Regulations concerning the Supervision and Administration over Cosmetics (Draft) 化妆品监督管理条例 China Food and Drug Administration (CFDA) Translated by Chemlinked Release Date: 2014/11/08
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Regulations concerning the Supervision and AdministraA ation over Cosmetics Chapter I General Provisions Article 1 (Legislative Purpose) The purpose of enactmentt of this Regulation is to regulate production and operation of cosmetics, strengthen supervision and administrationn of cosmetics, ensuree quality and safety of cosmetics and safeguard consumers health. Article 2 (Scope) In the territory of People's Republic of China, C the research, production, operation, supervision and administration of cosmeticss shall comply with this Regulation. Article 3 (Definition of Cosmetics) In this Regulation, cosmetics refer to products intended to be applied on the surface of human body (such as skin, hair, nails, lips etc. ), teeth and oral mucosa by spreading, spraying or other similar ways for the purpose of cleansing, protecting, beautifying or grooming skin or maintaining the good condition of skin. Article 4 (Assignment of Responsibility) China Food and Drug Administration is responsible for the supervision andd administration of cosmetics in China. The relevant departments of the State Council are responsible for the supervision and administrationn of cosmetics within their respective areass of responsibility. The food and drug administration departments of local people's p governments above the county level are responsible for the supervision and administration of cosmetics within their respective administrative areas. The relevantt departments of local people's governments above the county level aree responsible for the supervision and administration of cosmetics within theirr respectivee areas of responsibility. Tel: +86 571 8700 7545 Fa: +866 571 8700 7566 Email: contact@chemlinked.com
Article 5 (the First Basic Principle: the principle of main liability of manufacturers) Cosmetics manufacturers and operators bear the main responsibility for the quality and safety of cosmetics. They should comply withh laws, regulations and standards in the process of production and operation activities, strengthen administration, keep credibility and self-discipline to ensure the quality and safety of cosmetics, and bear civil liabilityy for the damage to consumers caused by quality and safety problems of cosmetics. Article 6 (the Second Basic Principle: the principle of industry self-discipline) Cosmetics Industry Association shall strengthen industryy self-discipline, supervise and guide cosmetics manufacturers and operators to comply with laws, regulations and standards in the process of production and a operation activities, promote the development of the industry credibility system, and widen the publicity of the knowledge of quality and safety of cosmetics. Article 7 (the Third Basic Principle: social supervision) Any organizations and individuals are entitled to report any activities done by cosmetics manufacturers and operators which violate this Regulation, and also make comments and suggestions on the supervision andd administration of cosmetics. Where reports concerning the quality and safety of cosmetics are proved to be true, food and drug supervision and administrationn departments will reward relevant organizations or individuals according to the relevant regulations. Article 8 (Information Disclosure) The food and drug administrationn departments shall promptly disclose cosmetics administration information through the unified information platform. Chapter II Raw Materials and Products Administrationn Article 9 (Raw Materials Catalog Administration) In China, the inventory administrationn is implemented for cosmetics raw materials. The inventories of prohibited cosmetics ingredients, restricted ingredients, certain raww materials allowed for use, and eisting ingredients are developed, adjusted and Tel: +86 571 8700 7545 Fa: +866 571 8700 7566 Email: contact@chemlinked.com
promulgated by the CFDA. Article 10 (Evaluation of New Ingredients) When using new ingredients to produce cosmetics, the applicant shall be apply for eamination and a approval to the CFDA. The CFDA shall consider the information of new ingredients including the study of history of new materials, physical and chemical properties, QSAR, efficacy characteristics, etc., to develop the standard of classification eamination and scientifically carry out the eamination and approval for new materials. In accordance with the requirements of the protection off public health, the CFDA shall establish the observation period for new cosmetics ingredients which have been eamined and approved. The observation period iss 4 years from the date of approval. Within the observation period, the applicant shall regularly report on the safety situation of new ingredients.. When the observation period iss epired, if there is still no safety risk, the ingredients will be put intoo the inventory of eisting cosmetic ingredients. Article 11 (Cosmetics Classification) According to the usage of products, cosmetics are divided into special use cosmetics and non-special use cosmetics. Special use cosmetics include cosmetics for hair dyeing, hair perming, whitening, sun proof and other cosmetics which contain a high safety risk. The specific catalog is developed, adjusted and promulgated by the CFDA. C Article 12 (Administration) Special use cosmetics shall be approvedd by the CFDA before production and import. The CFDA can authorize food f and drug administrationn departments of people's governments of provinces, autonomous regions and municipalities to carry out the eamination and approval for partt of special use cosmetics. Non-special use cosmetics shall bee filed by food and drug administration departments of people's governments of provinces, autonomous regions and municipalities. Article 13 (Products Registration) For application of registration of special use cosmetics, the following information shall be submitted: : Tel: +86 571 8700 7545 Fa: +866 571 8700 7566 Email: contact@chemlinked.com
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