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Chapter 2. Technical regulations
Article 6. The Purposes of Adoption of Technical Regulations
1. The technical regulations shall be adopted for the purpose of:
protection of life or health of people, property of natural or legal persons, state or municipal property;
protection the environment, life or health of animals and plants;
prevention of actions misleading the purchasers.
2. Adoption of technical regulations for other purposes is not allowed.
Article 7. The Matter and Application of Technical Regulations
1. The technical regulations, taking into account the risk degree of causing harm, shall establish the minimally necessary requirements, providing:
emanation safety; biological safety; explosion safety; mechanical safety; fire safety; industrial safety; thermal safety; chemical safety; electrical safety; nuclear and radiation safety; electromagnetic compatibility regarding safety operation of devices and equipment; uniformity of measurements.
2. The requirements of technical regulations may not serve as a barrier to realization of business activity in the greater degree, than it is minimally necessary for execution of the purposes specified in Clause 1 of Article 6 of this Federal law.
3. The technical regulation shall contain the exhausting list of products, processes of production, operation, storage, transportation, marketing and utilization, in relation to which its requirements are established, and the rules for identification of technical regulating object for the purposes of application of the technical regulation. The technical regulation, with a view of its adoption, may contain the rules and forms of conformity assessment (including the schemes of conformity assurance), defined in view of a risk degree, deadlines of conformity assessment in relation to every technical regulating object and (or) the requirements for terminology, packing, marking or labeling and the rules of their affixing.
The conformity assessment shall be carried out in the form of state control (supervision), accreditation, testing, registration, conformity assurance, acceptance and commissioning of an object whose construction is completed, and in other forms.
The obligatory requirements, contained in technical regulations, for products, processes of production, operation, storage, transportation, marketing and utilization, the rules and forms of conformity assessment, the rules of identification, the requirements for terminology, packing, marking or labeling and the rules of their affixing shall be exhausting, shall have direct action in the whole territory of the Russian Federation and may be changed only by inserting of amendments and addenda in the appropriate technical regulation.
The requirements for products, processes of production, operation, storage, transportation, marketing and utilization, the rules and forms of conformity assessment, the rules of identification, the requirements for terminology, packing, marking or labeling and the rules of their affixing, not included into technical regulations, may not be the obligatory ones.
4. The technical regulation shall contain the requirements for product performances, processes of production, operation, storage, transportation, marketing and utilization, but shall not contain the requirements for design and modification, except for the cases, when the reaching of the purposes of the technical regulation adoption, specified in Clause 1 of Article 6 of this Federal law, is not ensured because of absence of the requirements for design and modification in view of a risk degree of causing harm.
5. The technical regulations, in view of a risk degree of causing harm, may contain the special requirements for products, processes of production, operation, storage, transportation, marketing and utilization, the requirements for terminology, packing, marking or labeling and the rules of their affixing, providing the protection of separate categories of people (minors, pregnant women, nursing mothers, invalids).
6. The technical regulations shall be applied in identical way and in equal measure irrespective of the country and (or) place of product origin, realization of processes of production, operation, storage, transportation, marketing and utilization, types or peculiarities of bargains and (or) natural and (or) legal persons being manufacturers, executors, sellers, purchasers, taking into account the provisions of Clause 9 of this Article.
7. The technical regulation may not contain the requirements for the products, causing harm to life or health of people, which is accumulated during long use of these products and depends on other factors, not allowing to determine the degree of permissible risk. In these cases the technical regulation may contain the requirement concerning the informing of the purchaser on possible harm and on factors upon which it depends.
8. The international standards and (or) national standards may be used in full or in part as a basis for development of draft technical regulations.
9. The technical regulation may contain the special requirements for products, processes of production, operation, storage, transportation, marketing and utilization, terminology, packing, marking or labeling and the rules of their affixing, applied in separate places of the products origin, if the absence of such requirements can result, taking into account the climatic and geographical peculiarities, in non-reaching of the purposes specified in Clause 1 of Article 6 of this Federal law.
