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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II EXAMINATION AND APPROVAL OF HYGIENE LICENSES FOR PRODUCTION ENTERPRISES OF COSMETICS CHAPTER III SUPERVISION OVER THE HYGIENE QUALITY AND SAFETY USE OF COSMETICS CHAPTER IV EXAMINATION AND APPROVAL OF IMPORTED COSMETICS CHAPTER V REGULAR HYGIENE SUPERVISION CHAPTER VI HYGIENE SUPERVISION ORGANS OF COSMETICS AND THEIR RESPONSIBILITIES CHAPTER VII PENALTY PROVISIONS CHAPTER VIII SUPPLEMENTARY PROVISIONS DETAILED RULES FOR THE IMPLEMENTATION OF THE REGULATION ON THE HYGIENE SUPERVISION OVER COSMETICS CHAPTER I GENERAL PROVISIONS Article 1. These Detailed Implementation Rules are formulated pursuant to Article 34 of the Regulation on the Hygiene Supervision of Cosmetics (hereinafter referred to as the Regulation). Article 2. The people's governments at all levels shall strengthen their leadership of the hygiene supervision over cosmetics. The health administrative departments at or above the county level shall seriously perform their duties of hygiene supervision over cosmetics, strengthen their cooperation with the relevant departments, improve the hygiene supervision and inspection institutions of cosmetics, strengthen their technical abilities in supervision and inspection, improve the quality of hygiene supervisors over cosmetics, and ensure the implementation of the Regulation. CHAPTER II EXAMINATION AND APPROVAL OF HYGIENE LICENSES FOR PRODUCTION ENTERPRISES OF COSMETICS Article 3. The procedures for examining and approving Hygiene Licenses for Production Enterprises of Cosmetics shall be: (1) A production enterprise of cosmetics shall obtain an Application Form for Hygiene Licenses for Production Enterprises of Cosmetics in triplicate (see Annex I) from the health administrative department at or above the prefecture or municipal level and fill it out, and file an application to the health administrative department at or above the prefecture or municipal level after obtaining the approval of the provincial department in charge of enterprises. The specific measures for applying for Hygiene Licenses for Production Enterprises of Cosmetics shall be formulated by the health administrative department of each province, autonomous region or municipality directly under the Central Government, and shall be submitted to the Ministry of Health for archival filing; (2) An enterprise that is found to be qualified upon examination of the health administrative department of a province, autonomous region or municipality directly under the Central Government shall be issued a Hygiene License for Production Enterprises of Cosmetics. The health administrative department shall give a reply on whether or not approve an application within three months upon receipt of an application form, and shall explain the reasons if the application is disapproved; and (3) The system of uniform serial numbers shall be adopted for Hygiene Licenses for Production Enterprises of Cosmetics, and the valid term thereof shall be four years. The health administrative department of each province, autonomous region or municipality directly under the Central Government shall conduct a re-examination of enterprises in light of original declaration materials once every two years. Article 4. A new application shall be filed pursuant to these Detailed Implementation Rules three months prior to the expiration of the valid term of a Hygiene License for Production Enterprises of Cosmetics. A new certificate shall be issued if the aforesaid application is approved, and the serial number of the original Hygiene License for Production Enterprises of Cosmetics may be continuously used. Article 5. In case an enterprise that has obtained a Hygiene License for Production Enterprises of Cosmetics produces any new cosmetic product, it shall report it to the health administrative department of the province, autonomous region or municipality directly under the Central Government for archival filing. Article 6. In case a joint venture production enterprise of cosmetics covers two or more provinces, autonomous regions and municipalities directly under the Central Government, a separate application for Hygiene Licenses for Production Enterprises of Cosmetics shall be filed at each region involved. In case a production enterprise of cosmetics changes its site of factory, establishes a branch or a workshop at a place outside the factory complex, it shall apply for a Hygiene License for Production Enterprises of Cosmetics to the health administrative department of the province, autonomous region or municipality directly under the Central Government. The branch (workshop) shall be indicated on the Hygiene License for Production Enterprises of Cosmetics. Article 7. No Hygiene License for Production Enterprises of Cosmetics may be altered, transferred, forged or sold. A production enterprise of cosmetics that changes its name shall apply for recertification at the license issuing organ. The loss of a Hygiene License for Production Enterprises of Cosmetics shall be timely reported to the license issuing organ, and a new license shall be applied for. A production enterprise of cosmetics that voluntarily suspends its business shall timely cancel the Hygiene License for Production Enterprises of Cosmetics at the license issuing organ. Article 8. A Hygiene License for Production Enterprises of Cosmetics shall be issued pursuant to Article 6 of the Regulation. Where the requirements as prescribed in Item (5) of Paragraph 1 of Article 6 of the Regulation are not met, a qualified hygiene supervision and inspection organ of non-cosmetics may be entrusted for the inspection within a prescribed time limit. The specific