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EFSA’s toxicological assessment of aspartame: was it even-handedly trying to identify possible unreliable positives and unreliable negatives?

Millstone EP, Dawson E (2019) Arch Public Health.  2019 Jul;77: 34. doi: 10.1186/s13690-019-0355-z. eCollection 2019. 

Web URL: Read this and related abstracts on PubMed here



A detailed appraisal is provided of the most recent (December 2013) assessment of the safety and/or toxicity of the artificial sweetener aspartame by the European Food Safety Authority's Panel on Food Additives and Nutrient Sources Added to Food.

That appraisal is prefaced with a contextualising chronological account drawn from a documentary archive of the key highlights of the antecedent scientific and policy debates concerning this sweetener from the early 1970s onwards. The appraisal focuses specifically on Section 3.2 of the panel's review, which is headed 'Toxicological data of aspartame'.


The methodology of the appraisal focusses on the extent to which the panel was symmetrically alert to possible false positives and false negatives, which in toxicological terms denote misleading indications of possible toxicity or misleading indications of safety.

The methodology involved identifying and tabulating the prima facie indications of each of 154 empirical studies, and then comparing them with the way in which the panel chose to interpret the studies' findings, by focussing primarily on whether the panel deemed those studies to be reliable or unreliable.  If the panel had been even-handed, the criteria for assessing reliability should have been the same for both putative positive and negative studies.


Eighty-one studies were identified that prima facie did not indicate any possible harm, and of those the panel deemed 62 to be reliable and 19 as unreliable.  Seventy-three studies were identified that prima facie did indicate possible harm; of those the panel deemed all 73 to be unreliable; none were deemed reliable.

A qualitative comparative review of the criteria of appraisal invoked by the panel to judge the reliability of putative negative and positive studies is also provided.


The quantitative result indicate that the panel's appraisal of the available studies was asymmetrically more alert to putative false positives than to possible false negatives.

The qualitative analysis shows that very demanding criteria were used to judge putative positive studies, while far more lax and forgiving criteria were applied to putative negative studies.


That quantitative and qualitative patterns are very problematic for a body supposed to prioritise the protection of public health. Given the shortcomings of EFSA's risk assessment of aspartame, and the shortcomings of all previous official toxicological risk assessments of aspartame, it would be premature to conclude that it is acceptably safe. They also imply that the manner in which EFSA panels operate needs to be scrutinised and reformed.


This review casts very serious doubt on the independence and judgement of EU regulators during their assessment the research evidence submitted concerning the safety (or otherwise) of the widely used artificial sweetener, aspartame.

As experts in neurotoxicology, the authors present a detailed catalogue of criticisms, showing on statistical ground alone (given the studies accepted as providing reliable evidence, versus those rejected) that EFSA's review, and its subsequent conclusions on the safety of aspartame, were extremely unlikely to have been free from bias.
As they also emphasise - the lack of transparency surrounding the review process itself is also enough to undermine confidence in the independence of the current EU regulatory system.

For more information and FAB comment, see the associated news article: