INTRODUCTION AND OPENING OF THE SESSION (Agenda Item 1)
1. The 28th Session of the Codex Committee on Food Additives and Contaminants was held in Manila, the Philippines from 18–22 March 1996 at the kind invitation of the Governments of the Netherlands and the Philippines. Mr. Hans van der Kooi, Netherlands Department of Agriculture, Nature Management and Fisheries chaired the meeting. The meeting was attended by 145 delegates representing 35 member nations of the Commission and by 44 persons representing 31 international organizations.
2. Remarks were made by Mr. Eric T.J.T. Kwint, Ambassador of the Netherlands to the Philippines; Mr. V. Sibal, FAO Representative to the Philippines; Mr. A. Basaran, Regional Adviser in Environmental Health, WHO; and, Ms. M.R. Castillo, Assistant Secretary, Philippines Department of Agriculture.
3. Mr. M.M. Lantin, keynote speaker and Undersecretary, Philippines Department of Agriculture, stressed the importance and interest of the work of Codex to developing countries, especially in the context of the World Trade Organization Agreements related to the quality and safety of foods. Mr. Lantin noted the importance of harmonized international standards to increase market access. He expressed his deep gratitude to the Government of the Netherlands for its willingness to hold the 28th Session in Manila.
ADOPTION OF THE AGENDA1 (Agenda Item 2)
4. The Committee adopted the Provisional Agenda as proposed. The Committee agreed to hold informal Working Groups to discuss proposed amendments to the International Numbering System, Proposals for the Priority Evaluation of Food Additives and Contaminants and Methods of Analysis for the Determination of Food Additives and Contaminants in Foods.
APPOINTMENT OF RAPPORTEUR (Agenda Item 3)
5. The Committee agreed with the suggestion of the Chairman to appoint Dr. Simon Brooke-Taylor of Australia as Rapporteur.
MATTERS REFERRED FROM THE CODEX ALIMENTARIUS COMMISSION AND OTHER CODEX COMMITTEES2 (Agenda Item 4a)
6. The Committee noted matters arising from the 21st Session of the Codex Alimentarius Commission and/or other Codex Committees related to the Implementation of the Medium-Term Plan, the adoption of proposals to Base Codex Standards and Other Recommendations on Scientific Principles and the Code of Practice for All Foodstuffs Transported in Bulk. The Committee also noted that general methods of Analysis for contaminants developed or endorsed by the Codex Committee on Methods of Analysis and Sampling3 would need to be considered when establishing the General Standard on Contaminants and Toxins in Foods.
2 CX/FAC 96/2.
3 CX/FAC 96/2 - Annex II.
Carry-Over of Sulphur Dioxide
7. In discussing the request of the 21st Session of the Codex Committee on Fish and Fishery Products4 for advice on the carry-over of sulphur dioxide from raw material to the end product in the revised Codex Standard for Canned Shrimp and Prawns and other related products, the Committee agreed to request additional information by circular letter.
8. The Committee also agreed to seek additional information on a request from the Delegation of Turkey to raise the maximum level for sulphur dioxide in the Codex Standard for Dried Apricots from 2000 to 2500 mg/kg. The delegation of Turkey also agreed to provide additional information and justification for their proposal at the 29th CCFAC.
Codex Standard for Food Grade Salt
9. In discussing the request of the 19th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses5 to examine a proposal to lower the sodium chloride content in the Codex Standard for Food Grade Salt, the Committee discussed the proposal and since the product was mainly for domestic consumption no action was taken.
4 ALINORM 95/18, para. 93.
5 ALINORM 95/26, paras. 37–42.
CONSIDERATION OF THE REPORT OF THE JOINT FAO/WHO EXPERT CONSULTATION ON THE APPLICATION OF RISK ANALYSIS TO FOOD STANDARDS ISSUES6 (Agenda Item 4b)
10. The Committee was informed that the 21st Session of the Codex Alimentarius Commission, while endorsing the recommendations of the above Consultation in principle, noted that there was a need for further clarification of terms and definitions used for risk analysis.7 Comments were therefore requested under CL 1995/40-CAC for eventual consideration by the Codex Committee on General Principles. The Commission also agreed that the report and recommendations of the Consultation should be examined by relevant Codex Committees.
11. The Committee was informed of recent activities related to risk analysis undertaken by the Codex Coordinating Committee for Asia.8 The Committee also noted the importance of harmonized assessments for veterinary drugs, pesticides, food additives and contaminants as discussed at the Joint FAO/WHO Consultation for the Revision of Guidelines for Predicting Dietary Intake of Pesticide Residues9.
