Is red 33 (ci 17200) safe? Understanding the dye's safety profile

According to regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Commission, Red 33 (CI 17200) is considered safe for its approved uses in cosmetics and drugs. However, consumer concern persists regarding the safety of synthetic colorants, especially when considering potential allergies and specific usage limitations.

Quick Summary

An examination of Red 33 (CI 17200) details its use in cosmetics and certain drugs, highlighting regulatory approvals from entities like the FDA and EU. The review addresses potential allergic reactions and use restrictions, providing context on its safety profile and addressing common consumer questions.

Key Points

• Regulatory Approval: Red 33 (CI 17200) is approved for use in cosmetics and some drugs by major regulatory bodies like the FDA and EU, under specific conditions.

• Limited Use: The FDA prohibits the use of D&C Red No. 33 in cosmetics for the eye area, citing safety standards.

• Allergenic Potential: While considered safe for most, some individuals may experience an allergic reaction, such as skin irritation, especially at higher concentrations.

• Not Carcinogenic: Safety data and animal studies have not classified Red 33 as a known carcinogen, though some structurally related substances have raised concerns.

• Synthetic Azo Dye: Red 33 is a synthetic dye derived from petroleum or coal tar, valued by manufacturers for its stability and vibrant color.

• Alternatives Exist: Natural colorants, such as those from beets or anthocyanins, offer alternatives for consumers seeking to avoid synthetic dyes, though they differ in cost and performance.

What Is Red 33 (CI 17200)?

Red 33, also known by its Colour Index (CI) number 17200 and the U.S. designation D&C Red No. 33, is a synthetic azo dye. It is manufactured from petroleum or coal tar sources and is widely used to impart a purplish-red color to a variety of products. Its stability, color intensity, and ability to blend with other pigments make it a popular choice for manufacturers. It exists in a soluble form (dye) and an insoluble form (lake), with Red 33 Lake often used for products where color migration needs to be controlled, such as in drug tablet coatings.

Regulatory Status and Safety Assessments

Globally, Red 33 is subject to regulation by different health and safety authorities. Both the U.S. Food and Drug Administration (FDA) and European Union (EU) have assessed the ingredient and deemed it safe for specific applications, albeit with certain restrictions.

• U.S. FDA Approval: In the U.S., the FDA has approved D&C Red No. 33 for limited use. It is permitted for use in externally applied cosmetics, as well as in lip products, mouthwashes, and dentifrices. Crucially, it is not approved for use in cosmetics applied around the eye area. The FDA also certifies each batch of the colorant to ensure it meets strict specifications.
• EU Cosmetic Regulation: The EU's Cosmetics Regulation lists CI 17200 as an allowed colorant for all cosmetic and personal care products. This broader approval, compared to the FDA's, reflects the varying regulatory standards and assessments worldwide. The insoluble lake forms are also permitted, subject to purity and insolubility tests.
• Independent Safety Panels: The Cosmetic Ingredient Review (CIR) Expert Panel, an independent industry body, has also reviewed the ingredient's safety. Like regulatory agencies, they have found it safe for its approved uses in cosmetics.

Potential Health Risks and Concerns

While regulatory bodies consider Red 33 safe under specific conditions, there are some potential risks that consumers should be aware of, primarily concerning allergic reactions and cumulative exposure.

• Allergenic Potential: Research indicates that Red 33 may be allergenic in moderate doses, though it is not a common allergen. Those with pre-existing skin sensitivities or a known history of allergies to synthetic dyes may be at a higher risk of developing a reaction. Symptoms of an allergic reaction can include skin irritation, rashes, and swelling.
• Carcinogenic Risk: Concerns about carcinogenic effects, particularly due to the fact that it is an azo dye, have been raised. However, safety data sheets and regulatory bodies generally state that Red 33 is not considered carcinogenic based on available evidence. The Environmental Working Group (EWG) gives it a 'moderate' concern rating for cancer, based on structural similarities to other substances, but animal testing has not shown evidence of carcinogenicity.
• Inhalation Risk: Safety data sheets indicate that inhalation of Red 33 powder may cause respiratory irritation. This is more relevant for manufacturing environments where the dye is handled in powdered form, rather than for the final consumer.
• Eye Irritation: In its raw chemical form, Red 33 can cause serious eye irritation. This is why the FDA prohibits its use in cosmetics intended for the eye area, though the final product formulation is highly diluted.

