1. CODEX UPDATE SPS workshop - Addis Ababa 24 -27 September 2012 Tom Heilandt C O D E X A L I M E N T A R I U S

2. 185 members C O D E X A L I M E N T A R I U S 204 observers FAO/WHO Codex Alimentarius Commission

3. To protect the health of consumers To ensure fair practices in the food trade To promote coordination of all food standards work and to develop the Codex Alimentarius C O D E X A L I M E N T A R I U S

4. Standards, guidelines and codes of practice Structure and process for governments and organizations to find a consensus A RESULT A FORUM

5. C O D E X A L I M E N T A R I U S -Standards: prescriptive, what should be achieved; Limit; MRLs etc. -Guidelines: principles and guidance how to do something (e.g. Risk Analysis) -Codes of practice: advice or procedures what to do to avoid an issue or minimise the risk DIFFERENT TITLES – SAME STATUS IN WTO-SPS

6. C O D E X A L I M E N T A R I U S -Voluntary -Reference in the WTO SPS agreement -100% Member driven -Inclusive and transparent -By consensus (usually)

7. Aditivos Alimentarios (China) Contaminantes de los Alimentos (Países Bajos) Higiene de los Alimentos (Estados Unidos) Food Labelling (Canada) Residuos de Plaguicidas (China) Residuos de Medicamentos Veterinarios en los Alimentos (Estados Unidos) Horizontal/ general Committees Vertical/commodity Committees Milk and Milk Products (New Zealand) Processed Fruits and Vegetables (United States) Meat Hygiene (New Zealand) Fish and Fishery Products (Norway) Fresh Fruits and Vegetables (Mexico) Fats and Oils (Malaysia) Cereals, Pulses and Legumes (United States) Vegetable Proteins (Canada) Natural Mineral Waters (Switzerland) Cocoa Products and Chocolate (Switzerland) Ad-hoc intergovernmental task forces Foods derived from Biotechnology (Japan) Antimicrobial Resistance (Republic of Korea) Processing and Handling of Quick Frozen Foods (Thailand) Africa (Cameroon) Asia (Japan) Europe (Poland) Latin America and the Caribbean (Costa Rica) Near East (Lebanon) North America and South West Pacific (Papua New Guinnee) Executive Committee Secretariat Codex Alimentarius Commission Import and Export Inspection and Certification Systems (Australia) active adjourned sine die Fruit Juices (Brazil) Animal Feeding (Switzerland) dissolved active General Principles (France) Food Additives (China) Contaminants in Foods (Netherlands) Food Hygiene (United States) Pesticide Residues (China) Residues of Veterinary Drugs in Foods (United States) Nutrition and Foods for Special Dietary Uses (Germany) Methods of Analysis and Sampling (Hungary) FAO/WHO Coordinating Committees Sugars (Colombia)

8. Discussion paper S 1 S 8 Proposed draft standard Project document S2 drafting S3 consultation S4 discussion/ drafting S6 consultation S7 discussion/ drafting Codex standard Executive Committee (critical review) Committee or Task Force – existing or new Commission (adoption) S 5/5A Committee Draft standard consultation Endorsement by general committees Hold at Step 8

9. Roles in risk analysis Risk Assessment (FAO/WHO - Permanent bodies, Ad-Hoc Expert Consultations) Risk Management (Governments, CAC) Risk Communication: Governments, FAO/WHO – Infosan, IGos Functional separation + liaison

10. Risk Assessment for Codex: FAO/WHO scientific advice CCCF JECFA CCRVDF CCFA JMPR JEMRA CCPR Ad hoc consultations biotechnology Chemical hazardsMicrobiological hazards CCFH Biotoxins, melamine JEMNU Nutrition CCNFSDU TFFBT CCCF active chlorine CCFH nanotechnology Etc…

11. Codex meetings since November 2011 CCNFSDU33 CCFH43 CCEXEC66 TFAF6 CCMAS33 CCFA44 CCCF6 CCGP27 CCPR44 CCRVDF20 CCFL40 CCEXEC67 CAC35 CCFFV17 CCNASWP12 CCEURO28

12. General issues at CAC35 Failure to reach consensus on MRLs for ractopamine – vote to vote on MRLs: 68 – 64; vote for the MRLs: 69 – 67; MRLs adopted Bovine somatotropin – JECFA to re-evaluate Codex Strategic Plan 2014-2019 Codex Logo/ communication strategy Codex 50 th Anniversary session 2013 Further developments on Codex website/ cooperation with IPPC

13. Codex Strategic Plan 2014-2019 Strategic Goal 1: Establish international food standards that address current and emerging food issues Strategic Goal 2: Ensure the application of risk analysis principles in the development of Codex standards. Strategic Goal 3: Facilitate the effective participation of all Codex Members. Strategic Goal 4: Implement effective and efficient work management systems and practices.

14. SPS issues highlighted at the last training Food Hygiene Histamine - how are the levels set and do they reduce risk? Salmonella: are the criteria in the Standard for Bivalve Molluscs relevant and will they reduce risk? Zoonotic Parasites: Trichinella spiralis & Cysticerus bovis in meat Methods Methods for biotoxins Methods for ID Vibrio / gather further data to assist to develop model to assess whether measures assist to reduce risk Pesticide residues MRLs for minor crops Contaminants Mycotoxins (plant crops): Sorghum, fumonisins in maize, OTA in cocoa Melamine for liquid infant formula

15. Food hygiene Salmonella – decision will be taken at CCFFP32; criterion may be deleted countries need to ensure that they have shellfish sanitation programmes in place (CX/FFP 12/32/2/-Add.1) Histamine – FAO/WHO expert consultation was held (CX/FFP 12/32/2-Add.1) and further discussions will be held at CCFFP32. Open questions: – review the current levels, – develop sampling plans, is this possible at the international level (histamine is considered a microbiological criterion so when a limit is set, we need to also have sampling plans, etc.).

16. Food Hygiene 2: zoonotic parasites CCFH will discuss the proposed draft which takes a risk based approach to control of the two parasites - Trichinella spiralis & Cysticerus bovis. Many countries have measures which are not proportional to the risk, therefore a possible barrier to trade. Open questions: Should Codex have some general guidance for parasites. Are there other more important parasites to deal with that are of greater importance from public health perspective? Recent FAO/WHO expert consultation to rank parasites of public health importance. CCFH will discuss how to deal with these parasites – a general guidance with specific annexes? What is important at international level may differ to what is important at national or regional level and therefore the criteria used in the ranking exercise could be used by countries to determine what they should focus on. Work on parasites reinforces the need to have a coordinated approach with OIE and the same should apply at national level, cooperation between food safety and animal health.

17. FAO/WHO Trust fund Project on Microbiological criteria Pilot project to partner more experienced countries with less experienced countries to develop examples in the establishment and use of microbiological criteria in the context of CCFH has taken place in the first months of 2012, was evaluated in May and was deemed by all participating countries to have been very successful. FAO and WHO and the Codex Secretariat are considering other areas where such an approach might be used to advance Codex work.(CAC35/INF10)

18. Methods Biotoxin work continues and will be discussed at CCFFP32 – important to also get input from countries in the region (very little or none contributed up to now) Vibrio in seafood: FAO/WHO have developed criteria and will test these in South East Asia and if resources are found, this training will be extended to other regions (CX/FFP 12/32/2/- Add.1)

19. Pesticide Residues CCPR agreed on the criteria for use by CCPR and JMPR to determine the minimum number of field trials necessary to support the establishment of MRLs for minor crops / specialty crops in order to facilitate data submission to JMPR and to further develop these criteria including other related matters

20. Contaminants Mycotoxins: FAO/WHO Trust fund project (see next) on sorghum Difficulties in dealing with mycotoxins (e.g. fumonisins) when data is not provided to establish JECFA scientific advice to Codex. FAO studies development of a tool to assist design sampling plans for mycotoxin detection. Melamine ML for liquid infant formula adopted without footnote allowing for migration from packing

