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On 19th May 2014 the United States Food and Drug Administration (FDA) announced the safety of use of the additive advantame in food, with the exception of meat and poultry. The FDA final rule will be effective from 21st May 2014.
Food additives in USA are subjected to premarket review and approval by FDA – like in this case – or have to demonstrate their safety through the so called “GRAS” procedure. “GRAS” is an acronym for the phrase Generally Recognized As Safe and means that if a food additive has been adequately shown to be safe under the conditions of its intended use, there is no need of the premarket approval by FDA.
FDA evaluated data from 37 animal and human studies and did not identify possible toxic effects, such as reproductive, neurological, and cancer-causing effects. Therefore, advantame has been approved for use as a general-purpose sweetener and flavor enhancer and can be used in baked goods, non-alcoholic beverages (including soft drinks), chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings, and syrups.
In the meantime, the European Union was evaluating the approval of the substance as well.
On 31st July 2013 the European Food Safety Authority (EFSA) released a Scientific Opinion on the safety of advantame as food additive. EFSA’s findings were very similar to FDA evaluation and the Authority concluded for the safety of use of the substance.
Anyway, the evaluating Panel noted that there is an indication of advantame instability in acidic beverages and thermally treated foods, and also that there are critical effects observed in animal studies, especially about maternal toxicity (gastrointestinal disturbances) in the prenatal developmental toxicity study in rabbits.
For that reason the Panel established a precautionary ADI (adequate daily intake) of 5 mg/kg bodyweight/day, assessing that conservative estimate of advantame exposure for high level adults and children consumers were below the ADI for the proposed use levels.
On 15th May 2014 was published on the Official Journal of the European Union the new EU Regulation n. 497/2014, which authorize from 4th June 2014 the use of advantame in several categories of food, such as flavoured fermented milk products, confectionery, cocoa and chocolate products, fruit and vegetable preparations excluding compote, jam, jellies, sweetened chestnut puree, chewing gum, breakfast cereals, bakery products, flavoured drinks, fruit nectars, soups, sauces, dietary foods and food supplements. Advantame will be classified and indicated on labels as E 969.
In 2013, the sweetener was evaluated also by JECFA (Joint FAO/WHO Expert Committee on Food Additives) which issued the same conclusion again: advantame is safe for the intended use. The Committee proposed an acceptable daily intake (ADI) of 0–5 mg/kg body weight (bw) and agreed that the ADI also applies to those individuals with phenylketonuria, as the formation of phenylalanine from the normal use of advantame would not be significant in relation to this condition.
Advantame is an high-intensity sweetener, offering consumers and the food industry the option to choose from a wider selection of sweeteners, thus reducing the intake of each individual sweetener.