In the 1970s it became a requirement in the United States to label cosmetics intended for consumer purchase with a declaration of ingredients on the principle display panel. The purpose of this was to inform consumers about the contents of the product so they could make a “value” purchasing decision or avoid chemicals to which they are allergic. Professional use-only products are exempt except under certain conditions, which will be addressed later. The US Code of Federal Regulations lists1 the rules for displaying ingredients, and besides outlining the content that must be included and its order of appearance, the regulation describes use of the “may contain” clause, which while legally only applies to pigments, has been abused and is thus the main topic of this column.
Declaration of Ingredients
The US Code of Federal Regulations 701.3 lists1 the rules for displaying ingredients on product labels as follows:
1) Ingredients, other than color additives, present at a concentration greater than 1 percent, in descending order of predominance; followed by
2) Ingredients, other than color additives, present at a concentration of not more than 1 percent, without respect to order of predominance; followed by
3) Color additives, without respect to order of predominance. Ingredients specified in paragraph (f)(2) of this section may be included with those specified in paragraph (f)(1) of this section and listed in descending order of predominance.
g) A declaration of ingredients may include an ingredient not in the product if the ingredient is identified by the phrase “may contain” and:
1) It is a color additive added to some batches of the product for purposes of color matching; or
2)(i) The same declaration of ingredients is also used for other products similar in composition and intended for the same use, including products which may be assortments of products similar in composition and intended for the same use; and
ii) Such products are “shaded” products, i.e., those falling within the product categories identified in 720.4 (c)(3), (7) and (8)(v) of this chapter; and
iii) All products sharing the common declaration of ingredients are sold by the labeler under a common trade name or brand designation, and no trade name or brand designation not common to all such products appears in the labeling of any of them; and
iv) The ingredient is a color additive.
h) As an alternative to a declaration of color additive ingredients for each product, the color additives of an assortment of cosmetic products that are sold together in the same package may be declared in a single composite list in a manner that is not misleading and that indicates that the list pertains to all the products.
Considering these rules line by line, parts 1, 2 and 3 mean that all permitted color additives may be listed last in the ingredient statement regardless of their levels. This becomes quite important when a company tries to develop one label for both the United States and other countries. In (g)(1), the first reason for allowing a “may contain” section on a product label is described. This section shows that the US Food and Drug Administration (FDA) recognizes that individual colors will vary from batch to batch in their color, and therefore allows companies to add other colors to adjust this variation in order to obtain the same product shade.
Part (2)(i) expands upon the use of the “may contain” section under the condition that products are of a similar composition and intended for the same use. Notice it does not require the products to be of the exact same composition, which can mean they have the same ingredients but at different levels Section (ii) expands further on the use of “may contain” section by specifying that “shaded” products, which can consist of: eye makeup preparations such as eyebrow pencils, eyeliners, eye shadows, eye lotions, eye makeup removers, mascara and other eye makeup preparations; non-eye makeup preparations including blushers (all types), face powders, foundations, leg and body paints, lipsticks, makeup bases, rouges, makeup fixatives and other makeup preparations; and nail polish and enamels. Finally, part (iii) states that a product line of common ingredients with the same trade name may also use the text “may contain” when listing color declarations, and section (iv) limits the use of this text to permitted color additives.
A new regulation went into effect on Jan. 5, 2011, concerning carmine and cochineal extracts, in response to allergic reactions consumers had to foods and cosmetics containing these additives of insect origin. The new regulation requires all foods that contain carmine and/or cochineal to specifically list this ingredient in the declaration rather than using the generalized text, “Contains artificial and natural colors.” It further requires all professional use-only cosmetics containing carmine list the following text on the label: “Contains carmine as a color additive.”
While the FDA guidance document of April 2009 is subject to interpretation, it seems to indicate that carmine must be included in the main ingredient declaration, not in the “may contain” section, because the product either contains carmine or it does not. From a marketing standpoint, it also makes sense to list this ingredient in the main declaration because consumers who are allergic to carmine or do not want ingredients from animal origin may object and avoid buying the product if it appears in the “may contain” section, even if it is not actually present in the product.
The European Union
Under the current 7th Amendment to the EU Directive, Article 6, 1(g), states that coloring agents may be listed in any order after the other ingredients, in accordance with their color index number (C.I.) or denomination as adopted in Annex IV. Further, Article 4 prohibits the use of any coloring agent not listed on Annex IV. For decorative cosmetic products marketed in several color shades, all coloring agents used in the range may be listed provided that the words “may contain” or the symbol “+/-”are added. With new regulations, passed as the 8th Amendment known as the recast, Annex IV remains the same: Article 14, 1(c) prohibits colors not listed on Annex IV and Article 19, 1(g) (ii) repeats the old rules for “may contain,” so this is one area where there is no change from the current rules.
Health Canada also addressed the “may contain” phrase when it adopted mandatory ingredient labeling on Dec. 1, 2004, for all cosmetic products sold in Canada. According to its rules, makeup products such as lipstick, eye shadow, blush, etc., as well as nail polish and nail enamel—all of which are sold in several different color shades—may list all the coloring agents in the product range on the label provided that the symbols “±” or “+/-” or the phrase “May contain/Peut contenir” is also included. Since Health Canada does not manage an approved list of colors, it does not have other issues to deal with on this subject.
