Order of the State Administration for Market Regulation

No. 24

The "Measures for the Administration of Food Production Licenses" were reviewed and approved at the 18th Executive Meeting of the State Administration for Market Regulation in 2019 on December 23, 2019. They are hereby promulgated and shall come into force on March 1, 2020.

Director Xiao Yaqing

January 2, 2020

Measures for the Administration of Food Production License

(Announced by Order No. 24 of the State Administration for Market Regulation on January 2, 2020)

Chapter 1 General

Article 1 is to regulate food and food additive production licensing activities, strengthen food production supervision and management, and ensure food safety, in accordance with the "Administrative Licensing Law of the People's Republic of China", "Food Safety Law of the People's Republic of China" and "Implementation Regulations of the People's Republic of China Food Safety Law" And other laws and regulations, formulate these measures.

Article 2 Anyone engaged 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, review, decision and supervision and inspection of food production licenses.

Article 3 Food production licenses shall follow the principles of law, openness, fairness, justice, convenience and efficiency.

Article 4 The principle of one enterprise, one license shall be adopted for food production licenses, that is, the same food producer engaged in food production activities shall obtain one food production license.

Article 5 The market supervision and management department shall implement classified permits for food production in accordance with the risk level of the food, combined with factors such as food raw materials and production technology.

Article 6 The State Administration for Market Regulation is responsible for supervising and guiding the administration of food production licenses nationwide. Local market supervision and management departments at or above the county level are responsible for the supervision and management of food production licenses within their administrative regions.

Article 7 The market supervision and management departments of provinces, autonomous regions, and municipalities directly under the Central Government may determine the food production license management authority of the city and county-level market supervision and management departments based on the food category and food safety risk status.

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

Article 8 The State Administration for Market Regulation is responsible for formulating 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 formulate detailed food production license examination rules for local specialty foods according to the needs of food production license examination work in their respective administrative regions, implement them in their respective administrative regions, and report to the State Administration for Market Supervision and Administration. After the State Administration for Market Regulation formulates and publishes the relevant food production license review rules, the local specialty food production license review rules shall be automatically annulled.

The local market supervision and administration department at or above the county level shall comply with the general rules and detailed rules of food production license review when conducting food production license review.

Article 9 The local market supervision and management department at or above the county level shall speed up the construction of informatization, promote the online handling of the entire process of license application, acceptance, review, license issuance, and inquiries, and publish production license items on the website of the administrative agency to improve work efficiency .

Chapter II Application and Acceptance

Article 10 To apply for a food production license, one shall first obtain the business license and other legal subject qualifications.

For corporate legal persons, partnerships, sole proprietorships, individual industrial and commercial households, and farmers' professional cooperative organizations, the applicant shall be the subject specified in the business license.

Article 11 An application for a food production license shall be submitted in accordance with the following food categories: processed grain products, edible oil, fats and their products, condiments, meat products, dairy products, beverages, convenience foods, biscuits, cans, frozen drinks, quick-frozen Food, potato and puffed food, confectionery products, tea and related products, wine, vegetable products, fruit products, roasted seeds and nuts products, egg products, cocoa and roasted coffee products, sugar, aquatic products, starch and starch products, Cakes, soy products, bee products, health foods, formula foods for special medical purposes, formula foods for infants and young children, special dietary foods, other foods, etc.

The State Administration for Market Regulation may 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 food raw material processing and food processing, packaging, storage and other places suitable for the variety and quantity of the food produced, keeping the environment 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, with corresponding disinfection, dressing, washing, lighting, lighting, ventilation, antiseptic, dustproof, flies, rodents, insects, washing and treatment Equipment or facilities for storing waste water, garbage and waste; if the health food production process has pre-treatment processes such as raw material extraction and purification, it is necessary to have raw material pre-treatment equipment or facilities suitable for the variety and quantity of production;

(3) Having full-time or part-time food safety professional and technical personnel, food safety management personnel, and rules and regulations to ensure food safety;

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

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

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) Application for food production license;

(2) Food production equipment layout drawing and food production process flow chart;

(3) A list of main equipment and facilities for food production;

(4) Full-time or part-time food safety professional technical personnel, food safety management personnel information and food safety management system.

Article 14 To apply for the production license of special foods such as health foods, formula foods for special medical purposes, formula foods for infants and young children, the production quality management system documents and related registration and filing documents that are compatible with the food produced shall also be submitted.

Article 15 To engage in food additive production activities, a food additive production license shall be obtained according to law.

To apply for a food additive production license, it shall have the premises, production equipment or facilities, food safety management personnel, professional technical personnel and management systems that are compatible with the types 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) Application for food additive production license;

(2) Food additive production equipment layout diagram and production process flow chart;

(3) A list of main equipment and facilities for the production of food additives;

(4) Full-time or part-time food safety professional technical personnel, food safety management personnel information and food safety management system.

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

Article 18 Where an applicant applies for the production of multiple categories of food, the applicant shall independently choose one of the acceptance departments to submit application materials in accordance with the food production license management authority determined by the provincial market supervision and management department. The acceptance department shall promptly notify the market supervision and management department with corresponding approval authority and organize 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 conditions:

(1) If the application does not require a food production license in accordance with the law, the applicant shall be notified immediately of the rejection;

(2) If the application matters are not within the scope of the market supervision and management department's powers in accordance with the law, it shall immediately make a decision not to accept the application and notify the applicant to apply to the relevant administrative agency;

(3) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot, and the applicant shall sign or seal the correction office 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 notified on the spot or within 5 working days of all the contents that need to be supplemented and corrected. If notified on the spot, the application materials shall be returned to the applicant; if notified within 5 working days, the application materials shall be collected and proof of receipt of the application materials shall be issued. If the notification is not given within the time limit, the application will be accepted as of the date of receipt of the application materials;

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

Article 20 If 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 an acceptance notice; if it decides not to accept it, it shall issue a non-acceptance notice stating the reasons for not accepting it. And inform the applicant of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.

Chapter III Review 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. Where it is necessary to verify the substance of the application materials, on-site verification shall be conducted.

When conducting on-site inspections of food production licenses, the market supervision and management department shall conduct inspections in accordance with the application materials. For those who apply for a license for the first time or a change license for adding food categories, the inspection report of the trial-produced food shall be checked according to the requirements of the food production process flow. During the on-site inspection of food additive production licenses, inspection reports of trial-produced food additives and compound food additive formulas can be verified according to the characteristics of food additives. The trial-produced food can be inspected by the producer itself, or it can be entrusted with a qualified food inspection agency.

On-site inspections shall be conducted by food safety supervisors, and professional technical personnel may be hired as inspectors to participate in on-site inspections as required. There shall be no less than 2 inspectors. The inspector shall present a valid certificate, fill in the on-site inspection form for food production license, and prepare an on-site inspection record. After the applicant has verified that it is correct, the inspector and the applicant shall sign or seal the inspection form and record. If the applicant refuses to sign or seal, the inspector shall indicate the situation.

For items that have been subject to on-site verification during product registration or product formula registration for the production license of health food, formula food for special medical purposes, and infant formula milk powder, on-site verification may not be repeated.

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 applications. In principle, the on-site inspection of special food production licenses shall not be entrusted to the lower-level market supervision and management department to implement it.

The inspector 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 Except where an administrative license decision can be made on the spot, the local market supervision and management department at or above the county level shall make a decision on whether to grant an administrative license within 10 working days from the date of accepting the application. If the time limit needs to be extended due to special reasons, it may be extended by 5 working days with the approval of the person in charge of the administrative agency, and the applicant shall be informed of the reasons for the extension.

Article 23 The local market supervision and management department at or above the county level shall, based on the review of application materials and on-site verification, make a decision to approve the production license for those eligible, and report to the applicant within 5 working days from the date of the decision. Issuing food production licenses; if the conditions are not met, it shall promptly make a written decision of disapproval and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.

Article 24 If an application for a food additive production license meets the conditions, the local market supervision and management department at or above the county level where the applicant is located shall issue a food production license in accordance with the law and mark the food additive.

Article 25 The date of issuance of a food production license shall be the date when the licensing decision is made, and the validity period is 5 years.

Article 26 If the local market supervision and management department at or above the county level believes that the food production license application involves major matters of public interest and requires a hearing, it shall make an announcement to the public and hold a hearing.

Article 27 Where a food production license directly involves a significant interest relationship between the applicant and others, the local market supervision and management department at or above the county level shall notify the applicant and interested parties of the right to request a hearing before making an administrative licensing decision.

If the applicant or interested party submits an application for a hearing within 5 working days from the date of being notified of the right to a hearing, the market supervision and management department shall organize the hearing within 20 working days. The hearing period shall not be counted within the period of administrative license review.

Chapter IV License Management

Article 28 The food production license is divided into the original and the duplicate. The original and copy have the same legal effect.

The State Administration for Market Supervision and Administration is responsible for formulating food production license patterns. The market supervision and management departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the management of the printing and issuance of food production licenses in their respective administrative regions.
Article 29 A food production license shall specify: the name of the producer, social credit code, legal representative (person in charge), residence, production address, food category, license number, validity period, license issuing authority, and date of issuance And QR code.
The copy should also contain food details. For the production of health foods, formulas for special medical purposes, and formulas for infants and young children, the registration number or registration number of the product or product formula shall also be stated; for the production of health foods, the name and residence of the entrusting company shall also be indicated. information.
Article 30 The food production license number is composed of SC (the abbreviation of "production" in Chinese Pinyin) and 14 Arabic numerals. The numbers from left to right are: 3-digit food category code, 2-digit province (autonomous region, municipality) code, 2-digit city (region) code, 2-digit county (district) code, 4-digit sequence code, 1-digit check code .
Article 31 Food producers shall properly keep food production licenses, and shall not forge, alter, resell, lease, lend or transfer.
The food producer shall hang or place the original food production license in a conspicuous place of the production site.

Chapter 5 Change, Continuation and Cancellation

Article 32 During the validity period of the food production license, if the name of the food producer, the existing equipment layout and process flow, the main production equipment and facilities, the food category, etc. change, it is necessary to change the licensing items specified in the food production license. The food producer shall, within 10 working days after the change, submit an application for the change to the market supervision and administration department that originally issued the certificate.
Where a food producer’s production site moves, it shall reapply for a food production license.
Where there is a change in the items in the same food category specified in the copy of the food production license, the food producer shall report to the original market supervision and management department within 10 working days after the change.
If the food producer’s production conditions change and no longer meet the food production requirements, and need to go through the licensing procedures again, it shall be handled in accordance with the law.
Article 33 To apply for alteration of food production license, the following application materials shall be submitted:
(1) Application for alteration of food production license;
(2) Other materials related to the alteration of food production license items.
Article 34 Where a food producer needs to extend the validity period of a food production license obtained according to law, it shall apply to the market supervision and management department that originally issued the license 30 working days before the expiration of the food production license.
Article 35 When applying for renewal of a food production license, a food producer shall submit the following materials:
(1) Application for renewal of food production license;
(2) Other materials related to the renewal of food production license matters.
Manufacturers of health foods, formulas for special medical purposes, and formulas for infants and young children who apply for renewal of the food production license shall also provide a self-inspection report on the operation of the production quality management system.
Article 36 The local market supervision and management department at or above the county level shall, based on the licensee's application for renewal, make a decision on whether to approve the renewal before the expiration of the food production license.
Article 37 The local market supervision and management department at or above the county level shall review the application materials for alteration or renewal of food production licenses, and conduct on-site inspections in accordance with Article 21 of these Measures.
If the applicant declares that the production conditions have not changed, the local market supervision and management department at or above the county level may no longer conduct on-site inspections.
If the applicant’s production conditions and surrounding environment change, which may affect food safety, the market supervision and management department shall conduct on-site verification of the changes.
If the production process of health food, formula food for special medical purposes, and infant formula food is changed in registration or filing, the registration or filing modification procedures shall be completed first.
Article 38 If the market supervision and management department decides to approve the change, it shall issue a new food production license to the applicant. The food production license number remains unchanged, and the date of issuance is the date when the market supervision and administration department makes the decision to change the license. The validity period is the same as the original certificate. However, for a comprehensive on-site inspection due to relocation or other reasons, the validity period of the food production license renewed shall be calculated from the date of issuance.
Due to a major change in the national food safety standards, the national and provincial market supervision and management departments have decided to organize a re-inspection and renewed food production licenses. The issuance date of the food production license shall be subject to the reapproval date, and the validity period shall be calculated from the date of reissuance .
Article 39 If the market supervision and administration department decides to approve the renewal, it shall issue a new food production license to the applicant, the license number remains unchanged, and the validity period shall be calculated from the date when the market supervision and administration department makes the decision to renew the license.
If the license conditions are not met, the market supervision and management department shall make a written decision not to extend the food production license and explain the reasons.
Article 40 When a food producer terminates food production and its food production license is withdrawn or revoked, it shall apply to the original market supervision and management department to go through the cancellation procedures within 20 working days.
When a food producer applies for cancellation of a food production license, it shall submit an application for cancellation of a food production license to the market supervision and administration department that originally issued the license.
If the food production license is cancelled, the license number shall not be used again.
Article 41 In any of the following circumstances, if a food producer fails to apply for cancellation procedures in accordance with the regulations, the market supervision and management department that originally issued the license shall handle the cancellation procedures for the food production license in accordance with the law and make public announcements on the website:
(1) No application for renewal of the food production license expires;
(2) The main qualification of the food producer is terminated according to law;
(3) The food production license is withdrawn or revoked according to law, or the food production license is revoked according to law;
(4) The food production license cannot be implemented due to force majeure;
(5) Other circumstances under which the food production license shall be cancelled as provided by laws and regulations.
Article 42 The relevant procedures for the alteration, renewal and cancellation of food production licenses shall be implemented in accordance with the relevant provisions of Chapter 2 and Chapter 3 of these Measures.

Chapter VI Supervision and Inspection

Article 43 The local market supervision and administration department at or above the county level shall supervise and inspect the licensing matters of food producers in accordance with the duties prescribed by laws and regulations.
Article 44 Local market supervision and management departments at or above the county level shall establish a food licensing management information platform to facilitate inquiries by citizens, legal persons and other social organizations.
Local market supervision and management departments at or above the county level shall record the issuance of food production licenses, inspection of licensing matters, daily supervision and inspection, and investigation of illegal licensing activities in the food safety credit files of food producers, and publicize them to the public through the national enterprise credit information publicity system ; Food producers with bad credit records should increase the frequency of supervision and inspection.
Article 45 Local market supervision and management departments at or above the county level and their staff shall consciously accept the supervision of food producers and society when performing food production license management duties.
Upon receipt of reports of illegal activities by relevant staff in the process of food production license management, the market supervision and management department shall conduct investigation and verification in a timely manner. If the situation is true, it should be corrected immediately.
Article 46 The local market supervision and management department at or above the county level shall establish a food production license file management system, and timely file the relevant materials and license issuance for food production licenses.
Article 47 The State Administration for Market Regulation may regularly or irregularly organize the supervision and inspection of food production licenses nationwide; the market supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government may regularly or irregularly organize food production licenses within their administrative regions Carry out supervision and inspection.
Article 48 Without the consent of the applicant, the administrative agency, its staff, and personnel participating in the on-site inspection shall not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant. The law provides otherwise or involves national security or major issues. Except for social public interest.

Chapter VII Legal Liability

Article 49 Those engaged in food production activities without a food production license shall be punished by the local market supervision and management department at or above the county level in accordance with Article 122 of the Food Safety Law of the People’s Republic of China.

If the food produced by a food producer does not belong to the food category specified in the food production license, it shall be deemed to be engaged in food production activities without a food production license.

Article 50 Where a permit applicant conceals the truth or provides false materials to apply for a food production permit, the local market supervision and management department at or above the county level shall give a warning. The applicant shall not reapply for food production license within 1 year.

Article 51 Where a licensee obtains a food production license by deception or bribery or other improper means, the market supervision and management department that originally issued the license shall revoke the license and impose a fine of 10,000 yuan up to 30,000 yuan. The licensee shall not apply for a food production license again within 3 years.

Article 52 In violation of the provisions of Article 31, Paragraph 1 of these Measures, food producers who forge, alter, resell, lease, lend, or transfer food production licenses shall be ordered by the local market supervision and management department at or above the county level to make corrections. A warning shall be given and a fine of less than 10,000 yuan shall be imposed; if the circumstances are serious, a fine of 10,000 yuan up to 30,000 yuan shall be imposed.

In violation of the second paragraph of Article 31 of these Measures, if a food producer fails to hang or place a food production license in a conspicuous position of the production site as required, the local market supervision and administration department at or above the county level shall order correction; refuse to make corrections Yes, give a warning.

Article 53 In violation of the provisions of Article 32, Paragraph 1 of these Measures, within the validity period of the food production license, the name of the food producer, the layout of the existing equipment and process, the main production equipment and facilities have changed, and the food needs to be changed. If the licensing items specified in the production license are not applied for changes in accordance with the regulations, the market supervision and management department that originally issued the license shall order corrections and give a warning; if they refuse to make corrections, a fine of 10,000 yuan up to 30,000 yuan shall be imposed.

In violation of the second paragraph of Article 32 of these Measures, if a food producer does not reapply for a food production license after the relocation of its production site to engage in food production activities, the local market supervision and management department at or above the county level shall follow Penalties are imposed under Article 122 of the Security Law.

In violation of Article 32, Paragraph 3 and Article 40, Paragraph 1 of these Measures, if the items in the same food category specified in the copy of the food production license change, and the food producer fails to report as required, the food producer If the food production is terminated, the food production license is withdrawn, revoked, or the food production license is revoked, and the cancellation procedures are not applied in accordance with the regulations, the market supervision and management department that originally issued the license shall order correction; if it refuses to make corrections, a warning and concurrent punishment shall be given Fines below 5,000 yuan.

Article 54: Where a food producer violates the provisions of these Measures and has the circumstances specified in the first paragraph of Article 75 of the Regulations on the Implementation of the Food Safety Law of the People’s Republic of China, the legal representative, main responsible person, and direct The person in charge and other persons directly responsible shall be punished.

Food producers whose production licenses have been revoked and their legal representatives, directly responsible persons in charge and other directly responsible persons shall not apply for food production and business licenses, or engage in food production and business management work, or hold positions within 5 years from the date when the penalty decision is made. Food safety management personnel of food production and operation enterprises.

Article 55 If the market supervision and management department grants permission to applicants who do not meet the requirements, or grants permission beyond their legal authority, they shall be punished in accordance with Article 144 of the Food Safety Law of the People’s Republic of China.

Chapter 8 Supplementary Provisions

Article 56 A catering service provider who has obtained a food business license does not need to obtain a food production license as prescribed in these Measures to produce processed food at its catering service premises.

Article 57 The management principles, procedures, supervision and inspection and legal responsibilities of food additive production licenses shall be governed by the provisions of these Measures concerning food production licenses.

Article 58 The supervision and management of small food production and processing workshops shall be implemented in accordance with the specific management measures formulated by provinces, autonomous regions, and municipalities directly under the Central Government.

Article 59 The market supervision and management departments of provinces, autonomous regions, and municipalities directly under the Central Government may formulate specific implementation measures for the management of food production licenses based on the actual conditions of their administrative regions.

Article 60 The food production license electronic certificate produced by the market supervision and management department has the same legal effect as the printed food production license.

Article 61 These Measures shall come into effect on March 1, 2020. The former State Food and Drug Administration announced on August 31, 2015 that the "Measures for the Administration of Food Production Licensing" amended in accordance with the former State Food and Drug Administration’s "Decision on Amending Some Regulations" on November 7, 2017 shall be repealed at the same time.