Along an empty torso and under a thigh, the sun shines through the ocean waters and bathes corals and fish in aquatic light. On the lower legs, the lively frogs are excited, as if preparing to jump out of the dew-soaked leaves. A naughty child flashes and looks from the biceps inside the blue eyes.
In his home studio in the northern Italian village of Grado, Alex de Pass reviewed some of the thousands of designs photographs he had signed on in his career as a tattoo artist. However, it may not be possible to replicate these skinscapes in 2023 – at least not with the same color set.
The new rules on tattoo ink and permanent makeup, which went into effect across the European Union this January, aimed to reduce the risk of including ingredients that could pose a health risk. The regulations also caused the industry’s biggest shock in memory, with ink makers restructuring entire product lines to comply.
The next year, artists are likely to face more disruptions, when the ban on green and blue pigments will take effect, which ink makers say is impossible to replace. This has caused a stir among tattooists who have argued that limitations are pervasive, stitching unnecessary anxiety among clients and weakening their industry.
European regulations may signal changes in the United States, where the Food and Drug Administration has some oversight over ink and pigments. Last November, when Dr. Linda Katz, director of the agency’s Office of Cosmetics and Dyes, gave a presentation at a conference on tattoo protection in Berlin and was asked if the country would align its regulations with Europe, she replied: “It still remains. See you, and we’re working on that area ourselves. “
Mr de Pass, who is known for his tattoo photorealism – especially his portrait – which he paints in his home studio, says he carefully mixes different shades to achieve the subtlety of skin tone. “I’m well known for my color tattoos,” he said. “For me, that’s a problem.”
Tattoo Trends and Toxicology
Once a rebellious symbol for sailors and bikers, tattoos have long since become a marginal art form. Surveys indicate that a quarter of Europeans aged 18 to 35 and about one-third of American adults play tattoos. In the case of all inked meats, the recorded complications are relatively uncommon and usually involve a bacterial infection or an allergic reaction. But regulators haven’t kept up with the popularity of body art: only a few European countries have national oversight of tattoo ink. Until this year, there were no binding standards across the European Union.
Modern tattoo inks are complex concoctions. These include insoluble pigments that provide shade or color, binding agents to keep pigments in the liquid are transferred to the skin and water, and other solvents such as glycerin and alcohol that affect ink properties, including preservatives and other additives.
After injection, some of the pigment remains permanently on the skin, but it can also be transferred to the lymph nodes. When exposed to sunlight or during laser removal, pigments can split into new, potentially more toxic compounds and circulate throughout the body.
Over the years, traditional ink makers have incorporated heavy metals such as barium and copper into their pigments to create a wide palette of colors, and neurotoxic agents such as cadmium, lead, and arsenic have been documented in some high-density inks. These ingredients can also be found in so-called vegan inks, which exclude only glycerin and other ingredients obtained from animals.
Since 2015, Europe has forced manufacturers to label inks that indicate hazardous ingredients in them. But since raw pigments are made on an industrial scale for use in all kinds of products, including clothing and automobiles, they do not always have the purity that is expected of a substance injected into one’s skin.
Ines Schreiber, co-director of the Federal Institute for Risk Assessment in Germany, which focuses on tattoo toxicity, says that the initial questions about body exposure to ink remain unanswered. Unknown include how much ink enters the body, the relationship between exposure and adverse reactions that follow occasionally, and any illness that may appear years later.
“I wouldn’t use the word ‘safe’ or ‘unsafe’ to describe tattooed,” he said. “I ask my friends to let me know about the possible side effects and uncertainties.”
After lengthy negotiations by the European Chemical Agency, the European Commission decided to focus on substances known to be hazardous, banning a long list of already banned chemicals for use in cosmetics, and severely limiting the concentration of certain corrosive or irritating compounds.
The bans included two pigments, Blue 15: 3 and Green 7, based on decades-old research that linked their use of hair dyes to a higher risk of bladder cancer. The ink manufacturers objected that there was no alternative to these pigments but that there was a lack of evidence to ensure their safety, and the commission delayed its ban until next year.
“The substances are injected into the human body for permanent and long-lasting contact – for life,” said Anna Maria Blas Rico, commission policy officer. “That’s why it’s so defensive.”
