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New Regulations on Health Food Filing System Released

On July 28, 2015, the drafts of Administrative Measures for Registration and Filing of Health Foods, Administrative Measures on Health Food Labeling, and Administrative Measures on Health Food Raw Material Directory and Health Function Directory were officially released by CFDA for public consultation until Aug. 28, 2015.

A health food registration system has been implemented in China for the last more than ten years, regulated by the “Measures on the Administration of Health Food Registration” released in 2005. This has hindered the development of China’s health food industry due to the prohibitive financial and time investments required to comply with this regulation. If ratified the radical reforms proposed by the new health food regulations will offer an excellent opportunity for overseas health food enterprises to enter Chinese market.

New health food filing system:

The new health food filing system will apply to health foods using raw materials listed in the approved raw material directory as well as first-time imported health foods used for supplementing vitamins and minerals (nutrient supplements).

New health food raw material directory and functional directory:

Health food raw material directory will include information of raw materials that are permitted in health foods and the corresponding information list of:

  • Name of raw materials

  • Compatibility

  • Dosage

  • Permitted health functions

  • Quality standard

  • Functional ingredients

  • Testing method and relevant instructions

  • The health function directory will include the health permitted functional claims along with instructions and requirements to make such claims

New labeling requirements:

Enterprise information

1. Country (district) of origin;

2. Name, address and contact information of the agencies in China.

Product information

1. Product name;

2. Raw and additive materials;

3. Functional ingredients/iconic ingredients and their contents;

4. Health functions;

5. Health food symbol;

6. Health food registered number or filing number;

7. Product specifications and net content;

8. Manufacturing date, shelf life and batch number;

9.  Irradiated health food or health food containing irradiated raw materials should be indicated;

10. Nutrient supplements should indicate “nutrient supplements” on the label and indicate “XX nutrient supplement” in the function item;

11. Health food using genetically modified ingredient should be labeled remarkably.

Usage information

1. Directions for use and dosage;

2. Suitable and unsuitable groups;

3. Precautions;

4. Declaration of “the product is not a substitute of medicine”.

Storage information

Storage temperature, humidity, conditions and method

An online webinar will be held by Reach24H and the Chemlinked Food Team to interpret the new regulations on health foods in detail. Please click here for more details.

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