The Cosmetic Ingredient Review's Expert Panel plans to evaluate 300 ingredients in 2010 - including triclosan, one of 17 priorities for the year (see chart: " ¹ Cosmetic Ingredient Review 2010 Priority List ").

Found in antibacterial products, toothpastes and shave gels, triclosan has been the subject of enduring controversy.

The ingredient was added to CIR's priority list at FDA's request. It currently is being considered for addition to the Topical Antimicrobial Drug monograph (² Also see "CIR Expert Panel Questions Skin Whitener Kojic Acid" - HBW Insight, 5 October, 2009.).

CIR takes into account ingredients' extent of use and biological activity when developing its priority list, according to Director Alan Andersen.

"More product usage means more exposure and that means it's more important for us to look at [an ingredient]," he told "The Rose Sheet" March 11. "Once we've identified an ingredient we also look to see what other chemicals are in that same family, and if there are other chemicals, then we can form a group and do them together."

Washington, D.C.-based environmental group Food and Water Watch has sought to block all non-medical uses of triclosan, maintaining that the ingredient is toxic to aquatic life (³ Also see "Environmental Group Opposes FDA Addition Of Triclosan To OTC Monographs" - HBW Insight, 8 March, 2010.).

Rep. Ed Markey (D-Mass.) expressed concern about the ingredient in a Jan. 5 letter to FDA urging the agency to finalize the Topical Antimicrobial Drug monograph. FDA's delay "has allowed the use of chemicals in everyday antiseptic agents that may be both ineffective and unsafe to human health and the environment," he said (⁴ Also see "Triclosan Concern In Congress Spurs Call For Final Antimicrobial Monograph" - HBW Insight, 11 January, 2010.).

Finalizing the monograph was listed among the Department of Health and Human Services' goals for 2010 in its semiannual regulatory agenda.

Panel Prepares For "Massive" Talc Project

Among other notable ingredients on the CIR panel's priority list are Butyrospermum parkii (shea butter), amino acids and talc.

Reviewing talc will be a "massive project" due to its wide use in personal-care products, Andersen said.

FDA is surveying talc and talc-containing cosmetic products on the U.S. market with an eye out for asbestos contamination, prompted by reports of tainted products in cosmetics overseas.

The agency has not received any reports of adverse events associated with the substance, it says (⁵ Also see "FDA Surveying U.S. Cosmetic Products For Asbestos-Contaminated Talc" - HBW Insight, 15 March, 2010.).

A review of amino acids will pose unique challenges as well, Andersen suggested, as there is a lot of information available on the safety of amino acids as used for dietary purposes, but they also are widely used in cosmetics.

"We eat amino acids all the time, and the question is going to be: Can we combine the wealth of safety information that's available about amino acids in ingestion [and] combine that with an understanding of what happens when you put them on the skin?" Andersen said.

In total, CIR plans to review 50 percent more ingredients in 2010 than in 2009, with the help of an expanded staff (⁶ Also see "Policy Panel: Council Execs Highlight Regulatory Priorities At Home & Abroad" - HBW Insight, 8 March, 2010.).

Additional staff members bring chemistry and toxicology expertise, which "allows us to take new and different approaches to how we're going to be doing safety assessments," Andersen explained.

CIR's expert panel will meet April 5-6 in Washington, D.C. The only ingredient from the priority list that is up for review at the April meeting is dimethiconal and its esters, which are used in personal-care products as skin- or hair-conditioning agents.

Also at the April meeting, the panel will re-review five ingredients it evaluated previously - disperse blue 1, polyquaternium 7, quaternium 22, stearyl heptanoate and trimoniums - taking into account new data and either reaffirming previous conclusions or reopening safety assessments.

At its December meeting, the panel issued a formal insufficient data announcement for the pelargonic acid group as well as for polymethyl methacrylate (PMMA) and related compounds. The panel will review new data for those ingredients and for polypropylene glycol (PPGs) and cocamidoproply betaine (CAPB) in April. The experts also will take a first look at methyl acetate.

At its last meeting, the CIR team affirmed that cyclomethicones D4, D5, D6 and D7 and ingredients in the dimethyl steramine family are safe as used (⁷ Also see "CIR Panel Reopens File On PPGs While PEGs, Kojic Acid Get Tentative OK" - HBW Insight, 14 December, 2009.).

CIR gave a tentative final "safe as used" ruling to polyethylene glycols (PEGs) and the kojic acid group.

Kojic acid's tentative ruling was due to a lack of data. The panel requested information concerning dermal sensitization/irritation in concentrations up to 4 percent and data on the ingredient's skin lightening effects, but according to the CIR Web site, it has only received a portion of that data in advance of the April meeting.

An antioxidant, kojic acid has been used as an alternative to controversial skin-whitening ingredient hydroquinone, which is banned in the European Union ⁸ Also see "CIR Expert Panel Questions Skin Whitener Kojic Acid" - HBW Insight, 5 October, 2009.).

- Lauren Nardella ( ⁹ l.nardella@elsevier.com )

CIR Panel's Priorities For 2010 Include Triclosan, Amino Acids, Talc

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