Cosmetics and Color Additives
Cosmetics have been an integral part of human culture for centuries, serving various purposes like enhancing beauty, expressing individuality, and boosting self-confidence. Color additives play a significant role in cosmetics by providing vibrant and attractive shades to products such as lipsticks, eyeshadows, blushes, and nail polishes. However, the use of color additives in cosmetics requires careful scrutiny to ensure consumer safety.
In the United States, the Food and Drug Administration (FDA) is responsible for regulating cosmetics and color additives. Unlike drugs, cosmetics do not undergo pre-market approval by the FDA. Instead, the FDA monitors cosmetics on the market and takes action if safety issues arise. Color additives, however, require pre-approval by the FDA before being used in cosmetics, food, or drugs. The FDA evaluates color additives based on their safety and approved uses. Manufacturers must adhere to specific usage limitations and label their products accurately with the approved color additive names. Additionally, color additives are classified as either "certified" or "exempt from certification" based on their level of safety. The safety of color additives is of significant importance as they come into direct contact with the skin and mucous membranes. Extensive research and testing are conducted to evaluate the safety of color additives before their approval for use in cosmetics. To determine safety, manufacturers and the FDA conduct animal testing, cellular studies, and human clinical trials. These tests assess the potential for skin irritation, eye irritation, and other adverse effects. The FDA sets strict limits on the concentrations of color additives that can be used to minimize any potential risks to consumers. However, it's important to acknowledge that some safety testing methods have raised ethical concerns, and alternative testing approaches are being developed to reduce or eliminate animal testing.
While color additives in cosmetics undergo rigorous safety assessments, there is always the possibility of individual sensitivity or allergic reactions. Some people may develop skin irritation or allergic contact dermatitis in response to specific color additives or other ingredients in cosmetics. Allergic reactions can vary from mild irritation to more severe symptoms, and it is essential for consumers to be aware of any known allergies and to patch-test new cosmetics before full application. One area of concern regarding color additives in cosmetics is the potential presence of heavy metals. Certain color additives, particularly those used in some imported cosmetics, may contain trace amounts of heavy metals like lead, arsenic, and mercury. These metals can be harmful if absorbed through the skin or accidentally ingested. The FDA regularly tests cosmetics for heavy metal content and takes enforcement actions against products that exceed safe levels.
Cosmetics and color additives are essential components of the beauty industry, providing consumers with a wide range of options for self-expression and personal care. The regulation of color additives by the FDA helps ensure their safety and appropriate usage in cosmetics. Extensive testing and monitoring of color additives aim to minimize potential risks and protect consumers.
Color Certification FAQs. (2022). Retrieved from https://www.fda.gov/industry/color-certification/color-certification-faqs
U.S. and EU Cosmetics Regulation - Personal Care Products Council. (2023). Retrieved from https://www.personalcarecouncil.org/u-s-and-eu-cosmetics-regulation/
Cosmetics and Color Additives
Color additives are dyes and pigments that are added to products to give them color. They are usually added to make products more appealing to the consumer. They are often used in cosmetics, foods, and drugs. Adding color to products has been done since ancient times. The ancient Egyptians used artificial colors to add to cosmetics and hair dye (Color Additives History). In 1881, the US Department of Agriculture began researching the use of color additives in food. In the 1900s, many foods were being made with color additives that were harmful. This led to the Food and Drugs Act of 1906 and then the Food, Drugs, and Cosmetics Act of 1938. The Color Additive Amendments Act of 1960 defined what a color additive was and created a list of “suitable and safe” color additives that could be used.
Foods, drugs, and cosmetic products are regulated by the FDA and color additives must be approved before they can be used. All products sold in the United States whether domestic or imported are under control of the FDA. The FDA laboratories analyze products for color additives. Color additives are listed in Title 21 of the Code of Federal Regulations. Color additives listed in 21 CFR 73 originate from mineral, plant, or animal sources (Color Additives and Cosmetics). Products listed in 21 CFR parts 74 and 82 are synthetic organic dyes and pigments. Failure of a product to meet the requirements for color additives is a reason for a product to be considered adulterated. Color additives must be stated on the labels of cosmetic products.
