Health Food

Health foods refer to food products which claim to have specific health functions or to supplement one’s health with vitamins or minerals.

Requirements

Health foods that use the ingredients from the health food ingredients catalogue or health foods that are imported for the first time are required to register with CFDA; First time import of health foods that classified as nutritional supplement, such as vitamin supplements or mineral supplements, shall file with the CFDA; Other health foods, before launching Chinese market, shall file with local CFDA.

CFDA has released the announcement and started to accept the filing application from May 1, 2017.

Administrative department

China Food and Drug Administration (CFDA)

Relevant regulations

  • Administrative measures of health food registration and filing
  • Guidance for Health Food Registration (2016 Version)
  • Detailed Guidance for Health Food Registration Approval (2016 Version)
  • List of Auxiliary Materials for Health Food Filing and Terms of Use (Trial)
  • List of approved health food raw materials directory (the 1st batch)
  • Guideline for Health Food Filing Application (Trial)

Penalties

According to Food Safety Law, if producers or traders of health food violate the Law by engaging in unauthorized or illegal production or trading activities, the illegally gained benefits/foods and the tools, equipment and raw material used for production or trading will be confiscated. The producer or trader is also subject to a fine between RMB 50,000 to 100,000 if the total value of the commodity is less than RMB 10,000, or a fine between 10 and 20 times if the total value of the commodity exceeds RMB 10,000; for severe violation of the law, the business license of food producers and traders will be revoked.

REACH24H Service

Free Regulatory Consultation

Communication via email, phone or face to face communication

Main content:

1) Understanding of health food regulations

2) Registration and filing procedure of health food

3) Registration strategies for health food product

4) Customized consultation and training  

 Filing for domestic health food

File the nutrient supplements in order to gain market access into China

Main content:

1) Feasibility assessment of health food filing

2) Preparation of filing materials

3) Filing materials review by experts

4) Filing materials submission and filing number approval

 Filing for imported nutritional supplement

Achieve China market approval for imported nutritional supplements

Main content:

1) Feasibility assessment of health food filing

2) Preparation of filing materials

3) Filing materials review by experts

4) Filing materials submission and filing number approval

 Health food registration (imported/domestic)

Achieve China market approval for health food

Main content:

1) Pre-evaluation of health food registration: feasibility, timeline and cost

2) Dossier preparation of health food registration

3) Test monitoring for health food registration

4) Communication with assessment experts and authorities

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