卫生部令第三号
(Approved by the State Council on September 26, 1989, and issued by Decree No. 3 of the Ministry1 of Public Health on November 13, 1989)
颁布日期:19891113 实施日期:19900101 颁布单位:卫生部
Chapter I General Provisions
Article 1 These Regulations are formulated2 to strengthen hygiene3 supervision4 over cosmetics6 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 applied7 on the surface of any part of the human body (such as skin, hair, nails and lips) by way of smearing8, spraying or other similar methods to keep the body clean, to get rid of undesirable9 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 administrative10 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 jurisdiction11.
Article 4 All units or persons who are engaged in the production and business of cosmetics must abide12 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 License13 system. Hygiene License for the Production Enterprise of Cosmetics shall be approved and issued by the hygiene administration department at the provincial14, autonomous15 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 glazed16 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 technological17 process must meet the hygiene standard;
(5) it must have testing instruments and qualified18 technical personnel to carry out microbiological test on its cosmetic5 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, effusive19 dermatosis, dysentery, typhoid, virus hepatitis, and active tuberculosis20 shall not allowed to be directly engaged in the production of cosmetics.
Article 8 The materials and additives21 needed in the making of cosmetics and the immediate22 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 synthetic23 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 nourishment24, hair-dye, hair perm, hair removing, breast massage25, deodorant26, fading cream and antisunburn lotion27.
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 serial28 number of the hygiene license for the production enterprise must be clearly stated; on the smaller package or the specification29 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