Red No. 3, or Erythrosine, has been used for years to add a bright cherry-red color to baked goods, beverages, confectionery products, and specific pharmaceutical uses. Its affordability and stability in the long term in some uses led to its being a favorite synthetic coloring substance for decades. But changing regulatory policies and increasing safety concerns have altered the scenario. The FDA has banned the use of Red No. 3 in foods, dietary supplements, and internally consumed drugs. Firms now have to act under the compulsion of reformulating impacted products.
The FDA is banning Red No. 3 on grounds of carcinogenicity. By January 2025, this led to a final ruling officially prohibiting its use in foods eaten in the United States, with 2027 food and 2028 medicine compliance dates. This places the U.S. on the path toward catching up with the European Union, where it has traditionally placed stricter requirements on using Erythrosine in foods. Other countries, such as Japan’s MHLW, restrict or limit its use.
To global manufacturers, the reformulation hurdle is not exclusive to US markets. Compliance across jurisdictions requires recipe modification that maintains product quality while meeting international standards.
Before its ban, Red No. 3 played several vital roles:
It produces deep, rich red color for gels, frostings, and candies, and has shown consistent performance across pH and light conditions. Compared to many of its natural alternatives, it is an affordable coloring agent. Despite these advantages, its link with safety issues and consumer demand to know the origin of ingredients made it impossible for it to be used in the long run.
Producing products without Red No. 3 presents some technical and commercial challenges:
1. Color Matching: Identification of an alternative with the same cherry-red depth without color shift or bleaching during processing.
2. pH Sensitivity: Natural reds can be heat—and pH-sensitive, presenting formulation challenges in beverages and baked foods.
3. Cost and Supply: Botanical substitutes are more costly and derived from agricultural supply fluctuation, affecting price and supply.
Red No. 3 substitutes are under consideration by manufacturers in the form of natural and synthetic substitutes. Among the most prevalent ones are:
1. Rubra Red – Natural pink-red color from a beta-carotene material. It is suitable for processing at high heat and extensively used in fatty-based and dry mix products, particularly where warm red shades are desirable.
2. Paprika’s natural color — Paprika oil or Paprika oleoresin from red pepper (Capsicum annuum) gives it a rich red color. It is soluble in fat-based formulations and can be employed in numerous savory and fatty food items.
3. Carmine (Cochineal Extract)—This natural color, derived from the cochineal insect, is used for deep red to crimson tones. It is highly stable over a broad pH, heat, and light range and finds applications in beverages, milk products, confectionery, and bakery.
The choice relies on the product matrix, process conditions, and positioning of the target consumer.
Phasing out Red No. 3 comes with its own challenges like:
1. Longer R&D Time Frames: Comparative testing of alternative color sources under different processing and storage conditions.
2. Consumer Acceptance: The end product must satisfy appearance, taste, and shelf life requirements.
3. Transparent Labeling: Label natural alternatives or altered lists of ingredients clearly to prevent confusion.
4. Global Alignment: Regulatory-synced formulation development to address multiple regulatory requirements and reduce geographical variability.
Removing Red No. 3 represents a notable milestone in further moving toward non-petroleum-derived synthetic coloring agents. Short-term reformulation difficulties are traded for the opportunity for manufacturers to become innovative with artful natural alternatives that meet changing consumer attitudes and regulatory necessity. Natural colors provide a competitive edge to companies in an increasingly transparent, safe, and sustainable marketplace.
Vinayak Ingredients (INDIA) Pvt. Ltd. has over 24+ years of experience in delivering high-quality Food Additives. We focus and manufacture products obtained from Natural sources such as Natural Colors, Spray-dried Fruit and Vegetable Powders & Natural Extracts which are eco-friendly and environmentally sustainable.
