Interpretation on Health Food Filing Working Rules in China

1. Background

According to the CFDA Notice on Health Food Filing Matters, since 1 May 2017, the health food filing will finally come into force, and the filing work is just around the corner. On 7 February, CFDA released the Health Food Filing Working Rules (hereinafter referred to as “Working Rules”) for public comments, and the List of Excipients (Auxiliary Materials) Available for Health Food Filing is included in it as well. In order to help applicants better understand the Working Rules, CIRS has made a comprehensive interpretation on it and listed the highlights below.

2. Health food filing procedure


3. Key points in filing material requirements

S.N.

Key points

Main requirements

1

Product formula materials

a) The varieties and dosages of the used raw materials shall both comply with the Health Food Raw Materials Directory. Currently, the first batch is Directory of Health Function for Nutrition Supplement, which contains 24 vitamins & minerals (Please click here for more information about the Directory of Health Function for Nutrition Supplement).

b) For the excipients, they shall be compliant with the Name List of Excipients Available for Health Food Filing as well, which will be interpreted in details below.

c) If the raw materials and excipients are premixed, embedded, or microencapsulated, all used materials shall be listed.

2

Production process materials

a) The dosage form shall be reasonable, which mainly include tablet, capsule, granulas, and oral liquid. 

PS. A lot of drug dosage forms are forbidden for health food filing, such as sustained-release preparation, controlled release preparation, sprays, sublingual preparation, orally disintegrating tablet, etc.

b) It is not allowed to change the chemical structure and composition of the raw materials through reprocessing such as extraction or synthesis.

3

Safety and health function evaluation materials

Self- test reports of functional component, hygiene and stability for 3 batches samples pilot above level scales product shall be provided.

4

Label and instruction manuscript

a) The indicating order of functional components shall be same with the order in Health Food Raw Material Directory.

b) For the product with 3 or above vitamins & minerals, the health function shall be claimed as “Supplement multi vitamins or minerals”. It is not allowed to claim as “Supplement (XXX raw materials) + (multi vitamins or minerals)”. In addition, for the product with 3 or above B vitamins, the health function can be claimed as “supplement B vitamins”.

c) The warning of “This product cannot replace drug. It is not suggested for people except the suitable crowed.” shall be added on the label. The warning of “Should not exceed the recommended amount or consume with same nutrients at the same time” shall be added for nutrition supplement product.

Except above points, there are very detailed requirements on the labelling in the Working Rules. Applicants shall pay attention to the label and instruction designation.

5

Product technical requirement materials

a) For the functional content of nutrition supplement product, the vitamin content range shall be 80%-180% of the labeled value, and the mineral content range shall be 75%-125% of the labeled value.

b) The content range shall comply with the dosage requirements listed in the Health Food Raw Material Directory as well.

6

All items test reports

a) Applicant shall entrust legally qualified food test agency to carry out the all items test reports. Same with health food registration, there is a good variety of choices for applicants when deciding the test agency.

b) Test reports of functional component, hygiene and stability for 3 batches samples shall be conducted in accordance with the product technical requirement materials. Once the test report is issued, it cannot be altered.

7

Product name

The product name consists of trade name, general name and attribute name. For the general name, here are 2 examples:

a) If there are 3 or below nutrients, the general name shall be all of the used nutrients names, and the order shall be same with the order in Health Food Raw Material Directory.

b) If it is a nutrient supplement with 3 or above vitamins or minerals, the general name can be “Multi vitamins or minerals”. It is not allowed to claim as “(XXX raw materials) + (multi vitamins or minerals)”.

4. Name List of Excipients Available for Health Food Filing

As we mentioned above, there are explicit lists on both raw materials and excipients for health food filing products. For the Excipients List contained in this Working Rules, there are 169 kinds of excipients allowed to use. Furthermore, there are 3 additional cases that merit attention.

  • For the usage of essence, its composition shall be listed in GB 2760-2014 or Annex A of GB 30616. The dosage can be appropriate according to the production.
  • For the usage of coating premix, its composition shall be listed in GB 2760-2014 or Chinese Pharmacopoeia (2015 version). The dosage can be appropriate according to the production.
  • For the excipient used in preparing encapsulated and microencapsulated raw material, its composition shall be listed in GB 2760-2014 or the food raw materials in Health Food Raw Material Directory. The dosage can be appropriate according to the production.

Comparing with the previous 2 drafted excipients lists, there are less excipients in the new one. A great many of general food materials, such as coconut oil, are not included. The limited Excipients List will carry significant limitations to the health food filing products. Let’s expect on the final results after the formal Excipient List released.

5. CIRS comments

The Working Rules is a normative document for the filing agency and applicant. Although it is only a draft for the moment, based on CFDA’s intention to carry out filing work as soon as possible, we speculate the formal version will be issued in the near future. Besides, since other supporting documents such as Health Food Raw Material Directory have been officially issued, applicants are suggested to carry out some preparations for health food filing, such as formula review, to realize the filling possibility and help complete and submit the application materials faster.

Please click here for more information on health food registration and filing in China.

If you have any other questions, please contact us at service@cirs-reach.com.


Reference: http://www.sfda.gov.cn/WS01/CL0782/169362.html