chapter I general provisions

article 1 these measures are formulated in accordance with the administrative licensing law of the people's Republic of China, the food safety law of the people's Republic of China, the regulations for the implementation of the food safety law of the people's Republic of China and other laws and regulations in order to standardize the production licensing activities of food and food additives, strengthen the supervision and management of food production and ensure food safety.

article 2 whoever engages in food production activities within the territory of the people's Republic of China shall obtain a food production license according to law.

these measures shall apply to the application, acceptance, examination, decision, supervision and inspection of food production license.

article 3 the food production license shall follow the principles of legality, openness, fairness, impartiality, convenience and high efficiency.

article 4 the principle of one enterprise and one license shall be applied to the food production license, that is, the same food producer shall obtain a food production license when engaging in food production activities.

article 5 the market supervision and management department shall, according to the risk degree of food, combine factors such as food raw materials and production technology, implement classified licensing for food production.

article 6 the state administration of market supervision is responsible for supervising and guiding the administration of food production licenses throughout the country.

the local market supervision and administration departments at or above the county level are responsible for the supervision and administration of food production licenses within their respective administrative areas.

article 7 the market supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government may, according to the food categories and food safety risks, determine the administrative authority of food production licenses of the market supervision and administration departments at the city and county levels.

The market supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the production license of health food, formula food for special medical purposes, formula food for infants and young children, supplementary food for infants and young children, salt and other foods.

article 8 the state administration of markets is responsible for formulating the general rules and detailed rules for the examination of food production licenses.

the market supervision and management departments of provinces, autonomous regions and municipalities directly under the central government may, according to the needs of the food production license examination in their respective administrative areas, formulate detailed rules for the examination of food production licenses for local specialty foods, implement them within their respective administrative areas, and report to the State Administration of Markets. After the State Administration of Market Supervision has formulated and published the detailed rules for the examination of relevant food production licenses, the detailed rules for the examination of local specialty food production licenses shall be automatically abolished.

the local market supervision and management departments at or above the county level shall observe the general rules and detailed rules for the examination of food production licenses.

article 9 the local market supervision and management departments at or above the county level shall speed up the informatization construction, promote the online processing of the whole process of license application, acceptance, examination, issuance and inquiry, and publish the production license matters on the website of the administrative organ to improve the efficiency.

chapter ii application and acceptance

article 11 to apply for a food production license, one should first obtain the legal subject qualifications such as a business license.

enterprises as legal persons, partnerships, sole proprietorships, individual industrial and commercial households, farmers' professional cooperative organizations, etc., take the subject specified in the business license as the applicant.

article 11 an application for a food production license shall be made according to the following food categories: processed food, edible oil, grease and its products, condiments, meat products, dairy products, beverages, instant foods, biscuits, canned food, frozen drinks, quick-frozen foods, potatoes and puffed foods, candy products, tea and related products, alcohol, vegetable products, fruit products, roasted seeds and nuts, and egg products. Starch and starch products, cakes, bean products, bee products, health foods, formula foods for special medical purposes, infant formula foods, special dietary foods, other foods, etc.

the state administration of market supervision can adjust the food categories according to the needs of supervision and management.

Article 12 To apply for a food production license, the following conditions shall be met:

(1) Having a place for the processing of food raw materials and the processing, packaging and storage of food, keeping the environment of the place clean and tidy, and keeping a prescribed distance from toxic and harmful places and other pollution sources;

(2) having production equipment or facilities suitable for the variety and quantity of food produced, and having corresponding equipment or facilities for disinfection, dressing, washing, lighting, ventilation, corrosion prevention, dust prevention, fly prevention, rodent prevention, insect prevention, washing, wastewater treatment and garbage and waste storage; If the production process of health food has pretreatment procedures such as raw material extraction and purification, it is necessary to have raw material pretreatment equipment or facilities suitable for the variety and quantity of production;

(3) Having full-time or part-time food safety professionals, food safety managers and rules and regulations to ensure food safety;

(4) It has a reasonable equipment layout and technological process to prevent cross-contamination between food to be processed and directly imported food, raw materials and finished products, and to avoid food contact with toxic and unclean substances;

(5) Other conditions stipulated by laws and regulations.

