Interpretation of new cosmetics regulations

The new "Cosmetics Supervision and Administration Regulations (Draft)" reviewed and approved by the State Council on January 3 has always affected the industry.

On June 29, the State Council officially issued the “Cosmetics Supervision and Administration Regulations” (hereinafter referred to as the “new regulations”), which will be increased from 35 articles in the 1989 version to 80 articles, and will be officially implemented on January 1, 2021.

This means that the “Cosmetics Hygiene Supervision Regulations”, which have been implemented for more than 30 years, will be abolished in 6 months, and the cosmetics industry will enter a new “Basic Law” era with a new policy and regulatory environment.

01
4 fundamentals and 9 key points

According to the opinions expressed by the heads of enterprises on the entire industry chain of the cosmetics industry to Pinguan APP, the most concerned content of the new regulations involves four fundamentals, including nine major points.

1. Raw materials and products

1. Raw materials

New cosmetic raw materials should be registered or filed. The new raw materials under the registration system include those with functions of anti-corrosion, sun protection, coloring, hair coloring, freckle removal and whitening; other new raw materials are subject to the filing system.

The new raw materials are put into use after being registered or filed, and no safety problems will occur within 3 years before they can be included in the catalog of used cosmetic raw materials.

2. Classification of cosmetics

Cosmetics are divided into special cosmetics and ordinary cosmetics. Special cosmetics include hair coloring, perming, freckle and whitening, sun protection, anti-hair loss, and cosmetics that claim new effects; cosmetics other than special cosmetics are ordinary cosmetics.

For cosmetics registered for hair growth, hair removal, breast milk, bodybuilding, and deodorization that have been registered before the implementation of the regulations, a 5-year transition period will be set from the date of implementation of the regulations. During the transition period, production, import, and sales may continue. The cosmetics shall not be produced, imported, or sold after the full period.

3. Safety assessment and efficacy claims

Before the registration and filing of new cosmetic raw materials and cosmetics, the registration applicant and the filing party shall carry out a safety assessment by themselves or by a professional institution. The personnel engaged in safety assessment should possess professional knowledge related to cosmetics quality and safety, and have more than 5 years of relevant professional experience.

The declaration of the efficacy of cosmetics should have a scientific basis. The cosmetics registrant and the filing party shall publish the summary of the literature, research data or product efficacy evaluation data on which the efficacy claims are based on the special website prescribed by the State Council’s drug regulatory authority, and accept social supervision.

4. Management of toothpaste and soap

Toothpaste is managed in accordance with the provisions on ordinary cosmetics in these regulations. After the filing person conducts the efficacy evaluation in accordance with national standards and industry standards, it can claim the effects of preventing caries, inhibiting plaque, resisting dentin sensitivity, and reducing gum problems. This regulation does not apply to soap, but it is declared to have special cosmetic effects.

2. Production and operation

1. Person in charge of quality and safety

Cosmetics registrants, record holders, and entrusted manufacturing enterprises shall set up quality and safety persons responsible for corresponding product quality and safety management and product release responsibilities. The person in charge of quality and safety shall have professional knowledge related to the quality and safety of cosmetics and more than 5 years of experience in cosmetic production or quality and safety management.

2. E-commerce platform and cosmetics operators on the platform

The e-commerce platform operator shall register the real-name of the cosmetics operator on the platform, assume the management responsibility of the cosmetics operator on the platform, and find that the cosmetics operator on the platform violates the provisions of these regulations, shall promptly stop and report the location of the e-commerce platform operator The drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government; if serious violations are found, it shall immediately stop providing e-commerce platform services to the illegal cosmetics operators.

The cosmetics operators on the platform should fully, truthfully, accurately and timely disclose the information of the cosmetics they operate.

