Cosmetics are daily industrial products necessary for personal consumption. Because cosmetics are in direct contact with consumers' skin and directly affect consumers' health, their safety and efficacy are highly valued by consumers, manufacturers and government regulators. From the perspective of consumers, qualified cosmetics can play a role in cleaning, protection, beauty and modification, and bring pleasure to consumers; Unqualified cosmetics will cause a series of serious skin health problems such as cosmetic contact dermatitis, abnormal skin pigment, and hair damage. Health supervision of cosmetics has become an important and indispensable link to protect the health of consumers. From the perspective of operation, the violation of cosmetic hygiene regulations by cosmetic manufacturers will lead to great operating losses. If it occurs in the product listing process, it will lead to the product can not be listed on time, delay the market sales time; If it occurs in the product sales process, it will not only cause irreparable heavy losses to brand goodwill, but also lead to economic losses such as product removal, product recall, waste of channel entry fees, channel fines, scrap of packaging materials, consumer complaints and disputes, and administrative penalties. Especially in the current environment where supervision is increasingly in place and professional "anti-fake" is active, brand cosmetics enterprises should pay more attention to the compliance of cosmetics operation. Jiao Hanwei, lawyer of Shanghai Guohillhouse Law Firm, will discuss China's cosmetic hygiene supervision system from a legal perspective based on practical experience to provide reference for operators.

Cosmetic health regulatory agency

China's cosmetic health supervision agencies have a process of adjustment before and after. Before the adjustment of The State Council in 2008, the health supervision of cosmetics in China was mainly carried out by the Ministry of Health and related health administrative departments. After the adjustment of The State Council institutions in 2008, the responsibility of cosmetics health supervision in China was adjusted to the national food and drug supervision and administration department, which was specifically responsible for cosmetics policy formulation, cosmetics production license approval, health supervision and management, cosmetics license approval, cosmetics filing and other health supervision responsibilities.

Hygienic supervision of cosmetics

The State department for food and Drug supervision and administration shall exercise hygiene supervision over cosmetics according to law. There are two main ways of health supervision: pre-supervision and post-supervision. Prior supervision mainly refers to the supervision of the production of cosmetics by the food and drug regulatory authorities through the cosmetics licensing (filing) system before the product is put on the market. It mainly includes cosmetics production administrative license, domestic special use cosmetics health administrative license, import special use cosmetics health administrative license, domestic non-special use cosmetics record and import non-special use cosmetics record. Post-supervision refers to the organization of regular and irregular inspection by the cosmetic health supervision department of the enterprises that have obtained the "Cosmetic Production License" and the cosmetics at the marketing stage, in the specific form of: the cosmetic health supervision functional department regularly or irregularly extracts a certain proportion of cosmetics to the cosmetic production enterprises or the cosmetic market for supervision and testing. The contents of regular supervision and spot checks mainly include cosmetics health license, product microorganism, cosmetics prohibited substances, cosmetics restricted substances, etc., whether they violate China's cosmetics health supervision and regulations.

Cosmetics production license system

The cosmetics production license system refers to the domestic cosmetics production enterprises in the domestic production of cosmetics, the need to meet the technical specifications of cosmetics production enterprises and other conditions, to the provincial cosmetic health supervision department to apply for a production license, obtain the provincial cosmetic supervision department issued a cosmetic production license before the production of related cosmetics. The license system of cosmetics production is one of the important ways for the health supervision of cosmetics production enterprises. Article 5 of the Regulations on Cosmetic Hygiene Supervision stipulates that a hygiene license system shall be implemented for the hygiene supervision of cosmetic production enterprises; The health license of a cosmetic production enterprise shall be approved and issued by the health administrative department of the province, autonomous region or municipality directly under the Central Government. As far as the approval is concerned, the early stage is the health license of the cosmetic production enterprise, and the later stage is changed to the cosmetic production license. The State Food and Drug Administration issued No. 265 "Announcement on Matters related to the Production License of Cosmetics Production" in 2015, which stipulates that the "Cosmetic Production License" will be unified from January 1, 2017; The original "National Industrial Product Production License" and "Cosmetic Production Enterprise Health License" held by a cosmetic production enterprise are automatically invalid. At present, any new cosmetic production enterprises can apply to the local provincial food and drug supervision and administration department; The provincial food and drug supervision and administration department shall, in accordance with the requirements of the "Cosmetic Production License Work Standard", organize the audit of the enterprise and issue the "cosmetic production License" to meet the requirements. The validity period of the cosmetic production license is 5 years, and the model is formulated by the State Food and Drug Administration. At the same time, cosmetics packaging labels must be marked with cosmetics production license approval number. Cosmetics production license system is a pre-prevention system, by setting the pre-procedure of cosmetics production enterprises, it has played a better cosmetic safety prevention effect to a certain extent.

