ALINORM 04/27/13

JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX ALIMENTARIUS COMMISSION
Twenty-seventh Session
Geneva, 28 June - 03 July 2004

REPORT OF THE THIRTY-SIXTH SESSION OF THE
CODEX COMMITTEE ON FOOD HYGIENE

Washington D.C., United States of America, 29 March - 03 April 2004

NOTE: This report includes Codex Circular Letter CL 2004/11-FH

CX 4/20.2 CL 2004/11 - FH

TO: Codex Contact Points
Interested International Organizations

FROM: Secretary, Codex Alimentarius Commission
Joint FAO/WHO Food Standards Programme
Viale delle Terme di Caracalla, 00100 Rome, Italy

SUBJECT: Distribution of the report of the Thirty-sixth Session of the Codex Committee on Food Hygiene (ALINORM 04/27/13)

The report of the Thirty-sixth Session of the Codex Committee on Food Hygiene (CCFH) is attached. It will be considered by the Twenty-seventh Session of the Codex Alimentarius Commission, Geneva, 2004.

A. MATTERS FOR ADOPTION BY THE CODEX ALIMENTARIUS COMMISSION:
1. Draft Code of Hygienic Practice for Milk and Milk Products at Step 8 (ALINORM 04/27/13, Appendix II). See also paras. 15 through 53 of this report.
Governments wishing to comment on the above matter should do so in writing in conformity with the Uniform Procedure for the Elaboration of Codex Standards and Related Texts at Step 8 (Procedural Manual of the Codex Alimentarius Commission, Thirteenth Edition). Comments or proposed amendments should be sent to the Secretary, Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, Viale delle Terme di Caracalla, 00100 Rome, Italy preferably by e-mail: [email protected] or fax: +39 06 570.54593 before 15 May 2004.
2. Definitions on Food Safety Objective, Performance Objective and Performance Criterion (ALINORM 04/27/13, Appendix III). See also paras. 63-90 of this report.
Governments wishing to comment on the above matter should do so in writing. Comments should be sent to the Secretary, Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, Viale delle Terme di Caracalla, 00100 Rome, Italy preferably by e-mail: [email protected] or fax: +39 06 570.54593 before 15 May 2004.
B. REQUEST FOR COMMENTS AND INFORMATION:
1. Discussion Paper on the Management of the Work of the Committee (ALINORM 04/27/13, Appendix IV). See also paras. 54-62 of this report.
Governments and interested international organizations are invited to provide their comments on the above subject matter. Comments should be forwarded to F. Edward Scarbrough, U.S. Manager for Codex, Attn.: S. Amjad Ali, Room 4861 - South Bldg., Food Safety and Inspection Service, United States Department of Agriculture, 1400 Independence Ave. S.W., Washington D.C. 20250, U.S.A. (Fax No.:1.202.720.3157; E-mail: [email protected]), with a copy to Secretary, Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, Viale delle Terme di Caracalla, 00100 Rome, Italy, by Fax: +39 06 570.54593 or E-mail: [email protected] before 1 July 2004.
2. Proposed Draft Revision of the Code of Hygienic Practice for Eggs and Egg Products. See also paras. 101-106 of this report.
Governments and interested international organizations are invited to provide their comments on: processing of egg products, including emerging technologies; pasteurisation of eggs and egg products; hygienic provisions related to processing of egg and egg products; advice on the safe use and handling of eggs with particular focus on vulnerable groups; clarification of definitions, including collection and handling, grading and cleaning.
Comments should be forwarded to Dr Luba Tomaska, Food Standards Australia New Zealand, 55 Blackall Street, Barton ACT 2600, PO Box 7186, Canberra, MC ACT 2610, fax: 61-2-6271-2278, Email: [email protected] with a copy to Secretary, Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, Viale delle Terme di Caracalla, 00100 Rome, Italy, by Fax: +39 06 570.54593 or E-mail: [email protected] before 1 July 2004.

Contents
Summary and Conclusions page vi
List of Abbreviations page viii
Report of the Thirty-sixth Session of the Committee on Food Hygiene page 1
Summary Status of Work page 22

Paragraphs
Introduction 1
Opening of the Session 2-3
Adoption of the Agenda 4 - 8
Matters Referred by the Codex Alimentarius Commission and/or Other Codex Committees
to the Food Hygiene Committee 9 - 11
Endorsement of Hygiene Provisions in Codex Standards and Codes of Practice: Draft
Codex Code of Practice for Fish and Fishery Products and Draft Standard for Salted Atlantic
Herring and Salted Sprat 12 - 14
Draft Code of Hygienic Practice for Milk and Milk Products 15 - 53
Discussion papers on the Management of the Work of the Committee 54 - 62
Proposed Draft Process by Which the Committee on Food Hygiene Could
Undertake its Work in Microbiological Risk Assessment/Risk Management 54 - 62
Discussion Paper on the Development of Process, Procedures and Criteria to Establish
Priorities for the Work of the Codex Committee on Food Hygiene 54 - 62
Discussion Paper on the Development of Options for a Cross-Committee Interaction Process 54 - 62
Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk
Management 63 - 90
Proposed Draft Guidelines on the Application of General Principles of food Hygiene to the
[Management]of Listeria monocytogenes in Foods 91 - 100
Proposed Draft Revision of the Code of Hygienic Practice for Egg and Egg Products 101 - 106
Proposed Draft Guidelines for the Validation of Food Hygiene Control Measures 107 - 125
Reports of the Ad Hoc FAO/WHO Expert Consultations on Risk Assessment of
Microbiological Hazards in Foods and Related Matters 126 - 148
General Consideration of the Risk management Papers 128 - 137
Discussion Paper on Risk Management Strategies for Campylobacter spp. in Poultry 138 - 139
Discussion paper on the Risk Profile for Enterohemorragic Escherichia coli (EHEC)
Including the Identification of the Commodities of Concern, Including Sprouts,
Ground Beef and Pork 140 - 144
Discussion Paper on Risk Management Strategies for Salmonella spp. in Poultry 145 - 148
Discussion Paper on the Proposed Draft revision of the Recommended International Code
of Practice for Foods for Infants and Children 149 - 154
Proposed Draft Guidelines for the Hygienic Reuse of Processing Water in Food Plants 155 - 157
Discussion Paper on Proposed Draft Guidelines for Evaluating Objectionable Matter in Food 155 - 157
Other Business and Future Work: 158 - 160
Active chlorine 158
Antimicrobial resistance 159
Viruses in food 160
Date and Place of Next Session 161

Appendix I: List of Participants page 23
Appendix II: Draft Code of Hygienic Practice for Milk and Milk Products page 44
Appendix III Definitions to be included in the Procedural Manual page 83
Appendix IV Discussion Paper on the Management of the Work of the Committee page 84

SUMMARY AND CONCLUSIONS

The Thirty-sixth Session of the Codex Committee on Food Hygiene reached the following conclusions:

Matters for Adoption by the 27^th Session of the Codex Alimentarius Commission:
1. Draft Code of Hygienic Practice for Milk and Milk Products (ALINORM 04/27/13, paras. 15-53 and Appendix II).
2. Definitions on Food Safety Objective, Performance Objective and Performance Criterion (ALINORM 04/27/13, paras. 63-90 and Appendix III).
Matters of Interest to the Codex Alimentarius Commission
The Committee:
- combined the discussion papers related to the management of its work in one document and agreed to revise the consolidated version of the document on the basis of the discussion at the Committee and written comments submitted and to circulate it for further comments for consideration at its next session (paras. 54-62);
- replied to the request of the 26^th Session of the Commission regarding the development of specific guidelines on risk analysis (paras. 70-72);
- agreed to redraft the proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management on the basis of the discussion at the Committee and written comments submitted and to forward the definitions on Food Safety Objecitves, Performance Objective and Performance Criterion to the Commission for adoption with the understanding that these definitions would be included in the Procedural Manual (paras. 63-90);
- agreed to redraft the proposed Draft Guidelines on the Application of the General Principles of Food Hygiene to the Management of Listeria monocytogenes in Foods and to prepare an Annex to the Guidelines on the establishment of Food Safety Objectives and related performance objective and performance criteria, including microbiological criteria for Listeria monocytogenes in Ready-to-Eat Foods (paras. 91-100);
- agreed to revise the proposed draft Code of Hygienic Practice for Egg Products on the basis of the discussion at the Committee and written comments submitted (paras. 101-106);
- agreed to redraft the Proposed Draft Guidelines for the Validation of Food Hygiene Control Measures on the basis of the discussion at the Committee and written comments submitted (paras. 107-125);
- decided to develop risk management guidance documents for Campylobacter in Broiler Chickens; for Enterohemorrhagic Escherichia coli in ground beef and fermented sausages; and for Salmonella in Broiler Chickens. It also agreed to consider the Risk Profile of Vibrio spp in Seafoods at its next session (paras. 126-148);
- agreed to proceed with the revision of the Draft Revision of the Recommended International Code of Practice for Foods for Infants and Children at its next session (paras. 149-154);
- agreed to defer the consideration of the proposed draft Guidelines for the Reuse of Processing Water in Food Plants and the discussion paper on the Proposed Draft Guidelines for Evaluating Objectionable Matter in Food until the Committee develops its procedures for prioritization of work (paras. 155-157);
- while considering other business, agreed to prepare draft Terms of Reference for the FAO/WHO Expert Consultation on the Uses of Active Chlorine which would include safety/benefit issues; supported the establishment of a Codex/OIE Task Force on Antimicrobial Resistance and agreed to put the discussion paper on Viruses in Food on the list of activities for consideration regarding its prioritization (paras. 158-160).
Matters of interest to Other Committees:

Codex Committee for Fish and Fisheries (CCFFP)

Hygiene Provisions of the Code of Practice for Fish and Fishery Products and the Draft Standard for Salted Atlantic Herring and Salted Sprat

The Committee endorsed with minor amendment the food hygiene provisions of the Code of Practice for Fish and Fishery Products and the draft Standard for Salted Atlantic Herring and Salted Sprat with the understanding that the amendment should not cause any delay for the adoption by the Commission (paras. 12-14);
The Committee agreed that the risk profile of Vibrio spp. in seafood would be placed on the agenda of its next session in order to discuss how the risk management work on these issues should proceed (para. 137).

Codex Committee on Meat Hygiene (CCMH)

The Committee decided to develop risk management guidance documents for Campylobacter and Salmonella in broiler chickens and for enterohemorrhagic Escherichia coli in ground beef and fermented sausages (paras. 126 through 148).

LIST OF ABBREVIATIONS

REPORT OF THE 36^th SESSION OF THE CODEX COMMITTEE ON FOOD HYGIENE
INTRODUCTION
1. The Codex Committee on Food Hygiene (CCFH) held its Thirty-sixth Session in Washington, D.C, United States of America, from 29 March to 3 April 2004, at the kind invitation of the Government of the United States of America. Dr Karen Hulebak, Deputy Administrator, Office of Public Health and Science, Food Safety and Inspection Service, United States Department of Agriculture, chaired the meeting and Dr Michael Wehr served as Vice-Chairperson. The Session was attended by 196 participants from 43 Member countries and one Member organization¹ and 21 international organizations. A complete list of participants is given in Appendix I to this report.
OPENING OF THE SESSION
2. The Session was opened by Mr James R. Moseley, Deputy Secretary for the United States Department of Agriculture. Mr Moseley, speaking on behalf of Dr Elsa Murano, U.S.D.A. Undersecretary for Food Safety, noted that Codex has become an essential global organization, both with respect to protecting the health of consumers and facilitating international food trade. He emphasized the importance of the Codex Strategic Objectives and the implementation of the recommendations arising from the Codex Evaluation as means to enhance the effectiveness of Codex. Mr Moseley stressed the importance of Codex in continuing to base its standards on sound science, noting the importance of the work the Committee would be undertaking during the Session with respect to microbiological risk management and risk assessment. Mr Moseley commented upon the importance of the Codex Committee on Food Hygiene to effectively manage a workload that is both large and important. Mr Moseley also observed that the Codex Trust Fund had been implemented with support from the United States and several other countries and that this Session of CCFH was the first time that the fund had been utilized to support the attendance of developing countries at Codex meetings.
3. Dr Karen Hulebak emphasized the importance of the Committee’s work products in helping to ensure the production of and trade in safe food, and also pointed out the need for the Committee to establish a strategic, transparent, and orderly mechanism for setting its priorities and managing its own agenda, and in so doing, to maximize its ability to produce effective and timely risk management guidance documents.
ADOPTION OF THE AGENDA (Agenda Item 1)²
4. The Delegation of the United States drew the attention of the Committee to the fact that there were some overlapping areas in the documents in items 5 (a), (b), and (c) and proposed that the Committee convene a working group to merge the three documents in to a consolidated version.
5. Some delegations were of the view that there was a need to consolidate Agenda Items 5 (a) and (b) only, as they were related to the internal work of the Committee. Some delegations were of the view that issues covered under Agenda Item 5 (c) were of horizontal nature relating to cross-committee interactions and that more detailed consideration in the Plenary should be given in order to decide on how these documents might be merged. Other delegations indicated that there was necessity to ensure consistency of merged documents with the document on Proposed Draft Principles and Guidelines for Microbiological Risk Management. After some discussion, the Committee agreed that a Working Group led by the United States would meet during the sessions and to discuss how to restructure and consolidate the documents under Agenda Items 5 (a), (b), and (c) into one and, if possible, prepare a first draft of the document.
6. In order to allow some time for the preparation of the consolidated document, it was also agreed to rearrange the Provisional Agenda, switching Agenda Item 9 with Agenda Items 5 (a), (b), and (c).
7. The Delegation of the Netherlands drew the attention of the Committee to the fact that there was a possibility of advancing the document on the Proposed Draft Principles and Guidelines for Microbiological Risk Management (Agenda Item 6) and proposed to establish a Working Group in order to prepare a proposal for consideration of this item in the Plenary, however no consensus was reached on this proposal.
8. The Committee adopted the Provisional Agenda as the Agenda for the Session with the above modification.
MATTERS REFERRED BY THE CODEX ALIMENTARIUS COMMISSION AND/OR OTHER CODEX COMMITEES TO THE FOOD HYGIENE COMMITTEE (Agenda Item 2)³
9. The Committee was informed about matters arising from the 26^th Session of the Commission, from the 53^rd Session of the Executive Committee as well as the report on the FAO/WHO Workshop on the Provision of Scientific Advice to Codex and Member Governments. It noted that most of matters were for information purposes while only others would be discussed in more detail under relevant agenda items. In addition, the Committee noted the matters of interest to the Committee as follows:
Active chlorine
10. The Committee noted the request of the 36^th Session of the Codex Committee on Food Additives and Contaminants (CCFAC) (Rotterdam, 22-26 March 2004) to FAO/WHO to convene an Expert Consultation to conduct a comprehensive risk assessment of use of active chlorine, taking into account benefits and risks and that the CCFAC agreed on the need to clearly define the scope of the Consultation. It further noted that CCFAC would prepare clear terms of reference for the aspect relevant to its work and that it requested relevant Committees, including the Committee on Food Hygiene to consider safety/benefit issues relevant to uses of active chlorine within their respective purviews and to elaborate terms of reference for the expert consultation within their mandate and pose questions so that the Expert Consultation could be comprehensive. The Committee agreed to consider this matter on Agenda Item 14 “Other Business and Future Work” (see paras. 158).
Antimicrobial resistance
11. The Committee noted the information from the Representative of WHO regarding the conclusions of the Workshops on Non-human Usage and Antimicrobial Resistance (Geneva, 1-5 December 2003 and Oslo, 15-18 March 2004) and that some conclusions from these workshops were relevant to Committee’s work, therefore it agreed to consider this matter on Agenda Item 14 “Other Business and Future Work” (see para. 159).

ENDORSEMENT OF HYGIENE PROVISIONS IN THE CODEX STANDARDS AND CODES OF PRACTICE (Agenda Item 3)
Proposed Draft Code of Practice for Fish and Fishery Products⁴

