Professional interpretation of the "Regulations on the Supervision and Administration of cosmetics" five major changes | beauty and health law

Author: 国瓴律师
Published on: 2020-07-01 00:00
Read: 9

     Rules are the key to industrial development. The law establishes the rules for the development of industry and to a large extent determines the future of the development of industry. A law that keeps pace with The Times will guide and promote the development of the industry to a large extent, while a lagging law will restrict the development of the industry. As far as the cosmetics industry is concerned, China is currently the second largest cosmetics market, there are more than 4,000 cosmetics production enterprises in the country, but small and medium-sized enterprises account for about 90%, and the level of cosmetics management is uneven. As far as cosmetic products are concerned, cosmetics belong to fast-moving consumer goods, with regional and seasonal products, various types, fast sales cycle, frequent adjustment of product concepts, formulas and packaging, flexible and diverse sales channels, personalized consumer demand, personalized marketing concepts and promotion strategies. The Regulations on Hygiene Supervision of Cosmetics were promulgated in 1989 and implemented in 1990. In the 30 years of implementation, the Health Supervision Regulations have played a positive role in regulating the production and operation behavior of cosmetics and strengthening the supervision of cosmetics, but with the rapid development of economic society and the cosmetics industry, the consumer demand for cosmetics has grown rapidly, and new concepts, new raw materials, new technologies, new channels and new problems have emerged today, showing a great lag. On the one hand, the "Regulations on Cosmetic Hygiene Supervision" focuses on prior approval, heavy government supervision, light enterprise self-discipline, can not give full play to the role of market mechanism, deviates from the demand for industrial upgrading, and is inconsistent with the international trend of cosmetic supervision. On the other hand, the supervision means stipulated in the Regulations on Cosmetic Hygiene Supervision are relatively lacking, the legal responsibility is relatively extensive, the punishment for illegal acts is weak, and there is no systematic risk management system with enterprises as the main body, which is difficult to meet the actual needs of regulating the production and operation order of cosmetics. The revision of "Cosmetic hygiene Supervision Regulations" has become an urgent problem for the development of China's cosmetics industry. Since 2013, the revision of the Regulations on Cosmetic Hygiene Supervision has become a legislative work plan project of The State Council and has been put on the agenda. In 2015, the first revised draft was issued. After a long period of research and deliberation, the executive meeting of The State Council deliberated and passed the Regulations on Supervision and Administration of Cosmetics (Draft) on January 3, 2020 (hereinafter referred to as the "New Regulations"). The "new regulations" were officially announced on June 29, 2020, and will be implemented from January 1, 2021. The "new regulation" replaces the "Cosmetic Hygiene Supervision Regulation", which is in the "constitutional" status in China's cosmetics supervision legal system, and will have a fundamental impact on the development of China's cosmetics industry in the next stage. After the publication of the new regulations, cosmetics operators should pay great attention to the systematic changes in the following five aspects, accurately grasp the industry rules, take precautions, and better achieve commercial purposes.

      

