On 26 July, 2018, the State Administration
for Market Regulation (SAMR) issued a Notice on the Technical Guidelines for Formula Alteration Registration of Infant
Formula Milk Powder (Draft) for public comments. Opinions and advices shall
be given before 15 August, 2018.
In order to help companies obtain the key
information of the draft, CIRS has made an interpretation on the application
scope, alteration items, and application materials in
this draft.
1.
Application Scope
Scope
Details
Situations that need to apply for
alteration
I. Items that listed in the product registration certificate and
attachment changed.
II. Situations mentioned in the former CFDA Notice of
No.150, 2017 (Notice on Label
Alteration Application for Infant Formula Milk Powder Formula Registration)
Situations that do not need to apply for
alteration
The usage amount of food ingredients
including food additives are allowed to be reasonably adjusted within a
certain range under actual production, but the food ingredients, order of each
ingredient in ingredient list, and nutrition information shall remain
unchanged.
Situations that need to apply for
re-registration
I. Product formula has significant changes;
II. The nutrition information changed;
III. The production process type (wet process,
dry process and dry-wet process) changed.
2. Alteration
Items
Items
Details
Alterations that will not affect the science
and safety of the formulation
I. The product name changed;
II. The company name, name of production address, or legal
representative changed;
III. The allowed content claims in the label and
instruction changed;
IV. The registered trademark, graphics, product standard code, or
certification project in the label and instruction changed;
V. Others.
Alterations that may affect the science
and safety of the formulation
I. The categories, status or quality specifications of food
ingredients and food additives changed;
II. Compound ingredients and compound food additives are changed to
monomer ingredients and monomer food additives, or vice versa.
III. The usage amount of food ingredients and food
additives changed, resulting in change of order of ingredients in the ingredient
list.
IV. Enterprise relocate production address;
V. Others.
3. Application
materials of alteration
Application form.
Copies of infant formula milk powder registration certificate and
attachment.
Copies of qualification certifications of the applicant.
Guarantee promising that the applicant does not infringe patents of
others (it is not required for items I, II, III of the alterations that will
not affect the science and safety of the formulation).
Labels and instructions, and the revision note (if the label and
instruction changed).
Power of attorney (if the oversea applicant entrusts others to
handle the alteration).
Others.
Besides above materials, below additional
materials are required under specific alteration items:
Items
Additional materials
Alterations that will not affect the science
and safety of the formulation
product name changed
Guarantee promising that the name does
not infringe others, and trademark registration certificate if needed.
company name, name of production address,
or legal representative changed
Relevant alteration materials issued by
local government.
The registered trademark, certification project in the label and
instruction changed;
Prepare relevant materials according to
the product formula registration requirements.
Alterations that may affect the science
and safety of the formulation
I. Quality specifications of the food ingredients and additives (if
the specifications changed);
II. Formula comparison materials (before and after
the change);
III. Verification Report on the alteration;
IV. 3 batches of commercial production process
validation reports;
V. 3 batches of product test reports (shall be
entrusted to qualified food testing agencies);
If you have any needs or questions, please feel free to contact us at service@cirs-group.com.
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