3.3. Food Micro-Organisms and the EU Novel Food
Regulation
According to the European Novel Food Regulation
(258/97 EEC), novel foods and food ingredients are those
that have not hitherto been used for human consumption to a
significant degree within the Community. Specifically, foods
and food ingredients containing or consisting of, or produced
from, genetically modified organisms and foods consisting
of, or isolated from, micro-organisms, fungi or algae belong
to the category of novel foods. It should be noted, however,
that additives and processing aids fall outside the scope of
the regulation. The case of a processing aid or additive
consisting of live micro-organisms thus remains ambiguous.
Taken literally, the regulation detailed above would mean
that each new microbial strain (i.e., a strain not used before
1997) should be introduced according to the procedure
involving a thorough safety evaluation. In practice, no starter
strain or probiotic has so far been evaluated according to
regulation 258/97EEC. This is partly because the wide variety
of strains currently used in food manufacturing makes a
definition of a novel strain arbitrary, and because of the
known historical safety of most of the species, their specific
safety evaluation is a relatively low priority. Also, the
majority of currently-marketed probiotics were introduced
pre-1997, excluding them from the regulation.
This situation would dramatically change if GMOs were
introduced either as starter cultures or probiotics. While this
prospect remains remote in view of the present regulatory
climate and consumer opinion in the EU, there are certain
developments that might make this possibility actual. Findings
that lactococci engineered to produce human Il-10 can
be successfully used to treat experimentally-induced intestinal
inflammations in mice [25] could lead to engineered
probiotics with designed health promoting activities. While
these products would fall even more into the border area
between foods and medicines, their introduction would
undoubtedly create legal/regulatory precedent cases with
significant consequences in the functional food sector. But
for now, discrepancies concerning the status of lactic acid
bacteria in the various national regulations (additives, processing
aids or ingredients) continue to complicate harmonisation
of EU-wide regulatory measures.