In a press statement the European Food Safety Authority (EFSA) urged the Ramazzini Institute in Italy to release the data it had on aspartame. EFSA said it had first made its request in June afterRamazzini published its claims in a scientific journal. The request was renewed in September.
EFSA said it needs the primary data required to carry out a new risk assessment on aspartame.
"Whilst the panel is ready to start this evaluation as a matter of high priority, work cannot commence without the new data which are yet to be received," EFSA stated. Aspartame isused in more than 6,000 food and drink products in the EU.
Researchers at the Ramazzini Institute for cancer research in Italy caused a stir earlier this year by claiming that their study shows that aspartame causes lymphomas and leukaemia in femalelaboratory animals "at doses very close to the acceptable daily intake for humans". The authors of the study also say that while rats fed aspartame ate less food, there was nodifference in body weight between treated and untreated animals.
Following initial discussions with the Ramazzini Institute in June 2005 and prior to the study's publication, EFSA published a statement saying it would review the significance of the newfindings in the context of the extensive safety data already available on aspartame.
"Based on current evidence on the safety of aspartame, EFSA does not recommend that consumers who wish to choose foods containing aspartame make any changes to their dietary habits,"the regulator stated.
EFSA estimates it would take three to five months to carry out the risk assessment following receipt of the data.
Aspartame was first authorised for use by several EU member states in the 1980s. European legislation harmonising its use in foodstuffs was introduced in 1994 following safety evaluations in 1984,1987, 1988. A further review of all the original and more recent data on aspartame was carried out in 2002 by the bloc's food regulator.
Both published and unpublished data, including all the information on genotoxicity and carcinogenicity in animals and humans, were considered at that time and the SCF re-confirmed the previouslyestablished acceptable daily intake (ADI) for aspartame.
Various food associations have dismissed the Ramazzini study, saying it did not follow established scientific procedures.