Effective July 2003 Federal Law of the Russian Federation (No. 184-FZ of December 27, 2002) "On Technical Regulation". According to Article 47 of this law, the laws of the Russian Federation “On Standardization” and “On Certification of Products and Services” introduced since 1993 are recognized as invalid. In May 2007, Law No. 65-FZ “On Amendments to the Federal Law”, “On Technical Regulation” was approved. All provisions on technical regulation, standardization and certification will be presented in accordance with the changes made.

Efficient global market is an economic space in which goods move freely across the borders of states, capital, labor resources, where the most favorable conditions. The creation of such an economic space is possible if measures are taken to eliminate technical and tariff barriers, and the technical barrier is understood as the difference in requirements for products and other objects contained in the national standards of various states. Yes, because of different requirements to certain characteristics of automotive equipment, its import from Russia to many countries of the world is prohibited. According to the Economic Committee of the Asia-Pacific Cooperation, the programs developed to eliminate technical barriers have given countries about 45 billion US dollars. dollars of profit.

Technical regulation - legal regulation of relations in the field of establishment, application and execution mandatory requirements to products and related processes life cycle; establishment and application on a voluntary basis of requirements for products, design processes, production, installation, installation, operation, storage, sale, disposal; carrying out work in the field of conformity assessment. (ZhP - product life cycle is a fundamental concept in the doctrine of the quality management system and is a set of interrelated stages of changing the state of the product: marketing, design and manufacture, procurement, verification, implementation, operation, Maintenance, disposal after use).

Based on this definition, technical regulation comes down to three activities:

- first type of activity is implemented through the adoption and application of technical regulations having the force of law, by-laws and mandatory for application;

- second implemented by standardization activities through the development and approval of standards that must be applied on a voluntary basis;

- the third the type of activity is based on conformity assessment (certification, declaration of conformity).

Thus, the introduction of the law on technical regulation does not cancel standardization (especially the existing GOSTs) and certification as activities, but introduces certain changes, additions to the existing standardization and certification systems.

Question 2.2. The need to introduce technical regulation

The adoption of the Federal Law on Technical Regulation is due to three objective circumstances:

The need for convergence and interconnection, harmonization of requirements for products and activities under technical legislation in Russia with those in industrialized countries in order to eliminate technical, economic and organizational barriers when entering a single economic space;

The task is to remove excessive restrictions contained in state standards, sanitary, building codes and regulations and in a variety of industry documents that hinder entrepreneurial initiative and business of citizens;

The need to streamline names, mandatory requirements for the composition and quality of products, especially in Food Industry. This is due to the fact that the currently available set of mandatory requirements in numerous regulatory documents, technical specifications (TS) for products does not provide adequate quality and creates, in some cases, a danger to the health of citizens.

Question 2.3. Scope of application of technical regulation and objects

The objects of technical regulation are:

Products ( finished goods, raw materials, natural fuel, materials);

Services (tangible and intangible);

Processes at specific stages of the product life cycle that can create a risk of hazards. Risk is understood as the probability of causing harm to the life or health of citizens, property, the environment, taking into account the severity of this harm.

The federal law regulates relations in the following areas of activity:

When developing, adopting and fulfilling mandatory requirements for products or related design processes (including surveys) of production, construction, installation, commissioning, as well as operation, storage, transportation, sale and disposal;

When developing, adopting, applying and fulfilling on a voluntary basis the requirements for products or related design processes (including surveys) of production, construction, installation, commissioning, as well as operation, storage, transportation, sale and disposal, performance of works or services;

When evaluating conformity.

Thus, technical regulation can be reduced to three main activities:

Establishment, application and implementation of mandatory requirements for products and life cycle processes (technical regulation activities);

Establishment and application on a voluntary basis of requirements for products, processes of the life cycle program, the performance of work on the provision of services (standardization activities);

Legal regulation in the field of conformity assessment (certification activities).

The fourth sphere of application of technical regulation is the formation of requirements that ensure the unified and safe functioning of a unified system of communications.

The effect of the law "On technical regulation", taking into account the changes made, does not apply to:

For state educational standards, audit regulations and standards emissionsvaluable papers;

For socio-economic, organizational, sanitary and hygienic, medical and preventive measures in the field of labor protection.

Federal law does not regulate relations related to the application of measures to prevent the occurrence and spread infectious diseases human and soil protection, atmospheric air water bodies classified as places of mass recreation and tourism.

Under the term "acceptance of requirements» means their approval in accordance with the procedure established by law or regulation. "Acceptance of requirements" means their mandatory or voluntary choice in all cases for which they are accepted. By "compliance with requirements" is meant mandatory compliance in the relevant objects of technical regulation.

Question 2.4. The purpose of the adoption of technical regulations

The result of technical regulation is the approval of the technical regulation. Technical regulations - a document that is adopted and ratified in the manner prescribed by the legislation of the Russian Federation or federal law, a decree of the president, the government of the Russian Federation, and establishes mandatory requirements for the application and implementation of requirements for objects of technical regulation (products, buildings and structures, production processes, storage, transportation and disposal ). From this definition it follows that technical regulation contains mandatory requirements for objects of technical regulation.

Technical regulations are adopted in order to:

Protecting the life or health of citizens when using products and performing various processes. related products;

Protecting the property of individuals or legal entities from the risk of various hazards during construction, operation, dismantling;

Security environment life or health of animals and plants by establishing the minimum necessary veterinary-sanitary and phytosanitary measures.

Adoption of technical regulations for other purposes is not allowed.

Technical regulation reform should replace thousands of existing GOSTs, sanitary and building regulations with hundreds of technical regulations. Approval of technical regulations is supposed by law in order to clarify the quality of products for purchasers, thereby ensuring the achievement of the goals of technical regulations, as well as to simplify the conditions for promoting products on the market.

So, the first technical regulation"On the requirements for emissions of automotive equipment put into circulation in the territory of the Russian Federation harmful substances» was approved at the end of 2005 and is valid federal law. The effect of this technical regulation banned the production in the Russian Federation of internal combustion engines that do not meet the requirements of standards below EURO-2 in terms of environmental standards, and also imposed a ban on the import of obsolete models of automotive equipment from abroad.

Question 2.5. Basic principles of technical regulation

When developing technical regulations, codes of practice, standards, it is necessary to adhere to certain principles.

The main principles in the development of technical regulations are as follows:

1) compliance of technical regulations with the requirements of international standards, the level of development of the national economy and the material and technical base of production;

2) independence of accreditation and certification bodies from manufacturers, sellers and purchasers;

3) application of a unified system and rules accreditation ;

4) the inadmissibility of restricting competition in the implementation of certification and accreditation;

5) ensuring the unity of the rules and methods of testing, measurements during the procedures for mandatory and voluntary conformity assessment;

6) inadmissibility of off-budget financing state control(supervision) over compliance with the requirements of technical regulations.

The first principle is implemented by publishing a notification on the development of technical regulations in the monthly journal "Bulletin of technical regulation". The developer of the regulation is obliged to indicate the requirements in the technical regulation that differ from the corresponding requirements of international standards or standards in force in the Russian Federation. This principle indicates the need for conformity of products and material and technical level testing laboratories world indicators.

The second design principle technical regulations means the following: when confirming compliance in the form mandatory certification its participants are three parties - the 1st manufacturer (seller) of products, the 2nd certification body and (or) a testing laboratory that has a license and accreditation, the 3rd party is the purchaser (user, buyer) of the products. The independence of accreditation and certification bodies (2nd party) from purchasers (3rd party) and manufacturers (1st party) should be understood as the absence of any form of dependence - administrative, financial, economic. The independence of the certification body implies an objective assessment of the indicators for which certification is carried out.

Application of principle 3 It is aimed at the fact that the work on accreditation (proof of competence to perform work in a certain area) should be carried out according to uniform rules.

The fourth principle means the following: since in Russia they receive a certificate of accreditation every month a large number of organizations and laboratories, there may be competition for certification work. In this case, the applicant for conformity assessment services is given the opportunity to select an organization on the basis of a tender.

Principle 5 is necessary take into account when conducting mandatory and voluntary conformity assessment, in which the rules and test methods are carried out in accordance with the available methods established by certain regulatory documents (GOSTs, Rules, etc.).

Last sixth principle indicates that control (supervision) over compliance with the requirements of technical regulations is entrusted to state and authorized organizations financed from the budget.

Question 2.6. Content of technical regulations

To achieve the main goals of technical regulation, technical regulations must contain the necessary requirements to ensure:

fire safety;

electrical safety;

Nuclear and other types of safety as well as the unity of measurements.

In general, the structure of a technical regulation should contain the following main chapters:

1. General Provisions;

2. General requirements for the safety of the object of technical regulation;

3. Safety requirements at various stages of the life cycle;

4. Confirmation of compliance with safety requirements;

5. State control;

6. Final and transitional provisions;

1. In the articles of the chapter "General Provisions" the objectives of the application of this regulation and the objects of technical regulation are given, the definition of the main concepts that are important for an unambiguous understanding of technical regulations in accordance with standardized and generally accepted ones is given. The rules for identifying objects are considered (Identification - products is the establishment of the identity of the characteristics of the product to its essential features).

A list normative documents(international and national standards), legislative acts of the Russian Federation used in the technical regulations. The law states: “International standards should be used in whole or in part as a basis for the development of draft technical regulations, unless such use is recognized as impossible due to the geographical or climatic features of the Russian Federation; National standards can be used in whole or in part as a basis for the development of draft technical regulations.”

The objects to which the action of the technical regulation does not apply are also indicated.

2. In the articles of the chapter “ General requirements for the safety of a technical object regulation » a list of general safety requirements for the object of technical regulation is given, which are the most important since safety requirements not included in the technical regulation are applied only on a voluntary basis.

Requirements can be specified in the following ways:

a) general requirements, which qualitatively determine the required level of safety;

b) specific numerical values ​​of indicators.

The first way will be the main. The second method is widely used in the regulatory documents of ROSSTROY (former GOSSTROY) - building codes and regulations (SNiPah). According to the amendments to the law, the technical regulation must contain the rules for product identification

3. Chapter "Safety requirements forvarious stages of the life cycle" safety requirements are given during installation and commissioning, during operation, including requirements for fire, environmental safety to the materials included in the composition of the product.

4. In the chapter " confirmation of compliance with safety requirements» two forms must be specified mandatory confirmation conformity for products - declaration of conformity and mandatory certification. As follows from the concept of the Federal Law on technical regulation, the declaration of conformity is a priority form of confirmation of conformity. For objects like residential buildings and structures, the only way to confirm compliance is declaration.

5. In the chapter " state control» it is indicated that control (supervision) over compliance with the requirements of the technical regulation is carried out by the federal body executive power(Federal executive authorities - the Ministry of Industry and Energy, the Ministry of Health and Social Development, the Ministry of Agriculture, the Ministry of Emergency Situations of Russia, etc.). In relation to products, state control is carried out exclusively at the stage of product circulation (during deliveries and sales). For other facilities, control can also be carried out at the stages of design, installation and construction by state expertise bodies.

6. Chapter "final and transitional provisions" the responsibility of the subjects of technical regulation (legal entities and individuals engaged in the design, production, and circulation of products) for non-compliance with the requirements of technical regulations is determined. It is indicated that from the date of entry into force of this technical regulation, regulatory documents in terms of safety requirements for the object lose their force. The technical regulation adopted by the Federal Law shall enter into force six months after the date of publication.

All comments received in writing stakeholders the developer saves, finalizes the draft regulations.

A notice is printed in the journal about the completion of the public discussion of the project. After that, the developer submits a draft technical regulation to the government of the Russian Federation.

Draft resolution Government of the Russian Federation on technical regulations is sent for examination to the relevant expert commission. The conclusion of the expert commission on the draft technical regulation is published in the journal "Bulletin of technical regulation". The expert commissions include representatives of federal executive authorities, scientific organizations, public associations of entrepreneurs and consumers, and other interested parties. Meetings of expert commissions are open.

The draft Federal Law on Technical Regulations is adopted in the first reading State Duma published in print edition.

After a comprehensive discussion, amendments and additions, the draft is being prepared for the second reading in the State Duma.

After approval by the State Duma, the project acquires the force of law.