Color additives can be considered certifiable, exempt from certification, straight color, and lake. Certifiable colors are “coal-tar dyes” and “synthetic-organic colors”. These colors cannot be used unless the FDA analyzes the batch and it passes the standards of composition and purity. Colors that are exempt from certification are those that are derived from mineral, plant, or animal sources. These colors must comply with the regulations of 21 CFR 73 including labeling, restrictions, and uses. Straight color is any color listed in 21 CFR 73, 74, and 81, in which they have not been mixed with any substances. Lakes are commonly used in lipsticks to keep the color from “bleeding”.
The FDA uses visible spectrophotometry and TLC to inspect products for color additives. Other methods for cosmetic testing include LC and voltammetry. These methods are all time consuming. A new method of qualitative LC has been developed to identify 29 color additives in cosmetic products. It is designed to be used along with visible spectrophotometry, TLC, and LC methods that are currently used by the FDA. The new method does not require a large amount of solvents (Miranda-Bermudez, E., Harp, B.P. & Barrows).
The FDA certifies a sample from each batch of a product that is manufactured. Products cannot be used with that color additive until they are certified. The evaluation of the batch typically takes five days. The regulation of color additives is extremely important for our health and safety. The FDA has a major role in ensuring the prevention of adulteration of the products Americans consume.
Center for Food Safety and Applied Nutrition. (n.d.-a). Color additives and cosmetics: Fact sheet. U.S. Food and Drug Administration. https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet
Center for Food Safety and Applied Nutrition. (n.d.). Color additives history. U.S. Food and Drug Administration. https://www.fda.gov/industry/color-additives/color-additives-history#:~:text=Batch%20certification%20is%20required%20when,concern%2C%20such%20as%20carcinogenic%20constituents.
Miranda-Bermudez, E., Harp, B. P., & Barrows, J. N. (2014). Qualitative identification of permitted and non-permitted color additives in cosmetics. Journal of AOAC International, 97(4), 1039–1047. https://doi.org/10.5740/jaoacint.14-025
Color additives consist of dyes, pigments and other substances that are added to cosmetics, and medications to make them more appealing. Under the Food, Drug, and Cosmetic act (Chapter VII, section 721), “color additives except for coal tar hair dyes, are subject to FDA approval before they may be used in food drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time”.
Color additives have separate classifications depending on if they are either organic or inorganic products. Organic color additives indicate that the chemical structure of the color additive includes carbon atoms. Organic additives include straight colors, lakes, and mixtures. Straight colors are color additives that have not been mixed or have had a chemical reaction with another substance. Examples include FD&C Blue No.1 or Red 40. Lake colors are color additives that are formed by chemically reacting straight colors with precipitants and substrates. Lake dyes can be incorporated into food and examples include red 1 lake. Mixtures are color additives made by mixing one color additive with at least one more color additive or non-colored diluent., without a chemical reaction occurring. In organic color additives include mineral based colors such as iron oxide and zinc oxide. These additives are chemicals that can be found in nature but are synthetic since they made in a lab and mixed with other compounds to give the product the “perfect” shade.
Certifiable color additives are the man-made color additives derived from petroleum and coal sources. For this to be approved, a manufacturer must submit a sample batch to the FDA, and then the FDA tests the Sample to determine if the sample is of standard composition and purity. Once it passes standards, the FDA will issue a certification Lot number. Now, the batch can legally be used in FDA regulated products. Some additives that are obtained from plant, animal, or mineral sources are exempt from batch certifications. However, they still must follow regulatory requirements.
Finally, cosmetics are not FDA approved, but they are regulated by the FDA because of their use of color additives. It is vital to only use a product how its intended; do not use a color additive in the eye area unless the product states safe for eyes. For example, do not use a lipliner as and eye liner. Additionally, products such as mascara and eyebrow pencils have approved color additives, but there are no color additives approved to dye the eyebrows or eyelashes. Furthermore, any product labels “external use” is not safe for the lips or anybody surface covered by the mucus membrane.
Center for Food Safety and Applied Nutrition. “Color Additives.” U.S. Food and Drug Administration, FDA, www.fda.gov/industry/color-additives.
Commissioner, Office of the. “FD&C Act Chapter VII: General Authority.” U.S. Food and Drug Administration, FDA, www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-vii-general-authority#Part_B_-Colors__section_379e.
