Aspartame study findings published by the Hull York Medical School

The Food Standards Agency is today publishing the findings of a study carried out by Hull York Medical School, determining reactions to aspartame in people who have reported symptoms in the past compared to people with no reported symptoms. The study is also being published in the peer reviewed, open access journal, PLOS ONE.

The study concluded that the participants who were self-diagnosed as sensitive to aspartame showed no difference in their response after consuming a cereal bar, whether it contained aspartame or not. The study looked at various factors including psychological testing, clinical observations, clinical biochemistry and also metabolomics (which is the scientific study of small molecules generated by the process of metabolism).

The Hull/York paper was peer reviewed by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) in December 2013. COT concluded that ‘the results presented did not indicate any need for action to protect the health of the public’.

Guy Poppy, FSA Chief Scientific Advisor, said: ‘While the best available evidence shows that aspartame can be consumed safely, a number of individuals have reported adverse reactions after consuming food and drink containing aspartame. Given this anecdotal evidence it was appropriate to see if more could be found out about these reported effects. The Hull/York study was not designed to evaluate the overall safety of aspartame as it is already an approved additive.”

The study recruited individuals who reported reactions after consuming aspartame, alongside a matched control group of individuals who normally consume foods containing aspartame without problems. The aspartame was given in a cereal bar so that individuals could not distinguish between bars containing aspartame and the control bars.

The work took the form of a double blind randomised crossover study, the gold standard of scientific research. This type of study is designed to test the effect of a substance in such a way that neither the research team nor the participants know whether the bar consumed contains the test substance or not. Double blind studies therefore eliminate the risk of prejudgment by participants or researchers which could distort the results.

In December 2013, the European Food Safety Authority (EFSA) published an opinion on aspartame following a full risk assessment after undertaking a rigorous review of all available scientific research on aspartame and its breakdown products, including both animal and human studies. The EFSA opinion concluded that ‘aspartame and its breakdown products are safe for human consumption at current levels of exposure’.

The FSA will share the results of this study with EFSA.

(Source: FSA website)

The sweeter the better? EU and US approve advantame use as food additive

The following is my first article on LinkedIn as publisher, a special account released by the platform to influencers and valuable bloggers in their respective sector. Here you can find the article on LinkedIn.

Now you can follow me also on LinkedIn to share our thoughts about food safety and regulations on a broader platform. I hope this will give our blog a greater audience!


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.