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Labeling Requirements	Must meet strict CFS 21 Part 107 labeling and nutritional information requirements for infant formula.	Must comply with harmonized EU labeling rules, including allergens, nutrition info	Must comply with FSANZ labeling codes	Must follow GB labeling standards, including mandatory warnings	Must follow specific infant food labeling rules under FSSAI
Nutritional Composition Requirements	Specific nutrient content, quality control & Good Manufacturing Practices (GMP) required	Detailed compositional criteria for energy, protein, vitamins, and minerals	Must meet nutrition content standards specified by FSANZ	Stringent GB compositional standards; new updates in 2021	As per Schedules under FSSAI regulations, modeled on Codex guidelines
Claims Allowed	Limited; FDA approval required for structure-function or health claims	Only EU-authorized claims permitted; No health or nutritional claims on infant formula	Functional and nutrient claims allowed within Regulatory limits	Strict control; health/nutritional claims require SAMR review	Only pre-approved nutrition claims allowed; therapeutic claims not permitted
Clinical Evidence Required?	Yes – Especially for new formulations or ingredients	Yes – EFSA scientific dossier for novel ingredients or composition	Required for novel ingredients or changes in nutrient bioavailability	Yes – For new products or ingredient combinations	Yes – If deviating from standard composition or for novel formulations
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Need for Local Representative	Yes	Yes	No	Yes	Yes

Vangueria agrestis (Fadogia agrestis) Extract Considered a Novel Food in the EU

June 25, 2025

The application concerns a 10:1 extract from the root, stem, and aerial parts of Vangueria agrestis, intended for use in capsule form as a food supplement (2001000 mg/day).
The extract is produced via drying, grinding, and extraction using water, alcohol, or CO?, followed by filtration and standardization.
It contains active compounds: flavonoids (1525%), alkaloids (510%), and saponins (512%).
There is no documented history of its consumption in the EU prior to 15 May 1997.
Therefore, under Article 3(2)(a)(iv) of Regulation (EU) 2015/2283, it is officially considered a novel food.

Source

https://food.ec.europa.eu/document/download/e424ab6e-30c8-49fb-931c-ae9e23c4f87…

Consumer News Region

European Union

Consumer News Tags

Novel Food, Europen Union, Vangueria agrestis

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Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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Vangueria agrestis (Fadogia agrestis) Extract Considered a Novel Food in the EU

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