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RUSSIAN
FEDERATION
FEDERAL LAW
No.
184-ŌĒ, dated 27.12.2002
On Technical
Regulating
Adopted
15.12.2002 by State Duma
Approved 18.12.2002 by Council of Federation
Chapter 1. GENERAL PROVISIONS
A r t i c l e
1. Scope of This Federal Law
1. This
Federal law regulates the relations arising during:
development,
adoption, application and execution of obligatory requirements for products,
processes of production, operation, storage, transportation, marketing and
utilization;
development,
adoption, application and execution on a voluntary basis of the requirements
for products, processes of production, operation, storage, transportation,
marketing and utilization, executing of works or rendering of services;
conformity
assessment.
This
Federal law also defines the rights and duties of the participants, whose
relations are regulated by this Federal law.
2.
The requirements for operation of uniform communication network of the Russian
Federation and for products connected with ensuring of integrity, stability of
operation of the specified communication network and its safety, the relations
connected with ensuring of integrity of the uniform communication network of
the Russian Federation and using of radiofrequency spectrum, are respectively
established and regulated by the legislation of the Russian Federation in the
field of communications.
3.
The validity of this Federal law does not apply to the state educational
standards, to provisions (standards) for accounting and rules (standards) for
auditor activity, to standards for article issue and offering circulars of
article issue.
A r t i c l
e 2. Basic Concepts
The
following basic concepts are used for the purposes of this Federal law:
Accreditation – is the official recognition, by
accreditation body, of the competence of a natural or legal person to perform
operations in definite area of conformity assessment;
Safety
of products, processes of production, operation, storage, transportation,
marketing and utilization (hereinafter referred to as safety) –
is the condition during which there is no inadmissible risk connected with
causing of harm to life or health of people, to property of natural or legal
persons, to state or municipal property, to environment, to life or health of
animals and plants;
Veterinary-sanitary
and phytosanitary measures – are the obligatory requirements and
procedures, established for the purpose of protection against the risks,
arising in connection with penetration, assimilation or spreading of harmful organisms,
diseases, carriers of sicknesses or pathogenic organisms, including the cases
of their transfer or spreading by animals and (or) plants, products, cargoes,
materials and vehicles, in connection with the presence of additives,
contaminants, toxins, pests, weeds, pathogenic organisms, including those in
foodstuffs or forages, and also the obligatory requirements and procedures
established with a view of preventing any other harm connected with spreading
of harmful organisms;
Declaring
of conformity – is the form of conformity assurance of products
to the requirements of technical regulations;
Supplier’s
declaration – is the
document certifying the conformity of the released product to the requirements
of technical regulations;
Applicant –
is the natural or legal person carrying out the obligatory assurance of conformity;
Mark
of market access – is the
label intended for informing of purchasers on conformity of released products
to the requirements of technical regulations;
Mark
of conformity – is the
designation intended for informing of purchasers on conformity of certification
object to the requirements of voluntary certification system or the national
standard;
Identification
of products – is the ascertaining of identity of product
performances to its essential attributes;
Control
(supervision) over observance of the technical regulation requirements
– is the inspection of execution by a natural or legal person of the
technical regulation requirements for products, processes of production,
operation, storage, transportation, marketing and utilization, and taking
appropriate measures by inspection results;
International
standard – is the
standard, adopted by international organization;
National
standard – is the standard approved by national standardization
body of the Russian Federation;
Certification
body – is the natural or
legal person, accredited in accordance with the established procedure for
executing of works on certification;
Conformity
assessment – is the direct or indirect estimation of observance of
the requirements being lodged for an object;
Conformity assurance
– is the documentary certifying of conformity of products or other objects,
processes of production, operation, storage, transportation, marketing and
utilization, executing of works or rendering of services to the requirements of
technical regulations, provisions of standards or conditions of contracts;
Product –
is the result of activity, presented in physical form and designed for further
use with economic and other purposes;
Risk – is the probability of causing harm to
life or health of people, to property of natural or legal persons, to state or
municipal property, to environment, life or health of animals and plants,
taking into account the weight of this harm;
Certification –
the form of conformity assurance of objects to the requirements of technical
regulations, to provisions of standards or conditions of contracts, realized by
certification body;
Conformity
certificate – is the document certifying the conformity of an
object to the requirements of technical regulations, to provisions of standards
or conditions of contracts;
Certification
system – is the set of rules for executing of works on
certification, its participants and rules for operation of the certification
system as a whole;
Standard – is the document establishing, for the
purposes of voluntary multiple use, the product performances, the rules for
realization and the characteristics of processes of production, operation,
storage, transportation, marketing and utilization, executing of works or
rendering of services. The standard may also contain the requirements for
terminology, symbology, packing, marking or labeling, and the rules for their
affixing;
Standardization – is the activity on establishing of rules and performances
for the purpose of their voluntary multiple use, aimed at achievement of
orderliness in the spheres of production and circulation of products, and at
heightening of competitiveness of products, works or services;
Technical
regulating – is the legal
regulating of relations in the field of establishing, application and executing
of obligatory requirements for products, processes of production, operation,
storage, transportation, marketing and utilization, and also in the field of
establishing and application, on a voluntary basis, of the requirements for
products, processes of production, operation, storage, transportation,
marketing and utilization, executing of works or rendering of services, and
legal regulating of relations in the field of conformity assessment;
Technical
regulation – is the document, which is adopted either by the
Russian Federation international treaty ratified in accordance with the
legislation of the Russian Federation, or by the federal law, or by decree of
President of the Russian Federation, or by decree of the Russian Federation
Government, and which establishes the obligatory requirements for technical
regulating objects (for products, including buildings, structures and
constructions, for processes of production, operation, storage, transportation,
marketing and utilization);
Form
of conformity assurance –
is the definite order of documentary certifying of conformity of products or
other objects, processes of production, operation, storage, transportation,
marketing and utilization, executing of works or rendering of services to the
requirements of technical regulations, to provisions of standards or conditions
of contracts.
A r t i c l
e 3. Principles of Technical Regulating
The
technical regulating shall be carried out in accordance with the principles of:
application
of uniform rules for establishing of the requirements for products, processes
of production, operation, storage, transportation, marketing and utilization,
executing of works or rendering of services;
conformity
of technical regulating to a level of national economy, material basis, and
technology development;
independence
of accreditation and certification bodies from manufacturers, sellers,
developers and purchasers;
uniform system
and rules of accreditation;
unity of
rules and methods of researches (tests) and measurements when conducting the
procedures of obligatory conformity assessment;
unity
of application of the technical regulation requirements irrespective of types
or peculiar
properties of bargains;
inadmissibility
of competition limitation during accreditation and certification;
inadmissibility
of combining the powers of state control (supervision) body and certification
body;
inadmissibility
of combining the accreditation and certification powers by one body;
inadmissibility
of off-budget financing of the state control (supervision) over observance of
the technical regulation requirements.
A r t i c l e 4. Legislation of the Russian
Federation on Technical Regulating
1.
