MessagesOverviewWhat Is It? Hair dye Ingredients are substances used to color hair and generally fall into three categories: temporary, semi-permanent and permanent. Depending on the type of ingredient, the resulting color will last for a single treatment (temporary), a few days (semi-permanent) or several weeks (permanent). Why is it used in cosmetics and personal care products? Hair dye Ingredients have long been used safely for hair coloring. The specific ingredients used will vary depending on the desired coloring effect. Using combinations of ingredients allows the development of a wide range of shades and effects. The main reasons for this practice are cosmetic (e.g., to cover gray hair, to change to a color regarded as more fashionable or desirable, or to restore the original hair color after it has been discolored by hairdressing processes or sun bleaching). Hair coloring can be done either professionally by a stylist or independently at home. Scientific Facts: Archeological evidence indicates that as long as people have inhabited the planet, they have been fascinated with adorning and altering their physical appearance. This has often included a desire to color and adorn their hair. Archaeologists have found evidence to suggest that early man may have used minerals, plants, and insects to paint their bodies and hair either as a way to appeal to other humans, or as a way to assist early man in repelling predators. There is also recorded evidence from around 1500 B.C. that the Egyptians used henna as a hair coloring agent. In the days of the Roman Empire, grey hair was darkened by combing it with lead combs dipped in vinegar. The first color dyes for hair were derived from plants and insects. Henna, Chamomile, and Indigo, for example, were commonly used in Egypt to color the hair. Additionally, berries were often used to tint the hair as well. Lemon and other citrus juices, black sulphur, alum, and honey mixtures were used to encourage bleaching in the hair to lighten it. These types of plant-based or mineral-based hair dyes were the predominant source of hair coloring agents until the 19th century; when, at that time, scientific advances in chemistry allowed for the development of new coloring agents. SafetySafety Information: Hair dyes are among the most thoroughly assessed of all personal care products. Independent scientists have conducted numerous health studies over many years to determine whether hair dye ingredients may cause harm to consumers. These studies have overwhelmingly found that the hair dyes on the market today are safe based on the current scientific literature and when the dyes are used as directed. To monitor the continued safety of these products, the industry regularly evaluates and updates its safety assessments considering all the most current scientific data. Many of the basic ingredients used in hair dyes have been used for over a century and their safety has been reviewed by key scientific and regulatory bodies globally, including, the Cosmetic Ingredient Review [CIR] Expert Panel, the Scientific Committee on Consumer Safety in the EU, the Japanese Ministry of Health, Welfare and Labor (MHWL), and the Australian National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The European Commission's Scientific Committee on Consumer Safety (SCCS) and the U.S. Cosmetic Ingredient Review Expert Panel (CIR) consider all of the available data from the peer-reviewed scientific literature and information provided through other sources, such as cosmetic manufacturers. They then issue opinions concerning the safe use of hair dye Ingredients and these recommendations are published in the International Journal of Toxicology (CIR) or implemented under the provisions of the Cosmetics Directive (SCCS). What are coal-tar hair dyes? Why are they exempt from FDA’s color additives approval requirements? The term “coal-tar colors” is a historical one that dates back to the time when these coloring materials were by-products of the coal industry. Today, this is no longer the case and most hair dyes are synthetic (i.e., man-made) and originate from a petroleum base. Nonetheless, the FDA still refers to dyes by their original name. Coal-tar hair dyes—those color additives used for dyeing hair--include permanent, semi-permanent, and temporary hair dyes. The FDA exempts some hair dyes from its color additive approval process because they have been extensively tested over many years and have been found to be safe. This is established through the testing of individual dyeing ingredients as well in combination with the other the ingredients that are used to formulate the products. In addition to ensuring the safety of the individual ingredients, hair dye products are assessed to make sure that are not irritating or do not cause an unusual incidence of allergic reactions. How does FDA regulate coal-tar hair dyes? Like all cosmetic products, FDA regulations require that manufacturers ensure that hair dye products and their ingredients (including