1. What is the chemical substances inventory formation?
In the Russian Federation, chemical substances inventory formation is a part of a timed action plan* aimed at preparing of the industry for the entry into force of technical regulations of the Eurasian Economic Union “On the Safety of Chemical Products” (TR EAEU 041/2017).
The inventory is the first stage in the formation of the national part of the register of chemical substances and mixtures of the Union.
*This timed action plan was approved at a meeting of the subcommission on technical regulation, application of sanitary, veterinary-sanitary and phytosanitary measures of the Government Commission on Economic Development and Integration Proper protocol No. 1 dated 29 January 2019 and adopted by First Deputy Prime Minister of the Russian Federation - Minister of Finance of the Russian Federation, a Chairman of the Government Commission for Economic Development and Integration Anton Siluanov on 16 March 2019.
2. Are all chemical substances subject to inventory submission?
All chemical substances as such or within the mixture that your company is releasing or just planning to release for Russian (or Union) market are subject of inventory.
For chemical product released for Union’s market as a chemical substance, you need to do an inventory of the main component and all impurities and supplements presented in a concentration of more than 0.1% (by weight).
For mixtures, it is necessary to take into account all components presented in their composition in a concentration of more than 0.1% (by weight). In a case, if some substance is present in a concentration of less than 0.1%, but there is a probability of increasing of content, we recommend putting such substance into inventory, too.
The substances can be excluded from the inventory submission process if they are a part of chemical products that specified in Annex 1 of TR EAEU 041/2017 (a list of chemical products on which the technical regulation does not apply) as follows:
‒ chemical products intended for use in scientific research and development and/or obtained as a result thereof;
‒ minerals in their natural state of occurrence, as well as the following products, if not chemically changed: 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;
‒ medical products and preparations for veterinary use;
‒ perfumes and cosmetics;
‒ chemical products serving as a source of ionizing radiation (including wastes of such products), including their hazard classification, labelling and information on hazards due to the presence of radiation;
‒ food products, including biologically active supplements and food additives, as well as finished animal feed;
‒ products in articles which during treatment in the customs territory of the EAEU do not change their chemical composition and which are not subject to decomposition or oxidation processes, and which do not form dusts, vapours and aerosols containing chemicals that are hazardous to the life and health of humans, animals or plants, the environment, or property;
‒ wastes from the production and consumption of chemical products, if they are to be recycled;
‒ chemical products that are subject to the procedure of customs transit through the territory of the EAEU.
3. Why does our company need to participate in the inventory?
Chemical substances inventory is a voluntary procedure in which a company has the right to submit data on chemical substances for inclusion in the inventory list, thereby declaring them as existing in the customs territory of the Union. The inventory list will be the basis for the formation of the Register of chemical substances and mixtures of the Eurasian Economic Union.
After the entry force of the TR EAEU 041/2017, all chemical substances that are not in the Register will be considered “new” for the customs territory of the Union. Before the releasing of any chemical product containing such new substance, you must undergo a notification procedure of new substances. Notification is a comprehensive study of hazardous properties and analysis of risks to human health and the environment with filling in a chemical safety report. It is expected that only really new and unexplored chemicals will undergo notification procedure.
At the inventory stage, the regulator requests a piece of minimum information on chemical substances. The submission of information is free of charge and does not require the attaching of any documents confirming the fact of a substance circulation in the Russian Federation.
Those companies that for some reason has not been participated in the inventory and have realized that their substances are not in the Register after the entry force of the TR EAEU 041/2017, (and therefore they identified as new chemicals), can submit data in the Register within a deferred norm: before June 2, 2023 companies have the right to submit information on a chemical substance for inclusion in the Register without a notification procedure, but with attaching of the documents that confirm the circulation of a chemical substance on the Union market before the effective date TR EAEU 041/2017. Confirming documents may include a supply agreement (an act of purchase and sale), consignment note, information on the presence of a chemical substance in the national list of chemicals of a Member state, etc.
