From 5th January 2022, there are new rules for tattoo ink in Sweden and other EU member states. Norway and Great Britain have also chosen to follow the same path. Each country may have different variations of its regulations, but in general it is equivalent. They now choose to regulate tattoo ink via Reach (Registration, Evaluation, Authorization and Restriction of Chemicals). Everything is controlled within the EU via ECHA (European Chemical Agency) and our equivalent in Sweden is called the Chemicals Inspectorate. Supervision of colors in Sweden is carried out by the Medical Products Agency.
The new EU rules must ensure that tattoo inks do not contain too high levels of harmful substances. The Swedish Medicines Agency is given supervisory responsibility for the new rules and sees the rules as an important step towards safer tattoo inks in the EU.
- We welcome the new rules. Previous checks have shown that many tattoo inks on the Swedish market contain harmful substances such as arsenic, lead and polycyclic aromatic hydrocarbons. With the new EU-rules, there will be sharper requirements and clearer which rules apply in Sweden and other EU/EEAcountries, says Magnus Crona, investigator at the Medical Products Agency.
The new rules mean in brief:
- Concentration limits for thousands of harmful substances.
- Labeling requirements.
- Requirement that tattooists may only use products labeled "mixture for use in tattoos or permanent makeup" when tattooing.
- Requirement that tattoo artists must provide the customer with information about the tattoo color before tattooing.
- The requirement that tattoo artists provide the customer with information about the tattoo color must ensure that the customer receives the product's list of contents and information about the impurities nickel and chromium (VI) included. People who are allergic to nickel should therefore be able to avoid tattoo inks that contain the substance, says Magnus Crona, investigator at the Medical Products Agency.
Tattoo inks must also meet requirements in other EU legislation, the CLP regulation, which contains rules for the classification, labeling and packaging of chemical products. For tattoo inks on the Swedish market, our supplementary Swedish tattoo ink legislation also applies, which among other things requires that tattoo inks be sterile.
At least 12 percent of EU residents are tattooed and the tattoo inks used for tattooing and permanent makeup may contain harmful substances. The EUCommission therefore saw a need to produce common EUrules for tattoo inks to protect citizens' health. Since 15 December 2020, such rules have been in the EU's REACH chemical legislation, but it is only on 5 January 2022 that tattoo inks need to comply with the new rules.
Roles and responsibilities
The companies are responsible for ensuring that the tattoo inks they sell or use meet the regulations. The duties vary in extent depending on the role a company has. Those who manufacture or import tattoo inks have the most extensive obligations. Even those who distribute tattoo inks and tattoo artists who use tattoo inks have obligations.
Through changes in the Environmental Supervision Ordinance (2011:13), the Medical Products Agency will on 5 January 2022 be responsible for supervision and guidance linked to the new tattoo color regulations. This means that the Swedish Medicines Agency will carry out random checks of tattoo inks on the Swedish market and answer questions about the new rules.
