Brussels, 10/12/2013 (Agence Europe) - In a new eagerly awaited scientific opinion published on Tuesday 10 December, the European Food Safety Agency (EFSA) states that Aspartame (code name: E 951), an artificial sweetner authorised as a food additive in the EU, and its breakdown products are safe for human consumption at current levels of exposure, with one exception.
According to EFSA, the current Acceptable Daily Intake (ADI) of 40mg/kg bodyweight/day, established on the basis of chronic toxicity in animals, provides adequate protection 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 phenylalanine (an amino acid found in proteins). This is the conclusion that EFSA's Panel on Food Additives and Nutrient Sources Added to Foods (ANS Panel), reached after examining all the scientific information available and trials carried out on animals and humans.
In response to the European Commission's request in May 2011, which provided the panel with a mandate to proceed with a new comprehensive safety assessment of aspartame (the potential health risks and side-effects of this artificial sweetener explain why it is controversial), EFSA reiterates the conclusions reached in its preliminary opinion published last January.
At a press conference in Brussels, Dr Alicja Mortensen, the chair of the ANS Panel, stated that “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”. She also said that the current level of exposure is lower than the acceptable daily intake.
EFSA 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). Dr Claude Lambré, deputy chair of the ANS Panel explained that “phenylalanine is a component contained in all proteins. All products containing it are labelled as such because for people suffering from PKU, phenylalanine has to be controlled”.
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 committee was asked to explain what the ADI would be in the case of a child weighing 20 kg exposed to a cumulated risk of consuming aspartame in a number of different products (drinks, sweets and yoghurts, etc.). It stated that ADI is defined as 1% of the intake which, in an animal that is exposed to it throughout its life, does not produce any effect. There is no danger of exceeding the ADI in a balanced diet. One 1.5 litre bottle of Diet Coca-Cola Light contains 500 mg of aspartame, “from the point of view of a balanced diet, it is not healthy to drink a 1.5 litre of Diet Coke a day throughout one's life”.
The opinion describes the criteria used to identify appropriate risk assessment studies, as well as standards that should be applied when assessing scientific proof. EFSA experts examined all the different uncertainties related to aspartame assessment. The opinion explains how these grey areas have been taken into account in the risk assessments to ensure that potential risks linked to aspartame have not been under-estimated. George Kass, head of unit at EFSA, concluded that there is no safety concern, therefore there is no reason to revise the acceptable daily intake. Publication of this opinion was expected in May 2013 but was delayed due to the lack of an agreement between EFSA and the Commission. This gave EFSA experts more time to examine new information received following the public consultation organised on 9 January to 15 February on the draft opinion and to respond to the 219 submissions received by EFSA and debated by all stakeholders in April (see EUROPE 10848 and 10824). (AN/transl.fl)