Cosmetics business compliance (4) - Product production - Lawyer Guo Ling
As mentioned above, in terms of operation, compliance is one, and performance is zero. In the environment of increasing compliance requirements, business is not compliant, and all performance is temporary. 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. The production of cosmetics violates the hygienic regulations of cosmetics, which will lead to great operating losses from the perspective of operation. 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. Compared with the sale and promotion of cosmetics, the compliance of cosmetics production involves systematic business risks. Cosmetics operators should pay attention to the compliance of cosmetics production, especially the cosmetics production license system, the domestic special use cosmetics administrative licensing system and the domestic non-special use cosmetics filing system. This paper discusses the compliance problem of cosmetics production from the legal point of view for reference of business operators.
Administrative license for cosmetics production
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 supervision department of cosmetics to carry out the health supervision of cosmetics production enterprises in advance. 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 of domestic non-special use cosmetics
China has implemented a filing system for the supervision of non-special use cosmetics, but the operational 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.
Domestic special use cosmetics administrative license
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 the administrative license for special use cosmetics after obtaining the 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.
Based on the compliance requirements of the above cosmetics production, 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. If the production behavior of cosmetics is not compliant, it will bring irreparable goodwill loss to the brand, resulting in product removal, packaging material scrap, channel fines and other business consequences. In addition to economic losses, civil liability and administrative liability, cosmetic operators who produce or sell cosmetics that do not meet health standards and cause serious consequences, constituting a crime, shall 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 cosmetics production compliance work.