China Nutrient Supplements: Significant Regulatory Updates

Administrative Provisions on Nutrient Supplements(draft)and Requirements on Nutrient Supplements Dossiers(draft) English versions available

The establishment of Administrative Provisions on Nutrient Supplement (hereinafter Provisions) and Requirements of Application Dossiers (Hereinafter Requirements) can be regarded as the basis of notification scheme to be launched for nutrient supplements in future. The most important rules set out in the two drafts include the revision of positive lists and instruction for the preparation of application dossiers.

1. What is “Nutrient Supplement”?

China categorizes nutrient supplements as single substance vitamin and mineral supplements as well as vitamin and mineral complexes. It is a category of China’s health food. Supplements can only carry claims purporting to supplement normal vitamins and/or minerals intake.

Figure 1. Categories of China's Health Food

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2. Regulatory Instruments

Figure 2 Nutrient supplements regulatory instruments in accordance with Chinese legal hierarchy

As Figure 2 indicated, the Food Safety Law of People’s Republic of China is the foundation of all regulations and rules pertaining to food. This year’s draft amendment has passed an initial consultation period and is pending promulgation. On the second level, there are no administrative regulations for health foods. The third level concerns department rules. Currently, Administrative Provisions on Health Food Registration establishes a framework for CFDA regulation of nutrient supplements and all other health foods. The forth level relates to normative documents. With regard to the regulation of nutrient supplement, Provisions on Registration and Authorization of Nutrient Supplements plays a vital role and forms the basis for the draft of Provisions and Requirements. After promulgated, Provisions and Requirements are to supplement the above instruments. Administrative Provisions on Nutrient Supplements and Requirements on Nutrient Supplements Dossiers are released for public consultation. The two regulations establish strict technical standards for the nutrient supplements registration.  

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3. Analysis of Positive Lists Established by Provisions

The most important rules laid down in Provisions include the inclusion of a positive list of additive materials and the modification of the effective positive lists relating to vitamins and minerals as well as chemical substances used as sources of vitamins and minerals in the manufacture of food supplements. Table 1 compares the positive lists in force and their revisions established by draft of Provisions. Furthermore, revised positive lists are comparable to that established for the European vitamin and mineral supplements as regulated by 2002/46/EC. A comparison between the two frameworks is discussed in Table 2. 

Table 1: Changes of Positive List Relating to Minerals and Vitamins Used in the Manufacture of Nutrient Supplements 

Note: * Vitamin A and β—carotenes were counted separately. **Several substances may appear twice due to the way to organize them.

Table 2: Comparison between China’s and European Positive List Relating to Minerals and Vitamins Used in the Manufacture of Nutrient Supplements

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4. Introduction of Requirements on Nutrient Supplements Dossier 

Figure. 4 Example of Package Insert 

Terminology and definitions:

Multi-Vitamins/Multi-minerals supplements: Only if three or more vitamins or minerals are contained in the product, it is qualified for being named as multivitamins or multi-minerals supplements

Suitable Group: Product development targets a specific demographic defined as the “suitable group”.

Unsuitable Group:

• If consumption of a supplement poses risk to a specific groups this group is define as an “unsuitable group”.

• If the product is not suitable for infants and young children, pregnant women and lactating mothers they shall be listed in the “unsuitable group”

• For products that are suitable for “adults”, where the recommended daily intake (RDI) associated with specific vitamin and mineral components of the product do not meet the requirements for pregnant women and lactating mothers; they shall be listed in unsuitable group.

• Capsule, chewable tablet or large pill products, should not be used for infant and young children supplements.

Product Name: Power Essentials Super Adult Multi-vitamin product

Labelling Rationale:

• This is a multi-vitamin and multi-mineral supplement. All the raw materials (Vitamin A, Vitamin C……) and additive materials (Stearic Acid, Magnesium Stearate……) shall be indicated and must be consistent with the product formulation.

