83. The Delegation of Netherlands introduced the proposed draft. The Committee recalled that the 20th session of the Committee briefly discussed the proposed draft and in view of the importance of the standard and the short time available agreed to return the text to Step 3 for further consideration.
84. The Committee considered the Proposed Draft section by section and made the following amendments.
1. SCOPE
85. Canada and other delegations pointed out that all infant formula, including those for special dietary uses, should meet all the requirements under the standard, except those related to any nutrient that needs to be modified to meet the special nutritional requirement, to ensure that formulas were safe and nutritionally adequate in all other respects (additives, contaminants, hygiene). The Committee noted that although some requirements on an infant formula for specific health conditions might deviate from the provisions in the proposed draft, other aspects of the formula should comply with requirements in the proposed draft. The first paragraph of the proposed draft was amended. The Observer from the EC expressed serious concerns about the consequences of including products intended for infants not in good health in this standard. As regards of applicability of provisions of use of additives and labelling, taking into account that different such provisions might be set in other standards and notably the standard on Foods for Special Medical Purposes.
86. Regarding the reference to the International Code of Marketing of Breast Milk Substitutes and relevant World Health Assembly (WHA) resolutions, the Committee noted the proposed text submitted by the Delegation of Canada (CRD 6). Several delegations and the Observer from the EC opposed reference to WHA resolutions because it would bind the standard to future resolutions which contents are unknown. Other delegations and the Representative of UNICEF supported the reference. The Committee agreed to include the words “and relevant World Health Assembly resolutions” in square bracket.
87. The Delegation of Spain expressed the view that the legal implications of the reference should be carefully examined.
2. DESCRIPTION
Section 2.1.1
88. The Committee agreed to add “safe, potable and previously boiled” immediately before “water”, as the safety of water in preparation of infant formula was essential.
Section 2.1.2
89. Several delegations proposed to delete the text after “its directions for use” while others were opposed. The Committee noted that the words “four to six months” should be considered in conjunction with the discussion of Agenda Item 6 (see paras. 51-56).
3. ESSENTIAL COMPOSITION AND QUALITY FACTORS
Section 3.1
90. The Committee had an extensive exchange of views. Many relevant suggestions on this section, including those written in CX/NFSDU 98/6-Add. 1; Add. 2 and CRDs, were provided.
91. Referring to their comments in CRD 46, the Delegation of India opposed the current section 3.1.1, as the composition of infant formula should be in conformity with their national legislation.
92. The Committee noted that maximum values in the tables of vitamins and minerals should be based on scientific risk analysis and data. Further examination of individual figures for both minimum and maximum values should be done in the next session.
93. Regarding the footnote of the Vitamins and Minerals Table: the text in brackets in the first footnote was deleted, as scientific basis of the specified maximum needed further consideration; the proposed maximum ratio of Ca to P was replaced by 2.0 with square brackets; the fourth footnote was deleted, as Iron deficiency was a serious problem in some countries and Infant formula should always be fortified.
94. The words “protein partial hydrolysates” was added after the words “cow’s milk protein” in the section (e) to make it consistent with the provisions for soya protein.
95. The proposed title of section (f) “Fat and Linoleate” was replaced by the new title “Fat and Fatty Acids”, as this section deals with various fat components in addition to linoleate. The provisions for content of lauric and myristic acid were deleted, as the scientific justification of these provisions required further consideration. Several delegations raised concerns about proposed limits to trans fatty acids. The Observer from CRN asked that the recommendations or concerns of several delegates on DHA and ARA be specifically mentioned in the draft of the report in order to focus scientific discussion regarding what may be compelling and emerging data regarding benefit.
Section 3.2
96. In section 3.2.2, “and safety” were included after “usefulness”.
4. FOOD ADDITIVES
97. The Delegation of the United States suggested to add Diacetyl Tartaric Acid Esters of Monoand Diglycerides and Citric acid esters of mono-and diglycerides in the list of emulsifiers (CRD 16). Some delegations proposed to delete the thickening agents from the list.
98. The Committee noted that scientific justification should be provided when submitting additives for endorsement of the CCFAC. The Committee agreed that the Working Group which examines the section of food additives in the Proposed Draft Revised Standard for Cereal-Based Foods for Infant and Children (paras 72) should cover this task.
5. CONTAMINANTS
99. Regarding section 5.2, the Delegation of Spain repeated the concerns expressed in para. 72 and the view that the extent of “other contaminants” should be clarified. Some delegations proposed to include contaminants such as heavy metals, PCB, dioxins or radioactive elements. The Committee agreed that the discussion of this section should follow that of the section of contaminants in the Proposed Draft Revised Standard for Cereal-Based Foods for Infant and Children (Agenda Item 6)
6. HYGIENE
100. The Committee noted that the reference statements on food hygiene had been amended by the last Session of the Commission and agreed to amend the current section accordingly.
9. LABELLING
Section 9.1
101. In section 9.1.5, the Committee agreed to include the second sentence in square brackets, as the discussion of health claim had not yet been finalized.
102. In section 9.1.6, both paragraphs were put in square brackets.
Section 9.5
103. In section 9.5.2, the words “over six months of age” were put in square brackets.
Section 9.6
104. The Committee agreed that the entire paragraph of section 9.6.1 and 9.6.2 were put in square brackets for further consideration.
Annex 1
105. The Committee agreed to take the figures proposed by the Delegation of Canada (CRD 6).
STATUS OF THE PROPOSED DRAFT REVISED STANDARD FOR INFANT FORMULA
106. The Committee agreed to return the Proposed Draft Revised Standard to Step 3 for further consideration. (see Appendix V).
