Blue 1 Dye, or Brilliant Blue FCF or FD&C Blue No. 1, is a dye commonly added to certain foods, cosmetics, pharmaceuticals, and other consumer products. Along with many other colorant additives, it is FDA-approved for use in limited amounts. However, health concerns linked to blue food dyes exist.
This article explores the use of Blue 1 Dye, which products contain it, how to identify Blue 1 and its other names, and potential health concerns associated with this synthetic food colorant.
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What is Blue 1?
The chemical composition of Blue 1 Dye (Brilliant Blue FCF) is:
- Disodium;2-[[4-[ethyl-[(3-sulfonatophenyl)methyl]amino]phenyl]-[4-[ethyl-[(3-sulfonatophenyl)methyl]azaniumylidene]cyclohexa-2,5-dien-1-ylidene]methyl]benzenesulfonate
Some public interest groups consider the use of Blue 1 Dye concerning because it is a chemical. Artificial food dyes are typically made from petroleum and other substances. Synthetic blue dyes are created by chemical synthesis, often by adding sulphonic or carboxyl groups to natural dye molecules. These synthetic dyes are not found in nature.
Uses of Blue 1 Dye
Common foods and beverages that may contain Blue 1 include:
- Candies
- Jellies
- Beverages
- Desert powders
- Baked goods
- Canned peas
- Condiments
- Cereals
- Cakes
- Frostings
- Candies
- Popsicles
- Sports drinks and energy drinks
- Sugars
- Confections and chocolate candies
- Some dairy foods (frozen yogurts, flavored yogurts, sherbets, ice creams, etc.)
- Fruits, juices, and fruit gummy snacks
- Chewing gums
- Vitamins
Different countries have varying regulations about the use of Blue 1 Dye. They provide accepted daily intakes (ADIs), which are as follows:
- European Food Safety Authority (EFSA): 0-12.5 milligrams per kilogram of body weight daily
- United States Food and Drug Administration (FDA): 0-12 milligrams per kilogram of body weight daily
- Joint FAO/WHO Expert Committee on Food Additives (JECFA): 0-6 milligrams per kilogram of body weight daily
ADIs for Blue 2, another blue food dye, are lower compared to Blue 1.
Pharmaceuticals
Medications containing Blue 1 include:
- Cephalexin
- Cephalexin monohydrate
- Cetirizine hydrochloride
- Clindamycin hydrochloride
- Acetaminophen and oxycodone hydrochloride
- Amoxicillin trihydrate
- Hydroxyzine pamoate
- Methylphenidate hydrochloride
- Phentermine hydrochloride
- Tamsulosin hydrochloride
- Clonazepam
- Amphetamine and dextroamphetamine
- Amphetamine and dextroamphetamine extended-release
- Doxycycline Hyclate
- Fluoxetine hydrochloride
Blue 1 is present in some children’s vitamins, prenatal vitamins, pain relievers, cough and cold syrups, and allergy medicines.
Blue 1 has historically been added to enteral nutrition formulas to help detect gastric aspirate in critically ill patients. However, the FDA issued a warning about numerous reports of toxicity, including death, associated with using Blue 1 in enteral feeding solutions.
Cosmetic, Hygiene, and Skincare Products
Cosmetic and personal care products that may contain Blue 1 Dye include:
- Mouthwashes
- Lipsticks
- Eye creams
- Masks
- Makeup removers
- Skincare products
Check the product label on such products to determine if Blue 1 is an ingredient.
Other Uses
Blue Dye 1 is present in some pesticides with limits of no more than 0.2% of the pesticide formulations.
Health Effects and Safety Concerns
The use of Blue 1 is controversial because of the following health and safety concerns:
Potential Blue 1 Side Effects
Some studies show that Brilliant Blue FCF and Blue 2 contribute to toxic effects. Symptoms of an allergic reaction due to Blue 1 or other food dyes include:
- Hives
- Rashes
- Itchy skin
- Chest tightness
- Flushing
- Difficulty breathing
- Severe headaches
- Facial swelling
While most food dye allergic reactions are mild, some can become severe when not treated.
