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Registration of pesticides and agrochemicals in Russia. Requirements to Dossier and Application Procedure.

Registration duration, steps and requirements are defined in the Procedure for State Registration of Pesticides and Toxic Chemicals (Approved by Order of the Ministry of Agriculture of the Russian Federation No. 357 of July 10, 2007)


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The registration process in Russia is complex and lengthy.

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This article describes the main steps for registration of agrochemicals in Russia and the principle of cooperation with our company clients.



Two types of registration exist:


1) Temporary or „experimental”. Issued for 2 years. Requires 1 season of biological efficiency trials and 2 sesons of residue evaluation. From the moment of application the whole process usually takes 2,5-3 years.


2) Permanent registration. Issued for 10 years term. Requires 2 seasons of biological efficiency trials, 2 seasons of residue evaluation and full tox.evaluation of product and AI. From the moment of application the whole process usually takes 3 - 3,5 years

That is not complete list of requirements but difference of those for 2 and 10 years registration.


First year


1. Preparation of Application (data on pesticide), dossier and recommendations.

2. Inclusion into biological efficiency trials plan of the Ministry of Agriculture

(MoA) (3 month before trials start) + residue evalation

3. Communication of trials programme and calendar plan with MoA, RosSeklhozNadzor (All Russia Agricultural Inspection), MSU and Toxicological Institute n.a. Erisman (Erisman Institute) + delivery of samples

4. Higiene of labor trials (Erisman Institute), tox. Assessment of product formulation and active ingridient

5. First year of trials and residue (VIZR)

6. Development of ADI


Second year


1. Second year of biological efficiency trials and residue (VIZR)

2. Eological evaluation (effect on Bees) (MSU)

3. Development and approbation of method of determination of A.I. In product formulation (Grain quality research Center (Ramenskoe))

4. Approval of RosPotrebNadzor (All Russia Consumer Rights Inspection)

5. Collection of all conclusions

6. Ecological expertise (RosPrirodNadzor (All Russia Environmental Inspection)) – maybe canceled

7. Expertise of RosSelkhozNadzor and MoA

8. Registration

The registration process in Russia is complex and lengthy.

We can help you at any stage of registration.



Registration in Russia is rather expensive because many studies must be performed only in the country and only by state certified institutions.


Thus, there are not many alternatives where to make hygiene of labor or biological efficiency trials. Toxicological evaluation is made always by Erisman Institute and they prices are very high.

Cost of the registration depends greatly on crops and pests on the label.

Biological efficiency trials take major part of the expences.


Cost can vary from $90.000 to $300.000 and, in exceptional cases (like new molecule or very wide range of crops and pests) more. Average cost for generic product, herbicide, 1 A.I., 2-3 crops – around $160.000

Any delay in the payment of the registration steps can lead to failure. You can not suspend the registration process, and then continue it, the process will begin with the first stage, including the full payment !

Registration authorities:


• Ministry of Agriculture

• RosPrirodNadzor

• RosPotrebNadzor

Expert Institutions:

• Centre of grain quality

• VIZR, TSHA, etc

• FNCG n.a. Erisman


• And others



The division for authorities and expert institutions is conditional, as many

institutes issue expert conclusion for the registration after performing a study

and make official evaluation of the dossier submitted by an applicant.

Requirements: Application


Data on pesticide must include:

• Phys.-chem. information for A.I. And products

• Data on Biological Efficacy and Safety of product

• Toxicological and Hygienic Characteristics of A.I. and product

• Hygienic analysis of pesticide manufacturing and application

• Ecological Characteristics of Pesticide (both A.I. and product)

• Ecotoxicology


Application or Data on Pesticide or Dossier Summary must be prepared in Russian according to an established format and submitted to the Ministry of Agriculture, Erisman Institute, MSU and at the end RosSelkhozNadzor.


Data on pesticide is being constantly edited in the registration process, new, generated data added. Final version shall be prepared before submission of all documents to RosSelkhozNadzor/ MoA


Requirements: Format and Language


1. Application must be submitted as a hard copy

2. Study reports as a hard copy

3. All documents must be delivered from hands to hands, it is better to

avoid sending by post.

4. All expert conclusions must be collected and delivered to other

institutes (as required by the procedure) by an applicant

5. For every document except toxicological and ecological data from other

countries the language is Russian

6. For toxicological and ecological studies submitted to the Erisman

Institute and MSU English is allowed.

7. No German, French or any other language is accepted

8. Communication with authorities and institutions is possible only in Russian


The registration process in Russia is complex and lengthy.

We can help you at any stage of registration.

Requirements: Studies


Must be made in Russia:


1. Biological efficiency trials

2. Residue

3. ADI

4. Hygiene of labour

5. Approbation of method of

determination of A.I. in product

6. Ecological expertise



Can be made in Russia or imported:


1. 5-batch analysis

2. Reports on acute toxicology of technical product: acute oral, dermal toxicity, irritant effect on skin and eye mucosa, sensibilization, inhalation toxicity

3. Reports on subacute oral toxicity, subacute dermal toxicity, subacute inhalation toxicity

4. Reports on chronic toxicity, carcinogenicity, teratogenicity, mutagenicity

5. And toxicology of product formulation:acute oral, dermal toxicity, irritant

effect on skin and eye mucosa, sensibilization, inhalation toxicity according to GLP In particular many things are decided by Institutes on case by case basis. Negotiation is possible.

Data from the literature may be accepted.

Data ownership and data protection


There are no any special rules or Laws regarding confidentiality of data submitted to the authorities. It is assumed, that this information shall never be disclosed to a third party but there is no defined data protection mechanism. There is no data protection term and no expiration of data protection term is assumed. Thus, data generated for a certain registration is never supposed to become public. Every applicant shall provide same studies again and again even if a product is generic and has 20 analogues registered in the country.


All data, generated in the registration process belongs to the registration holder, even if it is a study on toxicology of active ingredient and the producer of A.I is different from the registration holder.

Answers to frequent questions


The registration process is governed by numerous legal regulations, laws and government institutions. We have prepared a checklist of key documents required for registration of agrochemicals and pesticides in Russia. (This is not a complete list of documents! Depending on the composition and originality of the agrochemical or pesticide, a list of documents can be adjusted of public authorities). In the checklist  identified what data should be generated locally and what may be imported, the language requirements for each of these documents.

Filling out the checklist, you will be able to  data gap analysis and find out if all requirements are covered.


Checklist for registration of agrochemicals in Russia ENG (CLICK)

Checklist for registration of pesticides in Russia ENG (CLICK)

1. There are 3 declared actors in a registration:

1) holder 2)producer of a formulation 3) producer of AI. This information is public.

2. It is possible to declare several of each.

3. It is not possible to sell a registration or to shift from one

company to another

4. Foreign company can be a registration holder

5. It is not possible to change a producer without performing

majority of studies again

6. It is not possible to register a second brand name

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