Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics

Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics (Promulgated by Order No.13 of the Ministry of Health on March 27, 1991, and amended by Order No.190 [2005] of the Ministry of Health on May 20, 2005) 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 dermatosis 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: a. name of the product; b. elements of the product and contents of restricted substances; c. brief descriptions and simple drawing of preparation techniques; d. basis for use of main elements in the product for hair nourishment, body building or breast building and the documents and materials thereon; e. materials on evaluation of hygiene and safety of the product; f. samples of the product (five to ten small packages) and the inspection report; and g. 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. (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: a. explanations on whether the elements of the product have been changed; b. explanations on whether the production techniques have been changed; c. a survey and final report on whether there are undesirable reactions after the products are put into the market for selling; and d. 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 Go......