Technical regulations on the safety of chemical products

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25.01.2018

Technical regulations on the safety of chemical products

DECISION -EAC chemical product technical regulation

About the technical regulations on the safety of chemical products
      GOVERNMENT OF THE RUSSIAN FEDERATION
DECISION from October 7, 2016 N 1019
About technical regulations on the safety of chemical products
In accordance with the Federal Law "On Technical Regulation", the Government of the Russian Federation
Decides:
  1. Approve the attached technical regulations on the safety of chemical products.
  2. The technical regulations approved by this Decree shall enter into force on July 1, 2021.
  3. The Ministry of Industry and Trade of the Russian Federation, in coordination with interested federal executive bodies, prepare and submit to the Government of the Russian Federation in the established order:
draft resolutions of the Government of the Russian Federation on the procedure for notifying new chemicals and on the procedure for the formation and maintenance of the register of chemicals and mixtures - no later than 24 months before the date of entry into force of the technical regulations approved by this resolution;
draft resolution of the Government of the Russian Federation on the definition of the body (bodies) of state control (supervision) authorized to exercise state control (supervision) over compliance with the requirements of the technical regulations approved by this resolution - no later than 3 months before the date of entry into force of the technical regulations, approved by this resolution.
  4. The Ministry of Industry and Trade of the Russian Federation, in consultation with the interested federal executive bodies, not later than 6 months before the date of entry into force of the technical regulations approved by this resolution, to submit to the Government of the Russian Federation a draft list of standardization documents containing rules and research (test) and measurement methods, misrepresented including sampling rules required for application and implementation of technical re parliament's main contribution approved present decision and assessment of compliance of said chemical products to the requirements of technical regulations.
  5. The Federal Agency for Technical Regulation and Metrology shall, with the participation of interested federal executive bodies and organizations, not later than 30 days before the entry into force of the technical regulations approved by this resolution, ensure the development and approval, as well as the publication in a printed publication of the federal executive body authorities on technical regulation and placement in the public information system in an electronic-digital form of the list of documents on the standard ation, as a result of which on a voluntary basis, compliance with technical regulations, approved by the present regulation.
 

Chairman of the Government
Russian Federation
D.Medvedev


Technical regulations on the safety of chemical products


APPROVED
Government Decree
Russian Federation
from October 7, 2016 N 1019


I. General Provisions


1. This technical regulation establishes the safety requirements for chemical products, taking into account the Globally Harmonized System of Hazard Classification and Labeling of Chemicals with regard to the establishment of:
  a) criteria for classifying the hazards of chemicals and mixtures for human health and the environment, as well as hazards due to their physicochemical properties;
  b) elements of the information system, including requirements for labeling and safety data sheets.
  2. This technical regulation is designed to establish in the territory of the Russian Federation mandatory for the application and implementation of requirements for chemical products, to ensure its free movement when issued in circulation in the territory of the Russian Federation.
 

II. Application area


3. This technical regulation is adopted with the aim of protecting the life or health of citizens, property of individuals or legal entities, state or municipal property, environmental protection, life or health of animals and plants, preventing actions that mislead the purchasers, including consumers, energy efficiency and resource saving.
  4. This technical regulation establishes the requirements for the use and performance on the territory of the Russian Federation of requirements for chemical products to be issued on the territory of the Russian Federation, as well as the rules and forms for assessing its compliance, identification rules, requirements for terminology, packaging, labeling or labeling and rules for their application.
Requirements for the processes of production, storage, transportation, sale and disposal are established in technical regulations, the effect of which applies to certain types of chemical products.
  5. The validity of this technical regulation applies to chemical products issued for circulation on the territory of the Russian Federation, with the exception of products listed in Appendix No. 1.
With regard to certain types of chemical products subject to regulation of other technical regulations setting specific requirements for these types of chemical products, the effect of this technical regulation is extended insofar as concerns classification requirements, precautionary labeling and safety data sheets for chemical products in the event that these requirements are not met are settled in other technical regulations.
 

