Heavy fines for illegal addition of cosmetics

Recently, the basic laws and regulations of my country's cosmetics industry have ushered in major changes in the past 30 years-the "Regulations on Cosmetics Supervision and Administration" was officially promulgated by the State Council, and the "Regulations on Cosmetics Hygiene Supervision," which has been implemented for 30 years, withdrew from the historical stage.

In November 1989, my country issued the "Regulations on Hygiene Supervision of Cosmetics", which came into effect on January 1, 1990. Over the past 30 years, my country has developed into the second largest cosmetics market in the world, with more than 5,200 cosmetics manufacturers. However, the rapid development has also brought about some problems, such as illegal addition of prohibited substances, fake and inferior and counterfeit materials, safety of raw materials, etc., hidden health concerns under the beautiful appearance. What changes will the cosmetics industry bring to the new regulations that will be implemented on January 1, 2021? How to make our beautiful career healthier? The public is full of expectations.

As a chemical industrial product that directly affects the human body, while cosmetics bring us beauty, health and safety must be guaranteed. We must have health before we can talk about beauty. However, some unhealthy phenomena in my country's cosmetics industry bring hidden dangers to the health of beauty lovers——

Illegal addition of prohibited substances that may be harmful to health, cosmetics preparation by beauty salons, fake and inferior products, fake well-known brand products, false propaganda and even claims to have medical effects, heavy packaging propaganda rather than technological innovation...

We want beauty, but also health and safety. Recently, the much concerned "Regulations on Supervision and Administration of Cosmetics" was officially promulgated. This also means that the 30-year-old "Regulations on Cosmetics Hygiene Supervision" will end its historical mission. The new regulations not only adapt to the new situation, but also solve old problems. Among them, there are many bright spots worthy of attention.

Highlight 1: Intensify the fight against "grey areas", illegally adding prohibited substances can be fined up to 30 times the value of the goods

In recent years, with the rapid development of my country’s cosmetics industry, illegal additions and other illegal phenomena have become more prominent. In the first half of this year, the State Food and Drug Administration issued a number of notices about problematic cosmetics. Most of these notified cosmetics are counterfeit or detected prohibited substances. According to media reports, some inferior cosmetics counterfeit well-known brands, or increase short-term effects by adding hormones and other prohibited substances, which have become industry "hidden rules" and "gray areas."

In 2018, Taizhou City, Jiangsu Province investigated and handled a very large case of illegally adding prohibited ingredients to cosmetics. Offenders purchase cosmetic raw materials with illegally added prohibited ingredients from multiple sources, or add large amounts of prohibited ingredients such as betamethasone, mercuric chloride, metronidazole, and chloramphenicol to facial masks, whitening, and anti-acne cosmetics. Semi-finished products, OEMs, and finished products are sold to thousands of beauty salons, cosmetics shops and tens of thousands of consumers in more than 20 provinces across the country. Local supervisors said that the case profoundly exposed the "hidden rules" formed in the cosmetics industry for a long time.

Compared with the old regulations 30 years ago, the new regulations have stepped up the crackdown on various illegal activities and increased the deterrence of the law. Yang Zhanxin, deputy director of the Comprehensive Planning Division of the Hebei Provincial Market Supervision Administration, noticed that there are 18 laws on penalties for illegal activities in the new regulations, which is double the old regulations; the content of the laws is also more detailed, covering various Illegal circumstances.

"The new regulations combine the practice of law enforcement in the past 30 years and the outstanding problems in the current cosmetics market. Any provision of prohibitive and obligatory provisions for producers and operators has set legal responsibilities in the legal liability part." Yang Zhanxin pointed out.

The new regulations comprehensively use confiscation, fines, order to suspend production and business, revocation of licenses, market and industry bans and other penal measures to combat illegal activities. Take fines as an example. The base of fines used to be "illegal income", but now it is adjusted to "value of goods", and the amount of fines has been greatly increased. For example, for illegal situations such as engaging in cosmetics production activities without permission, the old regulations "can be fined 3 to 5 times the illegal income" to "and impose a fine of 15 times or more and 30 times the value of the goods."

