Take a quick look at the 13 key issues of the Regulations on the Supervision and Administration of cosmetics | Beauty and health laws

Author: 国瓴律师
Published on: 2020-07-01 00:00
Read: 7

On June 29, 2020, The State Council issued Decree No. 727 of The State Council, officially announcing the Regulations on the Supervision and Administration of Cosmetics, which will come into effect on January 1, 2021. The regulations were first included in the revision plan by The State Council in 2013; Adopted at the Executive Meeting of The State Council on January 3, 2020; Officially promulgated on June 29, it is a landmark event in China's cosmetics industry. The new Ordinance consists of six chapters and 80 articles. Cosmetics operators should focus on 13 key issues involved in the new regulations, as follows:

 

01 The range of special cosmetics is adjusted to hair color, perm, freckle whitening, sun protection, anti-hair loss products and cosmetics claiming new effects; Hair care, hair removal, breast beauty, bodybuilding, deodorization products are no longer special cosmetics.

Article 4 Cosmetics are divided into special cosmetics and ordinary cosmetics. The state shall exercise registration administration for special cosmetics and archival administration for ordinary cosmetics.

Article 16 Cosmetics used for hair coloring, perm, freckle whitening, sun protection, hair loss prevention and cosmetics claiming new effects shall be special cosmetics. Cosmetics other than special cosmetics are general cosmetics.

02 Toothpaste refer to the management of cosmetics, products need to be filed before the market, operators should be prepared early.

Article 77 Toothpaste shall be administered in accordance with the provisions of these Regulations on ordinary cosmetics. After the toothpaste filing person evaluates the efficacy according to national standards and industry standards, he can claim that the toothpaste has the effect of preventing caries, suppressing dental plaque, anti-dentin sensitivity, and reducing gum problems.

03 Soap in two, with whitening and other special cosmetic effects soap belongs to cosmetics; Other soaps are not cosmetics.

Article 77 Soap shall not apply to these Regulations, but those claiming to have special cosmetic effects shall apply to these Regulations.

04 Cosmetics new raw materials to implement a combination of registration and record management system for new raw material innovation.

Article 4 Cosmetic raw materials are divided into new raw materials and used raw materials. The state implements registration management for new raw materials of cosmetics with a higher degree of risk, and archival management for other new raw materials of cosmetics.

Article 11 Natural or artificial raw materials used in cosmetics for the first time in China shall be new raw materials for cosmetics. New cosmetic raw materials with anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening functions may not be used until they have been registered by the drug regulatory department under The State Council; Other new cosmetic raw materials shall be filed with the drug regulatory department under The State Council before use.

05 New raw materials of cosmetics are still regulated as new raw materials within 3 years after registration or filing, and non-registrants or filing persons shall not use the new raw materials within 3 years.

Article 14 Within three years after the new cosmetic raw materials that have been registered and filed are put into use, the registrant and filing holder of the new raw materials shall report the use and safety of the new raw materials annually to the drug regulatory department under The State Council. For new cosmetic raw materials with safety problems, the drug regulatory department under The State Council shall cancel the registration or cancel the record. New cosmetic raw materials that have not caused safety problems within three years shall be included in the catalogue of used cosmetic raw materials formulated by the drug regulatory department under The State Council. Before the registered and filed new cosmetic raw materials are included in the used catalogue of cosmetic raw materials, they are still managed in accordance with the new cosmetic raw materials.

06 Cosmetics and new raw materials registration or filing, need to conduct safety assessment.

Article 21 Before the registration and filing of new raw materials and cosmetics, the registration applicant and the filing person shall carry out safety assessment by themselves or entrust professional institutions. Personnel engaged in safety assessment should have professional knowledge related to cosmetic quality and safety, and have more than 5 years of relevant professional experience.

07 Claims of cosmetic efficacy should be based on scientific evidence, and subsequent products should be claimed with caution.

Article 22 The claims of the efficacy of cosmetics shall have sufficient scientific basis. The registrant or recordholder of cosmetics shall publish the summary of the literature, research data or product efficacy evaluation data on which the efficacy claim is based on on the special website prescribed by the drug regulatory department under The State Council, and accept social supervision.

08 The content of the Chinese label of imported cosmetics should be consistent with the content of the original label, which means that the foreign label must not contain the content prohibited by Chinese law.

Article 35 Imported cosmetics may use Chinese labels directly or attach Chinese labels; If a Chinese label is affixed, the content of the Chinese label shall be consistent with that of the original label.

09 Cosmetics registrants, recordholders, and entrusted manufacturers shall establish contact packaging material purchase inspection records and product sales records.

Article 31 Cosmetics registrants, recordholders, and commissioned manufacturers shall establish and implement a record system for the purchase inspection of raw materials and packaging materials in direct contact with cosmetics, and a record system for product sales. Purchase inspection records and product sales records shall be true, complete and traceable, and the retention period shall not be less than one year after the expiration of the product use period; If the service life of the product is less than 1 year, the record keeping period shall not be less than 2 years.