The technical regulations shall also establish the minimally necessary veterinary-sanitary and phytosanitary measures in relation to products originating from the separate countries and (or) places, including the restriction of import, use, storage, transportation, marketing and utilization, providing biological safety (irrespective of the ways of safety assurance used by the manufacturer).
The veterinary-sanitary and phytosanitary measures may provide for the requirements for products, for methods of product processing and production, for procedures of product testing, inspection, conformity assurance, the quarantine rules, including the requirements connected with transportation of animals and plants, for materials necessary to ensure life or health of animals and plants during their transportation, and also for methods and procedure of sampling, for methods of research and evaluating of risk and other requirements contained in technical regulations.
The veterinary-sanitary and phytosanitary measures shall be developed and applied on the basis of scientific data, and also taking into account the appropriate international standards, recommendations and other documents of the international organizations with a view of observance the necessary level of veterinary-sanitary and phytosanitary protection, which is defined taking into account the degree of actual scientifically justified risk. When evaluating the risk degree there may be taken into consideration the provisions of the international standards, recommendations of the international organizations, whose participant is the Russian Federation, prevalence of diseases and pests, and also the measures taken by suppliers for struggle against diseases and pests, the ecological conditions, the economic consequences connected with possible causing of harm, the volume of expenses for preventing of causing the harm.
When the urgent application of veterinary-sanitary and phytosanitary measures is necessary for achievement of the purposes of veterinary-sanitary and phytosanitary protection, and the appropriate scientific substantiation is insufficient or can not be obtained in proper time, the veterinary-sanitary and phytosanitary measures, provided for by technical regulations in relation to definite types of products, may be applied on the basis of available information, including the information obtained from the appropriate international organizations, authorities of the foreign states, information on appropriate measures applied by others states or other information. Before adoption of the appropriate technical regulations in the case, established by this paragraph, veterinary-sanitary and phytosanitary measures are valid according to Clause 5 of Article 46 of this Federal law.
The veterinary-sanitary and phytosanitary measures shall be applied taking into account the appropriate economic factors - potential injury from reduction of volume of product manufacturing or sales in case of penetration, assimilation or spreading of any pest or disease, expenses for struggle against them or their liquidation, efficiency of application of alternative measures for limitation of risks, and also the necessity of minimizing the effect of the pest or disease on environment, production and circulation of products.
10. The technical regulation, adopted by the federal law or by decree of the Government of the Russian Federation, inures not earlier than in six months from the date of its official publication.
11. The rules and methods of researches (tests) and measurements, and also the rules of sampling for carrying out the researches (tests) and measurements, necessary for application of technical regulations, shall be developed, with observance of provisions of Article 9 of this Federal law, by federal executive bodies within the limits of their competence within six months from the date of official publication of technical regulations, and shall be affirmed by the Government of the Russian Federation.
12. The government of the Russian Federation shall develop proposals on ensuring of conformity of technical regulating to interests of the national economy, to a level of development of material basis and technological level, and also to the international norms and rules. For these purposes the Government of the Russian Federation shall affirm the program of development of technical regulations which is specified and published yearly.
The Government of the Russian Federation shall organize the continuous registration and analysis of all the cases of causing harm, as a result of violation of requirements of technical regulations, to life or health of people, property of natural or legal persons, state or municipal property, environment, life or health of animals and plants, taking into account the weight of this harm, and also shall organize the informing of purchasers, manufacturers and sellers on the situation in the field of observance of technical regulation requirements.
Article 8. Types of Technical Regulations
1. The following technical regulations are valid in the Russian Federation:
general technical regulations;
special technical regulations.
Obligatory requirements for separate types of products, processes of production, operation, storage, transportation, marketing and utilization shall be defined by set of requirements of general technical regulations and special technical regulations.
2. The requirements of general technical regulation are obligatory for application and observance in relation to any kinds of products, processes of production, operation, storage, transportation, marketing and utilization.
3. The requirements of express technical regulation shall take into account technological and other peculiarities of separate types of products, processes of production, operation, storage, transportation, marketing and utilization.
4. General technical regulations shall be adopted regarding:
safe operation and utilization of machines and equipment;
safe operation of buildings, structures, constructions and safe use of territories adjoining to them;
fire safety;
biological safety;
electromagnetic compatibility;
ecological safety;
nuclear and radiation safety.
