Sanitary and phytosanitary legislation in the russian federation: A general overview in light of the WTO SPS agreement and EU principles of food safety

Review of Central and East European Law

Volumn 35, Issue 3, 2010, Pages 225-255

  Kireeva, Irina ^a   Black, Robert ^a  

^a NONE

Author keywords

animal health; aquis communitaire; border controls; EU; food safety; pesticides; phytosanitary legislation; plant health; Russian Federation; sanitary legislation; SPS Agreement; TBT Agreement; WTO

Indexed keywords

EID: 77956542420     PISSN: 09259880     EISSN: 15730352     Source Type: Journal    
DOI: 10.1163/157303510X12650378240313     Document Type: Review

References (117)

1. International Plant Protection Convention, adopted 6 December 1951, entered into force 3 April 1952, available at .
2. The IPPC was approved by the Food and Agriculture Organization Conference at its Sixth Session (November 1951). The present text of the IPPC (the 1997 revision) entered into force on 2 October 2005 and has 170 contracting parties, including the Russian Federation. Russia joined the IPPC on 24 April 1956. The basic reporting is done by the Federal Service for Veterinary and Phytosanitary Surveillance; however no legal documents are reproduced on the official web site .
3. Opi Outhwaite, Robert Black, and Anglea Laycock, "The Pursuit of Grounded Theory in Agricultural and Environmental Regulation: A Suggested Approach to Empirical Legal Study in Biosecurity", 24(4) Law and Policy (2007), 493-528;
4. and Stewart Lockie and David Carpenter (eds.), Agriculture, Biodiversity and Markets (Earthscan, London, 2010)
5. in particular Robert Black and Irina Kireeva, "International Biosecurity Frameworks to Protect Biodiversity with Emphasis on Science and Risk Assessment", 77-99). More information in Russian with respect to sanitary and phytosanitary border control (i.e., legislation, explanatory notes and articles) can be found at and ; e.g.
6. E. V. Sem'ianov, "Hezakonnyi vvoz tovarov v Rossiiu i novaia protsedura tamozhennogo regulirovaniia", Arbitrazhnoe Pravosudie v Rossii (2008) No. 9.
7. Agreement on the Application of Sanitary and Phytosanitary Measures, adopted 15 April 1994, entered into force 1 January 1995: The Legal Texts. The Results of the Uruguay Round of Multilateral Trade Negotiations (Cambridge University Press, Cambridge, 13th ed. 2007), 59-72. Also available at .
8. As of spring 2009; for more information, consult the WTO website for Russia at .
9. Agreement on Technical Barriers to Trade, adopted 15 April 1994, entered into force 1 January 1995: see The Legal Texts, op. cit. note 3, 121-142.
10. EU exports to Russia in 2008 were worth €105 billion, while EU imports from Russia in 2008 were worth €173.2 billion. Imports from Russia are mainly energy and mineral-fuels products (69%), as well as chemicals and raw materials. EU exports to Russia are diversified, including machinery and transport equipment, manufactured goods, food, and live animals. Trade in services for exports was worth €18 billion and imports were worth €11.5 billion. EU investment in Russia was worth €17 billion, in comparison with €1 billion of Russian investment in the EU. For more statistics, see .
11. Regulation 178/2002/EC of the European Parliament and of the Council of 28 January 2002 Laying Down the General Principles and Requirements of Food Law, Establishing the European Food Safety Authority and Laying Down Procedures in Matters of Food Safety, Official Journal (OJ) (2002) L31/1, 1-24, as amended by Regulation 1642/2003/EC of the European Parliament and of the Council of 22 July 2003, OJ (2003) L245, 4-6.
12. Border controls include such internal measures as confinement of plants and animals in quarantine to subject them to observation and testing, as well as the containment and possible eradication of outbreaks of introduced pests and diseases. This defines the scope of 'biosecurity'.
13. Annex A of the SPS Agreement provides the following definition of SPS measures: "Sanitary or phytosanitary measures include all relevant laws, decrees, regulations, requirements and procedures including, inter alia, end product criteria; processes and production methods; testing, inspection, certification and approval procedures; quarantine treatments including relevant requirements associated with the transport of animals or plants, or with the materials necessary for their survival during transport; provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements directly related to food safety
14. ' Risk assessment is defined in the SPS Agreement as: "The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences; or the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs." Risk assessment is part of risk analysis and includes the processes of risk assessment, risk management, and risk communication (Annex A, SPS Agreement).
15. For more information on the OIE, consult the official website at .
16. Supra note 1.
17. For more information on the Codex Alimentarius, see the official website at .
