Dietary exposure of the Belgian adult population to 70 food additives with numerical ADI

Food Control 54 (2015) 86e94

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Dietary exposure of the Belgian adult population to 70 food additives with numerical ADI Joris Van Loco a, *, Stefanie Vandevijvere b, Oya Cimenci a, Christine Vinkx c,
verine Goscinny a Se a b c

Department of Food, Medicines and Consumer Safety, Scientific Institute of Public Health, Brussels, Belgium Department of Public Health and Surveillance, Scientific Institute of Public Health, Brussels, Belgium Federal Public Service of Health, Food Chain Safety and Environment, Brussels, Belgium

a r t i c l e i n f o

a b s t r a c t

Article history: Received 27 November 2014 Received in revised form 16 January 2015 Accepted 21 January 2015 Available online 31 January 2015

The safety of the use of food additives is evaluated through the intake assessment of the additives for the consumer. A stepwise approach (using EFSA's Food Additives intake model (FAIM), followed by Tier 2 and refined Tier 2) was used to assess the exposure of the Belgian adult population to food additives. Additives for which the daily intake exceeded the acceptable daily intake (ADI) were subjected to the next evaluation step. In total 70 additives with numerical ADI were identified on labels of food products for sale in the 5 most frequented supermarkets in Belgium. According to the refined Tier 2 assessment, the ADI could be exceeded for the stearoyl-2-lactylates and polysorbates. It was further concluded that the exposure to phosphates, sorbitan monolaurate, sorbitan monooleate, as well as to those additives with numerical ADI which are permitted as quantum satis, are to be studied further by using real use levels (Tier 3). © 2015 Elsevier Ltd. All rights reserved.

Keywords: Food additives Dietary intake Risk assessment FAIM Stearoyl-2-lactylates Polysorbates

1. Introduction Food additives play a crucial role in food production. They are intentionally added to food products for diverse reasons. Additives can be added for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of food. Each additive is assigned an identification code consisting (in the EU) of the letter “E” followed by a specific number, usually in line with the international numbering system for food additives (CAC/GL 36e1989) of Codex Alimentarius, which is yearly updated (Codex Alimentarius, 1989). This number contains 3 to 4-digits which identify the function performed by the additive (Dye E1xx; Conservative E2xx; Antioxidant and Acidifier E3xx; Texturant E4xx; Flavour E6xx; modified starch E14xx; Sweetener 950e968; Food enzymes 11xx). In total 320 additives are authorized to be used in food products and are listed in 26 categories based on their technofunctional property. Regulation (EC) Nr. 1333/2008 legislates the conditions of use of all authorized food additives in the European

* Corresponding author. E-mail address: [email protected] (J. Van Loco). http://dx.doi.org/10.1016/j.foodcont.2015.01.029 0956-7135/© 2015 Elsevier Ltd. All rights reserved.

Union (European Commission, 2008b). Within the European Union, the authorization of an additive in a foodstuff is going through a procedure described in Regulations 1331/2008 and 234/2011 including a risk assessment before marketing (European Commission, 2008a, 2011). Such risk assessments were performed by the SCF (Scientific Committee on Food) from 1974 until the creation of the EFSA in 2002 (European Food Safety Authority), who took over this task. An acceptable daily intake (ADI) is established to protect the consumer. The ADI can apply to a specific additive or a group of additives. A re-evaluation of food additives that were authorized on the market before 20 January 2009 is currently being performed by the EFSA (European Commission, 2010). Member States must regularly evaluate the exposure of their population to food additives, as required by article 27 of the regulation 1333/2008 (European Commission, 2008b). A step-wise or Tiered approach has been established by the European Commission to assess consumer exposure (European Commission, 2001; Kroes et al., 2002; Leclercq, Arcella, & Turrini, 2000; Leclercq, Molinaro, et al.,2000): Tier 1 ¼ theoretical food consumption data combined with MPLs of additives (Maximum Permitted Levels, corresponding to the maximum concentrations permitted in food by regulations); Tier

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2 ¼ actual national food consumption data combined with MPLs of additives; Tier 3 ¼ actual national food consumption data combined with the actual levels of additives in foodstuffs. Risk assessment of food additives has been performed in several European Member States (Bemrah, Leblanc, & Volatier, 2008; Bemrah et al. 2012; Connolly et al. 2010; Diouf et al. 2014; Leclercq, Arcella, et al., 2000; Leclercq, Molinaro, et al.,2000; Mischek & Krapfenbauer-Cermak, 2012; Verger, Chambolle, Babayou, Le Breton, & Volatier, 1998; Vin et al., 2013). In Belgium specifically, exposure assessments of the population to benzoates, nitrates and nitrites, sulphites, lycopene, and artificial sweeteners have recently been performed (Bilau, Matthys, Vinkx, & De Henauw, 2008; Huvaere, Vandevijvere, Hasni, Vinkx, & Van Loco, 2012; Temme et al. 2011; Vandevijvere et al. 2009, 2010; Vandevijvere et al., 2014.) The exposure of Belgian children to food colours has been assessed in the framework of the EXPOCHI Project (Huybrechts et al., 2011). The purpose of this study is to perform a comprehensive Tier 2 exposure assessment of the Belgian adult (>15y) population to food additives with a numerical ADI and to prioritize food additives for a subsequent Tier 3 assessment using a risk based approach (European Commission, 1998).

