The European Food Safety Authority (EFSA) reviewed two studies published last year: a carcinogenicity study in mice from the Ramazzini Institute (Soffritti et al., 2010) and an epidemiological study linking artificially-sweetened soft drinks to premature birth (Halldorsson et al., 2010).
Following a review conducted with the co-operation of the French food safety agency Anses, EFSA concluded that the studies “do not give reason to reconsider previous safety assessments of aspartame or of other sweeteners currently authorised in the European Union.”
Regarding Ramazzini study, which looked at long term exposure to aspartame through feed in mice, EFSA identified several flaws in its design. In particular the scientists said the length of the study meant that erroneous conclusions could be drawn – older mice may develop illness naturally over time.
And the Swiss mice used in the study are known to be susceptible to spontaneous hepatic and pulmonary tumours. EFSA said incidence of these tumours reported in the study fall within the historical control range.
In addition, hepatic tumours in mice are not regarded by toxicologists as being relevant for human risk assessment when induced from substances like aspartame that do not damage DNA.
EFSA is requesting the complete data set from the Ramazzini Institute and said that as it stands it therefore cannot comment fully on the validity of the study, its statistical approach or results.
Ailbhe Fallon, spokesperson for aspartame manufacturer Ajinomoto, told this publication that she is very pleased with the “clear and swift statement” from EFSA. Fallon added that this is the latest in a “cocktail of poor science” from the Ramazzini Institute, which has published three studies questioning aspartame safety.
Soft drink pregnancy study
Regarding the Halldorsson study, which suggested daily consumption of artificially sweetened soft drinks may be associated with increased risk of premature birth, EFSA said there is no evidence in the study to support a causal link.
EFSA said more research is needed to confirm or reject an association, recommending in particular that future studies investigate other confounding factors like exposure to other substances such as coffee than may affect pregnancy.
In addition, the scientists said medical history and criteria for medical decisions to induce delivery should be investigated further – this is because the link found in the study related mainly to medically induced rather than spontaneous premature birth.
Reacting to the EFSA statement, the International Sweeteners Association (ISA) said it welcomed the conclusions of the scientific review and went on the attack, criticizing those that question the safety of low calorie sweeteners.
“At a time when the risks associated with overweight and obesity, such as diabetes type 2 and cardio-vascular disease, pose the single biggest challenge to public health, unsettling potentially sensitive population groups about choices that help them control their weight is particularly irresponsible.”
At its plenary meeting today and tomorrow, EFSA’s Panel on Food Additives and Nutrient Sources added to Food (ANS) will consider the authority’s statement and the possible need for further work in relation to these studies.