5. Special technical regulations shall establish the requirements only for those separate types of product, processes of production, operation, storage, transportation, marketing and utilization, in relation to which the purposes, defined by this Federal law for adoption of technical regulations, are not ensured by the requirements of general technical regulations.
Special technical regulations shall establish the requirements only for those separate types of products, processes of production, operation, storage, transportation, marketing and utilization, whose risk degree of causing harm is higher than the risk degree of causing harm, taken into account by general technical regulation.
Article 9. Order of Developing, Adoption, Amending and Cancellation of Technical Regulation
1. The technical regulation shall be adopted by a federal law in the order established for adoption of federal laws, taking into account the provisions of this Federal law.
2. Any person may be the developer of draft technical regulation
3. The notification about development of draft technical regulation shall be published in the print of federal executive body on technical regulating and in information system of general-purpose in electronic-digital format.
The notification about development of draft technical regulation shall contain the information on products, processes of production, operation, storage, transportation, marketing and utilization, in relation to which the requirements being developed shall be established, with summary of the purpose of this technical regulation, with substantiation of necessity of its development and with specifying of those requirements being developed which differ from provisions of the appropriate international standards or obligatory requirements, which are valid in the territory of the Russian Federation at the moment of development of this draft technical regulation, and besides that the information on a method of familiarization with draft technical regulation, the denomination or surname, name and patronymic of the developer of the given draft technical regulation, the postal and e-mail (if any) addresses for receipt of written notices from the interested persons.
4. From the moment of publication of the notification on development of draft technical regulation this draft shall be available to the interested persons for familiarization. The developer is obliged on demand of the interested person to give him the copy of draft technical regulation. The payment for giving of this copy may not exceed an expenditure for its manufacture.
The developer shall update draft technical regulation taking into account the written notices of the interested persons, shall carry out public discussion of draft technical regulation and make the list of written notices of the interested persons with summarized contents of these notices and results of the discussion.
The developer is obliged to save written notices of the interested persons up to the date of coming into force of technical regulation, adopted by the appropriate normative legal act, and to grant them to deputies of State Duma, to representatives of federal executive bodies and expert commissions on technical regulating, specified in Clause 9 of this Article, at their inquiries.
The period of public discussion of draft technical regulation from the date of publication of the notification about development of draft technical regulation up to the date of publication of the notification about completion of public discussion may not be less than two months.
5. The notification about completion of public discussion of draft technical regulation shall be published in the print of federal executive body on technical regulating and in general-purpose information system in electronic-digital format.
The notification about completion of public discussion of draft technical regulation shall include the information on a method of familiarization with draft technical regulation and the list of written notices of the interested persons, and also the denomination or surname, name and patronymic of the developer of draft technical regulation, the postal and e-mail (if any) addresses for contact with the developer.
From the date of publication of notification about completion of public discussion of draft technical regulation the updated draft technical regulation and the list of written notices of the interested persons shall be available to the interested persons for familiarization.
6. The federal executive body on technical regulating is obliged to publish in the print the notification about development of draft technical regulation and of completion of public discussion of this draft within ten days from the moment of payment for publication of notices. The order of publication of notices and amount of payment for their publication shall be established by the Government of the Russian Federation.
7. The submission of draft federal law on technical regulation to State Duma by a subject of legislative leadership right shall be carried out in the presence of the following documents:
substantiation of necessity of adoption of federal law on technical regulation with specifying of those requirements, which differ from provisions of the appropriate international standards or obligatory requirements, which are valid in the territory of the Russian Federation at the moment of development of draft technical regulation;
financial and economic substantiation of adoption of federal law on technical regulation;
documents confirming the publication of notification about development of draft technical regulation according to Clause 3 of this Article;
documents confirming the publication of notification about completion of public discussion of draft technical regulation according to Clause 5 of this Article;
list of written notices of the interested persons specified in Clause 4 of this Article.