III. Basic concepts


6. For the purposes of applying this technical regulation, the following concepts and their definitions are used:
" bioaccumulation " - the ability of chemicals to accumulate in biological objects;
"explosive chemical products" means solid or liquid chemical products that are themselves capable of chemical reaction with the release of gases at such a temperature, such pressure and at such a rate as to cause damage to surrounding objects;
"flammable liquid" - a liquid having an ignition temperature not higher than 93 ° C;
"flammable chemical products that are in a solid state" - products that can easily catch fire or cause a fire or maintain combustion as a result of friction;
"danger sign" - a color image of a certain geometric shape using contrasting colors, graphic symbols and explanatory inscriptions, designed to warn citizens about immediate or potential danger, prohibition, prescription or permission of certain actions;
"selective toxicity" is a kind of influence that causes disruptions in the functions of individual organs (target organs) and (or) systems of a living organism in case of single and short-term or repeated and prolonged exposure;
"manufacturer" means a legal entity or an individual registered as an individual entrepreneur who performs, on his behalf or on behalf of, the manufacture or manufacture and sale of manufactured chemical products and is responsible for the compliance of these chemicals with the requirements of this technical regulation;
"importer" is a resident of the Russian Federation who has concluded a foreign trade contract with a non-resident of the Russian Federation for import of chemical products to the territory of the Russian Federation, sells chemical products and is responsible for its compliance with the requirements of this technical regulation;
"carcinogens" - agents that can cause or accelerate the development of malignant tumors (tumors);
"Carcinogenicity" - the ability of chemical products to cause mutations (changes in the genetic structure of a living cell), which can lead to the development of malignant tumors (tumors);
"classification" - the definition of the conformity of chemical products to a particular class (subclass, type) of hazard by hazard criteria;
"corrosive chemicals" - products that, as a result of chemical attack, can significantly damage or destroy materials;
"hazard criteria" - quantitative and (or) qualitative values ​​of the state of chemical products from the point of view of safety for humans, animals, the environment, as well as property, on the basis of which an assessment of the type and level of the hazardous effect is formed;
"mutagen" is a chemical product that leads to an increase in the number of mutations in the population of living cells and living organisms;
"mutagenicity" - the ability of chemical products to cause a mutation;
"new chemical" - a chemical not notified in the register of chemicals and mixtures;
"new chemicals" - chemical products that are a new chemical or contain new chemicals;
"Notification" - the procedure for entering information on new chemicals in the register of chemicals and mixtures;
"circulation of chemical products" - the movement of chemical products from the manufacturer to the consumer (acquirer), covering all stages of the life cycle of the product after the completion of its production;
"oxidizing chemicals" - chemical products that support and intensify combustion, which causes or contributes to the ignition of other substances as a result of an exothermic oxidation-reduction reaction (oxidizing chemical products in themselves are not necessarily inflammable (combustible);
"basic chemical" - a component of chemical products that is not an additive or impurity, constitutes a significant part of this product and is therefore used as a name for the chemical product and its detailed identification;
"Acute toxicity" means the negative consequences that occur after the introduction of the substance into the stomach, or the application of a single dose of the substance to the skin, or repeated exposure to the substance within 24 hours, or the ingress of a substance with inhaled air for 4 hours;
"organic peroxides" are organic substances in the liquid or solid state that contain a divalent structure and can be considered as a derivative of hydrogen peroxide product in which one or both of the hydrogen atoms are replaced by organic radicals (organic peroxides and their mixtures are thermally unstable, which can lead to their self-accelerating exothermic decomposition);
"Safety data sheet" means the safety data sheet for chemical products of established form containing information on the hazardous properties of chemical products, information on the manufacturer (the person authorized by the manufacturer), the importer of these products, warning measures and safety requirements for safe handling of chemical products on the territory of the Russian Federation;
" persistence " - the stability of chemical products to the processes of decomposition and transformation;
"consumer (acquirer)" means a registered legal entity or an individual as an individual entrepreneur, as well as an individual who intends to purchase (acquire) chemical products;
"pyrophoric chemical products" - chemical products that (even in small quantities) can ignite within 5 minutes after contact with air;
"Preventive measures" - measures that must be taken to minimize or prevent adverse effects caused by exposure to hazardous chemical products;
"Register of Chemicals and Mixtures" is an information resource containing information on the properties of chemicals and mixtures, including information on their prohibition, restriction or authorization of their use on the territory of the Russian Federation;
"self-heating chemical products" are chemical products in liquid or solid aggregate state (with the exception of pyrophoric chemical products) which, when in contact with air without external energy, is capable of self-heating (self-heating chemical products differ from pyrophoric in that they ignite only in large quantities (kilograms) and after a long period of time (hours, days);
"sensitizing effect" - increasing the sensitivity of the organism to the effects of xenobiotics , which cause an allergic reaction;
"mixture" is a mixture or solution consisting of two or more chemical substances in which these substances do not react with each other;
"toxicity" - the ability of chemical products to cause damage or death of the organism, affecting it non-mechanically;
"authorized person" - registered in accordance with the legislation of the Russian Federation in its territory, a legal entity or an individual as an individual entrepreneur performing the functions of a foreign manufacturer on the basis of a contract in terms of ensuring the compliance of chemical products with the requirements of this technical regulation and with regard to the liability for non-compliance of chemical products to the requirements of this technical regulation;
"chemical products" - chemical substance or mixture;
"chemical" means chemical elements and (or) their compounds that are in the natural state or obtained from any manufacturing process, including any additives necessary to ensure stability, and any impurities resulting from the production of chemical products, excluding any solvent that can be separated without disturbing the stability of the chemical or changing its composition (chemicals include chemical products in which a chemical is present in the concentration 80 percent (by weight) and more, with the remaining 20 percent (by weight) and less being considered impurities and (or) additives);
"chronic toxicity" is a kind of toxicity that causes disease and (or) death of a living organism under repeated and / or prolonged exposure;
" Ecotoxic chemical" is a chemical that can cause adverse effects in the environment.
 