Draft Standard for Salted Atlantic Herring and salted Sprat⁵

12. In accordance with the terms of reference of the Codex Committee on Food Hygiene, the Committee was invited to endorse the hygiene provisions of the Proposed Draft Code of Practice for Fish and Fishery Product, including Section 2.2 and 2.6 of Definitions; Section 6 – Aquaculture and Section 10 – Processing of Quick Frozen Coated Fish Product and of the draft Standard for Salted Atlantic Herring and Salted Sprat.
13. The Committee agreed to amend the third bullet of Section 10.3.5.1 “Sawing” to read “saw dust must not collect on the saw-table and must be collected in special containers under adequate hygienic conditions, if used for further processing” for consistency with the language used in the fourth bullet. The amendment should not cause any delay for the adoption by the Commission.
Status of the Endorsement of the Hygiene Provisions of the Proposed Draft Code of Practice for Fish and Fishery Product, and of the draft Standard for Salted Atlantic Herring and Salted Sprat
14. The Committee endorsed the hygiene provisions of the Proposed Draft Code of Practice for Fish and Fish Products, including Section 2.2 and 2.6 of Definitions; Section 6 – Aquaculture and Section 10 – Processing of Quick Frozen Coated Fish Product as amended above. It also endorsed the hygiene provisions of the draft Standard for Salted Atlantic Herring and Salted Sprat as proposed by the Committee on Fish and Fishery Products.
DRAFT CODE OF HYGIENIC PRACTICE FOR MILK AND MILK PRODUCTS (Agenda Item 4)⁶
15. The Committee noted that the 26^th Session of the Codex Alimentarius Commission adopted the proposed draft Code of Hygienic Practice for Milk and Milk Products at Step 5 as proposed by the 35^th Session of the CCFH.
16. The Committee first considered the outstanding issues, which were retained in square brackets, as follows:
Section 2.5 Definitions
Food Safety Objective
17. In noting that concrete progress had been done on the elaboration of a definition of “Food Safety Objective” and that the definition would be considered under Agenda Item 6 “Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management”, the Committee agreed to delete the square brackets and the definition and to retain the term, while adding a footnote referring to the Definition which occurs in the Principles and Guidelines (under development). Consequentially, the Committee agreed to retain the term “Food Safety Objective” without square brackets throughout the draft Code.
Validation
18. In recognizing the ongoing work on the development of “Proposed draft Guidelines for the Validation of Food Hygiene Control Measures” (Agenda Item 9), the Committee agreed to delete the square brackets and the definition and to retain the term, while adding a footnote referring to the Definition which occurs in the Guidelines (under development). Consequentially, the Committee agreed to retain the term “Validation” without square brackets throughout the draft Code.
Annex II Appendix B “Microbiocidal Measures”
Irradiation
19. The Committee noted the Appendices to Annex II contained examples of control measures applied around the world. In recognizing that irradiation was not an example of a microbiocidal measure and was not known to be practiced for milk and milk products at this time, the Committee agreed to delete the term and the description. It also deleted reference to irradiation in the third paragraph of Appendix B as a consequential change.
2.2 Process management
12 log reduction of C. botulinum
20. It was noted that the occurrence of C. botulinum in milk was extremely rare and/or insignificant, and that no cases of botulism linked to sterile milk had been reported, therefore, C. botulinum would not have had any relevance. The Committee deleted the text in square brackets.
IDF Standard 48.1969 (under review)
21. The Committee was informed that the IDF Standard was still under development, therefore, it deleted the reference to this standard.
22. The Committee next considered the draft Code section by section. In addition to several minor editorial amendments, the Committee agreed to the following changes:
Section 2.1 Scope
23. The Committee agreed to move a sentence from the Annex clarifying that the Code did not contain provisions for the production of raw drinking milk to the base Code. It also acknowledged that the Code, once adopted, would encompass dried milk; thus, the Code of Hygienic Practice for Dried Milk (CAC/RCP 31/1983) could be revoked.
Section 2.3 Overarching principles applying to the production, processing and handling of all milk and milk products
24. In recognizing that good agriculture practices are important measures applied at primary production to ensure the safety and suitability of milk and milk products and that there was not a formal definition of this term, the Committee added a reference to good agriculture practices in the narrative of the third bullet.
Section 2.4 Relatives Roles of Milk Producers, Manufacturers, Distributors and Competent Authorities
25. The Committee added the terms “retailers”, “transporters” and “consumers” to the title of the Section and added the term “retailers” in the second and third paragraph to emphasize the continuum of controls that are applied from production to consumption and in particular the role of retailers.
Section 2.6 Suitability
26. The Committee amended the third bullet to specify that management system should be based on HACCP principles. In addition, it changed “perished” to “spoiled” in the second indent of the fourth bullet for clarity purpose.
Section 3 Primary production
27. The Committee added “safety and” before “suitability” and changed “effectiveness” with “stringency” in the last paragraph of the section for clarity and consistency with the scope of the Code.
Section 3.2.3.1 Feeding
28. In recognizing that the definition of “contaminant” in the General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 4-2003), encompassed any biological or chemical agent, foreign matter or other substances not intentionally added to food which may compromise safety or suitability, the Committee deleted “ microbiological or chemical” from the first paragraph.
Section 3.2.3.3 Veterinary Drugs
29. The Committee amended the first paragraph to specifically refer to veterinary drugs authorized by the competent authority for consistency with the language used in other part of the Code. It also added a footnote to the Annex to refer that the treatment with veterinary drugs should be consistent with the Code of Practice to Minimize and Contain Antimicrobial Resistance, under development in the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF).
Section 5.1 Control of Food Hazards
30. The Committee recognized that when control measures should be designed so as to achieve a specified level of hazard control, it was too restrictive to give consideration to the establishment of Food Safety Objective only, therefore, it agreed to refer in a generic way to “FSOs and/or related objectives and criteria” and to amend, as appropriate, the rest of the Code consequentially.
31. To better highlight the specific procedures required for the implementation of the HACCP principles, the Committee divided the last paragraph of the Section into two.
Section 5.1.1 Hazard Identification; 5.1.2 Control Measure Selection
32. The Committee agreed on the following changes to align the Section with the language used in the HACCP Annex to the International Recommended Code of Practice: General Principles of Food Hygiene:
• Amended the title of Section 5.1.1 to “Hazard Identification and Evaluation”;
• Changed the second principle to refer to “the severity of its adverse health effects and reasonable likelihood of occurrence”;
33. In Section 5.1.2, the Committee agreed on the following changes:
• Amended the principle to read, “Following hazard evaluation, control measures and control measure combinations should be selected that will prevent, eliminate or reduce the hazards to acceptable levels.”
• Deleted the beginning of the second paragraph to start with “The next step…” and struck out the third paragraph.
Section 5.5 Water
34. In recognizing that in certain conditions, the source of water was not always potable but that potable water should be made available, the Committee amended the principle to read “Dairy processing establishments should have potable water available, …”.
Section 10.2 Training programs
35. For consistency with changes in section 2.4, the Committee added a reference to retail of milk in the first paragraph of the section.
Annex I – Guidelines for the Primary production of Milk
Section 3.2.3.3 Veterinary Drugs
36. The Committee inserted a footnote to the Section’s title to refer to the Code of Practice to Minimize and Contain Antimicrobial Resistance, under development in the CCRVDF.
Section 3.2.4 Hygienic milking
37. In recognizing that automatic milking is used and that foremilk from each teat contains higher number of microorganisms than the milk that is subsequently drawn by the same teat, the Committee amended the last paragraph of the Section to clarify that: the milker should check the milk of each animal for organoleptic or chemical/physical indicators; the milk that does not appear normal should not be used for human consumption; and, foremilk from each teat should be discarded or collected separately, and not used for human consumption, unless it can be shown that it does not affect the safety and suitability of the milk.
Section 3.3.2 Milk Storage Equipment
38. In the Additional Provisions for the Production of Milk Used for Raw Milk Products, the Committee changed the term whey to milk products, to make the text more comprehensive.
Section 3.4 Record Keeping
39. A last bullet was added to refer to records of equipment cleaning.
Annex II – Guidelines for the Management of Control Measures during and after Processing
Section 4 Definitions - Pasteurization
40. The Committee considered it more appropriate to refer to “pathogenic microorganisms” instead of “harmful microorganisms” to emphasize the focus on the control measures aimed at controlling hazards of public health concern.
41. The Committee agreed, in order to ensure consistency with wording used in other parts of the body of the Code, to transfer the definition of “process criteria” into part 2.5 “Definitions” of the main Code.
Section 5.1.1 Hazard Identification
42. The Committee amended the fifth paragraph to clarify that the role of the manufacture or other appropriate party was to document the conditions that specific sanitary measure are successfully applied. The sixth paragraph was amended to refer to control measures, as more appropriate term.
Section 5.2.1.2 Distribution of Finished Products – Perishable products
43. The Committee amended the first paragraph to recognize that validation might not be necessary when selected storage conditions are well established; a bullet point was added to the second paragraph to refer to product presented for retail sale.
Appendix A: Microbiostatic Control Measures
44. The Committee amended Appendix A as follows:

• In the description of pH reduction, the term “minimum pH value for preventing growth” was changed to “pH value for preventing growth” for clarity purpose;
• The example of “Pulse high-intensity light” was moved to Appendix B as typical example of microbiocidal control measure;
• The range of water activity values for preventing microorganism growth was broaden to 0.90 and 0.96 to encompass more pathogens and the reference to minimum was deleted.

45. The Delegation of Cuba while referring to CRD 32, called the attention of the Committee to the results of the most recent meeting of the FAO Global Lactoperoxidase Group of Experts, held in South Africa in February 2004. The Delegation noted that the meeting concluded that there was no scientific basis for the exclusion of milk and milk products treated by using the lactoperoxidase system from international trade.
46. In this regard, the Committee noted that the 26^th Session of the Codex Alimentarius Commission had considered this matter and endorsed the clarifications provided by the 35^th Session of the CCFH and that future consideration of this matter would depend on the availability of adequate microbiological and chemical risk assessments of process.⁷
47. The Delegation of Cuba informed the Committee that it was undertaking research on the use of lactoperoxidase system and that Cuba would provide the updated scientific information when available. In the light of the above, the Delegation reiterated their request to reconsider the exclusion of milk and milk products treated by using the lactoperoxidase system for international trade.
Appendix B: Microbiocidal Control Measures
48. The Committee agreed to refer to Centrifugation instead of Bactofugation® as the latter was a registered trade mark.
Section 1.2 Process Management
49. The Committee changed the term “process performance” to “performance criteria” as more appropriate.
50. In sub-section “Verification of process”, it amended the first paragraph to recognize that other methods than alkaline phosphatase reaction could be used to demonstrate that appropriate heat treatment has been applied to pasteurized products.
Section 2.2 Process Management
51. The Committee agreed to delete the phrase “thermal processing” in the second paragraph noting that the phrase was too limiting.
52. The Committee agreed to add a sentence to the last paragraph on “verification of process” reflecting that other methods can be used to verify the delivery of a process.
Status of the Draft Code of Hygienic Practice for Milk and Milk Products
53. The Committee forwarded the draft Code of Hygienic Practice for Milk and Milk Product to the Commission for final adoption to Step 8 (see Appendix II). It also requested the Commission to revoke the Code of Hygienic Practice for Dried Milk (CAC/RCP 31-1983), which provisions were covered by the new Code.
DISCUSSSION PAPERS ON THE MANAGEMENT OF THE WORK OF THE COMMITTEE (Agenda Item 5)
Proposed Draft Process by which the Committee on Food Hygiene could Undertake its Work in Microbiological Risk Assessment/Risk management (Agenda Item 5a) ⁸

Discussion Paper on the Development of Process, procedures and Criteria to establish Priorities for the Work of the Codex Committee on Food Hygiene (Agenda Item 5b) ⁹

Discussion Paper on the Development of Options for a Cross Committee Interaction Process (Agenda Item 5c) ¹⁰

54. As agreed during the adoption of the agenda (see para. 6), the Committee considered agenda items 5 (a), (b), and (c) on the basis of a consolidated document (CRD 2) prepared by a Working Group, which met during Sessions.
55. In introducing the document, the Delegation of the United States stated that the basic assumptions of the discussion paper were that:
• The document was an internal guide to the CCFH unless directed otherwise by Commission, and did not need to go through the Step process;
• Procedures would be consistent with the CAC umbrella procedures for the conduct of work within Codex Alimentarius;
• The document would articulate how the CCFH would implement the general procedures outlined in the CAC framework;
• The document would be available to other committees so that they are aware of the internal procedures used by the CCFH;
• Within the CCFH, the document would have the same weight as the Procedural Manual, but was limited to the internal operations of the CCFH; and,
• Procedures for cross-committee interactions would focus on how the CCFH would operate, and would not instruct other committees how they should operate.
56. The Delegation of the United States asked the Committee instructions on the general content of the document and revisions required for its further development.
57. The Committee noted that the document, once finalized by the Committee, should be included in the Procedural Manual, after endorsement by the CCGP and adoption by the Commission.
58. The Committee expressed its appreciation to the Working Group for the fast and valuable work. In noting that there had not been enough time to study the document in detail, it decided to focus its discussion on major issues to be considered by the drafting group, so as to provide general guidance, as follows:
59. The Committee agreed to delete Appendix 2 “Suggested elements to include in a microbiological risk management risk profile” and to include it in the proposed draft Principles and Guidelines for the Conduct of Microbiological Risk Management.
60. It was suggested that the document should be further simplified and shortened and that, in revising the document, the Working Group should take into account the following points:
• Written comments submitted at the Session;
• Impact on international food trade and potential regional impacts among the criteria for new work;
• Criteria for new work and prioritization should be transparent, consistent and as objective as possible;
• Weighing of the criteria (both new work and prioritization) and the need to meet more than one criteria;
• Frequency and modality of CCFH work on prioritization (e.g. every session versus every three years; during the adoption of the Agenda versus Working Group meeting; etc.);
• Consistency with proposed draft Principles and Guidelines for the Conduct of Microbiological Risk Management and explore the possibility to maintain a skeleton of the risk profile in the document;
• Focus on process rather than on product;
• Include discussion of implementation of Food Safety Objective, Performance Objective, Performance Criterion and Microbiological Criteria in the Committee’s risk management products;
• Be consistent with the Codex criteria for the establishment of work priorities.
Status of the Discussion Papers on the Management of the Work of the Committee
61. The Committee agreed to attach to this report the consolidated document, without the Appendix on Risk Profile, and to circulate it for comments (see Appendix IV). It further agreed that a working group led by the United States, with the assistance of the Australia, Canada, EC, Finland, India, Japan, the Netherlands, New Zealand, Norway, Sweden and United Kingdom will meet during the year to revise the document based on the above discussion and written comments submitted at the present Session and received in response to the Circular Letter, for circulation, comments and further discussion at its next Session.
62. The Committee agreed to hold a meeting of the working group on the Sunday immediately prior to its next Session to discuss the revised document and comments received and to present a report to the Session.
PROPOSED DRAFT PRINCIPLES AND GUIDELINES FOR THE CONDUCT OF MICROBIOLOGICAL RISK MANAGEMENT (Agenda Item 6)¹¹
63. The Committee recalled that the 35^th Session of the CCFH requested the drafting group led by France to redraft the document for circulation and consideration at the current session.
64. While introducing the document, the Delegation of France highlighted main changes made by the drafting group throughout the text and explained how the document was revised in order to accommodate guidance provided by the last session of the Committee.
65. The Delegation of France drew the attention of the Committee to the fact that further work was necessary in order to make the document more consistent with the proposed draft “Process by which the Committee on Food Hygiene could Undertake its Work in Microbiological Risk Assessment/Risk Management (Agenda Item 5a) and that there was a need to have a clear guidance from the Committee regarding Section on definitions, especially on Food Safety Objectives, Performance Objective and Performance Criterion, parts of texts that were left in square brackets especially in Section on Principles and in relation to regional differences; and to expand the chapter on implementation of microbiological risk management decisions. The Delegation also indicated that many comments presented in several CRDs could be incorporated in the text during the further elaboration of the document.
66. The Committee expressed its sincere appreciation to the Delegation of France and their drafting partners for their work. It decided to consider the document section by section focusing on major unresolved issues and to provide general guidance in the subsequent elaboration of the document.
Introduction and Scope
67. The Committee noted that the Commission had adopted at its 26^th Session Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius, which provided guidance in the framework of Codex so that food safety and health aspects of Codex standards and related texts be based on risk analysis.
68. It was proposed to clarify the Scope and better define whether the document was applicable to the Codex or to member governments. In this regard, it was pointed out that in the document it was already stated that it was applicable to Codex and to member governments however it was necessary to clarify in each relevant section what was applicable to member governments or to Codex or to both.
69. Several delegations were of the view that the Committee should not wait until the Committee on General Principles finalize the document on Working Principles for Risk Analysis for Application by governments and suggested to proceed with the elaboration of the Principles and Guidelines for the Conduct of Microbiological Risk Management applicable to both governments and Codex as this guidance was urgently needed. However, one delegation was of the view that this document should be prepared for application by Codex only.
70. While considering this matter, the Committee also noted the request of the 26^th Session of the Commission that relevant Committees develop or complete specific guidelines on risk analysis in their respective areas, for inclusion in the Procedural Manual. In this regard, it agreed to report to the Commission that the Committee:
• Had developed the Principles and Guidelines for the Conduct of Microbiological Risk Assessment (CAC/GL-30, 1999) document, which provided guidance on microbiological risk assessment for microbiological hazards in foods. The document was written with the aim of providing advice to member governments and to the Codex;
• Was currently developing the Principles and Guidelines for the Conduct of Microbiological Risk Management addressing issues that would be relevant to both member governments and to the Codex.
71. The Committee noted that both these documents covered many aspects of communication including between risk assessors and risk managers in ways that were relevant both to member governments and Codex.
72. The Committee requested the Commission’s advice whether this course of action was consistent with the Commission’s expectations.
73. Some delegations pointed out that there was an urgent need to proceed with the elaboration of the Principles and Guidelines for the Conduct of Microbiological Risk Management as the concept of FSOs which was included in the Guidelines was already introduced in other Codex documents and that delay in the consideration might have a negative impact in their further development.
74. The Committee agreed to continue work on the document. It requested the drafting group to articulate more clearly the applicability of the document in the Scope and better describe how different provisions could be applied by the Codex and/or by member governments in subsequent sections of the document.
Definitions
75. The Committee had a lengthy debate regarding the definition of Food Safety Objectives (FSOs). Several delegations were of the view that this definition should be limited to microbiological hazards only as it was within the purview of the document while others were of the opinion that FSOs should not be limited only to microbiological hazards as the broader concept of FSO include chemical, physical hazards, and that this was already introduced in other Codex documents under development, such as the draft Code of Hygienic Practice for Milk and Milk Products (see para. 17).
76. The Committee considered several amendments to the definitions and ways to proceed. After an extensive exchange of views, the Committee agreed to the proposals of a Working Group, which was convened during the Session, and agreed on broader definitions of FSOs, Performance Objective (PO) and Performance Criterion (PC) that apply to all types of hazards.
77. Some delegations were of the opinions that the definition of risk managers was too restrictive and not consistent with Principle 3, which stated that industry had the responsibility for producing a safe food. It was suggested that the drafting group discuss this definition and its use throughout the text.
Section 2 General Principles
78. Recognizing that limited time was available for discussion of the document, the following major suggestions were made:
• to amend the first sentence of Principle 2 to read: “The microbiological safety of food is typically assured by an integration of controls in primary production, product design and processing, and the application of good hygienic practice and safe handling, during the manufacturing, labeling, distribution, storage, retail and preparation, such that the desired level of risk management is achieved”;
• to consider Principle 3 in order to better reflect that not only industry but other stakeholders within the food chain have food safety responsibilities;
• to modify the first part of Principle 5 to emphasize that the whole process and not only the basis for decisions, should be transparent and communicated.
79. Different views were expressed in relation to Principle 6 on the dual roles of Risk Assessors and Risk Managers, especially in small or developing countries; however, it was pointed out that, irrespective of whether the roles were separated or combined, the scientific integrity and unbiased nature of the process should always be retained. It was further noted that explanatory text associated with this principle need to be consistent with that which appears in equivalent text in the General Principles and Guidelines for the Conduct of Microbiological Risk Assessment (CAC/GL 30-1999).
80. It was proposed to provide a more clear explanation on issues of general and specific applicability in Principle 7 and to take into account the reports of Kiel consultations¹² for basis in further elaboration of this Principle.
Section 5 Preliminary Microbiological Risk Management Activities
81. It was noted that the concept of regional differences in relation to certain pathogens had been acknowledged by the Committee. Therefore, it was proposed to add a new principle to this effect to read: “In the interest of safeguarding human health and minimizing the incidence of food-borne diseases, the existence of regional differences in the prevalence and level of various pathogens in the food chain should be recognized and taken into account in the Microbiological Risk Management process” and it was suggested that the remaining text on regional differences could be deleted.
82. It was also indicated that there was a need to further clarify and articulate the concept on regional differences.
83. As draft Principle 5 envisaged stakeholders’ involvement in the MRM policy, it was suggested that greater emphasis on this, especially in Sections 5 though 8, be given.
Section 6.2.2
84. Different views were expressed on the need to incorporate the aspects of shelf-life in the document and one Delegation suggested that because of this concept and the complexity of the subject, the Committee consider new work in this area.
Section 7 Selection of MRM options and implementation of MRM decisions
85. It was suggested to provide clearer separation and explanation in the Section on various options for risk management decisions and to simplify the flow chart on the overall framework for managing food-borne risks.
Status of the Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management
86. The Committee noted that the CCGP had referred the matter of definitions of FSOs to the relevant committees for consideration regarding their applications to specific food safety issues.
87. The Committee agreed to forward the definitions on Food Safety Objective, Performance Objective and Performance Criterion to the Committee on General Principles for endorsement and subsequent adoption by the Commission, with the understanding that these definitions would be included in the Procedural Manual (see Appendix III).
88. The Committee also agreed to return the Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management to Step 2 for revision by the drafting group led by France, with assistance of Argentina, Australia, Austria, Belgium, Canada, China, EC, Denmark, Finland, Germany, Hungary, India, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Sweden, the United Kingdom, the United States, ICMSF and IDF taking into account written comments submitted and the above discussion. The Committee noted that there was a need for the drafting group to meet physically and accepted the kind offer of the Delegation of the EC to provide the venue and facilities for the drafting group meeting. The revised document prepared by the drafting group will be circulated for comments at Step 3 before the next session of the Committee.
89. The Committee also agreed that a Working Group would be convened on the Saturday before the next session of the CCFH to review the comments received and, if appropriate to prepare a revised version of the Principles and Guidelines for consideration by the Committee.
90. The Committee noted that numerous comments of various nature were presented in CX/FH 04/6-Add.1 and in CRDs and therefore requested the drafting group to take them into account in further elaboration of the document.
PROPOSED DRAFT GUIDELINES ON THE APPLICATION OF GENERAL PRINCIPLES OF FOOD HYGIENE TO THE [MANAGEMENT] OF LISTERIA MONOCYTOGENES IN FOODS (Agenda Item 7)¹³
91. The 35^th Session of the CCFH agreed that a drafting group led by Germany would revise the proposed draft Guidelines at Step 2 for circulation, comments and further consideration at its next Session.¹⁴
92. The Delegation of Germany introduced the proposed draft Guidelines and informed the Committee about major discussions and numerous changes made by the drafting group.
93. The Committee decided not to discuss the proposed draft Guidelines in detail and focused its discussions on major issues to be considered by the drafting group, so as to provide general guidance to the drafting group, as follows:
General Comments:
94. The Committee thanked Germany and the drafting group for its work on the document and emphasized the practical information and guidance it provided in controlling Listeria in foods. Due to the scope of the document, it was suggested to revise the title of the document to “Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria monocytogenes in Ready-to-Eat Foods”. It was also suggested that the Scope should focus on Ready-to-Eat Foods that support the growth of Listeria monocytogenes.
Specific Comments:

Section 5. Control of Operation

95. It was suggested to refer to the reduction of the occurrence of Listeria monocytogenes in food instead of minimizing the risk of listeriosis.

Section 5.2.3 Microbiological and other specifications

96. Due to the decision reached on the definitions of Food Safety Objective (FSO), Performance Objective, and Performance Criterion (see paras. 75-76), it was agreed to initiate work on the establishment of FSOs and related performance objective and performance criteria, including microbiological criteria, and to include this information in an Annex to the Guidelines. The concepts included in the Principles and Guidelines for the Conduct of Microbiological Risk Management (CX/FH 04/6) should be applied in this Annex. In this regard, it was noted that the report of the FAO/WHO Expert Consultation on Risk Assessment of L. monocytogenes in Ready-to-Eat Food (to be published shortly) would provide data for this work. In order not to delay the further development of the Guidelines, it was agreed to proceed on the parallel development of the main guideline document and the Annex.

Section 9. Product Information and Consumer and Industry Awareness

97. It was suggested to consider the wording related to the provision of information to health care providers from the boxed area of the scope and to add wording on the need to validate information and consumer awareness programs to ensure that they are understandable and useful in guiding their target audience to make appropriate choices.

Section 9.1. Communication Programs

98. It was suggested to delete the wording concerning the programs to provide guidance for health care providers that facilitate rapid diagnosis of foodborne listeriosis as outside the scope of the Guidelines.

