1. The current product instruction format and content do not include a “Preface” section. After renewal, is it possible to continue to include the Preface contents in the product instruction?
Answer: According to the Key Points for the Centralized Review of Renewal of Health Foods “Without Expiration Date and Without Product Technical Requirements” in Production and on Sale, the registration certificates of “dual-no” products currently in production and on sale shall be standardized in accordance with existing laws and regulations. This includes setting the validity period of registration certificates, standardizing health function claims, and improving sample drafts of product labels and instructions. Therefore, after renewal, the format and content of product instructions must be strictly implemented according to current requirements.
For products approved for registration through the renewal procedure, the health food registrant and the manufacturer shall, within six months from the date of approval, strictly organize production according to the new technical requirements of the registration certificate. Products manufactured before that time are allowed to be sold until the end of their shelf life.
2. For “dual-no” products whose raw materials have been included in the Health Food Raw Material Catalogue and meet the filing technical requirements, should the application be made for “registration-to-filing conversion” directly, or should it apply for “dual-no renewal”? For “dual-no” products whose raw materials are included in the catalogue but whose excipients, and dosages do not meet the filing requirements, how should renewal be handled?
Answer: The Key Points for the Centralized Review of Renewal of Health Foods “Without Expiration Date and Without Product Technical Requirements” in Production and on Sale stipulates that for products using raw materials listed in the Health Food Raw Material Catalogue, if they meet the filing requirements, the registrant should apply for “registration-to-filing conversion” during the transition period. After the original registrant identity is confirmed, management will shift to filing.
For cases where excipients, dosages, or raw material and excipient quality standards do not meet the filing technical requirements, the registrant may adjust the technical requirements and then shift to filing management.
3. Due to updated regulations and standards, for “dual-no” products where the raw material dosage or the number of raw materials exceeds the current requirements, what are the specific requirements for the theoretical and literature basis in their safety demonstration report?
Answer: For “dual-no” products where the raw material dosage or the number of raw materials exceeds current requirements, the theoretical and literature basis for product safety should comply with the Service Guide for Health Food Registration Application (2016 edition) and other relevant regulations. Professionals with appropriate expertise shall conduct retrieval, screening, and analysis. The retrieval scope should be comprehensive and reasonable, and the screening criteria scientific and feasible. The content and scope of safety theoretical and literature basis should include: official international standards, national standards, risk assessments, and statistical data issued by internationally recognized food safety authorities or organizations, or by Chinese authoritative institutions or relevant departments; relevant records in traditional Chinese materia medica classics; literature analysis and evaluation reports; and scientific papers formally published in domestic core professional journals or international professional journals.
4. When conducting safety evaluation of new raw materials in “dual-no” health food products, is it necessary to provide component analysis of the new raw materials? For new raw materials with a consumption history only in certain foreign countries or limited domestic regions, is it necessary to provide teratogenicity tests?
Answer: For “dual-no” products using new raw materials for health foods, safety evaluation data shall be provided in accordance with relevant provisions on new health food raw materials in the Detailed Rules for the Review and Approval of Health Food Registration (2016 edition), the Service Guide for Health Food Registration Application (2016 edition), and the Technical Guidelines for Toxicological Testing and Evaluation of the Safety of Health Foods and Their Raw Materials (2020 edition) (hereinafter referred to as the “2020 Guidelines”). For component analysis, it should include the main components, functional/marker components, and possible harmful components of the raw materials, with corresponding analysis reports issued.
The 2020 Guidelines stipulate that the main toxicological tests include: acute oral toxicity test, genetic toxicity tests, 28-day oral toxicity test, teratogenicity test, 90-day oral toxicity test, reproductive toxicity test, toxicokinetics test, chronic toxicity test, carcinogenicity test, and combined chronic toxicity/carcinogenicity test. For new raw materials with consumption history only in certain foreign countries or local regions within China, toxicological evaluation requirements for new food raw materials should be referenced. In principle, materials for acute oral toxicity test, three genetic toxicity tests, 90-day oral toxicity test, teratogenicity test, and reproductive toxicity test should be provided. If literature and component analyses reveal no toxic effects, and the raw material has a long history of safe human consumption without harmful effects, then acute oral toxicity test, three genetic toxicity tests, 90-day oral toxicity test, and teratogenicity test may first be provided. If toxicological test results of raw materials indicate the need for further testing, and/or if the latest studies, food safety risk monitoring, or health food safety supervision find safety risks with the raw material, other toxicological tests should be provided in accordance with the requirements of the 2020 Guidelines.
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