IV. Rules for the circulation of chemical products on the market


7. Chemical products are issued for circulation on the territory of the Russian Federation when it complies with the requirements of this technical regulation, as well as with the requirements of other technical regulations that apply to it, and provided that it has passed an assessment of compliance with the technical regulations that apply to it.
  8. In the absence of information on chemical products in the register of chemicals and mixtures, the new chemicals in its composition should be notified, and information on them is included in the register of chemicals and mixtures in accordance with paragraphs 47-49 of this technical regulation before release into circulation on the territory of the Russian Federation of chemical products containing such chemicals.
  9. The procedure for the formation and maintenance of the register of chemicals and mixtures is established by the Government of the Russian Federation.
 

V. Rules for the identification of chemical products

10. The identification of chemical products is carried out by the manufacturer (the person authorized by the manufacturer), the importer of these products.
  11. Identification of chemical products includes:
  a) establishment of the name of chemical products;
  b) the attribution of chemical products to chemicals or mixtures;
  c) the establishment of a chemical name for the chemical according to the nomenclature of the International Union for Theoretical and Applied Chemistry (hereinafter referred to as the nomenclature of the International Union) and the identifier of the chemical entered in the register of the Chemical Abstract Service of the American Chemical Society (hereinafter - the substance number in the chemical identifier register) availability);
  d) determination of the chemical composition of the mixture with the identification for each of the constituent components of the identifiable components according to the nomenclature of the International Union and the substance number in the chemical identifier register (if any);
  e) establishing the presence of new chemical substances in chemical products in concentrations of more than 0.1 percent;
  (e) Assignment of chemicals in chemical products:
to new chemicals;
to chemical substances prohibited for use on the territory of the Russian Federation;
to chemicals restricted to use on the territory of the Russian Federation;
  g) definition of the field of application of chemical products;
  h) other necessary information.
  12. When determining the chemical composition of a chemical, it is necessary to identify:
  a) basic chemical substance;
  b) The hazardous chemicals in the composition additives and impurities if they are present in quantities exceeding the concentrations specified in the standards listed standardization documents, as a result of which the voluntary compliance with requirements of the Technical Regulations.
  13. When determining the chemical composition of the mixture must be identified:
  a) the chemical substances present in concentrations greater than 10 percent;
  b) The hazardous chemical substances present in quantities exceeding the concentrations specified in the standards listed standardization documents, as a result of which the voluntary compliance with requirements of the Technical Regulations.
  14. Manufacturers (manufacturer authorized person), importers of chemicals to identify it using the information on chemical substances and mixtures contained in the register of chemical substances and mixtures.

