As a natural pigment and antioxidant, anthocyanins enhance the color and nutritional value of food. This article explores their global regulatory status and highlights the importance of compliance for international market entry.

Anthocyanins: A Unique Dual-Function Ingredient

Anthocyanins are a class of compounds formed by anthocyanidins and sugars through glycosidic bonds. Naturally abundant in plant flowers, fruits, stems, leaves, and roots, they give plants vibrant red, purple, and blue hues.  

Typically extracted from fruits and vegetables, anthocyanins offer nutritional value. Their nature grants them a dual role—both as a food ingredient with health benefits and as a coloring agent classified as a food additive.

Regulatory Compliance of Anthocyanins as Food Additives  

As a natural colorant, anthocyaninss are widely used in food products, including beverages. However, regulatory approvals vary across regions. ZMUni Compliance Centre has reviewed the compliance status of anthocyanins as a colorant in key markets, including JECFA (FAO/WHO), China, the EU, the US, Thailand, and Brazil.

In the EU, approved anthocyanins (INS 163) refer to refined extracts from vegetables and edible fruits, covering all anthocyanin-based colorants under INS 163, including Grape Skin Extract (INS 163ii). The EU allows the widest range of anthocyanins as food colorants, while Grape Skin Extract (INS 163ii) is the most widely approved anthocyanin-based colorant globally.

✅ Point to note: 

Consumers generally prefer natural colorants over synthetic ones. Black carrot extract, a notable natural anthocyanin colorant, was evaluated by JECFA in 2019, establishing quality specifications for its use.

For companies seeking to introduce black carrot extract as a colorant in countries like China, Thailand, and Brazil, where it is not yet approved, a new food additive application must be submitted per local regulations. However, approvals from JECFA and the EU may simplify the application process in these regions by potentially waiving certain toxicology tests.

For example:

• China: Existing approvals from other countries or authoritative bodies can support toxicology test exemptions.

• Brazil: Under IN 344/25, JECFA and the EU are recognized as Autoridade Reguladora Estrangeira Equivalente (AREE), or Equivalent Foreign Regulatory Authority, allowing companies to follow a simplified application process, reducing both documentation requirements and official review time.

Regulatory Compliance of Anthocyanins as Food Ingredients  

✅ China

From 2023 to 2025, China has approved several new food ingredients rich in anthocyanins, highlighting the growing importance of anthocyanin-based ingredients in China. Research and application in this area are accelerating.

✅ Brazil

Brazil has approved two novel food substances derived from anthocyanins, specifically Maqui Berry and Moro Orange extracts, which have distinctive regional origins, primarily from South America and Italy, respectively.

✅ Point to note: 

The Maqui berry, known as a "superfruit" from South America, has high antioxidant content, and its anthocyanins have been approved for use in China. This opens the door for more unique ingredients, such as Moro orange extract from Brazil, to enter the Chinese market.

Other notable anthocyanin sources include blood orange, hibiscus, black soybean, waxberry, and mulberry anthocyanins, which are gaining traction in various regions.

ZMUni Reminder

As the demand for natural antioxidants and healthy foods grows, the market for anthocyanin-based ingredients is expanding. More plant-derived anthocyanins are expected to gain approval for use in functional foods and dietary supplements, providing high-quality options for public health.

The global regulatory approval process for anthocyanins is progressing, but challenges remain. Different countries and regions have varying requirements for the source, purity, and usage limits of anthocyanins. Companies planning to export anthocyanins should conduct targeted compliance assessments for each market.

At ZMUni Compliance Centre, we offer food compliance services in key markets, including the EU, the US, China, Thailand, and Brazil. Whether you need assistance with novel food applications, new food ingredient registrations, or new food additive approvals, our team provides tailored compliance solutions to help you navigate these markets successfully. For inquiries, please contact us at info@zmuni.com.