In accordance with Article 52 of the Treaty on the Eurasian Economic Union dated 29 May 2014 and Paragraph 29 of Annex No. 1 to the Rules of Procedure of the Eurasian Economic Commission, approved by Decision No. 98 of the Supreme Eurasian Economic Council dated 23 December 2014, the Council of the Eurasian Economic Commission decided:
1. To adopt the attached Technical Regulation of the Eurasian Economic Union "On the Safety of Chemical Products" (TR EAEU 041/2017).
2. The Eurasian Economic Commission, jointly with the governments of the Member States of the Eurasian Economic Union, shall develop and approve the procedure for establishing and maintaining the register of chemicals and mixtures of the Eurasian Economic Union (hereinafter referred to as the Union) and the procedure for notifying new chemical substances, ensuring that they enter into force by 1 December 2018.
3. To request that the governments of the Member States of the Union ensure the establishment, by 1 March 2021, of the national sections of the Union Register of Chemicals and Mixtures.
4. To establish that the Technical Regulation of the Union "On the Safety of Chemical Products" (TR EAEU 041/2017) shall enter into force on 2 June 2021, subject to the implementation of Paragraph 2 of this Decision, with the exception of requirements for pesticide formulations and the related processes of their production, storage, transportation, sale and disposal (processing). Before the date of entry into force of the Technical Regulation of the Union establishing requirements for pesticide formulations and the related processes of their production, storage, transportation, sale and disposal (processing), the provisions of acts of the Union bodies or the legislation of the Member States of the Union shall apply to such products and processes.
5. This Decision shall enter into force upon the expiry of 30 calendar days from the date of its official publication.
| Members of the Council of the Eurasian Economic Commission: |
From the Republic of Armenia | From the Republic of Belarus | From the Republic of Kazakhstan | From the Kyrgyz Republic | From the Russian Federation |
V. Gabrielyan | V. Matyushevsky | A. Mamin | O. Pankratov | I. Shuvalov |
ADOPTED
by Decision of the Council of the Eurasian Economic
Commission dated 3 March 2017 No. 19
Technical Regulation
of the Eurasian Economic Union "On the Safety of Chemical Products" (TR EAEU 041/2017)
This Technical Regulation was developed in accordance with Article 52 of the Treaty on the Eurasian Economic Union dated 29 May 2014, and also taking into account the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (2011) with regard to the establishment of:
hazard classification criteria for chemical substances and mixtures with respect to human health and the environment, as well as hazards associated with their physical and chemical properties;
elements of the information system, including requirements for labelling and the Safety Data Sheet.
This Technical Regulation was developed to establish, in the customs territory of the Eurasian Economic Union (hereinafter referred to as the Union), uniform requirements for chemical products that are mandatory for application and compliance, and to ensure their free movement when placed on the market in the customs territory of the Union.
I. Scope of Application
1. This Technical Regulation has been adopted to protect human life and health, property, the environment, the life and health of animals and plants, and to prevent actions that mislead consumers (purchasers).
2. This Technical Regulation establishes uniform requirements for chemical products that are mandatory for application and compliance in the customs territory of the Union and that are placed on the market in the customs territory of the Union, as well as the rules and forms of conformity assessment, identification rules, and requirements for terminology, labelling and the rules for applying it.
Requirements for the processes of production, storage, transportation, sale and disposal (processing) of chemical products are established by the Technical Regulations of the Union (Customs Union) applicable to specific types of chemical products.
3. This Technical Regulation applies to all chemical products placed on the market in the customs territory of the Union, except for the products listed in accordance with Annex No. 1.
With regard to specific types of chemical products that are subject to regulation by other Technical Regulations of the Union (Customs Union) establishing specific requirements for such types of chemical products, this Technical Regulation applies to the extent concerning requirements for classification, hazard labelling and the Safety Data Sheet for Chemical Products, if such requirements are not established by other Technical Regulations of the Union (Customs Union).
II. Basic Concepts
4. For the purposes of applying this Technical Regulation, the following concepts and their definitions are used:
"bioaccumulation" – the ability of chemical substances to accumulate in biological organisms;
"explosive chemical product" – a solid or liquid chemical product that is capable of a chemical reaction by itself, releasing gases at such a temperature and pressure and at such a rate that this causes damage to surrounding objects;
"flammable liquid" – a liquid having a flash point not exceeding 93 °С;
"flammable solid chemical product" – a product that can easily catch fire or cause ignition or sustain combustion as a result of friction;
"hazard pictogram" – a color graphic representation of a specific geometric shape using contrasting colors, graphic symbols and explanatory inscriptions, intended to warn citizens of an immediate or potential hazard, prohibit or prescribe certain actions, or permit certain actions;
"specific target organ toxicity" – a type of effect causing impaired functions of individual organs (target organs) and (or) systems of a living organism following a single and short-term exposure or repeated and prolonged exposure;
"importer" – a resident of a Member State of the Union that has concluded a foreign trade contract with a non-resident of a Member State of the Union for the import of chemical products into the customs territory of the Union, markets chemical products and is responsible for their compliance with the requirements of this Technical Regulation;
"carcinogenicity" the ability of chemical products to cause mutations (changes in the genetic structure of a living cell) that may lead to the development of malignant neoplasms (tumors);
"carcinogens" chemical products capable of causing or accelerating the development of malignant neoplasms (tumors);
"classification" – determination of whether chemical products correspond to a specific hazard class (hazard subclass, hazard type) according to hazard criteria;
"corrosive chemical product" – a product that, as a result of chemical action, may substantially damage or destroy materials;
"hazard criteria" – quantitative and (or) qualitative values of the state of chemical products from the perspective of safety for humans, animals, the environment and property, on the basis of which an assessment of the type and level of hazardous exposure is formed;
"mutagen" – chemical products capable of causing an increase in the number of mutations in a population of living cells and living organisms;
"mutagenicity" the ability of chemical products to cause mutations;
"new chemical product" – chemical products that are a new chemical substance or contain new chemical substances;
"new chemical substance" – a chemical substance whose information is not included in the Union Register of Chemicals and Mixtures;
"notification" – the procedure for entering information about new chemical substances into the Union Register of Chemicals and Mixtures;
"oxidizing chemical product" – a chemical product that supports and intensifies combustion, causes the ignition of other substances as a result of an exothermic redox reaction, or promotes such ignition (an oxidizing chemical product is not necessarily flammable (combustible) by itself);
"organic peroxides" – organic substances in a liquid or solid state that contain a divalent structure and may be regarded as derivatives of hydrogen peroxide in which one or both hydrogen atoms are replaced by organic radicals (organic peroxides and their mixtures are thermally unstable, which may result in their self-accelerating exothermic decomposition);
"main chemical substance" a component of chemical products that is not an additive or impurity, constitutes a significant part of such products and is therefore used as the name of the chemical products and for their detailed identification;
"acute toxicity" adverse effects occurring after a substance is administered into the stomach, or a single dose of a substance is applied to the skin, or repeated exposure to a substance occurs over 24 hours, or a substance enters with inhaled air over 4 hours;
"safety data sheet" a Safety Data Sheet for Chemical Products in the prescribed form, containing information about the hazardous properties of chemical products, information about the manufacturer (person authorised by the manufacturer), the importer of such products, precautionary measures and safety requirements to ensure the safe handling of chemical products in the customs territory of the Union;
"persistence" – the resistance of chemical products to decomposition and transformation processes;
"pyrophoric chemical product" – a chemical product that (even in small quantities) may ignite within 5 minutes after contact with air;
"consumer (purchaser)" – a registered legal entity or an individual registered as an individual entrepreneur, as well as an individual, intending to purchase (purchasing) chemical products;
"precautionary measures" – measures that must be taken to minimise or prevent adverse effects caused by exposure to hazardous chemical products;
"Union Register of Chemicals and Mixtures" – an information resource containing information about the properties of chemical substances and mixtures, including information about the prohibition, restriction or authorization of their use in the customs territory of the Union;
"self-heating chemical product" – a chemical product in a liquid or solid aggregate state (except for a pyrophoric chemical product) that, upon contact with air and without an external energy supply, is capable of self-heating (a self-heating chemical product differs from a pyrophoric product in that it ignites only in large quantities (kilograms) and after a long period of time (hours, days));
"sensitization" – an increase in the sensitivity of an organism to the effects of xenobiotics causing an allergic reaction;
"mixture" – a mixture or solution consisting of two or more chemical substances in which the chemical substances do not react with one another;
"toxicity" – the ability of chemical products to cause injury or death of an organism by affecting it through non-mechanical means;
"chemical products" – a chemical substance or mixture;
"chemical substance" – chemical elements and (or) their compounds occurring in a natural state or obtained as a result of any production process, including any additives necessary to ensure stability and any impurities resulting from the process of obtaining chemical products, excluding any solvent that can be separated without disrupting the stability of the chemical substance or changing its composition (chemical substances include chemical products in which the chemical substance is present at a concentration of 80 percent (by mass) or more, while the remaining 20 percent (by mass) or less are considered impurities and (or) additives);
"chronic toxicity" – a type of toxicity causing illness and (or) death of a living organism following repeated and (or) prolonged exposure;
"ecotoxic chemical substance" – a chemical substance capable of causing adverse effects in the environment.
III. Rules for the Identification of Chemical Products
5. Chemical products are identified by the manufacturer (person authorised by the manufacturer) and the importer of such products.