Section 9.2. Labelling

99. It was noted that it was more appropriate to refer to “ready-to-eat food” instead of “ready-to-eat raw foods”.
Status of the Proposed Draft Guidelines on the Application of General Principles of Food Hygiene to the [Management] of Listeria monocytogenes in Foods
100. The Committee returned the proposed draft Guidelines to Step 2 and agreed that a drafting group led by Germany with the assistance of Austria, Canada, China, Denmark, EC, Finland, France, Greece, Hungary, Italy, Japan, Norway, the United Kingdom, Uruguay, the United States of America, ICMSF, IDF and IFT would revise the proposed draft Guidelines based on the written comments received and the above discussion for circulation, comments at Step 3 and further consideration at its next Session. In addition, it agreed that a sub-group of the drafting group with the participation of the above listed countries and organizations plus Sweden, Switzerland, FAO and WHO would prepare an Annex to the Guidelines on the establishment of FSOs and related performance objective and performance criteria, including microbiological criteria for Listeria monocytogenes in Ready-to-Eat Foods for circulation, comments and further consideration at its next Session. The Committee noted the offer of FAO/WHO to make available experts to assist the sub-group in this work.
PROPOSED DRAFT REVISION OF THE CODE OF HYGIENIC PRACTICE FOR EGG PRODUCTS (Agenda Item 8)¹⁵
101. The 35th Session of the CCFH returned the proposed draft Revision of the Code of Hygienic Practice for Eggs and Egg Products to Step 2 for revision by the drafting group led by Australia, for additional comment and further consideration at its next session¹⁶.
102. In presenting the document, the Delegation of Australia noted that there was still a need for more information and guidance by the Committee on the structure, content and level of detail of the Code and on the nature of processing technologies to be incorporated.
103. The Committee generally supported the work of the drafting group in the further development of the Code and with the approach covering the whole food chain and the improved structure. However, it recognised the need for further elaboration. Therefore, the Committee decided not to discuss the proposed draft revised Code in detail and focused its discussions on matters to be considered by the drafting group so as to provide general guidance.
104. In addition to the written comments, it was suggested to further consider the Definitions, to provide practical guidance on Primary Production, to obtain more information on processing technologies and to consider the inclusion of that information, and to expand the Section on Product Information and Consumer Awareness to include more information on the safe handling and cooking of eggs in the home.
105. To assist in the preparation of the revised Code, the Committee agreed to request through a Circular Letter information on: processing of egg products, including emerging technologies; pasteurisation of eggs and egg products; hygienic provisions related to processing of egg and egg products; advice on the safe use and handling of eggs with particular focus on vulnerable groups; clarification of definitions, including collection and handling, grading and cleaning. The importance of responding to CL in good time in assisting drafting group was emphasized.
Status of the Proposed Draft Revision of the Code of Hygienic Practice for Eggs and Egg Products
106. The Committee agreed that the drafting group led by the Australia with the assistance of Argentina, Belgium, Canada, EC, Hungary, India, the Netherlands, New Zealand, Spain, Sweden, Switzerland, the United Kingdom, the United States of America, and ALA, would revise the proposed draft revised Code. The Committee agreed that the Code would be revised at Step 2 based on the above discussions and written comments submitted at the current meeting and submitted in response to the Circular Letter, for circulation, comments at Step 3 and further consideration at its next Session.
PROPOSED DRAFT GUIDELINES FOR THE VALIDATION OF FOOD HYGIENE CONTROL MEASURES (Agenda Item 9)¹⁷
107. The 35^th Session of the CCFH returned the proposed draft Guidelines for the Validation of Food Hygiene Control Measures to Step 2 for revision by the drafting group led by the United States for circulation, additional comment and further consideration at the current meeting.¹⁸
108. The Delegation of the United States introduced the proposed draft Guidelines and informed the Committee about major discussions and numerous changes made by the electronic drafting group.
109. The Committee decided not to discuss the proposed draft Guidelines in detail and focused its discussions on major issues to be considered by the drafting group, so as to provide general guidance, as follows:

General Comments

110. The Committee expressed appreciation for the significant progress done by the drafting group in the preparation of the document and for the general approach of the document. It was suggested: to further explore the relationship of validation with respect to good hygienic practice, HACCP and Risk Assessment; to consider validation in the context of equivalency; to clarify the respective roles of industry and the competent authority in validation and verification; to simplify the document to facilitate its application in smaller and less developed businesses; to consider whether the document could be presented as a stand-alone document or an attachment/annex to another document on food hygiene; and to clarify the relationship between these guidelines and other similar documents developed or under development by other organizations and, in particular with the draft ISO 22000 Food Safety Management Standard. The Delegation of the United States noted that ISO should align itself with Codex rather than other way around.
111. With regard to the ISO 22000, the Committee was informed of the decision of the 53^rd Session of the Executive Committee (February 2004) that the Codex Secretariat establish preliminary contact with the International Organization for Standardization (ISO) to obtain information on the current status of food safety-related work within the ISO and present its findings to the 54^th Session of the Executive Committee, together with the implications to the work being undertaken by Codex.¹⁹

Specific Comments on the Sections

Section II. Scope
112. It was suggested to broaden the scope of the document to include all types of validation, including validation of control measures and to clarify the roles and responsibility of the competent authority and the industry in validation.
Section III. Definitions
113. The Committee noted that “Food Safety Control System” was the only new definition contained in the document, while the other definitions were taken from other Codex texts (i.e. Control Measure, Monitoring, Validation, Verification) and from the WTO SPS Agreement (i.e. Appropriate Level of Protection - ALOP).
114. It was suggested: to develop a definition of “validation” that could be applied to the work of other Codex Committees for inclusion in the Codex Procedural Manual and to consider the development of definition of “validation” consistent with the ISO definition; to develop a definition of “validation of control measures”.
Section IV. Nature of Control Measures
115. It was suggested: to clarify the term “food animals” in the second bullet of “Controlling initial levels of hazard(s)”; to be more specific when referring to environmental control and to keep the document within the Codex mandate; and, to remove the examples in the second bullet of “Reducing the level of hazard(s)” as they were inappropriate.
Section V. Concept and Nature of Validation
116. In noting the difficulties in validating good agricultural practices, good hygiene practices etc, it was suggested to consider the degree to which different types of control measures can be validated.

