Administrative Measures for the Registration of Product Formulas of Infant Formula Milk Powder
Administrative Measures for the Registration of Product Formulas of Infant Formula Milk Powder
Administrative Measures for the Registration of Product Formulas of Infant Formula Milk Powder
Order of the China Food and Drug Administration No. 26
June 6, 2016
The Administrative Measures for the Registration of Product Formulas of Infant Formula Milk Powder, which was adopted at the Meeting of the China Food and Drug Administration (CFDA) on March 15, 2016, are hereby promulgated for implementation as of October 1, 2016.
Bi Jingquan, Director General
Administrative Measures for the Registration of Product Formulas of Infant Formula Milk Powder
Chapter I General Provisions
Article 1 In order to strictly administer the registration of product formulas and ensure the quality and safety of infant formula milk powder, these Measures are formulated in accordance with the Food Safety Law of the People's Republic of China and other laws and regulations.
Article 2 These Measures apply to the administration on the registration of product formulas of infant formula milk powder produced, sold in and imported to the territory of the People's Republic of China.
Article 3 The registration of the product formulas of infant formula milk powder refers to the activity in which the CFDA examines the applications for the registration of product formulas of infant formula milk powder and decides whether to grant registration in accordance with the procedures and requirements prescribed herein.
Article 4 The administration of the registration of the product formulas of infant formula milk powder shall follow the principles of scientific nature, rigorousness, openness, fairness and impartiality.
Article 5 The CFDA shall be responsible for administering the registration of the product formulas of infant formula milk.
The Administrative Acceptance Department of the CFDA ("the Acceptance Department") shall be responsible for accepting and processing the applications for the registration of the product formulas of infant formula milk.
The Examination Department of the CFDA ("the Examination Department") shall be responsible for examining the applications for the registration of the product formulas of infant formula milk.
The Inspection Department of the CFDA ("the Inspection Department") shall be responsible for inspecting the registration of the product formulas of infant formula milk on the spot.
The food and drug regulatory departments of all provinces, autonomous regions and municipalities directly under the Central Government shall assist the CFDA with on-site inspection and other work in connection with the registration of the product formulas of infant formula milk within their jurisdiction.
Article 6 The applicants shall guarantee the authenticity, integrity and legitimacy of submitted materials, and assume legal liability.
The applicants shall assist the food and drug administrative departments in conducting an on-site inspection, sampling and other work related to the registration.
Chapter II Application and Registration
Article 7 The applicants shall be manufacturers intending to produce and sell infant formula milk powder within the territory of the People's Republic of China or overseas manufacturers intending to export infant formula milk powder to the People's Republic of China.
The applicants shall have R & D capacity, production capacity and inspection capacity to manufacture infant formula milk powder, meet the requirements of the good manufacturing practice of infant formula foods, implement the hazard analysis and critical control point system, and inspect the products manufactured in batches in accordance with the relevant laws, regulations and national food safety standards for infant formula milk powder.
Article 8 The product formulas applying for registration shall meet the requirements of the relevant laws and regulations and national food safety standards, and the applicants shall provide the R & D and scientific argumentation report as well as adequate basis to prove the scientific nature and safety of product formulas.
Where they apply for the registration of product formulas of infant formula milk powder, the applicants shall submit the following materials to the CFDA:
1. Application for the registration of the product formulas of infant formula milk;
2. The entity qualification documents of the applicants;
3. The quality and safety standards for raw materials;
4. The R&D report of product formulas;
5. Statement on the production process;
6. Product inspection reports;
7. Supporting documents of R & D capacity, production capacity and inspection capacity;
8. Other evidence of the scientific nature and safety of formulas.
Article 9 Where the same enterprise applies for the registration of two or more product formulas for the same age group, there shall be a significant difference between product formulas, which shall have been proven in a scientific manner. In principle, each enterprise shall not apply for more than three series of formulas with nine product formulas. Each series includes infant formula milk powder (0-6 months, stage 1), elder infant formula milk powder (6-12 months, stage 2), and baby formula milk powder (12-36 months, stage 3).
Article 10 A wholly-owned subsidiary company that has already obtained the registration of the product formulas of infant formula milk powder and the production license can use the product formulas of infant formula milk powder registered by another wholly-owned subsidiary company of the same group company. Prior to organizing production, the group company shall submit a written report to the CFDA.