Moreover, the provision of "punishing people" for illegal acts has been added. The legal representative or the main person in charge, the directly responsible person in charge, and other directly responsible persons of a unit that seriously violated the law shall not only be fined, but may also be prohibited from engaging in cosmetics production and business activities for life.

For example, in combating counterfeit and inferior products and illegal additions, the new regulations make a series of new regulations: require cosmetics manufacturers to establish and implement a purchase inspection record system to ensure product traceability; illegal additions of substances that may harm human health are illegal. Acts can be fined up to 30 times the value of the goods, or even banned from engaging in cosmetics production and business activities for life. The new regulations also provide clear penalties for the unauthorized preparation of cosmetics by beauty salons, hotels, etc., and changes in the use period of cosmetics that were not specified in the old regulations.

In addition, the new regulations also emphasize that for cosmetics that cause human harm or have evidence that may endanger human health, the regulatory authorities can take emergency control measures that order the suspension of production and operation, and issue safety warnings.

"This is a wake-up call to the so-called "grey areas" in the cosmetics industry chain and corporate behaviors that need to be regulated at this stage." Beijing Technology and Business University professor Dong Yinmao said in an interview with the media.

Highlight 2: "Let the good steel be used on the blade" to ensure the safety of cosmetic raw materials more scientifically

According to the new regulations, cosmetics refer to daily-use chemical industrial products that are applied to the skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and modifying. As a chemical industrial product that directly acts on the human body, safety is the bottom line of cosmetics. In addition to illegal addition of prohibited substances, if there are problems with the raw materials of the cosmetics itself, it will also bring hidden dangers to the health and safety of consumers. The safety of raw materials is an important prerequisite for the safety of cosmetics.

"Generally speaking, cosmetics are a mixture of various raw materials processed and prepared in accordance with the formula ratio, and most of this preparation is a physical mixing process, and few chemical reactions are involved. Therefore, the safety and function of the raw materials It directly affects the safety and performance of finished cosmetics." Xu Liang, a member of the Expert Committee on Cosmetics Standards of the State Drug Administration, explained.

Compared with the old regulations, an important change in the new regulations is to emphasize risk management, that is, to implement different levels of classified management according to the level of security risks. Preservatives, sunscreens, coloring agents, hair dyes, freckle whitening agents and other high-risk new raw materials must be registered with the State Council's Drug Administration and approved before they can be used. Other new raw materials only need to be filed.

In addition, there is a "safety assessment period" for new raw materials-within 3 years after the new cosmetic raw materials are put into use, the registrant and recorder of the new raw materials should report the use and safety of the new raw materials to the drug regulatory department of the State Council every year. If there is a security problem, the registration or filing will be cancelled. No safety issues occurred at the end of the three-year period, and it was included in the list of used cosmetic raw materials formulated by the State Council's drug regulatory department.

The new regulations also stipulate that according to the development of scientific research, there is a change in the understanding of the safety of cosmetics and cosmetic raw materials, or if there is evidence that the cosmetics or cosmetic raw materials may have defects, the regulatory authority may order the registration of cosmetics or new cosmetic raw materials Persons and record holders conduct safety reassessment or directly organize safety reassessments. If the result of the reassessment shows that the safety of cosmetics or cosmetic raw materials cannot be guaranteed, the registration or filing shall be cancelled, and the supervisory authority shall include them in the list of raw materials prohibited to be used in the production of cosmetics and announce to the public.

It is worth noting that the new regulations require the establishment of a cosmetics risk monitoring and evaluation system to monitor and evaluate the risk factors that affect the quality and safety of cosmetics. Song Hualin, a professor at the School of Law of Nankai University, believes that through risk monitoring and evaluation, judging the risks contained in cosmetic raw materials, products, production and operation processes, and labeling, can have an overall grasp of the safety situation of cosmetics and understand the main factors in the safety and quality of cosmetics. problem.