The legislation of the Russian Federation on technical regulating consists of
this Federal law, the federal laws adopted according to it and other normative
legal acts of the Russian Federation.
2.
Provisions of the federal laws and other normative legal acts of the Russian
Federation, regarding the sphere of application of this Federal law (including
those directly or indirectly providing for control (supervision) over
observance of the technical regulation requirements), shall be applied
regarding their parts not contradicting to this Federal law.
3.
Federal executive bodies have the right to issue in the sphere of technical
regulating only the acts of recommendatory character, except for the cases
established by Article 5 of this Federal law.
4. If the
international treaty of the Russian Federation in the sphere of technical
regulating establishes other rules, than those stipulated by this Federal law,
then the rules of the international treaty shall be applied. And if the
international treaty provides for issuing of a national act for application of
the treaty, then the rules of the international treaty and the Russian
Federation legislation adopted on its basis shall be applied.
A r t i c l e 5. Peculiarities of technical regulating regarding the defensive and state secret-safeguarded
products (works, services)
1.
In case of absence of technical regulation requirements for the defensive
products (works, services) delivered for federal state needs under the state
defensive order, for the products (works, services) used for the purpose of
safeguarding the state secret data or categorized as the information of
restricted access and safeguarded according to the legislation of the Russian
Federation, and for the state secret-safeguarded products (works, services),
the obligatory requirements shall be those for products, their performances and
requirements for processes of production, operation, storage, transportation,
marketing and utilization, established by federal executive bodies being the
state customers of the defensive order within the limits of their competence,
and (or) by the state contract.
2. The
order of development, adoption and application of documents on standardization
regarding the products (works, services), specified in Clause 1 of this
Article, shall be established by the Government of the Russian Federation.
3.
The conformity assessment (including the state control (supervision) over
observance of obligatory requirements for products (works, services), specified
in Clause 1 of this Article, shall be carried out in the order, established by
the Government of the Russian Federation.
4.
The obligatory requirements for products (works, services), specified in Clause
1 of this Article, shall not contradict the technical regulation requirements.
Chapter 2. TECHNICAL REGULATIONS
A r t i c l
e 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.
A r t i c l
e 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.
A r t i c l
e 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.
A r
t i c l e 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.
A r t i c l e 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.
Chapter 3. STANDARDIZATION
A r t i c l
e 11. The Purposes of Standardization
Standardization
shall be carried out for the purposes of:
heightening
the safety level of life or health of people, property of natural or legal
persons, state or municipal property, ecological safety, safety of life or
health of animals and plants and assistance to observance of the requirements
of technical regulations;
heightening
the safety level of objects taking into account the risk of arising of extreme
situations of natural and man-caused character;
assurance of
scientific and technical progress;
heightening of
competitiveness of products, works and services;
efficient use
of resources;
technical and
information compatibility;
comparability
of results of researches (tests) and measurements, technical and
economic-statistical data;
interchangeability of products.
A r t i c l
e 12. Principles of Standardization
Standardization shall be carried out according to the principles of:
voluntary application of standards;
maximal
responsiveness of lawful interests of the interested persons during development of
standards;
application
of the international standard as a basis for development of the national
standard, except for the cases when such application is recognized to be
impossible as a result of noncompliance of requirements of the international
standards with climatic and geographical peculiarities of the Russian Federation, with technical and (or) technological peculiarities, or by other reasons, or if the Russian
Federation opposed against adoption of the international standard or its
separate provision in accordance with the established procedures.
inadmissibility
of creation the barriers to production and circulation of products, executing
of works and rendering of services in the greater degree, than it is minimally
necessary for execution of the purposes specified in Article 11 of this Federal
law;
inadmissibility
of establishing such standards which contradict technical regulations;
assurance of conditions for uniform application of
standards.
A r t i c l
e 13. Documents in the Field of Standardization
The
following documents shall be referred to documents in the field of
standardization, used in the territory of the Russian Federation:
national
standards;
rules
of standardization, norms and recommendations in the field of standardization;
classifications
applied in accordance with the established procedure, all-Russian classifiers
of technical and economic and social information;
standards of organizations.
A r
t i c l e 14. National Standards Body of the Russian Federation,
Technical Committees on Standardization
1.
National standards body of the Russian Federation (hereinafter referred to as
national standards body) shall:
affirm
national standards;
adopt the
program of development of national standards;
organize the
expertise of draft national standards;
ensure
the conformity of national standardization system to the interests of the
national economy, to condition of material basis and scientific and technical
progress;
realize
the registration of national standards, rules of standardization, norms and
recommendations in this area and shall ensure their availability for the
interested persons;
create
technical committees on standardization and shall coordinate their activity;
organize
publication and distribution of national standards;
participate,
according to charts of the international organizations, in development of the
international standards and shall ensure the taking into account of interests
of the Russian Federation in process of their adoption;
affirm the
image of a mark of conformity to national standards;
represent
the Russian Federation in the international organizations carrying out activity
in the field of standardization.
2.
The government of the Russian Federation shall define the body, authorized for
execution of functions of national standards body.
3. With a
view of this Article the publication of the national standard by national
standards body shall be understood as the publication of the national standard
in Russian in the print and in general-purpose information system in
electronic-digital format.
4.
The technical committees on standardization may include, on an equal footing
and voluntary basis, the representatives of federal executive bodies,
scientific organizations, self-regulated organizations, public associations of
businessmen and customers.
The order
of creation and functioning of technical committees on standardization shall be
affirmed by national standards body.
The
sessions of technical committees on standardization shall be open.
A r t i c l e 15. National Standards, All-Russian
Classifiers of Technical and Economic and Social Information
1.
The national standards and all-Russian classifiers of technical and economic
and social information, including the rules of their development and
application, represent the national standardization system.
2.
The national standards shall be developed in the order established by this
Federal law. National standards shall be affirmed by national standards body
according to rules of standardization, norms and recommendations in this area.
The
national standard shall be applied on a voluntary basis similarly and to equal
extent irrespective of the country and (or) place of a product origin,
processes of production, operation, storage, transportation, marketing and
utilization, executing of works and rendering of services, types or peculiarities of bargains and (or) the persons being
manufacturers, executors, sellers, purchasers.
Application
of the national standard shall be confirmed by a mark of conformity to the
national standard.
3. The
all-Russian classifiers of technical and economic and social information
(hereinafter referred to as all-Russian classifiers) are the normative
documents arranging the technical and economic and social information according
to its classification (classes, groups, types, etc.). The classifiers are
obligatory for application when creating the state information systems and
information resources and during interdepartmental information interchange.
The
order of development, adoption, enactment, maintenance and application of
all-Russian classifiers in socio economic area (including forecasting, statistical account, bank activity, taxation,
interdepartmental information exchange, creation of information systems and
information resources) shall be established by the Government of the Russian
Federation.
A r
t i c l e 16. Rules of Development and Approval of National Standards
1.
National standards body shall develop and approve the program of development of
national standards. The national standards body shall ensure the availability
of the program of development of national standards to the interested persons
for familiarization.
