According to (No. 38 of 2023), the State Administration for Market Regulation has organized and formulated the "Key Points for the Review of the Centralized Renewal of Certificates for "Double No" Health Foods in Production and Sales (Draft for Comments), which is now open to the public for comments, and the deadline for feedback is January 26, 2024. The public can put forward opinions and suggestions through the following channels and methods: 1. Log in to the State Administration for Market Regulation** (submit opinions through the "solicitation of surveys" in the "interaction" column on the homepage.)
2. Send comments and suggestions by e-mail to: [email protected], please indicate the subject of the email "Key Points for the Review of the Centralized Renewal of "Double No" Health Food in Production and Sale (Draft for Comments)" Public Solicitation of Opinions".
3. Mail the comments and suggestions to: No. 9, Madian East Road, Haidian District, Beijing, Special Food Department of the State Administration for Market Regulation, and indicate on the envelope the words "Key Points for the Review of the Centralized Renewal of Certificates of "Double No" Health Foods in Production and Sale (Draft for Solicitation of Comments)" for public solicitation of opinions".
State Administration for Market Regulation.
December 27, 2023.
"Double no" health food in production and on sale.
Key points of centralized renewal review
Draft for Comments).
In order to standardize the "no expiration date, no product technical requirements" (hereinafter referred to as "double no") health food registration certificates approved by the former Ministry of Health and other people at different times in the past, improve the registration information, and unify the regulatory standards, in accordance with the Food Safety Law of the People's Republic of China and its implementation regulations, the Administrative Measures for the Registration and Filing of Health Foods, the Administrative Measures for the Catalogue of Health Food Raw Materials and the Catalogue of Health Functions, and the Catalogue of Health Functions Allowed to be Claimed by Health Foods Non-Nutrient Supplements (2023 Edition) and the announcement of supporting documents, "Detailed Rules for the Review of Health Food Production License" and other laws and regulations, after extensive consultation, the main points of this review are formulated.
First, the overall goal
In accordance with the current laws and regulations, the registration certificate of "double no" products in production and sale shall be standardized, the validity period of the registration certificate shall be established, the health function claim shall be standardized, the sample product label manual, product technical requirements and product file information shall be improved, and the health food registration certificate (hereinafter referred to as the renewal certificate) shall be renewed, so as to realize the convergence of health food registration with production license and regulatory standards, and implement the main responsibility and territorial management responsibility of production enterprises.
II. Basic Principles
Adhere to the principle of "according to laws and regulations, classified disposal, and smooth transition", during the transition period, the provincial market supervision department will continue to issue production licenses in accordance with the current regulations, and shall not use the renewal of certificates as a precondition for the issuance or renewal of production licenses, so as to ensure the smooth and orderly renewal of "double no" products.
3. Scope of renewal
During the transition period, the "double no" products with a valid production license will be renewed centrally, and the provincial market supervision department in the place where the production license is issued will issue a renewal opinion. After obtaining the production license, the "double no" products that do not hold a valid production license can apply for renewal according to the procedures.
IV. Procedures for Replacement of Certificates
1) The registrant prepares the renewal materials as required, and applies to the food evaluation agency of the State Administration for Market Regulation for renewal in accordance with the change procedures, and changes the category to "double no" renewal.
2) The review agency shall carry out the renewal review in accordance with the current laws, regulations, standards and relevant provisions, and submit the review conclusions to the State Administration for Market Regulation for approval. If the requirements are met, a new registration certificate will be issued, and the registration number will be updated to "Guoshijian Note G J Era Number + Serial Number" (where "Era Number + Serial Number" remains unchanged), and the original product registration number, original product name and original registration certificate shall be marked in the remarks column of the certificate. If the requirements are not met, the application for the replacement certificate will not be approved, and the registrant may re-apply. The reissued registration certificate or the decision not to register shall be copied to the place where the registrant is located and the provincial market supervision department that issued the production license.
3) During the transition period, if the registration is approved, the health food registrant and the manufacturer shall organize production in strict accordance with the content of the new registration certificate within 6 months from the date of decision, and the products produced before are allowed to be sold until the end of the shelf life.
5. Specific requirements
1) Opinions of the provincial-level market regulation departments on the renewal of certificates.
1.The situation of obtaining a valid production license (SC number, issuance date, validity period) of the product issued by the provincial market supervision department that issued the production license, as well as the actual production and implementation of the product formula (name of raw materials and dosage ratio), production process (including raw material production process without applicable national standards, local standards, and industry standards), the specific content of product technical requirements and confirmation opinions. (Annex 1).
2.There is no abnormal self-examination of the registrant's entity qualifications and confirmation opinions from the provincial bureau issued by the provincial market regulation department where the registrant is located (abnormal circumstances include information that has been cancelled or revoked, entered into the list of abnormal business operations, and included in the list of the untrustworthy with serious violations (blacklist)).