Technical regulation may also be adopted by a decree of the Government of the Russian Federation and, in special cases, by an international treaty subject to ratification in the prescribed manner.

By January 1, 2010, the following priority technical regulations must be adopted:

Safety of machinery and equipment, wheeled vehicles;

Safety of food, chemical products;

building security, building materials, structures;

Safety of electrical and power equipment;

Medical device safety

Elevator and packaging safety.

Law on Technical Regulation a special procedure for the development and adoption of technical regulations is envisaged. This applies to exceptional cases in the event of circumstances leading to an immediate threat to the life or health of citizens. The President of the Russian Federation has the right to issue technical regulations without public discussion.

During the transition period from 2003 to 2010. Approximately 450 technical regulations are to be developed. Such an extensive fund can be created if the existing GOSTs are taken as a basis, sanitary rules and norms, building codes and regulations and other regulatory documents. And to simplify the procedures for adopting technical regulations.

Question 2.8. State control and supervision over compliance with the requirements of technical regulations

State control(supervision) over compliance with the requirements of technical regulations is carried out by the Federal executive authority, executive authorities of the constituent entities of the Russian Federation, state institutions authorized to carry out state control and supervision.

State control over Compliance with the requirements of technical regulations is carried out in relation to products exclusively at the stage of their circulation. The main goal of state control and supervision is to ensure the safety of the use of objects of technical regulation.

Bodies of State control and supervision have the right to:

Require the manufacturer (seller) to present documents confirming compliance;

Issue an order to eliminate violations of the requirements of technical regulations within the prescribed period;

Make a decision to ban the sale of products, suspend or terminate the declaration or certificate of conformity;

Hold the manufacturer (seller) liable in accordance with applicable law.

The main regulatory document that defines and interprets technical regulation is Federal Law No. 184-FZ "On Technical Regulation". Based on the definition given in this document, technical regulation means "legal regulation of relations in the field of establishing, applying and fulfilling mandatory requirements for products or for products and the processes of design (including surveys), production, construction, installation associated with product requirements , adjustment, operation, storage, transportation, sale and disposal, as well as in the field of establishing and applying on a voluntary basis requirements for products, design processes (including surveys), production, construction, installation, adjustment, operation, storage, transportation, sale and disposal, performance of work or provision of services and legal regulation of relations in the field of conformity assessment".

The main principles of technical regulation include:

Application of uniform rules for establishing requirements for products or for products and processes related to product requirements for design (including surveys), production, construction, installation, adjustment, operation, storage, transportation, sale and disposal, performance of work or provision of services;
independence of accreditation bodies, certification bodies from manufacturers, sellers, performers and purchasers, including consumers;
unified system and rules of accreditation;

the inadmissibility of combining by one body the powers of state control (supervision), with the exception of exercising control over the activities of accredited persons, with the powers of accreditation or certification;
the inadmissibility of combining the powers of accreditation and certification by one body;
inadmissibility of off-budget financing of state control (supervision) over compliance with the requirements of technical regulations;
the inadmissibility of simultaneous assignment of the same powers to two or more bodies of state control (supervision) over compliance with the requirements of technical regulations.

Technical regulation - a document adopted by an international treaty of the Russian Federation, subject to ratification in the manner prescribed by the legislation of the Russian Federation, or in accordance with an international treaty of the Russian Federation, ratified in the manner prescribed by the legislation of the Russian Federation, or federal law, or a decree of the President of the Russian Federation, or a decree of the Government of the Russian Federation, or a regulatory legal act of the federal executive body for technical regulation and establishes mandatory requirements for the application and execution of requirements for objects of technical regulation (products or products and design processes related to product requirements (including surveys), production, construction , installation, adjustment, operation, storage, transportation, sale and disposal).

Protection of life or health of citizens, property of individuals or legal entities, state or municipal property;
protection of the environment, life or health of animals and plants;
prevention of actions that mislead purchasers, including consumers;
ensuring energy efficiency and resource saving.

The Federal Law "On Technical Regulation" also defines the rights and obligations of participants in relations regulated by this Federal Law. In order to implement the provisions of this Law, decrees of the Government of the Russian Federation were developed.

Technical regulation system

A set of rules and regulations containing the procedure for carrying out work on the standardization of the Russian Federation and relating to virtually all major industries National economy countries, regardless of the level of government, is called state system standardization or GSS. The main legal documents governing this system, is a number of Interstate and State statutes, which contain the basic rules governing the organization and conduct of standardization work.

For this purpose, a specialized body was organized called the "International Council for Standardization, Metrology and Certification", the main tasks of which are determined by the following provisions:

1) submission of draft interstate standards for approval;
2) sampling promising directions in the field of standardization;
3) consideration and adoption of the main directions in the field of standardization and metrology, the costs of their implementation.

Also, the bodies of the standardization service include organizations, institutions, associations and divisions, the main component of whose activities lies in the area of ​​directly carrying out standardization work or in the area of ​​performing certain standardization functions.

State standardization is designed to solve a number of the following issues and tasks:

1) to develop State standards containing fundamental and general technical requirements, as well as requirements for regulating security issues labor activity, environmental protection, compatibility and interchangeability;
2) contribute to the fulfillment of the will of the customer;
3) review and approve State standards and a number of other normative acts, including: instructions, guidelines etc.;
4) ensure the principles of unity and reliability of measurements in the state, as well as contribute to the strengthening and accelerated development of the State Metrological Service;
5) to carry out organizational work on the direct use of International, regional and national standards of other states as State standards;
6) to publish and widespread State Standards in other regulatory documents;
7) engage in the preparation of works on international cooperation in the field of standardization, on the qualitative use of their results.

To organize the necessary work special standardization services are created for standardization issues. There is also State Committee Russian Federation for Standardization and Metrology - Gosstandart of Russia, which is entrusted with the obligation to conduct intersectoral coordination on metrology, standardization and certification. At the federal level, a body was also created - the Federal Agency for Technical Regulation and Metrology.

Its functions are determined by the leading role in the activities of the State Metrological Service, public service time, frequency and determination of the parameters of the Earth's rotation, the State Service for Standard Reference Data on Physical Constants and Properties of Substances and Materials.

The following research organizations are structurally subordinate to the Federal Agency for Technical Regulation and Metrology: unitary enterprise(FSUE) "All-Russian Research Institute for Classification, Terminology and Information of Standardization and Quality" ("VNIIKI"), FSUE "All-Russian Research Institute for Standardization" ("VNIIStandart"), OJSC "All-Russian Research Institute for Certification" (" VNIIS), FSUE All-Russian Research Institute for Standardization and Certification in Mechanical Engineering (VNIIN-MASH), FSUE All-Russian Research Institute of Metrological Service (VNIIMS), FSUE All-Russian Research Center for Standardization, Information and Certification of Raw Materials and Substances (VNITSSMV), Federal State Unitary Enterprise All-Russian Research Institute of Optical and Physical Measurements (VNIIOFI), Federal State Unitary Enterprise All-Russian Research Institute of Metrology named after V.I. D. M. Mendeleev” (“VNIIM named after D. M. Mendeleev”), OJSC “Research Institute for Standardization and Certification of Agro-Industrial Products” (“NIISSagroproduct”), etc.

Also subordinate to the Federal Agency are territorial bodies for metrology and standardization, as well as the so-called laboratories of state supervision of standards and measuring equipment, standardization services in organizations and industries, standardization services in ministries, standardization services at enterprises, organizations and institutions, services standardization of the level of the national economy and enterprises.

Areas of technical regulation

The Federal Law of the Russian Federation "On Technical Regulation", which came into force, determined new system establishing and applying requirements for products, production processes, works and services. The law is aimed at creating the foundations for a unified policy in the areas of technical regulation, standardization and certification that meets modern international requirements. As a result of the adoption of the law, new legal acts have appeared, primarily technical regulations, which significantly change the daily economic life of the Russian Federation.

The main instruments of technical regulation will be:

Technical regulations, which are mandatory rules introduced by federal laws; national standards - rules for voluntary use;
- conformity assessment procedures;
- accreditation;
- state control and supervision.

The Federal Law of the Russian Federation "On Technical Regulation" is aimed at creating a mechanism for ensuring the protection of life and health of citizens, environmental protection, defense and national security countries. The formation of a set of technical regulations in the country is primarily aimed at protecting national technical developments and using the results scientific and technical activities in the interests of the national economy, i.e. to ensure the technological security of the state.

Federal Law of the Russian Federation No. 184FZ "On Technical Regulation". The law was prepared by the State Standard of the Russian Federation jointly with the Ministry of Economic Development and Trade of the Russian Federation.

The main provisions of the Law are based on the provisions of the WTO Agreement on Technical Barriers to Trade, as well as on the EU Directive "On the procedure for submitting information in the field of technical regulations and standards" and fully meets modern global trends aimed at liberalizing trade relations.

The adoption of the new Law was caused by the need to move from the old technical and economic structure of the Russian economic system to the new one. systematic approach management Russian economy and technical regulation, as well as the need to comply with in full the requirements of agreements on technical barriers to trade in the WTO and the removal of these barriers.

After the entry into force of Law No. 184, the laws of the Russian Federation “On Standardization” and “On Certification” lost their force, and all the legal foundations of these laws were concentrated in the new Law.

The concept of "technical regulation" includes legal regulation in three areas: technical legislation, standardization, conformity assessment.

Law No. 184 defines the concept of technical regulation: this is the legal regulation of relations in the field of establishing, applying and fulfilling mandatory requirements for products (its entire life cycle), as well as in the field of establishing and applying on a voluntary basis requirements for products (its entire life cycle) , performance of work or provision of services and legal regulation of relations in the field of conformity assessment.

The main goal of technical regulation is the adoption of technical regulations (TR), which are adopted in order to protect the life and health of citizens, property of individuals and legal entities, state or municipal property; protection of the environment, life or health of animals and plants; prevent actions that mislead purchasers. In Law No. 184, the concept of technical regulation is defined as follows: “a document that is adopted by an international treaty of the Russian Federation, ratified in the manner prescribed by the legislation of the Russian Federation or federal law, or by a decree of the President of the Russian Federation, or by a decree of the Government of the Russian Federation and establishes mandatory requirements for the application and implementation of requirements for objects technical regulation (products, including buildings, structures and structures, processes of production, operation, storage, transportation, sale and disposal. Requirements for products, production processes, operation, storage, transportation, sale and disposal not included in technical regulations, rules and forms of conformity assessment, identification rules, requirements for terminology, packaging, labeling cannot be mandatory.The main goal of developing technical regulations is safety.

When developing technical regulations, the European model is taken as the basic basis, but the current Russian legislation and GOSTs are also used. The European model is based on the principles of the new global 2-tier approach (two-tier model).

The first level is the technical regulations, which formulate mandatory requirements that ensure the safety of products. The second level is the standards containing the requirements for voluntary application. According to the model adopted in Europe and called the principles of the New Approach, technical regulations formulate only essential requirements for products, that is, those that determine the minimum required level of safety. The specific indicators that the manufacturer must achieve in order to fulfill the requirements laid down in the technical regulations are included in voluntary standards. The sphere of standardization is a voluntary sphere, it is the receipt of products best quality in the best possible way production, so that the consumer can be offered best product in sufficient quantities and at the most reasonable price. Since the standards are voluntary for application, the manufacturer himself will choose whether he wants to use them or not, whether he needs them or not. According to Article 11 of Law No. 184 “The Purpose of Standardization”, standards should contribute to compliance with technical regulations.

This approach makes it possible to more effectively develop technical regulations based on existing standards. According to ISO/IEC Guide 2, a technical regulation is a regulation containing technical requirements, either directly or by reference to a standard, document specifications or set of rules, or by incorporating the contents of those documents. When developing technical regulations, references to national standards should be used whenever possible. This will contribute not only to the removal of barriers to trade, but most importantly, it will simplify and speed up legislative activity.

The two-tier model is quite flexible, since the specific technical requirements for products change quite often, which greatly contributes to improving its characteristics. Changing specific technical requirements in laws or government regulations is a very time-consuming process. It is more rational to do this in standards, and here the advantage of a two-level model becomes obvious. In its current form, the law "On Technical Regulation" makes it possible to implement this two-level model.