6. Identification of chemical products includes:
а) establishing the name of the chemical products;
б) classifying the chemical products as chemical substances or mixtures;
в) establishing, for a chemical substance, its name according to the nomenclature of the International Union of Pure and Applied Chemistry (hereinafter – IUPAC nomenclature) and the identifier of the chemical substance (CAS) entered in the register of the Chemical Abstracts Service of the American Chemical Society (hereinafter – CAS number) (if available);
г) determining the chemical composition of a mixture, establishing for each identifiable component included in its composition its name according to the IUPAC nomenclature and CAS number (if available);
д) establishing the presence of new chemical substances in the composition of chemical products at concentrations exceeding 0,1 %;
е) classifying the chemical substances contained in chemical products as:
new chemical substances;
chemical substances prohibited for use in the customs territory of the Union;
chemical substances restricted for use in the customs territory of the Union;
ж) determining the scope of application of chemical products;
з) other necessary information.
7. When determining the chemical composition of a chemical substance, the following must be identified:
а) the main chemical substance;
б) hazardous chemical substances contained in additives and impurities, if they are present in quantities exceeding the concentration values specified in the standards included in the list of standards, the application of which on a voluntary basis ensures compliance with the requirements of this Technical Regulation.
8. When determining the chemical composition of a mixture, the following must be identified:
а) chemical substances present at concentrations exceeding 10 %;
б) hazardous chemical substances present in quantities exceeding the concentration values specified in the standards included in the list of standards, the application of which on a voluntary basis ensures compliance with the requirements of this Technical Regulation.
9. Manufacturers (persons authorised by the manufacturer) and importers of chemical products use, for their identification, information about chemical substances and mixtures contained in the Union Register of Chemicals and Mixtures.
IV. Rules for Placing Chemical Products on the Union Market
10. Chemical products shall be placed on the market in the customs territory of the Union if they comply with the requirements of this Technical Regulation and the requirements of other Technical Regulations of the Union (Customs Union) applicable to them, and provided that they have undergone conformity assessment for the Technical Regulations of the Union (Customs Union) applicable to them.
11. If no information on chemical products is available in the Union Register of Chemicals and Mixtures, the chemical products shall be identified as new chemical products, and the new chemical substances included in their composition shall be subject to notification in accordance with paragraphs 46 – 48 of this Technical Regulation before the placing on the market in the customs territory of the Union of chemical products containing such chemical substances.
12. The procedure for establishing and maintaining the Union Register of Chemicals and Mixtures shall be established by the Eurasian Economic Commission.
13. Chemical products that comply with the requirements of this Technical Regulation and other Technical Regulations of the Union (Customs Union) applicable to them and that have undergone conformity assessment shall bear the single mark of product circulation on the market of the Union.
V. Requirements for the Classification of Chemical Products
14. The classification of chemical products shall be carried out by the manufacturer (person authorised by the manufacturer) or importer of such products.
The classification of chemical products shall be carried out in accordance with the list of international and regional (interstate) standards, or, in their absence, national (state) standards, through the application of which compliance with the requirements of this Technical Regulation is ensured on a voluntary basis.
15. The classification of chemical products according to hazardous properties shall take into account data on the hazardous properties of chemical substances and mixtures:
а) contained in the Union Register of Chemicals and Mixtures;
б) obtained as a result of their research (testing) for compliance with the criteria specified in the standards included in the list of standards, through the application of which compliance with the requirements of this Technical Regulation is ensured on a voluntary basis.
16. According to the types of hazardous effects on human life and health, property, the environment, and the life and health of animals and plants associated with the physicochemical properties of chemical products, chemical products are divided into:
а) explosive chemical products;
б) compressed gas (liquefied gas);
в) flammable gaseous chemical products (flammable gas);
г) flammable aerosol chemical products;
д) flammable (combustible) liquid;
е) flammable solid chemical products;
ж) self-decomposing (self-reactive) chemical products;
з) pyrophoric chemical products;
и) self-heating chemical products (except for pyrophoric chemical products);
к) chemical products hazardous in contact with water;
л) oxidizing chemical products;
м) organic peroxides;
н) corrosive chemical products.
17. The following chemical products are classified as chemical products exhibiting hazardous properties with respect to human and animal life and health if they contain hazardous chemical substances and mixtures in quantities exceeding the concentration values specified in the standards included in the list of international and regional (interstate) standards, or, in their absence, national (state) standards, through the application of which compliance with the requirements of this Technical Regulation is ensured on a voluntary basis:
а) chemical products exhibiting acute toxicity in relation to effects on living organisms;
б) chemical products causing corrosion (necrosis) and irritation of the skin;
в) chemical products causing serious eye damage (irritation);
г) chemical products causing sensitization;
д) chemical products possessing mutagenic properties (mutagens);
е) chemical products possessing carcinogenic properties (carcinogens);
ж) chemical products affecting reproductive function;
з) chemical products exhibiting specific target organ toxicity and (or) toxicity to systems of a living organism following single and short-term exposure or repeated and prolonged exposure;
и) chemical products presenting an aspiration hazard;
к) chemical products that are persistent and capable of accumulating toxic substances in biological objects;
л) chemical products characterised by particular persistence and bioaccumulation potential;
м) chemical products whose hazard level corresponds to the hazard level of compounds such as, in particular, endocrine disruptors, for which there is scientifically substantiated evidence of their likely serious effects on the environment and human health.
18. The following chemical products are classified as chemical products hazardous to the environment if they contain hazardous chemical substances and mixtures in quantities exceeding the concentration values specified in the standards included in the list of international and regional (interstate) standards, or, in their absence, national (state) standards, through the application of which compliance with the requirements of this Technical Regulation is ensured on a voluntary basis:
а) chemical products causing ozone layer depletion;
б) chemical products exhibiting acute and chronic toxicity to the aquatic environment;
в) chemical products possessing bioaccumulation potential;
г) chemical products resistant to degradation and transformation processes (persistence);
д) chemical products exhibiting toxicity to soil.
19. The main elements in the classification of chemical products hazardous to the aquatic environment are:
а) acute toxicity in the aquatic environment;
б) chronic toxicity in the aquatic environment;
в) bioaccumulation potential or actual bioaccumulation;
г) degradation (biotic and abiotic) – with respect to organic chemical substances.
20. Chemical products are classified as products causing ozone layer depletion if their composition contains at least one substance from the list of chemical substances causing ozone layer depletion. The list of chemical substances causing ozone layer depletion shall be determined by interstate agreements of the Member States of the Union (hereinafter – Member States) and international agreements to which all Member States have acceded, in the area of regulating the import into the customs territory of the Union of such chemical products.
21. The classification of chemical products hazardous to soil shall be carried out on the basis of a set of chemical product hazard indicators, which includes:
а) toxicity to soil organisms;
б) persistence in soil;
в) persistence in plants;
г) the ability of chemical products to migrate;
д) the effect on the nutritional value of agricultural products.
22. The classification of chemical products according to hazardous properties shall be based on data obtained as a result of research (testing) of the chemical substances included in their composition or of the mixtures as a whole, or on data obtained using calculation methods for chemical products that are mixtures.
23. The results of the classification of chemical products according to hazardous properties carried out using data obtained as a result of research (testing) of the chemical substances or mixtures included in their composition shall take precedence over classification results obtained using calculation methods.
24. The established hazard class (subclass, type) of chemical products shall be specified by the manufacturer (person authorised by the manufacturer) or importer of these products in the Safety Data Sheet for Chemical Products.
25. Research (testing) of chemical products for classification purposes shall be carried out by the manufacturer (person authorised by the manufacturer) or importer of these products in laboratories (centres) of their choice.
26. The classification of mixtures according to hazardous properties shall be carried out in accordance with the following principles:
а) if research (testing) data are available for the chemical substances in the mixtures or for the mixtures as a whole, classification shall be based on these data;
б) if research (testing) data are not available for the chemical substances in the mixtures or for the mixtures as a whole, interpolation or extrapolation methods shall be used (hazard assessment methods using available data on mixtures analogous to those being classified);
в) if research (testing) data for the mixtures as a whole are not available and there is no information that would allow interpolation or extrapolation methods to be applied, hazard assessment methods based on data concerning individual chemical substances in the mixture shall be used for classification.
27. Chemical products shall be subject to reclassification when their component composition changes if, as a result of such change, the concentration of the chemical substances included in their composition in relation to their initial concentration exceeds the permissible deviations in the content of hazardous chemical substances in chemical products in accordance with Annex No. 2.
VI. Safety Requirements for Chemical Products
28. The safety of handling chemical products shall be ensured by:
а) compliance by the manufacturer (person authorised by the manufacturer) or importer of chemical products with the requirements of this Technical Regulation;
б) use (application) of chemical products by the consumer (purchaser) for their intended purpose;
в) conformity assessment of chemical products for compliance with the requirements of this Technical Regulation;
г) implementation by the manufacturer (person authorised by the manufacturer), importer and consumer (purchaser) of chemical products of precautionary measures when handling chemical products;
д) replacement of hazardous chemical substances with chemical substances of a lower hazard class or with substances not classified as hazardous (where possible);
е) informing the consumer (purchaser) of the hazardous properties of chemical products with respect to human life and health, property, the environment, and the life and health of animals and plants, as well as of measures for their safe handling in the customs territory of the Union, including in the event of expiry of their shelf life or unsuitability for use;
ж) informing the consumer (purchaser) of methods for the safe disposal and neutralisation of chemical products.
