Since the beginning of this year, Beijing, Guangzhou, and other cities have successively released notifications regarding non-compliant cosmetics, exposing over a hundred products that do not meet regulations. At the same time, the National Medical Products Administration recently issued the “Administrative Penalty Discretion Application Rules for Drug Supervision and Management,” further clarifying the penalty discretion and application rules for cosmetics.
While policies are becoming stricter, violations persist. Through analyzing the inspection results announced by various regions this year, CHAILEEDO has found that issues such as excessive bacterial colonies, non-compliant preservatives, the use of prohibited ingredients, and non-compliance with regulations regarding hair dye and sunscreen agents remain persistent problems in the “troublesome areas” of face masks, hair dye, and acne treatment products.
However, many regions have already announced new rounds of special actions for the governance of cosmetics. So, where will the current focus of cosmetics inspections be concentrated? What are the key issues to be addressed in the targeted rectification efforts?
Skincare, hair dye, and sunscreen products dominate.
According to incomplete statistics from CHAILEEDO, the National Medical Products Administration, as well as Guangzhou, Beijing, Sichuan, and other regions, have collectively announced 184 batches of non-compliant cosmetics inspections this year. The National Medical Products Administration also reported 9 cases of banned ingredients. In less than two months, over a hundred companies and products have already made it onto the blacklist.
CHAILEEDO’s analysis found that among the 193 batches of non-compliant cosmetics, the main categories include skincare (essence, lotion, etc.), hair dye, sunscreen, face masks, toothpaste, hair care, makeup, and body wash. Among them, skincare (essence, lotion, etc.), hair dye, and sunscreen products accounted for 60% of the total, making them the key areas of non-compliance.
Specifically, skincare products accounted for the highest proportion, reaching 25%, and had the most complex non-compliance issues. In addition to common problems such as exceeding the total bacterial count and the use of prohibited ingredients, many skincare products also had other typical issues.
For example, violations related to whitening products mainly focused on “unlabeled whitening agents that were not indicated in the product label and registration information regarding technical requirements.” Unlabeled whitening agents included commonly used whitening ingredients such as niacinamide, 3-O-ethyl ascorbic acid, 4-butylresorcinol, and beta-glucoside.
It is worth noting that in August 2023, the National Medical Products Administration further clarified the testing methods and limited concentrations of the aforementioned whitening ingredients in documents such as “Testing Methods for 11 Ingredients including Ascorbyl Phosphate Magnesium in Cosmetics” and “Testing Methods for 4 Ingredients including Alpha-Arbutin in Cosmetics.” Prior to this, there were no specific dosage requirements for ingredients like arbutin, and the new testing methods provide clearer references for the inspection of whitening products. Based on the current publicized information, whitening agents have become a key target for inspections with the support of these methods.
In addition, violations related to acne treatment products almost exclusively centered around excessive salicylic acid content. Over half of the violations were due to exceeding the permitted level as a preservative, while a portion involved excessive amounts of salicylic acid as a skincare ingredient. Previously, industry insiders informed CHAILEEDO that salicylic acid is a commonly used ingredient in acne treatment products and is also a material that requires special attention. Acidic products have always been a focus of regulatory supervision. However, currently, the compliant use of acid-based products remains a key focus of cosmetic supervision and inspections.
Furthermore, the main reasons for non-compliance in hair dye products were the presence of ingredients that did not match the label. The problems were concentrated in several categories: detection of unmarked hair dye, failure to detect labeled hair dye, and excessive levels of hair dye. The hair dye products involved various types of dyes, including p-phenylenediamine, phenyl methyl pyrazolone, and p-aminophenol.
In fact, as a special type of cosmetic product, the labeling management of hair dyes has always been strict. The formula cannot be changed without authorization during actual production, and manufacturers are required to provide full ingredient labeling on product packaging. However, due to the wide range of colors in hair dye products, many companies, in order to save costs while meeting market demand, choose to adjust the formula based on the same approval document. This has resulted in hair dye products becoming a “one-size-fits-all” area of concern in the cosmetics industry.
Previously, senior industry engineers revealed that as more testing methods for sunscreen ingredients are introduced, the number of detectable sunscreen agents will continue to increase, and the proportion of non-compliant hair dye products in future inspections will also rise.
Similar to hair dye products, sunscreen products are also entangled in labeling issues. However, unlike hair dye products, most labeling problems with sunscreen products revolve around “undetected sunscreen agents that are not indicated in the product label and registration information regarding technical requirements,” which refers to the problem of falsely labeled sunscreen agents. In fact, this issue has always been a focus of regulatory authorities. Previously, Guangzhou Zicai Cosmetics Factory was fined 980,000 yuan for lacking sunscreen agents.
The 8 major issues remain the hardest hit areas, and the prohibition of ingredients continues unabated.
In terms of specific violations, the main non-compliant behaviors of the 193 batches of cosmetics are concentrated in eight areas: total bacterial count, sunscreen agents, hair dye, prohibited ingredients, preservatives, salicylic acid, and whitening agents. According to CHAILEEDO’s analysis, apart from the key issues mentioned earlier, total bacterial count and the addition of prohibited ingredients are also major areas of non-compliance. Taking the excessive total bacterial count as an example, this issue includes various categories such as skincare, face masks, toothpaste, and hair care, accounting for 26% of the non-compliant products.
It is worth noting that nearly 90% of face masks with excessive total bacterial count are seaweed masks. Many industry insiders have previously informed CHAILEEDO that due to factors such as production processes and product attributes, seaweed masks are more prone to exceed the bacterial limit compared to other types of masks, making them a key focus of regulatory inspections.
