Provisions for the Regulation of Food Additive Production

(Promulgated by the General Administration of Quality Supervision, Inspection and Quarantine on April 4 2010 and effective as of June 1 2010.)

Order of the AQSIQ No.127

Part One: General provisions

Article 1: These Provisions have been formulated pursuant to laws and regulations such as the PRC Product Quality Law , the PRC Food Safety Law and its Implementing Regulations and the PRC Regulations for the Administration of Industrial Product Production Permits in order to ensure food safety and strengthen regulation of the production of food additives.

Article 2: These Provisions shall govern the engagement in the production of food additives, and the imposition of production permission and regulation in the People's Republic of China.

For the purposes of these Provisions, the term “food additive” means an artificial or natural substance that has been approved by the State Council's health administration department, that has been made known to the public in the form of a standard, announcement, etc. and that is added to food for the purpose of enhancing its quality, colour, fragrance or flavour or to prevent spoilage, maintain freshness or for processing purposes.

A substance other than one as described in the preceding paragraph may not be produced as a food additive and permission for production thereof as a food additive may not be imposed.

Article 3: The General Administration of Quality Supervision, Inspection and Quarantine (the AQSIQ) shall be in charge of oversight of the quality of food additives produced throughout the country.

The competent provincial-level quality and technical supervision departments shall be in charge of oversight of the quality of food additives produced in their jurisdictions and be responsible for imposing permission for food additive production.

The competent city- and county-level quality and technical supervision departments shall be in charge of oversight of the quality of food additives produced in their jurisdictions.

Article 4: Producers shall engage in food additive production activities in accordance with the requirements of laws, regulations, rules and relevant standards, ensure that the quality of their products remains stable and up-to-standard, fulfil their responsibilities to society and the public, and submit to monitoring by the public.

Article 5: Regulation of the production of food additives shall comply with the principles of objectivity, impartiality, benefiting the people and efficiency.

Part Two: Production permits

Article 6: A producer may engage in the production of a food additive only after securing a production permit.

To secure a production permit, the following conditions shall be satisfied:

(1) having a lawful and valid business licence;

(2) having professional technical personnel appropriate for production of the food additive;

(3) having production premises and plant facilities appropriate for production of the food additive; and hygiene management being compliant with hygiene and safety requirements;

(4) having production resources, such as production equipment or facilities, appropriate for production of the food additive;

(5) having technical documents and process documents that are appropriate for production of the food additive and comply with relevant requirements;

(6) having sound and effective quality control and responsibility systems;

(7) having final inspection capabilities appropriate for production of the food additive; products satisfying relevant standards, and requirements in respect of ensuring human health and safety;

(8) compliance with state industrial policies and absence of outdated production processes, high energy-consuming, environmentally-polluting and resource-wasting facilities that the state has expressly ordered be eliminated, and the investment in which and construction of which it has prohibited; and

(9) other conditions as specified in laws and regulations.

Article 7: When applying to produce a food additive, the applicant shall submit a production permit application to the provincial-level quality and technical supervision department of the place where production is to take place (the Permit Granting Authority).

Article 8: When applying for permission to produce a food additive, the following materials shall be submitted:

(1) a written application for a food additive production permit;

(2) a photocopy of the applicant's business licence;

(3) the relevant production process text for the food additive that is the subject of the production permit application;

(4) documentation evidencing the lawful right to use the production premises that are appropriate for the food additive that is the subject of the production permit application, as well as the layout of the surrounding environment and photocopies of the layout plan of the plant facilities and equipment;

(5) documentation evidencing the lawful right to use the plant facilities and equipment that are appropriate for the production of the food additive that is the subject of the production permit application and a list thereof, and documentation evidencing the lawful right to use the inspection equipment and a list thereof;

(6) the text of the quality control and responsibility systems that are appropriate for the production of the food additive that is the subject of the production permit application;

(7) the list of the professional technical personnel that are appropriate for the production of the food additive that is the subject of the production permit application;

(8) the text of the food additive standard that applies to the production; and

(9) other materials as specified in laws and regulations.

Article 9: The Permit Granting Authority shall handle the permit application submitted by the applicant in the following manner depending on the outcomes set forth below:

(1) if the item applied for does not, in accordance with the law, require the securing of a production permit, it shall promptly inform the applicant that it is not accepting the application;

(2) if the item applied for does not, in accordance with the law, fall within the purview of the quality and technical supervision departments, it shall promptly render a decision not to accept the application and inform the applicant to apply to the relevant administrative authority;

(3) if any of the circumstances set forth in Article 78 or Article 79 of the PRC Administrative Permission Law applies, it shall promptly render a decision not to accept the application;

(4) if the application materials contain errors that can be corrected on the spot, it shall permit the applicant to make such corrections on the spot;

(5) if the application materials are incomplete or not in the statutory format, it shall, on the spot or within five days, inform the applicant of the additional materials to be submitted together with the requirements, and issue the applicant a written notice of the additional materials that need to be submitted for the permit application; if it has not notified the applicant within the five days, it shall be deemed as having accepted the application; or

(6) if the matter applied for falls within the purview of the quality and technical supervision departments, and the application materials are complete and in the statutory format or if the applicant has provided all of the additional application materials as required, it shall accept the production permit application and issue the applicant a written decision indicating its acceptance of the administrative permit application.

Regardless of whether the Permit Granting Authority accepts the permit application or not, it shall issue a dated written receipt bearing its seal.

Article 10: Once the Permit Granting Authority has accepted the application, it shall arrange for the conduct of a review to determine whether the applicant meets the production conditions required to ensure the ongoing production of an up-to-standard product.

The review shall include an onsite check of the application documentation and production premises and product quality testing.

Article 11: When arranging for an onsite check of the applicant, the Permit Granting Authority shall assemble a inspection team. The inspection team shall comprise two to four qualified inspectors and its work shall be subject to a team leader responsibility system and the supervision of the local quality and technical inspection department in accordance with relevant provisions.

Article 12: When arranging for an onsite check of the applicant, the Permit Granting Authority shall formulate an onsite check plan and, five days prior to the check, it shall send an onsite check notice to the applicant.

In general, an onsite check shall not exceed two days.

Article 13: When conducting the onsite check, the inspectors may not create difficulties for the enterprise, solicit or accept property or seek to obtain other illegitimate benefits.

The applicant shall cooperate with the inspection team in its onsite check, and if the time for the check needs to be postponed due to force majeure or other such reason, it shall submit a postponement application to the Permit Granting Authority in a timely manner.

Article 14: The inspection team shall conduct the onsite check of the applicant in accordance with the check plan and the requirements of the prescribed permission conditions, procedure, etc. and, depending on the outcome of the check, proceed as follows:

(1) if the applicant passes the onsite check, it shall take samples and place them under seal that the applicant shall then send, in accordance with the law, to a qualified testing institution for testing; or

(2) if the applicant fails the onsite check, it will not take samples of the product.

If the applicant refuses the check or fails to cooperate without just cause, making it impossible to conduct the onsite check within the specified period of time, the applicant shall be deemed to have failed the onsite check.

Article 15: During the onsite check, the leader of the inspection team shall keep an onsite check record, which shall be signed by the inspectors and be subject to confirmation by the applicant.

Article 16: The Permit Granting Authority shall complete the onsite check of the applicant and the sampling work, and send its onsite check conclusions to the applicant within 30 days from the date on which it accepted the application. If the applicant failed the onsite check, it shall explain the reason therefor.

Article 17: The testing institution responsible for the permit issuance testing shall test the food additive on the basis of the relevant standards and complete the testing within the prescribed period of time.

A testing institution responsible for food additive production permit issuance testing shall have the statutory qualifications and be on the list published by the AQSIQ.

Article 18: Once it has completed the testing, the testing institution shall issue a product test report. Such report shall be prepared in triplicate, with one copy sent to the applicant, one copy sent to the Permit Granting Authority and one copy kept on file by the testing institution.

Article 19: If the applicant disagrees with the test results, it may submit an application for re-testing to the original Permit Granting Authority within five days from the date on which it received the test report.

The re-testing shall be conducted by a qualified testing institution other than the original testing institution, and the conclusions of the re-test shall be the final conclusions.

If the re-test conclusions are consistent with those of the original test, the re-testing expenses shall be borne by the applicant and if the re-test conclusions are not consistent with those of the original test, the re-testing expenses shall be borne by the original testing institution.

Article 20: Depending on the outcome of its review, the Permit Granting Authority shall, within 60 days from the date on which it accepted the application, proceed as follows:

(1) if the applicant satisfies the conditions for the issuance of a permit, it shall, in accordance with the law, render a written decision approving the grant of a production permit and, within 10 days from the date on which it rendered its decision, issue the applicant a food additive production permit; or

(2) if the applicant does not satisfy the conditions for the issuance of a permit, it shall, in accordance with the law, render a written decision not to grant a production permit, give the applicant the reasons therefor and inform the applicant that it has the right, in accordance with the law, to apply for administrative review or institute an administrative action.

The time required for product testing shall not be counted as part of the time limit for granting a permit.

Article 21: The provincial-level quality and technical supervision department shall, in a timely manner, submit the list of producers that have secured food additive production permits to the AQSIQ for the record and publicly announce the same.

Article 22: If a producer that has secured a food additive production permit wishes to increase the types of products it produces, it shall submit an application in accordance herewith. The original Permit Granting Authority shall, in accordance herewith, arrange for a review of the additional product types applied for.

Article 23: If a relatively major change occurs in a producer's production conditions, inspection means, or production technology or process during the term of validity of its food additive production permit, it shall submit a review application to the original Permit Granting Authority in a timely manner, and the Permit Granting Authority shall arrange for a new review in accordance herewith.

Article 24: If there is a change in a producer's name, etc. but no relatively major change occurs in its production conditions, inspection means, or production technology or process, it shall, within one month after the change, apply to the original Permit Granting Authority for amendment of its production permit. The original Permit Granting Authority shall carry out the amendment procedures in accordance with relevant provisions.

Article 25: If a relatively major change in a relevant state law, relevant state regulations, a product standard or technical requirements occurs during the term of validity of a production permit, the AQSIQ may issue corresponding provisions as required and the original Permit Granting Authority shall arrange for a new review in accordance with the provisions.

Article 26: The Permit Granting Authority shall place the relevant documentation for an application for a food additive production permit on file in a timely manner. Such materials on file shall be kept for five years.

Article 27: A food additive production permit shall be valid for five years.

If a producer wishes to continue production after expiration of its permit, it shall apply to the original Permit Granting Authority for the issuance of a new permit six months before the expiration of its production permit.

If it does not apply for the issuance of a new permit before the deadline or if its application is not approved, its food additive production permit shall become invalid on the date the term thereof expires.

Article 28: A food additive production permit is divided into an original and duplicates.

The permit shall record the producer's name, domicile, production address, name of the food additive, permit number, issue date, term of validity, issuing authority (which shall affix its official seal), etc.

Article 29: The format and numbering rules for food additive production permits shall be stipulated centrally by the AQSIQ.

Article 30: In the event of the loss of, or damage to, its food additive production permit, the producer shall, in a timely manner, apply to the original Permit Granting Authority for the issuance of a replacement and publish in provincial- or higher-level media a statement to the effect that its food additive production permit has been lost and is nullified. The original Permit Granting Authority shall carry out the procedures for the issuance of a replacement in accordance with relevant provisions.

Article 31: If an applicant wishes to request withdrawal of its application for a food additive production permit before the permit decision has been rendered, it shall give the reason therefor and submit an application. If a permit application is withdrawn, the Permit Granting Authority shall confirm the same in writing and the permit application process shall terminate as a matter of course.

Article 32: If an applicant wishes to request termination of the permit of its food additive production, it shall give the reason therefor and submit an application to the original Permit Granting Authority. The original Permit Granting Authority shall, in accordance with relevant provisions, carry out the cancellation procedures in accordance with the law.

Article 33: The annulment, revocation and cancellation of food additive production permits shall be carried out in accordance with relevant provisions.

Article 34: No entity or individual may forge or alter a food additive production permit or its number.

A food additive producer that has secured a production permit may not lease, lend or otherwise transfer its production permit or number.

Part Three: Producers' quality obligations

Article 35: A producer shall conduct a final inspection of its food additive leaving the factory for sale, and may sell the same only after it has passed inspection.

Article 36: When producing a food additive, raw and auxiliary materials, packaging materials and production equipment that comply with relevant quality and safety requirements shall be used.

Article 37: A producer shall establish quality control systems for raw material procurement, production process control, final inspection and sale of the product, etc. and duly keep the following production management records:

(1) personnel training and assessment records;

(2) plant, facility and equipment use, maintenance, overhaul, cleaning and disinfection records; and

(3) records of the operation of the quality control system, including raw and auxiliary material ordering and acceptance records, production process control records, product final inspection records, product sales records, etc.

The aforementioned records shall be true and complete, and the producer shall be liable for their truthfulness and completeness. Records may not be kept for less than two years. If the product's shelf life exceeds two years, the records shall be kept for a period no shorter than such shelf life.

Article 38: A food additive shall have a label and instructions for use, and the label shall carry the words “food additive”.

The label and instructions for use shall specify the following particulars:

(1) the food additive's name, specifications and net content;

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

(3) the ingredients;

(4) the production date, and shelf life or safe use period;

(5) the storage conditions;

(6) the product standard number;

(7) the production permit number;

(8) the scope of use, quantity to be used, and method of use as specified in the food safety standard, and announced and approved by the State Council's health administration department; and

(9) other particulars that laws, regulations or relevant standards specify must be indicated.

Article 39: A food additive's label and instructions for use may not contain untruthful information or exaggerations and may not involve illness-prevention or treatment functions.

A food additive's label and instructions for use shall be clear, prominent, and easily distinguishable, and readable.

If a food additive has contraindications against use or notes for safe use, it shall carry a warning symbol or a warning in Chinese.

Article 40: A food additive shall be packaged and steps shall be taken to ensure that it is not contaminated.

Article 41: If a producer is engaged by a third party to process a food additive on its behalf, the producer so engaged shall have a food additive production permit falling within the scope of the production for which it has been engaged.

A food additive processed on behalf of another shall, in addition to being labelled and marked in accordance with the requirements of product quality and food safety laws and regulations and these Provisions, indicate the name, address and contact information, etc. of the engaged producer.

Article 42: If a food additive produced contains a hidden safety risk, the producer shall recall the same in accordance with the law.

The producer shall report on the food additive recall and the disposal of the recalled product to the quality and technical supervision department.

Article 43: A producer shall establish a system for the self-examination of its production management and examine its food additive quality and safety control and other such production management circumstances itself in accordance with relevant provisions.

Part Four: Regulation

Article 44: A quality and technical supervision department shall create files for the food additive producers in its jurisdiction that have secured production permits and, in such files, it shall record in detail the outcome of the production permission process, monitoring inspections, the investigation and handling of violations of the law, etc.

Article 45: A quality and technical supervision department shall conduct monitoring inspections of the food additive producers in its jurisdiction in accordance with its regulatory work plan, and duly keep records thereof in accordance with provisions.

Article 46: When an onsite monitoring inspection of a producer is conducted, at least two officers shall participate. When monitoring inspection personnel conduct a monitoring inspection, they shall present valid credentials.

Article 47: When a monitoring inspection of a producer is conducted, such inspection shall focus on the records of the operation of the producer's quality control systems and verifying doubtful points in the producer's self-examination reports; and effecting regulation in accordance with the law of a recall carried out by the producer.

A producer subject to a monitoring inspection shall designate working personnel to cooperate in the quality and technical supervision department's monitoring inspection work and truthfully provide relevant information.

Article 48: Any entity or individual may file a complaint against or report a violation of laws or regulations by production permit review personnel, a testing institution and its personnel or monitoring inspection personnel to the quality and technical supervision department at the relevant level.

Once a quality and technical supervision department has received a complaint or report, it shall investigate and handle the matter in a timely manner and report on its handling thereof to the person who lodged the complaint or made the report in a timely manner.

Part Five: Legal liability

Article 49: If a producer violates the first paragraph of Article 6, Article 22, Article 23, Article 24, Article 34, Article 35, Article 38, Article 39, Article 40 or Article 41 hereof and such violation constitutes a violation of the law as specified in relevant laws and regulations such as the PRC Food Safety Law, the PRC Product Quality Law and the PRC Regulations for the Administration of Industrial Product Production Permits, penalties shall be imposed in accordance with the relevant law or regulations.

Article 50: If a producer violates the third paragraph of Article 2, Article 36, Article 37 or Article 42 hereof and such violation constitutes a violation of the law as specified in relevant laws and regulations, penalties shall be imposed in accordance with the relevant law or regulations; if a violation of the law as specified in relevant laws and regulations is not constituted, the local quality and technical supervision department at the county level or above shall order rectification within a specified period of time and impose a fine up to Rmb30,000.

Article 51: If a member of the working personnel of a quality and technical supervision department at the county level or above violates these Provisions, or abuses his/her authority, is derelict in his/her duties or practises favouritism by committing fraud, his/her relevant legal liability shall be pursued in accordance with the law.

Article 52: If a concerned party disagrees with the administrative penalties imposed by an administrative authority in accordance with these Provisions, such party may apply for administrative review or institute an administrative action in accordance with the law.

Part Six: Supplementary provisions

Article 53: The division of the types of food additives that are subject to production permits as specified herein shall be handled in accordance with laws, regulations and relevant AQSIQ provisions.

Article 54: The AQSIQ shall be in charge of interpreting these Provisions.

Article 55: These Provisions shall be effective as of June 1 2010. In the event of a discrepancy between these Provisions and rules and normative documents on regulation over the production of food additives published by the AQSIQ prior to the implementation hereof, these Provisions shall prevail.