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- (g) Protection of Human Health
  1. The representative of the Russian Federation reminded Members that Rospotrebnadzor was the Federal Executive Authority in charge of implementation of control and supervision in the sphere of sanitary and epidemiological well-being of the population, protection of consumer rights and the consumer market. Rospotrebnadzor was under the jurisdiction of the MOH. He further explained that currently the following laws and regulations regulated the protection of human health in the Russian Federation: CU Commission Decision No. 299 of 28 May 2010 (as last amended by CU Commission Decision No. 622 of 7 April 2011) approved the Common List of Goods Subject to Sanitary-Epidemiological Supervision at the Customs Border and Customs Territory of the Customs Union; the uniform sanitary-epidemiological and hygienic requirements for products subject to sanitary-epidemiological supervision; common forms of documents confirming the safety of products; and, regulations on the implementation of sanitary and epidemiological surveillance of persons and vehicles crossing the customs border of the Customs Union; Federal Law No. 52-FZ of 30 March 1999 "On Sanitary and Epidemiological Well-being of the Population" (as last amended on 18 July 2011); the Law of the Russian Federation No. 5487-1 of 22 July 1993 "Fundamentals of Health Legislation of the Russian Federation"; as well as Regulations of the State Sanitary and Epidemiological Service of the Russian Federation and Regulations "On State Sanitary and Epidemiological Standardization" approved by Government Resolution No. 554 of 24 July 2000. Food safety standards were set-out in sanitary and hygienic regulations, respectively SanPiN 2.3.2.1078-01 for microbiological, chemical and radio nuclides standards, and Hygienic Norm G.N. 1.2.2701-10 for MRLs of pesticides in food plant products. The Russian Federation had also adopted in Federal Law No. 88-FZ of 12 June 2008 "On Technical Regulations for Milk and Milk Products" (as last amended on 26 July 2010), detailed quality and safety regulations on milk and milk products. He explained that these and other domestic normative legal acts remained in force to the extent they did not conflict with the Customs Union requirements.
  2. The representative of the Russian Federation explained that CU Commission Decision No. 299 established the "Common List of Goods Subject to Sanitary-and-Epidemiologic Supervision (Control) at the Customs Border and on the Customs Territory of the Customs Union" (Part I) and established food safety requirements for corresponding goods. Products produced in, or imported into the customs territory of the CU for distribution to the population, use in industry, agriculture, civil construction development, transportation with direct human involvement, or for private and household use, had to conform to the relevant requirements of sanitary and epidemiological rules, norms, and hygiene regulations. He further explained that the conformity to the safety requirements for certain groups of goods was to be confirmed by a State Registration certificate, as provided for in CU Commission Decisions and domestic law. The CU Commission had approved a list of goods for which State Registration certificates must be supplied during customs clearance.
  3. Some Members noted that under CU Commission Decisions, the State Registration procedure applied only to certain groups of goods included in the Common List in Part II of CU Commission Decision No. 299. In addition, under Federal Laws No. 52-FZ of 30 March 1999 "On Sanitary and Epidemiological Well-being of the Population" and No. 29-FZ of 2 January 2000 "On the Quality and Safety of Food Products", and Government Resolution No. 988 of 21 December 2000 "On the State Registration of New Foodstuffs, Materials and Items", and under Federal Law No. 88-FZ, State Registration was required for both new foodstuffs, materials and items first produced in the territory of the CU (CU products), and products imported into the territory of the CU for the first time and was based on sanitary and epidemiological assessment. Such an assessment>
  4. In response, the representative of the Russian Federation explained that the Russian national legal acts were applied to the extent that they did not contradict CU Commission Decision No. 299 of 28 May 2010. Such provisions in national law related to the determination of the competent authority, the order of involvement of organizations and experts into the procedure of State Registration, the order of appellation of refusal of State Registration, and keeping of the national part of the Register of State Registration Certificates. Since CU Commission Decision No. 299 specified the list of products subject to State Registration, it superseded national law. Thus, only products listed in CU Commission Decision No. 299 were subject to State Registration. Thus, the representative of the Russian Federation explained that the State Registration procedure applied:
  • only to certain groups of goods, which were listed in points 1 to 11 of Part II of the Common List of Goods Subject to Sanitary and Epidemiological Control, set-out in CU Commission Decision No. 299 (these include: mineral water, bottled drinking water packaged in containers, tonic beverages, alcoholic beverages; specialised foodstuffs, including food products for children, food products for pregnant and nursing women, dietary products; biologically active dietary supplements, raw materials for production of biologically active dietary supplements, organic products; foodstuffs derived from GMO, GMO; food additives, flavourings, technological aids including enzymes; and food contact material);
  • only if the goods were covered by CN codes listed in the table of Part II to the Common List of Goods Subject to Sanitary Controls (CU Commission Decision No. 299); and
  • if the goods were manufactured for the first time on the territory of the CU or imported for the first time into the CU territory, and no prior State Registration had occurred, or in cases where the introduction of CU requirements necessitated the issuance of a new State Registration certificate.

