Infant Formula Products.docx

1、Infant Formula ProductsStandard 2.9.1Infant Formula ProductsPurposeThis Standard provides for the compositional, and labelling requirements for foods intended or represented for use as a substitute for breast milk, herein referred to as infant formula products. This Standard applies to all infant fo

2、rmula products whether in powder, liquid concentrate or ready to drink forms. This Standard also provides for infant formula products intended for infants with special nutritional requirements.There are Guidelines for Infant Formula Products at the end of this Standard. These Guidelines do not form

3、part of the legally binding Standard.Standard 1.3.1 contains provisions relating to the food additives permitted in infant formula products. Standard 1.6.1 contains the microbiological limits in relation to infant formula products. Standard 1.3.4 contains specifications for permitted nucleotides and

4、 added nutrients. Standard 1.1.1 defines nutritive substances for the purposes of this Code.See Standard 1.5.1 Novel Foods for requirements for novel food and novel food ingredients.Table of ProvisionsDivision 1 General ProvisionsSubdivision 1 Interpretation1 Definitions2 InterpretationSubdivision 2

5、 Calculations3 Calculation of energy4 Calculation of protein5 Calculation of potential renal solute loadSubdivision 3 General compositional requirements6 Restrictions and prohibitions7 Permitted nutritive substances8 Limit on nucleotide 5-monophosphates9 Lactic acid cultures10 Limit on aluminiumSubd

6、ivision 4 General labelling and packaging requirements11 Representations of food as infant formula product12 Prescribed names13 Requirement for a measuring scoop14 Required warnings, directions and statements15 Print and package size16 Declaration of nutrition information17 Date marking and storage

7、instructions18 Statement of protein source19 Statement on dental fluorosis20 Prohibited representationsDivision 2 Infant Formula and Follow-on Formula21 Composition22 Protein23 Fat24 Vitamins, minerals and electrolytesDivision 3 Infant Formula Products for Special Dietary UseSubdivision 1 Infant for

8、mula products formulated for premature or low birthweight infants25 Composition and labelling26 Additional labellingSubdivision 2 Infant formula products for metabolic, immunological, renal, hepatic and malabsorptive conditions27 Composition28 Claims29 Composition of lactose free and low lactose for

9、mulas30 Claims relating to lactose free and low lactose formulasSubdivision 3 Infant formula products for specific dietary use based upon protein substitutes31 Composition32 Protein33 Vitamins and minerals34 Additional permitted triglyceridesSchedule 1 Permitted forms of vitamins and minerals in inf

10、ant formula productsGuidelines for infant formula products ClausesDivision 1Subdivision 1 Interpretation1 Definitions(1) The definitions in clauses 1 and 2 of Standard 1.2.8 apply to this Standard.(2) In this Code infant means a person under the age of 12 months.infant formula product means a produc

11、t based on milk or other edible food constituents of animal or plant origin which is nutritionally adequate to serve as the principal liquid source of nourishment for infants.infant formula means an infant formula product represented as a breast milk substitute for infants and which satisfies the nu

12、tritional requirements of infants aged up to four to six months.follow-on formula means an infant formula product represented as either a breast-milk substitute or replacement for infant formula and which constitutes the principal liquid source of nourishment in a progressively diversified diet for

13、infants aged from six months.lactose free formula and low lactose formula means infant formula products which satisfy the needs of lactose intolerant infants.pre-term formula means an infant formula product specifically formulated to satisfy particular needs of infants born prematurely or of low bir

14、thweight.soy-based formula means an infant formula product in which soy protein isolate is the sole source of protein.medium chain triglycerides means triacylglycerols which contain predominantly the saturated fatty acids designated by 8:0 and 10:0.protein substitute means (a) L-amino acids; or(b) t

15、he hydrolysate of one or more of the proteins on which infant formula product is normally based; or(c) a combination of L-amino acids and the hydrolysate of one or more of the proteins on which infant formula product is normally based.Editorial note:Subclause 1(2) is structured to indicate that the

16、definitions of specific infant formula products are within the more general infant formula product definition. Therefore the usual practice of listing definitions in alphabetical order has not been applied in this subclause.2 InterpretationA reference to any infant formula product in the composition

17、al provisions of this Standard is a reference to (a) a powdered or concentrated form of infant formula product which has been reconstituted with water according to directions; or(b) an infant formula product in ready to drink form.Subdivision 2 Calculations3 Calculation of energyThe energy content o

