In order to ensure the quality and safety of formula food for special medical purpose (FSMP) and promote the registration and administration of FSMP, the State Administration for Market Regulation issued the “Administrative Measures for Registration of FSMP” (Draft for comments) on October 18 to solicit public opinions until November 18, 2021. FoodMate has made a brief review of the main amendments to the draft.


1. Deepening the reforms to delegate power, streamline administration and optimize government services

(1) Applicants are given 30 working days to prepare for the on-site verification process;

(2) Relief measures shall be given to those who had confirmed not able to accept on-site inspection due to force majeure and other factors;

(3) Reduce the time limit for clinical verification from 40 working days to 30 working days;

(4) Set up priority review and approval procedures, clarify the scope of application and policy measures;

(5) The general principle requirements of clinical trials are proposed for the application for registration of specific full-nutrition formula foods;

(6) Cancel the review procedure for products that are not allowed to be registered in the review link. If the applicant has objections to the registration conclusion, he may submit an administrative review or file an administrative lawsuit;

(7) Clarify that the registration certificate of FSMP is an electronic certificate, and the validity period is 5 years. The e-certificate has the same legal effect as the previously printed certificate.


2. Further strict product registration review requirements

(1) Clarify that the products applied for registration need to be carried out on-site inspection and sampling inspection;

(2) Explicitly add product technical requirements items to the appendix of the registration certificate;

(3) Clarify that the use of food raw materials and food additives during actual production were allowed to fluctuate reasonably within a certain range; but for changes in food raw materials, food additives (except flavors and fragrances) and nutritional composition table, an application for change registration should be applied;

(4) Further strict labeling requirements, highlighting the FSMP labeling characteristics and warning words.


3. Implement the most stringent regulatory requirements

(1) Emphasize that the applicant shall bear the main responsibilities and obligations of the application for registration, and be responsible for the authenticity, accuracy, completeness and traceability of the application materials; mark trade secrets as required and cooperate with the registration-related work;

(2) Clarify nine situations of termination of review and non-registration;

(3) Strictly renew the registration, require the provincial food safety supervision and administration department to verify the production and sales of the products within the validity period of the registration certificate, and issue a renewal opinion letter based on the comprehensive situation of daily supervision and product sampling inspections, and the registration will not be renewed if there was no production or sales within the validity period of the registration certificate.


4. Implement the most severe penalty and accountability requirements

(1) Clarify the main responsibility of the applicant during the registration process, and if it is clearly suspected of a crime, it shall be transferred to the public security organization in accordance with the law and criminal responsibility shall be investigated;

(2) Where the applicant conceals the truth or provides false materials to apply for registration and obtain the registration certificate by fraud, bribery or other improper means, or has the behavior of alter, resell, rent, lend, or transfer the registration certificate of FSMP, punitive measures of announcement to the public have been added to the relevant clauses in addition to imposing corresponding penalties;

(3) Clearly assume the responsibilities of institutions and personnel that accept registration applications, technical reviews, on-site inspections, sampling inspections, and expert demonstrations. Any violations of laws and regulations in their work shall be verified and dealt with in a timely manner;

(4) Clarify that the applicant can withdraw the application during the review process. However, in the process of technical review, on-site inspection, and sampling inspection, if any illegal act is found to be suspected of concealing the truth or providing false information, it shall be dealt with in accordance with the law, and the applicant shall not withdraw the registration application.

In addition, during the revision process, the contents that overlap with food safety laws and regulations and national food safety standards in the "Administrative Measures for Registration of Formula Food for Special Medical Purpose" were deleted.