Article 2 The term "new resource foods" as mentioned in these Provisions refers to domestically produced and imported new resource foods licensed by the Ministry of Health according to the Food Hygiene Law of People's Republic of China (PRC) and the Measures for the Administration of New Resource Foods.
Article 3 The declaration and acceptance of new resource foods shall be carried out in strict accordance with the Administrative Measures for Health Administrative Licensing and the Procedures for Health Administrative Licensing of Health-related Products.
Article 4 General requirements of application materials:
(a) for the first time to declare the new resource food license, provide 1 original and 4 copies;
(two) the original application materials, in addition to the inspection report and official documents, should be stamped with the official seal or riding seal of the applicant page by page; If it is an individual application, the application materials shall be stamped with the name stamp or signature of the applicant page by page, and a copy of the ID card shall be provided;
(3) Print on A4 paper, use obvious distinguishing marks, arrange them in the prescribed order, and bind them into volumes;
(four) the use of Chinese legal units of measurement;
(five) the application materials should be complete and clear, and the same item should be filled in consistently;
(6) The foreign language in the application materials shall be translated into standardized Chinese, and the translation shall be attached to the corresponding foreign language materials, except for the English or Latin parts names and foreign addresses required by these Provisions;
(7) The application materials shall be true and lawful. The copy shall be reproduced by the original, and the copy shall be clear and completely consistent with the original. Article 5 To apply for a new resource food license, the following materials shall be submitted:
(1) Application Form for Hygienic Administrative License of New Resource Food (attachment1);
(2) Development report and safety research report;
(3) Brief description and flow chart of the production process;
(4) product quality standards;
(5) Research and utilization at home and abroad and related safety data;
(6) product labels and instructions;
(7) If the agent declares, a notarized certificate of entrustment shall be provided;
(eight) other materials that are helpful to the review.
Attach 1 unopened sample or 30g raw material.
To apply for the import of new resource foods, it shall also submit:
(1) A certificate issued by the relevant department or institution of the producing country (region) that it is allowed to produce (or sell) in that country (region) or the traditional eating history of the food in that producing country (region);
(2) Power of Attorney of the responsible unit in China.
Article 6 Where the declared products are manufactured by entrustment, in addition to the above provisions, the following materials shall be submitted:
(a) the entrusted processing agreement signed by the entrusting party and the entrusted party;
(two) imported products should provide the quality management system or good production practices of the entrusted production enterprise;
(three) the domestic products shall provide a copy of the hygiene license of the manufacturer of the entrusted party. Article 7 The contents of the research report shall conform to the requirements of the Guiding Principles for Research Reports on New Resource Foods (Annex 2).
Article 8 The safety research report shall include the following contents:
(1) Toxicological inspection report or data;
(two) health inspection report or information;
(3) composition analysis report and inspection method or data;
(4) Pathogenicity test report or data, drug resistance test report or data, and toxin-producing ability test report or data (microorganisms that are inedible in China and use new varieties of microorganisms in food processing need to be declared);
(5) Providing epidemiological data when necessary;
(six) other safety information that is helpful for the review.
Article 9 The production process brief description and flow chart shall include the following contents:
(a) detailed and standardized process description and process flow chart, technical parameters and key technical requirements, the names, specifications and quality requirements of raw materials and additives used, and the air cleanliness grade and regional division of the production environment;
(2) A brief description of the production process to be announced.
Article 10 Product quality standards shall meet the following requirements:
(1) The format of the quality standard shall conform to the relevant requirements of GB/T 1. 1-2000 standardization guidelines;
(2) The contents of quality standards shall include sensory indicators, physical and chemical indicators, microbial indicators, qualitative and quantitative detection methods of main components and other related contents.
Article 11 In addition to complying with the relevant provisions of the state, product labels and instructions should also indicate the following contents when necessary: the method of use, the scope of use, the people to eat and the amount to eat; Warning signs to be marked, including use taboos and safety precautions.
Twelfth domestic and foreign research and utilization and related safety information shall include the following contents:
(a) domestic and foreign approval or market utilization;
(two) the history of eating and the survey data of eating people.
Article 13 The certificate of agency shall meet the following requirements:
(1) The product name, the name of the entrusting unit, the entrusted matters and the entrusted date shall be clearly stated, and the official seal of the entrusting unit or the signature of the legal representative shall be affixed;
(2) If the agency certificate indicates multiple products, it shall be declared at the same time. One product should provide the original, and other products can provide copies, and submit a written explanation, indicating which product the original is in;
(3) The certificate of agency should be notarized for authenticity;
(4) If the agency certificate is in a foreign language, it shall be translated into standardized Chinese, and the Chinese translation shall be notarized by a Chinese notary office.
