Provisions on Food Hygiene Supervision and Administration at Entry/Exit Ports

Provisions on Food Hygiene Supervision and Administration at Entry/Exit Ports Promulgation date: 03-01-2006 Effective date: 04-01-2006 Department: ADMINISTRATIONS UNDER THE DIRECT CONTROL OF THE COMMISSIONS & MINISTRIES Subject: QUARANTINE Order of the General Administration of Quality Supervision, Inspection and Quarantine (No.88) The Provisions on Food Hygiene Supervision and Administration at Entry/Exit Ports, which were adopted through discussion at the executive meeting of the General Administration of Quality Supervision, Inspection and Quarantine on December 31, 2005, are hereby promulgated, and shall come into force as of April 1, 2006. Director General: Li Changjiang March 1, 2006 Provisions on Food Hygiene Supervision and Administration at Entry/Exit Ports Chapter I General Provisions Article 1 With a view to strengthening food hygiene supervision and administration at entry/exit ports, ensuring food hygiene safety of entry/exit ports, and safeguarding public health, the present Provisions are formulated in accordance with the Frontier Health and Quarantine Law of the People's Republic of China and its detailed implementation rules, Food Hygiene Law of the People's Republic of China, and other relevant laws and regulations. Article 2 The present Provisions shall be applicable to the hygiene supervision and administration on food production and operation entities at entry/exit ports and food production and operation entities at ports that provide food, drinking water services for entry/exit means of transport (hereinafter referred to as the food production and operation entities). Article 3 The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the GAQSIQ) shall take charge of the food hygiene supervision and administration work at entry/exit ports countrywide. The entry/exit inspection and quarantine organs (hereinafter referred to as the inspection and quarantine organs) established by GAQSIQ at each locality shall be responsible for food hygiene supervision and administration work at the entry/exit ports within their own jurisdictions. Article 4 The inspection and quarantine organs shall apply hygiene licensing administration on food production and operation entities; and apply heath licensing administration on the practitioners of food and drinking water (hereinafter referred to as the practitioners) within any entry/exit port and on entry/exit means of transport. The inspection and quarantine organs shall apply risk analysis and grading administration on food hygiene supervision and administration of ports. Article 5 The inspection and quarantine organs shall conduct hygiene supervision and administration on the food at entry/exit ports pursuant to the relevant state food hygiene standards. In case any national standard has not been formulated, it may conduct hygiene supervision and administration in light of the relevant standards designated by GAQSIQ. Chapter II Licensing Administration on Food Production and Operation Entities Article 6 A food production and operation entity shall accept hygiene supervision of the inspection and quarantine organ at its locality when it is newly built, expanded, or restructured. Article 7 A food production and operation entity shall, before undertaking food production and operation activities at a port, apply for handling the Hygiene License of the People's Republic of China for Food Production and Operation Entities at Frontier Ports (hereinafter referred to as the Hygiene License, See Attachment I) to the inspection and quarantine organ at its locality. Article 8 A food production and operation entity shall have the following hygiene conditions when applying for the Hygiene License: 1. It shall have business places, hygiene environment, and hygiene facilities and equipment fitting its food production and operation activities; 2. If it is in the catering industry, it shall make the operational rules that comply with the hygiene safety requirements for catering processing and operation process and the management system and responsibility system that can assure the quality of the food and drink processed and managed by it; 3. It shall have sound hygiene management organizations and systems; 4. The practitioners do not suffer from any infectious disease that is an impediment to food hygiene safety; and 5. The practitioners have the common sense of food hygiene safety accommodating to the food hygiene production and operation work undertaken by them. Article 9 A food production and operation entity shall submit the following materials to the inspection and quarantine organ when applying for handling the Hygiene License: 1. Application Letter for Hygiene License; 2. Photocopy of the Business License (submitting afterwards upon obtaining it); 3. Materials of internal hygiene management organizations, systems, and institutions; 4. Health Certificate and conformity certificate for hygiene knowledge training on the practitioners; 5. Ichnography of the production and business place and the drawing of the enterprise's production process flows; 6. Specifications on the components of production materials, materials of production equipment, hygiene facilities, and packaging materials of products; 7. Hygiene inspection report on water used for production submitted by the food production entity; 8. Product hygiene standards, product marking, hygiene inspection conclusions on the products produced, and safety hygiene control measures thereof; and 9. Other relevant materials that shall be submitted. Article 10 An inspection and quarantine organ shall make examination on the application materials as required to determine whether the materials are complete and comply with the requirements of the relevant provisions, and make a decision on accepting or rejecting the application, and then issue a written proof. If the materials submitted are not complete or not up to the standard, it shall notify the applicant to make them up on site or within 5 days after the application is accepted. If it fails to notify the applicant within the time limit, the day when the application materials are received shall be the day for acceptance. An inspection and quarantine organ shall, after accepting the application of a food production and operation entity, make examination on the application materials, and make on-site hygiene licensing examination and quantitative rating according to the provisions of the GAQSIQ. An inspection and quarantine organ shall, according to the conclusions of material examination, on site examination and rating, and within 20 days from the day of acceptance, make a decision on granting the license or not to the food production and operation entity (the on-site examination time shall be excluded, the time for on-site examination shall not exceed one month at the maximum), and shall issue or serve the hygiene licensing certificate to or on the applicant within 10 days from the day when the decision is made. The valid period of the Hygiene License shall be one year. In case the food production and operation entity needs to extend the valid period of the Hygiene License, it shall file an application to the inspection and quarantine organ within 30 days before the expiration of the valid period of the Hygiene License. Article 11 If, within the valid period of the Hygiene License, a food production and operation entity alters its production and operation items, changes its legal person or the name of the entity, moves its address, restructures, expands, or newly builds a project, it shall declare to the inspection and quarantine organ that has made the hygiene licensing decision. Article 12 A food production and operation entity shall go through write-off formalities at the inspection and quarantine organ that has made the hygiene licensing decision when it stops business operation and hand in the Hygiene License for revocation. Article 13 A food production and operation entity may, when providing food and products used as food to a food production and operation entity in another place, put this on archives at the inspection and quarantine organ at that place upon the strength of the effective Hygiene License. Chapter III Hygiene Administration on Practitioners Article 14 An inspection and quarantine organ shall apply health licensing administration on practitioners. The practitioners shall have health examination at the medical heath institution recognized by the inspection and quarantine organ each year, and the practitioners newly work and work temporarily shall have health examination before taking their job positions. Article 15 A practitioner shall apply for Health Certificate to the inspection and quarantine organ, and shall submit the following materials when applying for handling the Health Certificate: 1. Application Letter for the Health Certificate; 2. Effective identity certificate; and 3. Physical examination report issued by the medical heath institution that is recognized by the inspection and quarantine organ. An inspection and quarantine organ shall make examination on the aforesaid materials according to the relevant provisions of the GAQSIQ, and issue Health Certificate to the practitioners who are qualified after examination. The valid period of the Health Certificate shall be one year. No person may undertake food production and operation work at a port until after he has obtained the Health Certificate. Article 16 An inspection and quarantine organ shall be responsible for supervising, guiding and rendering assistance to the work for the training and examination of the personnel of a food production and operation entity at its port. A practitioner shall have food hygiene general knowledge and knowledge of food laws and regulations. Article 17 An inspection and quarantine organ shall make a chest card (See Annex II) on the results of qualified health examination and qualified hygiene knowledge training. A practitioner shall wear the chest card for inspection when working. Chapter IV Food Hygiene Supervision and Administration Article 18 A food production and operation entity shall improve the food hygiene management system of its own entity, equip with full-time or part-time food hygiene management personnel, so as to strengthen the work for the inspection of the food produced and managed by it. Article 19 A food production and operation entity shall establish check-for-acceptance system while replenishing its stock. When the entity purchases food and materials, it shall ask for conformity certificates of inspection or test sheets according to the relevant state provisions, and check the Hygiene License. Any entity that provides food to entry/exit means of transport shall establish check-for-acceptance system for replenishing stock, and meantime, it shall establish hygiene archives for the entities selling food and raw materials. The inspection and quarantine organ shall make spot check regularly on the food and materials purchased, and make examination on the hygiene archives thereof. The following materials shall be included in the hygiene archives: 1. Business license (photocopy); 2. Production license (photocopy); 3. Hygiene license (photocopy); 4. Hygiene certificate for import food (photocopy) shall be provided in case any import raw materials are used; 5. Contract or letter of intent for goods supply; 6. Conformity certificate of inspection on the relevant batches of goods or the test sheets thereof; and 7. Lists of products and other relevant materials required. Article 20 An inspection and quarantine organ shall conduct supervision and inspection on food production and operation entities in accordance with laws, regulations, and rules, as well as the requirements of the hygiene criterions, the supervision and inspection shall mainly cover: 1. Hygiene license, health certificate of practitioners and hygiene knowledge training thereof; 2. Hygiene management organizations and management systems; 3. Environmental health, personal health, overall arrangements of hygiene facilities and equipment, and technical flow; 4. The conditions concerning food production, collection, purchase, processing, storage, transportation, exhibition, supply, sale, and etc.; 5. The sensory properties of food materials, semi-products, and finished products, and etc., and the use of food additives and obtaining of certificates; 6. Food hygiene inspection conditions; 7. Conducting on-site inspection on the hygiene quality of food, tableware, kitchenware and containers for ready-to-eat foods, and taking necessary samples for inspection; 8. Hygiene conditions for water supply; 9. Hygiene conditions for using detergents and disinfectants; and 10. Conditions on the prevention and control of medical media organism. Article 21 An inspection and quarantine organ shall carry out routine hygiene supervision over food production and operation entities, and two or more port hygiene supervisors shall fill in the assessment form as required on the basis of on-site inspection conditions. The assessment form shall, after being verified as without error by the person in charge of the entity under supervision or the relevant personnel thereof, be signed jointly by the port hygiene supervisors and the person in charge of the entity under supervision or the relevant personnel thereof. If it is modified, the modification shall be covered by the signature or seal of the person in charge of the entity under supervision or the relevant personnel thereof. In case the person in charge of the entity under supervision or the relevant personnel thereof refuse to sign his/their name, the port hygiene supervisors shall indicate in the assessment form the reasons for refusal to sign. Article 22 An inspection and quarantine organ shall take samples in light of the relevant provisions of food hygiene inspection, and send them for inspection in a timely manner. It shall issue proof of samples (See Annex III) to the entity or individual from whom samples have been taken when taking them. Article 23 Any food production and operation entity that provides food or drinking water to entry/exit means of transport shall declare to the inspection and quarantine organ before supplying food or drinking water, and may not supply food and drinking water until after the inspection and quarantine organ has made examination on the registration records of the products supplied, the conformity certificate of quarantine of the relevant batches of goods and inspection report, as well as other necessary materials as qualified. Article 24 The aviation food production and operation entities shall positively implement such quality control and assurance system as Good Manufacturing Practice (GMP) of production enterprises, and Hazard Analysis and Critical Control Points (HACCP), and etc., so as to improve the level of food hygiene safety. Chapter V Risk Analysis and Graded Management Article 25 An inspection and quarantine organ shall, according to the provisions of the relevant laws, administrative regulations, and standards, and in combination with the on-site supervision conditions, apply risk analysis and graded management on food in entry/exit ports. Article 26 An inspection and quarantine organ shall organize technical power to make monitoring on the occurrence, spread, and distribution of food-sourced diseases at ports, and make prediction on the epidemic trend of food-sourced diseases at ports, and give solutions for prevention and control, and carry out risk analysis. Article 27 An inspection and quarantine organ shall, on the basis of the results of hygiene licensing examination on food production and operation entities at ports and routine hygiene supervision and inspection, implement graded management on different types of food production and operation entities. 1. Those entities which are good both in hygiene licensing examination and routine hygiene supervision and inspection shall be assessed as Grade A entities. The inspection and quarantine organs shall make supervision on Grade A entities once a month; 2. Those entities which are good either in hygiene licensing examination or routine hygiene supervision and inspection shall be assessed as Grade B entities. The inspection and quarantine organs shall make supervision on Grade B entities twice a month; 3. Those entities which are mediocre both in hygiene licensing examination and routine hygiene supervision and inspection shall be assessed as Grade C entities. The inspection and quarantine organs shall make supervision on Grade C entities four times a month; 4. Those entities which are bad in the hygiene licensing examination conclusion, or good in hygiene licensing examination conclusion but worse in routine hygiene supervision shall be assessed as Grade D entities. The inspection and quarantine organs shall not grant hygiene license to Grade D entities or shall not extend the hygiene license in the next year. Article 28 An inspection and quarantine organ shall make dynamic supervision and administration on the entities at different grades, and make necessary adjustment of upgrading or downgrading them once a year on the basis of risk analysis and routine supervision conditions (See Annex IV). Article 29 An inspection and quarantine organ shall, according to early warning report on food released by GAQSIQ, take effective measures in a timely manner, so as to prevent the relevant food from being supplied to entry/exit ports and entry/exit means of transport. Article 30 In case such accidents as food poisoning, food contamination, or food-sourced diseases, etc. occur at any entry/exit port, the inspection and quarantine organ shall start the Emergency Preparedness Plan for Food Poisoning at Entry-Exit Ports, so as to make handling in a timely manner, and circulate a report to the relevant departments pursuant to the requirements of the Preparedness Plan. Chapter VI Penalties Article 31 In case any food production and operation entity at a port has one of the following circumstances, the inspection and quarantine organ shall give it an administrative punishment in accordance with the Frontier Health and Quarantine Law of the People's Republic of China and its detailed implementation rules, and the relevant provisions of other laws and regulations: 1. Undertaking food production and operation activities without obtaining the Hygiene License or by forging the Hygiene License; 2. Altering or lending the Hygiene License; 3. Allowing any practitioner who has not obtained the Health Certificate to take a job position, or failing to remove any practitioner with any infectious disease that is an impediment to food hygiene safety as required; 4. Refusing to accept the hygiene supervision of the inspection and quarantine organ; or 5. Other acts in violation of laws and regulations or the relevant provisions. Article 32 In case any practitioner has one of the following circumstances, the inspection and quarantine organ shall give him an administrative punishment in accordance with the Frontier Health and Quarantine Law of the People's Republic of China and its detailed implementation rules, and the relevant provisions of other laws and regulations: 1. Undertaking food production and operation activities without obtaining the Health Certificate; 2. Forging physical examination report; or 3. Other acts in violation of laws and regulations or the relevant provisions. Article 33 In case any staff member of the inspection and quarantine organ misuses his duty, bends the law for personal gain and engages in fraud, or is derelict of duty, he shall be given an administrative punishment or subject to criminal liabilities according to law in light of the circumstances. Chapter VII Supplementary Provisions Article 34 The power to interpret the present Provisions shall remain with the GAQSIQ. Article 35 The present Provisions shall come into force as of April 1, 2006.