Only by knowing where there are problems can we better carry out targeted supervision. The new regulations point out that risk monitoring provides a scientific basis for formulating cosmetic quality and safety risk control measures and standards, and conducting random inspections of cosmetics. In addition, implement the national cosmetics safety risk monitoring plan to clarify the types, items and regions to be monitored. Song Hualin believes that this can "use good steel to the edge" and allocate risk supervision resources more scientifically and reasonably.

Highlight 3: Encourage technological innovation in cosmetics and give new functional products ample room for development

In fact, classified management is not only conducive to safety supervision, but also conducive to cosmetic technology innovation.

One aspect of the domestic cosmetics industry that has been criticized is the lack of technological innovation in product efficacy. Without innovation, one can only make a fuss about advertising and other packaging. In Xu Liang's view, many cosmetics companies don't work hard on technology, but instead use "storytelling" to attract consumers.

According to Xu Liang's analysis, according to the composition characteristics of cosmetics, in the current relatively mature preparation process, the innovation of cosmetics mainly depends on the innovation of raw materials, especially the development and innovation of functional raw materials and raw materials that contribute to the improvement of cosmetic formulations. However, the old regulations implemented the overall registration management of new cosmetic raw materials, and the review criteria were not refined in conjunction with the characteristics of the cosmetic raw materials. The enterprise declares a new raw material, "even if it is just a high-molecular polymer with no transdermal ability or can Common vegetable oils for consumption also often require multiple supplementary information, resulting in an average of several years for the declaration of new raw materials."

"On the one hand, the enthusiasm of enterprises to declare new raw materials has been affected. On the other hand, new raw materials that have been proven to have good performance and have been widely used in the world cannot be used in Chinese cosmetics. This has also increased China to a certain extent. There is a gap between cosmetics and foreign companies in terms of technology and innovation." He said that cosmetics have a fast update cycle, which requires companies to continuously introduce new products to the market.

According to the new regulations, common new raw materials for cosmetics are subject to record management, simplifying the use procedures. Dong Yinmao believes that the new regulations have changed the long-standing current situation of difficulty in approving new raw materials. The establishment of the new raw material filing model has opened up a brand-new model for enterprises to innovate and develop new raw materials, and has given ample room for innovation and development of product development and production for new functional products.

The new regulations encourage cosmetics companies to innovate not only in the management of new raw materials, but also clearly stated that the state encourages and supports the development of cosmetic research and innovation; encourages and supports the use of modern technology, combined with my country's traditional advantage projects and characteristic plant resources to research and develop cosmetics.

Xu Liang believes that this is a good thing for the healthy development of the entire industry, because "a company that does not have technical strength but only attracts consumers by ‘arranging stories’ will not last long." Dong Yinmao also believes that the new regulations "provide hope for companies dedicated to research on cosmetic raw materials, production technology, and product innovation."

Highlight 4: Cosmetic efficacy claims must have scientific basis and accept social supervision

Innovation is not enough, publicity comes together. It is not uncommon for false and exaggerated publicity to mislead consumers about the efficacy of cosmetics. Some people in the cosmetics industry even got the idea of medicines and promoted cosmetics as magical products with medical effects.

According to media reports, in January this year, on the train from Rizhao, Shandong to Jinan, someone sold a cosmetic called "Baicao Cream" as a medicine to passengers. The salesperson claimed that the product can relieve muscles and blood, relieve pain, and can also treat skin diseases, mosquito bites and other symptoms, describing this cosmetic as magic.

In the past few years, the concept of "drug cosmetics" was very popular in China. Cosmetics are next to medicines, as if the product's efficacy is more assured. However, in January 2019, the State Food and Drug Administration clearly stated that it is illegal to declare the concepts of "cosmeceuticals" such as "cosmeceuticals" and "medical skin care products" for products registered or filed in the name of cosmetics.

The new regulations promulgated this time further clarify the false propaganda behaviors such as claiming medical effects. The new regulations clearly state that cosmetics labels and advertisements must not explicitly or imply that the product has a medical effect, and must not contain false or misleading content.

Moreover, the new regulations stipulate that the efficacy claims of cosmetics should have a sufficient scientific basis, and the literature and research data on which the efficacy claims are based should be published and subject to social supervision. In other words, whether cosmetics are effective and why they are effective depends on science.