Navigating CFDA Testing in China

Functional Health Food is required to undergo various tests in CFDA certified labs in China in order to apply for a “Blue Hat” functional health food certificate. The tests required for each product depends on their functional health claim. Whereas relative simple animal tests are required for health food with claims such as “Enhancing the Immune system” and “Increasing Bone Density”, more extensive and complicated tests are required for products with claims like “Weight loss” and “Improving Growth and Development”. In this article, we have provided a brief overview of the tests required for various functional health food claims.

It is not possible to include all information on these tests in this simple overview. Any questions concerning these tests including sample requirements, documentations, etc. can be sent to info@knudsencrc.com

Health Food Function Claims and Tests Required

Table 1. Tests required for Functional Health Food

No. Testing Items
1

Physical, chemical, hygienic, stability, active ingredient etc. tests:
(Both Nutritional supplements and Function Health Food are required)

2 Toxicology test
3-1

*Function Group A /Animal Test

1. Enhancing the immune function

2. Improving sleeping quality

3. Alleviating physical fatigue

4. Enhancing anoxia endurance

5. Assisting irradiation hazard protection

6. Increasing bone density

7. Liver protection

3-2 *Function Group B/ Human Test

1. Alleviating eye fatigue

2. Removing acne

3. Removing chloasma

4. Improving the skin moisture condition

5. Improving the skin oil condition

3-3 *Function Group C /Human Test+ Animal Test

1. Assisting blood lipids reduction

2. Assisting blood sugar reduction

3. Antioxidant

4. Assisting memory improvement

5. Alleviating lead excretion

6. Throat clearance

7. Assisting blood pressure reduction

8. Facilitating lactation function

9. Weight loss

10. Improving the growth and development

11. Improving the nutritional anemia

12. Improving the intestinal flora condition

13. Promoting digestion

14. Alleviating constipation

15. Protecting on gastric mucosal injury

4 Doping test:

1. Alleviating physical fatigue

2. Weight loss

3. Improving the growth and development

* For more information, please, refer to the Table 2

Table 2. Types of Function Claims and Tests Required

NO. Types of Function claims Tests Required
1 Enhancing the immune function
增强免疫力功能
Animal Test*
  1. Organ/Weight Ratio
  2. Cellular Immunity
  3. Humoral Immunity
  4. Mononuclear phagocyte
  5. NK cells activity
2 Assisting blood lipids reduction
辅助降血脂功能
Animal Test*
  1. TC
  2. TG
  3. HDL-G
  4. LDL-G
Human Test
  1. TC
  2. TG
  3. HDL-G
  4. LDL-G
3 Assisting sugar lipids reduction
辅助降血糖功能
Animal Test* Plan A:

  1. FBG (Fasting Blood Glucose)
  2. Glucose Tolerance

Or Plan B:

  1. FBG
  2. Glucose Tolerance
  3. TC
  4. TG
Human Test
  1. FBG
  2. 2-hour postprandial blood glucose
  3. HbAlc or GSP
  4. TC
  5. TG
4 Antioxidation
抗氧化功能
Animal Test*
  1. Products of lipid oxidation: MDA or 8-Isoprostane
  2. Products of protein: CPOs
  3. Antioxidant enzyme: SOD
  4. GR
Human Test
  1. Products of lipid oxidation: MDA or 8-Isoprostane
  2. SOD
  3. GR
5 Assisting memory improvement
辅助改善记忆功能
Animal Test*
  1. Step-down
  2. Step-through
  3. Avoidance
  4. MWM
Human Test
  1. Directed memory
  2. Association learning
  3. Image remembrance
  4. Recognizance of senseless pictures
  5. Memory quotient
6 Alleviating eye fatigue
缓解视疲劳功能
Human Test
  1. Symptoms, Ophthalmoscopy, Blood, urine, liver and kidney test, Inquiry of symptoms’ and eye usage before and after test, chest X-ray, ECG, abdominal ultrasound before the test
  2. Duration of photopic vision
  3. Vision test
7 Alleviating lead excretion
促进排铅功能
Animal Test*
  1. Blood lead level
  2. Bone lead level
  3. Liver lead level
Human Test
  1. Blood lead level
  2. Urine lead level
  3. Urinary calcium
  4. Urinary zinc
8 Throat clearance
清咽功能
Animal Test*
  1. Rat cotton ball implantation test
  2. Rat foot swelling test
  3. Mouse ear swelling test
Human Test Symptoms and Vital sign
9 Assisting blood pressure reduction
辅助降血压功能
Animal Test*
  1. Blood pressure
  2. Heart rate
Human Test
  1. Symptoms and vital sign
  2. Blood pressure
  3. Heart rate
10 Improving sleeping quality
改善睡眠功能
Animal Test*
  1. Prolonged sleep time of sodium pentobarbitone
  2. Sub-threshold dose test of sodium pentobarbital or sodium barbital
  3. Incubation period induced by sodium pentobarbital
11 Facilitating lactation function
促进泌乳功能
Animal Test*
  1. Weight of female mice
  2. Weight of newborn mice
Human Test
  1. Breast distension
  2. Lactation
  3. Milk quality: lactoprotein
12 Alleviating physical fatigue
缓解体力疲劳
Animal Test*
  1. Load-bearing swimming
  2. LAC
  3. Urea
  4. Hepatic glycogen or muscle glycogen
Doping test
13 Enhancing anoxia endurance
提高缺氧耐受力功能
Animal Test*
  1. Anti-hypoxia experiment under normal pressure
  2. Survival test of sodium nitrite poisoning
  3. Survival test of acute brain ischemia
14 Assisting irradiation hazard protection
对辐射危害有辅助保护功能
Animal Test*
  1. PWBC
  2. DNA index or nucleated cell count in bone marrow
  3. Blood or tissue SOD
  4. Serum hemolysis
15 Weight loss
减肥功能
Animal Test*
  1. Weight gain
  2. Food intake, total calorie intake
  3. Body fat weight
  4. Body fat ratio
Human Test
  1. Waist, hip
  2. Body fat percentage
Doping test
16 Improving the growth and development
改善生长发育功能
Animal Test*
  1. Body length
  2. Food utilization
Human Test
  1. Height
  2. Chest width
  3. Bicep Circumference
  4. Lipid content
Doping test
17 Increasing bone density
增加骨密度功能
Animal Test*
  1. Bone calcium content
  2. Bone density
18 Improving the nutritional anemia
改善营养性贫血
Animal Test*
  1. Hb
  2. HCT/FEP
Human Test
  1. Hb
  2. SF
  3. FEP/Tfs
19 Liver protection
对化学肝损伤有辅助保护功能
Animal Test* Plan A:

