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