# FD&C Blue No. 1 (E133)

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**Safety rating:** CAUTION
**E-number:** E133
**CAS number:** 3844-45-9
**Category:** colorant
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

FD&C Blue No. 1 is a synthetic colorant approved by the FDA for use in foods, beverages, and pharmaceuticals. It is primarily used to impart blue coloring to a wide range of consumer products and has no reported adverse events or recalls in the FDA database.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | authorized |
| United Kingdom | approved |
| Canada | approved |
| Australia | approved |
| Japan | restricted |
| South Korea | approved |
| Brazil | approved |
| China | approved |
| India | approved |

## Detailed analysis

## What is FD&C Blue No. 1?

FD&C Blue No. 1, also known as Brilliant Blue FCF, is a synthetic azo dye with the CAS number 3844-45-9. It belongs to the class of colorants approved for use in the United States under the FDA's Color Additives Status List. The compound is produced through chemical synthesis and has been used in food, beverage, and pharmaceutical applications for decades.

## Common Uses

FD&C Blue No. 1 is widely used in the food and beverage industry to provide blue coloring. Common applications include:

- Confectionery and candy products
- Beverages (sports drinks, soft drinks, juices)
- Frozen desserts and ice cream
- Baked goods
- Dairy products
- Pharmaceutical tablets and capsules
- Cosmetics and personal care products

The colorant is chosen for its stability, consistency, and ability to produce vibrant blue hues that remain stable during processing and storage. It is often used alongside other colorants to achieve specific shades and color effects.

## Safety Assessment

The FDA permits FD&C Blue No. 1 for use in foods under 21 CFR Part 74. The additive has undergone safety evaluations and is listed as approved for use in foods. The FDA database shows zero reported adverse events and zero recalls associated with FD&C Blue No. 1, indicating a long history of use without documented safety incidents.

The European Food Safety Authority (EFSA) also permits the use of Brilliant Blue FCF (E133) in the European Union under specific conditions and with established maximum levels in various food categories. Both regulatory bodies have determined the additive to be safe for the general population at approved usage levels.

Toxicological studies on FD&C Blue No. 1 have examined acute toxicity, subchronic and chronic toxicity, genotoxicity, and reproductive/developmental effects. The available evidence supports the safety of the colorant when used in accordance with regulatory guidelines.

## Regulatory Status

In the United States, FD&C Blue No. 1 is approved by the FDA as a color additive for use in foods, with specific restrictions on maximum levels depending on the food category. It is not classified as "Generally Recognized as Safe" (GRAS) but rather as an approved color additive subject to regulatory oversight.

The additive is approved in most countries with developed food safety systems, including Canada, Australia, and the European Union (where it is designated as E133). Each jurisdiction establishes its own maximum permitted levels based on safety assessments.

## Key Studies

Numerous safety studies have been conducted on FD&C Blue No. 1 since its approval. Regulatory agencies have reviewed data on:

- Acute oral toxicity studies in laboratory animals
- 90-day subchronic toxicity studies
- Two-year chronic toxicity and carcinogenicity studies
- Genotoxicity and mutagenicity assessments
- Reproductive and developmental toxicity studies

These studies, conducted according to standardized toxicological protocols, have consistently supported the safety of FD&C Blue No. 1 at approved usage levels. The lack of adverse event reports and recalls in regulatory databases further supports its safety profile in actual use.

Regulatory agencies periodically review available literature to ensure continued safety monitoring. The absence of reported adverse events in FDA databases over decades of use suggests that FD&C Blue No. 1 has a well-established safety record when used as approved.

## Brands using FD&C Blue No. 1

- AIRHEADS (1 product)
- Actual Candy (1 product)
- Gomez Cuetara Hnos Sa De Cv (1 product)
- JFC International Inc. (1 product)
- Nissin Wafer Choco (1 product)
- Transnational Foods, Inc. (1 product)

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "FD&C Blue No. 1 (E133) — Safety, regulation, and evidence." https://additivefacts.com/additives/fd-c-blue-no-1. Accessed 2026-05-19.