Color additives are used in products to impart color to a food, drug, or cosmetic to the human body. The colors add to the attraction and appeal of a product to the consumer. The color additives can also trademark a particular item to help identify a product just upon sight.
Color additives are separated into three categories. One being straight colors, which are color additives that have not been mixed or chemically reacted with any other substances. For example, FD&C Blue No. 1 and Blue 1. The second are lakes, which are formed by chemically reacting straight colors with precipitants and substrata. For example, Blue 1 Lake. The third is mixtures, which are color additives formed by mixing one color additive with one or more other color additives or non-color diluents without a chemical reaction. For example, good inks used to mark confectionery are mixtures.
The FDA regulates all color additives used in the US. This includes the color additives used in food, dietary supplements, medications, cosmetics, and medical devices. By law, these need to be approved by the FDA and must be used only in compliance with the approved uses, specifications, and restrictions. The FDA ensures safe for its intended purpose, so it is very important to use a product with color additive only as it’s intended use. The FDA uses the Code of Federal Regulation to list out new color additives or a new intended use for a color additive.
Certifiable color additives are man-made color additives that are derived primarily from petroleum and coal sources. For this to be approved, a manufacturer submits a sample from the batch to the FDA, and then the FDA tests the sample to determine whether it meets the color additive’s requirements for composition and purity. If it does, the FDA certifies the batch and issues a certification lot number. After going through this process, the batch can now legally be used in FDA-regulated products. When looking at the label of products with certifiable color additives, you’ll see a prefix of “FD&C, D&C, or Ext. D&C; color; and a number.
Some additives are exempt from batch certifications. These color additives are obtained largely from plant, animal, or mineral sources. While they don’t require batch certifications, they must follow regulatory requirements because they still are artificial color additives.
Cosmetics are not FDA- approved but they are regulated by the FDA because of their use of color additives. It is extremely important to only use a product where it is intended. Do not use a color additive in the eye area unless it specifically states it is permitted in the area of the eye. While there are color additives approved for products like mascara and eyebrow pencils, there are no color additives approved to dye the eyebrows or eyelashes. Also, the term “externally applied cosmetics” does not apply to the lips or any body surface covered by the mucus membrane.
Center for Food Safety and Applied Nutrition. Color Additives and Cosmetics: Fact Sheet. U.S. Food and Drug Administration. https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet. Accessed January 28, 2021.
Center for Food Safety and Applied Nutrition. Color Additives History. U.S. Food and Drug Administration. https://www.fda.gov/industry/color-additives/color-additives-history. Accessed January 28, 2021.
How Safe are Color Additives? U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/how-safe-are-color-additives. Accessed January 28, 2021.
Under the FDA, color additives are subject to strict approval that is constantly monitored in new cosmetics coming on the market. All color additives used in cosmetics must be approved by the FDA, and there must be a regulation specifying the use of a color additive, its specifications, and restrictions. In addition, to approve the use of a color additive, it must also be certified in the United States. All color additives must meet the requirements for its purpose and use as stated in the code of federal regulations. In addition, they must have a maximum allowed concentration that can be held in the finished cosmetic product.
There are color additives categories that are either subject to certification , or color additives that are exempt for certification. The color additives that are subject to certification are mostly derived from petroleum and are sometimes known as coal tar dyes, or synthetic organic colors. These color additives must not be used unless FDA has certified the batch, and it passes an analysis/test of purity. On the other hand, colors exempt from certification primarily come from minerals, plants, or animal sources. These color additives are not subject to batch certification requirements; however, they are still considered artificial colors and must comply with the identity, specifications, uses, and restrictions stated in the regulations. A common color additive that is used in cosmetics it's called a Lake , which is a straight color that does not include any combination of ingredients made by simple mixing process. Lakes are not soluble in water, and they are often used in products that are more prone to bleeding such as lipstick. There are also regulations set to regulate whether color additives belong on certain parts of the face that are more sensitive, such as the eye area. A color additive may not be used in the eye area unless it has a specific regulation that is approved and permits the additive to be used in the area of the eye. Although there are color additives approved for use in mascara and eyebrow pencil's, no color additive is approved for dyeing the eyebrows or eyelashes.
Lastly, color additives are categorized into either organic or inorganic products. Organic color additives indicate that the chemical structure of the color additive includes carbon atoms. Organic color additives usually include synthetic dyes, lakes, and botanicals. On the other hand, inorganic color additives usually include mineral based colors such as, iron oxide and zinc oxide. Inorganic color additives are synthetic and are usually made in a lab to ensure customer safety. While many of the compounds in the inorganic group can be found in nature, it is often made in a lab and mixed with other chemical compounds that gives the color additive it's perfect shade. The term “natural” on cosmetic labels is currently unregulated and as a result, you can see many makeup manufacturers who use iron oxides, and claim they are 100% natural. In 2016, over 5 companies falsely claimed that they were using all-natural products when in reality, they were using inorganic color additives made in a lab.
Loretz L et al. (2005) Exposure data for cosmetic products: lipstick, body lotion, and face cream. Food chem toxicol. 43(2):279-291
Center for Food Safety and Applied Nutrition. (n.d.). Color Additives and Cosmetics: Fact Sheet. Retrieved November 04, 2020, from https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet
Cosmetics & Color Additives - Dr. Michelle Lam
Power Point & Script
Written by: Denise Cotter and Niyati Doshi
Color additives are considered a dye, pigment, or other substance that when added to a food, drug, cosmetic, or the human body adds color to it (essentially what provides the hue to the product). The purpose of these color additives are to make that item more attractive, appealing, appetizing, and informative to the consumer. The purpose of the U.S. Food and Drug Administration’s (FDA) role is to make sure the color additive is being used safely and appropriately. Color additives have different classifications such as, straight colors, lakes, and mixtures. Straight colors are color additives that have not yet been mixed or have had a chemical reaction with another substance, these include FD&C Blue No. 1 or Blue 1. Lake colors are color additives that are formed by chemically reacting straight colors with precipitants and substrata, an example of this would be Blue 1 Lake. Lake dyes can be used for food, but these must be made from certified batches of straight colors. Mixtures are color additives made by mixing one color additive with at least one more color additive or non-colored diluent, without a chemical reaction occurring.
The FDA will list out new color additives or a new use for a color additive that has been proven to be safe in the Code of Federal Regulation (CFR), which will conduct a certification program for batches of color additives. These color additives need to be certified through this program before being put on the market and it also serves to monitor the use of color additives being used in products in the US and product labeling. Color additives used in food, drugs, cosmetics, and medical devices must be compliant with the listings issued by the FDA, otherwise using an unlisted color additive, improper use of a listed color additive, or using a color additive that does not conform to the purity and identity specifications of the listing regulation may lead to an adulterated product. Usually only a small amount of a color additive is used, so in this case a small amount of a color additive adulterates a large amount of product.
Although cosmetics are not FDA-approved, they are FDA-regulated due to the use of color additives. This is to make sure that the product is safe to use and will not cause harm to the consumer. Cosmetics can contain color additives as long as it is not to be used in the eye-area such as mascara and eyebrow pencils. The only way the cosmetic can be approved for this use is if it is approved by the CFR. Color additives are also not approved for injectable purposes. Other products that contain color additives and are regulated by the FDA include: color changing pigments, composite pigments, fluorescent colors, glow in the dark colors, halloween makeup, liquid crystal colors, tattoo pigments, and theatrical makeup. For safe use to the consumer, avoid the products if they have changed in color, have an odor, try applying a small amount to your wrist to check for irritation or signs of an allergic reaction, do not share eye cosmetics, avoid use if eyes become irritated, and throw away products should you notice signs of infection.
Center for Food Safety and Applied Nutrition. “Color Additives History.” U.S. Food and Drug Administration, FDA, www.fda.gov/industry/color-additives/color-additives-history.
Center for Food Safety and Applied Nutrition. “FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved.” U.S. Food and Drug Administration, FDA, www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated.
Color additives are dyes, pigments, or other substances added to a food, drug, cosmetic, or the human body. They are used in many cosmetic items to make them visually appealing, and as such, are heavily regulated by the Food Drug and Administration (FDA). Before such regulations, these color additives were directly linked to health injuries in the general population. Currently, the FDA overlooks color additives used in cosmetic products. All substances must first be approved by the FDA and must demonstrate safety for their specific approved uses. If they are derived from petroleum, they are batch certified to determine composition and purity if they are to be used in cosmetics. They are given three-part names to denote their status as a certifiable color: a prefix FD&C, D&C, or External D&C; a color; and a number. Once they have established a standard of identity, those substances may then be used for their intended uses. Color additives that are derived from mineral, plant, or animal sources are exempt from the certification process, though they must follow all other regulation requirements.
