The Food Evaluation Center of the General Administration of Market Supervision issued health food raw materials and related technical requirements.

Release time:

2021-10-12 15:01

Since the implementation of the Measures for the Administration of Health Food Registration (Trial), the number of health foods using new resource foods or new food resources as raw materials has been increasing. Applicants have questions about the application of new health food raw materials, declaration requirements and review principles. To facilitate the application for registration, the relevant questions are now answered as follows:

According to the relevant provisions of the "Health Food Registration Management Measures (Trial)" and the "Notice on the Implementation of the ", before the State Administration issues new regulations, the use of health food raw materials and The approval is temporarily implemented in accordance with the "Notice of the Ministry of Health on Further Regulating the Management of Health Food Raw Materials" (Wei Fa Jianfa [2002] No. 51) issued by the Ministry of Health.

According to the "Notice of the Ministry of Health on Further Regulating the Management of Health Food Raw Materials" (Wei Fa Jianfa [2002] No. 51), the 2. is reviewed according to the following principles:
(I) ordinary food can be used as raw materials for the production of health food.
If food additives are involved in the health food (II) applying for registration, it shall comply with the provisions of the Hygienic Standard for the use of Food Additives, that is, the varieties used shall be listed in the Hygienic Standard for the use of Food Additives (GB2760), the Hygienic Standard for the use of Food Nutrition fortifiers (GB14880) or the new varieties of food additives in the list announced by the Ministry of Health.
(III) fungal health food refers to the use of edible large fungi and small filamentous fungi fruit body or mycelium production of products. If fungal items are involved in the health food applied for registration, except for the fruit bodies and mycelium of edible fungi that have been used for a long time, the list of fungal species that can be used in health food shall be the strains in the list of fungal species that can be used in health food published by the State Food and Drug Administration, and the genetically modified strains shall not be used in the production of health food.
(IV) probiotic health food refers to the micro-ecological products that can promote the ecological balance of intestinal flora and play a beneficial role in the human body. If probiotic products are involved in the health food applied for registration, the probiotic strains must be members of the normal human flora, and their live bacteria, dead bacteria and their metabolites can be used. The list of probiotic strains that can be used in health food should be the "list of probiotic strains that can be used in health food" published by the State Food and Drug Administration, Genetically modified strains shall not be used to produce health food.
New resources or new resources of food approved by the Ministry of Health of (V) (only for use by the reporting unit specified in the new resources or new resources of food production approval documents).
If the health food for which the (VI) applies for registration involves animal and plant items, the items shall be those specified in the list of articles that are both food and medicine and the list of articles that can be used in health food issued by the Ministry of Health.
(VII) newly developed, newly discovered, newly introduced items that have no eating habits in my country or have eating habits only in individual areas and meet the basic requirements of food are called new food resources or new resource foods, and the application for registration of health food involves food New resources or new resource foods should be implemented in accordance with the relevant provisions of the "New Resources Food Hygiene Management Measures, the applicant shall provide the corresponding safety toxicology evaluation test report and relevant food safety information according to the following requirements:
1. According to the provisions of document No. 51 [2002] issued by Wei Fa Jianfa, the total number of animal and plant articles (or raw materials) in the health food applied for registration shall not exceed 14, and the total number of animal and plant articles (or raw materials) other than the list of articles that are both food and medicine (Annex 1) and the list of articles that can be used for health food (Annex 2) shall not exceed 1, and the article (or raw material) should refer to the relevant requirements of the "Food Safety Toxicology Evaluation Procedure" (GB15193.1-1994) and the "Health Food Inspection and Evaluation Technical Specification (2003)" for safety toxicology tests. In principle, the first and 2. three-stage toxicity tests should be carried out, and the necessary population epidemiological investigation, and the fourth stage test should be carried out if necessary. The specific provisions are as follows:
(1) When raw materials or ingredients that have no edible history at home and abroad are used as health food raw materials, four-stage toxicity tests should be conducted on the raw materials or ingredients.
(2) For raw materials or ingredients that have a history of consumption only in a few foreign countries or some domestic areas, in principle, the first and 2. three-stage toxicity tests should be carried out for the raw materials or ingredients, and the fourth stage toxicity test should be carried out if necessary.
(3) If according to the relevant literature and composition analysis, no toxic or very little toxic substances are found to constitute health damage, and a large number of people have a long history of consumption without harmful effects of animals, plants and microorganisms, etc., the first and second stages of toxicity tests can be carried out on the substance, and after preliminary evaluation, it is decided whether the next stage of toxicity test is needed.
(4) Where a known chemical substance is used as raw material, the international organization has carried out a systematic toxicological safety evaluation on it, and at the same time affirms that the quality specifications of our products are consistent with those of foreign products, the first and second stage toxicity tests can be carried out on the chemical substance. If the test results are consistent with the results of foreign products, further toxicity tests are generally not required, otherwise the third stage toxicity test should be carried out.
(5) For raw materials widely consumed in many foreign countries, on the basis of providing safety evaluation data, conduct the first and second stage toxicity tests, and decide whether to conduct the next stage toxicity test according to the test results.
2. According to the provisions of the "Fungal Health Food Application and Evaluation Regulations (Trial)" issued by the State Food and Drug Administration, the health food that applies for registration uses fungal strains other than the "List of Fungal Species that Can be Used in Health Food". Species, in addition to the confirmed genus name, species name, culture conditions, preservation method, strain identification report and strain safety evaluation (including virulence test) and other information, the following information shall also be provided:
(1) Research report on the efficacy of the strain (test report or literature);
(2) Safety data of long-term consumption of bacteria at home and abroad;
(3) The strain and its metabolites do not produce any toxic and harmful effects.
3. According to the provisions of the Provisions on the Application and Evaluation of Probiotic Health Food (Trial) issued by the State Food and Drug Administration, the health food that applies for registration uses probiotic bacteria other than the List of Probiotic Bacteria that can be used in Health Food, in addition to the confirmed genus name, species name, culture conditions, preservation method, strain identification report and strain safety evaluation (including virulence test) and other information, the following information shall also be provided:
(1) Research report on the efficacy of the strain (test report or literature);
(2) Safety data of long-term consumption of bacteria at home and abroad;
(3) The strain and its metabolites do not produce any toxic and harmful effects.
4. Provide the certification documents issued by the administrative department at or above the provincial level that the new food resource or the new resource food has a wide edible history. The supporting documents shall include the edible area, the population involved and the edible time.
5. Provide a search report on the food safety, edible history and adverse reactions of the new food resources or new resources issued by professional institutions at or above the provincial level. The search report shall be the relevant content of food, and the content of medicinal use shall not be approved.
6. Other documents that contribute to the food safety evaluation of new food resources or new resources.

