The European Commission’s Scientific Committee on Consumer Safety (SCCS) recently issued its final opinion on fullerenes, hydroxylated fullerenes, and hydroxylated fullerenes in a hydrated form (nano). SCCS stated that the potential genetic toxicity of fullerenes (C60 and C70) cannot be ruled out. Existing evidence also indicates the genetic toxicity of the hydrated form of hydroxylated fullerenes. Consequently, SCCS deems their use in cosmetics as not safe. Has this ingredient begun to be phased out?
SCCS considers Fullerenes as not safe for use in cosmetic products
Fullerene is a carbon allotrope comprising 60 carbon atoms arranged in a structure resembling a soccer ball, hence also known as C60. It possesses a distinctive molecular structure akin to closed carbon nanotubes or buckyballs. Fullerene exhibits remarkable properties such as high chemical stability, mechanical strength, and excellent electron transfer capabilities. Its immense potential has been showcased in fields like medicine, materials science, and nanotechnology, believed to contribute to the development of new drugs, materials, and technologies.
Discovered in 1985 and later proven in 1992 to possess excellent free radical scavenging abilities, the discoverers of fullerene were awarded the Nobel Prize in Chemistry in 1996 for this achievement.
In 2003, Mitsubishi Corporation’s subsidiary, Vitamin C60 BioResearch Corporation (later known as VC60 Corporation), became the first company to successfully apply fullerene in the skincare industry.
In the realm of cosmetics, fullerene is recognized for various properties like antioxidation, anti-aging, and moisturizing. Its most acknowledged function in skincare is its protection against ultraviolet (UV) radiation. Additionally, it is believed to have skin whitening and hair care benefits.
While fullerene has been confirmed to have extensive potential in cosmetics, its application faces challenges due to incomplete biological research, difficulties in production and purification, as well as its insolubility in water, leading to various formulations and derivatives. These factors pose potential risks to fullerene’s application.
Moreover, the mechanisms of fullerene’s actions are presently speculated to revolve around its antioxidative nature (free radical scavenging), yet there is a lack of literature providing a clear explanation of its specific mechanisms, significantly reducing its credibility.
The paper titled Fullerene Nanoparticle in Dermatological and Cosmetic Applications jointly authored by S. Zeinab Mousavi MD from the University of California, and Shohreh Nafisi, Department of Chemistry, IAUCTB, in 2017 indicates that while fullerene showcases outstanding antioxidative capabilities, making it a promising core ingredient in many dermatological and skincare products, “However, fullerene has the potentials to display a range of activities resulting in cell death or dysfunction.”
As there is a lack of specialized clinical trials and evidence confirming the safe use of fullerene in cosmetics, most products in the market utilizing this ingredient are from niche brands. Notably, global beauty conglomerates do not incorporate this substance into their products. Some relatively recognized brands like Dr.Ci: Labo and the Taiwanese brand Dr. Wu products contain fullerene.
The SCCS stated that the potential genetic toxicity of fullerenes (C60 and C70) cannot be ruled out. Current evidence also suggests that the hydrated form of hydroxylated fullerenes exhibits genetic toxicity; hence SCCS deems their use in cosmetics unsafe.
Once became popular in China
Fullerene experienced a surge in the Chinese cosmetics market in 2019. During the 51st China (Guangzhou) International Beauty Expo, products centered around the concept of fullerene were prominently showcased across various exhibition halls.
Starting in 2018, cosmetics with names containing fullerene exploded in the domestic market. In 2018 alone, there were over 1,200 newly registered cosmetics containing fullerene, compared to 190 in 2017, 60 in 2016, 20 in 2015, and merely 4 in 2014.
This year, fullerene was further popularized by internet-famous economist Ren Zeping.
On May 31, Ren Zeping launched the “Rensheng Zefa” brand, unveiling a “Rensheng Zefa Scalp Conditioning Kit” priced at 398 yuan. According to the product details, the kit comprises a scalp-conditioning shampoo and a scalp-conditioning essence. The shampoo contains 10ppm of added fullerene, while the essence shows an addition of 100ppm of fullerene.