Validation vs. Verification and Monitoring

117. It was suggested to add appropriate examples for verification and monitoring and to include a separate heading emphasizing the importance that Governments establish Food Safety Objectives, (FSOs) and Performance Objectives (POs) as far as possible in order to facilitate the evaluation of the effectiveness of Food Safety Control Systems.
Relationship of HACCP to the Appropriate Level of Protection
118. It was suggested: to revise the relation between ALOP and validation; to reconsider the subsection in the light of the revised definitions of Food Safety Objective (FSO) and Performance Objective (PO) (see paras. 75-76); to consider validation in the context of equivalency; to change the terms “broad public health goals” to “identified risks” as ALOP under the SPS agreement refer to protection against an identified risk; and, to modify the first example to read “reasonable assurance of no harm”.
Relationship of HACCP to Validation of Food Hygiene Control Measures
119. It was suggested to further clarify the link between HACCP principles and validation of the management measures and to stress that the pertinence and efficacy of the HACCP plans in terms of food safety should be validated by the industry, on a scientific basis, without prejudice of the individual management measures or of the set of management measures combinations.
Section VI. Steps prior to Validation
120. It was suggested to add a new paragraph on the evaluation of technical and administrative feasibility and cost implications and their relationship to ALOP.
Section VII. Design of Food Safety Control Systems
121. It was suggested to clarify the different types of validation required in various food safety control systems (e.g. single system, combined system, entire food safety control system).
Section VIII. Approach to Validation
122. In noting that in the second paragraph it was indicated that in some cases on-farm practices would be essential food hygiene control measures and will need to be validated, it was suggested to explicitly name which on-farm practices include essential food hygiene control measures to be validated in order to avoid any misinterpretations.
Section IX. Limitations to Validation
123. It was suggested: in the first paragraph, to use a more specific and practical approach when referring to the incorporation of significant safety factors into the control measures established for the product; in the second bullet, to indicate that it is necessary to validate that the observed gap does not exceed the pre-established levels; and, to modify the last bullet to read: “Lack of technical expertise and information: lack of technical expertise and information can also be a limitation to validation in case of small scale producer/manufactures, especially in the developing countries. Necessary assistance should be provided by national and international organizations.”
124. It was also suggested to add a new bullet to address the need for validation of control measures that lie beyond the responsibility of the producers or processors and the means (e.g. statistical studies using time/temperature monitoring devises) required to validate them.
Status of the Proposed draft Guidelines for the Validation of Food Hygiene Control Measures
125. The Committee returned the draft Guidelines to Step 2. It agreed that a drafting group led by United States, with the assistance of Argentina, Australia, Canada, France, Germany, New Zealand, Norway, Peru, Spain, Sweden, Thailand, Uruguay, ICMSF, IDF and IFEH, would revise the proposed draft Guidelines on the basis of the written comments submitted at the current Session and the above suggestions for circulation, comment at Step 3 and further consideration at the next session of the Committee.
REPORTS OF THE AD HOC FAO/WHO EXPERT CONSULTATIONS ON RISK ASSESSMENT OF MICROBIOLOGICAL HAZARDS IN FOODS AND RELATED MATTERS (Agenda Item 10)²⁰
126. The Representative of FAO provided the Committee with an update of the microbiological risk assessment activities undertaken by FAO and WHO. The Committee was reminded that the risk assessments on Salmonella in eggs and broiler chickens and Listeria monocytogenes in ready-to-eat foods had now been completed. Further work had been undertaken on the risk assessment on Campylobacter spp. in broiler chickens and five different scenarios were evaluated to allow a comparison of general and specific risk reduction strategies. The Committee was also informed that progress had been made on the risk assessments on Vibrio spp. in seafood that should facilitate the discussion of this issue at the Committee’s next Session.
127. The Representative of FAO requested the Committee to consider the utility of this work in the development of risk management guidance and highlighted the need for further guidance from the Committee in terms of undertaking risk assessment work on enterohemorrhagic Escherichia coli.
GENERAL CONSIDERATION OF THE RISK MANAGEMENT PAPERS
128. The Delegation of New Zealand strongly supported the microbiological risk management work of the Committee but noted that the manner in which the outcomes of the microbiological risk assessment activities of FAO and WHO could be best used in the development of risk management guidance by the Committee was yet to be determined. The Committee agreed that a decision needed to be made concerning the format of risk management guidance documents that the Committee wanted to develop, taking into consideration its work in other areas including the elaboration of “Principles and Guidelines for the Conduct of Microbiological Risk Management”.
129. Several delegations noted that the division of risk management tasks between this and other committees had to be considered to avoid duplication of work and ensure that the work of this Committee provided the specialized risk management guidance that was needed to address current and future food safety concerns. The Committee agreed that the working groups would consider existing codes and guidance documents to avoid duplication.
130. The Committee considered two model formats for risk management guidance documents:
• The Recommended International Code of Practice: General Principles of Food Hygiene together with Annexes. Such annexes could include information on risk management options, expanded consideration of primary production issues, etc.
• The format for a microbiological risk management guidance document as outlined in Appendix II of the “Discussion Paper on the Management of the Work of the Committee”, which was available to the Committee as CRD 2.
131. Several delegations expressed reservations regarding the applicability of the Recommended International Code of Practice: General Principles of Food Hygiene as a model for the further development of these risk management papers indicating that it did not adequately reflect new developments in the area of microbiological risk management and risk based approaches, which linked management strategies with a reduction in the burden of food borne disease. Other delegations were of the opinion that this was a workable approach but that in using this approach certain issues would require special attention. In particular, consideration of how such guidance would fit in with HACCP and guidance to competent authorities on the implementation of these risk management documents would be needed.
132. The Delegation of Germany reminded the Committee of the positive experience of the Listeria Working Group in using the International Recommended Code of Practice – General Principles of Food Hygiene approach to advance the work on developing guidance for the control of Listeria monocytogenes. The Delegation highlighted the flexibility of this approach and indicated that the inclusion of annexes enabled the consideration of risk based management options. The Delegation also cautioned the Committee that the Working Group had previously tried to use the alternative format under consideration and found it was not practical.
133. This link between the development of these management documents and the “Discussion Paper on the Management of the Work of the Committee” was noted. It was highlighted that this discussion paper was defining the way in which the Committee would work in the future and in developing management documents on these pathogen commodity combinations the Committee should begin moving in that direction. It was also suggested that developing risk management guidance documents for pathogen-commodity combinations according to this new process would give the Committee useful experience for the optimisation of the format of future risk management guidance documents.
134. Although there were some suggestions to postpone further development of the pathogen commodity risk management papers until the new format for risk management guidance documents was further clarified next year, it was noted that the significance of these pathogens in terms of food safety was considerable and therefore the Committee decided to continue to progress these documents in the coming year.
135. As there was no clear consensus as to the type of risk management guidance documents to develop and considering that the new format for such documents to be developed by the Committee was still being elaborated, it was decided that the most useful way for the Committee to proceed would be to develop two types of risk management guidance documents – one based on the international code of practice and the other based on the draft format for risk management guidance documents, presented to the Committee in CRD2. The Committee was of the opinion that this would allow it to better evaluate each approach at its next session while at the same time proceeding with the work on these pathogen-commodity combinations of concern.
136. The Committee noted that the development of risk management guidance documents on these pathogen/commodity combinations had not yet been approved as new work by the Commission. In order to submit these as proposals for new work, the Committee would need to complete project documents for consideration by the Executive Committee. It was agreed that these documents would also be prepared by the Working Groups for submission by the next session of the Committee.
137. The Committee agreed that the risk profile of Vibrio spp. in seafood would be put on the agenda of its next Session in order to discuss how the risk management work on that issue should proceed.
DISCUSSION PAPER ON RISK MANAGEMENT STRATEGIES FOR CAMPLYOBACTER SPP. IN POULTRY (Agenda Item 10a)²¹
138. The Delegation of the Netherlands introduced this discussion paper and indicated that it had been further refined since the 35^th session of the CCFH. In particular the working group had focussed on the identification of risk management options and included some new concepts to approaching risk reduction. The Committee was reminded that its 35^th session had not made any specific recommendations with regard to the format of the document and in order to progress this work further the Committee should now provide the working group with clear guidance on the format of the document.
Status of the Discussion Paper on Risk Management Strategies for Campylobacter spp. in Poultry
139. The Committee agreed that the drafting group led by the Netherlands, with the assistance of Australia, Belgium, Canada, China, Denmark, EC, Finland, Japan, the Netherlands, New Zealand, Norway, Philippines, Sweden Thailand, the United Kingdom, the United States of America, and ALA would progress with the development of this paper in the microbiological risk management guidance document format presented in CRD 2. In order to reflect this it was decided to change the title to “Discussion Paper on Guidelines for Microbiological Risk Management Options for Campylobacter in Broiler Chickens”.
DISCUSSION PAPER ON THE RISK PROFILE FOR ENTEROHEMORRHAGIC ESCHERICHIA COLI (EHEC) INCLUDING THE IDENTIFICATION OF THE COMMODITIES OF CONCERN INCLUDING SPROUTS, GROUND BEEF AND PORK (Agenda Item 10b)²²
140. The Delegation of the United States introduced this discussion paper and expressed its appreciation to their drafting partners for their assistance in its preparation. Following the request of the 35^th CCFH, additional information had been solicited by Circular Letter on the top five serotypes of human EHEC isolates, the top five commodities of concern and animal husbandry practices that should be included in the risk profile. The discussion paper had been updated accordingly. The Delegation of the United States informed the Committee that in order to proceed with this work clear guidance was needed as to the format of the risk management document to be developed and the specific food commodity to be considered.
141. Based on the risk profile the Delegation of the United States proposed that future work focus on ground beef. The similarity, at least with respect to the ingredients, of fermented sausage to ground beef was noted and the drafting group was requested to also consider this commodity. The representative of WHO noted that the biggest outbreak of food borne illness caused by EHEC was linked to sprouts and cautioned the Committee against limiting its work to one commodity only.
142. The Committee noted that the risk profile was a good starting point to begin risk management work on EHEC but observed that several gaps still needed to be addressed. They welcomed the global approach taken in the risk profile discussion paper and highlighted the importance of primary production in the development of risk management guidance.
143. The Committee noted that no risk assessment had yet been undertaken for this pathogen and suggested this could be the next step.
Status of the Discussion Paper on Risk Management Strategies for Enterohemorrhagic Escherichia coli
144. The Committee agreed that the drafting group led by the United States, with the assistance of Austria, Australia, Canada, China, EC, France, Germany, Japan, the Netherlands, New Zealand and Sweden would progress with the development of this paper in the format of the Recommended International Code of Practice: General Principles of Food Hygiene together with an Annex. The Committee agreed that the Working Group would take a systematic approach to reviewing the available information and, according to the type of risk management document to be developed, identify very specific questions for any necessary risk assessment work or specific scientific advice. It also agreed to change the title to “Discussion Paper on Guidelines for the Application of the General Principles of Food Hygiene to the Risk Based Control of Enterohemorrhagic Escherichia coli in Ground Beef and Fermented Sausages”.
DISCUSSION PAPER ON RISK MANAGEMENT STRATEGIES FOR SALMONELLA IN POULTRY (Agenda Item 10c)²³
145. In introducing this discussion paper the Delegation of Sweden informed the Committee that it had been revised taking into consideration information received from members as a result of a Circular Letter. A literature survey was also undertaken and relevant information incorporated into the discussion paper. The Delegation of Sweden requested clear guidance from the Committee on whether and how to proceed and also on the final format to be used for the document.
Status of the Discussion Paper on Risk Management Strategies for Salmonella in Poultry
146. The Committee agreed that the drafting group led by Sweden, with the assistance of Australia, Canada, China, Czech Republic, Denmark, EC, France, Germany, the Netherlands, New Zealand, Thailand, the United States of America, and ALA would progress with the development of this paper in the format of the Recommended International Code of Practice: General Principles of Food Hygiene together with Annexes as may be appropriate. In order to reflect this it was decided to change the title to “Discussion Paper on Guidelines for the Application of the General Principles of Food Hygiene to the Risk Based Control of Salmonella in Broiler Chickens”.
147. The Committee noted that particular consideration needed to be given to primary production and that if necessary this could be addressed in an Annex.
148. The Committee noted numerous comments were submitted in CX/FH 04/10-Add.3 and in CRDs and requested the drafting group to take them into account in further development of document.
DISCUSSION PAPER ON THE PROPOSED DRAFT REVISION OF THE RECOMMENDED INTERNATIONAL CODE OF PRACTICE FOR FOODS FOR INFANTS AND CHILDREN (Agenda Item 11)²⁴
Joint FAO/WHO Meeting on Enterobacter sakazakii and other Microorganisms in Powdered Infant Formula [Agenda Item 11 (a)]²⁵
149. At the 35^th session of the CCFH, the Committee agreed to revise the Recommended International Code of Hygienic Practice for Foods for Infants and Children, particularly for dried infant formula. The Committee also agreed that the United States would update the Risk Profile of Enterobacter sakazakii in Powdered Infant Formula. In addition, FAO and WHO were requested to convene an expert consultation on the Enterobacter genus, including E. sakazakii, and Clostridium botulinum, which was held in February 2004.²⁶
150. The Delegation of Canada presented the discussion paper and requested the Committee to provide comments on the suggested structure and the content and invited delegations to propose additional inclusions for updating the Code.
151. The Representative of the WHO informed the Committee about the FAO/WHO Meeting on Enterobacter sakazakii and other microorganisms in powdered infant formula and introduced the key outcomes of this meeting. He urged the Committee to expedite its work on this issue. It was proposed to revise the current microbiological criteria and to elaborate specific criteria for E. sakazakii in the light of the recommendations of the above meeting. It was also suggested that the revision on criteria should progress as fast as possible.
152. During the Committee’s discussion the following issues were emphasized:
• the need to take into consideration the range of microorganisms of concern including the availability of appropriate microbiological methods;
• the need to control the safety of infant formula by applying control measures during production and during and after reconstitution;
• the need to identify and define high risk infant populations;
• the necessity to provide more specific guidance for hospitals, day-care centres, food handlers, and caregivers for infants;
• the development of specific information and/or recommendations on the labeling regarding the preparation, use, and handling of powdered infant formula for users;
• the need for realistic expectations about implementation of controls that depends on consumer behavior;
• the necessity to take into account the situation in developing countries (e.g. availability of boiling water and refrigerators for keeping bottles with reconstituted milk);
• to carefully consider the use of commercially sterile liquid infant formula with regard to microbiological aspects and secondary recontamination;
• to consider other foods for infants that contain powdered infant formula (e.g. foods containing both cereals and powdered infant formula).
153. The Representative from FAO informed the Committee that the framework for a more extensive risk assessment model had been developed and could be further elaborated to facilitate the revision of the Code. The Committee agreed that this would be useful and requested JEMRA to further develop the model.
154. The Committee agreed that a working group, lead by Canada, with assistance of Belgium, EC, France, Germany, Italy, Japan, the Netherlands, Spain, Switzerland, the United Kingdom, the United States of America, Uruguay, FAO/WHO, IBFAN, ICMSF and IDF to proceed with the revision of the International Code of Hygienic Practice for Foods for Infants and Children and development of microbiological criteria on E. sakazakii and other relevant microorganisms. The Committee agreed to proceed with this work as quickly as possible.
PROPOSED DRAFT GUIDELINES FOR THE REUSE OF PROCESSING WATER IN FOOD PLANTS (Agenda Item 12)²⁷
DISCUSSION PAPER ON THE PROPOSED DRAFT GUIDELINES FOR EVALUATING OBJECTIONABLE MATTER IN FOOD (Agenda Item 13)²⁸
155. The Committee noted that at its 34^th Session it had agreed that in view of its heavy workload and the need to prioritise work, it decided to discontinue the consideration of the above Agenda Items for the time being, with the understanding that this decision would be reviewed at its 36^th Session.
156. Due to the long Agenda and the fact that procedures for prioritization of the work of the Committee were not yet in place, the Committee agreed with the proposal of the Chairperson and deferred consideration of these Agenda Items and to consider these two items again when the Committee had established its procedures for acceptance and prioritization of work.
157. Some delegations, while not opposing to this decision, pointed out that the Guidelines on Water Reuse deserved particular attention.
OTHER BUSINESS AND FUTURE WORK (Agenda Item 14)
OTHER BUSINESS
Active chlorine
158. The Committee agreed that a drafting group lead by Canada with assistance of Austria, Denmark, EC, France, Ireland, Japan, Republic of Korea, the Netherlands, the United States of America and IDF would prepare draft terms of reference for the FAO/WHO Expert Consultation on the uses of active chlorine which would include safety/benefit issues and prepare questions within its terms of reference of the Committee.
Antimicrobial resistance
159. The Committee noted the information of the Representative of WHO on this matter and suggested the Commission to take into account the outcome of the FAO/WHO/OIE consultative process in the deliberation of a future policy for Codex work in the area of antimicrobial resistance. In particular, the Committee supported the establishment of a Codex/OIE Task Force to develop broad risk management options for antimicrobial resistance related to non-human use of antimicrobials. In doing this, efficient interaction between this Task Force and the CCFH and relevant Codex committees should be ensured.
Viruses in food
160. The Committee agreed with the proposal of the Delegation of the Netherlands to put the discussion paper on Viruses in Food, which had been considered at the 32^nd session of the CCFH, on the list of activities for consideration regarding prioritization.
DATE AND PLACE OF THE NEXT SESSION (Agenda Item 15)
161. The Committee noted the kind offer of the Delegation of Argentina to co-host the 37^th Session of the CCFH, tentatively scheduled from 14 to 19 March 2005, subject to confirmation by the host Governments and the Codex Secretariat.
SUMMARY STATUS OF WORK

