China finished revision for infant formula registration

Publish time:7/6/2017 12:00:00 AM      Source: CCM
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China’s government has published the revision of infant formula registration in the country, which will lessen the workload for domestic and overseas companies to get the application done before the deadline of January 1, 2018.


Source: Pexels

On May 25, 2017, the General Administration of the People’s Republic of China has announced the Publication of the Materials and Requirements for the Registration of Pharmaceutical Products for Infant Formula (Trial) as well as the Technical Guidelines for the Standardization of Labeling for Milk Powder Formula for Infants and Young Children.  

According to market intelligence firm CCM, the revision has simplified the requirements for registration as well as the related workload for both, domestic and overseas manufacturers. However, the deadline for completing the application of registration is set to be January 1, 2018, which puts pressure on the enterprises to get their paperwork done in time.  

As a result, Manufacturers are not required to submit formulation R&D reports or material certificates anymore, according to the revision. Furthermore, explanation of the Production Technique Confirmation has been canceled, which reduces the number of required production techniques from three to two.  

Another point that has been deleted in the revised version is the requirement of scientific and safe formulation by the means of different evidences. After all, it seems likely that if official flexibility was possible in interpreting the original requirements, this will be less possible now with the reduced stipulations  

According to CCM, the new revised version by the Administration is way more practical than the previous one and will ease the application for manufacturers overseas and domestic.  

The revision of the issues was explained by the government with further promoting the registration of infant formula milk powder product formulation as well as strengthen the infant formula registration work and standardise the registration tag management of infant formula milk powder products.


Earlier this year, the Administration held a meeting about the revisions of the infant formula standards. In the meeting, discussions centred on problems with the existing supervision of the standards, serving as the starting point for this year's revisions. Four major suggestions were given in the meeting to revise.  

First of all, the protein standards on infant formula products for older infants and young children will be changed. This includes, that the protein content in stage 2 and 3 formula should be increased or decreased as appropriate to cut costs and target the age different needs. Secondly, infant formula products for infants (birth-6 months; stage 1), older infants (6-12 months; stage 2) and young children (12-36 months; stage 3) will be assessed by 3 standards respectively, instead of just two.  

Thirdly, the different nutrition types in infant formula products will be clearly indicated. In fact, ambiguities in nutrition information provided on infant formula may easily mislead customers. The new standard will provide relevant enterprises with specific guidelines and help customers make informed choices. And fourthly, the inspection methods for the nutritional contents of formulae will be made more effective and more comprehensive.  

According to CCM, there have been 104 infant formula producers in China by the end of 2015. In 2016, 221,000 tonnes of infant formula worth USD3.0 billion were imported. So, the new revisions will have a serious impact on both domestic and foreign producers. The process looks certain to include adjusting the formulations and pack designs.  

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