2022 is the second year that the Regulations on the Supervision and Administration of Cosmetics is officially implemented, and it is also the "capacity building year" for the supervision of cosmetics.
With the introduction of relevant regulations and their supporting secondary regulations, the "tight hoop" hanging over cosmetics enterprises is being tightened. According to incomplete statistics in Future Beauty, as of press release, 18 relevant regulations have been issued and implemented by the State Food and Drug Administration, the State Market Supervision Administration and other departments in the past year, and 90 group standards have been formulated by 35 industry associations; In addition, Tiktok, Taobao, Jingdong, Kwai and other e-commerce platforms have also successively released 8 platform specifications.
01 Tighter and tighter, 19 new industrial regulations are added in a year
With the formal implementation of the Regulations on the Supervision and Administration of Cosmetics, the secondary laws and regulations matching them have also been introduced. This year, the national regulatory authorities have issued 19 legal provisions and draft for comments, which cover the production, products, publicity and operation of cosmetics related enterprises. In addition, the management categories of subdivided categories, such as beauty instruments and raw materials, have been redefined.
From the above table, we can see that the current laws and regulations have three characteristics.
First, in general, the current supervision mode of the cosmetics industry is increasingly close to that of pharmaceuticals.
One or two can be seen from the severe punishment of the market supervision department for violations of laws and regulations. According to statistics, since this year, relevant departments have issued five "industry ban fines" for cosmetics related enterprises, including two "lifelong industry ban" fines.
In March, Guangzhou Saiyin Cosmetics Co., Ltd. was imposed a fine of 40000 yuan by Guangdong Provincial Drug Administration and its legal representative was banned from business for 10 years because its products were found to contain salicylic acid, an ingredient not identified on the label/filing certificate. This is also the first "ban ticket" issued this year.
In April, a trading company in Suzhou was fined for selling counterfeit and shoddy products. The Changshu court imposed a fine on the trading company, and sentenced Wang and Zhang to two years and ten months' imprisonment and two years and three months' imprisonment respectively; At the same time, Wang and Zhang are prohibited from engaging in the production, sales and other business activities of daily chemical products within three years after serving their sentences.
In August, Guangzhou Goode Cosmetics Co., Ltd., which produced children's cosmetics, was found to contain substances that may endanger human health, and was fined 120000 yuan, and its illegal income was confiscated. The company was banned from business for 10 years, and its legal representative was banned from business for life and fined.
In October, four batches of children's cosmetics produced by Guangzhou Henglan Biotechnology Co., Ltd. were found to contain the banned cosmetics substances "clobetasol propionate", "halobetasol propionate" and "cyproheptadine". In the end, the legal representative and production director of Henglan Company were punished with lifelong ban on cosmetics production and operation. It is worth noting that the person in charge of production was banned for life as the first punishment in the industry.
On October 14, the administrative penalty notice issued by the Shanghai Municipal Administration of Supervision showed that the cosmetics store operated by Zhu was found to sell expired cosmetics twice in a year (March 14 and September 13 this year). Due to the serious crime, Zhu was fined 4786.22 yuan and banned from business for 10 years.
In addition, unlike the old version of "Article 105", the inspection points of the "Inspection Points and Judgment Principles of the Cosmetic Production Quality Management Standard" (the new "Article 105") are more strict, which clearly points out that enterprises that fail to meet the three key items of the raw material use, production and product release management system can be directly ordered to stop production for rectification.
Although the regulatory approach is increasingly aligned with drugs, the boundaries between cosmetics and drugs are becoming clearer. In addition to not recognizing the concept of "pharmaceutical makeup", cosmetic claims related to medicine and efficacy are being continuously hit by high pressure.
For example, in the Measures for the Administration of Cosmetic Labels officially implemented in May this year, it was clearly pointed out that cosmetic labels are prohibited to use "medical terms, names of medical celebrities, words describing medical effects and effects, or approved drug names that express or imply that the product has medical effects".
