FEDERATION TO THE WORLD TRADE ORGANIZATION 36 страница

951. One Member noted that the Russian Federation had adopted some phytosanitary measures that were inconsistent with international standards and guidelines, and had not provided a scientific justification or a risk assessment done in accordance with Article 5 of the WTO SPS Agreement. Specifically:

(a) On the import of raw sugar, the Russian Federation requires the submission of a phytosanitary certificate for this product that is processed, for which the reasons given by the Russian Federation do not seem to be compatible with the IPPC and WTO SPS Agreement. This Member asked whether the Russian Federation was prepared to eliminate the application of this document as phytosanitary requirement for a product that is processed, requirements that must be governed by other international standards (Codex Alimentarius).

(b) On imports of leather leaf fern (Rumohra adiantiformis), requirements requested by the Russian Federation do not correspond to pests associated with this crop, which denotes the absence of a pest risk analysis to justify the scientific application of those requirements.

952. In response to these concerns, the representative of the Russian Federation stated that when taking phytosanitary measures, Russian authorities followed the relevant international practice and provisions established in the IPPC and the WTO SPS Agreement, including conducting a risk assessment. He explained that Government Resolution No. 329 "On the National Organization for Quarantine and Plant Protection", named Rosselkhoznadzor as the Federal Agency responsible for fulfilling the duties stipulated in Article IV of the IPPC. He confirmed that, from the date of accession of the Russian Federation to the WTO, if the phytosanitary requirements of the Russian Federation resulted in a higher level of protection than would be achieved by measures based on relevant international standards, recommendations or guidelines, the Russian Federation would apply its phytosanitary requirements in accordance with the WTO SPS Agreement, in particular Article 3.1 of that Agreement. He also confirmed that the authorities of the Russian Federation would consult with exporting Members on the measures in question, if requested. Furthermore, from the date of accession of the Russian Federation to the WTO, if phytosanitary requirements applied in the Russian Federation resulted in a higher level of protection than would be achieved by measures based on relevant international standards, recommendations or guidelines, Rosselkhoznadzor would provide explanations of the reasons for such phytosanitary measure, including the relevant risk assessment, on a bilateral basis following receipt of a request from an exporting Member pursuant to Article 5.8 of the WTO SPS Agreement. The representative of the Russian Federation also confirmed that the radiation certificate on import of raw sugar into the customs territory of the Russian Federation was not required by the CU or Russian legislation. The Working Party took note of these commitments.

953. Some Members raised concerns that CU and Russian measures called for, and their officials applied less favourable treatment to imported products than domestically produced products. They noted that according to the CU Regulation "On Carrying out of Phytosanitary Control" (adopted by CU Commission Decision No. 318 of 18 June 2010), visual inspection (examination) of vehicles (bullet 4.2), and visual inspection (examination) of regulated products (bullet 4.3) were carried out at the crossing points of the CU border. Furthermore, Article 9, paragraph 5 of Law No. 99 and the new draft Law "On Plant Quarantine", provided that: regulated goods imported into the territory of the Russian Federation would be subject to initial State quarantine phytosanitary control, including inspection, at the crossing points of the CU and a second State quarantine phytosanitary control, including inspection, at destination in the Russian Federation. These Members noted that these products had a phytosanitary document and had been inspected where produced. The requirement of the Russian Federation for inspection when it crossed into the territory of the Russian Federation and then a full re-inspection for all shipments when clearing customs appeared to be unjustified for SPS reasons, a burden on trade, and inconsistent with national treatment.

954. The representative of the Russian Federation explained that the procedure for inspection at the border and at destination was not burdensome and that the Russian Federation was not inspecting 100 per cent of shipments at the border, but was moving towards an inspection system based on risk. The representative further clarified that the provisions for border control were approved by CU Commission Decision No. 318 and were applied by all Customs Union Parties.

955. The representative of the Russian Federation confirmed that in accordance with Article 29.2 of Federal Law No. 164-FZ of 8 December 2003 "On Basics of Regulation of Foreign Trade Activity", SPS requirements must be implemented in respect of products originating from foreign countries in the same way they are applied in respect of similar products of Russian origin. Furthermore, according to Article 6 of the draft Federal Law "On Plant Quarantine", phytosanitary requirements applied to regulated products originating from a foreign country in the same manner as they applied to the same regulated products of Russian origin. The appropriate level of sanitary or phytosanitary protection was defined as the required level of protection established by a technical regulation for products produced on the territory of the Russian Federation aimed at prevention of factual scientifically grounded risks. He confirmed that CU Agreements, CU acts, and legislation of the Russian Federation did not and would not in future establish additional SPS requirements for imported products that exceeded the requirements established for CU or domestic products. The Working Party took note of these commitments.

(g) Protection of Human Health

956. 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.

957. 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.

958. 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 was not referred to in CU Commission Decisions. Members requested information on whether domestic provisions of the Russian Federation still applied, and, if so, what criteria were used for determining that a product was marketed for the first time in the territory of the CU or the territory of the Russian Federation.

959. 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").

960. 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.

961. 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.

962. 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.

963. 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.

964. 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.

965. 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.

966. 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.

967. 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.

968. 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.

969. 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 was not possible to replace State Registration by self-declaration of conformity in all cases.

970. 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.

971. 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.

972. 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.

973. 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.

974. 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.

975. 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 was not a food safety issue.

976. 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

(i) Harmonization with International Standards and Norms

977. 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 was not clear. In addition, some Members expressed concerns that the status of work on harmonization was not clear, and requested information on what work will remain to be done after the accession of the Russian Federation.