P93 Infant Formula SOR

Supplementary Final Assessment - (Inquiry - s .24)

Supplementary Report [ PDF format 117 kb ]

PROPOSAL P93 - FOR RECOMMENDING A STANDARD FOR INFANT FORMULA PRODUCTS

The Australia New Zealand Food Authority (ANZFA) has before it Proposal P93 to develop a draft standard for infant formula products for inclusion in Volume 2 of the Food Standards Code and a draft variation to Standard A11 in Volume 1 and Standard 1.3.4 in Volume 2 of the Food Standards Code.

STATEMENT OF REASONS

ANZFA recommends the adoption of the draft Standard and draft variations, as amended, for the following reasons:

  1. to protect the health and safety of formula-fed infants, who are the most vulnerable group in the Australian and New Zealand population and who may consume infant formula products as the sole or principal source of nourishment;
  2. to ensure carers have adequate information about infant formula products to enable them to make appropriate choices in feeding their infant and in the safe use of products;
  3. to ensure that food regulations reflect contemporary scientific knowledge about breast milk substitutes and infant nutritional requirements to protect the health of infant consumers;
  4. to ensure that innovation in the infant formula industry that would benefit infant health is not hindered; and
  5. to harmonise the food regulations applying to infant formula products in Australia and New Zealand.

Following consideration of public comments and an assessment against the objectives of the Australia New Zealand Food Authority Act 1991 (ANZFA Act), a draft standard for Infant Formula Products has now been prepared, for Volume 2, with draft variations recommended for Standard A11 (Volume 1) and Standard 1.3.4 (Volume 2) of the Food Standards Code.

The proposed standard includes provisions for different categories of infant formula products to cater for different ages and special purpose formula intended for infants with specific diseases or disorders that contraindicate breastfeeding or the use of formula for healthy infants.

The proposed provisions are generally aligned internationally except where necessary to protect the health of infants in Australia and New Zealand. The following elements have been incorporated into the proposed standard -

  • The quality and quantity of the protein content of infant formula products are regulated but it was considered not necessary to regulate the protein source. However, information about the source of protein will be declared on the label to assist carers make suitable product selection.
  • The total energy, total fat, and essential and long chain polyunsaturated fatty acid contents are regulated to ensure infants who are formula fed receive sufficient but not excess energy and fatty acid intakes. Fatty acids that are considered harmful to infants are restricted where necessary to protect infants from adverse health consequences.
  • The carbohydrate content of infant formula is indirectly controlled by the regulations on protein, fat and energy content.
  • Unlimited vitamin and mineral contents for infant formula products represented as human milk substitutes are not recommended as in the best interests of infants, and maximum levels of these nutrients have been imposed. To eliminate unnecessary cost for industry, mandatory maximum levels are prescribed only for those vitamins and minerals which are considered to pose a significant risk to infants if consumed in excess, whilst advisory maximum levels are recommended for other nutrients whose risk characterisation is provisionally assessed as 'not of significance on the basis of current scientific knowledge'. Guidelines are included to provide manufacturers with guidance as to these recommended maximum levels and the implementation of these guidelines is expected to occur by Good Manufacturing Practice.
  • The potential renal solute load of follow-on formula and infant formula for metabolic, immunological renal, hepatic or malabsorptive conditions is regulated to minimise the risk of dehydration illness from formula with high protein and electrolyte contents.
  • Permission is given to voluntarily add carnitine, taurine, choline, inositol and specific nucleotides to infant formula. The maximum permitted content of these substances in infant formula is regulated, as is the minimum claimable level.
  • Novel ingredients, nutrients, nutritive substances or novel sources of these are required to be assessed as safe and suitable for infants (under Standard 1.5.1 - Novel Foods) prior to approval being given for their use in infant formula products.
  • Limits for lead and aluminium contents are imposed to protect infants. The limit for lead is controlled within Standard 1.4.1 - Contaminants and Natural Toxicants. An advisory labelling statement to alert carers to seek specific health advice is proposed for formula with unnecessarily high fluoride contents as sold.
  • The risk to infants in Australia and New Zealand from potential gluten content of infant formula is such that gluten is directly prohibited in infant formula products.
  • ANZFA supports the use of soy-based infant formula by infants for whom human milk or a modified cow's milk formula is contraindicated. Soy-based infant formula products will be regulated as special purpose infant formula products if a nutrient claim or a claim for special medical purpose is made for the product; other wise they will be regulated as general purpose infant formula products.
  • Microbiological criteria and the use of specific food additives are recommended to ensure safety of infant formula. The microbiological criteria are contained within the Standard 1.6.1 - Microbiological Limits for Foods and Standard 1.3.1 - Food Additives provides specific permissions on food additives in infant formula.
  • Specific labelling is required to inform carers to seek health advice to determine whether formula is the most appropriate method of feeding and if so, whether the specific formula is most appropriate for the individual infant. Labelling is also required to ensure carers have advice as to the nutritional content of the formula and the safe preparation, storage, and use of the formula. The relevant labelling provisions of the WHO International code of Marketing Breast-milk Substitutes are also reflected within the Standard. These include a reference to breast milk as the optimum source of nourishment for infants so that potential purchasers of infant formula products can be informed of the full range of feeding options.