The representative of the Russian Federation specified that these three cumulative criteria, to determine whether a State Registration certificate was required, were specified in the last paragraph of point 11 in Part II to the Common List of Goods Subject to Sanitary and Epidemiological Control ("Goods specified in points 1 to 11 of the present Part, included in the following comprehensive headings of the FEACN CU, manufactured for the first time on the Customs Union customs territory, as well as imported for the first time to the Customs Union customs territory, are subject to State Registration").
  1. Some Members noted that points 1 to 11 of Part II of the Common List of Goods Subject to Sanitary and Epidemiological Control included Non-Food Products, such as disinfectants, cosmetics or hazardous chemical substances. The representative of the Russian Federation clarified that CU Commission Decision No. 299 covered the protection of human health in general from risks derived from both food and non-food products.
  2. Some Members asked which entity should submit a request for registration. In response, the representative of the Russian Federation explained that the supplier/producer of the importer was authorised to submit a request for registration. A proof that the State Registration certificate had been obtained had to be presented at the border, for example, in the form of an electronic copy of the certificate or presentation of the original certificate.
  3. In response to another question from a Member, the representative of the Russian Federation noted that the procedure for obtaining State Registration was described in CU Commission Decision No. 299, and the rate of State duty, as prescribed by Article 333.33 point 67 of the Tax Code of the Russian Federation, was RUB 3,000.
  4. With regard to sanitary and epidemiological assessment requirements in place before the establishment of the CU, the representative of the Russian Federation explained that an expert evaluation of the sanitary and epidemiological situation was conducted prior to the commencement of industrial production or reprocessing in the territory of the Russian Federation, and in the case of imported products, prior to conclusion of the contract, and following a request from the exporter interested in supplying products to the Russian market. The expert evaluation consisted of a review of the documentation submitted, additional laboratory examination, if necessary, and when the product has complied with all requirements, issuance of the positive assessment necessary for issuing a State Registration certificate. This evaluation was carried out on the basis of the relevant WHO/FAO recommendations and guidelines.
  5. The State Registration certificate was issued for a given type of product and was valid for exports from the relevant country without time limitation, provided there had been no violations of the regulations during the preceding period. If there were violations found during surveillance at the border, the State Registration certificate could be temporarily revoked. Applications for evaluations were to be submitted to Rospotrebnadzor or its territorial bodies. State Registration certificates were valid throughout the entire territory of the CU. For domestically produced products, sanitary and epidemiological surveillance was conducted by the territorial authorities of Rospotrebnadzor at the stage of distribution of products on the Russian domestic market. In response to questions from a Member of the Working Party, the representative of the Russian Federation stated that the State Registration certificates for domestic products were also issued for a given type of product and were valid for an unlimited time period. In his view, the respective procedures and requirements did not discriminate between domestic and imported products. The process for issuing a State Registration certificate could not exceed 30 days after application was received. If the application was rejected, Rospotrebnadzor sent a letter to the applicant explaining what needed to be changed. After corrections were made, the applicant could re-submit the application.
  6. Members expressed appreciation for the information on how the Russian Federation applied certain SPS measures, but continued to seek further information and assurances regarding whether the Russian Federation required or had a scientific basis for measures applied to products such as processed foods. In response to a question from a Member of the Working Party about sanitary and epidemiologic assessment in the framework of the CU, the representative of the Russian Federation explained that since 1 July 2010, sanitary and epidemiologic assessments (conclusions) were no longer required. State Registration, however, was required on a different basis.
