Infant Formula

Requirements for infant formula

From May 1, 2014, overseas manufacturers of infant formula should submit their registration applications to China AQSIQ through their national/local competent authorities, and pass the onsite facility audit prior to market entry to China. In addition, infant formula manufactured in or imported to China should get their formula registered with registration certificate, and mark the registration number on the label and instruction of the product from January 1, 2018.

Competent Authorities

China Food and Drug Administration (CFDA)

General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)

Certification and Accreditation Administration (CNCA)

Laws and 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)

Key Points and Judging Principles for On-Site Verification and Inspection of 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

REACH24H service

1.  Overseas manufacturer registration with CNCA

 a)  Pre-audit of onsite facility for overseas infant formula manufacturer

 b)  Pre-review of registration materials to ensure completeness and accuracy

2.  Registration of infant formula recipes 

 a)  Communication on the requirements of registration materials; Preparation of registration proposal

 b)  Registration material translation

 c)  Registration dossier compilation and submission  

 d)  Registration progress follow-up and updates

 e)  Preparation of supplementary materials

3.  Registration dossier pre-review for infant formula recipes 

 a)  Dossier pre-review by REACH24H experts

 b)  Double confirmation of registration dossier by authoritative experts

4.  Onsite review of infant formula registration

 a)  Onsite review on registration dossier by REACH24H experts

 b)  Onsite review on registration dossier by authoritative experts to ensure the approval rate of CFDA audit 

Why REACH24H

  • Rich industry experience: we have been following and researching food regulations for years, and have rich experience in practical compliance work.
  • Profound resources and channels: we have connections with authoritative experts in the industry. Together with them we provide pre-review service of registration to ensure high approval rate.
  • Firm connections with the authorities: we have frequent communication with officials of competent authorities to get effective information and suggestions to our registrations.
  • International service competence: we provide barrier-free services with multiple languages including Chinese, English, Japanese, and German to international clients
  • Tailored compliance service: We have served many top 500 companies and chain stores, and are good at providing customized high-quality service.  

contact us


  • Tel: 0571-87007036
  • Fax: 0571-87007566
  • Add: 14th Floor, Building No. 3, Haichuang Technology Center, 1288 West Wen Yi Road, Hangzhou, China 311121
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