provides a revised assessment of exposure based on these new data and takes into account the proposed extension of use in flavourings used in clear soft drinks. 2. NEW ADDITIONAL INFORMATION ON THE USE OF SUCROSE ESTERS OF FATTY ACIDS AS A SURFACE TREATMENT AGENT FOR FRUITS Sucrose esters of fatty acids are a component in formulations used for the surface treatment of certain tree and tropical fruit, in particular climacteric fruit that have a high respiration rate during ripening. Climacteric fruit include, but are not limited to, apples, apricots, avocados, bananas, cantaloupes, figs, guavas, kiwis, mangoes, nectarines, peaches, pears, persimmons, plums, and tomatoes (Salunkhe and Kadam, 1995). The coating retards ripening by restricting the passage of respiratory gases (Bhardwaj et al., 1984). Sucrose ester of fatty acids coatings are applied post-harvest to fruit and vegetables, typically by pack line spraying over brushed rollers. The resulting levels of sucrose ester of fatty acids in fruits, after applying recommended use levels in order to obtain the technologically required effect, are provided in Table 1. These levels range from 7.8 mg/kg fruit in Bartlett pears to 74 mg/kg fruit in pineapples and bananas. The residue figures in Table 1 are based upon the entire fruit after treatment. Consumers would be exposed to these levels of sucrose ester of fatty acids only if they were to consume all parts of the fruit, including skin or peel. EFSA Journal 2012;10(5):2658 5

Further information provided by Tennant (2010) showed that virtually no migration occurs from the skin to the pulp. Thus, in fruit which is peeled before consumption, minimal intake of the formulation components occurs. Table 1: Levels of sucrose esters of fatty acids in fruit (Tennant, 2010) Fruit Level of sucrose esters of fatty acid in fruit (mg/kg fruit) Level of sucrose esters of fatty acid in fruit for use in exposure assessment (mg/kg fruit) Bartlett pear 7.8 7.8 Thin-skinned mango 19.0 ns Packhams pear 11.0 11 Melon 25.0 ns Papaya 25.0 ns Apples 15.6 15.6 Cherry 22.2 22.2 Durian 62.0 ns Bread fruit 62.0 ns Plum 23.0 23 Banana 74.0 ns Pineapple 74.0 ns Easy peeler citrus 24.7 ns Citrus 29.7 ns ns - Levels considered not significant because peel is rarely or never consumed Information provided by Tennant (2010) confirmed that whilst sucrose esters are considered to be the active component of the fruit coating, they account for only 31 % by weight of the coating solution, the balance being made up by carriers and water, i.e. 69% of a carrier blend of two quantum satis listed additives (sodium carboxy methyl cellulose (E 466) and mono and diglycerides of fatty acids (E 471)). 3. REVISED EXPOSURE ASSESSMENT The current dietary exposure estimates to sucrose esters of fatty acids have been calculated following the same approach used by the Panel in its original opinion, taking into account the new additional information of its use as a surface treatment agent for fruits, and use levels provided by industry for food-groups in which sucrose esters of fatty acids are permitted. To maintain a conservative approach, it has been assumed that all fruits consumed contain the maximum residue of sucrose esters of fatty acids from Table 1 (23 mg/kg). The use levels provided are considerably lower (approximately 780 times) than the value used by the Panel, as a worst-case approximation, in its former evaluation (EFSA, 2010). Therefore, the exposure assessment was updated taking into account the newly provided use levels of sucrose esters of fatty acids as a surface treatment for fruits. For the purpose of obtaining exposure estimates based on the additional information provided, only Tier 3 calculations have been performed. This was done by combining national Irish data on fruit consumption with the revised usage level for a surface treatment of fruits and data on consumption of other food-groups and their corresponding maximum reported use levels. In order to ensure consistency with the previous exposure assessment by EFSA (EFSA, 2010), only Irish food consumption data have been used. Table 2 details the maximum reported use levels of sucrose esters EFSA Journal 2012;10(5):2658 6

