Caramel colours were evaluated by the Committee at its thirteenth, fifteenth, and twenty-ninth meetings (Annex 1, references 19, 26, and 70). Caramel colour II (caustic sulfite caramel) differs from the other three classes of caramel colour (caramel colour I – plain caramel or caustic caramel; caramel colour III – ammonia caramel; caramel colour IV – ammonia sulfite caramel) in that it is manufactured from sulfite compounds and not from ammonium compounds. The processes used in the production of each of the four classes of caramel colour and their synonyms are given in the toxicological monograph prepared by the Committee at its twenty-ninth meeting (Annex I, reference 72). When evaluating the safety of caramel colours produced by the ammonium sulfite process at its twenty-fourth meeting (Annex 1, reference 53), the Committee noted that no ADI had been allocated to caustic sulfite caramel colour (named ‘caramel colour II’ at the twenty-ninth meeting). At its twenty-ninth meeting, the Committee concluded that caramel colour II is sufficiently different from other classes of caramel colours to warrant a separate evaluation but that there were insufficient data to do so. No ADI was established.

The present Committee was informed that caramel colour II is manufactured only in France and the USA and on only a relatively small scale, representing less than 1% of total caramel colour production. Caramel colour II is used mainly in distilled spirits (e.g. rum, whisky, brandy, and cognac), and the primary intake of this compound is from consumption of these alcoholic beverages. Caramel colour II may also be used in plant infusions, coffee extracts, vanilla extracts, meat and fish extracts, salted meats, sauces, bouillon, soups, and tea beverages (International Technical Caramel Association, 2000).

Two reports were submitted to the Committee regarding the dietary intake of caramel II: one from the International Technical Caramel Association that provided information on intake in the USA and one from the Australia–New Zealand Food Authority. The report from the International Technical Caramel Association did not provide estimates of the dietary intake of caramel II, but in a personal communication the President of the Association considered that dietary intake would be very low. Consumption would depend on imports, exports, and stock storage of both the caramel II compound and the alcoholic beverages containing it.

The dietary intake of caramel II in the USA was assessed on the basis of data on its production and assuming that all of the caramel II produced is consumed and that it is consumed by all people living in the country of production. These estimates were not corrected for waste, imports, exports, or stock storage of either the caramel II product or the alcoholic beverages containing it.

The population of the USA is about 270 million, and the production of caramel II in 1998 was 430 000 pounds (200 t). The average daily intakes were estimated for three groups: all people, adults > 20 years, and adults > 20 years who consume distilled spirits (Table 1). The intake estimate for ‘all people’ is based on the assumption that everyone in the population consumes the product, including children. The per capita consumption of distilled spirits in the USA is shown in Appendix 1 to this monograph.

Maximum levels of use of caramel II in three groups of foods—beer and related products (1000 mg/kg), cider (fermented cider) and perry (fermented pear juice) (1000 mg/kg), and spirits and liqueurs (1000 mg/kg)—were used to estimate the intake of this food colour by the Australian population (Baines, 2000). No information was available from the manufacturers on levels of use in these and other foods, and it was assumed that all foods in these groups contained caramel II at the maximum level. It was also assumed that the mean body weight of all respondents aged ³ 2 years was 67 kg. Intake was estimated from one 24-h recall during the 1995 National Nutrition Survey, which comprised 13 858 persons aged ³ 2 years. For all respondents, the mean intake was 160 mg/day, or 2.0 mg/kg bw per day. For the 2400 consumers only, the mean intake was 910 mg/day, or 12 mg/kg bw per day, the median was 580 mg/day, or 7.6 mg/kg bw per day; for consumers in the 95th percentile of intake, the mean was 3000 mg/day or 38 mg/kg bw per day.

The contributions of the three food groups to intake of caramel II were 96% from beer and related products, 1.2% from cider and perry, and 2.4% from spirits and liqueurs.

Because the Australian estimate assumed that caramel II was present in beer at the maximum level of use, it is probably an overestimate. Beer is usually coloured with caramel III rather than caramel II, and it is not clear whether cider and perry contain caramel II. If this food additive is found only in spirits and liqueurs and not in beer, cider, or perry, the estimated intake for the Australian population would be a mean of 3.8 mg/day, or 0.05 mg/kg bw per day for all consumers, and a mean of 22 mg/day (0.28 mg/kg bw per day) for consumers only with intake at the 95th percentile of 72 mg/day (0.91 mg/kg bw per day).

A search of the literature for articles relative to the dietary intake of caramel II resulted in only two papers (Chappel & Howell, 1992; Myers & Howell, 1992), which however gave no specific information on dietary intake, concentrations in beverages and foods, or other information relevant to estimating intake. Contact with the Flavor and Extracts Manufacturers’ Association of the United States, the International Food Information Council, the International Life Science Institute, and the Distilled Spirits Council of the USA did not result in any additional information on the use of caramel II in foods or dietary intake of this substance. These organizations suggested that questions about caramel II be referred to the International Technical Caramel Association.

Thus, the estimates of intake of caramel II intake are based on the Australian assessment of individual dietary records and data on production in the USA.

The dietary intake of caramel II by a population group can be estimated from information on the level of use in specific alcoholic beverages and the average dietary intake of these beverages by the entire adult population and by consumers of the beverages in the population. Data on the concentration used and consumption would allow calculation of the average dietary intake of caramel II for the population as a whole and for those who consume products containing caramel II. Unfortunately, information on the concentrations of caramel II in specific alcoholic beverages was not available.

The following information would be required to allow adequate estimates of dietary exposure to caramel II:

Baines, J. (2000) Submission regarding caustic sulfite caramel from the Australia New Zealand Food Authority, Canberra.

Chappel, C.I. & Howell, J.C. (1992) Caramel colours—A historical introduction. Food Chem. Toxicol., 30, 351–357.

Department of Agriculture (1995) 1989–91 Continuing Survey of the Food Intakes of Individuals (CSFII). Food and Nutrient Intakes by Individuals in the United States (NFS Report No 91-2). Riverdale, Maryland, USA.

Economic Research Service (undated) Food Consumption, Prices, and Expenditures, 1990–97. Online at www.ers.usda.gov/publications/food/food consumption, prices, and expenditures. Washington DC: Department of Agriculture.

International Technical Caramel Association (2000) Caramel Colour Class II (Caustic Sulfite Caramel). Submitted to WHO.

Myers, D.V. & Howell, J.C. (1992) Characterization and specifications of caramel colours: An overview. Food Chem. Toxicol., 30, 359–363.

Individual intake of distilled spirits by persons ³ 20 years^b

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       Toxicological Abbreviations