Why Isn’T Tattoo Ink Fda Approved?
The FDA issued a Safety Advisory on May 15, 2019 warning consumers, tattoo artists, and retailers about using or selling certain tattoo inks contaminated with microorganisms. For details on all tattoo ink recalls, please see our Recalls & Alerts Page. As with any cosmetic product, if you experience an adverse event that you think may be related to the use of tattoo inks, you should report the event to the FDA.
- 1 Is tattoo ink regulated in us?
- 2 Is tattoo ink cancerous?
- 3 Is tattoo ink FDA certified?
- 4 Does tattoo ink get in your bloodstream?
- 5 Is tattoo ink FDA approved?
- 6 Do tattoos contain heavy metals?
Why are they banning tattoo pigments?
What’s Dangerous About Tattoo Ink? – Not all tattoo ink is dangerous or contains harmful ingredients. However, with public health and safety in mind, EU organization REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) has taken the decision to ban the use of thousands of ingredients in inks.
These inks are usually used for brightly-colored tattoos and permanent makeup, with the focus on the removal of the Blue 15:3 and Green 7 pigments. They aim to reduce harm to the general public from chemicals and chemical compounds.
They’re banning any pigments that may cause cancer, genetic mutations, and reproductive difficulties. Due to Brexit, the UK is not following suit. However, they are reviewing inks used within the market. They’re also asking artists and manufacturers to disclose any used ingredients.
Is tattoo ink regulated in us?
The production of tattoo ink and pigments in the US is unregulated. There are no guidelines or standards issued by national agencies. However, the practice of tattooing is regulated at the state and local levels but varies widely. Adverse events are addressed when a problem is reported.
- © 2015 S;
- Karger AG, Basel One out of five adults (21%) in the US today has a tattoo;
- This amounts to over 50 million people, and the number is increasing;
- The fact that the art of tattooing is associated with health risks is undeniable and openly acknowledged by the US Food and Drug Administration (FDA) [ 1 ];
Therefore, due to the large number of people at risk for adverse reactions from tattooing procedures and the deposition of pigment into the body, meaningful regulation of tattoo ink production and the tattoo industry in the US is crucial. The structure of the legal system in the US differs from that in Europe.
- The country’s Constitution grants specific powers to the national or ‘federal’ government;
- The 10th Amendment to the US Constitution states that ‘powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States, respectively, or to the people’;
Therefore, the individual states have the power to regulate everything else. As laws governing the tattoo artistry are not outlined in the US Constitution, rules relating to this field are controlled independently by each of the 50 states. The result is that different rules apply in different states, with the extent of regulation varying widely.
Is tattoo ink cancerous?
Cancer – Do tattoos cause skin cancer? This has been a question that researchers have been exploring for years. While there is no direct connection between tattoos and skin cancer, there are some ingredients in tattoo ink that may be linked to cancer.
When it comes to cancer, black ink can be especially dangerous because it contains a very high level of benzo(a)pyrene. Benzo(a)pyrene is currently listed as a carcinogen by the International Agency for Research on Cancer (IARC).
Health officials and researchers are especially concerned about the effects of black tattoo ink, as it is the most commonly used color for tattooing. “Blackout” tattoos have also raised significant concern among health officials and researchers. This hot new trend may be especially dangerous since it requires individuals to have large portions of their bodies covered in thick, heavy solid black ink.
In addition to the fear of carcinogens contained in the ink, individuals are also concerned about the way these tattoos cover the body. A change in skin pigmentation is one of the earliest signs of skin cancer, particularly melanoma.
When the body is “blacked out” with tattoo ink, individuals may not be able to notice these changes right away. For this reason, tattoos should never be placed over pre-existing moles, birth marks, or other skin discolorations or abnormalities. Another cause for concern is what happens to a tattoo after you’ve had it for a while.
What are the dangers of tattoo ink?
Know the risks – Tattoos breach the skin, which means that skin infections and other complications are possible, including:
- Allergic reactions. Tattoo dyes — especially red, green, yellow and blue dyes — can cause allergic skin reactions, such as an itchy rash at the tattoo site. This can occur even years after you get the tattoo.
- Skin infections. A skin infection is possible after tattooing.
- Other skin problems. Sometimes an area of inflammation called a granuloma can form around tattoo ink. Tattooing also can lead to keloids — raised areas caused by an overgrowth of scar tissue.
- Bloodborne diseases. If the equipment used to create your tattoo is contaminated with infected blood, you can contract various bloodborne diseases — including methicillin-resistant Staphylococcus aureus (MRSA), hepatitis B and hepatitis C.
- MRI complications. Rarely, tattoos or permanent makeup might cause swelling or burning in the affected areas during magnetic resonance imaging (MRI) exams. In some cases, tattoo pigments can interfere with the quality of the image.
Medication or other treatment might be needed if you experience an allergic reaction to the tattoo ink or you develop an infection or other skin problem near a tattoo.
Why are red tattoos banned?
A new ban on colored ink for tattoos has come into force across the European Union on Tuesday, officials confirmed, despite opposition from tattoo artists across the bloc. The move follows a health assessment from EU experts that found that the chemicals used in most pigments for tattoo ink contain dangerous substances – such as azo dyes, aromatic amines, polycyclic aromatic hydrocarbons, metals and methanol – that can cause cancers, skin allergies and other health issues.
READ MORE: UK hit by bird flu outbreak What you need to know about Lateral Flow Tests Top stories in China during 2021 “The restriction covers carcinogenic, mutagenic and reprotoxic substances, chemicals prohibited in cosmetics, skin sensitisers, skin and eye irritants, metal impurities, aromatic amines and some pigments,” the European Commission said.
“The protection of public health of European citizens is our primary concern, and hazardous chemicals in tattoo ink can represent such a concern,” Commission spokesperson Sonya Gospodinova told journalists as the ban became effective. All 27 EU member states agreed on the new regulation in mid-2020, but the ban has yet to be applied across the entire bloc. Tattoo artist Bruno Menei, owner of the tattoo studio “InkSecte”, shows flasks of ink at his shop, as new EU restrictions on coloured tattoo come into force, in Rixensart, Belgium. /Reuters/Yves Herman Tattoo artist Bruno Menei, owner of the tattoo studio “InkSecte”, shows flasks of ink at his shop, as new EU restrictions on coloured tattoo come into force, in Rixensart, Belgium. /Reuters/Yves Herman What’s the harm? The centuries-old art of tattoos has been really booming in the past few decades, with the number of people getting tattooed rising significantly, especially among younger generations.
- At the moment, the regulation is only effective in Belgium, France, Germany, the Netherlands, Spain, Slovenia and Sweden;
- According to the European Commission, tattooing is a phenomenon that now involves more than 60 million Europeans, with statistics showing that 12 percent of EU citizens are tattooed, a number that could double among young adults;
The way tattoos traditionally work is through an injection of ink through the dermis – the second and thickest of our three layers of skin. Tattoos are supposed to last forever, a characteristic that intrinsically puts the skin into close contact with chemicals for an awfully long time.
- The European Commission argues there aren’t yet enough large-scale data to fully judge the long-term impact of these chemicals on our health, but several reports have found a link between tattoos and the development of skin infections, skin disorders and cancers;
These same chemicals contained in tattoo inks are the same “hazardous” substances banned in cosmetic products and, according to the Commission, there’s no reason why these should exceptionally be allowed in tattoo inks. How has the industry taken the ban? Tattoo artists have expressed their concern that the new ban will significantly hurt their industry, despite the European Chemicals Agency saying that retailers and consumers would be unlikely to see price rises as a result of the ban.
The main issue raised by tattoo artists is that replacements for pigmented inks aren’t easily available and even when they can be found they might not provide the same vibrant colors the now-banned inks offer.
“It’s ridiculous. It’s like taking the flour from a bakery, it’s a stupid as that. If we don’t have any colors or ink to work with, what are we going to work with?” star tattoo artist Tin-Tin, who heads the French tattoo industry union SNAT, told Reuters. A man, wearing a protective face mask to prevent the spread of the coronavirus, is tattooed at Paul and Friends tattoo parlour in downtown Brussels, Belgium. /AP/Francisco Seco, File A man, wearing a protective face mask to prevent the spread of the coronavirus, is tattooed at Paul and Friends tattoo parlour in downtown Brussels, Belgium. /AP/Francisco Seco, File But tattoo artists also complain about the restriction to their artistic freedom and the lack of conclusive research that informed the ban, saying there’s not enough proof showing these chemicals are inherently bad for people’s health.
In order for tattoo artists to find alternative replacements, the EU has given a grace period of one year to two colors, blue and green. Amsterdam-based tattoo artist Tycho Veldhoen told AP the ban on colored inks was a terrible loss for their work, saying that “like a painter, you suddenly lose a gigantic part of your palette.
” The ban also comes at a time when the tattoo industry is still recovering from a tough time of losses and closures during the pandemic. “It has been announced [ahead of time] but we had nothing to prepare,” Angelo Bedani, owner of the Boucherie Moderne tattoo parlor in Brussels, told AP.
