Japan’s Current Stance on Red No. 3 Following US Ban and Future for Using Colorants in Japan

In a significant move to protect public health, the United States has officially revoked its authorization for Red No. 3, a synthetic food dye, which marks a sweeping ban on its use in food, beverages, dietary supplements, and ingested drugs in the U.S..

As this policy shift roll-out, Japan's Consumer Affairs Agency (CAA) has issued a timely update on the regulatory status of Red No. 3. This article explores Japan's current stance on Red No. 3 and development trends of colorants in the future.

Food Dye Red No. 3

Red No. 3, also known as Erythrosine (CAS 16423-68-0), is a synthetic red food coloring. It is commonly used in the food industry and known by various names across different regions. In the United States, it is referred to as "Red No. 3", while in Taiwan, China it is called "Food Red 7". Its chemical structure is characterized by its red (or reddish-brown) color in solid form, which can appear as either a powder or granules at room temperature.

Red No. 3 is highly soluble in water and also soluble in ethanol, propylene glycol, and glycerol. It has good heat stability, which makes it suitable for use in food products that may undergo processing at higher temperatures. Additionally, it is known for excellent staining properties, especially on proteins, making it an ideal colorant in various circumstances.

In the food industry, Red No. 3 is typically found in sweets and confectionery products, including candies, ice pops and cherries, as well as cake-decorating gels. As a food additive, it carries the "E-number E127" within the European Union, which signifies its approved use in food products.

While it has a wide range of uses, it's essential to note that the safety and regulatory status of Red No. 3 is subject to scrutiny in different regions.

Current Use Standard for Red No. 3 in Japan

Red No. 3 has been designated as a food additive in Japan since 1948 and is commonly used in various foods. Due to its heat and reduction resistance, it is used in traditional Japanese sweets and fermented foods. Additionally, its strong dyeing ability on proteins makes it suitable for use in fish paste products like kamaboko. However, in recent years, the market has seen a shift toward using natural colorants, which leads to the decrease in its usage.

The following table outlines the use standards of Red No.3 in the current Food Additive Use Standards. While no maximum limit has been established for its use, certain products are prohibited from containing Red No. 3. This prohibition is intended to prevent consumer’s potential misunderstandings related to the perceived quality and freshness of the products when Red No. 3 is used as a colorant.

Currently, the CAA has stated that there is "no data" indicating any health risks associated with the use of Red No. 3 as a food colorant. Despite its ban by the U.S. Food and Drug Administration (FDA) due to concerns about cancer in laboratory rats, Red No. 3 remains legal for use in Japan.

Moreover, the acceptable daily intake (ADI) for Red No. 3, as established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), is set between 0 to 0.1 mg per kg of body weight per day. According to a survey conducted by the Ministry of Health, Labour and Welfare in 2023, the average daily intake of Red No. 3 by Japanese consumers is well below the ADI, amounting to only 0.048% of the established limit.

Growing Global Scrutiny of Synthetic Coloring

This ban on Red No. 3 is not an isolated case. Many countries worldwide have introduced similar bans on synthetic colorants, reflecting an intensifying trend toward stricter regulation. As a result, more synthetic dyes may face similar fates in the future.

In the United States, Red No. 40 has been banned in Pennsylvania due to its association with hyperactivity in children and its inclusion of carcinogenic substances. Other dyes, including Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3, are also under investigation by various states. Furthermore, Red No. 40 is banned in countries like the United Kingdom and Switzerland due to health concerns.

In the European Union (EU), although Red No. 40 has not been fully banned, it is subject to strict regulations. Products containing Red No. 40 must bear a warning label stating that the dye "may have an adverse effect on activity and attention in children." 

Yellow 5 and Yellow 6, commonly used in the U.S., have been banned in Finland and Norway due to their adverse side effects. While the EU does not ban these additives, any product containing them must also carry a warning label due to potential health risks.

Future Trends: Rise of Natural Alternatives

Both consumers and businesses are shifting toward safer, natural alternatives. This growing preference for natural additives is driven by not only consumer demand for healthier options but also the stronger industry regulations for synthetic ones. 

Downstream companies are recommended to consider using natural plant-based extracts for coloring when producing finished products. In Japan, the following natural colorants that can achieve red hues may serve as potential alternatives for Red No. 3.

1. Monascus Red (Benikoji, Monascus Pigment, Red Koji)

Monascus red is a pigment derived from the culture of the Monascus mold, a type of fungus. After drying and grinding the cultured mold, the pigment is extracted with the aid of alcohol or organic solvents. The primary ingredients of this pigment are monascorubrin and ankawarabin. When acidic alcohol is used in the extraction process, yellow pigments can also be obtained.

This pigment, known as "red koji," is widely used in the production of alcoholic beverages, particularly in brewing processes. It imparts color to traditional Chinese liquor (lao jiu) and Okinawan awamori.

Common Uses: fish paste, seasoned octopus, processed meat products, seasonings, etc.

2. Cochineal (Carmine, Carmine Acid, Cochineal)

Cochineal is a natural red dye obtained from the dried bodies of the Dactylopius coccus insect, which parasitizes cacti in southern Spain and Central and South America. The pigment is extracted through water or alcohol, with carminic acid as the primary ingredient, which produces a color range from orange to purplish-red. This dye has been traditionally used in the coloring of Italy's famous liqueur, Campari.

Notably, although cochineal is considered by some consumers as a "natural" choice, its origin remains somewhat controversial, especially among vegans and certain religious groups. Its "animal-derived" nature makes it unacceptable to many, which limits its widespread acceptance.

Common Uses: soft drinks, alcoholic beverages, frozen desserts, confections, meat products, fish pastes, etc.

3. Beet Red

Beet red, a natural pigment extracted from the roots of beets (also known as red turnips), is characterized by its vibrant red color and primarily consists of isobetanin and betanin.

Common Uses: Dairy drinks, pollock roe, chocolate, cakes, etc.

In terms of producing method of colorants, precision fermentation is emerging as a sustainable method for producing natural colorants. By cultivating specific microorganisms to secrete pigments like beet red, large quantities of stable, high-purity colorants can be produced. This method overcomes the limitations of traditional extraction, such as low yields and instability. Microbial fermentation is more resource-efficient, requiring less energy, land, and raw materials.

Companies like Chromologics, Phytolon, and Michroma have made early advancements in this technology. The process not only offers sustainability benefits but also reduces production costs and increases colorant’s purity.

Summary and Recommendations

1. Legality of Red No.3: While the United States has banned the use of Red No. 3 in food products, the dye remains legal in Japan.

2. Impact on Western and Potential Global Spread: The ban currently affects Western countries, particularly the United States. However, if the restrictions extend to Asia and Japan, it could significantly impact Japanese food businesses and global companies seeking to export food products to Japan.

3. Consumer Concerns and Regulatory Trends: With growing consumer concerns about food safety and the increasing global trend toward stricter regulations on synthetic colorants, it is advisable for enterprises to explore alternatives. Natural colorants such as monascus red, and cochineal may be viable options in Japan. By proactively adopting these alternatives, enterprises can not only stay ahead of regulatory shifts but also tap into the growing market demand for safer, natural ingredients.