Article 1 The Measures are formulated according to “Food Safety Law of the People’s Republic of China” in order to specify the filing of infant formula and ensure the safety of infant formula.

 

Article 2 The Measures apply to filing of infant formula and its supervision and administration carried out within the territory of the People’s Republic of China.

 

Article 3 Enterprises producing infant formula shall submit the materials related to food raw materials, food additives, product formulas and labels to the food and drug administration departments for archiving, public inspection and for future reference in accordance with the procedures, conditions and requirements stipulated in the Measures.

 

Article 4 China Food and Drug Administration is responsible for supervising and guiding food and drug administration departments of all provinces, municipalities and municipalities directly under the Central Government to carry out filing of infant formula.

 

Food and drug administration departments of provinces, municipalities and municipalities directly under the Central Government are responsible for the filing work of infant formula of infant formula production enterprises within their respective administrative regions and organizing food and drug administration departments at municipal and county levels to carry out supervision and administration on filed enterprises.

 

Food and drug administration departments at municipal and county levels are responsible for the supervision and administration on filed infant formula within their respective administrative regions.

 

Article 5 The filing of infant formula shall follow the principles of being scientific, open, fair, convenient for the people and efficient.

Article 6 The production enterprises of infant formula shall be responsible for the truthfulness, completeness and compliance of the filing materials submitted and bear the corresponding legal liabilities.

 

Article 7 The China Food and Drug Administration encourages the food and drug administration departments of all provinces, municipalities and municipalities directly under the Central Government to carry out the filing and production permit of infant formula simultaneously.

 

 

Article 8 When the production enterprises apply for filing of infant formula, they shall submit the following materials to the food and drug administration departments of the province, municipality or municipality directly under the Central Government where it locates:

 

       (1) Infant formula filing information Form;

 

       (2) documentary evidence for subject qualification of production enterprise;

 

       (3) Quality and safety standards of raw and auxiliary materials (raw food materials, food additives);

 

       (4) R&D report of product formula;

 

       (5) Sample manuscripts of label and specification.

 

For the raw and auxiliary materials containing compound raw materials, compound food additives, the compositions shall be listed.

 

Article 9 After the food and drug administration department receives the filing materials and the filing materials meet the requirements, the department shall carry out the filing work within 5 working days; if the filing materials do not meet the requirements, the department shall inform to supplement and correct the relevant materials at one time.

 

Article 10 The food and drug administration departments shall archive the filing information for future reference, issue the filing number, and release the filing information to the public within 15 working days after filing.

 

Article 11 Provincial food and drug administration departments, production enterprises of infant formula and their routine administration departments shall keep the filing materials.

 

Article 12 For the relevant information on infant formula filed in the food and drug administration department that has changed, its production enterprise shall re-file with the filing number unchanged.

 

For laws and regulations, food safety standards and related provisions that have changed, the enterprises shall promptly adjust the filing contents and re-file.

 

Article 13 After the China Food and Drug Administration has approved the formula registration, change of registration, continuation of registration of infant formula milk powder product in accordance with the “Administrative Measures for Formula Registration of Infant Formula Milk Powder Product”, the materials required in Article VIII can be shared with the food and drug administration departments of the province, municipality or municipality directly under the Central Government where the production enterprise of infant formula milk powder locates through information means, which is regarded as filing. The production enterprise of infant formula milk powder no longer submits the filing materials.

 

The registration number of product formula of infant formula milk powder is regarded as the filing number, and filing number is no longer issued.

 

Article 14 It is required that the product label and specification of infant formula are to be implemented in accordance with “Technical Guiding Principles for the Label Specification in Formula Registration of Infant Formula Milk Product (Trial)”.

 

 

Article 15 For the infant formula production enterprises that fail to file the items such as raw food materials, food additives, product formulas and labels to the food and drug administration departments, they cannot organize the production.

 

Article 16 For the raw food materials, food additives, product formulas and labels used for production of infant formula that have been changed and need to be re-filed, the original raw food materials, food additives, product formulas and labels cannot be used for production.

 

Article 17 The units and individuals involved in the filing administration of infant formula shall keep the trade secrets known in the filing work.

 

Article 18 The following situations shall not be filed:

 

       (1) Where infant formula is produced by means of sub-assembly and consigned processing;

 

       (2) Where the same enterprise uses the same formula to produce infant formula with different brands;

 

       (3) Where colostrum raw material is used or spices and flavorings are used in infant formula product (0-6 month age);

 

       (4) Other situations that shall not be filed stipulated by laws and regulations.

 

Article 19 The food and drug administration department that performs filing shall cancel the filing of infant formula under any of the following circumstances:

 

       (1) Where the filing materials are false;

 

       (2) Where the food production license of the production enterprise of infant formula milk powder has been revoked or cancelled;

 

       (3) Where the product formula of infant formula has safety problem;

 

       (4) Where the production enterprise of infant formula proposes to cancel the filing;

 

       (5) Under other circumstances that the filing shall be cancelled according to laws.

 

 

Article 20 For the illegal filing acts of infant formula that have been stipulated in Food Safety Law and other laws and regulations, carry out in accordance with the provisions.

 

Article 21 The ones who violate the provisions of Article 15 in the Measures shall be punished by the food and drug administration departments at or above the county level according to the provisions of Paragraph 1 of Article 126 of the Food Safety Law.

 

Article 22 The ones who violate the provisions of Article 16 of the Measures shall be ordered to make corrections by the food and drug administration department at or above the county level and be fined of not less than 2,000 RMB but not more than 30,000 RMB.

 

Article 23 For the infant formula produced by the enterprise that is inconsistent with the filing information, the food and drug administration department at or above the county level shall order it to make corrections and impose a fine of not less than 2,000 RMB and not more than 30,000 RMB.

 

Article 24 The infant formulas involved in the Measures refer to infant formula and older infant and young children formula stipulated in the relevant national food safety standards, that is, the liquid or powder products produced with milk and milk protein products and/or soy and soy protein products as the main raw materials with the addition of the right amount of vitamins, minerals and/or other components by physical methods only. It applies to normal infants within 0-36 months of age, and its energy and nutrients can meet the normal nutritional requirements of infants within 0-36 months of age.

 

Article 25 The format of filing number of infant formula is: infant formula filing + 2 digits of province, region, city code + 4 digits of year number + 3 digits of enterprise serial number +4 digits of product serial number.

 

Article 26 The Measures are interpreted by the China Food and Drug Administration.

 

Article 27 The Measures will be implemented since the date of xx/xx/2018.



(The above translation is for reference only, and the final interpretation right is reserved by the Translation Department of Foodmate.)