Transcript Outcome of the re-evaluation of aspartame

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
3
Food additives
 New Food Additives:
Risk assessment required by EFSA with dossiers.
 Existing Food Additives:
Risk assessment required by EFSA without dossiers
- Food colours
- FA other than food colours
& sweeteners
- Sweeteners
by 2015
by 2015, 2016 & 2018
by 2020
Exception: Aspartame by 2013
The Food Additive Evaluation Process
in the EU
European
Commission
Request
European Parliament
Member States
Assessment by
Panel
Opinion
Legislation
5
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.
6
Where do we find aspartame?
7
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)
8
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 =
9
10
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)
11
What is Aspartame?
Phenylalanine
Aspartic acid
Methanol
12
Phenylalanine
Aspartic acid
Methanol
13
So what about methanol, phenylalanine
and aspartic acid??
 Methanol
o A physiological molecule produced by our body to give a source of
carbon.
o Excess is converted to carbon dioxide
o Methanol from aspartame is handled identically
to methanol produced by the body
 Phenylalanine and aspartic acid are two amino acids
o Components of the proteins in our normal diet
o Used to produce new proteins in our body and other important
physiological substances
14
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
o
o
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.
15
Could aspartame be dangerous during
pregnancy?
 Early developmental studies performed in rabbits at high
doses of aspartame showed health effects:
o Maternal toxicity: the rabbits stopped eating, lost weight and abortions
occurred
o 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.
16
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
17
Blood Phenylalanine
How much aspartame is required to reach
the cut-off value?
Life time
Cut-off value applied
by ANS PANEL
18
Blood Phenylalanine
Life time
EFSA’s limit
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.
20
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?
21
Should we be surprised about this conclusion?
Based on exposure:
NO!
22
Thank you very much for your attention