General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China "Regulations on the Supervision and Administration of Food Additive Production" (General Administration Order No. 127)

　　No. 127

　　The "Regulations on the Supervision and Administration of Food Additive Production" were reviewed and approved at the meeting of the General Administration of Quality Supervision, Inspection and Quarantine on March 10, 2010, and are hereby promulgated, effective from June 1, 2010.

　　Director

　　April 4, 2010

　　Regulations on the Supervision and Administration of Food Additive Production

　　Chapter 1 General Provisions

　　Article 1 To ensure food safety and strengthen the supervision and administration of food additive production, these regulations are formulated in accordance with the "Product Quality Law of the People's Republic of China", the "Food Safety Law of the People's Republic of China" and its implementing regulations, and the "Regulations on the Administration of Production Licenses for Industrial Products" and other relevant laws and regulations.

　　Article 2 These regulations apply to the production of food additives, implementation of production licenses, and supervision and administration within the territory of the People's Republic of China.

　　The food additives referred to in these regulations mean artificial synthetic or natural substances approved by the health administrative department of the State Council and announced by standards, bulletins, etc., which can be added to food to improve food quality, color, aroma, and taste, as well as for preservation, freshness, and processing technology needs.

　　Other substances not specified in the preceding paragraph shall not be produced as food additives, nor shall production licenses for food additives be implemented for them.

　　Article 3 The General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (hereinafter referred to as the General Administration of Quality Supervision) is responsible for the quality supervision and administration of food additive production nationwide.

　　Provincial quality and technical supervision departments are responsible for the quality supervision and administration of food additive production within their administrative regions and for implementing food additive production licenses.

　　Municipal and county-level quality and technical supervision departments are responsible for the quality supervision and administration of food additive production within their administrative regions.

　　Article 4 Producers shall engage in food additive production activities in accordance with laws, regulations, rules, and relevant standards, ensure continuous and stable product quality, be responsible to society and the public, and accept social supervision.

　　Article 5 The supervision and administration of food additive production shall follow the principles of scientific fairness, convenience, and efficiency.

　　Chapter 2 Production License

　　Article 6 Producers must obtain a production license before engaging in food additive production.

　　To obtain a production license, the following conditions must be met:

　　(1) A legally valid business license;

　　(2) Professional technical personnel suitable for food additive production;

　　(3) Production sites and plant facilities suitable for food additive production; their sanitation management meets health and safety requirements;

　　(4) Production equipment or facilities and other production conditions suitable for food additive production;

　　(5) Technical documents and process documents that meet relevant requirements and are suitable for food additive production;

　　(6) A sound and effective quality management and responsibility system;

　　(7) Factory inspection capabilities suitable for food additive production; products meet relevant standards and requirements to protect human health and personal safety;

　　(8) Compliance with national industrial policy provisions, with no outdated processes, high energy consumption, environmental pollution, or resource waste that are explicitly eliminated or prohibited by the state for investment and construction;

　　(9) Other conditions prescribed by laws and regulations.

　　Article 7 Applicants for food additive production shall submit production license applications to the provincial quality and technical supervision department (hereinafter referred to as the licensing authority) where the production is located.

　　Article 8 The following materials shall be submitted when applying for a food additive production license:

　　(1) Food additive production license application form;

　　(2) Copy of the applicant's business license;

　　(3) Relevant production process documents of the food additive for which the production license is applied;

　　(4) Proof of legal use rights of the production site suitable for the food additive for which the production license is applied, as well as copies of the surrounding environment layout plan and plant facilities and equipment layout plan;

　　(5) Proof of legal use rights and lists of production equipment and facilities suitable for the food additive for which the production license is applied, and proof of legal use rights and lists of inspection equipment;

　　(6) Texts of quality management and responsibility systems suitable for the food additive for which the production license is applied;

　　(7) List of professional technical personnel suitable for the food additive for which the production license is applied;

　　(8) Text of the food additive standards implemented in production;

　　(9) Other materials prescribed by laws and regulations.

　　Article 9 The licensing authority shall handle the application according to the following situations:

　　(1) If the application matter does not require a production license according to law, the applicant shall be informed immediately that the application will not be accepted;

　　(2) If the application matter is not within the management scope of the quality and technical supervision department according to law, a decision of non-acceptance shall be made immediately and the applicant shall be informed to apply to the relevant administrative authority;

　　(3) If there are circumstances stipulated in Articles 78 and 79 of the "Administrative Licensing Law of the People's Republic of China", a decision of non-acceptance shall be made immediately;

　　(4) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them immediately;

　　(5) If the application materials are incomplete or do not meet the legal form, the applicant shall be informed once on the spot or within five days of the materials and requirements to be supplemented, and a notice of supplementation of application materials shall be issued; if not notified within the time limit, it shall be deemed accepted;

　　(6) If the application matter falls within the authority of the quality and technical supervision department, and the application materials are complete and meet the legal form, or the applicant submits all supplementary application materials as required, the production license application shall be accepted and a decision of acceptance of the administrative license application shall be issued to the applicant.

　　The licensing authority shall issue a written certificate stamped with the official seal of the authority and indicating the date for acceptance or non-acceptance of the license application.

　　Article 10 After accepting the application, the licensing authority shall organize a review of whether the applicant has the necessary production conditions to continuously produce qualified products.

　　The review content includes on-site verification of the application materials and production site, as well as product quality inspection.

　　Article 11 The licensing authority shall organize an on-site inspection of the applicant and shall form an inspection team. The inspection team shall consist of two to four qualified inspectors. The team operates under the responsibility system of a team leader and is subject to supervision by the local quality and technical supervision department according to relevant regulations.

　　Article 12 The licensing authority shall formulate an on-site inspection plan for the applicant and issue an on-site inspection notice to the applicant five days before the inspection.

　　The on-site inspection generally shall not exceed two days.

　　Article 13 Inspectors conducting on-site inspections shall not make things difficult for enterprises, shall not solicit or accept property, and shall not seek other improper benefits.

　　The applicant shall cooperate with the inspection team's on-site inspection. If the inspection time needs to be extended due to force majeure or other reasons, the applicant shall promptly apply for an extension to the licensing authority.

　　Article 14 The inspection team shall conduct the on-site inspection of the applicant according to the inspection plan and the prescribed licensing conditions and procedures, and shall handle the results as follows:

　　(1) If the on-site inspection is qualified, samples shall be taken and sealed according to regulations, and the applicant shall submit them to a qualified testing institution for inspection in accordance with the law;

　　(2) If the on-site inspection is unqualified, no further product sampling shall be conducted.

　　Refusal to allow inspection or failure to cooperate without valid reasons, resulting in the inability to conduct the on-site inspection within the prescribed time limit, shall be deemed as failing the on-site inspection.

　　Article 15 The on-site inspection record shall be filled out by the team leader of the inspection team, signed by the inspectors, and confirmed by the applicant.

　　Article 16 The licensing authority shall complete the on-site inspection and product sampling of the applicant within thirty days from the date of acceptance of the application and issue a notice of the on-site inspection conclusion to the applicant. If the inspection is unqualified, reasons shall be explained.

　　Article 17 The testing institution responsible for certificate inspection work shall inspect food additives according to relevant standards and complete the inspection within the prescribed time.

　　The testing institution responsible for the inspection work of food additive production license issuance shall have statutory qualifications and be listed uniformly by the State Administration for Market Regulation.

　　Article 18 After completing the inspection, the testing institution shall issue a product inspection report. The inspection report shall be made in triplicate: one copy for the applicant, one for the licensing authority, and one for the testing institution's archives.

　　Article 19 If there is any objection to the inspection results, the applicant may apply for re-inspection to the original licensing authority within five days from the receipt of the inspection report.

　　The re-inspection shall be conducted by a qualified testing institution other than the original one, and the re-inspection conclusion shall be final.

　　If the re-inspection conclusion is consistent with the original inspection conclusion, the re-inspection fee shall be borne by the applicant; if inconsistent, the fee shall be borne by the original testing institution.

　　Article 20 The licensing authority shall make the following decisions within sixty days from the date of acceptance of the application based on the review results:

　　(1) If the applicant meets the licensing conditions, a written decision to grant production permission shall be made according to law, and the food additive production license shall be issued to the applicant within ten days from the date of the decision;

　　(2) If the applicant does not meet the licensing conditions, a written decision to deny production permission shall be made according to law, with reasons explained, and the applicant shall be informed of the right to apply for administrative reconsideration or initiate administrative litigation according to law.

　　The product inspection time shall not be included in the licensing period.

　　Article 21 The provincial quality and technical supervision department shall promptly file the list of producers who have obtained the food additive production license with the State Administration for Market Regulation and make it public.

　　Article 22 Producers who have obtained the food additive production license and need to add product varieties shall apply in accordance with these regulations. The original licensing authority shall organize a review of the added product varieties according to these regulations.

　　Article 23 During the validity period of the food additive production license, if the producer's production conditions, testing methods, production technology, or processes undergo significant changes, the producer shall promptly apply for a review to the original licensing authority, which shall reorganize the review according to these regulations.

　　Article 24 If the producer's name or other information changes but the production conditions, testing methods, production technology, or processes do not undergo significant changes, the food additive producer shall apply for a production license change to the original licensing authority within one month after the change. The original licensing authority shall handle the change procedures according to relevant regulations.

　　Article 25 During the validity period of the production license, if relevant national laws, regulations, product standards, and technical requirements undergo significant changes, the State Administration for Market Regulation may make corresponding provisions as needed, and the original licensing authority shall reorganize the review according to the provisions.

　　Article 26 The licensing authority shall timely archive relevant materials related to the handling of food additive production licenses. The retention period for archive materials is five years.

　　Article 27 The validity period of the food additive production license is five years.

　　Upon expiration of the validity period, if the producer needs to continue production, an application for renewal shall be submitted to the original licensing authority six months before the expiration of the production license.

　　If the renewal application is not submitted on time or is not approved, the food additive production license shall become invalid from the date of expiration.

　　Article 28 The food additive production license certificate is divided into an original and a duplicate.

　　The certificate shall state the producer's name, domicile, production address, food additive name, certificate number, issuance date, validity period, issuing authority (with official seal), and other contents.

　　Article 29 The format and numbering rules of the food additive production license certificate shall be uniformly stipulated by the State Administration for Market Regulation.

　　Article 30 If the food additive production license certificate is lost or damaged, the producer shall promptly apply to the original licensing authority for a replacement and simultaneously publish a statement of loss and invalidation of the original license in media at or above the provincial level. The original licensing authority shall handle the replacement procedures according to relevant regulations.

　　Article 31 Before the licensing decision is made, if the applicant requests to withdraw the food additive production license application, reasons shall be explained and an application submitted; the licensing authority shall confirm the withdrawal in writing, and the license shall naturally terminate.

　　Article 32 If the producer requests to terminate the food additive production license, reasons shall be explained and an application submitted to the original licensing authority; the original licensing authority shall handle the cancellation procedures according to relevant regulations.

　　Article 33 The revocation, withdrawal, and cancellation of the food additive production license shall be implemented in accordance with relevant regulations.

　　Article 34 No unit or individual shall forge or alter the production license certificate and number of food additives.

　　Producers of food additives who have obtained a production license shall not rent, lend, or transfer the production license certificate and number by other means.

　　Chapter 3 Producer Quality Obligations

　　Article 35 Producers shall conduct factory inspections on food additives before sale, and may only sell after passing inspection.

　　Article 36 When producing food additives, raw and auxiliary materials, packaging materials, and production equipment that meet relevant quality and safety requirements shall be used.

　　Article 37 Producers shall establish quality management systems for raw material procurement, production process control, product factory inspection, and sales, and keep the following production management records:

　　(1) Training and assessment records of producer personnel;

　　(2) Records of use, maintenance, upkeep, repair, cleaning, and disinfection of plants, facilities, and equipment;

　　(3) Operation records of the producer's quality management system, including raw and auxiliary material acceptance records, production process control records, product factory inspection records, and product sales records.

　　The above records shall be true and complete, and producers are responsible for their authenticity and completeness. The retention period of records shall not be less than two years; if the product shelf life exceeds two years, the retention period shall not be shorter than the product shelf life.

　　Article 38 Food additives shall have labels and instructions, and the label shall indicate the words "Food Additive."

　　Labels and instructions shall indicate the following items:

　　(1) Name, specification, and net content of the food additive product;

　　(2) Name, address, and contact information of the producer;

　　(3) Ingredients or ingredient list;

　　(4) Production date, shelf life, or safe usage period;

　　(5) Storage conditions;

　　(6) Product standard code;

　　(7) Production license number;

　　(8) Scope, dosage, and usage methods approved by food safety standards and announced by the State Council health administrative department;

　　(9) Other items required to be marked by laws, regulations, or related standards.

　　Article 39 Food additive labels and instructions shall not contain false or exaggerated content, nor involve disease prevention or treatment functions.

　　Labels and instructions of food additives shall be clear, obvious, and easy to recognize and read.

　　Food additives with contraindications or safety precautions shall have warning signs or Chinese warning instructions.

　　Article 40 Food additives shall be packaged and ensure that the food additives are not contaminated.

　　Article 41 When processing food additives entrusted by others, the entrusted producer shall have a food additive production license within the scope of the entrusted production.

　　Entrusted processed food additives, in addition to complying with product quality, food safety laws, regulations, and these provisions for food additive labeling, shall also indicate the name, address, and contact information of the entrusted producer.

　　Article 42 If the produced food additives have safety hazards, the producer shall implement recalls according to law.

　　Producers shall report the recall of food additives and the handling of recalled products to the quality and technical supervision department.

　　Article 43 Producers shall establish a self-inspection system for production management and conduct self-inspections on food additive quality and safety control and other production management according to relevant regulations.

　　Chapter 4 Supervision and Management

　　Article 44 The quality and technical supervision department shall establish files of food additive producers who have obtained production licenses within the administrative region, recording in detail the production licenses, supervision inspection results, and handling of illegal acts.

　　Article 45 The quality and technical supervision department shall conduct supervision and inspection of food additive producers within the administrative region according to the supervision and management work plan and keep records as required.

　　Article 46 On-site supervision and inspection of producers shall be conducted by two or more staff members. Supervisors shall present valid credentials during supervision and inspection.

　　Article 47 Supervision and inspection of producers shall focus on checking the operation records of the producer's quality management system, verifying suspicious issues in the producer's self-inspection report, and supervising and managing the recall of products by producers according to law.

　　The supervised producers shall designate staff to cooperate with the quality and technical supervision department's supervision and inspection work and truthfully provide relevant materials.

　　Article 48 Any unit or individual may file complaints or reports to quality and technical supervision departments at all levels regarding illegal acts by production license reviewers, inspection agencies and their staff, and supervision and inspection personnel.

　　Quality and technical supervision departments at all levels shall promptly investigate and handle complaints and reports and timely feedback the handling results to the complainants or reporters.

　　Chapter 5 Legal Liability

　　Article 49 Producers who violate the provisions of Article 6 Paragraph 1, Articles 22, 23, 24, 34, 35, 38, 39, 40, 41 of these regulations, constituting illegal acts under the Food Safety Law of the People's Republic of China, Product Quality Law of the People's Republic of China, Administrative Regulations on the Production License of Industrial Products of the People's Republic of China, and other relevant laws and regulations, shall be punished according to the relevant laws and regulations.

　　Article 50 Producers who violate the provisions of Article 2 Paragraph 3, Articles 36, 37, 42 of these regulations, constituting illegal acts under relevant laws and regulations, shall be punished according to the relevant laws and regulations; if not constituting illegal acts, the local quality and technical supervision department at or above the county level shall order correction within a time limit and impose a fine of up to 30,000 yuan.

　　Article 51 Relevant staff of quality and technical supervision departments at or above the county level who violate these regulations or abuse power, neglect duties, or engage in malpractice shall be held legally responsible according to law.

　　Article 52 Parties dissatisfied with administrative penalties imposed by administrative organs according to these regulations may apply for administrative reconsideration or file administrative litigation according to law.

　　Chapter 6 Supplementary Provisions

　　Article 53 The classification of varieties of food additives subject to production licensing as stipulated in these regulations shall be implemented in accordance with laws, regulations, and relevant provisions of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China.

　　Article 54 These regulations shall be interpreted by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China.

　　Article 55 These regulations shall come into effect on June 1, 2010. In case of any inconsistency between the rules and normative documents on the supervision and administration of food additive production promulgated by the General Administration of Quality Supervision, Inspection and Quarantine before the implementation of these regulations, these regulations shall prevail.