FD & C Colors – An Introduction

Artificial colors have wide applications across products belonging to various manufacturing industries like cosmetics, pharmaceuticals, food ingredients, and personal care products. The colors used by these industries have special significance because they are for human consumption in many forms that can affect health. In industrial parlance, these color additives or pigments, better known as FD & C colors or Food, Drugs, and Cosmetics dyes and lakes or artificial colors must meet certain safety standards to ensure their suitability for human use. Therefore, these color additives must comply with the US FDA requirements to ensure that they are non-toxic and safe for human use in various products like shampoos, body washes, toothpaste, hand washes, cleansers, creams lotions, deodorants, wipes, baby products, food ingredients, and medicines. FD & C colors are ensuring the safe use of colors, dyes, and pigments in products meant for human consumption.

What are FD& C color pigments?
FD & C colors are nomenclatures of synthetic colors or color additives mentioned on cosmetics and food labels. In the early days, many color pigments were manufactured from coal tar, which is no longer true. The color additive certification process is administered by US FDA to meet the regulatory listings. This process has undergone many changes over the decade and the oversight/approval has become stricter over time. There is a Federal Food, Drug, and Cosmetics Act to protect public health which requires pre-market approval of color additives. The FDA maintains a permitted list of food colors. Broadly speaking the FD & C colors are permitted for use in food, drugs, and cosmetics.

Safe use of FD & C colors:
Since the use of artificial colors is unavoidable in a wide range of products meant for human consumption by contact with the body, externally or internally, FDA has an approved list of synthetic colors that are safe to use. Manufacturers using synthetic colors in their products must adhere to the approved list of the FDA to ensure that the FD&C colors they use are safe for use in drugs, foods, and cosmetics. All FD & C colors belong to the list of FDA-approved colors. When you buy any product, check the label to ensure that it contains only permissible color ingredients. It would ensure that the colors are listed under 21 CFR81.1 Part 82 of 21 CFR of the FDA and are safe for use.

Decoding the safety symbols:
To know about the safety of any artificial color you must understand the FDA code corresponding to a specific color. For example, if you come across an additive listed as FD&C Red4, it implies that it’s an artificial red color made by using ingredients safe for human use. Sometimes, you might see the name ‘aluminum lakes’ or ‘lakes’ appearing in the name like FD&C Red33 Aluminum Lake. Sometimes the name might not use FD&C but instead, just mention Blue1 or Blue1 Lake.

Meaning of ‘lake’:
So, what does the term ‘lake’ mean for artificial colors? The term ‘lake’ indicates that the manufacturing process consisted of a reaction between a dye and an inert binder like some metallic salt, usually aluminum. Hence, the name aluminum lake appears in the color’s name. FD& C colors are especially popular in cosmetics because it adds brilliant shades to the products.

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