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Welcome to GPC Eurasia - Regulation

The Ministry of Agriculture of the Russian Federation No. 357 approves the registration process of agrochemicals in Russia. The Federal Law based on the “Production and consumption waste”, in compliance with Article 14 every legal entity and individual entrepreneurs who are involved in the generation of waste of I-IV danger class in the business are obligated to confirm the assignment of waste to a particular class of hazard class it belongs to the process that has established executive authority performing state regulation in the field of environmental protection. The information on origin, characteristic, composition of waste and specific conditions of waste disposal technologies, facilities, use, disposal and the classification of waste materials to a particular class of danger to the environment needs to be provided by the manufacturer to the respective body.   

The agrochemicals used in Russia for the protection of crop and yield improvement, the process of registration in quite long process with complexity.   

The law of Russian Federation “About safe handling of pesticides and agrochemicals” governs the regulation of agrochemicals that regulates the registration process and approval.   

The Federal Law based on " Production and Consumption Waste" and "On approval of the Federal Waste Classifier ", belonging to the order of the MNR of Russia No.786 differentiates waste based on its origin, physical state, aggregative, hazardous properties and environmental hazard class (Article 4.1). The Federal Phytosanitary and veterinary surveillance service which is also known as Rosselkhoznadzor belonging to the MOA of the Russian Federation takes part in monitoring phytosanitary and veterinary conditions in Russia and enforce legal requirements and action for the same. The Federal agency for the technical metrology and regulation belonging to Ministry of industry and trade helps in the management of processing, assessing and servicing for the determination of products to national certification criteria and standards. 

 

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The chemical substances that are sold in the market must be registered in the Russian Federation. The requirement of the registration is mandatory for the main legal act in the field of environmental protection that is “On Protection of the Environment” (10.01.2002, No. 7 –FZ), Federal Act of the Russian Federation. Basically, there are two types of registration that are,   

Temporary registration that is valid for 2 or 5-3 years and includes biological efficiency trials and process of the application. The second type of registration is the permanent registration that is issued for 10 years.   

The registration cost depends on the type of pests and crops on the label. The general cost varies around $90.000- $300.000, however in some exceptional it goes to $160, 0000 if there is a new molecule. The delay in paying the amount results in repeating the complete process along with the payment.   

During the process of registration, the indication of manufacturer is important. The producer or manufacturer for the registration process needs provide the data. In some case where the applicant and the manufacturer are a different person then it is necessary that the applicant has a contract with the manufacturer of the pesticide/agrochemical preparation he/she wishes to register.   

The general obligations for the products to contain in their label are it should have the name of the product, manufacturer data, net volume or weight, Composition, GMO related information, storage conditions, use-by-date or expiry date, production and packaging date, limitations to the use and Eurasian Conformity mark (EAC).  

For the transportation of waste belonging to classes I-IV the safety requirements refer to labelling requirements. The sae storage, use, transportation, disposal, testing and recycling of agrochemicals requires hygienic conditions with set of sanitary rules and regulation by the approval of State sanitary and epidemiological service of the Russian Federation.  

The Federal Law based on " Production and Consumption Waste" and "On approval of the Federal Waste Classifier ", belonging to the order of the MNR of Russia No.786 differentiates waste based on its origin, physical state, aggregative, hazardous properties and environmental hazard class (Article 4.1).  

The classification of waste depends on the level of negative impact on the environment established by the Federal Executive Authority that is responsible for the safe regulation for environment protection (ROSTEHNADZOR). The criteria for the classification of hazardous waste and regulations are developed by the Russian federation Natural resources and Ministry of Environment that approves for completing some documentation that includes methodology for drafting waste generation standards, FWC and waste disposal limits. The registration of waste generation, handling, and recycling in the housing system and for updating the relevant section of the state waste inventory was approved by the State construction and Committee for housing for the generation of waste coming out of rural and urban infrastructure.   

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post submission support and technical liaison with authorities. 

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Eurasian Economic Union members; Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia created a common Technical regulation 041/2017 "On chemical product safety" (inofficially called Eurasia REACH).

This technical regulation introduces new requirements to chemical products handled in the territory of the Eurasian Economic Union, as well as rules for conformity assessment, identification, notification, classification, marking and labeling. 

The second tier/part of the regulation, containing clarifications and dates for pre-registration and registration was expected to be adopted in 2018, but was postponed to March 2021.

Eurasia REACH is expected to enter into force on June 2, 2021.

From this dates importers and manufacturers of chemical products are to comply with the provisions of Eurasia REACH.

The compliance assessment with the requirements of the TR 041 is carried out in one of the following ways:

Notification registration 

  • For substances that are listed (e.g. notified) in the Eurasian chemical inventory:
    • that do not do not contain prohibited and (or) restricted to use chemicals and mixtures.
    • that contain restricted to use chemicals and mixtures in concentrations below the established limit, according to Appendix N 4.

Document requirements:

  • Application form (in accordance with Appendix 5);
  • SDS  in accordance with paragraphs 36-43 of TR 041/2017;
  • Protocols of studies (tests) carried out in test  laboratories, and (or) documents containing information obtained from official information sources. NOTE: Research protocols are not required if the chemical product is already listed in the register of chemicals and mixtures of the Union.

The registration certificate is provided online and has no expiration date.

Permissive registration 

  • For substances that are NOT listed in the Eurasian register of chemical substances and mixtures.
  • New chemical products
  • Chemical products that contain chemicals and mixtures (included in the register of chemical products) limited to use on the territory of the Union, in concentrations, exceeding the limits established in Appendix 4.