of fatty acids used in the refined estimate, taking into account the new additional information on usage of sucrose esters of fatty acids as a surface treatment agent for fruits. Table 2: Maximum Permitted Levels (MPL) of sucrose esters of fatty acids in beverages and foodstuffs according to the European Parliament and Council Directive No 95/2/EC 4 and levels of sucrose esters of fatty acids used in the refined exposure assessment. MPL Levels used in the refined exposure assessment Beverages (g/l) (g/l) Non-alcoholic aniseed-based drinks 5 5 2 Non-alcoholic coconut and almond drinks 5 5 2 Spirituous beverages (excluding wine and beer) 5 5 2 Dairy-based drinks 5 5 2 Canned liquid coffee 1 1 2 Dairy-based drinks 5 5 1 Non alcoholic clear/colourless beverages 0.03 4 Foodstuffs (g/kg) (g/kg) Heat-treated meat products 5 (on fat) 5 2 Fat emulsions for baking purposes 10 10 2 Fine bakery wares 10 5 1 Beverage whiteners 20 20 1 Edible ices 5 0.9 1 Sugar confectionery 5 5 2 Desserts 5 0.43 1 Sauces 10 10 2 Soups and broths 2 2 2 Fresh fruits, surface treatment quantum satis 0.023 1 Powders for the preparation of hot beverages 10 10 2 Food supplements as defined in Directive 2002/46/EC quantum satis 10 3 Chewing gum 10 10 2 Cream analogues 5 5 2 Sterilised cream and sterilized cream with reduced fat content 5 5 2 1 Maximum reported use level from the industry (Tennant, 2010). 2 Maximum permitted level from the European Parliament and Council Directive No 95/2/EC. 3 quantum satis data. An MPL of 10 g/kg has been assumed based on the comparability of the substrate with powders for the preparation of hot drinks. 4 Additional proposed use in flavourings. 3.1. Refined estimates Refined exposure estimates have been performed for Tier 3 using reported use levels presented in Table 2 for children and the adult population following the same approach as in the former opinion (EFSA, 2010). Table 3 summarises the anticipated exposure to sucrose esters of fatty acids in children and the adult population. 4 European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners. OJ L 61, 18.3.1995, p. 1. EFSA Journal 2012;10(5):2658 7

Table 3: Summary of anticipated exposure to sucrose esters of fatty acids using tiered approach (EC, 2001) in children and the adult population. Food Group Tier 3 Level Estimates (Total) Irish Adult Population (18-65) 95 th (Total) Irish Children Population (5-12) Mean percentile Contribution Mean percentile Contribution mg/kg bw/day (%) mg/kg bw/day (%) Beverages, excluding clear 0.9 5.0 3.3 14.0 beverages (10%) (1) 6.9 16.8 Clear beverages(2) 0.01 0.06 0.08 0.04 0.18 0.2 Milk Based Beverages 0.06 0.5 0.6 5.5 3.1 Spirituous Beverages 0.5 2.7 3.8 0 Cream sterilised and UHT 0.003 0.02 0.001 0.01 Desserts 0.1 0.5 0.8 0.2 0.8 1.0 Edible ices 0.09 0.4 0.7 0.4 1.6 2.0 Fat Emulsions 2.6 6.8 19.8 2.6 6.6 13.2 Fine Bakery Ware 2.2 6.4 16.8 4.2 10.5 21.4 Fruit (3) 0.013 0.05 0.10 0.03 0.10 0.2 Fat from Processed meat 0.4 1.2 3.0 0.7 2.1 3.6 Sauces (4) 2.3 8.0 17.5 3.2 10.1 16.3 Soups (4) 0.7 3.1 5.3 0.7 4.5 3.6 Sugar Confectionery 0.1 0.6 0.8 2.0 7.5 10.2 Coffee Whitener 0.001 0.01 0 Hot Drink Powders (5) 3.1 3.3 23.6 1.5 9.3 7.6 Supplements (6) 0.02 0.06 0.2 0.03 0.07 0.2 Chewing Gum 0.006 0.000 0.05 0.09 0.6 0.5 Total excluding food 13.1 22.5 19.6 42.7 supplements 99.8 99.8 Total including food supplements 13.1 22.6 100 19.6 42.8 100.0 (1) Sucrose esters of fatty acids are permitted only in non-alcoholic soft drinks based on aniseed, coconut or almond. No such products were found in the Irish Food Consumption Databases (IUNA 2001, IUNA 2005). Therefore and due to the specificity of these beverages, exposure was estimated assuming that 10% of non alcoholic beverages contain sucrose esters of fatty acids (10% presence probability). (2) Clear flavoured beverages (e.g. lemonades, excluding all cola and coloured fruit based beverages) for which an additional use has been proposed (0.03 g/l). (3) Fruit which was reported as being consumed or used in a recipe as whole (e.g. unpeeled). (4) Excluding homemade products. (5) As consumed (i.e. made up). (6) Sucrose esters of fatty acids are permitted in food supplements at quantum satis. A MPL of 10 g/kg has been assumed based on the comparability of the substrate with powders for the preparation of hot drinks. As consumption of food supplements is reported in units rather than in mass, exposure could not be calculated as part of the overall distributional exposure. The average unit weight of a typical food