FD&C Red No. 3, also called erythrosine or E127, gives a bright cherry-pink color to candy, cake decorations, frostings, cocktail cherries, some snacks and some dessert products. FDA has revoked its authorization for use in food and in ingested drugs. For food the compliance date is January 15, 2027. After that date a food containing Red No. 3 that is offered for sale in the United States uses a color additive with no valid authorization, and FDA can treat it as adulterated. The rule applies to imported foods in the same way as to US-made foods.
The key dates
- January 15, 2027: Red No. 3 may no longer be used in food sold in the United States. FDA has revoked the listing at 21 CFR 74.303.
- January 18, 2028: the same deadline for ingested drugs, such as some tablets, syrups and chewables. FDA has revoked the listing at 21 CFR 74.1303.
FDA revoked the authorization under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. That clause bars FDA from authorizing a food or color additive that has been found to cause cancer in humans or animals. Red No. 3 has not been allowed in cosmetics or externally applied drugs since 1990, so this action closes the remaining food and ingested-drug uses.
Why foreign exporters are more exposed than they think
Few foreign manufacturers add Red No. 3 on purpose for the US market. The risk usually comes from somewhere else in the supply chain:
- A recipe developed years ago for the US market that nobody has reviewed since.
- A compound ingredient such as sprinkles, colored sugar, fruit pieces, fillings or decorations bought from a supplier that uses erythrosine.
- A product sold in markets that still allow E127 for some uses, with the same recipe shipped to the United States.
- Private-label products made to a US buyer's old specification.
Color additive problems are a common reason for import refusals, and they are easy to spot from the label. Our case study of pomegranate juice refused for an illegal color shows how one unapproved color can stop an entire shipment at the border.
A reformulation checklist
- Search every US product specification for "FD&C Red No. 3", "Red 3", "erythrosine", "E127" and CI 45430.
- Ask each supplier of colored or compound ingredients for a written statement that the material contains no erythrosine, and keep it in your supplier file.
- Choose a replacement color that is authorized for your food category in 21 CFR Parts 73 and 74. Some colors require FDA batch certification, and color additives cannot be used beyond the uses and limits in their listing.
- Test the new recipe for color stability, shelf life and taste. Natural colors often fade faster under light and heat.
- Update the ingredient list. Certified colors must be declared by their specific names, such as "Red 40", and colors exempt from certification must be declared as required by 21 CFR 101.22.
- Plan your stock. Agree with your US importer how much old inventory is in the US channel and when the last Red No. 3 lot can be shipped so that it is sold before the deadline.
Label changes are part of the work
Any color change means a new ingredient list and often new artwork. This is a good moment to check the rest of the label as well: Nutrition Facts, allergen declarations, net quantity, and the name and address of the manufacturer or distributor. Our complete guide to FDA food labeling for foreign exporters covers each required element. Confectionery makers should also read our guide to exporting confectionery and chocolate to the United States, because those categories carry the highest Red No. 3 risk.
Beyond Red No. 3
Red No. 3 is the color with a fixed legal deadline. FDA has also publicly encouraged the food industry to move away from other petroleum-based synthetic dyes, and several US states have passed their own color restrictions, for example in school foods. Those state rules and voluntary programs are separate from the federal revocation and change often. If you are reformulating anyway, many exporters now choose colors from natural sources, so they do not have to change the recipe again later.
Keep the rest of your FDA file current
Reformulation does not change your facility's obligations. Keep your food facility registration and US Agent current, and confirm that each shipment's Prior Notice describes the product correctly. When the new label is ready, FDABridge's food label review can check it before you print.
Sources
- FDA, FD&C Red No. 3: https://www.fda.gov/industry/color-additives/fdc-red-no-3
- 21 CFR Part 74, Listing of Color Additives Subject to Certification: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74