Dr. Jেনrgen Sarp, a Danish dermatologist who has been running a well-known “tattoo clinic” at the Bispberger’s Hospital in Copenhagen since 2008, said the regulations were overdue. But according to him, these were badly targeted, failing to address known problems such as bacterial contamination of the ink during production as well as banning many substances that would not be used in tattoos. Among the thousands of patients he treated for complications, he found that red was usually associated with an allergic reaction. “Clinically, there is no reason to ban blue and green,” he said.
According to Leslie Quiros-Alkal, an assistant professor at the Johns Hopkins Bloomberg School of Public Health and an expert on chemical exposure and their potential health effects, regulators are in a difficult position. More than 40,000 chemicals are known for commercial use, and little is known about the dangers they pose. Furthermore, these hazards can vary for a person based on many factors, including exposure to the substance, genetic predisposition, and pre-existing disease. “No scientist can tell you right now that this chemical is what you need to worry about the most,” he said.
But banning substances and leaving the industry to find alternatives is not the answer. “It’s not uncommon for us to replace chemicals that we know can increase the risk of adverse health effects with traumatic alternatives,” said Mrs Quiros-Alkala.
The United States has more hands-on approaches than Europe. The FDA has the regulatory authority to approve pigments as safe, but no tattoo ink manufacturer wants that title, and no U.S. ink manufacturer is required to disclose the ingredients.
With less surveillance over a larger section of cosmetics, the agency is usually limited to following adulterated or incorrectly labeled products and issuing safety warnings. Consumer advocates have called on Congress to update the 83-year-old Food, Drugs and Cosmetics Act to give the agency more oversight, with little benefit. In response to the question, the agency issued a written statement indicating that it was aware of European regulations but did not assess the risk of limited pigments.
Adjust or fight back
Tattooists, suddenly worried that their art form might be endangered, protested the regulations. In October 2020, some launched a petition for “Save the Pigments”, which spread through the tattoo artists’ global community and their widespread social media following. To date, the petition has received more than 178,000 signatures.
Among the petition shareholders was Mario Berth, chief executive of Intense Tattoo Inc., a Las Vegas-based ink manufacturer. He said the industry could deviate from regulations by developing its own standards, and he blamed the lack of cooperation from ink manufacturers who still tend to see themselves as counterculture alone. “So, those who had no idea, they just said, ‘OK, then, let’s ban it all.’
In the United States, where many tattoo inks used in Europe are produced, manufacturers rush to refine their products to meet new standards. One of the leading suppliers, the world famous Tattoo Ink has a new facility at Greenville, SC, where 400,000 bottles are filled and packaged in a sterile clean room every month.
The owner, Lou Rubino, opened his first tattoo shop in St. Mark’s Place, New York, in 1998, shortly after the city council lifted a long-standing ban on tattooing so that underground artists could work in public again. At the time, the company made its ink in a warehouse on Long Island. “I had people sitting at the bottom with bottles and a bottle of commercial iced tea,” he recalls.
World Famous had previously updated its products, for example removing the formaldehyde-based preservative that was banned in Switzerland. But Mr Rubino said the new regulations required far-reaching changes, forcing the company to pay extra to laboratories to see if the products met the approved limits for chemicals. Because World Famous has not tested its products on animals, employees and their families and friends have volunteered their skin to measure the effectiveness of the new ink.
Although World Famous is exploring the replacement of banned pigments, Mr Rubino says they have not yet found a suitable alternative. “If that doesn’t work, the tattoos will be much less blue and green,” he said.
The company has spent millions of dollars building new inks to comply with the regulations, he estimates – and he could not say whether the results are safe. “We’re still not sure if these are better or worse because we’re adding other things that haven’t been used to make tattoos before.”
Nordic Tattoo Supplies, which distributes ink across Europe, says the world-famous color products are the first set to sell under the new rules in early January – more than double the price of their previous ink. Still, demand was much higher than supply, and they had to ration the amount of sales per customer. Jenny Lehtovara, a spokeswoman for Nordic, said the situation was improving because other manufacturers had brought new compliant inks to market, but the selection was limited. “We don’t have the same palette as in the past, not even close.”
Mr de Pass, who also owns a chain of nine tattoo parlors, said workers discarded their old ink by the end of 2021 and only worked in black and gray for the first three weeks of this year. Now, his studios are spending about 5,000 euros, about $ 5,200 a month, to stock up on new colored ink. Mr de Pass was pleased with their performance, but said it would take a few years to see how they tolerated the skin of his clients.
“Safety must come first,” he said, but it needs to be balanced against some tolerance for risk. He noticed that a tobacco shop in front of his studio was selling cigarettes and cigars all day. “There’s a fine line.”