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 21 – 2014

This week on the RASFF database (Rapid Alert System for Food and Feed) we have two recalls from consumers in EU in the information for follow up and border rejection notifications:

Foreign bodies: metal fragments in grill meat, following company’s own check. Origin Austria, distributed also to Germany. Information for follow up;

Residues of veterinary medicinal products: residue level above MRL for oxytetracycline in frozen shrimps, following a border control. Origin Vietnam, notified by Germany.  Border rejection.

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

Allergens: undeclared soya in canned beans with spicy sausage, following an official control on the market. Origin Hungary, notified by Slovakia;

– Heavy metals: arsenic and mercury in frozen shark steak, following an official control on the market. Origin Suriname, notified by Netherlands, distributed also to Germany and Norway;

– Pathogenic micro-organisms: Salmonella Spp. in poultry sausage (chipolata), following company’s own check. Origin France, notified by France, distributed also to Germany;

 – Heavy metals: mercury in frozen slices of blue shark, following an official control on the market. Origin Spain, notified by Italy.

Amongst border rejections we have Salmonella spp. in frozen spiced turkey breasts and frozen poultry meat preparations from Brazil and in paan leaves from Bangladesh, shigatoxin-producing Escherichia coli in frozen lamb meat, lamb chops and mutton legs from New Zealand, norovirus in frozen cooked whole white clams from Vietnam, aflatoxins in pistachio nuts without shell from Turkey, in peanuts kernels from the United States, in blanched groundnut kernels from China and in blanched peanut halves from Argentina. Undeclared colour E 102 – tartrazine and unauthorised use of colour E 127 – erythrosine in fruit juices from the Philippines, unauthorised irradiation of Cassia nomame extract from China, unauthorised substance yohimbine, synephrine, 1,3 dimethylamylamine (DMAA) and methylsynephrine in food supplements from the United States, prohibited substance nitrofuran (metabolite) furazolidone (AOZ) in frozen raw peeled prawns from India, unauthorised novel food ingredient zeolite in zeolite from the United States, rodent excrements in various food products and attempt to illegally import paan leaves from Bangladesh, missing import declaration for pomelos from China, poor temperature control of frozen mullet roe from Mauritania and of frozen hake from Namibia, omethoate  in beans with pod from Cambodia and formetanate in fresh peppers from Turkey.

For feed, we don’t have any relevant notification this week.

For food contact materials we have an information for attention notification, followed by a recall from consumers:

Migration of primary aromatic amines and too high level of overall migration from plastic ladles, following an official control on the market. Origin China, notified by Cyprus.

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