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.

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FoodMate China
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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?.........................................................................................................4
Question 2: what materials are needed for the product that has been sold on the market? ..........4
Question 3: how to fill in other problems that need to explain in the application?.........................4
Question 4: what do acceptance serial number and check code on the notice of acceptance do?.5
Question 5: what to do with regard to modification when filling in the applicantion or after
uploading the application?................................................................................................................5
Question 6: can the application materials be printed with papers of other sizes? Is duplex printing
allowed?............................................................................................................................................6
Question 7: which English contents in registration materials should be translated into Chinese
contents? Do all English references need to be translated? .............................................................6
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?.....7
Question 9: which materials are needed for renewal of registration? .............................................9
Question 10: which materials are needed for change of registration?...........................................10
Question 11: under what circumstances should change of product formula registration of infant
and young children formula milk powder be applied for?..............................................................10
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”?.................................................................................................................................11
Question 13: how to describe the basic situations of R&D personnel, production personnel and
inspection personnel?.....................................................................................................................11
Question 14: what are the requirements on letter of authorization for the transaction of
registration affairs by domestic agency entrusted by the overseas applicant? ..............................12
Question 15: which materials does the subject registration certification document of overseas
applicant refer to?...........................................................................................................................12

3. Q&A Summary for Infant Formula Registration in China
FoodMate Internal Confidential Documents
Question 16: which materials should be submitted for application materials containing registered
trademark?......................................................................................................................................13
Question 17: how to submit materials for the product with label but without package insert？ .13
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?..........................................................................................................................................14
Question 19: how to submit product inspection report involving item without national standard
inspection method? ........................................................................................................................14
Question 20: what items does the inspection report on all items issued by the inspection agency
include?...........................................................................................................................................15
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?......................................................................................15
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?...............15
Question 23: do requirements on the format of inspectin report apply to overseas producing
enterprises? ....................................................................................................................................16
Question 24: may the inspection report on all items adopt non-national standard method or
foreign inspection method?............................................................................................................16
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? ..........................................16
Question 26: shall verificaiton of production process be conducted respectively for products of
different packing sizes produced according to the same formula?.................................................17
Question 27: how to provide the quality safety standard of base powder?...................................17
Question 28: may the quality safety standard of food additive be pharmacopeia standard? How to
submit materials?............................................................................................................................17
Question 29: may a same kind of raw and auxiliary material come from several suppliers? How to

4. Q&A Summary for Infant Formula Registration in China
FoodMate Internal Confidential Documents
submit materials?............................................................................................................................17
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？ ................18
Question 31: how to understand the tracking evaluation scheme in product formula R&D report?
Is there any requirement on tracking evaluation scheme?.............................................................18
Question 32: how to mark DHA, ARA, FOS and GOS in the nutrition facts?...................................19
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?.........................................19
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? .........................19
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?..........................................................................................................20
Question 36: how to fill in the list of formulation dosage with regard to such liquid material as
raw milk?.........................................................................................................................................20
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?............................................................................................21
Question 38: if product formula does not change, can the trial sample be used as three batches of
products produced through commercial production line?.............................................................21
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. ..............................................21
Question 40: how to mark the edible vegetable oil in formula composition?................................22
Question 41: how does the applicant find the lost account number or password causing
unsuccessful login when applying for registration through information system............................22