As long as it’s a raw material listed in the “Catalogue of Already-used Cosmetics Raw Materials,” can it be used freely? The answer is no.
Recently, a penalty notice was published on the National Enterprise Credit Information Publicity System, revealing that a Shanghai-based company was fined 435,600 yuan for using the coloring agent CI 61585 in a hand cream, which did not comply with the scope of use for that ingredient.
Industry professionals have expressed that “it is not only the use of prohibited ingredients that constitutes a violation, but many ingredients also have usage restrictions. This case serves as a warning to the industry.”
Fined nearly 440,000 yuan for exceeding the scope of raw material use
According to an administrative penalty decision issued by the Shanghai Municipal Food and Drug Administration, on February 29th of this year, during an on-site inspection prompted by a report, the Shanghai Municipal Food and Drug Administration discovered that the packaging of the Weilan Soft and Fragrant Hand Cream (Misty Clear Tea) under the brand of “Shanghai Company Cosmetics” indicated the ingredient “CI 61585.” Additionally, the instructions for the product stated, “After cleaning the skin of the hands, take an appropriate amount of the product and apply it evenly to the skin of both hands. Use fingertips to massage the hands until the product is fully absorbed.”
According to publicly available information from the National Medical Products Administration, the implicated hand cream was registered on October 21, 2023, and the registration was canceled on February 23 of this year. Upon investigation, it was found that from November 2023 to January 2024, Shanghai Company Cosmetics commissioned Shanghai Inpai Cosmetics Co., Ltd. to produce two batches of Weilan Hand Cream. The former was responsible for formula design and raw material procurement, while the latter was only responsible for formulation and packaging. When Shanghai Company Cosmetics registered the product, the formula included the coloring agent “CI 61585.”
The Shanghai Municipal Food and Drug Administration stated that according to the “Cosmetic Safety Technical Specification (2015 Edition),” CI 61585 is a permitted coloring agent for cosmetics, and its scope of use is “specifically for cosmetics that only temporarily contact the skin.” Since the packaging of Weilan Hand Cream indicates instructions such as “After cleaning the skin of the hands, take an appropriate amount of the product and apply it evenly to the skin of both hands. Use fingertips to massage the hands until the product is fully absorbed,” the product is not a cosmetic that only temporarily contacts the skin and does not fall within the scope of use for CI 61585.
Therefore, the Shanghai Municipal Food and Drug Administration determined that Shanghai Company Cosmetics had violated the regulations by using the raw material CI 61585 in the production of cosmetics in a manner that does not comply with the technical specifications mandated by national standards and regulations.
From February 20th to 29th, 2024, Shanghai Company Cosmetics conducted a recall of the two batches of Weilan Hand Cream mentioned above, totaling 12,748 boxes, with 2,497 boxes from batch L17AY and 10,251 boxes from batch A03A2. The value of the recalled cosmetics amounted to 38,500 yuan, and Shanghai Company Cosmetics obtained illegal gains of 12,600 yuan.
In the end, the Shanghai Municipal Food and Drug Administration confiscated 12,748 boxes of illegally produced Weilan Hand Cream, confiscated the illegal gains of 12,600 yuan, and imposed a fine of 423,000 yuan. In other words, Shanghai Company Cosmetics was fined a total of 435,600 yuan for exceeding the scope of use of the coloring agent “CI 61585.”
Multiple colorants have usage restrictions
It is understood that colorants are widely used cosmetic raw materials, mainly used to give products or their application areas color. Generally, adding colorants to hand creams is mainly for making the cream look more aesthetically pleasing and enhancing the user’s psychological pleasure.
According to the “Catalogue of Already-used Cosmetics Raw Materials,” CI 61585 must be used in accordance with the requirements of the “Cosmetic Safety Technical Specification,” which specifies its scope of use as “specifically for cosmetics that only temporarily contact the skin.” Several cosmetic development engineers have informed Qingyan that this ingredient is a blue water-soluble pigment commonly used in shower products such as shampoos and shower gels.