Draft federal law on technical regulation with attached documents specified in this Clause, submitted to State Duma, shall be addressed by State Duma to the Government of the Russian Federation. Within one month after that the Government of the Russian Federation shall address to State Duma its comments for draft federal law on technical regulation, prepared in view of a conclusion of the expert commission on technical regulating.
8. Draft federal law on technical regulation, adopted by State Duma in the first reading, shall be published in the print of federal executive body on technical regulating and in general-purpose information system in electronic-digital format.
The corrections to draft federal law on technical regulation, adopted in the first reading, after termination of a period of their handing in shall be published in general-purpose information system in electronic-digital format not later than one month prior to consideration by State Duma of draft federal law on technical regulation in the second reading.
Federal executive body on technical regulating is obliged to publish in its print the draft federal law on technical regulation within ten days from the moment of payment for its publication. The order of publication of draft federal law on technical regulation and amount of payment for its publication shall be established by the Government of the Russian Federation.
Draft federal law on technical regulation, prepared for the second reading, shall be addressed by State Duma to the Government of the Russian Federation not later than one month before consideration of the specified draft by State Duma in the second reading. Within one month after that the Government of the Russian Federation shall address to State Duma its comments for draft federal law on technical regulation, prepared in view of a conclusion of the expert commission on technical regulating.
9. The expertise of draft technical regulations shall be carried out by expert commissions on technical regulating, which consist, on an equal footing, of representatives of federal executive bodies, scientific organizations, self-regulated organizations, public associations of businessmen and consumers.
The order of creation and functioning of expert commissions on technical regulating shall be affirmed by the Government of the Russian Federation. Federal executive body on technical regulating shall affirm the personnel of expert commissions on technical regulating and shall provide its functioning. The sessions of expert commissions on technical regulating shall be open.
The conclusions of expert commissions on technical regulating are subject to obligatory publication in the print of federal executive body on technical regulating and in general-purpose information system in electronic-digital format. The order of publication of such conclusions and amount of payment for their publication shall be established by the Government of the Russian Federation.
10. In case of noncompliance of technical regulation with the interests of the national economy, with development of material basis and technological level, and also with the international norms and rules, the Government of the Russian Federation is obliged to start the procedure of inserting the amendments into the technical regulation or procedure of cancellation of the technical regulation.
The inserting of amendments and addenda into technical regulation or its cancellation shall be carried out in the order, provided for in this Article and Article 10 of this Federal law regarding development and adoption of technical regulations.
Article 10. Special order of development and adoption of technical regulations
1. In case of arising of unusual circumstances, resulting in direct threat to life or health of people, to environment, life or health of animals and plants, and in cases when for safety assurance of products, processes of production, operation, storage, transportation, marketing and utilization it is necessary to adopt immediately the appropriate normative legal act about technical regulation, President of the Russian Federation has the right to publish the technical regulation without its public discussion.
2. Technical regulation may be adopted by an international treaty (including the treaty with the CIS countries), subject to ratification in the order established by the legislation of the Russian Federation. In this case the draft technical regulation shall be developed in the order established by Clauses 2 to 6 of Article 9 of this Federal law.
3. Before coming into force of the federal law on technical regulation the Government of the Russian Federation shall have the right to publish a decree about appropriate technical regulation, developed in the order established by Clauses 2 to 6 of Article 9 of this Federal law.
Draft decree of the Government of the Russian Federation on technical regulation, prepared for consideration at session of the Governments of the Russian Federation, not later than one month before its consideration shall be sent for expertise to appropriate expert commission on technical regulating, which is created and realizes its activity in the order, established by Clause 9 of Article 9 of this Federal law. The draft decree of the Government of the Russian Federation about technical regulation shall be considered at session of the Government of the Russian Federation in view of the conclusion of appropriate expert commission on technical regulating.
Draft decree of the Government of the Russian Federation about technical regulation shall be published in the print of federal executive body on technical regulating and in general-purpose information system in electronic-digital format not later than one month before its consideration at session of the Government of the Russian Federation. The order of publication of the specified draft decree shall be established by the Government of the Russian Federation.
4. The appropriate technical regulation, issued by decree of President of the Russian Federation or decree of the Government of the Russian Federation, loses force from the date of coming into force of federal law on technical regulation.
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