ORDER OF THE MINISTER OF AGRICULTURE OF THE REPUBLIC OF KAZAKHSTAN

of January 30, 2015 No. 4-4/61

About approval of Rules of carrying out registration (melkodelyanochny and production) testing and state registration of pesticides

According to the subitem 7) of article 6 of the Law of the Republic of Kazakhstan "About protection of plants", the subitem 1) of article 10 of the Law of the Republic of Kazakhstan "About the state services" and the subitem 4) of Item 1 of article 12 of the Law of the Republic of Kazakhstan "About permissions and notifications" I ORDER:

1. Approve the enclosed Rules of carrying out registration (melkodelyanochny and production) testing and state registration of pesticides.

2. To provide to department of production and conversion of crop products and phytosanitary safety of the Ministry of Agriculture of the Republic of Kazakhstan in the procedure established by the legislation:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction it the copy on official publication in periodic printing editions and in information system of law of Ad_let;

3) placement of this order on Internet resource of the Ministry of Agriculture of the Republic of Kazakhstan.

3. To impose control of execution of this order on the supervising Vice-Minister of Agriculture of the Republic of Kazakhstan.

4. This order becomes effective after twenty one days after day of its official publication.

Approved by the Order of the Minister of Agriculture of the Republic of Kazakhstan of January 30, 2015 No. 4-4/614

Rules of carrying out registration (melkodelyanochny and production) testing and state registration of pesticides

Chapter 1. General provisions

1. These rules of carrying out registration (melkodelyanochny and production) testing and state registration of pesticides (further - Rules) are developed according to the subitem 7) of article 6 of the Law of the Republic of Kazakhstan "About protection of plants" (further - the Law), the subitem 4) of Item 1 of article 12 of the Law of the Republic of Kazakhstan "About permissions and notifications" (further - the Law on permissions and notifications) and the subitem 1) of article 10 of the Law of the Republic of Kazakhstan "About the state services" (further - the Law on the state services) and determine procedure for carrying out registration (melkodelyanochny and production) testing and state registration of pesticides.

2. In these rules the following basic concepts are used:

1) active ingredient - biologically active part of pesticide which use in the form of different preparative forms leads to toxic impact on harmful organism, especially dangerous harmful organism, quarantine object, alien type or on growth and development of plants;

2) the vegetative period (vegetation season) - the period from crops before maturing of specific crop;

3) the commonly accepted name - the name appropriated to active ingredient of pesticide by International Organization for Standardization or accepted by authorized body in the field of technical regulation and metrology for the use as patrimonial (group) or private (only for specific active ingredient) names;

4) re-registration - the repeated state registration of pesticide after effective period of the registration certificate on pesticide which is carried out without additional testing;

5) the combined pesticide - the medicine containing two and more active ingredients in structure;

6) No. 232 is excluded according to the Order of the Minister of Agriculture of the Republic of Kazakhstan of 15.06.2023

7) the organization contractor – the research and research and production organizations which are performing assessment of biological, economic efficiency of pesticides, having necessary for this purpose scientific and methodical and material logistics, specialists of the corresponding profile and qualification, accreditation according to the order of the Minister of science and the higher education of the Republic of Kazakhstan of July 25, 2023 No. 335 "About approval of rules of accreditation of subjects of scientific and (or) scientific and technical activities" (it is registered in the Register of state registration of regulatory legal acts No. 33182), and also laboratories of the organizations performing the toxicological assessment, development, adaptation and approbation of methods of the analysis of pesticides, studying of their residual quantities having accreditation according to the Law of the Republic of Kazakhstan "About accreditation in the field of assessment of conformity";

8) the distinctive (trade) name of pesticide - the name under which - passes this pesticide registration (melkodelyanochny and production) tests, is registered, labeled, advertized and used only by his registrant (applicant) with the purpose to make product distinguished from other pesticides;

9) the short file on pesticide - data on biological, physical and chemical and toxicological properties of pesticide;

10) regulations of use of pesticides - the requirements to conditions and procedure for use of pesticides containing information on consumption rate of pesticide, culture, the processed object, harmful organism, especially dangerous harmful organism, quarantine object, method, processing time, restriction, consumption of working liquid, term of the last processing, the maximum frequency rate of processings with pesticide;

11) registration (melkodelyanochny and production) testing of pesticides - the procedure of confirmation of efficiency and safety of use of pesticides performed on melkodelyanochny experiences and under production conditions, including biological, economic, toxicological, hygienic and ecological estimates of pesticides according to these rules;

