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Aspartame and Pregnancy: The ISA welcomes the EFSA Panel statement on low calorie sweeteners and looks forward to EFSA conclusions

February 2011
ISA welcomes the announcement today by the Food Additives and Nutrient Sources (ANS) Panel of the European Food Safety Authority (EFSA) that EFSA will shortly provide a scientific statement on two papers alleging safety concerns about aspartame and other low calorie sweeteners used in soft drinks when consumed during pregnancy.


ISA notes the concerns already raised by the EFSA Panel in their initial discussion on the studies by Halldorsson1 and Soffritti2 at the ANS meeting last week and is confident that after thorough consideration of these 2 studies EFSA will once again re-confirm the safety of aspartame and other low calorie sweeteners.

  • There is no link between the consumption of low calorie sweeteners and the risk of premature birth

The use of low calorie sweeteners has been very well studied both in humans and in animals. This research has shown no adverse effects on the mother or the developing baby related to the use of low calorie sweeteners.3

Following their initial consideration of the Halldorsson study in pregnant women,4 the EFSA Panel notes in its statement, "This epidemiological study cannot, in and of itself, establish a cause and effect relationship between the intake of artificial sweeteners and risk of preterm delivery. As indicated by the authors, further research (including experimental studies) would be required to confirm or reject these findings."5

  • Methodology and conclusions of previous studies on aspartame by the Ramazzini Institute have been dismissed by EFSA and other independent scientific bodies

In April 2009, following further claims by the Ramazzini Institute about the safety of aspartame, EFSA concluded, “On the basis of all the evidence currently available including the last published ERF study there is no indication of any genotoxic or carcinogenic potential of aspartame and there is no reason to revise the previously established ADI for aspartame of 40 mg/kg bw/day.” 6


In a statement last week the ANSES (French Food Safety Authority) concluded, “The methodology used (exposure to very high doses during a life time) is not used by any other group of researchers and, importantly, does not follow accepted reference methodology (OECD).” 7


Today’s statement from the EFSA Panel on their initial consideration of the latest Ramazzini study on aspartame suggests that EFSA scientists have similar concerns about the methodology used. For example, the Panel notes: “the type and incidence of tumours reported by Soffriti et al (2010) appear spontaneously at high rates in male mice. This finding is not consistent with a typical dose-response.


ISA welcomes EFSA’s announcement to request the complete data set from the authors of this study for review and would highlight the consistency of the opinions of health authorities around the world which have dismissed the findings of studies carried out by the Ramazzini Institute on aspartame.


  • Consumer intake of low calorie sweeteners is well below the established ADIs

The Acceptable Daily Intake (ADI) is a level which is safe to consume every day throughout a lifetime. For example, in order to reach the established ADI for aspartame (40mg/kg/ bodyweight/day, a woman weighing 60kg would have to consume every day during their lifetime 280 tabletop sweeteners or 30 cans of low calorie sweetened soft drinks.


A recent study by the WIV (Scientific Institute for Public Health), conducted on behalf of the Belgian government, concludes that low calorie sweeteners do not pose a health risk for adults, nor for diabetics or heavy consumers of light/diet products.8 The study shows that adults who regularly consume products containing low calorie sweeteners only reach a maximum of 25% of the accepted daily intake (ADI) for cyclamate, 17% for acesulfame-K, 5% for aspartame , 11% for saccharin and 7% for sucralose. Even when consuming large amounts of food, the concentration of low calorie sweeteners is well below the European scientific standards.


  • Health benefits of sweeteners

By providing sweetness without calories, sweeteners can make a useful contribution to a healthy, calorie-controlled diet. 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.


1 Intake of artificially sweetened soft drinks and risk of preterm delivery. Halldorsson TI et al. AJCN, 30 June 2010

2 Aspartame Administered in Feed, Beginning Prenatally Through Life Span, Induces Cancers of the Liver and Lung in Male Swiss Mice. Soffritti et al. American Journal of Industrial Medicine, September 2010

3 Safety Evaluation in Pregnancy', by Robert S. London – Jay T Rorick Jr.published in 'Clinical Evaluation of a Food Additive, Assessment of Aspartame', (Edition 1996), by Tschanz et al
Intake of artificially sweetened soft drinks and risk of preterm delivery. Halldorsson TI et al. AJCN, 30th June 2010
Statement of EFSA ANS Panel, 7th February 2011: http://www.efsa.europa.eu/en/efsajournal/pub/1996.htm
EFSA Opinion, published 20th April 2009:

7 Aspartame : point d'étape sur les travaux de l'Anses : http://www.anses.fr/ (Translation EN)

© ISA 2011