1. 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

2. Additives in Food and the role of EFSA

3. 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

4. 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

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

6. 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.

7. Where do we find aspartame?

8. 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)

9. 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 =

11. 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)

12. What is Aspartame?
Phenylalanine
Aspartic acid
Methanol

13. Phenylalanine
Aspartic acid
Methanol
Aspartame

14. 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

15. 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.

16. 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.

17. 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

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

19. Blood Phenylalanine
EFSA’s limit
Life time

20. 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.

21. 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?

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

23. Thank you very much for your attention