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58. The Committee recalled that the Proposed Draft Standard had been returned to Step 3 for further comments and consideration at the last session. The Committee discussed the Proposed Draft section by section and made the following amendments.

Section 1. Scope

59. The Delegation of Canada expressed the view that since the Standard was under revision, it would be necessary to consider the updating of the Statement on Infant Feeding. This view was supported by some delegations and opposed by others. However the Committee noted that it was not its mandate to consider the statement. This view was supported by some delegations.

60. The Delegation of Bulgaria, supported by several delegations supported the deletion of the reference to healthy infants, as the standard should cover the needs of all infants. The Delegation of Canada, supported by several delegations and the Observer of IBFAN, also stressed that infant formula intended for special dietary uses should meet the requirements of the standard to ensure that the product was safe and nutritionally adequate in all other aspects (composition, additives, contaminants, hygiene), with the understanding that specific provisions could be added where necessary; the current text of the second sentence should therefore be retained. The Delegation of Tanzania pointed out that the exclusion of special dietary foods from the Scope would detract from the applicability of the International Code of Marketing of Breast-Milk Substitutes, which was essential from the point of view of public health in developing countries.

61. The Delegation of Switzerland expressed the view that infant formula for medical purposes should be excluded from the standard and that the second sentence should therefore be deleted. This position was supported by several other delegations and the Observer of the EC, who pointed out that foods for special medical purposes should bear specific provisions regarding food labelling in order to avoid confusion as provided in the current standard for the Labelling of and Claims for Foods for Special Medical Purposes. It was also suggested that such products should be covered by current provisions for foods for special medical purposes. The Committee however recalled that the Standard for the Labelling of and Claims for Foods for Special Medical Purposes covered only labelling and claims but did not include composition requirements. The sentence was retained in square brackets.

62. The Representative of WHO, supported by the Representative of UNICEF, indicated that the International Code of Marketing of Breast-Milk Substitutes covered all types of formula used as a replacement for breast milk, including those intended for infants with special nutritional or medical needs, and that the definition did not refer to healthy infants.

63. The Committee could not come to a conclusion at this stage on the rewording of the Scope. It was agreed that the Delegation of Germany, in co-operation with Canada, Tanzania, ISDI and other interested delegations and observers, would prepare proposals to address the issue of infant formula for special medical purposes as related to the current standard or other relevant standards, as necessary, for consideration by the next session.

Section 1.3

64. The Committee had an extensive debate on the necessity of referring to the relevant World Health Assembly Resolutions. Several delegations, while supporting the reference to the Code in view of its essential importance for public health purposes, expressed their objections to a reference to the WHA Resolutions since it would imply that such resolutions would be automatically integrated into the text without an opportunity to review their content.

65. Several other delegations supported the inclusion of the reference to the resolutions since they were fundamental to ensure the promotion of breast-feeding and prevent practices which would be detrimental to the health of infants, especially in developing countries. They pointed out that these resolutions were well known and accepted by WHO member countries and their inclusion should not therefore cause difficulties.

66. The Delegation of the United States noted the written comments of other delegations to retain the reference to WHA Resolutions, adding to date in square brackets with the list of resolutions in a footnote also in square brackets as proposed by India, so that member countries would be allowed to consider them in more detail prior to the next session. The Committee agreed with this proposal as a compromise, and with the understanding that the whole issue would require further consideration. Some delegations and the Observer of EC objected to this decision and wished that the square brackets be retained on whole text "and relevant World Health Assembly Resolutions to date".

Section 2. Description

67. Several delegations and the Observer of ENCA proposed to replace the current text with a reference to the nutritional requirements of infants during the first six months of life, as this should correspond to the duration of exclusive breast-feeding. Some delegations indicated that their national legislation, based on the International Code of Marketing of Breast-Milk Substitutes, specifically referred to the first six months. Several other delegations supported the reference to the first four to six months of life, since it corresponded to current practice in their countries. The Delegation of Romania noted that there was no definition of infant formula and proposed a rewording of 2.1.2 to become 2.1.1.

68. Other delegations also pointed out that the notion that infant formula should satisfy nutritional requirements by itself was essential and should be retained. The Delegation of Malaysia proposed to retain this concept and to leave only the age in square brackets, as a compromise. The Committee could not come to a consensus on this point and the current section was retained with the reference to nutritional requirements and the age of infants in square brackets.

Section 3 Essential Composition and Quality Factors

69. The Delegation of India proposed to restrict the essential composition of infant formula to milk based products and to delete the end of section 3.1.1 which referred to other ingredients.

70. The Committee noted that due to time constraints, the detailed nature of the provisions and the extensive technical comments received, it would not be possible to review Section 3.1 in detail at the current session. The Committee therefore accepted the proposal of the Delegation of the United States that a Working Group[10], open to all interested countries and observers, and working by electronic mail should consider the comments received and prepare a revised section for consideration by the next session.

Section 3.2 Optional Ingredients

71. Section 3.2.3 was amended to reflect that when other nutrients are added, the amount should be sufficient to achieve the intended effect since this was more precise than the reference to significant amounts.

Section 3.4 Consistency and Particle Size

72. The Committee agreed that the wording should not be too prescriptive and agreed on a general recommendation that the products should be suitable for adequate feeding of young infants.

Section 4. Additives

73. Following the decision taken at the last session, the Delegation of the Netherlands presented the list of additives prepared by a Working Group on the basis of the proposals received by several delegations and observers, for consideration by the Committee. The Delegation of India expressed the view that the entire section should be deleted as there was no need for additives in infant formula.