6 WHO/FNU/FOS/95.3.
7 ALINORM 95/37, paras. 27–30.
8 ALINORM 97/15, paras. 65–66.
9 WHO/FNU/FOS/95.11.
CONSIDERATION OF THE SUMMARY REPORT OF THE FORTY-SIXTH MEETING OF THE JOINT FAO/WHO EXPERT COMMITTEE ON FOOD ADDITIVES10 (Agenda Item 5a)
12. The Summary Report of the forty-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), held in Geneva from 6 to 15 February 1996, was introduced by the Joint Secretaries, Dr J.L. Herrman (WHO) and Dr J. Paakkanen (FAO).
13. JECFA confirmed that the occurrence of proliferative lesions in the adrenal medulla of rats fed polyols and lactose is a species-specific phenomenon not relevant to the toxicology of polyols and lactose in humans and therefore, the previous evaluations of the polyols were maintained.
14. Nearly 50 flavouring agents in three chemical groups were evaluated using the approach developed at the forty-fourth meeting of the Committee (WHO Technical Report Series No. 859) and described in Annex 5 of WHO Food Additives Series No. 35. JECFA concluded that there were no safety concerns at current levels of intake.
15. Aflatoxins B1, B2, G1, G2, M1 and M2 were evaluated following a request from CCFAC for an assessment of their carcinogenic potency and estimates of the risks from exposure. A large number of toxicity and epidemiological studies were considered, as well as biochemical markers of exposure and levels of contamination of foodstuffs. However, the evaluation was not completed at the meeting, and therefore JECFA recommended that it be continued at its next meeting devoted to food additives and contaminants.
16. Specifications for identity and purity were considered for 95 substances. New specifications were prepared for 37 substances, revised for 56 existing specifications and maintained for one substance. No specification was prepared for one substance. These specifications will be published in FAO Food and Nutrition Paper (FNP) 52 - Addendum 4.
17. General matters considered by JECFA included the harmonization of its specifications with those of other internationally recognized bodies, the lowering of existing general limits for lead and heavy metals in food additives where possible, the withdrawal of arsenic limits except where the nature and source of the substance or the level of consumption indicated that limits were necessary and the avoidance of the use of solvents and reagents in specification methods of analysis which were known or suspected carcinogens or are environmentally undesirable.
18. The Joint FAO/WHO Expert Consultation on Application of Risk Analysis to Food Standards Issues, held in Geneva in March 1995, recommended that exposure assessments, being primarily a scientific task, should continue to be carried out by Expert Committees such as JECFA. Therefore, a group of experts on intake participated in the forty-sixth meeting of JECFA to provide advice on aflatoxin intakes. At the next JECFA meeting, the membership of the group will be expanded to include experts from other countries.
19. JECFA noted that many data to be considered were submitted long after the deadline specified in the request for data, making it difficult to produce adequately reviewed working papers in time for the meeting. JECFA emphasized the importance of timely data submissions.
ACTION REQUIRED AS A RESULT OF CHANGES IN ADI STATUS AND OTHER TOXICOLOGICAL RECOMMENDATIONS11 (Agenda Item 5b)
20. The Committee was informed that no action was required as a result of toxicological evaluations arising from the 46th JECFA Session as previous ADIs were maintained and no new ADIs were established for additives with current Codex uses.
11 Conference Room Document 1.
21. Although JECFA had requested additional studies on the pharmacokinetics and metabolism of dodecyl, octyl and propyl gallates as a group, the Committee noted that the ADI for propyl gallate was maintained and therefore, no action was required. However, as the temporary ADIs for dodecyl and octyl gallate were revised to “not allocated” ADIs, the Committee noted that unless ADIs were established in the future by JECFA, they should not be included in the General Standard for Food Additives. The report was appended (see Appendix II) for information.
CONSIDERATION OF REVISIONS TO THE CODEX ALIMENTARIUS PROCEDURAL MANUAL CONCERNING THE FORMAT OF STANDARDS AND RELATIONS BETWEEN CODEX COMMITTEES12 (Agenda Item 6)
22. Following the request of the Codex Committee on General Principles13 (CCGP) for clarification on the interaction between the CCFAC and commodity committees in the framework of the General Standard for Food Additives (GSFA), the Committee considered a number of proposals for inclusion in the Procedural Manual (Guidelines for Codex Committees). The 21st Session of the Commission had also confirmed that endorsement of additive provisions should continue according to current procedures pending completion of the GSFA. With regard to the format of standards, the Commission had reasserted that the additives section should be included as an integral part of Codex Standards until such time as the General Standard for Food Additives was finalized.14
23. The Committee agreed with the general recommendations proposed in the paper (para. 12), as follows:
24. In order to integrate these objectives into current procedures and to clarify the endorsement process, the Committee agreed to propose the following amendments to the Guidelines for consideration by CCGP:
Status of the Amendments to the Procedural Manual (Guidelines for Codex Committees)
25. The Committee agreed to forward the amendments, as included in Appendix III, to the Committee on General Principles for consideration, with the understanding that governments would have the opportunity to comment in the framework of the CCGP.