to assess the exposure of the Belgian population to food additives (EFSA, 2012a). Additives with a numerical ADI and which are authorized for use in food products with maximum permitted level were subjected to the first evaluation step using FAIM. The exposure estimates were calculated by multiplying the data on the MPLs of the selected additives with the 2004 consumption data of the Belgian population over 15 years old (Devriese et al., 2005) for the different food groups (1 e Dairy products and analogues, 2 e Fats and oils, and fat emulsions, 3 e Edible ices, 4 e Fruit and vegetables, 5.1 e Cocoa and Chocolate products, 5.4 e Chewing gum, 6 e Cereals and cereal products, 7 e Bakery wares, 8 e Meat, 9 e Fish and fisheries products, 10 e Eggs and egg products, 11 e Sugars, syrups, honey and table-top sweeteners, 12 e Salts, spices, soups, sauces, salads and protein products, 13 e Foods intended for particular nutritional uses, 14.1 e Non-alcoholic beverages, 14.2 e Alcoholic beverages, 15 e Ready-to-eat savouries and snacks, 16 e Desserts, 17 e Food supplements, 18 e Processed foods, 99 e other foods). The mean and the 95th percentile exposure estimate were calculated for each additive. Additives for which the exposure estimates exceeded the ADI were subjected to a Tier 2 exposure assessment.

2. Material and methods

2.2.2. Tier 2 exposure assessment This assessment was carried out by multiplying the MPL of the selected additives with the refined consumption data for the different food groups of the Belgian Food Consumption Survey of 2004, (De Vriese et al. 2005). Only respondents with two completed 24-h recalls were included in the exposure assessment (n ¼ 3083; 1546 men and 1537 women). The individual intake of the additives was estimated using the following equation:

2.1. Market survey of the use of additives in food products in Belgium An inventory was made of the use of food additives in foodstuffs on the Belgian market. This was performed by a label survey which was complemented by commercially available data on the use of additives in foodstuffs on the Belgian Market (“full Belgian Ingredient system” bought from Euromonitor International Ltd, London, UK). The labels of foodstuffs available in the five most frequented food retailers (Carrefour: Anderlecht; Colruyt: Anderlecht; Delhaize: Saint-Gilles; Lidl: Forest; and Aldi: Forest) in the region of Brussels were inventoried from June to July 2012. In total 1500 labels were photographed then regrouped by food category following the Food Classification System (FCS). From this list, we checked for the presence of all the targeted food additives, and reported in a database the food items confirming their presence while avoiding redundant products with similar label description for the additives. At the end of this process, we have 526 food products classified by food category and a description of the food additives reported on their labels. 2.2. Dietary exposure of the Belgian population to food additives The exposure assessments were performed in a Tiered approach, as suggested by the European Commission (European Commission, 2001). Tier 1 was not used. We started the Tier 2 approach with a screening method using the Food Additives Intake Model (FAIM) (EFSA, 2012a). 2.2.1. Food additives intake model (FAIM) FAIM was specifically developed by EFSA, to support the calculation of estimates of exposure of populations to food additives and their by-products and to harmonize the submission of the related data (EFSA, 2012b). The purpose of the FAIM is to provide a screening tool for estimating chronic exposure of consumers to food additives. It allows the user to estimate the mean and high level exposure to food additives of different population groups throughout several European countries. A pilot version of the FAIM template (FAIM-V1 Food Additives Intake Model, EFSA, It) was used

 P Xd;i  MPLd Yi ¼

d

bwi

where: Yi is the daily additive intake of a given individual i (mg/kg bodyweight/day); bwi is the self-reported bodyweight of a given individual iXd, i is the amount of a commodity consumed on average per day (kg); MPLd is the maximum amount allowed by regulation 1333/2008 for the studied additive in the foodstuff (mg/kg food) (European Commission, 2008b). The usual intake distribution for the additives was estimated with the Nusser method (Nusser, Carriquiry, Dodd, & Fuller, 1996) using the C-side software (version 1997, Iowa State University). This method eliminates the intra-individual variance and additionally transforms the data to obtain approximately normally distributed data. The usual intake distribution was weighted and adjusted for age and sex distribution of the Belgian population and adjusted for day of the week and season.

2.2.3. Refined Tier 2 exposure assessment taking into account use information Additives for which the exposure estimates, calculated with the equation described in 2.2.2, exceeded the ADI were subjected to a refined Tier 2 exposure assessment. In this assessment, the actual use of the additives in foodstuffs on the Belgian market was taken into account as follows. If the additive was not used in a particular commodity, Xd,I was set to zero in the equation for the Tier 2 calculation. In that way, the refined Tier 2 assessment is more accurate, since it corrects for the absence of indications of use of additives in a particular foodstuff (or group of foodstuffs). The data of the market survey (label study and Euromonitor data) were used for this purpose.