12) toxicological assessment of pesticides - assessment of the tested pesticides on safety indicators (residual quantity in harvest, objects of the environment and their compliance to the approved standard rates);

13) residual amount of pesticides - quantitative index of content of pesticides in crop products and objects of the environment by means of which their safety for the person and animals is estimated;

14) amendments to the list of pesticides - the list of the pesticides which are in addition registered annually and included in the List of the pesticides permitted to production (formulyation), import, storage, transportation, realization and application in the territory of the Republic of Kazakhstan;

15) consumption rate of pesticides - the weight or amount of pesticide per unit of the processed area (kilogram or liter on hectare/ton / square meter);

16) danger of pesticide - probability of adverse effect per capita and the environment;

17) biological efficiency of use of pesticide - the result of use of pesticide expressed by indicators of death or decrease in number of harmful organisms of especially dangerous harmful organisms, quarantine objects, alien types or damage rates of the plants protected by it;

18) preparative form of pesticide - form of use of pesticide depending on its physical and chemical properties, toxicity, appointment and method of use (emulsion concentrate, suspension concentrate, granules, paste, the microencapsulated suspension, the moistened powder and (or) other forms);

19) pesticide prototype - the sample of the unregistered pesticide intended for registration and production testing, and also scientific research in the quantity sufficient for their carrying out;

20) the registration certificate on pesticide - the document resolving import, production (formulyation), storage, transportation, realization and use of pesticide in the territory of the Republic of Kazakhstan;

21) the list of pesticides - the list of the registered pesticides permitted to production (formulyation), import, storage, transportation, realization and application in the territory of the Republic of Kazakhstan;

22) the registration file on pesticide - set of the documents submitted on registration of pesticide and containing the confidential data confirming their efficiency, safety and quality;

23) economic efficiency of use of pesticide - the result of use of pesticide in field conditions expressed by indicators of quantity and quality of the kept agricultural products;

24) the analytical standard - chemically net sample of active ingredient of pesticide;

25) risk - degree of probable danger of pesticide in specific conditions of its application;

26) biological medicine with low risk - medicine, low-toxic for warm-blooded and bees, belonging to the III-IV class of biological danger in which the operating beginning is the microorganism or product of its life activity (microorganisms, bacteria, mushrooms, viruses and so on);

27) the registrant (applicant) - the physical person or legal entity which submitted the application for carrying out registration (melkodelyanochny and production) testing of pesticides, and also state registration of pesticides for receipt of the registration certificate;

28) registration process - procedure for carrying out registration (melkodelyanochny and production) testing and state registration of pesticides;

29) reference pesticide - the registered pesticide similar to the tested pesticide on phytosanitary appointment and chemical group.

3. Registration process includes:

1) order taking for carrying out registration (melkodelyanochny and production) testing and state registration of pesticides;

2) organization of carrying out registration (melkodelyanochny and production) testing and toxicological assessment of residual amounts of pesticides;

3) carrying out registration (melkodelyanochny and production) testing and toxicological assessment of residual amounts of pesticides organizations contractors;

4) consideration of reports on results registration (melkodelyanochny and production) testing and toxicological assessment of residual amounts of pesticides;

5) consideration of the registration file of the registrant (applicant);

6) approval of state registration of pesticides of authorized body in the field of environmental protection and state body in the field of sanitary and epidemiologic wellbeing of the population (further - authorized state bodies);

7) state registration of pesticide;

8) issue of the registration certificate on pesticide;

9) entering of pesticide into register of state registration of pesticides in form according to appendix 1 to these rules, in the list of pesticides and amendment to the list of pesticides.

3-1. The list of the main requirements to rendering the state service "State Registration (Re-registration) of Pesticides, Temporary Registration of Pesticide of Biological Medicine with Low Risk" is stated in annex 1-1 to these rules (further – the List of the main requirements).

3-2. To the registrant (applicant) on the web portal of "the electronic government" (further – the portal) information on the status of consideration of request for rendering the state service, and also the notification with indication of date and time of receipt of result of the state service goes to "personal account".

3-3. The employee of office of department of authorized body in the field of protection of plants (further – Department) performs acceptance and document registration in day of their receipt and sends to the head of the structural unit of Department which appoints the executive in charge.

In case of the address of the registrant (applicant) after the termination of working hours, in days off and holidays according to the labor law of the Republic of Kazakhstan, documents acceptance and issue of result of rendering the state service are performed the next working afternoon.

The executive in charge of structural division of Department within 2 (two) working days from the moment of document registration checks completeness of the submitted documents.

