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Rules of Court Regarding PCPC’s Withholding of TiO2 Prop. 65 Warnings, OEHHA extends comment period

Posted on by darion

According to a report by Bergeson and Campbell, PC, on June 12, 2024, the United States District Court for the Eastern District of California ruled in favor of the Personal Care Products Council (PCPC). The Board alleged that the California Office of Environmental Health Hazard Assessment (OEHHA) warning requirements under Proposition 65 (Prop. 65) apply to TiO2 in cosmetics and personal care products violated the First Amendment.

The court issued an injunction preventing the California Attorney General and any private enforcement agency from enforcing Prop 65’s “cancer” warning requirement as applied to listed titanium dioxide (i.e., titanium dioxide consisting of airborne, unbound particles of a size suitable for inhalation) in cosmetics and personal care products.

See in the archive: Urban Decay goes to court over respirable TiO2 in Eyeshadow Palettes

TiO2 and Prop. 65 History

TiO2 was added to Prop. 65 in 2011 due to the International Agency for Research on Cancer (IARC) classification in Group 2B. This classifies the ingredient as possible a carcinogen if it occurs in the form of “airborne, unbound particles of an inhalable size.”

According to OEHHA, the Safe Drinking Water and Toxic Substances Act of 1986, called Prop. 65, “requires businesses to provide a clear and reasonable warning before knowingly and intentionally exposing humans to a chemical listed as a carcinogen or toxic to reproduction.”

It was this warning mandate that opened the door to over 600 people Infringement notifications related to the presence of titanium dioxide in cosmetics, a Greenberg Glusker Limited Liability Company The source added that cosmetics companies are having difficulty defending themselves “due to the lack of an established safe harbor threshold for titanium dioxide, which leaves uncertainty as to when a warning is necessary.”

View in the archive: PCPC calls for action to include TiO2 on the Prop 65 list

Questionable risk

Moreover, as Bergeson and Campbell, PC note, the IARC Group 2B classification was based on evidence of carcinogenicity in animals, not in humans. Additionally, more recent studies, such as one published in 2022 in Scientific Reports, have found no evidence of carcinogenicity of TiO2 nanoparticles in an animal inhalation model.

In Europe, the Scientific Committee on Consumer Safety (SCCS) issued an opinion on TiO in 20202 used in cosmetic products that cause inhalation exposure. According to the source, “the use of pigment TiO2 to a maximum concentration of 25% in a typical hair styling spray is not safe for either regular consumers or hairdressers.” However, it continues: “The safety assessment showed that the use of pigment TiO2 in loose powder up to a maximum concentration of 25% in typical facial make-up use is safe for the average consumer.”

The Commission adds that ‘these conclusions are based on the safety assessment of TiO2 in the context of possible classification as a category 2 carcinogen (by inhalation). This means that the conclusions drawn in this opinion apply to the use of pigment TiO2 in a cosmetic product that may result in inhalation exposure of the consumer (i.e. aerosol, spray and powder products). Therefore, the opinion is not applicable to any pearlescent pigment due to the complex nature of such materials, including TiO2 is only a small component.”

“No significant level of risk” guidance.

Considering the need for a safe harbor threshold. to determine when a warning is not required, OEHHA proposes adopting a “No Significant Risk Level” (NSRL) under section 25705(c) for “titanium dioxide (airborne, unbound, respirable-sized particles).” The proposed NSRL would apply when the average daily exposure level is equal to or less than both of the following.

  • For unbound airborne particles 10 micrometers (µm) or less in diameter, the proposed NSRL is 440 micrograms (µg); AND
  • For unbound airborne particles 0.8 µm or less in diameter, the proposed NSRL is 44 µg.

Public comment has been requested

At the request of PCPC and the American Chemistry Council (ACC), OEHHA extended the deadline for submitting public comments on amending Title 27, California Code of Regulations, Section 25705(b), to include proposed NSRL for titanium dioxide (TiO2) (airborne, unbound particles of an inhalable size). OEHHA must now receive comments on the proposed regulation by July 1, 2024.