化妆品卫生监督条例(1)
卫生部令第三号 Chapter I General Provisions Article 1 These Regulations are formulated to strengthen hygiene supervision over cosmetics so as to ensure hygiene quality and safety use of cosmetics and to safeguard the consumers' health. Article 2 The term “Cosmetics” referred to in these Regulations means those daily used chemical products applied on the surface of any part of the human body (such as skin, hair, nails and lips) by way of smearing, spraying or other similar methods to keep the body clean, to get rid of undesirable smell, to protect the skin, to make up the face and to increase the beauty of the appearance. Article 3 The State shall enforce hygiene supervision over cosmetics. The health administrative department under the State Council is in charge of the nationwide hygiene supervisory work on cosmetics while the health administration departments at or above county government level are in charge of the hygiene supervisory work on cosmetics within their respective jurisdiction. Article 4 All units or persons who are engaged in the production and business of cosmetics must abide by these Regulations. Chapter II Hygiene Supervision over the Production of Cosmetics Article 5 The State shall exercise hygiene supervision over the enterprises engaged in the production of cosmetics by means of Hygiene License system. Hygiene License for the Production Enterprise of Cosmetics shall be approved and issued by the hygiene administration department at the provincial, autonomous regional or municipal (directly under the Central Government) level. The term of validity of a Hygiene License for the Production Enterprise of Cosmetics is four years and it must be verified after two years. No enterprise shall be allowed to engage in the production of cosmetics without a Hygiene License. Article 6 A production enterprise of cosmetics must meet the following hygiene requirements: (1) it must be built in a clean area and away from areas contaminated with poisonous or other harmful matters at a certain distance as required by the relevant hygiene regulations; (2) the production building must be strong and clean. The ceiling, walls and floors inside the workshop must be built with smooth and glazed material. The workshop must be well-lit and have necessary facilities and equipment to kill rats and insects and to prevent them from causing harm to the products and from multiplying; (3) it must have adequate depository for materials and finished products and workshops of appropriate capacity for processing and packing purposes; (4) the workshops must be equipped with the necessary facilities to meet the specific requirements of the products, and the technological process must meet the hygiene standard; (5) it must have testing instruments and qualified technical personnel to carry out microbiological test on its cosmetic products. Article 7 The staff and workers directly involved in the production of cosmetics are required to have a physical check-up every year. Only those who hold a health certificate shall be allowed to engage in the production. Any worker who suffers from ringworm of fingers, ringworm of finger-nails, hand eczema, hand scale, effusive dermatosis, dysentery, typhoid, virus hepatitis, and active tuberculosis shall not allowed to be directly engaged in the production of cosmetics. Article 8 The materials and additives needed in the making of cosmetics and the immediate containers and packing materials of cosmetics must meet the State hygiene standards. Article 9 Before a new kind of material is used to make cosmetics, an application must be made to the health administrative department under the State Council for approval. “New kind of material” refers to natural or synthetic materials that are used to make cosmetics for the first time in China. Article 10 The production of special cosmetics must be approved by the health administrative department under the State Council. Only after an approval document is obtained from this department can the factory start the production. “Special Cosmetics” refer to those substance used for hair nourishment, hair-dye, hair perm, hair removing, breast massage, deodorant, fading cream and antisunburn lotion. Article 11 Before putting its cosmetic products onto the market, the producer is required to conduct hygiene quality examination in accordance with the Hygiene Standard for Cosmetics formulated by the State and mark the qualified products. The products that are not examined or are not up to the required hygiene standard are not allowed to be shipped out of the factory. Article 12 On the label of a cosmetic product, the name of the product, the name of the producer and the serial number of the hygiene license for the production enterprise must be clearly stated; on the smaller package or the specification sheet, the date of production and expiry must be stated. In the case of special cosmetic products, the approval document number must also be printed. In the case of cosmetics that may cause undesirable reactions, warnings and instructions on the use of the product must be stated in the specification sheet. No indications, curative effect and medical terms are allowed to be written on the label, on the inner packing or on the specification sheet of cosmetic products. Chapter III Hygiene Supervision over Cosmetics Sales |