title: Safety evaluation of food flavorings.
abstract: 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.
authors.affiliation: International Flavors & Fragrances Inc., Regulatory Policy and Industry Issues, 1040 Broad Street, Shrewsbury, NJ 07702, USA. ken.schrankel@iff.com
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Schrankel
mesh_terms: D004341:Drug Evaluation; D005060:Europe; D005421:Flavoring Agents / Q000009:adverse effects*; D005503:Food Additives / Q000009:adverse effects*; D007880:Legislation, Drug; D014481:United States
chemical_list: D005421:Flavoring Agents; D005503:Food Additives