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3. Results and discussion 3.1. Market survey The market study revealed a total of 155 additives (out of the 320 authorized additives) being used in food products on the Belgian Market. Seventy additives with numerical ADI and 85 with ADI not specified were identified (Table 1). Some of these additives were inventoried based on their group name. This was the case for: E222, E226, E227, E251, E252, E392, E482 and E472b, d and f. It is interesting to note that no additives containing aluminium (E173, E520, E521, E522, E523, E541, E554, E555, E556, E558, E559, E1452) were identified on the labels. These findings were unexpected since EFSA has reported that the intake of these aluminium additives might largely exceed the Tolerable Weekly Intake (TWI) of 1 mg/kg bw (EFSA, 2013c). Probably the manufacturers were anticipating the Commission Regulation (EU) No. 380/2012 of 3 May 2012 (European Commission, 2012). Only additives that have a numerical ADI and which are not authorized as quantum satis can be taken into account in a Tier 2 exposure assessment (EFSA, 2014). The additives E141, E150aed, E160a, E160c, E334e336 and E472e were authorized as QS and were thus not included in the FAIM evaluation. Their intake levels should be assessed taking into account their real use levels (Tier 3). E100 (curcumin) is authorized with MPL but may be used quantum satis in a number of food categories. EFSA concluded that at the maximum levels of use, intake estimates for adults for E100 were below the ADI, but not for children (EFSA, 2010b). Rosemary extract (E392) was also not included in the exposure assessment since there is no numerical ADI, however E392 is not classified as “ADI not specified” either. Further assessment of E392 is unneeded since it was concluded by EFSA that the proposed uses and use levels would not be of safety concern (EFSA, 2008). Therefore, these 2 additives were not addressed further in the study. 3.2. Exposure of the Belgian adult population to food additives 3.2.1. FAIM Given the large number of compounds to be studied, it was preferable to achieve a pre-estimation on additive intake. FAIM was used for this purpose. Food additives on the Belgian market for which the exposure is well below the ADI were consequently discarded from a refined evaluation. The results obtained with FAIM were summarized in Table 2. There was a potential exceeding of the ADI for approximately half of the studied additives. As expected,

Table 1 Inventory of the additives identified during the label survey. Additives with numerical ADI E 100, E 102, E 104, E 110, E 120, E 122, E 123, E 124, E 127, E 131, E 132, E 133, E 141, E 150a, E 150b, E 150c, E 150d, E 160a, E 160b, E 160c, E 200, E 202, E 203, E 210, E 211, E 212, E 220, E 221, E 222, E 223, E 224, E 226, E 227, E 228, E 250, E 251, E 252, E 297, E 310, E 316, E 320, E 321, E 334, E 335, E 336, E 338, E 339, E 340, E 341, E 343, E 385, E 392, E 435, E 442, E 444, E 445, E 450, E 451, E 452, E 472e, E 473, E 475, E 476, E 481, E 482, E 950, E 951, E 952, E 954, E 955 Additives with ADI not specified E101, E140, E150a, E153, E163, E170, E171, E172, E242, E260, E261, E262, E263, E270, E282, E290, E296, E300, E301, E304, E306, E307, E322, E325, E326, E327, E330, E331, E332, E333, E351, E401, E402, E406, E407, E410, E412, E413, E414, E415, E417, E418, E420, E422, E440, E460, E463, E466, E470b, E471, E472a, E472b, E472c, E472d, E472f, E500, E501, E503, E504, E508, E509, E511, E514, E524, E525, E530, E551, E553b, E575, E579, E585, E621, E627, E631, E640, E902, E903, E953, E965, E966, E967, E1105, E1200, E1422, E1442 Note: Some of the additives were inventoried based on their group name: E222, E226, E227, E251, E252, E392, E482 and E472b, d and f.

the intake was above the ADI for more additives when comparing the high consumers (P95) versus the mean consumer. The highest mean exposure estimates were observed for annatto, sorbitan monolaurate and mono-oleate, saccharine, sucralose and the sulphites. Another exceedance of the ADI can be observed for phosphates. However, phosphates might also occur naturally in foods. To assess correctly the risks, all sources (and not only the additives) contributing to the intake should be taken into account. Therefore, further evaluation of phosphate additives was not performed, since actual phosphate concentration should be used in the intake assessment. When comparing the results of FAIM with the tier 1 results of the European intake report (2001), it shows that for nitrates and EDTA, the conclusion that there is no concern, is confirmed. For E123 amaranth, a change is due to a lowering of the ADI by EFSA (EFSA, 2010c). The use of the screening tool FAIM has additionally estimated that the exposure of the population to 10 additives is safe, showing the effectiveness in reducing the number of additives to be studied in detail. The FAIM exposures were compared in Table 3 with Tier 2 estimates from previous studies for sweeteners (E950 e 952, E954 and E955), benzoic acid (E210 e 213) and sulphites (E220 e 228). It can be deduced from the results in Tables 3 and 4, that the exposure estimates with FAIM were always higher than the Tier 2 estimates of usual intake estimated with refined food groups. The estimates for E 954 (saccharin) and E 955 (sucralose) were especially high, certainly if compared with the Tier 2 estimates of Huvaere et al. (2012). This extreme overestimation compared to Tier 2 warrants some caution in interpreting and using FAIM estimates in risk assessment. Indeed FAIM was initially developed by EFSA to provide applicants of new additives an exposure assessment tool to support the calculation of estimates of exposure to the food additive and its by-products. Here, we used FAIM as a screening tool for exposure assessment. The advantage of FAIM is that it is easy to use, that it has a European wide standardized format and it uses real consumption data. Therefore FAIM is certainly a valid alternative for Tier 1, where theoretical food consumption data are combined with the MPLs for the additive (European Commission, 2001). Since Tier 2 estimates are already overestimating considerably food additive exposures, using the FAIM as a standalone exposure tool is not recommended. However, it can be utilized in a stepwise risk assessment as a first screening tool. 3.2.2. Tier 2 and refined Tier 2 exposure assessment In total 14 Additives and 4 groups of additives were selected for the Tier 2 assessment based on the FAIM results. Sweeteners (E 950e952, E 954 and E 955), benzoic acid (E 210e213) and sulphites (E 220e228), were excluded since they have previously been studied for the Belgian adult population (Huvaere et al., 2012; Vandevijvere et al., 2009, 2010). In addition, several food colorants were already studied by EFSA. It was concluded that the intake for Quinoline Yellow (E104) at the maximum levels of use of with refined (Tier 2 and Tier 3) intake estimates are generally well over the ADI of 0.5 mg/kg bw/day (EFSA, 2009b). For E110 and E123 European Adult populations are below the ADI (EFSA, 2011a, 2010c, 2013b). The EFSA Panel concluded for Ponceau 4R (E124) that at the maximum levels of use, intake estimates for adults (P97.5) and for 1- to 10-year old children (mean and P97.5) were generally above the ADI even in the refined intake estimates (EFSA, 2009a). It was further concluded for Erythrosine (E 127) that the UK high consumer is well below the ADI. (EFSA, 2011b) Additives which were studied by EFSA or when other sources (then food additives) might contribute to a large extent to the population exposure (phosphates) were also not studied in Tier 2. Additives with an ADI as a