2. Any person
may be the developer of the national standard.
3.
The notification about development of the national standard shall be addressed
to national standards body and shall be published in general-purpose
information system in electronic-digital format and in the print of federal
executive body on technical regulating. The notification about development of
the national standard shall contain the information on those provisions,
contained in draft national standard, which differ from provisions of the
appropriate international standards.
The
developer of the national standard shall ensure availability of draft national
standard to the interested persons for familiarization. The developer is obliged, on demand of the
interested person, to grant him the copy of draft national standard. The
payment for granting of the specified copy may not exceed an expenditure for
its manufacture.
In
case the developer of the national standard is the federal executive body, the
payment for granting the copy of draft national standard shall be effected to
the federal budget.
4.
The developer shall update the draft national standard in view of written
notices of the interested persons, shall carry out public discussion of the
draft national standard and shall make the list of written notices of the
interested persons with summary of the notices contents and results of their
discussion.
The
developer is obliged to save written notices of the interested persons up to
approval of the national standard and to represent them to national standards
body and technical committees on standardization upon their inquiries.
The
period of public discussion of draft national standard from the date of
publication of notification about development of draft national standard up to
the date of publication of notification about completion of public discussion
may not be less than two months.
5.
The notification about completion of public discussion of draft national
standard shall be published in the print of federal executive body on technical
regulating and in general-purpose information system in electronic-digital
format.
From
the date of publication of notification about completion of public discussion
of draft national standard the updated draft national standard and the list of
written notices of the interested persons shall be available for the interested
persons for familiarization.
6. The
order of publication of notification about development of draft national
standard and notification about completion of public discussion of draft
national standard and the amount of payment for their publication shall be
established by the Government of the Russian Federation.
7.
Draft national standard simultaneously with the list of written notices of the
interested persons shall be represented by the developer to technical committee
on standardization, which organizes the conducting of expertise of the given
draft.
8.
On the basis of documents, specified in Clause 7 of this Article, and taking
into account the expertise results the technical committee on standardization
shall prepare the motivated proposal on approval or rejection of draft national
standard. The given proposal shall be addressed to national standards body
simultaneously with the documents and expertise results specified in Clause 7
of this Article.
The
national standards body on the basis of documents, represented by technical
committee on standardization, shall make a decision on approval or rejection of
the national standard.
The
notification about approval of the national standard is subject to publication
in the print of federal executive body on technical regulating and in
general-purpose information system in electronic-digital format within thirty
days from the date of the approval of the national standard.
In
case the national standard is rejected, the motivated decision of national
standards body with attachment of the documents, specified in Clause 7 of this
Article, shall be addressed to developer of the draft national standard.
9.
The national standards body shall affirm and publish in the print of federal
executive body on technical regulating and in general-purpose information
system in electronic-digital format the list of national standards which may be
applied on a voluntary basis for observance of the requirements of technical
regulations.
A r t i c l
e 17. Standards of Organizations
1.
Standards of organizations, including the mercantile, public, scientific,
self-regulated organizations and associations of legal persons may be developed
and affirmed by them independently proceeding from necessity of application of
these standards for the purposes specified in Article 11 of this Federal law,
for perfecting of production and quality assurance of product, executing of
works, rendering of services, and also for spreading and using of results of
researches (tests), measurements and developments, obtained in different fields
of knowledge.
The order
of development, approval, registration, amendment and cancellation of
standards of organizations shall be established by them independently taking
into account the provisions of Article 12 of this Federal law.
The draft
standard of organization may be represented by the developer to technical
committee on standardization, which organizes the expertise of the given draft.
On the basis of expertise results of the given draft the technical committee on
standardization shall prepare the conclusion, which is addressed to developer
of this draft standard.
2.
Standards of organizations shall be applied similarly and to equal extent
irrespective of the country and (or) place of a product origin, production
processes, operation, storage, transportation, marketing and utilization,
executing of works and rendering of services, types or peculiarities of bargains and (or) persons being manufacturers, executors, sellers or
purchasers.
Chapter 4. CONFORMITY
ASSURANCE
A r t i c l
e 18. The Purposes of Conformity Assurance
Conformity
assurance shall be carried out with the purposes of:
certifying
the conformity of products, processes of production, operation, storage,
transportation, marketing and utilization, works, services or other objects to
technical regulations, standards, conditions of contracts;
assistance
to purchasers in competent selection of products, works and services;
heightening
of competitiveness of products, operations and services in the Russian and
international markets;
creation
of conditions for assurance of free migration of goods in the territory of the
Russian Federation, and also for implementing of international economic,
scientific and technical cooperation and international trade.
A r t i c l
e 19. Principles of Conformity Assurance
1.
Conformity assurance shall be carried out on the basis of:
availability
of information on procedure of conformity assurance for the interested persons;
inadmissibility
of application of obligatory conformity assurance for the objects, in relation
to which the requirements of technical regulations are not established;
establishing
of the list of forms and schemes of obligatory conformity assurance in relation
to definite types of products in appropriate technical regulation;
reduction
of periods of obligatory conformity assurance and expenditures of an applicant;
inadmissibility
of forcing to voluntary conformity assurance, including any definite system of
voluntary certification;
protection
of property interests of applicants, observance of commercial secret in
relation to data obtained during conformity assurance;
inadmissibility
of substitution of obligatory conformity assurance by voluntary certification.
2.
Assurance of conformity shall be developed and applied similarly and to equal
extent irrespective of the country and (or) place of a product origin,
processes of production, operation, storage, transportation, marketing and
utilization, executing of works and rendering of services, types or peculiarities of bargains and (or) persons being manufacturers,
executors, sellers or purchasers.
A r t i c l
e 20. Forms of Conformity Assurance
1.
Conformity assurance in the territory of the Russian Federation may be both
voluntary or obligatory.
2.
Voluntary conformity assurance shall be carried out in the form of voluntary
certification.
3. Obligatory conformity assurance shall be carried out in the forms of:
supplier's declaration;
obligatory
certification.
4.
The order of application of forms of obligatory conformity assurance is
established by this Federal law.
A r t i c l
e 21. Voluntary Conformity Assurance
1.
Voluntary conformity assurance shall be carried out on an applicant’s
initiative on conditions of agreement between the applicant and certification
body. Voluntary conformity assurance may be carried out for the ascertaining of
conformity to the national standards, to standards of organizations, systems of
voluntary certification or conditions of contracts.
The
objects of voluntary conformity assurance are the products, processes of
production, operation, storage, transportation, marketing and utilization,
works and services, and also other objects in relation to which the standards,
systems of voluntary certification and contracts establish the requirements.
Certification
body shall:
realize
the conformity assurance of objects of voluntary conformity assurance;
issue
the certificates of conformity for objects, that have passed the voluntary
certification;
grant
to applicants the right for application of a mark of conformity if this
application is stipulated by appropriate system of voluntary certification;
suspend
or terminate the certificates of conformity given to them.
2.
