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.

EFSA final aspartame evaluation as safe

Aspartame and its breakdown products are safe for human consumption at current levels of exposure, EFSA concludes in its first full risk assessment of this sweetener. To carry out its risk assessment, EFSA has undertaken a rigorous review of all available scientific research on aspartame and its breakdown products, including both animal and human studies.

 

“This opinion represents one of the most comprehensive risk assessments of aspartame ever undertaken. It’s a step forward in strengthening consumer confidence in the scientific underpinning of the EU food safety system and the regulation of food additives”, said the Chair of EFSA’s Panel on Food Additives and Nutrient Sources Added to Foods (ANS Panel), Dr Alicja Mortensen.

 

Experts of ANS Panel have considered all available information and, following a detailed analysis, have concluded that the current Acceptable Daily Intake (ADI) of 40mg/kg bw/day is protective for the general population. However, in patients suffering from the medical condition phenylketonuria (PKU), the ADI is not applicable, as they require strict adherence to a diet low in

 

English: aspartame; Asp-Phe methyl ester Deuts...
English: aspartame; Asp-Phe methyl ester Deutsch: Aspartam; Asp-Phe Methylester (Photo credit: Wikipedia)

 

(an amino acid found in proteins).

 

Following a thorough review of evidence provided both by animal and human studies, experts have ruled out a potential risk of aspartame causing damage to genes and inducing cancer. EFSA’s experts also concluded that aspartame does not harm the brain, the nervous system or affect behaviour or cognitive function in children or adults. With respect to pregnancy, the Panel noted that there was no risk to the developing fetus from exposure to phenylalanine derived from aspartame at the current ADI (with the exception of women suffering from PKU).

 

The opinion makes clear that the breakdown products of aspartame (phenylalanine, methanol and aspartic acid) are also naturally present in other foods (for instance, methanol is found in fruit and vegetables). The contribution of breakdown products of aspartame to the overall dietary exposure to these substances is low.

 

The opinion describes the criteria used to identify the studies relevant for the risk assessment and standards applied to evaluate the scientific evidence. EFSA’s experts examined all uncertainties related to the evaluation of aspartame. The opinion explains how these were addressed in the risk assessment to ensure that potential risks from aspartame were not underestimated.

 

The comprehensive review carried out by the ANS Panel was made possible following two public calls for data which made available a large body of scientific information, comprising both published and previously unpublished data and studies.

 

EFSA received over 200 comments during the public consultation on the draft opinion (that took place from 9 January 2013 to 15 February 2013) and all of these were considered. During the consultative phase EFSA also held a hearing with interested parties to discuss its draft opinion and the feedback received from the online public consultation. EFSA’s dialogue with stakeholders revealed that there were important aspects of the draft opinion that needed to be clarified in the final output.

 

EFSA is also publishing today the comments on the draft opinion received during the public consultation, its responses to the comments received and a statement on two recent publications, one from the US Environmental Protection Agency and the other Gift et al., that were brought to EFSA’s attention after the closure of the public consultation. Neither of these studies alters EFSA’s conclusion on aspartame.

 

 

(Source: EFSA Website)

 

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