SAMR Issued the Technical Guidelines for Formula Alteration Registration of Infant Formula Milk Powder (Draft) for Public Comment

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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-reach.com.

Reference:

SAMR Notice