Regulations Concerning the Hygiene Supervision over Cosmetics (2019 Revision)

Regulations Concerning the Hygiene Supervision over Cosmetics (2019 Revision) Regulations Concerning the Hygiene Supervision over Cosmetics (Approved by the State Council on September 26, 1989; issued by the Order No. 3 of the Ministry of Health of the People's Republic of China on November 13, 1989; and revised in accordance with the Decision of the State Council to Amend Certain Administrative Regulations on March 2, 2019) 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 cosmetics supervision and administration department under the State Council is in charge of the nationwide hygiene supervisory work on cosmetics while the cosmetics supervision and administration department 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 Cosmetics production enterprises shall be subject to the production permit system. Cosmetics production permits shall be approved and issued by the cosmetics supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government. A cosmetics production permit shall be valid for five years. No entity may engage in the production of cosmetics without a cosmetics production permit. 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 cosmetics supervision and administration 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 cosmetics supervision and administration 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 anti-sunburn lotion. Art......