1. Log on to the Legal Information Network of China Municipal Government (website:) and enter the "Consultation System for Draft Departmental Regulations" on the left side of the home page to make comments and suggestions.
2. Send the comments and suggestions by letter to the Legal Affairs Department of China Food and Drug Administration, Building 2, No.26, Xuanwumen West Street, Xicheng District, Beijing (postal code 100053), and indicate the words "Measures for the Administration of Infant Formula Milk Powder Registration for Comments" on the envelope.
3. Send the comments and suggestions to [emailprotected] by e-mail, and the subject of the e-mail should be marked with the words "Measures for the Administration of Formula Registration of Infant Formula Milk Powder for Soliciting Opinions".
4. Fax the comments and suggestions to: 0 10-63098765.
Click the attachment: Measures for the Administration of Formula Registration of Infant Formula Milk Powder (Draft for Comment)
Legal Department of the Food and Drug Administration of the United States
September 2(nd)
Measures for the Administration of Formula Registration of Infant Formula Milk Powder Products (Trial) (Draft for Comment)
Chapter I General Principles
Article 1 In order to strictly manage the registration of infant formula milk powder products and ensure the quality and safety of infant formula milk powder, these Measures are formulated in accordance with the Food Safety Law of People's Republic of China (PRC) and its implementing regulations, the Administrative Licensing Law of People's Republic of China (PRC) and other laws and regulations.
Article 2 These Measures shall apply to the registration administration of infant formula milk powder produced in People's Republic of China (PRC).
Article 3 The product formula of infant formula milk powder as mentioned in these Measures refers to all raw and auxiliary materials used in the production of infant formula milk powder and their dosage, as well as the content of nutrients in the product.
Article 4 The formula registration of infant formula milk powder refers to the examination and approval process in which China Food and Drug Administration examines the formula R&D report of infant formula milk powder products applied for registration, and decides whether to approve the registration.
Article 5 China Food and Drug Administration shall be responsible for the registration management of infant formula milk powder products.
The municipal administrative licensing institution of China Food and Drug Administration is responsible for accepting the application for formula registration of infant formula milk powder products.
The food evaluation agency of China Food and Drug Administration is responsible for the evaluation of formula registration of infant formula milk powder products.
Article 6 China Food and Drug Administration is responsible for establishing an expert database for the registration and evaluation of infant formula milk powder products, which is composed of experts in the fields of food nutrition, food safety, clinical medicine and food engineering.
Article 7 The applicant for formula registration of infant formula milk powder products shall be an enterprise that produces infant formula milk powder in People's Republic of China (PRC) and China.
The applicant shall implement good manufacturing practices for powdered infant formula food, implement hazard analysis and critical control point system, and have the research and development ability of product formula and the inspection ability of all items specified in the standard.
Article 8 After obtaining the production license of infant formula milk powder according to law, an enterprise shall organize production according to the approved and registered product formula, truthfully record the production and sales information of the product, realize the traceability of the product and ensure the quality and safety of infant formula milk powder.
Article 9 Only one product can be produced from the product formula registered by the same enterprise, and different brands of infant formula milk powder shall not be produced with the same formula.
Enterprises shall not limit regional sales or customize production for sellers.
Article 10 The staff responsible for the formula registration of infant formula milk powder products and the experts participating in the review shall keep confidential the technical secrets submitted by the applicant.
Eleventh infant formula milk powder product formula registration management, should follow the principles of science, justice, fairness and openness.
Chapter II Application and Approval
Article 12 To apply for formula registration of infant formula milk powder products, the following materials shall be submitted to China Food and Drug Administration:
(1) An application for registration of infant formula milk powder product formula;
(two) product formula research and development report and production process description;
(3) product inspection report;
(four) proof materials of production, research and development and inspection capabilities;
(5) Design samples of product labels and instructions;
(six) other materials that show the scientific and safety of the formula.
Article 13 An applicant who applies for formula registration of infant formula milk powder products shall be responsible for the authenticity and legality of the submitted materials.
Article 14 The formulas of products of the same age applied for registration by the same enterprise should be obviously different, and there should be more than six optional ingredients stipulated in the national food safety standards, which should be confirmed by scientific basis. (Scheme I)
There should be obvious differences between the product formulas of the same age group that the same enterprise applies for registration, and there is scientific evidence to prove that each enterprise should not exceed 5 series 15 product formulas. (Scheme II)
Fifteenth China Food and Drug Administration shall inform the applicant of the acceptance in writing within 5 working days. If the applicant is not informed within the time limit, it shall be accepted from the date of receiving the application materials.
If the application materials are incomplete or inconsistent with the statutory form, the applicant shall be informed of all the contents that need to be supplemented at one time.
After the application for registration is accepted, other materials submitted by the applicant will not be accepted.
Article 16 The food evaluation agency of China Food and Drug Administration is responsible for organizing on-site verification of product formula research and development capability, research and development situation and original data, as well as the applicant's ability to implement good manufacturing practices for powdered infant formula food, implement hazard analysis and critical control point system, and all the items specified in the standards, and issuing verification reports.
