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EU policy makes its mark – EURACTIV.com

Welcome back to EURACTIV’s first health brief of 2022!

If one of your new year’s resolutions is to get a tattoo but you’ve always had health concerns about it, you might not need to (th)ink again.

Starting from 4 January, thousands of hazardous chemicals found in tattoo inks and permanent make-up have been restricted in the EU under the REACH regulation.

The regulation aims to improve the protection of human health and the environment from the risks that can be posed by chemicals.

Mark Blainey, the head of the unit for Risk Management at European Chemicals Agency (ECHA), which manages the technical and administrative aspects of the implementation of REACH, told EURACTIV that this restriction will make “tattooing and permanent make-up inks safer for all Europeans”. 

“The EU is not banning tattooing or permanent make-up – the aim is to protect the health of citizens,” he stressed.

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. 

“As a result of the restriction, we expect that chronic allergic reactions and other inflammatory skin reactions from tattoo and permanent make-up inks will decrease,” Blainey said. 

He added that “more serious effects such as cancer, harm to our DNA or the reproductive system potentially originating from chemicals used in the inks could also decrease.”

‘Blending’ the bloc

This restriction was adopted in December 2020, after 4 years of the consultation process. 

Speaking at the time, Environment Commissioner Virginijus Sinkevičius warned that toxic chemicals found in tattoo inks are harmful to health and, given that tattooing is increasingly popular in Europe, “it is urgent that we regulate those chemicals now.” 

Until the start of this year, member states had their own national rules on the restriction of chemicals in tattoo inks. 

On 4 January, a Commission’s spokesperson said that “this is not something which is either a surprise or a complete novelty, it is a sort of generalisation of practice, which already exists in quite a few member states”. 

Contacted by EURACTIV, the EU official added that 7 member states: Belgium, France, Germany, the Netherlands, Spain, Sweden and Slovenia, already had all these chemicals forbidden to be used in tattoo inks.

ECHA’s Blainey highlighted that this restriction “harmonises legislation across the EU, citizens are equally protected irrespective of the country where they get tattooed and whether the ink is manufactured in the EU or elsewhere”.

Concerns from the artists

But the industry thinks that the decision is just (tat)too bad. 

Over 176,000 people signed tattoo artist Erich Mähnert’s petition from October 2020 which focuses on the impacts of the EU-wide ban on specific pigments ‘Blue 15’ and ‘Green 7’.

This is because these pigments, unlike others, don’t have alternatives available in the market. 

As such, this would have a “lengthy negative impact” on the economic competitiveness of European tattooists and pigmenters vis-a-vis providers of those services outside the EU and would jeopardise the existence of that sector, he argued. 

As such, the ban on these two pigments will come into force one year later, as of 4 January 2023, to allow more time for businesses to find safe alternatives for these two pigments, according to a Commission press release. 

But tattoo artists argue that the 2-year transition period from 2020 to 2022 to find alternatives for the other pigments is “far too short” for the tattoo industry. 

In his statement, Mähnert argued that these shades are “essential for tattooing” and are also needed for “permanent make-up and especially in the area of nipple reconstructions after breast removal”.

“If the consumer no longer receives these from reputable tattoo artists in Europe, he will either go to other EU countries or to non-official and dubious providers,” he warned. 

Commission: Tattoo industry had enough time

But the Commission claims that this won’t harm the tattoo industry, given that “for many of the chemicals which have been banned, there are substitutes”, a Commission’s spokesman said on 4 January.

Regarding Pigment Blue 15 and Pigment Green 7, the Commission’s official said that the development of alternatives by the tattoo industry “is well underway” but conceded that this “still requires some time”. 

ECHA’s Blainey concurred, stating that ink manufacturers and tattooists have had “ample opportunity” to seek alternatives. 

He added that “analyses from the Member States where national legislation had already been in place revealed no issues in sourcing alternatives for the majority of the inks”.

Blainey also stressed that the restriction process has been transparent, participatory and science-based. 

