Resolution No. 839 of September 23, 2013
The Ministry of Education and Science has elaborated this draft resolution to implement provisions of Article 7 of the Federal Law on State Regulation of Genetic Engineering (hereinafter referred to as the Federal Law). In accordance with the amendments made to this Federal Law by Federal Law No. 262-FZ of October 4, 2010, genetically modified organisms (hereinafter referred to as GMO) designed for release into the environment, and the products obtained or containing such organisms (hereinafter referred to as GMO-containing products), shall be subject to state registration according to the procedure established by the Government.
State registration of GMO and GMO-containing products is an indispensable element of security with a view to ensuring the wellbeing of the population in conditions where new, unconventional technology and live organisms are being produced by genetic engineering.
The signed resolution shall endorse the Rules for the State Registration of GMO and GMO-containing Products (hereinafter referred to as the Rules) under which this registration is carried out by:
The Ministry of Healthcare regarding GMO and GMO-containing products used to produce pharmaceuticals for medical purposes;
Roszdravnadzor (the Federal Service for Supervision of Healthсare and Social Development) regarding GMO or GMO-containing products used to manufacture medical goods;
Rospotrebnadzor (the Federal Service for Supervision of Consumer Protection and Welfare) regarding GMO or GMO-containing products used to make food staples and products;
Rosselkhoznadzor (the Federal Service for Veterinary and Phytosanitary Supervision) regarding GMO plants and animals designed for growing and breeding on the territory of the Russian Federation; agricultural GMO micro-organisms; GMO and GMO-containing products used to produce fodder and feed supplements for animals and medicines for veterinary purposes.
In accordance with the Rules, the registering authorities issue certificates on the state registration of GMO and GMO-containing products on the basis of an application from a legal entity and enclosed results of examination (studies). The expiration date is not established.
Under the Rules, GMO used to conduct examination or R&D in line with the established sanitary norms and procedures are not subject to state registration. The same applies to the products obtained by the combination or processing of GMO-containing registered products if these processes do not change the genetic material of these products.
To regulate this information, the Ministry of Healthcare is instructed to keep a combined state registry of GMO and GMO-containing products.
The resolution will enter into effect on July 1, 2014, with the exception of items providing for the elaboration of legal acts by executive authorities.
The resolution will make it possible to fulfill the norms of the Federal Law and create an effective mechanism for state regulation of genetic engineering, as well as to provide for transparent procedures of state registration of GMO and GMO-containing products, for assessment of their safety and for monitoring of their use.
Implementation of the resolution will not require additional allocations from the federal budget.