time limit shall be prescribed by the health administrative department of each province, autonomous region or municipality directly under the Central Government in light of specific conditions. Article 9. The selection of site, construction and design for newly built, rebuilt or expanded production sites of cosmetics shall comply with the hygiene standards and requirements of cosmetics. The health administrative department of each province, autonomous region or municipality directly under the Central Government shall conduct examination to the aforesaid selection of site, construction and design, and participate in the completion-based check and acceptance. Article 10. Any person (including a temporary worker) directly engaged in the production of cosmetics shall be subject to a physical check-up pursuant to the Regulation: (1) A production enterprise of cosmetics shall be responsible for organizing the physical check-up of its employees. It shall submit a name list of the persons that shall make a physical check-up to the health administrative department at or above the county level, and organize the said persons to a medical and health institution at or above the county level for a physical check-up; (2) A physical check-up shall be conducted pursuant to the unified requirements and standards. A physical check-up institution shall seriously fill out a physical check-up form, and notify the physical check-up results within 15 days upon conclusion of the physical check-up; (3) The health administrative department shall seriously examine the physical conditions of any person subject to the physical check-up, and issue a health certificate to a qualified person, and shall notify the entity to remove those who are found to be unqualified from the positions directly engaged in the production of cosmetics. The health administrative department shall issue a health certificate or a transfer notice within 15 days upon receipt of the physical check-up results; (4) The treatment of those employees who suffer from diarrhea, typhoid, viral hepatitis and active pulmonary tuberculosis shall be conducted pursuant to the Law on Prevention and Treatment of Infectious Diseases; and any employee who suffers from ringworm of fingers, ringworm of finger-nails, hand eczema, hand scale or effusive dermatitis may not resume his work unless he is completely recovered after treatment as checked and proved by the original physical check-up hospital. The measures for the administration of physical check-ups shall be implemented pursuant to the relevant provisions as set down by the health administrative department under the State Council. CHAPTER III SUPERVISION OVER THE HYGIENE QUALITY AND SAFETY USE OF COSMETICS Article 11. The hygiene and safety evaluation of products shall be conducted prior to putting special cosmetics into the market. An entity which conducts hygiene and safety evaluation of products shall be subject to the accreditation of the health administrative department under the State Council. Article 12. The human tryout or patch test of special cosmetics shall be conducted by an entity as approved by the health administrative department under the State Council after the products pass the preliminary examination. The entity as referred to in the preceding Paragraph shall work out a final report within one month upon conclusion of the human tryout or patch test as entrusted by an enterprise, and submit it to the Ministry of Health and send a copy to the entrusting entity. Article 13. The procedures for examining and approving special cosmetics shall be: (1) A production enterprise shall obtain an Application Form for Hygiene Examination of Special Cosmetics in triplicate (see Annex II) from the health administrative department at or above the prefecture or municipal level and fill it out, and file an application to the health administrative department at or above the prefecture or municipal level upon approval of the department in charge of enterprises. The materials and samples listed as follows shall be provided for an application: 1. name of the product; 2. elements of the product and contents of restricted substances; 3. brief descriptions and simple drawing of preparation techniques; 4. basis for use of main elements in the product for hair nourishment, body building or breast building and the documents and materials thereon; 5. materials on evaluation of hygiene and safety of the product; 6. samples of the product (five to ten small packages) and the inspection report; and 7. instructions (or draft) on the use of the product, label, package design and packing materials; (2) The health administrative department of a province, autonomous region or municipality directly under the Central Government shall conduct a preliminary examination. The product that is found to be qualified through preliminary examination shall be reported to the health administrative department under the State Council. The health administrative department of each province, autonomous region or municipality directly under the Central Government shall complete the preliminary examination within three months as of the next day upon receipt of all declaration materials, and work out a reply on whether or not report it to the Ministry of Health for re-examination; and (3) The health administrative department under the State Council shall organize the appraisal group for the safety of cosmetics for re-examination within six months upon receipt of preliminary examination materials and the report on human tryout or patch test, and make a decision on whether or not to approve it within two months after the re-examination. An approval document number and a certificate for special cosmetics