Define the product and age range
Identify the exact product type, the intended age in months where appropriate and the market covered by the entry. Infant formula, follow-on products and foods for young children are distinct categories.
- State the intended feeding context and age range.
- Identify the formulation, pack and label version.
- Explain the market classification and any restrictions relevant to the application.
Composition and suitability
Include the information needed to assess the product for the stated age and conditions of use.
- Composition specifications, quantities, units and data sources.
- Preparation and feeding instructions, including water or dilution information where relevant.
- Warnings, exclusions and the basis for suitability at the stated age.
- Quality, stability and relevant batch records with dates and scope.
Evidence for the intended age
Evidence needs to address the intended age, formulation and use. Where a source concerns a different product or population, explain the relationship and the limits of applying it.
General adult studies are not a substitute for age-relevant evidence without a sound and explicit justification. Submit published or appropriately de-identified supporting material; do not include identifiable child or patient records.
Public information and award statements
The category review considers the public record, product image, award wording, digital mark and any physical labels for the specified market.
An award statement must not imply superiority to breastfeeding or be used for a prohibited promotion. The assessment of a product and permission for a particular public presentation are separate decisions. Provide the full context of the proposed presentation, including nearby wording and images.
Preparing the application
The category requirements bring together infant or paediatric nutrition, product safety and relevant market expertise. Supply the age, composition, evidence and publication information with the common application documents.