 

VI. Requirements for classification of chemical products

15. Classification chemical products carried by the manufacturer (manufacturer authorized person) importing of such products.
Classification of chemical products carried out in accordance with the standards included in the list of documents for standardization, as a result of which the voluntary compliance with requirements of the Technical Regulations.
  16. Classification of chemical products is carried out based on the data on the hazardous properties of chemical substances and mixtures:
  a) contained in the register of chemicals and mixtures thereof;
  b) obtained as a result of their research (test) to meet the criteria specified in the standards listed standardization documents, as a result of which the voluntary compliance with requirements of the Technical Regulations.
  17. By type of adverse effects in relation to human life and health, property, environment, life and health of animals and plants associated with the physical and chemical properties of chemicals, chemical products are:   a) explosive chemical products;
  b) compressed gas (LPG);
  c) flammable gaseous chemical products (flammable gas);
  g) Flammable Aerosol;
  d) inflammable (combustible) liquid;
  e) flammable chemical products, which is in the solid state;
  g) Self ( SELF ), chemical products;
  h) the pyrophoric chemicals;
  i) self-heating chemical products (except for pyrophoric chemicals);
  k) chemical products, dangerous when in contact with water;
  l) oxidizing the chemical products;
  m) organic peroxides;
  n) corrosive chemical products.
  18. chemical products exhibiting hazardous properties with respect to the life and health of humans and animals, include chemical products, as part of which contains dangerous chemical substances and mixtures in quantities exceeding the concentrations specified in the standards included in the list of documents on standardization, as a result of which the voluntary compliance with requirements of this technical regulation:
  a) having the acute toxicity of the impact on living organisms;
  b) Corrosive (necrosis) and irritation of the skin;
  c) causing severe damage (irritation) Eye;
  d) providing a sensitizing effect;
  d) mutagenic (mutagens);
  e) having carcinogenic properties (carcinogenic);
  g) the effects on reproduction;
  h) having selective toxicity for separate organs (target organs), and (or) system of a living organism with a single and brief exposure or use and repeated prolonged exposure;
  u) representing the risk of aspiration;
  a) persistent, capable to accumulate in biological systems;
  l) characterized by particular resistance and ability to bioaccumulate ;
  m) the level of danger which corresponds to the level of danger such as, in particular, compounds such as endocrine disruptors, for which there is scientific evidence of probable serious effects on human health.
  19. Chemical products, dangerous to the environment, concerns the following chemical products, which are contained in the composition of the hazardous chemicals hazardous mixture in an amount exceeding the concentration values specified in the standards listed standardization documents, as a result of which, on a voluntary basis, compliance with the requirements of this technical regulations:
  a) destroying the ozone layer;
  b) having the acute and chronic toxicity to aquatic life;
  c) having an ability to bioaccumulate ;
  g) having the persistence ;
  e) possess toxic soil.
  20. Chemical products refers to products that deplete the ozone layer, if its composition contains at least one substance from the list of chemicals that deplete the ozone layer. A list of chemical substances that deplete the ozone layer, defined by international agreements of the Russian Federation in regulating entry into the territory of Russian Federation such chemical products.
  21. The main elements of the classification of chemical products, dangerous in relation to the aquatic environment are:
  a) acute aquatic toxicity;
  b) chronic toxicity in the aqueous medium;
  c) potential for bioaccumulation or actual bioaccumulation ;
  g) degradation (biotic and abiotic) - for organic chemicals.
  22. Classification of chemical products, dangerous for soil, is based on a set of indicators of hazardous chemical products, which includes:
  a) toxicity to soil organisms;
  b) persistence in the soil;
  c) the persistence in plants;
  d) the ability to chemical migration products;
  e) the impact on the nutritional value of agricultural products.
  23. Classification of chemicals is based on data obtained from studies (tests), the results or data obtained by calculation methods.
  24. The results of the classification of chemical products conducted using the resulting (tests) of data take precedence over classification results obtained by means of calculation methods.
  25. Fixed a class (a subclass type) the dangers of chemicals specified by the manufacturer (person authorized by the manufacturer), the importer of these products in the safety data sheet.
  26. Research (test) of chemical products for the purposes of classification carried out by the manufacturer (person authorized by the manufacturer), the importer of these products in laboratories (centers) of their choice.
  27. Classification mixtures is carried out in accordance with the following principles:
  a) when data (tests) for the classification of mixtures generally is carried out based on these data;
  b) in the absence of data (tests) for mixtures are generally used interpolation or extrapolation methods (methods of assessing the risk of using the available data for mixtures similarly classified);
  c) in the absence of these studies (test) the mixture as a whole and there is no information which would allow to apply interpolation or extrapolation techniques, methods are used to classify risk assessment based on the data of the individual components (chemicals) mixture.
  28. Chemical products when changing its composition shall be re-classification, if the change in the concentration of the constituent chemicals with respect to their initial concentration resulted in exceeding the allowable deviations of hazardous chemicals in chemical products according to Annex N 2.
 

