3.2. Food Micro-Organisms and National Legislation in
Europe
In European countries, the existing traditional starter
strains are classified either as food ingredients, processing
aids or additives. In practice, this means that if classified as
an ingredient, they should be listed within the additive list of
the finished product [7]. Probiotic cultures, when incorporated
in food, are most often classified as food supplements or
dietetics, but also in some cases as pharmaceuticals. To date,
it is only in Denmark that the relevant authority (in this case
the Danish Veterinary and Food Administration) must be
notified by the manufacturer prior to the use of new strains.
The Danish statute on food additives (BEK nr. 282 af
19/04/2000) lists the necessary documentation, including
“microbiological/toxicological investigations which make it
possible to estimate if the culture in question can be used
justifiably as stated”. However, no specific tests are listed. In
France, a premarket approval system for novel strains is also
being considered. The proposed recommendations, published
in 2002 by Agence Francaise de Securite Sanitaire des
Aliments (AFFSA), on the inventory of data required to
assess the safety of micro-organisms in the agrifood and feed
sector include a “decision tree” based approach. In case there
is a need to generate data relating to the sanitary risks of thestrain or when there is a need to guarantee the absence of
risk for the anticipated use, there are detailed instructions of
the toxicological testing of the strain, including laboratory
animal studies. The AFSSA guidelines are intended for new
strains or strains used in novel applications, while genetically
modified micro-organisms (GMOs) per se are outside their
scope.