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Table 2 Results of the label study of food additives on the Belgian market and intake estimations with FAIM for the Belgian adult population. Intake (mg/kg bw/day)b

Label study #E

Name

E 102 Tartrazine E 104 Quinoline yellow E 110 Sunset yellow FCF E 120 Carmines/Cochineal E 122 Azorubine E 123 Amaranth E 124 Ponceau 4R E 127 Erythrosine E 131 Patent blue V E 133 Brilliant blue FCF E 160b Annato E200e203 Sorbates E 200 Sorbic acid E 202 Potassium sorbate E 203 Calcium sorbate E 210e213 Benzoates E 210 Benzoic acid E 211 Sodium benzoate E 212 Potassium benzoate E 213 Calcium benzoate E220e228 sulphites E 220 Sulphur dioxide E 221 Sodium sulphite E 222 Sodium hydrogen sulphite E 223 Sodium metabisulphite E 224 Disulfite de potassium E 226 Calcium sulphite E 227 Calcium hydrogen sulphite E 228 Potassium hydrogen sulphite E249e250 Nitrites E 249 Potassium nitrite E 250 Sodium nitrite E251e252 Nitrates E 251 Sodium nitrate E 252 Potassium nitrate E 297 Fumaric acid E 310 Propyl gallate E 316 Sodium erythorbate E 320 Butylated hydroxyanisole (BHA) E 321 Butylated hydroxytoluene (BHT) E338e341, E450e452 Phosphates E 338 Phosphoric acid E 339 Sodium phosphates E 340 Potassium phosphates E 341 Calcium phosphates E 450 Diphosphates E 451 Triphosphates E 452 Polyphosphates E 385 Calcium disodium EDTA E432e436 Polysorbates E 432 polysorbate 20 E 433 polysorbate 80 E 434 polysorbate 40 E 435 polysorbate 60 E 436 polysorbate 65 E 442 Ammonium phosphatides E 444 Sucrose acetate isobutyrate E 445 Glycerol esters of wood rosins E 473 Sucrose esters of fatty acids E 474 Sucroglycerides E 475 Polyglycerol esters of fatty acids E 476 Polyglycerol polyricinoleate E481e482 Stearoyl-2-lactylates E 481 Sodium stearoyl-2-lactylate E 482 Calcium stearoyl-2-lactylate E 491 Sorbitan monostearate E 492 Sorbitan tristearate E 493 Sorbitan monolaurate E 494 Sorbitan monooleate E 495 Sorbitan monopalmitate E 950 Acesulfame K E 951 Aspartame E 952 Cyclamates

ADI (mg/kg bw/day)a

Detected on the labels

7.5 0.5 1c 5 4 0.15 0.7 0.1 15d 6 0.065

þ þ þ þ þ þ þ þ þ þ þ

25

5

0.7

þ þ þ þ þ þ  þ þ  þ þ   þ

0.1

 þ

5e

þ þ þ þ þ þ þ

6 0.5 6 1 0.25

160.35f

2.5

10

30 10 12.5 40 40 25 7.5 20g 25 25 5 5 25 9 40 11

þ þ þ þ þ þ þ þ    þ  þ þ þ þ  þ þ þ þ      þ þ þ

Mean

P95

0.5 0.4 0.4 0.9 0.7 0.1 0.7 0.4 0.4 0.4 0.3

1.8 1 1.1 2.2 2 0.5 1.2 0.9 0.9 0.9 1

16.4

24.1

8.4

16

4

6.6

0.1

0.3

0.2

0.9

9.3 1.1 0.7 1.1 0.04

22 2.2 3.6 2.2 0.26

106.5 106.4 106.4 106.5 107.1 107.1 107.1 0.7

151.2 151.2 151.2 151.2 151.8 151.8 151.8 1.3

11.2

19.6

2.4 1 3.3 143.4 143.4 11.4 4.5

11.2 5.7 19.1 301.5 301.5 32.9 10.8

61.4

165.4

19.1 19.5 19.7 19.1 19.1 2 6.9 0

40.6 41 41.2 40.6 40.6 6.6 14.7 4.6 (continued on next page)

