PPA Registration in Russia

The closed and non-public market in Russia is the outcome of the closed and non-public nature of the Russian Ministry of Agriculture, which oversees it.

In 2022, the list of registered pesticides in the Russian Federation, including the regulations for their use, is discreetly published on the ministry's website, mcx.ru, but only in an unreadable and unprocessed word file format.

Even the author, a Russian-speaking specialist, finds it difficult to read the file, never mind foreigners who might try to understand the situation.

Whoever has experienced the challenge of obtaining an import license will understands that the procedure for issuing a positive conclusion is unpredictable and is dependent on two bureaucrats, one who checks the documents and another who signs it. The process can last from a few weeks to several months. A difference in approach can be clearly seen in the subsequent license registration application process of the Ministry of Industry and Trade, which provides result electronically exactly after 21 days.

Despite the fact that Russia aims to have an e-government by the 22nd century, the Ministry of Agriculture is stuck in the 90s and served the interests of a limited number of people, by protecting and adding barriers to stifle competition in the domestic pesticide market.

The process for registering formulations is closed and unpredictable, and there is a constant battle between the bureaucratic offices of relevant individuals and institutions wishing to control the process. Since the early 2000s, the cost of registration in Russia rose from $50,000 to $300,000 for new multi-component formulations, and trends to reduce barriers to market entry are still unclear.

According to information from the Federal Registration Chamber of Chemical and Biological Agents united by the Russian Chamber of Commerce and Industry announced at the annual international conference, Pesticides 2022, organized by CREON, the following problems were discovered during registration trials of plant protection products:

- A lack of transparent interactions between state authorities involved in the assessment process.

- A high level of corruption during trials and assessments.

- A lack of proper control over trials and assessments of pesticides.

- A high number of falsified assessments that led to the registrations of pesticides and agrochemicals.

- A lack of monitoring by law enforcement of some federal laws that regulate trials and expertise in registering pesticides and agrochemicals.

- Businesses do not take part in presenting proposals in terms of amendments to federal laws to improve control mechanism of research and expertise.

Over the past 10 years in Russia, a temporary registration procedure for pesticides and agrochemicals has been implemented, and according to information obtained by the author, it is still in force, which is unusual.

Let us take a look at an overall picture, or algorithm, of registration activities in Russia, from the example of a single-component formulation product based on the information obtained from the commercial proposals of companies involved in registration formalities.

CLAUSE 1

Application for the planned registration of a pesticide at the MINISTRY OF AGRICULTURE

CLAUSE 2

The research program approved by the MINISTRY OF AGRICULTURE is being conducted by:

• Russian State Agrarian University - Moscow Timiryazev Agricultural Academy (TSHA) and/or the All-Russian Institute of Plant Protection (VIZR).

1. Researching biological efficiency → report;
   

2. Studying residual quantities → report;

3. expert opinion

• Lomonosov Moscow State University (MGU):

1. Ecological conclusion about the impact of pesticide on the environment.
   

• FEDERAL BUDGETARY SCIENTIFIC INSTITUTION "FEDERAL RESEARCH CENTER FOR HYGIENE. F.F. ERISMAN FEDERAL SERVICE FOR SUPERVISION OF CONSUMER RIGHTS PROTECTION AND HUMAN WELFARE (FNTsG) :

1. Assessment of equivalence of active ingredient (s) (certificate, analysis of five batches) → conclusion about equivalence.

2. Hygiene assessment of working conditions → report; reasons for terms of entry into the mechanized process.

3. Report on the most admissible level of pesticides on each culture (basis on the report on remaining balance from TSHA) (becomes in the absence of the standard rate).

4. Report on admissible daily dose (ADD) of medicines affecting a human body, based of the report on remaining levels.

5. Report on toxicity and danger of medicine (including inhalation effect also prepares).

6. Report on maximum allowable concentration in water.

7. Report on the subchronicle.

8. Report on a mutagenicity.

RESULT OF CLAUSE 2:

• Expert opinion of FNTsG
  

• The letter to Rospotrebnadzor – the conclusion about confirmation

CLAUSE 3

State environmental assessment

Copies of the file with conclusions on biology, toxicity and remains, as well as data on medicines, tare labels, material safety data sheets, and recommendations for the application.

RESULT OF CLAUSE 3:

• Conclusion of the environmental assessment by the Ministry of Agriculture.

FINAL RESULT:

Certificate on the state registration of a pesticide.

Summary of the process

1. Submission of registration documents and a testing plan to be performed from November to February. The document pack must contain data on the pesticide, including its name, producers of active ingredients and a preparative form, relevant regulations about the physical and chemical properties of active ingredient(s) of the pesticide, the composition of the pesticide, and toxicological data.

2. Testing programs are organized by institutes based on the general program approved by the Ministry of Agriculture, in which the quantity of the samples necessary for carrying out tests must be provided. Based on this general program, if necessary, the the import license must be delivered on the territory of the Russian Federation continuing pesticide registration samples in the necessary quantity.

3. Documents, most notably data on the pesticide, as well as recommendations for the application, the draft of the tare label, the material safety data sheet must be prepared for transfer to relevant institutes.

FNTsG must still provide the documents below:

The quality certificate for active ingredients with data on the purity of a technical product and what impurities are present and in what quantities, as well as an analysis report for five batches, i.e. these indicators.

All available information for the registrant concerning the toxicity of active ingredients (acute toxicity, the remote effects, determination methods, etc.).

Approval letters from producers regarding the preparative form resolving registration of the pesticide.

Indian and Chinese producers must provide a pesticide production license.

To the TSHA or VIZR, except documents on the analytical sample of each for century and the necessary quantities of samples of the applied pesticide must be provided.

Contracts with each institutes can be signed both in rubles or in the currency of the applicant, but not all organizations have a currency account.

After completing all required research, each institute must seek expert opinion.

The expert opinion of FNTsG must also be sent to Rospotrebnadzor, which arranges a letter of federal legacy.

4. A state-level environmental assessment is carried out by Rosprirodnadzor of the Russian Federation. An application for carrying out GEE must be done after the start of registration, but the conclusion is made based on the conclusions of all relevant institutes. GEE, the final document in a series of registration reports.

5. In the presence of all documents, the pesticide file is created by the Ministry of Agriculture. The ministry writes and makes the final conclusion based on the results of registration testing and the regulations for using medicine vises, as well as the arranged state certificate of pesticide registration. At the same time, the Ministry of Agriculture provides the numbers for tare labels.

LIST OF COSTS