REACH INFO
From the 5th of January 2022, there are new rules for tattoo color in Sweden and other EU member states. Norway and the United Kingdom have also chosen to follow the same path. Each country may have different variants of its regulations, but on the whole it is equivalent. They now choose to regulate tattoo color 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 Swedish Chemicals Agency. Supervision of colors in Sweden is done by the Medical Products Agency.
Qoute from Lakemedelsverket.se below:
The new EU regulations for tattoo inks apply from 5 January 2022. The rules mean concentration limits for harmful substances in tattoo inks, requirements for labeling and requirements for the tattooists who use the products. The new EU rules will ensure that tattoo inks do not contain too high levels of harmful substances.
The Medical Products Agency will be given supervisory responsibility for the new rules and sees the rules as an important step towards safer tattoo colors in the EU. - We welcome the new rules.
Previous inspections have shown that many tattoo inks on the Swedish market contained harmful substances such as arsenic, lead and polycyclic aromatic hydrocarbons. With the new EU rules, it will be sharper requirements and clearer which rules apply in Sweden and other EU / EU countries, says Magnus Crona, investigator at the Medical Products Agency.
In short, the new regulations mean:
Concentration limits for thousands of harmful substances. Labeling requirements. Requirement that tattooists may only use products marked with "mixture for use in tattoos or permanent makeup" when tattooing. Requirement that tattooists before tattooing must provide the customer with information about the tattoo color. - The requirement that tattooists must provide the customer with information about the tattoo color must ensure that the customer receives the product's table of contents and information about the contaminants nickel and chromium (VI) is 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 in Sweden. Tattoo inks must also meet the requirements of other EU legislation, the CLP Regulation, which contains rules for the classification, labeling and packaging of chemical products. For tattoo colors on the Swedish market, our supplementary Swedish tattoo color legislation also applies, which, among other things, requires that tattoo colors must be sterile.
At least 12% of EU citizens are tattooed and the tattoo inks used for tattooing and permanent makeup can contain harmful substances. The EU Commission therefore saw a need to develop common EU rules on tattoo colors in order to protect the health of citizens. Since 15 December 2020, such rules have been in the EU chemicals legislation REACH, but it is only on 5 January 2022 that tattoo paints need to comply with the new rules. Roles and responsibilities The companies are responsible for ensuring that the tattoo colors they sell or use comply with the rules. The obligations vary in scope depending on the role of a company. 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 amendments to the Environmental Supervision Ordinance (2011: 13), the Medical Products Agency will on 5 January 2022 be given responsibility for supervision and guidance linked to the new tattoo color rules. This means that the Medical Products Agency will carry out random checks of tattoo inks on the Swedish market and answer questions about the new rules.