The mixtures for tattoo inks and permanent makeup may contain toxic chemicals that raise serious health concerns, such as allergies, skin issues and even “genetic mutations, cancer and reproductive harm” (European Chemicals Agency, 2020). In order to protect the EU citizens’ health and to create a safer Internal Market, the Commission adopted new restrictions under the EU legislation governing chemicals. These restrictions aim to harmonize the different approaches of the EU Member States regarding the substances to be incorporated in tattooing inks and permanent makeup products.
These restrictions were adopted as a result of a multi-stakeholder involvement, including the European Chemicals Agency (ECHA) and the Member States through industry and NGO representatives.
What are the New Rules?
Through this initiative, the Commission instates new maximum concentration limits for several substances that are considered hazardous when incorporated into tattooing inks and permanent makeup, such as “certain azodyes and carcinogenic aromatic amines, polycyclic aromatic hydrocarbons (PAHs), metals and methanol” (The European Commission, 2020).
These restrictions will become binding for the Member States after a 12-months transition period. As a result, after this period, the tattooing inks and permanent makeup products containing ingredients exceeding the maximum concentration levels will no longer be permitted to enter the EU market.
The Legal Angle
Tattooing inks and permanent makeup products that enter the EU market have to comply with the provisions of various legal acts, such as the General Product Safety Directive (2001), the Regulation on the Classification, Labelling and Packaging of products (2008). In addition to this, they may be required to comply with the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (2006), if the products contain hazardous substances, and the Biocidal Products Regulation (2012), if they contain certain preservatives.
However, it is also interesting to explore the provisions of the Medical Device Regulation (2017) that may impact certain aspects of the tattooing industry.
According to Annex XVI of the MDR, equipment emitting high intensity electromagnetic radiation, which is intended for use on the human body, such as lasers and intense pulsed light equipment, intended for skin resurfacing, tattoo or other skin treatment, is now falling under the scope of this Regulation, even though this sort of equipment does not serve a medical purpose.
However, tattooing inks and permanent makeup products are excluded from the scope of the MDR (Official Journal of the European Union, 2017, Annex XVI.3).
In other words, the substances used for tattooing and permanent makeup must comply with different regimens, which are determined on a case-by-case basis (including the GPSD, the CLP Regulation, the REACH regulation, the BPR), while the equipment utilized for performing or removing the tattooing or the permanent makeup fall under the scope of the Medical Devices Regulation.
The EU legal framework is developing at an accelerated pace, in order to create a safer market for EU citizens and address the potential risks to their health. However, this dynamic approach may impede the entering on the EU market of tattooing and permanent makeup products manufactured outside the EU, together with their accompanying applying or removing equipment.
Regulatory Affairs Department
If you are a non-EU manufacturer and you envisage placing on the EU market tattooing or permanent makeup equipment, we invite you for a discussion to see how we can help you achieve MDR compliance for your products.
- Official Journal of the European Union. (2001) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety. Retrieved on 21/12/2021 from https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32001L0095
- Official Journal of the European Union. (2006) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) , establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Retrieved on 21/01/2021 from https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32006R1907
- Official Journal of the European Union. (2008) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Retrieved on 21/12/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32008R1272
- Official Journal of the European Union. (2009) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.Retrieved on 21/01/2021 from https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:32009R1223
- Official Journal of the European Union. (2012) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. Retrieved on 21/12/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32012R0528
- Official Journal of the European Union. (2017) REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retrieved on 21/01/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
- Sinkevičius, V. (2020). Commissioner for Environment, Oceans and Fisheries. Chemicals: EU takes action for safer tattooing inks and permanent make-up. Retrieved on 21/01/2021 from https://ec.europa.eu/newsroom/growth/item-detail.cfm?item_id=697334
- The European Chemicals Agency. (2020). Tattoo inks and permanent make-up. Retrieved on 21/01/2021 from https://echa.europa.eu/hot-topics/tattoo-inks
- The European Commission. (2020). Chemicals: EU takes action for safer tattooing inks and permanent make-up. Retrieved on 21/01/2021 from https://ec.europa.eu/newsroom/growth/item-detail.cfm?item_id=697334