The Cosmetic Ingredient Review Expert Panel has opted not to re-open a review of parabens following changes to European guidance on the preservative ingredient, but instead views the concerns of overseas experts as cause for examining the differentiating factors in infant skin.

From CIR’s point of view, an infant skin examination would be considered a stand-alone topic for the panel, not affiliated with a specific ingredient safety assessment. Though “not unlinked from parabens because that’s how it came up, it’s really much broader than parabens,” according to CIR Director Alan Andersen.

In a revised opinion issued in late 2011 – after Denmark instituted a plan to prohibit parabens in cosmetics for young children due to concerns about endocrine disruption – the European Commission’s Scientific Committee on Consumer Safety acknowledged that parabens could pose a risk to infants when used in diaper-area products Also see "CIR To Consider Re-Review Of Parabens Following Europe’s New Guidance" - HBW Insight, 5 March, 2012..

At its March 6 meeting, the CIR panel agreed that SCCS’s concerns do not necessitate another look at parabens, which the panel reviewed in 2006 and found to be safe for use in cosmetics Also see "Parabens “Safe As Used” In Cosmetics, CIR Concludes" - HBW Insight, 19 June, 2006..

However, the SCCS opinion does raise questions as to how infant skin differs from that of children and adults.

“We thought it would be good to put together a paper looking at what is known about absorption, penetration [and] metabolism in infant children as we go forward and deal with issues of products being used on them,” explained panel member Donald Belsito, a clinical professor of dermatology at the University of Missouri-Kansas City.

Panelist James Marks, professor and chairman of Penn State University’s dermatology department, agreed and recommended that an expert be brought in to discuss the biology and physiology of infant skin with the panel at a future meeting.

The panel’s consumer liaison, Rachel Weintraub, director of product safety and senior counsel at the Consumer Federation of America, noted that such an undertaking could inform future panel decisions beyond parabens.

“Allowing the CIR to look at this issue closely and have experts come to do an in-depth analysis on this, you’ll have a much better understanding moving forward for every ingredient,” she remarked.

From CIR’s point of view, an infant skin examination would be considered a stand-alone topic for the panel, not affiliated with a specific ingredient safety assessment. Though “not unlinked from parabens because that’s how it came up, it’s really much broader than parabens,” according to CIR Director Alan Andersen.

“And as for the paraben safety assessment itself, it stands,” he added.

Personal Care Products Council Satisfied

The CIR panel’s decision to affirm parabens’ safety was favorably received by the Personal Care Products Council.

“We brought this issue to the panel because we felt it was important ... to see if the panel’s decision on the safety of parabens still stands,” Chief Scientist Halyna Breslawec said at the meeting.

In a March 7 release, she states: “We are gratified that the panel has done so and confirmed the safety of these ingredients.”

FDA Office of Cosmetics and Colors Director Linda Katz also supported the panel’s move.

“At this point, we agree with the panel’s decision on the data. ... There’s no need to go forward with the exception of the baby skin area,” she said at the meeting.

Formaldehyde Assessment Upheld

Also during the meeting, the panel opted not to take another look at formaldehyde/methylene glycol. The panel had received a letter from NGO Women’s Voices for the Earth asking it to impose limitations on the ingredients’ use in nail hardeners, but the panel decided to maintain its initial “safe as used” assessment.

The expert panel decided to re-open reviews for alkyl esters, polyglycol lanolins and PEGylated oils to consider adding new ingredients to the ingredient groups.

The panel issued final “safe as used” assessments for ammonium hectorites, alkyl PEG sulfosuccinates, galactomannans, ethanoloamines, ethanolomides and citric acid and determined that currently there are insufficient data for bis-diglyceryl polydiacyladipates and amino acids (see related chart: [A#02120312007]).

The next panel meeting will be June 11-12 in Washington.

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CIR Panel Affirms Paraben Safety, Will Investigate Infant Skin Properties

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