shall be issued to any approved product; and a reply shall be given if a product is disapproved. Article 14. The approval document number for a special cosmetic product shall be the production voucher of this product, while the certificate for a special cosmetic product shall be the preparation voucher and can be used for the technical transfer of this product. Article 15. An approval document number for special cosmetics shall be re-examined once every four years. An enterprise shall file a new application to the health administrative department of the province, autonomous region or municipality directly under the Central Government upon the strength of the original approval document and the following materials four to six months prior to the expiration of the approval document number, and fill out an application form (see Annex III) in triplicate: (1) explanations on whether the elements of the product have been changed; (2) explanations on whether the production techniques have been changed; (3) a survey and final report on whether there are undesirable reactions after the products are put into the market for selling; and (4) the altered format shall be provided if the instructions, label, package or packing materials of the product are changed. The application shall be subject to the examination and approval of the health administrative department under the State Council upon approval of the health administrative department of the province, autonomous region or municipality directly under the Central Government. The original approval document number may be continuously used if the application is approved. While the original approval document number shall be invalidated if there is no applicant within the time limit. The health administrative department of the province, autonomous region or municipality directly under the Central Government shall put forward suggestions within one month as of the next day upon receipt of all declaration materials. The health administrative department under the State Council shall make a decision on whether or not to approve an application within three months upon receipt of all declaration materials. Article 16. An enterprise that has accepted the technical transfer of an approved special cosmetic product shall separately file an application for an approval document number for the special cosmetic product to the health administrative department of the province, autonomous region or municipality directly under the Central Government. When filing the application, the certificate and samples (five to ten small packages) of this special cosmetic product and the inspection report shall be provided. Upon approval of the health administrative department of the province, autonomous region or municipality directly under the Central Government, the application shall be reported to the health administrative department under the State Council for examination and approval, and a approval document number shall be issued. The health administrative department of each province, autonomous region or municipality directly under the Central Government shall put forward suggestions within one month as of the next day upon receipt of all declaration materials. The health administrative department under the State Council shall make a decision on whether or not to approve the application within three months after receipt of all declaration materials. Article 17. In case an enterprise produces any approved special cosmetic product at the joint venture, it shall report it to the health administrative department of the province, autonomous region or municipality directly under the Central Government at the place where the joint venture is located, while the approval document number for the product shall remain unchanged. Article 18. No approval document number for special cosmetics may be altered, transferred, forged or sold. Article 19. An enterprise that produces non-special cosmetics shall provide the following materials and samples, and report it to the health administrative department of the province, autonomous region or municipality directly under the Central Government for archival filing within two months after the products are put into the market: (1) name and type of the product; (2) elements of the product and contents of restricted substances; (3) an inspection report on the hygiene quality of products; (4) samples of the product (five to ten small packages); and (5) instructions (or draft) on the use of the product, label, package design and packing materials. For the non-special cosmetics that are put into the market prior to the promulgation of these Detailed Implementation Rules, the archival filing therefor shall be conducted at the health administrative department of the province, autonomous region or municipality directly under the Central Government within three months after the promulgation of these Detailed Implementation Rules. Article 20. Pursuant to the requirements as set down by Article 12 of the Regulation, if the hygiene quality of a cosmetic product may be changed within three years, the valid using term (or using term) shall be stated. Article 21. The contents that shall be indicated on labels, instructions and small packages of cosmetics as prescribed by Article 12 of the Regulation shall be stated in Chinese, and the name of factory as stated in the label may be the name of the entity responsible for the quality of products. The serial number of the Hygiene License for Production Enterprises of Cosmetics for the place where the production enterprise is located shall be indicated on the labels of products produced by a trans-provincial joint venture. CHAPTER IV EXAMINATION AND APPROVAL OF IMPORTED