Στις 8 Ιανουαρίου 2013, η Ευρωπαϊκή Αρχή για την Ασφάλεια
των Τροφίμων (EFSA) εξέδωσε το προσχέδιο της επιστημονικής της γνωμοδότησης
σχετικά με την ασφάλεια της γλυκαντικής ουσίας χαμηλού θερμιδικού περιεχομένου
ασπαρτάμης.
Για να διεξαγάγει αυτήν την πλήρη αξιολόγηση κινδύνου, η
EFSA προέβη σε ενδελεχή εξέταση της επιστημονικής και άλλης βιβλιογραφίας, η
οποία θεωρείται έγκριτη στο χώρο, σχετικά με την ασπαρτάμη και τα παράγωγα από
τη διάσπασή της. Σε αυτήν λήφθηκαν υπόψη και νέες μελέτες σε ανθρώπους. Η EFSA
κατέληξε στο συμπέρασμα ότι η ασπαρτάμη και τα παράγωγα της διάσπασής της δεν
ενέχουν κανένα τοξικολογικό κίνδυνο για τους καταναλωτές στα σημερινά επίπεδα
έκθεσης. Η σημερινή Αποδεκτή Ημερήσια Πρόσληψη (ΑΗΠ) θεωρείται ασφαλής για τον
γενικό πληθυσμό και η έκθεση των καταναλωτών στην ασπαρτάμη είναι χαμηλότερη
αυτής της ΑΗΠ.
Στην παρούσα αξιολόγηση κινδύνου, επιβεβαιώνονται παλαιότερα
πορίσματα για την ασφάλεια της ασπαρτάμης. Η πρώτη αξιολόγηση της ασφάλειας της
ασπαρτάμης που πραγματοποιήθηκε στην Ευρώπη δημοσιεύτηκε από την πρώην
Επιστημονική Επιτροπή Τροφίμων (SCF) της Ευρωπαϊκής Επιτροπής, το 1984.
Ακολούθησαν συμπληρωματικές αξιολογήσεις από την SCF το 1988, το 1997 και το
2002. Από τη σύσταση της EFSA το 2002, η Αρχή έχει εκδώσει συμβουλές για τις
νέες επιστημονικές μελέτες που συνδέονται με αυτήν τη γλυκαντική ουσία το 2006,
το 2009 και το 2011
"Aspartame:
EFSA consults on its first full risk assessment
8 January
2013
The
European Food Safety Authority (EFSA) has today launched a public consultation
on its draft scientific opinion on the safety of the artificial sweetener
aspartame. To carry out this full risk assessment, EFSA has undertaken an
in-depth review of peer-reviewed scientific and other literature on aspartame
and its breakdown products, including new human studies. All stakeholders and
interested parties are invited to comment on the draft opinion through the
online public consultation by 15 February 2013. As part of this important
process and the Authority’s commitment to actively engaging with stakeholders,
EFSA will also hold a meeting with interested parties to discuss its draft
opinion and the feedback received from the online public consultation.
Regulatory
bodies around the world have evaluated the safety of aspartame since the 1980s;
however, this is the first full evaluation of aspartame that has been requested
of EFSA and has been carried out by the Authority’s Scientific Panel on Food
Additive and Nutrient Sources Added to Food (ANS Panel). In this re-evaluation
of the safety of aspartame, EFSA’s scientific experts have drawn upon all
available information on aspartame and its breakdown products and, following a
detailed and methodical analysis, have concluded in this draft opinion that
they pose no toxicity concern for consumers at current levels of exposure. The
current Acceptable Daily Intake (ADI) is considered to be safe for the general
population and consumer exposure to aspartame is below this ADI.
In setting
the ADI, the ANS Panel considered findings from long-term studies conducted in
experimental animals related to toxicity and carcinogenicity and possible
adverse health effects of phenylalanine, one of aspartame’s breakdown products,
on the developing fetus. Phenylalanine is an amino acid making up protein found
in many foods. It is known to be toxic at high intake levels, in particular to
the developing fetus in women suffering from the medical condition
phenylketonuria (PKU). This inherited disorder increases blood phenylalanine
concentrations to levels toxic to the developing brain. The Panel confirmed
that the ADI, while protective of the general population, is not applicable to
people who suffer from PKU, as they require strict adherence to a low
phenylalanine diet.
The ANS
Panel’s draft opinion has benefitted from the latest scientific thinking and
methodological approaches. This comprehensive review was made possible
following two public calls for data which made available a large body of
scientific information, comprising both published and previously unpublished
data and studies. This included the 112 original documents on aspartame that
were submitted to support the request for authorisation of aspartame in Europe
in the early 1980s. In the interest of transparency and openness EFSA published
the full list of these scientific studies and also made publicly available
previously unpublished scientific data. This information has been critically
evaluated and interpreted by EFSA’s experts to underpin the key discussion
points addressed in the draft opinion.
Also
published today, EFSA has prepared a set of Frequently Asked Questions to help
explain some of the key scientific concepts and initial conclusions of the
draft opinion. Feedback from the consultation will be compiled in a report and,
where appropriate, incorporated into the final scientific opinion, which the
ANS Panel aims to adopt by May 2013."
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