The Provisions on the Supervision and Administration of Food Additives Production, which was deliberated and adopted at the executive meeting of the General Administration of Quality Supervision, Inspection and Quarantine on March, 2065, is hereby promulgated and shall come into force on June, 2065. Director Wang Yong 20 10 April 4th.
[Edit this paragraph] Provisions on the Supervision and Administration of Food Additives Production
Chapter I General Provisions
Article 1 In order to ensure food safety and strengthen the supervision and management of the production of food additives, these Provisions are formulated in accordance with the Product Quality Law of People's Republic of China (PRC), the Food Safety Law of People's Republic of China (PRC) and its implementing regulations, and the Regulations of the People's Republic of China on the Administration of Production Licenses for Industrial Products. Article 2 These Provisions shall apply to the production, licensing, supervision and administration of food additives in People's Republic of China (PRC). The term "food additives" as mentioned in these Provisions refers to artificial or natural substances approved by the administrative department of health of the State Council and published by means of standards and announcements, which can be added to food to improve the quality, color, aroma and taste of food and meet the needs of preservation, antisepsis and processing technology. Other substances other than those specified in the preceding paragraph shall not be produced as food additives, nor shall they be allowed to be used as food additives. Article 3 The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as AQSIQ) is in charge of the quality supervision and administration of food additives throughout the country. The provincial quality and technical supervision department is in charge of the quality supervision and management of food additive production within its administrative area, and is responsible for the implementation of the food additive production license. City and county quality and technical supervision departments shall be responsible for the quality supervision and management of food additive production within their respective administrative areas. Article 4 Producers shall engage in the production of food additives in accordance with the requirements of laws, regulations, rules and relevant standards, ensure stable and qualified product quality, be responsible to the society and the public, and accept social supervision. Article 5 The production supervision and management of food additives shall follow the principles of being scientific, fair, convenient and efficient.
Chapter II Production License
Article 6 A producer must obtain a production license before engaging in the production of food additives. To obtain a production license, the following conditions shall be met: (1) a legal and valid business license; (2) Having professional and technical personnel suitable for the production of food additives; (3) production sites, factories and facilities suitable for the production of food additives; Health management meets health and safety requirements; (4) Production conditions such as production equipment or facilities suitable for the production of food additives; (five) technical documents and process documents that meet the relevant requirements and are suitable for the production of food additives; (six) improve the effective quality management and responsibility system; (7) Having the ability of ex-factory inspection suitable for the production of food additives; The products meet the requirements of relevant standards and the protection of human health and personal safety; (eight) in line with the provisions of the national industrial policy, there is no backward technology, high energy consumption, environmental pollution and waste of resources; (nine) other conditions stipulated by laws and regulations. Article 7 To produce food additives, the applicant shall apply to the provincial quality and technical supervision department (hereinafter referred to as the licensing authority) where the production is located. Article 8 To apply for a food additive production license, the following materials shall be submitted: (1) An application for a food additive production license; (2) A copy of the applicant's business license; (3) The production process text of the food additive for which the production license is applied; (4) The certification materials of the legal right to use the production site, the plan of the surrounding environment and the plan of the plant facilities and equipment that are suitable for the food additives for which the production license is applied; (5) Certification materials and lists of the legal right to use the production equipment and facilities that are suitable for the food additives for which the production license is applied, and certification materials and lists of the legal right to use the inspection equipment; (six) the text of the quality management and responsibility system that is suitable for the food additive for which the production license is applied; (seven) a list of professional and technical personnel who are suitable for the food additives for which the production license is applied; (eight) the standard text of food additives implemented in production; (nine) other materials as prescribed by laws and regulations. Article 9 The licensing authority shall handle the license application submitted by the applicant according to the following circumstances: (1) If the application matters do not need to obtain a production license according to law, it shall immediately inform the applicant that it will not be accepted; (two) if the application matters do not belong to the management scope of the quality and technical supervision department according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ; (3) In case of any of the circumstances stipulated in Articles 78 and 79 of the Administrative Licensing Law of People's Republic of China (PRC), a decision of rejection 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 on the spot; (5) If the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed of the materials and requirements that need to be supplemented at one time on the spot or within five days, and a Notice of Supplement and Correction of License Application Materials shall be issued to the applicant; Fails to inform, as accepted; (6) Where the application matters fall within the scope of functions and powers of the quality and technical supervision department, and the application materials are complete and conform to the statutory form, or the applicant submits all the corrected application materials as required, it shall accept the application for production license and issue a decision on the acceptance of the application for administrative license to the applicant. When a licensing authority accepts or refuses to accept a license application, it shall issue a written certificate stamped with its special seal and dated. Article 10 After accepting the application, the licensing authority shall organize to examine whether the applicant has the necessary production conditions for continuously producing qualified products. The contents of the review include on-site verification of application materials, production sites and product quality inspection. Article 11 The licensing authority shall organize a verification team to conduct on-the-spot verification on the applicant. The verification team consists of two to four qualified inspectors. The team leader is responsible for the work of the verification team and accepts the supervision of the local quality and technical supervision department in accordance with relevant regulations. Article 12 The licensing authority shall make a plan for on-site inspection of the applicant and issue a notice of on-site inspection to the applicant five days before the inspection. On-site verification work generally does not exceed two days. Thirteenth in the field inspection, inspectors shall not make things difficult for enterprises, shall not ask for or accept property, and shall not seek other illegitimate interests. The applicant shall cooperate with the field verification of the verification team. If it is necessary to extend the verification time due to force majeure and other reasons, it shall apply to the licensing authority for an extension in time. Article 14 The verification team shall conduct on-site verification on the applicant according to the verification plan, prescribed licensing conditions and procedures, and make the following treatments according to the verification results: (1) If the on-site verification is qualified, the samples shall be taken and sealed in accordance with the regulations, and the applicant shall send them to an inspection agency that meets the prescribed requirements for inspection according to law; (two) if the on-site inspection is unqualified, the product sampling will no longer be carried out. Refuse to check or not cooperate without justifiable reasons, resulting in on-site verification can not be implemented within the prescribed time limit, as on-site verification is unqualified. Fifteenth field verification work shall be completed by the head of the verification team, signed by the inspectors and confirmed by the applicant. Article 16 The licensing authority shall, within 30 days from the date of accepting the application, complete the on-site verification and product sampling of the applicant, and issue a notice of the conclusion of the on-site verification to the applicant. If the verification is unqualified, the reasons shall be explained. Article 17 Inspection institutions undertaking certification inspection shall inspect food additives in accordance with relevant standards and complete the inspection within the specified time. The inspection institutions that undertake the certification and inspection of food additive production licenses shall have legal qualifications and shall be uniformly announced by the AQSIQ. Article 18 After completing the inspection, the inspection institution shall issue a product inspection report. The inspection report is made in triplicate, one for the applicant, one for the licensing authority and one for the inspection organization. Article 19 If the applicant disagrees with the inspection results, he may apply to the original licensing authority for re-inspection within five days from the date of receiving the inspection report. The reinspection shall be conducted in an inspection institution that meets the specified requirements other than the original inspection institution, and the conclusion of the reinspection shall be final. If the reinspection conclusion is consistent with the original inspection conclusion, the reinspection fee shall be borne by the applicant; If the re-inspection conclusion is inconsistent with the original inspection conclusion, the re-inspection fee shall be borne by the original inspection institution. Article 20 The licensing authority shall, within 60 days from the date of accepting the application, make the following treatment according to the examination results: (1) If the applicant meets the conditions for issuing the license, it shall make a written decision to approve the production license according to law, and issue the food additive production license certificate to the applicant within 10 days from the date of making the decision; (2) If the applicant does not meet the certification requirements, it shall make a written decision not to grant the production license according to law, explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law. Product inspection time is not included in the license period. Twenty-first provincial quality and technical supervision departments shall promptly report the list of producers who have obtained the production license of food additives to the AQSIQ for the record and announce it to the public. Twenty-second producers who have obtained the production license for food additives need to increase the variety of products, and shall apply in accordance with these provisions. The original licensing authority shall, in accordance with these provisions, organize the examination of the product varieties applied for increase. Article 23 During the validity period of the food additive production license, if the producer's production conditions, inspection means, production technology or process have undergone major changes, the producer shall promptly submit an application for examination to the original licensing authority, which shall reorganize the examination in accordance with these Provisions. Article 24 Where the producer's name is changed, but the producer's production conditions, inspection means, production technology or process have not changed greatly, the food additive