China Regulatory Status
Regulatory Agency
National Medical Products Administration (NMPA) (formerly known as State Food and Drug Administration)
Regulatory Category(ies)
- GOS, FOS: Nutrition fortifier
- Inulin: Novel food
- Lactulose: Food additive
- Health food (with health function). This is one of 27 accepted health functions for a health food. However, there is no link between an ingredient and accepted health claim.
Prebiotic Types
‘Fructooligosaccharides (FOS), Inulin, Galactooligosaccharides (GOS), Lactulose
Fiber Definition
No information available
Position on "Prebiotic Claim"
- Consensus: FOS, GOS and Inulin are prebiotics
- No reference to “prebiotic” made from internet search
Rationale if not permitted (Include Reference / Regulation)
Not applicable
Facts Panel Declaration (per category)
Depending on ingredient, used in food, health food, baby food, supplements allowed
Approved Health Claim(s)
- Prebiotic claim is used mainly online; not always allowed (i.e., not on infant food label/on-pack)
- Regulating gastrointestinal flora
Dose Specifics
No information available
Regulatory Submission
No information available
Claims Substantiation
No information available
Regulatory Approval Process
- Depending on the ingredient, food ingredient, novel food, food additive, etc.
- Pre-market 4-step process over a 1-2 year period, as follows:
- Local Testing
- Formal Review
- Expert Review
- Administrative Review
Post-Approval Process (i.e., Amendment and Renewal)
No information available
Enforcement Practice
- High level of rejected imported shipments for minor label errors
Link to Reference Documents
No information available
If you have updated information for this page, please submit it to Regulatory Lead Tania John for review: tjohn@nutrasource.ca. Thank you.