  7. The representative of the Russian Federation explained that, since 1 July 2010, a State Registration certificate was issued in accordance with the common CU form and was valid throughout the customs territory of the CU. The certificate confirmed that the controlled goods conformed to CU Common sanitary and epidemiologic and hygienic requirements. The period of validity of the State Registration certificate covered the whole period of manufacture or delivery of controlled goods to the territory of the Customs Union. He further noted that sanitary and epidemiological assessment and certificates of State Registration issued before 1 July 2010 remained valid in the Russian Federation until 1 January 2012 and could be used to import goods into the customs territory of the CU. As of 1 January 2012, for the importation of products included in Part II of the Common List of Goods Subject to Sanitary and Epidemiological Control, set-out in CU Commission Decision No. 299, a new State Registration certificate had to be obtained to confirm the conformity with CU sanitary and epidemiological requirements, even if they had been marketed in or imported into CU territory before that date. If pursuant to CU acts, the Russian Federation had adopted more stringent requirements than existed prior to the adoption of the CU requirements, a new expert evaluation had to be conducted in order to obtain this new State Registration certificate. If the CU requirements were not more stringent than the requirements previously applicable in the Russian Federation, the procedure of issuance of such a new State Registration certificate was purely administrative. The representative of the Russian Federation further explained that the State Registration certificate was harmonised among the CU Parties and that each Party recognised the right of each other Party to issue this certificate and that a State Registration certificate would be valid throughout the territory of the CU. Furthermore, he explained that the CU had instituted a transition period until 1 January 2012 for the CU Parties to implement the harmonised State Registration certificates.
  8. The representative of the Russian Federation stated that the term "new products" meant products developed and industrially manufactured for the first time on the territory of the Russian Federation and also products imported into the territory of the Russian Federation for the first time, i.e., which were not on sale in the Russian Federation before. The absence of a prior State Registration indicated that the product was new to the market of the Russian Federation and State Registration was required. He also explained that the producer, supplier, or importer could submit an application for State Registration of products.
  9. In response to a question from a Member of the Working Party about whether the evaluation and State Registration of products constituted a single process, the representative of the Russian Federation stated that sanitary and epidemiological experts' evaluation was a part of the State Registration of products. The State Registration certificate was a document that was issued on the basis of the evaluation of a product. The components of this process were the following: (i) application; (ii) evaluation; and (iii) issuance of the document (State Registration certificate). Based on a positive result on the sanitary and epidemiological experts' evaluation for the products subject to State Registration, a State Registration certificate was issued.
  10. Some Members expressed concern that this assessment for State Registration, which made it necessary to provide a set of analytical results of microbiological tests and chemical tests on one selected sample of the product, was an administrative burden with little added value as regards the safety of the exported products. They asked if this assessment procedure could be replaced by a declaration of conformity of the manufacturer and if so, in which cases. The representative of the Russian Federation responded that State Registration was a form of State assessment of the conformity of goods, which was carried out by State authorities of the Russian Federation, the Republics of Belarus, and Kazakhstan, and was a guarantee of independent and accurate research, and as a result, human safety. CU Parties would ensure that, in the future, only one type of confirmation of conformity, such as State Registration or declaration of conformity, would be required for each product. State Registration would be required only if the risk associated with the product required an independent assessment in an authorised laboratory. For this reason, it>
  11. A Member of the Working Party asked whether such an independent safety assessment could not be obtained through official controls, applied via post-market monitoring, instead of State Registration. The representative of the Russian Federation answered that, at present, there was no legal basis for carrying out such State surveillance. The current legislation only allowed officials to take samples of goods on the market, if this was justified by suspicion of non-compliance.
  12. The representative of the Russian Federation explained that officials who carried out sanitary quarantine control at the border of the CU were entitled to organize sanitary-and-epidemiologic and hygienic evaluation of controlled goods in terms of their compliance with common sanitary-epidemiologic and hygienic requirements in the following cases specified in point 22 of the Regulation "On the Procedure of Sanitary-Epidemiological Control (Supervision)", adopted by CU Commission Decision No. 299:

- infringement of transportation conditions, integrity of containers, stevedore barges, etc.;

- package damage;

- arrival of goods from countries, with unfavourable epidemiological situation, and (or) from countries infected as a result of radioactive, chemical and biological accidents of areas (at revealing of exceeding admissible values of capacity of radiation dose and superficial pollution by radio nuclides at transportation of radioactive materials; dangerous cargoes in damaged package with signs of contents' leak), and (or) with signs of presence of rodents and insects;

- receipt of information on discrepancy of goods under control to common sanitary requirements; or

- presence of information on discrepancy of goods under control declared in transport (transportation) and (or) commercial documents.

Based on the results of an examination of the goods under control, carried out by an accredited laboratory as specified in CU Commission Decision No. 299, the official (a representative of Rospotrebnadzor), who carried out sanitary-quarantine control, would make the decision on import permission or prohibition into the territory of the CU.