Filing system for domestic non-special use cosmetics

China has implemented a filing system for the supervision of non-special use cosmetics, but the details have changed. At the beginning, domestic non-special use cosmetics were put on record after listing, that is, China's cosmetics production enterprises can produce domestic non-special use cosmetics after obtaining a makeup production license; Cosmetics manufacturers can put related products on the market after completing the internal quality control procedures and passing the inspection; Cosmetic manufacturers shall submit the relevant product information to the provincial cosmetic health regulatory functional department for written record within the legal period after the product is listed and sold, and obtain written non-special use cosmetic filing vouchers after the record is passed. In the practice of cosmetics business, the rate of post-filing implementation is very low. In order to strengthen the management of domestic non-special use cosmetics, and taking into account the improvement of the filing efficiency of a large number of non-special use cosmetics in cosmetic manufacturing enterprises, the national food and drug regulatory department adjusted the filing of non-special use cosmetics to the listing front in 2014. Since June 1, 2014, domestic non-special use cosmetics should be listed in accordance with the requirements of the "Domestic non-special use cosmetics information filing Regulations", product information online filing, filing information confirmed by the provincial food and drug regulatory authorities, by the State Food and Drug Administration government network unified publication for public inquiry, The provincial food and drug administration department will no longer issue a written "Record Certificate of Domestic non-special Use Cosmetics". According to this, cosmetic manufacturers shall submit the information of product formula (excluding content, except for restricted substances) and sales packaging (including product labels and product instructions) to the provincial food and drug regulatory authorities in the administrative region according to the requirements through a unified network platform; Product safety assessment data, product production process description, product production equipment list, product technical requirements and product inspection report and other data shall be properly stored by the manufacturer for future reference. For entrusted products, the entrusting parties shall respectively submit the information for the record to the provincial food and drug supervision and administration department within their respective administrative regions. For export only, the actual production enterprise shall submit the archival information to the provincial food and drug supervision and administration department within the administrative region. Through the online filing of non-special use cosmetics information and the opening of the public inquiry channel, it guarantees the realization of consumers' right to know, meets the needs of enterprise operation efficiency, and also normalizes the market order of non-special use cosmetics to a large extent.

Sanitary licensing system for domestic special use cosmetics

Special purpose cosmetics refer to cosmetics with special effects compared with ordinary cosmetics, including nine types of cosmetics, such as hair growth, hair coloring, perm, hair removal, beauty, bodybuilding, deodorization, whitening and freckle removal, and sun protection. China implements a licensing system for the supervision of special use cosmetics, that is, if China's cosmetics manufacturers want to produce special use cosmetics, they need to apply for a special use cosmetics license after obtaining a makeup production license, and then they can produce the corresponding special use cosmetics. The Regulations on the Supervision and Control of Cosmetics Hygiene stipulate that the production of cosmetics for special purposes must be approved by the administrative department of health under The State Council, and the approval number can only be obtained before production, thus establishing the health administrative licensing system of cosmetics for special purposes in China. In addition, domestic cosmetics manufacturers in the production of hair care, hair color, perm, hair removal, beauty, bodybuilding, deodorization, whitening freckle, sun protection nine special purpose cosmetics, but also need to mark the accurate approval number on the cosmetics packaging label. At this stage, the health license for special use cosmetics is centralized in the State Food and Drug Administration. Due to different product testing items, the license processing cycle varies greatly, and the processing cycle is generally about 12-18 months. The national food and drug regulatory department has conducted technical review of special use cosmetics in advance through the special use cosmetics licensing supervision system, effectively controlling the safety of special use cosmetics. Cosmetics enterprises should fully consider the product license cycle when developing special use cosmetics, so as not to affect the product listing plan. Cosmetics belong to fast-moving consumer goods, the market changes rapidly, product update iteration is particularly fast, the current 12-18 months certification cycle greatly delayed the special use of cosmetics new product development, listing cycle, obviously can not meet the business needs of cosmetics business enterprises, still need to be further improved.

Cosmetics illegal behavior and legal responsibility

Based on the consideration of the operation compliance of cosmetics enterprises, cosmetics manufacturers and cosmetics sales enterprises need to understand and strictly abide by the above cosmetic health regulations and regulations to prevent unnecessary business risks. In practice, the typical health violations of cosmetics production enterprises are: without obtaining the "cosmetics production license" without authorization; Transfer, forge or resell the Cosmetic Production License; The production of domestic non-special use cosmetics is not recorded; Production of cosmetics for special purposes without approval number without authorization; Marking a false approval number for special use cosmetics; Knowingly produce and sell cosmetics that do not meet health standards. If the cosmetics operators implement the above illegal acts, it will bring irreparable goodwill loss to the brand, resulting in product removal, packaging material scrap, channel fines and other business consequences. Specifically, cosmetics operators need to bear the following legal responsibilities: First, cosmetics operators need to assume administrative responsibilities in accordance with relevant regulations such as the Regulations on the Supervision of Cosmetics Hygiene and the Implementation Rules of the Regulations on the Supervision of Cosmetics Hygiene. For example, the production of cosmetics for special purposes without the approval number, the cosmetics regulatory department has the right to confiscate the products and illegal income, impose a fine of 3 to 5 times the illegal income, and may order the enterprise to stop production or revoke the cosmetics production license. Secondly, cosmetics cause human injury or poisoning accidents, cosmetics operators also need to bear civil liability for compensation, by the directly responsible production enterprises and business units or individuals to compensate for consumer losses. Finally, cosmetic operators who produce and sell cosmetics that do not meet health standards and cause serious consequences, constituting a crime, should also bear criminal responsibility. China's Criminal Law stipulates that whoever produces cosmetics that do not meet hygiene standards, or knowingly sells cosmetics that do not meet hygiene standards, thereby causing serious consequences, shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention and shall also, or shall only, be fined not less than 50 percent but not more than two times the amount of sales. Therefore, cosmetics operators should pay attention to compliance work.

Jiao Hanwei

Chief partner and lawyer of Shanghai Guohillhouse Law Firm

Have more than 10 years of legal service experience and more than 5 years of cosmetics business experience, familiar with law, familiar with business, He is good at providing enterprises with legal counsel, contract review, brand management, business compliance, business negotiation, intellectual property management, tax planning, equity transfer, corporate structure design, equity incentive, investment and financing, restructuring and merger, dispute resolution and other solutions for the whole stage of enterprise development from the perspective of law and business operation.