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Table 2 (continued ) Intake (mg/kg bw/day)b

Label study #E

Name

ADI (mg/kg bw/day)

E 954 E 955

Saccharine Sucralose

5 15

a

Detected on the labels

Mean

P95

þ þ

374.4 1475.6

375.7 1479.5

Notes. a Additives with an ADI for the group are in bold. b Intake calculated via FAIM V1. Intake estimates exceeding the ADI are underlined. c Temporary ADI of 1 mg/kg bw/day has been increased to 4 mg/kg bw/day in 2014. d Re- evaluated by EFSA in May 2013 and ADI was decreased to 5 mg/kg bw/day. e Expressed as sodium nitrate. f Phosphates have an ADI group set at 70 mg/kg bw/day (expressed as mg phosphorus). The MPLs are in terms of mg of P2O5.The ADI is equivalent to 160.35 mg/kg bw/day (expressed as P2O5). g Re- evaluated by EFSA in 2013 and ADI was increased from 20 to 22 mg/kg bw/day.

group (i.e. polysorbates: E432e436), were included in the Tier 2 study when one of the additives were found during the label survey (i.e E 435). The Tier 2 calculations were performed for: E160b, E297, E310, E320, E321, E444, E445, E475, E476, E491, E492, E493, E494, E495, nitrite (E249, E250), polysorbates (E432, E433, E434, E435, E436), sucrose esters of fatty acids and sucroglycerides (E473, E474) and stearoyl 2-lactylates (E481, E482). The Tier 2 intake estimates were presented in Table 4. The number of additives with potential intake above the ADI was greatly reduced after the Tier 2 assessment. A very small part of the adult population (<1%) might have an additive intake above the ADI for annatto (E160b), sorbitan mono- and tristearate (E491e492) and sorbitan monopalmetate (E495). A higher daily over consumption is observed for fumaric acid (E297), nitrites (E249e250), polysorbates (E432e436) and stearoyl-2-lactylates (E481e482). For the latter additives, the population might exceed the ADI. The Tier 2 exposure estimates for sorbitan monolaurate (E493) and sorbitan monooleate (E494) were well above the ADI. They were not identified during the label survey. Hence, a refined Tier 2 cannot be performed. These compounds are hardly studied. Vin et al. (2013) has evaluated the exposure of E493 and E494 and concluded their exposure will exceed the ADI for adults and children in Tier 3. Bakery products were the main contributors to the intake. Bakery products in Belgium are mostly sold in a bakery without ingredient lists on the packaging. Consequently, their intake should be studied in more detail in a Tier 3 exposure study, where real use levels of additives will be used instead of MPLs. It is unlikely that the Belgian adult population might have an intake exceeding the ADI for annatto (E160b), sorbitan

Table 3 Comparison of the FAIM estimates for benzoates, sulphites and sweeteners with Tier 2 estimates of previous exposure studies on the Belgian adult population. FAIM (mg/kg bw/day)

E E E E E E E

210e213a 220e228b 950c 951c 952c 954c 955c

Benzoates Sulphites Acesulfame K Aspartame Cyclamates Saccharine Sucralose

Tier 2 (mg/kg bw/day)

Mean

P95

Mean

P95

8.4 4 2.0 6.9 0.0 374.4 1475.6

16 6.6 6.6 14.7 4.6 375.7 1479.5

1.58 0.34 0.9 1.9 0.4 0.3 0.8

3.42 0.89 3.6 6.8 2.0 1.1 3.1

Tier 2 intake data come from other studies. a Vandevijvere et al., 2009. b Vandevijvere et al., 2010. c Huvaere et al., 2012.

monostearate (E491), sorbitan tristearate (E492) and sorbitan monopalmitate (E 495). Tier 2 assessments are in general very conservative. Vin et al. (2013) have demonstrated that only children might exceed the ADI for E 491e492, E 495 in Tier 2. In Tier 3 intake, no exceedance of the ADI was observed. Bemrah et al. (2012) have studied the exposure to annatto for the French population via a total diet study. The ADI was not exceeded. Verger et al. (1998) have made the same conclusions. Diouf et al. (2014) however have found a potential risk for annatto for children and toddlers with Tier 2 and for toddlers with the refined Tier 2 approach. Consequently further assessment of these additives for the Belgian adult population was found unnecessary, but should certainly be envisaged for youngsters. Vin et al. (2013) have demonstrated also a potential risk of exceeding the ADI for nitrites, polysorbates and lactylates with Tier 2. In view of the results of the market survey (Table 5), where it was concluded that nitrite was used in all broad commodities in which they were allowed, a refined Tier 2 will not change the results: 17% of the Belgian adult population might have a daily intake above the ADI. Nitrite intake in Italy, UK, France and Ireland were above the ADI at P97.5 in Tier 2 and below ADI in Tier 3 (Vin et al., 2013). The nitrite consumption of the French population was below the ADI (Bemrah et al., 2012). However, when the total nitrite intake was estimated, including endogenous conversion of nitrate to nitrite, approximately 12% of the 4-year-old Swedish children exceeded €ck, & Merino, 2011). Morethe nitrite ADI (Larsson, Darnerud, Ilba over, in the opinion of the EFSA Panel on nitrite in meat products, it appeared that the average exposure in Tier 2 exceed the ADI for some European countries (EFSA, 2010a). In Belgium, an intake estimate of nitrite was carried out in 2006 based on analytical data. It was concluded that the average intake was only 6% of the ADI (Temme et al., 2011). Even if nitrite contribution of vegetables and other sources is added to the nitrite intake via additives, it is unlikely that the total nitrite intake will be above the ADI (De Wil, 2006). By the end of 2015, EFSA will re-evaluate these additives (European Commission, 2010). Therefore, Tier 3 Nitrite intake for adults is not recommended as a high priority, but this recommendation might be reconsidered based on the outcome of EFSA's re-assessment in 2015. The additives fumaric acid, stearoyl-2-lactylates and polysorbates have been subjected to a more refined Tier 2 assessment. The approach used in the refined Tier 2 is to correct the Tier 2 calculations for food items or food groups where the additives were not used. Food additive use was only assumed for those items if labelling of foods available in Belgian supermarkets confirmed the commercialisation or if confirmed by the Euromonitor census on the use of additives collected by manufacturers distributing in Belgium (Table 5). Additive intake from specific food items or food groups is set equal to zero when the market study did not confirm