21. FAO/WHO Trust fund project on Mycotoxins in Sorghum Objectives: – To survey occurrence of mycotoxins in sorghum, the type and level of mycotoxins, to determine the mycotoxin producing fungi that are present in different varieties of sorghum. – To enhance scientific and technical input to Codex on health and trade issues of particular importance to developing countries. – To collect information on sorghum production systems and practices Outcome will serve for future analysis of possible ways and means to reduce mycotoxin contamination which is beyond the scope of this pilot project. Participants: Burkina Faso, Ethiopia, Mali and Sudan (four major sorghum producing/exporting countries).

22. Other food safety texts adopted by CAC35 Guidelines on the Application of General Principles of Food Hygiene to the Control of Viruses in Food Annex on Melons to the Code of Hygienic Practice for Fresh Fruits and Vegetables Maximum Level for Total Aflatoxins in Dried Figs, including Sampling Plan MRLs for amoxicillin (cattle, sheep and pig tissues and cattle and sheep milk) and monensin (cattle liver) ; narasin (cattle); ractopamine Principles and Guidance for the Selection of Representative Commodities for the Extrapolation of Maximum Residue Limits for Pesticides to Commodity Groups

23. New food safety work adopted Revision of the Code of Hygienic Practice for Spices and Dried Aromatic Plants Annex on berries to the Code of Hygienic Practice for Fresh Fruits and Vegetables Revision of the Maximum Levels for Lead in various products Annex for Prevention and Reduction of Aflatoxins and Ochratoxin A in Sorghum to the Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals (CAC/RCP 51-2003) Code of Practice for the Prevention and Reduction of Ochratoxin A contamination in Cocoa Code of Practice to Reduce the Presence of Hydrocyanic Acid in Cassava and Cassava Products and Maximum Levels for hydrocyanic acid in cassava and cassava products Levels for Radionuclides in Food

24. Thank you!

25. Agenda Codex Breakout 830 – 845 : Presentations 845 – 915 : Collect questions 915 – 945 : Codex website presentation 945 – 1015: Codex website exercise 1015 – 1030: Exercise/Coffee break 1030 – 1045: Website exercise review 1045 – 1145: Codex risk analysis 1145 – 1300: Questions and answers

26. Questions/topics Are Codex standards mandatory for members of Codex or WTO Specific standard for Coco Circumstances of developing countries Status of Use of ractopamine Codex vies on GMOs CCRVDF functions and how often it meets CTF how is it administered/ future of the CTF Africa dominated by standards coming from outside – what is Codex doing to rectify this Effective ways of Codex work in the country Possibility of one unit responsible for food safety Standards for organic food Substance used Ripening of fruits – any side effects What is Codex doing to increase participation of developing countries Micronutrient deficiency – 5 vehicles for vitamin a – develop specification – problems of overdose

27. Questions 2 Special and differential treatment for LDCs in food safety How can african axports be compatible with importing market standards (US/EU) How can the consistency of participation of developing countries be addressed? Risk analysis overview JECFA JEMRA … Consensus principle in Codex – is it a danger if decision is reached by vote? What is the fate of such standards? Focus person for import and export – are there special principles from Codex Specific treatment for LDC in Codex? What major role does country play in food safety What measure will a country take to set its own standards that would meet the international standards How to assist SADC members in coordinating their position. Consolidate solicit comments in good time. What basic measures a country should take in food safety How does Codex work with member countries Codex view on dietary supplements/ border between food and drug. Is there any future plan to set standards. Fortified foods – is there any Codex support? What is the Codex support to set national standards? National Codex Committee.

