Report of the Working Group on the Codex General Standard for Food Additives
Proposed Draft Guidelines for the Development of Maximum Level of Use For Food Additives With Numerical Acceptable Daily Intakes (Annex A) (Agenda Item 7b)
DRAFT CODEX GENERAL STANDARD FOR FOOD ADDITIVES; REVISED TABLES 1, 2 AND 3, INCLUDING ANNEX TO TABLE 3 (Agenda Item 7a)[9]
32) The ad hoc Working Group on the Codex General Standard for Food Additives and Contaminants was chaired by Dr. Rulis (USA) and co-chaired by Dr. Keefe (USA), with Mrs. Bente Fabech (Denmark) as Rapporteur. The Chairman of the Working Group briefly summarised its discussions and proposed several recommendations to the Committee.
33) As the GSFA was being developed on an additive-by-additive basis rather than by functional class, the Committee agreed to amend the footnote to Section 1.1 of the Preamble of the General Standard for clarification purposes. The Committee agreed to send the proposed amendment for comments at Step 3 of the Accelerated Procedure as it was non-controversial (see Appendix V).
34) The Committee generally agreed that the food additive provisions in Codex Commodity Standards needed to be included in the GSFA. The Delegation of the United States offered to assist the Codex Secretariat to incorporate them in the adopted sections of the General Standard to be included in the revised Codex Volume 1A.
Group I, Additives for which the Budget Method Screen does not present intake concern
35) The Committee discussed 26 additives which passed the Budget Method (Proposed Draft Annex A). It was pointed out that these additives did not present intake concerns. The Committee agreed to the changes in the entries for several additives as proposed by the Working Group
36) The Committee agreed to include Nitrous oxide in Table 3 as its uses as a propellant correspond to GMP. Its use as a packaging gas was referred back to JECFA for review.
37) The Committee agreed to move to Table 3 Alpha-Amylase (1100) and Protease (Aspergillus oryzae var.) (1101I) on the basis of their evaluation by JECFA, and noted that provisions for their use in flours and starches would consequently be included in Tables 1 and 2.
38) As these enzymes could also be used as processing aids the Committee decided to add the following statement to the GSFA Preamble Section 6: "Tables 1, 2 and 3 do not include reference to uses of substances as processing aids".
39) The Committee agreed that in view of their non-controversial nature, this amendment and the amendment to the footnote should be sent for comments at Step 3 of the Accelerated Procedure (see Appendix V).
40) The Committee agreed that Azodicarbonamide (927a) should be listed only for use in flours and starches, as it had been evaluated only as flour treatment agent.
41) The Committee decided that Benzoyl Peroxide (928) needed to be evaluated by JECFA as new uses for this additive had been identified.
42) The Committee decided to maintain GMP provisions for Caramel Colour Class III and Class IV although these additives had numerical ADIs, as they were normally regulated by GMP provisions in member states. The Observer from IFU stated that the use of Caramel Colours was not necessary in concentrates (liquid or solid) for fruit juices although they may be used in finished products.
43) The Observer from the EC expressed concern that the Committee should forward to the Commission for adoption at Step 8 food additives for which JECFA had allocated a numerical ADI, without proposing numerical maximum use levels for all food categories in question. The Delegations of Switzerland and Norway supported this statement. Members were requested to provide information on suitable numerical values for consideration at the next session.
44) The Committee agreed to remove the reference to Glycerol Esters of Wood Rosin (445) in chewing gum as this substance was used as an ingredient in the gum base only.
45) As recommended by the Working Group, the Committee agreed that Stearyl Tartrate should be referred back to JECFA and retained at Step 7 pending reevaluation by JECFA as an emulsifier and flour treatment agent.
46) The Committee agreed to forward the revised Table 1 containing the remaining provisions for these additives (Group I) to the 23rd Session of the Commission for adoption at Step 8 (see Appendix II).
