Food additive approval is based on a robust hazard and risk
characterization, leading to the establishment of an ADI and often
a maximum permitted level (MPL) in foods. They must be subjected
to a wide range of tests, devised to assess potential risks
to the consumer, before they are allowed in food. Tests assesshow the additive reacts in the body and also look for any toxic effects
at and above the levels the additive is to be used in food. This
includes testing to see if there is any chance of genetic damage or
cancers being caused by the long-term use of the additive. A formal
process for safety evaluation exists at national and international
levels for analysing the test data on food additives, setting the ADIs
and publishing the results.
In Europe, food additives permitted before 20 January 2009
must go through a new risk assessment by EFSA; furthermore, at
any time, the authority can revise its decision on the basis of
new data reporting toxicological effects. In the case of aspartame,
this process was undertaken almost every year, with the production
of a relevant number of opinions and statements, all confirming
no safety concerns below the established ADI.
With reference to epidemiologic data, evidence on low-calorie
sweeteners – and specifically aspartame – does not support the
existence of a consistent association with hematopoietic neoplasms,
brain cancer, digestive sites, breast, prostate and several
other neoplasms; similarly, low-calorie sweeteners are not related
to vascular events and preterm deliveries.