How Would FDA’s Removal of Red 3 Affect Food Manufacturers in Asia Pacific?
FDA Revokes Approval for Red 3, Effective 2027
On January 15, 2025, the United States Food and Drug Administration, or FDA, announced their decision to revoke the authorization for the use of FD&C Red No. 3 in food and ingested drugs. This will be effective January 15, 2027, for food products and January 18, 2028, for ingested drugs. Although the US Red 3 ban doesn’t directly affect Asia Pacific, it’s wise to consider how food manufacturing practices may change across the region.
What is FD&C Red No. 3?
FD&C Red No. 3, also referred to as FD&C Red 3, Red 3, Red #3, or Erythrosine, is a synthetic food dye that imparts a bright pink or red color to food products like strawberry milk, baked goods, and confectionery. While the dye doesn’t have any known nutritional benefits, it has been used for over 100 years in the US due to its stability under heat among other conditions.
Why did the FDA Remove Red 3?
The FDA reconsidered the use of Red 3 as a food color after a petition from non-governmental organizations and consumer groups in 2022. The decision to remove Red 3 is linked to the Delaney Clause, which prohibits food and color additives that have been shown to cause cancer in humans or animals.
Two studies found that high levels of FD&C Red #3 caused cancer in male laboratory rats. Because of this evidence, the FDA revoked its earlier approval of Red 3 for use in food and drugs for humans.
However, the studies indicated that the cancer caused in rats is due to a hormonal mechanism specific to rats, meaning this effect doesn’t occur in humans.
Is Red 3 Used in Asia Pacific?
Yes, Red 3 is still present in many products across the Asia Pacific region today, as well as globally. According to data from Mintel GNPD, Asia Pacific ranks second for the highest number of food and beverage product launches containing Red 3 from 2020 to 2024. Interestingly, we see a consistent increase in its usage over the years, particularly in India, Indonesia, and China, which are the top three markets for new products featuring this ingredient.
Is Red 3 Banned in Asia Pacific?
Red 3 is generally permitted in Asia Pacific, but with specific restrictions based on the country. The region is quite diverse, and each country has its own set of rules regarding this ingredient.
Take India, for instance. Manufacturers in India are allowed to use Red 3 as a food additive in dairy products and analogues at a limit of 50 mg/kg. In contrast, Indonesia doesn’t permit the use of Red 3 in this category at all.
Australia and New Zealand have the most limited regulation for Red 3. The Food Standards Australia New Zealand (FSANZ) only allows Red 3 to be used in two product categories: preserved cherries (including maraschino cherries, cocktail cherries, or glacé cherries) and certain icings and frostings.
Ripple Effects of US Red 3 Ban on Asia Pacific
Since the FDA’s announcement on January 15, 2025, there haven’t been any changes to the regulations in the region. Our regulatory teams haven’t noticed any activity from the regulators in the APAC area, but we’re always monitoring the regulatory landscape. We work closely with our teams and customers to stay informed. That said, let’s take a closer look at some potential effects of the FDA’s announcement.
Export Restriction and Compliance Costs
Asian food manufacturers that export products to the US will need to reformulate recipes to comply with the new regulations. This may require sourcing alternative colorants, conducting additional safety tests, and updating packaging to meet US labeling standards. These adjustments could lead to increased production costs and potential disruption in supply chains.
Influence on Domestic Regulations
In the past, US food bans have set global precedents, prompting Asian countries to reevaluate their own standards. For example, when the US banned artificial trans fats in 2015, several Asian nations, including Thailand and India, followed suit with stricter regulations. Similarly, after the US restrictions on brominated vegetable oil (BVO), countries like Japan and South Korea either banned or heavily regulated its use. Given this trend, some Asian governments may consider phasing out Red 3 or imposing stricter labeling requirements in response to the US ban.
Changing Consumer Preferences
Asian consumers, especially those in urban areas with growing health awareness, may start avoiding products containing Red 3 due to media coverage of the US ban. This could become a driving factor for local food manufacturers to proactively reformulate products, even if local regulations do not put a restriction on them. Brands that adopt “clean-label” marketing may gain a competitive edge. Research by Sensient supports this trend, with 3 in 4 consumers expressing concern about artificial colors in food and beverages, and 74% stating that they view brands more positively when they replace artificial colors with natural alternatives.
How to Convert from Red 3
and Synthetic Colors to Natural
If your brand is preparing to address the new FDA action by removing Red 3 but isn’t prepared to make a full conversion to natural colors, developers can look to other synthetic colors as alternatives. According to our technical experts, Red 40 offers a similarly stable and cost-effective red across applications. Red 40 won’t match the intensity of Red 3’s bright, almost neon, pink, but is an excellent option for brands seeking minimal process, formula, or cost impacts.
To find the best Red 3 substitute or fully convert products to natural colors, several technical considerations will come into play to ensure successful color performance. Heat, acidity, processing, ingredient interaction, and light exposure can all impact natural color stability depending on the color source.
Some of the most common natural Red 3 alternatives include:
Beet
Anthocyanins
Carmine
Lycopene
Red Iron Oxide
As a leading global color manufacturer, Sensient’s decades of expertise and unique blending capabilities open the door to custom shades in both the natural and synthetic realms.
Brands, developers, and manufacturers can lean on our deep pool of color resources and experience to find the best solutions for Red 3 replacements and synthetic color conversion.
Red 3 Replacement Resources
We’ve been preparing for a transition away from synthetic colors for over a decade, and recent consumer sentiments and legislative moves are accelerating brand interest in natural colors.
These resources may help you on the first steps toward Red 3 replacement in your products:
We’re Here to Help
At Sensient, we understand what a daunting process conversion away from Red 3 and other synthetic ingredients can be. Our team of color experts is ready to guide you through the path to natural colors quickly and seamlessly with technical insights and an extensive portfolio of successful, optimized natural color solutions across the rainbow.
Reach out today for a free consultation or to request a color sample.
