Tattoo artists face gray palette in Europe

Together bare torso and thigh, the sun shines in the ocean waters and floods the corals and fish with aquatic light. Bright frogs tensed on their shins, as if preparing to jump from the dewy foliage. Naughty child with shimmery blue eyes looks from the inner biceps.

At his home studio in the northern Italian village of Grado, Alex De Paz viewed photos of some of the thousands of drawings he has drawn during his career as a tattoo artist. But these skinscapes may not be able to be reproduced in 2023 – at least with the same set of colors.

New regulations on tattoo inks and permanent makeup, which came into effect in the European Union in January this year, were designed to reduce the risk of including ingredients that could pose a health hazard. The rules also caused the industry’s biggest memory change, as ink makers reformulated entire product lines to comply.

Looming over artists’ heads is the possibility of even more destruction next year when bans on green and blue pigments, which ink makers say cannot be replaced, come into effect. This caused an uproar among tattoo artists, who argued that the restrictions were excessive, causing unnecessary anxiety among clients and undermining their art.

European rules may 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 cosmetics and ink department, gave a talk at a tattoo safety conference in Berlin and was asked if the country would bring its rules in line with European ones. answered: “That remains to be seen, and we’re working on that very area.”

mr. De Pace, known for the photorealism of his tattoos, especially the portraits he paints in his home studio, says he carefully mixes different shades to achieve subtle skin tones. “I am well known for my colored tattoos,” he said. “It’s a problem for me.”

Once a rebellious sign of sailors and bikers, tattoos have long since shed any trace of a minor art form. Polls show that about a quarter of Europeans aged 18 to 35 and almost one third american adult sports tattoos. Given all that inked flesh, documented complications are relatively rare and usually involve bacterial infections or allergic reactions. But regulators have not kept pace with the popularity of body art, with only a few European countries having national oversight of tattoo inks. Until this year, there were no mandatory standards in the European Union.

Modern tattoo inks are complex mixtures. These include insoluble pigments that impart hue or color, binders that keep the pigments liquid when transferred to the skin, and water, as well as other solvents such as glycerin and alcohol that affect the quality of the ink, as well as preservatives and other additives.

When injected, some the pigment stays permanently in the skinbut can also migrate to the lymph nodes. Under the influence of sunlight or during laser removal, pigments can also be broken down into new, potentially more toxic compounds and circulated throughout the body.

Over the years, traditional ink manufacturers have incorporated heavy metals such as barium and copper into their pigments to create an expanding palette of colors, and neurotoxic substances such as cadmium, lead and arsenic have been reported in high concentrations in some inks. These elements can also be found in so-called vegan inks, which simply exclude glycerins and other animal-derived ingredients.

Since 2015, Europe has required manufacturers to label ink with a list of hazardous ingredients it contains. But since raw pigments are produced commercially for use in all sorts of products, including clothing and automobiles, they are not always as pure as one would hope for when injected under the skin.

Ines Shriver, co-director center of dermatotoxicology at the Federal Institute for Risk Assessment in Germany, said basic questions about the effects of ink on the body remained unanswered. Among the unknowns are the amount of ink that enters the body, the relationship between this exposure and the adverse reactions that sometimes follow, and the disease that may appear years later.

“I wouldn’t use the words ‘safe’ or ‘unsafe’ to describe tattoos,” she said. “I tell my friends to be aware of possible side effects and uncertainties.”

After lengthy discussions at the European Chemicals Agency The European Commission decided to focus on substances known to be dangerous, by banning a long list of chemicals already banned for use in cosmetics, and by drastically limiting the concentration of certain corrosive or irritating compounds.

The ban covered two pigments, Blue 15:3 and Green 7, based in part on years of research that linked their use in hair dyes to an increased risk of bladder cancer. Given objections from ink manufacturers that there were no substitutes for these pigments, but lacking evidence of their safety, the commission delayed the ban until next year.

“Substances are introduced into the human body for constant and long-term contact – for life”, said Ana Maria Blass Rico, policy officer. “So that’s why he’s so protective.”

Dr. Jørgen Serup, a Danish dermatologist who has run a “tattoo clinic” at Copenhagen’s Bispebjerg Hospital since 2008, said the rules were already overdue. But in his opinion, they were poorly targeted, banning many substances that would never be used in tattoos and not addressing known problems such as bacterial contamination of ink during production. Among the thousands of patients he treated for complications, he found that the color red was most commonly associated with allergic reactions. “From a medical point of view, there is no reason to ban blue and green,” he said.

