Fine Print: Color Coding
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Examining labeling regulations for color additives.
by Holly C. Young and Marcus TiradoHirschhorn + Young Graphics
Today, there are more makeup and cosmetic colors on the market than ever before. With constant demand for new colors comes a constant demand for closer regulatory scrutiny.
In the United States
FDA is responsible for regulating all color additives used in the United States. A color additive, defined by FDA, is “any dye, pigment, or substance that can impart color.” All new color additives are subject to a rigorous certification process, which ensures the safety, quality, consistency, and strength of a color additive prior to its use.
FDA is also responsible for regulating and enforcing all labeling guidelines. All color additives must be listed by their FDA name, which consists of a color and usually a number. Because color additives are considered ingredients, they must be listed in the ingredients declaration portion of a label and follow all of the regulations for ingredient declarations. Color additives may be declared in any order following noncolor ingredients with a concentrated use of 1% or less.
In addition, for certain shaded cosmetics products with the same composition and use but that contain different color additives (for instance, a lip gloss sold in various shades), one universal label may be used. All color additives may be listed in any order in the ingredient declaration on a label after the words may contain. This signifies that some product shades may or may not contain certain color additives.
Just recently, FDA issued a new labeling guideline for the very popular color additive carmine. Not-for-sale samples and professional-use products that contain carmine must now declare this ingredient on their labels.
In the European Union
In the EU, regulations for color additives or coloring agents are somewhat similar to FDA’s, but they follow a different labeling format. All coloring agents in the EU must be identified by their Colour Index number, which is listed in the EU Cosmetic Directive. If a Colour Index number cannot be located, then the INCI (International Nomenclature of Cosmetic Ingredients) designation can be used.
As in the United States, coloring agents in the EU must be listed in the ingredient declaration portion of a label and may be listed in any order after the other noncolor ingredients. For colored cosmetic products in different color shades with identical noncolor ingredients, the EU allows declaring all coloring agents at the end of the ingredient declaration after the words may contain or the symbol “+/-.”
Reference:
Directive 2003/15/EC, (FDA) 21 CFR 701.3, Cosmetic Ingredient Labelling in the European Union-COLIPA.