CONSIDERATION OF METHODS OF ANALYSIS FOR THE DETERMINATION OF FOOD ADDITIVES AND CONTAMINANTS IN FOODS15 (Agenda Item 7)
26. The Delegation of Canada introduced a List of Methods of Analysis for the Determination of Food Additives and Contaminants in Foods, which it had revised and updated based on comments submitted in response to CL 1995/10-FAC. The Committee expressed its appreciation to Canada for its comprehensive work.
27. An informal working group (Canada, Finland, Netherlands, United States, AOAC) considered the document to prioritise substances for which methods were required to facilitate international trade.
28. The Committee agreed that methods for food additives and contaminants should be prioritized and selected according to the following criteria:
Status of Methods of Analysis for the Determination of Food Additives and Contaminants in Foods
29. The Committee agreed to forward the Methods of Analysis for the Determination of Food Additives and Contaminants in Foods (see Appendix IV) for endorsement by the Codex Committee on Methods of Analysis and Sampling, with the understanding that the methods will eventually be included in a future revision of Codex Alimentarius Volume 13 (Methods of Analysis and Sampling).
30. The Committee also agreed that governments would be invited by circular letter to provide additional methods for food additives or contaminants based on the above criteria on a continuing basis.
15 CX/FAC 96/4 and comments from Thailand (CRD 11).
ENDORSEMENT AND/OR REVISION OF MAXIMUM LEVELS FOR FOOD ADDITIVES IN CODEX STANDARDS16 (Agenda Item 8)
31. The Committee noted that no maximum levels for food additives had been submitted for endorsement since its 27th Session and therefore, no action was taken.
CODEX RISK ASSESSMENT AND MANAGEMENT PROCEDURES: EXPOSURE ASSESSMENT METHODS IN SUPPORT OF THE CODEX GENERAL STANDARD FOR FOOD ADDITIVES17 (Agenda Item 9)
32. Following the recommendations of the Commission on the integration of risk assessment procedures in the work of Codex Committees (see para. 10), and the decision of the last CCFAC session to address issues related to exposure assessment18, the Committee considered the proposals of the Delegation of the United Kingdom on exposure estimation methods.
18 ALINORM 95/12A, paras. 30–35.
33. The Committee agreed that the 4-tiered approach proposed was acceptable in principle, although the limitations of the methodology was recognized. It was recognized that at the 4th tier it will be necessary to identify the major sources of uncertainty and assessments should be made on the most efficient way to include additional information. This may include national food intake data to estimate the exposure to additives where this may approach the ADI. In this regard, it was stressed that cooperation between JECFA and CCFAC was required.
34. The Committee agreed that the Delegation of the United Kingdom would provide exposure assessments in a timely manner in order to support the USA in developing the General Standard on Food Additives prior to the 29th CCFAC and should also continue developing the methodology for exposure assessment thereafter. It was agreed that comments, including comments related to body weight and regional diets, should be taken into account, and that JECFA should be consulted on future developments in this area.
CONSIDERATION OF THE CODEX GENERAL STANDARD FOR FOOD ADDITIVES
35. The meeting of the Working Group on the Codex General Standard for Food Additives was chaired by Dr. A. Rulis (USA). Dr. D. Keefe (USA) acted as Vice Chairman and Mrs. B. Fabech (Denmark) acted as rapporteur.
36. After thanking the delegations involved for their outstanding efforts, the Committee considered the report of the Working Group19 and agreed with the following recommendations.
Consideration of Compressed Worksheets for Antioxidants and Preservatives20 (Agenda Item 10a)
37. The Committee recalled that the compressed worksheets had been established to summarise data received from Member countries and that different levels of compression had been applied. The Committee agreed that these compressed schedules would be a useful tool, although it was recognized they were not intended to be the final standard.
Consideration of Stabilizers, Thickeners and Sweeteners21 (Agenda Item 10b)
38. The Committee agreed that the data collected on these classes of additives would be incorporated into the final Standard on the basis of the principles developed previously for antioxidants and preservatives. The Delegation of the United States agreed to perform this task.
Consideration of Government Comments to Annex A22 (Agenda Item 10c)
39. In view of the Committee's discussion concerning exposure assessment, the Committee decided that the United Kingdom should redraft Annex A in light of their paper for circulation, comment and further consideration by the next session.
19 Conference Room Document 2.
Consideration of the Codex Food Identification System23 (Agenda Item 10d)
40. Several Delegations pointed out that the present system did not list foods which were widely consumed in some regions, such as Asia, and the Committee agreed that categorization should include all foods consumed world-wide. It was however recalled that a clear distinction should be made between food consumption and food categorization as the latter is only a technical description of foods for the purpose of establishing food additives provisions.