The third area of ​​technical regulation is the assessment or confirmation of conformity. Conformity assessment is a documentary evidence of the conformity of products or other objects, production processes, operation, storage, transportation, sale and disposal, performance of work or provision of services with the requirements of technical regulations, the provisions of standards or the terms of contracts (Article 2 of the Federal Law "On Technical Regulation") .

The conformity assessment procedure can be both voluntary and mandatory. Mandatory confirmation of conformity is carried out according to the requirements of technical regulations (TR) in the form of mandatory certification or declaration of conformity.

Mandatory certification is carried out by the certification body on the basis of an agreement with the applicant. Certification schemes used for certification of certain types of products are established by the relevant technical regulations.

Declaration of conformity is carried out according to one of the following schemes:

Acceptance of a declaration of conformity based on own evidence;
acceptance of a declaration of conformity based on own evidence obtained with the participation of the certification body and (or) accredited testing laboratory (center) (third party). The scheme for declaring conformity with the participation of a third party is established in the technical regulation if the absence of a third party leads to failure to achieve the goals of conformity assessment. When declaring conformity on the basis of their own evidence, the applicant independently generates evidentiary materials in order to confirm the conformity of products to the requirements of technical regulations. The composition of evidentiary materials is determined by the relevant technical regulations.

The Declaration of Conformity and the Certificate of Conformity have equal legal force regardless of the schemes of mandatory confirmation of conformity and are valid throughout the territory of the Russian Federation. Voluntary confirmation of compliance is carried out in the form voluntary certification at the initiative of the applicant on the terms of an agreement between the applicant and the certification body.

Voluntary conformity assessment can be carried out to establish compliance with national standards, organization standards, codes of practice, voluntary certification systems, and contract terms.

By order of the Government of the Russian Federation, the Program for the Development of Priority Technical Regulations was adopted. Changes to the Program of Technical Regulations were approved by order of the Government of the Russian Federation.

AT new Program included 41 draft technical regulations. Taking into account the experience of implementing previous versions of the Program, new edition designed for execution. Of the draft technical regulations included in the Program, 26 will be adopted in the form of a Government Decree, 15 in the form of a Federal Law.

Thus, of the priority TRs of the Program provided for by the Federal Law are: TR “On the safety of chemical products”, “On food safety” TR “On the safety drinking water».

At present, the Government of the Russian Federation has submitted a concept for the development of a national standardization system, developed by the Federal Agency for Technical Regulation and Metrology and agreed with 27 ministries (departments).

A new Federal Law "On Ensuring the Uniformity of Measurements" was adopted.

Russia has a long and difficult way to go through the formation of its own system of technical regulation. The intended separation of the spheres of mandatory and voluntary demands It is designed, on the one hand, to take into account the increased importance of security problems, on the other hand, to resist state overregulation of the market and increase the effectiveness of market regulation of economic relations.

Objects of technical regulation

According to the new Federal Law, the objects of technical regulation are:

Products are the result of a long-term representation in material material form;
production processes;
operation processes;
storage processes;
transportation processes;
implementation parameters;
recycling options;
provision of services.

The objects of technical regulation, presented in the technical regulations, are:

1. Products.
2. Processes of the life cycle of products directly related to ensuring product safety.

The objects partially or completely excluded from the scope of application of the norms of the Federal Law on technical regulation include:

A) state educational standards;
6) provisions (standards) on accounting;
c) rules (standards) of audit activity;
d) communication network of the Russian Federation; radio frequency spectrum;
e) the sphere of defense and means of protecting information constituting a state secret.

According to latest changes Federal Law on Technical Regulation, the law does not regulate relations related to:

A) with the use of sanitary-hygienic and sanitary-anti-epidemiological measures to prevent mass infectious diseases, prevent human diseases, provide medical care(except for the development, adoption and implementation of mandatory requirements for products, including medical equipment, food products);
b) using environmental protection measures;
c) circulation of medicines;
d) with the establishment of industrial safety requirements;
e) with the establishment of requirements for nuclear safety, as well as radiation safety (with the exception of product requirements);
f) with the establishment of requirements for products and processes in the field of space activities.

The subjects of technical regulation are the authorities (Government and ministries of the Russian Federation).

In accordance with the administrative reform carried out, the subjects vested with executive and administrative powers at the federal level include the President and the Government of the Russian Federation, federal executive bodies (hereinafter - FON B).

The three-tier structure of federal executive authorities is defined:

federal ministries;
federal services;
federal agencies.

All federal executive authorities are subordinate to higher authorities.

In this three-link (three-level) system, each link has its own tasks:

Ministry - development of state policy and legal regulation;
service - implementation of supervision and control;
agency - rendering public services, management of state property (including research institutes), implementation of law enforcement functions in the established field of activity.

Such a structure is designed to exclude the possibility of an absolute monopoly of one or another federal executive authority in the field of activity headed by it, to prevent cases of a conflict of interest in the course of activity in this area.

The main subjects of activity in the field of technical regulation are:

Ministry of Industry and Trade of the Russian Federation (Ministry of Industry and Trade of Russia);
- Federal Agency for Technical Regulation and Metrology (Rosstandart).

The Gosstandart agency is subordinate to the Russian Ministry of Industry and Trade. These two federal executive authorities differ in their functions.

The Ministry of Industry and Trade of Russia performs the functions of a federal body for technical regulation.

The Ministry has a structural subdivision - the Department of State Policy in the Field of Technical Regulation and Metrology.

The Ministry of Industry and Trade of Russia approves the administrative regulations for the performance of state services (functions) by the State Standard - maintaining the federal information fund of technical regulations, a list of products subject to mandatory confirmation of conformity, etc.

Gosstandart is a national body for standardization and practically (informally - by law) a national body for metrology. Unlike the Ministry of Industry and Trade of Russia, Rosstandart has not only a central office, but also territorial bodies in the constituent entities of the Russian Federation.

The Agency performs the following functions: permitting (issuing licenses); property management (it has research institutes, as well as state metrological services); for the provision of services (metrological); for supervision (supervision of compliance with the requirements of technical regulations, national standards, metrology rules).

As a national standardization body, Rosstandart performs a number of tasks, including approval of national standards; organizes the publication and dissemination of national standards; represents the Russian Federation in international organizations for standardization.

Technical regulation of products

For a long time, before the expansion of the contractual method of determining quality requirements, the task state regulation quality was solved mainly with the use of systems of standardization and certification of products, goods, works and services. The leading role in the legal regulation of quality belonged to the Law No. 5154-1 "On Standardization", which determined the measures of state protection of the interests of consumers and the state through the development and application of regulatory documents on standardization. The concept of standardization is defined by this Law as an activity to establish norms, rules and characteristics in order to ensure: the safety of products, works and services for the environment, life, health and property; technical and information compatibility, as well as interchangeability of products; quality of products, works and services in accordance with the level of development of science, engineering and technology; unity of measurements; saving all kinds of resources; safety of economic facilities, taking into account the risk of natural and man-made disasters and other emergencies; defense capability and mobilization readiness of the country.

According to this Law, the normative documents on standardization included:

State standards of the Russian Federation; duly applied international (regional) standards, rules, norms and recommendations for standardization; all-Russian classifiers technical and economic information;
- industry standards; enterprise standards; standards of scientific and technical, engineering societies and other public associations (in this case, the industry is understood as a set of subjects economic activity regardless of their departmental affiliation and forms of ownership, developing and (or) producing products (performing work and providing services) of certain types that have a homogeneous consumer or functional purpose).

In parallel with standardization, product quality was regulated by a certification system. The term "certification" comes from Latin word"certum" - certain, true, correct, and means checking the correctness of the manufacture of goods, performance of work, provision of services. There were two main ways to confirm the conformity of products to established requirements. The first of these was a statement by the manufacturer (supplier) that its products meet the requirements. Such a statement could be included in the product catalog, shipping documents, instruction manual, product label, etc. However, such direct confirmation of conformity was allowed only if the products were not subject to certification as a special procedure for confirming the conformity of the goods to the established requirements by a third party competent in the chosen field of activity.

A technical regulation is a document adopted by an international treaty of the Russian Federation, ratified in accordance with the procedure established by the legislation of the Russian Federation, or a federal law, or a decree of the President of the Russian Federation, or a decree of the Government of the Russian Federation, and establishes mandatory requirements for the application and implementation of requirements for objects of technical regulation (products, in including buildings, structures and structures, production processes, operation, storage, transportation, sale and disposal).

The legislator clearly defines the goals to be achieved by the adoption of technical regulations, as well as the content of the latter. Technical regulations are adopted in order to: protect the life or health of citizens, property of individuals or legal entities, state or municipal property; protection of the environment, life or health of animals and plants; prevention of actions that mislead purchasers. Adoption of technical regulations for other purposes is not allowed.

Technical regulations, taking into account the degree of risk of causing harm, establish the minimum necessary requirements to ensure:

Radiation safety;
- biological safety;
- explosion safety;
- mechanical safety;
- fire safety;
- industrial safety;
- thermal safety;
- chemical safety;
- electrical safety;
- nuclear and radiation safety;
- unity of measurements.

The requirements of technical regulations cannot serve as an obstacle to the implementation entrepreneurial activity to a greater extent than is the minimum necessary to fulfill the above objectives.

The technical regulation must contain an exhaustive list of products, processes of production, operation, storage, transportation, sale and disposal, in respect of which its requirements are established, and the rules for identifying the object of technical regulation for the purposes of applying the technical regulation. For the purpose of its adoption, a technical regulation may contain rules and forms of conformity assessment (including conformity assessment schemes) determined taking into account the degree of risk, deadlines for conformity assessment in relation to each object of technical regulation and (or) requirements for terminology, packaging, labeling or labels and rules for their application.

Conformity assessment is carried out in the form of state control (supervision), accreditation, testing, registration, conformity assessment, acceptance and commissioning of the facility, the construction of which is completed, and in another form.

Mandatory requirements contained in technical regulations for products, processes of production, operation, storage, transportation, sale and disposal, rules and forms of conformity assessment, identification rules, requirements for terminology, packaging, marking or labels and rules for their application are exhaustive, have direct effect throughout the territory of the Russian Federation and can only be changed by making changes and additions to the relevant technical regulations.

Conformity assessment is carried out in the form of state control (supervision), accreditation, testing, registration, conformity assessment, acceptance and commissioning of the facility, the construction of which is completed, and in another form.

Documents of technical regulation

The main goal of the Federal Law of the Russian Federation "On Technical Regulation" is to create the basis for a unified policy in the field of standardization and certification. As a result of the adoption of the law, a constellation of new norms appeared in the domestic legal field, which significantly change the economic life of the country. This law can be called the "Constitution for Industry": it cancels the laws "On Standardization" and "On Certification of Products and Services" and a number of other regulations. The law requires amendments and additions to a significant number of documents of the current legislation, including up to 50 federal laws and more than 60 thousand normative and legal acts: orders, orders and resolutions of the Government of the Russian Federation and ministries and departments. They are known as GOSTs, OSTs, SNIPs, SanPiNs, fire and veterinary safety standards, etc. All of them will remain in effect until they are replaced by the appropriate technical regulation. Moreover, such a change should take place smoothly.

An equally important goal of the adoption of the Federal Law of the Russian Federation "On Technical Regulation" is to bring Russian standardization and certification procedures in line with the requirements of the World Trade Organization (WTO) - World Trade Organization (WTO), and first of all, with the requirements of the WTO Agreement on technical barriers in trade. This law counteracts the transformation of national standards and various technical requirements to products and services as an instrument of protectionism in relation to any groups of commodity producers. Harmonization of the national system of standardization with the international one makes it easier for Russian high-tech products to enter the world markets, and makes it possible to organize cooperation in their production by subcontractors from developed countries.

A good example of technical regulation is the decision of the International Organization civil aviation on the entry into force of a convention tightening the requirements for the noise level of aircraft engines operating on international routes of the European Union (European Union). The economic consequences for Russian airlines using domestic aircraft that do not meet these standards on international flights are obvious, and much has been said about this.

