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FSANZ call for comments on revisions to regulatory requirements for infant formula


On September 8, 2021, the Food Standards Australia New Zealand (FSANZ) issued Notification Circular 170-21, which call for comments on
Proposal P1028 – Infant Formula Consultation Paper 3 - Regulatory framework and definitions.

FSANZ proposes the following regulatory and risk management approaches for Standard 2.9.1 and relevant schedules.

1) Deferring consideration of requirements to permit new novel foods and nutritive substances in infant formula products to the broader review of the Code’s provisions applicable to all foods.

2) Amending Schedule 25 Novel foods to include conditions for existing permissions for novel foods to restrict them from use in infant formula products, infant foods, and formulated supplementary food for young children (FSFYC).

3) Regulating special infant formulas that are sole or principal sources of nutrition as infant formula products. Supplementary infant products such as human milk fortifiers are proposed to be regulated by Standard 2.9.5.

4) Amending definitions for infant formula products, infant formula, and IFPSDU (including subcategories of IFPSDU).

5) Renaming specialised infant formulas as ‘infant formula products for special medical purposes’ (IFPSMP) which introduces consistency with Standard 2.9.5. Along with this change, new or amended provisions are proposed for compositional requirements and defining the purpose of products categorised as IFPSMP, extension of use beyond infancy, restriction of sale and labelling considerations.

The deadline for solicitation is October 6, 2021.

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