41. The Committee agreed that the Belgian Delegation, in cooperation with the CIAA, would draft explanatory notes on the use of the Food Identification System for inclusion into the GSFA Preamble. It was also agreed that a revision by the United States of the categorization system would take into account the comments received at the current meeting and future submissions in order to prepare the proposed draft Standard.
Consideration of Technological Justification and Need for the Use of Food Additives (Agenda Item 10e)
42. The Committee confirmed its decision from its last session24 that technological justification and need was one of the criteria to be taken into account in the elaboration of the standard. It was therefore agreed that the Delegations of New Zealand, Australia and Iceland would draft a paper providing a step-wise procedure for the evaluation of technological justification and need for the use of food additives, to be circulated prior to the next Session for eventual inclusion into the Preamble of the GSFA.
43. The Committee also noted that a clear distinction should be made between issues relating to exposure assessment and technological justification.
Report of the Working Group on the Codex General Standard for Food Additives25 (Agenda Item 10 f)
Consideration of the carry-over principle
44. Following the request of the 21st Session of the Commission to reconsider those provisions in the Preamble relating to the carry-over of additives into foods, the Committee agreed to amend the current text of the carry-over principle by adding a new paragraph as follows:
“An additive is permitted in a raw material or other ingredient if the raw material or ingredient is used exclusively in the preparation of a food which is in conformity with the provisions of the standard.”
Procedure for the amendment of the GSFA
45. In order to facilitate future revisions to the Standard, the Committee agreed with the offer of the United States to establish draft procedures for amending the GSFA in the Preamble of the Standard. Situations requiring amendment would include the addition or deletion of additives, new use levels for an existing additive in a given food category, new food categories for a listed additive, and an updated or new JECFA ADI.
24 ALINORM 95/12A, paras. 43–45.
25 Conference Room Document 2.
Food Additive Classes to Study Next
46. The Committee agreed that work should be initiated on colours, colour retention agents, bulking agents and emulsifiers on the same basis as previous requests. The Committee also reaffirmed that additives with an ADI “not specified” should be included in the standard on a class by class basis.
Future Work
47. The observer of the EC and other delegations suggested that the United States might consider all additives with an ADI “not specified” in a separate list in accordance with principles of good manufacturing practice as well as a negative list of foods where additives were not allowed. However, the Committee did not support this proposal.
48. The Committee accepted the offer of the US to apply the principles and tools already established to the data collected on antioxidants and preservatives, and if possible, stabilizers, thickeners and sweeteners and to prepare a proposed draft standard as soon as possible for circulation, comment and consideration by the Working Group next year. The Committee also requested that the US support the document with explanatory notes on the application of the principles and tools as well as information on the procedures used to develop the General Standard. The United States agreed to do so. The Committee reinstated the WG under the Chairmanship of the USA.
CONSIDERATION OF SPECIFICATIONS FOR THE IDENTITY AND PURITY OF FOOD ADDITIVES ARISING FROM 44TH JECFA MEETING BASED ON THE REPORT OF THE WORKING GROUP ON SPECIFICATIONS26 (Agenda Item 11)
49. The Working Group on Specifications considered government comments submitted in response to CL 1995/41-FAC on Specifications for the Identity and Purity of Food Additives Arising from the 44th JECFA Meeting (FAO FNP 52-Addendum 3). The Chairman of the Working Group, Dr. P.M. Kuznesof (USA), presented the report. Mrs. Harriet Wallin (Finland) acted as rapporteur.
50. Notwithstanding a JECFA recommendation that potassium bromate was not appropriate for use as a flour treatment agent, the substance was retained on the list in view of its other minor food uses, e.g in the malting for beer.
51. The Committee agreed to refer the thirteen substances in Categories I and II (see Appendix V) to the Commission for adoption as Codex Advisory Specifications. The Committee reinstated the working group under the Chairmanship of the USA.
PROPOSED AMENDMENTS TO THE INTERNATIONAL NUMBERING SYSTEM27 (Agenda Item 12)
52. The Chairman of the informal Working Group on the International Numbering System, Dr Simon Brooke-Taylor (Australia), presented a verbal report of the Group's discussions. Representatives of Australia, Denmark, Finland, Germany, Malaysia, Netherlands, New Zealand, Philippines, Thailand, United States, Biopolymar, IFAC, Marinalg, OFCA and SIAP attended the meeting.
53. The Committee agreed that proposals made by the Delegation of Brazil during the current meeting should be submitted in writing for consideration at the 29th CCFAC.
27 Comments from Malaysia (CX/FAC 96/12).
54. The Committee agreed to assign INS 469 to Carboxy Methyl Cellulose, enzymatically hydrolysed and INS 907 to Hydrogenated Poly-1-Decenes for adoption by the Commission. The Committee also agreed that requests for amendments to the INS would be a standing agenda item.