FD&C Blue 1 Health Hazards
Based on several research studies, potential health hazards that may be linked to FD&C Blue 1 include neurotoxicity, hyperactivity in children, allergic reactions, cancer, organ damage, fertility problems, and genetic defects.
While more research is needed regarding the use of Blue 1 on attention-deficit/hyperactivity disorder (ADHD), a review found a potential link because of Blue 1’s ability to cross the blood-brain barrier.
Studies also show a link between Blue 1 and developmental delays in mice and autism in children.
The American Academy of Pediatrics reports that common children’s food products may worsen ADHD symptoms.
Blue 1 Cancer Risk
Blue 1 and numerous other food dyes may be associated with cancer, particularly in animal studies. A review found that Blue 1 causes kidney tumors in mice and is linked to death after ingestion via a feeding tube.
The Center for Science in the Public Interest recommends further research to determine if Blue 1 is actually safe.
Researchers report being shocked by the legal amounts of artificial food dyes the FDA allows in drugs, cosmetics, and foods. They suggest that the public is often unaware of the truth behind deceptive artificial colorings.
Comparison with Other Blue Dyes
In addition to Blue 1, other blue colorants exist in foods, supplements, drugs, and other consumer products.
Blue 1 vs. Blue 2
Blue 1 and Blue 2 (Indigo Carmine) are different chemically and functionally. Blue 2’s chemical composition is disodium;2-(3-hydroxy-5-sulfonato-1H-indol-2-yl)-3-oxoindole-5-sulfonate. Unlike Blue 1, Blue 2 isn’t made from petroleum. Rather, it’s a synthetic version of plant-based indigo dye.
Blue 1 and blue 2 are both used to color foods, drinks, medications, vitamins, and other consumer products. However, their colors are slightly different. Blue 1 is a lighter blue or greenish-blue dye, while Blue 2 is darker blue or indigo in color.
Regulatory differences between Blue 1 and Blue 2 also exist. Guidelines for consumption include:
- EFSA Blue 1: 0-12.5 milligrams per kilogram of body weight daily
- EFSA Blue 2: 0-5 milligrams per kilogram of body weight daily
- FDA Blue 1: 0-12 milligrams per kilogram of body weight daily
- FDA Blue 2: 0-2.5 milligrams per kilogram of body weight daily
- JECFA Blue 1: 0-6 milligrams per kilogram of body weight daily
- JECFA Blue 2: 0-5 milligrams per kilogram of body weight daily
These agencies allow higher levels of Blue 1 than Blue 2.
Natural Blue Colorants
Natural blue colorants sometimes replace Blue 1 and Blue 2. Researchers report that common natural blue colorants studied in literature are:
- Anthocyanins (E163): present in grapes, berries, other fruits, cabbage, potatoes, radishes, and other vegetables.
- Gardenia blue: obtained from G. jasminoides fruits that grow in forests in Taiwan, Japan, China, and Vietnam.
- Phycocyanin: sourced from algae.
- Natural indigo: present as water-soluble glucoside indicant in plants.
These natural blue colorants are extracted using classical or sophisticated extraction techniques, such as ultrasound-assisted extraction, supercritical fluid extraction, high-pressure extraction, or pressurized liquid extraction. However, they are often more expensive than synthetic dyes.
The only FDA-approved natural blue colorants for use in foods are grape and grape skin extracts, which are both anthocyanin grape pigments.
Environmental Impact
Blue 1 Dye and other food dyes may impact the environment and its wildlife.
Degradation and Persistence
Researchers found that when not treated properly, wastewater contains contaminants like dyes and hormones that may harm public health.
The researchers suggest that Blue 1 Dye and other food additives used in the food supply cause problems in wastewater because of their stable chemical and photolytic structures.
