3.113.  As with standards and technical regulations, the legal and institutional framework for SPS protection is a mixture of national and EEC competences. There were no major changes to that framework during the review period.[260] In 2018, the Russian Federation adopted rules for controls carried out at overseas production, processing, and dispatch sites of planting materials intended for importation into its territory.[261]

3.114.  Pursuant to the EAEU Treaty (Articles 56-57 and Annex 12), the EEC remains responsible for coordinating the elaboration and implementation of SPS measures by EAEU member States.[262] Its remit includes: (i) approving the common lists of goods subject to sanitary-epidemiological, veterinary, and phytosanitary controls at the EAEU border; (ii) setting common sanitary, epidemiological, veterinary, phytosanitary, and hygienic requirements for goods marketed within the EAEU; (iii) approving standardized SPS certificates[263]; and (iv) establishing unified procedures for inspections and market monitoring activities carried out by the competent national authorities. The EEC also adopts EAEU technical regulations, some of which relate to SPS measures

3.115.  As at March 2021, common phytosanitary controls on imports from third countries applied to 128 product groups. The corresponding figures for common veterinary and sanitary‑epidemiological controls were 110 product groups and 19 product groups, respectively.[264] Goods marketed within the EAEU were subject to 106 phytosanitary requirements, and a range of veterinary and sanitary‑epidemiological requirements. The bulk of these requirements were set out in more than 25 EAEU technical regulations. The authorities affirm that no export restrictions or prohibitions were introduced for SPS reasons during the review period, and all SPS-related import restrictions were duly notified to the WTO

3.116.  Pursuant to the EAEU Treaty, member States can unilaterally implement provisional SPS measures that have not been harmonized at the Union level, declare disease-free and pest-free zones (based on the regionalization principle), and implement a higher level of protection than in the rest of the EAEU, based on scientific justification.[265] Any national laws relating to SPS measures are to be applied to the extent that they do not contradict the EAEU Treaty and the acts constituting the law of the EAEU. The Russian authorities affirm that all unilaterally implemented SPS measures affecting international trade are duly notified to the WTO

3.117.  The institutional framework for SPS measures within the Russian Federation remains broadly unchanged since the previous Review.[266] The Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) under the Ministry of Agriculture remains responsible for implementing and enforcing EAEU and domestic measures related to plant and animal health. The remit of Rosselkhoznadzor also comprises drugs for veterinary use, pesticides and agrochemicals, animal feed, genetically modified organisms, diseases common to humans and animals, and food safety at the border. According to the authorities, Rosselkhoznadzor operates 10 electronic information systems aimed at facilitating the admission of imports subject to SPS controls. These systems also serve as the backbone for a rapid alert system, operated in conformity with the relevant provisions of the Agreement on Trade Facilitation

3.118.  The Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor), reporting directly to the Government, remains in charge of, inter alia, developing and approving national sanitary and epidemiological guidelines and hygienic norms, as well as carrying out sanitary and epidemiological surveillance

3.119.  The Russian Scientific and Technical Centre for Information on Standardization, Metrology and Conformity Assessment (Standartinform) is the national enquiry point, whereas the MED is the notification authority under the SPS Agreement. The Russian Federation submitted 39 regular and 49 emergency notifications to the WTO between June 2016 and March 2021. SPS measures adopted at the EAEU level were the subject of nearly half of the regular notifications. Approximately 87% of the measures announced in regular notifications and 92% of emergency measures were based on international standards. During the same period, the Russian Federation was asked to respond to six specific trade concerns raised by several Members at the Committee on Sanitary and Phytosanitary Measures. The Russian Federation also raised four specific trade concerns and supported six concerns raised by other Members.[267]

3.101.  There have been no major changes to the legal and institutional framework for standards, technical regulations, and conformity assessment procedures since the previous Review.[250] An EAEU‑level Agreement on the Intra-Union Circulation of Products Not Covered by EAEU Technical Regulations and Rules for Ensuring Their Safety was concluded on 3 February 2020. Pursuant to this Agreement, member States retain regulatory competence to develop and apply within their territory technical regulations in the areas of defence and security, protection of state secrets, and nuclear power

3.102.  The EAEU Treaty (Articles 51-55 and Annexes 9-11) sets out a regulatory system based on a set of requirements and procedures common to all member States.[251] Common requirements may take the form of compulsory conformity assessment for product groups (originally 67) slated to become subject to EAEU technical regulations[252] and lists of standards whose voluntary application is deemed to ensure compliance with EAEU technical regulations (lists for 42 technical regulations approved as of 2020). Procedural harmonization initiatives have resulted in standardized conformity assessment schemes and documents, a single register of accredited conformity assessment entities, a single register of issued conformity assessment documents, and mutual recognition of measurement uniformity assurance outcomes.[253]

