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1. Background

Numerous artists, deeply committed to their clients' health and safety, have raised questions about the potential impact of azo dyes on well-being. For this article, we collated insights from 21 experienced Powder Brows artists, each with over four years of professional experience. Our initial objective was to grasp these artists' perspectives on the issue. We consulted with a dermatologist and two chemists to augment our findings, forming an expert panel. This approach aimed to assess the artists' views critically and develop a more thorough understanding of the implications and safety concerns associated with azo dyes in pigmentation.

Wider Context

Azo dyes are distinguished by their azo groups, which consist of two nitrogen atoms connected by a double bond — picture it as two nitrogen atoms joining forces tightly.

These dyes are prominent in the industry, constituting about 60-70% of all dyes utilized across various sectors. To illustrate their prevalence, over 2,000 distinct azo dyes are available today. They are employed for coloring various materials, including natural fibers like cotton, silk, and wool and synthetic items such as plastics and rubbers. They're also found in paints and varnishes. Their most common applications include textiles like sportswear, swimsuits, underwear, hats, and towels; leather goods such as handbags, wallets, chair covers, and leather jackets; accessories like wristwatch straps, wigs, gloves, and sleeping bags; and in the cosmetic industry as colorants in pigments.

Why are azo dyes so ubiquitous?

The straightforward answer is their cost-effectiveness and ease of application. Additionally, they deliver vibrant, eye-catching colors. From bright red apparel to vividly colored plastics, azo dyes are often behind the scenes. As a result, despite regulatory differences across regions, using azo dyes remains an attractive option, particularly in many Asian countries, where their application continues to be widespread.

2. Azo Dyes in Pigments

To fully grasp Azo Dyes, it's essential to understand their context within the broader spectrum of colorants used in Permanent Makeup (PMU). In PMU, "Pigment" typically refers to the complete mixture that includes colorants and additives such as solubles, binders, fillers, and preservatives. These colorants are further classified into Pigments, Dyes, and Lacquers.

Pigments

Pigments are insoluble color particles blended with a carrier to form ink or pigment paste. They originate from various materials, including minerals, metals, or organic compounds. Pigments are known for their high stability and resistance to fading, making them ideal for permanent or semi-permanent applications like tattoos and Powder Brows. Common inorganic pigments in PMU include iron oxides for earthy tones and titanium dioxide for white pigmentation.

Dyes

Dyes differ from pigments in that they are soluble substances that impart color by absorbing light. Generally, dyes are less stable than pigments and more prone to fading under environmental factors like sunlight or water exposure. Due to their reduced stability, dyes are typically not used for permanent applications but are popular in textiles and other temporary coloring tasks. Azo dyes fall under this category and are an organic compound that has sparked health and safety discussions due to their chemical nature.

Lacquers

Lacquers are dyes transformed into insoluble forms through precipitation or adsorption onto a substrate. This alteration causes them to act more like pigments in terms of insolubility. Despite this, they are used less frequently in permanent makeup due to potential safety concerns and regulatory restrictions.

Therefore, while pigments, dyes, and lacquers all function as colorants, they vary significantly in their chemical properties, stability, and typical uses. When we talk about Azo Dyes in the context of PMU, we're specifically referring to the category of colorants known as "dyes."

3. Dyes - Organic Pigment Colorants

In the world of colorants, pigments are categorized as inorganic or organic. Inorganic pigments, typically mineral-derived, are commonly utilized in various fields, including cosmetics and permanent makeup. Examples such as Titanium Dioxide and Iron Oxide are staples in creating products like Powder Brows. On the other hand, organic pigments are primarily carbon-based, often sourced from petrochemicals, but can also be derived from plant or animal origins. Notable examples include Phthalocyanine Blue and Quinacridone pigments, known for their vibrant hues. Classification of Dyes in Semi-Permanent Makeup

Let's delve into the various classes of dyes used in semi-permanent makeup.