supplement is 100 mg, therefore an additional exposure of 1 mg per unit can be assumed. Mean and 95 th percentile daily unit intake were 1.5 and 4 units and 1 and 2 units in adults and in children, respectively. These were added to the distributional exposure figures, expressed per kg/bw. Estimates calculated for Irish children (aged 5-12 years and weighing on average 33 kg) give a dietary exposure to sucrose esters of fatty acids of 19.6 mg/kg bw/day at the mean, and 42.8 mg/kg bw/day at the 95 th percentile. The main contributors to the total anticipated exposure to sucrose esters of fatty acids were fine bakery wares (21%), beverages (17%) and sauces (16%). Estimates calculated for the Irish adult population give a dietary exposure to sucrose esters of fatty acids of 13.1 mg/kg bw/day at the mean, and of 22.6 mg/kg bw/day at the 95 th percentile. The main contributors to the total anticipated exposure to sucrose esters of fatty acids were hot drinks prepared from powders (24%), fat emulsions (20%) and sauces (18 %). 95 th EFSA Journal 2012;10(5):2658 8

Refined intake estimates for the additional proposed use of sucrose esters of fatty acids to be used in flavourings in clear soft drinks have been estimated by the Panel, based on Irish adult and children populations and usage data provided by the applicant. For adults a mean intake of 0.01 mg/kg bw/day and a 95 th percentile intake of 0.06 mg/kg bw/day were calculated, contributing 0.1% to total mean intake of sucrose esters of fatty acids. For children, a mean intake of 0.04 mg/kg bw/day and high intake (95 th percentile) of 0.18 mg/kg bw/day was calculated, contributing 0.2% to the total mean exposure of sucrose esters of fatty acids. 4. DISCUSSION The results of the current exposure assessment for sucrose esters of fatty acids, are considerably lower than those of the previous opinion of the Panel (EFSA, 2010). The current total mean and high (95 th percentile) intake of sucrose esters of fatty acids was 13.1 and 22.6 mg/kg bw/day in adults and 19.6 and 42.8 mg/kg bw/day in children, respectively, while in the original opinion of the Panel, the estimated total mean and high (95 th percentile) intake of sucrose esters of fatty acids were 29.1 and 64.2 mg/kg bw/day in adults and 51.6 and 117.3 mg/kg bw/day in children, respectively. Compared to the previous worst-case estimates this represents a decrease of 55% and 65% in the mean and high intake estimates for the adult population, and 62% and 63% for children. For both population groups, the main dietary contributors also changed, with the top contributors for adult intake being hot drinks prepared from powders (24%), fat emulsions (20%), sauces (18%) and fine bakery ware (17%); the top contributors for children s intake were fine bakery ware (21%), beverages (17%), sauces (16%) and fat emulsions (13%). It should be noted that for children the contribution from beverages (17%) to the estimated intake contains a high degree of uncertainty, as sucrose esters of fatty acids are permitted only in nonalcoholic soft drinks based on aniseed, coconut or almond. No such products were found in the Irish Food Consumption Databases or in the European Comprehensive Food Consumption Database, and it can be assumed that consumption of these types of beverages is rare, especially in children. Therefore, due to the specificity of these beverages, exposure was estimated assuming that 10% of non-alcoholic beverages contain sucrose esters of fatty acids (10% presence probability). Considering that these estimates aim to provide lifelong exposure estimates, the latter is likely to provide an over-estimate of actual intake in this food-group. No information on consumption of food supplements was available and intake estimates from this source is also based on assumptions (see Table 3). As these assumptions incorporate a high degree of uncertainty, results should be interpreted with caution. In the original opinion (EFSA, 2010), the Panel concluded that an additional use of sucrose esters of fatty acids in clear flavoured soft drinks would only contribute a few percent to the group ADI of 40 mg/kg bw/day for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) established by EFSA in 2004 (EFSA, 2004). However, the total mean exposure to sucrose esters of fatty acids in adults and mean and 95 th percentile exposure