The concept of the law "On Technical Regulation" provides that all mandatory requirements for products and services are established only by technical regulations, which are determined by Federal laws and decrees of the Government of the Russian Federation. Technical regulations should contain minimum requirements to ensure the safety of products (services) and the scope of mandatory requirements is reduced to a minimum. Moreover, after the entry into force of technical regulations, the mandatory requirements of the standards cease to be mandatory and state control (supervision) begins to be carried out over compliance with the requirements of technical regulations.

By the way, world practice defines technical regulations, international, national and regional standards, conformity assessment procedures, accreditation of certification bodies and testing laboratories (centers), control and supervision as the main regulatory elements of technical regulation.

Nevertheless, the Federal Law of the Russian Federation "On Technical Regulation" is ideological and framework. It contains a number of ambiguous premises that, under certain conditions, can worsen the current situation in this area. So, some sections of the existing GOSTs on standardization contradict the provisions of the law; there is no clear definition on the participation of the Federal Agency for Technical Regulation and Metrology in the systems of domestic and international certification. However, the law provides for a transitional period of seven years, during which new and old elements of technical regulation (i.e., relevant regulations - documents containing mandatory legal norms and adopted by the relevant executive authority) and standards will coexist.

The full force of the Federal Law of the Russian Federation "On Technical Regulation" will begin to work after the introduction of technical regulations and then the Russian Federation will come to the formation of the Unified Code of Laws on Technical Regulation.

Legal technical regulation

Technical regulation is the legal regulation of relations in the field of establishing, applying and fulfilling mandatory requirements for products or related design processes (including surveys), production, construction, installation, commissioning, operation, storage, transportation, sale and disposal, as well as in areas of establishment and application on a voluntary basis of requirements for products, design processes (including surveys), production, construction, installation, adjustment, operation, storage, transportation, sale and disposal, performance of work or provision of services and legal regulation of relations in the field of conformity assessment.

The fundamental role in special regulation is assigned to Federal Law No. 184-FZ "On Technical Regulation".

The objects of technical regulation (OTR) include:

Products (including buildings, structures and structures);
- processes (production, operation, storage, sale, transportation and disposal);
- work, services.

Technical regulation is carried out in accordance with the principles:

Application of uniform rules for establishing requirements for products or related processes of design (including surveys), production, construction, installation, adjustment, operation, storage, transportation, sale and disposal, performance of work or provision of services;
- compliance of technical regulation with the level of development of the national economy, the development of the material and technical base, as well as the level of scientific and technical development;
- independence of accreditation bodies, certification bodies from manufacturers, sellers, performers and purchasers;
- the unity of the rules and methods of research (testing) and measurements in the course of mandatory conformity assessment procedures;
- uniform application of the requirements of technical regulations, regardless of the types or features of transactions;
- inadmissibility of restriction of competition in the implementation of accreditation and certification;
- inadmissibility of combining the powers of the state control (supervision) body and the certification body;
- inadmissibility of combining by one body of powers for accreditation and certification;
- inadmissibility of off-budget financing of state control (supervision) over compliance with the requirements of technical regulations;
- inadmissibility of simultaneous assignment of the same powers to two or more bodies of state control (supervision) over compliance with the requirements of technical regulations.

The legislation of the Russian Federation on technical regulation consists of the said Federal Law, federal laws adopted in accordance with it, and other normative legal acts of the Russian Federation. The provisions of federal laws and other regulatory legal acts of the Russian Federation relating to the scope of this Federal Law (including those directly or indirectly providing for control (supervision) over compliance with the requirements of technical regulations) shall apply to the extent that they do not contradict this Federal Law.

If an international agreement of the Russian Federation in the field of technical regulation establishes other rules than those provided for by the Federal Law, the rules of the international agreement are applied, and in cases where it follows from the international agreement that its application requires the issuance of a domestic act, the rules of the international agreement and the adopted based on the legislation of the Russian Federation.

The document that establishes the mandatory requirements for the application and implementation of the OTR is a technical regulation - a document that is adopted by an international treaty of the Russian Federation, ratified in the manner prescribed by the legislation of the Russian Federation, or an intergovernmental agreement concluded in the manner established by the legislation of the Russian Federation, or federal law, or a decree of the President of the Russian Federation, or by a decree of the Government of the Russian Federation, or by a regulatory legal act of the federal executive body for technical regulation and establishes mandatory requirements for the application and implementation of requirements for objects of technical regulation (products, including buildings, structures and structures or processes related to product requirements design (including surveys), production, construction, installation, commissioning, operation, storage, transportation, sale and disposal) (as amended by Federal Law No. 385-FZ "On Technical Regulation").

The purpose of adopting technical regulations is solely to ensure the safety of life and health of citizens and property (state, municipal, personal, etc.), the environment.

In technical regulations, taking into account the degree of risk of causing harm, mandatory minimum necessary requirements are established that can ensure different kinds product safety (for example, radiation, fire, thermal, chemical, electrical, nuclear, etc.); electromagnetic compatibility, which ensures the safety of the operation of instruments and equipment, as well as the uniformity of measurements.

The technical regulation contains a list of objects of technical regulation in respect of which its requirements are established, as well as rules and forms of conformity assessment, taking into account the degree of risk; deadlines for conformity assessment in relation to each OTR and requirements for terminology, packaging, marking or labels and the rules for their application. The requirements for OTP contained in the technical regulations, the rules and forms of conformity assessment, etc., are exhaustive, have direct effect and can only be changed by making changes directly to the technical regulation.

The technical regulation must contain requirements for product characteristics, production processes, operation, storage and other OTS, but not for the design and execution itself, unless the non-inclusion of these requirements does not ensure the achievement of safety and environmental protection. Requirements for OTR, rules and forms of evaluation, terminology, packaging, etc., not included in the technical regulation. are not mandatory. Direct or indirect determination of compliance with the requirements for OTP is called conformity assessment.

The Russian Federation has general and special technical regulations. Mandatory requirements for certain types products, production processes, operation and other OTR are determined by a set of requirements of general and special technical regulations.

The requirements of the general technical regulation are mandatory for application and compliance with any OTR. They are accepted on issues related to ensuring all types of security (operation of buildings, machines, equipment; fire, nuclear, etc.).

Special technical regulations establish requirements only for those individual technical regulations in respect of which the requirements of general technical regulations are either not met, or the degree of risk of causing harm is higher than the degree of risk taken into account by the general technical regulation.

The developer of a technical regulation can be any person (natural or legal). The Law "On Technical Regulation" stipulates the procedure for adopting technical regulations. Notification on the development of a draft technical regulation is published in the press. It contains indications to which OTR the requirements of the technical regulation and its goals are established, the necessity is justified and its differences from the current regulations, domestic or international standards are indicated. Taking into account the comments received from interested parties, the developer organizes and conducts a public discussion of the draft technical regulation and draws up a list of comments. This list, together with the text of the technical regulation and the financial and economic justification, is attached to the draft federal law on the introduction of the regulation and submitted to the State Duma. The State Duma sends a set of documents for review to the government of the Russian Federation. The government must give a review prepared by an expert commission within a month, after which, if positive feedback the draft federal law is adopted in the State Duma in the first reading. The adoption of a law is a public and lengthy process. In exceptional cases, if there is an immediate threat to life or health or the need to ensure the safety of products or other objects of the OTP, the President of the Russian Federation has the right to issue technical regulations without public discussion. The technical regulation shall enter into force not earlier than six months from the date of its official publication.

Before starting the preparation of a technical regulation, developers, in accordance with R 50.1.044, must check a number of key issues, including:

Are there alternatives to technical regulations that do not require government intervention to solve the problem, such as the use of general legislation, voluntary standards, economic instruments (taxes, sale of property rights), insurance and liability laws, etc.;
- whether the introduction of technical regulations provides a minimum of costs or a maximum of benefits for society in comparison with alternative solutions;
- whether the technical regulation is focused more on the result to be achieved than on the means to achieve it, i.e. on the requirements for the final product, and not on the processes and procedures that are the means to an end. End product requirements provide both flexibility and predictability of outcomes, enabling firms to incentivize compliance and innovation costs to achieve the end result through the development of new technologies;
- is the proposed technical regulation compatible with international obligations and international standards (e.g. ISO; European Economic Commission UN - UNECE; European Commission for Standardization - CEN; International Electrotechnical Commission - IEC, etc.), if not, why not.

When conducting such an analysis, developers should keep in mind that technical regulations should ensure the minimization of trade barriers and not be used to create unjustified obstacles to international trade. The Technical Barriers to Trade (TBT) Agreements of the World Trade Organization (WTO) recognize the importance of product standards, stating that “whenever possible, the parties to the Agreement should develop technical regulations based on the requirements for products in terms of their final performance. than design and descriptive characteristics". The WTO TBT Agreements state that the parties to the Agreement must use international standards as the basis for technical regulations. Technical regulations are largely based on standards.

Scope of technical regulation

The objects of technical regulation are:

- products (finished products, raw materials, natural fuels, materials);
– services (tangible and intangible);
- processes at individual stages of the product life cycle that can create a risk of hazards. Risk is understood as the probability of causing harm to the life or health of citizens, property, the environment, taking into account the severity of this harm.

The federal law regulates relations in the following areas of activity:

When developing, adopting and fulfilling mandatory requirements for products or related design processes (including surveys) of production, construction, installation, commissioning, as well as operation, storage, transportation, sale and disposal;
- in the development, adoption, application and execution on a voluntary basis of requirements for products or related design processes (including surveys) of production, construction, installation, commissioning, as well as operation, storage, transportation, sale and disposal, performance of works or services;
- when evaluating conformity.

Thus, technical regulation can be reduced to three main activities:

Establishment, application and implementation of mandatory requirements for products and life cycle processes (technical regulation activities);
- establishment and application on a voluntary basis of requirements for products, processes of the life cycle program, performance of work on the provision of services (standardization activities);
- legal regulation in the field of conformity assessment (certification activities).

The fourth area of ​​application of technical regulation is the formation of requirements that ensure the unified and safe functioning of a unified system of communications.

The effect of the law "On technical regulation", taking into account the changes made, does not apply to:

On state educational standards, regulations on auditing and standards for issuing securities;
- on socio-economic, organizational, sanitary and hygienic, medical and preventive measures in the field of labor protection.

The federal law does not regulate relations related to the application of measures to prevent the occurrence and spread of human infectious diseases and to protect the soil, atmospheric air of water bodies classified as places of mass recreation and tourism.

The term "acceptance of requirements" means their approval in the manner prescribed by law or regulation. "Acceptance of requirements" means their mandatory or voluntary choice in all cases for which they are accepted. By “compliance with the requirements” one should understand their obligatory observance in the relevant objects of technical regulation.

Principles of technical regulation

Two groups of principles can be conditionally formulated:

The first group is the basic principles of technical regulation for the domestic market.

They provide for the following:

Compliance of the technical regulation system with the level of development of the national economy, material and technical base and scientific and technical development. The requirements established in the technical regulations should be the minimum necessary to achieve the objectives of the regulation;
application of uniform rules for establishing requirements for products and processes for their design (including surveys), production, construction, installation, adjustment, operation, storage, transportation, sale and disposal, as well as for the performance of work or the provision of services;
unity and obligation to fulfill the requirements of technical regulations throughout Russia;
application of national standards as an evidence base for meeting the requirements of technical regulations;
formation of a mechanism for technical regulation based on risk assessment of product use;
independence of accreditation bodies and certification bodies from manufacturers, sellers, performers and consumers;
the presence of a unified system and rules for accreditation, the inadmissibility of combining accreditation and certification activities and restricting competition in the performance of these works;
the inadmissibility of combining the powers of the state control (supervision) body and the certification body;
establishment of operational characteristics in technical regulations.

The essence of the second group of principles is to ensure that the imposed on manufacturers and sellers different countries mandatory requirements for products and related processes of their design, production, construction, etc. did not develop into trade barriers. Countries should strive to create mechanisms that would avoid barriers to trade when enacting technical regulations, standards and conformity assessment procedures. International practice in this area is based on the following basic provisions.

Removal of excessive barriers to trade. Technical barriers are the result of countries adopting technical regulations, standards and conformity assessment procedures. At the same time, due to the difference in socio-economic development, climate, national traditions, tastes, etc. These regulations, standards and procedures may vary from country to country. States are free to take these factors into account in legislation at the level they deem necessary. At the same time, it is necessary to strive to develop flexible technical regulations that would be minimally restrictive for trade. Therefore, technical regulations should establish operational rather than structural requirements.

