Interpretation of Formal Regulation on Formula Registration of Infant Formula Milk Powder


8 June 2016, CFDA released the formal version of Administrative Measures on Product Formula Registration of Infant Formula Milk Powder, which will come into force on 1 October 2016. Based on the analysis of CIRS, there are not many differences between the formal version and the one submitted to WTO before. Meanwhile, the allowed quantity of registered formula that has much concern by the public has been official stipulated in this measure.
 
Application Scope
 
This regulation is applicable for the registration of product formula of infant formula milk powder which is produced and distributed in China and imported to China.
 
What is the product formula of infant formula milk powder?
 

The product formula of infant formula milk powder means all the raw materials, food additives and their dosages, and the product’s nutrition content.
 
Who should apply for the registration of product formula of infant formula milk powder?
 
The applicant should be the manufacturer of the infant formula milk powder in China or the overseas manufacturer plan to export infant formula milk powder to China.
 
Who should be responsible for the management of the registration of product formula of infant formula milk powder?
 
CFDA acceptance agency, evaluation agency, and examination agency should be responsible for the acceptance, evaluation, and on-site inspection of registration of product formula of infant formula milk powder, respectively.
 
What are the required materials?
 
  • Application form
  • Qualification certificate of applicant.
  • Quality and safety standards of raw materials
  • Formula research report
  • Production process specification
  • Product testing report
  • Evidentiary materials of the production, research and testing capabilities
  • Other materials to prove the scientificity and safety of the formula 
 
How many formulas could be registered by one company?
 
1. There should have a significant difference between each registered product formula which is produced by the same company and for the same age. It should be confirmed by scientific basis, and there are at most 3 series 9 kinds of formulas for one company in principle. One series includes infant formula (0-6 months, 1 stage), older infant formula (6-12 months, 2 stage), and young children formula (12-36 months, 3 stage).
 
2. One wholly-owned subsidiary who has get the formula registration license and production license is allowed to produce the registered product from another wholly-owned subsidiary in the same group company.
 
Contents of the certificate
 
  • Product name
  • Company name, legal representative, and production address
  • Approval number, approval date and validity period
  • Production process
  • Product formula
 
Registration procedure of the formula of infant formula milk powder


 
 
Forbidden content on the label and specification
 
a. Express and imply with the function of disease prevention or treatment.
b. Express and imply with health function.
c. Express and imply with the function of improving intelligence, strengthening resistance or immunity, protecting intestine, etc.
d. Words like ‘zero- added’, ‘no added’, ‘do not contain’ for the materials that are not allowed to add in the product in accordance with relevant food safety standard.
e. Contents that are false, exaggerated, violating the principles of science or absolute.
f. Other claims that are inconsistent with the product formula registration content.
 
 
The formal regulation will come into force on 1 October and related enterprises should get ready to apply for the registration by collating required materials etc. CIRS will keep in touch with authority and focus on the new updates in the following days since the registration details have not been published. Any progress, we will inform on the website immediately for timely response. 
 
Reference

http://www.sfda.gov.cn/WS01/CL0053/155260.html
http://www.cirs-group.com/food/news/CFDA_Product_Formula_Registration_Administration_
Measures_Infant_Formula_Milk_Powder.html

 
Contact us

Ms. Alice Yang, Food safety and regulatory affairs department, CIRS China
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel: +86 571 8971 6579 | Fax: +86 571 8720 6533
Email: Alice.Yang@cirs-group.com
 
 
① 凡本网注明"稿件来源:“杭州瑞旭科技集团有限公司"的所有文字、图片和音视频稿件,版权均属杭州瑞旭科技集团有限公司所有,任何媒体、网站或个人未经本网协议授权不得转载、链接、转贴或以其他方式复制发表。已经本网协议授权的媒体、网站,在下载使用时必须注明"稿件来源:杭州瑞旭科技集团有限公司",违者本网将依法追究责任。
② 本网未注明"稿件来源:杭州瑞旭科技集团有限公司 "的文/图等稿件均为转载稿,本网转载出于传递更多信息之目的,并不意味着赞同其观点或证实其内容的真实性。如其他媒体、网站或个人从本网下载使用,必须保留本网注明的"稿件来源",并自负版权等法律责任。如擅自篡改为"稿件来源:杭州瑞旭科技集团有限公司",本网将依法追究责任。如对稿件内容有疑议,请及时与我们联系。
③ 如本网转载稿涉及版权等问题,请作者在两周内速来电或来函与杭州瑞旭科技集团有限公司联系。
News
Contact Us
Tel:+86 (0) 571 87206538
Email:cathy.yu@cirs-group.com
ADD: 11/F., Bldg 1, Dongguan Hi-Tech Park, 288 Qiuyi Rd Binjiang District Hangzhou, China