In April 2020, Russia’s Ministry of Industry and Trade (Minpromtorg), announced an extension of the deadline for inventory notification, from previous 1 May, until 1 August 2020, due to the impact on companies of the Covid-19 pandemic. Later in June, Minpromtorg published the transitional inventory on the State Information System for Industry – GISP website. Chemicals not listed there will be considered new chemicals under Technical Regulation 041/2017. Work on the inventory in the other member states is still pending. Companies that miss this date may still add chemicals without going through the new substance notification procedure, as long as they can prove that the chemicals have existed on the market prior to 2 June 2023. Details on how this will be done or how companies can demonstrate this is not known at the moment.
The CIS centre provides guidance and FAQ for the inventory process and manually checks submissions. Manufacturers and importers (through their nominated representatives) should nominate substances and those used in their mixtures. There are no small volume exemptions, which means that industry may consider notifying impurities or additives which are in concentrations of 0.1% or more. Although mixtures are also subject to registration under the technical regulation, they are exempt from the inventory notification. It is important to note that this ‘notification’ or nomination process is applicable to the creation of the inventory and is different from the process for new chemical notification. Once the final inventory is announced, chemicals on this list would be considered an existing chemical and those not on the list a new chemical.
Companies should consider nominating all of their chemicals on the market regardless of scope as the new substance notification requirements are much more rigorous and undergoing that procedure is more costly in time and money.
The inventory nomination procedure is relatively quick and easy. Notification/nomination needs to be submitted to the State Information System for Industry or GISP. Companies with no Russian legal entity may appoint nominated representatives (NRs) to submit the chemical notification/nomination. After registration, notification to the inventory is submitted through the official template. The information that needs to be submitted is given in Annex 1 of the Draft Order on inventory formation. The inventory notification template in Russian can be downloaded at https://ciscenter.org/tabstest/
The following information must be submitted:
- substance identification (Iupac name in Russian, Cas and EC no, name in English);
- uses or application;
- annual tonnage; and
- applicant’s details.
Other information specified in the template (for example, synonyms, customs code, structural formula, classification) is recommended but not essential according to our source, a national representative, from their practical examples.
CIS guidance on inventory notification is available at https://ciscenter.org/tabstest/downloads/instruction_pattern.pdf
and Ministry of Industry and Trade (Minpromtorg) Instructions at the GISP website.
Notification of new chemicals
Once the inventory of existing chemicals is created, substances introduced to the EEU and not found on the inventory or exempted must undergo the new chemical notification process prior to being placed on the market. Under this process, the following information must be submitted:
- substance identification information (Iupac name, CAS no. , structural formula, degree of purity of the chemical);
- intended uses;
- method of disposal and transportation as well as measures for risk prevention and elimination;
- analytical report;
- physico-chemical properties;
- data on toxicology and ecotoxicology;
- chemical safety report (structure per Appendix 3 of TR 041/2017);
- copies of study data (tests) of a chemical substance for the determination of bioaccumulation, carcinogenicity, mutagenicity, toxicity, carried out in testing laboratories (centres), recognised as complying with the principles of GLP.
Russia’s Ministry of Industry and Trade has estimated that notification of new substances will cost approximately 250, 000 euros and take more than two years to complete. Once the chemical in the product is notified, the product itself must also undergo conformity assessment in order to obtain a conformity marking, indicating approval for distribution. All of the information indicated here, substance identification data, intended uses, disposal and transport information, analytical reports, physico-chemical properties, toxicity and ecotoxicity data, chemical safety report, GLP test data will need to be submitted for the notification procedure after the TR 041/2017 comes into force – after 2 June next year. According to TR 041/2017, the current deadline for the formation of the national components of the register is 1 March 2021. But this date might change depending on whether the EAEU can agree to publish the second tier regulations.
Registration of chemicals
In addition to the notification process, chemical products in circulation in the EAEU are subject to conformity assessment. Conformity can be demonstrated via the registration certificate which is granted after the completion of the registration process. While the EAEU uses the word ‘registration’, this process is similar to a licensing scheme and has a different meaning and procedures to the registration process in the EU and in South Korea.
Two types of ‘registration’ or licensing exist in the EAEU:
- Accounting state registration is required for existing chemicals (those that are listed in the inventory) which are not restricted or prohibited for use or exceed the threshold for use under Annex 4 of TR 041/2017; and
- Permissive state registration is required for new chemical products or those that exceed the restrictions listed in the inventory or under Annex 4 of TR 041/2017.
Permissive state registration is valid for five years and could be changed to accounting state registration if there is no issue over that time from the registration date. Accounting state registration is only required once. For both types of registrations, it is expected that the data submission will mainly include information from the safety data sheet (chemical passport) and some chemical properties.
Small quantity exemptions do not exist in the EAEU or Russia. Any new substance with the quantity of 0.1% by weight and above must be disclosed and registered. Mixtures must also be registered from 2027 according to secondary legislation.