G/TBT/N/CHN/1636  
1 December 2021  
(21-9053) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  CHINA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  State Administration for Market Regulation (SAMR)  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different fr om above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Infant 
formula milk powder; (HS: 040210); (ICS: 67.100.01)  
5. Title, number of pages and language(s) of the notified document:  Management 
Measures for Registration of Food for Special Medical Purpose (17 page(s), in Chinese)  
6. Description of content:  In order to further make it clear that enterprises should take 
the major responsibility for the whole process of registration i.e. research, development, 
production, inspection, etc, to effectively guarantee the quality and safety of foods for 
special medical purposes  (FSMP), to  strengthen the review and maintenance of product 
safety, nutritional adequacy and clinical effects for food  for special medical purposes, and 
to maintain the health and safety of the people, the Management Measures for 
Registration of Food  for Special Medical Purpose  issued in 2016 is hereby revised with the 
main contents of the revision as follows: (1) Optimize FSMP approval administration: 
firstly,  reduce the time limit for clinical verification from 40 working days to 30 working 
days; secondly, set up review and approval priority  procedures and clarify the scope of 
application and policy measures  thereof  to guide and encourage enterprises to develop 
and register special medical foods that  are used for  urgent clinical needs  and rare 
diseases; thirdly,  cancel the re -examination procedure in the evaluation process for 
products that are not allowed to be registered to improve the efficiency  of the registration; 
fourthly, make  it clear that the registration certificate of foods for special medical 
purposes is  electronic certificate.  (2) Set  stricter requirements for product registration: 
firstly, make it clear that the products that are applying for registration shall be subject 
to on -site and sampling inspection; secondly, cons idering  that the current national food 
safety standards for special medical care are not completed, make it clear that the product 
technical requirements (including testing methods)  shall added in  the registration 
certificate appendix; thirdly,  further str engthen the requirements on labelling and 
marking to  highlight the characteristics of special medical food  and warnings thereof, so 
as to remind  consumers that these products should be purchased and used  under the 
guidance of doctors or clinical nutritioni sts and to guide consumers to choose and 
purchase correctly. (3) Carry out  the most strict supervision: firstly,  emphasize that 
applicants shall undertake  the main responsibilities and obligations for the application and 
be responsible for the authenticity , accuracy, completeness and traceability of application 
materials.  They shall also mark trade secrets and business information as required and G/TBT/N/CHN/1636  
 
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  cooperate in registration -related work; secondly,  clarify nine situations of review 
termination and non -registra tion. (4) Implement the most severe punishment and 
accountability requirements: firstly,  make it clear that the applicants shall take 
major  responsibility for  the registration process, and  if the application process is illegal, 
the applicant will be transf erred to the public security organ and be prosecuted for criminal 
liabilities in accordance with the law; secondly, according to  the relevant provisions of the 
newly revised "Administrative Punishment Law ", for those who conceal the truth or 
provide false materials for the application, use fraud, bribery and other improper means 
to obtain registration certificates, or altering, reselling, renting,  lending  and transferring  
the certificates, more punishment measures, such as making announcements to the 
public  for the penalties, will be implemented in addition to corresponding punishment; 
thirdly,  clarify the responsibilities of institutions and personnel that  are in charge of 
registration application acceptance, technical review, on -site and sampling inspectio n, 
and expert judgement. Any violations of laws and regulations in their work shall be 
verified and dealt with in a timely manner.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
- 
9. Proposed date of adoption:   To be determined.  
Proposed date of entry into force:   To be determined.  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
China WTO/TBT National Bulletin Consulting Center  
Tel：+86 10 57954633/ 57954627  
Email：tbt@customs.gov.cn  
https://members.wto.org/crnattachments/2021/TBT/CHN/21_7469_00_x.pdf