Commencing on August 1, 2024, or one year after the Effective Date, whichever is later, Defendant shall not sell any Covered Product that: (1) when measured using air capture, contains greater than 250 respirable-sized unbound TiO2 particles per liter (str/L) of air, or for elongate fibers of TIO2, greater than 75 str/L; or (2) when measured using bulk testing, greater 5.0 X 103 respirable-sized TiO2 unbound particles. This would be measured using either of the following methods: Air Capture: Testing should be carried out in a sealed laboratory glovebox or containment free from external air movements or contaminates. Released particulate should be collected on a 25mm air monitoring cassette with a 0.45-micron MCE filter, connected to a personal air sampling pump calibrated to a flow rate of 2.0 L / min.
2. With the air sampling pump running, use a makeup applicator or brush and apply enough pressure to transfer the product onto the tool. Tap or blow off excess product. Simulate applying the product to a gloved hand or other nonporous surface located no more than 20 cm from the air cassette, for 10 minutes. Allow the air sampling pump to run for another 5 minutes with no disturbance of the product. Prepare the resulting filters from the air cassettes for TEM by collapsing the filter, coating with carbon evaporated in high vacuum (10-4 to 10-5 Pa), placing onto TEM grids, and dissolving away residual filter material. Particulate should be analyzed via a TEM with an acceleration voltage of 100KeV equipped with EDXA and SAED at magnifications of at least 15,000x. Calculated concentration should be made relevant to effective filter area (EFA) divided by the area analyzed, relative to the liters of air sampled, i.e., on a str/L basis.
B. Bulk Testing
1. Preparation for qualitative presence or absence and quantification of TiO2 particles unbound in the respirable-size fraction by TEM are conducted as follows: The product is prepared for analysis by weighing and suspending a portion of the suspect material in an alcohol/deionized water mix. Measured aliquots of the sample suspension are then filtered through a 0.2 µm mixed cellulose ester filter (MCE). It has been determined that the optimal range of material extracted from the product falls between 10-50 mg suspended in a 400 mL 50/50 DI H2O/isopropyl alcohol solution*, from which 1-5 mL aliquots are drawn and filtered. The final MCE filter is dried, collapsed with acetone, and coated with carbon in a vacuum evaporator. The fibers and solids collected on the carbon-coated filter replicate are transferred onto copper grids for TEM analysis.
2. The resulting preparation is then scanned to assure a particle loading of the filter between 5-15%, and then quantified by analysis, measuring lengths and widths and chemistries of particulate to determine overall percent TiO2 and size bin categorized for comparison with target value compliances. Only particles less than 10 µm relative aerodynamic diameter not touching or adhering to other materials on the filter preparation that reveal only titanium (and oxygen) peaks by EDS will be considered for quantification. To observe and quantify all such structures down to unbound particles as small as 50 nm (minimum dimension of 0.050 µm), the analysis should be conducted at 20-25,000x magnification. Sufficient area of the filter shall be analyzed to reach an analytical sensitivity of at least 5.0 X 103 RPTi /mg of product.
3. Products prepared and analyzed by this bulk screening protocol that are found to contain >5.0 X 103 RPTi /mg of product shall be deemed as “Fails TiO2 screening test”, as would any product found to contain respirable titanium dioxide fibers (mineralogically, acicular to fibrous rutile) observed on the filter analyzed to the specified analytical sensitivity (5.0 X 103 RPTi /mg). Product samples thusly failing this standard would then be recommended for further testing to confirm releasability such as product use simulation in a controlled environment with appropriate air testing, etcetera. Alternatively, such products may be reformulated by the manufacturer or removed as noncompliant.
Should EHA reach a court-approved settlement with another cosmetics manufacturer alleging a violation of Proposition 65 with respect to TiO2, Defendant may comply with the reformulation standard in that settlement and will be deemed in compliance with Proposition 65.
Covered Products’ compliance with the either the air capture or bulk testing standard set forth in this section constitutes compliance with Proposition 65 as to TiO2. Clear and Reasonable Warnings
For Covered Products that contain TiO2 in a concentration exceeding the Reformulation Standard set forth in section 2.1 above, and which are distributed or directly sold by Carter in the State of California on or after the Effective Date, Carter shall provide one of the following warning statements. Option 1:
WARNING: This product can expose you to chemicals including airborne, unbound particles particles of Titanium Dioxide, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Option 2:
WARNING: Cancer- www.P65Warnings.ca.gov.
This warning statement shall be prominently displayed on the Covered Products, on the packing of the Covered Products, or on a placard, shelf tag, or sign provided that the statement is displayed with such conspicuousness, as compared with other words, statements, or designs as to render it likely to be read and understood by an ordinary individual prior to sale. If the warning statement is displayed on the Covered Products’ packaging, it must be in a type size no smaller than the largest type size used for other consumer information on the product. In no case shall a warning statement displayed on the Covered Products’ packaging appear in a type size smaller than 6-point type. The same warning shall be posted on any websites under the exclusive control of Carter where Covered Products are sold into California. Carter shall instruct any third-party website to which it directly sells its Covered Products to include the same warning as a condition of selling the Covered Products in California.
2.3 Sell-Through Period
Notwithstanding anything else in this Consent Judgment, Covered Products that are manufactured, packaged, or put into commerce within one year of the Effective Date shall be subject to the release of liability pursuant to this Consent Judgment, without regard to when such Covered Products were, or are in the future, distributed or sold to customers. As a result, the obligations of Carter, or any Releasees (if applicable), stated in this Section 2 do not apply to Covered Products manufactured, packaged, or put into commerce up to one year after the Effective Date.