10 Cosmetics registrants, record holders or entrusted production enterprises should be responsible for quality and safety, responsibility to the person.

32nd cosmetics registrants, record holders, entrusted production enterprises shall be responsible for quality and safety, assume the corresponding product quality and safety management and product release responsibilities.

The person in charge of quality and safety shall have professional knowledge related to cosmetic quality and safety, and have more than 5 years of experience in cosmetic production or quality and safety management.

11 Cosmetics violations, the maximum penalty in accordance with the value of 30 times, there will be a sky-high ticket.

Article 59 Under any of the following circumstances, the department in charge of drug supervision and administration shall confiscate the illegal gains, cosmetics produced or traded illegally, raw materials, packaging materials, tools, equipment and other articles specially used for the illegal production or marketing; If the value of cosmetics illegally produced and traded is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 150,000 yuan shall be imposed; If the value of the goods is not less than 10,000 yuan, a fine of not less than 15 times but not more than 30 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to stop production and business operation, the filing department shall cancel the filing or the original issuing department shall revoke the cosmetic license, and shall not handle the cosmetic filing or accept the cosmetic administrative license application submitted by it within 10 years. The legal representative or the main person in charge of the illegal unit, the directly responsible person in charge and other directly responsible personnel shall be fined not less than 3 times but not more than 5 times the income they obtained from the unit in the previous year, and they shall be banned from engaging in the production and operation of cosmetics for life; Where a crime is constituted, criminal responsibility shall be investigated according to law: (1) engaging in cosmetic production activities without permission, or the registrant or recordholder of cosmetics entrusts an enterprise that has not obtained the corresponding cosmetic production license to produce cosmetics; (2) production, marketing or import of unregistered special cosmetics; (3) The production of cosmetics using raw materials prohibited for the production of cosmetics, new raw materials that should be registered but are not registered, the illegal addition of substances that may endanger human health in cosmetics, or the use of cosmetics or raw materials that have exceeded their useful life, waste or recycling to produce cosmetics.

12 Cosmetics violations, the enterprise and the responsible person to implement double penalties.

Article 62 Under any of the following circumstances, the department responsible for drug supervision and administration shall order a correction, give a warning and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; If the circumstances are serious, it shall be ordered to suspend production and business operation, and shall be fined not less than 30,000 yuan but not more than 50,000 yuan. The legal representative or the main person in charge, the person in charge directly responsible for the violation, and other persons directly responsible shall be fined not less than 10,000 yuan but not more than 30,000 yuan: (1) failure to publish in accordance with the provisions of these Regulations the summary of the basis for claiming the efficacy of cosmetics; (2) failure to establish and implement the purchase inspection record system and product sales record system in accordance with the provisions of these Regulations; (3) failure to self-inspect the implementation of cosmetic production quality management practices in accordance with the provisions of these Regulations; (4) failure to store and transport cosmetics in accordance with the provisions of these Regulations; (5) failing to monitor and report adverse reactions to cosmetics in accordance with the provisions of these Regulations, or failing to cooperate with adverse reactions to cosmetics investigations conducted by adverse reaction monitoring institutions and departments responsible for drug supervision and administration.

13 Cosmetics violations, the responsible person may be banned from cosmetics production and operation for life.

Article 64 Where an administrative license for cosmetics is applied for by providing false information or taking other deceptive means, no administrative license shall be granted; where an administrative license has been obtained, the administrative license shall be revoked by the department that has made the decision on administrative license, the application for cosmetics related license shall not be accepted within five years, and the illegal gains and cosmetics that have been produced or imported shall be confiscated; If the value of the cosmetics produced or imported is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 150,000 yuan shall be imposed; If the value of the goods is not less than 10,000 yuan, a fine of not less than 15 times but not more than 30 times the value of the goods shall be imposed; The legal representative or the main person in charge of the illegal unit, the directly responsible person in charge and other directly responsible personnel shall be fined not less than 3 times but not more than 5 times the income they obtained from the unit in the previous year, and they shall be banned from engaging in the production and operation of cosmetics for life.

Rules are the key to industrial development. A law that keeps pace with The Times will guide and promote the development of the industry to a large extent. Standing in the critical period of the development of China's cosmetics industry for 30 years, the new Regulations have systematically reshaped the rules of the cosmetics industry, designed the development rules of the cosmetics industry from the full perspective of cosmetics category, cosmetics raw materials, product claims, product production, business responsibilities, etc., and made the responsibility clear to people, which is the progress of legislation and the future development direction of the cosmetics industry. It has far-reaching influence on the development of cosmetics industry in China. Enterprises should master the rules and plan ahead.

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