menu

On the regulation on the procedure for applying standard schemes for assessing (confirming) compliance with the requirements of the technical regulations of the Customs Union

Regulation on the procedure for the application of standard schemes for assessing (confirming) compliance with the requirements of the technical regulations of the Customs Union

  1. The regulation on the procedure for applying standard schemes for assessing (confirming) compliance with the requirements of the technical regulations of the Customs Union was developed in order to implement the provisions of the Agreement on Common Principles and Rules of Technical Regulation in the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation dated November 18, 2010.
  2. In relation to products, the requirements for which are established by the technical regulations of the Customs Union (hereinafter referred to as technical regulations),conformity assessmentit is carried out in the form of conformity assessment (declaration of conformity, certification), registration, including state, examination, suitability assessment, testing, state control (supervision) and (or) other form.
    Conformity assessment in the form of registration, examination, suitability assessment, state control (supervision) and (or) in another form is established by the developer in specific technical regulations, taking into account the specifics of the product, as well as the object of technical regulation (for example - electromagnetic compatibility and others), the degree of risk of harm and is carried out by the relevant authorized bodies of the member states of the Customs Union.
  3. State registration of products is carried out by bodies and institutions authorized in the field of sanitary and epidemiological welfare of the population with the registration of a certificate of state registration.
    For products subject to state registration, the primary form of conformity assessment is declaration of conformity.
  4. State registration of production facilities is carried out by the authorized body of a member state of the Customs Union on the basis of an application for state registration of a production facility.
  5. The choice of forms and schemes of conformity assessment should be carried out taking into account the total risk from an unreliable conformity assessment and harm from the use of products that have passed the conformity assessment. When choosing forms and schemes, the following main factors should be taken into account: 
    • the degree of potential danger of the products;
    • sensitivity of the specified indicators to changes in production and (or) operational factors; sensitivity of the specified indicators to changes in production and (or) operational factors;
    • applicant status (manufacturer, manufacturer's authorized person, seller, supplier);
    • the adequacy of the degree of evidence of compliance and the costs of conducting an assessment of compliance with the objectives of the technical regulations.
  6. Confirmation of conformity is carried out in the forms of certification or declaration of conformity according to standard schemes.
    Certificates of conformity can be used as evidentiary materials when adopting a declaration of conformity, registration and approval (approval) of a product type, if this procedure is established in the technical regulations.
  7. A typical conformity assessment scheme is a set of actions (elements), the results of which are used to make a decision on the compliance (non-compliance) of products with the requirements of technical regulations. In general, such actions (elements) can be considered:
    • analysistechnical documentation;
    • identification, product testing, product type research;
    • production evaluation, production control;
    • issuance of a certificate of conformity, adoption of a declaration of compliance with technical regulations in a single form approved by the Customs Union Commission (hereinafter -certificate of conformity,declaration of conformity);
    • registration of the declaration of conformity;- application of a single product circulation mark on the market of the member states of the Customs Union (hereinafter - application of a single circulation mark);
    • inspection control.
  8. Analysis of technical documentation should be an integral element of each standard scheme and may include: 
    • analysis for product identification;
    • analysis to determine the suitability of technical documentation for conformity assessment;
    • project research.
  9. The composition of technical documentation confirming the conformity of products with the requirements of technical regulations is established in a specific technical regulation, and in general, may include:
    • technical specifications/descriptions (if available);
    • operational documents (if available);
    • the list of standards interrelated with the technical regulations, the requirements of which this product meets (when applied by the manufacturer);
    • description of the adopted technical solutions confirming compliance with the requirements of the technical regulations, if there are no standards related to the technical regulations or have not been applied;
    • protocols of acceptance, acceptance and other tests carried out by the applicant and/or accredited testing laboratories (centers) confirming the conformity of products with the requirements of technical regulations;
    • documents confirming the safety of products in accordance with the legislative acts of the Customs Union and the member states of the Customs Union;
    • certificates of conformity for management systems;
    • certificates of conformity or test reports for raw materials, materials, components or components of the product; other documents confirming the safety of products.
  10. The study of the product design can be carried out by analyzing the technical documentation according to which the products are manufactured, the results of calculations carried out, tests of experimental samples of products.
  11. Product type research can be carried out by:
    • studies of a sample for planned production as a typical product representative;
    • analysis of technical documentation, testing of product samples or critical components of products.
  12. Production evaluation can be represented by the following main types:
    • analysis of the state of production;
    • certification of the management system.
  13. Production control is carried out by the manufacturer to ensure the stability of compliance of the manufactured products with technical documentation and the requirements of technical regulations.
  14. Registration of declarations of conformity is carried out according to the notification principle in accordance with the procedure established by the Customs Union Commission.
  15. Inspection control is carried out only within the framework of certification and may include:
    • testing of samples of certified products;
    • analysis of the state of production;
    • inspection control of a certified management system.
  16. Control over products whose conformity is confirmed by the declaration of conformity is carried out within the framework of state control (supervision).
  17. In order to grant the applicant the right to choose the most acceptable conformity assessment scheme in the technical regulations for specific products, it is recommended to establish several standard schemes that are equivalent in degree of proof of compliance with the requirements of the technical regulations, taking into account the conditions of their application.
  18. Depending on the standard certification scheme, conformity confirmation in the form of certification is carried out by an accredited certification body for products, an accredited certification body for management systems included in the Unified Register of Certification Bodies and Testing Laboratories (centers) of the Customs Union (hereinafter referred to as the certification body for products, the certification body for management systems).
  19. Depending on the standard scheme of declaration of conformity, confirmation of conformity in the form of declaration of conformity is carried out on the basis of its own evidence and (or) evidence obtained with the participation of a product certification body, a management systems certification body, an accredited testing laboratory included in the Unified Register of Certification Bodies and Testing Laboratories (centers) of the Customs Union (hereinafter - accredited testing laboratory).
  20. You can find out about standard certification schemes here.
  21. You can see typical schemes of declaration of conformity here.
  22. Description of typical certification schemes
  23. Description of typical schemes of declaration of conformity
  24. Storage of technical documentation. The procedures for storing technical documentation, including documents confirming compliance, are established in a specific technical regulation. In general, technical documentation, including documents confirming compliance in the territory of the member states of the Customs Union should be stored on: 
    • products from the manufacturer (a person authorized by the manufacturer) for at least 10 years from the date of withdrawal (termination) from the production of these products;
    • a batch of products (a single product) from the seller (supplier), manufacturer (a person authorized by the manufacturer) for at least 10 years from the date of sale of the last product from the batch.
    • Documents and materials confirming the results of certification are stored in the certification body that issued the certificate of conformity for at least 5 years after the expiration of the certificate of conformity.

The above documents must be provided to the state supervisory authorities upon their request