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Abstract: In 2002, the Joint FAO/WHO Expert Committee on Food Additives requested information relating to the toxicity, intake and specifications of annatto. Previous intake estimates for annatto provided ambiguous results because the bixin/norbixin content of annatto extract was unclear. European annatto producers consulted with the food industry to determine use levels of specific annatto extracts. These data were combined with the levels of bixin/norbixin in particular extracts to estimate the concentration of bixin/norbixin in foods. Concentrations in food were combined with data about food consumption using various methods to estimate consumer intakes, which ranged from less than 1–163% of the acceptable daily intake (0.065mg/kgbw/day). Higher intake estimates are conservative because they assume that a consumer always chooses a food that is coloured with annatto extracts. In practice this is extremely unlikely, since annatto is associated only with certain product/flavour combinations. [Copyright &y& Elsevier]

Food flavorings are an essential element in foods. Flavorings are a unique class of food ingredients and excluded from the legislative definition of a food additive because they are regulated by flavor legislation and not food additive legislation. Flavoring ingredients naturally present in foods, have simple chemical structures, low toxicity, and are used in very low levels in foods and beverages resulting in very low levels of human exposure or consumption. Today, the overwhelming regulatory trend is a positive list of flavoring substances, e.g. substances not listed are prohibited. Flavoring substances are added to the list following a safety evaluation based on the conditions of intended use by qualified experts. The basic principles for assessing the safety of flavoring ingredients will be discussed with emphasis on the safety evaluation of flavoring ingredients by the Food and Agriculture Organization (FAO) and World Health Organization (WHO) Joint Expert Committee on Food Additives (JECFA) and the US Flavor and Extract Manufacturers Expert Panel (FEXPAN). The main components of the JECFA evaluation process include chemical structure, human intake (exposure), metabolism to innocuous or harmless substances, and toxicity concerns consistent with JECFA principles. The Flavor and Extract Manufacturers Association (FEMA) evaluation is very similar to the JECFA procedure. Both the JECFA and FEMA evaluation procedures are widely recognized and the results are accepted by many countries. This implies that there is no need for developing countries to conduct their own toxicological assessment of flavoring ingredients unless it is an unique ingredient in one country, but it is helpful to survey intake or exposure assessment. The global safety program established by the International Organization of Flavor Industry (IOFI) resulting in one worldwide open positive list of flavoring substances will be reviewed. [Copyright &y& Elsevier]