PROPOSED AMENDMENTS TO THE REVISED INVENTORY OF PROCESSING AIDS28 (Agenda Item 13)
55. The Committee considered the revised condensed version of the Inventory (ALINORM 95/12A, Appendix V) as presented by the Delegation of Germany at the 27th CCFAC. Comments on the revised version were requested under CL 1995/10-FAC.
56. The Committee decided to maintain the format of the Inventory of Processing Aids29 as adopted by the Codex Alimentarius Commission in 1989. The Committee also agreed to solicit amendments to the Inventory on a standing basis for consideration under “Other Business” at future CCFAC meetings.
28 Comments from Spain and AMFEP (CX/FAC 96/13).
29 Codex Alimentarius Volume 1A, Section 5.8.
ENDORSEMENT AND/OR REVISION OF MAXIMUM LEVELS FOR CONTAMINANTS IN CODEX STANDARDS30 (Agenda Item 14)
57. The Committee noted that no maximum levels for contaminants had been submitted for endorsement since its 27th Session and therefore, no action was taken.
CODEX RISK ASSESSMENT AND MANAGEMENT PROCEDURES: METHODS TO ENSURE PUBLIC SAFETY WHILE DEVELOPING THE CODEX GENERAL STANDARD FOR CONTAMINANTS AND TOXINS IN FOOD31 (Agenda Item 15)
58. The Delegation of the United Kingdom gave a short introduction to the paper which presented a proposed methodology and recommendations for setting contaminant standards. The United Kingdom suggested that the proposed methodology should be further developed and incorporated into the General Standard for Contaminants and Toxins in Foods. It was also suggested that such work could be undertaken in cooperation with Denmark and the Netherlands prior to the 29th CCFAC.
59. The United States stressed that exposure and risk assessment was primarily a JECFA responsibility whereas risk management was under the responsibility of CCFAC. They further stated that the establishment of maximum levels for contaminants should only be justified in cases of significant risks to public health as related to exposure and only for known problems in international trade.
60. Several delegations and the representative of WHO supported the recommendation that the GEMS Food Programme should be further developed to provide a reliable source of data which could be used as a basis for establishing contaminant levels. The importance of taking account of regional variations in diets and body weight was also stressed.
61. The Committee thanked the Delegation of the United Kingdom for their outstanding work, and agreed that future work on exposure assessment should be carried out within the context of the Codex General Standard on Contaminants and Toxins in Food. The Committee also stressed the importance of clearly defining the respective responsibilities of JECFA and the CCFAC.
62. The Committee concluded that the Delegations of Denmark, the Netherlands and the United Kingdom would produce a paper to provide guidance on the further development of methodology and principles for exposure assessment for comments and consideration at the 29th CCFAC and in consultation with JECFA.
CONSIDERATION OF THE CODEX GENERAL STANDARD FOR CONTAMINANTS AND TOXINS IN FOODS
63. The Committee thanked the Delegations of Denmark and the Netherlands for their work on the General Standard and noted that the Annexes were adopted at Step 5 by the 21st Session of the Commission32. The authors reflected on comments received at Step 6 in reply to CL 1995/37-FAC33.
64. The Committee stressed that levels for contaminants should only be established for substances which present a significant risk to public health and a known or expected problem in international trade.
Status of the Draft Annexes I, II and III of the Codex General Standard for Contaminants and Toxins in Foods
65. After discussing the recommendations and comments made by several Delegations during the Session, the Committee agreed that the authors would revise Annexes I, II and III of the Draft General Standard for forwarding to the 22nd Session of the Commission for adoption at Step 8. The revised Annexes are attached to this report as Appendix VI.
Consideration of Annexes IV and V to the Codex General Standard for Contaminants and Toxins in Food34 (Agenda Item 16b)
66. The Committee thanked the Delegations of Denmark and the Netherlands for their work on the revised Annexes IV and V of the General Standard. The authors presented a background and summary of the comments submitted.
Annex IV - Annotated List of Contaminants and Toxins
67. The Committee recognized the need to prioritize its work in developing the General Standard and decided to focus on arsenic, tin and patulin. The Committee accepted the offers of a number of delegations to prepare discussion papers on arsenic (Denmark), patulin (France, with data from the United Kingdom) and tin (Australia, Indonesia and Thailand) for circulation and comment prior to the 29th CCFAC.
32 ALINORM 95/37, para. 55 and Appendix 4.
33 CX/FAC 96/16 (comments from Egypt, South Africa, Spain and Uruguay).
68. The Committee recognized the value of maintaining Annexes IV(A) and IV(B) as a source of general information, but noted that their integral incorporation in the General Standard was not necessary. The authors stated that they would aim at presenting an updated version of the Annexes as an information document to the 29th CCFAC and requested all interested parties to submit contributions for improvements to the text.
