Interpretation | Administrative measures on Product Formulation Registration of Infant Formula Milk Powder (Draft for comment 2019)

On June 26, 2019, the State Administration for Market Regulation (SAMR) solicited public opinions on Administrative measures on Product Formulation Registration of Infant Formula Milk Powder (Draft). The deadline for solicitation is July 25, 2019.

The current measures was enforced on October 1, 2016, so, what are the differences between the draft version and the current version? Global Foodmate summarised few key points, for your reference.

The production, sales and import of infant formula are subjected to the measures, as always.

l  More Stringent Registration

1.  The applicant is required to have acomplete production process, otherwise, it is a sub-packaging behavior, which does notmeet the requirements of applicants for infant formula registration.

2.  7 Situations of registration rejection: 

a. The applicant does not have the R&D capability, production capacity or inspection capability that is corresponding to the applied infant formula;

b. The application materials for registration do not support the scientific, safety of the product or with insufficient basis; the content of the application materials is contradictory, untrue, doesnot comply with the laws and regulations and the national food safety standards; the supplementary materials are not submitted within the deadline orthe supplementary material submitted does not meet the requirements;

c. The applicant cannot confirm the on-site inspection within the deadline, refuses or does not cooperate with the on-site verification; the on-site verification indicates that the application materials are incorrect, inconsistent, cannot be traced back or with major defects; the rectification is not completed on time;

d. The applicant refuses or does not cooperate with the sampling test; the product inspection is unqualified; the test result demonstrates that the measurement method is unscientific and cannotbe reproduced;

e. There is no significant difference in product formulation between the formula applied for registration and the formula of the same stage of the same enterprise;

f. The applicant that is listed in the List of Enterprises with Serious Illegal and Dishonest Acts;

g. Other situations

3. Refine the prohibition requirements on labels and instructions and clarify the source of raw milk. Using of the image of infants and women,the term of ‘human breast milk’ or similar terms are prohibited.

4. Clarify the requirement of materials for formulation alteration, including the demonstration report of formulation alteration (which is not mentioned in current version).

l  More Strict Punishment

1. Applicants listed in the List of Enterprises with Serious Illegal and Dishonest Acts shall be rejected for registration; 

2. Further regulate the action of copying, reselling, leasing, lending, and transferring infant formula registration certificates and increase the penalty to 10,000 RMB-30,000 RMB

Please note:The original article of Global Foodmate Information Service and Business Department, please indicate the source from the Global Foodmate if reprint.

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