- “The new inks have just been available from last week, so it may be all right but we don’t know how to deal with it now, so I don’t know;
- ] It is going to be complicated for us as we can no longer use the ink that we have, allegedly, so we will have to buy everything new, and a bottle costs double the ones we have today,” he added;
Tattoo parlors also fear the new ban will drive people to seek illegal tattooing. There’s also currently a legal way out of the bloc’s ban, just across the Channel: the new EU ban doesn’t apply to the UK, a fact that would technically allow European tattoo artists to still work with colored inks as guest artists in Britain. China’s Linpeng Zhang, left, shows his tattoos as he gestures during the World Cup 2022 group B qualifying soccer match between China and Vietnam at Sharjah stadium in Sharjah, United Arab Emirates in October 2021. /AP Photo/Kamran Jebreili/ China’s Linpeng Zhang, left, shows his tattoos as he gestures during the World Cup 2022 group B qualifying soccer match between China and Vietnam at Sharjah stadium in Sharjah, United Arab Emirates in October 2021. /AP Photo/Kamran Jebreili/ Forbidden tattoos Tattoos have been around since the Stone Age, research has found, but their history has not always been one of popularity and mainstream success.
But the British government has announced it will also soon launch an inquiry into the health risks associated with the chemicals in some inks. In different historic times, tattoos have been the trademark of criminals, pirates and gangs; during colonialism, traditional body art was stigmatized as “uncivilized.
” The weight of these associations is hard to shake off and it still influences how tattoos are perceived today in certain cultures, or within certain age cohorts. A new regulation launched in China in late December 2021 forbids Chinese soccer players from having tattoos and recommends removing the ones they might already have.
Specifically, the country’s General Administration of Sport “strictly prohibited” recruiting new players with tattoos at the national level and the youth leagues, in order to set “a good example. ” In Chinese culture, tattoos are traditionally associated with crime and body art is still a mark of organized crime groups in East Asia.
Cover image: REUTERS/Yves Herman Source(s): AFP ,AP ,Reuters.
Which tattoo ink is safest?
There are a bunch of new colours and tattoo techniques on offer — neons, brighter shades, memorial tats where you mix in a bit of a loved one’s ashes (don’t judge; everyone grieves differently). But how far is too far? Take a look What are the safest colours? * Neon skin inks are loaded chemicals and mercury.
The reds are perhaps the worst, because they also contain the highly toxic iron oxide and cadmium. * If you really want to get a permanent tattoo, stick with the basics. Black remains safest. Blue and green inks with copper phthalocyanine pigments are safe too.
Some parlous mix their own inks; it’s generally safest to use branded inks that list their ingredients, says Dr Amit Karkhanis, laser and cosmetic physician. Are there any natural alternatives? * Some tattoo studios have yellows and blues that are turmeric- and indigo-based. Stick with the basics. Black remains safest. Blue and green inks with copper phthalocyanine pigments are safe too. (Shutterstock) Be cautious and plan well * Skin tone is important when planning a tattoo. Because melanin acts as a filter, bright colours such as reds, sky blues and yellows won’t look as you expect them to, says Ritopriyo Saha, founder of the Trippink tattoo studio in Bengaluru.
- There are other colours that are naturally derived, but also many that make false claim, so always check the contents;
- * A good tag to look for is EU certification;
- Inks that say they are compliant with EU quality standards will have the lowest levels of toxicity possible;
* For dark skin tones, black and most shades of green work well. * Even if it’s not your first tattoo, do a patch test. Tattoo inks change; skin tones change. Take nothing for granted. * If there even a tiny chance that you will want the tattoo removed later on, avoid reds, yellows and oranges.
- They are the most resistant to laser removal treatments;
- Even for the other colours, removal takes an average of 15 visits over 8 weeks;
- Best and worst spots * Muscular parts of the body — upper arms, calves, back — are good places if you plan to get a tattoo, says Dr Karkhanis;
* Avoid areas where the skin stretches such as the crease lines on the wrist, elbows or near the knees. “It will likely take longer to heal as there is constant pulling of the skin here,” he adds. * Avoid hands and feet. Sustained and direct exposure to sun, soap and water would make healing difficult and could cause the tattoo to fade.
Are there any FDA approved tattoo inks?
It is important to understand FDA’s role in monitoring the safety of tattoos. You should also be aware of what has not been approved by FDA. FDA has not/does not do the following: FDA has not approved any inks for injection into your skin.
Does tattoo ink need to be FDA approved?
Resources – JSTOR is a digital library for scholars, researchers, and students. JSTOR Daily readers can access the original research behind our articles for free on JSTOR. By: Jessica C. Dixon Administrative Law Review, Vol. 58, No. 3 (Summer 2006), pp. 667-687 American Bar Association Morbidity and Mortality Weekly Report, Vol.
Is tattoo ink FDA certified?
