Describes standards, identifies the national standards, accreditation bodies, and lists the national testing organization(s) and conformity assessment bodies.
Russia has a unique system of standards, which uses a combination of various international standards, but relies mostly on product testing as a key element of the product approval process. Russia does not have an association agreement with the EU or the United States and does not recognize internationally recognized certificates, such as the EU’s CE mark or U.S. Food & Drug Administration certificates. Such certificates can often be part of an application file submitted to the relevant Russian government agencies, but additional tests would have to be carried out in Russia.
In 2010, Russia became part of the Russia-Kazakhstan-Belarus Customs Union (CU), which was later transformed into Eurasian Economic Union (EAEU) in 2015. The process has forced member countries to start aligning their standards with the other five member-states and creating common markets for industries such as pharmaceuticals and medical devices.
The main Russian standards body is the Federal Agency for Technical Regulations and Metrology (Rosstandart). In the late 1990s, the Agency was responsible for developing the Russian GOST-R standards (state standards for Russia), similar to GOST standards (state standards) in the former Soviet Union. The regulatory document for which the company applied was called the GOST-R certificate and it indicated that the products conformed to the requirements of these standards.
Later, the agency started developing Russian Technical Regulations (TU) that were sector specific. When the Russia-Kazakhstan-Belarus Customs Union (CU), and later the Eurasian Economic Union (EAEU), was established, it gradually discontinued the creation of Russian Technical Regulations. Now the Eurasian Economic Commission (ECC), a permanent supranational regulatory body of the EAEU, oversees the alignment of standards and the creation of new Technical Regulations (TR) for all five member-countries.
Currently Russia uses a combination of 47 Russian and EAEU technical regulations. Once EAEU Technical Regulations come into force, they prevail over the relevant Russian technical regulations for the same products.
Russia is a member of the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC) and many other standards organizations, the list of which can be found on Rosstandart’s website.
Testing, Inspection and Certification
In the past, bureaucratic incongruities, overlapping fields of activity, and the application of different procedures and criteria in the accreditation process were common in Russia. To improve the certification system, the Russian government issued Presidential Decree No. 86 on January 24, 2011, “On the Unified National System of Accreditation,” according to which a new approval agency, the Federal Service on Accreditation (RosAccreditation), was established. This agency reports to the Ministry of Economic Development and is responsible for the establishment of the Unified National System of Accreditation. It controls all legal entities and entrepreneurs accredited as testing laboratories and issues certificates to organizations.
Various federal executive authorities previously had responsibility for carrying out accreditation in accordance with the relevant legislation. There were 16 government agencies with accreditation oversight, including Rosstandart, Rostekhnadzor, Rospotrebnadzor, and Rossvyaz. Currently, RosAccreditation publishes the list of certification bodies and accredited testing laboratories, as well as all issued declarations and certificates of conformity. Rosstandart previously performed this function.
RosAccreditation has signed 16 bilateral agreements with counterpart organizations in Saudi Arabia, Vietnam, Germany, Greece, India, Spain, Kyrgyzstan, Macedonia, Moldova, Mongolia, Serbia, China, Iran, Slovakia, Abhazia and Ukraine. In addition, RosAccreditation is a member of the following international organizations:
From 2013-2015, RosAccreditation started to work with the European co-operation for Accreditation (EA) to commence a project called “Bringing the Russian and European Accreditation Systems Closer.” Now the representatives of RosAccreditation regularly take part as observers in meetings of the relevant committees and working groups of EA, as well as in its annual general assembly.
Confirmation of compliance is designed to confirm that goods conform to the statutory quality and consumer characteristics requirements. Confirmation of compliance in Russia is based on the Russian national regulations and on the legislation of the EAEU. The technical rules of the EAEU establish a unified list of goods that are subject to mandatory confirmation of compliance in the form of (i) certification or (ii) declaration of compliance, and further establish unified forms for the (i) certificate and (ii) declaration of compliance that are issued by the accredited agencies and laboratories of the EAEU member states and are valid throughout the EAEU.
As a result of the establishment of the EAEU, the system of obtaining certification documents has evolved. Now there are two sets of documents dedicated to TR and Sanitary Regulations.