  1. Some Members of the Working Party requested clarification of the basis for assessing which countries had an unfavourable epidemiological situation. The representative of the Russian Federation explained that this determination was based on information displayed on the website of the World Health Organization. Other sources of information taken into account included alerts from the Rapid Alert System for Food and Feed, other official information from foreign governments, and other reliable information such as sources of information set-out in international medical and sanitary rules, and sources of information specified in CU Commission Decision No. 299.
  2. The representative of the Russian Federation explained that some commodities were also subject to mandatory confirmation of conformity to CU requirements. The list of such commodities, which also contained references to quality standards and quality requirements for these products, was approved by the Decision of the Customs Union Commission No. 319 of 18 June 2010, and included the following food and feedstuffs: (i) canned food products (fish, caviar, seafood); (ii) coffee and coffee products; (iii) tea; (iv) sugar (cane and beet); (v) spices; and (vi) feeds for animals, including formula feeds, pre-mixes, protein feed additives, such as oilseeds meal and cake, fish meal, protein vitamin additives, dry milk for feeding and dry milk replacements. Until 1 January 2011, confirmation of conformity for these food products was carried out in accordance with national legislation of each CU Party. From 1 January 2011, the declaration of conformity was provided upon assessment by the certification bodies and testing laboratories (centres) included into the Single Register of Certification Bodies and Testing Laboratories (centres) of the CU. With regard to feedstuffs, from 1 July 2010, self-declaration of conformity could be made on the basis of an assessment provided by the producer. Foreign manufacturers, located outside the territory of the CU, could apply for a certificate/declaration of conformity that was issued in accordance with national legislation of a CU Party or for a CU uniform certificate of conformity, as approved by CU Commission Decision No. 319 of 18 June 2010. The representative of the Russian Federation further explained that references to quality standards and quality requirements with regard to products on the List of Commodities Subject to Mandatory Confirmation of Conformity would be revised as the CU Parties adopted CU technical regulations on specific products.
  3. Some Members expressed concern about these additional "quality-related" requirements for the importation of certain food products and feedstuffs. These requirements did not appear to be related to food safety and placed an unwarranted additional burden on imports of these products. These Members requested the immediate elimination of measures that were not related to the food safety characteristics of these products.
  4. The representative of the Russian Federation responded that CU Common Sanitary Epidemiological and Hygiene Requirements and State Sanitary-Epidemiological Rules and Standards of the Russian Federation contained only requirements concerning safety of foreign and domestic goods for human use or consumption. He noted, however, that the Russian Federation considered nutritional value to be a safety issue with regard to dietetic and infant nutrition. Some Members noted that Codex had defined quality standards for many products and that under Codex the issue of nutritional value pertained to the fair practices in food trade, and>
  5. Members of the Working Party asked for clarification of the difference in purpose and in procedure between the State Registration and the means of confirmation of conformity. In response, the representative of the Russian Federation explained that "confirmation of conformity" encompassed multiple means of establishing that a product met CU requirements and that the type of confirmation required, depended on the degree of responsibility of the product in economic activity (level of risk). Higher risk products were subject to State Registration. Products of lower risk were subject to confirmation of conformity either through a certificate of conformity from third-parties, or a declaration of conformity. State surveillance was also conducted. He also noted that in future, only one form of confirmation would be required for a product and that this would be specified in the relevant technical regulations.

- (h) Compliance of the SPS Regime with Specific Provisions of the WTO SPS Agreement
            1. - (i) Harmonization with International Standards and Norms
  1. Some Members of the Working Party expressed concern that ongoing efforts to harmonize the procedures of the Russian Federation for sanitary and phytosanitary control, inspection and approval may not be sufficient to address concerns of Members, as comments by Members were not always solicited. In the view of these Members, the decision-making process for determining harmonization of new measures in the Russian Federation>
  2. Some of these Members also expressed concern that the requirements of the MOH were not always clear, consistent with international standards (e.g., OIE or the Codex Alimentarius) or sufficiently supported by scientific justification. These Members noted that maximum residue levels laid down in the Russian legislation for pesticide residues and veterinary drugs, such as the MRL for tetracyclines which are, however, authorised in use in the Russian Federation for animals, were in many cases well below the levels set in the Codex Alimentarius and that the Russian Federation had not provided any scientific justification to substantiate the deviation. They also noted that maximum levels for contaminants and radio nuclides, as well as microbiological standards, were not set following methodology recommended by international guidelines. In the view of these Members, the decision-making process for determining the approval for distribution of a product on the Russian market was sometimes arbitrary and it appeared that the regulation of products by the MOH, duplicated the State Registration process, and should be eliminated.