3. Supervision and management

1. Cosmetics inspection agency

Only after obtaining relevant qualification accreditations in accordance with relevant national certification and accreditation provisions can they engage in cosmetics inspection activities. The qualification requirements for cosmetics inspection agencies shall be formulated by the drug regulatory authority of the State Council and the market regulatory authority of the State Council. The cosmetics inspection specifications and the regulations on the management of cosmetics-related standard products shall be formulated by the drug regulatory department of the State Council.

2. Adverse reaction monitoring/safety risk monitoring and evaluation of cosmetics

The state establishes a monitoring system for adverse reactions in cosmetics. The cosmetics registrant and the filing party shall monitor the adverse reactions of their cosmetics on the market, carry out timely evaluations, and report to the cosmetics adverse reaction monitoring agency in accordance with the regulations of the drug regulatory authority under the State Council. If the entrusted manufacturing enterprise, cosmetics operator and medical institution finds possible adverse reactions related to the use of cosmetics, it shall report to the agency for monitoring the adverse reactions of cosmetics.

The state establishes a cosmetics safety risk monitoring and evaluation system. Monitor and evaluate the risk factors that affect the quality and safety of cosmetics, and provide a scientific basis for formulating risk control measures and standards for cosmetics quality and safety and conducting cosmetic sampling inspections.

4. Legal liability

For cosmetics in terms of raw materials, registration and filing, production permits, production environment, packaging materials, use period, etc., the maximum punishment can be reached: for illegal production and operation enterprises, the value of the cosmetics value of illegal production and operation is 10,000 yuan For the above, a fine of 15 times or more and 30 times or less of the value of the goods shall not be accepted, and the cosmetics filing or administrative license application submitted by the operator will not be accepted within 10 years; if it is an illegal unit, the legal representative or the main person in charge and direct person in charge of the illegal unit The person in charge and other directly responsible personnel are prohibited from engaging in cosmetics production and business activities for life.

02
Safety assessment and efficacy evaluation become "just needed"

Pinguan APP once pointed out in the article "The Basic Law of Cosmetics was reviewed and approved by the State Council, and enterprises are most concerned about this issue" that cosmetics companies are most concerned about the new regulations in the field of "new raw materials". In fact, in addition to new raw materials, the content of cosmetics safety assessment and efficacy claims in the new regulations is also the focus of cosmetics companies.

Because, with the vigorous development of my country's cosmetics market, various cosmetic concepts and claims are emerging in an endless stream, but the real effect is unknown, and consumer rights cannot be effectively protected. As early as the beginning of 2018, the industry has started discussions and related suggestions around product safety and effectiveness.

Now that the new regulations are in place, not only are the requirements clearly clarified in this regard, but also the third-party cosmetics inspection agencies that undertake inspection and testing responsibilities are expected to usher in an explosion.

Wang Jing, general manager of Bird Innovation (Guangzhou) Biotechnology Co., Ltd. (hereinafter referred to as Bird Innovation), said to Pinguan APP that Bird Innovation has invested a lot of time in inspection and testing of software and hardware, and the new regulations The introduction of inspections has become a "just need" for cosmetics companies, and Bird Research can naturally enjoy the benefits of customer orders.

Mao Yongjin, deputy general manager of Guangzhou Elephant Flying Information Technology Co., Ltd., also believes that the new regulations have turned safety assessment and efficacy evaluation into a hard demand for enterprises, which not only puts forward higher requirements for the rigorous and scientific process of enterprise R&D, Purifying the phenomenon of market competition concept will also greatly promote the development of third-party inspection agencies.

However, the challenge is also obvious. As of press time, there were 223 "cosmetic registration and record inspection and testing institutions" announced by the State Food and Drug Administration, an increase of 35 from the 188 when Pinguan APP was counted on January 13. According to Wang Jing, the number of third-party cosmetic inspection agencies is still increasing. This status quo means that while the country continues to release inspection and testing rights to third-party institutions, third-party institutions will also face increasingly stringent supervision at the national level.

