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Formaldehyde in its pure form is a colorless gas. However, Formaldehyde gas is not used as a cosmetic ingredient. Instead, Formaldehyde may be dissolved in water and used as Formalin. Other ingredients that slowly release Formaldehyde may also be added to cosmetic and personal care products as preservatives.
Formaldehyde and Formaldehyde-releasing ingredients are used as a preservatives to kill microorganisms, or prevent or inhibit their growth in products. Preservatives are ingredients designed to help ensure the safety of products by protecting them against contamination by microorganisms during storage and during continued use by consumers.
Follow this link for more information about how preservatives protect cosmetics and personal care products.
Formaldehyde containing polymers, such as Tosylamide/Formaldehyde Resin, may also be used in cosmetics and personal care products. The Formaldehyde in these compounds is tightly bound in the polymer molecule. Search this website for the specific Formaldehyde polymer for more information about these compounds.
The Food and Drug Administration (FDA) has reviewed the safety of Formaldehyde and approved its use as an indirect food additive in a number of materials having contact with food. The FDA has also indicated that Formaldehyde can be used in nail hardener products.
Follow this link for more information about the use of Formaldehyde in nail hardener products.
The safety of Formaldehyde has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Formaldehyde in cosmetics and personal care products was safe to the great majority of consumers for use as a preservative in cosmetics at concentration levels that do not exceed established limits and in nail hardening products in the present practices of use and concentration.
The CIR Expert Panel indicated that because of skin sensitivity of some individuals to this agent, the formulation and manufacture of a cosmetic product should ensure use at the minimal effective concentration of Formaldehyde, 0.074% or less.
The CIR Expert Panel recommended that Formaldehyde should not be used in cosmetic and personal care products intended to be aerosolized. Aside from its use as a preservative, Methylene Glycol, the liquid form of Formaldehyde, is used in hair straightening products. In 2011, the CIR Expert Panel reviewed it for safety in this application.
The CIR Expert Panel determined that safety of Formaldehyde/Methylene Glycol in hair straightening products depends on a number of factors, including concentration, the amount of product applied, the temperature used during the application process, and the ventilation provided at the point of use. The CIR Expert Panel concluded that under present practices of use and concentration, Methylene Glycol and Formaldehyde are unsafe in hair straightening products.
CIR Safety Review:
The CIR Expert Panel noted that Formaldehyde is normal metabolite of all mammals. Formaldehyde is a highly reactive compound. It is this reactivity that makes it useful as a preservative, but it also is responsible for its irritant activity. The CIR Expert Panel indicated that the toxic effects of Formaldehyde are all concentration and time dependent. Formaldehyde can be employed usefully at concentrations that are not irritating.
The CIR Expert Panel concluded that Formaldehyde in cosmetics and personal care products was safe to the great majority of consumers. Because of the skin sensitivity of some individuals to this agent, the formulation and manufacture of a cosmetics and personal care product should be such as to ensure use at the minimal effective concentration of Formaldehyde, 0.074% or less. The CIR Expert Panel recommended that Formaldehyde should not be used in cosmetics and personal care products intended to be aerosolized.
Link to FDA Code of Federal Regulations for Formaldehyde
Formaldehyde is listed in the Cosmetics Directive of the European Union and may be used at maximum concentration of 0.2% (free Formaldehyde), and a maximum concentration of 0.1% in oral hygiene products. It is not permitted for use in aerosol products (see Annex VI), and aerosol dispensers. Finished products must be labeled with a warning "contains Formaldehyde" if Formaldehyde concentrations exceed the a value of 0.05% (Preamble of Annex VI). Nail hardener products may contain up to 5% Formaldehyde (see Annex III).
Health Canada permits the use of Formaldehyde in non-aerosol cosmetics at concentrations of 0.2% or less, except in nail hardeners where the concentrations can be up to 5%, and in oral care products where concentrations limited to 0.1% or less. Nail hardeners containing Formaldehyde must be sold with nail shields, directions for use, and a caution regarding sensitization potential.
Formaldehyde is generally supplied as a 30-56% (by weight) aqueous solution known as formalin. In cosmetics and personal care products, the principal function of Formaldehyde solution (formalin) and Formaldehyde-releasing compounds is that of an antimicrobial agent.
The European Commission's Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) opinion concerning A Clarification on the Formaldehyde and Para-Formaldehyde Entry in Directive 76/768/EEC on Cosmetic Products
EU Cosmetic Ingredient Inventory http://ec.europa.eu/consumers/cosmetics/cosing/
The Agency for Toxic Substances and Disease Registry's factsheet on Formaldehyde
Search the FDA Code of Federal Regulations
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