Official answer: Frequently asked questions about cosmetics production and operation

In accordance with the Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the "Regulations") and the Measures for the Supervision and Administration of Cosmetics Production and Operation (hereinafter referred to as the "Measures"), the Department of Cosmetics Supervision of the State Food and Drug Administration sorted out the main issues that the cosmetics industry is concerned about in the implementation of the Measures and answered them one by one. The details are as follows:

▌Can the person in charge of quality and safety concurrently serve as a cosmetics registrant, filing person, or entrusted manufacturer?

Answer: In order to ensure the quality and safety of cosmetics and ensure that the person in charge of quality and safety implements the responsibilities of product quality and safety management and product release in accordance with the law, in accordance with the principle of "one certificate and one person", apply for more than two (including two) cosmetics production licenses, and the same natural person shall not serve as the person in charge of quality and safety of the above-mentioned enterprises; Different cosmetics registrants and filing persons shall not be subject to the same natural person as the person in charge of quality and safety. When a cosmetics registrant, a filing person and a entrusted production enterprise belong to the same group company and implement the same quality management system, and the entrusted production enterprise accepts the entrustment of the registrant or filing person to produce cosmetics, the registrant, filing person and the entrusted production enterprise may employ the same natural person as the person in charge of quality and safety.

▌Can the person in charge of quality and safety authorize others to perform their duties on their behalf?

Answer: Article 28 of the Measures stipulates that the person in charge of quality and safety shall assist the cosmetics registrant, filing person, legal representative and main person in charge of the entrusted production enterprise to undertake the corresponding product quality and safety management and product release responsibilities in accordance with the requirements of the cosmetics quality and safety responsibility system.

According to the needs of the operation of the production quality management system of the cosmetics registrant, the filing person and the entrusted production enterprise, with the written consent of the legal representative or the main person in charge, the person in charge of quality and safety may authorize others to perform their duties on their behalf. The authorized person shall have the corresponding qualifications and ability to perform their duties. The time authorized by the person in charge of quality and safety, the authorized personnel, and the authorized matters shall be truthfully recorded to ensure that the authorized acts can be traced. The person in charge of quality and safety shall supervise the performance of duties by the authorized person, and the legal responsibility that he or she should bear shall not be transferred to the authorized person.

▌How to correctly understand that "the production process of labeling should be completed in the cosmetics manufacturer that has completed the last production process that touches the contents of cosmetics"?

Answer: Article 63 of the Measures stipulates that the production process of cosmetics labeling shall be completed in the cosmetics manufacturer that has completed the final production process of contact with the contents of cosmetics.

The original legislative intent of this provision was to prohibit cosmetics from leaving the factory before the product label is completed, resulting in the product being untraceable. For the purposes of this article, the term "production process for labeling cosmetics" refers to the production process in which labels are applied to packaging materials that come into contact with the contents of cosmetics.

It is worth noting that under the premise that the production process of labeling the original packaging of imported cosmetics has been completed and traceable, the act of affixing Chinese labels can not be completed in the cosmetics manufacturer that has completed the final production process of contacting the contents of the cosmetics.

▌Who are the people directly engaged in the production of cosmetics? What are the diseases that hinder the quality and safety of cosmetics as stipulated by the competent health department of the State Council?

Answer: The scope of "personnel directly engaged in cosmetics production activities" stipulated in the Regulations shall be determined according to the actual situation, and in principle, it shall include personnel engaged in cosmetics production, inspection and warehouse related operators. Such employees shall undergo health examinations in accordance with regulations before and during their employment, and obtain a physical examination report issued by a medical institution with complete examination items and clear conclusions before they can take up their posts.

According to the Regulations, the competent health department of the State Council shall stipulate the scope of diseases that hinder the quality and safety of cosmetics. Before the promulgation of the relevant regulations by the competent health department of the State Council, the scope of diseases that hinder the quality and safety of cosmetics as stipulated in the original regulations "Regulations on the Hygiene Supervision of Cosmetics" is currently implemented, including: dysentery, typhoid, viral hepatitis, active tuberculosis, hand skin diseases (ringworm of the hand, nail fungus, hand eczema, psoriasis or scales occurring on the hands) and exudative skin diseases. People suffering from these diseases cannot directly engage in cosmetics production activities.

▌Should cosmetics operators establish and implement a product sales record system?

Answer: According to the provisions of the "Regulations" and the "Measures", cosmetics registrants, record-filing persons and entrusted production enterprises shall establish and implement a product sales record system. Cosmetics operators such as shopping malls and supermarkets are not required to establish and enforce a product sales record system, but shall take effective measures to ensure that products can be traced. If the sales target of a cosmetics business operator is other cosmetics business operators, they are encouraged to establish and implement a product sales record system.

▌Can beauty salons, hotels, etc. prepare and fill cosmetics?

