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EFSA to issue statement on two studies on safety of artificial sweeteners

EFSA will issue a scientific statement on two recent studies on the safety of artificial sweeteners by the end of February 2011, responding to a request for technical assistance from the European Commission. Guided by the statement of the Panel on Food Additives and Nutrient Sources added to food (ANS) published today, EFSA’s scientific evaluation will be carried out in close co-operation with the French agency for food, environmental and occupational health safety, ANSES[1], and will help inform the Authority’s ongoing work on artificial sweeteners.

One of the studies published was conducted by the Ramazzini Institute and focuses on the potential carcinogenicity of aspartame in mice (Soffritti et al., 2010[2]). The other is an epidemiological study that examines the association between the consumption of sugar-sweetened and artificially-sweetened soft drinks and the risk of preterm delivery in Danish pregnant women (Halldorsson et al., 2010[3]).

At their plenary meeting on 1 – 3 February 2011, EFSA scientists on the ANS Panel had an initial discussion on these recent publications and highlighted further scientific work which could be considered. The Panel noted that the type and incidence of tumours reported by Soffriti et al (2010) appear spontaneously at high rates in male mice. The Panel also observed that the increased incidence of these tumours in mice exposed to aspartame through feed, whilst statistically significant, remained within the historical control range for these tumours in these mice[4]. EFSA will support the Panel in further analysing the results and conclusions in the Ramazzini paper and will request the complete data set from the authors for possible review.

The ANS Panel also considered the Danish epidemiological study whose findings suggest that the daily intake of artificially sweetened soft drinks may be associated with an increased risk of preterm delivery. These findings are based on a statistical association between the consumption of artificially sweetened soft drinks and preterm delivery observed in a prospective cohort study[5]. 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. The Panel advised on the need for specialised expertise to provide additional insights on the methodology and statistical aspects of this study, including the implications of possible confounding factors.

EFSA will provide a scientific statement on the two papers by the end of February 2011, responding to a request for technical assistance from the European Commission.

[1] Further information on the work initiated by ANSES
[2] Soffritti M. et al., Aspartame administered in feed, beginning prenatally through life span, induces cancers of the liver and lung in male Swiss mice. Am. J. Ind. Med. 2010, 53, 1197-1206.
[3] Halldorsson T.I. et al., Intake of artificially sweetened soft drinks and risk of preterm delivery: a prospective cohort study in 59,334 Danish pregnant women. Am. J. Clin. Nutr. 2010, 92: 626-33,
[4] EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on two recent scientific articles on the safety of artificial sweeteners. EFSA Journal 2011;9(2):1996. [5 pp.] doi:10.2903/j.efsa.2011.1996 .
[5] A prospective cohort study is a cohort study that follows over time a group of similar individuals ("cohort") who differ with respect to certain factors under study, in order to determine how these factors affect rates of a certain outcome. This study concerns 59,344 women from the Danish National Birth Cohort (1996-2002).

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