Identify the intended population
State who the product is intended for and the nutritional purpose it serves. The population-specific requirements apply alongside the product’s actual legal category in its market.
Children and young people
Specify the age range and explain the basis for composition, serving and suitability.
Pregnancy and lactation
Identify the intended life stage and provide evidence relevant to the proposed dose and use.
Older people
Describe the population and nutritional need rather than treating all older adults as one group.
Other defined needs
Explain the particular nutritional requirement and conditions of use.
Describe the product and its use
Make the category, intended population and instructions consistent across the application.
| Information | Include |
|---|---|
| Category and market | The product’s legal category, where it is supplied and the basis for that status. |
| Age or life stage | The intended age range or population and any exclusions. |
| Nutrition and preparation | Composition, serving or dose, frequency, preparation and feeding instructions where relevant. |
| Role of the product | Whether it supplies complete or partial nutrition and the context in which it is used. |
| Supervision | The actual label instructions where medical supervision is required. |
Evidence for the intended users
Explain how the evidence applies to the stated population, formulation and use. Include the basis for suitability, relevant safety information and limitations.
If evidence comes from a different population, identify the difference and explain the justification and limits of applying it here. General adult data cannot simply be scaled down for children or transferred to another life stage without that explanation.
Clinical and infant nutrition
These categories have additional requirements for composition, evidence, the proposed public award statement and mark use.
Foods for special medical purposes
Requirements for the stated dietary-management need and conditions of medical supervision.
Clinical nutrition requirementsInfant and young-child nutrition
Requirements for the age range, product category, feeding context and market.
Infant and young-child requirementsSpecialist assessment and documents
Review assignments follow the population and subject expertise needed for the entry, with clinical, food-science or regulatory input where the category requires it.
- Include the common product and evidence documents.
- Add the information for the specified population and conditions of use.
- Explain the proposed public description and the markets in which recognition would be communicated.
- Keep identifiable patient and child records out of the submission.