Our Services
- Feasibility analysis for the registration and filing of health food
- Application for the registration of health food (including initial registration, changes, transfers, and continuations)
- Application for the filing of health food (including initial filing and changes)
- Testing services
- Other customized consulting and compliance services
Definition of Health Food in China
According to the "National Food Safety Standard for Health Food" (GB 16740), health food in China is defined as food that claims to have specific health functions or is intended to supplement vitamins and minerals. It is suitable for specific groups of people, has a regulatory function on the body, is not intended to treat diseases, and does not cause acute, subacute, or chronic harm to the human body. The most important symbol distinguishing health food from other food is the "blue hat" logo.
Regulatory Approach for Health Food in China
Before health food can be marketed in China, companies need to apply for and obtain a registration or filing certificate for health food.
Filing of Health Food
Applicable to:
- Health food with ingredients listed in the Catalogue of Health Food Raw Materials.
- First-time imported health food that belongs to nutritional substances such as vitamins and minerals.
Qualifications of Applicants:
- For domestic health food filing applications, the applicant should be a health food production enterprise.
- For imported health food filing applications, the applicant should be a foreign manufacturer of health food that is already on the market (foreign manufacturers refer to legal persons or other organizations whose products meet the market requirements of the country or region they are located in).
The filing certificate for health food has no expiration date and cannot be transferred. Changes or cancellations of the filing can be made, but the corresponding application procedures must be completed.
Registration of Health Food
Applicable to:
- Health food with ingredients outside the Catalogue of Health Food Raw Materials.
- First-time imported health food (excluding health food that belongs to nutritional substances such as vitamins and minerals).
Qualifications of Applicants:
- For domestic health food registration applications, the applicant should be a legal entity or other organization registered in China.
- For imported health food registration applications, the applicant should be a foreign manufacturer of health food that is already on the market.
The registration certificate for health food is valid for 5 years. Changes, transfers, or cancellations are allowed, but the corresponding application procedures must be completed.
If the registration certificate for health food that has been produced and sold is about to expire and needs to be extended, the registrant should apply for an extension six months before the expiration date.
Catalogue of Health Food Raw Materials in China
The Catalogue of Health Food Raw Materials currently includes Coenzyme Q10, Ganoderma Spore Powder (Cracked Reishi Spores), Spirulina, Fish Oil, Melatonin, Soy Protein Isolate, Whey Protein, and Nutritional Supplements (2023 version).
Related National Standards and Supporting Documents for Health Food in China
- Food Safety Law of the People's Republic of China
- Measures for the Registration and Filing Administration of Health Food
- GB 16740-2014 National Food Safety Standard for Health Food
- Guidelines for Health Food Filing (Trial)
- Guidelines for Health Food Registration Application Services (2016 version)
- Detailed Rules for the Evaluation and Approval of Health Food Registration (2016 version)
- Catalogue of Permitted Health Functions for Health Food (Nutritional Supplements, 2023 version)
- Catalogue of Permitted Health Functions for Health Food (Non-nutritional Supplements, 2023 version)
- Regulations on the Use of Auxiliary Materials in Filing Products of Health Food (2021 version)
- Technical Requirements for Dosage Forms of Filing Products of Health Food (2021 version)
- Technical Guidelines for Toxicology Evaluation and Assessment of Health Food and Its Ingredients (2020 version)
- Technical Guidelines for Safety Evaluation and Assessment of Microorganisms Used in Health Food Ingredients (2020 version)
- Technical Guidelines for Physicochemical and Hygienic Index Testing and Evaluation of Health Food (2020 version)
- Methods for Function Evaluation and Assessment of Health Food (2023 version)
- Technical Guidelines for Function Evaluation and Assessment of Health Food (2023 version)
- Guidelines for Ethical Review of Human Sensory Evaluation of Health Food (2023 version)
- Regulations on the Use of Auxiliary Materials in Filing Products of Health Food (2021 version)
- Technical Requirements for Dosage Forms of Filing Products of Health Food (2021 version)
- Naming Guidelines for Health Food (2019 version)
- Guidelines for Warning Statements on Health Food Labels
- Specifications for Health Food Marking