The specific provisions in the drafting prepared after Full Assessment (1995), Preliminary Inquiry (May 1999), Inquiry (November 1999) and Supplementary Final Assessment (Inquiry - s24) (Feb 2002) have been amended for the following reasons:

Purpose

  • The word ' microbiological' has been deleted from this part of the standard to reflect the change to Clause 27 detailed below.
  • Reference to Standards that contain requirements pertaining to Standard 2.9.1 have been included.
  • The term ' added nutrients' has been included in reference to Standard 1.3.4 containing specifications for certain oils used as sources of long chain polyunsaturated fatty acids.

Clause 1 - Definitions

  • Inclusion of definitions from clauses 1 and 2 of Standard 1.2.8 as this standard does not apply to infant formula products unless specified.
  • The definitions for infant formula product, infant formula, follow-on formula, lactose-free and low lactose, and pre-term formula have been altered as follows:
  • Concerns were raised in submissions about the proposed definition of infant formula products stating that these are suitable as the principal source of nourishment for infants, when those over 6 months of age are being introduced to weaning foods. The definition for infant formula product has therefore been revised to: a product based on milk or other edible food constituents of animal or plant origin and which is nutritionally adequate to serve as, the principal liquid source of nourishment for infants.
  • The definition of infant formula has been changed to be consistent with the then intent of the draft codex standard. The new definition is: an infant formula product represented as a breast milk substitute for infants and which satisfies the nutritional requirements of infants aged up to four to six months.
  • The definition of follow-on formula has been changed to be consistent with the direction of the codex standard for follow-up formula to acknowledge that it can either replace breast milk or infant formula and to identify the place of follow-on formula in the diet of infants who are being introduced to new foods. The new definition is: 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 infants aged from six months.
  • The definition of lactose free and low lactose formula has been changed to be consistent with other definitions in the standard. The new definition is: infant formula products which satisfy the needs of lactose intolerant infants.
  • The definition of pre-term formula has been changed to accommodate concerns that pre-term formulae can be used for infants who are both born early or who are of low birth weight. The new definition is: an infant formula product represented as being suitable as the principal source of food for infants born prematurely or of low birth weight.
  • The definition for protein equivalent has been removed, as there is no reference made to this definition in the standard.

Clause 4 - Calculation of protein

  • This clause has been re-formatted for general consistency with Volume 2 of the Food Standards Code.

Clause 5 - Calculation of Potential Renal Solute Load (PRSL)

  • The calculation of PRSL has been modified to exclude the unavailable phosphorus content of formula from the estimation of PRSL. The calculation has also been modified to calculate PRSL using nitrogen rather than protein. Comment was received that manufacturers measure nitrogen, not protein, and therefore the protein value for inclusion in the calculation of PRSL would need to be derived from the nitrogen value.
  • This clause has been re-formatted for general consistency with Volume 2 of the Food Standards Code.

Clause 6 - Calculation of amino acid score

  • This clause has been removed and the table to Clause 6 transferred to Clauses 22 and 32 as calculation of amino acid score is no longer required.

The removal of Clause 6 has reduced the clause numbering by one from that proposed at Preliminary Inquiry (May 99) and the tables to Clauses have been re-numbered accordingly.

Clause 8 Permitted nutritive substances (Now Clause 7)

  • The title of this clause has been changed from ' permitted optional nutritional substances' to ' permitted nutritive substances' to be generally consistent with Volume 2 of the Food Standards Code.
  • The values in the table to Clause 8 for carnitine, choline and inositol have been modified to correct an error at Preliminary Inquiry. The new maximum values are 0.8 mg/100 kJ for carnitine, 7.1 mg/100 kJ for choline and 9.5 mg/100 kJ for inositol.
  • An editorial note has also been added to note that it is the intent of the standard to regulate the maximum level of nutritive substances of formula only when the substance is added to the formula. In this case the maximum level refers to both the naturally occurring level and that which is added as an ingredient. This has arisen over some concerns about the setting of a maximum level for added carnitine, which some groups claimed was lower than the level of carnitine naturally present in milk.

