Agriculture Reference
In-Depth Information
Nutrition 1 (SCAN; European Commission,
2001). As all feed additives, microbial
products should also be assessed for target
animal safety, user safety, consumer safety
and environmental safety, as well as for
ei cacy in target animals. Detailed guidance
documents on how to perform the safety
and
With conventional microorganisms, the
primary question is whether the intended
use is going to increase signii cantly the
levels of the microorganism in the receiving
environment. If a viable GMM is to be used
as a feed additive, then the environmental
safety assessment should be done according
to the principles laid out in the EFSA
technical guidance of 2011a mentioned
above.
To facilitate the safety assessment of
microorganisms, the concept of a qualii ed
presumption of safety (QPS) has been
introduced (EFSA, 2007a). According to the
QPS approach, a microorganism that has an
established safety record can be notii ed to
the EFSA without the studies for the target
animal, consumer or environmental safety
formally required in the guidance documents
cited above. h is applies also to microbial
products, such as enzymes, derived from a
QPS microorganism. h e EFSA Panel on
Biological Hazards (BIOHAZ) updates
annually the list of QPS organisms. So far,
no GMM has a QPS status and therefore
feed additives produced by GMMs are, in
principle, subject to the full safety
assessment, even in the cases when the
parental organism of the GMM is on the
QPS list.
Microbial biomasses derived from GMMs
are a special case. Formally, microbial bio-
masses used as feed ingredients do not need
any specii c notii cation. If, however, the
biomasses consist of GMMs, their safety has
to be assessed by the EFSA. According to the
relevant guideline (EFSA, 2011b), the
general principles of the GMM guidance
(EFSA, 2011a) regarding the presence of
viable GMMs and recombinant DNA in the
product apply. Additionally, the document
gives detailed instructions on the com-
positional analysis and for the experimental
design to dei ne the safe use level for target
animals. Assessment of the user and
consumer safety is done according to the
principles outlined for microbial feed
additives.
ei cacy
assessments
have
been
published by the FEEDAP Panel.
h e tolerance test (with, if possible, at
least tenfold overdoses) to establish the
safety for target animals should be
performed according to the instructions in
the technical guidance on tolerance and
ei cacy studies in target animals (EFSA,
2008a). h e aim is to provide a limited
evaluation of the short-term toxicity of the
additive and to establish a margin of safety
if the additive is consumed at higher doses
than are recommended.
h e safety for the user (the person
handling the feed) should be established
according to the technical guidance on
studies concerning the safety of the additive
for users/workers (EFSA, 2008b). h e
studies include tests for respiratory toxicity
(in case the additive contains more than 1%
on a weight basis of particles with a diameter
of 50 μm), skin and eye irritation and skin
sensitization, all performed using the com-
mercial formulation. Microbial additives, as
proteinaceous substances, are considered
automatically as respiratory sensitizers and
the general recommendation is to treat
them accordingly.
Regarding the consumer, the safety
concern is the potential contamination of
animal products by unknown microbial
metabolites produced during the manu-
facturing process. Accordingly, both geno-
toxicity tests (assays for point mutations
and clastogenicity) and 90-day repeated
dose feeding studies on laboratory animals
are formally required, unless the product is
intended for companion animals only (EFSA,
2008c).
h e environmental safety of micro-
organisms is usually assessed case by case.
 
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