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CFDA Issues Draft of Infant Formula Regulation Rules

1. The new infant formula formulation registration rule is for domestic IF manufacturers so it won’t have any impact on imported IF products yet. 2. Individual domestic companies will be permitted to produce a maximum of 5 brands which will greatly reduce the number of domestic IF brands in China.

On 2 Sep 2015, China Food and Drug Administration (CFDA) released the draft of “Administrative Measures for Registration of Infant Formula Formulations” for public comments. Companies can send their comments to CFDA before 1 Oct.

Who does the regulation apply to?

The applicant for formulation registration should be approved domestic Infant formula manufacturers. Last year, CFDA approved 92 manufacturers to produce IF products in China (see CL food news on 5 Dec 2014).

Competent authority

Companies should apply for registration to CFDA, which will be responsible for reviewing the R&D report and other supporting documents as evidence of the scientific/nutritional soundness and the safety of the formulation. CFDA will establish an expert database specialized in areas such as food nutrition, food safety, clinical medicine, food engineering, etc. to examine and evaluate the formulations.

Registration documents needed to be submitted

Domestic IF manufacturers should provide the following documents to CFDA for review:

  • Application form;

  • R&D report and description of production technics;

  • Product testing report;

  • Supporting materials to provide the production, R&D and testing capabilities;

  • Labels and instructions;

  • Other materials that manifest the science and safety of formulations. 

Principles for differentiating formulations

The difference in formulation among different brands should be very obvious, like

  • Option 1: at least 6 selected ingredients listed in the national standards (GB 10765 & GB 10767) are different and there is scientific evidence to support choice of ingredients.

  • Optional 2: every manufacturer should have 5 series totalling 15 formulas at most. 

Related companies cannot use one formulation to produce different brands. Meanwhile, companies shall not restrict sales area or customize products for traders. 

Registration procedures & timeline

CFDA conducts format check of registration documents

5 working days

Local FDA conducts on-site inspection of the manufacturers in line with GB 23790-2010 requirements, establish HACCP (GB/T 27342-2009), be capable of innovating formulations and have full testing ability of items listed in the national standards (GB 10756 & GB 10767). After that, local FDA issues a verification report.

<20 working days

CFDA entrusts a certified lab (the list of lab will be issued later) to test samples

<30 working days

CFDA organizes an expert panel to comprehensively evaluate the registration documents, on-site verification report, sample testing report, etc.

<60 working days

CFDA makes the decision to approve or not and issues registration certificate to qualified manufacturers

<20 working days

In total

135 days at most

The validity of the certificate will be 5 years. The applicant should apply for renewal of the certificate (registration) within 60 days before it expires.

CFDA will not allow re-registration if

  • an infant formula product is found not complaint more than twice during spot checks conducted by provincial FDAs

  • the manufacturer fails to maintain its production, R&D and testing ability;

  • the manufacturer does not record the production and sale of their infant formula products and does not establish a traceability system  

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