Investigation into the levels of benzene in soft drinks, squashes and flavoured waters

May 2008

The results presented in this report relate solely to the individual samples/batches tested and do not necessarily reflect the general status of the products listed. Where elevated benzene levels were detected, these were brought to the attention of the relevant manufacturer or supplier and were addressed in a satisfactory way.

1 Table of Contents

Summary ...... 3 Introduction ...... 4 Survey details ...... 6 Results ...... 6 Conclusion…………………………………………………………….7 References…………………………………………………………….12

Table 1: Levels of benzene detected in soft drinks…………………8

2 Summary The Food Safety Authority of Ireland (FSAI) has a statutory responsibility to ensure the safety of food consumed, distributed, produced and sold on the Irish market. In order to achieve this aim, the FSAI inter alia coordinates the collation of food safety surveillance information from laboratories run by its official agencies, the Health Service Executive, the Department of Agriculture, Fisheries and Food, the Marine Institute, the Sea Fisheries Protection Authority (SFPA) and the local authorities. The FSAI also conducts targeted food safety surveillance in areas where potential safety issues have been identified.

In mid-February 2006, the US Food and Drug Administration (FDA) reported that some soft drinks were contaminated with the chemical benzene at levels above the World Health Organization (WHO) limit for drinking water of 10 parts per billion (ppb). Benzene can be produced in soft drinks through the interaction of sodium benzoate (E211) and ascorbic acid (Vitamin C) (E300). In light of these reports, the FSAI carried out a survey on benzene in 2006 in order to establish the levels of benzene present in soft drinks and other beverages available on the Irish market1. A recommendation of the 2006 survey was that the FSAI should continue to regularly monitor the levels of benzene in soft drinks and other beverages. Therefore, this current study is a direct follow up to that recommendation. In this present study, the FSAI, in conjunction with the Galway Public Analyst’s Laboratory, sampled 63 samples of soft drinks, squashes and flavoured waters available on the Irish market, in order to establish the levels of benzene present therein. Determination of benzene levels was made on the samples as purchased. Single samples of each product were taken at retail level and therefore, the results of this survey can only indicate a limited picture of the status of benzene contamination in soft drinks on the Irish market. This report provides the results of this targeted surveillance study.

Out of the 63 samples tested, 54 (86%) did not contain detectable levels of benzene and 97% of samples had benzene levels below 10 parts per billion (ppb). Two samples analysed contained benzene above 10 ppb, which is the WHO limit for drinking water and was used as the guideline action limit in this survey in the absence of legislative limits. The two samples which exceeded the WHO limit were analysed as purchased. However, it should be noted that both of these samples require dilution before consumption, as recommended by the manufacturers on the product label. Therefore, once the recommended dilution factors have been applied to these two samples, the resultant benzene levels are well below the WHO limit. Nevertheless, the FSAI has followed up these slightly elevated levels with the respective retailers and distributors involved, in order to alert them to the results found for these particular products and corrective action was taken.

The results of this study show that the levels of benzene measured in soft drinks, squashes and flavoured waters which are available on the Irish market are generally very low, and do not pose a safety concern for consumers of these products. These findings show an improvement to those found in the 2006 survey, with no samples above the WHO limit of 10 ppb once dilution of the samples were taken into account. These results also concur with those found by other agencies both at EU and international level. The FSAI will continue to periodically monitor products for benzene and other chemical contaminants, in order to safeguard the health of consumers in Ireland.

3

Introduction In mid-February 2006, the US Food and Drug Administration (FDA) reported the results of tests showing that some soft drinks were contaminated with the chemical benzene at levels above the World Health Organization limit for drinking water of 10 parts per billion (ppb). The problem had originally been identified in the early 1990s, when it was demonstrated in laboratory trials that benzene could be produced in soft drinks through the interaction of the preservative sodium benzoate (E211) and ascorbic acid (Vitamin C) (E300) or erythrobic acid, which is also known as D- ascorbic acid. The benzoates are preservatives and can occur naturally, for instance, in cranberries. Benzoates are used in beverages to inhibit the growth of bacteria, yeasts and moulds. A maximum amount of 150 mg/L benzoates may be added to non-alcoholic flavoured beverages (except milk based beverages). Ascorbic acid can also occur naturally in many berries and fruit, but can also be added as an antioxidant in order to maintain colour and other quality characteristics. No maximum numerical limits for ascorbic acid are laid down in EU legislation. However, in accordance with the quantum satis principle, ascorbic acid shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided that it does not mislead the consumer. The presence of these two food additives in food products must be declared by their functional class followed by their specific name or EC number in the ingredients list on the food packaging or label, in accordance with the EU legislation on food labelling.