Annex V - Food Categorization System to be Used in the GSC
69. The Committee discussed Annex V (including sections A and B). It was agreed that wherever possible the food categorization system used for contaminants should be consistent with systems already developed for food additives and pesticides residues. The Committee also recognized that additional classes and product descriptions may be needed in the food categorization system to be used in the GSC.
Status of the Proposed Draft Annexes IV and V to the Codex General Standard for Contaminants and Toxins in Foods
70. After discussing the recommendations and comments made by several delegations during the Session, the Committee agreed that the authors would revise Annexes IV and V of the General Standard for forwarding to the 43rd Session of the Executive Committee for adoption at Step 5 and would continue to take responsibility for further action as necessary on this subject. The revised Annexes are attached to this report as Appendix VII.
Position Paper on Aflatoxins35 (Agenda Item 17a)
71. The United Kingdom introduced the position paper which focused on the reduction of aflatoxin contamination in food and feed to the lowest reasonably achievable levels based on sound risk management principles. It also considered methods of analysis and sampling, practical aspects of contamination control, source directed measures and potential trade problems. The Committee noted that other specific studies on aflatoxins were being carried currently out by other bodies and that these may be taken into account in the future.
72. The Committee thanked the Delegation of the United Kingdom for its valuable work in clarifying complex issues, and had an exchange of views on exposure estimates and overestimates and the difficulties pertaining to harmonization, the relation between contamination of feedstuffs and milk, and the cost effectiveness of prevention measures as related to consumer protection.
73. The Committee also noted the activities of FAO and WHO on the prevention and control of mycotoxins contamination, especially through workshops and training programmes in developing countries.
74. The Committee was informed that JECFA was scheduled to assess the carcinogenetic potency and estimates of the risks presented by aflatoxins at its next meeting.
75. The Committee welcomed the offer of the UK to revise the paper and to incorporate the comments made at the current meeting in the context of the principles set out in the General Standard for Contaminants and Toxins in Foods.
35 CX/FAC 96/18 and comments from Canada, Spain and Uruguay (CX/FAC 96/18-Add.1).
Consideration of the Draft Maximum Level for Aflatoxin M1 in Milk36 (Agenda Item 17b)
76. The 27th CCFAC agreed to maintain the draft maximum level at Step 7 pending an estimate from JECFA on the toxicological potency of aflatoxins B1 and M1 and the lack of consensus on the proposed level of 0.05 μg/kg.
77. Some countries were of the opinion that the proposed limit would be difficult to reach, was not required for the protection of consumers, and that methods of analysis and sampling were difficult to reproduce. Other countries supported the proposed level as necessary for consumer protection in view of existing trade in milk and milk products.
78. The Representative of WHO pointed out that it was the responsibility of the Committee to decide on the level of acceptable risk as part of its risk management tasks.
79. The Committee decided to maintain the draft maximum level at Step 7 pending the re-evaluation of aflatoxins by JECFA.
Consideration of Government Comments on the Draft Codex Guideline Levels and Sampling Plans for Total Aflatoxins in Peanuts37 (Agenda Item 17c)
80. The draft guideline level and sampling plan for total aflatoxins in peanuts recommended by the CCCPL was adopted by the 21st Session of the Commission at Step 5. Comments were requested under CL 1995/37-FAC.
81. The countries supporting the proposal to advance the guideline level and sampling plan to Step 8 pointed out that the level was the lowest practical limit necessary to protect consumers, and that lower levels did not significantly increase consumer protection. It was noted that the level was for unprocessed products in international commerce.
82. Other delegations were of the opinion that a lower level was necessary for consumer protection.
83. The Committee deferred a decision on the sampling plan and guideline level of 15 μ/kg for total aflatoxins in peanuts intended for further processing because of a lack of consensus. The Committee decided to return the draft level and sampling plan to Step 6 (see Appendix VIII) for additional comment, particularly as related to the scientific basis for a lower limit.
Consideration of the Code of Practice on the Reduction of Aflatoxins in Raw Materials and Supplementary Feeding Stuffs for Milk Producing Animals38 (Agenda Item 17d)
84. The Delegation of Canada introduced the proposed draft Code, which it had revised at the request of the 27th CCFAC. The Committee expressed its appreciation to Canada for its work.
38 CX/FAC 96/20 and comments from Spain, Uruguay (CX/FAC 96/20-Add.1) and Denmark (CRD 9).
85. The Committee agreed to delete the specific feed to milk ratio in Section 1.3 as this may vary according to milk yield. The Committee also agreed to delete the reference to the “risks of sun drying in high humidity” in Section 2.2.3 in view of prevailing conditions in some countries.
86. The Committee had an exchange of views on the risks inherent in blending of contaminated feeds and decontamination and decided to delete Sections 2.5.3.3 and 2.5.3.4.
87. The Committee agreed to advance the proposed draft Code of Practice, as included in Appendix IX, to Step 5 for adoption by the Executive Committee. The need to clarify the legal position of advisory documents such as a code of practice was stressed by several delegations.