74. The Secretariat informed the Committee that in the framework of the General Standard for Food Additives, several sections had been adopted or were proposed for adoption at Step 8 or 5 by the Commission[11]. These sections contained additives at levels of use that did not correspond to the proposals included in the current text, and this might require further consideration in order to achieve consistency throughout Codex. The Committee did not consider the section due to time constraints and it was retained in square brackets for further consideration at the next session.

Section 5. Contaminants

75. The Committee had an exchange of views on the opportunity of referring to free from contaminants, as proposed by the Delegation of India. The Committee agreed that it was not possible scientifically to ensure that any product was free from contaminants or pesticide residues.

76. The Secretariat informed the Committee of the general wording proposed for pesticide residue limits by the Committee on Pesticide Residues, and it was included accordingly. As regards Other Contaminants, the Committee agreed to replace the current section with a new text referring to amounts which may represent a hazard to health and to compliance with the limits established by the Commission, as proposed by the Delegations of France and Canada, and for consistency with the standard wording used in other commodity standards.

77. The Committee was also informed that the last session of the Committee on Additives and Contaminants had advanced to Step 8 a maximum level for lead in infant formula of 0.02 mg/kg, in the framework of the General Standard for Contaminants and Toxins in Foods[12].

Section 6. Hygiene

78. The current section was replaced with the revised wording for hygiene provisions adopted by the 23rd Session of the Commission and included in the 11th Edition of the Procedural Manual.

Section 9. Labelling

79. In section 9.1.3, the Committee agreed to specify that the label for infant formula based on cow s milk might be used when cow s milk was the only source of protein, to replace the earlier reference to 90% of milk protein.

80. In section 9.1.4, the Delegation of India, supported by other delegations, proposed that products containing no milk or milk derivatives must be labelled as such, especially to address the needs of allergic infants, and that in addition the labelling should refer to soybean formula when applicable. The Committee did not come to a conclusion on this question and retained the section in square brackets.

81. In section 9.1.5, the Observer from the EC proposed to delete the reference to health claims, the definition of which was still under consideration in the Committee on Food Labelling. The Committee recalled that the inclusion of foods for special medical purposes in the standard was still under consideration and agreed that no conclusion could be reached at this stage on the corresponding labelling requirements. Section 9.1.5 was therefore retained in square brackets, including the reference to health claims, for further consideration.

82. The Committee had an exchange of views on the provisions related to the declaration of iron, and could not reach a consensus at this stage. Several delegations pointed out that the current Table 1 referred to minimum and maximum levels of iron; however, this section had not been finalized and the Committee agreed to consider the labelling provisions further after finalization of the Section on Composition (including the Table).

Section 9.5 Information for Use

83. The Committee agreed with the proposal of the Delegation of Germany to transfer section 9.5.2 on the use of complementary foods to section 9.6 Additional Labelling Requirements since it did not relate to the information for use of the product.

Section 9.6 Additional Labelling Requirements

84. The Committee agreed to delete the square brackets around sections 9.6.1 and 9.6.2, since there was general agreement on the need to ensure that the label did not discourage breast-feeding. However it did not come to a consensus on the statement proposed as an example, and the protection offered by breast milk against diarrhoea and other illnesses. Some delegations expressed the view that this was an additional health claim, and that there was not enough scientific basis to include such a general statement. Other delegations referred to the recommendations of WHO, which clearly established the positive health effects of breast milk in this respect. The section was retained in square brackets for further consideration.

85. The Committee agreed to refer to breast-feeding and breast milk for clarification purposes, and to the advice of an independent health worker, as proposed by the Delegation of Canada. It was also agreed to include a warning statement that remaining formula should be discarded after each feeding, in order to prevent contamination, as proposed by the Delegation of Mexico and other delegations. An additional statement concerning the difference between infant formula and follow-up formula was introduced as proposed by the Delegation of India and put in square brackets.

Section 10. Methods of Analysis and Sampling

86. The Observer from AOAC informed the Committee that two methods had been adopted by AOAC for the determination of choline and Vitamin K and the Committee agreed to include them in the standard, with the understanding that they would be forwarded to the CCMAS for endorsement at a later stage.

Status of the Proposed Draft Revised Standard for Infant Formula

87. The Committee returned the Proposed Draft Standard, as amended during the current session, to Step 3 for further comments and consideration by the next session (see Appendix V).

[9] ALINORM 99/26 APPENDIX V; CXNFSDU 00/6 (comments of Argentina, Germany, Japan, Korea, Republic of, Poland, Spain, ENCA, IBFAN, ISDI); CX/NFSDU 00/6-Add.1(The Use of Additives in Infant Formula); CRD 3 (comments of IFAC); CRD 6 (comments of Canada, India, Malaysia, Mexico, Thailand, Uruguay); CRD 18 (comments of India, USA, ILCA), CRD 28 (comments of Philippines), CRD 30 (comments of Poland)
[10] United States (coordinator), Australia,Austria, Bolivia, Botswana, Bulgaria,Canada, China, Cuba, Egypt, France, Germany, Hungary, India,Japan, Malaysia, Philippines, Poland, Portugal, Romania, Republic of Korea, Switzerland, Tanzania, Turkey, Thailand, United Kingdom, Uruguay, CRN, EC, EHPM, IBFAN, ISDI
[11] ALINORM 99/12A, Appendix II and ALINORM 01/12, Appendices III and V
[12] ALINORM 01/12, Appendix XI

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