The formation of benzene in soft drinks is often exacerbated when the beverages are stored for extended periods at elevated temperatures. Light can also promote benzene formation. Evidence indicates that nutritive sweeteners (sugar, high fructose corn or starch syrup) can delay the reaction as the phenomenon seems most noticeable in diet beverages, however the longer the shelf-life of a product, the greater potential for benzene formation if its precursors are present. There is also some evidence to suggest that ethylene diamine tetraacetic acid (EDTA), which is used as a sequestrant, may mitigate the reaction by complexing metal ions that may act as catalysts. EDTA is an approved additive in the EU, but it is only permitted in a small number of products and to date, it is not approved for use in soft drinks. The structure of benzene is given in Figure 1.

Figure 1: The structure of benzene

4 The initial FDA report attracted widespread media attention, because exposure of humans to benzene has been associated with leukaemia and other blood disorders. Benzene is a solvent that was widely used in the past and is still used in industry and in a variety of applications. These applications include its use as an additive in unleaded petrol. It is found in air, particularly in urban areas, as a result of emissions from motor vehicle exhaust, service stations and industrial emissions. Benzene also occurs naturally at a low level in some foodstuffs of plant origin. People are therefore exposed routinely to benzene via their environment. The PEOPLE project2 estimated the levels of benzene in Dublin city and recorded a median city background level of 2.1µg/m3 (0.66ppb). It also assessed different population groups and found that exposure to benzene was the greatest among the volunteers that smoked. According to the WHO, cigarettes have been found to have a mean benzene content of 395.3µg per cigarette, making smoking and second-hand smoke sources of benzene exposure3. Benzene is considered by the International Agency for Research on Cancer (IARC) to be a human carcinogen inducing a variety of different types of leukaemias in occupationally exposed workers4. Like all carcinogenic substances for which no toxicological threshold value can be indicated, benzene intake should be minimised and/or avoided as far as possible in line with preventive consumer protection. Over the last number of years, the European soft drinks industry, represented by UNESDA, has been working with regulatory authorities in order to reduce and where possible, to completely eliminate the formation of benzene, whilst still ensuring the microbiological stability and quality of soft drinks. Industry has produced a guidance document to mitigate the formation of benzene in soft drinks5 and this was presented at the EC Standing Committee on Food Chain and Animal Health, Toxicological Safety held in Brussels at the end of March, 2006. Industry reported that levels in soft drinks are typically found at the analytical limit of detection (1-5 ppb) and always below 10 ppb. There are currently no legal limits for benzene that apply directly to finished soft drinks. There are several regulatory guidelines and limits set for drinking water and bottled water ranging from the World Health Organization limit of 10 ppb, to the U.S. EPA/FDA level of 5 ppb and the EU level of 1 ppb. However, as a result of discussions at an EC Standing Committee meeting in 2006, a consensus was reached among the EU Member States that a general approach should be taken and a limit for control and enforcement purposes should be set for benzene and an action limit of 10 ppb was proposed.

Since 2006, a number of surveys have been carried out by food safety agencies and other bodies throughout the EU and also on an international scale, in order to ascertain the levels of benzene present in beverages. These include a previous survey carried out by the FSAI in 20061 in which 76 samples of soft drinks, squashes and flavoured waters available on the Irish market were tested for benzene. The data from these surveys indicate that for the majority of products analysed, benzene could either not be detected or was present at levels that were too low to reliably measure.