Article 13 To apply for a food production license, the following materials shall be submitted to the local market supervision and administration department at or above the county level where the applicant is located:

(1) An application for a food production license;

(2) the layout of food production equipment and the flow chart of food production process;

(3) List of major equipment and facilities for food production;

(4) information of full-time or part-time food safety professionals and food safety management personnel and food safety management system.

article 14 when applying for the production license of special foods such as health food, formula food for special medical use, formula food for infants and young children, the documents of production quality management system and relevant registration and filing documents that are suitable for the foods produced shall also be submitted.

article 15 whoever engages in the production of food additives shall obtain the production license of food additives according to law.

to apply for a food additive production license, one should have a place, production equipment or facilities, food safety management personnel, professional and technical personnel and management system suitable for the variety of food additives produced.

Article 16 To apply for a food additive production license, the following materials shall be submitted to the local market supervision and administration department at or above the county level where the applicant is located:

(1) An application for a food additive production license;

(2) Layout diagram of food additive production equipment and production process flow chart;

(3) List of major equipment and facilities for the production of food additives;

(4) information of full-time or part-time food safety professionals and food safety management personnel and food safety management system.

article 17 an applicant shall truthfully submit relevant materials and reflect the real situation to the market supervision and management department, be responsible for the authenticity of the application materials, and sign or seal the application form and other materials.

article 18 where an applicant applies for the production of multiple categories of food, the applicant shall independently select one of the acceptance departments to submit the application materials according to the food production license management authority determined by the provincial market supervision and administration department. The accepting department shall promptly inform the market supervision and management department with the corresponding examination and approval authority and organize a joint review.

Article 19 The local market supervision and administration department at or above the county level shall handle the food production license application submitted by the applicant according to the following circumstances:

(1) If the application matters do not need to obtain a food production license according to law, it shall immediately inform the applicant that it will not be accepted;

(2) If the application matters do not fall within the scope of functions and powers of the market supervision and management department according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ;

(3) if there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot, and the applicant shall sign or seal the correction place and indicate the date of correction;

(4) if the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed of all the contents that need to be corrected on the spot or within five working days. Informed on the spot, the application materials shall be returned to the applicant; If it is notified within 5 working days, it shall collect the application materials and issue the credentials for receiving the application materials. Fails to inform, since the date of receipt of the application materials is accepted;

(5) If the application materials are complete and conform to the statutory form, or the applicant submits all the supplementary materials as required, the application for food production license shall be accepted.

Article 21 Where the local market supervision and administration department at or above the county level decides to accept the application submitted by the applicant, it shall issue a notice of acceptance; If it decides not to accept the application, it shall issue a notice of rejection, explain the reasons for rejection, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

chapter iii examination and decision

article 21 the local market supervision and administration department at or above the county level shall examine the application materials submitted by the applicant. If it is necessary to verify the substantive contents of the application materials, on-site verification shall be conducted.

when conducting on-site verification of food production licenses, the market supervision and management department shall conduct verification according to the application materials. For those who apply for a license for the first time or increase the license for the change of food category, the inspection report of trial-produced food shall be checked according to the requirements of food production process and other requirements. When carrying out on-site inspection of food additive production license, the inspection report of trial-produced food additives and the formula of compound food additives can be checked according to the characteristics of food additives. Trial-produced food can be inspected by the producers themselves or by a qualified food inspection agency.

On-site inspection shall be conducted by food safety supervisors, and professional technicians may be hired as inspectors to participate in the on-site inspection if necessary. The number of inspectors shall not be less than 2. The inspectors shall produce valid certificates, fill in the on-site inspection form of food production license, and make on-site inspection records, which shall be signed or sealed by the inspectors and the applicant after being verified by the applicant. If the applicant refuses to sign or seal, the inspector shall indicate the situation.

for the items that have been checked on the spot during product registration or product formula registration, the on-site inspection may not be repeated when applying for the production license of health food, formula food for special medical use and infant formula milk powder.

the market supervision and management department may entrust the lower-level market supervision and management department to conduct on-site verification of the accepted food production license application. In principle, the on-site verification of special food production license shall not be entrusted to the lower market supervision and management departments for implementation.

the inspectors shall complete the on-site inspection of the production site within 5 working days from the date of accepting the on-site inspection task.

article 22 in addition to making a decision on administrative license on the spot, the local market supervision and administration department at or above the county level shall make a decision on whether to approve the administrative license within 11 working days from the date of accepting the application. If it is necessary to extend the time limit due to special reasons, it may be extended for 5 working days with the approval of the person in charge of this administrative organ, and the applicant shall be informed of the reasons for extending the time limit.

article 23 the local market supervision and management department at or above the county level shall, according to the examination of application materials and on-site verification, make a decision on granting a production license to those who meet the requirements, and issue a food production license to the applicant within 5 working days from the date of making the decision; If it does not meet the requirements, it shall make a written decision on disapproval in time and explain the reasons, and inform the applicant that he has the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

article 24 if the application for food additive production license meets the requirements, the local market supervision and administration department at or above the county level where the applicant is located shall issue the food production license according to law, and mark the food additive.

article 25 the date of issuing the food production license is the date when the licensing decision is made, and the validity period is 5 years.

article 26 if the local market supervision and administration department at or above the county level thinks that the application for food production license involves major matters of public interest and needs a hearing, it shall make an announcement to the public and hold a hearing.

article 27 where the food production license directly relates to the significant interests between the applicant and others, the local market supervision and administration department at or above the county level shall inform the applicant and interested parties of their right to request a hearing before making a decision on administrative license.

if the applicant or interested party applies for a hearing within 5 working days from the date of being informed of the right to a hearing, the market supervision and management department shall organize a hearing within 21 working days. The time limit for hearing is not counted in the time limit for examining administrative license.

chapter iv license management

article 28 food production licenses are divided into originals and duplicates. The original and the copy have the same legal effect.

the state administration of market supervision is responsible for formulating the model of food production license. The market supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the printing and distribution of food production licenses in their respective administrative areas.

article 29 a food production license shall specify: producer's name, social credit code, legal representative (person in charge), domicile, production address, food category, license number, expiration date, issuing authority, issuing date and two-dimensional code.

the copy shall also contain the details of the food. Where health food, formula food for special medical use or formula food for infants and young children are produced, the registration number or filing registration number of the product or formula shall also be indicated; Where the production of health food is entrusted, it shall also specify the name and domicile of the entrusted enterprise and other relevant information.

Article 31 The serial number of a food production license consists of SC (Chinese phonetic alphabet abbreviation for "production") and 14 Arabic numerals. Numbers from left to right are: 3-digit food category code, 2-digit province (autonomous region or municipality directly under the Central Government) code, 2-digit city (prefecture) code, 2-digit county (district) code, 4-digit sequence code and 1-digit check code.

article 31 food producers shall properly keep their food production licenses, and shall not forge, alter, resell, lease, lend or transfer them.

food producers should hang or place the original food production license in a prominent position in the production site.

Chapter V Alteration, Extension and Cancellation

Article 32 If the name of the food producer, existing equipment layout and technological process, main production equipment and facilities, food category and other matters change during the validity period of the food production license, and it is necessary to change the licensing items specified in the food production license, the food producer shall submit an application for change to the market supervision and administration department that originally issued the license within 11 working days after the change.

if the production site of a food producer is relocated, it shall apply for a food production license again.

if the items in the same food category specified in the copy of the food production license change, the food producer shall report to the market supervision and administration department that originally issued the license within 11 working days after the change.

if the production conditions of food producers change and no longer meet the requirements of food production, and it is necessary to go through the licensing procedures again, it shall be handled according to law.

Article 33 To apply for changing the food production license, the following application materials shall be submitted:

(1) An application for changing the food production license;

(2) Other materials related to the change of food production license.

article 34 if a food producer needs to extend the validity period of a legally obtained food production license, it shall apply to the market supervision and administration department that originally issued the license 31 working days before the expiration of the validity period of the food production license.

Article 35 When applying for the extension of the food production license, a food producer shall submit the following materials:

(1) an application for the extension of the food production license;

(2) Other materials related to the renewal of food production license.

Where a manufacturer of health food, formula food for special medical use and infant formula food applies for renewal of food production license, it shall also provide raw materials.