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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of January 18, 2023 No. 35

About procedure for state registration of the gene engineering modified organisms intended for release to the environment, and also the products received using such organisms or containing such organisms, including the specified products imported on the territory of the Russian Federation, and recognition voided some acts and separate provisions of some acts of the Government of the Russian Federation

According to article 7 of the Federal law "About State Regulation in the field of Genetically Engineered Activities" Government of the Russian Federation decides:

1. Approve the enclosed Rules of state registration of the gene engineering modified organisms intended for release to the environment and also the products received using such organisms or containing such organisms including the specified products imported on the territory of the Russian Federation.

2. Determine that issued before entry into force of the Rules approved by this resolution, certificates on state registration of the gene engineering modified organism or the certificate on state registration of products received with use of the gene engineering modified organisms are effective before the expiration of the term specified in them.

3. Determine that:

The Federal Service for the Oversight of Consumer Protection and Welfare and Federal Service for Veterinary and Phytosanitary Surveillance perform according to spheres of maintaining impact monitoring per capita and the environment of the gene engineering modified organisms and the products received using such organisms or containing such organisms, and also control of release of the gene engineering modified organisms to the environment;

The Ministry of Health of the Russian Federation provides maintaining the summary state register of the gene engineering modified organisms, and also the products received using such organisms or containing such organisms;

the powers provided by this resolution are implemented within the number of workers of the corresponding federal executive bodies and budgetary appropriations provided in the federal budget on management and management in the sphere of the established functions established by the Government of the limiting Russian Federation.

4. Recognize invalid acts and separate provisions of acts of the Government of the Russian Federation according to the list according to appendix.

5. This resolution becomes effective since September 1, 2023 and is effective till September 1, 2029.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of January 18, 2023 No. 35

Rules of state registration of the gene engineering modified organisms intended for release to the environment and also the products received using such organisms or containing such organisms including the specified products imported on the territory of the Russian Federation

I. General provisions

1. These rules determine procedure for state registration of the gene engineering modified organisms intended for release to the environment (further - the modified organisms), and also the products received using such organisms or containing such organisms including the specified products imported on the territory of the Russian Federation (further - products), and also procedure for maintaining the summary state register of the gene engineering modified organisms, and also the products received using such organisms or containing such organisms including the specified products imported on the territory of the Russian Federation (further - the summary register).

2. Are not subject to state registration:

the modified organisms used when conducting examinations and research works according to the established health regulations and regulations;

the gene engineering modified organisms not intended for release to the environment;

the medicines for medical application received using the modified organisms or the containing such organisms;

the medical products received using the modified organisms or the containing such organisms;

products received by combination, processing or conversion of the registered products containing the modified organisms if such processing and conversion do not lead to change of genetic material of products.

3. State registration is performed by the following federal executive bodies (further - registering bodies):

Federal Service for the Oversight of Consumer Protection and Welfare - concerning the modified organisms used for production of food staples and foodstuff, and also the food staples and foodstuff received using the modified organisms or containing such organisms;

Federal Service for Veterinary and Phytosanitary Surveillance - concerning the modified animals and the plants intended for cultivation and (or) cultivation in the territory of the Russian Federation, the modified microorganisms of agricultural purpose, the modified organisms used for production of forages and feed additives, the modified organisms used for production of medicines for veterinary application, and also the forages and feed additives and medicines for veterinary application received using the modified organisms or containing such organisms.

4. Data on the registered modified organisms and products are placed in the summary register.

5. If the international agreements and acts constituting the right of the Eurasian Economic Union and also the international agreements of the Russian Federation establish other procedure for state registration of the modified organisms and products, this procedure with the subsequent inclusion of the corresponding data on products in the summary register is applied.

6. Effective period of state registration of the modified organisms (if such organisms are subject to state registration), is determined by registering body based on the conclusions provided by the subitem "b" of Item 11 of these rules and cannot exceed 10 years.

Effective period of state registration of products shall correspond to effective period of state registration of the modified organism using which the registered products are received or which the specified products contain.

If products contain several modified organisms in the structure, effective period of state registration of products shall correspond to effective period of state registration of the modified organism which the specified products contain, having earlier expiry date.

7. In case of identification by registering body by results of the carried-out impact monitoring per capita and the environment of the modified organisms and products, the confirmed conclusions of examinations (researches), stipulated in Item 11 these rules, negative impact of the modified organism and (or) products on health of the person, animals, plants and (or) the environment state registration is cancelled or changes in part of establishment of special conditions of use of the modified organism or products are entered in the summary register.

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