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.
About CCM
CCM
is the leading market intelligence provider for China’s agriculture, chemicals,
food & ingredients and life science markets.
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