Data on Benzene in Soft Drinks and Other Beverages

Data through May 16, 2007

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Background

In November 2005, the Food and Drug Administration (FDA) received private laboratory results reporting low levels of benzene in a small number of soft drinks that contained benzoate salts (an antimicrobial) and ascorbic acid (vitamin C). FDA has no standard for benzene in beverages other than bottled water, for which FDA has adopted the US Environmental Protection Agency (EPA) maximum contaminant level (MCL) of 5 ppb for drinking water, as a quality standard.

Benzene is found in the air from emissions from burning coal and oil, gasoline service stations, and motor vehicle exhaust. Benzene is a carcinogen and has caused cancer in workers exposed to high levels from workplace air. Benzene can form at the parts per billion (ppb) level in some beverages that contain both benzoate salts and ascorbic acid (vitamin C) or erythorbic acid (a closely related substance (isomer) also known as d-ascorbic acid). Elevated temperatures and light can stimulate benzene formation in the presence of benzoate salts and vitamin C, while sugar and EDTA salts inhibit benzene formation.

As follow-up to the November 2005 benzene findings, FDA's Center for Food Safety and Applied Nutrition (CFSAN) initiated a limited survey of beverages with a focus on soft drinks that contain both benzoate salts and ascorbic or erythorbic acid. The vast majority of beverages sampled to date (including those containing both benzoate preservative and ascorbic acid) contain either no detectable benzene or levels below the 5 ppb EPA MCL for drinking water.

The data

In May 2006, FDA posted results obtained between November 2005 through April 20, 2006, from CFSAN's survey of benzene in beverages (Table 1). Over 100 soft drinks and other beverage samples were collected from retail stores in Maryland, Virginia, and Michigan. Only four beverage products containing both added benzoates and ascorbic acid contained benzene levels above the 5 ppb EPA MCL for drinking water. One cranberry juice beverage product with added ascorbic acid and only natural levels of benzoic acid (i.e., no added benzoates) also contained benzene above 5 ppb. All five products have been reformulated by the manufacturers. CFSAN tested samples of these reformulated products and found that benzene levels were less than 1 ppb.

FDA is now updating the survey data with results from 86 additional samples that were analyzed from April 21, 2006, through May 16, 2007 (Table 2). These additional samples were collected from retail stores in Maryland, Maine, and Massachusetts. Only five products containing both added benzoates and ascorbic acid contained benzene levels above 5 ppb. Four of these products have been reformulated. CFSAN tested samples of these reformulated products and found that benzene levels were less than 1.5 ppb. The fifth product is no longer manufactured. We are presenting these data to inform the public of FDA’s progress.

Limits of the data

These data should not be understood to be a reflection of the distribution of benzene in beverages in the US food supply. The data cover a limited number of products, a limited number of brands, and a limited geographic region. The data do not fully address the variation from one production lot of a product to another lot. For example, when additional lots of some beverage samples initially found to contain benzene levels greater than 5 ppb were analyzed, the results indicate that benzene levels can be highly variable from lot to lot. Even products from the same lot collected at different locations may have different benzene levels depending on many factors such as time at elevated temperatures and amount of light exposure during shipping, handling, and storage. Finally, the choice of products for testing in this limited survey should not be taken as an indicator of product choices by consumers.

What this means for consumers

Because of the limited survey data to date, we cannot yet understand the sources of variation in measured benzene levels, such as variability between different product lots and the effects of storage and handling. For example, although one sample from a production lot may contain elevated benzene levels, it does not mean that all the products from that lot will have elevated levels, or that all lots of a given product will contain elevated levels. We will continue to collect and analyze samples and to work with industry to better understand the sources of variability. We believe that appropriate steps currently are being taken by industry as well as FDA to make sure that benzene formation in beverages is minimized to levels below EPA’s drinking water standard of 5 ppb. FDA has followed up with companies whose samples of products were found to contain elevated levels of benzene in CFSAN's survey and will continue to follow up with manufacturers as survey results warrant.

Manufacturers have reformulated products, if still manufactured, which have been identified as containing greater than 5 ppb benzene. CFSAN tested samples of these reformulated products and found that benzene levels were less than 1.5 ppb. Reformulated products were provided by the manufacturers or purchased at retail markets and are identified as reformulated in Tables 1 and 2. Additional consumer information may be found in FDA's Statement "Benzene in Soft Drinks" and "Questions and Answers on the Occurrence of Benzene in Soft Drinks and Other Beverages."

