Agriculture Reference
In-Depth Information
13.4 PROBIOTIC REGISTRATION
Probiotics can be used as feed additives/ingredients and/or as drugs, with both requiring
pre-marketing authorization prior to their use. With regards to feed for livestock, probiotics
are usually required to be marketed and used only after they have undergone pre-marketing
assessment based on their quality, composition, safety and efficacy. The same applies to
drugs, with of course extensive requirements for additional clinical trials to support efficacy.
In some countries, however, the efficacy of probiotics is not always of such concern as it is
widely believed that the market will dictate. This appears to be the position in India and to some
extent the US (allowing GRAS microorganisms to be used as direct fed microbials without nec-
essarily any other pre-marketing authorization). However, with regards to most other countries
including the EU, Canada, Brazil and Chile, improvement or optimization of certain perfor-
mance parameters (e.g. feed efficiency, feed digestibility, daily growth rate etc.) encountered
in normal animal husbandry production (which may or may not improve welfare) are usually
acceptable claims. Health claims including survivability clearly linked to disease conditions
are not acceptable for feed additives and must be considered as 'drug-like' and/or 'medici-
nal' claims. This is not to be confused with using probiotics to optimize normal husbandry
conditions because of the quite frequent references to use as 'replacements of antibiotics'.
Probiotics are usually administered to optimize normal animal husbandry, especially prior
to attaining undesirable situations that irreversibly degenerate into diseases. Drugs are used
for preventive or therapeutic purposes and their registration, in comparison with registration
as feed additives, is usually much more prohibitive in costs; thus there are few or no reported
probiotic registrations for typical medicinal use purposes.
Finally, one of the main stumbling blocks from an industrial point of view is that potential
probiotic species/strains must satisfy stringent regulations. Safety and efficacy considerations
are increasingly taken into account when considering the development of probiotics. As an
example, the EU regulates the authorization, marketing and use of probiotics as feed addi-
tives under the Regulation of the European Parliament and of the Council (Regulation EC
no. 1831, the Feed Additive Regulation). In accordance with this Regulation, the Commis-
sion, having first consulted the European Food Safety Authority (EFSA), has established rules
(Commission Regulation EC no. 429/2008) concerning the preparation and the presentation of
applications. The registration of a probiotic requires the preparation of a dossier with data and
studies demonstrating the efficacy and safety of the product for the animals, the product han-
dler, the consumer and the environment. These safety concerns are of the utmost importance in
aquaculture since, as mentioned by Wang et al . (2008), new species and specific strains iden-
tified as potential probiotics for aquatic species do not share the historical safety of traditional
or widely tested strains such as LAB (Adams 1999).
A long term research and development project, initiated from 2001 through the OFIMER
program with BioMar AS and several research institutions, has resulted in the first EU approval
of the use of probiotics for salmonids in August 2009, quickly followed by an authoriza-
tion for use in shrimps. The goal of seeking and obtaining this authorization allowed BioMar
to develop an innovative dietary probiotic concept, resulting in the introduction of the first
approved industrial trout and salmon feed containing probiotics in 2010 (Castex and Aarestrup
2011). In 2012, the same probiotic product formulated with the strain P.acidilactici MA18/5M
received another positive scientific opinion from the EFSA Panel on Additives and Products or
 
Search WWH ::




Custom Search