producer shall apply to the original licensing authority for changing the production license within one month after the change. The original licensing authority shall go through the formalities for alteration in accordance with the relevant provisions. Article 25 In case of major changes in the relevant national laws, regulations, product standards and technical requirements during the validity period of the production license, the AQSIQ may make corresponding provisions as needed, and the original licensing authority shall reorganize the examination according to the provisions. Article 26 The licensing authority shall timely file the relevant materials for handling the production license of food additives. Archival materials shall be kept for five years. Article 27 The validity period of the food additive production license is five years. Where a producer needs to continue production at the expiration of the validity period, it shall apply to the original licensing authority for replacement six months before the expiration of the validity period of the production license. If the applicant fails to apply for replacement or the application is not approved within the time limit, the food additive production license shall be invalid from the date of expiration. Article 28 The production license for food additives is divided into original and duplicate. The certificate shall specify the producer's name, domicile, production address, name of food additive, certificate number, date of issuance, period of validity, 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 AQSIQ. Article 30 If the production license certificate of food additives is lost or damaged, the producer shall promptly apply to the original licensing authority for a replacement production license, and at the same time publish a statement on the loss and invalidation of the original production license certificate in the media at or above the provincial level. The original licensing authority shall go through the formalities of replacement in accordance with the relevant provisions. Article 31 Before the licensing decision is made, if the applicant requests to return the application for food additive production license, it shall explain the reasons and submit the application; If the license application is returned, the licensing authority shall confirm it in writing and the license will terminate naturally. Article 32 Where a producer requests to terminate the food additive production license, it shall explain the reasons and apply to the original licensing authority; The original licensing authority shall go through the cancellation procedures in accordance with the relevant provisions. Article 33 The revocation, withdrawal and cancellation of the production license for food additives shall be carried out in accordance with the relevant provisions. Article 34 No unit or individual may forge or alter the production license certificate and serial number of food additives. A food additive producer who has obtained a production license shall not lease, lend or transfer the production license certificate and number by other means.
Chapter III Quality Obligations of Producers
Article 35 Producers shall conduct ex-factory inspection on food additives sold ex-factory. Article 36 In the production of food additives, raw and auxiliary materials, packaging materials and production equipment that meet the quality and safety requirements shall be used. Article 37 Producers shall establish quality management systems such as raw material procurement, production process control, product ex-factory inspection and sales, and make the following production management records: (1) Records of training and assessment of producers' employees; (two) the use, maintenance, maintenance, cleaning and disinfection records of the plant, facilities and equipment; (three) the operation records of the producer's quality management system, including the purchase and acceptance records of raw and auxiliary materials, the production process control records, the product ex-factory inspection records, and the product sales records. The above records shall be true and complete, and the producer shall be responsible for their authenticity and integrity. The retention period of records shall not be less than two years; If the shelf life of the product exceeds two years, the shelf life shall not be shorter than the shelf life of the product. Article 38 Food additives shall have labels and instructions, and the words "food additives" shall be marked on the labels. Labels and instructions shall indicate the following items: (1) the name, specifications and net content of food additive products; (2) The name, address and contact information of the producer; (3) List of ingredients or ingredients; (4) Date of production, quality guarantee period or safe use period; (5) storage conditions; (6) product standard code; (seven) the production license number; (eight) in line with the provisions of food safety standards and approved by the administrative department of health of the State Council City, the scope of use, the amount of use and the method of use; (nine) other matters that must be marked by laws, regulations or relevant standards. Article 39 Labels and instructions of food additives shall not contain untrue or exaggerated contents, and shall not involve the functions of disease prevention and treatment. Labels and instructions of food additives should be clear and easy to read. Food additives with contraindications or safety precautions shall have warning signs or Chinese warning instructions. Article 40 Food additives shall be packaged and guaranteed to be free from pollution. Article 41 Where someone entrusts others to process food additives, the entrusted producer shall obtain a food additive production license within the scope of entrusted production. The food additives entrusted for processing shall be identified in accordance with the laws and regulations on product quality and food safety and the requirements of these Provisions, and the name, address and contact information of the entrusted producer shall also be indicated. Article 42 Where there are potential safety hazards in the food additives produced, the producers shall recall them 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-inspection for production management such as quality and safety control of food additives in accordance with relevant regulations.
Chapter IV Supervision and Administration
Article 44 The quality and technical supervision department shall establish a file of producers of food additives who have obtained production licenses within their respective administrative areas, and record in detail the production licenses or the results of supervision and inspection, and the investigation and punishment of illegal acts. Forty-fifth quality and technical supervision departments shall, according to the supervision and management work plan, supervise and inspect the producers of food additives within their respective administrative areas, and make records in accordance with regulations. Forty-sixth on-site supervision and inspection of producers, there should be more than two staff members to participate. When carrying out supervision and inspection, the supervision and inspection personnel shall produce valid certificates. Forty-seventh supervision and inspection of producers should focus on the operation records of the quality management system of producers and verify the doubts in the self-inspection report of producers; And supervise and manage the recall of producers according to law. Producers subject to supervision and inspection shall designate personnel to cooperate with the supervision and inspection work of the quality and technical supervision department and provide relevant information truthfully. Forty-eighth any unit or individual may complain to the quality and technical supervision departments at all levels and report the illegal acts of production license examiners, inspection agencies and their staff, as well as supervision and inspection personnel. Quality and technical supervision departments at all levels shall promptly investigate and handle complaints and report the results to the complainant in a timely manner.
Chapter V Legal Liability
Article 49 Producers who violate the first paragraph of Article 6, Article 22, Article 23, Article 24, Article 34, Article 35, Article 38, Article 39, Article 40 and Article 41 of these Provisions constitute the Food Safety Law of People's Republic of China (PRC), the Product Quality Law of People's Republic of China (PRC) and the Food Safety Law of People's Republic of China (PRC). Fiftieth producers who violate the provisions of the third paragraph of Article 2, Article 36, Article 37 and Article 42 of these Provisions and constitute illegal acts as stipulated in relevant laws and regulations shall be punished in accordance with the provisions of relevant laws and regulations; If it does not constitute an illegal act as stipulated in relevant laws and regulations, the local quality and technical supervision department at or above the county level shall order it to make corrections within a time limit and impose a fine of not more than 30,000 yuan. Article 51 Any staff member of the quality and technical supervision department at or above the county level who violates these provisions or abuses his power, neglects his duty or engages in malpractices for selfish ends shall be investigated for relevant legal responsibilities according to law. Article 52 If a party refuses to accept the administrative punishment given by an administrative organ in accordance with these Provisions, it may bring an administrative reconsideration or an administrative lawsuit according to law.
Chapter VI Supplementary Provisions
Article 53 The classification of food additives subject to production license in these Provisions shall be implemented in accordance with laws and regulations and the relevant provisions of the AQSIQ. Article 54 The AQSIQ shall be responsible for the interpretation of these Provisions. Article 55 These Provisions shall come into force on June 1 day, 2065. If the regulations and normative documents on the supervision and administration of food additives promulgated by AQSIQ before the implementation of these Provisions are inconsistent with these Provisions, these Provisions shall prevail. Hope to adopt