VII. Requirements for the Labelling of Chemical Products
29. The labelling of chemical products shall include the following information:
а) the name of the chemical product established during its identification (the name of the chemical product may additionally include a trade (brand) name);
б) the name, location (address of the legal entity), including the country, and telephone number of the manufacturer (person authorised by the manufacturer) and importer of the chemical products;
в) the names of chemical substances and mixtures classified as hazardous and contained in the chemical products in quantities exceeding the concentration values specified in the standards included in the list of international and regional (interstate) standards, or, in their absence, national (state) standards, as a result of the application of which, on a voluntary basis, compliance with the requirements of this Technical Regulation is ensured;
г) storage conditions and the manufacturer's warranty obligations (shelf life, storage period, etc.);
д) the designation of the document in accordance with which the chemical products were manufactured (if available);
е) information on the hazardous properties of the chemical products, including hazard labelling.
30. The labelling of chemical products placed on the market in the customs territory of the Union shall be provided in Russian and, where required by the legislation of the Member States, in the state languages of the Member State in whose territory the chemical products are sold.
31. The labelling shall be clear and legible, resistant to mechanical impact, exposure to chemical substances and climatic factors, and shall remain intact until the chemical products have been completely used and/or disposed of (processed).
32. The labelling of chemical products may contain additional information.
33. The labelling of chemical products shall be applied directly to the product packaging or to a label attached to the packaging. The hazard labelling elements shall be visually distinguishable from other information contained in the labelling of the chemical products and shall comply with GOST 31340-2013.
34. If there is insufficient space on the packaging for applying the labelling, the chemical products shall be accompanied by a tag or insert containing the complete information specified in paragraph 29 of this Technical Regulation.
VIII. Requirements for Hazard Labelling
35. Hazard labelling shall be applied in the form of a hazard pictogram, hazard symbol and signal word and shall contain a description of precautionary measures in accordance with GOST 31340-2013.
IX. Requirements for the Safety Data Sheet
36. The manufacturer (person authorised by the manufacturer) and importer of chemical products placing chemical products on the market in the customs territory of the Union shall prepare a safety data sheet.
When preparing the safety data sheet, information on the properties of chemical substances and mixtures contained in the Union Register of Chemicals and Mixtures may be used.
37. When chemical products are supplied, the safety data sheet shall be included in the accompanying documentation for the chemical products.
38. The safety data sheet shall be prepared before the chemical products are placed on the market in the customs territory of the Union.
39. The requirements for the information to be contained in the safety data sheet are specified in GOST 30333-2007.
40. The original safety data sheet shall be retained by the manufacturer (person authorised by the manufacturer) and importer of the chemical products.
41. The validity period of the safety data sheet is unlimited.
42. The safety data sheet shall be updated and reissued in the following cases:
а) change in the name and/or address of the manufacturer (person authorised by the manufacturer) or importer of the chemical products;
б) change in the composition of the chemical products resulting in the reclassification of these products in accordance with paragraph 27 of this Technical Regulation;
в) receipt of additional or new information increasing the completeness and reliability of the data.
43. At the request of consumers (purchasers) of chemical products and any interested registered legal entities or individuals acting as individual entrepreneurs, as well as individuals, a copy of the safety data sheet shall be provided to them free of charge by the manufacturer (person authorised by the manufacturer) or importer of these products.
X. Ensuring the Compliance of Chemical Products with the Requirements of the Technical Regulation
44. Compliance of chemical products with this Technical Regulation shall be ensured by fulfilling its requirements.
45. The test methods for chemical products shall be established in the standards included in the list of international and regional (interstate) standards, or, in their absence, national (state) standards containing rules and methods for tests and measurements, including sampling rules, necessary for the application and fulfilment of the requirements of this Technical Regulation and for carrying out conformity assessment of chemical products.
XI. Notification of New Chemical Substances
46. Notification of new chemical substances shall be carried out by entering information about them in the Union Register of Chemicals and Mixtures.
47. Notification shall be carried out by the authorized bodies of the Member States (hereinafter referred to as the authorized bodies) with respect to new chemical substances placed on the market in the customs territory of the Union after the entry into force of this Technical Regulation, in the procedure established by the Eurasian Economic Commission.
48. The information submitted to the authorized body for the purpose of notifying new chemical substances shall include:
а) a Chemical Safety Report in accordance with the structure set out in Annex No. 3;
б) the name of the chemical substance according to the IUPAC nomenclature, including in English;
в) the structural formula of the chemical substance;
г) the CAS number;
д) instrumental analysis data for the chemical substance;
е) the degree of purity of the chemical substance;
ж) the intended areas of use of the chemical substance;
з) the intended methods for disposing of (processing) the chemical substance;
и) the method of transporting the chemical substance and measures to prevent and eliminate emergency situations that have arisen;
к) analytical control methods;
л) physicochemical data on the chemical substance;
м) toxicity data for the chemical substance;
н) ecotoxicity data for the chemical substance;
о) copies of data (test reports) from studies (tests) of the chemical substance to determine bioaccumulation, carcinogenicity, mutagenicity and toxicity, conducted in laboratories (centres) recognised by the authorized body as complying with the principles of Good Laboratory Practice in accordance with the legislation of the Member State (studies (tests) may be conducted in other laboratories (centres) for 2 years from the date of entry into force of this Technical Regulation).