First, reshaping the classification of cosmetics has brought challenges and opportunities.
The concept, category and classification of cosmetics are the basic problems of the compliance of cosmetics business and the basic problems of the supervision of cosmetics. Products belong to the category of cosmetics is the premise of the application of cosmetics laws and regulations. Although they are all cosmetics, different types of cosmetics are subject to different regulatory regimes; Different kinds of cosmetics require different production qualifications, and even the classification boundaries of cosmetics affect the boundaries of contractual rights and interests such as endorsement contracts to a certain extent. For a long time, the definition of cosmetics in relevant cosmetics laws and regulations in our country is not uniform. Nowadays, with the endless emergence of new cosmetics products, the disunity of the definition and boundary of cosmetics has also brought certain troubles to the cosmetics business. In business practice, there is often a debate about whether a certain product is a cosmetic product, such as toothpaste, beauty needles, soap, hand sanitizer, mouthwash, and so on. The "New Regulations" clearly stipulate that cosmetics refer to daily chemical industrial products used to rub, spray or other similar methods on the skin, hair, nails, lips and other human body surfaces for the purpose of cleaning, protecting, beautifying and modifying. While qualitative cosmetics belong to "daily chemical industry products", the definition clarifies that the category of cosmetics refers to products applied to the surface of the human body. At the same time, the "new regulations" also adjust the scope of ordinary cosmetics and special cosmetics. While continuing the registration of special cosmetics and the filing management of ordinary cosmetics, special cosmetics will be adjusted from the original 9 types of cosmetics to: cosmetics that dye hair, perm hair, freckle whitening, sun protection, hair loss prevention and cosmetics that claim new effects. At the same time, the "new Regulations" further stipulates that the drug regulatory department under The State Council shall formulate and publish cosmetic classification rules and classification catalogues according to the claims of cosmetic efficacy, parts of action, product dosage forms, users and other factors. This means that the subsequent classification rules and classification catalogs will be more specific and more operable. Under the "new regulations", the five categories of hair care, hair removal, beauty milk, bodybuilding, deodorization originally belonging to the category of special cosmetics are no longer included in the category of special cosmetics, if the product management is changed from the registration system to the filing system, which means that the cosmetics business enterprises to produce the above five kinds of effective products will be more convenient, and bring new opportunities for the cosmetics business operation, and need to be clarified. In addition, the "new regulations" clarify the qualitative issues of toothpaste and soap. Although the main purpose of oral care products such as toothpaste is to clean and beautify, in line with the definition of cosmetics, and the United States, the European Union, Japan and other countries and regions will be oral care products into the management of cosmetics, but early in China's oral care products such as toothpaste do not belong to the category of cosmetics. In order to maintain the coherence of the work and make reference to international practice, the "new regulations" will be regulated by referring to the provisions on ordinary cosmetics; Specific measures for the administration of toothpaste shall be formulated by the drug regulatory department under The State Council and submitted to the market regulatory department under The State Council for examination and issuance. The above adjustment will certainly bring new challenges to the dental products industry such as toothpaste. However, considering the characteristics of products such as toothpaste, the "new regulations" should retain moderate flexibility while regulating the efficacy claims of toothpaste; It is clearly stipulated that the toothpaste filing person can claim that the toothpaste has the effect of preventing caries, suppressing dental plaque, anti-dentin sensitivity, reducing gum problems and so on after the efficacy evaluation according to national standards and industry standards. In addition, the "new Regulations" also make it clear that soap does not apply to this Regulation, but those claiming to have special cosmetic effects apply to this Regulation.
Second, establish a new raw material management system that combines registration and filing to free up the innovation of cosmetic raw materials.
Cosmetics are a mixture of natural, synthetic or extracted basic raw materials, auxiliary raw materials and functional raw materials with different functions, processed by heating, stirring and emulsifying production processes and production processes. The quality of cosmetics is affected by many factors such as raw materials, formula, production process, production process and environment, among which raw materials have the greatest impact on the quality of cosmetics. Cosmetic raw materials are directly related to the quality and safety of cosmetics, the efficacy of products, and the health of consumers. The Regulations on Cosmetic Hygiene Supervision stipulate that all new cosmetic raw materials should be approved before they can be used. In the cosmetics business practice, due to the harsh licensing conditions for new raw materials and cumbersome procedures, the enthusiasm of cosmetics enterprises to declare new raw materials for cosmetics is not high, and the number of new raw materials approved by the cosmetics is limited, which is not conducive to the innovation of the cosmetics raw materials industry, but also restricts the development and upgrading of China's cosmetics industry. The "new Regulations" refer to international experience, and still implement catalog management of cosmetics raw materials, and formulate a catalog of cosmetics used raw materials, prohibited raw materials and restricted raw materials. However, the "new Regulations" have made major adjustments to the management system of new raw materials for cosmetics, from the new raw material licensing system to the combined management system of new raw material registration and filing. Among them, the high-risk raw materials such as preservatives, sunscreens, colorants, hair dyes and whitening agents with a higher degree of risk are registered, and other new raw materials can be used for filing. The adjustment of cosmetic raw materials with low risk from the licensing system to the filing system for the use of new raw materials for cosmetics is not only conducive to the innovation of the cosmetic raw material industry, but also to a large extent for the scientific and technological upgrading of the cosmetic industry to create favorable conditions. Ingredient efficacy determines product efficacy to a large extent, as far as the main science and technology wind and ingredients of cosmetics companies, cosmetics new raw material innovation loosening, whether from the perspective of product efficacy, or from the perspective of brand publicity, will be a great deal.
Third, establish a product management system with efficacy claims and safety evaluation as the core, which sets a tight spell for product development.
