CSAR Subsidiary Regulations: China Clarifies the Requirements for Cosmetics GMP

On Sep. 28, 2020, China NMPA released the draft Good Manufacturing Practices (GMP) for Cosmetics for public consultation ^[1]. Any suggestions can be mailed to ChemLinked ([email protected]) before Oct. 14, 2020, and we will submit to the NMPA.

Main Contents

CSAR stipulated that cosmetic registrants, notifiers, and entrusted production enterprises should organize the cosmetics production in accordance with the requirements of the Good Manufacturing Practices for Cosmetics. The Practices are divided into nine chapters and two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall.

Key Points

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

1. Establish a Cosmetic Production Quality Management System

Cosmetic registrants, notifiers, and entrusted production enterprises shall establish a cosmetics production quality management system to realize the control and traceability of the entire process of cosmetics material procurement, production, inspection, storage, sales, and recall.

Enterprises' responsibilities include:

• Establish and implement management systems such as suppliers selection, ingredients acceptance, equipment management, production process, and quality control, product inspection and sample retention, product sales, record management, traceability management, etc.;

• Designate qualified personnel in charge of quality and safety, the quality department, and the production department;

• Formulate batch number management rules for materials and products. Each batch of products should have corresponding batch numbers and production inspection records to ensure the traceability of production, quality control, storage and transportation.

• Establish and implement a purchase inspection and recoding system of ingredients and primary packaging materials. For ingredients derived from plant and animal, the source, preparation technology and application area should be clarified.

• Implement management system of quality and safety risk, and conduct quality risk assessments on key links in the production process.

• Conduct self-inspection at least once a year and generate a report. Self-inspection can be conducted by a qualified third party.

• Record all the activities related to the Practices, and the record retention period should be more than one year after the product expiry date.

*Other responsibilities can be found in the English translated version.

2. Recognize Technical Schemes Equivalent to the Practices

More advanced management models or technologies than the requirements specified in the Practices are encouraged. Under the premise of ensuring product quality and safety, the enterprise can adopt technical schemes equivalent to the Practices’ requirements and should keep the necessary verification documents and records.

3. Non-cosmetic Products that Adversely Affect the Cosmetic Quality are Prohibited from being Produced Together with Cosmetics

The Practices stipulate that non-cosmetic products that have an adverse effect on the cosmetic quality should not be produced in the cosmetics production workshop, unless the ingredients used are in compliance with the cosmetic ingredient regulations and specification requirements, and the reports on quality management system and risk analysis are provided.

4. Include All the Requirements of ISO 22716 Good Manufacturing Practice for Cosmetics

The Practices include all the requirements of ISO 22716 Good Manufacturing Practice for Cosmetics to promote international cosmetics trade development.

*English Translations of these three regulations will be uploaded to ChemLinked soon. So keep updated on any CSAR updates by following ChemLinkeds’ dedicated CSAR Homepage.

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[English Translation]

• Instructions for Cosmetic Registration and Notification Dossiers (Draft for Comments)

• Instructions for New Cosmetic Ingredient Registration and Notification Dossiers

• Administrative Measures on Cosmetic Registration

• Cosmetic Classification Rules and Catalog

• Technical Guidelines for Cosmetic Safety Assessment

• Administrative Measures on Cosmetic Labeling

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