There are only 7 months left for infant formula registration in China, both domestic and international companies bet on the formula registration to win their future in China. Here we provide the summary of the most frequent questions and answers during infant formula registration process.

1. 1120
FoodMate China
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SHANDONG PROVINCE
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Q&A Summary for Infant Formula Registration
in China
FoodMate is dedicated to providing end to end regulatory services
& solutions for our clients to enter and stay in Chinese market

2. Q&A Summary for Infant Formula Registration in China
FoodMate Internal Confidential Documents
Items
Question 1: if references quote contents in some book, does the full text of the book need to be
submitted in the form of a CD?..........................................................................错误!未定义书签。
Question 2: what materials are needed for the product that has been sold on the market?错 误 !
未定义书签。
Question 3: how to fill in other problems that need to explain in the application?错误!未定义书
签。
Question 4: what do acceptance serial number and check code on the notice of acceptance do?
...........................................................................................................................错误!未定义书签。
Question 5: what to do with regard to modification when filling in the applicantion or after
uploading the application?.................................................................................错误!未定义书签。
Question 6: can the application materials be printed with papers of other sizes? Is duplex printing
allowed?.............................................................................................................错误!未定义书签。
Question 7: which English contents in registration materials should be translated into Chinese
contents? Do all English references need to be translated? ..............................错误!未定义书签。
Question 8: which matters shall the applicant pay attention to for submission of registration
application materials for product formula of infant and young children formula milk powder?错误!
未定义书签。
Question 9: which materials are needed for renewal of registration? ..............错误!未定义书签。
Question 10: which materials are needed for change of registration?..............错误!未定义书签。
Question 11: under what circumstances should change of product formula registration of infant
and young children formula milk powder be applied for?.................................错误!未定义书签。
Question 12: how to understand “the overseas applicant shall submit the name of the inspection
agency for implementing lot by lot inspection and the materials for certifying the statutory
qualification”?....................................................................................................错误!未定义书签。
Question 13: how to describe the basic situations of R&D personnel, production personnel and
inspection personnel?........................................................................................错误!未定义书签。

3. Q&A Summary for Infant Formula Registration in China
FoodMate Internal Confidential Documents
Question 14: what are the requirements on letter of authorization for the transaction of
registration affairs by domestic agency entrusted by the overseas applicant? .错误!未定义书签。
Question 15: which materials does the subject registration certification document of overseas
applicant refer to?..............................................................................................错误!未定义书签。
Question 16: which materials should be submitted for application materials containing registered
trademark?.........................................................................................................错误!未定义书签。
Question 17: how to submit materials for the product with label but without package insert？ .错
误!未定义书签。
Question 18: how does the applicant submit materials for change of marked value of nutritional
ingredient of the product that has been sold on the market due to issuance of new inspection
method?.............................................................................................................错误!未定义书签。
Question 19: how to submit product inspection report involving item without national standard
inspection method? ...........................................................................................错误!未定义书签。
Question 20: what items does the inspection report on all items issued by the inspection agency
include?..............................................................................................................错误!未定义书签。
Question 21: for the inspection reports on all items of three batches of products produced in
accordance with product formula that is applied for registration, may inspection of each batch be
entrusted to different inspection agency?.........................................................错误!未定义书签。
Question 22: for inspection report on all items that is issued before the implementation date of
new method and adopts old national standard method among application materials that are
submitted after the implementation date of new national standard method announced by the
National Health and Family Planning Commission, is the inspection report applicable?错误 !未定
义书签。
Question 23: do requirements on the format of inspectin report apply to overseas producing
enterprises? .......................................................................................................错误!未定义书签。
Question 24: may the inspection report on all items adopt non-national standard method or
foreign inspection method?...............................................................................错误!未定义书签。
Question 25: in the inspection report on all items, may the result of item without national
standard inspection method be calculated according to the formula? .............错误!未定义书签。

4. Q&A Summary for Infant Formula Registration in China
FoodMate Internal Confidential Documents
Question 26: shall verificaiton of production process be conducted respectively for products of
different packing sizes produced according to the same formula?....................错误!未定义书签。
Question 27: how to provide the quality safety standard of base powder?......错误!未定义书签。
Question 28: may the quality safety standard of food additive be pharmacopeia standard? How to
submit materials?...............................................................................................错误!未定义书签。
Question 29: may a same kind of raw and auxiliary material come from several suppliers? How to
submit materials?...............................................................................................错误!未定义书签。
Question 30: do the overseas applicant entrusting more than one angencies with transaction of
registration affairs need to submit the instruction for difference between formulas？错 误 ! 未 定
义书签。
Question 31: how to understand the tracking evaluation scheme in product formula R&D report?
Is there any requirement on tracking evaluation scheme?................................错误!未定义书签。
Question 32: how to mark DHA, ARA, FOS and GOS in the nutrition facts?......错误!未定义书签。
Question 33: the template format given for the nutrition facts contains whey protein and lactose,
so do the two items need to be marked in product label mandatorily?............错误!未定义书签。
Question 34: OPO, DHA and AA belong to fat category as well as optional components, and
lactoferrin belongs to protein category as well as optional component, shall they be marked in fat
and protein category or optional component category in the list of ingredients?错 误 ! 未 定 义 书
签。
Question 35: do the requirements on the “Nutrition Facts” in product formula (3) apply to just
application materials or also the label? Is the numerical value in the “Nutrition Facts” design
value or product label value?.............................................................................错误!未定义书签。
Question 36: how to fill in the list of formulation dosage with regard to such liquid material as
raw milk?............................................................................................................错误!未定义书签。
Question 37: what the range of materials during actual production allowed to fluctuate or be
adjusted reasonably will be? Need it be marked in application materials? Does the list of
ingredients refer to that on the label?...............................................................错误!未定义书签。
Question 38: if product formula does not change, can the trial sample be used as three batches of
products produced through commercial production line?................................错误!未定义书签。

5. Q&A Summary for Infant Formula Registration in China
FoodMate Internal Confidential Documents
Question 39: must the feeding quantity during sample trial production be the amount for making
1000kg product in accordance with the list of formulation dosage. .................错误!未定义书签。
Question 40: how to mark the edible vegetable oil in formula composition?...错误!未定义书签。
Question 41: how does the applicant find the lost account number or password causing
unsuccessful login when applying for registration through information system错误!未定义书签。