Color additives are not interchangeable. They can’t be used in cosmetic items that they aren’t approved for (e.g., FD&C Red No. 5 is only approved for lipstick and can’t be used for eye shadow).
Additional restrictions exist for color additives intended for use in specific areas, such as eye-area use, externally applied cosmetics, and injections for tattooing. Color additives that are not approved specifically for these intended uses should not be used.
It’s important to recognize allergies to certain color additives are uncommon, but can happen, especially in carmine, tartrazine (FD&C Yellow No. 5), annatto, and saffron.
1. Color Additives and Cosmetics: Fact Sheet. U.S. Food and Drug Administration. https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet. Published 2020. Accessed June 22, 2020.
2. How Safe are Color Additives?. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/how-safe-are-color-additives. Published 2020. Accessed June 22, 2020.
Color additives are often added to food, drug, or cosmetic products to make them more attractive or appealing. They are subject to the Federal Food, Drug, and Cosmetic Act and must meet certain requirements. Color additives in cosmetics must be approved by the FDA. In addition, certain ones must also be batch certified in order to be used in cosmetics and marketed in the U.S. All color additives must follow Code of Federal Regulations’ (CFA) criteria for identity and other specifications. They must only be used as intended and as approved for. The maximum permissible concentration must not be surpassed in the final product.
Color additives can be separated into different categories: certifiable, exempt from certification, straight colors, and lakes. Certifiable additives, such as FD&C and D&C, are derived primarily from petroleum. They are also known as “coal-tar dyes” or “synthetic organic” colors. Color additives derived primarily from mineral, plant, or animal sources are exempted from batch certification requirements.
Regulations exist that restrict the intended use of color additives. They may not be used in area of eye unless specifically permitted by CFR. Those approved for externally applied cosmetics may not be applied to the lips or mucus membranes. Color additives may not be used for injections, such as into the skin for tattooing or permanent makeup, unless specifically approved for such use. Color additives with special effects and novelty uses (color-changing pigments, fluorescent pigments, Halloween makeup, tattoo pigments, theatrical makeup, etc) are subject to the same regulations.
To avoid color additive violations that can cause cosmetic products to be adulterated, check labels when purchasing cosmetic products, be aware of regulations, and confirm certification statuses if needed.
Color Additives and Cosmetics: Fact Sheet. U.S. Food and Drug Administration. https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet. Accessed June 1, 2020.
Color additives are added in goods, cosmetics, medication, etc to help improve the appeal of these products. The color additives added in cosmetics have to be FDA approved to be sold. They need to be batch certified by the FDA if they are used for cosmetics. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR). Lastly they can only be used for the intended purpose and what they are approved for. There are different categories of color additives: certifiable, exempt from certification, straight color and lake. Regardless of the color additives being approved for cosmetics, there are special restrictions put in place by the FDA. They are not intended to be used in the eye area unless they are approved by the code of federal regulations. Some examples of these are mascara and eyeliners. No color additives are approved for injections, which includes injection into the skin for tattooing purposes or permanent makeup. Another restriction is the color additives approved for external use only may not be used in products that come in contact with the lips or mucous membranes. Therefore, these additives cannot be used in lipsticks, unless the regulations permit the use of these additives.
The biggest concern for patients is if these color additives are safe to consume, or put on their face. Working in a community setting we often get patients who are allergic to certain dyes so it is important for us to be knowledgeable in these topics in order to provide the most accurate information to the patient. The dyes approved by the FDA are considered safe to use. The FDA tests each batch of dye that is made by the manufacturer to provide certification. They test to see if the batch meets their requirements of composition and purity. If they pass the test, that batch receives the approval and a certification lot number. This lot number is required for manufacturers to use the dye in FDA approved products. This rigorous testing is optimal to ensure the safety of our patients.
Commissioner Oof the. How Safe are Color Additives? U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/how-safe-are-color-additives. Accessed June 1, 2020.
Center for Food Safety and Applied Nutrition. Color Additives and Cosmetics: Fact Sheet. U.S. Food and Drug Administration. https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet. Accessed June 1, 2020.