How are new food additives evaluated in Europe?

Johanne Trautmann, Germany

All food additives must have not only a demonstrated useful purpose but also a thorough and rigorous scientific safety evaluation before they can be approved for use.

Since 2003 the European Food Safety Authority (EFSA) is responsible for the evaluation of additives, not anymore the detached EU Scientific Committee on Food (SCF). The Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (Panel AFC) is advising them, too.

Safety assessment of food additives, is based on reviews of all available toxicological data, including observations in humans and in animal models. From the available data, a maximum level of an additive that has no demonstrable toxic effect is determined. This is called the 'no-observed-adverse-effect level' (NOAEL) and is used to determine the 'Acceptable Daily Intake' (ADI) figure for each food additive. The NOAEL is expressed in milligrams of the additive per kilogram of bodyweight per day (mg/kg bodyweight/day). The NOAEL is then divided by a safety factor, usually 100, which results in a large margin of safety - for two main reasons: First, the NOAEL is determined in animals, not humans. It is therefore prudent to adjust for possible differences by assuming that man is more sensitive than the most sensitive test animal. Secondly, the reliability of toxicity tests is limited by the number of animals tested. Such tests cannot represent the diversity of the human population, subgroups of which may show different sensitivities (e.g. children, the old and the ill). Again, it is prudent to adjust for these differences. The ADI provides a large margin of safety and refers to the amount of a food additive that can be taken daily in the diet, over a lifetime span, without any negative effect on health.

The ADI is compared with "average" and "extreme" consumption estimates in the population as whole or in particular subgroups of the population. Provided that intakes for average and extreme consumers are within the ADI, it is unlikely that any harm will result because the ADI is based on a no-observed adverse effect level, to which a large safety margin has been applied. To ensure that consumers are not exceeding the ADI by consuming too much or too many products containing a particular additive, EU legislation requires that intake studies be carried out to assess any changes in intake patterns.