1. Physical WG on the REVISION OF THE PRINCIPLES FOR THE ESTABLISHMENT AND APPLICATION OF MICROBIOLOGICAL CRITERIA FOR FOODS EFSA, Parma, May 29 to June 1, 2012 Prepared by Japan and Finland

2. History of the revision of MC 41 st CCFH (2009) : Agreed thr project document of the New Work 1 st pWG in Tokyo (2010) 33rd CAC (2010), Agreed the new work 42 nd CCFH (Uganda) 2 nd pWG in Grange (2011) 43 rd CCFH in session WG and the plenary – to restructure the main document, as proposed by Australia with modifications; – to retain the three categories of microbiological criteria, as the concepts could be useful; and – to focus on food safety criteria and process hygiene criteria and not to address food processing environment criteria at this time. 3 rd pWG in Parma (EFSA) in 2012

3. MAIN ASPECTS TO BE COVERED Guidance will be introduced in the document to reflect current best practice regarding the utility of microbiological criteria in the context of specific applications. The following aspects are required attention:

4. MAIN ASPECTS TO BE COVERED the principles of establishing microbiological criteria for within-lot evaluation of food product acceptability, the principles for establishing microbiological criteria for between-lot evaluation of food product acceptability in relation to verification of process control, effectiveness of HACCP programs, and other trend analysis application, the appropriate roles of microbiological testing for verification of process control within the context of HACCP and validation of control measures, the establishment and interpretation of microbiological criteria related to hygiene indicator microorganisms, the principles and practices for relating the stringency of a microbiological criterion to required or recommended risk management outcomes; i.e., means for relating the performance of sampling plans for both within-lot and between-lot applications to food safety risk management metrics (e.g., FSO, PO, PC), Actions to be taken in case of non-compliance to microbiological criteria and other risk management metrics ( e.g., PO, PC), the role of microbiological testing to monitor environments in which foods are exposed and the establishment of performance criteria by competent authorities and industry to indicate an acceptable level of control.

5. The scope of the work in the project document bringing the establishment and application of microbiological criteria for foods by governments and industry in line with the latest knowledge and practices. introducing the new risk management metrics (Food Safety Objective (FSO), Performance Objective (PO), and Performance Criterion (PC)) developed in the framework of microbiological risk management and other quantitative microbiological limits (e.g., process control based criteria, testing for HACCP verification) not currently dealt with in the general guidance document. providing guidance on the relationship between microbiological criteria, risk management metrics and other quantitative microbiological limits according to the latest knowledge and practice, including the application of microbiological criteria in the context of risk metrics and other quantitative microbiological limits

6. Terms of References of the pWG (para 56 of the 43 rd CCFH report ) elaborate an Annex with practical examples on the establishment and application of microbiological criteria for different purposes through electronic means by teams of two or more countries; finalize these practical examples; and review and complete the main document based on the examples and the comments received before and during the current session

7. Elaboration of practical examples To elaborate practical examples, through electronic means by teams of two or more countries (lead country and two or more collaborating countries). Support from the Codex Trust Fund – facilitate the active participation of developing January to April 2012

8. Example Drafting teams Example 1 : A GHP-based approach. – Drafting team: European Union (lead), Benin, Cameroon, Ghana and Panama. Example 2: Microbiological Criterion is established for food to assess the acceptability of a food lot. – Drafting team: United States of America (lead), Argentina, Thailand and Uruguay. Example 3a: Microbiological Criterion is established for the food to verify the performance of a HACCP System – Drafting team: IDF (lead), Bolivia, Gambia, and Nigeria. Example 3b: Microbiological Criterion is established for the food to verify the performance of a Food Safety Control System. – Drafting team : New Zealand (lead), Costa Rica, Kenya, Kiribati and Samoa. Example 4: Microbiological Criterion is established for a high prevalence foodborne pathogen for a risk based approach. – Drafting team: Denmark (lead), Brazil, Colombia, Costa Rica, Senegal and ALA. Example 5a: Operationalising a Performance Objective with a Microbiological Criterion for a risk-based approach. – Drafting team: Canada (lead), Brazil, France and India. Example 5b: Operationalising a Performance Objective with a Microbiological Criterion for a risk-based approach. Drafting team: United States of America (lead) and Brazil.

9. the circulation on 27 th April 2012 The purposes of this circulation are: 1. To request comments on the document Proposed Draft Revision of Principles for the Establishment and Application of Microbiological Criteria for Foods” based on the review of the examples. Please identify missing / inappropriate parts, or area which needs to be modified in the document, in light of the 7 examples. 2. To request comments on the examples. Specifically, we would like to pose the following questions: Q1: Are these examples useful in order to understand different types of microbiological criteria and their application? Q2: Should we keep the examples as an Annex to the MC document? Q3: if the answer to the Q2 is “Yes”, then please answer what the examples Annex should look like? Please address issues such as: the levels of detail, length, etc.

10. Comments received ARGENTINA, EU, FRANCE, NEW ZEALAND, PERU, US, Switzerland and Belgium

11. Presentations of examples To understand the backgrounds and contents of examples To identify lessons learned through the drafting exercise To identify the missing text in the main document to reflect the examples identify some key points from your examples that might be useful for inclusion or consideration in the main document,

12. Main document Discussed at the Grange pWG Fix 1-4 Focus on Sec. 5 (5.1 to 5.6)

13. Future of the examples Option 1: Attached to the main document Option 2: extract math parts, and send FAO/WHO to integrate

14. Time Table TUEWEDTHUFRIDAY AM 1 Welcome, Introduction, Example #1 Main doc. 1-2 Main doc 5 Finalized the main doc, Decide the future of the examples AM 2 Example #2-4Main doc, 3 continue PM 1 Example 5A, 5BMain doc 4 continueReview the meeting report PM 2 Discussion to identify inf. to be included in the Main Doc. continueMain doc 6,7