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Table 4 Tier 2 dietary intake estimates for the Belgian adult population. #E

E 160b E 249eE 250 E E E E E E E E

297 310 320 321 432eE 436 444 445 473eE 474

E 475 E 476 E 481eE 482 E E E E E

492 493 494 491 495

Name

Annato Potassium nitrite Sodium nitrite Fumaric acid Propyl gallate Butylated hydroxyanisole (BHA) Butylated hydroxytoluene (BHT) Polysorbate 20, 40, 60, 65, 80 Sucrose acetate isobutyrate Glycerol esters of wood rosins Sucrose esters of fatty acids Sucroglycerides Polyglycerol esters of fatty acids Polyglycerol polyricinoleate Sodium stearoyl-2-lactylate Calcium stearoyl-2-lactylate Sorbitan tristearate Sorbitan monolaurate Sorbitan monooleate Sorbitan monostearate Sorbitan monopalmitate

ADI (mg/kg bw/day)

0.065 0.1

FAIM

Tier 2 (MPL)

Mean (mg/kg bw/day)

Mean (mg/kg bw/day)

SD (mg/kg bw/day)

P95 (mg/kg bw/day)

Population exceeding ADI (%)

0.3 0.1

0.024 0.067

0.011 0.037

0.043 0.137

0.17 17.28

6 0.5 1 0.25 10 10 12.5 40

9.3 1.1 1.1 0.04 11.2 1 3.3 143.4

1.626 0.150 0.150 0.008 4.402 0.033 0.007 7.814

2.002 0.091 0.091 0.005 2.189 0.086 0.017 4.694

5.920 0.325 0.325 0.017 8.500 0.218 0.035 16.800

4.85 0.70 0.00 0.00 2.09 0.00 0.00 0.00

25 7.5 20a

11.4 4.5 61.4

3.037 1.003 10.921

2.058 0.781 5.289

6.980 2.530 20.900

0.00 0.00 6.16

25 5 5 25 25

19.5 19.7 19.1 19.1 19.1

8.007 10.408 11.153 8.007 8.007

4.541 5.897 6.243 4.541 4.541

16.500 21.400 23.100 16.500 16.500

0.75 83.19 86.46 0.75 0.75

a Re- evaluated by EFSA in 2013 and ADI was increased from 20 to 22 mg/kg bw/day. There is no impact on the final conclusions. ADI: Acceptable Daily Intake; FAIM: Food Additives Intake Model; MPL: Maximum Permitted Level.

the use of the additive in Belgium. From the data presented in Table 5 it can be deduced that use of additives in some food groups might be missed when only label survey data were included in the assessment. This might lead to an underestimation of the daily additive intake with a refined Tier 2 assessment for stearoyl-2lactylates. The EFSA call for use data showed uses for flavoured fermented milk products which were not noted in our market study (EFSA, 2013a). The results for the refined Tier 2 assessment of fumaric acid, stearoyl-2-lactylates and polysorbates were presented in Table 6. For fumaric acid the ADI was exceeded at the 100th percentile of the population, while for polysorbates the ADI was exceeded above the 97th percentile and above the 90th percentile in the case of lactylates. It is unlikely that the Belgian adult population will exceed the ADI for fumaric acid (E297), since the intake exceeded the ADI only at the 100th percentile of the population and taking into account that assumptions in a refined Tier 2 are still conservative. Little studies have been performed for fumaric acid until now. Only Verger et al. (1998) has studied the intake and concluded that there was no risk for the French population. More data on actual use levels of fumaric acid are necessary. Dietary intake of the polysorbates (E432e436) was above the P97 and above P90 in the case of stearoyl-2-lactylates (E481e482). The consumption of these food additives is scarcely studied. Vin et al. (2013) has published recently a study on these additives. Intake of stearoyl-2-lactylates might exceed the ADI for adults and children in Tier 2, and only for children in Tier 3. Children were at risk for exceeding the ADI for polysorbates. Verger et al. (1998) studied the dietary intake of stearoyl-2lactylates and concluded that the French population was not at risk. EFSA concluded that for the mean adult population including the elderly that the intake is below the ADI, but exceeds the ADI for other groups of the population at mean level and for all groups of the population at high level (EFSA, 2013a). A Tier 3 dietary intake assessment for the whole Belgian population is recommended for both additives.

