CIR Panel Poised To Issue Final Word On Nonoxynols, With NGO Watching

At its December meeting, the Cosmetic Ingredient Review Expert Panel will consider issuing a final safety assessment for nonoxynols in personal-care products, taking into account new information provided by industry and additional requests by NGO Women's Voices for the Earth regarding use in feminine-care products specifically.

NGO-generated discussion concerning nonoxynol-9 safety in feminine-care products has one company reformulating to remove the substance ahead of an expected final assessment from the Cosmetic Ingredient Review Expert Panel on the full nonoxynol ingredient group.

At the Dec. 14-15 CIR meeting in Washington, the expert panel will pick up review of nonoxynols where it left off in September, armed with new information on the ingredient in question. Nonoxynols function mostly as surfactants and emulsifying agents in cosmetics and personal-care products.

The group issued a tentative amended final assessment on the ingredient group at its last meeting, finding 27 nonoxynols to be safe under current practices and use concentrations when formulated to be non-irritating. The position represents a shift in the panel's approach from a 1999 assessment that characterized a number of the same nonoxynols as safe for use in rinse-off products and at levels not exceeding 5% in leave-on products.

Previous consideration of the ingredient group has taken into account a 0.1% limit on nonoxynols in the EU due to environmental concerns, which the panel determined irrelevant to human health and therefore outside of its decisional purview.

A final safety assessment from the panel was put on hold in September due to concerns regarding nonoxynol-9 safety (Also see "CIR Panel Revises Nonoxynol Position, Considers NGO's Feminine-Care Concerns" - HBW Insight, 5 Oct, 2015.).

CIR report materials included findings from human and non-human studies linking nonoxynol-9 to genital irritation, erythema, inflammation, genital lesions and other adverse health effects.

In discussing the ingredient group at the September meeting, panelists took into consideration a letter from NGO Women's Voices for the Earth, which raised concerns about nonoxynols-9's use in feminine-care washes and the ingredient's potential to cause mucus-membrane irritation.

WVE pointed specifically to Very Private pH Balanced Body Wash, which lists nonoxynol-9 as an ingredient, and noted that the product had garnered numerous negative Amazon reviews suggesting adverse reactions.

Panelists said they were unable to properly consider the ingredient's safety in the feminine-care context without knowing the concentration used in the Very Private offering. The team noted that in a concentration as high as 20% nonoxynol-9 is a spermicide, while a non-voting FDA representative said the ingredient's use in concentrations as low as 5% can have contraceptive effects.

In preparatory materials for the December meeting posted to the CIR website, the Personal Care Products Council's Chief Scientist Beth Lange says in a memo that Very Private distributor Brandwynne Corp. has identified the concentration of nonoxynol-9 as 3% in the product at issue.

Additionally, the Los Angeles-based company says it is in the process of removing nonoxynol-9 from the formula since becoming aware of the potential safety issues, according to PCPC.

While the findings may help to reassure the panel, a decision to finalize the previously rendered tentative safety assessment is not likely to satisfy WVE.

WVE Seeks Harder Line On Feminine-Care Use

According to WVE, available data suggest that nonoxynol-9 cannot be used safely in any concentration in feminine-wash products, and the CIR panel's assessment should expressly acknowledge that, the group suggests.

In a Dec. 3 letter to the panel, WVE Director of Science and Research Alexandra Scranton questions the applicability of the group's tentative final position – that all nonoxynols should be formulated to be non-irritating – to nonoxynol-9's use in feminine-care formulas.

"Given the data available for nonoxynol-9, in which irritation occurred at every level tested, does this recommendation make practical sense?" Scranton asks. "Can you direct manufacturers to formulate a product to be non-irritating in the absence of any proven no-effect level for vaginal irritation?"

The safety issue is complicated by what WVE sees as inconsistencies in how feminine-wash products are labeled, typically directing against vaginal application, and the way such products are marketed and actually used by consumers.

Scranton argues that it is common practice for feminine washes to be used both internally and externally, and says marketing language for Very Private makes it clear that internal use is intended.

WVE has raised similar concerns about feminine cleansing products that contain color additives approved by FDA for external use only (Also see "NGO Seeks FDA Guidance On Colorant Use In Feminine Cleansers" - HBW Insight, 3 Sep, 2015.).

The exec also points to research suggesting that nonoxynol-9 can increase the risk of HIV infection, attributed to "the penetration of the virus into the vaginal epithelium resulting from vaginal irritation caused by N-9."

"As women frequently report the use of products such as feminine wash before and after being sexually active, it appears that chemicals like nonoxynol-9 are highly inappropriate and potentially unsafe in these products," she says.

Scranton suggests that CIR's final recommendation include language advising against use of all nonoxynols in products intended for vaginal exposure.

Further, WVE urges the CIR panel to take a closer look at octoxynol-9, given the ingredient's similarity to nonoxynol-9, and lists eight feminine cleansing products that contain octoxynol-9. The group cites a 2004 CIR report on octoxynols noting that octoxynols and nonoxynols are similar in chemical structure and safety test data on nonoxynols is applicable to octoxynols.

Category-Specific Protocol Encouraged

Finally, Scranton advocates for CIR members to develop a standard protocol for assessing the safety of vaginally applied products.

"The same ingredients that may be tolerable and safe by external epithelial skin are not necessarily safe for mucosal vaginal tissue," she says.

"Unfortunately," she continues, "the CIR has not acknowledged this distinction in their deliberations. Despite the fact that the VCRP data indicated products containing nonoxynols are used on mucous membranes, no discussion about the potential for vaginal mucous membrane exposure was initiated by any member of the CIR until our letter addressed the topic."

Also at the December meeting, the CIR panel will consider issuing final safety assessments on alkonium clays, alkyl taurate amides and taurate salts, apple-derived ingredients, citrus fruit-derived ingredients, inorganic hydroxides, monoglyceryl monoesters and silk proteins.

The panel will evaluate the safety of, and potentially advance tentative safety assessments for, hexamethylene diisocyanate (HDI) polymers, polymerized tetramethylcyclotetrasiloxanes and trimellitic anhydride copolymers and draft safety assessments on 1-hydroxyethyl 4,5-diamino pyrazole sulfate, citrus flower- and leaf-derived ingredients, citrus peel-derived ingredients, citrus plant- and seed-derived ingredients and helianthus annuus (sunflower)-derived ingredients.