The food and drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government where the applicant is located shall participate in the on-site inspection.
Seventeenth China Food and Drug Administration Food Review Agency commissioned a qualified food inspection agency to sample the trial-produced samples of enterprises.
China Food and Drug Administration announced the list of food inspection agencies that undertake the registration sampling inspection of infant formula milk powder products.
Article 18 The food review agency of China Food and Drug Administration selects experts from the expert database of infant formula milk powder product formula registration review to form an expert group, which will conduct technical review on the applicant's application materials, on-site inspection reports and product inspection reports, and make a review conclusion.
Nineteenth China Food and Drug Administration shall make a decision on examination and approval according to the conclusion of the examination. If the registration is granted, the applicant shall be issued with a formula registration certificate for infant formula milk powder products. If it is not registered, it shall notify the applicant in writing and explain the reasons.
Twentieth China Food and Drug Administration shall make a decision on examination and approval within 20 working days from the date of acceptance. The time spent on on-site inspection, sampling inspection and expert review is not included in the 20 working days. On-site inspection time shall not exceed 20 working days, sampling inspection time shall not exceed 30 working days, and expert review time shall not exceed 60 working days.
Article 21 The contents of the formula registration approval certificate of infant formula milk powder products include: enterprise name, enterprise address, product name, product formula, product label and description, registration number, approval date and validity period.
Twenty-second China Food and Drug Administration shall publish the approval and registration information of infant formula milk powder products according to law.
Twenty-third infant formula milk powder product formula registration certificate is valid for 5 years; If it is necessary to continue to use the original formula of infant formula milk powder at the expiration of the validity period, the applicant shall apply for re-registration 60 working days before the expiration of the validity period.
Article 24 To apply for re-registration of infant formula milk powder product formula, the applicant shall submit an application for re-registration of infant formula milk powder product formula to China Food and Drug Administration, the opinions of the food and drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government where the applicant is located, and the approval certificate of infant formula milk powder product formula registration; China Food and Drug Administration shall organize a review of the application materials within 60 working days. If it meets the requirements, it shall renew the approval certificate to the applicant, with the registration number unchanged, and the validity period shall be recalculated from the date of approval; Do not meet the requirements, issued by the infant formula milk powder re-registration application inadmissible certificate, and explain the reasons.
Twenty-fifth any of the following circumstances, shall not be registered again:
(1) Failing to apply for re-registration within the prescribed time limit;
(2) After the product formula is approved and registered, the enterprise fails to obtain the production license of infant formula milk powder;
(3) The products registered with the product formula are unqualified for more than 2 times in the supervision and sampling inspection by the food and drug supervision and administration department at or above the provincial level within one year;
(4) The enterprise fails to maintain its production capacity, research and development capacity and inspection capacity;
(five) the enterprise fails to truthfully record the production and sales information of the registered products of the formula, so as to realize the traceability of the products;
(six) other circumstances that do not meet the relevant provisions.
Twenty-sixth infant formula milk powder product formula registration certificate within the validity period, the name of the enterprise, the name of the production address, the label and the description style are changed, it shall apply to the China Food and Drug Administration for change. China Food and Drug Administration will no longer organize on-site verification and sampling inspection, and shall make a decision within 20 working days from the date of acceptance. Those who meet the requirements shall go through the formalities for change according to law. The issuance date of the registration approval certificate is subject to the change approval date, and the validity period of the certificate remains unchanged. Other items specified in the formula registration approval certificate of infant formula milk powder products shall not be changed.
Apply for a new product formula to replace the approved product formula, and apply for registration according to the new product formula.
Article 27 An applicant applying for formula change of infant formula milk powder shall submit the following application materials:
(1) An application for change of formula registration of infant formula milk powder products;
(two) infant formula milk powder product formula registration certificate;
(3) Certification materials related to the change.
The materials submitted to apply for the registration of formula change of infant formula milk powder products shall be true, legal and effective, and comply with the provisions of relevant laws and regulations. The legal representative of the enterprise shall sign and seal the application for registration change of infant formula milk powder and other materials, and be responsible for the legality and authenticity of its contents.
Chapter III Labels and Instructions
Twenty-eighth infant formula milk powder packaging should be labeled, and the contents of the label should be true, accurate, scientific and legal, and easy to understand. Labels should be clear and durable, clear and obvious, and easy to identify.
The labels and instructions of infant formula milk powder sold in the market shall be consistent with the product formula registration approval certificate.
Twenty-ninth labels shall indicate the items specified in Article 67 of the Food Safety Law of People's Republic of China (PRC), and shall be implemented in accordance with relevant laws and regulations and food safety standards.
Article 30 The product name of infant formula milk powder may be marked as infant formula milk powder, and it shall be clearly marked in the largest font except the trademark at the position next to the trademark.
If the raw material of infant formula milk powder is goat milk (powder), the product name can be marked as infant formula goat milk powder, and the proportion of goat milk (powder) in each 100g product and the source of whey protein powder can be indicated in the ingredient list.