Voluntary certification system may be created by legal and (or) natural person
or by several legal and (or) natural persons.
The
person or persons, created voluntary certification system, shall establish the
list of objects, subject to certification, and their performances for
compliance with which the voluntary certification is being carried out, the
rules of execution the works provided for by the given voluntary certification
system and the order of payment for these works, and shall define the
participants of the given voluntary certification system. The voluntary
certification system may provide for application of a mark of conformity.
3.
Voluntary certification system may be registered by federal executive body on
technical regulating.
The
following documents shall be submitted to federal executive body on technical
regulating for registration of voluntary certification system:
certificate
of the state registration of legal and (or) natural person;
rules of
operation of voluntary certification system, which stipulate the provisions of
Clause 2 of this Article;
image
of a mark of conformity applied in the given voluntary certification system, if
application of this mark of conformity is provided for, and the order of
application of this mark of conformity;
document of
payment for registration of voluntary certification system.
The
registration of voluntary certification system shall be carried out within five
days from the moment of submission the documents, provided for by this Clause
for registration of voluntary certification system, to federal executive body
on technical regulating. The order of registration of voluntary certification
system and amount of payment for registration shall be established by the
Government of the Russian Federation. The payment for registration of voluntary
certification system is subject to transfer into the federal budget.
4.
The refusal of registration of voluntary certification system is allowed only
in case of non-submission the documents, provided for by Clause 3 of this
Article, or in case of coincidence of the system’s name and (or) image of a
mark of conformity with system’s name and (or) image of a mark of conformity of
any voluntary certification system registered earlier. The notification about
refusal of registration of voluntary certification system shall be addressed to
an applicant within three days from the date of decision-making on refusal of
registration of this system with specifying of reasons for this refusal.
The
refusal of registration of voluntary certification system may be appealed
against in judicial order.
5.
Federal executive body on technical regulating shall maintain the uniform
register of registered voluntary certification systems, containing information
on legal and (or) natural persons, created voluntary certification systems, on
the rules of operation of voluntary certification systems, which provide for
the provisions of Clause 2 of this Article, on marks of conformity and the
order of their application. Federal executive body on technical regulating
shall ensure availability of information, contained in the uniform register of
registered voluntary certification systems, to the interested persons.
The order
of maintaining the uniform register of registered voluntary certification
systems and the order of granting the information, contained in this register,
shall be established by federal executive body on technical regulating.
A r t i c l
e 22. Marks of Conformity
1.
The certification objects, certified in voluntary certification system, may be
labeled by a mark of conformity of voluntary certification system. The order of
application of such mark of conformity shall be established by the rules of
appropriate system of voluntary certification.
2.
Application of a mark of conformity to the national standard shall be carried
out by an applicant on a voluntary basis by any way convenient for the
applicant in the order established by national standards body.
3.
The objects, whose conformity is not confirmed in the order established by this
Federal law, may not be labeled with a mark of conformity.
A r t i c l
e 23. Obligatory Conformity Assurance
1.
Obligatory conformity assurance shall be carried out only in the cases
established by appropriate technical regulation, and only for conformity to the
requirements of technical regulation.
The
object of obligatory conformity assurance may be only the product produced for
circulation in the territory of the Russian Federation.
2.
The form and schemes of obligatory conformity assurance may be established only
by technical regulation taking into account the risk degree of non-reaching the
purposes of technical regulations.
3. The
supplier’s declaration and the certificate of conformity have equal legal force
irrespective of the schemes of obligatory conformity assurance, and are valid
in the whole territory of the Russian Federation.
4.
The works on obligatory conformity assurance shall be paid by an applicant.
The
government of the Russian Federation shall establish a technique of
determination the cost of works on obligatory conformity assurance, which
provides for application of uniform rules and principles of ascertaining the
prices for products of identical or similar types irrespective of the country
and (or) place of their origin, and also the persons being applicants.
A r t i c l
e 24. Declaring of Conformity
1. Declaring
of conformity shall be carried out using one of the following schemes:
assuming
of supplier's declaration on the basis of own proofs;
assuming
of supplier's declaration on the basis of own proofs, the proofs obtained with
participation of certification body and (or) accredited test laboratory
(center) (hereinafter referred to as third party).
When
declaring the conformity the applicant may be both legal or natural person,
registered according to the legislation of the Russian Federation in its
territory, or being the manufacturer or seller, or executing the functions of a
foreign manufacturer on the basis of a contract with it regarding the
conformity assurance of delivered products to the requirements of technical
regulations and regarding the responsibility for nonconformity of delivered
products to the requirements of technical regulations (the person executing the
functions of a foreign manufacturer).
The
range of applicants shall be established by appropriate technical regulation.
The
scheme of declaring of conformity with participation of a third party shall be
established in technical regulation in case when the absence of the third party
results in non-reaching of the purposes of conformity assurance.
2.
When declaring the conformity on the basis of own proofs the applicant shall
independently form the evidentiary materials for the purpose of conformity
assurance of products to the requirements of technical regulations. The
technical documentation, the results of own researches (tests) and measurements
and (or) other documents, which can serve as the motivated basis for conformity
assurance of products to the requirements of technical regulations, shall be
used as evidentiary materials. The set of evidentiary materials shall be
defined by appropriate technical regulation.
3.
When declaring the conformity on the basis of own proofs and those obtained
with participation of a third party, an applicant, at his own will and in
addition to his own proofs formed in the order provided for in Clause 2 of this
Article, shall:
include
in evidentiary materials the reports of researches (tests) and measurements
carried out in accredited test laboratory (center);
grant
the certificate of quality system, in relation to which there is provided for
the control (supervision) of certification body, which has issued the given
certificate, over certification object.
4.
The certificate of a quality system may be used together with the proofs when
assuming the supplier's declaration for any products, except for the case when
technical regulations stipulate for such products other form of conformity assurance.
5.
Supplier’s declaration shall be made in Russian and shall contain:
name and
location of the applicant;
name and
location of the manufacturer;
information
on conformity assurance object, allowing to identify this object;
name
of technical regulation, for conformity to whose requirements the products are
being assured;
scheme of
declaring of conformity;
statement
of the applicant about product’s safety during its use according to
special-purpose assignment, and about taking measures by the applicant for
assurance of the product’s conformity to the requirements of technical
regulations;
information
on carried out researches (tests) and measurements, on quality system
certificate, and also on documents being as a basis for assurance of conformity
of products to the requirements of technical regulations;
period of
validity of the supplier’s declaration;
other
information provided for by appropriate technical regulations.
Period
of validity of the supplier’s declaration shall be defined by the technical regulation.
The
form of the supplier’s declaration shall be affirmed by federal executive body
on technical regulating.
6.
The supplier’s declaration, made out according to established rules, is subject
to registration by federal executive body on technical regulating within three
days.
For
registration of the supplier’s declaration the applicant shall submit to
federal executive body on technical regulating the supplier’s declaration made
out according to the requirements of Clause 5 of this Article.