28. Website exercises 1: Find all Codex MRLs for hormones in meat 2: Find the Commission report where MRLs for testosterone were adopted 3: Which countries have been coordinators for Africa? 4: Find all Codex texts developed by the Committee on General Principles 5: Find all Codex MRLs for DDT 6: When and where will the next Codex Committee for Fish and Fishery Products be held? 7: Find all Codex MLs for Ochratoxin A 8: What are the functional classes of Beeswax as additive

29. Codex has been implementing risk analysis since its creation in 1960s... then what is actually new? –1980s Uruguay Round of the Multilateral Trade Negotiation SPS Agreement and creation of WTO –1991 FAO/WHO Conference on Food Standards, Chemicals in Food and Food Trade Sanitary measures applied by WTO members should be based on scientific principles (art. 2.1) and on risk assessments (art. 5.1) Sanitary measures conforming to international standards are deemed necessary to protect human health (art. 3.2) LOGICAL CONCLUSION: International standards and related texts have to be developed according to risk analysis principles ! What is new?

30. Role of science “The... C O D E X A L I M E N T A R I U S shall be based on the principle of sound scientific analysis and evidence, involving a thorough review of all relevant information, in order that the standards assure the quality and safety of the food supply. (CAC decision 1995)”

31. Aditivos Alimentarios (China) Contaminantes de los Alimentos (Países Bajos) Higiene de los Alimentos (Estados Unidos) Food Labelling (Canada) Residuos de Plaguicidas (China) Residuos de Medicamentos Veterinarios en los Alimentos (Estados Unidos) Horizontal/ general Committees Vertical/commodity Committees Milk and Milk Products (New Zealand) Processed Fruits and Vegetables (United States) Meat Hygiene (New Zealand) Fish and Fishery Products (Norway) Fresh Fruits and Vegetables (Mexico) Fats and Oils (Malaysia) Cereals, Pulses and Legumes (United States) Vegetable Proteins (Canada) Natural Mineral Waters (Switzerland) Cocoa Products and Chocolate (Switzerland) Ad-hoc intergovernmental task forces Foods derived from Biotechnology (Japan) Antimicrobial Resistance (Republic of Korea) Processing and Handling of Quick Frozen Foods (Thailand) Africa (Cameroon) Asia (Japan) Europe (Poland) Latin America and the Caribbean (Costa Rica) Near East (Lebanon) North America and South West Pacific (Papua New Guinnee) Executive Committee Secretariat Codex Alimentarius Commission Import and Export Inspection and Certification Systems (Australia) active adjourned sine die Fruit Juices (Brazil) Animal Feeding (Switzerland) dissolved active General Principles (France) Food Additives (China) Contaminants in Foods (Netherlands) Food Hygiene (United States) Pesticide Residues (China) Residues of Veterinary Drugs in Foods (United States) Nutrition and Foods for Special Dietary Uses (Germany) Methods of Analysis and Sampling (Hungary) FAO/WHO Coordinating Committees Sugars (Colombia)

32. Discussion paper S 1 S 8 Proposed draft standard Project document S2 drafting S3 consultation S4 discussion/ drafting S6 consultation S7 discussion/ drafting Codex standard Executive Committee (critical review) Committee Commission (adoption) S 5/5A Committee Draft standard consultation Endorsement by general committees Hold at Step 8

33. Integrating Risk Analysis into the Codex process Role of science and other factors in the Codex process (1995) Role of food safety risk assessment (1997) Risk Analysis Terms Related to Food Safety (1997) Criteria for the consideration of “other factors” (2001) Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius (2003) Specific risk analysis principles/policies: –food additives and contaminants (2005/2007) –residues of veterinary drugs in foods (2007) –pesticide residues (2007) –nutrition (2009) –hygiene (2010)

34. Advice for governments 2007 : Working Principles for Risk Analysis for Application by Governments

35. Risk assessment policy Risk assessment policy should be established by risk managers in advance of risk assessment, in consultation with risk assessors and all other interested parties. This procedure aims at ensuring that the risk assessment is systematic, complete, unbiased and transparent. The mandate given by risk managers to risk assessors should be as clear as possible. Where necessary, risk managers should ask risk assessors to evaluate the potential changes in risk resulting from different risk management options.

