At Sensient Beauty, we know the importance of ensuring the compliance of raw materials with regulations for all markets and at all levels. May it be during production, transportation, usage and disposal, we ensure our company and products do not harm users and the environment. We spoke with our global regulatory team to find out more about the recent regulatory updates regarding titanium dioxide (TiO2) and PFAS.
What is PFAS?
Per- and polyfluoroalkyl substances (PFAS) are synthetic organofluorine chemical compounds that have multiple fluorine atoms attached to an alkyl chain. As such, they contain at least one perfluoroalkyl moiety. Known as “forever chemicals” because they are almost impossible to destroy and thus remain in the environment for an extended period PFAS are often used to make cosmetics longer-wear, waterproof, easier to spread, more absorbable on skin, as well as to give the appearance of smoothness or shimmer. PFAS are also common in non-stick cookware, cleaning products, fire-fighting foam, food packaging, and processing equipment. The most well-known PFAS is Perfluorooctanoic acid, or PFOA, commonly used to make Teflon.
Most recently, the nonprofit GMO/Toxin Free USA has filed a suit against CoverGirl Cosmetics and parent company Coty Inc. for “environmental and product safety misrepresentations due to indicators of toxic PFAS [per- and polyfluoroalkyl substances] chemicals found in their products.” Hence it is best practice that brands are informed by suppliers if their ingredients contains any PFAS from the get go.
Regulatory updates on PFAS
Following is a sampling of recent state laws and regulations concerning the banning of PFAS:
California: In 2020, California banned 13 PFAS in cosmetics in the Toxic Free Cosmetics Act, also known as AB 2762. It goes into effect on January 1, 2025. Another proposed bill, AB 2771, would ban all PFAS in California – not just the 13 covered under existing law. A second proposed bill, AB 2247, would require annual registration of all products containing PFAS that are sold in California on a publicly accessible reporting platform.
New York: A new law requires notification of added PFAS by 2024. By 2025, the sale of products with added PFAS will be completely banned in the state.
Maine: In July 2021, the state of Maine passed a law that requires companies to submit notifications to the state if there are added PFAS in their products. The state will ban the sale of products with additional PFAS by 2030.
Maryland: Maryland recently enacted H.B. 643, which prevents certain substances from being included in cosmetic products sold within the state. It goes into effect on January 1, 2025 and will prohibit businesses from “knowingly” manufacturing, selling, delivering, holding, or offering for sale in the State a cosmetic product that contains certain ingredients” that include 13 PFAS chemicals or any salts of the named PFAS. The ban includes eleven other chemicals, including mercury and formaldehyde, as well as two phthalates.
Sensient Beauty does not use PFAS as ingredients in our cosmetic products. Products which contain raw materials with PFAS as residuals or as unavoidable traces will be reformulated to phase out PFAS.
What is Titanium Dioxide (TiO2)?
For several years, titanium dioxide (TiO2) has been in the eye of legislators in Europe. TiO2 exists in two important forms: the pigmentary form, which is white and opaque, and the nano form, which is transparent. The pigmentary form is widely used in make-up, skin care and toothpaste, while the nano form is intentionally manufactured to the nano scale for use as a UV filter in products like sunscreens.
What should you know on the tightened rules of TiO2 usage
Effective October 21, 2021, the European Chemical Agency (ECHA) issued a harmonized classification for TiO2 as carcinogenic (category 2) by inhalation under regulation (EU) 2020/217. As a result, TiO2 must be classified as a carcinogen if inhaled (Carc. 2, H351 (inhalation) when supplied on its own or in mixtures, where the substance or mixture contains 1 % or more of TiO2 particles with an aerodynamic diameter ≤10 μm. All suppliers have to test the aerodynamic diameter of their TiO2 to determine if the TiO2 in powder form is considered as a carcinogenic 2 by inhalation. Until July 2021, the relevant trade associations had evaluated different methods for determining the aerodynamic diameter to find the most appropriate method. Based on our testing, all of Sensient’s titanium dioxide in powder form (e.g., pigmentary, nano form, and pearlescent pigments) are not considered as carcinogenic 2 by inhalation. All of our products have been appropriately labeled before the deadline of October 1, 2021.
The Scientific Committee on Consumer Safety (SCCS) has published a final dossier for TiO2 in the nano form (SCCS/1516/13) finding that the nano form is safe to be used as a UV filter within certain specifications and with certain allowed coatings, but excluding applications that may lead to exposure of the end-user’s lungs by inhalation.
Regarding pigmentary use, considering ECHA’s conclusion on TiO2 as carcinogenic 2 by inhalation, the European manufacturers formed a consortium to defend the usage of this form in 2017. Sensient is part of this consortium with other manufacturers and customers. The target was to cover all the uses of the pigmentary form of TiO2. As a result, the SCCS published in October 2020 the final version of their opinion (SCCS/1617/20) and ECHA added some restriction in Annex III that apply to TiO2 containing 1% or more of particles with an aerodynamic diameter below 10 µm.
In parallel, the European Food Safety Authority (EFSA) published a report in March 2021 that resulted in a ban on the use of titanium dioxide in food (https://www.efsa.europa.eu/fr/efsajournal/pub/6585). In response to this ban in the food industry, the cosmetics consortium prepared another dossier with a comprehensive and up-to-date review of the genetoxicity database and other scientific evidence to demonstrate the safety of pigmentary and nano form of TiO2 in cosmetic products. The consortium submitted this dossier to the European Commission in May 2022 to request the SCCS to re-assess the safety of TiO2 with focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray). On June 22, 2022, the European Commission responded by issuing a mandate to SCCS to re-evaluate the safety of TiO2. The SCCS will have nine months to issue its report.
Sensient Beauty has carefully following developments in the regulatory landscape of titanium dioxide. In the meantime, our innovation team have developed a replacement for titanium dioxide that we call SensiOp White which was launched April 2022.
Feel free to contact us if you are interested to find out more about our product portfolio.