The sweeter the better? EU and US approve advantame use as food additive

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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 ASafe 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.

Food recalls in EU – Week 7 – 2014

This week on the RASFF database (Rapid Alert System for Food and Feed) we have one recall from consumers in EU in the alert notification:

– Pathogenic micro-organisms: Listeria Monocytogenes in raw milk cheese coated with grape marc, following company’s own check. Origin and notification from France, distributed also to United Kingdom.

We have also one information for follow-up notification, followed by a recall:

– Composition: carbon monoxide treatment in chilled tuna, following an official control on the market. Origin Spain, notification from Italy.

Between the alert notifications, followed by a withdrawal from the market of the product:

– Industrial contaminants: benzo(a)pyrene and heavy polycyclic aromatic hydrocarbons in smoked sprats, following an official control on the market. Origin Latvia, notification from Hungary;

– Industrial contaminants: hydrogen peroxide in vanilla chocolate pudding, following food poisoning. Origin Germany, notification from Italy;

– Industrial contaminants: benzo(a)pyrene and heavy polycyclic aromatic hydrocarbons in smoked sprats, following an official control on the market. Origin Estonia, notification from Hungary;

– Pathogenic micro-organisms: shigatoxin-producing Escherichia coli in chilled cheese, following an official control on the market. Origin France, notification from Belgium;

– Pathogenic micro-organisms: shigatoxin-producing Escherichia coli in chilled beef shoulder, following an official control on the market. Origin and notification from Belgium, distributed also to France;

– Pathogenic micro-organisms: Salmonella Enteritidis in frozen raw chicken meat, following company’s own check. Origin Poland, notification from France;

– Pesticide residues: ethephon in table grapes, following an official control on the market. Origin Peru, notification from Netherlands, distributed also to France, Germany, Norway and Sweden;

– Residues of veterinary medicinal products: prohibited substance 17-alpha-boldenone in bull, following an official control on the market. Origin Spain, animal slaughtered and notification from France, distributed also to Greece;

Regarding border rejections we have, among the others, Salmonella typhimurium in chicken breast from Thailand, Salmonella spp. in frozen meat preparations from Brazil and in seasoning mix from India. Shigatoxin-producing Escherichia coli in frozen bovine meat from Brazil. Norovirus in chilled clams from Tunisia, poor temperature control of frozen prawns from Greenland, histamine in frozen sardines from Morocco. Excrements of insects and live insects in instant noodles and in basmati rice from India. Absence of health certificate(s) for nuts mix from India. Unauthorised novel food ingredient Siraitia Grosvenorii in protein bar from the United States and E 216 – propyl p-hydroxybenzoate unauthorised in food supplement from Brazil. Unlabelled irradiation of dog chew from China. E 385 – calcium disodium ethylene diamine tetra acetate (CDEDTA) unauthorised and unauthorised food additive brominated vegetable oil (BVO) in soft drinks from the United States. Acetamiprid in pepper from the Dominican Republic and in tea from Morocco, acetamiprid and fipronil in green jasmine tea from Morocco, oxamyl in strawberries, dimethoate in fresh oranges and carbendazim in fresh artichokes from Egypt, chlorpyriphos-ethyl in mint from Morocco, procymidone, clofentezine and formentanate in sweet peppers from Turkey, prochloraz in chili peppers from Thailand.

For feed, we have an alert for mycotoxins (aflatoxins) in organic soybeans from Kazakhstan. Notification from Denmark.

For food contact materials we don’t have any notification this week.

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