Happy Nice Mall

Along a bare torso and a thigh downThe sun shines in the ocean waters and bathes the corals and fish in the watery light. On its lower leg, live frogs are taut, as if preparing to jump off damp leaves. a naughty boy sparkling blue eyes looks out from an inner biceps.

At his home studio in the village of Grado, in northern Italy, Alex De Pase viewed photos of thousands of designs he made during his career as a tattoo artist. But these skins may not be replicated in 2023 – at least with the same color set.

New regulations regarding tattoo inks and permanent makeup, which came into effect in the European Union this January, were aimed at reducing the risk of containing substances that could be harmful to health. The regulations also caused the industry’s biggest memory jolt as ink manufacturers reorganized entire product lines to accommodate.

Next year, when bans come into effect on green and blue pigments, which ink manufacturers say may be impossible to replace, the possibility hangs over the heads of artists even more. This caused a commotion among tattooists, who claimed the restrictions were overly broad, causing unnecessary concern among clients and undermining their art.

Europe’s regulations may herald changes in the United States. The Food and Drug Administration has some oversight over inks and pigments.. Last November, director of the agency’s Office of Cosmetics and Colors, Dr. When Linda Katz gave a presentation at a conference on tattoo safety in Berlin and was asked whether the country would align its regulations with those of Europe, she replied: “There is something to see and we are working on this area itself.”

Known for the photorealism of his tattoos—especially his portraits—which he paints in his home studio, Mr. De Pase says he carefully mixes different hues to achieve subtleties of skin tone. “I am known for my colorful tattoos,” he said. “For me that’s a problem.”

Tattoo Trends and Toxicology

Tattoos, once the rebel sign of sailors and bikers, were long ago an extreme art form. Surveys show that nearly a quarter of Europeans aged 18 to 35 and nearly one third adult sports tattoos Given all that inked meat, documented complications are relatively rare and typically include bacterial infections or allergic reactions. But regulators haven’t kept up with the popularity of body art: Only a few European countries enforce national oversight of tattoo inks. Until this year, there were no binding standards across the European Union.

Modern tattoo inks are complex mixtures. These include insoluble pigments that provide shade or color, binders to suspend pigments in the liquid as they are transferred to the skin and water, and other solvents such as glycerine and alcohol, which affect the quality of the ink, as well as preservatives and other additives.

Upon injection, some pigments remain in the skin permanently, but may also migrate to the lymph nodes. When exposed to sunlight or during laser removal, pigments can further break down 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 an expanding color palette, and neurotoxic agents such as cadmium, lead and arsenic have been documented at high concentrations in some inks. These elements can also be found in vegan inks that only exclude glycerine and other ingredients of animal origin.

Since 2015, Europe requires manufacturers to label the ink stating the hazardous substances they contain. However, because raw pigments are produced on an industrial scale for use in all manner of products, including clothing and automobiles, they are not always of the purity that can be hoped for in a substance injected into a person’s skin.

Ines Schreiver, co-director of the German Federal Institute for Risk Assessment, focused on the toxicology of tattoosFundamental questions about body exposure to inks remain unanswered, he said. Among the unknowns are how much ink enters the body, the relationship between that exposure and occasional adverse reactions, and any illness that may occur years later.

“I wouldn’t use the word ‘safe’ or ‘unsafe’ to describe a tattoo,” she said. “I tell my friends to inform themselves about possible side effects and uncertainties.”

After long negotiations by the European Chemicals Agency, The European Commission has chosen to focus on substances It bans a long list of chemicals known to be dangerous, already banned for use in cosmetics, and sharply limits the concentrations of certain corrosive or irritating compounds.

The ban included two pigments, Blue 15:3 and Green 7, based in part on decades of research linking their use in hair dyes to an increased risk of bladder cancer. Acknowledging ink manufacturers’ objections that these pigments are not substitutes but lacking evidence to confirm their safety, the commission delayed its ban until next year.

“Substances are injected into the human body for permanent and prolonged contact – for life” aforementioned Ana María Blass Rico, a commission policy officer. “So that’s why it’s so protective.”

Having run a renowned “tattoo clinic” at Copenhagen’s Bispebjerg Hospital since 2008, Danish dermatologist Dr. Jørgen Serup said the regulations were delayed. But in his view, these were poorly targeted and while banning many substances that would never be used in tattoos, they failed to address known issues such as bacterial contamination of inks during manufacture. He found that among the thousands of patients he treated for complications, red was more commonly associated with allergic reactions. “There’s really no reason to ban blue and green from a clinical standpoint,” he said.