VII. General safety requirements

29. The safe handling of chemical products should be ensured by means of:
  a) Compliance manufacturer (manufacturer authorized person) importer chemical production requirements hereof;
  b) the use (application) of the user (purchaser) of chemical products to the destination;
  c) assessing compliance chemicals requirements hereof;
  g) implementation of the manufacturer (the person authorized by the manufacturer), importer and consumer (buyer) of chemical products preventive measures when handling chemical products;
  d) replacing the hazardous chemicals to the chemicals of lower class of danger or not classified as dangerous (when possible);   e) inform the customer (the purchaser) on the hazardous properties of chemicals in relation to human life and health, property, environment, life and health of animals and plants and measures for its safe handling in the territory of the Russian Federation.  

VIII. Requirements for labeling of chemicals

30. Labeling of chemical products must include the following information:
  a) Mark of market access;
  b) name of the chemical product, when it is set identification (name of the chemical product may further include commercial (brand) name);
  c) the name, location (legal address), including the country, and the manufacturer (manufacturer's authorized phone number of the person), chemical products importer;
  g) the name of chemicals and mixtures classified as hazardous and contained in the composition of chemical products in quantities exceeding the concentrations specified in the standards listed standardization documents, as a result of which the voluntary compliance with requirements of this technical regulation;
  d) storage conditions;
  e) the designation of the document, according to which chemical products made (if any);
  g) information on the hazardous properties of chemicals, including warning markings.
  31. Labeling of chemical products manufactured in circulation in the territory of the Russian Federation, should be prepared in Russian.
  32. Marking shall be clear and easy to read , mechanical resistance, resistance to chemicals, climatic factors, and must be maintained until the full use and (or) recycling (recycling) of chemical products.
  33. Labeling of chemical products may contain additional information.
  34. Labeling of chemical products applied directly to the product packaging or on its label attached to the packaging. Elements of warning labels should be allocated in comparison with the other information contained in the labeling of chemical products, and must comply with GOST 31340-2013 "label warning of chemical products. General requirements" .
  35. If the location for the marking on the package is insufficient, the chemical products are accompanied by a label or an insert in which the full details are set forth in paragraph 30 of this Technical Regulations.
 

IX. Requirements for precautionary labeling

36. Preventive marking is applied as a sign of danger, the danger symbol, signal word and contains a description of the measures for the prevention of danger in accordance with GOST 31340-2013 "label warning of chemical products. General requirements".
 

X. Requirements for Safety Data Sheet

37. The manufacturer (manufacturer's authorized person), the importer of chemicals that produce chemical products in circulation in the territory of the Russian Federation, the safety data sheet.
When drawing up the safety data sheet can be used data on the properties of chemical substances and mixtures contained in the register of chemical substances and mixtures.
  38. Material Safety Data Sheet in the supply of chemical products should be included in the documentation for chemical products.
  39. Material Safety Data Sheet is made prior to the release of chemicals in circulation in the territory of the Russian Federation.
  40. The requirements for the information to be contained in the safety data sheet are indicated in GOST 30333-2007 "Safety Data Sheet of chemical products. General requirements" .
  41. The safety data sheet original is kept by the manufacturer (manufacturer's authorized person), chemical products importer.
  42. SDS never expires.
  43. Material Safety Data Sheet is subject to updating and reprinting the following cases:
  a) changing the name and (or) the address of the manufacturer (manufacturer authorized person), chemical products importer;
  b) changes in the composition of chemical products, resulting in re-classification of the product in accordance with item 28 of this technical regulation;
  c) receipt of additional or new information that improves the completeness and accuracy of the data.
  44. At the request of customers (buyers) of chemical products and any interested registered legal entities or natural persons as individual entrepreneurs, as well as individuals MSDS copy must be provided to them free of charge by the manufacturer (person authorized by the manufacturer), the importer of these products.
 

XI. Ensuring that the chemical products to the requirements of these technical regulations


45. Compliance with chemical products this technical regulation ensures the implementation of its requirements.
  46. ​​Research Methods (tests) of chemical products established in the standards listed for Standardization document containing rules and checks (tests) and measurement methods, including sampling rules required for application and performance requirements of the Technical Regulations of the assessing and compliance with chemical products to the requirements of this technical regulation.
 

