30 September 2016

Tattoo inks: in need of a positive list of approved ingredients to guarantee safety

Vienna, 30/09/16. Last year, during the Press Conference of the 24th EADV Congress in Copenhagen, Dr. Christa De Cuyper, from Brugge, Belgium took the floor to raise the issue of risks from tattooing, namely infections, allergy and toxic effects of the chemicals in the inks. ‘We need a positive list of safe pigments and ingredients. Tattoo inks should at least meet the same standards as cosmetic products’ she argued during her talk. ‘We need further research, but as a first step, we need a uniform European standard to protect consumers! And let’s not forget that up to 20% of individuals regret their decision of having a tattoo and ask for medical advice to get it removed! To avoid regret and complications I insist that tattooing should be a well informed decision, performed by a well trained professional, in hygienic conditions and with safe materials,’ she had concluded.[1]

The EADV has been quite active on the matter, and under the guidance of Dr. De Cuyper, released last June a cartoon video, as part of an awareness raising campaign, targeting young people of ages 18-25 years in order to speak about the importance of making the right decisions before getting a tattoo.

Dr. De Cuyper returned to this year’s Press Conference to speak about all the latest developments with regard to tattoo inks regulations in Europe and the importance of developing a strategy on the European level to reduce the negative impact of body art on public health.

‘I would like to talk to you about what has been happening on the European level with regard to regulating the tattoo inks,’ she said after her opening remarks. She went ahead and presented the two initiatives, which are currently in the pipeline: one on hygiene and one on safety of the inks.

Firstly, The CEN 435 project is about developing a European standard on hygiene for the tattooists. This is the work of a Project Committee, established in 2014 by the European Committee for Standardization (CEN).

Secondly, building on the preparative work of the Consumer Safety Network subgroup on tattoos and permanent make-up, JRC (the Joint Research Centre of the European Commission's, which is essentially its science and knowledge service) recently published their final Report on the Safety of Tattoos and Permanent Make-Up.[2] ‘This report underwrites the strategy we proposed in 2015 and stresses the importance of informing the young generation,’ highlighted Dr. De Cuyper. ‘The report also confirms that the requirements for inks as proposed in the Council of Europe CoE ResAp2008(1)[3] are insufficient to guarantee the safety of the inks,’ she added.

Based on this publication, the European Commission requested the European Chemicals Agency (ECHA) to assess whether there is a need to restrict certain substances used in tattoo inks and permanent make-up (PMU) in the framework of REACH. As part of this process, ECHA has launched a call for evidence to gather information on substances used in tattoo inks and permanent make-up. Once started the ECHA has one year to make their final report.

REACH (Registration, Evaluation, Authorization and Restriction of Chemical substances) is the EU system for the industry’s registration of chemicals produced in amounts over one ton per year. The system was introduced in 2007 and since then some 120.000 chemicals have been registered. ‘The information ECHA needs to make a decision about the tattoo inks highly depends on the cooperation of manufacturers and importers. Tattoo inks are complex formulations; mixtures of different substances including pigments, dyes, preservatives and additives. Some are imported as finished products mostly from the USA, others are manufactured in Europe (European Economic Area) with components that are imported or produced in Europe. Other sources are from the Asian/Chinese market. This means that the quality and composition of the finished product is often not in accordance with the requirements that was proposed in the CoE  Resolution ResAp2008(1) and some of them contain CMR (carcinogenic, mutagenic and reprotoxic) ingredients or could release toxic metabolites in the skin under the influence of sunlight or laserlight,’ said Dr. De Cuyper.

‘The interested parties now await the conclusion of ECHA on whether chemicals used in tattoo inks will come under REACH with some anxiety. Indeed, if the decision is positive, there is a very high risk that many current inks will ultimately be considered unsafe. This practically means that if tattooists can no longer order the colours of their choice, with the brightness and texture they prefer there could be a shift towards the black market and this could create an even more unsafe situation. So no, over-regulation is also not the answer in this problem. Starting from a positive list of approved ingredients could be a better solution. We realise that this will be a slow and difficult process, with lobbying from various sides. We hope that with our scientific knowledge we will be able to influence the decisions in a favourable direction in order to create safe inks and limit the risks of toxicity in the future,’ concluded Dr. De Cuyper.

About the Speaker:

Dr. Christa De Cuyper is a Belgian dermatologist and has been working in the Sint-Jan General Hospital in Brugge for 35 years. She has a long experience in laser treatment, mostly in particular with tattoo removal. She has published a book on “Dermatological complications with Body Art: Tattoos, Piercings and Permanent Make-up” and has written several chapters and articles on this subject. Dr De Cuyper is a founding member of the European Society on Tattoo and Pigment Research (ESTP). In April 2015 she organized the second congress on Tattoo and Pigment Research in Brugge,  to which the authorities as well as the different stakeholders (scientists, manufacturers, retailers and professional users of tattoo and PMU inks) contributed actively. As the Belgian representative she is involved in the CEN 435 project on hygiene standards for tattooists.  She has also represented Belgium in the Consumer Safety Network subgroup on safety of tattoos and PMU.

[1] Press Release – EADV Press Conference 24th EADV Congress in Copenhagen on Tattoos

[2] JRC Report on safety of tattoos and permanent make up.

[3] ResAp2008(1)

Download the Press Release (PDF) >