Eurasian Chemical Regulation
Eurasia REACH (TR041)
What is TR041 (EURASIA REACH)?
The Eurasian Economic Union (EAEU) Council consists of five member states, that are, Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. EAEU approved a regulation on March 3, 2017, and it is expected to come into force on November 30, 2022. The regulation, known as ‘Technical Regulation of Eurasian Economic Union on Safety of Chemical Products- TR EAEU 041/2017, establishes requirements for chemical substances, mixtures, and other chemical products that will be placed on the EAEU market.
TR EAEU 041/2017 is also known as Eurasian REACH. It covers all chemicals except the ones listed in Annex I of the regulation. According to the regulation, there are different requirements and processes for new and existing substances. Existing substances are those nominated into the Russian inventory while new substances are the chemicals that are absent from the Russian inventory. Existing substances will require simplified registrations while new substances will require standard registrations.
Non-EAEU companies that export or want to export chemicals to the EAEU are required to appoint Nominated Representative located in the EAEU to carry out their importer obligations.
What are the compliance requirements of TR041?
The compliance assessment with the requirements of the TR 041 is carried out in one of the following ways:
1) 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.
2) 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)
2) Chemical Safety Report (> 10 ton per year)
- Human hazard assessment, physicochemical properties assessment, environmental hazard assessment and PBT/vPvB assessment;
- Exposure Scenario is required if classified as dangerous or PBT/vPvB; operational conditions and risk management measures for each use; exposure estimation
