DEFINITION
The table below provides a comparative overview of how various countries and regions define and regulate novel foods. It highlights key regulatory authorities, definitions, and approval processes, reflecting the global diversity in novel food governance.
|
Country/Region |
Definition of Novel Food |
Regulatory Authority / Notes |
|---|---|---|
|
Australia / New Zealand |
Non-traditional foods: any food or food-derived with no significant history of consumption, or those with potential for adverse effects due to composition, preparation, source, or consumption levels and requiring public health and safety assessment considerations. Includes plants, animals, extracts, probiotics, single chemicals, etc. |
FSANZ (Food Standards Australia New Zealand) [5]; novel food regulated under Standard 1.5.1. Requires pre-market health and safety assessment. |
|
Brazil |
Foods or substances with no history of consumption, or foods containing existing substances used at much higher levels than in the regular diet. |
Regulated by ANVISA. 1999 Guidance and RDC 839/2023 updated definitions and strengthened risk assessment processes. [11, 31] |
|
China |
“New food raw materials” are items with <30 years of consumption history in a Chinese province. Includes new animals, plants, microbes, isolated components, and structurally changed ingredients. |
Approval process managed under the “New Food Raw Materials” framework, still in use as of 2025. [27, 28, 29, 30] |
|
Europe (EU) |
Any food not significantly consumed in the EU before 15 May 1997. Includes foods with new structures, from new sources (e.g., fungi, algae, animals, cell/tissue cultures), novel production processes, nanomaterials, etc. |
Regulated under Regulation (EU) 2015/2283 [1]. Requires EC approval and possibly EFSA safety assessment [48]. Specific categories like GMOs, enzymes, additives are excluded and governed by separate laws. |
|
India |
Foods or ingredients with no history of consumption in India, or made with innovative processes that alter composition or nutritional profile, or never used before. |
Regulated by FSSAI under 2016 regulations. Approval required by the Scientific Panel for safety. [32] |
|
South Africa |
No formal definition or specific regulations for novel foods. |
Regulated generally under the Department of Health (DOH); lacks a dedicated novel food framework. |
|
United States |
No formal definition of novel foods. |
Regulated jointly by the FDA and USDA, depending on the product. Oversight based on general food safety laws and technology-specific guidelines. [3] |