¹ CRD 10 (EC Annotated Agenda).

² CX/FH 04/1.

³ CX/FH 04/2; CRD 11(Report of the FAO/WHO Workshop on the Provisions of Scientific Advice to Codex and Member Countries); CRD 12 (Matters Referred by the Codex Alimentarius Commission and/or Other Codex Committees).

⁴ ALINORM 04/27/18, Appendix V; Comments submitted by India (CRD 22) and Indonesia (CRD 29).

⁵ ALINORM 04/27/18, Appendix II; Comments submitted by Indonesia (CRD 29).

⁶ ALINORM 03/13A, Appendix III; Comments submitted by Australia, Brazil, Canada, Egypt, Mexico, New Zealand, Switzerland, Uruguay, IDF (CX/FH 04/4), Argentina, Thailand (CX/FH 04/4-Add.1), EC (CRD 14), India (CRD 23), Indonesia (CRD 31) and Cuba (CRD 32).

⁷ ALINORM 03/41, paras. 221-222.

⁸ CX/FH 04/5; Comments submitted by Argentina, Canada, Ghana (CX/FH 04/5-Add.1), EC (CRD 15), Indonesia (CRD 33) and Peru (CRD 40).

⁹ CX/FH 04/5-Add.2; Comments submitted by EC (CRD 15) and Indonesia (CRD 33).

¹⁰ CX/FH 04/5-Add.3; Comments submitted by USA (CRD 8) and India (CRD 24).

¹¹ CX/FH 04/6; Comments submitted by Mexico, United States of America, IDF (CX/FH 04/6, Add. 1); Switzerland (CRD 7); ICMSF (CRD 13); EC, Thailand (CRD 16), India (CRD 30), Indonesia (CRD 34), Argentina (CRD 37) and Peru (CRD 39).

¹² The Interaction between Assessors and Managers of Microbiological Hazards in Food, Report of a WHO Expert Consultation, Kiel, Germany, 21-23 March 2000 and Principles and Guidelines for Incorporating Microbiological Risk Assessment in the Development of Food Safety Standards, Guidelines and Related Texts, Report of a Joint FAO/WHO Consultation, Kiel, Germany, 18-22 March 2002.

¹³ CX/FH 04/7; Comments submitted by Canada, United States of America (CX/FH 047-Add. 1), EC (CRD 17), Peru (CRD 45) and Brazil (CRD 47).

¹⁴ ALINORM 03/13A, para. 109.

¹⁵ CX/FH 04/8; Comments submitted by Argentina, Canada, Colombia, Iran, Mexico, USA (CX/FH 04/8-Add. 1), EC, Thailand (CRD 3), India (CRD 25), Indonesia (CRD 35) and Peru (CRD 41).

¹⁶ ALINORM 03/13A, para. 156.

¹⁷ CX/FH 04/9; Comments submitted by Ghana, Iran, Mexico (CX/FH 04/9, Add. 1), Switzerland (CRD 7), EC, Thailand (CRD 18), India (CRD 26), Peru (CRD 43) and Brazil (CRD 46).

¹⁸ ALINORM 03/13A, para. 164.

¹⁹ ALINORM 04/27/3, para. 99.

²⁰ CX/FH 04/10.

²¹ CX/FH 04/10 – Add. 1,CRD 1 (Additional information submitted by the Netherlands and its drafting partners); Comments submitted by EC (CRD 19).

²² CX/FH 04/10-Add. 2

²³ CX/FH 04/10-Add.3; Comments submitted by Australia, Thailand, Mexico (CRD 5), EC (CRD 20), India (CRD 27), Indonesia (CRD 36) and Peru (CRD 38).

²⁴ CX/FH 04/11; Comments submitted by EC (CRD 4) and India (CRD 28).

²⁵ CX/FH 04/12; CX/FH 04/12-Add.1; Comments submitted by ESPHAN (CRD 6).

²⁶ CX/FH 03/13, paras. 172-173.

²⁷ CX/FH 01/9; CX/FH 01/9-Add.1; Comments submitted by Switzerland (CRD 7), EC (CRD 21), India (CRD 28) and Peru (CRD 42).

²⁸ Comments submitted by India (CRD 28).