The Cosmetic Ingredient Review's Expert Panel plans to re-open a review of disperse blue 1 based largely on the European Union's decision to ban the hair-dye ingredient (see chart: " ¹ Cosmetic Ingredient Review Report Status ").

While disperse blue1 is not currently used in products on the U.S. market, the panel sees fit to re-examine the ingredient's safety and carcinogenicity data.

The European Union's 2003 addition of disperse blue 1 to the list of banned or restricted chemicals established by its "Limitations Directive for Dangerous Substances and Preparations" (76/769/EEC) was a motivating factor, panel member Donald Belsito indicated during the panel's 114th meeting in Washington, D.C. April 5-6.

"We acknowledge the fact that it doesn't appear to be used currently in the U.S., but if we don't reopen it, then we're saying it can safely be used [in concentrations] up to 1 percent," he said.

"Perhaps that is the case. ... But if we do say it's safe up to 1 percent, that will be somewhat controversial as we will have different opinions on either side of the Atlantic Ocean on the safety of this ingredient."

During its previous review of disperse blue 1 in 1995, the CIR expert panel determined it was "safe as used in hair dyes at concentrations up to 1 percent." The ingredient was used in 112 hair coloring preparations at the time.

Based on data then available, the panel concluded that the ingredient was poorly absorbed through the skin and did not pose a risk to humans in concentrations up to 1 percent.

The panel has not received significant data on disperse blue 1 since its 1995 review of the substance, but the International Agency for Research on Cancer and the National Toxicology Program both have indicated that the ingredient could be carcinogenic. The NTP listed the ingredient in its 11 Report on Carcinogens as "reasonably anticipated to be a human carcinogen."

The Environmental Working Group's Skin Deep database does not show use in any cosmetic products and a concentration-of-use survey conducted by the Personal Care Products Council also did not turn up any users.

At the meeting, Linda Katz, director of FDA's Office of Cosmetics and Colors, urged the panel to ask the European Union for any data that factored into its decision prohibiting use of disperse blue 1.

Also at the meeting, the Expert Panel decided to re-open reports for trimoniums, used as hair- and skin-conditioning, anti-static and surfactant-emulsifying agents, and stearyl heptanoate, a skin-conditioning agent.

In taking another look at trimoniums, the panel will consider adding ingredients to the group - including behentrimonium chloride, which made CIR's priority list for 2010.

The panel decided not to re-open reports for polyquaternium 7 and quaternium 22, both used as anti-static agents, film formers and hair-conditioning agents. Lacking significant new data or literature, it opted to uphold safety conclusions from reports published in 1995.

Final OK For Kojic Acid

Issuing its only final safety assessment of the session, the expert panel deemed kojic acid "safe as used" in concentrations up to 1 percent.

Kojic acid - used as an antioxidant and a skin lightener - has gained attention as an alternative for controversial hydroquinone, though its safety has been disputed as well.

In September 2008, the European Commission's Scientific Committee on Consumer Products determined that the use of kojic acid at a maximum concentration of 1 percent poses a risk to human health due to potential systemic effects and skin sensitization risks (² Also see "CIR Expert Panel Questions Skin Whitener Kojic Acid" - HBW Insight, 5 October, 2009.).

The CIR team initially reviewed kojic acid in 2006. At its last meeting in December, it requested data concerning the ingredient's skin-lightening effects and potential for dermal sensitization/irritation in concentrations up to 4 percent.

The group has deemed data inconclusive for concentrations in excess of 1 percent, moving it to issue the safety assessment with that limitation.

For both pelargonic acid and polymethyl methacrylate (PMMAs), the panel issued tentative final safety assessments.

CIR took a unique approach in reviewing PMMAs, taking into consideration FDA data on the chemicals' use in medical devices.

"This was breaking new ground," according to panel member James Marks. "We used a lot of the toxicologic data from medical-grade PMMA and that should be noted also, using that data to support cosmetic safety."

At its December meeting, the panel decided to re-open the file on polypropylene glycols - which have more than 9,000 uses as moisturizers and formula stabilizers - in response to its use in higher concentrations than were previously deemed safe.

Relying on new data affirming PPGs' safety in those concentrations, the panel issued a tentative amended safety assessment, with the condition that products are formulated to be non-irritating.

Skin and hair conditioning agent dimethiconol - the only ingredient reviewed from CIR's top priority list - was given a formal insufficient data ruling.

The panel invites information on the ingredient's manufacturing impurities, dermal absorption, sensitization potential and reproductive toxicity.

Methyl acetate also drew an insufficient data announcement. CIR seeks insight into its safety in concentrations up to 17 percent.

Methyl acetates are used for fragrance and as solvents, skin-conditioning agents, pH adjusters, buffering agents, viscosity controllers, astringents, skin protectants and antifoaming agents in a variety of personal-care products.

Review of cocamidopropyl betaine (CAPB) was tabled so its report could be clarified to include information on the ingredient's sensitization, impurity level and the concentration levels at which it was tested, as well as a quantitative risk assessment.

The next Expert Panel meeting is slated for June 28-29.

- Lauren Nardella ( ³ l.nardella@elsevier.com )

In Light Of European Ban, CIR Experts Will Revisit Disperse Blue 1

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