Requirements for Infant Formula

From May 1, 2014, overseas manufactures of infant formula must submit their registration applications to China GACC through their national/local competent authorities as well as pass on-site facility audit prior to China market entry. In addition, from January 1, 2018, infant formula manufactured in or exported to China must pass recipe registration and obtain the registration certificate as well as mark product registration number and instruction on the label upon importation.

Competent Authorities

• State Administration for Market Regulation (SAMR)

• General Administration of Customs of China (GACC)

Relevant Regulations

• Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes (AQSIQ Order 26)

• Provisions on the Administration of the Registration of Overseas Manufacturers of Imported Foods (AQSIQ Order 145)

• Items and Requirements of Application Materials for Registration of Infants and Young Children Milk Powder Formula Recipes (Trial)

• GB 10765-2010 National Food Safety Standard Infant Formula

• GB 10767-2010 National Food Safety Standard Older Infants and Young Children Formula

Our Services

Overseas Manufacturer Registration

• Pre-audit for ensuing onsite facility inspection for overseas infant formula manufacturer

•  Preview of registration materials to ensure complete and accurate

Infant Formula Registration

• Communication on the requirements of registration materials; Preparation of registration proposal

•  Registration material translation

• Registration dossier compilation and submission

•  Registration progress follow-up and updates

•  Preparation of supplementary materials

Infant Formula Registration Dossier Review

•  Dossier review by REACH24H technical experts

• Review support form authoritative experts On-site Review of

Infant Formula Registration

•  On-site review of registration dossier by REACH24H experts

•  On-site review of registration dossier by authoritative experts to ensure passes CFDA audit