Food additive production supervision and management regulations

    (April 4, 2010, State administration of quality supervision, inspection and quarantine to 127th announced as of June 1, 2010) Chapter I General provisions

    First in order to guarantee food security, strengthening supervision and management on the production of food additives, in accordance with the People's Republic of China product quality law and the People's Republic of China Food Safety Act and its implementing regulations and the People's Republic of China regulations on the administration of production license for industrial products and other relevant laws and regulations, this provision is enacted.

    Article in the People's Republic of China territory of food additive production licensing and supervision, implementation management, these provisions shall apply.

    Food additives mentioned in the regulations is approved by the health Administrative Department under the State Council and with standard, bulletin, published as improving food quality, color, aroma, taste, as well as corrosion protection, preservation and processing of synthetic or natural substances need to be added to food.

    Material other than the provisions of the preceding paragraph shall not be used as food additive production shall not be used as food additive production license.

    Third State administration of quality supervision, inspection and quarantine (hereinafter referred to as AQSIQ) competent national quality supervision and management of the production of food additives.

    Provincial quality and technical supervision Department in charge of the quality supervision and management of the production of food additives in the administrative area, is responsible for implementation of the food additive production license.

    City and County within the administrative area of quality and technology supervision departments are responsible for the supervision and administration of the quality of the production of food additives.

    Fourth producer shall, in accordance with laws, rules, regulations and requirements of the relevant standards in food additive production activities to ensure product quality stability, responsible for the society and the public, subject to public supervision.

    Fifth food additive production supervision and management, and should follow the principle of science fair, accessible and efficient.

    Chapter II production license

    Sixth after the producer must obtain a licence to produce, before engaging in the production of food additives.

    Obtain a licence to produce shall satisfy the following conditions:

    (A) legal and effective business license;

    (B) professional and technical personnel in conformity with production of food additives;

    (C) fitting in with the production of food additives plant facilities and production sites; its health management in line with health and safety requirements;

    (D) fitting in with the production of food additives in the production equipment or facilities such as production conditions;

    (E) fitting in with the production of food additive complies with the relevant requirements of the technical documentation and process documents;

    (F) the sound and effective management and accountability;

    (G) fitting in with the production of food additives factory inspection capacity products meet the requirements of the relevant standards and the protection of human health and safety;

    (H) compliance with provisions of the national industrial policy, there is no national has been officially eliminated and a ban on investment-building process backward, high energy consumption, environmental pollution and waste of resources;

    (IX) other conditions stipulated by laws and regulations.

    Seventh production of food additives, the applicant shall provide the provincial quality and technical supervision Department (hereinafter referred to as licensing authority) submit their licensing applications.

    Eighth application of food additives in the production license, shall submit the following materials:

    (A) food additive production license application;

    (B) a photocopy of the applicant;

    (C) the application for licensing related to food additives, production of texts;

    (D) fitting in with the production permitted food additives production site the legal right of evidentiary materials, floor plans and facilities and its surrounding environment, copies of equipment layout plans;

    (E) compatible with the applications for licensing of food additive production equipment, facilities, legal right of evidentiary materials and the list, list of legal right of evidentiary materials and test equipment;

    (F) fitting in with the production permitted food additive quality management and liability for text;

    (VII) adapt to the applications for licensing of food additives list of professional and technical personnel;

    (H) production of food additive standards performed by text;

    (I) the laws and regulations of other materials.

    Nineth licensing authorities on the applicant's application for leave shall be made according to the following circumstances:

    (A) the application does not need to obtain a license in accordance with law, shall immediately inform the applicant will not be accepted;

    (B) the application does not fall within the scope of quality and technical supervision departments in accordance with law, shall immediately make a decision inadmissible, and inform the applicant to apply to the relevant administrative authorities;

    (C) People's Republic of China on administrative licensing law article 78th, 79th provision, shall immediately make a decision inadmissible;

    (D) application errors that can be corrected on the spot, shall permit the applicant to be corrected on the spot;

    (V) application materials are incomplete or do not comply with the statutory format, it shall, on the spot or within the 5th disposable materials and requirements of informed correction, correction notice and issue to the applicant a license application materials; fails to inform, regarded as inadmissible;

    (F) applications fall within the ambit of quality and technical supervision departments, application materials are complete and in compliance with the statutory form, correction or applicants are required to submit all application materials, production permit application shall be accepted and issue to the applicant a written decision on the administrative license application processing.

    Licensing authority to accept or not to accept an application for leave shall seal and date the certificate with the organ-specific written confirmation.

    Article tenth after acceptance of the application, shall organize and on whether he has the necessary production conditions for continued production of qualified products for review.

    Review includes the application information field verification, production facilities and product quality inspection. Article 11th organization in situ verification by the applicant, shall organize the verification team.

    Verification team consisting of two to four qualified inspectors, the verification team leader accountability system into practice, and in accordance with the relevant provisions of supervised by the local quality and technical supervision Department.

    Article 12th organs in situ verification by field verification should be developed by the applicant, and in the 5th issue to the applicant a notice of verification in the field of verification.

    Field verification work is generally not more than 2nd.

    13th inspectors to conduct on-site verification, shall not make things difficult for enterprises, may not ask for or accept property, shall not seek other improper benefits.

    On-site verification of the applicant shall cooperate with the inspection team, due to force majeure or other reasons necessary to extend the time of verification, should be submitted to the licensing authority in a timely manner the extension application.

    14th the verification team shall, in accordance with the verification provisions of the plan and permit conditions, procedures and other requirements in situ verification by the applicant, and according to the results of the verification are as follows:

    (A) qualified field verification, extraction and storage of samples in accordance with regulations, according to law by the applicant to comply with the requirements of the inspection agency tested;

    (B) in situ verification failed not to conduct product sampling.

    Without good reason refused to verify or fails to cooperate, leading to on-site verification cannot be implemented within the prescribed time, as a field verification failed.

    15th field verification work should be completed by a verification team leader on-site verification records, signed by inspectors and confirmation by the applicant. 16th licensing authority shall, from the date of acceptance of the application in the 30th, and completed on-site verification of applicant and product sampling and on-site verification conclusion issued notice to the applicant.

    Verification failed, it shall explain the reasons.

    Article 17th certification inspection inspection bodies shall be tested according to the relevant standards on food additives and at the required time to complete the inspection work.

    Bear the food additive production license certification inspection inspection bodies shall meet the statutory list of qualified and issued by the State administration of quality supervision. 18th inspection agencies upon completion of the inspection, shall issue a test report.

    Test report in triplicate, one copy sent to the applicant, sent a licensing authority, an inspection agency archive.

    Article 19th disagrees with the results of testing, applicants from the date of receipt of the inspection report to the licensing authority within the 5th review applications.

    Retest should be outside of the original inspection bodies comply with the requirements of the inspection agencies, review the conclusions for the final conclusion.

    Review conclusions consistent with the original conclusion, review the expenses shall be borne by the applicant; review concluded with the original conclusion was not consistent, recheck fee shall be borne by the original testing institution.

    Article 20th licensing authority shall, within 60 days from the date of the acceptance of the application, based on the review results as follows:

    (A) the applicant meets the conditions for issuance, written decision to grant license according to law, and make a decision within 10th of food additive production licenses issued to the applicant;

    (B) the applicant does not meet the conditions for issuing, shall make written decision of no production license, and rationale, and inform the applicant enjoys the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.

    Product testing are not included in the license expires.

    21st provincial quality and technical supervision departments should be promptly will receive a production license of producers of food additives list to the State administration of quality supervision for the record and to the public. 22nd were food additive producers need to increase product variety of production license, an applicant shall, in accordance with the rules.

    The licensing authority shall, in accordance with the regulations to apply to increase product variety organization to review.

    23rd in food additive production license validity period, producers production conditions, tests, production of larger changes in technology or processes, review of applications by producers should be submitted to the licensing authority in a timely manner, the licensing authority shall, in accordance with the provisions of the organizational review. 24th producer name changed and producers such as production conditions, inspection methods, production techniques or processes have not changed, food additive producers shall within one month after the change to the original licensing authority licensing change request.
Original licensing authority in accordance with the relevant provisions of the change.

    25th in production licence is valid within the relevant State laws and regulations, product standards and technical requirements, great changes have taken place, the State General Administration of quality supervision in accordance with appropriate provisions need to be made, the original licensing authorities, in accordance with provisions of the organizational review. Article 26th bodies handle food additive production license of relevant information should be filed in a timely manner.

    The preservation of archival materials for a period of five years.

    27th food additive production permits are valid for five years.

    Has expired, the producer needs to continue production, production permit expired six months ago to the licensing authority for licence applications.

    Fails to apply for permits or applications not approved food additive production license from the date of expiry of failure.

    28th food additive production license includes an original and a copy.

    Certificates shall include the producer's name, residence, address, food additive name, certificate number, date of issue, period of validity, the issuing body (stamped), and so on.

    29th food additive production license format and numbering rules stipulated by the State administration of quality supervision. 30th food additive production license is lost or damaged, producers should apply to the licensing authority proposed a replacement license, and also above the provincial media original production license lost and invalid declaration.

    Original licensing authority in accordance with the relevant provisions of additional procedures.

    31st before the licensing decision, the applicant requesting the return of food additive production license application, it shall explain the reasons, and submitted applications returned the license application, the licensing authority confirmed in writing, permit natural end.

    Articles 32nd to terminate the production of food additives producer license, it shall explain the reasons, and submitting an application to the licensing authority; the licensing authority in accordance with the relevant provisions of the law for cancellation procedures.

    Article 33rd food additive production license revocation, withdrawal, cancellation, in accordance with the relevant provisions.

    34th article of any unit and individual shall forge, alter food additive production license and serial number.

    Obtain production permits food additives producers may not rent, lend or otherwise transfer the production license and serial number.

    Chapter III obligations quality producers

    35th producer factory for sale of food additives should be factory inspection, inspection before the sale.

    36th production of food additives should be used in accordance with the relevant safety requirements for quality of raw and auxiliary materials, packaging materials and production equipment.

    37th article producers must set up purchase of raw materials, production process control, product inspection and sale of quality management system of production management records and do the following:

    (A) training and assessment record producer in China;

    (B) the premises, facilities and equipment, maintenance, service and repair, and cleaning and disinfection of records;

    (C) producers of quality management system of records, including raw material incoming inspection record, production process control records, product sales, product inspection record records. Such records shall be true, complete, and producers responsible for their authenticity and integrity.

    Records retention periods shall be not less than two years; product shelf-life of more than two years, retention period should be not less than the product shelf-life.

    Article 38th of food additives should have labels, instructions, and stated the label "food additives".

    Labels or instructions shall be marked with the following:

    (A) the product name, net contents and specifications for food additives;

    (B) the producer's name, address and contact information;

    (C) the ingredient or ingredients;

    (D) the production date, shelf, or the safe use of the term;

    (E) storage conditions;

    (F) code of product standards;

    (G) production licence number;

    (H) the food safety standards and approved by the health Administrative Department under the State Council announcement use, usage, and usage;

    (I) the laws and regulations, or other matters must be marked under the relevant standards.

    39th food additives labels or instructions shall not contain untrue or exaggerated, not related to disease prevention and treatment.

    Food additives labeling, instructions should be clear, obvious, and easy to distinguish understanding reading.

    There are contraindications or security considerations for use of food additives, should have the warning marks or warning specifications in Chinese.

    40th food packaging and food additives are not contaminated.

    Of other processed food additives 41st, commissioned by the delegate producer should have food additive production within the production license.

    Processed food additives, except in accordance with product quality and food safety laws and regulations and food additives the requirements of this provision identifies the callout, preferred to be entrusted with the producer name, address and contact information, and so on.

    42nd production of unsafe food additives, manufacturers should recall in accordance with law.

    Producers of food additives should be recalled and disposition of recalled products to the quality and technology supervision departments report.

    Article 43rd producers self-examination production management system should be established, in accordance with the relevant provisions on the control of quality and safety of food additives, such as production management presided.

    Supervision and administration of the fourth chapter

    44th of quality and technical supervision departments should be established within the administrative area of the permission of the production of food additives producer archives, detailing production permit or supervise inspection result, violations investigated, and so on.

    Article 45th supervision and administration of quality and technology supervision departments shall, in accordance with plans, the supervision and inspection of the food additive producers within the administrative area and records in accordance with regulations. Article 46th conduct supervision and inspection over the producer, should have at least two staff members to attend.

    Supervision and inspection personnel when conducting supervision and inspection, shall produce certificates.

    47th imposed on producers should focus on producers of the quality management system of supervision and inspection record, verify producer self-examination report of puzzles and the producer recall of supervise and administer according to law.

    Producers shall specify staff being supervised and examined with the quality and technology supervision departments of supervision and inspection work, and provide relevant information.

    48th no unit or individual can complain to the quality and technical supervision departments at all levels to report licensing Inspector, inspection staff of the institutions and their staff, as well as the supervision and inspection of illegal behavior.

    Quality and technology supervision departments at all levels received a complaint shall promptly investigate and deal with complaints and to report feedback results in a timely manner.

    The fifth chapter legal liability

    49th article producers violation this provides sixth article first paragraph, and 22nd article, and 23rd article, and 24th article, and 34th article, and 35th article, and 38th article, and 39th article, and 40th article, and 41st article, provides, constitute People's Republic of China food security method, and People's Republic of China products quality method, and People's Republic of China industrial products production License Management Ordinance, about legal regulations provides of violations of, in accordance with about legal regulations of provides be punishment.

    50th producers in violation of the provisions of the second paragraph, 36th, 37th, 42nd and other provisions, constitute violations of the relevant laws and regulations, shall be punished in accordance with the relevant laws and regulations; do not constitute violations of the relevant laws and regulations, local quality and technical supervision departments at and above the county level shall be ordered to correct within a penalty of between 30,000 yuan.

    51st article quality and technology supervision departments above the county level staff in violation of these provisions or abuse of power, negligence, malpractice, and lawfully investigate the relevant law.

    52nd on an administrative organ refuses to accept the given administrative punishment pursuant to these provisions, it may initiate administrative reconsideration or administrative proceedings.

    The sixth chapter supplementary articles

    53rd to the production under license of variety of food additives Division, in accordance with the laws and regulations and the relevant provisions of the State administration of quality supervision.

    54th this provision by AQSIQ to interpret. 55th article of the regulations come into force on June 1, 2010. AQSIQ announced prior to the implementation of the provisions of the relevant food additive production supervision and management regulations and regulatory documents are inconsistent with this provision, is subject to this provision.