Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p67
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 182007–185085

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 group (i.e. an infant formula-fed group that is not exposed to the proposed compositional change), an exposure group (i.e. a formula-fed group that is exposed to the proposed compositional change, plus a breastfed reference group. If a breastfed reference group is not included, a rationale for its omission is required.

       (iv) Information on the quality and strength of the evidence must include descriptions of the study design, methodology and characteristics of the study population and study limitations (refer to subsection 3.1.5.A of Guideline 3.1.1) for guidance).

       (v) Evidence to demonstrate there is no risk of nutrient imbalances as a result of infants fed the infant formula product containing the proposed compositional change must be provided. If this evidence is not applicable, a rationale for its omission is required.

(c) Efficacy of the proposed compositional change

    Any nutritive substance (including energy or macronutrient), novel food or novel food ingredient must meet the respective requirements of Guideline 3.3.3 (sections D or E) or Guideline 3.5.2 (section E). In addition, for a compositional change to infant formula products, efficacy and potential beneficial effect(s) of consumption of the substance at the proposed level must be described and supported by evidence as outlined below:

       (i) Description and measures of the physiological, biochemical or functional effect(s) of the substance.

       (ii) Description and measures of a health outcome. If no health outcome is specified, a rationale must be provided for its omission.

       (iii) Study designs must align with the requirements for nutritional safety and tolerance outlined in paragraph A.3.1(b) of this Guideline (3.6.2).

Note:

The beneficial role of substances in infant formula products may be determined by the measurement of physiological, biochemical or functional effects and health outcome. Examples of these effects include enzyme pathways, blood levels, microbiological composition and counts, liver, kidney, gastrointestinal or other organ functions. An example of a possible health outcome may be reduced incidence of diarrhoea or ear infection.

Evidence from non-human studies will add weight to the determination of a substance's role, particularly in understanding the mode of action.

     A.3.2 For a food additive or processing aid

Compositional changes involving a food additive or processing aid must meet the respective safety requirements of Guidelines 3.3.1 and 3.3.2. In addition, the following must be provided:

(a) Tolerance of the proposed compositional change

    Evidence to support tolerance must include appropriate human studies. This includes an explanation of the way in which this evidence relates to infants.

(b) Efficacy of the proposed compositional change