Where is Red 33 (CI 17200) Found?

Red 33 is used in a wide range of products due to its vibrant color and stability. Its applications include:

• Cosmetics: Lipsticks, lip glosses, makeup, skin care products, shampoos, and conditioners.
• Personal Care: Soaps, mouthwashes, and dentifrices.
• Drugs: Ingestible drugs and externally applied medications, subject to specific dosage limits.
• Hair Dyes: Used in some non-oxidative hair dye formulations.

The Consumer Choice: Weighing the Evidence

The decision to use products containing Red 33 is ultimately a personal one, influenced by individual sensitivities and comfort levels. The key takeaway from regulatory reviews is that at the low concentrations used in consumer products, Red 33 is not considered a significant health risk for the general population. The primary concern for most people is the potential for a mild allergic reaction, a risk that exists with many ingredients, both synthetic and natural. For those seeking alternatives, natural red colorants from sources like beet juice, anthocyanins (from fruits like purple sweet potato), and carmine are available, though they may have different color intensity, stability, and cost.

Comparison: Red 33 vs. Natural Red Alternatives

Feature	Red 33 (CI 17200)	Natural Red Alternatives (Beetroot, Carmine)
Source	Synthetic (petroleum/coal tar)	Plant-based (beetroot, purple sweet potato) or insect-derived (carmine)
Color Intensity	Very high, predictable, and vibrant	Varies, can be less intense and more dependent on pH
Stability	Highly stable against light and heat	Varies; some are sensitive to heat, light, and pH
Cost	Generally lower cost	Often significantly more expensive
Allergenic Risk	Low, but possible for some individuals	Possible, as seen with some carmine allergies
Regulatory Status	FDA and EU approved with specific limitations	Generally food-grade and widely accepted, but approval varies
Use Case	Wide range of cosmetics, drugs, personal care	Popular for 'clean-label' and natural products

Conclusion

The safety of Red 33 (CI 17200) is a well-researched topic, with major international regulatory bodies, including the FDA and EU, concluding that the dye is safe for its intended uses within specified limitations. The primary concerns revolve around potential allergic reactions in sensitive individuals, not systemic toxicity or carcinogenicity, which have been ruled out by animal studies and safety assessments. For most consumers, Red 33 is a safe and effective colorant in the products they use daily. However, for those with known sensitivities or who prefer to avoid synthetic ingredients, natural alternatives are available, albeit with different performance characteristics and cost. The evidence suggests that while a personalized approach based on individual health needs is prudent, there is no need for alarm for the general public regarding the safety of Red 33.

Further Reading

For more information on the regulation of color additives in the U.S., you can visit the official FDA page on the topic. U.S. FDA Color Additive Regulations

Frequently Asked Questions

What is Red 33 (CI 17200)?

Red 33, or CI 17200, is a synthetic, petroleum-derived azo dye used as a colorant in various cosmetic and drug products to give them a purplish-red hue.

Is Red 33 approved for cosmetic use?

Yes, regulatory bodies in both the U.S. and Europe have approved Red 33 for use in cosmetics. The U.S. FDA, however, has specific restrictions, including prohibiting its use in eye-area cosmetics.

Can I have an allergic reaction to Red 33?

Yes, some individuals may be sensitive to Red 33 and experience an allergic reaction, especially with higher exposure. Symptoms could include skin irritation or rashes.

Is Red 33 carcinogenic?

Based on available safety data and animal studies, Red 33 is not considered carcinogenic by major regulatory bodies. Any concern is often linked to other structurally similar substances.

Is Red 33 safe to ingest?

The FDA has approved D&C Red No. 33 for use in some ingested drugs, but only up to a specific limit. It is not approved as a food additive in the U.S..

Why do manufacturers use Red 33 instead of natural colors?

Manufacturers often use synthetic dyes like Red 33 because they are more stable, have more intense and consistent color, and are generally less expensive than natural alternatives.

Where can I find products without Red 33?

To find products without Red 33, look for natural alternatives or read the ingredient list for 'CI 17200' or 'D&C Red No. 33'. Natural colorants like beet juice or anthocyanins are commonly used in 'clean-label' products.