Safety and Regulatory Background – FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics. When we identify a safety problem associated with a cosmetic, including a tattoo ink, we investigate and take action, as appropriate, to prevent consumer illness or injury.
The pigments used in the inks are color additives, which are subject to premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other competing public health priorities and a previous lack of evidence of safety problems specifically associated with these pigments, FDA traditionally has not exercised regulatory authority for color additives on the pigments used in tattoo inks.
The actual practice of tattooing is regulated by local jurisdictions. During 2003 and 2004, FDA became aware of more than 150 reports of adverse reactions in consumers to certain permanent makeup ink shades, and it is possible that the actual number of women affected was greater.
The inks associated with this outbreak were voluntarily recalled by the company that marketed them in 2004. In the spring of 2012, we received reports of infections from contaminated inks, resulting in their recall and market withdrawal.
In the fall of 2017, a firm voluntarily recalled several colors and sizes of tattoo inks, due to microbial contamination identified by an FDA survey. In addition, concerns raised by the scientific community regarding the pigments used in tattoo inks have prompted FDA to investigate their safe use.
FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on tattoo inks. As new information is assessed, we will consider whether additional actions are necessary to protect public health.
In addition to the reported adverse reactions, areas of concern include tattoo removal, infections that result from tattooing, and the increasing variety of pigments and diluents being used in tattooing. More than fifty different pigments and shades are in use, and the list continues to grow.
Although a number of color additives are approved for use in cosmetics, none is approved for injection into the skin. Using an unapproved color additive in a tattoo ink makes the ink adulterated. Many pigments used in tattoo inks are not approved for skin contact at all.
Some are industrial grade colors that are suitable for printers’ ink or automobile paint. Nevertheless, many individuals choose to undergo tattooing in its various forms. For some, it is an aesthetic choice or an initiation rite. Some choose permanent makeup as a time saver or because they have physical difficulty applying regular, temporary makeup.
- For others, tattooing is an adjunct to reconstructive surgery, particularly of the face or breast, to simulate natural pigmentation;
- People who have lost their eyebrows due to alopecia (a form of hair loss) may choose to have “eyebrows” tattooed on, while people with vitiligo (a lack of pigmentation in areas of the skin) may try tattooing to help camouflage the condition;
Whatever their reason, consumers should be aware of the risks involved in order to make an informed decision.
Do tattoos shorten your life?
the MPR take: – Having a tattoo may mean an earlier death, says a new report in the American Journal of Clinical Pathology. Investigators compared the deaths of people with and without tattoos and found that people with tattoos appeared to die earlier than people without (mean age of death: tattooed: 39yrs; nontattooed: 53yrs).
Does tattoo ink get in your bloodstream?
How Long Does Tattoo Ink Stay In Your Blood? – The tattoo ink is never and will never be injected directly into the bloodstream. However, the ink is injected into the dermis when tattooing, which is the second layer of skin. This layer of skin contains tiny blood vessels that could carry some of the ink particles through the body.
Can tattoos cause death?
Safety concerns: – Tattooing and piercing break the skin and may cause bleeding. They cause open wounds and infection is possible. Infections at the site may cause permanent deformity, scarring, severe illness and even death. Skin infected with resistant organisms such as methicillin-resistant Staphylococcus aureus (MRSA) can be life-threatening.
Needles and other equipment used contribute to the risk of cross-contamination and disease. If equipment is not new or properly sterilized, or if proper hygienic guidelines are not followed, blood-borne diseases, like hepatitis B and C (which may lead to life-long liver damage and subsequent liver cancer), HIV, tetanus and tuberculosis, may be transmitted.
One concern about tattooing is the dye used. Many dyes specific to tattooing are made from metals and can cause skin irritations and allergic reactions. Allergic reactions can only be remedied by removing the parts of the tattoo causing irritation. While irritation is not life threatening, the area will itch and the tattoo will not look as it should.
The potential carcinogenic effect of dyes has not been well studied. There are safety concerns related to piercing some parts of the body (e. , ear cartilage, tongue, eyebrows, nipples, navel, genitals). There is an increased possibility of infection when cartilage is pierced because the blood supply is less.
Piercing can easily cause keloids, greatly enlarged scars that project above the surface of the skin. Tongue studs and rings have been associated with tooth breakage, and some nipple piercings have been associated with partial removal of the breast due to infection or abscess.
Do tattoos cause early death?
Abstract – Objectives: At autopsy, tattoos are recorded as part of the external examination. An investigation was undertaken to determine whether negative messages that are tattooed on a decedent may indicate a predisposition to certain fatal outcomes.