18、f infant formula product, expressed in kilojoules (kJ), must be calculated using (a) only the energy value contributions of the fat, protein and carbohydrate ingredients of the infant formula product; and(b) the relevant energy factors set out in Standard 1.2.8.4 Calculation of proteinThe prescribed

19、 formula for the calculation of the protein content of infant formula product for the purposes of this Standard is FormulaFor milk proteins and their partial protein hydrolysates Protein content = nitrogen content x 6.38; orIn any other case Protein content = nitrogen content x 6.25.5 Calculation of

20、 potential renal solute loadThe prescribed formula for the calculation of the potential renal solute load for the purposes of this Standard is FormulaPotential renal solute load in mOsm/100 kJ = Na (mg/100 kJ) /23 + Cl (mg/100 kJ) /35+ K (mg/100 kJ) /39 + P avail (mg/100 kJ)/ 31 + N (mg/100 kJ) /28)

21、.In this formulaP avail = P of milk-based formula + 2/3 of P of soy-based formulas.Subdivision 3 General compositional requirements6 Restrictions and prohibitions(1) A vitamin, mineral, food additive or nutritive substance must not be added to infant formula product unless (a) expressly permitted by

22、 this Code; or(b) it is naturally present in an ingredient of the infant formula product.(2) Infant formula product must contain no detectable gluten.7 Permitted nutritive substances(1) Any nutritive substance listed in column 1 of the Table to this clause may be added to infant formula product prov

23、ided that (a) the nutritive substance is in one or more of the forms specified in column 2 of the Table in relation to that substance; and(b) the total amount of the nutritive substance in the infant formula product is no more than the added and any naturally occurring amount specified in column 4 o

24、f the Table.(2) The label on a package of infant formula product must not include any words indicating, or any other indication, that the product contains a nutritive substance specified in column 1 or in column 2 of the Table to this clause unless the total amount of the added and any naturally occ

25、urring nutritive substance in the food is no less than the amount specified in column 3 of the Table.Table to clause 7Column 1Column 2Column 3Column 4Nutritive substancePermitted formsMinimum amount per 100 kJMaximum amount per 100 kJAdenosine 5-monophosphateAdenosine 5-monophosphate0.14 mg0.38 mgL-

26、carnitineL-carnitine0.21 mg0.8 mgCholineCholine chlorideCholine bitartrate1.7 mg7.1 mgCytidine 5-monophosphateCytidine 5-monophosphate0.22 mg0.6 mgGuanosine 5-monophosphateGuanosine 5-monophosphateGuanosine 5-monophosphate sodium salt0.04 mg0.12 mgInosine 5-monophosphateInosine 5-monophosphateInosin

27、e 5-monophosphatesodium salt0.08 mg0.24 mgLutein Lutein from Tagetes erecta L.1.5 g5 g InositolInositol1.0 mg9.5 mgTaurineTaurine0.8 mg3 mgUridine 5-monophosphateUridine 5-monophosphate sodium salt0.13 mg0.42 mg8 Limit on nucleotide 5-monophosphatesInfant formula product must contain no more than 3.

28、8 mg/100 kJ of nucleotide 5-monophosphates.Editorial note:Standard 1.3.4 contains specifications for nucleotides.9 Lactic acid culturesL(+) producing lactic acid cultures may be added to infant formula product. 9A Permitted inulin-derived substances and galacto-oligosaccharides (1) Infant formula pr

29、oduct may contain no more than (a) 110 mg per 100 kJ of inulin-derived substances; or(b) 290 mg per 100 kJ of galacto-oligosaccharides; or(c) 290 mg per 100 kJ of combined inulin-derived substances and galacto-oligosaccharides, where the inulin-derived substances is no more than 110 mg per 100 kJ.(2

30、) For subclause (1) the maximum permitted amount only applies when the substances are added. In that case the maximum permitted amount then applies to the sum of the naturally occurring and the added substances. 10 Limit on aluminium(1) Infant formula product, other than a pre-term formula or soy-ba

31、sed formula product, must contain no more than 0.05 mg of aluminium per 100 mL.(2) Pre-term formula must contain no more than 0.02 mg of aluminium per 100 mL.(3) Soy-based formula must contain no more than 0.1 mg of aluminium per 100 mL.Editorial note:Standard 1.4.1 contains the maximum level (ML) of lead contaminant in infant formula products. Subdivision 4 General labelling and packaging requirements11 Representations of food as infant formula productA food must not be represented as an infant formula product unless it complies with th