The Cosmetic Ingredient Review Expert Panel is issuing an informal data request for quantitative estimates of exposure to parabens through certain consumer products, the panel announced during its Sept. 12-13 meeting in Washington, D.C.

Data submitted to the panel should address products "that will be directly used on babies, products that will be used on pregnant women and products that will be used on women and might transfer to babies through breast milk," CIR Director Alan Andersen, PhD, said.

Andersen noted an exposure assessment should include information regarding the levels of parabens in such products and daily usage by consumers.

CIR will review any information it receives this year during its Dec. 12-13 meeting. However, if the panel does not receive sufficient data by that time, the review may be postponed until its April 2006 meeting, according to Andersen.

Parabens were found to be safe by CIR in 1984, but the panel reopened its assessment in 2004 in light of a British study linking the substances to breast cancer (¹ Also see "CIR Panel To Reopen Parabens Review To Consider New Data" - HBW Insight, 5 July, 2004., p. 4).

The ingredients have recently been the subject of scrutiny from consumer advocacy groups as well as regulatory agencies. In August, the National Toxicology Program Board of Scientific Counselors recommended that toxicity tests be conducted on butylparaben due to its widespread exposure to humans through personal care products, food and pharmaceuticals (² Also see "Butylparaben Toxicity Testing Recommended By NTP Board" - HBW Insight, 29 August, 2005.. p. 3).

The panel was slated to review parabens last March, but tabled the discussion until September to give members enough time to look at the large volume of unpublished data submitted, and to receive further unpublished data (³ Also see "CIR Paraben Review Delayed While Panel Examines Data" - HBW Insight, 28 March, 2005., p. 5).

Additional information submitted to CIR included unpublished data from the Cosmetic, Toiletry and Fragrance Association, a 2003 binding study and uterotrophic assay, a 2005 study on parabens and reporter cell lines and a 2005 safety assessment.

The data prompted concerns over possible male reproductive toxicity and some weak estrogenic activity, but the studies as a whole revealed "uncertainty" regarding the ingredients' safety, according to Andersen.

He added while some studies showed effects, the "endpoints are particularly variable" and there are studies that show an "absence of effect."

The CIR panel also discussed whether to reopen a safety assessment of another controversial ingredient group, phthalates, following a review of new safety data on the substances' effect on reproductive development in males.

Determined safe for use in cosmetics in 1985, phthalates were brought before the CIR panel again in 2002 after questions rose regarding their safety; however the panel reaffirmed the safe as used status (⁴ Also see "Phthalates Group “Safe As Used” In Cosmetics, CIR Concludes" - HBW Insight, 25 November, 2002., p. 3).

Among studies the panel reviewed at the most recent meeting was one conducted by Shanna Swan, PhD, University of Rochester Department of Obstetrics and Gynecology, et al., which indicated prenatal exposure to phthalates could negatively affect reproductive development in male infants (⁵ Also see "Phthalate Exposure Linked To Male Reproductive Underdevelopment" - HBW Insight, 6 June, 2005., p. 9).

While the study was of "greatest concern" among the new data, the panel noted its results may be compromised by flaws in its methodology. Team leader Donald Belsito, MD, University of Kansas Medical Center, criticized the study for having no historical controls and asserted the findings "were not significant."

Other new studies submitted to CIR failed to "raise any new red flags" regarding the safety of phthalates, he added.

The panel concurred with Belsito, reaffirming its safety recommendation, but agreed with him to review updated safety information on phthalates "at least on a yearly basis."

CTFA President Bailey On CIR Review Process, Resource Issues

Excerpted remarks by Cosmetic, Toiletry and Fragrance Association President Pam Bailey to the Cosmetic Ingredient Review Expert Panel during its Sept. 12-13 meeting.

"As a newcomer to this industry and someone who has worked in health care all of her career with a great deal of experience working with FDA, I really was stunned when I found out about CIR because it really is unique. I think it serves as an example of the private sector stepping forward, working collaboratively with FDA in the sense that we don't ask FDA to do all of the work in terms of protecting the public."

"I think [the CIR review process] is unique and fascinating, and one of my challenges personally is to tell the story about CIR...and do it in a way that is well recognized and well appreciated, by not just your colleagues, not only in this country but in other countries that worry about these issues, so consumers can understand the independence and the rigor and the scientific details with which you do your work and with which you look out for their interests."

"Clearly you are independent and preserving your independence and your ability to do your work independently, and to make sure you have the resources, whether it's data, whether it's budget, whether it's staff, is a primary responsibility I think of CTFA. We're putting our budget together now for next year, we're examining policy issues, and at the forefront of all of these discussions is always CIR, the importance of CIR, the importance of its independence and...resources for it."

"I think [the April 25 meeting with FDA Commissioner Lester Crawford to present CIR Expert Panel meeting results] was a good exchange of views and an opportunity to present to the commissioner what CIR does and...to talk about what needs to be done on the government side to complement what we do. It is clear to me...that resources are a problem at FDA, and I don't think that's going to get any better...It makes your work and our work together even more important because government is not going to be able to step forward without perhaps some different policies."

CIR also reaffirmed the safety determination for three other ingredients - DMDM hydantoin, polyquaternium-10 and aminophenols, a hair dye ingredient (see chart: " ⁶ Cosmetic Ingredient Review Report Status ").

The panel additionally agreed to add its hair dye epidemiology "boilerplate" to the report on aminophenols.

Panel members approved three pending final reports during the meeting. Alcohol denat. was determined to be safe as used, but only when denatured with denatonium benzoate and previously approved denaturants.

However, data are insufficient to support the safety of alcohol denat. when denatured with quassin, brucine and brucine sulfate, the panel concluded.

Polaxamers were moved to final report status with a safe as used ruling. CIR issued a final amended report on propyl gallate, determining the ingredient is safe for use at concentrations of = 0.1%.

CIR decided to table hair dye ingredient 3-methylamino-4-nitrophenoxyethanol so it can review a large volume of data submitted shortly before the meeting.

A tentative amended final report, safe as used, was issued for cocamidopropylamine oxide, but only for rinse-off products. Data was insufficient for leave-on products, the panel concluded.

The panel also issued a tentative final report for 1, 1, 1-trichloroethane as safe as used for cosmetic purposes, at the same time acknowledging in the ingredient report that EPA has declared the ingredient a class 1 ozone depleting chemical and has banned all but essential uses.

CIR placed its review of enthanolamine thioglycolate group on hold to allow the panel time to receive studies that are still in progress, and announced a tentative addendum for n-butyl alcohol use in non nail products will be discussed at the December meeting. CIR decided to re-open a review of n-butyl alcohol in June (⁷ Also see "CIR Reopens N-Butyl Alcohol Review To Address Non-Nail Uses" - HBW Insight, 20 June, 2005., p. 3).

CIR Requests Parabens Exposure Data, Reaffirms Phthalates Safety

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