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Provisions for Food Production Licensing

(Decree No.16 of China Food and Drug Administration)

Provisions for Food Production Licensing, adopted at the executive meeting of China Food and Drug Administration, is hereby promulgated and shall be effective as of October 1, 2015.

Minister: Bi Jingquan
August 31, 2015


Provisions for Food Production Licensing

Chapter I General Provisions

Article 1 The Provisions is formulated in accordance with Food Safety Law of the People's Republic of China and Administrative License Law of the People's Republic of China, etc., to standardize the production licensing activities of food or food additives, strengthen supervision and administration of food production and ensure food safety.

Article 2 Those engaged in food production activities within the territory of the People's Republic of China shall obtain food production license according to law.

The Provisions is applicable to the application, acceptance, review, decision as well as supervision and inspection for Food Production License.

Article 3 Food production licensing shall follow the principles of being lawful, open, fair, just, convenient to the people, and efficient.

Article 4 Food production licensing shall abide by the principle of "one license one enterprise", that is, one food producer engaging in food production activities shall obtain one Food Production License.

Article 5 Food and drug regulatory departments shall implement classified licensing for food production in accordance with degree of food risk.

Article 6 China Food and Drug Administration shall be responsible for supervising and guiding the administration of food production licensing nationwide.

Local food and drug regulatory departments at or above county level shall be responsible for the administration of food production licensing within their respective administrative areas.

Article 7 Food and drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government may determine the food production licensing competence of food and drug regulatory departments at city or county level based on food category and food safety risk.

The production licensing for health food, formula food for special medical purposes and infant formula food shall be taken charge of by the food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government.

Article 8 China Food and Drug Administration shall be responsible for formulating general rules and detailed rules for the review of food production licensing.

The food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government may, in the need for food production licensing review within their respective administrative areas, formulate detailed rules for production licensing review for local unique food, implement them within their respective administrative areas, and report to China Food and Drug Administration for the record. Once China Food and Drug Administration formulates and promulgates relevant detailed rules for food production licensing review, the detailed rules for the production licensing review for local unique food shall become invalid automatically.

Local food and drug regulatory departments at or above county level shall abide by general rules and detailed rules for the review of food production licensing in the implementation of food production licensing review.

Article 9 The food and drug regulatory departments at or above county level shall speed up informationization construction, and release matters in regard with production licensing on their websites, so as to facilitate applicants to submit production licensing application electronically and etc., and improve work efficiency.

Chapter II Application and Acceptance

Article 10 To apply for food production license, a business license and, etc. shall be obtained in advance as a legal entity qualification.

For enterprises, partnership enterprises, sole proprietorship enterprises, and privately or individually-owned business, etc., the applicant shall be the person who is authorized in the business license.

Article 11 The application for food production license shall be submitted in accordance with the following food categories: processed grain products, edible oil and fats as well as its products thereof, condiment, meat products, dairy products, beverage, instant food, biscuit, canned food, frozen drinks, quick-frozen food, potato and puffed food, candy products, tea and relevant products, liquor, vegetable products, fruit products, roasted seeds and nut products, egg products, cocoa and baked coffee products, edible sugar, aquatic products, starch and starch products, pastry, bean products, bee products, health food, formula food for special medical purposes, infant formula food, special dietary food and others.

China Food and Drug Administration may adjust the above food categories in the need of supervision and administration.

Article 12 The following requirements shall be met for the application for food production License:

(1) There shall be sites for raw material and food processing, packing and storage adapted to the variety and quantity of produced food, which shall be maintained in clean environment and be kept at specified distance from poisonous or hazardous site as well as other sources of contamination.

(2) There shall be production equipment or facilities adapted to the variety and quantity of produced food, including corresponding equipment or facilities for disinfection, dressing, washing, lighting, illumination, ventilation, preventing corrosion, dust, fly, rat, insect and lavation as well as disposing waste water, storing garbage and other wastes; for pre-treatment procedures including raw material extraction and purification in production process of health foods, there shall be equipment or facilities for raw materials pre-treatment adapted to the variety and quantity of produced food, if applicable.

(3) There shall be full-time or part-time management person in charge of food safety and a series of rules and practices for food safety.

(4) There shall be appropriate equipment layout and processing procedure, to prevent cross contamination between the foods to be processed and ready-to-eat foods, and between raw materials and finished products, and prevent the foods from contacting with poisonous substances or impurities.

(5) Other requirements specified in applicable laws and regulations.

Article 13 To apply for food production license, the applicant shall submit to the local food and drug regulatory departments at or above county level in the place where the applicant is located the following materials:

(1) Application form for food production license.

(2) A copy of Business License.

(3) Layout plan of food production and processing sites and the surroundings, layout plan of each functional zone, layout of processing equipment and flow chart of food production process.

(4) List of major equipments and facilities for food production.

(5) Rules and systems such as incoming goods checking recording, production process control, release test recording, food safety self-inspection, employees health management, unsafe food recalling and food safety accident handling, etc. to ensure food safety.

Where applicants entrust others to handle the application for food production license, the agent shall submit a letter of authorization and his/her identity document.

Article 14 To apply for production license of health food, formula food for special medical purposes and infant formula food, the document of production quality management system adapted to the food produced as well as relevant registration and filing documents shall also be submitted.

Article 15 To be engaged in food additives production, the producers shall obtain food additives production license according to law.

To apply for food additives production license, a site, production equipment or facilities, management personnel for foodsafety, professionals and management system adapted to the variety of food additive produced shall be in existence.

Article 16 To apply for food additives production license, the applicant shall submit to the local food and drug regulatory authorities at or above county level in the place where the applicant is located the following materials:

(1) Application form for food additives production license.

(2) A copy of business license.

(3) Layout plan of food additives production and processing sites and the surroundings, layout plan of each functional zone.

(4) List of major equipments, facilities and layout for production of food additives.

(5) Rules and systems such as food safety self-inspection, incoming goods checking recording and release test recording, etc. to ensure safety of food additives.

Article 17 Applicants shall truthfully submit relevant materials to food and drug regulatory departments and report the real situation, be responsible for the truthfulness of relevant materials and sign or seal the materials including application form.

Article 18 Local food and drug regulatory departments at or above county level shall handle food production license applications according to the following situations respectively:

(1) Where according to the law, the matter of application is not subject to food production licensing, they shall immediately notify the applicant of unacceptance.

(2) Where a matter of application is not within the competence, they shall immediately make the decision of unacceptance and inform the applicant to submit the application to relevant administrative authorities.

(3) Where there are errors in application dossiers that can be corrected on the spot, they shall allow the applicant to correct the errors on the spot and request the applicant to sign by or seal on the correction with date indicated.

(4) Where the application dossier is incomplete or failing in conformance with the legal format, they shall give one notice to the applicant, on the spot or within 5 working days, of all the materials required for supplementation or correction. In case of on-spot notice, they shall return the application dossier to the applicant. In case of noticing within 5 working days, they shall accept the application dossier and issue a voucher for receipt. Where no notice is made before the due date, they shall regard the application as accepted as of the date of receiving the application dossier.


(5) Where the application dossier is complete and in conformance with the legal format, or the applicant submits all supplementary and corrected materials as required, they shall accept the application for food production license.

Article 19 Where the local food and drug regulatory departments at or above county level make a decision of acceptance of the application, they shall issue a notice of acceptance; where the local food and drug regulatory departments at or above county level make a decision of unacceptance, they shall issue a notice of unacceptance, state the justifications and inform the applicant of his/her legal right to apply for administrative reconsideration or institute an administrative lawsuit.

Chapter III Review and Decision

Article 20 Local food and drug regulatory departments at or above county level shall review the application dossier submitted by applicants. Where the substantive content in application dossier needs to be verified, an on-site inspection shall be conducted.

Where food and drug regulatory departments conduct on-site inspection for food production licensing, they may, in accordance with the requirements for food processing flow, etc., check the test report which shows that the food for trial production is qualified. Where food and drug regulatory departments conduct on-site inspection for food additives production licensing, they may check, in accordance with the characteristics of food additive, the test report which shows that the food additives for trial production is qualified, and the composition of compound food additives.

On-site inspection shall be conducted by qualified inspectors, the number of which shall not be less than two. Inspection personnel shall show valid identity document, fill in on-site inspection form for food production licensing and make record. After confirming as correct by the applicant, the form and the record shall be signed or sealed by the inspectors and applicant. Where the applicants refuse to sign or seal, the inspectors shall make a note.

On-site inspection may not be conducted again for the applications of production license of health food, formula food for special medical purpose and infant formula food, if it has been conducted during product registration.

Food and drug regulatory departments may entrust the inferior food and drug regulatory departments to conduct on-site inspection for those accepted applications for food production license.

Inspectors shall complete on-site inspection on production sites within 10 working days upon acceptance of such task.

Article 21 Except for the circumstances that administrative licensing decision may be made on the spot, local food and drug regulatory departments at or above county level shall make the decision on whether or not to issue the administrative licenses within 20 working days upon acceptance of the application. Where the time limit needs to be extended due to special reasons, the time limit can be extended by additional 10 working days with the approval of the responsible person of the administrative authorities, andthe applicant shall be informed of the reasons for extension.

Article 22 Local food and drug regulatory departments at or above county level shall, in accordance with the situation of application dossier review and the on-site inspection, make a decision of production approval for those meeting requirements, and issue food production license to the applicant within 10 working days upon the date of decision; or timely make a decision of rejection with justifications in written form for those failing to meet requirements, and meantime inform the applicant of his/her right to apply for administrative reconsideration or institute an administrative lawsuit.

Article 23 Where the application for food additives production license meets the requirements, local food and drug regulatory departments at or above county level in the place where the applicant is located shall issue food production License as per legal procedures with food additives indicated.

Article 24 Date of issue of food production license shall be the date when the approval decision is made, and period of validity of the license is five years.

Article 25 Where local food and drug regulatory departments at or above county level consider that the food production license application involves important matters of public interests and a hearing is required, they shall make a public announcement and hold the hearing.

Article 26 Where the food production licensing directly involves major interest relationship between the applicant and others, local food and drug regulatory departments at or above county level shall, prior to making the decision of administrative licensing, inform the applicant and stakeholders of their right to require a hearing.

Where the applicant and stakeholders submit application for hearing within 5 working days upon such notification, food and drug regulatory departments shall organize the hearing within 20 working days.The time limit for hearing shall not be included in the period of the administrative licensing review.

Chapter IV License Management

Article 27 The Food Production License shall have a major part and a counterpart, and both have the same legal effect.

China Food and Drug Administration shall be responsible for formulating the model of major part and counterpart of food production license. The food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for management of food production license including printing and release within their respective administrative areas.

Article 28 Food production license shall specify: name of producer, social credit code (ID card number for individual producer), legal representative (responsible person), residential address, address of the production site, food category, license number, period of validity, routine supervision authority, routine supervision person(s), complaint hotline, license-issuing authority, person of signature, date of issue and 2D code.

The counterpart shall also specify details of the food and specific addresses of external warehouses (including self-owned and rented warehouses). For production of health food, formula food for special medical purpose and infant formula food, the counterpart shall also specify approval number for product registration or number for filing; for contract production of health food, the name and residential address of entrusted party and other relevant information shall also be specified.

Article 29 Food production license number consists of SC (abbreviation of the Chinese pinyin for "production") and 14 Arabic digits. The digits, in order from the left to the right, are: 3 digits for food category code, 2 digits for province (autonomous region, municipality directly under the central government) code, 2 digits for city (prefecture) code, 2 digits for county/district code, 4 digits for sequence code, and 1 digit for check code.

Article 30 Routine supervision personnel shall be the working staff for routine supervision on food production. Where the routine supervision personnel have a change, a corresponding alteration may be made on the license by way of signature and seal.

Article 31 Food producers shall properly keep food production license, and shall not forge, alter, resell, lease out, lend out and transfer it.

Food producers shall hang or place the major part of food production license on prominent position in production site.

Chapter V Change, Renewal, Reissuance and Cancellation

Article 32 Where within the validity period of food production license, the items like the existing processing equipment layout and technological process, main production equipment and facilities and food categories change, and alteration on the items specified in the food production license is needed, the food producers shall submit application for such alteration to the original license-issuing authority within 10 working days upon the change.

Where a production site is moved outside the jurisdiction of the food and drug regulatory department which originally issued the license, the food producer shall re-apply for food production license.

Where a change happens to the items of the same food category, or address of external warehouse specified on the counterpart of the food production license, food producer shall report to the original license-issuing authority within 10 working days upon the change.

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

(1) Application for change of food production license.

(2) Major part and counterpart of food production license.

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

Article 34 To extend the period of validity of food production license legally obtained, food producer shall submit application to the original license-issuing authority 30 working days prior to the expiration date of the license.

Article 35 To apply for renewal of food production license, food producer shall submit the following materials:

(1) Application for food production license renewal.

(2) Original and counterpart of food production license.

(3) Other materials related to food production license renewal.

Producers of health food, formula food for special medical purpose and infant formula food shall also provide self-inspection report on operation of production quality management system to apply for license renewal.

Article 36 Local food and drug regulatory departments at or above county level shall, in accordance with the extension or renewal application of the licensee, make a decision on whether or not to approve the extension or renewal prior to the expiration date of the license.

Article 37 Local food and drug regulatory departments at or above county level shall review the application dossier for change or renewal of food production license.

Where applicants declare there is no change of production conditions, local food and drug regulatory departments at or above county level may not conduct on-site inspection again.

Where a production condition of the applicant changes and the food safety may be affected, the food and drug regulatory departments shall conduct on-site inspection on the change. Where a change of production process of registered health food, formula food for special medical purpose and infant formula food takes place, procedures for change of registration or filing shall be performed first.

Article 38 Where the food and drug regulatory department which originally issued the license decides to approve the change, it shall issue a new food production license to the applicant. The number of the food production license shall not be changed, the date of issuance shall be the date on which the decision to change the license is made by the food and drug regulatory department, and the period of validity shall be consistent with the original license. However, where an overall on-site inspection is conducted due to reasons like site move, the period of validity of the changed food production license shall be counted from the date of its issuance.

Where China Food and Drug Administration and provincial food and drug regulatory departments decide to organize a re-inspection, resulting in reissuance of the food production license due to change(s) of product standard or requirements, the date of issuance shall refer to the date of reissuance, and the period of validity shall be counted as of the date of reissuance.

Article 39 Where the food and drug regulatory department which originally issued the license decides to approve the renewal, it shall issue a new food production license to the applicant, the number of the production license shall not be changed, and the period of validity shall be counted from the date on whichthe food and drug regulatory department decides to approve the renewal.

For those failing to meet the licensing requirements, the food and drug regulatory department which originally issued thelicense shall make a decision in written on rejection of the food production license renewal with justifications.

Article 40 Where a food production license is lost or damaged, an application for reissuance shall be submitted to the food and drug regulatory department which originally issued the license, and the following materials shall be provided:

(1) Application for reissuance of food production license;

(2) Where food production license is lost, applicants shall submit relevant materials to make an announcement of such a loss on the website of local food and drug regulatory departments at or above county level, or in other main media above county level; where food production license is damaged, applicants shall submit the damaged one.

Where the materials submitted meet requirements, local food and drug regulatory departments at or at or above county level shall reissue the license within 20 working days upon acceptance.

For a food production license reissued due to loss or damage, its number shall not be changed, and the date of issuance and the period of validity shall be consistent with the original.

Article 41 Where a food producer terminates its production, a food production licensing is withdrawn or cancelled, or food production license is revoked, such producers shall submit application for cancellation to the food and drug regulatory department which originally issued the license within 30 working days.

Food producers shall submit the following materials to the food and drug regulatory department which originally issued the license to apply for nullifying the licensing:

(1) Application for nullifying the food production licensing.

(2) Major part and counterpart of the food production license.

(3) Other materials related to nullification of the food production licensing.

Article 42 Where any of the following situations exists, and a food producer fails to apply for nullification as required, the food and drug regulatory department which originally issued the license shall perform the procedures of nullification:

(1) Failing to apply for food production license renewal upon expiration of validity date.

(2) The subject qualification of food producers is terminated as per laws.

(3) The food production licensing is legally withdrawn or cancelled, or food production license is legally revoked.

(4) The licensed food production items cannot be implemented due to force majeure.

(5) Other situations under which the food production license shall be nullified as specified by laws and regulations.

Where a food production licensing is nullified, the license number shall not be used again.

Article 43 Relevant procedures for change, extension, reissuance and nullification of food production license, shall be performed in reference to Chapter II and III herein.

Chapter VI Supervision and Inspection

Article 44 Local food and drug regulatory departments at or above county level shall, based on the responsibilities specified by applicable laws and regulations, conduct supervision and inspection on the licensed items of food producers.

Article 45 Local food and drug regulatory departments at or above county level shall establish food licensing management information platform, so as to facilitate the inquiries by citizens, legal persons and other social organizations.

Local food and drug regulatory departments at or above county level shall record the information on issuance of license, inspection on licensed items, routine supervision and inspection, and investigation and treatment of unlawful licensing-related acts in the food safety credit files of food producers, and legally release them to the public. The frequency of supervision and inspection shall be increased for food producers with poor credit record.

Article 46 Routine supervision and administration personnel of local food and drug regulatory departments at or above county level shall be responsible for the supervision and inspection on the licensed items of the food producers under their jurisdiction, and if necessary, shall inspect relevant food storage or logistics enterprises in accordance with law.

Routine supervision staff shall, in accordance with the specified frequency, implement inspection to all food producers under their jurisdiction.

Article 47 Local food and drug regulatory departments at or above county level and the staff shall consciously accept the supervision by food producers and the society in fulfilling their administration responsibility for food production licensing.

Upon receipt of complaints of violation by relevant persons during administration of food production licensing, food and drug regulatory departments shall conduct timely investigation and verification. Where the violation is true, correction shall be made immediately.

Article 48 Local food and drug regulatory departments at or above county level shall establish file management system for food production licensing, and timely archive the relevant materials in handling food production license and information about license issuance.

Article 49 China Food and Drug Administration may organize regular or irregular supervision and inspection on the practice of food production licensing nationwide; the food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government may organize regular or irregular supervision and inspection on the practice of food production licensing within their respective administrative areas.

Chapter VII Legal Liabilities

Article 50 Where a food production activity is conducted without obtaining food production licensing, local food and drug regulatory departments at or above county level shall impose penalty on it in accordance with Article 122 of the Food Safety Law of the People's Republic of China.

Article 51 Where an applicant conceals true information or provides false materials to apply for food production licensing, a warning shall be given by the local food and drug regulatory department at or above county level. The applicant shall not re-apply for food production licensing within one year.

Article 52 Where the licensee obtaining food production license with improper means such as deception and bribery, the food and drug regulatory department which originally issued the license shall revoke the license and concurrently impose a fine not less than RMB 10,000 yuan and no more than RMB 30,000 yuan. The licensee shall not re-apply for food production licensing within three years.

Article 53 Where a food producer, in violation of Paragraph 1 of Article 31 hereof, forges, alters, resells, leases out, lends out or transfers a food production license, local food and drug regulatory departments at or above county level shall order them to make rectification, give a warning, and concurrently impose a fine not more than 10,000 yuan(RMB), if the circumstances are serious, a fine not less than 10,000 yuan(RMB) and no more than 30,000 yuan( RMB)shall be imposed.

Where a food producer, in violation of Paragraph 2 of Article 31 hereof, fails to hang or place food production license on prominent position in the production site, local food and drug regulatory departments at or above county level shall order them to make rectification, or give a disciplinary warning for those refusing to make correction.

Article 54 Where a food producer, in violation of Paragraph 1 of Article 32 hereof, fails to apply for the change as required for the licensed items specified on food production license due to the change of processing equipment layout, processing flow, main production equipment and facilities, and food category, etc., the food and drug regulatory department which originally issued the license shall order them to make rectification and give a disciplinary warning; or, impose a fine not less than 2,000 yuan(RMB) and no more than 10,000 yuan(RMB)for those refusing to make correction.

Where a food producer, in violation of Paragraph 3 of Article 32 or Paragraph 1 of Article 41 hereof, fails to report the change of the items pertaining to the same food category, or address of external warehouses specified on the counterpart of food production license as required, or fails to apply for nullification procedure for the termination of food production, withdrawal or cancellation of food production licensing or revocation of food production license, the food and drug regulatory department which originally issued the license shall order them to make rectification; or, give a disciplinary warning and concurrently impose a fine not more than 2,000 yuan(RMB)for those refusing to make correction.

Article 55 For the food producer whose production license is revoked, he and his legal representative, and the person in charge who is direct responsible and the person with direct accountability shall not apply for food production and distribution license, or be engaged in food production and distribution management, or act as food safety management personnel of enterprises engaged in food production and distribution within five years upon the date of decision of penalty.

Article 56 Where the food and drug regulatory departments issue license to applicants failing to meet relevant conditions, or issue license beyond their competence, punishment shall be imposed in accordance with the provisions in Article 144 of the Food Safety Law of the People's Republic of China.

Chapter VIII Supplementary Provisions

Article 57 Where catering service providers with food distribution licensing prepare and process foods at the site for catering service, the food production licensing specified herein is not required.

Article 58 The provisions for food production licensing herein are applicable to the administration principles and procedures, supervision and inspection as well as legal liability for production licensing of food additives.

Article 59 The individual workshops for food production and processing shall be subject to supervision and administration in accordance with the specific provisions formulated by corresponding provinces, autonomous regions and municipalities directly under the central government.

Article 60 The production license that food producers have obtained prior to the implementation of the Provisions shallcontinue to be effective within its period of validity.

Article 61 The food and drug regulatory departments of all provinces, autonomous regions and municipalities directly under the central government may formulate specific implementation provisions for food production licensing management based on the actual situation in their respective administrative areas.

Article 62 The Provisions shall be effective as of October 1, 2015.


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