Russia: Revised rules for GMO registration

As of 1 September 2023, revised rules for the registration of GMOs and GMO-containing products start to apply.

The Rules apply to GMOs intended for releasing into the environment and to products made with the use of GMOs or containing GMOs.

The revised version provides that the following products are not subject to the state registration in Russia:

-          modified organisms used in expert assessments and research work in accordance with established sanitary rules and regulations;

-          genetically modified organisms not intended for release into the environment;

-          medicinal products for medical use obtained with the use of modified organisms or containing such organisms;

-          medical devices obtained with the use of modified organisms or containing such organisms; and

-          products obtained by combination, processing or processing of registered products containing modified organisms, if such processing and processing does not lead to a change in the genetic material of the product.

All GMOs are subject to state registration in Russia.

There is a GMO register that is to be maintained by the Ministry of Healthcare of the Russian Federation.

GMOs must be registered taking into consideration their intended use. There are following intended uses that are possible:

a) production of food raw materials and food products;

b) production of feed and feed additives;

c) production of medicinal products for veterinary use;

d) breeding and (or) cultivation on the territory of the Russian Federation of modified animals and plants, as well as modified microorganisms for agricultural purposes.

Registration of GMO-containing products must take place after the GMOs contained in these products have been registered.

Law:  Decree of the Government of the Russian Federation of January 18, 2023 N 35 "On the procedure for state registration of genetically modified organisms intended for release into the environment, as well as products made with the use of such organisms or containing such organisms, including products imported into the territory of the Russian Federation"

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