If the circumstances that led to the increased requirements no longer exist, or if the objectives of the regulation can be achieved by other, less restrictive measures, such measures should be applied. Similar actions should also be taken if the adopted regulatory conditions do not correspond to the risk of not achieving the goals. Commitments to remove technical barriers to trade also apply to conformity assessment procedures and standards.

non-discriminatory basis. This principle establishes that the requirements of technical regulations for the admission of imported products into the country should establish no less favorable treatment than for the admission own products to your market. The same regime applies to conformity assessment procedures. This, in particular, means that the terms of certification for imported products should be applied on a non-discriminatory basis, including in terms of its duration and cost.

Fundamentals of technical regulation

Technical regulation - legal regulation of relations in the field of establishing, applying and fulfilling mandatory requirements for products, production processes, operation, storage, transportation, sale and disposal, as well as in the field of establishing and applying on a voluntary basis requirements for products, production processes, operation, storage, transportation, sale and disposal, performance of work or provision of services and legal regulation of relations in the field of conformity assessment (according to the federal law "On technical regulation" No. 184-FZ).

Application of uniform rules for establishing requirements for products or related processes of design (including surveys), production, construction, installation, adjustment, operation, storage, transportation, sale and disposal, performance of work or provision of services;
compliance of technical regulation with the level of development of the national economy, the development of the material and technical base, as well as the level of scientific and technical development;
independence of accreditation bodies, certification bodies from manufacturers, sellers, performers and purchasers.

Unified system and rules of accreditation;

Unity of rules and methods of research (tests) and measurements in the course of mandatory conformity assessment procedures;
uniform application of the requirements of technical regulations, regardless of the types or features of transactions;
the inadmissibility of restricting competition in the implementation of accreditation and certification;
the inadmissibility of combining the powers of the state control (supervision) body and the certification body;
the inadmissibility of combining the powers of accreditation and certification by one body;
the inadmissibility of simultaneous assignment of the same powers to two or more bodies of state control (supervision) over compliance with the requirements of technical regulations;
inadmissibility of off-budget financing of state control (supervision) over compliance with the requirements of technical regulations.

By Decree No. 316 “On Measures to Implement the Federal Law “On Technical Regulation”, the Government of the Russian Federation endowed the State Committee of the Russian Federation for Standardization and Metrology (Gosstandart of the Russian Federation) with the functions of an executive body for technical regulation. Accordingly, on the ground, these functions should be performed by territorial bodies - federal state institutions (centers for standardization, metrology and certification). By Decree of the President of the Russian Federation N 314 “On the System and Structure of Federal Executive Bodies”, Gosstandart was transformed into the Federal Service for Technical Regulation and Metrology and the Decree of the Government of the Russian Federation No. 194 “Issues of the Federal Service for Technical Regulation and Metrology” was approved. Then, by decree of the President of the Russian Federation No. 649 “Issues of the structure of federal executive bodies” federal Service for Technical Regulation and Metrology was transformed into the Federal Agency for Technical Regulation and Metrology. Decree of the Government of the Russian Federation N 294 approved the "Regulations on the Federal Agency for Technical Regulation and Metrology" and declared Decree No. 194 invalid.

Thus, the Federal Agency for Technical Regulation and Metrology is a federal executive body that performs the functions of providing public services, managing state property in the field of technical regulation and metrology. The agency is administered by the Ministry of Industry and Trade of the Russian Federation (Minpromtorg).

According to the federal law “On Technical Regulation” (hereinafter referred to as the federal law), all requirements for products are divided into two categories: voluntary for application (contained in standards) and mandatory (established by technical regulations).

Technical regulation - a document adopted by an international treaty of the Russian Federation, ratified in the manner prescribed by the legislation of the Russian Federation, or a federal law, or a decree of the President of the Russian Federation, or a decree of the government of the Russian Federation, and establishes mandatory requirements for application and implementation of requirements for objects of technical regulation.

Objects of technical regulation - products, including buildings, structures and facilities, processes of production, operation, storage, transportation, sale and disposal.

The technical regulation must contain an exhaustive list of products, processes of production, operation, storage, transportation, sale and disposal, in respect of which its requirements and rules for identifying the object of technical regulation for the purposes of applying the technical regulation are established. For the purpose of its adoption, a technical regulation may contain rules and forms of conformity assessment (including conformity assessment schemes) determined taking into account the degree of risk, deadlines for conformity assessment in relation to each object of technical regulation and (or) requirements for terminology, packaging, labeling or labels and rules for their application. Conformity assessment is carried out in the form of state control (supervision), accreditation, testing, registration, conformity assessment, acceptance and commissioning of the facility, the construction of which is completed, and in another form.

The technical regulation should contain requirements for product characteristics, production processes, operation, storage, transportation, sale and disposal, but should not contain requirements for design and execution, except in cases where, due to the lack of requirements for design and execution, taking into account the degree of risk causing harm does not ensure the achievement of the objectives of the adoption of the technical regulation. Also, for these reasons, they may contain special requirements that ensure the protection of certain categories of citizens (minors, pregnant women, nursing mothers, disabled people).

Technical regulation of certification

One of the main principles of Russia's accession to the WTO (World Trade Organization) is compliance with the principles of technical regulation established in the Agreement on Technical Barriers to Trade, the Agreement on the Application of Sanitary and Phytosanitary Measures, as well as in the Code of Voluntary Practice. In this regard, the Federal Law “On Technical Regulation” No. 184 was adopted in Russia, which is the main source of technical law in Russia.

Technical legislation is a set of legal norms that regulate the requirements for technical objects: products, processes of its life cycle, works (services) and control (supervision) over compliance with established requirements.

Reasons for reform technical legislation in Russia - the elimination of non-tariff barriers to trade between countries (Technical barriers are differences in the requirements of national and international standards, leading to additional costs funds and/or time to promote products to the relevant market). Only with this harmonization can our business fit into the modern economic space.

So, in New York was recalled from outlets a batch of Russian milk "Mozhayskoye" and "Darling Mila", as sulfonamide, a substance that can cause an allergic reaction in a person, was found on the products. The reason is the difference in the requirements of national standards. Although Russian GOSTs on food products in general is tougher, but they did not provide for a test for sulfonamide (in connection with this incident, negotiations are underway for the purchase of - appropriate - testing equipment).

This example illustrates a natural “technical barrier. But in practice there are a lot of artificially created technical barriers for Russia, which is not a member of the WTO. Very often they arise due to the lack of agreements on mutual recognition of the results of conformity assessment. For example, to our household appliances(cars, refrigerators) entering the European market | are often presented individual characteristics more stringent requirements than for products of other European countries, despite the presence of certificates of conformity issued by internationally recognized certification bodies and recognized in the EU countries. In connection with the above, Russia, like all other countries, should develop programs to overcome barriers to trade, especially since the implementation of these programs gives a huge economic effect. According to the Economic Committee for Asia-Pacific Cooperation (APEC), the developed programs on non-tariff barriers to trade (standardization, conformity assessment) give the APEC countries 0.26% of the profit from the actual gross domestic product (about $ 45 billion), while the program tariff regulation - only 0.14% (almost half as much). Programs to overcome technical barriers are based on the activities of states in the field of technical regulation. Regulation refers to the actions of the state that organize the behavior of economic entities in the market.

Technical regulation - legal regulation of relations in the field of establishing, applying and fulfilling mandatory requirements for products, production processes, operation, storage, transportation, sale and disposal, as well as in the field of establishing and applying on a voluntary basis requirements for products, production processes, operation, storage, transportation, sale and disposal, performance of work or provision of services and legal regulation of relations in the field of conformity assessment.

This definition includes the main elements of technical regulation:

Establishment, application and implementation of mandatory requirements for products and product life cycle processes;
- establishment and application on a voluntary basis of requirements for products, product life cycle processes, performance of work or provision of services;
- legal regulation of relations in the field of conformity assessment.

The objects of technical regulation are products, product life cycle processes, works and services.

The subjects of technical regulation are:

Authorities;
- bodies of state control (supervision) over compliance with the requirements of technical legislation;
- certification bodies, accredited testing laboratories;
- business entities;
- developers technical laws and standards.

Technical regulation is carried out in accordance with the principles:

1. application of uniform rules for establishing requirements for products;
2. compliance of technical regulation with the level of development of the national economy, the development of the material and technical base, as well as the level of scientific and technical development;
3. independence of accreditation bodies, certification bodies from manufacturers, sellers, performers and purchasers;
4. unified system and rules of accreditation;
5. unity of rules and methods of research and measurements in the course of mandatory conformity assessment procedures;
6. uniform application of the requirements of technical regulations, regardless of the types or features of transactions;
7. inadmissibility of restriction of competition;
8. inadmissibility of combining the powers of the state control (supervision) body and the certification body;
9. inadmissibility of combining by one body of powers for accreditation and certification;
10. inadmissibility of off-budget financing of state control over compliance with the requirements of technical regulations.

Technical regulation - a document that is a carrier of mandatory requirements.

Technical regulations are adopted in order to:

1. protection of life or health of citizens, property of individuals or legal entities, state or municipal property;
2. protection of the environment, life or health of animals and plants;
3. prevention of actions that mislead purchasers.

Technical regulations establish the minimum necessary requirements to ensure:

Radiation safety; biological; explosion safety; mechanical; fire department; industrial; thermal; chemical; electrical; nuclear and radiation safety;
- electromagnetic compatibility in terms of ensuring the safety of the operation of instruments and equipment;
- unity of measurements.

Types of technical regulations: general technical regulations; special technical regulations. The requirements of the general technical regulation are mandatory for application and compliance with any type of product.

The requirements of the special technical regulation take into account the features of certain types of products, the degree of risk of causing harm to which is higher than that established by the general technical regulation. Technical regulations are adopted by federal law.

Confirmation of conformity (certification) - documentary evidence of compliance of products or other objects, processes of production, operation, storage, transportation, sale and disposal, performance of work or provision of services with the requirements of technical regulations, provisions of standards or terms of contracts.

Confirmation of conformity is carried out in order to:

1. certification of the conformity of products, processes of the life cycle program, works, services or other objects with technical regulations, standards, terms of contracts;
2. grants applicants the right to use the mark of conformity, if the use of the mark of conformity is provided for by the relevant system of voluntary certification;
3. suspends or terminates the certificates of conformity issued by him.

The principles of conformity assessment are:

1. availability of information on the procedure for carrying out conformity assessment to interested parties;
2. establishment in the relevant technical regulation of the list of forms and schemes mandatory compliance in relation to objects;
3. focus on reducing the duration of the procedure for mandatory confirmation of conformity and the costs of the applicant;
4. inadmissibility of coercion to exercise voluntary confirmation compliance;
5. the inadmissibility of replacing the mandatory confirmation of compliance with voluntary certification;
6. protection of property interests of applicants, preservation trade secret in relation to the information obtained during the confirmation of compliance;
7. the inadmissibility of applying mandatory confirmation of conformity to objects in respect of which the requirements of technical regulations are not established;
8. presumption of conformity of products marked with the mark of conformity.

Compliance confirmation base:

Legislative
- organizational and methodological,
- scientific and technical.

The subjects of certification are:

The first party - manufacturers of products or services, sellers selling products;
- the second party - buyers and consumers of products and services;
- third party - independent organizations that carry out conformity assessment - certification bodies, testing laboratories, the federal executive body for technical regulation.

Certification objects: products, works, services. There are two forms of confirmation of conformity:

Certification - a form of implementation by the certification body of confirmation of compliance of objects with the requirements of technical regulations, the provisions of standards or the terms of contracts;
- declaration of conformity - a form of confirmation of compliance of objects with the requirements of technical regulations. The Declaration of Conformity and the Certificate of Conformity have equal legal force and are valid throughout Russia.

Regulatory and technical regulation

In the Federal Law "On Technical Regulation", technical regulation is defined as the legal regulation of relations in the field of establishing, applying and fulfilling mandatory requirements for products, production processes, operation, storage, transportation, sale and disposal, as well as in the field of establishing and applying on voluntary basis of requirements for products, production processes, operation, storage, transportation, sale and disposal, performance of work or provision of services and legal regulation of relations in the field of conformity assessment.

