Have you ever wondered what’s inside your tattoo ink?
In recent years, there has been a notable increase in the number of people, especially young individuals, opting for tattoos and permanent or semi-permanent makeup. The inks used in these procedures contain a variety of components, from colorants to solvents, stabilizers, humectants, pH regulators, emollients, preservatives, and thickeners.
Since tattoos and permanent makeup involve direct intervention on the skin or mucous membranes, there is a high risk that the body will absorb the inks or their components. Although the colorants initially tend to stay on the surface, over time, soluble ingredients can disperse into the body, which could pose a health risk. Some inks contain hazardous substances or may release harmful compounds as they break down or interact with the skin’s metabolism, leading to growing concerns in recent years.
In this article, we explore how tattoo inks are regulated in both the European Union (EU) and the United States (US), two markets that address the concerns related to these products in very different ways.
Tattoo Ink Regulation in the European Union
In December 2020, the European Union took a decisive step in protecting citizens’ health by adopting Regulation (EC) 2020/2081, which harmonizes measures on hazardous chemicals in tattoo inks.
This Regulation amended Annex XVII of Regulation (EC) 1907/2006 (REACH), which sets restrictions on the manufacture, marketing, and use of certain substances.
Thus, as of January 4, 2022, over 90 specific compounds used in tattoo inks (including those used for permanent makeup and micro-blading) have been restricted.
Below is a list of representative examples with their corresponding limits:
- Several heavy metals, including:
- Mercury (CAS No. 7439-97-6); Organotin compounds (CAS No. 7440-31-5); Antimony (CAS No. 7440-36-0); Arsenic (CAS No. 7440-38-2); Cadmium (CAS No. 7440-43-9); Cobalt (CAS No. 7440-48-4): 0.00005%; Nickel (CAS No. 7440-02-0): 0.0005%; Lead (CAS No. 7439-92-1): 0.00007%
- Benzo[a]pyrene (CAS No. 50-32-8): 0.0000005%
- Polycyclic aromatic hydrocarbons (PAHs), classified in Part 3 of Annex VI of Regulation (EC) No. 1272/2008 as carcinogenic or germ cell mutagenic 1A, 1B, or 2: 0.00005% (individual concentrations)
- Arylamines:
- o-Anisidine (CAS No. 90-04-0); o-Toluidine (CAS No. 95-53-4); 3,3′-dichlorobenzidine (CAS No. 91-94-1); 4-methyl-m-phenylenediamine (CAS No. 95-80-7); 4-chloroaniline (CAS No. 106-47-8); 5-nitro-o-toluidine (CAS No. 99-55-8) and 24 other substances in this family: 0.0005%
- 44 individual pigments and/or colorants (e.g., Pigment Red 7/CI 12420 (CAS No. 6471-51-8); Pigment Yellow 87/CI 21107:1 (CAS No. 15110-84-6); Acid Violet 17 (CAS No. 4129-84-4); Disperse Red 17 (CAS No. 3179-89-3)): 0.1%
In addition to these substances, the restriction generally limits the presence of the following types of substances in tattoo inks:
- Substances prohibited in cosmetic products according to Annex II of Regulation (EC) 1223/2009
- Colorants listed in Annex IV of Regulation (EC) 1223/2009 with the following conditions of use:
- Not to be used in products applied on mucous membranes;
- Not to be used in eye products;
- Permitted only in rinse-off products;
- Other conditions, such as those relating to purity, etc.
- Substances classified in the EU under Regulation (EC) No. 1272/2008 for carcinogenicity, mutagenicity, or reproductive toxicity (cat. 1A, 1B, or 2), skin sensitization (cat. 1, 1A, or 1B), skin corrosion (cat. 1, 1A, 1B, or 1C), skin irritation (cat. 2), serious eye damage (cat. 1), or eye irritation (cat. 2). Except for those whose effects are solely due to inhalation exposure.
Additionally, the following labeling requirements were made mandatory:
- Include the phrase: “Mixtures for use in tattoos or permanent makeup.”
- Specify the batch number.
- List ingredients.
- Indicate all ingredients classified as hazardous to human health according to Part 3 of Annex VI of Regulation (EC) 1272/2008, without exceptions.
- Incorporate safety information on the packaging or in the instructions for use.
- Indicate the presence of nickel, chromium (VI), and pH-regulating substances.
Tattoo Ink Regulation in the United States
The Food and Drug Administration (FDA) is responsible for regulating these products in the United States. The FDA considers inks used in intradermal tattoos, including permanent makeup, to be cosmetics because they are articles intended to be introduced into or applied to the body to beautify, promote attractiveness, or alter appearance.
Therefore, they are subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its most recent amendment, The Modernization of Cosmetics Regulation Act of 2022 (MoCRA). If you want more information about this regulation, you can consult it in this article.
Pigments in tattoo inks are considered color additives and require pre-market approval. However, unlike regulations in the European Union, there is no specific list of restricted substances for tattoo inks in the United States; only certain local restrictions and the general FDA prohibitions for all cosmetic products apply, covering 10 substances or substance families.
In recent years, the FDA has focused its attention on microbial contamination of inks. In June 2023, it issued a draft guidance to help manufacturers and distributors identify and prevent this type of contamination: “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry.”
The main measures recommended to ensure inks are free of harmful microorganisms include:
- Testing inks and their components for microbial contamination.
- Ensuring that the manufacturing process does not introduce contaminants.
- Validating any sterilization method used.
- Ensuring that sterilization methods do not alter the product.
- Implementing Good Manufacturing Practices (GMP).
Comparison Between the European Union and the United States
While the European Union has opted for a preventive approach, banning dangerous substances such as cobalt, nickel, or certain azo dyes in advance, the United States has adopted a more flexible system where the responsibility largely falls on manufacturers and post-market controls. This difference in approach is reflected in the greater variety of inks available in the United States but also in a higher risk to consumer health. For example, certain blue and green pigments linked to allergic reactions are banned in the EU, while their use is still permitted in the US.
This regulatory diversity has significant implications for the tattoo industry. In Europe, tattoo artists and ink manufacturers must adhere to stricter standards, which may limit the range of colors available and increase production costs. However, this also ensures a higher level of safety for customers. In the United States, the industry has more freedom to innovate but must also take on greater responsibility for ensuring the quality and safety of its products.
It is important to note that regardless of regulation, the choice of tattoo artist is crucial. A qualified professional will use quality inks and follow rigorous hygienic practices, thereby minimizing health risks. When choosing a tattoo studio, make sure to inquire about the products they use and ensure that they comply with current health regulations.