After the entry into force of the TR EAEU 041/2017 and the termination of the deferred norm, you must notify all chemical substances that are not in the Register before it being released to the Union market (even as part of the mixture).
4. Who can submit data on substances for the inventory?
In Russia, data may be submitted only by the resident of Russia (Russian legal entity). A foreign company that does not have a branch in the Russian Federation can appoint by a mutual agreement a Russian representative for data submission. There are no special requirements to the representative like sufficient knowledge in the practical handling of the substances as it is in REACH Regulation. You can ask your Russian importer or customer be your representative for inventory data submission.
5. How and where do I need to submit the contact details of responsible for the inventory employees at our company? Why is this needed?
To include information on chemical substances at the inventory stage, it is necessary to fill out a single template and submit it electronically to the Ministry of Industry and Trade of the Russian Federation after receiving a message about the start of data reception. Please note that the newsletter will be conducted on an updated database of contacts in accordance with received data responsible for the inventory employees from Russian companies. Please make sure that your Russian representative submits contacts to the Ministry.
6. How to submit data on substances for the inventory?
Russian company needs to send an information letter on the official letterhead of the organization signed by the director with contact details of responsible employees. Please, put the following topic: “On the issue of inventory of chemicals”. Send the original letter directly to the expedition of the Ministry of Industry and Trade of the Russian Federation at the following address: Moscow, Presnenskaya Naberezhnaya, 10, bld. 2 (Tower 2). The deadline for receiving letters is extended until the end of September 2019. Based on the received information, an updated list of companies will be formed for sending out information messages on the inventory of chemical substances.
7. The submission letter of the Ministry of Industry and Trade of the Russian Federation No. ЕВ-30646/13 of 13.05.2019 indicates that companies must do the inventory before 10th August 2019. Do we understand correctly that we must send the completed templates by this date?
It is recommended conducting an inventory by August 10 in order to submit information to the Ministry of Industry and Trade of the Russian Federation in a timely manner at an additional request. However, this is not a deadline. On the contrary, 10th August 2019, is the preliminary start date for accepting completed templates. The Ministry will inform about the exact date additionally (approximately in August-September of this year) by an information letter to the address of the responsible persons of organizations. Currently, preparatory work is underway to ensure the reception and processing of data. We expect that the ability to submit data on substances as part of the inventory will be extended until the middle of next year.
8. A supplier refuses to provide data on the composition of the chemical products due to trade secrets, and there are only hazardous components in the Safety Data Sheet (SDS). What do I need to do?
It is necessary to explain to the supplier the consequences of not providing information at the inventory stage about the chemical substances (see the answer to the question “What for our company needs to participate in the Inventory?” and “Are all chemicals subject to inventory?”). We also recommend clarifying to your supplier that all information about chemical substances is requested for the inventory without reference to the final product and the percentage in the composition, i.e. the supplier need to give a list of all the chemical substances in a single list. In addition, they do not need to duplicate the information, if several mixed products contain the same substance.
9. We have found information about our substance in the initial list of chemicals in circulation in industry and trade of Russia. Does this mean that we do not need to provide information on it in the template?
The presence of a substance in the initial list does not exclude the need to submit data (or to fill information on it in the template) at the inventory stage since the basis for the Register of chemical substances and mixtures of the Union will be formed according to data provided by industry. A basic list can be used as a source of identification of chemical substances.
10. How to include polymer information in a template?
At the inventory stage, it is necessary to provide information on monomers, as well as on all additive components in accordance with the formulation (for example, plasticizers, polymerization activators, etc.) in an amount of more than 0.1%. Due to the high variety of polymers, notification of them is not applicable and information about them is optional for the inventory.
11. We produce a complex and variable composition article, which consists of many components. Some components cannot be determined. Should I fill out the inventory template for the product as a whole or for each of the components in the composition?