Industry insiders have stated that the company in question did not use prohibited ingredients but rather used materials listed in the catalog of already-used raw materials. However, they exceeded the specified scope of use, which is a more concealed violation that is difficult to detect. The insider stated, “Generally, companies are likely not intentionally making this mistake but may be unfamiliar with the regulations. However, it cannot be ruled out that they deliberately used it to create a ‘unique’ color.”
It is worth noting that CI 61585 is not the only colorant with usage restrictions. In the “Cosmetic Safety Technical Specification,” the “Permissible Cosmetic Colorants (Table 6)” lists a total of 157 colorant raw materials, and most of them have usage restrictions. For example, “SORGHUM RED,” commonly known as “high sorghum red,” is applicable to “cosmetics other than eye cosmetics.” Multiple colorants such as CI 73900, CI 73915, and CI 74100 have the same usage requirements as CI 61585 and are classified as colorants for “cosmetics that only temporarily contact the skin.” In addition, many colorants have prohibited usage, such as CI 73900, CI 74160, and CI 74260, which are not allowed in hair dye products.
Not only colorants but also many other ingredients among the nearly 9,000 already-used cosmetic raw materials have usage restrictions, usage concentrations, and other limitations and requirements. For example, the “Cosmetic Safety Technical Specification” clearly identifies 47 restricted components for cosmetics. Taking salicylic acid as an example, the maximum allowable concentration of this ingredient is 2%, and it is not allowed in products for children under three years old, except for shampoos. Products using this ingredient also need to label “Contains salicylic acid; do not use for children under three years old.”
“In fact, many ingredients have usage restrictions and requirements. It is not the case that any ingredient listed in the ‘Catalogue of Already-used Cosmetics Raw Materials’ can be used freely. Some companies may be unaware of the regulations, but it cannot be ruled out that some companies knowingly violate them to take advantage of loopholes,” said an industry insider who wished to remain anonymous. “Any violation of the ‘Cosmetic Safety Technical Specification’ is considered a serious violation.” The aforementioned penalty case is a clear example, where the value of the hand cream was 38,500 yuan, but the fine amount exceeded 420,000 yuan, more than ten times the value.
Experienced industry professionals suggest, “If you have products that use colorants or restricted ingredients, it is advisable to conduct a self-inspection as soon as possible to avoid being penalized by regulatory authorities.”
Material safety is a serious matter.
There is no doubt that the quality and safety of cosmetics to a certain extent depend on the safety of the ingredients. Since the new regulations, regulatory authorities have been under high pressure to crack down on violations of raw materials. In addition to the use of ingredients beyond the specified scope, severe penalties are also imposed for the use of prohibited ingredients and expired materials.
For example, last year, the National Medical Products Administration conducted inspections and found 79 batches of cosmetics containing prohibited ingredients. The companies involved in these cases were all severely punished, with some even facing fines exceeding one million yuan. As an example, a children’s product company was fined up to 2.49 million yuan because their product was found to contain the prohibited ingredient progesterone.
According to statistics, in the first half of this year, the National Medical Products Administration has also issued information on nine batches of cosmetics that were found to contain prohibited ingredients. Regarding cosmetics that fail to meet the requirements during inspections, the National Medical Products Administration stated that “the drug supervision and management departments of each province (region, city) must order relevant cosmetics operators to immediately stop the sale of the aforementioned cosmetics, investigate their purchase and inspection records in accordance with the law, trace the origin of illegal products, and handle any violations seriously in accordance with the law. If any criminal behavior is suspected, it shall be transferred to the public security organs in accordance with the law.”
In fact, several cosmetic companies have been penalized in the past for using expired materials. For example, in July 2022, Zhangzhou Yijia Cosmetics Co., Ltd. was fined a total of 1.1635 million yuan, 15 times the amount, for producing baby moisturizing cream using expired materials. In January of the same year, Shanghai Ruofan Biotechnology Co., Ltd. was fined 652,000 yuan by the Shanghai Medical Products Administration, which is 20 times the value of three batches of cosmetics (with a total value of 32,600 yuan), for producing cosmetics using white truffle mushroom extract that had exceeded the expiration date.
Industry professionals have emphasized that material safety is a serious matter. “If product safety is the lifeline of a brand, then cosmetic companies should all prioritize the safety of their ingredients.”
