Despite positive changes in the last several years, the standards regime in Russia still lacks transparency. Russia continues to rely on product testing as a key element of the product approval process. Other types of product safety assurance, such as plant auditing, quality systems, and post market vigilance, are underdeveloped. Russia continues to adhere to redundant practices of further testing of internationally accepted certified products, which can delay entry of a variety of products into the country.
In addition, the former federal authority on standardization, Gosstandart, was restructured twice as part of a larger government reorganization begun in May 2004, which led to some uncertainty as to exactly who in the agency did what, further adding to delays in discharging its functions. The current authority for standardization, metrology and certification matters is the Federal Agency for Technical Regulations and Metrology under the jurisdiction of the Ministry of Industry and Trade. However, the old name for this agency, Gosstandart, remains in use. Affiliated with this new agency are 478 technical committees, comprised of research institutes, which develop standards.
Russia’s complicated, cumbersome and often changing system of certification as well as cultural and language barriers create a challenge to foreign companies attempting to certify products without appropriate legal advice or assistance from experienced distributors or consultants.
The Department of Technical Regulations and Metrology estimates that Russia must develop approximately 2,000 technical regulations by 2010. It is recommended that U.S. companies work with reliable partners and consulting companies on registration and certification issues.
In recent years there has been a substantial movement toward the adoption of common international language on product standards and certification procedures and some improvements have been made. In 1998, the Russian government established a public information service for regulations covered by the Technical Barriers to Trade (TBT) Agreement in the World Trade Organization (WTO); however, technical difficulties have plagued this service and it has not been an easily accessible or reliable source of information. On July 31, 1998, new amendments to Russia’s Law on Certification of Products and Services went into effect, which generally meet requirements of the TBT Agreement. The law allows a manufacturer to submit a declaration of conformity in the certification procedure for a limited number of products. The government has established a list of 200 products eligible for this procedure, which periodically changes. Russian standards and certifications bodies worked closely with the U.S.-Russian Business Council, the American Chamber of Commerce in Russia, and several U.S. government agencies in order to become acquainted with international practice in this area and the concerns of international companies. As a result, approximately 35% of the 25,000 Russian standards now conform to international norms, and many deficiencies in the standards and certification process have been removed. The Russian government is looking to harmonize 87% of its existing standards to international standards.
Russian officials claim that with adoption of the federal law “On Technical Regulations” which came into force on July 1, 2003, the certification situation has improved. The law was intended to change the existing cumbersome standardization and certification systems and to harmonize the Russian legislation with international standards. In addition, the intent was to establish a transparent system for adoption of standards and to reduce significantly the number of requirements and steps in the certification process for imported goods. The government has established a 7-year transition period for technical regulations reform to be completed. Over this period, all mandatory standards requirements must be transformed into technical regulations, and remaining standards will become voluntary. This monumental task requires the development and enactment of several thousand laws and regulations. Current technical regulations will remain in effect until new ones have been developed and approved by the government, or until the end of the seven year transition period.
Many products imported for sale into the Russian Federation are required to have a certificate of conformity issued by The Federal Agency for Technical Regulations. The Agency currently tests and certifies products according to Russian government standards rather than other widely- accepted international standards (e.g., the ISO-9000 system). The Federal Agency for Technical Regulations and its authorized agents are chief sources for certification in Russia. However, other agencies are involved in certification of certain products, including the Ministry of Agriculture (food products) the Ministry of Health (medical devices and pharmaceuticals), the State Communications Committee (telecommunications equipment and services), the State Mining and Industrial Inspectorate GOSGORTECHNADZOR (equipment for mining, oil and gas industries), the Federal Security Service (encryption devices and security equipment and systems), and others.
Russia participates in the following international certification systems:
• System of the International Electrotechnical Commission (IEC) for tests of electrical equipment on conformity to safety standards
• System of certification of passenger cars, trucks, buses and other transport vehicles (UN EEC)
• System of certification of handguns and ammunition
• System of certification of electronic articles (IEC)
• International system of certification of metrology equipment and instruments
• Agreement on mutual recognition of tests of imported aircraft and certification of elements of airplanes
• UN International Navigation Organization (Navigation Safety Convention).
Presently in Russia, various federal executive authorities carry out accreditation in accordance with the relevant legislation. Bureaucratic incongruities, overlapping fields of activity and the application of different procedures and criteria in the accreditation process are common occurrences. Often, the accreditation and certification activities of several federal executive authorities are superimposed.
Certification authorities and test laboratories, both Russian and foreign, are accredited in accordance with ISO/IEC Guideline 5 and ISO/IEC Standard 17025. Currently, each individual Ministry, Gosstandart of Russia and the Research Institute for Certification (VNIIS) can accredit laboratories in their relevant industry sectors. GOSSTANDART of Russia runs the state register of all accredited organizations.
The Department of Technical Regulations and Metrology is currently developing legislation on accreditation of organizations that assess compliance with technical regulations. It is still undecided as to whether the system of a single accreditation body or a number of such bodies will be most efficient in Russia.