2) The name of the product.
The name of the product shall comply with the current regulations. Where the reason for retaining the product name is reasonable, it is allowed to retain the original product name. If the product name is adjusted, the original product name can be marked in parentheses after the new product name and used until the end of the validity period of the certificate.
3) The applicant's qualifications.
1.The applicant for the change and replacement certificate shall be the registrant. If the same product registration certificate involves multiple registrants, the registration application shall be jointly submitted, and the application registration materials shall be jointly stamped with their respective official seals.
2.Where registrants are in abnormal circumstances such as deregistration, revocation, or entry into the list of abnormal business operations or the list of untrustworthy enterprises with illegal activities, acceptance is to be suspended.
3.If the registrant is a natural person, submit a notarized contract for the transfer of ownership of technical data such as product research and development, trial production, and inspection, or a notarized contract for the transfer of ownership of the registration certificate. If they meet the requirements, they will be converted into registrants who meet the current requirements.
4.If the original holder of the original copy is used for the production of the approved copy, the original holder may jointly apply for the renewal of the certificate, and if the requirements are met, the registration certificate jointly held by the holder of the original copy shall be reissuedOr submit the formula, process, product manual, product technical requirements, toxicology, function, hygiene, stability, functional ingredients and landmark ingredient test report and other materials according to the current new product registration requirements, and renew the registration certificate and registration number.
4) Registration to filing.
If the raw materials in the health food raw material catalogue are used and meet the filing requirements, the identity of the original registrant shall be confirmed and transferred to the filing management. Among them, if the dosage form, excipients, dosage, and quality standards of raw and auxiliary materials do not meet the technical requirements for filing, the registrant is allowed to adjust the technical requirements and then change from registration to filing management.
5) Safety evaluation.
Due to the update of regulations and standards, if it is necessary to reconfirm the raw materials of the formula, they shall be classified and disposed of according to the following circumstances:
1.If there is no basis for the use of raw materials or the amount of raw materials exceeds the current regulations, the registrant shall adjust the formula (including replacement raw materials) in accordance with the current regulations, improve the safety and quality requirements of the product, and re-carry out the toxicology, function, hygiene, stability and other verification tests according to the registration of the new product to demonstrate the safety, quality and function of the product.
2.If the formula contains new raw materials for health food, and no raw material safety evaluation materials were provided at the time of original registration, the safety evaluation and association review of the new raw materials and products shall be carried out in accordance with the relevant requirements of the Technical Guidelines for Safety and Toxicological Testing and Evaluation of Health Foods and Their Raw Materials (2020 Edition).
3.If the formula contains two or more new raw materials for health food, and no raw material safety evaluation materials were provided at the time of original registration, each new raw material and product shall be subject to acute oral toxicity test, three genotoxicity tests, 90-day oral toxicity test and teratogenicity test, as well as the association review of the new raw material and the product in accordance with the Technical Guidelines for Safety and Toxicological Testing and Evaluation of Health Food and Its Raw Materials (2020 Edition). If necessary, other toxicity tests will be carried out, and a comprehensive assessment will be carried out in combination with the consumption history, use of new raw materials, and the food safety analysis report of the population after the product is launched.
f) Functional claim adjustments.
1.Where only the expression of the adjustment function claim is involved, the function claim expression and the scope of the appropriate population (including the situation where the functional test is carried out or not required) are adjusted according to the new version of the function catalog.
2.If the product function claim is not within the scope of the function catalog, the application for change and replacement certificate will not be accepted. In accordance with the Implementation Rules for the Technical Evaluation of New Functions and Products of Health Foods (for Trial Implementation), the registrant may propose to adjust the health care functions and apply for replacement with the functions in the catalogue or new functions on the basis of full research and verification.
7) Production process, product technical requirements.
1.The registrant shall, on the basis of filing or actively disclosing the implementation of enterprise standards, research and formulate product technical requirements that meet the current regulations and national standards. If it involves the updating or revision of quality control indicators, it is also necessary to submit the revision description and the corresponding hygienic, stability, functional ingredient and landmark ingredient test report and other materials.
2.According to the registrant's application and the renewal opinion issued by the provincial market supervision department, the review process will include raw materials, auxiliary materials, main processes and key process parameters, and raw material related review information into the technical requirements of the products attached to the certificate in accordance with the current regulations.
3.If the same product contains multiple dosage forms (forms) and does not affect the quality and safety of the products, the original approved product dosage forms (forms) shall be maintained.
8) Information system filling and information disclosure.
The registrant shall submit a full set of electronic declaration materials in accordance with the current regulations, and complete the information system such as basic product information, product manual, and product technical requirements. Acceptance, review, approval, certificate making, archiving and other links are completed in the new version of the registration information system. After the registration certificate is renewed, the product information will be disclosed in a timely manner.