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LAW 39806 > Lecture 9- Pre-market authorization > Flashcards

Lecture 9- Pre-market authorization Flashcards

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1
Q

Who is the competent authority for novel foods, new food additives (new food-related products)?

A

Health Administration under the State Council

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2
Q

What are examples of special foods?

A
  • New functional ingredients to be used in health foods
  • Food for Special Medical Purposes (FSMP)
  • Infant formula
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3
Q

Who is the competent authority for special foods?

A

Food and Drug Administration under the Sate Council

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4
Q

What is the Chinese definition of food additives?

A

“[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”

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5
Q

What is included in the Chinese definition of food additive that is not included in the EU definition?

A
  • flavorings
  • enzymes
  • processing aids
  • chewing gum bases
  • addition of vitamins and minerals
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6
Q

What is the definition of Food Safety in Chinese law?

A

“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”

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7
Q

What is the application procedure for new food additives?

A

Application dossier -> safety + technological need -> Technical review by the NHC -> Generic approval

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8
Q

What falls under the technical review?

A
  • Public comments
  • Onsite inspections
  • Technical assessment by experts
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9
Q

What is the definition of novel foods in China?

A

Food and food ingredients that have not been traditionally consumed (one generation/30 years) in China

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10
Q

What are the four categories of novel foods defined under the Administrative Measures on the Safety review of Novel Food Materials (2013)?

A
  • 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
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11
Q

What does not fall under novel foods in China?

A
  • genetically modified foods
  • food additives
  • health foods
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12
Q

What is the application procedure for novel foods?

A
  • application procedure
  • technical review
  • authorization
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13
Q

China has four categories for novel foods, what about the EU?

A

The EU has 9 categories

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14
Q

What is the definition of Health Food in China?

A

Health foods are foods that promote and protect health, health foods do not serve to prevent or treat a disease

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15
Q

What are the two categories Health Foods in China?

A
  • Functional health foods
  • Nutritional supplements
  • Conventional foods cannot be health foods
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16
Q

What is the application procedure for Health Foods?

A
  • Registration procedure through the SMAR
  • Technical review
  • Authorization
17
Q

What is included in the technical review of Health Foods during the application procedure?

A
  • Application dossier
  • Technical evaluation and onsite inspection
  • health claims limited to a list of 27 permitted physiological parameters
  • full product review
18
Q

Listed function ingredients are subject to notification procedure at a provincial level with no technical review except?

A

Except for imported functional health foods which require a registration procedure and nutritional supplements that require a notification at the national level

19
Q

Why is a comparison with EU law relevant again?

A
  • 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
20
Q

What is the definition of FSMP in China FSL?

A

“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”

21
Q

What is the application procedure for FSMP?

A
  • SAMR
  • Application dossier
  • Clinical tests required for FSMP with complete nutrition targeting specific subpopulations
22
Q

What is the definition of infant formula in China?

A

-infant formula: (0-6m)
stage 1
-older infant formula: (6-12m) stage 2
-young children formula: (12-36m) stage 3

23
Q

Explain the application procedure for infant formula in China?

A
  • 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)
24
Q

What is required of imported infant formula?

A
  • 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)

LAW 39806 (12 decks)

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