Meanwhile, another category with serious issues of excessive bacterial count is toothpaste. In fact, in recent years, there have been numerous significant penalties for toothpaste. For example, just last month, Guangzhou Monitane Daily Chemicals Co., Ltd. was fined 524,400 yuan by the Guangzhou Municipal Bureau of Supervision for the excessive bacterial count in multiple toothpaste products it produced.
It is worth mentioning that since December of last year, the “Supervision and Administration Measures for Toothpaste” have been officially implemented, and the filing of toothpaste products must strictly follow the “Regulations on the Management of Filing Information for Toothpaste.” This means that the toothpaste category will face the “strictest supervision” in 2024. If companies fail to adjust according to the new regulations in a timely manner, there may be an increase in compliance penalties related to toothpaste in the future.
Furthermore, the use of prohibited ingredients remains a key focus in cosmetic violations. CHAILEEDO’s analysis found that among the 193 batches of non-compliant products, 31 products violated regulations by adding prohibited ingredients. The ingredients involved include metronidazole, ketoconazole, clindamycin, fluocinolone acetonide, and terbinafine. Previously, product researchers also told CHAILEEDO that based on the published penalty results this year, the authorities may focus on the issue of prohibited ingredients in children’s cosmetics.
It is worth noting that in the recently released “Administrative Penalty Rules for Drug Supervision and Administration,” there is a special mention of the discretion standards for ingredient regulation. It clearly states that if the party involved engages in activities such as “using prohibited ingredients in the production of cosmetics, producing children’s cosmetics with new ingredients that should be registered but are not, or illegally adding substances that may harm human health to children’s cosmetics” as stipulated in Article 61(1) of the “Measures for the Supervision and Administration of Cosmetics Production and Operation,” they should be subject to administrative penalties based on the severity of the situation.
This reflects the regulatory authorities’ clear stance: stricter supervision and more severe penalties will be imposed on the issue of prohibited ingredients, especially in the field of children’s cosmetics.
In its analysis, CHAILEEDO also found that many companies have raised objections to the regulatory authorities, claiming that the products were not produced by their company. This accounts for 18% of all non-compliant products. For example, OLAY’s Water Gel Whitening Essence was found to contain unmarked whitening agents, and Procter & Gamble raised objections to the National Medical Products Administration. After investigation, it was clarified that “the company did not produce or import the batch of products that did not comply with the regulations.”
In other words, 18% of the products in the regulatory authorities’ samples are counterfeit products, which also reflects the massive number of counterfeit and inferior products in the current market. Senior industry insiders have previously told CHAILEEDO that if it is confirmed that a product is counterfeit, the company selling counterfeit goods will also be penalized for “failure to organize production in accordance with the requirements of cosmetic production quality management regulations,” among other violations.
However, there are also companies falsely claiming that their products are counterfeit in an attempt to escape penalties. For example, Guangzhou Aocai Biotechnology Co., Ltd. previously raised objections regarding the authenticity of its tested hair dye product samples. However, after review by the Guangdong Provincial Medical Products Administration, it was found that they provided “false information, concealed the true situation, and falsely denied producing or importing the batch of products that did not comply with the regulations.”
Multiple policies are about to be implemented, and stricter regulation is on the horizon
It is evident that with the continuous introduction of relevant regulatory guidelines, the testing methods and standards of regulatory authorities are also improving and becoming more detailed. Increasingly more non-compliant behaviors will be brought under regulation.
In addition to the current implemented policies and regulations, there will be more standards coming into effect this year. For example, in addition to the “Test Methods for α-Arbutin and Other Four Raw Materials in Cosmetics” mentioned earlier, there are five test methods, including “Test Method for Acrylamide in Cosmetics,” “Test Method for 51 Raw Materials Including Desloratadine in Cosmetics,” “Test Method for Eight Raw Materials Including Thioglycolic Acid in Cosmetics,” and “Test Method for Free Formaldehyde in Cosmetics,” which will be officially adopted from March 1st this year. It can be foreseen that non-compliant behaviors related to these raw materials will be increasingly exposed to regulatory scrutiny.
Furthermore, starting from April 1st this year, according to the announcement by the National Medical Products Administration, radiofrequency treatment devices and radiofrequency skin treatment devices will be classified as Class III medical devices, and home-use radiofrequency beauty devices will also enter the era of comprehensive regulation. Similarly, on February 23rd, a program on China Central Television’s Focus Interview openly pointed out that “medical aesthetics belongs to medical activities, and the so-called ‘product promotion’ behavior carried out in most medical aesthetics livestreaming rooms at present is suspected of illegally advertising medical services.” CHAILEEDO has noticed that currently, mainstream livestreaming platforms cannot search for content related to “medical aesthetics livestreaming.” In the future, the boundary between cosmetics and medical devices will become clearer.
On May 1st, the full version of the safety assessment report for cosmetics will also be officially implemented. The registration, filing, and regulation of cosmetics will enter the “strictest” era. How to maintain a high level of product quality and innovation under various pressures such as cost and talent will be a major challenge for every cosmetics company.
By July 1st, toothpaste products that previously used simplified filing procedures will be required to update their product labels as required. Non-compliant old packaging will need to be discarded, and non-compliant products will need to be eliminated. A new round of competition is about to begin.
In addition, the recently announced “Administrative Penalty Rules for Drug Supervision and Administration” will be officially implemented on August 1st this year. The unified administrative penalty discretion at the national level will ensure consistent and fair penalty decisions for different illegal behaviors in different regions.
Overall, the ultimate goal of regulations is to ensure the safety of cosmetics. Both manufacturers and brands should not relax during this process and must always abide by the law, maintain product quality, and avoid ruining the bright future of their companies for the sake of short-term gains.