- Methods: Tattooed and nontattooed persons were classified by demography and forensics;
- Tattoos with negative or ominous messages were reviewed;
- Statistical comparisons were made;
- Results: The mean age of death for tattooed persons was 39 years, compared with 53 years for nontattooed persons (P =;
0001). There was a significant contribution of negative messages in tattoos associated with nonnatural death (P =. 0088) but not with natural death. However, the presence of any tattoo was more significant than the content of the tattoo. Conclusions: Persons with tattoos appear to die earlier than those without.
There may be an epiphenomenon between having tattoos and risk-taking behavior such as drug or alcohol use. A negative tattoo may suggest a predisposition to violent death but is eclipsed by the presence of any tattoo.
Keywords: Autopsy; Drug overdose; Forensic sciences; Suicide; Tattooing; Violence. Copyright© by the American Society for Clinical Pathology.
Do tattoos affect your immune system?
Immune defenders rush to tattoo’s tiny wounds – More than 30% of Americans are tattooed today. Yet, few studies have focused on the biological impact beyond risks of cancer or infection.
Tattooing creates a permanent image by inserting ink into tiny punctures under the topmost layer of skin. Your body interprets a new tattoo as a wound and responds accordingly, in two general ways. Innate immune responses involve general reactions to foreign material. So getting a new tattoo triggers your immune system to send white blood cells called macrophages to eat invaders and sacrifice themselves to protect against infection.
Your body also launches what immunologists call adaptive responses. Proteins in the blood will try to fight and disable specific invaders that they recognize as problems. There are several classes of these proteins — called antibodies or immunoglobulins — and they continue to circulate in the bloodstream , on the lookout lest that same invader is encountered again.
They’re at the ready to quickly launch an immune response the next time around. This adaptive capacity of the immune system means that we could measure immunoglobulins in saliva as approximations of previous stress caused by tattooing. In American Samoa, Howells and I worked at the Historic Preservation Office to recruit study participants with help from tattoo artists Joe Ioane of Off Da Rock Tattoos , Duffy Hudson of Tatau Manaia and traditional hand-tap tattooist Su’a Tupuola Uilisone Fitiao. We collected saliva at the start and end of each tattoo session, controlling for the tattoo duration. We also measured recipients’ weight, height and fat density to account for health. From the saliva samples, we extracted the antibody immunoglobulin A, as well as the stress hormone cortisol and inflammatory marker C-reactive protein. Immunoglobulin A is considered a frontline immune defense and provides important protections against frequent pathogens like those of the common cold.
- Our sample of 25 tattoo recipients included both Samoans and tourists to the island;
- By comparing the levels of these biological markers, we determined that immunoglobulin A remains higher in the bloodstream even after tattoos heal;
Furthermore, people with more time under the tattoo needle produced more salivary immunoglobulin A, suggesting an enhanced immune response to receiving a new tattoo compared to those with less or no tattoo experience. This effect appears to be dependent on receiving multiple tattoos, not just time passed since receiving one.
This immune boost may be beneficial in the case of other skin injuries and for health in general. Tattooing seems to exert a priming effect: That’s what biologists call it when naive immune cells are exposed to their specific antigen and differentiate into antibodies that remain in the bloodstream for many years.
Each tattoo prepares the body to respond to the next. Other studies find that short-term stress benefits the immune system. Stress’s bad rap comes from chronic forms that really do undermine immune response and health. But a little bit is actually good for you and prepares your body to fight off germs.
Regular exercise provides immune function benefits through repetition , not necessarily single visits to the gym. We think this is similar to how each tattoo seems to prepare the body for vigilance. Our Samoan findings supported the results of my first study in Alabama.
But of course correlation does not imply causation. Enhanced immune response is correlated with more tattoo experience, but maybe healthier people heal easily from tattooing and like to get them more. How could we find out if getting tattoos could actually make a person healthier?.
Can you get leukemia from tattoos?
– While researchers have studied the possible link between tattooing and cancer for years, any direct association is currently regarded as a myth. There’s no concrete evidence supporting the development of skin cancer from getting a tattoo. Instead, researchers believe that there may be a coincidence between the two.
Why are they trying to ban blue and green tattoo ink?
If you’re a big fan of tattoos , it’s likely you’ll have heard about the European Union’s new ban on coloured tattoo ink, which has come into place yesterday (4 January). It’s all to do with chemicals found in certain tattoo inks, which are thought to be harmful when used on or under the skin.
Understandably, news of the ban has caused concern for those of us who’ve already gone under the needle , with many questioning: Should we be worried? To answer that question, it’s important to take a look at exactly why these inks have been banned.
The EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) have found certain chemicals used in coloured tattoo inks can cause “cancer or genetic mutations”. Despite their concerns, the regulatory board has emphasised that “the aim is not to ban tattooing, but to make the colours used in tattoos and permanent make-up safer.