Impact on Wildlife and Ecosystems
Blue 1 Dye might also affect wildlife, including aquatic and terrestrial organisms and their ecosystems. Several studies report the toxic effects of Blue dyes on animals. This is problematic when the dyes are present in water and soil.
Another study found that azo dyes cause toxic effects on microalgae, zebrafish embryos, and cladocerans — and colorants in water bodies should be tightly regulated to prevent negative environmental impacts.
Regulations and Standards
Regulations and standards developed for Blue 1 Dye are as follows:
US Regulations
The FDA has approved Blue 1 for use in limited amounts in foods and other products. FDA guidelines for Blue 1 are:
- 1-12 milligrams of Blue 1 per kilogram of body weight daily
The Blue 1 certification process involves batch testing, which means the FDA analyzes a representative sample of each dye batch to ensure it meets the required specifications before use.
International Standards
International standards include:
- European Union regulations for Blue 1 Dye are: 1-12.5 milligrams of Blue 1 per kilogram of body weight daily.
- JECFA accepted daily intake levels for Blue 1 are: 0-6 milligrams of Blue 1 per kilogram of body weight per day.
However, the Center for Science in the Public Interest recommends further research to determine if Blue 1 Dye is indeed safe for humans.
California has advanced a bill that eliminates Blue 1 and other food dyes from school meal menus.
Emerging Research and Development
Innovative Uses
New applications in food and pharmaceutical industries may use natural food colorants instead of Blue 1 and other synthetic dyes. They might increasingly add “dye-free” terminology to food and pharmaceutical product labels as public awareness regarding the potential dangers of artificial food dyes heightens.
Future Trends
Potential developments in synthetic and natural blue dyes could include phasing out synthetic dyes in favor of safer natural colorants over time.
Alternatives and Replacements
While natural blue colorants are rare, emerging natural dyes, such as those sourced from red cabbage and other fruits and vegetables, show promising results. New research and regulations may emerge as a result of these new developments.
Frequently Asked Questions
The following information addresses common questions regarding Blue 1 Dye:
What is Blue 1 and Blue 2?
Blue 1 and Blue 2 are synthetic dyes made of chemicals and used to color foods, drinks, cosmetics, vitamins, other dietary supplements, medications, and more.
What is the purpose of Blue 1?
The purpose of Blue 1 Dye is to add blue coloring to consumer products to enhance appeal.
What does Blue 1 do to your body?
While many government agencies deem Blue 1 Dye safe in limited amounts, this artificial food colorant has the potential to cause allergic reactions, ADHD symptoms, cancer (Blue 1 Dye caused kidney tumors in mice), organ problems, genetic defects, and bronchial constriction. It may also contribute to fertility issues and negative effects on the central nervous system (CNS).
What is Blue 1 made of?
Blue 1 Dye is typically made from petroleum and other chemical substances.
Is Blue 1 safe for consumption?
The FDA, JECFA, and EFSA, have all deemed Blue 1 Dye safe for consumption in limited amounts. However, studies show that some individuals, including young children who eat large amounts of highly processed bright-colored foods, might exceed current ADIs.
Some organizations have recommended removing Blue 1 and other food dyes from the food supply due to potential health concerns.
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Key Takeaways
- Blue 1 Dye is a common artificial dye used to color foods, cosmetics, medications, vitamins, and other consumer products.
- The FDA, JECFA, and EFSA deem Blue 1 safe in specific amounts based on an individual’s body weight.
- Potential health concerns exist when consuming large amounts of Blue 1, including hyperactivity in children, cancer, neurotoxicity, organ damage, fertility problems, genetic defects, and others.
- It’s beneficial to limit or avoid synthetic food dyes and other food additives as much as possible to reduce the risk of potential health concerns.
- Look for dye-free foods or those that use natural colorant alternatives, such as anthocyanins (E163), gardenia blue, phycocyanin, or natural indigo. Or purchase organic products, including fresh produce from local farmer’s markets when available.
- It’s helpful to monitor potential changes in food dye manufacturing, regulations, and updated research to make informed decisions about products containing Blue 1 Dye.
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