18. The Preamble to the SPS Agreement makes a reference to international organizations, stating that members of the WTO desire "to further the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organizations, including the Codex Alimentarius Commission, the International Office of Epizootics, and the relevant international and regional organizations operating within the framework of the International Plant Protection Convention, without requiring Members to change their appropriate level of protection of human, animal or plant life or health".
19. Art.2(4), Regulation 882/2004/EC of the European Parliament and the Council on Official Controls Performed to Ensure the Verification of Compliance with Feed and Food Law, Animal Health and Welfare Rules, OJ (2004) L191, 1.
20. Art.13 "Implementation" of the SPS Agreement, as well as Art.8 "Control, Inspection and Approval Procedures" and Annex C to the SPS Agreement.
21. The competence is shared between the Department of Sanitary and Epidemiological Oversight, Sanepidnadzor and the Federal Service for Veterinary and Phytosanitary Surveillance, Rosselkhoznadzor. See more in section 6 of this Article.
22. An enquiry point for TBT measures is also required.
23. For more information, see the Ministry's official website at .
24. In Russia, it is the Federal Agency for Technical Regulations and Metrology. For more information, see its official website at .
25. In Russia, this is the Ministry of Agriculture. For more information, see the Ministry's official website at . "This Regulation provides the basis for the assurance of a high level of protection of human health and consumers ' interest in relation to food, taking into account in particular the diversity in the supply of food including traditional products, whilst ensuring the effective functioning of the internal market. It establishes common principles and responsibilities, the means to provide a strong science base, efficient organizational arrangements and procedures to underpin decision-making in matters of food and feed safety. 2. For the purposes of paragraph 1, this Regulation lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and national level. It establishes the European Food Safety Authority
26. See Section 4.2 of this article infra.
27. Op. cit. note 7.
28. Ibid. The European Food Safety Authority's official website is at .
29. Emphasis added.
30. Federal nyi Zakon "O kachestve 1 bezopasnosti produktov" (with subsequent amendments) No. 29-FZ, signed 2 January 2000, as amended by Federal Laws No. 196-FZ, signed 30 December 2001;
31. No. 15-FZ, signed 10 January 2003;
32. No. 86-FZ, signed 30 June 2003;
33. No. 122-FZ, signed 22 August, 2004;
34. No. 45-FZ, signed 9 May 2005;
35. No. 151-FZ, signed 5 December 2005;
36. No. 199-FZ, signed 31 December 2005;
37. No. 45-FZ, signed 31 March 2006;
38. No. 266-FZ, signed 30 December 2006;
39. Sobranie Zakonodatel'stva Rossiiskoi Federatsii (SZRF) (2000) No. 1 item 29 (hereinafter "2000 Russian Law on Food Products Quality and Safety").
40. Zakon "O veterinarii" (with subsequent amendments) No. 4979-1, signed 14 May 1993, as amended by Federal Laws No. 196-FZ of 30 December 2001;
41. No. 58-FZ, signed 29 June 2004;
42. No. 122-FZ, signed 22 August 2004;
43. No. 45-FZ, signed 9 May 2005;
44. No. 199-FZ, signed 31 December 2005;
45. No. 232-FZ, signed 18 December 2006;
46. No. 266-FZ, signed 30 December 2006;
47. Rossiiskaia gazeta, 16 May 1993 (hereinafter "1993 Russian Law on Veterinary Services"). No official, consolidated version of the text of this law has been published to date; however, a non-official version is available at .
48. Op. cit. note 7.
49. For more information, see the official website of the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) at .
50. For more information, see the official website of the FederalAgency for Oversight of Consumer Protection and Human Health (Rospotrebnadzor) at .
51. As of 1 March 2008, the Russian Federation consists of 83 federal 'subjects' (members of the Federation). In 1993, when the Constitution was adopted, there were 89 federal subjects; the 2008 number is the result of merger: see, e.g.
52. Hans Oversloot, "The Merger of Federal Subjects of the Russian Federation During Putin's Presidency and After", 34(2) Review of Central and East European Law (2009), 119-135.
53. Rezoliutsiia "O priniatii sanitarnykh pravil", No. 36, signed 14 November 2001, Rossiiskaia gazeta, 21 November 2001, also available at .
54. This is the Resolution "On Implementation of Sanitary Rules", 2.3.2 Food raw materials and food products hygienic requirements for food safety and food nutritional value, Sanitary Regulations and Norms (Sanitarnye Pravila i Normi, referred to as "SanPiN"), 2.3.2.1078-01.
55. Salmonella is a general name for a group of about 2, 000 closely related bacteria that cause illness by reproducing in the digestive tract. Salmonella are destroyed at cooking temperatures above 150 degrees F (65°C). Baking is usually done at 18o°C and over. So, per definition, all the tests of baked bread are negative as to Salmonella.