” To achieve this, REACH has given ink suppliers a deadline of January 2023 to find new, REACH-approved chemicals for popular ink colours including Blue 15 and Green 7. But, it’s worth noting though, that this is not the first time REACH has banned certain tattoo inks.
In fact just two years ago, in January 2020, the regulatory board made 4,000 chemicals typically used in colourful tattoo ink prohibited. Getty Images So, is there actually cause for concern? Unlike the EU, the UK is not yet following suit on the ban, with the Health and Safety Executive (HSE) instead asking tattoo manufacturers and artists to provide information about the ingredients found in tattoo ink (which include iron oxides, metal salts, plastics and other chemicals). Before deciding whether to ban these and other chemicals, UK lawmakers want to know more, given that scientists have not yet found a direct link between the chemicals in coloured tattoo ink and cancer. However, some chemicals in these inks are proven to be carcinogenic – which means they can cause cancer.
Speaking to Cosmopolitan UK , cosmetic tattooist and college lecturer Liarna Jessica Yearwood , explained that: “In a nutshell, the government will be implementing new restrictions on the use of certain chemicals and colours used in tattoo inks, permanent makeup pigments and cosmetics.
The purpose is to protect consumers that want to get a tattoo or permanent make-up. ” Yearwood adds, “At the moment, it will not impact tattooists too much, because many of the harmful chemicals have already been banned, and many ink manufacturers have already found compliant alternative ingredients.
” As for how the new rules impact those looking to get tattooed, or those who already have been, the expert points out that: “If you have already have a tattoo or permanent make up, and you are not experiencing any health concerns, then you should be fine.
” “If you do have concerns, it would be a good idea to seek advice from a medical practitioner,” she advises. “It is also a good idea to check that your tattooist is suitably qualified, insured and using good quality products before you go ahead. Don’t be afraid to ask for this information.
” Jade Biggs Jade Biggs (she/her) is Cosmopolitan UK’s Features Writer, covering everything from breaking news and latest royal gossip, to the health and fitness trends taking over your TikTok feed. This content is created and maintained by a third party, and imported onto this page to help users provide their email addresses.
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Are they banning coloured tattoo ink?
Why are coloured tattoos being banned? – The reason for the ban comes down to the chemicals found in the coloured ink used for tattoos. The EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) had 4,000 chemicals typically used in colourful tattoo ink prohibited in January 2020. Tattoos with coloured ink will be banned in the EU from January 2023 (Picture: Getty) The regulatory body said the chemicals – some of which are already banned in products applied on top of the skin – can cause ‘cancer or genetic mutations’. REACH have made an effort to clarify that ‘the aim is not to ban tattooing but to make the colours used in tattoos and permanent make-up safer’. Ink suppliers have been given until January 4 2023 to find different, REACH-approved chemicals to create the same colours.
Is tattoo ink FDA approved?
Given the popularity of tattoos, one would expect the physical effects to be well known. But in fact, the question has only recently been examined, most recently with studies that suggest that tattoo ink can leach into the lymph nodes , and that tattoos may reduce sweating.
Reduced sweating impedes the body’s ability to cool off, potentially presenting problems for anyone who is heavily tattooed and exercising in the heat. But sweating aside, are there long-term risks to tattoos? Nobody really knows.
Many tattoo inks are chemically similar or even identical to commercial pigments used in printers or even paint. Are there serious adverse effects to injecting industrial paint under your skin? Nobody really knows. The largest regulator of food and personal items, the FDA , has authority over pigments used in external-use cosmetics, such as lipstick.
- Artificial pigments must be approved by the FDA and tested to ensure that they contain approved ingredients, but colors derived from natural sources are not tested at all;
- In practice, due to limited resources and a belief that cosmetics pose little health risk, approved cosmetic pigments are mostly regulated directly by the cosmetic industry;
There’s loophole, however, large enough for a body suit. The FDA only exercises oversight over cosmetic pigments used externally. Internal use, i. permanently inserting pigments into the skin, is not regulated by the FDA at all. In a bizarre catch-22, since the pigments are not FDA-approved for use in tattoos, and only FDA pigments are covered by the industry’s testing scheme, most inks are de facto unregulated (The FDA will act if an obvious health problem is identified).
Furthermore, FDA ingredient labeling requirements only apply to products sold directly to consumers. Ink is sold wholesale in bulk to shops, so not only are the inks not FDA-approved, the ingredients are kept secret from users.
That leaves the regulation of tattoos to the states, where there is enormous variability in oversight. Many states, not all, have some regulations regarding the practice of tattooing, but there are few regulations regarding the contents or safety of the ink.