Position Paper on Ochratoxin A39 (Agenda Item 17e)
88. The Delegation of Sweden introduced the position paper on Ochratoxin A, which followed up its earlier work on the subject at the request of the last session40. The paper reviewed toxicological evaluations and intake data as well as maximum limits currently applied and made specific recommendations, especially for establishing a maximum level for ochratoxins in cereals and the development of a code of practice to minimise exposure to Ochratoxin A. It was also noted that no barriers to trade had been reported.
89. The Committee expressed its appreciation to the Delegation of Sweden for its work. The Committee discussed issues related to methods of analysis and sampling, potential problems in trade and the possible development of a code of practice. It was noted that the carcinogenicity of Ochratoxin A had been evaluated twice by JECFA (37th and 44th meetings).
90. The Committee decided to request comments on the recommendations in the working paper, particularly in regard to economic problems in countries if a level of 5 μg/kg was established, as well as potential trade barriers and levels found in different commodities.
40 ALINORM 95/12A, paras. 114–116.
INDUSTRIAL AND ENVIRONMENTAL CONTAMINANTS IN FOOD
91. The Committee was informed that the last session of the Codex Committee on Food Hygiene had completed the revision of the Recommended International Code of Practice - General Principles of Food Hygiene (ALINORM 97/13, Appendix II), advanced to Step 8 for adoption by the 22nd Session of the Commission.
92. As the Code included a section on Primary Production setting general provisions to avoid environmental and other contamination, the Committee agreed that the intended scope of a general Code of Practice on Source Directed Measures was covered by the GPFH and that no further action of CCFAC was required at this time.
PROPOSED DRAFT Maximum Levels for LEAD41 (Agenda Item 18b)
93. The working paper and proposed draft levels for lead amended as requested by the 27th CCFAC were presented by the Delegation of Denmark. The paper included a summary of toxicological data and evaluations, potential health problems, intake and consideration of Codex and national maximum limits.
94. Discussions concerned the need to pay particular attention to infants and children, analytical methods, laboratory qualification, conversion factors between raw and processed products, the need for levels and/or revision of existing levels and the importance of dietary exposure in relation to total exposure. the importance of taking account of regional diets and body weights as well as the establishment of levels for specific commodities was also stressed.
95. The Committee agreed to circulate the revised proposed draft maximum levels for comment at Step 3, with the understanding that they will be included in Schedule 1 of the GSC. The levels are attached to this report as Appendix X.
Consideration of Government Comments on DRAFT Guideline Levels for Cadmium and Lead in Cereals, Pulses and Legumes42 (Agenda Item 18c)
96. The Committee noted that the 20th Session of the Commission agreed with the decision of the 9th Session of the Codex Committee on Cereals, Pulses and Legumes (CCCPL) to request additional comments at Step 6 (CL 1994/35-CPL) on the draft guideline levels for cadmium (0.1 mg/kg) and lead (0.5 mg/kg) in cereals, pulses and legumes. As the 21st Session of the Commission adjourned the CCCPL sine die, the CCFAC was responsible for their further consideration.
97. As it was noted that the levels of lead and cadmium varied widely in different commodities, further consideration was required. The Committee decided to return the draft guideline levels for cadmium and lead in cereals, pulses and legumes to Step 6 (see Appendix VIII) for comment, and further information from JECFA.
Discussion Paper on PCBS and DIOXINS43 (Agenda Item 18d)
98. The Netherlands briefly introduced the revised version of the working paper as requested by the 27th CCFAC44. The Committee thanked the Delegation of the Netherlands for its efforts.
99. The paper included information on indications of potential health problems, methods of analysis, risk assesment and management of dietary exposure and conclusions and recommendations.
100. In view of the Committee's decision not to proceed with the collection of information on dioxins and PCB's (see para. 101), it was agreed that an information paper may need to be prepared for consideration at a future meeting, inview of the expected forthcoming assessments from several national and international bodies.
42 CL 1994/35-CPL and comments from Czech Republic, Poland (CX/FAC 96/24) and Thailand (CRD 11).
44 ALINORM 95/12A, Paras. 132–137.
Government Comments on Cadmium, PCBS, Dioxins, Polycyclic Aromatic Hydrocarbons and Hydrogen Cyanide in FOODS45 (Agenda Item 18e)
101. In view of other priorities, the Committee decided to suspend the collection of information on PCB's, Dioxins, Polycyclic Aromatic Hydrocarbons and Hydrogen Cyanide. This decision was taken with the understanding that action could be taken by the Committee at a future meeting if new information became available on potential health or trade problems.