36. Risk assessment I Scope and output clearly stated in accordance with Risk Assessment Policy. Experts involved in risk assessment should be objective, not be subject to any conflict of interest. Information on them and their selection should be transparent. Four steps hazard identification, hazard characterization, exposure assessment and risk characterization. Based on scientific data most relevant to the national context. Quantitative information (preferred) or qualitative. Take into account relevant production, storage and handling practices including traditional practices, methods of analysis, sampling and inspection and the prevalence of specific adverse health effects.

37. Risk assessment II Constraints, uncertainties and assumptions having an impact on the risk assessment should be explicitly considered at each step in the risk assessment and documented in a transparent manner. Quantitative (preferred) or qualitative. Based on realistic exposure scenarios in accordance with risk assessment policy. Consideration of susceptible and high-risk population groups; acute, chronic (including long-term), cumulative and/or combined adverse health effects. The responsibility for resolving the impact of uncertainty on the risk management decision lies with the risk manager. The conclusions should be made available in understandable and useful form to all interested parties.

38. Risk management I Primary objective is the protection of the health of consumers. Structured approach: preliminary risk management activities, evaluation of risk management options, implementation, monitoring and review of the decision taken. Based on risk assessment, and should be proportionate to the assessed risk. Based on Codex standards and related texts, where available. Taking into account: – where appropriate, other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade (second statement of principle) – relevant production, storage and handling practices including traditional practices, methods of analysis, sampling and inspec­tion, – Feasibility of enforcement and compliance, and the prevalence of specific adverse health effects. – The economic consequences and the feasibility of risk management options.

39. Risk Management II The risk management process should be transparent, consistent and fully documented. The outcome of the preliminary risk management activities and the risk assessment should be combined with the evaluation of available risk management options in order to reach a decision on management of the risk. Assess options in terms of the scope and purpose of risk analysis and the level of consumer health protection they achieve. The option of not taking any action should also be considered. Ensure transparency and consistency in the decision making process. Assess potential advantages and disadvantages of options. Between different options, equally effective in protecting the health of the consumer, select least trade restrictive measures Continuing process review

40. Risk Communication promote awareness and understanding of the specific issues under con­ sideration during the risk analysis; promote consistency and transparency in formulating risk management options/recommendations; provide a sound basis for understanding the risk management decisions proposed; improve the overall effectiveness and efficiency of the risk analysis ; strengthen the working relationships among participants; foster public understanding of the process, so as to enhance trust and confidence in the safety of the food supply; promote the appropriate involvement of all interested parties; exchange information in relation to the concerns of interested parties about the risks associated with food; and respect the legitimate concern to preserve confidentiality where applicable.

41. Food hygiene Principles and Guidelines for the Conduct of Microbiological Risk Assessment (CAC/GL 30-1999) Principles and Guidelines for the Conduct of Microbiological Risk Management (CAC/GL 63-2007)

42. Biotechnology Principles for the risk analysis of foods derived from modern biotechnology (CAC/GL 44-2003) Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants (CAC/GL 45-2003) Guideline for the conduct of food safety assessment of foods produced using recombinant-DNA micro- organisms (CAC/GL 46-2003) Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA animals (CAC/GL 68-2008)

43. Who does risk analysis – Role Players Risk Assessment (FAO/WHO - Permanent bodies, Ad-Hoc Expert Consultations) Risk Management (Governments, CAC) Risk Communication: Governments, FAO/WHO – Infosan, IGos Functional separation + liaison

44. 4 steps of food safety risk assessment Hazard Identification – What is the agent? Exposure Assessment – How much will a given population be exposed to it? Hazard Characterization – What harm will it do? Risk Characterization – What will be the harm to a given population

45. Risk Assessment for Codex: FAO/WHO scientific advice CCCF JECFA CCRVDF CCFA JMPR JEMRA CCPR Ad hoc consultations biotechnology Chemical hazardsMicrobiological hazards CCFH Biotoxins, melamine JEMNU Nutrition CCNFSDU TFFBT CCCF active chlorine CCFH nanotechnology Etc…