5 Survey Details

Individual samples were purchased from various retailers and were analysed at the end of May and beginning of June 2007. The samples consisted of concentrates (squashes), carbonated and non-carbonated drinks and some flavoured waters. All samples were analysed as purchased, including the squashes which normally require dilution prior to consumption, in line with the manufacturers’ instructions.

The analysis method used for the determination of benzene was an accredited method and involved headspace sample pre-treatment and gas Chromatography (GC) coupled with mass spectrometry detection (MS). A recovery factor of 0.94 was applied to all results. The limit of quantitation (LOQ) for the method was 1 ppb.

Results

The results of this survey are presented in Table 1 and from this it can be seen that nine of the sixty three samples contained benzene above the limit of quantitation (LOQ) of 1 ppb. From these nine samples, only two products containing added benzoates had benzene levels above the 10 ppb WHO limit for drinking water. These two samples were a Tesco low calorie lemon drink concentrate which had a benzene level of 18.1 ppb and a Rose’s diabetic orange squash which had a level of 18.3 ppb. However, it must be stressed that these levels were found in the concentrated product as purchased and did not take into account the dilution factor of 1 in 5 as recommended by the manufacturers on the label. Once the dilution factor is applied to these two products, the levels found were well below the WHO threshold limit of 10 ppb.

Despite the fact that both products were below the WHO limit once dilution was performed, both Tesco and Musgraves (distributors of the Rose’s diabetic orange squash) were informed about the slightly elevated benzene levels found in these products. In the case of the Tesco low calorie lemon drink, the manufacturers re- visited the original test results for this product and confirmed that the benzene levels were within acceptable limits at the time of production. Tesco intended to remove sodium benzoate from this range of drinks by April 2008. For the Rose’s diabetic orange squash product, Musgraves has informed the FSAI that it has discontinued this product line and no longer supplies it to its stores.

The limitations of the data from this survey should be noted. In all cases, samples of each product were taken from only one production lot therefore variations from one production lot of a product to another were not addressed in this survey. The data may not therefore represent the distribution of benzene in soft drinks and flavoured waters in the general Irish food supply.

6 Conclusion

The results indicate that the levels of benzene found in soft drinks, squashes and flavoured waters to date do not pose a safety concern for consumers. Almost all of the samples tested in this survey (97%) contained benzene below analytical detection levels or levels below 10 ppb (the WHO guidelines for safe levels in drinking water which was used as an appropriate comparator in this survey). These results are consistent with those found in the previous FSAI study carried out in 20061 and also with those carried out by other national and international governmental agencies and those by the beverage industry. Appropriate follow-up action has been taken in respect of the two products found to contain slightly elevated levels of benzene. However, it must be stressed that both of these products are in compliance with the WHO limit once dilution is taken in account. The continued intensive monitoring worldwide has resulted in manufacturers working to reformulate their products in order to ensure benzene formation is minimised or eliminated. In addition, the International Council of Beverage Association (ICBA) has produced a guidance document for industry on ways to reduce the formation of benzene5.

The FSAI will continue to monitor benzene in these products on an ongoing basis, and endorses the view that the levels reported in soft drinks are generally very low resulting in a low risk to health. However, the levels of benzene should be maintained below 10 ppb and the FSAI will endeavour to take the appropriate action, where necessary, in order to ensure consumer health protection. These findings support the conclusion that exposure of the population in Ireland to benzene via soft drinks is very low and does not raise any concerns for human health.

7 Table 1: Benzene Results for samples as purchased (not as prepared for consumption).

Sample Number Brand Product BBD Batch Number Result (µg/L or ppb)