In addition, the Technical Guidelines for Speckle Removing and Whitening Special Cosmetics (Draft for Comments) also clearly stipulates the special cosmetics with relatively obvious effects. The guiding principles point out that "the freckle removing and whitening effects of cosmetics should be relatively mild and mild, and should conform to the definition of cosmetics... They should not be used for medical purposes, and should not have severe or irreversible effects on human physiological functions."
It can be seen that although the cosmetics supervision is increasingly strict and tends to drug supervision, cosmetics are always not drugs and should be "mild" rather than "cured". The boundary between them is clear.
Second, the division of responsibilities of personnel in cosmetics related enterprises should be more clear, with responsibility and punishment assigned to each individual.
The Cosmetics Production Quality Management Standard has made requirements on the organization, quality department, staffing, main responsible person and other institutions and personnel of cosmetics enterprises. It is stipulated that the legal representative of the enterprise is the primary responsible person for the production quality management of cosmetics.
In addition, the business conditions and job responsibilities of the person in charge of quality and safety of the enterprise are defined in the management specification for the first time. The person in charge of quality and safety is required to have a college degree or above in cosmetics, chemistry, chemical industry, biology, medicine, pharmacy, public health or food and other related majors, have knowledge of cosmetics quality and safety related majors and regulations, and have more than 5 years of experience in cosmetics production or quality management
Then, in the Inspection Points and Judgment Principles of Cosmetic Production Quality Management Norms (new Article 105) officially implemented on December 1, the brand as the entrusting party was required to participate in the quality supervision of the product supply chain. Since then, standardized production is no longer a matter for production enterprises, and the brand side has officially bid farewell to the era of "leaving the shopkeeper behind".
In addition, on August 11, the State Food and Drug Administration issued the Qualification Confirmation Conditions for Cosmetic Inspection Institutions (Draft for Comments) (hereinafter referred to as the confirmation conditions), which also specified the requirements for employees of inspection institutions. First, it stipulated that personnel of inspection institutions should not work part-time; Second, the human efficacy evaluation and testing personnel shall hold the dermatologist qualification certificate.
Third, the supervision is becoming more and more detailed, and the supervision of children's cosmetics is more strict.
The new regulations and secondary supporting regulations issued this year involve the whole chain supervision of the whole cosmetics market from production to sales and operation, and have made detailed regulations on production quality, testing institutions, adverse reaction monitoring, commodity packaging, live broadcast e-commerce, advertising language and other aspects.
First of all, we started to manage the market segments, such as beauty instrument market and spot whitening products. The consumer demand of these two categories is large, and more and more enterprises participate. Based on this, in March this year, the State Food and Drug Administration issued an announcement on the adjustment of the Classification Catalog of Medical Devices, saying that by April 2024, radio frequency beauty instruments will be included in the three categories of medical devices for management. The three categories of medical devices are the highest level medical devices and are also the highest level medical devices.
In August, the China Institute for Food and Drug Control issued the Technical Guidelines for Speckle Removing and Whitening Special Cosmetics (Draft for Comments), which made specific technical requirements for the basic information, product name, product formula and raw material use, product implementation standards, packaging labels, product inspection reports and safety assessment data of the speckles removing and whitening special cosmetics.
In addition, the current regulatory system is more strict on children's cosmetics.
The Measures for the Administration of Cosmetics Sampling Inspection (Draft for Comments) clearly proposed that children's cosmetics should be one of the categories of focus. In April, the China Institute for Food and Drug Control issued the Technical Guidelines for Children's Cosmetics (Draft for Comments), which further refined seven requirements, including the name, product formula, and product implementation standard of children's cosmetics. In addition, it is worth noting that in the two cases of "lifetime ban" mentioned above, illegal addition of children's cosmetics is targeted.
It is not difficult to find that the formulation of current laws and regulations is becoming more detailed and keeps pace with the times. Every regulation is closely related to the enterprise, so that the enterprise can move in the right direction and avoid detours.
Contact Person: Mr. Fan