“We also held personal interviews with industry representatives, the medical/research community and with tattoo artists,” he concluded.

National market surveillance will now be responsible for checking the implementation of the new rules in the member states.

(G.P.)

Subscribe to EURACTIV’s Health Brief, where you’ll find the latest roundup of news covering Health from across Europe.

What to expect in 2022?

Over the last two years, COVID-19 has brought many changes to Europeans’ lives but also to the EU’s agenda, making sure that the renewed focus on health is here to stay in 2022.

Dementia

Worldwide cases of dementia are predicted to increase almost three-fold to 153 million in 2050, according to new research, although some experts have criticised these “apocalyptic projections”.

Pollution and health

Some 1.8 million excess deaths and nearly two million asthma cases have been attributed to air pollution in 2019 worldwide, according to two studies published in The Lancet Planetary Health journal.

Future of Europe citizen’s panel

As part of the Conference on the Future of Europe, Warsaw hosted some 200 Europeans on 7-9 January 2022, who came for the third and final session of the European citizens’ panel dedicated to climate change, environment and health. Panellists suggested a change in the EU treaties that would introduce a legal base for more EU action on health. They called for equal quality and at fair cost health treatments across the EU should. Citizens also suggested that a new European procurement agency could negotiate better prices for medicines for all member states. Additionally, panellists urged to stop considering female sanitary products as luxury goods and taxed extra, calling on mental health and sexual education inclusion in school curricula.

Pharmaceutical legislation

The EU’s pharmaceutical association (EFPIA) listed the priority areas for legislative change in the general pharmaceutical legislation in a comprehensive study published on Thursday (6 January). In its suggestions, they ask for a more agile centralised authorisation framework and for an expanded role of the EMA in assessing drug-device or diagnostic combination products.

Pregnancy

On Tuesday (11 January) during EMA’s press briefing it was warned that pregnant women are more likely to get severely ill from COVID19 compared to women who are not pregnant. Data show that COVID 19 vaccines reduce the risk of hospitalisation and death during pregnancy without causing pregnancy complications or harming the unborn baby.

COVID

Quarantine changes. On 7 January ECDC released Guidance on quarantine of close contacts to COVID-19 cases and isolation of COVID-19 cases, in the current epidemiological situation. The overall guidance regarding quarantine remains unchanged, but the options proposed include shorter quarantine periods in case of high and extreme pressure on healthcare systems and society as well as testing with rapid antigen detection tests to release patients from quarantine.

COVID therapeutics. On Monday (10 January) European medicines agency (EMA) received Pfizer Europe’s application for conditional marketing authorisation for Paxlovid, an oral antiviral medicine that reduces the ability of SARS-CoV-2 to multiply in the body. It would be used for the treatment of mild-to-moderate COVID 19 in adult and adolescent patients who are at high risk of progression to severe COVID 19. EMA will assess the benefits and risks of Paxlovid under a reduced timeline and could issue an opinion within weeks. At the time EMA is evaluating marketing authorisation applications of two other therapeutics, 6 therapeutics are already authorised in the EU. 

Twindemic. On 7 January ECDC warned about twindemic – influenza and COVID-19 – putting excessive pressure on overstretched health systems. A paper published in December 2021 found that “coinfection with SARS-CoV-2 and influenza had no effect on overall mortality”. It is highlighted that further studies are needed to better understand whether simultaneously infected with these two viruses influences disease severity. Maria Van Kerkhove, Infectious Disease Epidemiologist and COVID-19 Technical Lead at WHO, tweeted with more people mixing with limited use of public health & social measures, PLUS circulation of flu & COVID19, we will see co-infection occurring”.  

Macron is going after the unvaccinated. Deputies in the French National Assembly once again suspended a session debating the draft bill for the so-called “vaccine pass” early on Wednesday (5 January). This time, it was triggered by President Emmanuel Macron’s controversial comments about the unvaccinated. EURACTIV France reports.