In other words, technical regulation is everything that relates to the regulation of requirements for products, processes, standardization, certification, conformity assessment, state and other types of control over products, processes, services and other objects of technical regulation.

The experience of designing, building and operating industrial and agricultural facilities in the Tyumen region has shown that the existing system of regulatory and technical regulation frankly contradicts the strategy of deregulation (debureaucratization) of the Russian economy, and therefore hinders the overall strategy of reforming the sectors of the Russian economy.

President of the Russian Federation D.A. Medvedev, in his messages to the Federal Assembly of the Russian Federation, set the task of reducing the interference of officials in business affairs, eliminating excessive mandatory certification, developing entrepreneurial initiative and increasing the competitiveness of Russian products.

However, the instructions of the President and the transition of regulation to legislative norms direct action in practice further complicated the solution of urgent business problems. During the transition period, many tasks of normative and technical regulation cannot be solved within the framework of existing practice.

It is already obvious that many norms are outdated or simply not needed in the market conditions. These rules include the rules process design(NTP). These documents should act as recommendations. However, in the absence of new scientific and technical progress, they are considered as guiding documents for the modernization of existing ones and the creation of new ones. modern productions.

Many industry-specific scientific and technological progress or their individual provisions compete with technical regulations and other documents of normative and technical regulation. Contradictions in the documents do not allow unambiguously solving business problems. These contradictions or uncertainties put a huge burden on the business in the form of many redundant requirements.

Ultimately, all these uncertainties in the procedures for creating and applying technical regulations and norms are regulated by administrative measures not in favor of business. This situation does not allow the Russian economy to develop normally.

The Russian economy has already become a market economy, but the system of technical regulation has remained at the level of a command-administrative system and total control.

The existing system creates favorable conditions for the modernization not of the economy, but of corruption itself. Corruption becomes institutionalized and begins to operate almost openly. New camouflaged schemes of interaction between economic entities are being built, which have become the norm in the relationship between interested representatives of the authorities and businesses close to the authorities, for example, with technological connections to engineering networks.

Many problems behind the norms of technical regulation are simply not perceived by the state authorities and thus stifle enterprises and projects with old norms and excessive regulation.

Any regulation bears responsibility, and in the period of strengthening the fight against corruption, civil servants of sectoral federal and regional ministries and departments, in order to avoid trouble, simply avoid solving problems under various pretexts, including references to lack of authority.

The state begins to move away from the performance of its basic administrative functions. And by strengthening and tightening the control regimes, the effect cannot be achieved. No one wants to initiate research into these problems and work to solve them. This not normal! It is necessary to create a system of professional self-government capable of understanding and solving the problems of technical regulation.

Goals of technical regulation

The federal law did not directly declare the goals of the technical regulation reform. However, an analysis of the Federal Law and other regulatory legal acts makes it possible to identify these goals and priorities.

One of the main goals is to build a two-level system of normative acts that establish mandatory minimum requirements (technical regulations) and acts of voluntary application that provide for more “burdensome”, specifying requirements, including an innovative component (national standards, codes of practice, etc.). The task of the reform was to harmonize Russian legislation in the field of technical regulation with international standards in this area.

In essence, the goal was aimed, among other things, at establishing an acceptable balance between the rights of purchasers to safe products and service delivery processes and the rights of product manufacturers and service providers to the free movement of goods, services and financial resources. In addition, the current regulatory framework in the field of technical regulation does not meet the modern requirements of scientific and technological progress, which also encourages the reform of technical regulation to develop towards innovation. Russian production.

It should be noted that in order to achieve these goals, it is necessary to ensure the involvement of the efforts of business and production in this process. Particularly important are the initiatives of these participants in the development of an array of technical regulations and national standards, the provision of scientific support for the reform of technical regulation.

To date, the business community is often on the sidelines of these processes, which is explained by the established practice, built on the sovereignty of middle-level officials, in fact, their complete lack of interest in the final result.

According to paragraph 1 of Art. 46 of the Federal Law, from the date of its entry into force until the entry into force of the relevant technical regulations, the requirements for products, production processes, operation, storage, transportation, sale and disposal established by regulatory legal acts Russian Federation and regulatory documents of federal executive bodies are subject to binding only in the part corresponding to the goals:

– protection of life or health of citizens, property of individuals or legal entities, state or municipal property;
– protection of the environment, life or health of animals and plants;
– prevention of actions that mislead purchasers.

In addition, the Federal Law made significant changes to the system of standardization and certification of products (works, services).

In Russia, 52 federal executive bodies were involved in control, supervision, setting requirements and certification. Therefore, the draft federal law caused misunderstanding and resistance of civil servants, and numerous criticisms of experts. Both methods of implementation and goals were criticized.

Seven years have passed since the entry into force of the Federal Law, and technical regulations are just beginning to be adopted. Out of more than two dozen instructions to the Government of the Russian Federation on the approval, establishment of various procedures, rules, methods in accordance with the Federal Law, only a few came out. In addition, it is necessary to correct more than a hundred existing federal laws and about 600 decrees of the Government of the Russian Federation.

For numerous reasons, which are quite widely and fully covered in periodicals, over the past period, most of the practical goals of the Federal Law have not been achieved. On the other hand, given the existing bureaucratic machine, which is simultaneously undergoing continuous administrative restructuring, even those few results obtained can be considered an achievement. Unfortunately, the Government of the Russian Federation was unable to involve the business community, self-regulatory organizations of manufacturers and public organizations in this area in the development of technical regulations on a large scale, which do not feel the state's interest in cooperating with them.

Technical regulation of services

Special place in ensuring the quality of services, it is assigned to technical regulation, which is regulated by the Federal Law on Technical Regulation. In fact, it was adopted in order to harmonize with international requirements on the eve of WTO accession, however, from the point of view of state regulation of the quality and safety of services, it brought more questions than solutions.

According to this law, technical regulation is the legal regulation of relations in the field of establishing, applying and fulfilling mandatory requirements for products, production processes, operation, storage, transportation, sale and disposal, as well as in the field of establishing and applying on a voluntary basis requirements for products, production processes , operation, storage, transportation, sale and disposal, performance of work or provision of services and legal regulation of relations in the field of conformity assessment. At the same time, the objects of technical regulation are products, a number of processes of its life cycle, works and services.

Mandatory requirements for the safety of these facilities can only be fixed in technical regulations. All other documents that contain certain requirements for products, processes and services can only be voluntary.

Technical regulation is a document adopted by an international treaty of the Russian Federation, ratified in accordance with the procedure established by the legislation of the Russian Federation, or by a federal law, or by a decree of the President of the Russian Federation, or by a decree of the Government of the Russian Federation, and establishes mandatory requirements for the application and implementation of requirements for objects of technical regulation ( products, including buildings, structures and facilities, production processes, operation, storage, transportation, sale and disposal).

Technical regulations are adopted in order to: protect the life or health of citizens, property of individuals or legal entities, state or municipal property; protection of the environment, life or health of animals and plants; prevention of actions that mislead purchasers.

Requirements not included in technical regulations cannot be mandatory. Therefore, all other documents containing certain requirements for objects of technical regulation can only be applied on a voluntary basis. Considering that the objects of the technical regulation are only products and processes, services fall out of the scope of state regulation in the field of security, despite the fact that many services carry potential risks to human life and health ( catering, car repair, etc.). It is believed that market mechanisms can stimulate the voluntary application of requirements for the quality and safety of services, as this is an additional competitive advantage. However, this requires a sufficiently broad education of consumers in the field of quality and safety.

In turn, the standard is a document in which, for the purpose of voluntary reuse, product characteristics, implementation rules and characteristics of production processes, operation, storage, transportation, sale and disposal, performance of work or provision of services are established. The standard may also contain requirements for terminology, symbols, packaging, marking or labels and the rules for their application.

Thus, the Law "On Technical Regulation" ensures the creation of a two-tier system of normative documents: technical regulations that contain mandatory requirements and voluntary standards. It should also be noted that the normative and normative legal acts of the federal executive bodies adopted before July 1 may contain as mandatory only those requirements that correspond to the objectives of the adoption of those. regulations (safety of life and health of people, animals and plants, protection of property, environment and prevention of actions misleading consumers). These mandatory requirements will be in effect until the appearance of the relevant technical regulations, but not more than 7 years. Thus, it can be stated that all mandatory requirements for the quality of services, which are considered in acc. federal laws can be considered to be of a recommendatory nature.

The main type of documents that contain requirements for the quality of services are standards, which can be of three types: international, national and enterprise standards. Previously existing industry standards should be transferred either to the rank of national or to the rank of enterprise standards.

Conformity assessment of services can only be carried out on a voluntary basis, usually through voluntary certification.

The objects of voluntary certification include services, works, processes, quality systems, service organizations, personnel and other objects for which there are established requirements and assessment methods.

Voluntary certification is carried out by certification bodies that are part of the voluntary certification system formed by any legal entity that has registered this system with a specially authorized federal body.

Types of technical regulation

In the Russian Federation there are:

General technical regulations;
- special technical regulations.

Mandatory requirements for certain types of products, processes of production, operation, storage, transportation, sale and disposal are determined by a combination of requirements of general technical regulations and special technical regulations.

The requirements of the general technical regulation are mandatory for application and compliance with any type of product, production process, operation, storage, transportation, sale and disposal.

The requirements of a special technical regulation take into account technological and other features of certain types of products, production processes, operation, storage, transportation, sale and disposal.

General technical regulations are adopted on the following issues:

Safe operation and disposal of machinery and equipment;
- safe operation buildings, structures, structures and safe use of the territories adjacent to them;
- fire safety;
- biological safety;
- electromagnetic compatibility;
- environmental safety;
- nuclear and radiation safety.

Special technical regulations establish requirements only for those individual types of products, processes of production, operation, storage, transportation, sale and disposal, in respect of which the goals defined by this Federal Law for the adoption of technical regulations are not met by the requirements of general technical regulations.

Special technical regulations establish requirements only for those individual types of products, processes of production, operation, storage, transportation, sale and disposal, the degree of risk of causing harm to which is higher than the degree of risk of causing harm, taken into account by the general technical regulation.

The main regulatory document that defines and interprets technical regulation is the Law “On Technical Regulation”. Based on the definition given in this document, technical regulation means “legal regulation of relations in the field of establishing, applying and fulfilling mandatory requirements for products, production processes, operation, storage, transportation, sale and disposal, in the field of establishing and applying on a voluntary the basis of requirements for products, production processes, operation, storage, transportation, sale and disposal, performance or provision of services, as well as legal regulation of relations in the field of conformity assessment”.