1) Technical Regulations (Certificate of Conformity/Declaration of Conformity)
Any U.S. exporter planning to enter the Russian market should check to see whether its products are included in the “Unified list of products and are subject to mandatory conformity and issuance of a Certificate of Conformity or Declaration of Conformity”. On February 20, 2020, products that contain nicotine were added to this list. For the more detailed information, see decision (No. 146 on October 18, 2016). On September 15, 2017, some amendments were made to the list.
A manufacturer can choose whether to apply for a Certificate or a Declaration of Conformity, and manufacturers can also choose between EAEU and Russian certifications. EAEU certifications enable the product to be imported by any EAEU member country and transferred/reexported to other member states. Only Russian legal entities can apply for these Certificates or Declarations, so U.S. manufacturers must work with a Russian distributor or importer. Once obtained, certificates are valid for five years. Only EAEU accredited testing and certification organizations can perform the necessary tests and issue certificates or declarations. If the product is not included on the unified list of products subject to mandatory conformity, then it should go through the conformity process according to the national standards of the five EAEU countries, depending on the final destination of the product. U.S. manufacturers should also check similar unified lists for all five countries to ensure full compliance with all the regulations. Companies can find this list for Russia on the website of Rosstandart.
2) Sanitary Regulation (Certificate of State Registration)
After July 1, 2010, the Certificate of State Registration was established for all products that need a sanitary certificate. Products which need a Certificate of State Registration are listed in part II of the “Unified list of products subject to sanitary and epidemiological supervision at Customs and on the territory of the EAEU” that was approved by Decision 299 of CU Commission on May 28, 2010 and later amended by the Decision 146 of Eurasian Economic Commission on September 18, 2014.
Several additional mandatory and voluntary certification systems also exist, which are partly managed by other ministries or agencies (please see the “contacts” section of this document).
Publication of Technical Regulations
The development of Russian Technical Regulations was discontinued in January 2015 and only the Russian and EAEU TRs already approved can be found at https://www.gost.ru/portal/gost/home/standarts/technicalregulationses.
EAEU draft technical regulations are published in Russian on the EEC website for at least 60 days, after which notification is sent to the WTO. Any Russian or foreign entity may comment (in Russian) to the contact listed on the website. The final EAEU Technical Regulations are published on the EEC website, after which Russia submits notification of the regulation to the WTO. In practice, requisite WTO notifications have not always been provided by EAEU member states.
Members of the World Trade Organization (WTO), including Russia, are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to notify to the WTO proposed technical regulations and conformity assessment procedures that could affect trade. “Notify U.S.” (www.nist.gov/notifyus) is a free, web-based e-mail registration service that captures and makes available for review and comment key information on countries’ draft regulations and conformity assessment procedures. Users receive customized e-mail alerts when new notifications are added by selected countries and industry sectors of interest and can also request full texts of regulations. This service and its associated website are managed and operated by the United States Government’s WTO TBT Inquiry Point, housed within the National Institute of Standards and Technology, part of the U.S. Department of Commerce.
The following are the key government standards organizations in Russia:
Federal Agency for Technical Regulations and Metrology (Rosstandart)
Kitaygorodsky proezd, 7, building 1
Tel: +7 (499) 236 03 00
Fax: 7 (499) 236 62 31
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Slavyanskaya sq. 4, building 1
Tel.: +7 (495) 698 4538
Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor)
Vadkovskiy pereulok, house 18, stroenie 5 and 7
Tel.: +7 (499) 973 26 90
Federal Environmental, Industrial and Nuclear Supervision Service (Rostechnadzor)
ul. Lyukyanova 4, building 1
Tel: +7 (495) 645 33 26;
Fax: +7 (495) 645 89 86
Federal Communication Agency (Rossvyaz)
Nikoloyamskiy per. 3 A, building 2
Ms. Marina Kuznetsova, Head of Conformity Department
Tel: +7 (495) 986 30 61
Fax: +7 (495) 986 30 48
Federal Service for Accreditation (RosAccreditation)
nab. Presnenskaya, 10, str. 2,
Tel: +7 (495) 539 26 70
For more information on standards in agricultural sector in Russia, please contact:
U.S. Foreign Agricultural Service, U.S. Embassy Moscow
8 Bolshoy Deviatinsky Pereulok, Moscow 121099
Tel: +7 (495) 728-5222
Fax: +7 (495) 728-5133
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