XII. Conformity Assessment of Chemical Products with the Requirements of the Technical Regulation
49. Chemical products shall be subject to conformity assessment before being placed on the market in the customs territory of the Union.
50. Conformity assessment of chemical products with the requirements of this Technical Regulation shall be carried out in the forms of:
a) notification-based state registration;
b) authorization-based state registration.
51. For notification-based state registration and authorization-based state registration of chemical products, applicants may be legal entities or natural persons registered in accordance with the legislation of a Member State in its territory as individual entrepreneurs, who are manufacturers (persons authorised by the manufacturer) or importers of these products.
52. Notification-based state registration and authorization-based state registration of chemical products shall be carried out by the authorized body.
53. Notification-based state registration of chemical products shall be carried out where the information on the chemical products is included in the Union Register of Chemicals and Mixtures and one of the following requirements is met:
a) the chemical products do not contain prohibited and (or) restricted chemical substances and mixtures included in the Union Register of Chemicals and Mixtures;
b) the chemical products contain restricted chemical substances and mixtures, information on which is included in the Union Register of Chemicals and Mixtures, in concentrations below the established threshold content in accordance with Annex No. 4.
54. For notification-based state registration of chemical products with the issuance of a Certificate of Notification-Based State Registration of Chemical Products, the applicant shall submit the following documents to the authorized body:
a) an application for notification-based state registration of chemical products in the form set out in Annex No. 5;
b) a safety data sheet prepared in accordance with paragraphs 36 43 of this Technical Regulation;
c) test reports issued by testing (research) laboratories (centres), and (or) documents containing information obtained from official information sources. Test reports shall not be submitted for chemical products included in the Union Register of Chemicals and Mixtures, or for chemical products that can be classified using calculation methods.
55. Notification-based state registration of chemical products may be carried out electronically.
56. For notification-based state registration of chemical products in accordance with paragraph 55 of this Technical Regulation, the applicant shall submit electronically to the authorized body the documents specified in paragraph 54 of this Technical Regulation.
57. The review of the documents submitted by the applicant, both electronically and in hard copy, the adoption of a decision on notification-based state registration of chemical products or refusal thereof, the assignment of an individual registration number to the chemical products, the issuance of a Certificate of Notification-Based State Registration of Chemical Products in the form set out in Annex No. 6, and the entry of a registration mark electronically shall be carried out by the authorized body within 10 working days from the date of receipt of the documents specified in paragraph 54 of this Technical Regulation.
58. The validity period of the Certificate of Notification-Based State Registration of Chemical Products and the electronic registration mark shall be unlimited.
59. Authorization-based state registration shall be carried out for:
a) new chemical products;
b) chemical products containing restricted chemical substances and mixtures, information on which is included in the Union Register of Chemicals and Mixtures, in concentrations exceeding the threshold content established in Annex No. 4 to this Technical Regulation.
60. For authorization-based state registration of chemical products, the applicant shall submit the following documents to the authorized body:
a) an application for authorization-based state registration of chemical products in the form provided for in Annex No. 5 to this Technical Regulation;
b) a safety data sheet prepared in accordance with paragraphs 36 – 43 of this Technical Regulation;
c) test reports issued by testing (research) laboratories (centres), and (or) documents containing information obtained from official information sources. Test reports shall not be submitted for chemical products, information on which is included in the Union Register of Chemicals and Mixtures, or for chemical products that can be classified using calculation methods;
d) the information specified in paragraph 48 of this Technical Regulation.
61. The review of the documents submitted by the applicant, the adoption of a decision on authorization-based state registration of chemical products or refusal thereof, the assignment of an individual registration number to the chemical products, the entry of information on the name, chemical composition and properties of the chemical products in the Union Register of Chemicals and Mixtures, and the issuance of an Authorization for the Use of Chemical Products in the form set out in Annex No. 7 shall be carried out by the authorized body within 45 working days from the date of receipt of the documents specified in paragraph 60 of this Technical Regulation.
62. The validity period of the Authorization for the Use of Chemical Products shall be 5 years from the date of its issuance.
If, within 5 years from the date of issuance of the Authorization for the Use of Chemical Products, the authorized body has not raised any objections regarding the non-compliance of the chemical products with the requirements of this Technical Regulation, the authorized body shall automatically re-register these products.
63. The preparation and issuance of the Certificate of Notification-Based State Registration of Chemical Products and the Authorization for their Use shall be carried out by the authorized body in accordance with the procedure for establishing and maintaining the Union Register of Chemicals and Mixtures and the procedure for notification of new chemical substances.