3.3. Uncertainties of the study Several factors might influence the uncertainty of a dietary exposure assessment (EFSA, 2006). Scientific uncertainties involved in a dietary exposure study are typically intrinsic to food consumption surveys such as under/over reporting of consumption data, misreporting of consumed foods in wrong food groups and the erroneous estimation of consumed quantities and sample size uncertainties and could therefore contribute to an under/overestimation of food consumption and affect the exposure assessment. Specifically for this study, the consumption originates from 2004. Although we used the latest nationally representative food intake data from Belgium, it is reasonable to assume that eating habits have changed over the years. Some food groups could not be taken into account, such as food supplements, which is an element of underestimation. The use of MPLs (Tier 2 and refined Tier 2) instead of real use levels (Tier 3) will contribute to an overestimation of the intake. The market survey (refined Tier 2) will reduce the possible overestimation of the true exposure, but on the other hand it will add uncertainty to the estimate since an overcorrection might occur if certain uses were missed during the survey. For example: i) not all foods have labels, among other the foods sold in bulk (not pre-packaged) or where no ingredients list is required; ii) modified starches and packaging gases are not labelled individually; iii) carriers and those additives in composite foods which were carried over from ingredients and which don't have a function in the composite food are not labelled; iv) Labels could contain errors; v) other (natural) sources of exposures. 4. Conclusions A stepwise approach (FAIM e Tier 2 e refined Tier 2) was used to study the intake of additives by the Belgian adult population. Belgium herewith fulfils its obligation to assess the intake of food additives as required by the Regulation 1333/2008. Additives for which the daily intake might exceed the ADI were subjected to the next evaluation step. This is to our knowledge the first study that

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Table 5 Market survey of the food additives Fumaric acid, lactylates and polysorbates: food additive use was assumed for those items where labelling confirmed the use of the additive or when confirmed by Euromonitor data. The census was used to refine the Tier 2 exposure assessment. (þ: presence confirmed). Food categories

Nitrites 08.2.1 08.2.2 08.2.4.1

(E 249e250) Non-heat-treated processed meat Heat-treated processed meat Traditional immersion cured products (meat-based products which were immersed in a brine containing nitrites and/or nitrates, salt and other components) 08.2.4.2 Traditional dry cured products. (The process of dry curing involves application of a dry mixture of brine containing nitrites and/or nitrates, salt and other components on the surface of the meat followed by a period of stabilization/maturation.) 08.2.4.3 Other products traditionally cured. (Curing processes, immersion or dry, used in combination or where nitrite and/or nitrate is included in a compound product or where the brine is injected into the product before cooking.) Fumaric acid (E 297) 01.4 Flavoured fermented dairy products, including heat-treated 05.2 Other sweets, including small breath mints 05.3 Chewing-gum 05.4 Decorations, coatings and fillings, not including fruit-based fillings relevant to category 4.2.4 14.1.4 Flavoured drinks 14.1.5.2 Others 16. Desserts, not including products relevant to categories 1, 3 and 4 Polysorbates (E432e436) 01.4 Flavoured fermented dairy products, including heat-treated 01,8 Dairy substitutes, including beverage whiteners 02.2.2 Other emulsions of oils and fat, including spreadable fats as defined in regulation (CE) no 1234/2007 of the Council, and liquid emulsions 03. Ice-cream 05.2 Other sweets, including small breath mints 05.3 Chewing-gum 05.4 Decorations, coatings and fillings, not including fruit-based fillings relevant to category 4.2.4 07.2 Fine bakery products 12.5 Soups and broths 12.6 Sauces 13.2 Dietary foods for special medical purposes as defined in directive 1999/ 21/CE (not including products relevant to category 13.1.5) 13.3 Dietary foods for weight control, intended to replace a meal or daily food intake (in whole, or in part) 16. Desserts, not including products relevant to categories 1, 3 and 4 17.1 Food supplements in solid form, including in capsule form and tablets with other, similar forms, not including forms you have to chew on 17.2 Liquid food supplements

Label Euromonitor survey in data supermarkets þ þ þ

þ

þ

þ þ þ

þ

þ







þ

þ 

þ þ

  

  









þ

þ

 

 

 

 

   

þ   

















Table 5 (continued ) Food categories

Euromonitor Label data survey in supermarkets

17.3





















 

þ 





 

 

 þ þ þ  

þ þ þ þ  





  