3. food new resources or new resources food safety toxicology test (including strain virulence test) should be completed by the identified inspection agency.

4. the new resources or new resource foods involved in the health food applied for registration have been used in approved health foods, the following situations should still be evaluated in accordance with the provisions of the New Resource Food Hygiene Management Measures:
The (I) is not included in the list that can be used for health food announced by the State Food and Drug Administration or the edible list announced by the Ministry of Health;
(II) is not included in the list of new food resources or new resource foods published or approved by the Ministry of Health;
(III) the Ministry of Health has approved it as a new food resource or new resource food, the applicant for health food registration is inconsistent with the reporting unit stated in the food new resource or new resource food production approval.

When the 5. applies for registration of health food involving new food resources or new resource food, the State Food and Drug Administration shall organize health food review experts to review the new food resources or new resource food involved while reviewing the health food, and strictly control it. The basic principles are as follows:
If the (I) food new resources or new resource food fails to conduct safety toxicology evaluation in accordance with the relevant provisions of the "New Resource Food Hygiene Management Measures", the health food applying for registration shall not be approved.
If the (II) has provided new food resources or new food safety evaluation test reports and related materials as required, it shall be reviewed according to the following principles:
1. After review by experts, it is believed that the new food resource or new resource food has exact health care functions, meets the basic requirements of food, can be eaten and safe, and the declaration information is complete and standardized, and can be used for health food.
2. After review by experts, it is believed that the food safety evaluation test of the new food resource or new resource is incomplete, irregular, or mainly medicinal, does not meet the basic requirements of the food, and cannot be eaten, and the edible safety judgment basis is insufficient. It cannot be used for health food, and the health food applied for registration will not be approved.
3. After review by experts, it is believed that the new food resource or new resource food health care function is accurate, the safety evaluation test is standardized and complete, and meets the basic requirements of food, and its safety can be preliminarily determined. However, it is still necessary to provide extensive food certificates, search reports and other supporting materials or literature materials to further confirm its food safety, and it is allowed to supplement relevant materials before retrial.

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