46. Conduct of Risk Assessment Generation of data Review of Risk Assessments Consideration of Risk Management options Choice of a Risk Management option Implementation of a Risk Management measure Monitoring and Surveillance Project Cycle of Risk Analysis Communication

47. Risk AssessmentRisk Management Risk AssessmentRisk Management Codex Standard National Regulation National expert body FAO/WHO Expert Body

48. Challenges Priority setting at the Codex Committee level Funding of FAO/WHO Expert Bodies Data generation in developing countries Training of experts in developing countries Divergent Risk Assessment Policies –e.g. qualitative vs quantitative Divergent Risk Management Approaches –e.g. use of precaution

49. Example: GMOs Approval on non-approval by National Food Safety Management Authority National Safety Assessment Body SafeNon safe or Codex Principles on Risk Analysis Codex Guidelines on Food Safety Assessments

50. Precaution Precaution is an inherent element of risk analysis. Many sources of uncertainty exist in the process of risk assessment and risk management of food related hazards to human health. The degree of uncertainty and variability in the available scientific information should be explicitly considered in the risk analysis. Where there is sufficient scientific evidence to allow Codex to proceed to elaborate a standard or related text, the assumptions used for the risk assessment and the risk management options selected should reflect the degree of uncertainty and the characteristics of the hazard.

51. The melamine case

52. Risk Assessment/Risk Management Interaction CCCF CCCF Priority List for the Evaluation of Contaminants JECFA Risk Assessment  PTWI/PMTDI ALARA Risk Management  ML (GSCTF) Governments Ad hoc consultation

53. Terms used PMTDI (Provisional Maximum Tolerable Daily Intake) The endpoint used for contaminants with no cumulative properties. PTWI (Provisional Tolerable Weekly Intake) An endpoint used for food contaminants such as heavy metals with cumulative properties. ALARA the normal mechanism is for CCCF to set levels of contaminants which are as low as reasonably achievable

54. Melamine contamination of milk products - timeline 9 September 2008: The Shanghai Daily reported that 14 infants from Gansu Province were suffering from kidney stones after drinking a particular brand of powdered infant milk formula 11 September 2008: FAO and WHO learn about the problem 12 September 2008: The State Council of China reported 432 cases and 1 death. 16 September 2008: An INFOSAN Emergency Alert was distributed to the entire network alerting INFOSAN members of the event and of the possibility of contaminated products finding their way to other markets. 17 September 2008: The Singapore reported the first melamine findings outside of China in Chinese milk and milk products

55. Timeline (contd) 26 September 2008: FAO/WHO Press release: –The World Health Organization (WHO) and the UN Food and Agriculture Organization (FAO) are urging affected countries to ensure safe feeding of millions of infants following the ongoing melamine milk crisis in China. The two agencies also called on countries to be alert to the possible spread of melamine-contaminated dairy products. –Over 54 000 children have sought medical treatment in China related to the consumption of melamine-contaminated infant formula. Almost 12 900 are currently hospitalized. –One of the largest food safety crises in recent years

56. Timeline (contd) 1 December 2008: confirmed total of 6 deaths and 294,000 cases associated with the consumption of melamine contaminated milk and milk products 3 December 2008: INFOSAN has issued eleven INFOSAN Emergency Alert Updates in relation to the melamine event In total, 47 countries received melamine­ contaminated products.

57. Country risk management response Some: testing of all imported Chinese products. Others: testing on implicated products, 68 countries banned or recalled foods suspected of containing melamine Several countries: (interim) limits for melamine in food and feed (e.g., Australia, Canada, China, European Union, Malaysia, New Zealand, United States). Other countries: melamine should be absent (“zero­ tolerance” approach).

58. Problems with zero-tolerance Low levels (usually in the microgram per kilogram range) of melamine are found in some foods due to normal food production and processing (e.g., migration from food contact material, pesticides, or fertilizer use). Such levels are not a health concern. “zero tolerance” in practice is dependant on the performance of the analytical method used.

