Okay I confess I am getting on my soap box…..and for damned good reason. There is an epidemic of companies flagrantly disregarding cosmetic regulations and it is putting YOU the consumer at risk of bacterial contamination and bacterial growth. The obsession with natural seems to have thrown common sense and safety out the window.
The new natural trend is for colour pigments to come from fruit and vegetables. Now here are the facts….IT IS ILLEGAL and completely disregards the FDA cosmetic regulations and every other countries as well. So if you are using a product that contains them know that you are putting your own health at risk and you are dealing with a company that is not following the cosmetic regulations.
General restrictions on use of color additives.
The use of pigments in colour cosmetics is highly regulated. Especially any colourant used near the eye area. In the United States, the use of color additives is strictly regulated. A number of color additives approved for cosmetic use in general are not approved for use in the area of the eye. There are cosmetics that are imported that contain illegal colourants and they are not considered safe.
All colorants are required to undergo individual batch testing to ensure compliance with the regulations. The use of fruit and vegetables to colour cosmetics is not covered in this regulation and as such the use of them is completely illegal.
The FDA strictly regulates color additives and their approved uses in cosmetics. Per the FDA, the definition of a color additive is a follows (source: Sec 201)
(1) The term "color additive" means a material which—
(A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and
(B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.
Whilst the cosmetic industry is largely self-regulating with regard to the ingredients used, color components are strictly regulated. If a company states that their COLOR comes from non-approved ingredients, then they are flat out not in compliance with the FDA and are subject to a warning letter, fines, and possibly seizure of their products. To top off the illegal use of fruit pigments for colouring these products also don't contain any preservatives, leaving the product to be a contamination zone for bacterial and fungal growth. I can't stress this enough…..consumers have actually died from contaminated cosmetics. This isn't something to take lightly.
These fruit and vegetable cosmetics sound so appealing. They are natural where is the harm? The risk is massive. There are no preservatives used in these products and there has not been safety testing done on the use of them either. The safety for external color additives normally undergo safety testing which includes acute oral toxicity, primary irritation, sensitization, subacute dermal toxicity on intact and abraded skin, and carcinogenicity by skin application.
Here is a listing of important documents regarding the colors that can and cannot be used in cosmetics in the US.
Basic Requirements of colorants
Coloring your cosmetic product is not as simple as finding some plant or flower that has a pretty color, distilling that color and using it in your formula. You specifically CANNOT do this. Some of the approved colorants are plant derived but many are not. Here are some basic facts about regulated colors in cosmetics.
- All colors used in your formula must be approved by the FDA. If it's not on the approved list (no matter where it comes from) it can't be used.
- Nearly all colors must also be certified by the FDA. For most colorants every batch of the color has to be inspected and approved by the FDA. You can't just make your own colors in the kitchen.
- All colors must meet specifications before being used.
- Colors are restricted in the ways and amounts in which they can be used.
These are the colorants that are exempt from certification. THIS DOES NOT INCLUDE FRUIT AND VEGETABLE EXTRACTS.
These are the colourants that are approved and need to undergo batch testing and certification
Some Basic Requirements
- Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance's use as a color additive, specifications, and restrictions.
- Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.
- Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).
- Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.
How are color additives categorized?
The FD&C Act Section 721(c) [21 U.S. C. 379e(c)] and color additive regulations [21 CFR Parts 70 and 80] separate approved color additives into two main categories: those subject to certification (sometimes called "certifiable") and those exempt from certification. In addition, the regulations refer to other classifications, such as straight colors and lakes.
- Colors subject to certification. These color additives are derived primarily from petroleum and are sometimes known as "coal-tar dyes" or "synthetic-organic" colors. (NOTE: Coal-tar colors are materials consisting of one or more substances that either are made from coal-tar or can be derived from intermediates of the same identity as coal-tar intermediates. They may also include diluents or substrata. (See Federal Register, May 9, 1939, page 1922.) Today, most are made from petroleum.)
- Except in the case of coal-tar hair dyes, these colors must not be used unless FDA has certified that the batch in question has passed analysis of its composition and purity in FDA's own labs. If the batch is not FDA-certified, don't use it.
- These certified colors generally have three-part names. The names include a prefix FD&C, D&C, or External D&C; a color; and a number. An example is "FD&C Yellow No. 5." Certified colors also may be identified in cosmetic ingredient declarations by color and number alone, without a prefix (such as "Yellow 5").
- Colors exempt from certification. These color additives are obtained primarily from mineral, plant, or animal sources. They are not subject to batch certification requirements. However, they still are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations [21 CFR 73].