  3. The representative of the Russian Federation responded that pursuant to Article 38 of Federal Law No. 52-FZ of 30 March 1999 "On Sanitary and Epidemiological Well-being of the Population", sanitary rules and safety criteria must be based on a risk assessment using, as appropriate, the results of scientific research and epidemiological studies, as well as on monitoring of human health and harmful environmental factors. Sanitary requirements were aimed at ensuring the safety of products and human life and health. He asserted that all rules, criteria and requirements in respective fields were applied uniformly and without discrimination between domestic and imported goods, Article 38 and the Statute on the State Sanitary and Epidemiological Regulation approved by Resolution of the Government of the Russian Federation No. 554 of 24 July 2000 (Sections 5 and 6), required that international requirements and recommendations must be analysed and used in national sanitary regulations and legislation to the extent it is practicable and reasonable to do so. The harmonization proceeded with reference to documents of the FAO/WHO Codex Alimentarius Commission, OIE, WHO recommendations, and documents of other international organizations.
  4. The representative of the Russian Federation stated that the harmonization process would be carried out in cooperation with the interested WTO Members. The representative of the Russian Federation informed Members that, as regards MRLs of pesticides, between 2009 and 2010, the CU had adopted levels corresponding to the international standards for 244 pesticides active substances in CU Commission Decision No. 622 of 7 April 2011.
  5. The representative of the Russian Federation confirmed that the CU would apply MRLs on chlorothalonil, clofentezine, cyprodinil, kresoxim-methyl, iprodione, propamocarb, pirimicarb, thiabendazole, carbendazim, famoxadone, copper compounds, and lambda cyhalothrin that corresponded to international standards in conformity with the WTO SPS Agreement no later than the date of the accession of the Russian Federation to the WTO, and that these MRLs would be set-out in CU acts. The Working Party took note of this commitment.
  6. As regards MRLs of veterinary drugs, the representative of the Russian Federation confirmed that MRLs for penicillins, streptomycin and bacitracin (in rabbit meat and milk for the latter) had been harmonized with Codex standards and were set-out in Addendum 22 to SanPiN 2.3.2.1078-01. Furthermore, grisin was no longer authorised for use by the MOA. Tetracyclines MRLs had not been harmonised with international standards, because the Russian Federation considered that the Codex levels represented a too high risk for the health of its citizens, due to large scale use of tetracyclines in both veterinary and human medicine.
  7. Some Members of the Working Party noted that on 31 August 2011, the Russian Federation had issued a report entitled "Scientific Justification for Requirements for Residual Levels of Tetracycline Antibiotics in Foods". These Members reviewed the report and noted that the analysis and procedures set-out in the report were not consistent with international standards for conducting a health risk analysis, and did not support maintaining MRLs for tetracyclines antibiotic residues in excess of relevant Codex standards. The data in the report actually supported the conclusion that even at the reported dietary intakes, with all foods at the maximum MRLs recommended by Codex, no consumer group was likely to exceed the international recommendation for acceptable daily intake. Members also noted many methodological problems with the report. The report, for example, did not include a proper identification of the risk, incorrectly over-estimated exposures; failed to characterise or compare the different impacts on human health from its recommended actions; omitted an analysis of variability, uncertainty, and sensitivity of its conclusions, and presented purely hypothetical scenarios and concerns as if they were scientific evidence. Members expressed concern that the report had not undergone peer review in a manner consistent with international standards. Thus, in their view, the report did not justify the maintenance and application in the Russian Federation of MRLs for tetracyclines that were more stringent than Codex standards, lacked a scientific justification and>
  8. The representative of the Russian Federation confirmed that the Russian Federation, before the date of its accession to the WTO, would provide to any interested Member scientific evidence and an assessment of the risk associated with tetracyclines antibiotics residues, developed in accordance with methods of scientific evaluation set by the Codex Alimentarius, sufficient to justify the application of MRLs more stringent than those provided for in the relevant Codex standards. If such a scientific justification and risk assessment for a more stringent MRL>
  9. Some Members noted that the Russian Federation had maintained MRLs for tetracyclines that were much more stringent than international standards for many years and that despite repeated requests to be provided any risk assessment and scientific justification for these stringent requirements, Members had not received any scientific justification or risk assessment. These Members noted that it appeared that some form of risk assessment was now being done and expressed concern regarding the timing and procedures being followed. In the view of these Members, the risk assessment>
  10. A Member of the Working Party noted that the harmonization process for MRLs of veterinary drugs should also include elimination of non-tolerance or very low tolerance in food of veterinary substances when these substances are authorised in use in the Russian Federation under similar conditions to those in place in exporting countries.
  11. The representative of the Russian Federation stated that norms for veterinary drugs were under revision and this work was expected to be finalised no later than December 2011.
  12. As regards maximum levels for contaminants, the representative of the Russian Federation informed Members that maximum levels for nitrates in lettuce and cadmium in poppy seeds had been reviewed and revised in accordance with international recommendations and set-out in Addenda 10 and 18 of SanPiN 2.3.2.1078-01. These revised levels had been included in amendments to the Unified Sanitary and Epidemiological Requirements set in CU Commission Decision No. 299.
  13. Furthermore, the representative of the Russian Federation confirmed that as of the date of the accession of the Russian Federation to the WTO, the maximum levels of nitrates would be revised in accordance with international standards, recommendations, and guidelines. The Working Party took note of this commitment.
  14. The representative of the Russian Federation stated that radio nucleide levels and microbiological standards were being revised in accordance with international recommendations. The proposals would be transmitted to the CU Commission in due course to avoid inconsistency with international standards as of the date of the accession of the Russian Federation to the WTO.
  15. Members expressed concern about a measure (SanPiN), adopted pursuant to Federal Law No. 52-FZ, which would limit the use of frozen poultry meat for further processing. These Members noted that similar provisions appeared to be included in a CU Commission Decision. Members questioned the scientific basis for this measure and noted that no risk assessment had been provided to Members despite requests for the assessment.
  16. In response the representative of the Russian Federation stated that these norms were operated as recommendations and their entering into force had been postponed. If the scientific justification of these norms would be identified as insufficient upon the date of accession of the Russian Federation to the WTO, they would be eliminated. Specifically, the representative of the Russian Federation explained that the ban on the use of frozen poultry for the production of all types of poultry products, foreseen to enter into force from 1 January 2011, had been delayed and revised. The ban on the use of frozen poultry meat in the manufacture of dietetic food, baby food and food for pregnant or breastfeeding women, which had been in place since 1 January 2010, would be extended to gourmet products (pastrami, raw dried and raw smoked products). Further, only chilled poultry meat would be allowed for the production of chilled semi-finished products and products that have not undergone heat treatment. An amendment to SanPiN 2.3.2.1078-01 introducing these changes was available on the website of Rospotrebnadzor. The representative of the Russian Federation indicated that at the CU level, CU Commission Decision No. 299 included a ban on the use of frozen poultry meat in the manufacture of dietetic food, baby food and food for pregnant or breastfeeding women (point 16 of Chapter II, Part 1 of the Uniform Sanitary and Epidemiological and Hygienic Requirements). He stated that the CU Parties would not extend this ban to other categories of persons or products.
  17. The representative of the Russian Federation further explained that pursuant to Federal Law No. 52-FZ "On Sanitary and Epidemiological Well-being of the Population" sanitary-epidemiological rules and norms "Hygienic Requirements on Food Safety and Food Value" (SERN) had been enacted. SERN set up hygienic safety and value norms on food for humans, and also requirements on compliance with these norms for production, importation and turnover of food products. Furthermore, Article 2 of Federal Law No. 29-FZ "On Quality and Safety of Food Products" provided for the implementation of the international norms, when they contradicted the mentioned Law.
  18. The representative of the Russian Federation also recalled that Government Resolutions No. 159 and No. 329 established the necessary legislative framework to allow for the compliance of Russian veterinary and phytosanitary measures with the relevant international standards; guidelines and recommendations in the OIE and IPPC. He added that specific provisions of international standards relating to procedures for State control and surveillance, including Codex Alimentarius, OIE, and IPPC were included in the draft technical regulations in the SPS sphere. A Member noted that Government Resolution Nos. 159 and 329 related to the OIE and IPPC and asked if a similar Government Resolution had been adopted for the Codex Alimentarius. If such a resolution did not exist, this Member asked when the Russian Federation expected to adopt it. The representative of the Russian Federation explained that pursuant to CU Commission Decision No. 721 of 22 June 2011, in the absence of CU or national documents in force on the territory of the CU, establishing obligatory veterinary (veterinary-sanitary) requirements for live animals and products of animal origin; obligatory phytosanitary requirements for plants and plant products; obligatory sanitary-and-epidemiologic and hygienic requirements for products of animal origin and products of plant origin, it was necessary to apply standards, recommendations and guidance of the International Office of Epizootics, the International Plant Protection Convention, and the Commission of Codex Alimentarius, respectively. Furthermore, if veterinary, phytosanitary and sanitary-and-epidemiologic and hygienic requirements in force on the territory of the CU were more stringent than relevant international standards, in the absence of scientific justification of risk to human, animal or plant life or health, in corresponding part international standards were applied.
  19. Some Members expressed concerns that, according to Federal Law No. 52-FZ and also requirements adopted pursuant to CU Commission Decision No. 299, sanitary and phytosanitary import policy of the Russian Federation, rules and legislation appeared to be based on the results of scientific research, epidemiological studies and monitoring rather than on international standards, guidelines and recommendations, which were only used "to the extent practicable". In the view of these Members, Article 3.1 of the WTO SPS Agreement required that sanitary and phytosanitary measures be based on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in the WTO SPS Agreement, in Article 3.3. These Members sought a commitment that the Russian Federation would respect the provisions of Article 3 of the WTO SPS Agreement and amend Federal Law No. 52-FZ and CU Commission Decision No. 299 to ensure compliance with the SPS provisions.
  20. A Member noted that the Russian Federation had required some sanitary and phytosanitary certificates that included provisions that appeared to be inconsistent with international standards, guidelines and recommendations e.g., those of the OIE, Codex, IPPC, and the WTO SPS Agreement. This Member asked whether the Russian Federation was prepared to undertake modifications of these certificates to bring them into compliance with these standards and obligations. Members also asked the Russian Federation to confirm that it did not require the exporting country to have identical or very similar measures to those applied in the Russian Federation as long as the exporting Member demonstrated that its measures achieved the appropriate level of sanitary or phytosanitary protection of the Russian Federation.
  21. The representative of the Russian Federation explained that his Government had adopted Resolution No. 761 of 28 September 2009 "On Implementing Harmonisation of the Russian Sanitary Epidemiological, Veterinary and Phytosanitary Measures in Compliance with International Standards" which established a process to amend measures that were found to be more stringent than international standards. The Resolution instructed the Ministry of Health and the Ministry of Agriculture to review all legal acts establishing sanitary-epidemiological requirements, veterinary and phytosanitary measures for their compliance with international (IPPC, OIE, Codex Alimentarius) standards and to bring them in line with such standards when the deviation>
  22. A Member of the Working Party expressed concern that requests submitted by this Party in the framework of Resolution No. 761 had received negative answers from Rosselkhoznadzor without scientific justification. Thus, in the view of this Member, Resolution No. 761 did not have the expected effect on harmonization of Russian norms with international standards and recommendations.
  23. In response, the representative of the Russian Federation explained that in order to improve the situation, relevant authorised bodies had established an internal procedure of forwarding requests from interested parties, including foreign governments, and had determined the responsible divisions for the examination procedure. The procedure was adopted by relevant Orders of the MOA (No. 49 of 21 February 2011), Rosselkhoznadzor (No. 39 of 10 February 2011) and the MOH (No. 98 of 10 February 2011, No. 378 of 29 April 2011).
  24. A Member indicated that, despite adoption of the said procedure, the situation remained alarming as most submitted comments were ignored by the Russian authorities.
  25. Some Members noted that CU Parties now had competence to regulate SPS measures and requested information on how the CU technical regulations on SPS and other acts at the CU and national level would be harmonized with international standards, guidelines, and recommendations. These Members expressed concern that recent draft CU SPS technical regulations did not reflect international standards, guidelines and recommendations. Members also requested information on what SPS measures would apply until such time as the CU Commission adopted SPS technical regulations.
  26. The representative of the Russian Federation informed Members of the Working Party that the CU Commission had adopted Decision No. 625 of 7 April 2011 "On Harmonization of CU Legal Acts in the Field of Sanitary, Veterinary and Phytosanitary Measures with International Standards". This CU Commission Decision created at CU level a procedure similar to Resolution No. 761 of the Russian Federation. CU SPS measures that, after examination, were recognized as more stringent than international standards, without scientific justification for such restriction or risk to human, animal or plant life or health would be brought into conformity with international standards. He noted that foreign governments could bring measures to the attention of the CU Parties and participate in the examination.
  27. The representative of the Russian Federation further informed Members of the Working Party that in connection with implementation of CU Commission Decision No. 625, the CU Commission had by Decision No. 801 of 23 September 2011, adopted the Regulation "On the Uniform Procedure of Carrying Out Examination of Legal Acts of the Customs Union in the Sphere of Implementation of Sanitary, Veterinary, and Phytosanitary Measures" which entered into effect on 29 October 2011. Some Members of the Working Party expressed concern that the implementation procedure was unnecessarily burdensome and lengthy.
  28. The representative of the Russian Federation stated that once the procedure for implementation of the harmonization process set-out in CU Commission Decision No. 625 had entered into effect, the Russian Federation would start the process of aligning its procedures under Resolution No. 761 with the CU procedures.
  29. Some Members of the Working Party expressed concern as regards the timing envisaged by the Russian Federation for harmonization of SPS measures applicable on the territory of the Russian Federation with international standards, requirements and guidelines and asked the representative of the Russian Federation to clarify how the Russian Federation would ensure that SPS measures applied in the Russian Federation would be harmonized with international standards, guidelines and recommendations by the date of its accession to the WTO.
  30. The representative of the Russian Federation replied that from the date of entry into force of CU Commission Decision No. 721 of 22 June 2011 "On Application of International Standards, Guidelines and Recommendations", such international standards, recommendations and guidelines, as provided in paragraphs , , , and would be applied in the territory of the Russian Federation. In accordance with this Decision, such standards would continue to apply unless the review of a measure pursuant to CU Commission Decision No. 625 or Government Resolution No. 761, as appropriate, resulted in a finding that there was a risk assessment and scientific justification that complied with the WTO SPS Agreement, and which justified the application of a standard which was more stringent than the relevant international standard. Some Members expressed concerns over the fact that, pursuant to CU Commission Decision No. 773 of 16 August 2011, CU Commission Decision No. 721 would enter into force not earlier than the date of accession of the first CU Party to the WTO. In response, the representative of the Russian Federation specified that CU Commission Decision No. 721 would enter into force on the date of accession of the Russian Federation to WTO.
  31. The representative of the Russian Federation stated that according to paragraph 4 of Article 15 of the Constitution of the Russian Federation, the universally-recognised norms of international law and international treaties and agreements of the Russian Federation were an integral part of its legal system. If an international treaty or agreement of the Russian Federation established other rules than those envisaged by law, the rules of the international agreement must be applied. Furthermore, pursuant to Article 2 of Federal Law No. 29-FZ of 2 January 2000 "On Quality and Safety of Food Products", if an international treaty of the Russian Federation established any rules other than those stipulated by the legislation of the Russian Federation in the field of ensuring the quality and safety of food products, then the rules of the international treaty were to apply. He also referred Members to the Section "Framework for Making and Enforcing Policies", which described the status of international agreements, including the WTO Agreement, once the Russian Federation had ratified its Protocol of Accession, within the national legal system of the Russian Federation and within the framework of the CU. In this regard, the representative of the Russian Federation noted the effect of the Treaty on the Multilateral System in ensuring that CU Agreements, CU Commission Decisions, and other CU Acts were consistent with the WTO commitments of a CU Party, including those under the WTO SPS Agreement. The representative of the Russian Federation also recalled that under Article 2 of the Treaty on the Multilateral System, the CU Parties would adopt measures to adjust the legal framework of the CU and the decisions of its Bodies to comply with the WTO Agreement. Prior to adoption of such adjustment measures, the relevant provisions of the WTO Agreement including those of the WTO SPS Agreement, would prevail over respective provisions of treaties concluded within the framework of the CU and of decisions adopted by its Bodies.
  32. One Member requested the Russian Federation to confirm that, in application of Article 3.1 of the WTO SPS Agreement, the Russian Federation would review all of its existing sanitary and phytosanitary measures to ensure that, by the date of accession, they were based on international standards, guidelines and recommendations or, in the event that the Russian Federation considered that international standards did not meet its appropriate level of protection, they were scientifically justified in accordance with Article 3.3 of the WTO SPS Agreement. In cases where relevant scientific evidence was insufficient, he requested that the Russian Federation confirm that it would comply with Article 5.7 of the WTO SPS Agreement.
  33. The representative of the Russian Federation confirmed that, as of the date of accession, in application of Article 3.1 of the WTO SPS Agreement, all sanitary and phytosanitary measures, whether adopted by Russian Federation or the competent bodies of the CU, would be based on international standards, guidelines or recommendations as provided for in the WTO Agreement. Further, the representative of the Russian Federation confirmed that measures which were not based on international standards, guidelines and recommendations, where they exist, would not be applied in the Russian Federation without providing Members a scientifically based justification of the measures, in accordance with the WTO SPS Agreement, including Article 3.3. In cases where relevant scientific evidence was insufficient, he confirmed that any measure adopted, whether by the Russian Federation or the competent bodies of the CU would comply with the WTO SPS Agreement, in particular with Article 5.7 thereof. In the event that international standards were not considered to meet the appropriate level of protection, the Russian Federation would provide scientific justification for measures applied in the Russian Federation, in accordance with Article 5.8 of the WTO SPS Agreement. The Working Party took note of these commitments.