China.com, January 7, 2022 The State Food and Drug Administration recently issued the "Good Manufacturing Practice for Cosmetics" (hereinafter referred to as the "Code"), which will be implemented from July 1, 2022.
The Code requires cosmetics registrants, recorders and entrusted production enterprises engaged in cosmetics production activities (hereinafter collectively referred to as "enterprises") to establish and implement a health management system for employees. Personnel directly engaged in cosmetics production activities shall undergo health examinations before taking up their posts, and undergo health examinations every year after taking up their posts. Persons suffering from diseases that hinder the quality and safety of cosmetics as prescribed by the competent department of health under the State Council shall not directly engage in cosmetics production activities. Enterprises shall establish health files of employees and keep them for at least 3 years.
The "Specification" proposes that enterprises should establish and implement a traceability management system, formulate clear batch number management rules for raw materials, inner packaging materials, semi-finished products and finished products, and all records related to the production of each batch of products should be related to each other to ensure that all activities such as material procurement, product production, quality control, storage, sales and recall can be traced.
Establish and implement a quality management system self-inspection system. A self-inspection plan shall be formulated before the implementation of the self-examination, and a self-examination report shall be formed after the completion of the self-examination. The self-inspection report shall include problems found, product quality and safety evaluation, rectification measures, etc. Conduct an annual self-examination of the implementation of the Good Manufacturing Practice for Cosmetics.
The "Specification" makes it clear that enterprises should store sampled products and keep sample records in accordance with the provisions of relevant laws and regulations and the requirements of label marking. The retention period of sample retention shall not be less than 6 months after the expiration of the product use period. If it is found that the sampled product has deteriorated within the period of use, the enterprise shall promptly analyze the reasons and recall the batch of cosmetics that have been put on the market for sale in accordance with the law, and take the initiative to eliminate safety risks.
In addition, the "Specification" also stipulates the management of plant facilities and equipment, material and product management, production process management, entrusted production management, product sales management, etc.
According to the requirements, from July 1, 2022, cosmetics registrants, recorders and entrusted production enterprises shall organize the production of cosmetics in accordance with the requirements of the Code. Enterprises that have obtained cosmetics production licenses before July 1, 2022, and whose hardware conditions such as plant facilities and equipment must be upgraded, shall complete the upgrading and transformation before July 1, 2023, so that their plant facilities and equipment comply with the requirements of the Code.
(Editor: Dong Xiaodi)
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