Frequently Asked Questions and Management of Cosmetics (3)
Author:China Medical News Information Time:2022.07.25
In order to further regulate the supervision and management of cosmetics and protect consumers' legitimate rights and interests, the Cosmetics Supervision Department of the State Drug Administration has compiled the more concerned issues in the industry. Now, in accordance with the current cosmetics regulations and relevant technical specifications of my country's current cosmetics regulations:
Question: How to fill in the safety information of cosmetics raw materials correctly during cosmetics registration and filing?
Answer: According to the "Regulations on the Supervision and Administration of Cosmetics", "Administrative Measures for Cosmetics Registration and Registered", and "Technical Specifications for Cosmetics Safety" and other regulations and technical specifications, cosmetics registered persons and recorders shall conduct safety risk assessment of cosmetics raw materials, and during the registration process, Fill in the safety information used by the product formula. In order to promote the level of raw material safety management in my country's cosmetics industry, the State Drug Administration makes full use of informationization methods to organize the establishment of cosmetic raw materials security information reporting platforms to facilitate the uniformly filling in raw materials safety information and generate raw materials reporting code. Cosmetics registered persons and recorders can only fill in the raw material reporting code provided by the raw materials manufacturers to be associated with the platform. There is no need to fill in detailed material security information to improve the efficiency of cosmetics registration and filing work.
Based on the protection of business secrets, the raw material security information platform is used for filling in use only for cosmetics and raw materials. While providing cosmetics registered people and filing provided with raw materials, the raw material enterprises should also provide the necessary cosmetic raw materials safety information. For those who have no raw materials, it does not affect cosmetics registration and filing. Cosmetics registrars and recorders can fill in the safety information of raw materials on the cosmetics registration and filing platform according to the raw material security information documents issued by the raw material manufacturer.
Q: How to correctly understand the evaluation of the efficacy of cosmetics? How to deal with registered and filing products can we meet the requirements of cosmetics efficacy to declare management regulations?
Answer: In order to implement the Regulations on the Supervision and Administration of Cosmetics, the evaluation of the standards and guidance of the efficacy of cosmetics, the State Drug Administration has formulated and released the "Cosmetic Effective Evaluation Specifications" (No. 50, 2021, hereinafter referred to as the "Specifications"). According to the requirements of the "Specifications", not all cosmetics need to be evaluated. The majority of the listing cosmetics can be directly identified by the sensory such as visual and smell (such as cleaning, removing makeup, beauty modification, aroma, refreshing, hair dyeing, perm, hair color care, deodorization and auxiliary shaving or shaving or shaving or shaving hair or shaving shaving or shaving hair or shaving shaving or shaving hair or shaving or shaving or shaving or shaving or shaving or shaving or shaving or shaving or shaving or shaving or shaving shaving or shaving or shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving shaving or shaving. It is declared that the effect of simply physical coverage, adhesion, friction, etc.) is declared, and the effective evaluation is avoided; only a few of them have strong functions and strictly managed in most countries and regions in accordance with the foreign products of drugs or pharmaceuticals (such as freckle freckle removal, etc. Whitening, sunscreen, anti -hair loss, acne removal, nourishing, repair, etc.) declared that the human efficacy evaluation test was required; other effects declared that it could be carried out through literary data research, research data analysis, or cosmetic efficacy declaration test testing and other means to conduct evaluation tests and other means. Evaluation.
For cosmetics that have been registered and filed before May 1, 2021, cosmetics registrars and recorders shall upload relevant product effects to claim to be based on the transition period. After the registered person and the recorder claims the efficacy of the relevant products in accordance with the requirements of the Regulations, the evaluation results cannot support the content of the product name or label involved in the label. The classification and encoding of the product is adjusted, and the product name or label -related content is modified at the same time to meet the requirements of regulations.
Question: How should cosmetics registrars and recorders be sampled to the product? How to determine the number of samples?
Answer: According to the "Measures for the Supervision and Management of Cosmetics Production and Management", "Regulations on the Management of Cosmetics Registration Recording Data Management", and "Regulations for the Management of Quality Management of Cosmetics Production", cosmetics registered persons and recorders shall reserve samples of products per batch of products. The purpose of this sample system is to ensure the quality and safety of the product, compact cosmetics registered people, and the recorder's main responsibility for product quality and safety; The legality and safety of each batch of products.
In the actual implementation of the sample system, in accordance with the above regulations, in order to save the operating costs of enterprises, comprehensively consider factors such as different product categories, packaging specifications, and finished states. The situation has sorted out the number of samples (see the table below) sold on the market for the reference of Guangda enterprises in the practice of production and operation. For the types of products that are not listed in the table below, please cosmetics registered and recorders to determine the number of samples in accordance with the requirements of the regulations.
Cosmetics registered person, the number of samples of the product products
Note: The net content of makeup products is less than 1 gram. While the finished product is reserved, it can be sampled by the semi -finished product. The sample should meet the needs of the product quality inspection.
Question: Where should the importers of imported cosmetics and the recorder be left for the cosmetics imported in China?
Answer: In November 2021, the State Drug Administration issued the "Announcement on Implementation of the Measures for the Supervision and Management of Cosmetics Production and Management" (relevant matters "(No. 140, 2021) People should leave samples for each batch of products imported in China, and the samples and records are preserved by the responsible persons in the country. Those who import the same production batch products in multiple times shall be left for at least one time when they are imported.
According to the "Model Management Specifications for Cosmetics Production", the cosmetics registrar and recorder entrusted to produce should be left on their residence or main operating venues, or they can be left in other operating venues where their residences or main operating venues are located.The understanding of the "location" in the "where its residence or the main business place is located" is usually identified as the administrative area that does not exceed the same local cities or the same municipality.The person responsible for the domestic responsible person should be implemented with reference to the above provisions.The choice of leaving places should be able to meet the provisions of laws and regulations and product storage requirements for label labels.Source: State Drug Administration
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