Regulators are in a tough spot, according to Lesliam Quirós-Alcalá, an assistant professor at the Johns Hopkins Bloomberg School of Public Health and an expert on chemical exposures and potential health effects. There are more than 40,000 chemicals known to be in commercial use, and little is known about the hazards they pose. In addition, these hazards may differ depending on many factors such as the level of exposure to the substance for a person, genetic predisposition and pre-existing disease. “At the moment, no scientist can tell you that this is the chemical you should be most worried about,” he said.

But banning substances and leaving the industry to find substitutes isn’t necessarily a solution either. “It’s not unusual for us to replace chemicals that we know can increase the risk of adverse health effects with sad alternatives,” said Ms. Quirós-Alcalá.

The United States has taken a more interventionist 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 manufacturers have been required to disclose ingredients.

With less oversight over the broader category of cosmetics, the agency is often limited to tracking mixed or mislabeled products and issuing safety alerts. Consumer advocates have urged Congress to update the 83-year-old Food, Drug, and Cosmetic Act to give the agency little benefit in providing greater oversight. In response to inquiries, the agency issued a written statement stating that it is aware of European regulations but has not assessed the risk of restricted pigments.

Adapt or Fight Against

Suddenly worried that their art form might be in danger, tattooists protested the regulations. In October 2020 some “Save Pigments”, spread through the global tattoo artists community and large social media followings. To date, the petition has gathered more than 178,000 signatories.

Among those who shared the petition was Mario Barth, CEO of Las Vegas-based ink manufacturer Intenze Tattoo Ink. He said the industry could avoid regulation by developing its own standards, and blamed the lack of cooperation on ink manufacturers, who still tend to see themselves as isolated against the counterculture. “I mean, people who had no idea just said, ‘OK, let’s ban them all then.

In the United States, where many of the tattoo inks used in Europe are produced, manufacturers rushed to reformulate their products to meet the new standards. World Famous Tattoo Ink, one of the leading suppliers, has a new facility in Greenville, SC where 400,000 bottles are filled and packed each month in a sterile clean room.

Owner Lou Rubino opened his first tattoo supply store in St. Petersburg in 1998, shortly after City Hall. Opened in Marks Place. lifted Long ban on tattooing so underground artists can work openly again. At that time, the company made its inks in a warehouse on Long Island. “There used to be people sitting there filling bottles with a commercial iced tea pot with a spout at the bottom,” he recalled.

World Famous had previously updated its products, for example, to remove a formaldehyde-based preservative that was banned in Switzerland. But Mr. Rubino said the new regulations require far-reaching changes, forcing the company to pay labs extra to assess whether products meet allowable limits for chemicals. Because their world-famous products don’t test on animals, employees and their families and friends voluntarily used their skins to measure the performance of the new inks.

While World Famous is researching replacements for banned pigments, Mr Rubino said they have yet to find a suitable substitute. “If that doesn’t work, there will be a lot less blue and green in tattoos,” he said.

He estimated it cost the company millions of dollars to create new inks to comply with regulations—and he couldn’t say whether the results were any safer. “We are not yet sure if these are better or worse because we are adding other things that have not been used in tattooing before.”

Nordic Tattoo Supplies, which distributes inks across Europe, said World Famous’s color products are the first set to comply with the new regulations, going on sale in early January for more than double the price of their previous inks. However, demand far exceeded supply and they had to ration the quantity sold per customer. Nordic spokesperson Jenni Lehtovaara said the situation has improved as other manufacturers bring new compatible inks to the market, but the choice remains limited. “We don’t have the pallets of the past, we’re not even close.”

Mr. De Pase, who also owns nine tattoo parlor chains, said staff ditched their old colored ink at the end of 2021 and spent the first three weeks of this year working only in black and gray colors. Now, studios spend about 5,000 euros, about $5,200 per month to stock up on new color inks. Mr. De Pase was pleased with their performance, but said it would take years to see how they held up to his clients’ skin.

“Safety should come first,” he said, but that needs to be balanced with some tolerance for risk. He observed that a tobacco shop overlooking one of his studios was selling cigarettes and cigars all day long. “There is a fine line.”