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Public hearing ENVI Committee 16 March 2011

Risk assessment of aspartame H. Kenigswald Head of the Food additives and Nutrient Sources added to food Unit. Public hearing ENVI Committee 16 March 2011. Previous European evaluations.

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Public hearing ENVI Committee 16 March 2011

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  1. Risk assessment of aspartameH. KenigswaldHead of the Food additivesand Nutrient Sources added to food Unit Public hearing ENVI Committee 16 March 2011

  2. Previous European evaluations • Scientific Committee for Food (SCF) in 1984:original evaluation establishment of the ADI (40 mg / kg bodyweight / day) • SCF in 1988: new studies on potential behaviouraland neurotoxic effects • SCF in 1997: epidemiological study by Olney et al. (1996) • SCF in 2002: update of previous SCF opinions • EFSA in 2006: 1st European Ramazzini Foundation (ERF) carcinogenicity study in rats exposed to aspartame (Soffrittiet al., 2006) , National Toxicology Program carcinogenicity studies (2003), National Cancer Institute (2006) • EFSA in 2009: 2nd ERF study in rats exposed to aspartame (Soffritti et al., 2007) • National experts report in 2010: comprehensive review including new scientific literature and other data submitted in response to a public call for data Public hearing by ENVI Committee 16 March 2011

  3. Recent activities by EFSA • Request for technical and scientific assistance made by the European Commission on 1 February 2011: • “undertake a scientific evaluation of the studies presented in these two articles and indicate whether these studies should trigger a revision of the existing opinions of EFSA related to the safety of food additive sweeteners, including the recent EFSA opinions of May 2006, and March 2009 which reaffirmed the safety of aspartame” • The ANS Panel has adopted a scientific statement on 3 February 2011 advising EFSA on further work on the Soffritti et al. (aspartame) and Halldorsson et al. (sweeteners) 2010 publications • EFSA statement on the Soffritti et al. and Halldorsson et al. 2010 publications - published on 28 February 2011. Public hearing by ENVI Committee 16 March 2011

  4. Soffritti et al. 2010(aspartame) • Carcinogenicity study in Swiss mice exposed to aspartame • The validity of the study cannot be assessed based on the information available: • absence of information on objectives, specific hypotheses to be tested, outcome variables • insufficient information on randomization, blinding, allocation ratio • The relevance of its statistical analyses cannot be assessed: • absence of detailed description of methods used • absence of description of the specific hypotheses tested • The tumours observed in Swiss mice are not relevant for human risk assessment: • hepatic tumours induced by non-genotoxic compounds • high spontaneous incidence of hepatic and pulmonary tumoursin Swiss mice Public hearing by ENVI Committee 16 March 2011

  5. Halldorsson et al. 2010 (soft drinks with sugar or artificial sweeteners) • Epidemiological study on the association between maternal soft drink consumption and preterm delivery • Halldorsson et al. 2010 study is exploratory only:“The aim of this study was to explore the association between maternal soft drink consumption in pregnancy and preterm delivery.”It cannot establish a cause – effect relationship • Further studies are needed to confirm or reject the findings (as stated by the authors) • Association mainly driven by medically-induced preterm deliveries => should be further investigated • Association cannot be ascribed to any specific sweetener • Confounding factors should be investigated Public hearing by ENVI Committee 16 March 2011

  6. Conclusion of EFSA statement • Overall, the Soffritti et al. and Halldorson et al. 2010 publications do not provide sufficient scientific evidence to give reason to reconsider the previous evaluations of aspartame or other sweeteners authorised in Europe Public hearing by ENVI Committee 16 March 2011

  7. EU Member Statesand international activities • EFSA liaises with the national risk assessors in the Member States through its Advisory Forum • ANSES has published an opinion on the Soffritti et al. and Halldorsson et al. 2010 publications on 15 March 2011conclusions similar to those of the EFSA statement of 28 February 2011 • EFSA liaises with food safety agencies in USA, Canada, Australia, New Zealand and Japan Public hearing by ENVI Committee 16 March 2011

  8. Ongoing EFSA activities • The ANS Panel will undertake further work and prepare an opinion on: • -interpretation of the results reported by Soffritti et al. (2010) • - suggested implications of methanol • The opinion by the ANS Panel is foreseen to be finalised by December 2011. • EFSA has requested specific information on the design and statistical methodology of the study to Dr Soffritti and will meet Dr Soffritti on 23 March 2011 • Continuous monitoring of scientific literature Public hearing by ENVI Committee 16 March 2011

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