The Food Safety Law enacted on October 1, 2015 stipulates that infant formula products must be registered. Since January 1, 2018, infant formula milk powder produced domestically or exported to China can only be sold after obtaining the registration certificate for the infant formula milk powder product.
I.Regulatory Background
Articles 74 and 81 of the Food Safety Law of the People's Republic of China:
• The state imposes strict supervision and management on ... and special foods such as infant formula food.
• The product formula of infant formula milk powder shall be registered with the State Food and Drug Administration.
Articles 1 and 2 of the Regulations for the Management of Registration of Infant Formula Milk Powder Product Formulas:
• In order to strictly manage the registration of infant formula milk powder product formulas, ensure the quality and safety of infant formula milk powder, this method is formulated according to the Food Safety Law of the People's Republic of China and other laws and regulations.
• The management of the registration of infant formula milk powder product formulas produced, sold, and imported within the territory of the People's Republic of China shall apply this method.
II.Registration Management Agency
The National Food and Drug Administration is responsible for the management of the registration of infant formula milk powder product formulas.
III.Applicant Requirements
The applicant should be:
1.A production enterprise intending to produce and sell infant formula milk powder within the territory of the People's Republic of China, or
2.A foreign production enterprise intending to export infant formula milk powder to the People's Republic of China.
The applicant should have the research and development capability, production capacity, and testing ability suitable for the production of infant formula milk powder. They should comply with the good manufacturing practices for powdered infant formula food, implement a Hazard Analysis Critical Control Point (HACCP) system, and conduct batch-by-batch inspections of the factory's products according to relevant laws, regulations, and national food safety standards for infant formula milk powder.
When a single enterprise applies to register more than two product formulas for the same age range, there should be a significant difference between the product formulas, which is scientifically confirmed.
In principle, each enterprise should not have more than three formula series and nine product formulas. Each formula series includes infant formula milk powder (0-6 months, Stage 1), older infant formula milk powder (6-12 months, Stage 2), and toddler formula milk powder (12-36 months, Stage 3).
V. Application Process and Time Frame
From the preparation of materials to the completion of the application, the application time frame for the registration of infant formula milk powder usually takes about 1.5 to 2.5 years.
VI. Application Materials
Application materials for infant formula milk powder product formula registration:
1)Application form for registration of infant formula milk powder product formula;
2) Applicant's main qualification documents;
3) Quality and safety standards of raw and auxiliary materials;
4) Product formula development report;
5) Description of the production process;
6) Product inspection report;
7) Proof materials of R&D capability, production capacity, and testing capability;
8) Other materials demonstrating the scientific nature and safety of the formula.
The product formula applied for registration should comply with relevant laws, regulations, and national food safety standards, and provide a research and development report and sufficient evidence demonstrating the scientific nature and safety of the product formula.
The validity of the infant formula milk powder product formula registration certificate is 5 years. If the registration certificate needs to be extended upon expiration, the applicant should submit an application for extension to the National Food and Drug Administration 6 months before the expiration of the certificate's validity.
VIII. Related Regulations
* Food Safety Law of the People's Republic of China
* Regulations for the Management of Registration of Infant Formula Milk Powder Product Formulas
* Items and Requirements for the Application Materials for Registration of Infant Formula Milk Powder Product Formulas (Trial)
* Technical Guidance Principles for Labeling Standards for Registration of Infant Formula Milk Powder Product Formulas (Trial)
* Key Points and Judgment Principles for On-site Verification of Registration of Infant Formula Milk Powder Product Formulas (Trial)
IX. Our Services
ZMUni can provide enterprises with services related to the registration of infant formula milk powder formulas:
* Feasibility analysis of infant formula milk powder registration
* Registration application for infant formula milk powder (including first registration, change, extension)
* Other customized consultation compliance services
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