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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of July 23, 2009 No. 808

Some questions of carrying out approbation (testing) and registration of genetically modified organisms, grades of agricultural plants

(as amended on 09-09-2020)

According to article 7 of the Law of Ukraine "About the state system of biosafety during creation, testing, transportation and use of genetically modified organisms" the Cabinet of Ministers of Ukraine decides:

1. Approve applied:

Procedure for carrying out the state approbation (testing) for genetically modified organisms of grades of Agricultural plants in open system;

Procedure for the state registration of genetically modified organisms of grades of agricultural plants in open system.

2. Declare invalid the resolution of the Cabinet of Ministers of Ukraine of August 17, 1998 No. 1304 "About approval of the Temporary procedure for import, the state testing, registration and use of transgene plant varieties in Ukraine" (The Official Bulletin of Ukraine, 1998, No. 33, the Art. 1243).

 

Prime Minister of Ukraine

Yu. Tymoshenko

Approved by the Resolution of the Cabinet of Ministers of Ukraine of July 23, 2009, No. 808

Procedure for carrying out the state approbation (testing) for genetically modified organisms of grades of agricultural plants in open system

1. This Procedure determines the procedure of carrying out the state approbation (testing) of genetically modified organisms of grades of agricultural plants in open system (further - genetically modified organisms).

2. The state approbation (testing) of genetically modified organisms consists in carrying out their research for the purpose of determination of influence on:

increase in area of wild-plants and contamination in crops of cultural plants by them as a result of not controlled reproduction;

sources of infections which attract emergence of epiphytoties;

producing special specific substances in vegetative and generative organs of plants which stimulate reproduction of wreckers that creates conditions for emergence of epizooty.

3. Object of the state approbation (testing) of genetically modified organisms is specifically certain grade of agricultural plant (its part or seeds) which is considered suitable for reconstruction of complete plants.

4. Subject of regulation is the legal entity or physical person which performs the activities connected with the address with genetically modified organisms and has permission to the carrying out the state approbation (testing) genetically modified organisms in open system issued by the Ministry of the environment in the procedure established by the Cabinet of Ministers of Ukraine.

5. The state approbation (testing) is carried out according to the approved Ministries of Economics in coordination with the Ministry of the environment and MZ to techniques for each type of genetically modified organism in which specifics and difference of genetically modified organisms in comparison with traditional grades, the term of approbation (testing) and condition of its termination and certain mechanism of transfer by the subject of regulation of pilot material to the company, organization or organization which carries out the state approbation (testing) are considered.

6. For carrying out the state approbation (testing) genetically modified organisms the subject of regulation gives Ministry of Economics concerning each genetically modified organism the petition in the form established by the Ministry in which it is noted:

scientific name of genetically modified organism;

botanical taxon;

name of the legal entity or surname, name and middle name of physical person, location of the legal entity or residence of physical person, phone, telefax, e-mail address.

Are applied to the petition:

legal entities - copies of constituent documents (the charter or the foundation agreemtn);

physical persons - passport copies and certificates of identification number;

the technical description on genetically modified organism, constituted in the form approved by Ministry of Economics, and containing exhaustive information on initial grade of plant and genetically modified organism, features of implementation of its monitoring and control;

the summary (the short summary) to the technical description on genetically modified organism;

notarial and attested copy:

import permits on customs area of Ukraine of the unregistered genetically modified organism for the research purposes or the state approbations (testing) issued to MON in the procedure established by the Cabinet of Ministers of Ukraine;

the permission to carrying out the state approbation (testing) of genetically modified organism in open system issued by the Ministry of the environment in the procedure established by the Cabinet of Ministers of Ukraine;

the conclusions on environmental impact assessment and the state sanitary and epidemiologic examination concerning compliance of genetically modified organisms to requirements of biological and genetic safety;

the conclusions of developer of genetically modified organism about its safety for health of the person or the surrounding environment with reference to results of its research.

7. The Ministry of Economics after receipt properly of the drawn-up petition and documents in full makes in a month the decision on the beginning of carrying out by the company, organization or the organization of the state approbation (testing) of genetically modified organism and notifies on it the Ministry of the environment. Conditions, the term of carrying out the state approbation (testing) and the name of the company, organization or organization are noted in permission to carrying out the state approbation (testing) genetically modified organism in open system.

8. The subject of regulation has the right to get acquainted with intermediate results of the state approbation (testing) of genetically modified organisms.

9. The company, organization or the organization which carries out the state approbation (testing) after the end of approbation (testing) prepares in a month the report on its results in the form established by Ministry of Economics and gives it to the Ministry.

The Ministry of Economics based on noted report prepares within 15 days in the form approved by the Ministry the conclusion about the level of safety of use of genetically modified organisms in which information concerning increase in area of wild-plants and contamination by them crops of cultural plants as a result of not controlled reproduction, sources of infections which attract emergence of epiphytoties, producing special specific substances in vegetative and generative organs of plants which stimulate reproduction of wreckers which creates conditions for emergence of epizooty and issues it to the subject of regulation together with the copy of the report is noted.

The Ministry of Economics provides the Ministry of the environment the copy of the conclusion about the level of safety of use of genetically modified organisms and the report on results of the state approbation (testing).

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