The same regulatory document provides a list of the basic concepts necessary for optimal technical regulation:

1) accreditation, which is the official recognition by the State body for accreditation of the competence of a legal or natural person with the ability to perform work in the field of conformity assessment;

2) the safety of goods, processes of production, storage, use, transportation, sale and disposal, which means such a state in which the risk of possible harm to the life and health of citizens, property of legal or individuals and property of municipal and state bodies, the environment, as well as the life and health of animals and plants;

3) veterinary and sanitary and phytosanitary measures, which mean mandatory procedures and requirements created to protect against the risks that are possible during the penetration, spread and establishment of harmful and pathogenic organisms, diseases and their vectors, including cases of their spread through plants or animals through contact with goods, cargo, vehicles and various materials, due to the presence of a variety of additives, toxins, other pollutants, weeds, pests, pathogens that may be present in feed and food products, as well as procedures and requirements for protection against the spread of other possible harmful organisms;

4) declaration of conformity, which is a form of confirmation of product compliance with the requirements of technical regulations;

5) declaration of conformity, which is understood as a document certifying the compliance of the goods released into circulation with the requirements of various technical regulations;

6) an applicant who is a natural or entity, carrying out confirmation of compliance on a mandatory basis;

7) a sign of circulation on the market, which is understood as a designation that serves to supply consumers with information on the degree of compliance of the goods put on the market with the requirements of technical regulations;

8) conformity mark, which is a designation that serves to inform consumers of any product regarding its compliance with the requirements of the certification system or the national standard;

9) identification of products, which implies the identification of the characteristics of the identity of the goods to its essential features;

10) control (supervision) over compliance with the requirements of various technical regulations, which is a verification of the fulfillment by an entrepreneur or legal entity of the requirements of a technical regulation for manufactured products, as well as for the processes of production, storage, transportation, use, sale and disposal, including the adoption of adequate measures based on the results of the audit;

11) International Standard, which means a standard adopted by an international organization;

12) national standard, which means the standard adopted by the national standardization body;

13) a certification body, which is any entrepreneur or legal entity that has received accreditation for established rules for the purposes of various works for certification;

14) conformity assessment, which is presented in the form of a direct or indirect determination of compliance with the requirements for the object;

15) confirmation of conformity, which implies a certain documentary certification of goods and other objects and processes of production, storage, sale, use, disposal, as well as services and works, confirming compliance with standards, technical regulations, terms of contractual obligations;

16) products as a result of activity, presented in a tangible form, the purpose of which is the subsequent use for other economic purposes;

17) risk as a possibility of causing harm to the life and health of people, as well as various property owned by any legal or natural persons or state and municipalities. This also includes damage to the environment. ecological atmosphere and health or life of any animals and plants, with a reservation about the severity of this harm;

18) certification, which is a form of documentary confirmation carried out by the State certification body on the compliance of these objects with the provisions of technical regulations, standards or terms of contracts;

19) certificate of conformity, presented in the form of a document certifying the compliance of the object with the requirements of standards, technical regulations and terms of contracts;

20) the certification system, presented in the form of a set of rules for carrying out certification work, determining the participants in the certification process, as well as establishing the rules for the operation of the certification system as a whole;

21) a standard, which is a kind of document that establishes the characteristics of the product, the rules and characteristics of the processes of its production, storage, use, transportation, sale and disposal. The same list includes the provision of various services to the population and the performance of works. In addition, the standard may include requirements regarding packaging, marking, labels, terminology, as well as rules for their use;

22) standardization as an activity to develop those rules and characteristics that can be used many times and lead to streamlining in the field of trade and production, as well as to the development of competition in the market for goods, works or services;

23) technical regulation is understood as the legal regulation of all relations on the establishment and implementation of those mandatory requirements that regulate the quality of the product, the production processes of this product, as well as issues related to its storage, sale, transportation and disposal, including the performance of various works and services to the public. Second area of ​​application legal regulation become a relationship on the issue of conformity assessment;

24) technical regulation, presented in the form of a document that can be adopted either international treaty of the Russian Federation, or by the Federal Law of the Russian Federation, or by a Decree of the Government of the Russian Federation, or by a Decree of the President of the Russian Federation, formulates requirements that are mandatory for all for all possible objects of technical regulation, and these are: goods, various buildings and facilities, processes of production, storage, use, transportation, sale and disposal;

25) conformity confirmation form as a specific order documentary evidence, which contains confirmation of the compliance of a product or any other object and process of production, storage, use, transportation, sale and disposal, including the performance of a number of works and services, with the mandatory requirements of state technical regulations, as well as standards and terms of contracts.

2. Basic principles of technical regulation

The Law of the Russian Federation "On Technical Regulation" also formulates the basic principles of technical regulation. These include the following:

1) the principle of using uniform rules and establishing requirements for goods, the processes of their production, storage, transportation, use, sale and disposal, including the performance of various works and the provision of services to the population. This principle can be considered one of the main conditions for introducing standardization requirements into technical regulations, which authorizes the harmonization of these requirements and their presentation in technical regulations and a number of other documents required in the field of standardization;

2) the principle of compliance of technical regulation with the degree of development of the national economy, as well as the degree of formation of the material and technical base and the development of science and technology;

3) the principle of independence from sellers, manufacturers, purchasers and performers. In other words, accreditation and certification bodies must be independent in administrative, organizational, financial, economic terms;

4) a uniform system of rules for obtaining accreditation should be established;

5) there should be a unified system of rules and methods for research, measurements and tests in the implementation of conformity assessment procedures;

6) the principle of unity of use of the requirements of various technical regulations should be implemented in conditions of independence, features and type of the transaction being carried out; that is, the technical regulation has the status of being mandatory for all legal entities and individuals on the territory of the Russian Federation, regardless of the relationships that arise between them in the course of doing business. The main direction of the use of technical regulations are contractual relationships;

7) the principle of unacceptability of any restriction of competition when carrying out activities related to obtaining accreditation and certificates, which can be interpreted as maintaining healthy competition between applicants for accreditation as certification bodies, as well as as testing laboratories, and subsequently - and increasing their efficiency and productivity by increasing competitiveness in the provision of certification services;

8) the principle of inadmissibility of combining in one person the executor of the powers of the certification body and the supervisory or control State body;

9) the principle of impermissibility of combining by any one body of powers and accreditation body and certification body;

10) the principle of inadmissibility of extra-budgetary financing of the State body for control and supervision over compliance with the requirements of technical regulations. Speaking about the principles of technical regulation, one cannot fail to mention the mechanisms formulated in the Law “On Technical Regulation”, which are aimed at resolving issues related to achieving the following goals:

a) elimination of various administrative obstacles in the field of doing business; and we are talking here about the reduction of excessive regulation, control and mandatory certification;

b) elimination different kind restrictions for advancing along the path of technological progress and know-how;

c) an increase in the activity of entrepreneurs in the legislative sphere.

3. Legal basis

According to the provisions of the Law "On Technical Regulation", the legislation of the Russian Federation consists of this Federal Law, as well as a number of other regulatory acts,

adopted in accordance with the currently existing legislation of the Russian Federation on this issue. At the same time, the supremacy of International laws over this Russian legislation in case of conflicts in the settlement of any issue. According to Art. 1 of the above Law of the Russian Federation, its legal norms help regulate relations that are emerging:

1) in the process of development, application, use, adoption on a voluntary basis of requirements for goods, processes for their production, storage, transportation, sale and disposal, including in the field of work and the provision of various services to the population;

2) in the process of conformity assessment.

Specifically stipulated are the areas of business that are not covered by the provisions of this Law. They do not affect State Educational Standards, standard provisions relating to accounting and issuance of securities and prospectuses of securities, as well as rules governing auditing. Further, this normative act introduces a system of basic terms and concepts necessary in the field of implementation of technical regulation, as well as standardization and certification.

Following this, the main principles of technical regulation are formulated, as well as its features in connection with defense products, work, services and products, information about which constitutes a state secret. The Law also describes the procedure for accreditation of certification bodies, formulates the possibilities for monitoring compliance with the requirements of technical regulations, as well as advice on their optimal development. A special place in the Law is given to issues related to standardization, its principles and goals. The powers of the National Standardization Body and technical committees for standardization are formulated, the rules for the development and approval of organizational and national standards are determined. In connection with the changes that are constantly taking place in the economic life new Russia, old system State standardization and mandatory certification fell into disrepair and required speedy change and reform. And among the new processes in the economy, one can name such as the change of owners of most of the current organizations, enterprises and firms, the formation of a fairly free market in the field of commodity production, the use of new market principles of regulation production activities, introduction of know-how, entry of many enterprises into the world market. And as soon as the system of application of mandatory technical requirements covers all phases of the production of goods, including the phases of entry and circulation of goods on the market, the requirements of the legal norms of international law apply to it.

To these legal regulations, first of all, include multilateral trade agreements adopted within the framework of the activities of the World Trade Organization (WTO). Perhaps the main condition for Russia's entry into the WTO is compliance with the basic principles of technical regulation formulated in the following documents: "Agreement on Technical Barriers to Trade", "Agreement on the Application of Sanitary and Phytosanitary Measures" and "Code of Good Practice".

In addition to technical regulations, standards, conformity assessment procedures, accreditation, as well as supervisory and control functions are considered to be the main components of technical regulation. July 1, 2003 is considered an important starting point for starting the process of developing new technical regulations, since it was then that the provisions of the Federal Law “On Technical Regulation” came into force. The date of completion of this process is 2010.

The principles of interconnectedness, consistency and sufficiency, as well as the principle of consistency with the basic norms of the above agreements, became the basis for the future harmonious system of technical regulations, conformity assessment procedures and national standards. For example, the WTO Agreement on Technical Barriers to Trade focuses on the formation of certain mechanisms that help overcome various obstacles in the trade process, which, as a rule, result from the provisions of technical regulations, standards and conformity assessment procedures. Thanks to the priority of International Standards, Guidelines and Recommendations regulated by this agreement, a number of issues of the emergence of unforeseen technical barriers to trade are removed, which corresponds to the implementation of the principle of harmonization.

To address the same issues of overcoming technical barriers, the Code of Good Practice is directed, formulating conformity assessment procedures and standards. importer. Concerning federal law RF on technical regulation is aimed at creating a two-level system of regulatory documents. And these are, firstly, technical regulations, which indicate mandatory requirements for all, and, secondly, voluntary standards.

4. Provisions of the State system of technical regulation and standardization

The set of rules and regulations containing the procedure for carrying out work on the standardization of the Russian Federation and relating to virtually all the main sectors of the national economy of the country, regardless of the level of management, is called the State Standardization System or GSS. The main legal documents regulating this system are a number of Interstate and State Charters, which contain the basic rules governing the organization and conduct of standardization work. For this purpose, a specialized body was organized called the "International Council for Standardization, Metrology and Certification", the main tasks of which are determined by the following provisions:

1) submission of draft interstate standards for approval;

2) a selection of promising areas in the field of standardization;

3) consideration and adoption of the main directions in the field of standardization and metrology, the costs of their implementation.

Also, the bodies of the standardization service include organizations, institutions, associations and divisions, the main component of whose activities lies in the area of ​​directly carrying out standardization work or in the area of ​​performing certain standardization functions.

State standardization is designed to solve a number of the following issues and tasks:

1) to develop State standards containing fundamental and general technical requirements, as well as requirements for regulating issues of labor safety, environmental protection, compatibility and interchangeability;

2) contribute to the fulfillment of the will of the customer;

3) to consider and approve State standards and a number of other normative acts, including: instructions, guidelines, etc.;

4) ensure the principles of unity and reliability of measurements in the state, as well as contribute to the strengthening and accelerated development of the State Metrological Service;

5) to carry out organizational work on the direct use of International, regional and national standards of other states as State standards;

7) engage in the preparation of works on international cooperation in the field of standardization, on the qualitative use of their results.

To organize the necessary work on standardization issues, special standardization services are created. There is also the State Committee of the Russian Federation for Standardization and Metrology - Gosstandart of Russia, which is entrusted with the responsibility of inter-sectoral coordination on metrology, standardization and certification. At the federal level, a body was also created - the Federal Agency for Technical Regulation and Metrology. Its functions are determined by the leading role in the activities of the State Metrological Service, the State Service for Time, Frequency and Determining the Parameters of the Earth's Rotation, the State Service for Standard Reference Data on Physical Constants and Properties of Substances and Materials. The following research organizations are structurally subordinate to the Federal Agency for Technical Regulation and Metrology: Federal State Unitary Enterprise (FSUE) "All-Russian Research Institute for Classification, Terminology and Information of Standardization and Quality" ("VNIIKI"), FSUE "All-Russian Scientific Research Institute for Standardization (VNIIStandart), JSC All-Russian Scientific Research Institute for Certification (VNIIS), Federal State Unitary Enterprise All-Russian Scientific Research Institute for Standardization and Certification in Mechanical Engineering (VNIIN-MASH), Federal State Unitary Enterprise All-Russian Research Institute of Metrological Service (VNIIMS), FSUE All-Russian Research Center for Standardization, Information and Certification of Raw Materials, Materials and Substances (VNITSSMV), FSUE All-Russian Research Institute of Optical and Physical Measurements ( "VNIIOFI"), Federal State Unitary Enterprise "All-Russian Research Institute of Metrolo gi im. D. M. Mendeleev” (“VNIIM named after D. M. Mendeleev”), OJSC “Research Institute for Standardization and Certification of Agro-Industrial Products” (“NIISSagroproduct”), etc.

Also subordinate to the Federal Agency are territorial bodies for metrology and standardization, as well as the so-called laboratories of state supervision of standards and measuring equipment, standardization services in organizations and industries, standardization services in ministries, standardization services at enterprises, organizations and institutions, services standardization of the level of the national economy and enterprises.

