Formaldehyde, a simple substance consisting of hydrogen, oxygen and carbon, (also known as methanal) is a gas with a pungent smell. It is the simplest of a class of compounds called aldehydes and is a natural part of our world. Formaldehyde is part of our human metabolism and it occurs naturally in the air that we breathe. Plants and animals also produce Formaldehyde. It is even emitted as a by-product of certain vegetables, such as Brussels sprouts and cabbage, when they are cooked. Formaldehyde was first used as a biological preservative more than a century ago.
Preservatives are ingredients designed to help ensure the safety and quality of products by protecting them against contamination by microorganisms during storage and, most importantly, during continued use by consumers. Bacteria, yeasts and molds are always present on our skin, in the air around us and even in the water we drink. Without preservatives, cosmetic products, just like food, can become contaminated, leading to product spoilage and possibly irritation or infection. Microbial contamination of products, especially those used around the eyes and on the skin, can cause significant problems. Preservatives help to prevent such problems.
Formaldehyde-releasing preservatives are ingredients that are highly efficient in helping to ensure the safety of products by protecting them against contamination by microorganisms during storage and during continued use by consumers.
Formaldehyde-releasing preservatives have the ability to release Formaldehyde in very small amounts over time. The use of Formaldehyde-releasing preservatives ensures that the actual level of free Formaldehyde in the products is always very low but at the same time sufficient to ensure absence of microbial growth.
If pure Formaldehyde was used, addition of enough Formaldehyde at the beginning to ensure preservation over the whole lifetime of a product would be necessary, because Formaldehyde is slowly used up over time.
This benefit is the reason why only Formaldehyde-releasing preservatives and not Formaldehyde itself is used to preserve today’s cosmetic products.
As the FDA observed in a 2006 statement explaining its current position on Formaldehyde, in 1984, the Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of Formaldehyde and concluded that when it makes up less than 0.2 percent of a cosmetic product applied to the skin, it is safe to the great majority of consumers. The Panel believed that, because of skin sensitivity (allergy) of some individuals to this agent, the formulation and manufacture of a cosmetic product should be such as to ensure use at the minimal effective concentration of Formaldehyde, not to exceed 0.2 percent measured as free Formaldehyde.
The safety of Formaldehyde as used in nail hardeners has been reviewed by the Food and Drug Administration. In this case, Formaldehyde is not used as a preservative but as part of a system used to coat and harden the surface of brittle or cracking nails. Formaldehyde is used as an ingredient only in nail hardeners, not in nail polish. As in the case of preservatives, the Formaldehyde used in nail hardeners is not pure formaldehyde, but rather a solution (formalin). According to the recommendations issued by FDA, nail hardeners often contain Formaldehyde as the active ingredient. Although Formaldehyde may be irritating to the skin or cause allergic reactions, the FDA has in the past, not objected to its use as an ingredient of nail hardeners provided the product:
• Contains no more than 5% Formaldehyde,
• Provides the user with nail shields which restrict application to the tip (and not the nail bed or fold),
• Furnishes adequate directions for safe use, and
• Warns consumers about the consequences of misuse and potential for causing adverse reactions in consumers who are sensitized to formaldehyde.
The typical levels of formaldehyde used in nail hardeners are well below 5%.
Formaldehyde gas is a listed substance under California’s Proposition 65. However, the state of California has determined that Formaldehyde exposure from nail hardeners in salons and elsewhere is so low that no warnings are required under Proposition 65.
The FDA recommends that cosmetic manufacturers follow the recommendations of the CIR Expert Panel. The levels of free Formaldehyde released from the preservative ingredients currently used in cosmetic and personal care products is well below the levels recommended by the CIR.
The International Agency for Research on Cancer (IARC), which is part of the World Health Organization (WHO), was founded in 1969 to evaluate the carcinogenic risk of chemicals to man. IARC coordinates and conducts research on the causes of human cancer and develops scientific strategies for cancer control. The Agency is involved in both epidemiological and laboratory research but does not make recommendations for regulation or legislation.
In 1987 IARC classified Formaldehyde as 2A “probable human carcinogen” for a rare form of nasal cancer. The U.S. Environmental Protection Agency (EPA) has similarly classified Formaldehyde as a probable human carcinogen under conditions of unusually high or prolonged exposure. In fact, formaldehyde is not typically added directly to cosmetics and personal care products, other than as a component of some nail hardening products. Therefore, Formaldehyde is not inhaled. Some ingredients release very small amounts of Formaldehyde into the product as needed to protect against the growth of bacteria. Regarding inhalation of large amounts of Formaldehyde, IARC considered new studies again in 1995 and maintained the rating at 2A. In 2004, IARC convened a Working Group of scientists to review all available scientific data. The Working Group voted to recommend reclassification of Formaldehyde as a known human carcinogen. The IARC Working Group based its reclassification decision on new information from studies of persons exposed to Formaldehyde, which in its view provided sufficient evidence to establish that exposure to Formaldehyde causes nasopharyngeal cancer in humans under certain circumstances. It also found strong evidence of a link between Formaldehyde and leukemia, though the evidence was not sufficient to establish a causal relationship. It is important to recognize, however, that the IARC Working Group’s reclassification decision appears to have been based on findings for Formaldehyde at high concentrations with exposure to gaseous Formaldehyde such as those seen in industrial settings. These exposures do not occur in cosmetic and personal care products.