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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of March 3, 2020 No. 210

About approval of the Regulations on the state registration of feed additives

(as amended of the Resolution of the Cabinet of Ministers of Ukraine of 01.07.2022 No. 749)

According to part three of Article 17 and part of the twenty first article 18 of the Law of Ukraine "About safety and hygiene of forages" the Cabinet of Ministers of Ukraine decides:

1. Approve Regulations on the state registration of feed additives which are applied.

2. Declare invalid the paragraph third the deciding part of the resolution of the Cabinet of Ministers of Ukraine of November 21, 2007 No. 1349 (The Official Bulletin of Ukraine, 2007, No. 89, the Art. 3273).

Prime Minister of Ukraine

A. Goncharuk

Approved by the Resolution of the Cabinet of Ministers of Ukraine of March 3, 2020 No. 210

Regulations on the state registration of feed additives

General questions

1. This Provision determines procedure for the state registration of feed additive, preparation and form of the expert opinion (express conclusion) with the recommendation about such registration or its refusal, the simplified procedure for the state registration, re-registration of feed additives, form and procedure for maintaining the State register of feed additives, limiting amounts of import (transfer) of the feed additives which are not included in the State register of feed additives.

2. In this Provision terms are used in such value:

maintaining the State register of feed additives - complex of the actions performed by Gosprodpotrebsluzhboy and directed to creation of the electronic database which contains data on feed additives, and also development of the software for its maintaining, providing access to this information and administrations of such database;

The state register of feed additives (further - the Register) - the electronic database which contains data on the registered feed additives.

Other terms are used in the value given in the Law of Ukraine "About safety and hygiene of forages" (further - the Law).

3. The state registration of feed additives and maintaining the Register are performed by Gosprodpotrebsluzhba in electronic form.

State registration of feed additives

4. For implementation of the state registration of feed additives the operator of the market (further - the applicant) or person authorized by it is given:

in referens-laboratory three samples of feed additive;

in National institution on veterinary medicines and feed additives (further - National institution) the statement in form according to appendix 1 and other documents determined by part three of article 18 of the Law.

5. The national institution carries out scientific assessment (examination) of feed additive during the term which is not exceeding 180 days from the date of receipt of the statement and other documents.

The Referens-laboratory conducts necessary researches (testing) and submits to National institution the report in time which is not exceeding 90 days from the date of receipt of the statement.

6. After receipt of the report of referens-laboratory the National institution carries out scientific assessment (examination) of feed additive and prepares the corresponding expert opinion according to Items 11 - the 14th this provision.

7. Services in scientific assessment (examination) of feed additive and service of referens-laboratory are paid and are provided to the applicant on a contract basis. The amount of payment for providing such services is determined on the basis of method of calculation of cost of services in scientific assessment (examination) of feed additives and services of the referens-laboratory approved by Minagropolitiki.

8. The decision on the state registration of feed additive is made by Gosprodpotrebsluzhboy based on the corresponding expert opinion of National institution in the terms determined by the Law.

9. Date of the state registration of feed additive day of acceptance is considered Gosprodpotrebsluzhboy of the decision on the state registration of feed additive.

10. Within five working days after acceptance Gosprodpotrebsluzhboy of the decision on the state registration of feed additive information on such feed additive is entered in the Register in form according to appendix 2.

Preparation of the expert opinion (express conclusion) with the recommendation of the state registration of feed additive or refusal in such registration

11. During the term provided for carrying out scientific assessment (examination), the National institution prepares for Gosprodpotrebsluzhbe the expert opinion (express conclusion) with the recommendation of the state registration of the corresponding feed additive or refusal in such registration.

12. For preparation of the expert opinion (express conclusion) the National institution checks compliance of the documents provided by the applicant to article 18 of the Law and compliance of feed additives to requirements of article 17 of the Law, the report of referens-laboratory.

13. In case of implementation of registration of zootechnical feed additives, koktsidiostatik and gistomonostatik, and also feed additives which contain consist or are made with use of genetically modified organisms, in the expert opinion (express conclusion) of National institution the offer on recognition of the applicant by the operator of the market who has exclusive right to introduce the corresponding feed additive into circulation shall be specified (with indication of its name and the location).

14. The expert opinion (express conclusion) with the recommendation of the state registration of feed additive of National institution is constituted in form according to appendix 3, and in case of refusal in such registration - in form according to appendix 4.

The simplified procedure for the state registration

15. The state registration of feed additives on the simplified procedure is performed according to general requirements to the state registration of feed additives taking into account the features determined by article 19 of the Law.

16. The decision on recognition of requirements of foreign state or the international organizations (integration associations of the states) equivalent to the requirements for the state registration of feed additives established by the legislation of Ukraine on sterns accepts Minagropolitiki.

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