COSMETICS Article 22. The procedures for hygiene examination and approval of imported cosmetics shall be: (1) For the cosmetics first imported into our country for the first time, the foreign manufacturer or its agent shall obtain an Application Form for Hygiene Licensing for Imported Cosmetics in triplicate (see Annex IV) from the health administrative department at or above the prefecture or municipal level at the place of import and fill it out, and directly file an application to the health administrative department under the State Council. The materials and samples listed as follows shall be provided for an application: 1. name and type of the product; 2. elements of the product and contents of restricted substances; 3. quality standards and inspection methods of the product, and the Chinese translation thereof shall be attached (three copies) to; 4. certificate on approval of production and selling of products at the country (or region) where the product is made (three photocopies); 5. certificate on registration and approval of selling the products at any other country (or region) (three photocopies); 6. appraisal reports on examination and approval of production, registration and selling of the product issued by the country (or region) where the production is made or any other country (or region), and a Chinese translation thereof shall be attached (five copies for each document) to; 7. materials on the evaluation of hygiene and safety of products, and inspection reports on the hygiene and quality of the products (five copies); 8. labels of products, instructions on the use of products, and the Chinese translation thereof shall be attached (three copies for each document) to; and 9. samples of products with complete package (three small packages); (2) The health administrative department under the State Council shall organize the appraisal group for the safety of cosmetics for re-examination upon receipt of all declaration materials. Upon approval of the health administrative department under the State Council, an approval document on hygiene licensing for imported cosmetics and an approval document number shall be issued for the products being examined and approved. The health administrative department under the State Council shall organize an appraisal group for the safety of cosmetics for examination within six months upon receipt of all declaration materials, and make a decision on whether or not to approve it within two months after the examination. The information on the examination and approval shall be notified to the health administrative department of the province, autonomous region or municipality directly under the Central Government. Article 23. The "hygiene and safety evaluation of products and the inspection of hygiene quality of products" as referred by Item (1) of Paragraph 1 of Article 22 of these Detailed Implementation Rules shall be conducted by an entity as accredited by the health administrative department under the State Council. The products that are exempted from the hygiene and safety evaluation of products and the inspection of hygiene quality shall be determined by the health administrative department under the State Council. Article 24. The valid term of an approval document on hygiene licensing for imported cosmetics shall be four years. An application for recertification may be filed to the health administrative department under the State Council four to six months prior to the expiration thereof, and no material is required to be attached when filing the application. If there is no applicant within the valid term, it shall be dealt with as not having an approval document. Article 25. No approval document on hygiene licensing for imported cosmetics or approval document number may be altered, transferred, forged or sold. Article 26. An approval document on hygiene licensing for imported cosmetics is applicable only to the category, producing country and manufacturer as stated thereon. A foreign manufacturer or its agent shall handle the importing formalities pursuant to the relevant state provisions upon the strength of an approval document on hygiene licensing for imported cosmetics. Article 27. The cosmetics whose import is approved shall be subject to the inspection of the national inspection department of commodities at the port pursuant to the Law of the People's Republic of China on Commodity Inspection. CHAPTER V REGULAR HYGIENE SUPERVISION Article 28. Each health administrative department at or above the prefecture or municipal level shall conduct regular and irregular inspections to the enterprises that have obtained the Hygiene Licenses for Production Enterprises of Cosmetics. A regular inspection shall be conducted every first and third quarter of each year, and one regular inspection shall be reduced in the year when an examination for issuance of a Hygiene License for Production Enterprises of Cosmetics is conducted or the year when a re-examination is conducted. The specific measures shall be formulated by the health administrative department of each province, autonomous region or municipality directly under the Central Government, and be submitted to the Ministry of Health for archival filing. The regular and irregular inspection results shall be reported to the next higher health administrative department and the hygiene supervision and inspection organ of cosmetics, and a copy thereof shall be sent to the department in charge of enterprises. Article 29. The regular and irregular inspections of production enterprises of cosmetics shall be conducted on: (1) supervision and inspection of the hygiene situation during the production process; (2) supervision and inspection whether any