- Straight color. "Straight color" refers to any color additive listed in 21 CFR 73, 74, and 81 [21 CFR 70.3(j)].
- Lake. A lake is a straight color extended on a substratum by adsorption, coprecipitation, or chemical combination that does not include any combination of ingredients made by a simple mixing process [21 CFR 70.3(l)]. Because lakes are not soluble in water, they often are used when it is important to keep a color from "bleeding," as in lipstick. In some cases, special restrictions apply to their use. As with any color additive, it is important to check the Summary of Color Additives Listed for Use in the United States in Foods, Drugs, Cosmetics and Medical Devices and the regulations themselves [21 CFR 82, Subparts B and C] to be sure you are using lakes only for their approved uses.
How can I guard against color additive violations?
Several precautions can help you avoid color additive violations that will cause your cosmetic to be adulterated:
- Do not confuse certified colors with their uncertified counterparts. For example, FD&C Yellow No. 5 is the certified form of tartrazine, and is approved for use in cosmetics generally. But tartrazine, which has not undergone FDA analysis and received FDA certification, must not be substituted for or identified in an ingredient declaration as FD&C Yellow No. 5.
- Do not confuse certified colors with colors identified only by a Colour Index (CI) number, or by the E number sometimes used in European color identification. You must not use a color subject to certification unless FDA has certified the batch in question [FD&C Act, sec. 721(a)(1)(A). A CI or E number does not indicate FDA certification.
- When purchasing color additives subject to certification, check the label. If the lot is certified, the color's label must state the legal name for the color (such as "FD&C Yellow No. 5"), or, if it is a mixture, the name of each ingredient; the FDA lot certification number; and the color's uses and restrictions as stated in the CFR [21 CFR 70.25).
- Check the Summary of Color Additives on FDA's Web site. Although this table is not a substitute for the regulations, it is an easy-to-use reference that introduces you to FDA-approved color additives and directs you to the regulations addressing specific color additives.
- Become familiar with the regulations themselves. The color additive regulations are in 21 CFR Parts 70 through 82. Specific color additives are addressed in Parts 73, 74, and 82. The color additive regulations are posted on FDA's Web site. To purchase printed copies of the CFR by credit card, call the Government Printing Office at (202) 512-1800, Monday through Friday, from 8:00 a.m. to 4:00 p.m., Eastern Standard Time. To pay by check, write to the Superintendent of Documents, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954. Contact the Government Printing Office directly for current costs.
- Confirm the status of color additives before use. There may be changes in color additive approvals and changes in the uses and restrictions that apply to a color additive. Such changes may affect colors subject to certification as well as colors exempt from certification. To stay current with the regulations, you can check the latest edition of the CFR and FDA Dockets. You also may contact FDA at Color.Cert@fda.hhs.gov.
- When purchasing colors subject to certification, confirm that the manufacturer has requested certification. For example, you can choose a manufacturer from FDA's list of companies that have requested color certification within the past two years. If the company that appears on the color additive label is not on this list, you may contact FDA at Color.Cert@fda.hhs.gov to determine whether the company has in fact requested certification of its color additives.
Must I match colors with intended use?
Yes. No matter whether a particular color is subject to certification or exempt from certification, U.S. law prohibits its use in cosmetics (or any other FDA-regulated product) unless it is approved specifically for the intended use [FD&C Act, sec. 721(a)(1)(A); 21 U.S.C. 379e(a)(1)(A)].
The regulations also restrict intended use as follows:
- Eye-area use: You may not use a color additive in the area of the eye unless the regulation for that additive specifically permits such use [21 CFR 70.5(a)]. The "area of the eye" includes "the area enclosed within the circumference of the supra-orbital ridge and the infra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge" [21 CFR 70.3(s)]. Although there are color additives approved for use in products such as mascara and eyebrow pencils, none is approved for dyeing the eyebrows or eyelashes.
- Externally applied cosmetics: This term does not apply to the lips or any body surface covered by mucous membrane. For instance, if a color additive is approved for use in externally applied cosmetics, you may not use it in products such as lipsticks unless the regulation specifically permits this use [21 CFR 70.3 (v)].
- Injection: No color additive may be used in injections unless its listing in the regulations specifically provides for such use. This includes injection into the skin for tattooing or permanent makeup. The fact that a color additive is listed for any other use does not mean that it may be used for injections [21 CFR 70.5(b)]. There are no color additives listed in the regulations as approved for injections.
What about special effects and novelty use?
No matter how exotic or novel the color additive or its intended use, it is subject to the same regulations as the more everyday colors and products. The following items are a sampling of some out-of-the-ordinary color additives. This list is not exhaustive. Rather, it is intended to show how the regulations apply to such colors: