Infant Formula

On 23.11.2017, NMPA and AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) published a notice on the registration requirements for imported infant formula (for children from 0 to 36 months). Accordingly, infant formula produced after 01.01.2018 requires NMPA registration before it can be imported, sold and used in China. In 2017, 201 infant formulas were registered by foreign manufacturers in China and in 2018, the number dropped to 71 infant formulas.

Infant formula for special medical purposes falls under the category Food for special medical purposes.

  • GB 10767-2010 National Food Safety Standard Older Infants and Young Children Formula
  • GB 10765-2010 National Food Safety Standard Infant Formula
  • GB 25596-2010 General Rules of Infant Formula Foods for Special Medical Use

  • NMPA Nr. 26-2016 Administrative Measures for Registration of Infant and Young Children Milk Powder Formula
  • NMPA Nr. 66-2017 Guidelines for the Labeling of Infant and Young Children Milk Powder Formula (Trial)
  • NMPA Nr. 65-2017 Application Documents Items and Requirements for Registration of Infant and Young Children Milk Powder Formula
  • Service Guide for the Registration Approval of Infant and Young Children Milk Powder Formula

If you require access to the official sources, we gladly share the relevant links with you.

The process of China NMPA registration of infant formula is demanding. Our experienced consultants can guide you through China's regulatory process. The NMPA approval for infant formula is valid for 5 years.

The NMPA Legal Agent for infant formula is responsible for the registration, supervision of tests and administrative aspects during the certificate application. In addition, the manufacturer and the NMPA Legal Agent have a joint obligation to ensure that the application complies with Chinese law and regulations and that the supporting documentation, such as the test report, is true and accurate. Infant formula manufacturers who want to appoint their Chinese distributor as NMPA Legal Agent should be aware of involved risks. If your distributor does not hand over your original certificates to you, you are entering into a dependency that prevents you from changing distributors, requesting a change or renewal of your NMPA registration, and consequently importing your products. The only way out in most cases is to change the NMPA Legal Agent and re-register the product.

  • Are you a manufacturer and want to sell your infant formula in China?
  • Are you wondering if you can register more than 3 brands (3x3 infant formulas) in China?
  • Would you like to know how much time and money you must expect for the China NMPA registration of your infant formula?
  • Unsure who to appoint as your NMPA Legal Agent?
  • Do you have concerns about revealing the exact manufacturing method of your infant formula during registration?
  • Advice on relevant regulations
  • Legal representation in China as NMPA Legal Agent for registration and regulatory affairs
  • Communication and coordination between the Chinese authorities and you in technical and cultural terms
  • Application of China NMPA registration
  • Provide documents including templates and advice on their correct completion
  • Analysis of ingredients and packaging for compliance with Chinese regulations
  • Translation and notarization of documents and Chinese label
  • Support of necessary tests in China
  • Follow-up of the results until hand-over of the NMPA certificate
  • Comprehensive assistance for follow-up activities (e.g. registration changes and renewals)

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