64. Notification-based state registration and authorization-based state registration of chemical products may be refused in the event of:
a) the applicant submitting incomplete or inaccurate information specified in paragraphs 54 and 60 of this Technical Regulation;
b) non-compliance of the chemical products with the requirements of this Technical Regulation.
65. Where the component composition of chemical products changes, the products shall be subject to repeat notification-based state registration or authorization-based state registration if, as a result of such change, the concentration of the hazardous chemical substances contained in the products, relative to their initial concentration, exceeds the permissible deviations specified in Annex No. 2 to this Technical Regulation.
66. The placing on the market of chemical products in the customs territory of the Union may be suspended by the authorized body if:
a) chemical products placed on the market in the customs territory of the Union do not comply with the requirements of this Technical Regulation;
b) new safety requirements have been established for the chemical products.
XIII. Labelling of Chemical Products with the Single Mark of Product Circulation on the Market of the Union
67. Chemical products that comply with the requirements of this Technical Regulation and other Technical Regulations of the Union (Customs Union) applicable to them, and that have undergone conformity assessment in accordance with the provisions of this Technical Regulation, shall be marked with the single mark of product circulation on the market of the Union.
68. The single mark of product circulation on the market of the Union shall be applied before the chemical products are placed on the market in the customs territory of the Union.
69. The single mark of product circulation on the market of the Union shall be applied to each unit of chemical products (consumer and transport packaging, or a label, or an identification tag) by any method that ensures a clear and distinct image throughout the entire shelf life of such chemical products.
If it is impossible to apply the single mark of product circulation on the market of the Union to the consumer and transport packaging, or a label, or an identification tag, it may be applied to the accompanying documentation.
70. The marking of chemical products with the single mark of product circulation on the market of the Union certifies that the chemical products comply with the requirements of this Technical Regulation and other Technical Regulations of the Union (Customs Union) applicable to them.
XIV. State Control (Supervision) over Compliance with the Requirements of the Technical Regulation
71. State control (supervision) over compliance with the requirements of this Technical Regulation in respect of chemical products shall be carried out in accordance with the legislation of the Member States.
ANNEX No. 1
to the Technical Regulation
of the Eurasian Economic Union
"On the Safety of Chemical Products" (TR EAEU 041/2017)
LIST
of chemical products to which the Technical Regulation of the Eurasian Economic Union "On the Safety of Chemical Products" (TR EAEU 041/2017) does not apply
1. Chemical products intended for research and development activities and (or) constituting the result of research and (or) experimental design development.
2. Mineral resources in their natural occurrence, as well as the following products, unless they have been chemically modified: minerals, ores, ore concentrates, cement clinker, natural gas, liquefied gas, gas condensate, process gas and its components, dehydrated, desalted and stabilized crude oil, associated petroleum gas, coal, coke.
3. Medicinal products and veterinary medicinal products.
4. Perfumery and cosmetic products.
5. Chemical products that are sources of ionizing radiation (including waste from such products), insofar as concerns the classification, labelling and provision of information on hazards caused by the presence of radiation in them.
6. Food products, including biologically active food supplements and Food Additives, as well as ready-made animal feed.
7. Products incorporated into articles that, during circulation in the customs territory of the Eurasian Economic Union, do not change their chemical composition or state of aggregation, are not subject to degradation or oxidation processes, and do not generate dust, vapours or aerosols containing chemical substances that pose a hazard to human life and health, animal and plant life and health, the environment or property.
8. Waste from the production and consumption of chemical products, if it is subject to disposal (recycling).
9. Chemical products subject to the customs transit procedure through the customs territory of the Eurasian Economic Union.
ANNEX No. 2
to the Technical Regulation
of the Eurasian Economic Union
"On the Safety of Chemical Products"
(TR EAEU 041/2017)
Permissible deviations in the content of hazardous chemical substances in chemical products
Initial content of hazardous chemical substances in chemical products (С), % | Permissible deviations, % |
1 | 2 |
С ≤ 2,5 | ± 30 |
2,5 < C ≤ 10 | ± 20 |
10 < C ≤ 25 | ± 10 |
25 < C ≤ 100 | ± 5 |
APPENDIX No. 3
to the Technical Regulation
of the Eurasian Economic Union
"On the Safety of Chemical Products"
(TR EAEU 041/2017)
STRUCTURE
of the Chemical Safety Report
APPROVED
(full name, position of the applicant)
"____"20____
Seal
I. General Information
1. Applicant details (manufacturer (person authorised by the manufacturer), importer of chemical products) (name (surname, first name, patronymic) and location (address of the legal entity) of the applicant, state registration numbers, bank and postal details, telephone number, email address).
