On August 2, 2021, the State Administration for Market Regulation (SAMR) officially published the Measures for Supervision and Administration of Cosmetic Production and Operation. This document will go into effect on January 1, 2022.
Based on Regulation on the Supervision and Administration of Cosmetics, the Measures have been developed to regulate activities involved in cosmetics production and operation, as well as to ensure cosmetics quality and safety. In 2020, the National Medical Products Administration (NMPA) drafted the Measures for Supervision and Administration of Cosmetic Production and Operation (draft for comments), and on July 21, 2020, the NMPA issued a notice for public opinions.
The Measures consist of 4 major aspects that are detailed through 7 chapters and 66 articles. The major aspects are illustrated below:
1. Optimize the production licensing procedures
According to the Measures, notification and commitment system should still be implemented for the cosmetics production license. Supervision measures after the notification and commitment will also be strengthened. Licenses that don’t meet the requirement shall be revoked according to law. The classification principles for a cosmetics production license are clarified, and the production of cosmetics related to children's skin care and eye skin care are required to be under special conditions. This document also improves the review and approval procedures for production license changes under different circumstances. When a company needs to have a license renewal due to production changes, a comprehensive on-site inspection will be carried out and a new cosmetics production license will be issued if the on-site inspection is qualified. The validity period of the license will be recalculated to reduce the burden and increase efficiency for enterprises.
2. Clarify the requirements for cosmetics production management
This document requires the cosmetics registrant, recorders, and entrusted production enterprises to establish a series of measures to ensure proper cosmetics production. These established measures include but are not limited to: a production quality management system, the implementation of a quality and safety responsibility system, as well as refining the requirements for sample retention management, self-examination, and the obligations of rectification, production halt, and reporting. Qualifications and specific responsibilities for quality and safety leaders are refined. As a result, conditions and obligations of the entrusting party and the entrusted production enterprises are clarified. At the same time, label management requirements are elaborated on in different aspects including cosmetics naming, special labeling of children's cosmetics, and label defects identification. Administration for false publicity and illegal declaration of cosmetics are also clarified.
3. Clarify the requirements for cosmetics operation management
Regulations on purchase inspection, product inspection, as well as storage and transportation record systems will be improved. In addition, the document defines the obligations of beauty salons, hairdressers, and hotels when they use cosmetics for business purposes or provide cosmetics for consumers. Moreover, it refines the responsibilities for the review, report, inspection and deterring of illegal behavior for all channels. These channels include the e-commerce platform, centralized trading market and exhibition organizers. The document also emphasizes the obligations for the platform to report major information involving quality and safety.
4. Strengthen the supervision measures and responsibilities for regulatory authorities
The document specifies the standards for cosmetics production quality management, and clarifies the key points and assessment principles of production quality management inspection developed by the NMPA. It also strengthens the management requirements for key regulatory objects, and refines the requirements for sampling inspection of drug regulatory departments at all levels. Concurrently, it stipulates that if the cosmetics sampling inspection is unqualified, the cosmetics registrant and recorder shall be responsible for self-examination and recalling the products in accordance with the law. Finally, according to this document, adverse reaction monitoring of cosmetics should comply with the reporting principle for any suspicious reaction.
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