Along a bare torso and down a thigh, the sun glints through the ocean waters and bathes in the coral and aqueous light in the fish. On a lower leg, vivid frogs tense, as if preparing to jump from dewy leaves. A mischievous child with twinkling blue eyes stares out from an inner bicep.
In his home studio in the northern Italian village of Grado, Alex De Pase reviewed some of the thousands of designs he had inked over his career as a tattoo artist. But these skinscapes may not be possible to replicate in 2023 – at least not with the same set of colors.
New regulations on tattoo inks and permanent makeup that began taking effect across the European Union this January were meant to reduce the risk of including ingredients that could be health hazards. The regulations also have the biggest shakeup of memory in the industry, with ink manufacturers adapting to entire product lines.
The possibility of even more disruption hangs over artists’ heads next year, when bans go into effect on green and blue pigments that manufacturers say may be impossible to replace. This has provoked an uproar among tattooists who have argued the restrictions are overbroad, unnecessary concern among clients and undermine their art.
Europe’s regulations could portend changes in the United States, where the Food and Drug Administration has some oversight of inks and pigments. Last November, when Dr. Linda Katz, director of the agency’s Office of Cosmetics and Colors, gave a presentation at a conference on tattoo safety in Berlin and asked if the country would align its regulations with Europe’s, she responded: “That is going to be seen, and we ‘ re working on that area itself. “
Mr. De Pase, who is known for his photorealism of his tattoos – especially his portraits – which he inks in his home studio, says he carefully mixes different shades to achieve the subtleties of skin tone. “I’m well-known because of my color tattoos,” he said. “For me, this is an issue.”
Tattoo Trends and Toxicology
Once the rebellious mark of sailors and bikers, tattoos long ago left any vestige of being a fringe art form. Surveys travel about a quarter of Europeans aged 18 to 35 and nearly one-third of American adults sport tattoos. Given all that inked flesh, documented complications are relatively uncommon and typically involve bacterial infections or allergic reactions. But regulators have not kept up with the popularity of body art: only a few European countries exert national oversight of tattoo inks. Until this year, there were no binding standards across the European Union.
Modern tattoo inks are complex concoctions. They include insoluble pigments that provide shade or color, binding agents to keep the pigments suspended in the liquid as they are transferred to the skin and water and other solvents such as glycerin and alcohol that influence the ink’s qualities, as well as preservatives and other additives.
Upon injection, some pigment is permanently in the skin, but it can also migrate to the lymph nodes. When exposed to sunlight or during laser removal, pigments may also cleave into new, potentially more toxic compounds and circulate throughout the body.
Over the years, traditional ink manufacturers have incorporated heavy metals such as barium and copper into their pigments to create a widening palette of colors, and neurotoxic agents like cadmium, lead and arsenic have been documented in some inks at high concentrations. These ingredients may also be found in so-called vegan inks, which simply exclude animal-derived glycerins and other ingredients.
Since 2015, Europe has required makers to label hazardous ingredients. But because raw pigments are manufactured at industrial scale for use in all manner of products, including clothing and automobiles, they are not always a purity one might hope for in a substance injected into one’s skin.
Ines Schreiver, co-director of the Federal Institute for Risk Assessment in Germany that focuses on toxicology, said that basic questions about the body’s exposure to inks remain unanswered. Among the unknowns are how much ink enters the body, the relationship between the exposure and the adverse reactions that follow frequently and any illness that may emerge years later.
“I wouldn’t use the word ‘safe’ or ‘unsafe’ to describe tattooing,” she said. “I tell my friends about possible side effects and the uncertainties about themselves.”
After lengthy deliberations by the European Chemicals Agency, the European Commission opted to focus on substances known to be hazardous, banning a long list of chemicals already prohibited for use in cosmetics and sharply limiting concentrations of certain corrosive or irritating compounds.
The ban includes two pigments, Blue 15: 3 and Green 7, based in decades-old research that linked their use in hair dyes with elevated risk of bladder cancer. Acknowledging ink manufacturers’ objections that there were no substitutes for those pigments but lacking evidence affirming their safety, the commission was delayed until its prohibition next year.
“The substances are injected into the human body for permanent and prolonged contact – for life,” said Ana María Blass Rico, a commission policy officer. “So that’s why it’s so protective.”
Dr. Jørgen Serup, a Danish dermatologist who since 2008 has run a renowned “tattoo clinic” at Copenhagen’s Bispebjerg Hospital, said regulations were overdue. But in his opinion, these were poorly targeted, proscribing many substances that would never be used in tattoos while failing to address known problems like bacterial contamination during inks during production. Among the thousands of patients he treated for complications, he found that red was more commonly associated with allergic reactions. “There is, from the clinical side, no reason really to ban blue and green,” he said.