• The description of functional substances and corresponding contents, the information on nutrient values should be expressed based on the minimum units of consumption and explicitly numerical. Any expression of range shall not be included. As it declares in figure 4 each single dose softgel contains Vitamin A 0.33 mg, vitamin C 59.4 mg……;

• Suitable and Unsuitable Group -The product is aimed at adults who need to supplement multi-vitamins and multi-minerals, but is not aimed at young children.

• The intake amount and instruction for use should be expressed precisely like presented in Figure.4. It should be consumed after a meal, 1 time/day and 1 tablet /time. The intake amount goes first, followed by usage that is suggested.

• To describe the product specification it is necessary to list the net content of the minimum unit of consumption. This product is solid, so the quality is measured with the measurement gram, 2.2 g/tablet.

• The Shelf life as well as the Product Storage is decided on the basis of features and stability of the product. The shelf life of the product is 18 months with the storage condition of room temperature 15-30 ℃(59-86F).

• The product must bear the following disclaimer: this product cannot replace medicine; consumers should not exceed the recommended intake or should not be taken with other nutrient supplements of the same kind.

• Other notes are required based on relevant standards and product properties.

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5.Time Scale for Health Food Registration

For the registration of health foods (not including than nutrient supplements), it usually takes 2 ~ 2.5 years while for nutrient supplements it usually takes 1.5 years . More details on the explanation of the time scale are shown in Table 3.

Table 3 The Health food Registration Time Scale 

Annex 1 51 Testing Agencies accredited by CFDA

1. National Food Safety Risk Assessment Center

2. Chinese Academy of Inspection and Quarantine Comprehensive Testing Center

3. General Logistics Department of the Ministry of Health Drug and Instrument

4. Tianjin CDC

5. Liaoning Institute for Food & Drug Control

6. Liaoning disease Prevention and Control Center

7. Shanghai Institute for Food & Drug Control

8. Shanghai Municipal Center for Disease Control and Prevention

9. Jiangsu Institute for Food & Drug Control

10. Jiangsu Provincial Center for Disease Control

11. Anhui Institute for Food & Drug Control

12. Fujian CDC

13. Jiangxi Provincial Institute for Food & Drug Control

14. Jiangxi Province CDC

15. Henan Provincial Institute of Food & Drug Control

16. Hubei Institute for Food & Drug Control

17. Hubei CDC

18. Hunan Institute for Food &Drug Control

19. Hunan CDC

20. Hunan Hospital for Occupational Disease Prevention

21. Sichuan Institute for Food & Drug Control

22. Sichuan CDC

23. National Institute for Food & Drug Control

24. Beijing Institute for Food & Drug Control

25. Beijing CDC

26. Tianjin Institute for Drug Control

27. Zhejiang Institute for Food & Drug Control

28. Zhejiang CDC

29. Guangdong Institute for Food & Drug Control

30. Guangzhou Drug Control

31. Shenzhen Institute for Drug Control

32. Nanjing Medical and Health Analysis Testing Center

33. Hebei Institute for Food & Drug Control

34. Jilin Institute for Food & Drug Control

35. Jilin Provincial Center for Disease Control and Prevention

36. Heilongjiang Provincial Center for Disease Control and Prevention

37. Fujian Institute for Drug Control

38. Shandong Institute for Food & Drug Control

39. Shandong Center for Disease Control and Prevention

40. Henan Center for Disease Control and Prevention

41. Center for Disease Control and Prevention of Guangdong Province

42. Guangxi Institute for Food & Drug Control

43. Guangxi Center for Disease Prevention and Control

44. Sanitary Inspection Center of Harbin Medical University

45. Center for Sanitary Analysis and Testing of Shandong University

46. Center for Analysis and Testing of West China School of Public Health of Sichuan University

47. Hebei Center for Disease Prevention and Control

48. Jilin Chinese Medical University

49. Zhejiang Medical University

50. Medical Testing and Safety Evaluation Center of Shandong Medical University

51. Food and Cosmetics Inspection Center of Shanxi Chinese Medical Research Center

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 This article is jointly contributed by senior regulatory specialists Emily Xu and Spring He from REACH24H Consulting Group.