Changes in product certification in the EAEU /Russia- Impact

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28.03.2022

On March 4, the Federal Law No. 46-FZ that makes amendments to some legal acts has been approved.

The major changes related to product certification in the EAEU that will enter into force as of March 21:

1. Annual Inspection /Inspection Control can be carried out based on the Production condition analysis (PCA) via audio and video conferencing or based on tests of product samples.

The certification body may make decision on postponing the inspection check for up to 6 months.

2. The validity period of compliance assessment documents that expire in the period from the enactment date of the Decree of the Government of the Russian Federation No. 353 On Specifics of Licensing Activities in the Russian Federation in 2022 dated March 12, 2022 to September 1, 2022, is extended for 12 months.

Manufacture release of products for circulation in the territory of the Russian Federation, in respect of which the above compliance assessment documents have been issued (adopted), is allowed until the expiration of the validity period of such documents, taking into account its extension, without the need to carry out a repeated compliance assessment and periodic assessments of the certified products.

3. When importing products to the territory of the Russian Federation, it is allowed not to present mandatory compliance assessment documents to customs authorities in respect of products that are:

- spare parts imported for maintenance and (or) repair of finished products that had been previously released for circulation in the territory of the Russian Federation, subject to providing the customs authorities with details of the finished product compliance assessment document which was valid at the release date of such finished products (except for compliance assessment documents that had been declared invalid in the prescribed manner).

For this purpose, spare parts mean parts, assemblies, and (or) units of finished products that are intended to replace (repair) the same parts, assemblies, and (or) units that are (were) in operation (worn out, defective, failed) in order to maintain or restore the product operability with no object of their distribution in the territory of the Russian Federation in the course of commercial activities (except for transferring them free of charge or for a consideration to legal entities or individuals who are registered in the prescribed manner as individual entrepreneurs engaged in maintenance and (or) repair of finished products);

- accessories, components, raw materials, and (or) supplies for manufacture (production) of products in the territory of the Russian Federation that are (were) imported by the manufacturer of the same products or a person having a contract with the manufacturer for the supply of such accessories, components, raw materials, and (or) supplies, exclusively for the specified purposes (unless otherwise provided for in the technical regulations).

4. It is allowed to import to the territory of the Russian Federation products that are intended exclusively for circulation in the territory of the Russian Federation without labelling, including their labelling with the single mark of product circulation in the market (ЕАС).

The above labels must be applied to products before such products are sold to consumers, marking could be done by the distributor locally

5. It is allowed to replace certification and declaration based on tests carried out by an accredited Testing Laboratory (TL) with declaration based on the applicant's own evidences from March 21, 2022, to September 1, 2022, subject to the following:

1. registration of compliance declarations is allowed only on behalf of applicants from the Russian Federation;

2. registration of compliance declarations is allowed only for a product batch (or a single product);

3. the set of documents and data, as a ground for accepting a compliance declaration, must include:

  • a copy of the contract (supply agreement) and shipping documents that identify the product batch or a single product, including its size;
  • a copy of operation documents (if any);
  • description of engineering solutions adopted and risk assessment results that confirm the compliance with mandatory requirements;
  • the list of standards with their designations and names, as well as sections (paragraphs, subparagraphs) (if applied in the product manufacture);
  • other documents, at the applicant's discretion, that were used as the ground for adopting the compliance declaration; as such documents, it is allowed to submit, inter alia, certificates of compliance (other documents confirming the product compliance) obtained under third countries' compliance certification systems, issued by third countries' certification bodies, accredited national accreditation bodies that signed IAF (IAF MLA) Mutual Recognition Arrangements (Agreements), and (or) reports of trials (tests) and measurement of product specimens (samples) carried out by third countries' testing laboratories accredited by national accreditation bodies that signed ILAC (ILAC MRA) Mutual Recognition Arrangements (Agreements).

Documents and data used as the ground to accept a compliance declaration that were executed in a foreign language shall be accompanied by their Russian translations (except for schedules to trial (test) and measurement reports).

4. the validity period of a compliance declaration is 6 months after its registration with the Federal State Information System (FGIS).

There will be an additional list of products that allow replacing certification with declaration, and a list of products that do not allow such replacement.

6. After importing a product batch under a declaration issued based on the applicant's own evidence, the applicant can, at its own discretion, obtain certificate of compliance or compliance declaration based on tests carried out by a TL pursuant to requirements of the Technical Regulations of the Customs Union. In this case, product samples (specimens) for testing can be selected from the imported batch.

7. Until March 1, 2023, GLN data or GLONASS coordinates can be specified in certificate of compliance or compliance declaration at the applicant's discretion.

8. In the period from the enactment date hereof to September 1, 2022, the Governmental Decrees (GD) No. 934 and No. 936 will not apply.

GD No. 934 On Approval of the Regulations for Making Decisions by a National Accreditation Body on Invalidating Documents Issued by Accredited Testing Laboratories as a Result of Their Activities.

GD No. 936 On the Procedure for Registration, Suspension, Renewal, and Cancellation, Invalidation of Compliance Declarations and the Procedure for Suspension, Renewal, Cancellation, and Invalidation of Certificates of Compliance.

Ostrovskiy Roman Regulatory Compliance Specialist Email roman@mintest.ru Mobile +7 903 288-47-68 www.mintest-russia.ru

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