2. Information on chemical products (name, component composition, CAS number (if available)), their production and use.
3. Classification and labelling.
4. Guidance on safe use.
5. Results of studies of physicochemical, toxicological and ecotoxicological properties.
6. Proposals for additional testing.
7. Information on hazards to human life and health, animal and plant life and health, the environment and property.
8. Assessment of the possibility of using safe chemical substances as alternative components of the chemical products being registered.
II. Hazard Assessment
1. Health hazard assessment.
2. Explosion and fire hazard assessment.
3. Environmental hazard assessment.
4. Assessment of persistence, bioaccumulation capacity and toxicity.
5. Exposure assessment (for hazardous and/or persistent, bioaccumulative and toxic chemical substances).
6. Exposure scenarios (for hazardous and/or persistent, bioaccumulative and toxic chemical substances).
7. Risk characterization (for hazardous and/or persistent, bioaccumulative and toxic chemical substances).
APPENDIX No. 4
to the Technical Regulation
of the Eurasian Economic Union
"On the Safety of Chemical Products"
(TR EAEU 041/2017)
Threshold content of restricted chemical substances in chemical products
Hazard types of chemical substances | Concentration (С), % (by weight) |
1 | 2 |
Carcinogens (classes 1 and 2) | 0,1 |
Mutagens (class 1) | 0,1 |
Mutagens (class 2) | 1 |
Reproductive toxicants (classes 1 and 2) | 0,1 |
Hazardous to the aquatic environment through chronic toxicity (class 1) | 1 |
APPENDIX No. 5
to the Technical Regulation
of the Eurasian Economic Union
"On the Safety of Chemical Products"
(TR EAEU 041/2017)
(form)
APPLICATION
for conducting state
(notification‑based or authorization‑based – indicate as applicable)
registration of chemical products*
"___" 20___ No.___ |
(name of the authorized body of a Member State of the Eurasian Economic Union) |
From
(name and location (address of the legal entity) of the applicant – legal entity, or full name and location of the applicant – individual entrepreneur)
(name (full name) and location (address of the legal entity) of the manufacturer, if the applicant and the manufacturer are not the same person)
(state registration number)
(bank and postal details, telephone number, email address)
I request registration of:
(name of chemical products, indicating the trade (brand) name (if available) and their intended purpose (field of application))
The following documents are attached to the application:
Applicant:
(signature) (full name)
To be completed by a specialist of the authorized body:
Application accepted on "___" 20__ and registered under No.
Employee who accepted
the application:
(position) (signature) (full name)
*The application shall be drawn up on the applicant's letterhead.
APPENDIX No. 6
to the Technical Regulation
of the Eurasian Economic Union
"On the Safety of Chemical Products"
(TR EAEU 041/2017)
(form)
CERTIFICATE
of Notification‑Based State Registration of Chemical Products
No. dated "____" 20___
Validity period: permanent
(name of the authorized body of a Member State of the Eurasian Economic Union)
This certificate is issued to: ,
(information on the state registration of a legal entity or the full name of an individual registered as an individual entrepreneur, including location
(address of the legal entity) – for a legal entity, or place of residence – for an individual registered as an individual entrepreneur – indicate as applicable, telephone
and fax numbers, email address)
being
(manufacturer (person authorised by the manufacturer), importer of chemical products – indicate as applicable)
.
(name of chemical products)
The specified chemical products comply with the requirements of the Technical Regulation of the Eurasian Economic Union "On the Safety of Chemical Products" (TR EAEU 041/2017), and information on them has been entered in the Union Register of Chemicals and Mixtures under No. .
Intended purpose (field of use, restriction on use) of the chemical products:
(position of the official of the authorized body of a Member State of the Eurasian Economic Union) |
(signature) |
(full name) |
Seal
APPENDIX No. 7
to the Technical Regulation
of the Eurasian Economic Union
"On the Safety of Chemical Products"
(TR EAEU 041/2017) (form)
AUTHORIZATION
for the Use of Chemical Products
No. dated "____" 20___
Valid until "____" 20___
(name of the authorized body of a Member State of the Eurasian Economic Union)
This authorization is issued to: ,
(information on the state registration of a legal entity or the full name of an individual registered as an individual entrepreneur, including location (address of the legal entity) – for a legal entity, or place of residence – for an individual registered as an individual entrepreneur – indicate as applicable, telephone and fax numbers, email address)
being
(manufacturer (person authorised by the manufacturer), importer of chemical products – indicate as applicable)
.
(name of chemical products)
The specified chemical products are permitted for circulation in the customs territory of the Eurasian Economic Union in accordance with the requirements of the Technical Regulation of the Eurasian Economic Union "On the Safety of Chemical Products" (TR EAEU 041/2017), and information on them has been entered in the Union Register of Chemicals and Mixtures under No. .
Intended purpose (field of use, restriction on use) of the chemical products:
(position of the official of the authorized body of a Member State of the Eurasian Economic Union) |
(signature) |
(full name) |
Seal
