CONSIDERATION OF THE CODEX GENERAL STANDARD FOR FOOD ADDITIVES

REPORT OF THE WORKING GROUP ON THE CODEX GENERAL STANDARD FOR FOOD ADDITIVES (Agenda Item 7a)
ANNEX OF FOOD CATEGORIES OR INDIVIDUAL FOOD ITEMS WHERE THE USE OF FOOD ADDITIVES WITH GOOD MANUFACTURING PRACTICE LIMITATIONS ON USE ARE NOT ALLOWED OR RESTRICTED (Agenda Item 7b)
DRAFT SCHEDULES FOR ANTIOXIDANTS, PRESERVATIVES, STABILIZERS, THICKENERS AND SWEETENERS (Agenda Item 7c)
PROPOSED DRAFT SCHEDULES FOR COLOURS, COLOUR RETENTION AGENTS, BULKING AGENTS AND EMULSIFIERS (Agenda Item 7d)
WORKSHEETS FOR ACIDITY REGULATORS, ANTICAKING AGENTS, ANTIFOAMING AGENTS, FIRMING AGENTS, FLAVOUR ENHANCERS, FLOUR TREATMENT AGENTS, FOAMING AGENTS, GLAZING AGENTS, HUMECTANTS, PROPELLANTS AND RAISING AGENTS (Agenda Item 7e)
PROPOSED DRAFT REVISED ANNEX A (Agenda Item 7f)
COMMENTS ON TECHNOLOGICAL JUSTIFICATION AND NEED FOR THE USE OF FOOD ADDITIVES (Agenda Item 7g)

REPORT OF THE WORKING GROUP ON THE CODEX GENERAL STANDARD FOR FOOD ADDITIVES (Agenda Item 7a)[6]

22. The meeting of the ad hoc Working Group on the Codex General Standard for Food Additives was chaired by Dr. Rulis (USA) and co-chaired by Dr. Keefe (USA). Bente Fabech (Denmark) acted as rapporteur. The Chairperson of the Working Group gave a comprehensive introduction of the Working Group report and thanked all delegations for their constructive input.

23. The Codex Secretariat informed the Committee that theWorld Trade Organization Agreement on Sanitary and Phytosanitary Measures (SPS) states:

• that Members should harmonise sanitary and phytosanitary measures on as wide a basis as possible. Members shall base these measures on international standards, guidelines and recommendations (i.e. Codex) (Article 3.1), and;
• that Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification (article 3.3).

24. The SPS Agreement recognizes, for food safety, the standards, guidelines and recommendations established by Codex relating to food additives, etc. The definition makes no distinction between standards, guidelines and recommendations, nor does it provide definitions for these terms (Annex A).

25. In relation to the GSFA, it was noted that Codex standards, guidelines or recommendations are not mandatory, that members have the option to deviate from them, and therefore, Codex work should not be constrained by such issues.

26. The Committee agreed on the proposed components of the General Standard for Food Additives. The components are attached to this report at Appendix II.

27. The Committee reaffirmed that the food category system was flexible and that Codex Members and international organizations had the opportunity to comment on any aspect of the GSFA at any time for further discussion by the CCFAC.

28. OtherMatters

• The Committee agreed to forward Canthaxanthin, Annatto, Iron Oxides and Erythrosine for evaluation of national intake data for the 53^rd JECFAin 1999 (see para. 109).
• The Committee reaffirmed the decision of the 29^th CCFAC to remove the food category “Foods in General, Unless Otherwise Specified (0.0)” for additives with a numerical ADI from Tables 1 and 2 (previously referred to as Schedules 1 and 2). As this resulted in some information on additive use being omitted from the Tables, the Committee agreed that comments should be requested on specific use levels for additives contained in all the Tables under its consideration. The Committee also noted that if in exceptional situations it appeared that the use of an individual additive might exceed the ADI, such cases should be referred to JECFA for evaluation of intake data. As more information would become available, any specific cases could be discussed at the Committee’s next meeting.
• The Committee further agreed that all Tables 1 and 2 under its consideration would be condensed and simplified, where appropriate, to have one entry for each food category, for each food additive with multiple functions and for additives with group ADIs. When simplifying Tables 1 and 2, numerical use levels would be retained in preference to GMP levels for additives with numerical ADIs. Where there were no numerical levels, comments would be requested on provisions with GMP levels with a view towards establishing numerical levels.
• The Committee decided to convene the ad hoc Working Group prior to its next session under the chairmanship of the USA.