in children consumers exceeded the ADI (EFSA, 2010). The current conservative exposure assessment performed by the Panel resulted in a considerably lower exposure estimate compared to its original assessment (where the main contributor was fruit consumption due to the assumption for the residual level in treated fruits). However, children high level consumers were still found to exceed the ADI by 7%. The Panel noted that the exposure to sucrose esters of fatty acids resulting for its use as a surface treatment for fruits represents less than 0.25% of the ADI. The Panel also noted that the exposure to sucrose esters of fatty acids resulting from the additional proposed use in clear flavoured soft drinks represent less than 0.1% of the ADI. CONCLUSIONS The current exposure estimates differ considerably from those of the original Panel opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings, with an observed reduction ranging from 55 to 65%, depending on the considered population. This difference in exposure estimates results from the EFSA Journal 2012;10(5):2658 9

differences in the use levels for the surface treatment for fruits which was 18 000 mg/kg fruit in the previous exposure assessment and is now 23 mg/kg fruit based on the data provided to EFSA. The Panel concluded that the total mean and high intake of sucrose esters of fatty acids amounts to 13.1 and 22.6 mg/kg bw/day for adults and to 19.6 and 42.8 mg/kg bw/day for children, respectively. For children high level consumers the estimated intake exceeds by 7% the group ADI of 40 mg/kg bw/day for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) established by EFSA in 2004. The Panel also concluded that the exposure to sucrose esters of fatty acids resulting from its use as a surface treatment for fruits represents less than 0.25% of the ADI. The Panel also concluded that the exposure resulting from the additional use of sucrose esters of fatty acids in clear flavoured soft drinks would only represent less than 0.1% of the ADI. DOCUMENTATION PROVIDED TO EFSA 1. Tennant, 2010. Food Chemical Risk Analysis. Potential intakes of sucrose esters of fatty acids resulting from their use as surface treatment agents for fruit. Submitted by AJH Consulting, August 2011. Further clarifications on this report were provided to EFSA in September 2011, January 2012 and March 2012 by AJH Consulting. 2. Technical Justification for the use of Sucrose Esters in fruit flavoured Beverages. Submitted by AJH Consulting. Submitted to EFSA on 5 th August 2011. REFERENCES Bhardwaj CL, Jones, HF and Smith IH, 1984. A study of the migration of externally applied sucrose esters of fatty acids through the skins of banana, apple and pear fruits. Journal of the Science of Food and Agriculture. 33/3, 322-331. EFSA (European Food Safety Authority), 2004. Opinion of the Scientific Panel on food additives, flavourings, processing aids and material in contact with food (AFC) on sucrose esters fatty acids, E473 and glucoglycerides, E474 based on a request from the Commission related to sucrose esters of fatty acids (E 473). The EFSA Journal (2004) 106, 1-24. Modified on 25 January 2006. Available at: http://www.efsa.europa.eu/en/efsajournal/doc/106.pdf EFSA (European Food Safety Authority), 2010. Scientific Opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings. EFSA Journal 2010; 8(3); 1512. Available at: http://www.efsa.europa.eu/en/scdocs/doc/1512.pdf. IUNA (Irish Universities Nutrition Alliance), 2001. North/South Ireland Food Consumption Survey, 1997-1999 http://www.iuna.net/index.php/research/northsouth-food-survey. IUNA (Irish Universities Nutrition Alliance), 2005. National Children's Food Survey, 2004. http://www.iuna.net/childrens_survey/. Salunkhe DK and Kadam SS, 1995. Handbook of Fruit Science and Technology. Production, composition, storage, and processing. Marcel Dekker, Inc., N.Y., 611 pp. Tennant, 2010. Food Chemical Risk Analysis. Potential intakes of sucrose esters of fatty acids resulting from their use as surface treatment agents for fruit (unpublished report). EFSA Journal 2012;10(5):2658 10

GLOSSARY AND/OR ABBREVIATION ADI Acceptable Daily Intake ANS Scientific Panel on Food Additives and Nutrient Sources added to Food EFSA European Food Safety Authority EC European Commission MPL Maximum Permitted Level EFSA Journal 2012;10(5):2658 11