Infant Formula2018-09-04T09:37:07+00:00


Infant formula is considered a specific and unique category of dairy products in China. In recognition that these are products designed for the most vulnerable consumer group, infants, the Chinese regulators have implemented a specific process of establishment registration and subsequently brand registration to ensure the products available in the market are subject to rigorous assessment and review to provide the highest possible level of food safety.

The process for gaining CNCA registration for Infant Formula manufacturers requires completion of a specific set of documentation.

The registration process requires that the completed documentation is provided to the CNCA via DAWR in Australia. Once the documents have been reviewed, the CNCA will then need to undertake a physical audit of the establishment. New exporters wishing to ship infant formula products to China should be aware that this can be a lengthy process.  Recent experience has seen several Australian applicants wait for 16 months to have their establishment audited, and three months later are awaiting the report from this audit.

In addition to the CNCA registration process, the CFDA have implemented a requirement for CNCA registered establishments to register their brand formulations.

Brands are able to gain clearance for sale into the China market after 1 January 2018 if they have not been granted CFDA brand registration.  Establishments may apply for up to 3 brands to be registered with the CFDA, and each brand must disclose the details of the formulation, and scientific justification for the ingredients used to demonstrate the nutritional value. Each of the three brands must have formulations that are significantly different.

The dossier to be submitted for the brand application is very detailed. A checklist if items to be included can be found in the table below.

  • Application form for product formula registration of infants and young children formula milk powder
  • Evidentiary documents proving the subject qualification of the applicant
  • Quality and safety standards for the raw and auxiliary materials
  • Product formulation
  • Product formula research and development report
  • Explanation of production process
  • Product inspection report
  • Evidentiary materials of production ability, R&D ability and inspection ability
  • Samples of labels and instructions as well as explanatory and evidentiary materials of claims thereof.

It should also be noted that all dairy products exported to China are governed by the requirements of the Food Safety Law. Dairy products must all meet the requirements of the relevant GB standards.

What are GB standards?

GB standards are China’s national standards, also known as ‘Guo Biao Standards’. China’s GB Standards are classified in two stages by their prefix code: “GB” are Mandatory standards; “GB/T” are Recommended standards (Quasi-Mandatory standards).

Mandatory standards have the force of the law as do other technical regulations in China. They are enforced by laws and administrative regulations and concern the protection of human health, personal property and safety.

Recommended standards
In addition to the General Standards which may apply, there are specific GB Product Standards for each product category which must be complied with. Click the menu item below titled “GB Standards” to download the relevant GB Product Standard for this product, as a PDF file.

Use the easy-to-follow checklist (clickable links) below to help you establish all the necessary requirements needed to export Infant Formula into China.