In case of representation by the registrant (applicant) of incomplete document package according to the List of the main requirements and (or) documents with the expired effective period, Department refuses documents acceptance.

3-4. The result of rendering the state service goes through the portal to "personal account" of the registrant (applicant) in electronic form certified by the digital signature (further – the EDS) the head of Department, or person fulfilling its duties.

3-5. In case of identification of the bases for refusal in rendering the state service, stipulated in Item 9 Lists of the main requirements, the executive in charge notifies the registrant (applicant) on the provisional solution about refusal in rendering the state service, and also time and the place (method) of carrying out hearing for opportunity to express to the registrant (applicant) line item according to the provisional solution.

The notification on hearing goes at least in 3 (three) working days prior to completion of term of rendering the state service. Hearing is carried out no later than 2 (two) working days from the date of the notification.

By results of hearing Department makes the decision on issue of the registration certificate on pesticides/notifications on adoption of the request for inclusion in the plan of carrying out melkodelyanochny testing / notifications on adoption of the request for inclusion in the plan of carrying out production testing or motivated refusal in rendering the state service.

4. The organization of carrying out registration (melkodelyanochny and production) testing, toxicological assessment of residual amounts of pesticides and state registration of pesticides is carried out by Department according to the subitem 17) of article 6 of the Law.

5. The list of the organizations contractors is created by Department based on letters requests from the organizations contractors given annually to Department till February 1 of the current year.

Chapter 2. Procedure for carrying out registration (melkodelyanochny) testing of pesticides

6. Registration (melkodelyanochny) testing of pesticides (further - melkodelyanochny testing) are carried out in field conditions on melkodelyanochny experiences for the purpose of development of regulations of use of the pesticides ensuring their biological and economic efficiency and safety for human health and the surrounding environment.

7. The request for carrying out melkodelyanochny testing of pesticide in form according to appendix 2 to these rules, with application of documents, the main requirements specified in Item 8 of the List, moves in Department the registrant (applicant) electronically by means of the portal from December 10 of previous year to February 1 of the current year.

The application for carrying out melkodelyanochny testing of pesticide on the basis of biological substance (v) is submitted together with the request for carrying out production testing of pesticide on the basis of biological substance (v).

The request for carrying out melkodelyanochny testing of pesticide is filled in on each pesticide separately. The name of pesticide shall differ from the names registered in accordance with the established procedure pesticides. The name of pesticide shall not consist of one figures, mislead concerning properties and origin of pesticide.

8. By provision by the registrant (applicant) of complete document package according to the List of the main requirements, Department considers documents for carrying out melkodelyanochny testing and accepts one of decisions:

1) about issue of the notification on adoption of the request for inclusion in the plan of carrying out melkodelyanochny testing in form according to appendix 2-1 to these rules;

2) about issue of motivated refusal in rendering the state service in form according to appendix 14-1 to these rules.

9. For carrying out melkodelyanochny testing of pesticides the registrant (applicant) provides to the organizations contractors:

1) pesticide prototype in original packing with the certificate of conformity or the certificate of the analysis;

2) reference pesticide in original packing with the certificate of conformity or the certificate of the analysis, except as specified, the these rules specified in Item 9-1;

3) analytical standard of active ingredient;

4) analytical standards of metabolites for carrying out laboratory researches.

9-1. In the absence of the reference pesticide registered in the Republic of Kazakhstan with the consent of Department use of reference pesticide of the similar appointment registered in state members of the Eurasian Economic Union, in the following priority is allowed:

1) the pesticide matching on active ingredient, its content in formulyation, to preparative form, range of cultures and harmful organisms, especially dangerous harmful organisms, quarantine objects and alien types;

2) the pesticide which is matching on active ingredient, its content in formulyation, to range of cultures and harmful organisms, especially dangerous harmful organisms, quarantine objects and alien types, but not matching in preparative form;

3) the pesticide which is matching on active ingredient, preparative form, range of cultures and harmful organisms, especially dangerous harmful organisms, quarantine objects and alien types, but not matching on content of active ingredient in medicine;

4) in the absence of the pesticides specified in subitems 1), 2) and 3) of this Item as standard pesticide gets out of the chemical group of the same name with the tested pesticide, different or coincident in preparative form and matching on range of cultures and harmful organisms, especially dangerous harmful organisms, quarantine objects and alien types;

5) in the absence of the pesticides specified in subitems 1), 2), 3) and 4) of this Item as standard pesticide gets out of other chemical group, different or coincident in preparative form and matching on range of cultures and harmful organisms, especially dangerous harmful organisms, quarantine objects and alien types.

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