Clause 9 - Limit on nucleotide 5' -monophosphates (Now Clause 8)

  • The figures proposed at Preliminary Inquiry for nucleotides were based upon the EC directive, which appears to have underestimated the levels of nucleotides in breast milk. The drafting has been amended to allow for a maximum permitted total 5' -monophosphate nucleotide content of 3.8 mg/100 kJ as recommended in the Life sciences Research Office (LSRO) report.

Clause 11 - Food additives (Transferred to Standard 1.3.1)

  • The drafting for the permission to add carrageenan has been amended slightly to more expressly permit its addition. The wording proposed at Preliminary Inquiry was interpreted as implying that carrageenan was not permitted to be added.
  • The appropriate food additives numbers have been added to the mono- and di-glycerides entry to clarify which food additives are permitted.
  • This clause has been moved to the Standard 1.3.1 - Food Additives.

The transfer of Clauses 11 and 12 to Standard 1.3.1 - Food Additives has reduced the clause numbering by another two from that proposed at Preliminary Inquiry (May 99) and the tables to Clauses have been re-numbered accordingly.

Clause 10 - Lactic acid cultures (Now Clause 9)

  • The drafting of the this clause has been has been slightly amended by the removal of -subject to Standard 1.6.1- as Standard 1.6.1 has general application and reference to lactic acid cultures should automatically required compliance with Standard 1.6.1.

Clause 11 - Limit on Aluminium (Now Clause 10)

  • Clause 14 (previously Limit on lead) as been removed and replaced with an editorial note referring to Standard 1.4.1 - Contaminants and Natural Toxicants that now contains the limits on lead. This editorial note to Clause 11 has been changed to 'The maximum level (ML) of lead in infant formula products is specified in Standard 1.4.1'to better reflect terminology used in Standard 1.4.1.

Clause 14 - Requirement for a measuring scoop (Now Clause 13)

  • The drafting of this clause has been amended to exempt both single serve sachets, or a package containing single serve sachets from being required to contain a scoop to facilitate the use of infant formula products in accordance with the directions contained in the label on the package.

Clause 15 - Composition of lactose-free and low-lactose formulas (Now Clause 29)

  • This clause has been moved to Part 3, Division 2 - Infant formula products formulated for metabolic, immunological, renal and malabsorptive conditions as it is more appropriately situated in this part of the Standard.
  • The clause has been amended to specify that low lactose formula must contain no more than 0.3 g lactose per 100 mL of infant formula product to be consistent with the new limit imposed for general purpose foods.

Clause 15 - Required statements (Now Clause 14)

  • It was proposed at Preliminary Inquiry that manufacturers place a statement on the label that contained information about the superiority of breast milk over infant formula and that formula should only be used on the advice of a medical practitioner or health worker. The actual wording of the statement was left to manufacturers to develop. There was considerable concern expressed about this in submissions. The drafting of this clause has therefore been amended to require the following statement on labels: Breast milk is best for babies. Before you decide to use this product, consult your doctor or health worker for advice. Clause 14 (3) has been added to exclude products for metabolic, immunological, renal, hepatic or malabsorptive conditions from requiring this statement as it is considered not appropriate for these products
  • It was proposed in subclause (1) to require the statement ' Inappropriate use or preparation can make your baby very ill' . This statement has been amended to ' Incorrect preparation can make your baby very ill' on the advice of stakeholders.
  • the wording to subclause (3)(e) has also been amended to clarify the intent.

Clause 16 - Print and package size (Now Clause 15)

  • The drafting of this clause has been amended to classify a small package as 500g or less. This means that the wording of the warning statements and other required statements will be 1.5mm on these packages, and 3mm on larger packages. This change was made as a result of concerns with the proposal at Preliminary Inquiry that a small package was defined as 1 kg, as the majority of packages of infant formula products are less than 1 kg.

Clause 17 - Declaration of nutrition information (Now Clause 16)

  • This clause has been amended to require nutrient declaration only per 100 mL as consumed and to require the declaration of the weight of product per scoop and proportion of solution on a weight/volume basis for the product to reduce the amount of label space required to provide nutrient information.
  • This clause has been re-formatted to improve clarity.