color additives) are safe before being sold. In addition, FDA requires that all hair dye product labels include a special caution statement and the product must come with adequate directions for consumers to do a skin test before they dye their hair. This is the caution statement: Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness. The quality of Hair Dyes and Hair Colors is established through rigorous Quality Assurance and Good Manufacturing Practices. In addition, the safety of these products is monitored in the marketplace through reports of consumer comments and complaints. Companies include a phone number on their products where comments or complaints may be reported. More safety Information: Three common areas of discussion are found when reviewing scientific literature or media reports on hair dyes: (1) Can hair dyes cause allergic skin reactions?, (2) Is there an association between hair dye use and cancer? (3) Can women use hair dyes safely during pregnancy? Here are some key facts: Hair Dye Allergies: Just like some foods, drugs or other products in common use, hair dyes can cause allergic skin reactions in some individuals. The number of consumers who report allergic reactions from the use of hair dye is very small. The majority of these reported reactions occur at the site of contact after hair dye use and resemble other contact-allergy reactions like those observed from contact with nickel, poison ivy, etc. With the aim of reducing the risk of allergic reactions as much as possible, it is recommended that users conduct a skin test before applying hair color. If a consumer experiences an adverse reaction to a hair dye ingredient, he or she should avoid use of hair dyes and consult with a physician immediately and before further use. Cancer Allegations: Over time, much research has been devoted to determining what, if any, links there are between hair dye use and the development of certain diseases, such as cancer. This research has included both in-laboratory basic biology and human epidemiology studies. Although a few studies have suggested that some hair coloring products may increase risks of cancer, the weight of the currently available and reliable scientific evidence supports the conclusion that there is no established link between hair dye use and cancer. An independent review of more than 80 epidemiology studies on hair dyes published in 2006 concluded that no causal link has been established between long-term use of hair dyes and any type of cancer (1). In February 2008, the International Agency for Research on Cancer (IARC; the specialized cancer agency of the World Health Organization [WHO]) evaluated exposure from personal use of hair colorants. After considering all of the published studies, IARC concluded that the evidence for an association between hair dye use and any type of cancer was inadequate (i.e., permitted no conclusions regarding a causal association). In 2014, the U.S. Cosmetic Ingredient Review (CIR) Expert Panel summarized these and other more recent studies on its website in which they state, “The available epidemiology studies are insufficient to conclude there is a causal relationship between hair dye use and cancer and other endpoints.” Hair Dye and Pregnancy: Studies conducted on the use of hair dyes during pregnancy have not found a risk of harm to the fetus. Several authoritative organizations have commented on the safety of hair dye use during pregnancy. According to the March of Dimes, the "amount of dye you would normally use on your hair is not enough to pose an increased risk to either you or your developing baby." The American College of Obstetricians and Gynecologists (ACOG) has stated that “hair dyes are believed to be safe to use during pregnancy.” However, women who are pregnant should consult their doctor if they have any questions or concerns. In summary, based upon the extensive available safety data, consumers should feel confident in the safety of hair dye formulations. Hair dye manufacturers are fully committed to funding ongoing research in the area of safety, with a goal to provide ever increasing levels of confidence and reassurance to consumers. ResourcesResources: Information on Authoritative Safety Assessment Programs: CIR safety review program CIR report of finding EU Cosmetic Regulation SCCP SCCS Some potentially useful references include: (1)Hueber-Becker F, Nohynek GJ, Dufour EK, Meuling WJ, de Bie AT, Toutain H, Bolt HM. (2007) Occupational exposure of hairdressers to [14C]-para-phenylenediamine-containing oxidative hair dyes: a mass balance study. Food Chem Toxicol. 45(1):160-9. (2) Takkouche B, Etminan M, Montes-MartÃnez A. (2005) Personal use of hair dyes and risk of cancer: a meta-analysis. J. American Medical Assoc. 293(20): 2516-25. (3) Federal Food, Drug, and Cosmetic Act. 21 U.S.C. 301. (4) Council Directive 76/768/EEC. The Cosmetics Directive is the overall piece of EC legislation that regulates the manufacture and placing on the market of cosmetic products.