 

  • Document requirements:
    • Application form (in accordance with Appendix 5);
    • SDS  in accordance with paragraphs 36-43 of TR 041/2017;
    • Protocols of studies (tests) carried out in test  laboratories, and (or) documents containing information obtained from official information sources. NOTE: Research protocols are not required if the chemical product is already listed in the register of chemicals and mixtures of the Union.
    • Information required in paragraph 48;
      • a) chemical safety report in accordance with the structure in accordance with Appendix N 3;
      • b) the name of the chemical according to the IUPAC nomenclature, including in English;
      • c) the structural formula of a chemical substance;
      • d) CAS number;
      • d) data of instrumental analysis of a chemical substance;
      • e) the degree of purity of the chemical;
      • g) the intended uses of the chemical;
      • h) proposed methods of disposal (processing) of a chemical substance;
      • i) a method of transporting a chemical substance and measures to prevent and eliminate emergencies;
      • j) analytical methods of control;
      • k) physicochemical data of a chemical substance;
      • l) toxicity data for the chemical;
      • m) data on the ecotoxicity of the chemical;
      • n) copies of data (protocols) of studies (tests) of a chemical substance for the determination of bioaccumulation, carcinogenicity, mutagenicity, toxicity, carried out in laboratories (centers), recognized by the authorized body in accordance with the principles of good laboratory practice in accordance with the legislation of the Member State ( research (testing) in other laboratories (centers) within 2 years from the date of entry into force of this technical regulation).

NOTE: The permissive registration is valid for 5 years ( If the product complies with the TR 041 and the resposible institution has no remarks, the permission is automatically prolonged after 5 years) 

1. Chemical products intended for scientific research work.

2. Minerals in a state of occurrence, as well as the following products, if they have not been chemically modified: minerals, ores, ore concentrates, cement clinker, natural gas, liquefied gas, gas condensate, process gas and its components, dehydrated, desalted and stabilized oil, associated petroleum gas, coal, coke.

3. Medicines and veterinary medicines.

4. Perfume and cosmetic products.

5. Chemical products that are a source of ionizing radiation (including waste from such products), in terms of classification, labelling and communication of the dangers caused by the presence of radiation in it.

6. Food products, including biologically active food additives and nutritional supplements, as well as ready-made feed for animals.

7. Products included in manufactured articles that, being in circulation in the territory of the Russian Federation, do not change their chemical composition and aggregate state, are not susceptible to destruction and oxidation processes, do not generate dust, vapour or aerosols containing hazardous chemical substances having a harmful effect on human life and health, life and health of animals and plants, environment or property.  

8. Wastes from the production and consumption of chemical products, if they are subject to utilization (processing).

9. Chemical products subject under transit through the customs territory of the Eurasian Economic Union.

 

Request for Quote

A common Eurasian inventory for chemical substances and mixtures is expected to be formed as a part of the decision taken by the Eurasian Economic Union Comission (EAEU Comission) on the formation of the TR 041. 

There are two major steps that are outlined in the EAEU Comissions decision; 

1) Before 1st december 2018, the EAEU Comission and the member countries are expected to establish the order of formation of Eurasian inventory and the order of notiffication of new chemical substances.

  • This step has not been fully fullfiled due to disagreements between the Union's member countries.

2)  All member countries of the Union are expected to form their national parts of  the inventory before 1st March 2021.

However, due to disagreements, only Russia has opened up for national inventory notification so far. For more information on the Russian inventory please see "The Russian inventory".

The dealine for nominations to the Russian inventory is 1st August 2020.

The Russian inventory of chemicals and mixtures has been established as a first step in the formation of a common Eurasian inventory (thus the Russian inventory is a part of the Eurasian Inventory!)

The main aim of the inventory is to aquire information about chemical products and mixtures that are currently in circulation on the Russian market.

The Russian inventory is currently open for nominations and the last date for the inventory nominations is 1st of August 2020,

  • Nomination requires minimum information about chemical substances/mixtures.
  • The nomination is free of charge.
  • The inventory nomination is a volontary process - there is no requirement for every manufacturer/importer to nominate it's sustances.However, companies are very much encouraged to submit the substances to the inventory.
  • When a chemical substance is nominated, it is listed as "existing" on the Russian market. When TR EAEU 041/2017 will enter into force, all other chemicals not presented in the inventory list will be considered “new” and therefore will fall under the notification procedure.

 

Please note! 

  • Chemicals that are subject to another technical regulation are nominated voluntarily                                                                                       
  • Information about polymers is submitted per monomer and all its additives in concentration more than 0.1% per mass.                                                         
  • Information on substances with a complex and variable composition (which cannot be identified based on molecular and structural formulas) is presented for the chemical substance as a whole.​

Excemptions:

Substances in pesticide formulations

Substances listed in Appendix 1: 

  1. Chemical products intended for scientific research work.

    2. Minerals in a state of occurrence, as well as the following products, if they have not been chemically modifiedminerals, ores, ore concentrates, cement clinker, natural gas, liquefied gas, gas condensate, process gas and its components, dehydrated, desalted and stabilized oil, associated petroleum gas, coal, coke.

    3. Medicines and veterinary medicines.

    4. Perfume and cosmetic products.

    5. Chemical products that are a source of ionizing radiation (including waste from such products), in terms of classification, labelling and communication of the dangers caused by the presence of radiation in it.

    6. Food products, including biologically active food additives and nutritional supplements, as well as ready-made feed for animals.

    7. Products included in manufactured articles that, being in circulation in the territory of the Russian Federation, do not change their chemical composition and aggregate state, are not susceptible to destruction and oxidation processes, do not generate dust, vapour or aerosols containing hazardous chemical substances having a harmful effect on human life and health, life and health of animals and plants, environment or property.  

    8. Wastes from the production and consumption of chemical products, if they are subject to utilization (processing).

    9. Chemical products subject under transit through the customs territory of the Eurasian Economic Union.

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