Lecture 9- Pre-market authorization Flashcards
Who is the competent authority for novel foods, new food additives (new food-related products)?
Health Administration under the State Council
What are examples of special foods?
- New functional ingredients to be used in health foods
- Food for Special Medical Purposes (FSMP)
- Infant formula
Who is the competent authority for special foods?
Food and Drug Administration under the Sate Council
What is the Chinese definition of food additives?
“[A]ny synthetic or natural substance added to food for improving its quality, color, flavor, or taste or as needed by antiseptic, freshness-keeping, or processing techniques, including nutrient supplements”
What is included in the Chinese definition of food additive that is not included in the EU definition?
- flavorings
- enzymes
- processing aids
- chewing gum bases
- addition of vitamins and minerals
What is the definition of Food Safety in Chinese law?
“The assurance that food is non-toxic, harmless, and compliant with reasonable nutritional requirements, and will not cause any acute, chronic and potential hazards to human health”
What is the application procedure for new food additives?
Application dossier -> safety + technological need -> Technical review by the NHC -> Generic approval
What falls under the technical review?
- Public comments
- Onsite inspections
- Technical assessment by experts
What is the definition of novel foods in China?
Food and food ingredients that have not been traditionally consumed (one generation/30 years) in China
What are the four categories of novel foods defined under the Administrative Measures on the Safety review of Novel Food Materials (2013)?
- Animals, plants, or microorganisms
- Substances derived from animals, plants, or microorganisms
- Substances of which the structure has been altered
- (Other) newly developed food materials, such as materials resulting from high-tech production methods
What does not fall under novel foods in China?
- genetically modified foods
- food additives
- health foods
What is the application procedure for novel foods?
- application procedure
- technical review
- authorization
China has four categories for novel foods, what about the EU?
The EU has 9 categories
What is the definition of Health Food in China?
Health foods are foods that promote and protect health, health foods do not serve to prevent or treat a disease
What are the two categories Health Foods in China?
- Functional health foods
- Nutritional supplements
- Conventional foods cannot be health foods
What is the application procedure for Health Foods?
- Registration procedure through the SMAR
- Technical review
- Authorization
What is included in the technical review of Health Foods during the application procedure?
- Application dossier
- Technical evaluation and onsite inspection
- health claims limited to a list of 27 permitted physiological parameters
- full product review
Listed function ingredients are subject to notification procedure at a provincial level with no technical review except?
Except for imported functional health foods which require a registration procedure and nutritional supplements that require a notification at the national level
Why is a comparison with EU law relevant again?
- Certain use of additives used in the EU may be not permitted in China and need market authorization
- Novel foods exported to China must be proven legally produced and market in the EU
What is the definition of FSMP in China FSL?
“Foods that meet the special need of the population with eating restrictions, disorders of digestion and absorption, metabolic disorders, or special diseases with respect to nutrients or diets”
What is the application procedure for FSMP?
- SAMR
- Application dossier
- Clinical tests required for FSMP with complete nutrition targeting specific subpopulations
What is the definition of infant formula in China?
-infant formula: (0-6m)
stage 1
-older infant formula: (6-12m) stage 2
-young children formula: (12-36m) stage 3
Explain the application procedure for infant formula in China?
- it is applicant specific
- different brands cannot have the same recipe
- food businesses can register up to nine different product formulas of three formula series (all different recipes)
What is required of imported infant formula?
- Facility registration (dairy products)
- Shelf life of at least 3 months upon clearing at customs
- Repackaging (and thus bulk products) are not permitted
- Chinese label must be directly printed on the package (no sticker)