prohibited substance is used or any restricted substance is overused for producing cosmetics; (3) inspection records of the hygiene quality of each batch of products prior to their ex-factory; (4) the hygiene quality of products; (5) whether the labels of products, small packages and instructions comply with Article 12 of the Regulation; (6) the hygiene situation of the production environment; and (7) the information on transferring employees directly engaged in the production of cosmetics but suffering from any disease as prescribed in Article 7 of the Regulation. Article 30. The measures for inspecting the hygiene quality of products as referred to in Item (4) of Article 29 of these Detailed Implementation Rules are: (1) Number Of Inspections (the number of regular inspection plus the number of irregular inspection) 1. In case the number of categories of products produced in a year is 1 up to 9, 100% of them shall be subject to selective examination; 2. In case the number of categories of products produced in a year is 10 up to 100, 1/2 of them shall be subject to selective examination, but the number of products subject to selective examination in a year may not be less than 10; and 3. In case the number of categories of products produced in a year is more than 100, 1/3 of them shall be subject to selective examination, but the number of products subject to selective examination in a year may not be less than 50. (2) Focus Of Inspection Those products that have not been reported to the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government for archival filing, those products that are newly put into the market by enterprises, those products whose hygiene quality is not stable, those products that may cause undesirable human reactions, and those products that are complained by consumers shall be the key products subject to inspection. (3) Items Of Inspection 1. For any product that has not been reported to the health administrative department of a province, autonomous region or municipality directly under the Central Government for archival filing, the elements of the product shall be examined, an inspection report on the hygiene quality of the product shall be produced, and the supervision and inspection of the hygiene quality of the product in the aspects of microorganism, hygiene and chemistry shall be simultaneously conducted. If an enterprise can not provide an inspection report on the hygiene quality of the product or the inspection report on the hygiene quality of the product as provided can not prove the safe use of the product, the hygiene supervision and inspection organ of cosmetics will conduct a compulsory appraisal. 2. For any other product, a supervision and inspection of the hygiene quality of the product in the aspects of microorganism, hygiene and chemistry shall be conducted. Where necessary, the hygiene safety appraisal of an approved product may be conducted upon approval of the health administrative department at the corresponding level. (4) A product subject to selective examination shall be inspected pursuant to the Hygiene Standards of Cosmetics of the State and the measures thereof. (5) If an enterprise holds objection to the hygiene quality appraisal of products as made by a hygiene supervision and inspection organ, the appraisal shall be reviewed by the next higher hygiene supervision and inspection organ. Article 31. The requirements of the hygiene supervision over the selling of cosmetics are: (1) Any operator of cosmetics (including wholesale and retail operators) shall abide by Article 13 of the Regulation; (2) When a production enterprise sells its cosmetics to a seller, it shall show its Hygiene License for Production Enterprises of Cosmetics (photocopy), and the seller shall check whether the serial number of the Hygiene License for Production Enterprises of Cosmetics and the name of factory on the labels of products comply with that on the Hygiene License for Production Enterprises of Cosmetics (photocopy) held thereby; (3) An operator of cosmetics shall check whether there are the following marks or certificates on the cosmetics purchased thereby when it replenishes its stocks. Any cosmetic product that does not have the following marks or certificates may not be purchased or sold: 1. There shall be the serial number of the Hygiene License for Production Enterprises of Cosmetics and the quality ex-factory inspection certificate for the products of the enterprise on the label or small package of a home-made cosmetic product, while an approval document number issued by the health administrative department under the State Council shall be provided for a special cosmetic product. 2. An approval document (photocopy) issued by the health administrative department under the State Council shall be provided for an imported cosmetic product; and (4) The bulk cosmetics to be sold shall be clean and healthy, and may not be polluted. Article 32. An irregular inspection shall be conducted on an operator of cosmetics, and the emphasis of inspection shall be given to whether the operator has implemented the Regulation and Article 31 of these Detailed Implementation Rules. The patrol supervision of all wholesale operators of cosmetics within the jurisdiction shall be conducted at least once a year, while the patrol supervision of all retail operators of cosmetics within the jurisdiction shall be conducted at least once every two years. The inspection results shall be regularly reported to the next higher health administrative department and the health supervision and inspection organ of cosmetics, and a copy shall be sent to the department in charge of enterprises. As a general rule, the sampling inspection may not be