XII. Notification of new chemical substances


47. Notification of new chemical substances is carried out by entering information about them in the register of chemical substances and mixtures.
  48. Notification is carried out by an authorized Government of the Russian Federation, federal executive body (hereinafter - the authorized body) for new chemicals produced in circulation in the territory of the Russian Federation after the entry into force of the technical regulations, in accordance with the procedure established by the RF Government.
  49. The information sent by the applicant to the authorized body for the purpose of notification of new chemical substances must include:
  a) a chemical safety report in accordance with the structure according to the application N 3;
  b) Chemical name according to the nomenclature of the International Union;
  c) the chemical structural formula;
  d) substances Registry number of the chemical ID (if available);
  d) Data of instrumental analysis of the chemical;
  e) the degree of purity chemical;
  g) the intended application of the chemical;
  h) the estimated disposal methods (processing) of the chemical;
  i) a method of transporting chemical substances and measures to prevent and eliminate any emergencies;
  a) analytical methods of control;
  l) The physico-chemical data of the chemical;
  m) the data on chemical toxicity;
  n) data ecotoxicity chemical;
  a) the name of a new chemical in the English language;
  f) copy of the data (protocol) (tests) to determine the chemical bioaccumulation , carcinogenicity, mutagenicity, toxicity, carried out in test laboratories (centers), recognized by the relevant principles of good laboratory practice in accordance with the Federal Law "On Technical Regulation" . Allowed studies (tests) in other laboratories (centers), accredited in accordance with the Federal Law "On accreditation in national accreditation system" and having the appropriate scope of accreditation for 2 years from the date of entry into force of this technical regulation.
  XIII. Conformity assessment of chemical products to the requirements of these technical regulations 50. conformity assessment of chemical production requirements hereof carried out in the forms:
  a) the accounting of state registration;
  b) permitting the state registration;
  c) the state control (supervision) - in the manner prescribed by the legislation of the Russian Federation.
  51. When accounting for state registration and licensing of state registration of chemical products by the applicants can be registered in accordance with the legislation of Russian Federation on the territory of legal entities or natural persons as individual entrepreneurs, is a manufacturer (authorized personnel only), importers of the product.
  52. Accounting state registration and state registration of the authorization of chemical products carried out by the authorized body.
  53. Accounting State registration of chemical products is carried out if:
  a) information on chemical products included in the register chemicals and mixtures thereof;
  b) in the composition of chemical products are not prohibited, and (or) limited to the use of chemicals and mixtures are included in the register chemicals and mixtures thereof;
  c) comprises chemical products limited to the use of chemicals and mixtures are included in the register chemicals and mixtures thereof in concentrations not exceeding the limit values ​​of the content in the composition of chemical products limited to the use of chemical substances according to Annex N 4.
  54. For accounting of chemical products state registration the applicant shall submit to the authorized body the following documents:
  a) a request to hold the account of state registration of chemical products in the form according to appendix N 5;
  b) arranged in accordance with paragraphs 37-44 of this technical regulation MSDS;
  c) studies (tests) carried out in the test (research) laboratories (centers), and (or) documents containing information obtained from official sources of information. Research Protocols (Test) is not submitted for chemical products included in the register chemicals and mixtures thereof, and chemical products, which can be classified using computational methods.
  55. Consideration of documents submitted by the applicant, the decision on account of the state registration of chemical products, or to refuse it, the assignment of chemical products a unique registration number, the introduction of information about chemical products, its chemical composition and properties of the registry of chemical substances and mixtures, the issuance of a certificate of account state registration chemical products according to the Annex N 6 are performed by the authority within 20 working days ostupleniya documents mentioned in paragraph 54 of this Technical Regulations.
  56. Validity of certificates of registration of state registration of chemical products is not limited.
  57. Allowing the state registration is carried out in respect of:
  a) new chemical products;
  b) chemical products, which contain limited to the use of chemicals and mixtures are included in the register chemicals and mixtures thereof in concentrations exceeding the values ​​specified in Annex N 4 to this technical regulation.
  58. In order to permit the state registration of chemical products the applicant shall send to the authorized body the following documents:
  a) a request for authorization state registration of chemical products in the form required application N 5 to this technical regulation;
  b) arranged in accordance with paragraphs 37-44 of this technical regulation MSDS;
  c) studies (tests) carried out in the test (research) laboratories (centers), and (or) documents containing information obtained from official sources of information. Research Protocols (Test) is not submitted for chemical products included in the register chemicals and mixtures thereof, and chemical products, which can be classified using computational methods;
  g) information in accordance with item 49 of this Technical Regulations.
  59. Consideration of documents submitted by the applicant, a decision on the authorization of state registration of chemical products, or to refuse it, the assignment of chemical products a unique registration number, the introduction of information about chemical products, its chemical composition and properties of the registry of chemical substances and mixtures, the issuance of permits for the use of chemical products according to the Annex N 7 are performed by the authority within 45 working days of receipt of the Documentation comrade indicated in paragraph 58 of this Technical Regulations.
  60. Validity of authorization for the use of chemical products is 5 years from the date of its issuance.
In the absence of 5 years from the date of issuance of the permit for the use of chemical products observations from the competent authority of non-compliance of chemical products to the requirements of these technical regulations by the authorized body is carried out automatically discount the state registration of these products.
  61. The preparation and issue of certificates of registration of state registration of chemical products and its use permits are carried out by the authorized body in accordance with the procedure of forming and maintaining the register of chemical substances and mixtures and the procedure of notification of new chemical substances, approved by the RF Government.
  62. The registration and licensing of state registration of chemical products may be refused if:
  a) the furnishing of incomplete or inaccurate information specified in paragraphs 54 and 58 of this technical regulation;
  b) non-compliance of chemical products to the requirements of this technical regulation.
  63. Chemical products when changing its component composition be accounting state registration or licensing registration state if the change in concentration of the constituent of hazardous chemicals with respect to their initial concentration exceeded the tolerance specified in Annex N 2 to this technical regulation.
 