Article 14 The certification documents issued by the relevant departments or institutions of the producing country (region) that the food is allowed to be produced (or sold) in that country (region) or that the food has a traditional edible history in the producing country (region) shall meet the following requirements:
(a) issued by the competent government departments and trade associations in the country of production or origin. If the original document cannot be provided, a copy can be provided, which must be confirmed by the issuing unit or the embassy (consulate) of China in the country where the product is produced;
(2) The name of the product, the name of the reporting entity and the name of the entity that issued the document shall be clearly stated, and the seal of the entity or the signature of the legal representative (or its authorized person) and the date of issuance of the document shall be affixed;
(3) The product name and the name of the applicant shall be completely consistent with the contents of the declaration;
(4) If the certification documents specify multiple products, they shall be declared at the same time. One product needs to provide the original, others can provide a copy, and provide a written explanation, indicating which product application materials the original is in;
(5) If the certification document is in a foreign language, it shall be translated into standardized Chinese, and the Chinese translation shall be notarized by a Chinese notary office;
(six) unable to submit documents, the Ministry of health can audit the production site.
Article 15 The contents of the power of attorney of domestic responsible units shall meet the requirements of Announcement No.2 of the Ministry of Health in 2007.
Article 16 The submission of supplementary materials shall meet the following requirements:
(1) Submit 1 original complete supplementary materials, which shall be stamped with the seal of the applicant page by page or signed (sealed) by the applicant, and indicate the date of supplementary materials;
(two) after receiving the notice of extension of the technical examination of administrative license, the reporting unit shall submit supplementary information within one year, and if it fails to submit it within the time limit, it shall be deemed as termination of the declaration. In case of special circumstances, a written explanation shall be submitted.
Article 17 For the new resource food whose application is terminated or not approved, the applicant may apply in writing to return the submitted agency certificate, the certificate of production and sales in the producing country (excluding the original certificate of simultaneous declaration of multiple products) and the notarial certificate.
Article 18 The Ministry of Health shall be responsible for the interpretation of these Provisions.
Article 19 These Provisions shall come into force as of the date of promulgation. Where the relevant documents issued by the Ministry of Health are inconsistent with these Provisions, these Provisions shall prevail. abstract
According to the relevant requirements of the Measures for the Administration of New Resource Foods, the Guiding Principles for the Development Report of New Resource Foods were formulated.
According to the purpose, basis and main research contents of the research and development of new resource foods, this guiding principle makes general requirements for the writing content of the "research report" in the application materials, so as to guide registered applicants to form a standardized research report on the basis of comprehensive analysis and summary of the previous research and development work.
main content
The research report of new resource food should include the following contents in principle:
(1) Basic information;
(two) the purpose and basis of research and development;
(3) technical research;
(4) Quality control research;
(5) Determination and analysis of components;
(six) the basis for studying and determining the recommended consumption of people and the consumption in food;
(7) Toxicological safety research;
(8) Comparative analysis and research with similar products.
For some of the above research contents, we can write different contents according to the requirements of different categories of new resource foods.
Content requirements
(1) Basic information. At least the following contents shall be included:
1. Name: including trade name, common name, chemical name and English name.
2. Source: scientific name and Latin scientific name. Animals and plants should include information such as origin, edible parts, morphological description, biological characteristics, and methods and basis for variety identification and identification; Microbes should include source, taxonomic status, biological characteristics, identification of strains and identification methods and basis.
3. The food raw materials separated from animals, plants and microorganisms shall include the names and sources of animals, plants and microorganisms, and the basic information such as the physical and chemical characteristics and chemical structure of the main components of the separated products.
(two) the purpose and basis of research and development. This part mainly expounds the research background, research purpose and scientific basis of new resource food, which should at least include the following contents:
1. Objective: To briefly describe the declared purpose and use of research and development of new resource food, including the nutritional, physiological and functional functions of new resource food, and provide research progress and scientific basis or inference to support the research and development purpose, use or function; And the market application prospect and possible social and economic benefits of this product development.
2. Basis and R&D background: From the definition of new resource food, the history of eating at home and abroad, and the approval and market application of other countries, explain the reasons why products can be used as new resource food.
