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Algorithm for Laboratory Studies of Products Containing Living GMA
Test Samples Study Contents Study Results Decision
Products of
group I and II
Products of
group I and II
1. Quantity determination of viable 1. Quantity of microorganisms
GMA of technological microflora in 1 g in the product corresponds to a
of the product
normilized or the level claimed
by the manufacturer
2. Confirmation of generic and/or
specific belonging of microorganism
3. Identification of DNA of marker
vector genes (e.g. antibiotic resistant
genes) in the food products sample
2. Generic or specific belonging
of the microorganism has been
confirmed according to the
documentation submitted by
the applicant
3. Absence of DNA of marker
genes, plasmid DNA
4. Analysis of additional quality and 4. Characteristics adverse for
food product safety indicators (Clause customers have not been
5.6.1)
detected
1. Quantity determination of viable 1. Quantity of microorganisms
GMA of technological microflora in 1 g in the product does not
of the product
correspond to a normilized or
the level claimed by the
manufacturer
2. Confirmation of generic and/or
specific belonging of microorganism
3. Identification of DNA of marker
vector genes (e.g. antibiotic resistant
genes) in the food products sample
4. Analysis of additional quality and
food product safety indicators
2. Generic or specific belonging
of the microorganism has not
been confirmed
3. DNA of marker genes has
been detected
4. Pathogenicity factors,
plasmid DNA or noncompliance
with the safety
regulations of these Sanitary
Rules have been detected
Table 7
Positive decision on the study
results
Negative decision on the
study results
5.10.15. Algorithm for laboratory study of food products samples containing living GMM (food products and
raw materials of group I and II obtained with the use of or containing living GMM registerd in the Russian
Federation) includes:
5.10.15.1. Quantity determination of viable GMM of technological microflora in 1 g of the product; if the
detected quantities are not less than the normalized level or the level claimed by the manufacturer in the
normative and technical documentation, go to Clause 5.10.15.2.
5.10.15.2. Detection and identification of living GMM in the studied sample by microbiological methods. If the
detected GMM do not comply with the manufacturer's declaration, go to Clause 5.10.15.13, if the detected
GMM correspond to the ones stated in the technical documentation on the product and the data sheet
attached to the certificate of depositing, go to Clause 5.10.15.3, the reference strain from the depositary
(culture collections) shall be studied in parallel with the test strain of GMM from the product sample.