5. Bodies and committees for standardization

The Law of the Russian Federation "On Technical Regulation" (Article 14) formulates the main activities of the National Body of the Russian Federation for Standardization:

1) approval of national standards;

2) adoption of a program for the development of national standards;

3) organization of expertise of draft national standards;

4) ensuring the consistency of the national standardization system with the needs of the national economy, as well as its dependence on the level of the state of the material and technical base and scientific and technological progress;

5) taking into account the rules of standardization, national standards, other recommendations and regulatory framework in this area, and organizational work aimed at the availability of the above documents to all interested parties;

6) creation of technical committees for standardization and coordination of their activities;

8) active participation in the work on the creation of International Standards in accordance with the provisions of the charters of various International Organizations to ensure maximum benefits for the Russian Federation in case of their approval and use;

9) approval of the image of the sign of compliance with national standards;

10) representation of Russia and its interests in various international organizations working in the field of standardization.

According to the provisions of the above Law, the composition of technical committees to address standardization issues may include both representatives of scientific organizations and State federal executive bodies, as well as representatives of various public associations and other public organizations created by entrepreneurs or end users of goods and services. The procedure for the creation and operation of these technical committees must be approved by the National Standards Body. Public administration on issues of standardization in the Russian Federation is implemented by the Federal Agency for Technical Regulation and Metrology. The Ministry of Construction of Russia is responsible for carrying out activities on the issues of standardization of construction. For the part of the standardization work allocated to him, the State Standard Research Institute is responsible, respectively.

VNIIS is responsible for the development of "scientific, technical, legal and economic foundations for standardization of product quality management, state supervision over the implementation and compliance with standards, international cooperation in the field of standardization." In his own competence are questions of methodological management of enterprises. It develops VNIIS and issues of organizational, methodological, scientific, technical and legal problems that exist in the areas of standardization and certification, and also conducts scientific, technical and legal examination of standards, carries out work within the framework of ISO and some other International organizations.

VNIIMASH, in turn, is in charge of standardization in engineering industry and in the instrument-making industry, VNIIKI - in the field of scientific and technical terminology, information, metrology and product quality, GNITsVOK - in the field of strategic development and development of a uniform system for coding and classifying technical and economic information, in addition - in the field of development and implementation unified systems documentation in the automated control system, GNITsVOK - in the field of the adoption and use of all-Russian classifications for information in the technical and economic direction, as well as unified documentation.

If necessary, special standardization services are formed in the ministries of the Russian Federation, as well as parent organizations for standardization, which help to solve a number of organizational and coordinating tasks. Similar services can also arise directly at the enterprise. Their functions in this case are research, development and a number of other works on standardization issues, as well as assistance in performing similar work to other departments of the enterprise and the creation of an organizational, methodological and scientific and technical base for the optimal activity of the enterprise in the field of standardization. works of standardization services laid down recommendations for standardization services. In addition, standardization services carry out close interaction with various public organizations of consumers, the main task of contact with which is considered to be the most optimal correspondence to the interests of consumers.

As part of this cooperation, representatives of the above-mentioned public organizations are involved in resolving issues related to the formation of quality, nomenclature and methods for evaluating goods, as well as the formation of packages of proposals for the development and updating of standards.

6. Technical regulations: concept and essence. Application of technical regulations

The technical regulation is a complete list of the main requirements for one of the objects of standardization. Documents capable of changing the data of this list can only be its changes and additions. In addition, it is worth noting that not any document containing some mandatory requirements can be considered a technical regulation. For the adoption of technical regulations, there is a certain specially created procedure. And also the document itself must be created in a special way. The technical regulation must necessarily include: firstly, a list of those goods, the processes of their production, storage, transportation, use, sale and disposal, in connection with the presence and processing of which, in fact, its requirements are formed. Secondly, the technical regulation should contain the very requirements for the objects of technical regulation that are necessary for fulfillment. The main focus of these requirements of the technical regulation, according to the Law "On Technical Regulation" (Chapter 2), should be to ensure:

1) unity of measurements;

2) electromagnetic compatibility in the implementation of safety tasks for the operation of instruments and equipment;

3) radiation safety;

4) explosion safety;

5) biological, fire, thermal, mechanical, industrial, chemical, electrical, nuclear and radiation safety.

Also, some other requirements, rules and forms may be included in the technical regulation. For example, the first requirements include:

1) providing the previously mentioned types of security;

2) contributing to the maintenance of the principle of uniformity of measurements;

3) special requirements for terminology, packaging, labels and markings, as well as the rules for their application. Among the latter, it is necessary, first of all, to name the rules that identify the object of regulation, as well as the forms and rules for assessing conformity. The formulation of “deadlines for assessing the conformity of each object of regulation” can also be attributed to the same category of requirements.

According to the Law "On Technical Regulation", requirements for goods, processes of their production, storage, transportation, use, sale and disposal that are not included in the technical regulation are not mandatory. The following main objectives of the adoption of technical regulations follow from the provisions of the above-mentioned Law:

1) protection of life or health of people, as well as property of legal entities and individuals or property that is in municipal and state ownership;

2) protection of the environment, health and life of animals and plants;

3) prevention of actions that mislead purchasers.

There should be no other purposes for the adoption of technical regulations.

But in terms of explaining the concept and essence of a technical regulation, Article 8 of the Law "On Technical Regulation" defines two types of technical regulations, general and special. Thus, the requirements of the general technical regulation apply without fail to any type of goods and services, including in the process of creation, storage, transportation, use, sale and disposal. And, accordingly, the requirements of special technical regulations take into account technological features a number of groups of goods, as well as, accordingly, the processes of their creation, storage, transportation, sale, disposal or use. In addition, special technical regulations may establish their own requirements only for certain types of goods, as well as the processes of their creation, storage, transportation, consumption, sale or disposal, in respect of which the requirements of generally binding technical regulations are not met. It should also be noted that among the special technical regulations, a special variety is often singled out - macro-industry special technical regulations, covering, as a rule, several groups of homogeneous objects. So, for example, there is a macro-industry regulation that formulates the basic requirements for food additives or dyes for food products. However, many researchers believe that this type of technical regulation cannot be called a special regulation. As a rule, it is customary to divide the subjects of technical regulation into several separate categories:

1) business, the main point of which participants become clearly certain rules state control and games in the market;

2) consumers, the main indicator for which is the indicator of the protection of their interests and rights;

3) government bodies, whose tasks are the formation of tactics and strategies for the entire economic development of the country in the future. Wherein technical standards they are used as a kind of levers of influence on the economic processes taking place both within the country and abroad;

4) regulatory authorities, without any benefits or interests of their own.

The main activity for them should be to ensure the safety and protection of the rights of consumers in the matter of their environmental safety and protection from any man-made disasters. To ensure the optimal solution of the tasks assigned to the state, the Economic Department of the President of the Russian Federation formed Expert Councils involved in the development of general and special technical regulations. According to the form, the content of the technical regulation should include such information as: a list of goods, the processes of their creation, storage, transportation, use, sale and disposal, in respect of which the above requirements are developed; in addition, they formulate general rules identification of all objects subject to technical regulation to address issues of application of technical regulations.

Other information may also be included in the technical regulation, for example:

1) rules and forms of conformity assessment, determined taking into account the degree of risk;

2) deadlines for conformity assessment for each object of technical regulation;

3) mandatory requirements for packaging, marking and labels, terminology, as well as necessary rules their application.

According to the Law "On Technical Regulation", requirements not included in technical regulations are not mandatory. Also, the technical regulation may include requirements for the characteristics of goods, the processes of their production, use, storage, transportation, sale and disposal, but cannot include any requirements regarding design features goods, except in situations where, due to the absence of such design requirements, there is a possibility of risks of harm. Based on this provision, technical regulations may include in the list of requirements special requirements for marking, labels, packaging and terminology, as well as the rules for their application, which in the future will help increase the degree of protection for certain groups of citizens, such as: children, minors, pregnant women women, breastfeeding mothers, the disabled, pensioners.

In addition, the technical regulations may establish the minimum necessary measures in the field of veterinary and phytosanitary in relation to goods imported from hazardous areas or countries with restrictions on imports with our country. These measures of veterinary and phytosanitary safety are developed taking into account the received scientific data, as well as when considering other documents provided by international organizations.

First of all, we are talking about international standards, recommendations, etc. As an assessment criterion for risk issues, assessment criteria of international standards, as well as recommendations international organizations, which includes Russian representatives, prevalence of diseases and pests, pest and disease control measures applied by suppliers, environmental conditions, macroeconomic consequences associated with the possibility of harm, the extent of expenditures required to prevent harm. International and (or) national standards can serve as a basis for creating draft technical regulations.

8. Procedure for the development and adoption of technical regulations. Amendment and cancellation of technical regulations

The procedure for developing, adopting, amending and canceling technical regulations is discussed in detail in Art. 9 chapter 2 of the Law "On technical regulation". Before creating a draft technical regulation, the following concepts should be clearly formulated:

1) the object for which, in fact, the technical regulation will be created;

2) the objectives of the development of this regulation;

3) a list of basic requirements for the object;

4) a list of mandatory requirements for the facility established on the territory of the Russian Federation;

5) a list of International standards that present their requirements for the object.

Further, the above-mentioned normative act very clearly formulates the main points of the development of a draft technical regulation. So, any person can act as a developer of a draft technical regulation: an individual and a legal entity.

The stages of development of technical regulations are formulated, which include:

Stage 1: collection of applications for the development of technical regulations. Applicants can be government agencies, organizations, various public associations, scientific and technical societies, companies and firms, and private entrepreneurs;

Stage 2: the organizational stage, at which all work on the organization of the project is carried out by the Federal Agency for Technical Regulation and Metrology;

Stage 3: the draft technical regulation in the first edition must be brought into line with today's legislative framework, as well as with international rules and norms and National standards of foreign countries;

Stage 4: there is a publication of a notification on the development of technical regulations in one of the printed publications of the Federal Executive Authority for Technical Regulation, as well as in the information source of the so-called " common use”, usually in digital form. There are special recommendations on the content of the notice of the work on the creation of a draft technical regulation.

Thus, this notification should include information on the following issues:

1) for which product, processes of production, storage, transportation, use, sale and disposal requirements are being developed;

2) for what purpose this regulation is being developed;

3) direct presentation necessary requirements, which are not a repetition of already existing requirements set out in any international regulations or in national standards;

4) information about how familiarization with the created document will take place in the future;

5) the name of the organization or the initials of the person developing this project of the regulation, its postal and electronic coordinates, with the use of which the comments of interested persons are accepted;

Stage 5: public discussion of the project;

Stage 6: getting feedback on the project;

Stage 7: analysis of received feedback;

Stage 8: finalization of the project with the introduction of changes that take into account the received written comments from interested parties;

Stage 9: holding a public discussion of the draft technical regulation;

Stage 10: adoption of the draft in the first reading;

Stage 11: compiling a list of received written comments with a mandatory summary the essence of these comments, as well as the results of their discussion;

Stage 12: examination finished project technical regulation in the commission of experts on technical regulation, which may include representatives of various federal authorities executive power, as well as representatives of scientific institutions, public organizations, various funds and institutions of consumers and entrepreneurs;

Stage 13: adoption of the finished and revised draft in the second reading. It also provides for the procedure for the adoption and consideration of the draft Law of the Russian Federation "On Technical Regulations" in the State Duma and, further, in the government of the Russian Federation. The draft Law of the Russian Federation “On Technical Regulations” sent from the State Duma to the Government of the Russian Federation is considered within a calendar month, during which a review must be sent to the State Duma, created taking into account the provisions of the opinion issued by the expert commission on technical regulation. The draft Law of the Russian Federation “On Technical Regulations” prepared in this way is sent by the State Duma to the Government of the Russian Federation for the second reading, but not later than one month before the consideration of the above draft in the State Duma, also in the second reading. The government of the Russian Federation is also obliged to send its opinion to the State Duma on this project within a month, which also takes into account the conclusions received from the expert commission on technical regulation. Amendments and additions to the technical regulation adopted in this way or its cancellation shall take place in the same manner.