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The artificial sweetener aspartame has not been adequately proven to be safe for human consumption, a University of Sussex study said. The report is also highly critical of the European Food Safety Authority (EFSA) and EU food safety processes.   

Professor Erik Millstone and Dr Elisabeth Dawson’s EFSA’s toxicological assessment of aspartame: was it even-handedly trying to identify possible unreliable positives and unreliable negatives? Report  analysed the EFSA 2013 reassurance about the sweetener's safety. They found the EFSA panel “discounted the results of every single one of 73 studies that indicated that aspartame could be harmful while treating 84 per cent of studies providing no prima facie evidence of harm as unproblematically reliable”. 

Millstone had contributed a 30 document dossier to the 2013 proceedings which detailed inadequacies in 15 earlier studies which the EFSA had failed to pass on to its scientific advisors.  “It is clear from this research that the EFSA scientists failed to acknowledge numerous inadequacies in the reassuring studies but instead picked up on tiny imperfections in all the studies providing evidence that aspartame may be unsafe.

“In my opinion, based on this research, the question of whether commercial conflicts of interest may have affected the panel’s report can never be adequately ruled out because all meetings all took place behind closed doors.”

Since 1974, studies and scientists have warned of the risks of brain damage, liver and lung cancer, brain lesions and neuroendocrine disorders from consuming Nutrasweet, which is found in thousands of products around the world including diet soft drinks.

He is also advocating a radical overhaul of EU food safety processes including an end to behind closed door discussions.

Millstone said: “Our analysis of the evidence shows that, if the benchmarks the panel used to evaluate the results of reassuring studies had been consistently used to evaluate the results of studies that provided evidence that aspartame may be unsafe then they would have been obliged to conclude there was sufficient evidence to indicate aspartame is not acceptably safe.

“This research adds weight to the argument that authorisation to sell or use aspartame should be suspended throughout the EU, including in the UK, pending a thorough re-examination of all the evidence by a reconvened EFSA that is able to satisfy critics and the public that they operate in a fully transparent and accountable manner applying a fair and consistent approach to evaluation and decision making.”

Flaws in the 2013 Opinion highlighted by Millstone and Dawson included the panel: 

  • Breached EFSA guidelines on risk assessment transparency on multiple grounds;
  • Adopted a low-hurdle for the acceptability of negative studies - including studies previously dubbed “woefully inadequate” and “worthless” by experts;
  • Applied unreachably high hurdles for ‘positive’ studies indicating adverse effects - even though many of those 73 studies were far more reliable than most of the studies that provided no indication of risk; and
  • Demonstrated puzzling anomalies including inconsistent and unacknowledged assumptions.

The International Sweeteners Association responded to the study, saying scientific opinions from food safety authorities around the world “in line with the overwhelming body of scientific evidence available, have consistently confirmed that aspartame is safe”. Aspartame has been subject to “extensive safety assessments” and the 2013 EFSA Opinion was “the most comprehensive assessment of the aspartame safety database”, it said. 

Food Standards Australian New Zealand (FSANZ) told Food & Drink Business that under the Australian New Zealand Food Standards Code aspartame is regulated as a food additive.

It said: “Standard 1.3.1, together with Schedules 15 and 16 of the Code lists the types of substances used as food additives, the foods that are permitted to contain food additives, the additives that are permitted in each food group and the maximum permitted concentration of the additive in that food group. Aspartame is a permitted intense sweetener (additive number 951), which is used in a variety of foods.

“The use of any food additive in the food supply would not be permitted under the Code if there was independent evidence that there is a safety concern with its use in food. 

“FSANZ monitors new assessments of the safety of food additives, including  aspartame, and investigates reputable new research that comes to light, which could change our current conclusions and hence permissions.”

FSANZ updated information about the safety of aspartame in September 2017. 

Further information about how FSANZ assesses safety of substances added to food can be read here

 

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