2. 1 Definition of new resource food: Whether it conforms to the definition of new resource food in the Measures for the Administration of New Resource Food.
2.2 Briefly describe the consumption history at home and abroad: explain the consumption history of new resource foods at home and abroad, including at least information such as consumer groups, consumption amount, consumption time, consumption purpose and possible adverse reactions after people eat them. And all information should be quantified as much as possible.
2.3 Briefly describe the approval and application of other countries, such as the approval and listing of the United States, the European Union, Canada and Japan, and the management of food additives, new resource foods, dietary supplements, medicines and functional foods in other countries.
3. Briefly describe other background information related to R&D, such as the new resource food produced to change the process, explain the reasons for changing the process, the similarities and differences between the original process and the new process, and explain the changes in composition, content or structure of the food produced by the new process compared with the traditional food and the basis for confirmation.
(3) Process research. This part mainly expounds the rationality and safety of screening, determination and application of production technology research, including at least the following contents:
1. For the new resource foods of animals and plants that have not been processed or processed by simple mechanical physics, the process and conditions of animal and plant breeding or planting, and the methods and basis for determining the edible parts of the new resource foods should be briefly explained; Briefly describe the method of removing inedible parts or selecting edible parts, or the production process and key steps and conditions of simple physical processing.
2. Food raw materials separated from animals, plants and microorganisms:
2. 1 Briefly describe the preparation process of the product (mainly including starting materials, equipment used, method selection, key steps, etc. ) and screening of key technical parameters in the process.
2.2 Briefly describe the research content of production technology, with emphasis on raw material screening, feeding amount and output.
2.3 Briefly describe all kinds of extraction and separation solvents used in the process and their selection basis, and the removal or control methods of solvent residues.
2.4 Briefly describe possible impurities in the process and control methods.
3. Selection of culture conditions (culture medium, culture temperature, etc.) for microorganisms or new varieties of microorganisms used in food processing. ) and its basis are briefly described; Preservation methods, rejuvenation methods and passage times of strains; For domesticated or mutagenized strains, the methods of domestication or mutagenesis, and research materials such as domestication agents and mutagens should be provided.
(four) quality control research and standard setting. This paper mainly expounds the process of quality control research and quality standard formulation of new resource food, which should at least include the following contents:
1. Briefly describe the content of quality control research and the basis for its determination, and analyze the general requirements for the quality of new resource foods according to relevant laws or documents, combined with the production process characteristics and stability research results of new resource foods.
2. Briefly describe the main components related to quality and the analysis methods and basis of main quality indicators (such as literature basis, theoretical basis, experimental basis, etc.). ), as well as the contents and results of method verification.
3. Briefly describe the research results and data of stability and hygiene related to product quality and safety;
4. Briefly describe the drafting and revision process of quality standards, the items and judgment basis of quality standards, and the limits and judgment basis of quality standards.
(5) Determination and analysis of components. The composition, content and determination basis of components should be briefly described, including the content of main nutrients and possible natural harmful substances (such as natural toxins or anti-nutritional factors).
(6) Toxicological safety research. The contents and main conclusions of toxicological research related to food safety in the process of product development were briefly introduced, including the main test results of acute toxicity, subchronic toxicity, genotoxicity, teratogenicity, chronic toxicity and carcinogenicity. If there is no relevant research, a detailed literature review at home and abroad should be provided. And the related literature or safety evaluation data of other countries are comprehensively analyzed and summarized.
(seven) the scope of application and the recommended dosage, the scope and dosage used in food and the basis for determination.
1. According to people's diet history, toxicological research data, experimental research data on nutrition, physiology and function of animals and people, applications approved in other foreign countries, literature research data, etc. The application scope of this product for people and the basis for recommending edible dosage are expounded in detail.
2. Briefly describe the unsuitable population of new resource food and the judgment basis.
3. Combined with the above information, explain the scope of use in food and the basis for determining the dosage.
(8) Comparative analysis data with similar food raw materials. If there are traditional foods or approved new resource foods similar to the declared new resource foods, the following contents shall be included:
1. According to the name, source and other basic information of new resource food, briefly describe the basic characteristics and information of traditional food or approved new resource food similar to this product.
2. Briefly describe the material equivalence analysis data of new resource food and traditional food or approved new resource food, including source, composition and content, production technology, quality standard, application scope and dosage, recommended consumption, etc.