F1248-2007 Coca Cola Oasis, Citrus Punch August 07 A049WAA 09:50 <1.0 7103 18:28 5 F1249-2007 Lind House No added sugar orange squash April 08 <1.0 L7116 19:39 F1250-2007 MiWadi No added sugar tropical 26.12.07 <1.0 L7113 09:44 F1251-2007 C&C Club Source 8.10.07 <1.0 7091 20:17 D4 F1252-2007 Tesco Value Lemon low calorie drink January 08 18.1* D L7109 13:02 F1253-2007 C&C TK Lemonade 19.1.08 <1.0 7058 17:12 F1254-2007 Tesco Elderflower and lemon flavoured spring water February 08 <1.0 D7 20:29 7100 F1255-2007 Tesco High Juice Summerfruits squash April 08 <1.0 70860GG F1256-2007 Tesco Bitter Lemon August 07 <1.0 7118 21:49 C1 F1257-2007 Tesco Cloudy Lemonade October 07 <1.0 0202 2032 F1258-2007 Finches Sparkling Orange light November 07 <1.0 167D20:07A F1259-2007 GlaxoSmithKline Lucozade energy Orange October 07 <1.0 C L71141819 F1260-2007 C&C H2OH lightly sparkling water with a hint of 7 up 24.10.07 <1.0 L63411 F1261-2007 Dunnes Stores Lemon Squash 07.12.07 <1.0 D L 7088 12:17 F1262-2007 C&C TK Orange 29.12.07 <1.0 L63451 F1263-2007 Harneys PAK Blackcurrant drink 11.12.07 <1.0 L70641 F1264-2007 Kia Ora Orange Squash with no added sugar 05.12.07 <1.0 K4B 70180456 F1265-2007 St. Bernard Hi fruit sparkling soft drink with real orange juice October 07 <1.0 C L 70820239 F1266-2007 Ballygowan Hint of Orange and Mango Irish still water 23.9.07 <1.0

8 Table 1 (contd): Benzene Results for samples as purchased (not as prepared for consumption). Sample Number Brand Product BBD Batch Number Result (µg/L or ppb) C L70812201 F1267-2007 Ballygowan Hint of Strawberry and Cherry Irish still water 22.9.07 <1.0 Sparkling Apricot and Passion fruit Irish spring 6234 03:31 F1268-2007 Dunnes Stores water August 07 <1.0 08:57 G F1269-2007 Marks & Spencer Sparkling Florida orange 01.11.07 <1.0

F1270-2007 Marks & Spencer Lemon and Gingseng 16.8.07 <1.0 Still cranberry juice spring water drink fortified with SSB L7102 08:41 F1271-2007 Boots vitamins B&E 08.11.07 <1.0 SSB L7116 06:20 F1272-2007 Boots Sparkling cloudy lemonade spring water drink 22.11.07 <1.0 K4D 7169 06:20 F1273-2007 Freeway Cloudy Lemonade December 07 <1.0 7121 19:47 F1274-2007 Coolwater Peach naturally flavoured spring water drink May 07 <1.0 C L70900634 F1275-2007 Bulmers Ltd Cidona 21.9.07 <1.0 L70651 F1276-2007 Supervalu Lemon drink 06.3.08 <1.0 C L71160819 F1277-2007 Mi Wadi Nature’s goodness Orange 26.1.08 <1.0 7107 21:46 F1278-2007 Lind House Sparkling Peach Spring Water April 08 <1.0 K4D 7121 0934 F1279/2007 Freeway Iron Brew December 07 <1.0 K4D 7116 2201 F1280/2007 Freeway Lemon & Lime December 07 <1.0 7123 22:31 F1281/2007 Coolwater Lemon & Lime May 08 <1.0 BL 1852L72704 F1282/2007 Coca Cola Lilt fruit crush pineapple and grapefruit September 07 <1.0 F1283/2007 GlaxoSmithKline Lucozade Energy Citrus clear October 07 157A12:10A <1.0 BL2115L71204 F1284//2007 Coca Cola Sprite September 07 <1.0 L7038 08:17 F1285/2007 Mi Wadi Nature’s Goodness Lime 25.12.07 <1.0

