Зарегистрировано в Минюсте РФ 22 марта 2002 г - Cexgan

Clause 5.10.16.9, if the DNA target sequences have been detected in the isolated DNA, go to Clause
5.10.16.5, if not, go to Clause 5.10.16.10.
5.10.16.5. To render concrete the marker genes encoding resistance to antibiotics that have an essential
clinical significance in medicine and veterinary, if the stated genes are detected, go to Clause 5.10.16.10, if
not, go to Clause 5.10.16.6.
5.10.16.6. Determination of the nucleotide sequence of the target gene and comparison with the declared
nucleotide sequence, if the DNA target sequences have been detected, go to Clause 5.10.16.9, if not, go to
Clause 5.10.16.7.
5.10.16.7. Detection of the protein identity expressed by the target gene of GMM to the declared protein
(enzyme) by electrophoresis in PAG and immunoblot, if such correspondence has been detected, go to
Clause 5.10.16.9, if not, go to Clause 5.10.16.10.
5.10.16.8. Analysis of additional quality and food product safety indicators shall be carried out with additional
control in accordance with these Sanitary Rules.
5.10.16.9. The decision is made, according to which the product sample shall be assessed as complying with
the requirements of these Sanitary Rules, in the part regarding requirements for marking and information.
5.10.16.10. The decision is made, according to which the product sample does not comply with these Sanitary
rules, further studies are quitted.
5.11. After the accomplishment of the samples testing, examination of the enclosed documentation and
production, based on the obtained results analysis, the decision on the GMM (GMA) products compliance with
the requirements of the Sanitary Rules for labelling shall be made.
5.11.1. Depending on the results, the decision is made in the following way:
- if it is found that the food products samples contain GMM (and/or target genes of GMM, products of
expression of target genes) and/or GMA, corresponding to the manufacturer's declaration, if their belonging to
microorganisms -producers is confirmed as declared in the technical documentation and allowed for circulation
in the Russian Federation, and if the food products do not contain DNA and protein, but it is confirmed that
they contain microorganisms-producers declared in the technical documentation allowed for circulation in the
Russian Federation based on the results of the documentation examination or the additional testing, such
products shall be considered as meeting the requirements of the sanitary rules;
- if the samples contain food products obtained from/or with the use of GMM:
а) GMM (and/or target genes of GMM, products of expression of target genes, selective markers of GMM),
not corresponding to the declaration of the manufacturer, not specified in the technical documentation, not
registered and not allowed for circulation in the Russian Federation;
b) GMM or selective markers of GMM, plasmid DNA in the samples of the traditional food products,
obtained from/or with the use of GMA;
c) genes of transmissible antibiotic resistance and/or factors (markers) of pathogenicity in the food products
samples from GMM and GMA;
d) toxicity, genotoxicity, residual quantities of antibiotics, mycotoxins and other alien substances in the food
products samples, obtained from/or with the use of GMM and GMA, the decision is made on the noncompliance
of the products with the sanitary rules.
ConsultantPlus: note:
The numbering of Clauses is given in accordance with the official text of the document.
5.13. In the Section "Hygienic Characteristics of Products" of the sanitary and epidemiological opinions issued
on the food products, obtained from/or with the use of GMM in the column "Substances, Indices (Factors)" the
following line shall be additionally included: "GMM". Correspondingly, in the column "Hygienic Standard" of this
line it is required to specify the relation of the products to GMM, and particularly:
- " Contains GMM ( the name of the strain and the particular genetic modification)";
- " Obtained with the use of GMM ( the name of the strain and the particular genetic modification)";
5.12.1. Depending on the condition of technological microflora in the product the forms of the records in the
sanitary and epidemiological opinions on the food products obtained from/or with the use of GMM shall provide
for: