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          Regulations on the Supervision and Administration of Imported Civil Nuclear Safety Equipment (HAF604)

          1/12/2016 11:28:34 (Views: 1/12/2016 11:28:34)

          Decree of the State Environmental Protection Administration

          General Directorate Order No. 46


          Regulations on the Supervision and Administration of Imported Civil Nuclear Safety Equipment (HAF604)



          The Regulations on the Supervision and Administration of Imported Civil Nuclear Safety Equipment (HAF604) has been deliberated and approved by the Fourth Bureau Meeting of the State Environmental Protection Administration in 2007 on December 25, 2007, and is hereby promulgated, effective as of January 1, 2008 .

          Director of the State Environmental Protection Administration Zhou Shengxian



          December 28, 2007

          Subject word: Environmental Protection Regulations Import Civil Nuclear Safety Equipment Order

          Regulations on the Supervision and Administration of Imported Civil Nuclear Safety Equipment (HAF604)

          table of Contents

          Chapter I General Provisions Chapter II Registration of Overseas Units Chapter III Supervision and Inspection by the Nuclear Safety Supervision Department of the State Council Chapter IV Supervision, Pre-shipment Inspection, Supervision, and Acceptance of Civil Nuclear Facilities Operating Units Chapter V Imported Civil Nuclear Safety Equipment Safety Inspection Chapter 6 Legal Liabilities Chapter 7 Supplementary Provisions

          Chapter I General Provisions

          Article 1 In order to strengthen the supervision and management of imported civilian nuclear safety equipment, these regulations are formulated in accordance with the Regulations on the Supervision and Administration of Civil Nuclear Safety Equipment.

          Article 2 These Provisions apply to the registration and management of foreign units (hereinafter referred to as "foreign units") for the design, manufacture, installation and non-destructive inspection of civil nuclear safety equipment for civil nuclear facilities in the People's Republic of China, and the import of civil nuclear safety equipment Safety inspection.

          Article 3 The nuclear safety supervision department of the State Council is responsible for the registration and management of foreign units, and supervises and inspects the design, manufacture, installation and non-destructive inspection of civil nuclear safety equipment it engages in.

          The nuclear safety supervision department of the State Council and its affiliated inspection agencies conduct safety inspections on imported civilian nuclear safety equipment in accordance with law.

          Article 4 A civil nuclear facility operating unit shall clearly stipulate the following main contents in the foreign trade contract for civil nuclear safety equipment:

          (1) Overseas units shall cooperate with the supervision and inspection of the nuclear safety supervision department of the State Council;

          (2) Requirements concerning the supervision of manufacturing, pre-shipment inspection, supervision, installation, and acceptance of imported civil nuclear safety equipment;

          (3) Technical conditions for importing civil nuclear safety equipment and matters related to safety inspection.

          Chapter II Registration of Overseas Units

          Article 5 Overseas entities shall apply to the State Council's nuclear safety supervision department for registration in advance.

          Those who intend to engage in the design, manufacture or installation of civil nuclear safety equipment shall submit an application based on the type of activity (design, manufacturing, installation), equipment category and nuclear safety level.

          Those who intend to engage in non-destructive inspection of civil nuclear safety equipment shall apply in accordance with the non-destructive inspection method. Nondestructive inspection methods include: radiographic inspection (RT), ultrasonic inspection (UT), magnetic particle inspection (MT), eddy current inspection (ET), penetration inspection (PT), leak inspection (LT), visual inspection (VT), etc.

          Article 6 An overseas entity applying for registration shall meet the conditions stipulated in Article 31 of the Regulations on the Supervision and Administration of Civil Nuclear Safety Equipment, mainly including:

          (1) to abide by the laws and administrative regulations of the People's Republic of China;

          (2) Operating enterprises legally established for the country (region) where they are located;

          (3) Having work performance related to the activity to be engaged, and having completed at least 5 years;

          (4) Having workplaces, facilities and equipment suitable for the activities to be engaged in, and qualified professional and technical personnel who have passed the assessment;

          (5) Having a quality assurance system compatible with the activities to be undertaken;

          (6) Has obtained the corresponding qualifications prescribed by the nuclear safety supervision department of the host country;

          (7) The design, manufacturing, installation, and non-destructive testing technology of the civil nuclear safety equipment used is mature or verified;

          (8) Adopting national standards, industry standards for civil nuclear safety equipment of the People's Republic of China, or standards approved by the nuclear safety regulatory department of the State Council.

          Article 7 To apply for registration, the following application materials shall be submitted:

          (1) Application form for registration of overseas units;

          (2) Certification materials for the legal establishment of the operating enterprise in the country (region) where it is located;

          (3) Having obtained the certification materials required by the nuclear safety regulatory authorities of the host country, or other relevant qualification materials;

          (4) Explanatory materials on the performance of nuclear safety equipment activities in nuclear facilities;

          (5) Competence description materials related to the civil nuclear safety equipment activities to be undertaken, including staffing, plant, equipment, technical capabilities, and ability to execute standards and specifications;

          (6) Corresponding quality assurance outline or quality management manual;

          (7) Other materials required by the State Council's nuclear safety regulatory department.

          The above materials submitted by the applicant shall be in Chinese or in Chinese and English.

          Article 8 After receiving the application for registration , the nuclear safety supervision department of the State Council shall conduct a formal examination of the submitted application materials, and shall accept those that meet the requirements.

          Article 9 The nuclear safety supervision department of the State Council shall complete the review within 45 working days after accepting the application. If it meets the requirements, it shall be allowed to register, issue the "Confirmation Certificate of Registration of Overseas Units for Civil Nuclear Safety Equipment Activities of the People's Republic of China", Announcement; if the requirements are not met, notify the applicant in writing and explain the reasons.

          During the review process, the State Council ’s nuclear safety regulatory department may organize experts to conduct technical reviews, and if necessary, may send personnel to overseas application units for on-site verification. The time required for technical review and on-site inspection is not included in the time limit specified in the preceding paragraph.

          Article 10 Registration confirmations fall into four categories:

          (1) Confirmation of registration of overseas design units of civil nuclear safety equipment of the People's Republic of China;

          (2) Confirmation of Registration of Overseas Manufacturing Units of Civil Nuclear Safety Equipment of the People's Republic of China;

          (3) Confirmation of Registration of Overseas Installation Units of Civil Nuclear Safety Equipment of the People's Republic of China;

          (4) Confirmation of Registration of Overseas Non-Destructive Inspection Units for Civil Nuclear Safety Equipment of the People's Republic of China.

          Article 11 The registration confirmation shall specify the following:

          (1) the name of the unit, the country (region) where it is located, the residence and the legal representative;

          (2) the types and scope of activities for which registration is permitted;

          (3) the period of validity of registration;

          (4) the registration confirmation number;

          (5) Registration authority and date of issuance.

          Article 12 After the nuclear safety supervision department of the State Council completes the registration of an overseas unit, it shall copy the registration to the State Council ’s nuclear industry authority and other relevant departments.

          The nuclear safety supervision department of the State Council shall regularly announce the registration of foreign entities.

          Article 13 The validity period of the registration confirmation is 5 years.

          If the validity period of the registration confirmation expires and the foreign entity needs to continue to engage in related activities, it shall re-submit an application for registration to the nuclear safety supervision department of the State Council before the validity of the registration confirmation expires 6 months.

          Article 14 A registered foreign entity that changes the name, country (region), domicile or legal representative of a unit shall verify nuclear safety with the State Council within 30 days of the date of change of registration in the country (region) where it is located The supervisory authority submits the following materials to apply for the procedures for changing the registration confirmation:

          (1) Application for change of registration;

          (2) A copy of the original registration confirmation;

          (3) A description of the changes and relevant certification materials;

          (4) Other materials required by the State Council's nuclear safety supervision department.

          The nuclear safety supervision department of the State Council shall verify the changes in the registration confirmation of foreign units. If the situation is true, the procedure for changing the registration confirmation is permitted. The validity period of the registration confirmation after the change shall apply to the validity period of the original registration confirmation.

          Article 15 Any change in the type or scope of registered activities shall be resubmitted to the nuclear safety supervision department of the State Council.

          Article 16 It is forbidden to engage in the design, manufacture, installation, and non-destructive inspection of civil nuclear safety equipment without the registration confirmation or the types and scope of activities specified in the registration confirmation.

          Overseas units are prohibited from entrusting domestic units that have not obtained a license for civil nuclear safety equipment or overseas units that have not obtained a registration confirmation to perform civil nuclear safety equipment design, manufacturing, installation, and non-destructive inspection activities for civil nuclear facilities in the People's Republic of China.

          It is forbidden to forge, alter or transfer the registration confirmation.

          Article 17 When registering overseas entities, in the design, manufacture, installation and non-destructive inspection of civil nuclear safety equipment for civil nuclear facilities in the People's Republic of China, they shall abide by the relevant laws, administrative regulations and nuclear safety supervision of the People's Republic of China. Management regulations and responsible for the quality of the corresponding activities they perform.

          Chapter III Supervision and Inspection by the State Council's Nuclear Safety Supervision Department

          Article 18 When a registered foreign entity conducts civil nuclear safety equipment design, manufacturing, installation, and non-destructive inspection activities for domestic civil nuclear facilities, it shall accept the supervision and inspection of the nuclear safety regulatory department of the State Council and its dispatched agencies to truthfully reflect the situation And provide the necessary information.

          Article 19 The operating unit of civil nuclear facilities shall submit a written report to the nuclear safety supervision department of the State Council and its dispatched office within 20 working days from the date on which the foreign trade contract takes effect. The content of the written report shall include the relevant quality and technical provisions of the contract, the technical attachments to the contract, the delivery date, and the overall progress.

          The operating unit shall submit a written report to the nuclear safety regulatory department of the State Council and its dispatched agency one month before the relevant civil nuclear safety equipment design, manufacturing, installation, and non-destructive inspection activities begin. The content of the written report shall include the content, schedule, quality plan and operation unit supervision plan of the relevant civil nuclear safety equipment design, manufacturing, installation and non-destructive inspection activities.

          Article 20 The nuclear safety supervision department of the State Council and its dispatched agencies shall, in accordance with the relevant reports submitted by the operating units of civil nuclear facilities in accordance with these regulations, determine what needs to be supervised and inspected, formulate corresponding supervision and inspection plans, and notify the operating units in writing.

          The operating unit shall notify the nuclear safety supervision department of the State Council and its dispatched agency in writing two months before the start of the checkpoints identified in the supervision and inspection plan.

          Article 21 The nuclear safety regulatory department of the State Council and its dispatched agencies have the right to take the following measures when conducting supervision and inspection on the design, manufacture, installation and non-destructive inspection of civil nuclear safety equipment performed by overseas units:

          (1) Knowing the situation from the legal representative of the relevant unit and other relevant personnel;

          (2) Enter relevant units for on-site inspection;

          (3) consulting and copying relevant documents, records and other relevant materials;

          (4) Instruct the civil nuclear facility operating unit to investigate and deal with the quality problems or defects found, and submit relevant information and follow-up treatment reports.

          When the nuclear safety supervision department of the State Council and its dispatched agency conduct supervision and inspection, the operating unit shall send staff to cooperate at the scene.

          Article 22 The State Council ’s nuclear safety regulatory department and its dispatched agencies shall, when conducting supervision and inspection, make a record of the inspection content, problems found, and treatment, and shall be supervised and inspected by personnel, personnel of civil nuclear facilities operating units, and supervised and inspected The person in charge signed it.

          If the person-in-charge of the unit under supervision and inspection refuses to sign, the supervision and inspection personnel shall record the relevant situation on the record.

          Chapter IV Supervision, Pre-shipment Inspection, Supervision and Acceptance of Civil Nuclear Facilities Operating Units

          Article 23 The civil nuclear facility operating unit shall supervise the manufacture, pre-shipment inspection, and supervision of the import of civil nuclear safety equipment, and check the quality of the imported civil nuclear safety equipment.

          Article 24 The operating unit of civil nuclear facilities shall be equipped with a sufficient number of personnel for supervision of manufacturing, pre-shipment inspection, supervision of installation and acceptance with corresponding professional knowledge and business capabilities.

          Article 25 The civil nuclear facility operating unit shall formulate plans for supervision, pre-shipment inspection, supervision and inspection and acceptance, and formulate corresponding inspection requirements.

          The personnel responsible for the supervision, pre-shipment inspection, supervision and inspection and acceptance shall implement the supervision and inspection, supervision and inspection and inspection plans and inspection requirements.

          Article 26 The operating unit of civil nuclear facilities shall verify the quality of the design activities of imported civil nuclear safety equipment.

          Article 27 The operating unit of civil nuclear facilities shall verify the quality of non-destructive inspection activities of imported civil nuclear safety equipment.

          The verification stipulated in the preceding paragraph may be carried out by means of on-site witnessing and document review. If necessary, spot checks and re-inspections may be conducted.

          Article 28 A civil nuclear facility operating unit shall inspect the implementation of the quality assurance program or quality management manual of a registered foreign entity.

          Article 29 Relevant personnel of a civil nuclear facility operating unit shall make records of the contents of inspections, verifications or inspections, problems found, and treatments. If any non-compliance with the contract or relevant regulations is found, the operating unit shall deal with it in a timely manner and report the relevant situation to the nuclear safety supervision department of the State Council for the record.

          Chapter V Safety Inspection of Imported Civil Nuclear Safety Equipment

          Article 30 The nuclear safety supervision department of the State Council and its affiliated inspection agencies shall conduct safety inspection on imported civil nuclear safety equipment in accordance with law. Safety inspection can take the form of independent inspection or verification.

          Imported civilian nuclear safety equipment that has not passed the safety inspection or failed the safety inspection may not be used in civil nuclear facilities within the territory of the People's Republic of China.

          Article 31 The basis for safety inspection of imported civilian nuclear safety equipment mainly includes:

          (1) Laws, administrative regulations and nuclear safety supervision and management regulations of the People's Republic of China;

          (2) National nuclear safety equipment standards, industry standards, or standards approved by the nuclear safety regulatory department of the State Council when applying for registration of foreign units;

          (3) Foreign trade contracts;

          (4) Technical specifications of related equipment.

          Article 32 Personnel engaged in the safety inspection of imported civil nuclear safety equipment shall be familiar with relevant laws, regulations, standards and relevant technical documents, and possess corresponding inspection skills.

          Article 33 Before the imported civilian nuclear safety equipment arrives at the port, the civil nuclear facility operating unit shall report to the nuclear safety supervision department of the State Council and its inspection agency and provide the following materials:

          (1) Application form for inspection and inspection of imported civilian nuclear safety equipment;

          (2) A copy of the registration confirmation;

          (3) packing list;

          (4) Product quality certificate.

          The above materials submitted by the operating unit shall be Chinese or English.

          Article 34 The nuclear safety supervision department of the State Council and its affiliated inspection agencies shall review the inspection and inspection materials submitted by civil nuclear facility operating units in accordance with these regulations. Where necessary, inspections of landed equipment may be performed.

          Those that meet the requirements shall issue the “Port Inspection and Release Form for Import of Civil Nuclear Safety Equipment”. The operating unit holds the “Port Inspection and Release Form for Importing Civil Nuclear Safety Equipment” in accordance with the relevant laws and regulations to go through relevant inspection procedures at relevant agencies.

          For those that do not meet the requirements, the State Council ’s nuclear safety supervision department and its inspection agency shall notify the operating unit in writing and explain the reasons.

          Article 35 A civil nuclear facility operating unit shall report to the nuclear safety supervision department of the State Council and its inspection agency 20 working days before the unpacking inspection of the imported civil nuclear safety equipment plan, and submit the following materials:

          (1) Completion documents of imported civil nuclear safety equipment assembly drawings, factory inspection test reports and other products;

          (2) Reports on the results of inspection, supervision and inspection, and inspection and acceptance by the operating unit;

          (3) Report on the handling and closure of problems found during the supervision and inspection by the nuclear safety supervision department of the State Council;

          (4) Non-compliance of activities for importing civil nuclear safety equipment, and records of major and major non-compliances;

          (5) Other materials required by the State Council's nuclear safety supervision department.

          The above materials submitted by the operating unit shall be Chinese or English.

          The nuclear safety supervision department of the State Council and its affiliated inspection agencies shall review the above-mentioned unpacking inspection declaration materials, and send safety inspectors to the scene to witness before the unpacking inspection.

          The operating unit shall not conduct unpacking inspection before the safety inspection personnel arrive.

          Article 36 After unpacking inspection, the State Council ’s nuclear safety supervision department and its inspection agency shall issue an unpacking inspection report within 20 working days.

          If the inspection fails, the nuclear safety supervision department of the State Council and its inspection agency shall explain the reasons for the failure, and the civil nuclear facility operating unit shall not conduct installation and commissioning activities.

          Article 37 The nuclear safety supervision department of the State Council and its affiliated inspection institutions shall inspect the tests involving safety performance during the installation and commissioning stages before loading.

          The civil nuclear facility operating unit shall notify the State Council's nuclear safety supervision and its affiliated inspection agency 30 working days before the safety performance test of imported civilian nuclear safety equipment begins. The nuclear safety supervision department of the State Council and its affiliated inspection agencies shall make necessary site witnesses and produce witness records.

          The nuclear safety supervision department of the State Council and its affiliated inspection agency shall issue an inspection report within 30 working days from the end of all tests on the safety performance of imported civilian nuclear safety equipment.

          Article 38 The nuclear safety supervision department of the State Council and its affiliated inspection agency shall issue a safety inspection report after completing the test and inspection involving safety performance at the stage of document inspection, unpacking inspection, installation and commissioning before loading.

          If the safety inspection fails, the operating unit of civil nuclear facilities shall not operate.

          Article 39 The supervisors, inspectors and safety inspectors of imported civilian nuclear safety equipment shall keep the technical secrets and business secrets of the units under inspection; they shall not abuse their powers and infringe on the legitimate rights and interests of enterprises, or use their convenience to obtain and receive property ; Not engage in or participate in the business activities of civil nuclear safety equipment.

          Article 40 The safety inspection by the nuclear safety regulatory department of the State Council and its affiliated inspection agencies does not reduce or transfer the relevant responsibilities of overseas units and civil nuclear facilities operating units.

          Chapter VI Legal Liability

          Article 41 Where the State Council ’s nuclear safety regulatory department, its dispatched agency, its affiliated inspection agency, and relevant staff members commit one of the following acts, the person in charge directly responsible and other persons directly responsible shall be punished according to law; To investigate criminal responsibility according to law:

          (1) rejecting or registering an application for registration that complies with these regulations;

          (2) Failing to investigate or find violations of these regulations, or failing to deal with it according to law after receiving a report;

          (3) leaking the technical secrets or business secrets of the unit under inspection;

          (4) Abuse of powers, infringe upon the legitimate rights and interests of the enterprise, or use the convenience of his position to solicit and receive property;

          (5) Engaging in or participating in the business activities of civil nuclear safety equipment;

          (6) Other illegal acts in the supervision and management of imported civilian nuclear safety equipment.

          Article 42 Where an overseas entity commits one of the following acts, the nuclear safety supervision department of the State Council may temporarily suspend or withdraw the registration confirmation according to the seriousness of the circumstances:

          (1) Violating relevant laws, administrative regulations and nuclear safety supervision and management regulations of the People's Republic of China;

          (2) Failure to engage in the design, manufacture, installation and non-destructive inspection of civil nuclear safety equipment in accordance with the types and scope of activities specified in the registration confirmation;

          (3) changing the name, country (region), domicile or legal representative of the unit and failing to go through the formalities for changing the registration confirmation;

          (4) Alteration, transfer confirmation and other fraudulent acts.

          Chapter VII Supplementary Provisions

          Article 43 If an overseas entity applying for registration of civil nuclear safety equipment manufacturing and installation activities intends to conduct non-destructive inspection activities on its manufactured and installed civil nuclear safety equipment, it is not necessary to apply for separate non-destructive inspection activity registration.

          Article 44 Where a civil nuclear facility operating unit entrusts a civil nuclear safety equipment complete set supplier, a civil nuclear facility nuclear island construction general contractor, or a civil nuclear safety equipment license unit to purchase equipment, the entrusted procurement unit shall be responsible for Relevant responsibilities of the operating unit. However, the operating unit shall bear full responsibility for the use and operation safety of imported civilian nuclear safety equipment.

          Article 45 The meanings of the terms in these regulations are as follows:

          Safety inspection: refers to the inspection or verification of the safety performance of imported civil nuclear safety equipment on the premise that the inspection by overseas units is qualified, and the inspection, inspection and verification by the civil nuclear facility operating unit are pre-shipment inspection, inspection, and inspection. The relevant documents are recorded, inspected, unpacked, and tested for safety performance in the three stages of installation and loading.

          Article 46 These Provisions shall become effective on January 1, 2008.

          Attachment: 1. Application for Registration of Overseas Design Units of Civil Nuclear Safety Machinery and Equipment of the People's Republic of China

          Application for Registration of Overseas Design Units of Civil Nuclear Safety Electrical Equipment of the People's Republic of China

          Application for Registration of Overseas Manufacturing Units of Civil Nuclear Safety Machinery and Equipment of the People's Republic of China

          Application for Registration of Overseas Manufacturing Units of Civil Nuclear Safety Electrical Equipment of the People's Republic of China

          V. Application for Registration of Overseas Installation Units of Civil Nuclear Safety Equipment of the People's Republic of China

          Application Form for Registration of Overseas Non-Destructive Inspection Units of Civil Nuclear Safety Equipment of the People's Republic of China

          Application for change of registration of foreign units for civil nuclear safety equipment activities

          Confirmation of Registration of Foreign Units for Civil Nuclear Safety Equipment Activities

          Application Form for Inspection of Imported Civil Nuclear Safety Equipment

          X. Port Inspection and Release Form for Imported Civil Nuclear Safety Equipment


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