Health food refers to food that is specifically indicated to have certain health functions. It is suitable for specific groups of people, has the function of regulating the body, and is not intended to treat diseases. In order to strengthen the supervision and management of health food and ensure the quality of health food, health food must meet the following requirements according to relevant regulations.
Requirements for Health Food:
1. Through necessary animal and/or human functional tests, it is proven to have clear and stable health effects;
2. All raw materials and their products must meet food hygiene requirements and must not cause any acute, subacute, or chronic harm to the human body;
3. The composition and dosage of the formula must have scientific basis and clear effective ingredients. If the functional ingredients cannot be clearly identified under existing technical conditions, the main raw material names related to health functions should be determined;
4. Labels, instructions, and advertisements must not promote therapeutic effects.
Any food claiming to have health functions must be reviewed and confirmed by the Ministry of Health. The developer should submit an application to the provincial health administrative department where they are located. After preliminary approval, it is submitted to the Ministry of Health for approval. The Ministry of Health issues the "Health Food Approval Certificate" to health food that passes the review, with the approval number as "Wei Shi Jian Zi ( ) Di Hao". Health food that obtains the "Health Food Approval Certificate" is allowed to use the health food logo specified by the Ministry of Health.
Documents Required for Applying for the "Health Food Approval Certificate":
1. Health food application form;
2. Formula, production process, and quality standards of health food;
3. Toxicological safety evaluation report;
4. Health function evaluation report;
5. List of effective ingredients of health food, as well as qualitative and/or quantitative inspection methods for effective ingredients and stability test report. If the effective ingredients cannot be clearly identified under existing technical conditions, a list of main raw materials related to health functions should be submitted;
6. Samples of the product and its sanitary inspection report;
7. Labels and instructions (samples for review);
8. Relevant domestic and foreign materials;
9. Other materials required according to relevant regulations or product characteristics.
Other Related Requirements:
1. The Ministry of Health and provincial health administrative departments should establish evaluation committees to undertake technical evaluations. The committees should consist of experts in food hygiene, nutrition, toxicology, medicine, and other related fields.
2. The Ministry of Health Evaluation Committee holds four evaluation meetings each year, usually in the last month of each quarter. All materials that pass the preliminary review must be sent to the Ministry of Health by the end of the first month of each quarter. The Ministry of Health makes a decision on whether to approve within 30 working days after the evaluation.
If the Health Ministry Evaluation Committee deems it necessary to retest the health food declared, it will be retested by the inspection agency designated by the Ministry of Health. The retesting costs will be borne by the health food applicant.
3. When two or more collaborators jointly apply for the same health food, the "Health Food Approval Certificate" is co-signed, but the certificate is only issued to the responsible person jointly determined by all collaborators. In addition to submitting the materials listed in these regulations, the applicant should also submit a recommendation letter signed by all collaborators recommending the responsible person.
4. Holders of the "Health Food Approval Certificate" can transfer technology or co-produce with other parties based on this certificate. When transferring, a copy of the "Health Food Approval Certificate" should be applied jointly with the transferee to the Ministry of Health. When applying, the "Health Food Approval Certificate" should be presented, and a valid technology transfer contract should be provided. The copy of the "Health Food Approval Certificate" is issued to the transferee, who has no right to further transfer the technology.
5. Drugs approved for production and operation by relevant national departments cannot apply for the "Health Food Approval Certificate".
6. When importing health food, importers or agents must apply to the Ministry of Health. In addition to providing the materials required in Article 6, they must also provide relevant standards of the producing country (region) or international organizations, as well as certificates issued by relevant health authorities in the production and sales country (region) allowing production or sales.
7. The Ministry of Health issues the "Imported Health Food Approval Certificate" to imported health food that passes the review. Products that obtain the "Imported Health Food Approval Certificate" must label the approval number and the health food logo specified by the Ministry of Health on the packaging.
Imported food hygiene supervision and inspection agencies inspect the imported health food based on the "Imported Health Food Approval Certificate" and release it after passing the inspection.
