Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p66
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 179219–182255

Characterisation of proposed substance or the comparable substances in breast milk

    An application must include information about the presence of the proposed or comparable substance in breast milk. This supporting evidence includes:

       (i) The mean amount and range of the proposed or comparable substance in breast milk. Where possible, include reference to breast milk composition from Australian or New Zealand mothers, or if not available, from mothers. in countries with similar dietary patterns to Australia and New Zealand. The breast milk reference values must be relevant to the type of infant formula product under consideration, for example levels found in colostrum may not be a relevant basis for levels in follow-on formula.

       (ii) The variability of the levels of the proposed or comparable substance and consideration of the influence of maternal diet or other physiological factors. e.g. hormones, biochemical processes.

       (iii) Comparison of relevant biochemical, physiological and functional endpoints between breastfed infants and infants fed the infant formula product containing the proposed composition change.
    Where a proposed or comparable substance is not present in breast milk or no information is available on the presence or function of this substance in breast milk, the application must include an explanation of the reason(s) why the information is not provided.

(b) Nutritional safety and tolerance of the proposed compositional change

    A composition change involving a nutritive substance (including energy or macronutrient) or a novel food or novel food ingredient must meet the respective safety requirements of Guidelines 3.3.3 and 3.5.2.

Note:

The requirement for human studies is primarily intended to establish infant tolerance of the formula and to ensure that the formula is able to support normal infant growth and development (see (i) below) and, in certain circumstances, to ensure no adverse effects on the absorption of essential nutrients.

    The application must include evidence to support the nutritional safety and tolerance of the proposed composition change. This evidence includes:

       (i) Human infant studies demonstrating that the infant formula products containing the substance at the proposed level, will support normal infant growth and development over a minimum interval of 3–4 months, beginning no later than 1 month of age. Reported growth measures must include at least infant length and weight. If studies for infant formula products demonstrating normal growth and development have been conducted for 3–4 months for infants aged from 1 month, additional studies for the same substance at the same level in follow-on formula are not required.

       (ii) The exception to (b)(i) is an application for follow-on formula only (intended for use from 6 months). Studies must monitor and report growth measures for a minimum period of 2 months within the relevant age range.

       (iii) Human infant studies must include a control