Frequently Asked Questions on Supervision and Management of Cosmetics-Filling in Safety Information of Cosmetic Raw Materials, etc.

Release time:

2022-03-14 09:02

In order to further standardize the supervision and management of cosmetics and protect the legitimate rights and interests of consumers, the Cosmetics Supervision Department of the State Food and Drug Administration has sorted out the issues of concern to the industry, and is now answering them one by one in accordance with my country's current cosmetics regulations and relevant technical specifications:

How to correctly fill in the safety information of cosmetic raw materials during the registration and filing of cosmetics?

Answer: According to regulations and technical specifications such as the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Administration of Cosmetics Registration and Filing, and the Technical Specifications for Cosmetics Safety, cosmetics registrants and filers shall conduct safety risk assessments on cosmetic raw materials and fill in the registration and filing process. Fill in the safety information of raw materials used in the product formula. In order to promote the level of raw material safety management in China's cosmetics industry, the State Food and Drug Administration has made full use of information technology to organize the establishment of a cosmetics raw material safety information reporting platform to facilitate raw material enterprises to uniformly fill in raw material safety information and generate raw material reporting codes. Cosmetics registrants and filers can only fill in the raw material submission code provided by the raw material manufacturer for association by the platform, without repeatedly filling in detailed raw material safety information, thus improving the efficiency of cosmetics registration and filing.

Based on the consideration of protecting trade secrets, the raw material safety information platform is only used by cosmetic raw material enterprises. The raw material enterprise shall provide the necessary safety information of cosmetic raw materials while providing the raw material submission code to the cosmetic registrant and the filing person. If there is no raw material submission code, it will not affect the registration and filing of cosmetics. Cosmetic registrants and filers can fill in the raw material safety related information on the cosmetics registration and filing platform according to the raw material safety information documents issued by the raw material manufacturer.

How to correctly understand the evaluation of cosmetic efficacy claims? How to deal with the products that have been registered and filed in order to meet the requirements of cosmetic efficacy claims management regulations?

A: in order to implement the regulations on the Supervision and Administration of Cosmetics and standardize and guide the evaluation of cosmetic efficacy claims, the State Food and Drug Administration has formulated and issued the Standard for the Evaluation of Cosmetic Efficacy claims (No. 50 of 2021, hereinafter referred to as the "Standard"). According to the requirements of the Code, not all cosmetic products need to be evaluated for efficacy claims. The majority of cosmetics on the market that can be directly identified through the senses such as vision and smell (such as cleaning, makeup removal, beauty modification, fragrance, body refreshing, hair dyeing, perm, hair color care, hair removal, deodorization and auxiliary shaving or effects through simple physical covering, adhesion, friction, etc.) are exempted from efficacy evaluation; only for a few claims that have strong functions and are strictly managed according to drugs or external products of the pharmaceutical department in most countries and regions (such as freckle removal and whitening, sun protection, hair loss prevention, acne removal, nourishment, repair, etc.), human efficacy evaluation tests are required. Other efficacy claims can be evaluated by means of literature research, research data analysis or cosmetic efficacy claim evaluation tests depending on the situation.

For cosmetics that have been registered and filed before May 1, 2021, the cosmetic registrant and filer shall upload a summary of the basis for the claim of the efficacy of the relevant products in accordance with the transitional policy. After the registrant and the filing person have evaluated the efficacy claims of the relevant products in accordance with the requirements of the Code, if the evaluation results cannot support the efficacy claims involved in the product name or label, they may apply for change before the expiration of the transition period, adjust the classification code of the product according to the actual attributes of the product, and modify the relevant contents of the product name or label to make it meet the requirements of the regulations.

How should cosmetic registrants and filers keep samples of products? How to determine the number of samples?

Answer: According to the "Measures for the Supervision and Administration of Cosmetics Production and Operation", "Regulations on the Management of Cosmetics Registration and Filing Materials", and "Cosmetics Production Quality Management Regulations", cosmetics registrants and filers should leave samples for each batch of products that leave the factory. The purpose of the sample retention system is to ensure the traceability of product quality and safety, and to compact the main responsibility of cosmetics registrants and filers for product quality and safety; at the same time, when the sold products have quality and safety problems and are counterfeit, it is convenient to check The legality and safety of each batch of products.

In the actual implementation of the sample retention system, in accordance with the above-mentioned laws and regulations, and at the same time, in order to save the operating costs of enterprises, comprehensively consider different product categories, packaging specifications, finished product status and other factors, the Cosmetics Supervision Department of the State Food and Drug Administration refers to the actual supervision work and combines The industry research situation, sorted out the number of retained samples of common products sold on the market (see the table below), for reference in the majority of enterprises in production and operation practice. For the product types not listed in the following table, please cosmetics registrants and filers to determine the number of retained samples in accordance with the requirements of laws and regulations.

Note: If the net content of cosmetics products is less than 1g, the samples of finished products can be retained in combination with semi-finished products. The retained samples shall meet the requirements of product quality inspection.

Where should the registered person and the filing person of imported cosmetics leave samples for their imported cosmetics in China?

A: In November 2021, the State Food and Drug Administration issued the Announcement on Matters Related to the Implementation of the Measures for the Supervision and Administration of Cosmetics Production and Operation (No. 140 of 2021), specifying that overseas cosmetics registrants and filers shall keep samples of each batch of products imported into China after January 1, 2022, and the samples and records shall be kept by the responsible person in China. Where the same production batch of products is imported in multiple batches, samples shall be retained at least once at the time of the first import.

According to the "Cosmetics Production Quality Management Regulations", the registered person or the filing person who entrusts the production of cosmetics shall keep samples at their domicile or main business premises, and may also keep samples at other business premises where their domicile or main business premises are located. The understanding of "location" in "the place where his residence or main place of business is located" is usually determined as not exceeding the administrative area of the same prefecture-level city or the same municipality directly under the Central Government. Where the person responsible within the territory keeps the samples, the selection of the place where the samples are kept shall be carried out with reference to the above provisions. The selection of the place for sample retention shall be able to meet the requirements of laws and regulations and the product storage requirements marked on the label.

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