According to the European Union definition, a cosmetic claim refers to the express or implied communication of a cosmetic product feature or function in the form of words, names, trademarks, patterns, numbers or other forms through labelling, commercial supply processes and advertising. Cosmetic claims are divided into safety claims, efficacy claims and other claims, of which product efficacy claims are the most important. The claim of cosmetic efficacy refers to the claim of transmitting the function and use effect of cosmetics, such as sun protection, whitening, oil control, moisturizing, anti-dandruff, etc. Cosmetics belong to fast moving consumer goods, product efficacy claims are of great significance to the realization of cosmetics sales. For marketing purposes, cosmetic products often make claims about their efficacy. The claim of cosmetic efficacy is closely related to the protection of consumer rights and interests, and developed countries and regions such as the United States, the European Union and Japan have strictly regulated it. Regarding the management of cosmetic efficacy claims, the Regulations on Cosmetic Hygiene Supervision only clarify prohibitive provisions, such as not claiming medical effects, but lack corresponding system design for the positive management of product efficacy claims. The "new Regulations" stipulate that the efficacy claims of cosmetics should have sufficient scientific basis, the enterprise is responsible for the efficacy claims, and should disclose the relevant literature, research data or efficacy verification materials on the designated website, accept social supervision, and initially establish the product efficacy management system. At the same time, the "new Regulation" draws on the practice of the European Union, establishes the product safety evaluation system, and makes it clear that the cosmetic registration applicant and the record holder should carry out the cosmetic safety evaluation by themselves or entrust an independent third-party institution in accordance with the provisions of the Food and Drug Administration department of The State Council. At the same time, the personnel engaged in safety assessment should have professional knowledge related to cosmetic quality and safety, and have more than 5 years of relevant professional experience. The new regulation also further stipulates that product safety assessment data should be submitted when products are registered or filed. Therefore, cosmetics companies in the product development, should be rigorous treatment of product efficacy claims evaluation and safety evaluation, can not be capricious.
Fourth, establish the system of responsible persons for product quality and safety, and strengthen the supervision of the whole process of cosmetics production.
Compared with the "Regulations on Cosmetic Hygiene Supervision", the "new Regulations" on the one hand established the gatekeeper system of the production link, and clearly required the production enterprise to designate the quality and safety person responsible for product quality and safety management and product factory release. On the other hand, in the legal responsibility part, it is clear that the responsible person for quality and safety of the enterprise in a specific illegal situation should bear the administrative responsibility such as fines and industry bans, and by clarifying the responsible person for quality and safety and refining the legal responsibility of the responsible person for quality and safety, cosmetics enterprises are forced to pay attention to the quality and safety of the cosmetics production link. After the implementation of the "new regulations", the arrangement and appointment of the responsible person for quality and safety of cosmetic production enterprises will become increasingly important and should be paid attention to. In addition, the "new regulations" will be the original quality supervision department issued by the cosmetic production license and the original food and drug supervision department issued by the cosmetic production enterprise health license into a cosmetic production license, strict enterprise self-management obligations, the establishment of self-inspection and reporting system; Cosmetics registrants, recordholders and entrusted manufacturers shall regularly conduct self-checks on the implementation of cosmetic production quality management standards; If the production conditions change and no longer meet the requirements of the cosmetic production quality management code, corrective measures shall be taken immediately; If it may affect the quality and safety of cosmetics, it shall immediately stop production and report to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central government. Through the construction of systems such as prior cosmetic production license, in-process quality and safety responsibility person and enterprise self-inspection, and post-event product recall, the "new Regulations" have established the supervision of the whole business chain of cosmetic production in the three stages before, during and after the event.
Fifth, refine the illegal circumstances, increase penalties, and significantly increase the cost of illegal activities.
As far as the liability for cosmetics violations is concerned, the regulatory means stipulated in the Regulations on Cosmetic Hygiene Supervision are relatively lacking, the legal liability is relatively extensive, on the one hand, the punishment for illegal acts is weak, on the other hand, it also leaves a great amount of discretion for law enforcement, and the law enforcement standards are not uniform. The "new Regulations" specify the illegal liability for illegal acts, the setting of legal liability comprehensively covers all kinds of illegal situations, standardizes the discretion of law enforcement, and clarifies the boundaries for standardizing law enforcement standards. In terms of increasing the intensity of punishment, it is manifested in three aspects: increasing the amount of punishment, expanding the scope of responsible persons and adding new types of administrative punishment. First of all, as far as the amount of fines is concerned, the penalty base of illegal activities of producers and operators is adjusted from illegal income to the value of goods, and the minimum fine is provided, and the penalty amount is greatly increased. The value of the goods refers to the total price of the illegal production or operation of cosmetics (including those sold and unsold); If there is no price tag, the price shall be calculated according to the market price of similar cosmetics. According to the value of the penalty, there will be a sky-high ticket. Secondly, the "new regulations" stipulate that in addition to the punishment of enterprises for illegal acts of production enterprises, the natural persons responsible for the person in charge of the enterprise, the person in charge of quality and safety, the safety assessment personnel and other natural persons can be fined, the industry ban and other administrative penalties, and the main body of responsibility is expanded. Thirdly, the "new Regulations" also enable a new type of administrative punishment "qualification penalty". For certain illegal acts, cosmetics business units and individuals will face a ban from the cosmetics industry for 3, 5 or 10 years. Compared with the "Regulations on Cosmetic Hygiene Supervision", the "new Regulations" detailed the legal consequences of illegal acts, increased penalties, greatly increased the illegal costs of cosmetics business, and purified the competitive environment of the industry. At the same time, the new regulations also standardize the law enforcement standards of the cosmetics regulatory authorities, solve the unreasonable phenomenon of non-uniform penalty standards, reshape the new order of cosmetics competition, and will be conducive to large-scale enterprises and compliance enterprises to become bigger and stronger.

The new Regulations consist of six chapters and 80 articles, including general provisions, raw materials and products, production and operation, supervision and management, legal liability and supplementary provisions. In the future, there will be a series of supporting policies and the gradual adjustment of old policies. The introduction of the "new regulations" to ensure product safety as the bottom line, in order to promote the development of the industry for the purpose of creating a fair competition market environment for cosmetics enterprises, will greatly guide and promote the high-quality development of China's cosmetics industry. Standing in the critical period of the development of China's cosmetics industry for 30 years, the "new Regulation" has systematically reshaped the rules of the cosmetics industry, designed the development rules of the cosmetics industry from the full perspective of cosmetics category, cosmetics raw materials, product claims, product production, business responsibilities, etc., and made the responsibility clear to people, which is the progress of legislation and the future development direction of the cosmetics industry. It has far-reaching influence on the development of cosmetics industry in China.

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