- Research regarding long-term effects of modern pigments or how pigments react when tattoos are removed is almost completely lacking;
- As things currently stand, there is not yet evidence of long term harm to most tattoo recipients, nor does the sweating study provide evidence of risk;
While there have been a few infections caused by unsterile ink , licensed artists are mostly conscientious and infection transmission through tattoos is uncommon. (The infection rate is higher in informal settings such as prisons, or friends’ basements. .
Do tattoos contain heavy metals?
August 15, 2016 | A version of this story appeared in Volume 94, Issue 33 – Credit: Shutterstock According to current surveys in Italy, Denmark, and the U. , more women than men have tattoos. Humans have been tattooing themselves for millennia, motivated by reasons as diverse as the designs decorating their skin. Crusaders tattooed crosses on their bodies to ensure they’d go to heaven, while for centuries, sailors inked their bodies to boast about where they’d travelled.
The 61 tattoos on Ötzi, a 5,300-year-old mummy discovered in the Alps, were all located near his joints, leaving researchers to speculate that the tattoos may have been part of an ancient arthritis treatment.
These days, however, most of the 120 million tattooed people worldwide have inked themselves for fashion. This trend is on the upswing among young adults, especially women, who now possess more inked body art than men in Italy, Denmark, and the U. , according to Darren McGarry, who led a panel discussion about tattoo science and policy at the European Science Open Forum (ESOF) conference in Manchester, England, in late July.
- But if tattoos are now commonplace, knowing the ingredients and provenance of the colorful cocktail injected beneath the skin is not;
- It’s not widely known by the general public that the pigments found in tattoo inks can be repurposed from the textile, plastics, or car paint industry, said McGarry, who works at Joint Research Centre (JRC), which provides independent scientific advice to the European Commission;
Members of the ESOF panel voiced concern about patchy regulatory oversight of tattoo inks in the European Union and about a tattooing culture in which consumers rarely question tattoo artists about the origin of the pigments that decorate their bodies. Inked [+]Enlarge Credit: Joint Research Centre Tattooed inhabitants in these countries and regions compose less than one-quarter of the population. Source: Joint Research Centre According to a report the JRC released this year, European regulators and others are concerned that “pigments used in the formulation of tattoo and permanent make-up inks are not produced for such purpose and do not undergo any risk assessment that takes into account their injection into the human body for long-term permanence.
- Given these issues, they called for research on the long-term health risks of tattooing and for harmonizing regulations controlling tattoo parlors and inks across the EU;
- ” The report notes that in the U;
and Canada, policies that govern tattooing are also spotty. In those countries, the procedure is regulated at state or provincial levels, generating “a wide variety of guidelines and hygiene standards. ” Tattoo artists also have concerns. “There are certainly really good producers of ink.
But some of the inks on the market weren’t intended for tattooing. They just put them in a fancy bottle, put a dragon on the bottle, and write ‘tattoo’ on it,” said Jens Bergström , who has been a tattoo artist for 20 years and owns the Heavenly Ink Tattoo & Piercing studio in Åkersberga, Sweden.
“That’s how easy it is, and that’s the danger,” said Bergström, who was a panelist at ESOF. The 118-page JRC report —which compiled surveillance, ingredient analysis, and adverse reaction data—found that tattoo and permanent makeup products containing dangerous substances or contaminated by microbes “are available on the EU market.
- The main risks identified, in descending order, are the presence of polycyclic aromatic hydrocarbons, primary aromatic amines, microorganisms, heavy metals, and preservatives;
- ” “Most consumers are aware of the infection risks, but few are aware of the chemical risks,” said Anke Meisner , a policy officer at the German Federal Ministry of Food & Agriculture and a panel member at the ESOF conference;
According to the JRC report, from 2005 to 2015, chemical ingredients were the primary concern in 95% of the 126 tattoo ink cases reported to the EU’s rapid alert system for dangerous products. Inks imported from the U. were responsible for two-thirds of the tattoo-related alerts sent to European authorities, the JRC report says. Some azo pigments found in tattoos, such as Solvent Red 1, can degrade into problematic compounds such as o -anisidine, a potential carcinogen. Dermatologist Jørgen Vedelskov Serup of Bispebjerg Hospital says he’s cared for 500-plus problem tattoo cases. Serup told ESOF attendees he’s seen lumpy, so-called papulonodular skin elevation from pigment overload, chronic inflammation, long-term light sensitivity and other side effects from tattooing.
A further one-quarter of these problematic inks came from China, Japan, and some European countries, while the provenance of 9% of products was unknown. According to the JRC report, the bulk of tattoo health complications involve allergic reactions and hypersensitivity, mostly in red or black areas of tattoos.
