China divided health foods into two categories: nutrient supplements and functional health foods. Nutrient supplements refer to products that supplement vitamins and minerals instead of providing energy. Their functions are to supplement the deficiency of dietary supply, prevent nutritional deficiency and reduce the risk of some chronic degenerative diseases. To put it simply, it means that the raw materials of the formula are vitamins and mineral compounds, and the auxiliary materials are just products that only meet the technological needs of the products or improve the color, fragrance and taste of the products. Functional health food refers to health food with one or more of 27 functions. These 27 functions include: enhancing immunity, assisting in protecting radiation hazards, improving sleep, increasing bone density, relieving physical fatigue, assisting in protecting chemical liver injury, improving anoxia tolerance, relieving asthenopia, removing acne, removing chloasma, improving skin moisture, improving skin oil, assisting in reducing blood fat, assisting in lowering blood sugar, assisting in lowering blood pressure, assisting in protecting gastric mucosa, resisting oxidation, assisting in improving memory, and promoting blood circulation. Functions beyond this range can only be considered in the category of drugs.
How to register health food;
The steps of health food registration are relatively complicated, and the state will conduct a detailed review of the technical content of the products. If the applicant company has no experience, it is better to ask a professional agency to declare on its behalf, because they are very proficient in the standardization of data preparation and the overall arrangement of procedures, which will help to provide the passing rate. Registration can be carried out in the following steps: the first step is to evaluate the product;
The second step is registration inspection;
The third step is to sort out the application materials and fill in the health food registration management information system;
The fourth step is to submit it to the competent department, and those who pass the formal examination will be accepted;
Step 5: Technical review;
The sixth step is to supplement the information and be reviewed again;
Step 7: On-site verification and recheck inspection;
The eighth step is to obtain the approval documents for production and listing.
What information do you need to provide for health food registration?
1. health food registration application form;
2. Registration certificate of the applicant;
3. Product development report;
4. Product formula materials;
5. Production process materials;
6 safety and health function test evaluation materials (registration inspection report);
7. Types, names and standards of packaging materials in direct contact with health food;
8. Sample product labels and instructions;
9. Search materials and naming basis for products with different names;
10. qualification certificate of production enterprise;
1 1. Full text of references;
12. 3 minimum sales packaging samples;
Imported products also need to provide:
13. The qualification certificate of the registered applicant as an overseas manufacturer of listed health food;
14. the certification documents of the products that have been on the market for more than one year, or the safety report of the products sold overseas and eaten by people;
15. Certification document of the competent department of the exporting country (region) for permission to go on sale;
16. Original text of technical regulations or standards related to health food of product producing countries (regions) or international organizations;
17. Samples of packaging, labels and instructions of products listed in the producing country (region);
18. The original power of attorney and a copy of the business license of the domestic reporting institution;
19. certification documents that the production enterprise meets the good production quality management standards;
20. An explanation that the overseas production enterprises ensure that the health food exported to China conforms to the provisions of relevant Chinese laws and administrative regulations and the requirements of national food safety standards;
2 1. Self-inspection report to ensure the effective operation of the production quality management system, etc.
If you are not good at preparing the materials, it is better to ask an agent to register the company, and the applicant only needs to provide basic technical materials and supporting documents.
The registration of health food under the new regulations will be more difficult than before, which requires that the formula and technology of the product have scientific basis, that is to say, the birth of the product needs to go through literature inquiry and necessary experimental research. In fact, this is not a problem for a well-developed product, but the previous research process does not need to be provided for official review, but now it is needed. For those products that have not been studied, if you can make up the relevant research seriously and prove that your products are scientific, you can pass the examination and approval smoothly.
Legal basis:
Measures for the Administration of Health Food Registration and Filing
Article 1 These Measures are formulated in accordance with the Food Safety Law of the People's Republic of China for the purpose of regulating the registration and filing of health food.
Article 2 These Measures shall apply to the registration, filing, supervision and administration of health food within the territory of the People's Republic of China.
Article 3 The registration of health food refers to the examination and approval process in which the food and drug supervision and administration department systematically evaluates and reviews the safety, health care function and quality controllability of the health food applied for registration according to the application of the registration applicant and legal procedures, conditions and requirements, and decides whether to approve the registration.
Health food filing refers to the process that health food production enterprises submit materials showing product safety, health care function and quality controllability to food and drug supervision and management departments for filing, disclosure and future reference in accordance with legal procedures, conditions and requirements.
Article 4 The registration, filing, supervision and management of health food shall follow the principles of science, openness, justice, convenience and high efficiency.