Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p65
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 176191–179501

the proposed level in the relevant infant formula product(s). Where an added substance or compositional change has multiple purposes or functions, then these must be specified. This includes information on the target infant population(s) e.g. healthy term infants aged 0–12 months, or infants older than 6 months.

     A.2 General data requirements for supporting evidence

This includes the general evidential requirements whereas A.3 includes the specific information required for the assessment of nutritional safety and efficacy.

Studies provided as evidence to support an application must contain sufficient detail to enable an independent assessment of the methods and results to confirm the study conclusions.
An application must include human studies as supporting evidence for nutritional safety, tolerance and the efficacy of the proposed compositional change. This can include published studies, detailed reports of unpublished studies and systematic reviews (with underlying studies also provided). It may be acceptable in certain cases not to include human studies. In this situation, safety and efficacy must be demonstrated by relevant data (as specified elsewhere in this Handbook); and the application must include an explanation of why human studies are not applicable.

Note:

Further information on design and reporting of data and data quality is found in subsection E of Guideline 3.1.1.

Discussion and guidance on data requirements for changes to infant formula products is available from the following:

    (a) The US Institute of Medicine, Food and Nutrition Board guidelines that clarify the types and extent of safety testing necessary for new formula ingredients, particularly unconventional substances derived from novel sources or technologies. http://www.iom.edu/Reports/2004/Infant-Formula-Evaluating-the-Safety-of-New-Ingredients.aspx.
    (b) The US Food and Drug Administration discussion paper prepared by the US Academy of Pediatrics on the clinical testing of infant formulas which can be found at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm170649.htm.

     A.3 Specific information requirements for the nutritional safety, tolerance and efficacy of the proposed compositional change

This describes evidential requirements that must be addressed for a proposed change to the composition of infant formula products and it is divided into two components depending on the category of compositional change.

An application that relates to addition or changing the level of a nutritive substance (including energy or macronutrient), novel food or novel food ingredient must address the requirements listed in subsection A.3.1 of this Guideline (3.6.2).

An application that relates to a food additive or processing aid must address the requirements listed in component in subsection A.3.2 of this Guideline (3.6.2).

     A.3.1 Nutritive substance (including energy or macronutrient), novel food, or novel food ingredient

(a) 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