The order
of maintenance of the supplier’s declarations register, order of granting the
information contained in the specified register, and order of payment for
granting of this information shall be defined by the Government of the Russian
Federation.
7. The supplier’s
declaration and attached evidentiary documents shall be stored by the applicant
within three years from the moment of termination of period of validity of the
declaration. The second copy of the supplier’s declaration shall be stored in
federal executive body on technical regulating.
A r t i c l
e 25. Obligatory Certification
1.
Obligatory certification shall be carried out by certification body on the
basis of the contract with the applicant. The schemes of certification, applied
for certification of definite types of products, shall be established by
appropriate technical regulation.
2.
Conformity of product to the requirements of technical regulations shall be
assured by conformity certificate, issued to the applicant by certification
body.
The conformity
certificate shall include:
name and
location of the applicant;
name
and location of the manufacturer of certified products;
name
and location of certification body, which has issued the conformity
certificate;
information
on certification object, allowing to identify this object;
name
of technical regulation, for conformity to whose requirements the certification
was carried out;
information on
carried out researches (tests) and measurements;
information
on documents, submitted by the applicant to certification body as a proof of
products’ conformity to the requirements of technical regulations;
period of
validity of conformity certificate.
period
of validity of conformity certificate shall be defined by appropriate technical
regulation.
The
form of conformity certificate shall be affirmed by federal executive body on
technical regulating.
A r t i c l
e 26. Realization of Obligatory Certification
1.
Obligatory certification shall be carried out by certification body accredited
in the order, established by the Government of the Russian
Federation.
2.
Certification body shall:
engage
in carrying out of researches (tests) and measurements on contractual basis the
test laboratories (centers) accredited in the order, established by the
Government of the Russian Federation (hereinafter referred to as accredited
test laboratories (centers);
realize
the control of certification objects if such control is provided for by
appropriate scheme of obligatory certification and the contract;
maintain the
register of conformity certificates issued by it;
inform
the appropriate bodies of the state control (supervision) over observance of
the requirements of technical regulations about products, intended for
certification, but not passed it;
suspend
or terminate the conformity certificate issued by it;
provide
granting to applicants of the information on the order of holding the
obligatory certification;
establish
the cost of works on certification on the basis of a technique for definition
of cost of such works approved by the Government of the Russian
Federation.
3.
Federal executive body on technical regulating shall maintain the uniform
register of issued conformity certificates.
The
order of maintenance the uniform register of issued conformity certificates, order
of granting the information contained in the uniform register and order of
payment for granting the information contained in the specified register shall
be established by the Government of the Russian
Federation.
The
order of transfer the information on issued conformity certificates to the
uniform register of issued certificates shall be established by federal
executive body on technical regulating.
4.
The researches (tests) and measurements of products in case of obligatory
certification shall be carried out by accredited test laboratories (centers).
Accredited
test laboratories (centers) shall carry out researches (tests) and measurement
of products within the area of their accreditation on conditions of contracts
with certification bodies. Certification bodies have no right to grant to
accredited test laboratories (centers) the information on the applicant.
Accredited
test laboratory (center) shall make out the results of researches (tests) and
measurements by appropriate reports on the basis of which the certification
body makes a decision about issue or about refusal to issue the conformity
certificate. The accredited test laboratory (center) is obliged to ensure
reliability of results of researches (tests) and measurements.
A r t i c l
e 27. Mark of Market Access
1.
Products, whose conformity to the requirements of technical regulations is
confirmed in the order, provided for by this Federal law, shall be marked with
a mark of market access. The image of the mark of market access shall be established
by the Government of the Russian Federation. The given mark is not special
protected mark and is affixed for information purposes.
2.
Marking with a mark of market access shall be carried out by the applicant
independently by any convenient way.
Products,
whose conformity to the requirements of technical regulations is not confirmed
in the order established by this Federal law, may not be marked with a mark of
market access.
A r t i c l e 28. Rights and Duties of Applicant in
the Field of Obligatory Conformity Assurance
1. The
applicant has the right:
to choose
the form and scheme of conformity assurance, provided for definite types of
products by appropriate technical regulation;
for
realization of obligatory certification to address to any certification body
whose area of accreditation applies to products which the applicant intends to
certify;
to
address to accreditation body with complaints against wrongful actions of
certification bodies and accredited test laboratories (centers) according to
the legislation of the Russian Federation.
2. The
applicant is obliged:
to
assure products conformity to the requirements of technical regulations;
to
release into sale the products, subject to obligatory conformity assurance,
only after such conformity assurance;
to
specify the information on conformity certificate or supplier’s declaration in
accompanying technical documentation and during marking of products;
to submit
the documents, testifying for conformity assurance of products to the
requirements of technical regulations (supplier’s declaration, conformity
certificate or their copies), to state control (supervision) bodies over
observance of the requirements of technical regulations, and also to the
interested persons;
to
suspend or terminate the sale of products if the validity period of conformity
certificate or supplier’s declaration has expired, or the validity of
conformity certificate or supplier’s declaration is suspended or terminated;
to
inform certification body on the amendments inserted into technical
documentation or into production processes of certificated products;
to
suspend manufacturing of products, which have passed the conformity assurance
and do not meet the requirements of technical regulations, on the basis of
decisions of state control (supervision) bodies over observance of the
requirements of technical regulations.
A r t i c l e 29. Import of Products, Liable
to Obligatory Conformity Assurance, into the Territory of the Russian
Federation
1. The supplier’s
declaration, conformity certificate or documents about their recognition in
accordance with Article 30 of this Federal law, together with the customs
declaration, shall be submitted by an applicant or his authorized person to the
customs bodies for placing of products, liable to obligatory conformity
assurance, under the customs conditions, providing for possibility of
alienation or use of products according to their purpose in the customs
territory of the Russian Federation. The representing of the specified
documents shall not be required in case of placing these products under the
customs condition of a refusal for the benefit of the state.
The lists of products,
covered by the first paragraph of this Clause, with specifying of ŅĶ ĀŻÄ codes, shall be affirmed
for the customs purposes by the Government of the Russian Federation on the basis of
technical regulations.
2. The products, liable
to obligatory conformity assurance and defined in accordance with provisions of
the second paragraph of Clause 1 of this Article, imported into the customs
territory of the Russian Federation and placed under the customs conditions,
not providing for possibility of their alienation, shall be released by the
customs bodies of the Russian Federation into the territory of the Russian Federation
without submission of the conformity documents, specified in the first
paragraph of Clause 1 of this Article.
3. The order of import
into the customs territory of the Russian Federation of the products, liable to
obligatory conformity assurance and defined according to provisions of the
second paragraph of Clause 1 of this Article and taking into account the
provisions of clause 2 of this Article, shall be affirmed by the Government of
the Russian Federation.
A r t i c l
e 30. Recognition of Conformity Assurance Results
Conformity
assurance documents, marks of conformity, reports of researches (tests) and
measurements of product, obtained outside the Russian Federation territory, may
be recognized according to the international treaties of the Russian
Federation.
