Recently, the National Medical Products Administration issued a notice stating that six batches of cosmetics, including baby creams, produced by Guangzhou Kangcai Medical Supplies Co., Ltd. and other companies, were found to contain prohibited ingredients according to the product labels indicating the contracting party.
It is worth mentioning that among these six batches of products, half of them are baby creams.
Not long ago, Guangzhou Zhonghao Biotechnology Co., Ltd. (referred to as “Zhonghao Biotechnology”) was fined millions of yuan for producing red snail baby cream using the prohibited ingredient “tacrolimus”. Similarly, the listed company Golden Hair Rabbit was fined 2.6 million yuan at the end of last year for the presence of the prohibited ingredient “progesterone” in their products.
Taking into account the various incidents mentioned above, many industry experts believe that in 2024, the National Medical Products Administration’s focus on cracking down on prohibited ingredients may be on children’s cosmetics.
Three batches of baby creams were found to contain prohibited ingredients, and two of the involved companies are repeat offenders
According to the notice issued by the National Medical Products Administration, the three baby creams found to contain prohibited ingredients are “Baicui Ning Baby Moisturizing Repair Cream” from Guangzhou Henglan Biotechnology Co., Ltd. (referred to as “Guangzhou Henglan”), “Unlimited Love Baby Herbal Nourishing Cream” from Jiangsu Jiaoyan Barbie Cosmetics Co., Ltd. (referred to as “Jiangsu Jiaoyan Barbie”), and “Nobi Hang Baby Skincare Cream” from Shanghai Zhenxian Cosmetics Co., Ltd. (referred to as “Shanghai Zhenxian”).
The National Medical Products Administration pointed out that “Shanghai Zhenxian raised objections regarding the authenticity of the samples. After examination by the Shanghai Municipal Food and medical Administration, it was determined that the company did not produce or import the batch of products that did not meet the regulations.”
It is worth mentioning that Guangzhou Henglan and Jiangsu Jiaoyan Barbie can be considered habitual offenders. In October 2022, Guangzhou Henglan was found to have produced three batches of “Yingbeixuan Baby Skin Cream” and one batch of “Yingkang Probiotic Body Lotion” containing prohibited substances such as “chloramphenicol palmitate,” “halometasone,” and “clobetasone,” resulting in the revocation of their “Cosmetics Production License” and a 10-year ban on filing and registration applications for cosmetics. Jiangsu Jiaoyan Barbie, on the other hand, had their Tongtai Seven Herb Repair Cream found to contain prohibited ingredients by the National Medical Products Administration in 2021. The company was also notified by the National Medical Products Administration of deficiencies in their quality management system and ordered to stop production for rectification.
Why do companies continue to be found with prohibited ingredients in their products even after their production licenses have been revoked? Some industry experts speculate that “this may be due to products manufactured before the punishment still circulating in the market.”
The other three batches of products found to contain prohibited ingredients are Good Face Acne Treatment Cream, YULYNA Glitter Nail Polish Z19, and Meilipan Wandaifen Hair Dye Cream 7-srMP (used with Wandaifen 6% Hydrogen Peroxide). The manufacturing companies indicated on the labels are Guangzhou Meichun Cosmetics Co., Ltd., Yiwu Ruixue Cosmetics Co., Ltd., and Meilipan Corporation.
According to the “Regulations on the Supervision and Administration of Cosmetics,” “Measures for the Supervision and Administration of Cosmetics Production and Operation,” and “Methods for Sampling and Inspection of Cosmetics,” the National Medical Products Administration requires the medical regulatory authorities in Shanghai, Jiangsu, Zhejiang, and Guangdong provinces (municipalities) to investigate the registrants, filers, and entrusted manufacturing companies involved in the non-compliant cosmetics in accordance with the law, order the relevant companies to take immediate risk control measures and conduct self-inspection and rectification. “The medical regulatory authorities of each province (autonomous region, municipality) shall order the relevant cosmetics operators to immediately stop the operation of the above-mentioned cosmetics, investigate their purchase inspection records, and trace the origins of illegal products. Any discovered illegal activities shall be seriously dealt with in accordance with the law, and those suspected of a crime shall be transferred to the public security organs in accordance with the law.”
It is worth mentioning that on January 2nd of this year, Zhonghao Biotechnology, the producer of the previously highly scrutinized “Red Snail Baby Cream,” also received corresponding punishment. According to the administrative penalty information released by the Baiyun District Market Supervision Bureau in Guangzhou, the company was fined a total of 1.1 million yuan for producing Red Snail Baby Cream, Xingzhuangyuan Zhenhu Cream (Children’s Type), Xiaowawa Baby Moisturizing Cream, and other products containing the prohibited ingredient “tacrolimus.” Prior to this, Labi Baby, known as the “the first stock of mother and baby,” was fined 2.6 million yuan for their Baby Labi Egg Yolk Butter being found to contain the prohibited ingredient “progesterone.”
From “Big Head Baby” to “Toxic Cream,” the unauthorized addition of hormones and antibiotics in children’s cosmetics has always been a chronic problem in the industry. There is no doubt that the quality and safety of children’s cosmetics are of utmost importance, and the illegal addition of prohibited substances is an inviolable red line. It can be seen that this year, the National Medical Products Administration has mainly targeted children’s cosmetics in its crackdown on prohibited ingredients.
Last year’s crackdown in January and February was the most severe
In fact, based on the information released by the National Medical Products Administration throughout the year on cosmetics containing prohibited ingredients, hair care products dominated the list.
From the data compiled by CHAILEEDO from the National Medical Products Administration’s 2023 reports, a total of 79 batches of cosmetics were found to contain prohibited ingredients. Among them, 39 batches were hair care products, accounting for 49.4% of the total.
Specifically, the prohibited ingredients detected in hair care products were mainly triclosan, methylchloroisothiazolinone, methylisothiazolinone, and a mixture of magnesium chloride and magnesium nitrate (methylchloroisothiazolinone:methylisothiazolinone in a ratio of 3:1).
Triclosan is a common broad-spectrum antibacterial and antifungal agent. Studies have shown that triclosan is an endocrine disruptor that can affect thyroid function. According to the “Cosmetic Safety Technical Specification” (2015 edition), triclosan should not be detected in shampoos and hair conditioners. Triclosan is only allowed to be used in soap, bath products, deodorants (non-spray), powders, concealers, nail cleansers (with a frequency of no more than once every two weeks), and the permitted concentration is limited to 0.3%.
Methylchloroisothiazolinone, methylisothiazolinone, and the mixture of magnesium chloride and magnesium nitrate are mainly used as preservatives in cosmetics. Methylisothiazolinone (abbreviated as “MIT”) and methylchloroisothiazolinone (abbreviated as “CMIT”) belong to preservatives. According to the “Cosmetic Safety Technical Specification” (2015 edition), the maximum allowable concentration of “MIT” alone in cosmetics is 0.01%. The maximum allowable concentration of the mixture of “CMIT” and “MIT” and others in cosmetics is 0.0015%, and it is limited to rinse-off products and cannot be used simultaneously with methylisothiazolinone.
Several research and development engineers have told CHAILEEDO that surfactants are needed in rinse-off products, and corticosteroid preservatives are commonly used in surfactant raw materials. Therefore, methylchloroisothiazolinone, methylisothiazolinone, and the mixture of magnesium chloride and magnesium nitrate are also widely used in hair care products. In addition, some low-end shampoos may use corticosteroids as preservatives in their formulas, which can easily lead to overdosing of preservatives in the formula combined with the preservatives in the surfactants. “In addition, some factories may have poor hygiene conditions, and some companies may excessively add preservatives to avoid the risk of microbial contamination in raw materials, which ultimately leads to exceeding the limits.”
Overall, the National Medical Products Administration reported a relatively high number of batches containing prohibited ingredients in January and February, with 21 and 39 batches, respectively. In these two months, a total of 60 batches of cosmetics containing prohibited ingredients were reported, accounting for approximately 76% of the total for the year.
However, from March to July, the National Medical Products Administration did not report any cases of cosmetics containing prohibited ingredients. Afterward, from August to November, the National Medical Products Administration reported a total of 19 batches of cosmetics containing prohibited ingredients. In addition to hair care products, nail polish, face masks, and acne creams/essences were also categories with a significant number of products containing prohibited ingredients.
The complete version of safety assessment is expected to safeguard raw material safety
Clearly, recent cases of punishment have made many industry professionals fully aware of the importance of “raw material safety.” “Especially for children’s cosmetics, the safety of this category is definitely a top priority for regulation.” Some industry insiders even believe that “a raw material safety issue can bring a devastating blow to a company, leading to the downfall of all its brands and products.”
Another senior industry professional who preferred to remain anonymous stated that based on the notices issued by the National Medical Products Administration and the information on administrative punishment cases disclosed by various regions, the main sources of prohibited ingredients detected in cosmetics are through illegal addition, introduction during production, transportation, and storage processes, as well as the introduction of raw materials.
Apart from the first scenario of illegal addition, the situation where products are found to contain prohibited ingredients due to the other two reasons often “inflicts great harm” on the involved companies. For example, in the case of Gold 4 in the hair dye products, the company claimed that “progesterone was introduced through raw material egg yolk, and the company’s procurement of raw material egg yolk did not test for progesterone according to the ‘Analysis and Testing Report.’ The company also stated that its laboratory complies with the testing capabilities specified in Article 17, Paragraph 1 of the ‘Cosmetic Production Quality Management Standards,’ but lacks the capability to test for progesterone.”
However, some industry professionals also expressed that “even if a company lacks testing capabilities, they can entrust third-party testing organizations to conduct the tests.”
In summary, it is precisely because of the evident importance of raw material safety that the new regulations also require cosmetics filers/registrants to control and identify risk substances and conduct safety assessments of key raw materials.
It is worth mentioning that the complete version of safety assessment report, which will be implemented in May this year, requires companies to conduct risk assessments of raw materials during the cosmetics manufacturing process. If interactions exist between certain ingredients, such as chemical and biological interactions, it is necessary to assess the potential safety risks of the substances and/or interactions and take necessary measures to mitigate the risks.
Therefore, from this perspective, the implementation of the complete version of safety assessment may reduce the probability of cosmetics being found with prohibited ingredients to a certain extent, further ensuring the safety of consumers’ use of cosmetics.
Undoubtedly, raw material safety determines the safety of cosmetic products, and the safety of cosmetics is the bottom line of regulation. Therefore, at all times, companies should always prioritize “raw material safety.”
