Facts on Formaldehyde in Cosmetic Products and Position of FDA
by Nina Lieber
Lately there’s a lot of talking about the Brazilian keratin treatment and I saw some articles here as well. I wanted to give all stylist and the public some facts that are not based on some advertising reporters in some newspapers, check this out:
Formaldehyde Information
What is Formaldehyde? A simple substance consisting of hydrogen, oxygen and carbon, (also known as methanol) 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.
What is a preservative? 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.
Why are Formaldehyde-releasing preservatives used by the cosmetic industry? 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 these 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 were 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.
What is the regulatory status of Formaldehyde? 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.
Food and Drug Administration have reviewed the safety of Formaldehyde used in nail hardeners. 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
- Warn 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%.
What about recent reports about the safety of Formaldehyde? 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.
http://www.cosmeticsinfo.org/safety.php Thank you,
Nina Lieber.
