Circular of the State Administration for Market Regulation on Seeking Public Comments on the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment)
Circular of the State Administration for Market Regulation on Seeking Public Comments on the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment)
Circular of the State Administration for Market Regulation on Seeking Public Comments on the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment)
June 26, 2019
The State Administration for Market Regulation has organized the amendment to the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder and drafted the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment) (the "Measures") in order to faithfully ensure the quality and safety of infant formula milk powder and carry out relevant requirements of the Opinions of the Central Committee of the Communist Party of China and the State Council on Deepening Reform and Strengthening the Food Safety Work (Zhong Fa [2019]No. 17). The Measures are hereby issued for public comments. The public may present their comments on and prior to July 25, 2019 in any of the following ways:
1. logging onto the legislation information website of the Chinese government (http://www.chinalaw.gov.cn), and giving comments via the column "Comments Sought for Legislation" on the main menu of the homepage;
2. sending e-mails to liuxiaoyi@samr.gov.cn, indicating the words "Public Comments Sought on the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment)" as the email subject line; or
3. sending a letter to the Special Food Department of the State Administration for Market Regulation Building 1, Beiluyuan, Zhanlan Road, Xicheng District, Beijing, 100037, China, indicating the words "Public Comments Sought on the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment)" on the envelope.
Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment)
Chapter I General Provisions
Article 1 The Measures are formulated in accordance with the Food Safety Law of the People's Republic of China and other pertinent laws and regulations in order to strictly administer registration of product formula of infant formula milk powder and ensure the quality and safety of infant formula milk powder.
Article 2 The Measures apply to the administration of registration of product formula of infant formula milk powder produced and sold within, and imported to, the territory of the People's Republic of China.
Article 3 "Registration of Product Formula of Infant Formula Milk Powder" refers to the activity in which the State Administration for Market Registration ("SAMR") examines the applications for registration of product formula of infant formula milk powder and decides whether to approve the registration in accordance with the procedures and requirements prescribed by the Measures.
Article 4 The administration of registration of product formula of infant formula milk powder shall adhere to the scientific, rigorous, open, fair and impartial principles.
Article 5 The SAMR shall be responsible for administering the registration of product formula of infant formula milk powder.
The food evaluation agency of the SAMR (the "Evaluation Agency") shall be responsible for accepting and evaluating the applications for registration of the product formula of infant formula milk powder, and may organize those experts in such areas as food safety, food processing, nutrition and clinical medicine to conduct argumentation.
The inspection agency of the SAMR shall be responsible for inspecting registration of product formula of infant formula milk powder on the spot.
The departments of market regulation of all provinces, autonomous regions and municipalities directly under the Central Government shall cooperate with the SAMR in on-site inspections and other work in connection with registration of product formula of infant formula milk powder within their respective administrative regions.
Article 6 Applicants shall guarantee the authenticity, completeness and legitimacy of the submitted materials and assume relevant legal liability.
Applicants shall cooperate with the departments of market regulation to conduct on-site inspections, sampling inspections and other work related to the registration.
Chapter II Application and Registration
Article 7 Applicants shall be those manufacturers intending to produce and sell infant formula milk powder within the territory of the People's Republic of China or those overseas manufacturers intending to export infant formula milk powder to the People's Republic of China.
Applicants shall have the research and development ("R&D") capacity, production capacity and inspection capability to produce infant formula milk powder, have complete production technology, meet the requirements of good manufacturing practice for powdered formula foods for infants, implement the hazard analysis and critical control point system, and inspect the ex-factory products batch by batch in accordance with relevant laws, regulations and items prescribed by national standards for food safety of infant formula milk powder.
Article 8 The product formula which is filed for registration shall conform to relevant laws and regulations, as well as requirements of national standards for food safety. Applicants shall provide the R&D and argumentation reports as well as sufficient basis to prove the scientific nature and safety of the product formula.
Whoever applies for registration of product formula of infant formula milk powder shall submit the following materials to the SAMR:
1. an application for registration of product formula of infant formula milk powder;
2. the qualification certification of the applicant;
3. quality and safety standards for raw and auxiliary materials;
4. product formula;
5. R&D report of the product formula;
6. a statement on production technology;
7. a product inspection report;
8. supporting documents on the R&D capacity, production capacity and inspection capability; and
9. other documents proving the scientific nature and safety of the formula;
The applicant shall indicate the trade secrets embodied in the application materials according to pertinent state regulations and relevant bases.