9 Table 1 (contd): Benzene Results for samples as purchased (not as prepared for consumption). Sample Number Brand Product BBD Batch Number Result (µg/L or ppb) 08 1228L60112 F1286/2007 Coca Cola BPM Energy citrus green May 07 <1.0 L2A 7112 10:40 F1287/2007 Tesco Kick stimulation drink April 08 <1.0 7113 03:43 D4 F1288/2007 Tesco Lemon squash no added sugar January 08 1.8 7102 18:18 F1289/2007 Tesco Peach slightly sparkling spring water drink 11.10.07 <1.0 7117 17:15 D4 F1290/2007 Tesco value Orange low calorie drink January 08 <1.0 A 071WAA 03:03 F1291/2007 Coca Cola Oasis, Summer fruits September 07 <1.0 7112 22:01 D4 F1292/2007 Tesco Lime cordial January 08 1.8 30040855 F1293/2007 Finches Sparkling Orange January 08 <1.0 BL 1857L71204 F1294/2007 Coca Cola Fanta Icy Lemon October 07 1.5 BL 2316L72303 F1295/2007 Coca Cola Tanora Tangerine flavoured drink 08.12.07 <1.0 L1450J 10:38 F1296/2007 Rose’s Diabetic Orange squash September 07 18.3 L70106 F1297/2007 Super Valu Blackcurrant drink 10.1.08 <1.0 3101 2310 F1298/2007 Finches Sparkling rock shandy October 07 <1.0 DB 0550L71204 F1299/2007 Coca Cola Fanta Exotic September 07 <1.0 07D L7101 1157 F1300/2007 C&C Club diet Orange 11.11.07 <1.0 07D L7079 1157 F1301/2007 C&C Club Lemon 23.10.07 1.1 L7118 0804 F1302/2007 C&C Club Rock Shandy 23.11.07 <1.0 L7114 0128 F1303/2007 C&C Club Pomegranate 24.10.07 <1.0 L7023 20:57 F1304/2007 Mi Wadi Nature’s Goodness Lemon 23.10.07 <1.0 2102 1145 F1305/2007 Country Spring Orange November 07 3.9

10 Table 1 (contd): Benzene Results for samples as purchased (not as prepared for consumption). Sample Number Brand Product BBD Batch Number Result (µg/L or ppb) L7117 F1306/2007 Sunsqueeze Fruity shots orange and peach November 07 <1.0 L7117 F1307/2007 Sunsqueeze Fruity shots still apple and blackcurrant November 07 1.3 0602 1119 F1308/2007 TopStar Sparkling lemon made with spring water November 07 1.7 3004 2259 F1309/2007 TopStar Sparkling orange made with Irish spring water January 08 <1.0 SSB L7113 12:31 F1310-2007 Explosade Sparkling original glucose energy drink December 07 <1.0

Notes <1 = less than reporting limit of 1 µg/kg (ppb). All of the results are reported for the sample as purchased and the results have not been altered to take into account the recommended dilution factors. *This result as mentioned previously refers to the direct analysis of the sample, however, it is recommended on the product label to dilute 1 in 4 prior to consumption.

11 References

1. Food Safety Authority of Ireland (2006). Investigation into the levels of benzene in soft drinks, squashes and flavoured waters. Report available at http://www.fsai.ie/surveillance/food_safety/chemical/benzene_06/benzene_06 _index.asp

2. R.A. Field, P. Pérez Ballesta, A. Baeza Caracena, I. Nikolova, R. Connolly, N. Cao, M. Gerboles, D. Buzica, L. Amantini, F. Lagler, A. Borowiak, L. Marelli, G. De Santi and E. De Saeger (2005). Population Exposure to Air Pollutants in Europe (PEOPLE), Methodological Strategy and Basic Results. EUR 21810 EN.

3. European Commission Joint Research Centre (2005). Human Exposure Characterization (HEXPOC) of chemical substances; quantification of exposure routes p 36-59, EU 21501 EN.

4. International Agency for Research on Cancer (IARC) (1987). Overall evaluations of carcinogenicity: an updating of IARC Monographs volumes 1- 42: 120-122 (IARC Monographs on the evaluation of carcinogenic risks to humans). Lyon (France).

5. International Council of Beverages Associations (ICBA) (2006). Guidance document to migrate the potential for benzene formation in beverages. The guidance document can be accessed from the ICBA website at http://www.icba-net.org/ICBA-Benzene-Guidance.pdf

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