59. Adhoc expert meeting in Canada - results 5 December 2008 –Experts established a tolerable daily intake (TDI) for melamine: 0.2 mg/kg body weight i.e. 10mg per day for a 50 kg person. –Lower than previous national TDIs: "tolerable" level of unavoidable contaminant in food that a person can ingest on a daily basis without appreciable health risk. –Melamine is a contaminant that should not be in food. However, sometimes it is unavoidable. –To help national authorities set safe limits in food for withdrawal purposes should melamine be detected: –MLs in infant formula (1 part per million or ppm) and in other foods (2.5 ppm) introduced by many countries are assumed to provide a sufficient margin of safety as compared to the TDI

60. Ad hoc expert meeting in Canada - results The TDI applies to melamine alone. The TDI for cyanuric acid alone remains at 1.5 mg/kg body weight. Co-occurrence of melamine with cyanuric acid seems to be more toxic. However, adequate data are not available to allow the calculation of a health-based guidance value for this co-exposure.

61. Comparision Exposure estimates from adulterated products from this incident were 0.8–3.5 times the TDI. Estimated exposure of infants in China to adulterated infant formula, at median levels of the most affected brand, ranged from 8.6 to 23.4 mg/ kg body weight per day. These levels are about 40–120 times the TDI and explain the dramatic health outcome in Chinese infants.

62. And Codex? CCCF3 (2009) –Establish maximum levels for melamine in food and feed products resulting from non- intentional and unavoidable presence from different sources –To promote consistency in risk management practices related to such melamine presence in food and feed –Not applicable to deliberate addition of melamine in food and feed, as part of fraudulent activities, which are not to be tolerated at any level. –Not consider maximum levels for melamine-related chemicals e.g. cyanuric acid et al, but recognises that these chemicals present in combination with melamine represent a more unique toxicological concern compared to melamine alone. –Consideration will be given to the development of new maximum limits and/or revision of the proposed maximum limits, should new data become available. –Establishes EWG Levels proposed: –2.5 ppm melamine in food and feed products and, –1 ppm of melamine in infant formula products. CAC32 (2009): Approves new work

63. Decision CCCF4 (2010) – –Proposed Draft Maximum Levels for Melamine in Food (powdered infant formula and foods other than infant formula) and Feed – STEPS 5/8 CAC33 (2010) – Adopts MLs as proposed –Powdered Infant formula 1 mg/kg –Food (other than infant formula) and animal feed 2.5 mg/kg

64. Recently adopted Proposed Draft Maximum Level for at STEP 3 Liquid infant formula ML: 0.5 mg/kg

65. Lessons Significant confusion existed regarding which level of melamine in food presents a human health risk. Some 68 countries have taken different restrictive trade measures against a range of food products originating from China. Authorities should present clear, understandable reasons for any action or non-action taken. For many trading partner countries, it is difficult to assess the safety of future supplies and to decide on what basis to lift the restrictive measures imposed. Common understanding of the underlying science can lead to one harmonized international set of limits through the Codex Alimentarius Commission

66. Lessons Need to develop, at the international level, risk-based import­ inspection systems. Guidance regarding the necessary measures to demonstrate, with a certain degree of confidence, the appropriate levels of safety when a major food­safety event has seriously shaken confidence in the capabilities of a system to ensure the safety of the food it produces. The incident has also clearly demonstrated that food safety can only be ensured if all the stakeholders along the food chain are sharing information and data in a timely manner.

67. Food import and export inspection and certification systems Principles for Food Import and Export Certification and Inspection Guidelines for Food Import Control Systems Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems Guidelines for the Development of Equivalence Agreements Regarding Food Imports and Export Inspection and Certification Systems Guidelines on the Judgement of Equivalence of Sanitary Measures associated with Food Inspection and Certification Systems Guidelines for Design, Production, Issuance and Use of Generic Official Certificates Principles and Guidelines for the Exchange of Information in Food Control Emergency Situations Guidelines for the Exchange of Information between Countries on Rejections of Imported Foods Principles for Traceability / Product Tracing as a Tool Within a Food