ANNEX OF FOOD CATEGORIES OR INDIVIDUAL FOOD ITEMS WHERE THE USE OF FOOD ADDITIVES WITH GOOD MANUFACTURING PRACTICE LIMITATIONS ON USE ARE NOT ALLOWED OR RESTRICTED (Agenda Item 7b)[7]

29. The 22nd Session of the Commission adopted the above Annex at Step 8 on an interim basis, and requested the CCFAC to review the Annex at its current meeting in light of comments received and report its findings to the next Session of the Commission (ALINORM 97/37, para. 59).

30. The Codex Secretariat had already amended Appendix IV (i.e., Table 3) to reflect correct INS numbers and food additive names for publication in a revised version of Codex Alimentarius Volume 1A. The Committee recommended the deletion of the following food additives from Appendix IV (Table 3) as these had not been evaluated by JECFA:

• INS 368: Ammonium Fumarate
• INS 349: Ammonium Malate, DL-
• INS 517: Ammonium Sulphate
• INS 505: Iron (Ferrous) Carbonate
• INS 518: Magnesium Sulphate
• INS 560: Potassium Silicate
• INS 550(i): Sodium Silicate
• INS 514: Sodium Sulphate

31. The Committee recommended the replacement of the following food additive listing in Appendix IV (Table 3):

• INS 470: Salts of Fatty Acids (Ammonium, Calcium, Potassium, Sodium) by two entries:
• INS 470: Salts of Myristic, Palmitic and Stearic Acids (Ammonium, Calcium, Potassium, Sodium)
• INS 470: Salts of Oleic Acid (Calcium, Potassium, Sodium)

The Committee recommended that the following food additives be moved from the proposed draft Worksheets for Miscellaneous Additives (CX/FAC 98/8) to Appendix IV (Table 3) as these additives had an ADI of not specified:

• INS 576: Sodium Gluconate
• INS 577: Potassium Gluconate
• INS 578: Calcium Gluconate
• INS 580: Magnesium Gluconate

32. Several delegations proposed to amend the Annex to Appendix IV (Table 3), including its title, in order to reduce the potential for misinterpretation of its contents.

33. Several delegations asked for clarification on the relationship between the Appendix and existing Codex Commodity Standards. It was reaffirmed that food additive provisions in Codex Commodity Standards take precedence over entries in the GSFA but should be consistent with the principles of the GSFA, and that the GSFA was intended to address all foods whether standardized by Codex or not. The Committee noted that food additives had been removed from Appendix IV (Table 3) and that comments would be requested. Several delegations requested inclusion of fruit juices and wine in the Annex to Appendix IV (Table 3). The Committee, noting the Codex Standard for Fruit Juices, deferred a decision on these requests until its next meeting. The Committee agreed to request further comments on Appendix IV (Table 3) and the Annex to Appendix IV (Table 3) on the basis of the above discussion for further consideration at the 31^st CCFAC.

DRAFT SCHEDULES FOR ANTIOXIDANTS, PRESERVATIVES, STABILIZERS, THICKENERS AND SWEETENERS (Agenda Item 7c)[8]

34. The Commission adopted the proposed draft Schedules for Antioxidants, Preservatives, Stabilizers, Thickeners and Sweeteners at Step 5 (ALINORM 97/37, para 114).

35. In view of the above discussion and as recommended by the Working Group, the Committee agreed to return the draft Schedules (i.e., Tables) to Step 6 for consolidation (see para. 28), additional comment and further consideration at its next meeting (see Appendix III).

PROPOSED DRAFT SCHEDULES FOR COLOURS, COLOUR RETENTION AGENTS, BULKING AGENTS AND EMULSIFIERS (Agenda Item 7d)[9]

36. The Committee was informed that the 29^th CCFAC requested the USA to compress information previously obtained to create proposed draft schedules for circulation, comment and consideration at the current CCFAC session (ALINORM 97/12A, para. 31).

37. The representative of the OIV pointed out that there was an inconsistency between the OIV standards and the GSFA and therefore, the Committee encouraged the OIV to submit comments to eliminate these inconsistencies.

38. Several delegations expressed the need for further consideration on the use of colours in food. An offer made by the delegation of Denmark to prepare a discussion paper on this issue for consideration at the next CCFAC was accepted by the Committee.

39. The Committee decided to advance the revised proposed draft Schedules (i.e., Tables) for these food additive classes to the Executive Committee for adoption at Step 5 (see Appendix IV).

WORKSHEETS FOR ACIDITY REGULATORS, ANTICAKING AGENTS, ANTIFOAMING AGENTS, FIRMING AGENTS, FLAVOUR ENHANCERS, FLOUR TREATMENT AGENTS, FOAMING AGENTS, GLAZING AGENTS, HUMECTANTS, PROPELLANTS AND RAISING AGENTS (Agenda Item 7e)[10]

40. The Committee was informed that the 29^th CCFAC agreed to issue a circular letter on the remaining additives with numerical ADIs, except flavouring agents, as had been accomplished on previous requests for other food additive classes (ALINORM 97/12A, para. 37). Information and data submitted in response to CL 1997/9-FAC were used to elaborate the Worksheets contained in document CX/FAC 98/8.

41. The Committee forwarded the proposed draft Schedules (i.e., Tables) for these food additive classes to the Executive Committee for adoption at step 5 (see Appendix V).

PROPOSED DRAFT REVISED ANNEX A (Agenda Item 7f)[11]

42. The Committee was informed that the 29^th CCFAC agreed to prepare a new Annex A containing a description only of the budget method and its use for prioritizing additives for JECFA review of exposure. The Committee accepted the offer of Denmark, assisted by France and the United Kingdom, to prepare a revised Annex A, containing a new version of the budget method, for circulation and comment prior to its current meeting (ALINORM 97/12A, paras. 32-34).

43. Some delegations, while generally supporting this approach (i.e., CX/FAC 98/9), pointed out that regional dietary patterns should be taken into account and that further clarification would be required concerning the percentage of the total intake allocated for some food groups and the assessment of extreme intake. The Committee recalled that this was a screening method intended for the evaluation of maximum use levels and not for intake assessment purposes. It was also agreed that the inclusion of some examples of calculation in the document would be useful.

44. The Committee agreed to return the proposed draft Revised Annex to Step 2 for redrafting by the Delegation of Denmark in light of the above discussions and comments received for further consideration by the next session.

COMMENTS ON TECHNOLOGICAL JUSTIFICATION AND NEED FOR THE USE OF FOOD ADDITIVES (Agenda Item 7g)[12]

45. The 29^th CCFAC requested that comments on document CX/FAC 97/10 be considered at its current meeting (ALINORM 97/12A, para. 35).

46. It was noted that document CX/FAC 97/10 served to facilitate discussions on the technological justification and need for the use of food additives.

47. In the light of comments received on the paper, the following proposal put forward by Australia, with criteria for resolving concerns regarding the technological justification and need for the use of food additives in the GSFA, was agreed to by the Committee:

• Establish that at least two Codex Member States permit the use of the additive up to the maximum level proposed in Tables 1 and 2 in foods representative of the category. This establishes that trade may occur in the food containing the additive;
• Establish that the maximum level proposed is not limited to an obscure or unrepresentative food. If the maximum level is appropriate only to an obscure or unrepresentative food, consideration may be given to recognising that food and the level of additive use as a specific entry in the GSFA, and identifying a more representative level for the category as a whole;
• Where delegations continue to express concern about the proposed maximum levels of use square brackets may be appropriate, and;
• The GSFA Tables 1 and 2 are circulated for comments:
  • If a country considers that a proposed level of use is too high, data should be presented to demonstrate that use at this level presents a risk to public health, may lead to consumer deception about the nature of a food, or is otherwise technologically unnecessary, and;
  • If a country wishes to support a maximum level which has been identified as being of concern by other delegations, data should be presented to demonstrate that the product could not be made to a satisfactory quality using a lower level of additive or alternative additives that are permitted in the GSFA.

48. It was noted that this approach was consistent with the general criteria for technological justification and need in Sections 3 and 7 of the Preamble to the General Standard.