Notes for Table 1:

1. n.d. = nondetect (below the limit of detection (LOD) described in note 3 below for each respective method).
2. The designation "reformulated" identifies those products that manufacturers have reformulated to reduce or eliminate benzene formation in response to recent reports that benzene has been found in some products.
3. For Method 1, the estimated limit of detection (LOD) is 0.2 ppb when benzene is determined with cryogenic focusing using the m/z 78 ion in the scan mode. For Method 2, the estimated LOD is 0.02 ppb when benzene is determined without cryogenic focusing using the m/z 78 ion in the SIM mode.
4. Confirmation of benzene identity on the basis of ions m/z 78, 77, and 51, provides a higher degree of certainty that benzene was present in a sample. Ion ratios of m/z 77 divided by m/z 78 and m/z 51 divided by m/z 78 were used to confirm benzene identity. The ability to confirm benzene in soft drinks is matrix dependent and may be as low as 0.5 ppb or as high as 1.4 ppb.
5. The reportable limit of quantitation (LOQ) with confirmation is estimated to be approximately 1 ppb for benzene in beverages. Samples below this level but above the LOD were reported as <1 ppb; benzene may or may not be present in these samples (see note 4).
6. Multiple results reported for the same lot of a soft drink were usually obtained from a re-sampling of the same bottle at a later time.
7. Results indicate benzene levels measured on individual purchased beverages.
8. Samples were collected and analyzed by CFSAN except for reformulated samples that were provided by the manufacturer for CFSAN to analyze.

*Contains EDTA (a food ingredient used to promote flavor retention)
**Contains erythorbic acid (d-ascorbic acid, an isomer of vitamin C)
***May contain natural benzoic acid (benzoate)
†Manufacturer's warehoused reserve sample from this lot
††Kool-Aid Jammers 10 Juice Drink Cherry and Kool-Aid Jammers Juice Drink Kiwi-Strawberry both are reformulated products and do not contain benzoate. These products should have been included in the “Other” category when the results were presented in May 2006. Additionally, the designation as “reformulated” was inadvertently dropped from the description for Kool-Aid Jammers 10 Juice Drink Cherry.

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Notes for Table 2:

1. n.d. = nondetect (below the limit of detection (LOD) described in note 3 below for each respective method).
2. The designation "reformulated" identifies those products that manufacturers have reformulated to reduce or eliminate benzene formation. All products found to contain more than 5 ppb benzene in our survey have been reformulated, if still manufactured. CFSAN purchased reformulated products from retail stores or requested them from manufacturers only for those products found to contain benzene at levels greater than 5 ppb in our survey.
3. Method 2 was used to analyze all the samples reported in Table 2. Method 2 was subjected to additional validation studies. The estimated limit of detection (LOD) for results in Table 2 was recalculated using a slightly different approach than previously reported for results in Table 1. The recalculated LOD was determined to be 0.04 ppb. This change does not affect the results reported in Table 1.
4. Confirmation of benzene identity on the basis of ions m/z 78, 77, and 51, provides a higher degree of certainty that benzene was present in a sample. Ion ratios of m/z 77 divided by m/z 78 and m/z 51 divided by m/z 78 were used to confirm benzene identity. The ability to confirm benzene in soft drinks is matrix dependent and may be as low as 0.5 ppb or as high as 1.4 ppb.
5. The reportable limit of quantitation (LOQ) with confirmation is estimated to be approximately 1 ppb for benzene in beverages. Samples below this level but above the LOD were reported as <1 ppb; benzene may or may not be present in these samples (see note 4).
6. Multiple results reported for the same lot of a soft drink were usually obtained from a re-sampling of the same bottle at a later time.
7. Results indicate benzene levels measured on individual purchased beverages.
8. The majority of samples were collected by CFSAN at retail outlets in Maryland, Maine, and Massachusetts. All samples were analyzed at CFSAN.

*Contains EDTA (a food ingredient used to promote flavor retention)
**Contains erythorbic acid (d-ascorbic acid, an isomer of vitamin C)
***May contain natural benzoic acid (benzoate)
†††Black Cherry Blast is a discontinued product. Bellywashers are now made with 100% juice and no preservatives.

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Questions and Answers on the Occurrence of Benzene in Soft Drinks and Other Beverages July 12, 2007

Determination of Benzene in Soft Drinks and Other Beverages May 19, 2006