Article 31 Infant formula milk powder is divided into infant formula milk powder (0 ~ 6 months old, 1 segment), older infant formula milk powder (6 ~ 12 months old, 2 segments) and infant formula milk powder (12 ~ 36 months old, 3 segments). The label of infant formula milk powder shall indicate the applicable month age of infant formula milk powder, which can be marked by "1, 2,3" and "1, 2,3" at the same time.
Article 32 In the ingredient list of infant formula milk powder, the names of edible vegetable oils shall be marked in brackets in descending order of addition.
The table of nutritional ingredients shall be listed in the order of ingredients in the national food safety standards for infant formula milk powder.
Thirty-third infant formula milk powder using genetically modified raw materials, shall be marked in accordance with the provisions.
Article 34 The label shall indicate the name, address and contact information of the actual producer, and may also indicate the name and address of the group company.
The date of production, shelf life and other matters should be clearly marked.
Article 35 The label shall indicate the product formula registration number.
Thirty-sixth infant formula milk powder label involves quality, certification marks and quality commitments, etc., and must be true and legal.
Article 37 Where imported raw materials such as milk powder and base powder are marked, the true origin of the raw materials shall be indicated.
Do not label "imported milk source", "from foreign pastures" and other vague and misleading contents.
Article 38 For products with the same product formula produced by the same enterprise, the registered contents, styles and colors of the labels and instructions must be consistent.
Article 39 The naming and labeling of infant formula milk powder shall not contain the following contents:
(a) express or implied disease prevention and treatment functions;
(2) having the functions of improving intelligence, enhancing resistance or immunity, protecting intestines and other health care functions, which are expressed or implied;
(three) recommended or supervised by social organizations such as industry associations, consumer organizations and inspection agencies;
(4) Non-transgenic words;
(5) zero addition;
(six) other contents that are not allowed to be marked by laws, regulations and food safety standards.
Fortieth mandatory label content and background color should be in contrast color, and the brightness contrast should be above 70%.
Infant formula milk powder labels should use standardized Chinese characters, and pinyin, minority languages or foreign languages can be used at the same time. Foreign languages and pinyin except trademarks should have a strict correspondence with Chinese, and the font should not be larger than the corresponding Chinese characters.
Warning instructions or precautions should be printed in different fonts and colors, and the font height should not be less than 3.7 mm.
Chapter IV Legal Liability
Article 41 Under any of the following circumstances, China Food and Drug Administration shall cancel the product formula registration approval certificate according to law:
(1) The enterprise applies for cancellation;
(2) The enterprise is terminated according to law;
(three) the validity of the certificate has not been extended;
(4) The production license of infant formula milk powder has been cancelled according to law;
(5) Other circumstances that should be cancelled according to laws and regulations.
Article 42 Any of the following circumstances shall be punished in accordance with Article 124 of the Food Safety Law of People's Republic of China (PRC).
(a) the production and operation of infant formula milk powder that is not registered according to the regulations;
(2) Failing to organize production according to the requirements of the registered product formula;
(three) the same enterprise produces different brands of infant formula milk powder with the same formula;
(4) The labels and instructions of infant formula milk powder sold in the market are inconsistent with the product formula registration approval certificate.
Forty-third according to the provisions of these measures, it is necessary to conduct on-site verification or sampling inspection. If the applicant refuses, China Food and Drug Administration will not approve its application for product formula registration.
Article 44 Where an applicant conceals relevant information or provides false materials and samples to apply for formula registration of infant formula milk powder products, China Food and Drug Administration will not accept it, give a warning to the applicant and announce it to the public. The applicant shall not apply for the formula registration of infant formula milk powder products again within one year.
If the applicant obtains the registration approval certificate of infant formula milk powder products by cheating, bribery or other improper means, or by concealing the real situation or submitting false materials, it shall be revoked according to law. No more applications for registration within three years.
Article 45 In any of the following circumstances, the food and drug supervision and administration department at or above the county level shall impose a fine of 1 10,000 but not more than 30,000, and make an announcement.
(a) the same enterprise uses the same product formula to produce different products;
(2) The enterprise limits regional sales or customizes production for sellers.
Article 46 If a food inspection agency or food inspector issues a false inspection report and a certification agency issues a false certification conclusion, it shall be punished in accordance with the provisions of Articles 138 and 139 of the Food Safety Law of People's Republic of China (PRC).
Forty-seventh food and drug supervision and management departments and their staff in violation of the provisions of these measures, shall be given administrative sanctions in accordance with the relevant provisions of the Food Safety Law of People's Republic of China (PRC).
Chapter V Supplementary Provisions
Article 48 The format of the formula registration number of infant formula milk powder products is: YP+4-digit year number +4-digit serial number, where YP stands for the formula of infant formula milk powder products.
Article 49 The China Food and Drug Administration shall be responsible for the interpretation of these Measures.
Fiftieth these Measures shall come into force as of XX.