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Russian Technical Regulation for Chemical Product Safety

By Little Pro on 2017-01-04 Views:  Update:2017-03-31

7 Oct 2016, the Russian Federation approved its technical regulation for chemical product safety via government decree no. 1019.  The new technical regulation will come into force on 1 July 2021. The new regulation makes GHS labels and safety data sheets compulsory for chemical products in Russia and sets out requirements on new substance notification and chemical product registrations. In this article, we will give you a detailed introduction to the new regulation: scope, exemption, SDS and labelling requirements, new substance notification requirement and different types of chemical product registrations. If you wish to purchase English version, please contact us.

Definition of Substance and Chemical Product

It is very important to know the definition of substance, new substance, chemical product and new chemical product under the technical regulation since they are regulated differently. Key definitions are listed as follows:

  • chemical substance:  a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition (main constituent>=80% while the total content of impurities and/or additives <20% by mass); 
  • chemical product: include both substance and mixture;
  • base chemical substance: a component of a chemical product that is not an additive or an impurity, constitutes a significant part of a chemical product and, therefore, is used for the chemical product name and detailed identification;
  • register of chemical substances and mixtures: it is a database containing data on properties of chemical substances and mixtures including information on prohibition, restriction or permission of using them in the territory of the Russian Federation;
  • new chemical substance: a substance that cannot be found in the current register of substances and mixture.
  • new chemical product: a chemical product that is a new substance or that contains new chemical substances.

Scope and Exemption

The technical regulation applies to chemical products which include both substances and mixtures. The following chemical products listed in annex 1 are out of scope:

  • Chemical products used for scientific and research purpose and/or being a result of research and/or development.
  • Mineral resources in the state of deposit, and the following products unless they were chemically modified: minerals, ores, ore concentrates, cement clinker, natural gas, liquefied gas, gas condensate, process gas and its components, dehydrated, desalted and stabilized oil, casing-head gas, coal, coke.
  • Pharmaceutical products and veterinary products.
  • Perfume and cosmetic products.
  • Chemical products constituting a source of ionizing radiation (including wastes of such products) in respect of classification, labelling and information on hazards caused by the presence of radiation.
  • Food products, biologically active additives and nutrient additives; and ready-made feeds for animals.
  • 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.  
  • Chemical product production and consumption wastes if they are subject to disposal.
  • Chemical products that fall within the scope of the procedure of customs transit through the territory of the Russian Federation.

Russian Register of Substances and Mixtures

The register of substances and mixtures is very important because it is the key to determine whether a substance is new and whether a chemical product is new. It is more than a list of existing chemical substances. It is a database containing data on properties of chemical substances and mixtures including information on prohibition, restriction or permission in the territory of the Russian Federation.

GHS Implementation in Russia

The technical regulation requires that manufacturers and importers classify chemical products according to GHS, prepare safety data sheets and labels in accordance with various labelling and SDS standards. More info about SDS and labelling requirement can be found below:

New Substance Notification in Russia

The technical regulation requires that manufacturers and importers notify a new chemical substance to the register of substances and mixtures. There is no small quantity exemption. Any new substance with a concentration above 0.1% by weight must be disclosed and notified.

The following information needs to be submitted:

  • Substance identification info (IUPAC name, CAS no. impurtity info, etc.)
  • Intended uses
  • Method of disposal and transportation as well as measures for risk prevention and elimination
  • Analytical report
  • Physio-chemical properties
  • Data on toxicology and eco-toxicology
  • Chemical safety report

Comment: It is not clear whether Russia will adopt REACH-like tonnage-based data requirement for new chemical substances. The Ministry of Industry and Trade of the Russian Federation is preparing a separate decree on the procedure and requirement on new substance notification.

Chemical Product Registration

Unlike other countries, notifying a new substance is not sufficient for market entry in Russia. You have to demonstrate that your chemical product (substance or mixture) is compliant with the technical regulation irrespective of whether your product contains new substances or not. The way to do that is to apply for chemical product registrations and get registration certificates.

There are 2 types of chemical product registrations: accounting state registration and permissive state registration. Accounting state registration certificate is like a confirmation for low-risk product while permissive state registration certificate is like a permit for high-risk product. Their applicability and information requirement is listed as follows:

Registration type Required when Info requirement
 Accounting state registration (No expiration date)
  • the chemical product is already included in the register of chemical substances and mixtures; or
  • the chemical product does not contain any prohibited and/or restricted use substances included in the register of chemical substances and mixtures; or
  • the chemical product contains restricted substances included in the register of chemical substances and mixtures. However, their concentrations do not exceed maximum allowable concentration limits (see table below)
  • application form (with product info);
  • safety data sheet;
  • test reports or official source info (not required for products in the register and chemical products that can be classified by calculation method)

Permissive state registration (Valid for 5 years,. Will be changed to accounting state registration if there is no issue within 5 years.).

  • the chemical product is a new chemical product; or
  • the chemical product contains restricted substances included in the register of chemical substances and mixtures and their concentrations exceed maximum allowable concentration limits (see table below)
  • application form (with product info);
  • safety data sheet;
  • test reports or official source info (not required for products in the register and chemical products that can be classified by calculation method)
  • New substance notification info (if containing new substance)

Maximum Allowable Concentrations of Restricted Substances in Chemical Products

GHS classification Concentration limit (by weight)
Carcinogen category 1 and 2 0.1%
Mutagen category 1 0.1%
Mutagen category 2 1%
Reproductive toxicant category 1 and 2 0.1%
Chronic aquatic toxicity category 1 1%

How to Get the Regulation?

 

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