adopted for the patrol supervision of wholesale and retail operators of cosmetics. When the cosmetics sold by an operator have caused undesirable reactions or there is any other special reason, the health administrative department at or above the county level may organize a sampled inspection of cosmetics sold by the operator. Where a health administrative department at the county or municipal level organizes a sampled inspection, it may not implement the inspection until it reports its plan to the next higher health administrative department and the inspection is approved. The specific measures for the degraded administration of irregular inspection of operators of cosmetics shall be formulated by the health administrative department of each province, autonomous region or municipality directly under the Central Government, and be submitted to the Ministry of Health for archival filing. Article 33. The advertising of cosmetics shall comply with Article 14 of the Regulation, and the relevant formalities shall be handled pursuant to the provisions as prescribed by the state administrative department for industry and commerce. CHAPTER VI HYGIENE SUPERVISION ORGANS OF COSMETICS AND THEIR RESPONSIBILITIES Article 34. The main hygiene supervision responsibilities of the health administrative department under the State Council are: (1) formulating the guidelines and policies concerning the national hygiene supervision over cosmetics, inspecting and guiding the national hygiene supervision over cosmetics and organizing the exchange of experiences; (2) organizing to study and formulate the hygiene standards of cosmetics; (3) inspecting the hygiene quality and safe use of new raw materials of cosmetics, special cosmetics and imported cosmetics, and approving the use of new raw materials of cosmetics, the production of special cosmetics and the first-time import of cosmetics; (4) organizing the investigation and handling of significant cases involving the hygiene of cosmetics as determined by the health administrative department under the State Council; and (5) imposing administrative penalties pursuant to the Regulation and these Detailed Implementation Rules. The main hygiene supervision responsibilities of the health administrative department of each province, autonomous region or municipality directly under the Central Government are: (1) taking charge of the hygiene supervision over cosmetics of its own jurisdiction, and being responsible for inspecting and guiding the hygiene supervision over cosmetics by the health administrative departments at the prefecture or municipal level, and organizing the communication of experiences; (2) carrying out preventive hygiene supervision over production enterprises of cosmetics within its own jurisdiction, and issuing Hygiene Licenses for Production Enterprises of Cosmetics; (3) conducting preliminary examination to the hygiene quality of special cosmetics, and being responsible for the archival filing of non-special cosmetics; and (4) organizing the survey and handling of comparatively important cases involving the hygiene of cosmetics within its own jurisdiction as determined by the health administrative department of each province, autonomous region or municipality directly under the Central Government. The health administrative department at or above the county level shall take charge of the hygiene supervision over cosmetics within its own jurisdiction pursuant to Item (1) of Paragraph 1 of Article 3, Paragraph 2 of Article 10, Paragraph 1 of Article 28 and Paragraph 5 of Article 32 of these Detailed Implementation Rules. Article 35. Each health administrative department at all levels may designate a health and epidemic prevention department with inspection conditions at or above the county level to be the hygiene supervision and inspection organ of cosmetics to undertake the hygiene supervision and inspection tasks of cosmetics. Article 36. The health administrative departments at higher levels shall conduct supervision, inspection and guidance of the work undertaken by the health administrative departments and the hygiene supervision and inspection organs of cosmetics at lower levels. The hygiene supervision and inspection organs of cosmetics at higher levels shall conduct technical and professional guidance for the hygiene supervision and inspection organs of cosmetics at lower levels. A hygiene supervision and inspection laboratory of cosmetics shall obtain a qualification accreditation, and the specific measures shall be formulated by the health administrative department under the State Council. Article 37. In case a hygiene supervision and inspection laboratory of cosmetics does not have the required inspection abilities and conditions, or has failed to obtain a qualification accreditation, its inspection tasks shall be undertaken by the accredited laboratory as designed by the next higher health administrative department. Article 38. A health administrative department or a hygiene supervision and inspection organ of cosmetics shall arrange special persons to keep the production and technical materials as provided by production enterprises. Article 39. The hygiene supervisors of cosmetics of each province, autonomous region or municipality directly under the Central Government shall be appointed by the health administrative department of each province, autonomous region or municipality directly under the Central Government from the health administrative departments and the hygiene supervision and inspection organs of cosmetics at all levels, and shall be issued with a certificate and badge of China Hygiene Supervision if they are qualified upon examination. A national hygiene supervisor of cosmetics