Group II - Additives to be forwarded to JECFA for clarification of their ADIs
47) The Committee decided to forward the following additives to JECFA for clarification of their ADI's:
Sodium Ethyl p-Hydroxybenzoate (215), Sodium Propyl p-Hydroxybenzoate (217), Sodium Methyl p-Hydroxybenzoate (219), Calcium Sulfite (226), Sodium Formate (238), Calcium Formate (238), Synthetic gamma-Tocopherol (308), Synthetic delta-Tocopherol (309), Monomagnesium Orthophosphate (343i), Calcium Tartrate (354), Dipotassium Diphosphate (450iv), Calcium Dihydrogen Diphosphate (450vii), Dimagnesium Diphosphate (450viii), Sodium Calcium Polyphosphate (452iii), Trisodium Diphosphate (450ii), Sodium Trioleate (496).
Group III, Additives reviewed by the 51st JECFA meeting
48) The Committee, referring to the conclusions of the 51st JECFA (see para. 10), agreed to return the provisions for Benzoates, BHA, BHT, Sulfites and TBHQ to Step 6 for additional comments in accordance with the recommendations of JECFA that the levels in specific food categories be examined, because these provisions may contribute significantly to intake exceeding the ADI.
Annex to Table 3
49) The Committee agreed to amend the Title of the Annex to Table 3 to clarify its intention: "Food categories or Individual Food Items Excluded from the General Conditions in Table 3". The following statement was also added: "The use of additives listed in Table 3 in the following foods is governed by the provisions in Tables 1 and 2", for clarification purposes.
50) The Committee decided to include wine and fruit juices in the Annex to Table 3 and therefore agreed that any uses for Table 3 additives in these products would need to be specifically included in Tables 1 and 2. The Delegation of Thailand reserved its position on the inclusion of fruit juices in the Annex to Table 3.
51) Several delegations questioned whether wine should be covered by the General Standard. However, the Committee felt that wine was a foodstuff that should be represented in the Standard and that intake assessment of additives could not be done accurately if wine was excluded. The Committee also recalled that the Commission had previously accepted the food classification system used in the GSFA, including wine. The Committee noted the necessity for the GSFA to be consistent with the OIV standards for wine.
52) The Committee agreed to forward the amended Table 3 and the Annex to Step 8 for adoption by the 23rd Session of the Commission (see Appendix III).
53) The Committee agreed that all other additive provisions in the GSFA would be returned to Step 6 for redrafting on the basis of the comments received and the above discussion, circulation and consideration by the next session.
Other matters
54) The Committee noted the need for a small working group to consider Tables 1 and 2 of the GSFA between the sessions to identify errors and to confirm technological need and maximum use levels for remaining additives. The Delegations of South-Africa, Japan, United States, Brazil, Australia and the Observer from the EC agreed to participate to represent their respective continents. It was agreed that input from industry and consumer organizations would also be provided. The proposals of this working group would be submitted before the end of August 1999 to allow sufficient time for comments. The Committee also noted the offer of the Observer from Consumers International to prepare a paper on consumer deception but suggested that this information could be provided as a written comment.
55) The Committee decided to convene the ad hoc Working Group on the General Standard for Food Additives prior to its next session under the chairmanship of the United States and expressed its appreciation to the United States and the Working Group for their important work to address complex issues.
Status of the Draft General Standard for Food Additives
56) As indicated in the sections of the General Standard discussed above, the Committee agreed:
· to forward the revised Table 1 including Group I Additives and the revised Table 3 (and Annex) to Step 8 for adoption by the 23rd Session of the Commission (see Appendices II and III); · to retain Stearyl Tartrate and the additives in Group II at Step 7 pending their reevaluation by JECFA; · to return to Step 6 the additives in Group III reviewed by the 51st JECFA and all other additives under consideration for further comments and consideration by the next session; · to circulate at Step 3 of the Accelerated Procedure the Proposed Draft Amendments to the Preamble subject to the approval of the Commission (see Appendix V),; · to circulate for comments at Step 3 the additives which had been allocated an ADI "not specified" by the 51st JECFA (see Agenda Item 4b).
57) The Committee considered the paper prepared by the Delegation of Denmark, which set out the use of the Budget Method for screening use levels of food additives. The Committee agreed that the Budget Method as presented was a useful screening tool and that it should be incorporated into the General Standard.
Status of the Proposed Draft Guidelines for the Development of Maximum Level of Use for Food Additives with Numerical Acceptable Daily Intakes (Annex A to the GSFA)
58) The Committee decided that the proposed Draft Annex A (without the appendices included in the working paper) would be forwarded to the 23rd Session of the Commission for adoption at Step 5 (see Appendix IV).