Regulators are in a difficult position, according to Lesliam Quirós-Alcalá, an assistant professor at Johns Hopkins Bloomberg School of Public Health and an expert on chemical exposures and their potential health effects. There are over 40,000 chemicals known to be in commercial use, and little is known about the hazards they pose. Furthermore, those hazards may differ for a person based on many factors including their level of exposure to the substance, genetic predisposition and pre-existing disease. “No scientist could tell you right now that this is the chemical you are most worried about,” she said.
But banning substances and leaving industry to find substitutes is not necessarily a solution, either. “It’s not uncommon for us to replace chemicals that we know could increase the risk of adverse health effects with regrettable alternatives,” Ms. Quirós-Alcalá said.
The United States has taken a more hands-off approach than Europe has. The FDA has the regulatory authority to approve pigments as safe, but no tattoo ink manufacturer has sought that designation, and no US ink manufacturer has been required to disclose either.
With less oversight over the broader category of cosmetics, the agency is generally limited to pursuing adulterated or mislabeled products and issuing safety alerts. Consumer advocates have called on Congress to update the 83-year-old Food, Drug and Cosmetics Act to grant the agency greater oversight, to little avail. In response to questions, the agency provided a written statement indicating it was aware of European regulations but had not assessed the risk of restricted pigments.
Adapt or Fight Back
Tattooists, suddenly concerned that their art form might be in peril, protested the regulations. In October 2020, some launched a petition to “Save the Pigments,” which spread through the global community of tattoo artists and their widespread social media followings. To date, the petition has garnered more than 178,000 signatories.
Among those sharing the petition was Mario Barth, chief executive of Intenze Tattoo Ink, a Las Vegas-based ink manufacturer. He said the industry could have headed off by developing its own standards, and he had blamed a lack of cooperation in the manufacturers still prone to seeing themselves as counterculture loners. “So, the people who had no clue about it just said, ‘OK, then, let’s just ban it all.'”
In the United States, where many tattoo inks are used in Europe, manufacturers are rushed to reformulate their products to meet new standards. One of the leading suppliers, World Famous Tattoo Ink, has a new facility in Greenville, SC, where every month a sterile clean room, 400,000 bottles are filled and packaged.
The owner, Lou Rubino, opened his first tattoo supply shop in St. Louis. Marks Place in New York In 1998, shortly after the City Council lifted a longstanding ban on tattooing so that underground artists could work openly again. At the time, the company made its inks in a warehouse on Long Island. “I used to have people that would sit there filling the bottles with a commercial iced tea container with a spout on the bottom,” he recalled.
World Famous had updated its products, for example to remove a formaldehyde-based preservative that had been banned in Switzerland. But Mr. Rubino said the new regulations have required far-reaching changes, forcing company to pay laboratories additional assessments on products that allowable limits for chemicals. Because World Famous didn’t test its products on animals, employees and their families and friends volunteered to gauge their skin’s performance in the new inks.
Although World Famous has been exploring the banned pigments, Mr. Rubino said they had not yet found any suitable substitutes. “If that doesn’t work out, there’s going to be a lot less blue and green in tattoos,” he said.
Creating new inks to comply with the regulations cost the company millions of dollars, he estimated – and he couldn’t say whether the results were safer. “We’re not sure yet if these are better or worse because we’re adding other things that haven’t been used in tattooing before.”
Nordic Tattoo Supplies, which distributes inks across Europe, said World Famous’s color products were in compliance with the first set of new regulations that went on sale in early January – more than double the price of their previous inks. Nevertheless, demand far exceeded supply, and they had to ration the quantity sold per customer. Jenni Lehtovaara, a spokeswoman for Nordic, said the situation was improving as other manufacturers brought new compliant inks to the market, but the selection remained limited. “We don’t have the same palettes available in the past, not even close.”
Mr. De Pase, who also owns a chain of nine tattoo parlors, said the staff threw out their old color inks at the end of 2021 and spent the first three weeks working only in black and gray. Now, his studios are spending about 5,000 euros a month, about $ 5,200, to stock new colored inks. Mr. De Pase did not exactly match their performance, but he said it would take years to see how they endured in the skin of their customers.
“Safety must come first,” he said, but that needs to be balanced against some tolerance for risk. He observed one of his studios selling a cigarettes and cigars all day long. “There is a fine line.”