Azo Dyes. Renowned for their vibrant colors and cost-effectiveness. Anthraquinone Dyes. Valued for their bright and stable colors.
Indigoid Dyes. These are often synthetic forms of traditional Indigo dyes.
Phthalocyanine Dyes. Known for stable blues and greens.
Nitro and Nitroso Dyes. Less common in semi-permanent makeup, these dyes fall under a chemical-based classification.
Triarylmethane and Xanthene Dyes. Celebrated for their vivid and classic colors.
Quinone-imine Dyes. Offer a range of yellows, oranges, and reds.
Sulfur Dyes. Typically used for dark shades like blacks and browns in textiles.

Dyes are predominantly organic, containing carbon and hydrogen atoms in their molecular structure. This includes classes like Azo and Anthraquinone dyes.

Azo Dyes Color Index Range - CI 11,000 to 36,999

The Color Index (CI) provides a standardized naming system for colorants, assigning each a unique CI number for international consistency. This system is invaluable for artists and manufacturers for accurate color communication.

Organic Pigments. From CI 10,000 to 76,999, these carbon-based pigments are versatile and used in everything from cosmetics to inks.
Inorganic Pigments. Falling within CI 77,000 to 77,999, these mineral-based pigments are favored in permanent applications for their stability and fade resistance.
Azo Dyes. Typically, Azo dyes are classified within CI 11,000 to 36,999.

Understanding these classifications and the nature of different pigments and dyes is crucial for professionals in the semi-permanent makeup industry, ensuring they can make informed choices about the materials they use and communicate effectively about their work.

4. Colorants with Azo Dyes

Azo dyes are used in various applications, but their usage in certain regions may be limited due to different regulatory standards and safety concerns. Here is a consolidated list of well-known colorants containing Azo dyes organized by their Color Index (CI) codes.

CI 11767: Yellow pigment 97
CI 11783: Yellow pigment Yellow 120
CI 12475 or 12475:1: Red pigment Red 170
CI 14700: Red 4
CI 15510: Orange 1
CI 15850: Red 7
CI 15985: FD&C Yellow 6
CI 16035: Red 40
CI 19140:1: FD&C Yellow 5

It's important to recognize that this list is not exhaustive, and the market may introduce new Azo dyes. Additionally, possessing a CI code is not a standalone endorsement of the pigment's safety for all uses. Artists are most likely familiar with colorants like Yellow 120, Red 170, Yellow 5, and Yellow Pigment 97 from the labels on their pigment bottles. When considering using these dyes, especially in applications like semi-permanent makeup, it's crucial to be aware of and comply with local regulations and safety standards to ensure clients' well-being.

5. Risks Related to Azo Dyes

Firstly, certain Azo dyes have the potential to degrade into substances known as aromatic amines. These amines pose significant health risks as they're recognized for their toxicity and carcinogenic properties — meaning they have the potential to cause cancer. Introducing such substances into the body through semi-permanent makeup is a concern that should not be taken lightly.

Secondly, Azo dyes can provoke allergic reactions in some individuals. In the context of semi-permanent makeup, such as brow pigmentation, this can lead to persistent skin irritation or severe allergic responses. This isn't just about temporary discomfort; it could mean enduring swelling, redness, and other distressing symptoms, particularly problematic when it affects the face.

Thirdly, due to these health risks, Azo dyes are often subject to restrictions or outright bans in the cosmetics industry, including semi-permanent makeup in many jurisdictions. Using these dyes might endanger your health and place you in a precarious legal position if you violate local regulations.

How Azo Dyes Become Carcinogenic

Azo dyes can turn carcinogenic through a process known as photodegradation, which occurs when they're exposed to ultraviolet (UV) light. UV light has the energy to break chemical bonds in molecules, including those in Azo dyes. This breakdown results in smaller components, such as o-anisidine, which can be hazardous.

These smaller particles are tiny enough to penetrate the body's cellular structure. Once inside a cell, they can interact with various cellular components, including DNA. When these particles affect DNA, they can induce mutations, altering the DNA sequence. This mutagenic action can disrupt normal cell regulation, leading to uncontrolled cell division, a hallmark of carcinogenesis.

The cell's nucleus, home to DNA, is especially susceptible. Altered or damaged DNA within the nucleus without adequate repair mechanisms can set the stage for cancer development.

