Regulations - Food Biopreservation - page 112

the status of these products as legislation regarding their use in food may vary from
country to country. Similar commercial preparations consisting of bioactive LAb
cultures are also available in the US, like for example LactiGuard™, under approval
of the US-FDA and the USDA-FSIS.
From a regulatory point of view, bacteriocin-producing strains fall in the cate-
gory of microbial cultures. In the United States, a new strain of micro-organism for
use in food can either be classifi ed as an additive or as a Generally Recognised as
Safe (GRAS) substance (Wessels et al. 2004 ). Food additives are defi ned in a broad
sense as “anything that might come into contact with food (excluding GRAS sub-
stances),” and require pre-market approval by the US FDA based on toxicological
and effi cacy data. The consideration of GRAS status is based on the availability of
enough information relevant to the substance safe use for a given intended purpose:
“generally recognized, among experts qualifi ed by scientifi c training and experi-
ence to evaluate its safety, as having been adequately shown through scientifi c pro-
cedures (or, in the case as a substance used in food prior to January 1, 1958, through
either scientifi c procedures or experience based on common use in food) to be safe
under the conditions of its intended use” (US Food and Drug Administration 1999 ).
The intended use is an essential part of the GRAS status concept. For instance, the
GRAS status of a given strain for use in a yogurt product is not valid for the same
strain in infant formulae (Wessels et al. 2004 ). The GRAS status is determined by
qualifi ed experts, not by the FDA. The food company that uses the bacterium
assumes complete responsibility, regardless of its GRAS status.
Within the European Union, microbial food cultures with a long history of safe
use are considered as traditional food ingredients, and covered by general European
food law (Regulation 178/2002/EC; European Parliament and Council 2002a ).
Microbial cultures must also be safe for their intended use. Novel use of microbial
cultures is regulated in Regulation 258/97/EC (European Parliament and Council
1997 ) if a microorganism has not been consumed in a signifi cant degree before May
15, 1997. This may apply to selected bacteriocin producer strains isolated from a
source different than the food where they will be applied. There is also an ongoing
dispute in Europe regarding the food category of starter cultures with protective
properties, since they may be considered as cultures with specifi c technological
effects (preservatives). This may contradict current regulations on approval of new
preservatives, given the long history of consumption of fermented foods and the fact
that the original and primary purpose of fermenting food was to achieve a preserva-
tion effect. In this respect, guidance documents from the European Food Safety
Authority (EFSA 2007 , 2008 ) established a pre-market safety assessment of selected
groups of microorganisms leading to a “Qualifi ed Presumption of Safety (QPS)” if
the taxonomic group did not raise safety concerns or, if safety concerns existed, but
could be defi ned and excluded (the qualifi cation) the grouping could be granted
QPS status. Thereafter, any strain of microorganism the identity of which could be
unambiguously established and assigned to a QPS group would be freed from the
need for further safety assessment other than satisfying any qualifi cations specifi ed.
Microorganisms not considered suitable for QPS would remain subject to a full
safety assessment.