Article 11 The Acceptance Department shall process the applications for the registration of the product formulas of infant formula milk powder filed by the applicants in the following manners:
1.
......
Order of the China Food and Drug Administration No. 26
June 6, 2016
The Administrative Measures for the Registration of Product Formulas of Infant Formula Milk Powder, which was adopted at the Meeting of the China Food and Drug Administration (CFDA) on March 15, 2016, are hereby promulgated for implementation as of October 1, 2016.
Bi Jingquan, Director General
Administrative Measures for the Registration of Product Formulas of Infant Formula Milk Powder
Chapter I General Provisions
Article 1 In order to strictly administer the registration of product formulas and ensure the quality and safety of infant formula milk powder, these Measures are formulated in accordance with the Food Safety Law of the People's Republic of China and other laws and regulations.
Article 2 These Measures apply to the administration on the registration of product formulas of infant formula milk powder produced, sold in and imported to the territory of the People's Republic of China.
Article 3 The registration of the product formulas of infant formula milk powder refers to the activity in which the CFDA examines the applications for the registration of product formulas of infant formula milk powder and decides whether to grant registration in accordance with the procedures and requirements prescribed herein.
Article 4 The administration of the registration of the product formulas of infant formula milk powder shall follow the principles of scientific nature, rigorousness, openness, fairness and impartiality.
Article 5 The CFDA shall be responsible for administering the registration of the product formulas of infant formula milk.
The Administrative Acceptance Department of the CFDA ("the Acceptance Department") shall be responsible for accepting and processing the applications for the registration of the product formulas of infant formula milk.
The Examination Department of the CFDA ("the Examination Department") shall be responsible for examining the applications for the registration of the product formulas of infant formula milk.
The Inspection Department of the CFDA ("the Inspection Department") shall be responsible for inspecting the registration of the product formulas of infant formula milk on the spot.
The food and drug regulatory departments of all provinces, autonomous regions and municipalities directly under the Central Government shall assist the CFDA with on-site inspection and other work in connection with the registration of the product formulas of infant formula milk within their jurisdiction.
Article 6 The applicants shall guarantee the authenticity, integrity and legitimacy of submitted materials, and assume legal liability.
The applicants shall assist the food and drug administrative departments in conducting an on-site inspection, sampling and other work related to the registration.
Chapter II Application and Registration
Article 7 The applicants shall be manufacturers intending to produce and sell infant formula milk powder within the territory of the People's Republic of China or overseas manufacturers intending to export infant formula milk powder to the People's Republic of China.
The applicants shall have R & D capacity, production capacity and inspection capacity to manufacture infant formula milk powder, meet the requirements of the good manufacturing practice of infant formula foods, implement the hazard analysis and critical control point system, and inspect the products manufactured in batches in accordance with the relevant laws, regulations and national food safety standards for infant formula milk powder.
Article 8 The product formulas applying for registration shall meet the requirements of the relevant laws and regulations and national food safety standards, and the applicants shall provide the R & D and scientific argumentation report as well as adequate basis to prove the scientific nature and safety of product formulas.
Where they apply for the registration of product formulas of infant formula milk powder, the applicants shall submit the following materials to the CFDA:
1. Application for the registration of the product formulas of infant formula milk;
2. The entity qualification documents of the applicants;
3. The quality and safety standards for raw materials;
4. The R&D report of product formulas;
5. Statement on the production process;
6. Product inspection reports;
7. Supporting documents of R & D capacity, production capacity and inspection capacity;
8. Other evidence of the scientific nature and safety of formulas.
Article 9 Where the same enterprise applies for the registration of two or more product formulas for the same age group, there shall be a significant difference between product formulas, which shall have been proven in a scientific manner. In principle, each enterprise shall not apply for more than three series of formulas with nine product formulas. Each series includes infant formula milk powder (0-6 months, stage 1), elder infant formula milk powder (6-12 months, stage 2), and baby formula milk powder (12-36 months, stage 3).
Article 10 A wholly-owned subsidiary company that has already obtained the registration of the product formulas of infant formula milk powder and the production license can use the product formulas of infant formula milk powder registered by another wholly-owned subsidiary company of the same group company. Prior to organizing production, the group company shall submit a written report to the CFDA.
Article 11 The Acceptance Department shall process the applications for the registration of the product formulas of infant formula milk powder filed by the applicants in the following manners:
1.
......