If you cannot identify substances with complex and variable composition by chemical structure and molecular formula, you should determine them by the production technology, feedstock, typical content of components and definitive physicochemical parameters. Thus, you need to fill information on a substance of a complex and variable composition as a whole (without separation into components) with an indication of the CAS number assigned to it (if available).
12. How to fill in HS Code field if this code is assigned according to the commodity nomenclature for products (including mixed products), and not for individual substances?
The harmonized commodity codes are applicable for some substances placed on the market as the final products. If HS code is not applicable, please indicate that “Not applicable”.
13. Why is there no Russian name of a substance in the form of a template, but only English? There are substances that do not have an IUPAC name, CAS numbers, they are not exported and have a complex name, like "fractions...", "stillage residue...", etc.
The template was developed based on the draft procedure for the formation and maintenance of a list of chemical substances and mixtures of the Eurasian Economic Union and it corresponds to the information in Annex 1, where a field “Russian name” is not provided. We recommend indicating the Russian name, which does not follow with the IUPAC rules in the “synonyms” column.
14. What does the “Abbreviation” field mean? Is this a trade name of a substance? If not, in which section should I enter a trade name?
The abbreviation means a shortened name by the first letters, if applicable. For example, PVC for Polyvinyl chloride. You do not need to indicate the trade name in the inventory since the list of substances is compiled without reference to the final product.
15. In the “Application (scope of use)” field is it necessary to indicate the purpose of the product, which includes the given chemical substance, or to indicate the area in which the chemical substance is using in its pure form?
Information is providing on the substance in its pure form. Restrictions/instructions for completing this column are not provided.
16. How to fill the “Production Volume” section for chemical substances that are part of mixed products? Should I indicate the volume of the product itself?
For chemical substances in a composition of chemical products (components of a mixture) tonnage is not indicated (no need to recount it). You need to fill in the column with the phrase "As part of a mixture" (or “As part of a polymer” for monomers). For chemical substances provided to the Union market as a separate product, you need to indicate the average production/import volume for the last three years. For those substances that your company plans to release in the future (to expand the product line), you need to write the planned amount.
This information is requested to assess the upcoming workload in the framework of state registration of chemical products under the TR EAEU 041/2017 and justify the need (or lack thereof) for the phased introduction of state registration depending on the tonnage.
17. Should I specify the hazard classification for an individual substance or for a mixture containing this substance? Where can I get this data? Is it possible not to fill in the section if there is no data for an individual component of a mixture?
This column is filling in for a chemical substance, and, in the case of mixtures, for each component of a mixture separately. One line of the template should correspond to one chemical substance. If a substance is a part of several mixed products, then the information on it gives once in the template (no need to duplicate it). If there is no data on the results of the hazard classification of components, choose the "no data available" button. If you want to provide a hazard classification of the components, you need to collect all available data for each substance, including information from open sources. Hazard classification criteria are established by GOST 32419-2013.
18. Which sections are obligatory and which are not?
You need to complete all sections on an “if applicable” / “if available” basis. However, we recommend providing the information as fully as possible. Please, don't leave the field blank, use the phrase “No data available”, “Not applicable”.
19. The template contains information on the volume of production of chemical substances regarding the manufacturer. How will confidentiality information maintain?
Information on the volumes of production/import of chemical substances and the applicant will not be publicly available. The compiled inventory list of chemical substances dwelled in circulation on the territory of the Russian Federation will be anonymized.
20. When I had been filling in the template, I encountered a problem of editing text in cells. I wanted to remove the protection of the sheet, but the program requests a password. Please provide a password, or make the template on the site editable.
The template is password-protected to preserve the uniform settings for further automatic processing of the submitted data.
To solve the problem, send a detailed description and a screenshot of the error to email@example.com.
Also due to the fact that the template was compiled for a Russian user, problems may arise on software running on non-Russified Windows and MO Excel. Unfortunately, at the moment, this issue can be resolved only through the use of Russified software, or work in the virtual environment of Russian-speaking Windows.