Clause 18 - Date marking and storage instructions (Now Clause 17)

  • This title of this clause has been amended to be consistent with Standard 1.2.5 - Date Marking of Packaged Foods.
  • A subclause has been included to ensure compliance with Standard 1.2.5
  • The editorial note to Clause 18 has been simplified to 'The appropriate storage instructions should be valid for the full range of climatic conditions that exist in Australia and New Zealand'

Clause 19 - Statement of protein source (Now Clause 18)

  • This clause has been amended to clarify that the declaration of source, or sources, of protein should be specific rather than as class names.

Clauses 23 and 33 - Protein (Now Clause 22 and 32)

  • This clause has been amended to reflect the change in expression of protein quality to mg/100 kJ as at Clause 6. Due to this change the requirement for an amino acid score of 0.8 has been deleted. The Table to clause 6 has been transferred into clauses 23 and 33 and provides the minimum essential amino acid values /100 kJ.
  • The table to Clauses 22 and 32 has been modified to permit the summation of cysteine and methionine; and phenylalanine and tyrosine as originally proposed at Full Assessment (Schedule 1). The units of expression have been modified from amino acid per protein content (g/100 g) to a per energy value (mg/100 kJ). The amino acid values from Schedule 1 (FAO/WHO 1991) have been converted to mg/100 kJ.
  • Human milk is cysteine-rich and methionine-poor but infant formula products are made from cow' s milk proteins that are poor in cysteine but rich in methionine, therefore summation assists to overcome this difficulty. To ensure that some cysteine is present in infant formulas for very young infants, an absolute minimum cysteine content (6 mg/100 kJ) has been prescribed. Additionally for a similar reason a minimum value for phenylalanine (17 mg/100 kJ) has also been included.
  • A subclause has been included to allow addition of amino acids for the sole purpose of improving protein quality.

Clause 24 - Minimum percentage alpha linolenic acid (Now Clause 23)

  • The table to this clause has been amended to reduce the minimum percentage alpha linolenic acid (1.1%) consistent with recent research that shows this level is safe.

Clause 27 - Microbiological standards (Transferred to Standard 1.6.1)

  • The microbiological standards for infant formula products are regulated in Standard 1.6.1 - Microbiological Limits for Foods. This clause has therefore been deleted.

Clause 30 - Fat (Now Clause 23)

  • The drafting of clause 30(d) has been amended to provide for the ratio of total long chain omega 6 series fatty acids (C>= 20) to total long chain omega 3 series fatty acids (C>= 20) of approximately 2 in an infant formula or follow-on formula which contains those fatty acids. This change was made in recognition of the difficulty in ensuring that the ratio is exactly 2.
  • An Editorial Note has been included to provide reference of s pecifications for certain oils as sources of long chain polyunsaturated fatty acids in Standard 1.3.4 - Identity and Purity. These oils were assessed as safe for use in infant formula during the review of infant formula, and the safety assessment is included in the Supplementary Final Assessment (Inquiry) Report.

Clause 31 - Vitamins and minerals (Now Clause 24)

  • The selenium values proposed at Preliminary Inquiry (0.36-0.9 mcg/100 kJ) have been modified to 0.25-1.19 mcg/100 kJ. The maximum level is consistent with the maximum level of selenium recommended by LSRO based upon the upper limits of selenium in breast milk. The minimum level is consistent with the minimum level recommended in the standard for Foods for Special Medical Purposes (infants) recently adopted by the European Commission.
  • The table to Clause 31 has been amended to permit the following forms of vitamins and minerals to be added:

    - Retinyl propionate as a source of vitamin A

    - Cholecalciferol-cholesterol as a source of vitamin D

    - Dl - alpha- tocopherol succinate as a source of vitamin E

    - Phytylmenoquinone as a source of vitamin K

    - Sodium chloride iodised as a source of sodium

    - Cupric citrate as a source of copper

    - Manganese carbonate and manganese citrate as sources of manganese

    - Sodium selenate as a source of selenium

    - Pyridoxine-5' -phosphate.
  • The maximum zinc: copper ratio has been raised to 15:1 for formulas for infants less than 6 months of age and 20:1 for formulas intended for infants over 6 months of age to meet the manufacturing concerns of industry.