Therefore, using Azo dyes in semi-permanent makeup comes with considerable risks. From their potential to degrade into carcinogenic substances to the possibility of allergic reactions and the legal implications of using banned substances, the implications are serious.

6. Laser Removal and Azo Dyes

Laser removal, similar to the effects of UV light, can induce the breakdown of molecules and potentially release carcinogenic substances. Here's a closer look at the process and its implications.

Generation of Carcinogenic Elements

Laser removal procedures employ concentrated beams of light energy aimed at breaking down pigments in the skin through a process known as photothermolysis. The laser specifically targets the pigment, fracturing it into smaller particles that the body can more readily absorb or eliminate.

The issue emerges when these pigments contain substances like Azo dyes. The laser energy, like UV light, can disrupt the chemical structure of these dyes. This disruption can inadvertently lead to the release of potentially carcinogenic or mutagenic substances, such as o-anisidine.

Formation of Carcinogenic Cells

As these smaller, hazardous particles are generated, they can infiltrate the body's cells, causing UV-induced degradation. Once inside a cell, they can interact with various cellular components, most critically with DNA within the nucleus. If these particles induce mutations in the DNA, this can disrupt the normal cell cycle and potentially initiate carcinogenesis, leading to abnormal cell growth and cancer development.

7. REACH and Azo Dyes

In the European Union, the use of chemicals, including those in semi-permanent pigments for powder brows, is primarily regulated by REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals). This comprehensive framework is designed to control the use of chemicals that pose risks to human health.

Scrutinized Aromatic Amine Compounds

REACH pays particular attention to azo dyes or colorants, which can degrade into harmful amines under conditions like hydrolysis. Specifically, REACH's Appendix 8 lists 24 types of aromatic amine compounds known to be carcinogenic or otherwise harmful to human health.

As a result, REACH maintains a list of these hazardous aromatic amine compounds. Pigments containing azo dyes that can break down into these prohibited amines face restrictions within the EU. It's crucial to understand that the ban applies only to explicitly listed amines.

Regulation (EC) No. 1223/2009

Regulation (EC) No. 1223/2009 is also pivotal in cosmetics, including brow pigments. This regulation sets forth additional safety standards, particularly targeting certain banned azo dyes like o-dianisidine and those based on Benzidine, known for their potential harm.

EU Ecolabel

The EU Ecolabel Scheme is a voluntary initiative that awards an eco-friendly seal, symbolized by a flower-like label, to various consumer products, including cosmetics and pigments. Products bearing this label meet specific ecological criteria and are deemed safer for consumer use. While the EU Ecolabel indicates ecological compliance, it doesn't automatically guarantee complete safety for all uses or individuals.

Lab Testing

To ensure adherence to these stringent regulations, third-party lab testing is indispensable. Such testing checks whether a product contains restricted azo dyes at prohibited concentrations. Notable testing agencies include Eurofins, QIMA, SGS, CIRS, and ATS. These labs can guide which azo dyes need testing for your particular product and inform you about any updates to the list of restricted azo dyes and their allowable limits.

8. Problems with REACH

The issue with REACH regulations concerning semi-permanent makeup (PMU) pigments stems from the fact that no colorants used in PMU were initially developed specifically for the makeup industry. They are general-use colorants meant for a wide array of applications, leading to a regulatory gap due to the absence of a specialized list of colorants and dyes approved for PMU.

Long List of Unregulated Organic Compounds

This absence of industry-specific standards allows manufacturers to use a variety of unregulated organic components in their pigments. The extensive and poorly monitored list of these components poses a substantial concern for safety and regulation.

Inconsistent Laboratory Testing

Another significant issue is inconsistent lab testing. While the paperwork might be accurate for a sample sent to a laboratory, there are instances where the final product doesn't match the initially approved sample. This discrepancy is particularly prevalent among Asian manufacturers eager to access the EU market but who may compromise on quality and safety to cut costs. These manufacturers might use labs susceptible to manipulation, underscoring the importance of vigilance and thorough vetting by consumers and professionals.