“As a doctor, if you do a cosmetic procedure, by law, you have to tell the patients the risks. It’s amazing that the same is not [universally] required in tattooing,” Serup said. Tattoo inks can contain a cornucopia of compounds: Some 100 pigments and 100 additives have been found in these products, Maria Pilar Aguar Fernandez told ESOF attendees.
She is responsible for the Chemicals Assessment & Testing Unit at the JRC and was involved in writing the organization’s tattoo report. The top chemicals of concern found in tattoo inks, according to the report, are polycyclic aromatic hydrocarbons (PAHs), such as benzo[ a ]pyrene, which is listed as a human carcinogen by the International Agency for Research on Cancer (IARC).
The report notes PAHs can migrate from the skin to lymph nodes. These problematic chemicals are found mostly in black inks and are most likely impurities from industrial production—in fact, some tattoo formulations are only between 70–90% pure, the report says.
Tattoo inks may also contain potentially harmful metal impurities such as chromium, nickel, copper, and cobalt. Tattoo pigments themselves can be health hazards. “If the ink is really bright in color, it usually contains dangerous stuff,” tattoo artist Bergström said.
Fortunately, cinnabar, a mercury sulfide pigment, which was once a popular bright red in tattoo formulations, has been phased out of use. Currently, stakeholders are more concerned about azo pigments, the organic pigments making up about 60% of the colorants in tattoo inks.
- Although many of these azo pigments are not of health concern while chemically intact, they can degrade with the help of bacteria or ultraviolet light into potentially cancer-causing primary aromatic amines, notes the report;
Furthermore, during tattoo removal—by some surveys up to 50% of tattoo owners come to regret their ink—lasers are often used to blast apart pigments, sending problematic degradation products into the body. Researchers don’t know “how these degradation products are distributed in the body and how they get excreted,” Meisner said.
“There’s a knowledge gap about metabolism of ingredients. ” Another problematic component of tattoo inks is the preservatives that can be added to keep microbes from growing in the often nutrient-rich solutions.
In one survey of 229 tattoo inks by Swiss regulators, nearly a quarter of inks analyzed contained the antiseptic benzoisothiazolinone, which is a skin irritant. Also, 7% of inks in the study contained the preservative formaldehyde, which is classified as a carcinogen by the IARC.
The JRC report highlights the need to fund research on the toxicity of tattoo ingredients and how they degrade in the body as well as to fund the development of analytical techniques to detect and monitor impurities.
“Prospective epidemiological studies would be needed to ascertain the risk of carcinogenicity from tattoo inks constituents, including their degradation products,” says the report, which also lists this as a research priority. “We are facing a tremendous knowledge gap.
This is why it is so difficult to develop regulations,” dermatologist Serup said. Across the EU, tattoo inks are regulated under a blanket consumer product law that dictates only safe products may be placed on the market.
The European Chemicals Agency is currently investigating whether tattoo ink ingredients should be subject to region-wide regulatory restrictions. In 2008, the Council of Europe, an organization focused on promoting human rights and the integration of regulatory functions in the continent, recommended policies to ensure the safety of tattoos and permanent makeup.
This document lists 62 chemicals that should not be present in tattoos and permanent makeup products. It also recommends that tattoo ink bottles should list best-before dates, batch numbers, and “the name and address of the manufacturer or the person responsible for placing the product on the market,” among other things.
Motivated by the Council of Europe’s recommendations, about one-third of EU countries, including Germany, Spain, and France, implemented a mishmash of their suggestions through national laws. For example, among other regulations, Germany has made it illegal for tattoo inks in the country to contain any chemicals on the Council of Europe’s list of substances banned in cosmetics.
“What is not safe on the skin is not safe in the skin,” Germany’s Meisner said. Other EU countries have instituted licensing requirements for tattoo artists or made it illegal to tattoo without informing clients of potential health risks.
Meanwhile the JRC report points out that no information about tattoo regulations was available for Hungary, Iceland, Lithuania, and the U. “We have not done any market surveillance in the U. ,” said Robert Pinchen, a U. market surveillance representative at the ESOF conference.
- “I’m very concerned about the amount of potential counterfeit inks that are on the marketplace and all these do-it-yourself kits that are available,” Pinchen added;
- It’s frustrating that different countries have different rules, said Bergström, the tattoo artist;
“We want harmonized rules in the whole European Union. ” Until that happens, Bergström suggests that individuals getting a tattoo make informed decisions. “Nobody gets forced to have a tattoo. So it’s in your own interest as a consumer to ask questions. If the tattoo artist can answer your questions and produce some documents regarding the ink, that’s a good thing,” Bergström said.
“As a practitioner, it is my responsibility that I produce as [low a] risk as possible. ” But, he added, “Don’t just take for granted that all tattoo artists are good or all inks are good. You are also responsible for your own health.
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