Clauses 32-35 - Pre-term formula (Now Clause 25)

  • There was considerable concern expressed by submitters about the levels of vitamins, minerals and fats proposed at Preliminary Inquiry for pre-term formula, particularly in the absence of any international precedents. Clauses 32-35 have therefore been deleted and replaced with the following clause:' Infant formula product may be specifically formulated to satisfy the particular needs of premature infants or infants born low in birth weight and must comply with all the other requirements of this Standard that are not inconsistent with Division' .
  • ANZFA will raise a separate proposal to develop specific provisions for pre-term formula within 5 years of this Standard 2.9.1 coming into effect.

Part 3 Division 2 - Infant formula products formulated for metabolic and immunological conditions

  • The title of this Division has been amended to: Division 2 - Infant formula products formulated for metabolic, immunological, renal, hepatic and malabsorptive conditions. This amendment has been made to more specifically accommodate formulas for these conditions and has the effect of excluding anti-reflux formulas from being described as such.

An exemption from the compositional requirements for these products is provided for a period of 5 years to guarantee supply of specialised products. A Proposal to develop a standard for Foods for Special Medical Purposes (P242) is under development and these products may be covered by this new standard. These products are also exempted from the requirement to label 'Breast milk is best for babies. Before you decide to use this product, consult your doctor or health worker for advice 'as breast milk may not be appropriate for these babies and the advice of a doctor will already be being sought.

Clause 38 - Additional labelling (Now Clause 28)

  • The wording of this clause has been amended slightly to require the additional labelling on the broader range of products now covered under this part of the Standard (i.e. products for metabolic, immunological, renal, hepatic and malabsorptive conditions).

Clause 42 - Other permitted additions (Now Clause 34)

The following changes have been made to the table to Clause 42:

  • the appropriate food additives numbers have been added to the mono- and di-glycerides entry to clarify which food additives are permitted;
  • citric esters of mono- and di-glycerides of fatty acids are permitted for formulas based upon protein substitutes; and
  • the value for DATEM was changed to correct a typographical error of a factor of 10 in the Table at Preliminary Inquiry.

The table to this clause has been moved to the Standard 1.3.1 - Food Additives and therefore the title of the clause has be amended to 'Additional permitted triglycerides'

Specifications

  • As noted at Preliminary Inquiry, the specifications for nucleotides are moved to Standard 1.3.4 - Identity and Purity.
  • Specifications for certain oils as sources of long chain polyunsaturated fatty acids have been included in Standard 1.3.4 - Identity and Purity.
  • The provisions for bacteriological profile under part 9 of this section have been deleted as they are covered by Standard 1.6.1 - Microbiological Limits for Foods.

Regulation Impact

In meeting the objectives of this proposal, ANZFA has assessed the relative costs and benefits of regulatory options and their respective impacts on identified affected parties. As part of Preliminary Inquiry (May 1999), ANZFA undertook a regulation impact analysis. However, in recognition of the significant time delay and changes that have been made to the draft standard as proposed at Inquiry (Nov 1999), the previous draft regulation impact statement as assessed at Preliminary Inquiry has been revised and updated.

The revised regulation impact statement has recommended that the review of regulations for infant formula is of potential benefit to infant health. The Office of Regulation Review has assessed this revised regulation impact statement as adequate.

World Trade Organisation (WTO) Notification

Australia and New Zealand are members of the World Trade Organization (WTO) and are bound as parties to WTO agreements. In Australia, an agreement developed by the Council of Australian Governments (COAG) requires States and Territories to be bound as parties to those WTO agreements to which the Commonwealth is a signatory. Under the Treaty between the Governments of Australia and New Zealand on joint Food Standards, ANZFA is required to ensure that food standards are consistent with the obligations of both countries as members of the WTO.

In certain circumstances Australia and New Zealand have an obligation to notify the WTO of changes to food standards to enable other member countries of the WTO to make comment. Notification is required in the case of any new or changed standards which may have a significant trade effect and which depart from the relevant international standard (or where no international standard exists).

Following Preliminary Inquiry (May 1999), this matter was notified to the WTO as a technical barrier to trade matter as the proposed revisions to the existing infant formula standards are more prescriptive than other standards internationally. One submission from the United States of America was received on this matter.

Food Standards setting in Australia and New Zealand

The Governments of Australia and New Zealand entered an Agreement in December 1995 establishing a system for the development of joint food standards. On 24 November 2000, Health Ministers in the Australia New Zealand Food Standards Council (ANZFSC) agreed to adopt the new Australian New Zealand Food Standards Code. The new code was gazetted on 20 December 2000 in both Australia and New Zealand as an alternate to existing food regulations until December 2002 when it will become the sole food code for both count