56. Hazard Analysis and Critical Control Point (HACCP) is a systematic preventive approach to food and pharmaceutical safety addressing physical, chemical, and biological hazards as a means of prevention rather than of finished-product inspection. HACCP is a production control system for industry: a process that identifies points at which potential contamination can occur (the critical control points or 'CCPs') and strictly monitors these points as a way of ensuring the process is in control and that the safest product possible is being produced. HACCP is designed to 'prevent' rather than to 'catch' potential hazards. HACCP was developed by Pillsbury in cooperation with NASA in the 1960s; this resulted from a realization that one could not 'inspect' safety into food. Both NASA and Pillsbury felt that HACCP, using the prevention philosophy, would be the most effective system for preventing hazards from entering the food chain. HACCP is designed to deal with biological, chemical, and physicals and has been accepted by the international scientific community. Since then, HACCP has been recognized internationally as a logical tool for adapting traditional inspection methods to a modern, science-based, food safety system. Based on risk-assessment, HACCP plans allow both industry and government to allocate their resources efficiently in establishing and auditing safe food production practices. In 1994, the organization of International HACCP Alliance was established initially for the US meat and poultry industries to assist them with implementing HACCP; now, its membership has been spread over other professional/industrial areas. Hence, HACCP has been increasingly applied to industries other than food, such as cosmetics and pharmaceuticals. This method, which in effect seeks to plan out unsafe practices, differs from traditional 'produce and test' quality control methods which are less successful and inappropriate for highly perishable foods. The Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO) have published a guideline for all governments to handle the issue in small and less developed food businesses (FAO Food and Nutrition Paper 86, ISSN 0254-4725). For more information on HACCP
57. see H. Russell Cross, "HACCP: What is it and Why Should I Care?", (Texas A&M University, College Station, TX, 1995); reproduced at .
58. In some jurisdictions, annexes may not be attached to primary laws. In these cases, such lists or other information would appear in subordinate legislation.
59. Council Directive 2000/29/EC of 8 May 2000 on Protective Measures Against the Introduction into the Community of Organisms Harmful to Plants or Plant Products and Against their Spread within the Community, OJ (2000) L169/1 (hereinafter "2000 Plant Health Directive").
60. Council Directive 77/93/EEC of 21 December 1976 on Protective Measures Against the Introduction into the Community of Organisms Harmful to Plants or Plant Products and Against their Spread within the Community, OJ (1977) L26/20.
61. For further details, see, for example, Robert Black, "The Legal Basis for Controls on Importation of Animal and Plant Material into the United Kingdom", 5(3) Environmental Law Review (2003), 179-192.
62. John Holt, Robert Black, and Roshan Abdallah, "A Rigorous yet Simple Quantitative Risk Assessment Method for Quarantine Pests and Non-native Organisms", 149(2) Annals of Applied Biology (2006), 167-173.
63. Based at the RF Federal Research Institute of Animal Protection (Federal'nyi Issledovatel'skii Institut po zashite zhivotnyx) in the city of Vladimir; the exchange took place during the period 2007-2008. The official Center for Information and Analysis website is at .
64. The Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor), supra note 29.
65. Op. cit. note 26.
66. Ibid., Art.27.
67. Federal'nyi Zakon " O tekhmchiskom regulirovami" with subsequent amendments, No. 184-FZ, signed 27 December 2002
68. as amended by Federal Laws No. 45-FZ, signed 9 May 2005;
69. and No. 65-FZ, signed 1 May 2007;
70. SZRF (2002) No. 30 item 184 (hereinafter "2002 Law on Technical Regulations").
71. Op. cit. note 7
72. Op. cit. note 27
73. Federalnyi Zakon " O karantine rastenii" with subsequent amendments, No. 99-FZ, signed 15 July 2000
74. as amended by Federal Laws No. 116-FZ, signed 25 July 2002;
75. No. 122-FZ, signed 22 August 2004;
76. No. 45-FZ, signed 9 May 2005;
77. and No. 178-FZ, signed 30 December 2006;
78. SZRF (2000) No. 19 item 99 (hereinafter "2000 Law on the Quarantine of Plants").
79. Federal'nyi Zakon "O bezopasnom ispol zovanu agro-khimikatov" with subsequent amendments, No. 109-FZ, signed 19 July 1997, as amended by Federal Laws No. 1-FZ and No. 15-FZ, signed 10 January 2003;
80. No. 58-FZ, signed 29 June 2004;
81. SZRF (1997) No. 20 item 109 (hereinafter "1997 Law on the Safe Use of Pesticides and Agrochemicals").
82. Considering that this law does not address food safety concerns per se, the issue of the detailed examination of this legislation has been left by the authors of this article for a subsequent publication.
