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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations the absence of any other evidence, studies, or new scientific information addressing the flaws identified in the Moore study that would demonstrate that the use of lead acetate in hair dye is safe, we are denying the request for a hearing on this objection.
Objection 11. Combe objects to FDAs argument that the absorption percentage from Moore is invalid because it tested only a small patch of skin. See Submission, page 40. Combe acknowledges that the scalp has a larger surface area, but states that the use instruction for its hair dye product is to apply the dye to the hair while avoiding areas you want to keep gray and not to apply the product to the scalp. See Submission, page 41. Thus, Combe claims that its product would never touch the whole scalp. Ibid. Combe asserts that Moores approach of applying the lead acetate formulations directly to skin on the forehead was a conservative approach that would substantially overestimate absorption.
Combe further asserts that,
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Moore applied a small amount of hair dye to a small patch of skin and measured how much of that small amount was absorbed.
Thus, Moore was able to estimate the percentage of the applied dye that enters the body. This fraction 0.058 percent was then multiplied by the actual amount of hair dye that would reach the head, yielding the amount of absorption that can be expected from the whole application. By such multiplication, Moore took into account the application to more than just a small patch of skin. Moore considered the entire scalp.

See Submission, pages 4142.
Combe also asserts that the way Moore estimated absorption remains the standard way that industry and regulators do it today. See Submission, page 42. Specifically, Combe states that FDA evaluated the dermal absorption of lead as a percentage of the amount applied to the skin in its 2016 draft guidance for lead as an impurity in cosmetic lip products and externally applied cosmetics, and that this approach is similar to the approach in the Moore study. Ibid.
Response to Objection 11 Our criticism of the Moore study is not limited to its testing of only a small patch of skin; however, the size of the skin tested is one relevant factor.
We note that Combe asserts that lead acetate would never touch the whole scalp. See Submission, page 41. Yet, Combe failed to provide data showing how much of the scalp by the percent area is estimated to be exposed to the hair dye. Without such data, our assumption that the hair dye would be applied to the surface area of the scalp that would be expected to be treated
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with the hair dye product is consistent with the practices used in an appropriately designed dermal absorption study. For example, see the European Commissions Scientific Committee on Consumer Products SCCPs guidance for testing and evaluating safety of cosmetic ingredients Ref. 9. Page 44 of the SCCP guidance document states, Hence, when dermal absorption is expressed as a percentage, the absorbed amount resulting from in vitro tests has to be expressed as a percentage of the dose applied in real in use conditions, that can be estimated by the ratio of the default amount of formulation applied in real conditions and the respective default value of skin surface area per product type.
In addition, it is likely that some users would apply the product to the whole scalp. For example, Combes Grecian Formula16 liquid and cream products use instructions state that the user should apply the lead acetate-containing hair dye to cover gray totally, until hair feels slightly damp; comb hair as usual; if desired apply daily until hair reaches desired shade; and to maintain your natural look, apply once or twice a week thereafter Ref. 10.
The pictures provided in the use instructions appear to indicate that the dye may be applied on the area of the head covered by hair Ibid..
Accordingly, we expect that some users would follow these instructions and apply the dye and comb the damp hair such that the dye would widely reach the scalp.
Nonetheless, Combe asserts that Moore considered the entire scalp, by multiplying the percentage of the applied dye that enters the body i.e., the fractional absorption by the actual amount of hair dye that would reach the head. See Submission, page 41.
Experimental conditions can impact fractional absorption and are not independent of skin loading conditions, which can have dramatic effects on the results Refs. 11 and 12. The experimental conditions in the Moore study were drastically different from the intended conditions of use, thus the fractional absorption measured in this experiment is not representative of the real fractional absorption under the intended use conditions. For example, a fractional absorption obtained by applying 0.1 milliliter mL of hair dye formulation containing 0.12 percent lead acetate to an 8 or 10 cm2 area of skin on the forehead without many hair follicles and measured after 12 hours does not accurately reflect the actual use conditions where 0.18 mL of formulation containing up to 0.6 percent lead is applied to a 580 cm2 area of
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scalp area with many hair follicles and is reapplied every 24 hours until the hair reaches the desired shade Refs. 1
and 2. Thus, the relative dermal loading of the hair dye was 0.01 mL/cm2
0.1 mL/10 cm2 in the Moore study versus 0.00031 mL/cm2 0.18 mL/580
cm2, which is a 32-fold difference that influences dermal absorption. We do not consider a study design, in which the test formulation with lower lead acetate concentration was applied to a small surface area on the forehead instead of the full scalp and washed off after an application period-to be a conservative approach as Combe asserts, nor do we consider it an accurate measure of lead exposure from the product use. Thus, we believe that the Moore study underestimated the total amount of lead that was absorbed.
With regard to FDAs 2016 draft guidance, as discussed in our response to Objection 18, this guidance is specific to lead present in certain cosmetics as an impurity. It is important to note the maximum permitted use level of 6,000
ppm lead acetate intentionally added to a hair dye is 600 times greater than the maximum recommended lead level of 10 ppm as an impurity. For the draft guidance, FDA evaluated the dermal absorption of lead as a percentage of the amount applied to the skin in order to assess exposure more generally. The draft guidance incorporated usage data for three representative cosmetic product categories lipstick, eye shadow, and body lotion and estimated whole body exposure to lead. The draft guidance considered average daily usages of lipstick, eye shadow, and body lotion to make generalizations for lead as an impurity in all categories of cosmetics covered by this guidance, rather than in each specific category.
By contrast, for our review of lead acetate, we considered specifically how much lead would be absorbed from a hair dye to ensure that this intended use of lead acetate meets the safety standard for color additives. Because use of lead acetate as a hair dye is associated with a specific usage scenario limited to only the scalp, the intended conditions of use, including the surface area of application, were important in calculating absorption. Because of study design limitations with the Moore study, we used a published Kp value see response to Comment 12 that addresses the Kp value in a ConsExpo model to estimate exposure and predict potential percentages of dermal lead absorption for this specific usage scenario.
A hearing will not be granted on the basis of mere allegations or general descriptions of positions and
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