As of 1 July 2021, facilities placing chemical products on the market (mainly, manufacturers and importers) in Russia, have to comply with new requirements on chemical product registration, labeling, classification and conformity assessment. Decree No. 1019 of 7 October 2016 introduces technical regulation on safety of chemical products, which is meant to harmonize chemical product registration, labeling and classification requirements in Russia. It also consolidates and clarifies all the existing requirements, by providing a general legal framework, applicable to chemical registration, classification, safety data sheets, marking and labeling.
Technical regulation (TR) on safety of chemical products was adopted by Decree No. 1019 of 7 October 2016 and published on 12 October 2016. Technical regulation on safety of chemical products introduces new requirements to chemical products handled in the territory of the Russian Federation, as well as rules for conformity assessment, identification, notification, classification, marking and labeling.
The TR consolidates a lot of already existing provisions (classification of chemicals, precautionary labeling, etc.), clarifies the entangled nature of the existing system on chemicals, as well as introduces certain new requirements. For example, identification procedures, notification procedures, conformity assessments, and obligatory classification of chemicals do not currently exist.
The TR enters into force on 1 July 2021. The TR does not require any actions on behalf of facilities before this date.
The adopted TR is applicable to chemical products placed on the market in Russia, except for the products listed by Annex 1 to the TR. For example:
- drugs for medical use and veterinary medicines;
- perfume and cosmetic products;
- chemicals, which are a source of ionizing radiation (including waste from such products), in terms of classification, labeling and awareness of the danger caused by the presence of radiation in it; and
- chemical products under transit within Russia.
The TR sets out that requirements on manufacture, storage, transport, sale and disposal are subject to separate technical regulations, applicable to specific types of chemical products.
The TR introduces some definitions, for example:
- "Handling of chemical products": the movement of chemical products from a manufacturer to a consumer (purchaser), covering all stages of the product life cycle after the completion of its production.
- "Chemical product": a chemical substance or mixture.
- "Manufacturer": a legal entity or an individual entrepreneur, who manufactures or/and sells chemical products produced and who is responsible for compliance of the chemical products with the requirements of this technical regulation.
- "New chemical product": a chemical product which is a new chemical substance or a mixture containing new chemical substances.
- "New chemical substance": a substance which is not notified in the registry of chemical substances and mixtures.
Identification of chemical products
A chemical product has to be identified by the manufacturer or the importer of this product before the product is being placed on the market. The identification process includes:
- determination of the name of the chemical product;
- classification of the chemical product as a substance or a mixture;
- determination of the name of the chemical product in accordance with the chemical nomenclature of the International Union of Pure and Applied Chemistry (IUPAC) and the number of the chemical in accordance with the CAS registry (if applicable);
- determination of the presence in the chemical product of a new chemical in a concentration higher than 0.1 %;
- identification of the chemical substances within the chemical product as:
- new chemical substances;
- chemical substances the use of which is banned in Russia;
- chemical substances the use of which is restricted in Russia.
- determination of the area of use of the chemical product;
- other necessary information.
Chapter V of the TR gives more details on the identification of chemical products.
A chemical product has to be classified by the manufacturer or the importer of this product before the product is placed on the market.
Classification should be carried out in accordance with GOSTs (which already exist), which would be included into the list of standards the voluntary use of which would guarantee the compliance with the requirements of the TR. The list will be adopted by the Federal Agency for Technical Regulation and Metrology.
The TR also provides certain classifications, for example, upon its hazardous effect on human life and health, environment, life and health of animals and plants, related to physical and chemical properties of the chemical product, the product is classified into:
- compressed gas (LPG);
- flammable gaseous chemical products (flammable gas);
- flammable chemical products in aerosol containers;
- flammable (combustible) liquid; etc.
The classification corresponds to the one provided by GOST 32419-2013 and implements the provisions of the 4th revision of GHS. The set hazard class of the chemical product has to be indicated in the safety data sheet (SDS). Chapter VI of the TR gives more details on the classification of chemical products.
The label of the chemical product has to include the following information:
- mark on circulation at the market (знак обращения на рынке);
- the name of the chemical product established during identification of the product;
- name, address, contact information of the manufacturer and/or importer;
- name of chemical substances and mixtures classified as hazardous and contained in the chemical product in the quantity exceeding the level of concentration set by standards included in the list standards the voluntary use of which would guaranty the compliance with the requirements of the TR;
- conditions of storage;
- designation of the document in accordance with which the chemical product was manufactured;
- information on hazardous properties of the chemicals, including precautionary labeling.
Information on the label has to be in Russian. The elements of precautionary labeling have to stand out in comparison with other information and have to comply with GOST 31340-2013. Chapter VIII of the TR gives more details on the marking of chemical products.
Safety data sheets (SDS)
Manufacturers and importers, before placing a chemical product on the market, are obliged to prepare safety data sheets (паспорта безопасности химической продукции).
The TR sets out that requirements on the content of the SDS are contained in GOST 30333-2007. So there are no changes on the content of the SDS.
Notification of new chemical substances
"Notification" (нотификация) is defined as the procedure of inserting into the registry of chemical substances and mixtures information on new chemical substances.
All new chemical substances (the ones which are not included into the registry of chemical substances and mixtures) have to be notified, before chemical product containing such chemical substances are placed on the market.
The notification needs to be submitted to an authorized federal executive body - that will be defined later on by the Government, as well as the rules and regulations on functioning of the registry of chemical substances and mixtures. Applicants have to send to the authorities certain information, for example, a chemical safety report in accordance with Annex 3 to the report, a formula of chemical structure, CAS number, etc.
The TR sets out that a chemical product can be placed on the market only after the product has undergone a conformity assessment. The TR does not specify what products (all or just new) have to undergo conformity assessment. It is up to the manufacturers and importers of chemicals to go through the following steps to obtain it.
To obtain the conformity assessment the company must carry out:
- Account (учетная) state registration; or
- Permitting (разрешительная) state registration;
- Conformity assessment can also be carried out in the form of state control, the procedure and rules on which will be adopted by the Government separately.
Account state registration has to be carried out if:
- Information on chemical products are included into the registry of chemical substances and mixtures;
- Chemical products do not contain prohibited and/or restricted chemical substances and mixtures, included in the registry of chemical substances and mixtures;
- Chemical products contain restricted chemical substances and mixtures, included into the registry of chemical substances and mixtures in concentrations not exceeding the values of maximum allowed content of restricted chemical substances and mixtures within a chemical product, set out in Annex 4 of the TR;
Permitting state registration has to be carried out for:
- New chemical products;
- For chemical products which contain restricted-for-use chemical substances and mixtures, included into the registry of chemical substances and mixtures in concentration exceeding the values set out by Annex 4 to the TR.
Account and permitting state registration will be carried out by an authorized state body, which will have to be defined by the Government. All the requirements and provisions of the TR will be fully operational when the Government adopts a number of necessary legal acts, implementing the TR.