Chapter
5. ACCREDITATION OF CERTIFICATION BODIES AND TEST LABORATORIES (CENTERS)
A r t i c l e 31. Accreditation of Certification
Bodies and Test Laboratories (Centers)
1.
Accreditation of certification bodies and test laboratories (centers) shall be
carried out with a view of:
affirming
of competence of certification bodies and test laboratories (centers) executing
the works on conformity assurance;
ensuring
of manufacturers’, sellers’ and purchasers’ trust in activity of certification
bodies and accredited test laboratories (centers);
creation
of conditions for recognizing the results of activity of certification bodies
and accredited test laboratories (centers).
2.
Accreditation of certification bodies and test laboratories (centers),
executing the works on conformity assurance, shall be carried out on the basis
of the following principles:
voluntariness;
openness and
availability of accreditation rules;
competence
and independence of the bodies which are carrying out accreditation;
inadmissibility
of limitation of a competition and creation of barriers to use of services of
certification bodies and accredited test laboratories (centers);
ensuring
of equal conditions for the persons applying for getting of accreditation;
inadmissibility
of combining the accreditation and conformity assurance powers;
inadmissibility
of establishing the limits for validity of accreditation documents in separate
territories.
3.
Accreditation of certification bodies and test laboratories (centers), executing
the works on conformity assurance, shall be carried out in the order
established by the Government of the Russian Federation.
Chapter
6. STATE CONTROL (SUPERVISION) OVER OBSERVANCE OF TECHNICAL REGULATION
REQUIREMENTS
A r
t i c l e 32. Bodies of State Control (Supervision) over Observance of
Technical Regulation Requirements
1.
The state control (supervision) over observance of technical regulation
requirements shall be carried out by federal executive bodies, by executive
bodies of the Russian Federation subjects, and by official state bodies
subordinated to them and authorized for conducting the state control
(supervision) according to the legislation of the Russian Federation
(hereinafter referred to as state control (supervision) bodies).
2.
The state control (supervision) over observance of technical regulation
requirements shall be carried by officials of state control (supervision)
bodies in the order established by the legislation of the Russian
Federation.
A r
t i c l e 33. Objects of State Control (Supervision) over Observance of
Technical Regulation Requirements
1.
The state control (supervision) over observance of technical regulation
requirements shall be carried out in relation to products, processes of
production, operation, storage, transportation, marketing and utilization exclusively regarding the observance of the requirements of
appropriate technical regulations.
2. In
relation to products the state control (supervision) over observance of
technical regulation requirements shall be carried out exclusively at the stage
of products circulation.
3.
When carrying out the activities of state control (supervision) over observance
of technical regulation requirements, there shall be used the rules and methods
of researches (tests) and measurements, established for appropriate technical
regulations in the order, provided for by Clause 11 of Article 7 of this
Federal law.
A r t i c l
e 34. Powers of State Control (Supervision) Bodies
1. On the
basis of provisions of this Federal law and technical regulation requirements
the state control (supervision) bodies shall have the right to:
require
from the manufacturer (the seller or the person executing the functions of the
foreign manufacturer) the presentation of the supplier’s declaration or conformity
certificate, assuring the conformity of products to technical regulation
requirements, or their copies, if the application of such documents is
stipulated by appropriate technical regulation;
realize
actions of state control (supervision) over observance of technical regulation
requirements in the order established by the legislation of the Russian
Federation;
produce
instructions on elimination of violations of technical regulation requirements
within the time period, established taking into account the violation
character;
motivated
decisions on interdiction of products transfer, and also on total or partial
suspension of processes of production, operation, storage, transportation,
marketing and utilization, if otherwise it is impossible to eliminate the
violations of technical regulation requirements;
suspend
or terminate the supplier’s declaration or conformity certificate;
call
the manufacturer (the executor, the seller, the person executing the functions
of the foreign manufacturer) to account, provided for by the legislation of the
Russian Federation;
take
other measures, provided for by the legislation of the Russian
Federation, for the purpose of non-admission of causing harm.
2. State
control (supervision) bodies are obliged to:
carry
out, during actions of state control (supervision) over observance of technical
regulation requirements, the explanatory work on application of the legislation
of the Russian Federation on technical regulating, to inform on existing
technical regulations;
keep
commercial secrets and other secrets safeguarded by the law;
keep
order when conducting the state control (supervision) over observance of
technical regulation requirements and making up the results of such actions,
established by the legislation of the Russian Federation;
take
measures on elimination of consequences of violations of technical regulation
requirements on the basis of results of state control (supervision) over
observance of technical regulation requirements;
address
the information on products nonconformity to technical regulation requirements
according to provisions of Chapter 7 of this Federal law;
realize
other powers, provided for by the legislation of the Russian
Federation.
A r t i c l e 35. Responsibility of State Control
(Supervision) Bodies and Their Officials During Realization of State Control
(Supervision) over Observance of Technical Regulation Requirements
1.
The state control (supervision) bodies and their officials in case of
inadequate execution of their official duties during actions of state control
(supervision) over observance of technical regulation requirements and in case
of performance of illegal actions (idling inaction) shall bear responsibility
according to the legislation of the Russian Federation.
2.
The state control (supervision) bodies are obliged within one month to inform
the legal and (or) natural person, whose rights and lawful interests are
violated, on the measures taken in relation to officials of state control
(supervision) bodies, which are guilty in violation of the legislation of the
Russian Federation.
Chapter
7. INFORMATION ON VIOLATION OF TECHNICAL REGULATION REQUIREMENTS AND THE
RETRACTION OF PRODUCTS
A r t i c l e 36. Responsibility for Nonconformity
of Products, Processes of Production, Operation, Storage, Transportation,
Marketing and Utilization to Technical Regulation Requirements
1.
The manufacturer (developer, seller or person executing functions of the
foreign manufacturer) shall bear responsibility according to the legislation of
the Russian Federation for violation
of technical regulation requirements.
2. In
case of non-execution of prescriptions and decisions of state control
(supervision) body the manufacturer (developer, seller or person executing
functions of the foreign manufacturer) shall bear responsibility according to
the legislation of the Russian
Federation.
3.
If harm is caused to life or health of people, property of natural or legal
persons, state or municipal property, environment, life or health of animals
and plants, or there was a threat of causing such harm as a result of
nonconformity of products to technical regulation requirements, violations of
technical regulation requirements during conducting of processes of production,
operation, storage, transportation, marketing and utilization, the manufacturer
(developer, seller, person executing functions of the foreign manufacturer) is
obliged to compensate this harm and to take measures with the purpose of
non-admission of causing harm to other persons, their property, and environment
according to the legislation of the Russian Federation.
4.
The duty to compensate harm may not be restricted by the contract or
announcement of one of the parties. Agreements or announcements for limitation
of the responsibility shall be considered as negligible.
A r t i c l e 37. Information on Product
Nonconformity to Technical Regulation Requirements
1. The
manufacturer (developer, seller or person executing functions of the foreign
manufacturer) who knows about nonconformity of products, released into sale, to
technical regulation requirements, is obliged to inform about it to state
control (supervision) body according to its competence within ten days from the
moment of obtaining the specified information.
