The well-known whitening essence was detected as a toxic substance due to the pyrolysis of arbutin.
Recently, the Chongqing Municipal Drug Administration issued a random inspection notice, in which a product called "Oubangqi Brightening and Blemish Serum" was detected with a banned ingredient hydroquinone, with a content of 131μg/g, which has aroused widespread concern and discussion in the industry.
Because hydroquinone is a prohibited substance in the mainland, once the ingredient is detected in the product, it is judged to be a substandard product.
Hydroquinone, also known as hydroquinone, was widely used in freckle removal and whitening cosmetics in the early years. According to historical research data, if cosmetics containing high concentrations of hydroquinone are used for a long time, their melanocyte toxicity may cause irreversible skin lesions such as vitiligo. Due to its strong side effects, hydroquinone has been listed as a banned raw material for cosmetics by many countries, including the mainland, and was classified as a Group 3 carcinogen by the World Health Organization's International Agency for Research on Cancer in 2017. In the United States, hydroquinone is a permitted ingredient in cosmetics with a limit of 2%.
Brand: There is no intentional addition
The batch of the product involved in the case, "Oubangqi Brightening and Blemish Serum", is 81042, which is nominally produced by Ruimei Co., Ltd., registered by Oubangqi Cosmeceutical Cosmeceutical Co., Ltd., and sold by Yanli Cosmetics (China) Co., Ltd. Chongvientiane Branch, and its responsible enterprise in China is Oubangqi (Xi'an) Pharmaceutical Technology Co., Ltd.
At present, this product has been removed from the shelves of OBAGI overseas flagship store, and according to store information, the 30ml specification of the essence is priced at 889 yuan.
Consumer reports consulted OBAGI's overseas flagship store about the reason for the removal of the product, and the customer service said that the product had been sold out before, and there was no mention of random inspection.
In addition, according to the user review at the bottom of the sales link, although the store is an overseas flagship store, this "Oubangqi Brightening and Blemish Serum" is a domestic imported product, which has been seriously filed with the State Food and Drug Administration, and the approval number is the national makeup special entry J20211160, which means that this product must comply with relevant laws and regulations in the mainland.
Although this essence has been removed from the shelves of overseas flagship stores, there are still many daigou stores on Taobao that sell it.
In response to the sampling results, Ou Bangqi responded that "there is no intentional addition of hydroquinone in the production process", saying that the unqualified reason is that the arbutin raw material in the product formula, the product was sampled at the time of local summer, improper storage, transportation and display may cause the sample to be at an ambient temperature much higher than the recommended storage temperature, and the excessive hydroquinone content is due to arbutin pyrolysis.
Image courtesy of the Blue Eye
Obagi is a well-known American functional skin care brand, founded in 1988 by American dermatologists, and the company was listed on the NASDAQ in 2006. In December 2018, it entered the Chinese market and opened a number of online sales channels in China, such as Tmall OBAGI overseas flagship store, Tmall obagi Oubangqi flagship store and Obagi Jingdong self-operated flagship store, with considerable annual sales.
According to public information, in April 2004, Ou Bangqi released a prescription vitamin C product, Obagi-C Rx System, the main functional ingredient in addition to L-vitamin C, hydroquinone (hydroquinone), that is, hydroquinone.
Arbutin, a hot whitening ingredient, is newly restricted by the European Union
Released in China in 2022, Opagi Brightening and Blemish Serum (410 Small White Bottle) claims to be "double whitening ingredient gold ratio, specializing in whitening and blemish lightening". According to the filing information, the main functional ingredient in the formula of "Oubangqi Brightening and Blemish Serum" is ascorbic acid (vitamin C) and arbutin.
Arbutin is divided into α type and β type according to different structures. Chen Laicheng, vice chairman of the Cosmetics Committee of the China Daily Chemical Industry Association and chief strategic technology officer of Guangzhou Mashanghui Biotechnology Co., Ltd., reported to consumers: "The conventional arbutin refers to β-arbutin, and there is no difference in the cosmetics category it is suitable for. Just because the activity of α-arbutin is 8~10 times that of β-arbutin. ”
Peng Guanjie, a senior cosmetics formulator, told Consumer Reports: "β-Arbutin has the risk of hydroquinone being resolved by water under acidic, high-concentration, and long-term storage conditions. ”
He explained that the "410 vial" meets exactly these conditions: it adds 10% VC (ascorbic acid), 10% is a strong acidic environment, and 4% arbutin is not too low. The batch sampled was produced in May 2022 and stored for at least a year, which is enough time for degradation to occur.
In addition, Peng Guanjie believes that due to the differences in the policies of the two countries towards hydroquinone, they do not have a strong sense of crisis about hydroquinone.
Due to the inextricable relationship between arbutin and hydroquinone, the safety risks of such ingredients have been studied in many places around the world.
In May 2015, the SCCS (Scientific Committee on the Safety of Cosmetics) conducted a safety assessment of α-arbutin and arbutin, respectively, to determine the safe use concentrations of the two substances, but this conclusion does not cover the mixing of the above substances with other substances that may release hydroquinone.
In January 2023, the SCCS published an opinion on the safety of α-arbutin and β-arbutin in cosmetics, in which it was concluded that the use of 2% concentration of α-arbutin in creams, 0.5% concentration of α-arbutin in body milk is safe, and the use of 7% arbutin in creams is safe, while formulations containing α-arbutin or arbutin should have as low hydroquinone content as possible and not higher than the unavoidable trace concentrations of both arbutins.
According to the above opinions, in April this year, the latest revision of the EU cosmetics regulation was released, and α-arbutin and arbutin were included in the list of restricted substances in cosmetics. Cosmetics that do not comply with the new regulations will not be allowed to be placed on the EU market from February 1, 2025, and will not be sold on the EU market from November 1, 2025.
Image courtesy of SGS Makeup Cleaning Care
As a popular whitening ingredient in the industry, many well-known brands have launched products with arbutin or α-arbutin as the main functional ingredient, including HBN α-arbutin series water cream, Winona arbutin Brightening Moisturizing Softener, The Ordinary 2% Arbutin Hyaluronic Acid Serum, Xiyan Extract Olive Centella Asiatica Serum, etc.
At present, α-arbutin and arbutin are in the "Catalogue of Used Cosmetic Raw Materials" in mainland China, but the domestic standards have not made mandatory provisions on their use concentrations.
"On August 22, 2023, the State Food and Drug Administration promulgated the "Inspection Methods for 4 Raw Materials Including α-Arbutin in Cosmetics", which was officially implemented on March 1, 2024, thereby improving the detection standards of arbutin, α-arbutin and hydroquinone. Chen Laicheng said to consumer reports: "Usually the amount of arbutin is between 1% ~ 10%, the amount of α-arbutin is between 0.1% ~ 1.0%, and the content of some whitening and freckle removal products is 1.0% ~ 3.0%, and there are dermatological products added to 5% ~ 8% before." ”
He reminded that cosmetics containing arbutin and α-arbutin are recommended to be placed in a cool and dry place away from direct sunlight, otherwise it may cause discoloration of the product or the degradation of arbutin into hydroquinone. If consumers find white spots on their faces when using arbutin-containing products, they should immediately stop using the relevant products and seek medical treatment from the dermatology department of a public hospital as soon as possible.
In response to the results of the sampling test of "Oubangqi Brightening and Blemish Serum" containing hydroquinone and the quality of other batches of products, consumer reports called Oubangqi (Xi'an) Pharmaceutical Technology Co., Ltd. many times and wrote to inquire about the relevant situation, but did not receive a reply as of press time.