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Eurasia - Regulation

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.

 

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