The Cosmetic Ingredient Review Expert Panel issued a final amended report for parabens after reviewing a male reproductive study on the ingredient and research on breast cancer cells (see chart: " ¹ Cosmetic Ingredient Review Report Status "). The panel reached its decision during its June 12-13 meeting in Washington, D.C.

The final report follows a 90-day comment period on parabens, which was initiated following CIR's December meeting in which the panel issued a final tentative assessment for the ingredients (² Also see "Parabens Tentative Amended Final Report Issued By CIR" - HBW Insight, 19 December, 2005., p. 3).

Since then, CIR received and reviewed technical comments submitted by the Cosmetic, Toiletry and Fragrance Association, as well as a CTFA-sponsored 2005 male reproductive study on methylparaben, which found no observable effect level of general toxicity.

In addition, CIR assessed a new study on gene expression profiles in breast cancer cells exposed to parabens that was published in the 2006 Toxicity Letters, as well as a patch test study conducted by the North American Contact Dermatitis Group.

CIR re-opened the safety assessment of parabens in June 2004 after a British study linked the ingredients to breast cancer (³ Also see "CIR Panel To Reopen Parabens Review To Consider New Data" - HBW Insight, 5 July, 2004., p. 4). Since then, parabens have been the subject of scrutiny among consumer advocacy groups and regulatory agencies.

In addition to issuing a final report on parabens, the panel determined two hair dye ingredients, 3-methylamino-4-nitrophenoxyethanol and HC red no. 7, are safe as used in hair dye products and issued final safety rulings for the substances. The reports contain CIR's updated hair dye epidemiology statement (⁴ Also see "CIR Revised Hair Dye Statement More “Accessible” To Public – Panel" - HBW Insight, 19 December, 2005., p. 5).

Separately, CIR released a tentative final report for hyaluronic acid. In April, CIR tabled its report on the substance to review several studies on the relationship between hyaluronic acid and carcinogenesis data. After reviewing the data, however, the panel determined no additional data on the ingredient is necessary.

In line with its re-review process, the panel discussed whether to re-open a safety assessment on three ingredients, including tallow and its derivatives, which initially received a safe as used ruling in 1990.

Since the last CIR ruling on tallow, a new FDA regulation has been promulgated regarding tallow in cosmetic applications. However, the panel decided the original conclusion for tallow was still valid, and decided not to re-open its review.

Additionally, CIR decided not to re-open safety reviews for arachidyl propionate, an ingredient which received a safe as used ruling in 1990, and soap ingredient benzalkonium chloride, which the panel evaluated in 1989 and determined was safe as used in concentrations up to 0.1%.

The panel also was tasked with deciding whether to amend the report for ascorbic acid to increase the maximum "safe as used" concentration for the ingredient to 35%, per CTFA's request. In a 2001 final report, the ingredient was deemed safe in concentrations up to 10%.

CTFA submitted an unpublished human repeat insult patch test study supporting the use of 35% ascorbic acid in an unidentified face lotion. After reviewing the data, the panel determined ascorbic acid "can be used up to 35% when formulated to be nonirritating," and will thus change the "as used" determination in the report.

In light of that change, CIR discussed how to communicate future changes for the "as used" specification of reports, and concluded subsequent changes will appear in CIR's report summary and its findings table as well as in the Journal of Toxicity.

CIR voted on whether its recommended limit for arsenic, which is present in cosmetic products as a residue, should be lowered to comply with new requirements by the Environmental Protection Agency.

Since 1998, CIR's current limit recommendation for arsenic is 3ppm. However, EPA lowered the limit to 10ppb for arsenic in drinking water in 2001. The panel ultimately decided the amount of arsenic absorbed into the body from cosmetics would be lower than the amount ingested in drinking water, and determined its current limit is acceptable.

The panel agreed to table the report on phenylenediamine, an ingredient used in hair dye, after receiving industry comments that the safety assessment is difficult to understand.

Lastly, the panel will add kojic acid, used in skin lighteners, to its high-priority list. CIR staff is compiling data on the substance now.

- Melina Vissat

Parabens “Safe As Used” In Cosmetics, CIR Concludes

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