The
seller (developer or person executing functions of the foreign manufacturer),
which has obtained the specified information, is obliged to inform the
manufacturer about it within ten days.
2.
The person being not the manufacturer (developer, seller or person executing
functions of the foreign manufacturer) and which knows about nonconformity of
products, released into sale, to technical regulation requirements, has the
right to address the information on nonconformity of products to technical
regulation requirements to state control (supervision) body.
Upon
receipt of such information the state control (supervision) body is obliged
within five days to notify the manufacturer (seller or person executing
functions of the foreign manufacturer) about this receipt.
A r t i c l e 38. Duties of Manufacturer (Seller or
Person Executing Functions of the Foreign Manufacturer) in Case of Obtaining
the Information on Nonconformity of Products to Technical Regulation
Requirements
1. Within
ten days from the moment of obtaining the information on product nonconformity
to technical regulation requirements, unles the necessity of establishing more
long period results from the essence of conducted actions, the manufacturer
(seller or person executing functions of the foreign manufacturer) is obliged
to check the reliability of the obtained information. On demand of state
control (supervision) body the manufacturer (seller or person executing
functions of the foreign manufacturer) is obliged to present materials of the
specified check to state control (supervision) body.
In
case of obtaining the information on product nonconformity to technical
regulation requirements the manufacturer (seller or person executing functions
of the foreign manufacturer) is obliged to take necessary measures such, that
possible harm connected with circulation of the given product would not
increase up to completion of the check, provided for by the first paragraph of
this Clause.
2. After
confirming the reliability of the information on product nonconformity to
technical regulation requirements, the manufacturer (seller or person executing
functions of the foreign manufacturer) within ten days from the moment of
confirming the reliability of such information is obliged to develop the
program of measures for preventing of causing harm, and to coordinate it with
state control (supervision) body in accordance with its competence.
The
program shall include actions for notification of purchasers about presence of
threat of causing harm and ways of its preventing, and also the terms of
realization of such actions. In case, when for preventing of causing harm it is
necessary to bear additional expenses, the manufacturer (seller or person
executing functions of the foreign manufacturer) is obliged to realize himself
all the actions for preventing of causing harm, and in case of impossibility to
fulfill it he is obliged to declare about retraction of products and to pay damages, caused to purchasers in connection with
retraction of the products.
Elimination
of defects, and also delivery of products to a place of elimination of defects
and retrace of products back to purchasers shall be carried out by the
manufacturer (seller or person executing functions of the foreign manufacturer)
and at his expense.
3.
In case the threat of causing harm can not be eliminated by holding the actions
specified in Clause 2 of this Article, the manufacturer (seller or person
executing functions of the foreign manufacturer) is obliged to suspend
immediately the production and sale of products, to retract the products and
compensate to purchasers the losses which have arisen in connection with
retraction of the products.
4.
Within the whole period of operation of the program of actions for preventing
of causing harm the manufacturer (seller or person executing functions of the
foreign manufacturer) is obliged, at his own expense, to ensure for purchasers
the possibility of obtaining the operational information on necessary actions.
A r t i c l e 39. Rights of State Control
(Supervision) Bodies in Case of Obtaining the Information on Product
Nonconformity to Technical Regulation Requirements
1.
State control (supervision) bodies in case of obtaining the information on
product nonconformity to technical regulation requirements shall inspect
reliability of the obtained information within possibly short terms.
During
holding of inspection the state control (supervision) bodies shall have the
right:
to
require from the manufacturer (seller or person executing functions of the
foreign manufacturer) the materials of reliability inspection of the
information on product nonconformity to technical regulation requirements;
to make a
request to the manufacturer (executor, seller or person executing functions of
the foreign manufacturer) and other persons for additional information on
products, processes of production, operation, storage, transportation,
marketing and utilization, including the results of researches (tests) and
measurements which have been carried out during obligatory conformity
assurance;
to
address inquiries to other federal executive bodies;
if
necessary, to invite experts for the analysis of obtained materials.
2.
Upon recognition of reliability of the information on product nonconformity to
technical regulation requirements the state control (supervision) body shall
issue within ten days, in accordance with its competence, the prescription
about development by the manufacturer (seller or person executing functions of
the foreign manufacturer) of the program of actions for preventing of causing
of harm, shall assist in its realization and implement the control of its
execution.
State control
(supervision) body shall:
promote
dissemination of information on terms and the order of holding the actions for
preventing of causing harm;
make
a request to the manufacturer (seller or person executing functions of the
foreign manufacturer) and other persons for the documents, confirming holding
of the actions specified in the program of actions for preventing of causing
harm;
check
the observance of the terms specified in the program of actions for preventing
of causing harm;
make a
decision on reference to the court with a claim to coercive retraction of
products.
A r t i c l
e 40. Coercive Retraction of Products
1. In
case of omission of the prescription, provided for by Clause 2 of Article 39 of
this Federal law, or omission of the program of actions for preventing of
causing harm, the state control (supervision) body, in accordance with its
competence, and also other persons who have got to know about omission by the
manufacturer (seller or person executing functions of the foreign manufacturer)
of the program of actions for preventing of causing harm, have the right to
refer to the court with a claim to coercive retraction of products.
2.
In case of satisfaction of the claim to coercive retraction of products the
court shall oblige the respondent to undertake the definite actions connected
with retraction of products within the period established by the court and also
to inform purchasers on the court decision not later than one month from the
date of its coming into force via mass media or by another way.
In
case the respondent does not execute the court decision within established time
interval, the claimant shall have the right to undertake these actions at the
respondent’s expense by imposing of necessary charges on it.
3.
The measures of criminal and administrative prosecution may be applied according to the legislation of the Russian
Federation for violation of the requirements of this Federal law
for retraction of products.
A r t i c l e 41. Responsibility for Violation of
Rules of Executing of Certification Works
Certification
body and certification body official, violated the rules of executing of
certification works, if such violation has caused the release into sale of
products not corresponding to technical regulation requirements, shall bear
responsibility according to the legislation of the Russian Federation and the
contract for certification works.
A r t i c l e 42. Responsibility of Accredited Test
Laboratory (Center)
The
accredited test laboratory (center) and experts, in accordance with the
legislation of the Russian
Federation and the contract,
shall bear responsibility for non-reliability or non-objectivity of results of
researches (tests) and measurements.
Chapter
8. INFORMATION ON TECHNICAL REGULATIONS AND STANDARDIZATION DOCUMENTS
A r t i c l
e 43. Information on Standardization Documents
1. The
national standards and all-Russian classifiers, and also the information on
their development shall be accessible to the interested persons.
2.
Official publication of the national standards and all-Russian classifiers
shall be carried out by the national standards body in accordance with the
established procedure. The order of publication of the national standards and
all-Russian classifiers shall be defined by the Government of the Russian
Federation.
A r
t i c l e 44. Federal Information Corpus of Technical Regulations and
Standards
1.