Cases surging. From Paris to Podgorica, COVID-19 cases are surging across the continent in the wake of two weeks of festivities, exacerbated by the highly-infectious Omicron variant and challenges in national vaccination campaigns.

Healthcare systems stretched. Europe’s healthcare systems are being strained once again by the rapid spread of the Omicron variant of the coronavirus over the holiday period, with large numbers of key staff ill or self-isolating and experts predicting the peak of infections is yet to come.

Pfizer’s single shot. On 5 January Germany’s BioNTech and US pharma giant Pfizer, which together developed a COVID-19 vaccine in record time, said they are working on a singles shot using the same mRNA technology.

Vaccines against Omicron. EMA’s preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant.

MADRID

The Spanish government has worked for several weeks on a plan to approach the COVID-19 disease as if it was the common flu, EURACTIV’s partner EFE reported, quoting El País. By  Fernando Heller and Sarantis Michalopoulos |  EURACTIV.com and EuroEFE.EURACTIV.es. 

DUBLIN 

Ireland mulls mandatory vaccinations. Ireland’s National Public Health Emergency Team (NPHET) will consider introducing a vaccine mandate following the release of an upcoming paper by the Department of Health on the issue’s complexities. By  Molly Killeen |  EURACTIV.com

BUCHAREST

Vaccination will not be mandatory in Romania, says Health Minister. The vaccination against COVID-19 remains very important, but it should not be mandatory in Romania, the health minister Akexandru Rafila said. By  Bogdan Neagu |  EURACTIV.ro

BRUSSELS

Thousands protest COVID-19 rules in Brussels. Several thousand protesters marched in Brussels on Sunday (9th January) to oppose anti-coronavirus regulations, as European governments mull tighter rules in the face of the omicron wave.

There was no repeat of the violence that had marred previous, larger demonstrations in the Belgian capital, although police intervened to surround a small group that approached the EU headquarters. Belgium requires residents to show a COVID certificate to enter bars, restaurants and cultural events, and there have been several recent protests. (EURACTIV.com)

VIENNA

Mandatory vaccines pushed back to April. Due to technical complications, the registration of mandatory vaccines will only be possible by April, two months later than envisioned by the Austrian government. Meanwhile, experts are questioning the effectiveness of mandatory vaccinations. By  Oliver Noyan |  EURACTIV.de

BERLIN

German government parties drags feet on mandatory vaccine vote. The two biggest parties in Germany’s government coalition – Olaf Scholz’s Social Democrats (SPD) and the Greens – are in no hurry to call a parliamentary vote on mandatory vaccination despite both supporting it. By  Julia Dahm |  EURACTIV.de

PARIS

French MPs approve controversial vaccine pass. French MPs have adopted the COVID vaccine pass bill in the National Assembly on Thursday amid fierce debates laying bare the internal struggles of the right-wing. Now, only Senate approval remains. By  Davide Basso |  EURACTIV France 

ROME

Italian government wants in-person classes to resume, schools don’t. A return to in-person classes is unmanageable at the moment, 1,500 school principals wrote in a letter to Prime Minister Mario Draghi and Education Minister Patrizio Bianchi on Thursday. By  Eleonora Vasques |  EURACTIV.com

WARSAW

Morawiecki defends far-right party spreading COVID conspiracies. Following Facebook’s deletion of the page belonging to the opposition nationalist Confederation Party, the party and Prime Minister Mateusz Morawiecki condemned tech giants for throttling free speech. By  Aleksandra Krzysztoszek |  EURACTIV.pl

ATHENS

Call for free tests in Greece. The opposition and medical associations have mounted pressure on the Greek government to distribute free PCR tests for people, as Greeks seem to be the only EU citizens who still pay to get a molecular test. By Sarantis MIchalopoulos | EURACTIV.com

12 January – European Parliament’s health committee (ENVI) meeting. On the agenda: medicine and Brexit, artificial intelligence and health, health impacts of 5G

13 January – 10 February 2022 Oslo Medicines Initiative webinar series 

18 January – Where do we find the money to fund healthcare for an ageing population?



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