1 General Project Name
Ratification and issue of production license of major industrial products
Sub-project Name: Ratification and issue of Food Production License
2 Legal basis
Article 13 of Law of The People's Republic of China on Product Quality and article 2 of Rules on Production license of Industrial Products (Trial)
3 Conditions for Approval
(1) Food producing and processing enterprises shall fulfill the conditions for establishment of enterprises laid down by national laws, regulations and relevant policies and obtain business license, food hygiene license and enterprise code certificate (except those do not need code certificate);
(2) Food producing and processing enterprises shall have environmental conditions to ensure product safety and quality;
(3) Food producing and processing enterprises shall have production facilities, processing equipment and auxiliaries to ensure product safety and quality, and workshops and sites for treatment, processing, storage of raw materials suitable to ensure product safety and quality. For enterprises producing food products with special processing equipment, such as irradiation processing, conditions laid down by relevant regulations and rules including metrology regulations shall be fulfilled;
(4) Technological flow of food processing shall be scientific and reasonable and production process shall be strict and normative. Biological, chemical and physical contamination and cross infection including such infection of uncooked and cooked food, of raw materials, semi-products and final products, and of dated and fresh food shall be prevented;
(5) Raw materials and additives used for producing food by food production and processing enterprises shall be in conformity with relevant national rules. Non-edible raw materials and aids are prohibited;
(6) Production shall be organized according to effective product standards. Food quality and safety shall be in conformity with the requirement of laws, regulations and relevant mandatory standards or, in case no mandatory standards exist, other standards which the enterprises claim to being adopted;
(7) Principal and major managers of food production enterprise shall understand the knowledge of laws and regulations relevant to food quality and safety; food enterprises shall have specialized technical personnel, skilled workers and quality personnel suitable to food production. Personnel undertaking food production and processing shall be healthy and have no infectious disease and other disease which may have an adverse effect on food quality and safety;
(8) Food production and processing enterprise shall have quality inspection and measuring means suitable to its products. Enterprise shall have delivery inspection capability. The inspection and measuring instruments shall not be used unless they pass metrology verification. Enterprise without delivery inspection capability shall entrust inspection agency with legal capacity published by General Administration of Quality Supervision, Inspection and Quarantine to undertake the inspection;
(9) Food production and processing enterprise shall establish standard system for overall process of production to carry our standardized management, set up and improve quality management system to implement quality management for the overall process from raw materials purchasing, delivery inspection to after-service, and establish quality responsibility system to enhance quality examination and implement quality veto strictly;
(10) Packaging materials for food shall be clean and have no contamination to food. Packaging and labeling of food shall in conformity with relevant rules and requirements. Bulk food shall be labeled if label can be used on its big package when leaving the factory;
(11) Containers, packages, tools and equipments to store, transport and load and unload food shall be safe and clean and cause no contamination to food;
(12) Particular requirement in Detailed Rules for Examination of various kinds of food.
4 Implementing Organizations
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Shanghai Bureau of Quality and Technical Supervision, all borough or county bureaus of quality and technical supervision
Shanghai Food Production License Examination Center established in the Division of Supervision of Shanghai Bureau of Quality and Technical Supervision is responsible for market access regarding food quality and safety.
Production and processing enterprises of 5 groups of food including wheat powder, rice, edible vegetable oil, sauce and edible vinegar shall apply for Food Production License to Shanghai Food Production License Examination Center, except that the food production and processing enterprises of above5 groups of food in Chongming County shall submit application to the Bureau of Quality and Technical Supervision of Chongming County. Production and processing enterprises of 10 groups of food including meat products, milk products, beverage, flavorings (sugar, monosodium glutamate), instant noodle, biscuit, canned food, freezing beverage, chilled noodle and rice food, and popped food shall apply for Food Production License to the bureaus of quality and technical supervision of the borough or county where the enterprises locate. Following application materials shall be submitted:
a) Application for Food Production License (see Annex 2) in triplicate;
b) Copies of business license in triplicate;
c) Copies of Food Hygiene License in triplicate;
d) Enterprise Code Certificate (Copies in triplicate. except those do not need code certificate)
e) Copies of identification card of principal (legal representative) in triplicate;
f) Layout of production site (one);
g) Flow chart of production process (one);
h) Quality management document (one);
i) Text of enterprise standard ( for enterprise implementing enterprise standard) (one);
j) Certificate of HACCP, Exported food hygiene registration certificate (Provide by enterprises having already obtain the certificate. Copies in triplicate).
(2) Dealing with
A decision on acceptance or rejection of the application shall be made and a writing notice shall be issued within 5 days from the date of receiving such application.
(3) Expert examination and product inspection
An examination group established by Shanghai Food Production License Examination Center will undertake the on-site examination for the applicant.
In case the enterprise passes the on-site examination, samples shall be picked by examination group and be inspected by inspection agency before issuing license.
The examination records and inspection reports shall be verified by Shanghai Food Production License Examination Center and in case of all requirement being met, forwarded to General Administration of Quality Supervision, Inspection and Quarantine by Shanghai Bureau of Quality and Technical Supervision. General Administration of Quality Supervision, Inspection and Quarantines shall verify the application materials and examination results and make a decision on whether issuing the Food Production License.
6 Time limit
(1) Time limit for expert examination and product inspection
a) Finish the expert examination: within 60 days.
b) Finish the product inspection before issuing license: within 30 days (except for special products).
(2) Time limit for making decision:
20 days from the date of acceptance of the application (excluding time for expert examination and product inspection).
(3) Time limit for issuing license:
Food Production License shall be issued and send to the applicant within 10 days after a decision on issuing the Food Production License made by General Administration of Quality Supervision, Inspection and Quarantines.
(1) Enterprises applying for production license shall pay fees according to article 11 of Rules on Production license of Industrial Products (Trial)".
(2) The fees for production license include examination fee (including license fee, travel expense and information costs), product inspection fee and publication fee according to No. 127 Provisional Rules on Charges for Production License of Industrial Products of former Administration of Price and Ministry of Finance.
(3) Examination fee: According to Notice of Ministry of Finance and State Planning Commission on adjusting authorities in charge of fee charging items including examination fee for production license of industrial products, and etc. (Issuance No 19 (2002) Financial General of Ministry of Finance and State Planning Commission), examination fee is 2200 RMB per enterprise, and for the same examination an additional fee of 440 RMB shall be paid in case of one more unit is applied for license. The applicant shall pay the examination fee to Shanghai Food Production License Examination Center at the time of submitting the application.
Publication fee: Publication fee is 400 RMB per unit and is paid by the enterprises which obtain the production license to Shanghai Food Production License Examination Center at the time of submitting the application.
Inspection fee: Inspection fee shall be paid to inspection agency according to relevant existing national rules.