102. The Committee agreed to collect additional information on cadmium for consideration at its 29th Session.
45 Comments from Norway and Spain (CX/FAC 96/26).
PROPOSALS FOR THE PRIORITY EVALUATION ON FOOD ADDITIVES AND CONTAMINANTS BY JECFA46 (Agenda Item 19)
103. The Committee had before it the report of the informal working group on priorities for JECFA. The Committee agreed to the priorities proposed by the working group as set out in Appendix XI.
104. The Committee noted that while there was a need for JECFA to review some substances with ADIs “not specified” or “not limited” in the context of the development of the GSFA, this task should not take priority over other proposals for JECFA work, and should be duly justified by CCFAC.
OTHER BUSINESS AND FUTURE WORK (Agenda Item 20)
105. The Committee had no other business to discuss.
DATE AND PLACE OF NEXT SESSION (Agenda Item 21)
106. The Committee was informed that the 29th Session of the Codex Committee on Food Additives and Contaminants was tentatively scheduled to be held in The Hague from 17 – 21 March 1997.
46 Conference Room Document 12.
ANNEX
CODEX COMMITTEE ON FOOD ADDITIVES AND CONTAMINANTS
Current Status of Work
| SUBJECT | STEP | FOR ACTION BY | DOCUMENT REFERENCE |
|---|---|---|---|
| Annexes I, II and III of the General Standard for Contaminants and Toxins in Foods | 8 | 22nd CAC | ALINORM 97/12, Appendix VI |
| Codex Advisory Specifications | 8 | 22nd CAC | ALINORM 97/12, Appendix V |
| Amendments to the International Numbering System | 8 | 22nd CAC | ALINORM 97/12, para. 54 |
| Annexes IV and V of the General Standard for Contaminants and Toxins in Foods | 5 | 43rd EXEC Governments 29th CCFAC | ALINORM 97/12, Appendix VII |
| Code of Practice for the Reduction of Aflatoxin B1 in Raw Materials and Supplemental Feedingstuffs for Milk Producing Animals | 5 | 43rd EXEC Governments 29th CCFAC | ALINORM 97/12, Appendix IX |
| Amendment to the Codex Alimentarius Procedural Manual (Guidelines for Codex Committees) | -- | 12th CCGP Governments 22nd CAC | ALINORM 97/12, Appendix III |
| Methods of Analysis for the Determination of Food Additives and Contaminants in Foods | -- | 21st CCMAS Governments 22nd CAC | ALINORM 97/12, Appendix IV |
| Exposure Assessment Methods in Support of the General Standard for Food Additives | 2/3 | United Kingdom Governments 29th CCFAC | ALINORM 97/12, para. 34 |
| Revised Annex A to the General Standard for Food Additives | 2/3 | United Kingdom Governments 29th CCFAC | ALINORM 97/12, para. 39 |
| Explanatory Notes to the Codex Food Identification System | 2/3 | Belgium/CIAA 29th CCFAC | ALINORM 97/12, para. 41 |
| Technological Justification and Need | 2/3 | AUL/ICE/NZE Governments 29th CCFAC | ALINORM 97/12, para. 42 |
| Procedures for Amending the General Standard for Food Additives | 2/3 | United States Governments 29th CCFAC | ALINORM 97/12, para. 45 |
| Colours, Colour Retention Agents and Bulking Agents | 2/3 | USA/Secreteriat Governments 29th CCFAC | ALINORM 97/12, para. 46 |
| Amendments to the Inventory of Processing Aids | 3 | Governments 29th CCFAC | ALINORM 97/12, para. 46 |
| Methodology and Principles for Exposure Assessment - General Standard for Contaminants and Toxins in Foods | 2/3 | DEN/NET/UK Governments 29th CCFAC | ALINORM 97/12, para. 62 |
| Discussion Papers on Arsenic, Patulin and Tin | 2/3 | DEN/FRA/AUL Governments 29th CCFAC | ALINORM 97/12, para. 67 |
| Position Paper on Aflatoxins | 2/3 | United Kingdom 29th CCFAC | ALINORM 97/12, para. 75 |
| Maximum Level for Aflatoxins M1 in Milk | 7 | 29th CCFAC | ALINORM 97/12, para. 79 |
| Guideline Levels and Sampling Plans for Total Aflatoxins in Peanuts | 6 | Governments 29th CCFAC | ALINORM 97/12, para. 83 |
| Position Paper on Ochratoxin A | 3 | Governments 29th CCFAC | ALINORM 97/12, para. 90 |
| Maximum Levels for Lead | 3 | Governments 29th CCFAC | ALINORM 97/12, Appendix X |
| Guideline Levels for Cadmium and Lead in Cereals, Pulses and Legumes | 6 | Governments 29th CCFAC | ALINORM 97/12, Appendix VIII |
| Cadmium | -- | Governments 29th CCFAC | ALINORM 97/12, para. 102 |
| Food Additives and Contaminants Proposed for Priority Evaluation by JECFA | 3 | Governments 29th CCFAC | ALINORM 97/12, para. 103 |