3.103.  The EEC and the competent bodies of each member State may develop and submit draft technical regulations to the EEC Council for approval and adoption. Enforcement of technical regulations is carried out in accordance with national legislation. The EEC adopted recommendations on cooperation among compliance-controlling bodies and on their collaboration with member States' customs administrations in the enforcement of EAEU technical regulations in 2018 and 2019, respectively.[254] A draft Agreement on the Principles and Approaches of State Control (Surveillance) of Compliance with the Requirements of EAEU Technical Regulations is at the signing stage

3.104.  Standardization work may be carried out at the supranational and national levels. The Federal Technical Regulation and Metrology Agency (Rosstandart) remains the national standardization body. Rosstandart represents the Russian Federation in international and regional standards setting organizations, such as the International Organization for Standards (ISO), the International Electrotechnical Commission (IEC), the Euro-Asian Council for Standardization, Metrology and Certification (EASC), the Pacific Area Standards Congress (PASC), and the Standards and Metrology Institute for Islamic Countries (SMIIC).[255] Rosstandart also serves as the supervising authority for legal metrology, conformity assessment, and liability matters arising from the violation of technical regulations

3.105.  At end-June 2021, in addition to 43 EAEU technical regulations, there were two national‑level technical regulations (Table 3.14) and 36,839 national standards in force in the Russian Federation. Between June 2016 and June 2021, the EEC Council adopted 15 EAEU technical regulations, and the Russian Federation enacted over 7,500 national standards. The authorities affirm that standards and technical regulations implemented in the Russian Federation are generally based on international standards or relevant parts thereof, except when fundamental climatic, geographical, or technological factors render the latter ineffective or inappropriate for the fulfilment of legitimate objectives

3.106.  Between June 2016 and March 2021, the Russian Federation submitted 41 regular notifications to the WTO Committee on Technical Barriers to Trade (TBT Committee), all of which concerned EAEU-level measures. In 21 submissions (46% of the total) the allowed period for comments was 60 days or more. Only three notifications allowed for a comment period of less than 45 days

3.107.  The Russian Scientific and Technical Centre for Information on Standardization, Metrology and Conformity Assessment (Standartinform) is the national enquiry point, and the MED is the notification authority under the Agreement on Technical Barriers to Trade. Between June 2016 and March 2021, the Russian Federation was asked to respond to nine specific trade concerns raised by several Members to the TBT Committee. During that period, the Russian Federation also joined various delegations in raising eight specific trade concerns.[256]

3.108.  Accreditation in the EAEU is carried out in accordance with member States' respective national systems. Applicants wishing to carry out compulsory conformity assessment activities must be registered as a legal entity in the EAEU and must obtain accreditation in the jurisdiction of registration. Accredited conformity assessment entities (certification bodies and testing laboratories) may also be inscribed in the EAEU's single register; the relevant eligibility criteria were adopted in December 2018.[257] Conformity assessments performed by entities inscribed in the single register are recognized throughout the EAEU. EAEU member States aim to conduct, on an ongoing basis, joint comparative assessments of accreditation bodies in order to achieve equivalence of national systems

3.109.  At end-March 2021, 5,771 testing laboratories were accredited in the Russian Federation, of which 1,383 were inscribed in the EAEU's single register. The corresponding figures for product and service certification bodies were 584 and 273, respectively (Table 3.15)

3.110.  The Federal Service for Accreditation (RusAccreditation) is the national authority for accreditation. Through RusAccreditation, the Russian Federation is a party to 14 TBT-related technical cooperation instruments. RusAccreditation represents the Russian Federation in relevant international initiatives, including the International Laboratory Accreditation Cooperation (ILAC), the International Accreditation Forum, the Asia Pacific Accreditation Cooperation (APAC), and the EASC. During the review period, RusAccreditation joined the APAC mutual recognition agreement (MRA) and the ILAC MRA for the accreditation of testing and calibration laboratories

3.111.  General requirements for the packaging of goods and labelling requirements for foodstuffs are set out in EAEU technical regulations TR CU 005/2011 and TR CU 022/2011, respectively. In addition, packaging, marking, and labelling requirements are stipulated in all product-specific EAEU technical regulations. The authorities indicate that no packaging, marking, or labelling requirements are established at the national level

3.112.  Two agreements concluded in 2014 set the basis for the gradual establishment of a unified EAEU market for medicines and medical devices. As at December 2020, the body of EAEU legislation governing the intra-Union circulation of medicines and medical devices comprised more than 80 normative legal acts (EEC decisions and recommendations). The first volume of a EAEU Pharmacopoeia, a document intended to ensure a common approach to assessing the quality of medicines, was adopted in 2020.[258] A Union-wide regime for the compulsory registration of medicines superseded the relevant national systems as from 1 January 2020.[259] The transition period during which EAEU registration is an optional alternative to the national registration of medical devices is set to end on 31 December 2021. In the Russian Federation, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) under the Ministry of Health remains in charge of the circulation of medicines and medical devices