  1. ALT
  2. AST
  3. Histopathological examination of liver

Or Plan B:

  1. MDA
  2. GSH
  3. TG
  4. Histopathological examination of liver
20 Removing acne
祛痤疮功能
Human Test
  1. Number of acne
  2. Skin injury
  3. Skin oil (oil content on glabella)
21 Removing chloasma
祛黄褐斑功能
Human Test
  1. Chloasma area
  2. Chloasma color
22 Improving the skin moisture condition改善皮肤水份功能 Human Test Skin moisture (water content on glabella)
23 Improving the skin oil condition
改善皮肤油份功能
Human Test Skin oil (oil content on glabella)
24 Improving the intestinal flora condition调节肠道菌群功能 Animal Test*
  1. Bifidobacterium
  2. Lactobacillus
  3. Enterococcus
  4. Enterobacteriaceae
  5. Clostridium perfringens
Human Test
  1. Bifidobacterium
  2. Lactobacillus
  3. Enterococcus
  4. Enterobacteriaceae
  5. Clostridium perfringens
  6. Bacteroides
25 Promoting digestion
促进消化功能
Animal Test*
  1. Weight gain, food intake, food utilization
  2. Intestine movement
  3. Digestive enzyme activity
Human Test
  1. For child: Appetite, Food intake, Picky eating, Weight, Hb
  2. For adult: Symptom, Stomach/intestine movement
26 Alleviating constipation
通便功能
Animal Test*
  1. Intestine movement
  2. Defecting time
  3. Stool grains quantity
  4. Stool appearance
Human Test
  1. Symptom and vital sign (constipation, blood test, urine test, etc.)
  2. Stool appearance
  3. Defecting frequency
  4. Defecting condition
27 Protecting on gastric mucosal injury
对胃粘膜损伤有辅助保护功能
Animal Test*
  1. Gastric mucosal injury condition
  2. Gastric mucosal injury Integral
Human Test
  1. Symptom (Stomach ache, reflux, abdominal distention, etc.)
  2. Vital Sign (Mental health condition, blood test, urine test, etc.)
  3. Gastroscopy

* Measurement of animal weight is required

Example:

Antioxidation

Items, Principles and Result Assessment

  1. Items
    • Animal test
      • Record the weight of animal
      • Products of lipid oxidation: MDA or 8-Isoprostane
      • Products of protein: CPOs
      • Antioxidant enzyme: SOD
      • GR
    • Human test
      • Products of lipid oxidation: MDA or 8-Isoprostane
      • SOD
      • GR
  1. Principles
    • All the items listed for animal test and human test are essential
    • Either MDA or 8-Isoprostane can be chosen for products of lipid oxidation testing. For animal test, either SOD or GR can be chosen for testing
    • You can choose either choose oxidation injury model or aging model for testing
    • For human test, further observation is required to ensure the food safety (mental health condition, urine test, blood test, liver test, chest X-rays, etc.)
  2. Result Assessment
    • Animal test: if three of the four indexes (products of lipid oxidation, products of protein, SOD, and GR) are positive, it can be concluded that the result of antioxidation function test for the animal test is positive.
    • Human test: if two of the four indexes (products of lipid oxidation, SOD, GR) are positive and the product does no harm to the human body, it can be concluded that the test sample has antioxidation function.