1.4 Regulatory policies for cosmetics and drug between China and USA.

中国与美国对化妆品和药品法规管理

(1) Outline of China supervising and standardizing the cosmetics and raw materials hygiene4

(a ) In order to strengthen the hygiene supervision of the cosmetics, and guarantee hygiene quality of the cosmetics and security of using, and ensure consumer's health, on September 26 1989 the State Council approved the third order of Health Ministry of issuing the cosmetics" the hygiene supervision and the management rule " on November 13 1989. In 2002, Health Ministry revised " hygiene standard of the cosmetics" newly, Standard carry on the cosmetics and examine and approve and supervise work according to coming to ask the unit concerned strictly. To make cosmetics of our country industry development, and satisfy the people and beauty the request for life, have made regulations to ensure.

In the cosmeceuticals in our country, involve breed hair, hair-perming, hair-peeling, hair dye, enlarging breast, anticellulite, deodorant cosmetics, dispelling spot, and sunscreen, these nine kinds of cosmetics, is called functional cosmetics,3,7,8,9 Necessary with the approval of hygiene administrative department of the State Council, namely present Chinese Food and Drug Bureau of Supervision and Administration (FDA. of China ), it will be approved after making approving the gentle number, then, produced and marketed. China FDA invites scientific research, medical, manufacture, the hygiene, and the relevant expert, in order to evaluate the safety property of the cosmeceuticals. Make up and sample the kind special use more for cosmetics of importing, the above: the new raw materials of and the cosmetics carry on the safety property to evaluate, the great accident caused to the cosmetics carries on the technical appraisement.

(b) The request that the personnel is healthy stipulates clearly for production: The personnel engaged in the cosmetics and produced directly, must carry on health examination every year. After making the health card, engaged in the activity in production of the cosmetics. Any personnel suffering from tinea manus, nail tinea, eczema of hand part, psoriasis in hand part, oozing out nature skin complaints, and suffering from dysentery, typhoid fever, and the of infectious diseases such as viral hepatitis, active pulmonary tuberculosis, etc. does not have engaged in the activity in production of the cosmetics directly.

(c) Requisition on cosmetics raw materials. "Cosmetics Hygiene Regulation Standard (CHRS) presents to forbid using (The hygiene legal supervising department of Ministry of Health of the People's Republic of China in November of 1999) one part Tab.2 of the general rule (1) and (2) in the group of the cosmetics gives forbidding material" the materials listed. The forbidding materials reach several hundred kinds, the materials have hypertoxicity or obviously have materials of chronic toxicity, and some have irritating to the skin or the mucous membrane.

In all " limited using material in Tab.3" of CHRS, the ones that must be accorded with and stipulated allow the density greatest, allow the scope of application and limit to use the condition. Combine have stipulated the mandatory declaration in the label.

The antiseptics must accord with "Tab. 4 of CHRS" that are inhibitors of the microorganism growing, the Nation claims antiseptic allowing density, greatest in the cosmetics, and the limit uses range. The antiseptics must prepare against the essential explanation on the condition and label.

In the "Tab.5 of CHRS", cosmetics ultraviolet absorbent must accord with "Tab.5 of CHRS". The standard stipulates that is avoiding poison, use the material of these under the prerequisite of side effect and strain divided by the ultraviolet ray, by protecting the danger not receiving ray.