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[Updated] CSAR Subsidiary Regulations: China Implements the Finalized Good Manufacturing Practices for Cosmetics

The Practices finalizes the qualification requirements and duties of the person in charge of quality and safety, ensures the traceability of products from production to market, refines the requirements for sample retention, further clarifies the requirements for entrusted production, etc.

Editor’s Note: This article was originally published on Jan. 10, 2022, and was updated on Jul. 1, 2022, as per the latest developments.

In September 2020 and 2021, China National Medical Products Administration (NMPA) released the first and the second draft of Good Manufacturing Practices for Cosmetics (hereinafter referred to as “Practices”). After two rounds of public consultation, on January 7, 2022, NMPA released the finalized Practices and implemented it on July 1, 2022. 1

  • Starting from July 1, 2022, cosmetics registrants, notifiers, and entrusted production enterprises (including cosmetic enterprises that only engage in the preparation of semi-finished products, and toothpaste enterprises) shall organize the cosmetic production in accordance with the Practices;

  • For enterprises that have obtained production licenses before July 1, 2022, if their facilities, equipment, etc., shall be upgraded according to the Practices, the upgrading and reconstruction shall be completed before July 1, 2023.

化妆品合规BANNER 810 150  gif.gifMain Contents

The Practices are divided into nine chapters with two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. The promulgation of the Practices indicates that cosmetics production in China enters a more standardized era.

Chapter I General Rules

Chapter II Institutions and Personnel

Chapter III Quality Assurance and Control

Chapter IV Plant Facilities and Equipment Management

Chapter V Materials and Products Management

Chapter VI Production Management

Chapter VII Entrusted Production Management

Chapter VIII Product Sales Management

Chapter IX Supplementary Rules

Annex I Electronic Record Requirements for Cosmetics Production

Annex II Environmental Requirements for Cosmetics Production Plant

Key Points

Based on the quality control requirements in Practice for Cosmetics Production Licensing issued in 2015, the Practices' formulation supplements and refines relevant contents combined with the problems found in regulatory and supervisory practice. The three key points of the Practices are as follows:

1. Finalizes the qualification requirements and duties of the person in charge of quality and safety

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