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 in composition and nutritive peculiarity, which shall have been proven in a scientific manner.
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June 26, 2019
The State Administration for Market Regulation has organized the amendment to the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder and drafted the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment) (the "Measures") in order to faithfully ensure the quality and safety of infant formula milk powder and carry out relevant requirements of the Opinions of the Central Committee of the Communist Party of China and the State Council on Deepening Reform and Strengthening the Food Safety Work (Zhong Fa [2019]No. 17). The Measures are hereby issued for public comments. The public may present their comments on and prior to July 25, 2019 in any of the following ways:
1. logging onto the legislation information website of the Chinese government (http://www.chinalaw.gov.cn), and giving comments via the column "Comments Sought for Legislation" on the main menu of the homepage;
2. sending e-mails to liuxiaoyi@samr.gov.cn, indicating the words "Public Comments Sought on the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment)" as the email subject line; or
3. sending a letter to the Special Food Department of the State Administration for Market Regulation Building 1, Beiluyuan, Zhanlan Road, Xicheng District, Beijing, 100037, China, indicating the words "Public Comments Sought on the Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment)" on the envelope.
Administrative Measures for Registration of Product Formula of Infant Formula Milk Powder (Draft for Comment)
Chapter I General Provisions
Article 1 The Measures are formulated in accordance with the Food Safety Law of the People's Republic of China and other pertinent laws and regulations in order to strictly administer registration of product formula of infant formula milk powder and ensure the quality and safety of infant formula milk powder.
Article 2 The Measures apply to the administration of registration of product formula of infant formula milk powder produced and sold within, and imported to, the territory of the People's Republic of China.
Article 3 "Registration of Product Formula of Infant Formula Milk Powder" refers to the activity in which the State Administration for Market Registration ("SAMR") examines the applications for registration of product formula of infant formula milk powder and decides whether to approve the registration in accordance with the procedures and requirements prescribed by the Measures.
Article 4 The administration of registration of product formula of infant formula milk powder shall adhere to the scientific, rigorous, open, fair and impartial principles.
Article 5 The SAMR shall be responsible for administering the registration of product formula of infant formula milk powder.
The food evaluation agency of the SAMR (the "Evaluation Agency") shall be responsible for accepting and evaluating the applications for registration of the product formula of infant formula milk powder, and may organize those experts in such areas as food safety, food processing, nutrition and clinical medicine to conduct argumentation.
The inspection agency of the SAMR shall be responsible for inspecting registration of product formula of infant formula milk powder on the spot.
The departments of market regulation of all provinces, autonomous regions and municipalities directly under the Central Government shall cooperate with the SAMR in on-site inspections and other work in connection with registration of product formula of infant formula milk powder within their respective administrative regions.
Article 6 Applicants shall guarantee the authenticity, completeness and legitimacy of the submitted materials and assume relevant legal liability.
Applicants shall cooperate with the departments of market regulation to conduct on-site inspections, sampling inspections and other work related to the registration.
Chapter II Application and Registration
Article 7 Applicants shall be those manufacturers intending to produce and sell infant formula milk powder within the territory of the People's Republic of China or those overseas manufacturers intending to export infant formula milk powder to the People's Republic of China.
Applicants shall have the research and development ("R&D") capacity, production capacity and inspection capability to produce infant formula milk powder, have complete production technology, meet the requirements of good manufacturing practice for powdered formula foods for infants, implement the hazard analysis and critical control point system, and inspect the ex-factory products batch by batch in accordance with relevant laws, regulations and items prescribed by national standards for food safety of infant formula milk powder.
Article 8 The product formula which is filed for registration shall conform to relevant laws and regulations, as well as requirements of national standards for food safety. Applicants shall provide the R&D and argumentation reports as well as sufficient basis to prove the scientific nature and safety of the product formula.
Whoever applies for registration of product formula of infant formula milk powder shall submit the following materials to the SAMR:
1. an application for registration of product formula of infant formula milk powder;
2. the qualification certification of the applicant;
3. quality and safety standards for raw and auxiliary materials;
4. product formula;
5. R&D report of the product formula;
6. a statement on production technology;
7. a product inspection report;
8. supporting documents on the R&D capacity, production capacity and inspection capability; and
9. other documents proving the scientific nature and safety of the formula;
The applicant shall indicate the trade secrets embodied in the application materials according to pertinent state regulations and relevant bases.
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 in composition and nutritive peculiarity, which shall have been proven in a scientific manner.
......