83. There are more than 30 EC Directives in respect to different types of goods; the full references and exact titles can be found at . However, the present article deals only with food safety and, therefore, will leave general product safety outside of the scope of the current examination. 51 See supra note 34. 52 Art.17, Regulation on Food Safety ("Responsibilities").
84. The OIE International Standards are available at .
85. The same adjective in Russian (zaraznyi) appears to be used in legislation for both 'infectious' and 'contagious', which are not the same thing.
86. For more information on the EPPO, see .
87. Op. cit. note 36.
88. Convention on Biodiversity, adopted 5 June 1992, entered into force 29 December 1993, available at . The Russian Federation has been a party to this Convention since 5 April 1995;
89. Rossiiskaia gazeta, 10 April 1995.
90. Op. cit. note 47.
91. Art.6, "Establishment and Cancellation of a Quarantine Phytosanitary Zone, Setting up and Cancellation of a Quarantine Phytosanitary Regime, Imposing and Lifting Quarantine Restrictions";
92. Art.7, "The State Quarantine Phytosanitary Control"; Art.8, "Quarantine Phytosanitary Certification of Regulated Products";
93. Art.9, "Protection of the Territory of the Russian Federation from Quarantine Objects";
94. Art.10, "Decontamination, Sanitation, Fumigation of Regulated Articles";
95. Art.11, "Responsibilities of Organizations, Sole Proprietors and Citizens in the Field of Plant Quarantine Measures";
96. Art.12, "Detection of Quarantine Objects and Prevention of Their Spreading (Dispersion) ";
97. Art.13, "Impoundment, Destruction, Return of Regulated Products";
98. Art.14, "Laboratory Analysis and Expert Examination of Regulated Products".
99. Op. cit. note 36. See, in particular, Arts.3-7 with references to Annexes I -V.
100. For more information, see the Department's official website at
101. See the remarks on bread and baked goods in Section 4.4.
102. For more information on HACCP, see ;
103. and Art.5, Regulation 852/2004/EC of the European Parliament and Council of 29 April 2004 on the Hygiene of Foodstuffs, OJ (2004) L226/3.
104. The Hygiene Package, one of the key elements of the EU's food-safety legislation, is composed of five parts, covering general hygiene, hygiene of foodstuffs of animal origin, official controls and animal health rules for products of animal origin intended for human consumption, and a directive repealing the previously existing legislation. For more information on the EU 2004 Hygiene Package and texts of European legislation, see and , respectively
105. Chapter III, "State Regulation in the Field of Assurance of Quality and Safety of Food Prod ucts, Materials and Articles";
106. and Chapter IV, "Requirements to the Assurance of Safety an-Quality of Foodstuffs".
107. See Section 4.4 above with reference to Russia's food certification regime.
108. It is not clear that this function falls squarely within the RF Ministry of Agriculture or Rosselkhoznadzor, since safety of products is also within the RF Ministry of Health, Rospotrebnadzor, as stated above;
109. see supra note 17.
110. In the EU, 'zero' effectively means the standardized default value of 0.01 mg/kg. Art.18, Regulation 396/2005/EC of the European Council and of the Parliament of 23 February 2005 on Maximum Residue Levels of Pesticides in or on Food and Feed of Plant and Animal Origin and Amending Council Directive 91/414/EEC, OJ (2005) L70/1.
111. Some highly-developed countries (e.g., the US) and most developing countries naturally give preference to the economic activities. The high priority given to environmental protection in the EU arises from Article 191 of the Consolidated Version of the Treaty on the Functioning of the European Union, OJ (2008) C115/47(ex Art.174), which states, in particular: "1. Union policy on the environment shall contribute to pursuit of the following objectives: -preserving, protecting and improving the quality of the environment, -protecting human health, -prudent and rational utilisation of natural resources, -promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combating climate change. 2. Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay." The Russian Federation does not clearly state the priority of environmental protection in its policy in a fashion similar to that of the EU.
112. Interview with two drafters of the 1997 Law; on file with authors.
113. For the Convention, see op. cit. note 50. The Cartagena Protocol on Biosafety to the Convention on Biological Diversity, adopted 29 January 2000, entered into force 11 September 2003, available at . The Russian Federation is not party to this Protocol. For more information consult .
114. For more information on GMOs in Russia, see .
115. For more information on GMOs in Russia, see . Ibid.
116. A 'technical regulation' in the TBT Agreement is defined as a "[d}ocument which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.
117. Op. cit. note 44.