The use of formaldehyde and methylene glycol in hair straightening products involving heat is unsafe, the Cosmetic Ingredient Review Expert Panel determined after an intense discussion of the issue during its June 28 meeting in Washington D.C.

That conclusion, which split the panel 50/50, broken by a final vote by Panel Chair Dr. Wilma F. Bergfeld, resulted in a revised tentative final report for formaldehyde/methylene glycol, with three sections pertaining to its varied use in cosmetics.

In addition to the “unsafe” recommendation for hair straighteners, the panel determined that dermal contact is safe at levels up to .074% for formaldehyde and equivalents.

In the third part of the decision, the panel determined that there is insufficient data to determine the safety of formaldehyde/methylene glycol in nail-care products, and the panel awaits further data on those products.

The decision will go out again to the public for a 60-day review period to allow industry to respond.

CIR took up its most recent review of formaldehyde and methylene glycol in March per the request of FDA and the Personal Care Products Council (Also see "CIR Panel Unsure About Safety Of Formaldehyde-Releasing Pro Hair Smoothers" - HBW Insight, 14 March, 2011.).

The issue of formaldehyde in hair straighteners came to light from investigations by Oregon's OSHA and Canadian regulatory body Health Canada, which reported high levels of formaldehyde in Brazilian Blowout-brand professional products.

During the March meeting, the CIR panel reaffirmed its 2005 conclusion that formaldehyde and methylene glycol are safe in cosmetic products “when formulated to ensure use at the minimal effective concentration” and not in concentrations exceeding 0.2%.

However, the panel could not conclude at that time that the ingredients are safe in cosmetic products intended to be aerosolized or when the vapor or gas of the ingredients is produced under conditions of use, as is the case with many keratin-based hair-straightening products.

Panel Splits In Opinion

According to CIR Director Dr. Alan Andersen, in developing its conclusion for formaldehyde and methylene glycol, CIR panel members differed in their recommended approaches to controlling the unsafe exposure to the substance.

The team led by Dr. James G. Marks “wanted to place the burden on the manufacturer of hair-smoothing products to produce products that would not result in sensory irritation, much like is often done when we say 'safe when formulated to be non-irritating'” Dr. Andersen said in recapping the decision.

However, Dr. Belsito, with support of his team, argued that “if you are going to apply heat, there is no way to guarantee no sensory irritation and still have a product that works,” Dr. Andersen noted.

During the discussion, Dr. Belsito argued that leaving the onus up to salons is dangerous, since salons vary greatly in their approaches to control exposure.

For example, he gave the example of a fully ventilated salon in which his daughter had a Brazilian blowout. However, in many instances, “you could have a cosmetologist who is licensed in the state but who practices in her basement” without proper ventilation.

“This is not simply about putting on a mouth shield,” Belsito said. “This is airborne vapor that affects other people who are around. If the consumer wants to take the risk to have their hair straightened,” that's one thing, but “this vapor effects everyone around it.”

Panel Addresses “Mislabeling”

The panel also discussed the fact that some marketers of hair-straightening products state their products are “formaldehyde-free” but the formulas contain methylene glycol or formalin, essentially the same substances.

Panel members agreed that companies involved in that practice are misleading consumers and mislabeling their products.

Panel member Rachel Weintraub of the Consumer Federation of America expanded on those sentiments, saying there is a vast amount of “misinformation” being handed down to salon workers and to consumers about the presence of formaldehyde in products.

“People who apply this product and consumers who ask whether these products contain formaldehyde – well, they are told they do not,” she said. “They're told, ‘Look at the box, there is no formaldehyde.’ So there is a huge gap in knowledge.”

When the panel reached its conclusion for the ingredient group, Weintraub applauded the decision, suggesting it was a step in the right direction of helping to clear up false information.

Formaldehyde For Other Uses

Addressing dermal contact limits for the substances, the panel discussed whether the 0.2% limit was “sufficiently protective” for individuals sensitized to formaldehyde.

The panel considered that sensitization studies that helped set the 0.2% limit possibly used formalin, a commercial solution of formaldehyde that is mixed with water, rather than straight formaldehyde.

“If formalin is considered to contain 37% formaldehyde, then the level of formaldehyde equivalents in those studies was actually closer to 0.07%,” CIR staff say in a memorandum to the expert panel.

Based on that information, the panel ultimately determined during the meeting that a limit of .074% for formaldehyde and equivalents is more appropriate than the 0.2% limit.

The panel is still concerned with the use of the substances in nail hardeners, specifically the levels in which they are formulated.

The Nail Manufacturers Council recently provided the panel with data showing that the use concentration of formaldehyde as a nail hardening ingredient in the market is less than 5% and that there are no adverse events associated with those products.

However, Dr. Belsito asserted that at his dermatology practice within the past two weeks, he has seen two patients who have reacted to nail polish hardeners containing formaldehyde.

He expressed concern over the fact that nail hardeners are sold widely over the Internet, and there is not a strong “mechanism for controlling” the distribution of the products or knowledge about the levels of formaldehyde in them.

Therefore he and the rest of the panel determined that available data is insufficient to make a recommendation on nail products until further analysis of nail hardeners is received.

The National Toxicology Program recently included formaldehyde on its list of known human carcinogens, per its 12^th Report on Carcinogens released June 10 (Also see "NTP Determines Formaldehyde “Known Human Carcinogen” In New Report" - HBW Insight, 20 June, 2011.).

While formaldehyde/methylene glycol group was perhaps the most anticipated of the ingredients assessed, the panel had a large number of substances to tackle this period.

The panel issued a final report for caprylyl glycol, as well as DEA, the latter receiving a revised tentative amended report.

The panel also reviewed seven reports that advanced through the process and considered two-re-reviews (see chart).

By Eileen Francis

CIR Expert Panel On Formaldehyde Hair Straighteners: “Unsafe”

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