The European Commission announced this week that a restriction on hazardous chemicals contained in mixtures for tattoo inks and permanent make-up entered into force in the EU as of 4 January 2022.
The Commission adopted the restriction in December 2020 following studies showing evidence of allergies and skin problems due to tattoos, responding to a request from Member States and based on scientific and socio-economic impact assessments done by European Chemicals Agency (ECHA).
ECHA, established in 2007 in Helsinki, Finland, is an EU agency responsible for implementing legislation to protect people and the environment from the hazards of chemicals.
As previously reported by The Brussels Times, the ban has been criticised by tattoo artists in Belgium. A shortage of inks that conform with the new rules means that most of Belgium’s approximately 2,000 tattoo shops now claim that they have little choice but to close doors rather than work with the banned inks illegally.
Although some substances in tattoo inks have been proven to be carcinogenic, no direct link between them and cancer has yet been found, according to the tattoo artists. They also complained about a lack of information and dialogue with the Belgian government about the implementation of the new rules.
While some member states already had national legislation in place to restrict hazardous chemicals in tattoo inks, the new rules at EU level were adopted to equally protect people across the EU, irrespective of the country where they get tattooed and whether the ink is manufactured in the EU or not.
Are there alternative colors already available?
According to the Commission, there are safe alternatives on the market for the substances which are prohibited as of this year. The ban on Pigment Blue 15 and Pigment Green 7 will only become applicable as of 4 January 2023. An additional one-year derogation was granted to allow businesses more time to find safe alternatives for these two pigments.
“Through our consultations, we asked the industry and citizens about the availability of alternatives,” a spokesperson for the ECHA told The Brussels Times. “If alternatives were not available, these cases were considered for derogations or granted longer transition periods.”
ECHA’s Committee for Risk Assessment (RAC) noted that information received during the consultation indicated that safer and technically adequate alternatives were currently unavailable for only two colourants – Pigment Blue 15:3 and Pigment Green 7.
Figures in ECHA’s report indicate that the price difference between compliant and non-compliant tattoo inks and permanent make-up (PMU) on the market is assumed to be 15% and 20% respectively, this is on the basis of the average response by stakeholders.
While tattoo ink is injected deep into the skin, into the dermis, pigments used for permanent makeup are injected into the epidermis, the outermost skin layer.
The study found that there are about 90 EU-based and international manufacturers of tattoo inks and about 55 PMU manufacturers on the EU market. Between 70% and 80% of the tattoo inks on the EU market are manufactured outside the EU, primarily from the United States.
What is the latest scientific evidence about the correlation between tattoos and health risks?
The new rules limit over 4 000 substances, many of which are already restricted under EU’s Cosmetic Products Regulation and as such are restricted for use on skin. Therefore, they should not be allowed to be used under the skin either, according to ECHA.
“These substances include those for which there is scientific evidence for effects such as carcinogenicity, mutagenicity, reproductive toxicity, skin sensitisation or irritation or corrosion, eye damage or irritation sufficient for an EU-wide harmonised classification.”
According to an on-going Swedish study at the University of Lund on the correlation between tattoos and cancer, the high prevalence of tattoos in Sweden (17%) has brought safety concerns into the spotlight. “There are plausible mechanisms through which the pigments in tattoo ink might act as a risk factor for cancer, but the long-term health effects have never been investigated.”
“The popularity of tattoos has skyrocketed during the last decades and the incidence rates of skin cancer and lymphoma have increased during the same period of time.” The research aims at filling a knowledge gap but research data have not been published yet.
Tattoo inks and permanent make-up are a mix of several chemicals, ECHA explains. They may contain hazardous substances that cause skin allergies and other more serious health impacts, such as genetic mutations and cancer.
Ink pigments can also migrate from the skin to different organs. Sometimes tattoos are removed using a laser that breaks down pigments and other substances into smaller particles. If these include harmful chemicals, the removal process will free them to circulate in the body.
As chemicals used in tattoo inks and permanent make-up may stay in the body for life, there is also the possibility for long-term exposure to the potentially harmful ingredients.
How accurate is the scientific evidence on health risks?
ECHA’s Committee for Risk Assessment (RAC) admits that while available human case studies show that specific negative health effects such as swelling, erythema or disfiguring scarring occur in the tattooed population, the relationship to skin tumours and systemic effects, such as malignant tumours, systemic immunological responses or harm to reproductivity, is much less clear.
“The risk of human cancers related to tattoo inks is not easy to assess. Cancer risk depends on multiple factors, usually requiring decades to become clinically observable, and a casual links with specific chemicals in tattoo ink are difficult to establish.”
However, RAC considers that the risk of carcinogenic, reprotoxic and other systemic effects cannot be excluded (in bold by ECHA).
This conclusion considers the intrinsic properties of chemicals that are or could be found in tattoo inks, and toxicokinetic data from humans and animals which indicate that only a few percent of the injected tattoo ink is retained in the skin, while the rest can migrate to lymph nodes, liver and can be systemically available in the human body.
What is the frequency of tattooing by member state, year and age group?
While detailed figures by EU member state are largely missing, about 12% of the EU population has at least one tattoo according to estimates for 2014. This is an increase from the 4-8% prevalence as of 2003. The prevalence for younger age groups is much higher and in some member states it is more than double the national average, exceeding 30% for some groups under 40-years-old.
Assuming the trend between 2003 and 2014 continues in the future, the population of people with at least one tattoo is expected to double and reach 26% by 2040.
It was also estimated that the PMU prevalence in the general population is between 3% and 20%. Due to the limited information and the possibility that a person with a permanent make-up could also have one or several tattoos, these estimates were not projected and added to the population with tattoos.
While in the early days of popularity (prior to the 1990s), tattoos were more typical for men, figures show that this trend is changing and in certain cases the tattoo prevalence is higher for women, particularly for younger generations.
The first tattoo is usually obtained at a young age, often much younger than 25 years old, e.g., in Denmark, 37% get their first tattoo before the age of 20, while in Germany, 17.6% before they are 18. Adolescents also get tattoos even though in some countries the minimum age for obtaining a tattoo is 18.
Is there a plan to require licensing of tattooists?
In its opinion, ECHA’s Committee for Risk Assessment (RAC) acknowledged that it would be difficult and time consuming to negotiate EU-wide standalone legislation due to a number of issues including business licenses, training and certification that are currently within the jurisdiction of local and regional authorities.
That said, member states can make national rules on issues that fall outside of those regulated by the restriction e.g. on sanitation or licensing, according to ECHA’s spokesperson.
Update: The Swedish research project mentioned in the article builds on large-scale national questionnaires to cancer patients in the Cancer Registry and random controls from the Population Register.
A member of the research team told The Brussels Times that the data collection via a questionnaire to 36,000 persons was concluded last year and will be analysed as soon as remaining statistics has been received. The results are expected later this year.
M. Apelblat
The Brussels Times