Regulators are in a difficult position, according to Lesliam Quiros-Alcala, an assistant professor at the Johns Hopkins Bloomberg School of Public Health and an expert on chemical exposures and their potential health effects. Over 40,000 chemicals are known to be used commercially and little is known about the dangers they pose. In addition, these hazards may differ for an individual depending on many factors, including the level of exposure to the substance, genetic predisposition, and pre-existing disease. “No scientist can tell you right now that this is the chemical you should be most concerned about,” she said.

But banning substances and leaving the industry in search of substitutes is not necessarily the solution either. “We often replace chemicals that we know can increase the risk of adverse health effects with deplorable alternatives,” Ms says. Quiros-Alcala said.

The United States has taken a more hands-off approach than Europe. The FDA has regulatory authority to approve pigments as safe, but no tattoo ink manufacturer has sought this designation, and no U.S. ink manufacturer has been required to disclose ingredients.

With less oversight of the broader category of cosmetics, the agency tends to be limited to pursuing counterfeit or mislabeled products and issuing safety warnings. Consumer advocates have called on Congress to update the 83-year-old Food, Drug and Cosmetics Act to give the agency more oversight, but to no avail. In response to questions, the agency provided a written statement that it was aware of the European regulations but had not assessed the risk of restricted pigments.

Tattoo artists, suddenly worried that their art form might be in danger, protested against the rules. In October 2020, some started a petition “save pigmentswhich spread through the global community of tattoo artists and their many social media followers. To date, over 178,000 people have signed the petition.

Among those who shared the petition was Mario Bart, CEO of Intenze Tattoo Ink, a Las Vegas-based ink manufacturer. He said the industry could have prevented regulation by developing its own standards, and blamed the lack of cooperation on ink makers who still tend to see themselves as counterculture loners. “So, people who had no idea about it just said, ‘OK, then let’s just ban the whole thing.'”

In the United States, where much of the tattoo ink used in Europe is made, manufacturers have been quick to reformulate their products to meet the new standards. One of the leading suppliers, World Famous Tattoo Ink, has opened a new facility in Greenville, South Carolina, 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. Louis. Marks Place in New York City in 1998, shortly after a city council meeting. raised a long-standing ban on tattooing so that underground artists can work openly again. At the time, the company manufactured its ink in a warehouse on Long Island. “I used to have people sit and fill bottles with a commercial iced tea container with a spout on the bottom,” he recalled.

In the past, World Famous has revamped its products, such as removing the formaldehyde-based preservative that was banned in Switzerland. But Mr. Rubino said the new rules require far-reaching changes, forcing the company to pay extra to labs to assess whether products meet acceptable chemical limits. Since World Famous did not test its products on animals, employees, their families and friends volunteered on their own skin to evaluate the effectiveness of the new ink.

While World Famous was looking to replace banned pigments, Mr. Rubino said they have not yet found a suitable replacement. “If that doesn’t work, there will be a lot less blue and green in the tattoos,” he said.

It cost the company millions of dollars to create the new ink to comply with the regulations, and he couldn’t say if the results were safer. “We’re not sure yet if they’re better or worse because we’re adding other things that haven’t been used in tattoos before.”

Nordic Tattoo Supplies, which distributes the ink across Europe, said the World Famous color products were the first set of color products to comply with the new regulations, which went on sale in early January – at a price more than double their previous inks. Nevertheless, demand far exceeded supply, and they had to ration the amount of goods sold per customer. Nordic spokeswoman Jenni Lehtovaara said the situation is improving as other manufacturers bring new compatible inks to market, but choice remains limited. “We don’t have palettes as accessible as in the past, not even close.”

mr. De Pace, who also owns a chain of nine tattoo parlors, said employees threw away their old color ink at the end of 2021 and spent the first three weeks of this year working only in black and gray. His studios now spend about 5,000 euros (about $5,200) a month on new color inks. mr. De Pace was pleased with their work, but said it would take years to see how they stood the test in the shoes of his clients.

“Safety has to come first,” he said, but it needs to be balanced with some tolerance for risk. He noticed that a tobacconist opposite one of his workshops sold cigarettes and cigars all day long. “There is a fine line.”