Outcome of the re-evaluation of aspartame George E.N. Kass, PhD (FIP unit) All Party Parliamentary Food and Health Forum London, 10 December 2013

Additives in Food and the role of EFSA

Food Additives in the EU: Conditions Regulation (EC) No 1333/2008 There must be a technological need for their use Their use must not mislead the consumer They must be of benefit to the consumer Food additives must be safe when used

Food additives New Food Additives: 13/09/2018 New Food Additives: Risk assessment required by EFSA with dossiers. Existing Food Additives: Risk assessment required by EFSA without dossiers - Food colours by 2015 - FA other than food colours & sweeteners - Sweeteners by 2020 Exception: Aspartame by 2013 by 2015, 2016 & 2018

The Food Additive Evaluation Process in the EU Request European Commission European Parliament Member States Assessment by Panel Opinion Legislation

Aspartame An artificial sweetener used as a sugar substitute in some foods and beverages. Is 180 times sweeter than sugar Is approved in the European Union as E951.

Where do we find aspartame?

The History of Aspartame’s Approval Nearly 40 years of evaluations by … FDA (1974, 1981) SCF (1984, 1988, 2002) JECFA (1975, 1976, 1978, 1980, 1981) and national authorities (AFSSA, FSA, etc)

The History of Aspartame’s Approval Conclusions of the evaluations of aspartame by SCF and JECFA Aspartame is safe for human consumption ADI* for aspartame was set to 40 mg aspartame per kg bw * ADI = Acceptable Daily Intake ADI = ADI =

EFSA and Aspartame Mandate received from EC to perform a full re-evaluation of aspartame by November 2013. EFSA’s actions Launch of a public call for data on aspartame Industry provided 112 original study reports Nearly 1000 additional documents (published studies, memos, commentaries, press releases etc) Working Group Aspartame created External scientific report commissioned to support WG Additional call for data on aspartame breakdown products Nearly 2000 publications and reports assessed A public consultation on the draft opinion (8 January-15 February 2013) A public event for further comments and discussions (9 April 2013)

What is Aspartame? Phenylalanine Aspartic acid Methanol

Phenylalanine Aspartic acid Methanol Aspartame

So what about methanol, phenylalanine and aspartic acid?? A physiological molecule produced by our body to give a source of carbon. Excess is converted to carbon dioxide Methanol from aspartame is handled identically to methanol produced by the body Phenylalanine and aspartic acid are two amino acids Components of the proteins in our normal diet Used to produce new proteins in our body and other important physiological substances

Aspartame and cancer?? Eight studies on rats and mice conducted by industry and the US National Toxicology Program showed NO evidence that aspartame causes cancer. However: Two studies by Soffritti and co-workers claimed that aspartame causes tumours (lymphomas) in rats EFSA and others analysed the data and suspected that the animals suffered from lung infections (Mycoplasma pulmonis). Conclusions from a reassessment of cancer studies from the Soffritti laboratory by pathologists from the US National Toxicology Program: inflammatory lesions caused by respiratory infections had been misinterpreted as lymphomas. Conclusions: No evidence that aspartame causes cancer.

Could aspartame be dangerous during pregnancy? Early developmental studies performed in rabbits at high doses of aspartame showed health effects: Maternal toxicity: the rabbits stopped eating, lost weight and abortions occurred The pups had decreased body weights and some minor malformations. Previous evaluations (FDA, JECFA and SCF) did not take these effects into account. Reasons not specified. Key observation: Phenylalanine caused effects in pregnant rabbits essentially identical to what aspartame did! Hypothesis: The effects of aspartame in pregnant rabbits are caused by the amino acid phenylalanine.

The Full Re-evaluation of Aspartame Phenylalanine is a toxic amino acid Phenylketonuria (PKU) is a hereditary human disorder that causes high levels of phenylalanine. High phenylalanine concentrations in blood are toxic to the developing brain. For the evaluation of aspartame: Considerable knowledge about the toxicity of phenylalanine in humans: Clinical guidelines to maintain ‘safe’ blood phenylalanine levels. Dose-concentration modeling to predict blood phenylalanine levels from aspartame consumption

How much aspartame is required to reach the cut-off value? Blood Phenylalanine Cut-off value applied by ANS PANEL Life time

Blood Phenylalanine EFSA’s limit Life time

Conclusions of the Opinion on Aspartame Aspartame does not cause cancer or pose any risk to the developing fetus at the current ADI. No other evidence for toxicity (e.g. genotoxicity) at the current ADI. Aspartame is safe for human consumption. There is no need to revise the current ADI of 40 mg/kg bw.

Should we be surprised about this conclusion? Aspartame does not enter the body but is fully broken down in the gut to phenylalanine, aspartic acid and methanol. What is the exposure to phenylalanine, aspartic acid and methanol from aspartame compared to the amount normally available in the diet?

Should we be surprised about this conclusion? Based on exposure: NO!

Thank you very much for your attention