The trend of policies and regulations has shown this. In September 2019, the Food and Drug Administration issued the "Cosmetic Registration and Recording Inspection Work Specification" to increase the qualifications of third-party institutions, and required all third-party institutions to re-record and record, from the previous provincial-level association to national approval.

Wang Jing revealed that the State Food and Drug Administration will also plan to evaluate the third-level testing agencies at three levels of A, B, and C, and relevant documents have been issued for the basic indicators, technical indicators, service indicators, and innovation of the three levels. The indicators are clearly defined.

03
Will 2000 cosmetics companies fall?

When the new bill was reviewed and approved, a financial media once quoted the opinion of "experts in the cosmetics industry": "Industry assessment will cause nearly 2,000 companies to fall." Pinguan APP learned that this conclusion may not necessarily be established.

For example, Li Huiliang, Chief Technology Officer of Huaxi Biology, the new regulations stipulate that the efficacy of cosmetics must have a scientific basis, but it does not specify that these effects must be made by manufacturers or third-party companies. Therefore, some companies may use literature or text. The language conversion expression can achieve the demand for the basis of efficacy claims.

He believes that enterprises should still maintain a prudent attitude towards these specific contents of the new regulations.

Zeng Wanxiang, the research and development director of Guangzhou Boxian Cosmetics Co., Ltd., told Pinguan APP that the new regulations stipulate that companies must set up quality and safety managers, and that they must have relevant professional knowledge and more than 5 years of production or quality management management experience. For enterprises, it is a hurdle. He believes that with the outbreak of third-party R&D and testing institutions, small businesses can also use external forces to achieve this. Therefore, the statement of "falling 2000 companies" is not accurate.

However, for large, well-managed companies, the benefits of the new regulations are generally recognized.

Zeng Wanxiang believes that regular enterprises that already have R&D, production, and quality control capabilities will be driven by the new regulations with multiple benefits, and can greatly promote the overall level of the industry.

Li Daoyang, general manager of Guangzhou Liji Packaging Materials Co., Ltd., also believes that the introduction of the new regulations actually protects well-managed enterprises and is a good direction.

04
Industry is going to a new level

I have to watch "How to go next"

The change of laws and regulations has always been an important driving force for an industry to move forward.

Pinguan APP learned when visiting the Korean Cosmetics Association earlier this year that before 2000, South Korea implemented trade protection and restricted the entry of foreign products. In addition, Korean cosmetics at that time were under the administration of the Pharmaceutical Affairs Law, and there was no separate regulation. South Korea The restrictions on cosmetics at the raw material and product levels are also strict, resulting in insufficient vitality of the entire industry.

In 2000, South Korea separately formulated cosmetics regulations and treated cosmetics as a separate format, gradually liberalizing raw materials and product licensing. The pace of product innovation, development cycle, and product diversity have been greatly improved. Explosive products such as BB cream.

Does this mean that, as the new regulations on the "Basic Law" of cosmetics are implemented, China's cosmetics industry can really usher in a historic change?

Shen Yingjie, Assistant General Manager of Cosmetics (China) Cosmetics Co., Ltd. explained that although the new regulations have great significance for the innovation of the Chinese cosmetics industry, in fact, South Korea and China have fundamental differences in the level of cosmetics supervision thinking.

For example, South Korea currently prefers ex-post supervision. Although China is also strengthening post-event supervision, the overall preference is for ex-ante supervision; South Korea is more open to the management of cosmetic raw materials, but the new regulations on the control of raw materials are still becoming stricter of.

He admitted that for the Chinese market, the effect of the new regulations "needs a process" to be fully released, and the impact of Korean cosmetics laws on the market has also experienced such a process.

While recognizing that the new regulations have great significance to the industry, Li Huiliang also believes that there are still many areas worthy of improvement in the new regulations. For example, whether the efficacy of raw materials represents the same effect as the corresponding formula; the punishment for violators is still in the " The punishment of "putting things right" is not strong enough; the protection of intellectual property rights in new raw materials and other aspects is not yet clear. Therefore, what is more important is "how to go next".