shall be appointed by the health administrative department under the State Council and be issued with a certificate and badge. Article 40. A hygiene supervisor of cosmetics shall meet the following requirements: (1) being in good political and ideological status, abiding by disciplines and laws, working with a serious manner, and handling affairs impartially; (2) having an educational background of study in a secondary or higher technical school or a technical title of doctor or higher, commanding the laws on the hygiene supervision over cosmetics and the hygiene knowledge on production, operation and use of cosmetics, and having the independent working ability; and (3) having not suffered from any of the diseases as prescribed by Article 7 of the Regulation. Article 41. The rules for hygiene supervisors of cosmetics are: (1) studying and commanding the Regulation on the Hygiene Supervision over Cosmetics and the relevant regulations, commanding the Hygiene Standards of Cosmetics and the hygiene knowledge on the production, operation and use, and unceasingly improving the level of policies and professional ability; (2) handling matters according to law, doing work dutifully, being polite, and not seeking private interests by making use of power, abusing authorities, resorting to frauds, issuing false proof, soliciting or accepting bribes; (3) being neatly dressed, wearing the badge of China Hygiene Supervision and showing the certificate for supervision during the time of work; selecting samples and asking for the relevant materials pursuant to the relevant provisions and issuing the checklist, and seriously and faithfully filling out the records; (4) rigorously implementing the system of instructions and reports; (5) undertaking the secret-keeping responsibilities for the secret technical materials as provided by production enterprises of cosmetics; and (6) Refraining from holding any concurrent job or acting as an advisor in a production or business entity of cosmetics, and from having any economic relation that may hinder the public affairs with any production or business entity of cosmetics. Article 42. A hygiene supervisor of cosmetics shall be subject to the entrustment of the health administrative department at the corresponding level and exercise the following duties: (1) participating in the selection of site, design and hygiene inspection of newly built, rebuilt or expanded production enterprises of cosmetics, and participating in the completion-based check and acceptance; (2) conducting hygiene supervision and inspection to the production and business entities of cosmetics, asking for relevant materials, and investigating and handling health accidents caused by cosmetics; and (3) putting forward suggestions on administrative penalties to be imposed on any entity or individual that violates the Regulation. Article 43. A system of annual hygiene supervision and inspection statements shall be implemented for the hygiene supervision and administration of cosmetics. The health administrative departments at all levels shall report the annual hygiene supervision and inspection statements level by level on a regular basis. A medical treatment institution at any level that finds any case of undesirable reactions of cosmetics shall timely report it to the local hygiene supervision and inspection organ of cosmetics of the district or county. The hygiene supervision and inspection organ of cosmetics at all levels shall regularly report to the health administrative department of the corresponding level, and send a copy to the next higher hygiene supervision and inspection organ of cosmetics. CHAPTER VII PENALTY PROVISIONS Article 44. The penalties as prescribed by the Regulation and these Detailed Implementation Rules may be jointly applied. Article 45. Anyone who commits any of the following acts shall be given a warning, and may be ordered to make improvements within the time limit at the same time: (1) violating any item of Article 6 of the Regulation; (2) a person directly engaged in the production of cosmetics suffers from any of the diseases as prescribed by Article 7 of the Regulation and has not be removed from his position; (3) violating Item (2) or (3) of Paragraph 1 of Article 13 of the Regulation; (4) altering a Hygiene License for Production Enterprises of Cosmetics; (5) altering any approval document number for special cosmetics; (6) altering a hygiene examination and approval document or any approval document number for any imported cosmetics; or (7) refusing the hygiene supervision. Article 46. An entity or individual that commits any of the following acts shall be imposed with a penalty of shutout or suspension of cosmetic sales for a maximum of 30 days, and its/his illegal proceeds may be confiscated or a fine of two to three times of its/his illegal proceeds may be imposed thereon at the same time: (1) failing to make improvements after a penalty of warning or ordering to make improvements within the time limit; (2) violating two or more items of Article 6 of the Regulation; (3) violating Item (1), (4) and (5) of Paragraph 1 of Article 13 of the Regulation; or (4) a business entity transfers, forges or sells an approval document number for special cosmetics. The penalty of shutout due to the violation of Article 6 of the Regulation shall be the suspension of production of unqualified cosmetics. Article 47. An entity or individual that commits any of the following acts shall be imposed with a penalty of cancellation of Hygiene Licenses for Production Enterprises of Cosmetics: (1) failing to make improvements after being imposed with a penalty of shutout, and having virtually no required conditions for producing cosmetics; or (2) transferring, forging or selling Hygiene Licenses for Production Enterprises of Cosmetics. Article 48. In case an entity or individual commits any of the following acts, its/his illegal proceeds may be confiscated or a fine of two to three times of illegal proceeds may not imposed thereon, and its/his approval document number for special cosmetics or imported cosmetics may be simultaneously cancelled: (1) A production enterprise transfers, forges or sells any approval document number for special cosmetics or (2) An approval document for production of imported cosmetics or an approval document number for imported cosmetics is transferred, forged or sold. Article 49. The products confiscated pursuant to the Regulation shall be destroyed under the supervision of a health administrative department. Article 50. The withdrawal of a Hygiene License for Production Enterprises of Cosmetics or the cancellation of an approval document number shall be subject to the approval of the original approval organ. Article 51. Any party involved that holds objection to any specific administrative act as made by a health administrative department may apply for a review or file a lawsuit pursuant to Article 30 of the Regulation. Article 52. In case the human injury or a poisoning accident is caused by violating the Regulation, the injured may file a lawsuit for compensation at the people's court pursuant to the Civil Procedure Law of the People's Republic of China. Article 53. In case a hygiene supervisor of cosmetics seeks private interests by making use of his power, abuses his authorities, resorts to frauds, issues false proof, solicits or accepts bribes or divulges technical materials as provided by any enterprise, the bribes shall be confiscated upon verification, and the health administrative department may impose upon him an administrative sanction in light of the severity of his circumstances, and his qualification as a hygiene supervisor of cosmetics may be cancelled. Where a serious consequence is caused and a crime is constituted, he shall be subject to criminal liabilities imposed by the judicial organ. CHAPTER VIII SUPPLEMENTARY PROVISIONS Article 54. The inspection of items as not listed in the Hygiene Standards of Cosmetics shall be conducted by reference to the inspection methods for medicines, food and other relevant state standards. Article 55. A "person directly engaged in the production of cosmetics" as mentioned in Article 7 of the Regulation refers to a person engaged in the mixture of materials, manufacturing, storage of semi-finished articles, washing of containers, perfusion or work on small packages during the course of production of cosmetics, or a managerial, technical or inspection person who frequently visits the workshops. Article 56. The term "special cosmetics" as mentioned in Article 10 of the Regulation mean: The "cosmetics for hair nourishment" refers to the cosmetics that are good for the growth of hair or the reduction of hair loss or break. The "cosmetics for hair dyeing" refers to the cosmetics that can change the color of hair. The "cosmetics for hair perm" refers to the cosmetics that can change the degree of curvature of hair, and keep the hair relatively stable. The "cosmetics for epilation" refers to the cosmetics that can reduce or eliminate the pilus. The "cosmetics for breast building" refers to the cosmetics that are good for the building of the breast. The "cosmetics for body-building" refers to the cosmetics that are good for the healthy and graceful body. The "cosmetics for deodorization" refers to the cosmetics used to eliminate the underarm odour. The "cosmetics against flecks" refers to the cosmetics used to reduce the sediment of coloring matters in the epidermis of the skin. The "cosmetics against suntan" refers to the cosmetics that can absorb ultraviolet radiation and reduce the injury to skin caused by solarization. Article 57. The "quality signal" as included in "any qualified product shall be attached with a quality signal" as described in Article 11 of the Regulation refers to the quality ex-factory inspection certificate (badge) for the products of the enterprise. Article 58. The "cosmetics imported for the first time" as mentioned in Article 15 of the Regulation refers to the imported cosmetics that have not been approved by the health administrative department under the State Council yet. Article 59. The "refusal of hygiene supervision" as mentioned in Item (7) of Paragraph 1 of Article 45 of these Detailed Implementation Rules refers to an act that hinders or retards a hygiene supervision organ or hygiene supervisor from performing its or his duties on the hygiene supervision over cosmetics by using various excuses or means. Article 60. The hygiene supervision and administration of imported cosmetics shall be conducted pursuant to the relevant state laws and regulations. Article 61. The charges for hygiene supervision and inspection of cosmetics shall be collected pursuant to the relevant provisions as prescribed by the Ministry of Finance and the State Price Control Bureau. Article 62. These Detailed Implementation Rules shall come into force as of the date of promulgation. Any ministerial rule as promulgated heretofore conflicts with the Regulation or these Detailed Implementation Rules, the latter shall prevail. Annex: I: Application Form for Hygiene Licenses for Production Enterprises of Cosmetics (omitted) II: Application Form for Hygiene Examination of Special Cosmetics (omitted) III: Application Form for Hygiene Re-examination of Special Cosmetics (omitted) IV: Application Form for Hygiene Licensing for Imported Cosmetics (omitted) |
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