Answer: Beauty salons, hotels, etc., that use cosmetics or provide cosmetics to consumers in their business operations shall perform the obligations of cosmetics operators stipulated in the "Regulations" and "Measures" in accordance with the law, and the cosmetics they provide to consumers shall comply with the provisions of the minimum sales unit label.

According to the "Measures", a cosmetics production license shall be obtained for the preparation, filling and filling of cosmetic contents. Beauty salons and hairdressing establishments shall not prepare cosmetics on their own, nor shall they fill or fill the contents of cosmetics without authorization, except in the case of on-site dispensing of cosmetics for consumers in accordance with the method of use on the cosmetics label or instructions. Cosmetics provided to consumers by hotels, bathing centers, wedding photo studios, confinement centers, etc., shall have product labels that comply with the regulations, and the labels shall indicate the product name, the number of the special cosmetics registration certificate, the name and address of the registrant, the filing person, and the entrusted manufacturer, the number of the cosmetics production license, the standard number of the product, the full ingredients, the net content, the period of use, the method of use, and the necessary safety warnings, as well as other contents that shall be marked according to laws, administrative regulations and mandatory national standards.

▌Can cosmetics operators "divide" large-package cosmetics into small packages and sell them?

According to the Regulations on the Supervision and Administration of Cosmetics, the smallest sales unit of cosmetics should be labeled. According to the Measures for the Supervision and Administration of Cosmetics Production and Operation, a cosmetics production license shall be obtained for the preparation, filling and filling of cosmetics contents. Accordingly, cosmetics business operators, as well as beauty salons and hotels that use cosmetics or provide cosmetics to consumers in their business (hereinafter collectively referred to as "cosmetics operators"), if they "package" large packages of cosmetics into small packages, if their behavior comes into contact with the contents of cosmetics, it is a cosmetics production act and shall obtain a cosmetics production license. Cosmetics business operators who sell cosmetics in a way that touches the contents of cosmetics without obtaining a cosmetics production license are suspected of violating the law and should be prohibited.

▌What should be included in the sample product label?

According to the Regulations on the Supervision and Administration of Cosmetics, the label of cosmetics shall be marked with the product name, the number of the special cosmetics registration certificate, the registrant, the filing person, the name and address of the entrusted manufacturer, the standard number of the product, the full ingredients, the net content, the expiration date, the method of use, and the necessary safety warnings. According to the relevant provisions of the Measures for the Administration of Cosmetics Labels and the Regulations on the Administration of Cosmetics Registration and Filing Materials, the sample of the product label is the basis for making the label of cosmetics. Cosmetics registrants and filing persons shall be responsible for the content of cosmetics label samples and bear the main responsibility for product quality and safety in accordance with law.

The sample product label shall include the text, symbols, numbers, and pattern descriptions used to identify and explain the basic information, attribute characteristics, and safety warnings of the product on the packaging of cosmetics to be marketed. In addition to the content that shall be marked on the label as stipulated by relevant laws and regulations, the content related to product safety and efficacy claims independently selected by the enterprise on the product label shall be filled in the sample product label. For the content that is not marked on the product label, such as the product brand concept, corporate culture, founder R&D story and other product advertising content of some enterprises, the cosmetics registrant and filing person should not fill in the sample product label.

▌How should cosmetics operators on the platform disclose cosmetics label information?

According to the Measures for the Supervision and Administration of Online Cosmetics Operations, cosmetics operators on the platform shall fulfill the obligation to disclose cosmetics information, and comprehensively, truthfully, accurately, clearly and timely disclose cosmetics labels and other information consistent with the registration or filing materials, among which the disclosed cosmetics label information shall include all the contents of the cosmetics labels they operate. With regard to the disclosure of the "expiration date" of products in the cosmetics label information, considering that cosmetics operators on the platform may operate multiple batches of products, it is difficult to disclose the expiration date of each batch of products one by one, in order to protect consumers' right to know, cosmetics operators on the platform can indicate the expiration date of the products in a prominent position on their product display pages, as detailed in the product sales packaging.

In addition, according to the Measures for the Supervision and Administration of Online Cosmetics Operations, in addition to disclosing cosmetics label information, cosmetics operators on the platform shall disclose other information related to product safety and efficacy claims that are consistent with the relevant content of the label information and the summary of the basis for efficacy claims in the registration or filing materials of cosmetics they operate. It should be emphasized that the "consistency" here is not the "exactly the same" in the text, but the consistency of the meaning expressed. Cosmetics operators on the platform may, on the product display page of the cosmetics they handle, advertise the safety and efficacy claims of the product within the scope and expression of intent that do not exceed the scope and meaning of "the relevant content of the label information and the summary of the basis for the efficacy claim in the product registration or filing materials".

This article is translated and organized by Yireh, please indicate the source for reprinting!

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