Technical regulations, documents of national standardization system,
international standards, standardization rules, norms of standardization and
recommendations for standardization, national standards of other states and the
information on international contracts in the area of standardization and conformity
assurance and on rules of their application constitute the Federal information
corpus of technical regulations and standards.
The
Federal information corpus of technical regulations and standards is the state
information resource.
The
order of creation and maintenance of the Federal information corpus of
technical regulations and standards, and also the rules of use of this corpus
shall be established by the Government of the Russian Federation.
2.
The uniform information system, designed for provision of the interested
persons with information on documents, included in the Federal information
corpus of technical regulations and standards, is being created and operates in
the Russian Federation in the order
and on conditions established by the Government of the Russian
Federation.
The easy
access to information resources, being created, shall be provided for the
interested persons, except for the cases when such access is restricted for the
sake of keeping state, official or commercial secret.
Chapter
9. FINANCING IN THE FIELD OF TECHNICAL REGULATING
A r t i c l e 45. Order of Financing the
Expenditures in the Field of Technical Regulating at the Expense of Federal
Budget
1.
The following expenditures may be financed at the expense of federal budget:
conducting
at the federal level of state control (supervision) of observance of technical
regulation requirements;
creation
and maintenance of the Federal information corpus of technical regulations and
standards;
realization
of the program of development of technical regulations and program of
development of national standards, provided for by Clause 12 of Article 7 and
Clause 1 of Article 16 of this Federal law, and also conducting of expertise of
separate draft technical regulations and national standards;
development of
all-Russian classifiers;
payment of
fees to the international standards organizations.
2.
The order of financing the expenditures, specified in Clause 1 of this article,
shall be defined by the Government of the Russian
Federation.
Chapter
10. CLOSING AND TRANSITION PROVISIONS
A r t i c l
e 46. Transition Provisions
1.
From the date of coming into force of this Federal law up to coming into force
of the appropriate technical regulations, the requirements for products,
processes of production, operation, storage, transportation, marketing and the
utilization, established by normative legal acts of the Russian Federation and
normative documents of federal executive bodies, are subject to obligatory
execution only regarding the part corresponding to the purposes:
protection
of life or health of people, property of natural or legal persons, state or
municipal property;
protection of
the environment, life or health of animals and plants;
prevention of
actions misleading purchasers.
2. From
the date of coming into force of this Federal law the obligatory conformity
assurance shall be carried out only in relation to products released into
circulation in the territory of the Russian Federation.
3.
The Government of the Russian Federation,
before coming into force of the appropriate technical regulations, shall yearly
define and supplement the list of separate types of products, in relation to
which the obligatory certification is substituted for declaring of conformity
realized in the order, established by this Federal law.
4.
Before coming into force of the appropriate technical regulations, the scheme
of declaring of conformity on the basis of own proofs is allowed for
application only by the manufacturers or only by the persons executing
functions of the foreign manufacturer.
5.
Before adoption of the appropriate technical regulations, the technical
regulating within the scope of veterinary-sanitary and phytosanitary measures
shall be carried out according to the Federal law "On Quarantine of Plants"
and the Law of the Russian Federation "On
Veterinary".
6. Before
adoption of the general technical regulation on nuclear and radiation safety,
the technical regulating in the field of nuclear and radiation safety shall be
carried out according to the Federal law "On Use of Atomic Energy"
and the Federal law "On Radiation Safety of the Population".
7.
The technical regulations shall be adopted within seven years from the date of
coming into force of this Federal law.
The
obligatory requirements for products, processes of production, operation,
storage, transportation, marketing and utilization, in relation to which the
technical regulations in the specified period are not adopted, shall terminate
their validity after its expiration.
8.
Accreditation documents, issued in accordance with the established procedure to
certification bodies and accredited test laboratories (centers) before coming
into force of this Federal law, and also the documents assuring the conformity
(conformity certificate, supplier’s declaration) and adopted before coming into
force of this Federal law, shall be considered valid up to termination of the
term established in them.
A r t i c l e 47. Bringing of Normative Legal Acts
in Compliance with This Federal Law
The
following documents shall be recognized invalid from the date of coming into
force of this Federal law:
The
law of the Russian Federation No. 5151-I, dated 10.06.93 "On Certification
of Products and Services" (Bulletin of Congress of People’s Deputies and
Supreme Soviet of the Russian Federation, 1993, No. 26, Article 966);
Decree
of Supreme Soviet of the Russian Federation No 5153-I, dated 10.06.93 "On
Enactment of the Law of the Russian Federation
"On Certification of Products and Services" (Bulletin of Congress of
People’s Deputies and Supreme Soviet of the Russian Federation, 1993, No. 26,
Article 967);
The
law of the Russian Federation N 5154-I, dated 10.06.93 "On
standardization" (Bulletin of Congress of People’s Deputies and Supreme
Soviet of the Russian Federation, 1993, No. 25, Article 917);
Decree
of Supreme Soviet of the Russian Federation 1993 N 5156-I, dated 10.06.93
"On Enactment of the Law of the Russian Federation "On
Standardization" (Bulletin of Congress of People’s Deputies and Supreme
Soviet of the Russian Federation, 1993, No. 25, Article 918);
Clauses
12 and 13 of Article 1 of the Federal law No. 211-ŌĒ, dated 27.12.95 "On
Inserting the Amendments and Addenda in Separate Legislative Acts of the Russian
Federation in Connection with Adoption of the Federal law "On
Fire Safety" (Code of Laws of the Russian Federation, 1996, No. 1, Article
4);
Clause
2 of Article 1 of the Federal law No. 30-ŌĒ, dated 03.03.98 "On Inserting
the Amendments and Addenda in Separate Legislative Acts of the Russian
Federation in Connection with Adoption of the Federal law "On
Advertising" (Code of Laws of the Russian Federation, 1998, No. 10,
Article 1143);
The
Federal law No. 154-ŌĒ, dated 31.07.98 "On Inserting the Amendments and
Addenda in the Law of the Russian Federation
"On Certification of Products and Services" (Code of Laws of the
Russian Federation, 1998, No. 31, Article 3832);
Article
2 of the Federal law No. 87-ŌĒ, dated 10.07.2002 "On Inserting the
Amendments into Article 6 of the Federal law "On Fundamentals of Social Servicing
of Population in the Russian Federation" and addenda into Article 2 of the
Law of the Russian Federation "On Standardization" (Code of Laws of
the Russian Federation, 2002, No. 28, Article 2791);
Articles
13 and 14 of the Federal law N 116-ŌĒ, dated 25.07.2002 "On Inserting the
Amendments and Addenda in Some Legislative Acts of the Russian Federation in
Connection with Perfecting of Governmental Management in the Field of Fire
Safety" (Code of Laws of the Russian Federation, 2002, No. 30, Article 3033).
A r t i c l
e 48. Coming into Force of This Federal Law
This Federal law shall come into force after
expiration of six months from the date of its official publication.
President
of the Russian
Federation
V. Putin
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