Appendix N 1. The list of chemicals for which technical
regulations on safety of chemical products not covered

Appendix N 1
to the Technical Regulations
on the safety of chemical products

  1. Chemical products intended for research works and (or) is the result of research and (or) development activities.   2. Mineral resources in the occurrence of the state, as well as the following products, if it was not chemically modified: minerals, ores, ore concentrates, cement clinker, natural gas, liquefied natural gas, gas condensate, process gas and its components, oil dehydrated and desalted stable, associated gas, coal and coke.   3. Drugs for medical use and veterinary medicines.   4. Perfume and cosmetic products.   5. Chemicals, which is a source of ionizing radiation (including waste products such), relating to the classification, labeling and awareness of the dangers caused by the presence of radiation in it.   6. Food products, dietary supplements and nutritional supplements, as well as ready to use feed for animals.   7. Products in articles, which in the process of circulation in the Russian Federation does not change its chemical composition and physical state, not subject to processes of degradation and oxidation, does not produce dust, vapors and aerosols containing hazardous chemicals with harmful effects on the lives and human health, life and health of animals and plants, environment and property.   8. Waste chemical products production and consumption, if they are subject to disposal (recycling).   9. Chemicals, subject to the procedure of customs transit through the territory of the Russian Federation.  

Annex N 2. Tolerances of hazardous chemicals in chemical products


Appendix N 2
to the Technical Regulations
on the safety of chemical products

 
Initial content of hazardous chemicals in chemical products (C) tolerances (Percent)
FROM 2.5 ± 30
2.5 ± 20
10 < C 25 ± 10
25 < C 100 ± 10
25 < C 100 ± 5

Annex N 3. Structure of chemical safety report


Appendix N 3
to the technical regulations
on safety of chemical products

I. General Information

1. Details of the applicant (the manufacturer (manufacturer's authorized person), chemical products importer) (name and legal address (location) of the applicant, state registration numbers, bank and post details, phone number, email address).
  2. Information on chemical products (name, component composition, number in the register of substances chemical identifier (if any), its production and use.
  3. Classification and labeling.
  4. Guidance on safe use.
  5. Results of studies physicochemical, toxicological and ecotoxicological properties.
  6. Proposals for additional testing. Information on the effects on human, property, environment, life and animal and plant health.
  7. Assessment of the possibility of using safe chemicals as alternative components registered chemicals.
 

II. hazard assessment

1. The risk assessment in respect of life and human and animal health.
  2. Assessment of explosion - and fire.
  3. Evaluation of hazard to the environment.
  4. Evaluation of durability, ability to bioaccumulate and toxicity.
  5. Impact Assessment (Hazardous and (or) Persistent capable of bioaccumulation and accumulation of toxic chemicals).
  6. impact scenarios (for hazardous and (or) Persistent capable of bioaccumulation and accumulation of toxic chemicals).
  7. Risk Characteristics (Hazardous and (or) Persistent capable of bioaccumulation and accumulation of toxic chemicals).
 

Annex N 4. limiting content in the chemical production limited to the use of chemicals

Appendix N 4
to the technical regulations
on safety of chemical products

Hazards of chemicals Concentration percent (by weight)
Carcinogens (grades 1 and 2) 0.1
Mutagens (Class 1) 0.1
Mutagens (Class 2) 1
Effect on reproductive function (grades 1 and 2) 0.1
Those with chronic toxicity to aquatic environment (Class 1) 1

Annex N 5. Statement on the implementation of chemical products state registration *

Appendix N 5
to the technical regulations
on safety of chemical products

(the form)

   

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