Announcement of the General Administration of Market Supervision on Issuing the General Rules for Examination of Food Production Licenses (2022 Edition)

Announcement of the General Administration of Market Supervision on Issuing the General Rules for Examination of Food Production Licenses (2022 Edition)

The revised General Rules for Examination of Food Production License (2022 Edition) are hereby issued and shall come into force on November 1, 2022.

General Principles for Examination of Food Production License (2022 Edition)

Chapter I General Provisions

Article 1 in order to strengthen the management of production license of food and food additives (hereinafter referred to as food) and standardize the examination of food production license, these general rules are formulated in accordance with the the People's Republic of China Food Safety Law, the regulations for the implementation of the the People's Republic of China Food Safety Law, the measures for the Administration of Food production license (hereinafter referred to as the measures) and other laws, regulations and national food safety standards.

Article 2 These general rules shall apply to the examination of food production license, change license and renewal license organized by the market supervision and administration department.

Article 3 The examination of food production license shall include the examination of application materials and on-site verification.

The examination of application materials shall examine the completeness, standardization and conformity of the application materials; on-site verification shall examine the consistency of the application materials with the actual situation and the conformity of the production conditions.

Article 4 These general rules shall be used in combination with the corresponding food production license review rules (hereinafter referred to as the review rules). The use of local characteristics of food production license review rules to carry out food production license review, shall comply with the provisions of Article 8 of the measures.

For food varieties that are not included in the Catalogue of Food Production Licenses and have no review rules, the local market supervision and management department at or above the county level shall, in accordance with the relevant requirements of the Measures and this general rule, combine the review rules and product implementation standards for similar foods Develop a review plan (except for infant formula foods and formula foods for special medical purposes), and implement food production license review.

Article 5 Where laws, regulations, rules and standards have special provisions on the examination of food production licenses, they shall also abide by their provisions.

Chapter II Examination of Application Materials

Article 6 An applicant shall have the subject qualification to apply for a food production license. The application materials shall comply with the provisions of the Measures and be submitted electronically or in paper form. The applicant shall be responsible for the authenticity of the application materials.

Electronic application materials, electronic licenses, electronic seals, electronic signatures, electronic files that meet the statutory requirements have the same legal effect as paper application materials, paper licenses, physical seals, handwritten signatures or seals, and paper files.

Article 7 If the market supervision and administration department responsible for license examination and approval (hereinafter referred to as the examination and approval department) requires the applicant to submit paper application materials, it shall determine the number of copies of paper application materials according to the needs of food production license examination, daily supervision and filing.

The application materials shall be complete in type, complete in content, and conform to the statutory form and filling requirements.

Article 8 Where an applicant is under any of the following circumstances, the examination and approval department shall examine the applicant in accordance with the requirements for applying for a food production license:

(I) the application for food production license is filed after the expiration of the validity period of the food production license due to force majeure;

Relocation of (II) production sites and reapplication for food production licenses;

(III) production conditions change significantly, need to re-apply for food production license.

Article 9 The application materials for applying for a food production license shall be examined in accordance with the following requirements:

(I) integrity

1. The application materials for food production license meet the requirements of Articles 13 and 14 of the Measures;

2. The application materials for the production license of food additives shall meet the requirements of Article 16 of the Measures.

(II) Normative

1. The application materials shall conform to the legal form and filling requirements. The paper application materials shall be filled in or printed with pens and signature pens. The handwriting shall be clear and neat. The amendment office shall be stamped with the official seal of the applicant or signed by the legal representative (person in charge) of the applicant;

2. The applicant's name, legal representative (person in charge), unified social credit code, residence, etc. are consistent with the business license;

3. The production address is the detailed address of the applicant engaged in food production activities;

4. The application materials shall be signed by the legal representative (person in charge) of the applicant or stamped with the official seal of the applicant, and the photocopy shall also be marked "consistent with the original" by the applicant ";

5. The filling of food and food additive categories, category numbers, category names, variety details and remarks in the product information table conforms to the relevant requirements of the Food Production License Classification Catalogue. For sub-packaging production, it shall be indicated after the details of the corresponding varieties.

(III) compliance

1. The applicant has the subject qualification to apply for food production license;

2. The list of major equipment and facilities for food production meets the requirements of Item (II) of Article 12 of the Measures and the corresponding review rules;

3. The food production equipment layout and food production process flow chart are complete and accurate, the layout is marked in proportion, the equipment layout and process flow are reasonable, meet the requirements of items (I) and (IV) of Article 12 of the Measures, and meet the requirements of the corresponding review rules and the implemented standards;

4. The applicant is equipped with full-time or part-time food safety professional and technical personnel and food safety management personnel, which meets the requirements of the corresponding review rules and Article 135 of the the People's Republic of China Food Safety Law;

5. The contents of the list of food safety management systems meet the requirements of Item (III) of Article 12 of the Measures and the corresponding review rules.

Article 10 Where an applicant has one of the following circumstances and applies for a change of food production license according to law, the examination and approval department shall examine it in accordance with the requirements for the change of food production license:

(I) existing equipment layout and process flow change;

Changes in the main production equipment and facilities of the (II);

Changes in the category of food produced by the (III);

Reconstruction and expansion of (IV) production sites;

(V) other production conditions or changes in the surrounding environment of the production site that may affect food safety;

Other matters specified in the (VI) food production license have changed and need to be changed.

Article 11 The application materials for changing the food production license shall be examined in accordance with the following requirements:

(I) the application materials meet the requirements of Article 33 of the Measures;

The matters for which the (II) applies for changes fall within the scope of changes as stipulated in Article 10 of these General Rules;

It is (III) that the application materials involving changes comply with the requirements of standardization and compliance in Article 9 of this General Rule.

Article 12 Where an applicant applies for the renewal of a food production license in accordance with the law, the examination and approval department shall examine it in accordance with the requirements for the renewal of the food production license.

Article 13 The application materials for the renewal of a food production license shall be examined in accordance with the following requirements:

(I) the application materials meet the requirements of Article 35 of the Measures;

It is (II) that the application materials involving continuation matters comply with the requirements of standardization and conformity in Article 9 of these General Rules.

Article 14 If the examination and approval department examines the food production application materials submitted by the applicant and meets the relevant requirements without on-site verification, it shall make an administrative licensing decision in accordance with the prescribed procedures. Where on-site verification is required, a decision on on-site verification shall be made in a timely manner and on-site verification shall be organized.

Chapter III On-site Verification

Article 15 Under any of the following circumstances, on-site verification shall be organized:

The (I) falls under the circumstances of applying for a food production license under Article 8 of these General Provisions;

The (II) falls under Items 1 to 5 of Article 10 of the General Rules of Changing the Food Production License, which may affect food safety;

Where the (III) falls under the circumstances of the continuation of the food production license in Article 12 of these General Provisions, the applicant declares that the production conditions or the surrounding environment have changed, which may affect food safety;

The (IV) needs to verify the content of the application materials, the type of food, and the conformity with the requirements of the relevant review rules and implementation standards;

(V) the national and provincial market supervision and management departments decide to organize re-verification due to major changes in national food safety standards;

Other circumstances requiring on-site verification as stipulated by (VI) laws, regulations and rules.

Article 16 On-site verification may no longer be conducted in the following circumstances:

(I) special food registration has completed the on-site verification (except for the change of production conditions after the on-site verification of registration);

(II) applying for renewal, the applicant declares that the production conditions have not changed.

Article 17 Before the examination and approval department or the lower-level market supervision and management department entrusted by it implements on-site verification, it shall form a verification team, prepare and promptly report to the applicant and the market supervision and management department that implements the daily supervision and management of food safety (hereinafter referred to as the daily supervision department) Serving the "Notice of On-site Verification of Food Production License" to inform the relevant matters of on-site verification.

Article 18 The inspection team shall be composed of food safety supervisors, and professional and technical personnel may be hired as inspectors to participate in on-site inspections as needed. The inspectors shall have the quality and ability to meet the requirements of on-site verification, and shall avoid having a direct interest in the applicant or other circumstances that may affect the fairness of on-site verification.

The food safety supervision personnel in the verification team shall not be less than 2 people, and the team leader responsibility system shall be implemented. The market supervision and management department that implements on-site verification shall designate the head of the verification team.

Article 19 The verification team shall ensure that the verification is objective, fair and true, and that the verification reports and other documents and records are complete, accurate and standardized.

The leader of the verification team is responsible for organizing on-site verification, coordinating the verification progress, summarizing the verification conclusions, reporting the verification materials, etc., and is responsible for the verification conclusions.

The members of the verification team are responsible for the scoring of the verification items within the scope of the on-site verification division. If they have different opinions on the on-site verification conclusion, they shall study and solve them with the leader of the verification team in time. If there are still different opinions, they can report to the examination and approval department in writing within 1 working day after the on-site verification.

Article 20 The daily supervision department shall send food safety supervision personnel as observers to cooperate with and assist in the on-site verification work. When there are food safety supervisors from the daily supervision department among the members of the verification team, observers will no longer be assigned.

Observers who have objections to the on-site verification procedures, processes, and results may report in writing to the approval department within 1 working day after the on-site verification.

Article 21 The verification team shall hold its first meeting before entering the applicant's production site for on-site verification. The verification team leader introduces the members of the verification team and the verification purpose, basis, content, procedures, arrangements and requirements to the applicant, and makes a confidentiality commitment and a statement of integrity and self-discipline on behalf of the verification team.

The participants in the first meeting include members and observers of the verification team, as well as the legal representative (person in charge) of the applicant or its agent, relevant food safety management personnel and professional and technical personnel, and sign on the first meeting of on-site verification of food and food additive production license (Annex 1).

Article 22 The verification team shall, in accordance with the verification items listed in the "Record Form for On-site Verification and Scoring of Food and Food Additives Production License" (Annex 2), adopt methods such as verification sites and equipment, consulting documents, verifying materials, and asking relevant personnel to implement on-site verification.

When necessary, the inspection team may conduct spot checks on the applicant's food safety management personnel and professional and technical personnel.

Article 23 The scope of on-site verification mainly includes production sites, equipment and facilities, equipment layout and process flow, personnel management, management system and its implementation, as well as trial-produced food inspection qualification reports.

On-site verification should be in accordance with the category of food verification, scoring. If the review rules refine the relevant contents of on-site verification or have special requirements, they shall be verified together and recorded in the "Record Form for On-site Verification and Scoring of Food and Food Additives Production License.

For those who apply for a license for the first time or increase the food category to change the food production license, the inspection report of the trial-produced food shall be verified in accordance with the requirements of the corresponding review rules and implementation standards. If the applicant declares that the production conditions and the surrounding environment have changed, the on-site verification shall be carried out on the change, and the verification items that do not involve the change shall be regarded as reasonable missing items and not as scoring items.

On-site verification scores for each item according to the three levels of compliance, basic compliance and non-compliance, and the total score of all verification items is 100. When a verification item is not applicable, it will not participate in scoring. Explain the reason for the inapplicability in the "Verification Record" column.

The results of the on-site verification are judged by the scoring rate. The percentage of the actual score of the item participating in the scoring to the total score of the item participating in the scoring is used as the scoring rate. If the single score of the verification item has no 0 sub-item and the total score rate is ≥ 85%, the category name and variety details are determined to pass the on-site verification; If the single score of the verification item has 0 sub-item or the total score rate is less than 85%, the category name and variety details are determined to have failed the on-site verification.

Article 24 According to the on-site verification, the verification team leader shall convene the inspectors to jointly study the scores of the items they are responsible for verification, summarize the verification results, and form preliminary verification opinions.

The verification team shall notify the legal representative (person in charge) of the applicant on the preliminary verification opinions and listen to their opinions.

Article 25 After the preliminary verification opinions and the feedback opinions of the applicants are discussed, the verification team shall score and judge according to the on-site verification of different types of food names, form a verification conclusion, and fill in the "On-site Verification Report of Food and Food Additives Production License" (Annex 3).

Article 26 The verification team shall hold a final meeting, and the verification team leader shall announce the verification conclusion. The inspectors and the legal representative (person in charge) of the applicant shall sign their opinions, sign and seal on the "Record Form for On-site Verification of Food and Food Additives Production License" and "On-site Verification Report for Food and Food Additives Production License. The observer shall sign and confirm the on-site verification report on the production license of food and food additives.

The "On-site Verification Report on Food and Food Additives Production License" is made in duplicate, one copy shall be kept by the applicant and one copy shall be kept by the verification team.

If the applicant refuses to sign or seal, the verification team leader shall indicate the situation on the on-site verification report on the production license of food and food additives.

The scope of personnel attending the last meeting is the same as that of the first meeting. The participants shall sign on the Sign-in Form of the Last Meeting for On-site Verification of Food and Food Additives Production License (Annex 4).

Article 27 If the on-site verification cannot be carried out due to the following reasons of the applicant, the verification team shall report to the market supervision and management department that has appointed it to carry out the on-site verification, and the conclusion of this on-site verification is determined to have failed the on-site verification:

The (I) does not cooperate with the on-site verification;

(II) the production equipment and facilities cannot operate normally during on-site verification;

(III) conceals relevant information or provides false materials;

(IV) other on-site verification cannot be carried out normally due to the subjective reasons of the applicant.

Article 28 The verification team shall complete the on-site verification within 5 working days from the date of accepting the on-site verification task, and report the relevant materials listed in the "List of Food and Food Additives Production License Verification Materials" (Annex 5) to the market supervision and management department that is assigned to implement the on-site verification.

Article 29 If on-site verification cannot be carried out due to force majeure, or objective reasons such as power supply or water supply, the applicant shall submit a written application for permission suspension to the examination and approval department. In principle, the suspension time shall not exceed 10 working days, and the suspension time shall not be included in the time limit for examination and approval of food production license.

If the production conditions of the applicant do not meet the prescribed conditions due to natural disasters and other reasons, the applicant shall apply for termination of the license.

If the on-site verification cannot be carried out after the expiration of the suspension time applied by the applicant, or if the applicant applies for termination of the license, the examination and approval department shall terminate the license.

Article 30 where an applicant is placed on file for investigation because of suspected food safety violations or suspected food safety crimes, the examination and approval department shall suspend the food production licensing procedure. The suspension time shall not be included in the time limit for the examination and approval of the food production license.

If the administrative penalty decision is to restrict the production and business activities, order the suspension of production and business, order the closure, restrict the employment, temporarily withhold the license, revoke the license, or transfer the case to the procuratorate for prosecution after filing the case for investigation, the food production license procedure shall be terminated. If the administrative penalty decision is a warning, a notice of criticism, a fine, confiscation of illegal income, confiscation of illegal property and the applicant performs the administrative penalty, or if the decision to withdraw the case is made after the applicant applies for the resumption of the food production license, the examination and approval department shall resume the food production license procedure.

Chapter IV Review Results and Rectification

Article 31 The examination and approval department shall, based on the review of application materials and on-site verification, make a decision to approve a food production license and issue a food production license if the conditions are met; if the conditions are not met, it shall promptly make a decision not to approve the license. Written decision and explain the reasons, and inform the applicant that he has the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.
The applicant for infant formula food and formula food for special medical purposes that have passed the on-site verification conclusion shall immediately rectify the problems found in the on-site verification, and after the rectification results pass the acceptance, the examination and approval department shall issue a food production license; the time required for the applicant to rectify and pass the acceptance shall not be included in the license time limit.
Article 32 Where a decision is made to approve a food production license, the examination and approval department shall promptly send the applicant's application materials and related licensing materials to the applicant's daily supervision department.
Article 33 If the on-site verification conclusion is judged to be passed, the applicant shall complete the rectification of the problems found in the on-site verification within one month from the date of making the on-site verification conclusion, and report the rectification results in writing to the daily supervision department.
If the applicant is unable to complete the rectification within the prescribed time limit due to force majeure, it shall promptly submit an application for extension to its daily supervision department.
Article 34 The daily supervision department of the applicant shall conduct a supervision and inspection of the certified enterprise within 3 months after the applicant obtains the food production license. For the enterprises that have carried out on-site verification, the focus is on the rectification of the problems found in the on-site verification; for the renewal and replacement enterprises that the applicant declares that the production conditions have not changed, the focus is on the maintenance of the production conditions.

Chapter V Supplementary Provisions

Article 35 The trial-produced food of the applicant shall not be sold as food.
Article 36th special food production license review rules otherwise provided, from its provisions.
Article 37 The provincial-level market supervision and management department may, in accordance with these general rules, formulate relevant food production license management documents based on the actual conditions of the region, supplement and refine the "Food and Food Additive Production License On-site Verification and Scoring Record Form" and "Food and Food Additive Production License On-site Verification Report.
Article 38 The State Administration of Market Supervision and Administration shall be responsible for the interpretation of these General Provisions.
Article 39 These General Rules shall come into force as of November 1, 2022. The former State Food and Drug Administration issued on August 9, 2016, the general principles of food production license examination shall be abolished at the same time.

Attachments:

1. Sign-in Form for the First Meeting of on-site Verification of Food and Food Additives Production License

2. Record of on-site inspection and scoring of food and food additive production license

3. On-site verification report of food and food additive production license

4. Food and food additive production license on-site verification last meeting sign-in form

5. List of food and food additive production license verification materials