“Telepathic Testing” and the Risks of Cheap Pigments

The term "telepathic testing" refers to cases where laboratories, even those with ISO 17025 certification, provide test reports without physically receiving or analyzing samples. This practice, found in some post-Soviet countries, involves issuing compliance documents based purely on a paid fee rather than actual testing. Such practices significantly heighten consumer risk and underscore why artists should avoid using cheap pigments and why customers should be well-informed about the brands their artists use.

Issues with Online Stores and Fake Certifications

Many online stores sell pigments accompanied by dubious, fake certificates or paperwork signed by individuals lacking the proper credentials to analyze the substances. Unfortunately, this practice is sometimes standard in some Asian countries, further complicating the trust and safety in the PMU pigment market.

Therefore, the problems with REACH regarding PMU pigments are multifaceted, involving a lack of industry-specific regulations, inconsistent lab testing, dubious certification practices, and using unregulated organic components. These issues highlight the critical need for rigorous due diligence from artists in selecting their materials and customers in choosing their service providers. Ensuring the safety and quality of pigments is paramount in the PMU industry.

9. Regulations in the US

In the United States, the regulation of azo dyes varies by industry and application, with specific rules in place for certain contexts. For instance, the Food and Drug Administration (FDA) oversees using azo dyes in foods, drugs, and cosmetics. Some azo dyes are prohibited in food due to potential health risks.

Textile and Apparel Industry

While there is no overarching federal ban on azo dyes in textiles, individual states like California have enacted regulations limiting the use of certain chemicals, including some azo dyes known to degrade into carcinogenic amines.

Semi-Permanent Makeup Pigments

In the realm of semi-permanent makeup, azo dyes fall under the category of color additives and are thus regulated by the FDA. The FDA approves color additives for specific applications and mandates adherence to purity and safety standards. However, it's worth noting that the regulatory framework in the U.S. is often perceived as less stringent compared to the European Union, which employs more rigorous controls under frameworks like REACH.

Comparison with Europe

The U.S. approach to chemical regulation, including that of azo dyes, is generally seen as less precautionary than Europe's. The EU's REACH, for example, imposes stricter restrictions and safety protocols. As a result, while certain azo dyes may be restricted or banned in Europe, they might still be permissible under U.S. regulations.

Lack of Regulations in Developing Countries

In many developing regions and places with informal economies, comprehensive regulations on azo dyes are often absent. This lack of oversight is usually due to resource constraints, local policies, or insufficient knowledge about the potential dangers of these substances. Consequently, products manufactured or imported in these areas may contain unregulated or prohibited azo dyes, posing significant health risks.

10. Conclusions

All pigments in Permanent Makeup (PMU) employ pigments or dyes as colorants. Specifically, within the organic dyes category, Azo Dyes fall within the range of CI 11,000 to CI 36,999.

Azo dyes are an economical solution for creating vibrant and attractive colors. They are widely used in consumer products, including textiles, leather goods, accessories, and cosmetic products such as PMU pigments for Powder Brows.

Azo dyes in pigments are generally not harmful, though they can sometimes trigger allergies. However, when subjected to UV light or laser removal procedures, Azo dyes can undergo photodegradation, breaking down into aromatic amines like o-anisidine. These degraded particles can interact with DNA and cause mutations, termed "mutagenic." Over time, these mutations can lead to uncontrolled cell division, known as "carcinogenic" or cancer-causing behavior.

In many developing countries, the regulation of Azo dyes is virtually non-existent. In contrast, the United States sees some level of regulation by the FDA. In Europe, the use of pigments is more rigorously governed by the EU through the REACH regulation package. Despite this, not all pigments on the market are guaranteed to be safe. Since pigments are not exclusively manufactured for the beauty industry, a wide range of organic dyes may be utilized, including a lengthy list of unregulated components that some manufacturers employ innovatively. Furthermore, some producers sell pigments with counterfeit certificates online or obtain documentation through unethical practices.

Therefore, the most reliable way to ensure the safety and quality of pigments is to source them from reputable producers known for their commitment to safety and compliance with regulatory standards. This approach is crucial for protecting the practitioner and the client from potential health risks.