SAMR Infant Formula Milk Powder Registration

Under the Administrative Measure on Product Formula Registration of Infant Formula Milk Powder (CFDA Order No. 26) released in 2016, companies shall submit a registration of imported infant formula milk powder to the State Administration for Market Regulation (SAMR). The registration not only applies to domestic infant formula milk powder produced and marketed in China, but also to imported infant formula milk powder produced abroad and put on the Chinese market.

News Updates

The Administrative Measures for the Registration of Infant Formula Products (hereinafter referred to as the Administrative Measures) was revised and issued on July 10, 2023, and came into effect on October 1, 2023 . To help enterprises make adjustments to cope with the new circumstances, we have summarized the changes to the old administrative measures as well as the strategies in response to the new regulations.

Who Shall Register?

• Manufacturers of infant formula milk powder in China.

• Foreign manufacturers selling infant formula milk powder to China.

Who Can Be The Applicant (The Certificate Owner) of Registration?

Domestic infant formula milk powder	Manufacturers of infant formula milk powder in China
Imported infant formula milk powder	Manufacturers of infant formula milk powder abroad

Manufacturers in China can submit an infant formula milk powder registration or appoint a local agent to do so. Foreign manufacturers must appoint a local Chinese agent such as CIRS China to submit the infant formula milk powder registration. The local agent should be knowledgeable and qualified to carry out the registration.

Our Services

CIRS China fulfills all the qualifications and requirements of being a local Chinese agent (registered capital, expertise, etc). We provide all the necessary services in one package to complete registration at the most competitive price in the market.

Our services include:

Formula Compliance Review (Registration Feasibility Analysis)	Evaluation of whether the recipe is compliant with Chinese regulations Preparation of an infant formula milk powder registration proposal
Health Food Registration	Data evaluation and data gap analysis Writing testing proposals, sending samples to certified labs Translation and notarization of certifying documents Dossier preparation and submission Tracking the registration status and communication with SAMR
Label Review	Review the Chinese packaging/label and provide modification suggestions

Further Information

【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Base Powder

【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Hydrolyzed Milk Protein

Latest Compliance Advances of Human Milk Oligosaccharides (HMOs) in China

Latest Compliance Advances of Human Milk Oligosaccharides (HMOs) in the EU and U.S.