2. The WTO Agreement on the Application of SPS Measures Prof. Elisaveta Stikova M.D., Ph.D. School of Medicine University “ St. Cyril and Methodius” – Skopje Republic of Macedonia

3. Why this lecture? zNeed for protection of human, animal and plant life and health, zFood Safety as a public health priority, zNeed for harmonization of food legislation zThe influence of international recommendations on the national food legislation.

4. Learning Objectives: yTo introduce the students to the role of international standards, rules, guidelines and recommendations for the protection of human, animal and plant life and health.

5. Performance Objectives: zDefinition of Sanitary and Phytosanitary (SPS) Measures zHarmonization of legislation, zRisk Assessment, zAppropriate level of SPS measures, zTransparency.

6. All countries have rights to take Sanitary and Phytosanitary (SPS) Measures for protection of human, animal and plant life and health SPS Agreement, Article 2.1.

7. International trade influences: zPromotion of the economic development, zAlleviation of poverty. SPS measures may influence on: zmany restrictions in international trade.

8. SPS measures: zMust be based on scientific evidence and risk assessment zMust not create any sort of unjustified barriers and zMust not create any restrictions in international trade.

9. Definition of SPS Measures (1) To protect: yhuman or animal life From: z additives, z contaminants, z toxins z disease-causing organisms

10. Definition of an SPS Measures (2) To protect zhuman life From z plant-carried or z animal-carried diseases (zoonoses)

11. Definition of an SPS Measures (3) To protect zanimal or plant life From z pests, z diseases or z disease-causing organisms

12. Definition of an SPS Measures (4) To protect za country From z damage caused by the entry, establishment or spread of pests

13. An important footnote: z“animal” includes wild fauna, fish, z“plant” includes forests, wild flora z“pests” include weeds, z“contaminants” include pesticides, veterinary drug residues, extraneous matter.

14. What type of measures? zProduct criteria, zQuarantine measures, zProcessing requirements, z Certifications, z Inspection, z Testing, z Health-related labeling All measures with SPS purpose including:

15. Legal obligations of other WTO agreements: zEnvironmental protection, zProtection of consumer’s interests, zWelfare of animals. They are addressed by other WTO agreements - TBT Agreement or Article XX of GATT 1994

16. Differences between SPS and TBT Agreements SPS zBased on risk assessment, zBased on scientific evidence, zRisk assessment from pests, diseases, additives, contaminants, toxins... TBT z Based on legitimate objective: - national security, - prevention from deceptive practice, - environmental protection, z Scientific evidence - one element to consider.

17. Beneficiaries of the SPS Agreement: zThe consumers, zThe exporters of agricultural products, zThe importers of food and other agricultural products.

18. The SPS Agreement helps: (1) zTo ensure that consumers are being supplied with safe food to eat – “safe” by the appropriate standards, zTo ensure that safety regulations are not being used as an excuse for protection of domestic producers.

19. The SPS Agreement helps: (2) zTo eliminate the unnecessary and unjustified trade barriers, zTo support international competition among producers regarding safer and healthier food production, zTo provide greater choice of safe foods for consumers on the market,

20. The SPS Agreement helps: (3) zTo increase the amount of available information for consumers as a result of greater transparency in governmental procedures, zTo increase the amount of available information for importers and to eliminate unjustified border measures.

21. Key Principles of SPS Measures: zHarmonization, zRisk assessment, zAppropriate level of protection, zRegional conditions, zTransparency.

22. Harmonization (1) Harmonization means: zEstablishment, zRecognition and zApplication of Common SPS measures by different countries.

23. Harmonization (1) zEstablishment, zRecognition and zApplication of common SPS measures by different countries. Harmonization means:

24. Harmonization (2) The SPS Agreement identifies 3 International organizations responsible for harmonization and standard setting.

25. Harmonization (3) The International Organizations are: zCodex Alimentarius for food safety and human health, zInternational Office of Epizootics for animal health and zoonoses, zInternational Plant Protection Convention for plant health.

26. Risk assessment: (1) zThe evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing country according to association with potential biological or economic consequences;

27. Risk assessment: (2) zThe 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.

28. Appropriate level of sanitary or phytosanitary protection: z The level of protection deemed appropriate by the country establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory. Many countries refer to this concept as the “acceptable level of risk”.

29. Pest- or disease-free area means: zAn area, whether all of a country, part of a country or all or parts of several countries, as identified by the competent authorities, in which a specific pest or disease does not occur.

30. Area of low pest or disease prevalence: zAn area, whether all of a country, part of a country, or all or parts of several countries, as identified by the competent authorities, in which a specific pest or disease occurs at low levels and which is subject to effective surveillance, control or eradication measures

31. Transparency (1): A chievement of greater degree of: zClarity, zPredictability and zInformation regarding trade policy, rules and procedures of WTO

32. Transparency (2): There are three different fields of activities: yPublishing regulations, yNotifications, yInformation.

33. Enquiry points (1) An office designated to receive and respond to any requests for information regarding the country’s SPS measures.

34. Enquiry Points (2) Locations of the Enquiry Points at the WTO’s home page: ”Documents on Line", search document symbol "SPS/ENQ/"). http://www.wto.org

35. Committee on Sanitary and Phytosanitary Measures is: zForum for consultations about food safety or animal and plant health measures which affect trade, zSupport for the implementation of the SPS Agreement.