þ þ þ



þ



þ



þ

Food supplements in the form of a syrup, or that you have to chew on 04.2.4.1 Preparations of fruits and vegetables, not including compotes Stearoyl-Lactylates (E481e482) 01.4 Flavoured fermented dairy products, including heat-treated 01,8 Dairy substitutes, including beverage whiteners 02.2.2 Other emulsions of oils and fat, including spreadable fats as defined in regulation (CE) no 1234/2007 of the Counsil, and liquid emulsions 03. Ice-cream 04.2.4.1 Preparations of fruits and vegetables, not including compotes 05.2 Other sweets, including small breath mints 05.3 Chewing-gum 05.4 Decorations, coatings and fillings, not including fruit-based fillings relevant to category 4.2.4 06.3 Breakfast cereals 06.7 Pre-cooked and processed cereals 07.1 Bread and buns 07.2 Fine bakery products 08.2.2 Heat-treated processed meat 13.2 Dietary foods for special medical purposes as defined in directive 1999/ 21/CE (not including products relevant to category 13.1.5) 13.3 Dietary foods for weight control, intended to replace a meal or daily food intake (in whole, or in part) 14.1.4 Flavoured drinks 14.1.5.2 Others 14.2.6 Sparkling drinks as defined in regulation (CE) n o 110/2008 14.2.8 Other alcoholic beverages, including mixtures of alcoholic and non-alcoholic beverages and spirits with an alcohol content less than 15%vol 15.1 Appetizers containing potatoes, cereals, flower or starch 16. Desserts, not including products relevant to categories 1, 3 and 4

uses FAIM to evaluate the safety for a large number of food additives. Although FAIM exposure estimates are very conservative, its easy to use standardized format and the use of real food consumption data, makes it an excellent alternative for Tier 1 intake assessments in a Tiered approach. Seventy additives with numerical ADI were identified on labels of food products in Belgium. Additives for which the daily intake estimates for adults with FAIM were found above the ADI were subjected to Tier 2. Phosphates intake was prioritized for Tier 3 assessment, since they occur naturally in foods. Based on the Tier 2 results, it was concluded that sorbitan monolaurate and sorbitan monooleate needed to be studied further in Tier 3 and that for fumaric acid, lactylates and polysorbates a refined Tier 2 exposure assessment was recommended. Here, the Tier 2 data were combined with the results of a label survey and Euromonitor data. The data were used to adjust for the presence of the additive on the Belgian market. It was noted that using only data from a label survey might result in underestimating the additive intake. According to the refined Tier 2 assessment, the ADI could be exceeded for the stearoyl-2-lactylates and polysorbates.

J. Van Loco et al. / Food Control 54 (2015) 86e94

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Table 6 Refined Tier 2 dietary intake estimates for the Belgian adult population.

Famaric acid (E297) Polysorbates (E432e436) Stearoyl-lactylates (E481e482)

ADI (mg/kg bw/day)

Mean (mg/kg bw/day)

SD (mg/kg bw/day)

P95 (mg/kg bw/day)

Max. (mg/kg bw/day)

6 10 20

0.2831 2.3766 7.2703

0.46916 3.48829 9.56066

1.1412 9.2246 24.8585

7.28 34.29 149.83

A Tier 3 estimate, using real concentration levels, is needed for phosphates, including phosphate salts (E339e341), polyphosphates (E450 e 452) and phosphoric acid (E338), as well as other sources of phosphate, for sorbitan monolaurate (E493) and sorbitan monooleate (E494), for polysorbates (E432e436) and for stearoyl-2lactylates (E481e482). These findings concur with the conclusions drafted in the EU report of 2001 (European Commission, 2001). Also additives with numerical ADI and which were permitted at Quantum Satis and are actually used in food (E141, E150aed, E160a, E160c, E334e336 and E472e) should be further studied in Tier 3. Tier 2 assessments for children could not be performed due to lacking of appropriate consumption data for the Belgian population below the age of 15years. It is expected that new consumption data for the whole Belgian population will be available as from 2016, as a food consumption survey is performed in 2014e2015, including children, adolescents and adults. Hence, a re-evaluation of these results for the adults and a tiered dietary intake estimate for children and adolescents should be undertaken. Acknowledgements The Federal Public Service of Health, Food Chain Safety and Environment of Belgium is greatly acknowledged for funding this study. References Bemrah, N., Leblanc, J. C., & Volatier, J. L. (2008). Assessment of dietary exposure in the French population to 13 selected food colours, preservatives, antioxidants, stabilizers, emulsifiers and sweeteners. Food Additives and Contaminants: Part B Surveillance, 1(1), 2e14. Jul. Bemrah, N., Vin, K., Sirot, V., Aguilar, F., Ladrat, A.-C., Ducasse, C., et al. (2012). Assessment of dietary exposure to annatto (E160b), nitrites (E249-250), sulphites (E220-228) and tartaric acid (E334) in the French population: the second French total diet study. Food Additives & Contaminants: Part A, 29(6), 875e885. http://dx.doi.org/10.1080/19440049.2012.658525. Bilau, M., Matthys, C., Vinkx, C., & De Henauw, S. (2008). Intake assessment for benzoates in different subgroups of the Flemish population. Food and Chemical Toxicology, 46(2), 717e723. Codex Alimentarius. (1989). Class names and the international numbering system for food additives CAC/GL 36. Connolly, A., Hearty, A., Nugent, A., McKevitt, A., Boylan, E., Flynn, A., et al. (2010). Pattern of intake of food additives associated with hyperactivity in Irish children and teenagers. Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment, 27(4), 447e456. De Vriese, S., Huybrecht, I., Moreau, M., De Henauw, S., De Backer, G., Kornlitzer, M., et al. (2005). The Belgian food consumption survey: aim, design and methods. Archives of Public Health, 63, 1e16. De Wil, M. (2006). Evaluation de l'ingestion de nitrate et nitrite par la population
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