The +/- Symbol in the United States
The former Cosmetic, Toiletry, and Fragrance Association (CTFA), now known as the Personal Care Products Council (PCPC), filed a request with the FDA in 1995 to permit use of the +/- symbol in place of the words “may contain” to allow for one symbol and simplify labels for products intended for the US, European and Canadian markets. The FDA rejected this request, stating there was no convincing evidence that US consumers would identify the +/- symbol with the phrase, “may contain.”
The Major Problem
The major problem with the described ingredient declaration rules is the lack of harmonization between groups, especially regarding the “may contain” section. This becomes evident when a company develops a line of eye shadows with many shades based on different colored pearlescent pigments. Such pigments are listed in the INCI dictionary as mixtures, although one cannot simply mix the components to produce the desired look. Consider the earliest pigments, which are mica and titanium dioxide. These popular pigments pose no problems in the United States because mica is a permitted color—see 21CFR73.2496 for its specifications and approval.
However, its use in the EU is a different issue. Mica is not on Annex IV and is therefore prohibited from the “may contain” section on an ingredient label. While one may think that since mica has a C.I. number (CI 77019) that it would be permitted, this is not the case; having a C.I. number does not make it an approved colorant. In fact, when a company uses the C.I. number for mica on a label, it means they are claiming it is a color and not a permitted colorant. While it is permitted as a cosmetic ingredient, by adding the C.I. number, it becomes prohibited. In fact, in 2009, products listing such colorants in the “may contain” section were subject to regulatory action in Scandinavian countries. So in the example of a line of eye shadows with many shades, what is one to do? Three solutions are possible. One is to eliminate the “may contain” section and print a separate label for each shade. Others are to create separate labels for the United States and the EU, or to completely discontinue use of the ingredients. Of course, a fourth option would be to seek to have mica approved in the EU as a color additive and placed on Annex IV.
It should be noted that recently, many new pigments have been introduced based on substrates other than the original titanium dioxide/mica and bismuth oxychloride pigments. These are usually listed as bulking agents or opacifying agents as their function. They include: synthetic fluorphlogopite, tin oxide, silica, calcium aluminum borosilicate, calcium sodium borosilicate, calcium titanium borosilicate, silica and glass. None of these are listed as permitted colors in the United States or the EU and are therefore are not allowed in the “may contain” listing. Further compounding the labeling rules are permitted colors that have been surface treated to make them more hydrophobic or hydrophilic. These pigments, again, are not permitted in the “may contain” listing.
Polyethylene Terephthalate Glitter
This author believes that polyethylene terephthalate (PET) glitters are some of the most dangerous ingredients used in cosmetics today. They mainly are produced for the toy and craft industries and not for application to the skin or hair; rather, for use in coloring books. The classic method to produce these ingredients is to take a sheet of film, apply a color, and cover it with another sheet. The layered sheets are then bound by heat and physically cut or chopped to the proper size. The cutting results in jagged edges that give glitter its desirable and most dangerous property. These jagged edges allow it to adhere to skin and hair but this same adherence is a major safety issue especially if the glitter gets into the eyes; the only way to remove it is to see a qualified physician since, if one tries to wash it out, the eye can be scratched. Also, since PET glitters are not sterile or handled in a sterile manner by consumers, eye infections can occur. It is therefore advisable to those who use glitter either in a loose powder or in formulations to warn consumers of the dangers of getting this material into their eyes as well as direct them to seek medical attention if this occurs.
The second issue with PET glitter is status of the colors that are used. Since the cosmetic industry uses only a small portion of the overall glitter produced, most glitter is made without FDA- or EU-permitted colors. In fact, it is often difficult even to find out what colors are in commercial glitter. Finally, PET is a substrate and not a color, so it cannot be in the “may contain” section of a personal care product label.
Resolving ‘May Contain’ Issues
It is easy to present the problems of colors and the “may contain” section of product labels; it is more difficult to provide solutions. The easiest solution is to eliminate the “may contain” section, which would require that individual labels be made for each shade and product. This would become quite expensive and not help product developers when shade adjustments are necessary. Another solution that is probably far more costly, and difficult, is to approve all the substrates as color additives in the EU and the United States. It is doubtful that this would happen but it would solve the problem.
The most obvious solution, in this author’s view, is to change the ingredients that are allowed in the “may contain” section from colors only to ingredients that are more workable, such as substrates and coatings bonded to permitted colors. This is an appropriate topic for the International Cooperation on Cosmetics Regulations (ICCR) to consider at its next annual meeting of regulators from the EU, United States, Canada and Japan. This group’s goal is to harmonize cosmetic regulations. If only the United States and EU could agree on this strategy and move to change their definitions, it could solve industry problems. Finally, the industry must do something about PET glitter. For cosmetic use, it should be made only with approved colors and include the proper warnings so that, if needed, consumers know how to respond; the ICCR would also likely agree on this point.
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1. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=701.3 (Accessed Jul 26, 2011)