According to the product details, it should contain two bottles of Renshengzefa Scalp Conditioning Shampoo and two bottles of Renshengzefa Scalp Conditioning Essence. In the introduction of the main ingredients, Fullerene occupies an entire page. The description highlights its “Nobel Prize honor,” being an “outstanding antioxidant ingredient,” with functions including “inhibiting inflammatory responses” and “repairing and protecting cells.”
“Rensheng Zefa” is a product under Suzhou Rensheng Zefa Biotechnology Co., Ltd., which counts Beijing Fullcan Biotechnology Co., Ltd (Fullcan). among its shareholders. According to the National Medical Products Administration’s government service portal, Fullcan has registered a product named “C60 Fullerene Brightening Essence Cream”, approved on May 6, 2021.
In reality, fullerene has been hyped as a concept in recent years due to concerns about its expensive raw materials, dispersion issues, transdermal penetration, and long-term safety concerns. In the medical and skincare industries, there is currently no definitive clinical evidence supporting the application of fullerene. Discussions about the potential toxicity of fullerene have previously sparked public attention.
The brand launched by this internet-famous economist hasn’t stirred a significant storm; its official flagship store on Taobao has just over 2,000 followers, and the sales of its products have remained relatively low, with each product selling just over 200 units.
According to data from the National Medical Products Administration, the number of registered cosmetics containing fullerene in China continues to rise. In November this year alone, there were as many as 38 registrations. Import data indicates that there were only two imported cosmetics containing fullerene in 2020, two in the regular cosmetics category in 2022, none in 2023, and only nine in 2021. The number of imported products with fullerene registered in the past three years is not even equivalent to one month’s worth of domestic registrations. This illustrates the popularity of fullerene in China, although major brands are not extensively involved, and it has not become a mainstream ingredient.
Difficult to become a mainstream ingredient in cosmetics?
Although fullerene has demonstrated some potential advantages in the cosmetics field, it hasn’t become a mainstream cosmetic ingredient. In fact, before the final opinion by SCCS, fullerene wasn’t widely used in cosmetics and hadn’t entered the mainstream ingredient landscape. This is primarily due to these four reasons.
Firstly, the high cost is a significant barrier. The production and extraction costs of fullerene are relatively high, potentially leading to increased final product prices. This restricts its usage in mass-market cosmetic products. While the cost of conventional fullerene has decreased, cosmetic standards demand high purity, resulting in elevated costs that deter manufacturing enterprises.
Secondly, there are existing technical challenges. Fullerene production and stability pose technical hurdles. Achieving high-purity fullerene and ensuring its stability in cosmetics might require intricate technology and processes, increasing the complexity and cost of product development. Additionally, its insolubility in water complicates mass production for cosmetic use. Attempts to dissolve fullerene in other solvents for cosmetic purposes raise safety concerns.
Another reason is the lack of market awareness. Fullerene, as a cosmetic ingredient, isn’t widely understood by the general public, resulting in lower consumer awareness of its effects and benefits. The absence of adequate market promotion and education might affect brand decisions regarding its use in cosmetics. Some internationally renowned brands and domestic industry leaders haven’t prioritized fullerene as a key ingredient, hence not incorporating it into their products. Despite an increasing number of registrations, these are mostly from smaller enterprises that haven’t captured consumer attention.
Lastly, and most importantly, there is a lack of convincing clinical trials and data to prove its efficacy and safety. While fullerene has shown potential advantages in laboratory research, more scientific validation and research are needed regarding its long-term usage and large-scale application. SCCS expressed concerns about the safety of fullerene, hydroxylated fullerenes, and their hydrated forms used in cosmetics due to their antioxidative properties. Despite thorough assessments, SCCS couldn’t conclusively determine their safety due to uncertainties and data gaps in physicochemical, toxicokinetic, and toxicological aspects.
In conclusion, regardless of whether SCCS has issued a final opinion regarding the safety of fullerene, from the market and consumer response, fullerene seems akin to a social media-famous ingredient in cosmetics: once popular, yet still struggling to become mainstream.
