Interpretation on China Health Food Filing Guideline

S.N.

Key points

Main requirements

1

Product formula materials

a) The varieties, dosages and standards of the used raw materials shall all comply with the Health Food Raw Materials Directory. Currently, the first batch is Directory of Health Function for Nutrition Supplement, which contains 22 vitamins & minerals, with 77 allowed compounds.

b) For the excipients, they shall be compliant with the Available Excipients for Health Food Filing and Their Usage Rules (Trial) as well, which will be interpreted in details below.

c) If the raw materials and excipients are pre-processed, all used materials shall be listed.

2

Production process materials

a) The main producing flow chart and detailed instructions including main process, key technology and technological parameters after the verification and conformation of pilot scale production shall be provided.

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

a) Test reports of functional component, hygiene and stability for 3 batches samples pilot above level scales product shall be provided.

b) If the applicant has test ability, the tests can be conducted by the applicant. If not, the tests can be entrusted to qualified lab.

4

Label and instruction manuscript

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

c) For the direction of nutrition supplement products, the total daily intake amount for solid preparation shall be ≤ 20g, and for liquid preparation shall be ≤ 30ml.

d) 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 Guideline. 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.

b) 3 batches of all items tests according to the product technical requirements shall be conducted. Once the test report is issued, it cannot be changed.

c) If the tests conducted in the same test agency of S.N. 3, the samples of them shall be different, and then there are 6 batches of samples required.

Excipient Name

Relevant standard

Maximum dosage for solid preparation

Maximum dosage for liquid preparation

Arabic gum

GB 29949

Appropriate

Appropriate

Grape skin extract

GB 28313

2.5 g/kg

2.5 g/kg

Soybean oil

GB/T 1535

Appropriate

Appropriate