Regulation on chemicals and cosmetics by the Ministry Social Affairs and Health to ensure the safety and supervision of tattoos
A tattoo is a permanent skin decoration with ink that is injected into the lower layers of the skin with the help of a needle. The regulations governing tattooing focus on colourants and other substances used in their creation, as well as to the tattoo services themselves. From a legal point of view, tattooing is not comparable to cosmetics.
How are the colourants and chemicals used in tattooing regulated?
The Ministry of Social Affairs and Health provides guidance and develops legislation on chemicals, which also covers colourants and auxiliary ingredients used in tattoos and permanent pigmentations. Earlier, these substances were covered by the regulation on cosmetics and their use for tattoos was not regulated at the EU level.
The gap in the legislation was corrected in January 2021 when the restriction under the REACH Regulation (Commission Regulation (EU) 2020/2081) restricted the use of or prohibited most of the chemicals used in tattooing colourants and auxiliary ingredients. REACH Regulation is Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals.
The purpose of the restriction is to ensure that the substances used in tattooing are safe.
How is tattooing regulated as a service?
The Consumer Services Safety Act of the Ministry of Economic Affairs and Employment (185/2025) also applies to tattooing services. Besides this, the tattooing businesses must comply with the Health Protection Act (763/1994) of the Ministry of Social Affairs and Health and provide the written notification required by law on setting up or taking into use a place of business to the municipal health protection authority.
The tattoo artist must provide a safety document including a plan for identifying and managing the risks associated with the service and communicating on them. The act also requires that operators inform consumers of the risks involved and ensure that the service and consumer goods provided do not pose a risk to health.
The Health Protection Act also applies to the premises where tattoo services are provided. According to the Health Protection Act, the tattoo artist must notify the local health protection authority of their operations in order that systematic supervision will be extended to the premises.
What are the health risks associated with tattoos?
Tattoos are not recommended for those under the age of 18. In particular, pregnant women, those with severe underlying conditions and those receiving medication that affects the immune system should be aware of the health risks associated with tattooing. Most of the adverse reac-tions associated with tattoos are unpredictable. They may occur at any time during a person's lifetime.
Tattoos are long-lasting, as ink usually remain in the skin for at least several decades. Some of the tattoo ink breaks down in the body over time or passes into the lymph nodes, for example. Within the framework of chemicals legislation, the use of substances specifically as tattooing colourants has not been separately assessed, so there is very little research on the risks of long-term exposure to them.
Hypersensitivity reactions caused by pigments and inks are the most common adverse reactions associated with needle tattooing.
In case of insufficient hygiene, needle tattooing may predispose customers to blood-transmitted infections such as hepatitis B and C, HIV and severe bacterial infections. Chronic skin disease may also break out in the tattooed skin area. So far, it is unclear whether there is a link between tat-toos and skin cancer.
Who is responsible for supervision related to tattoos?
The Finnish Safety and Chemicals Agency (Tukes) monitors that tattoo inks on the market comply with the requirements of chemicals legislation.
Tukes also monitors the safety of consumer services, i.e. that the facilities, equipment and other supplies used in the service comply with the requirements. The supervision also helps ensure that the customer has been given the necessary information and care instructions as well as knowledge of the potential risks.
Municipal health protection authorities supervise matters such as hygiene and the storage of equipment at tattoo parlours.
Customs may also intervene in violations of legislation when importing tattoo inks and accesso-ries.
Lisätietoja
Hanna Korhonen, Ministerial Adviser
Ministry of Social Affairs and Health, Department for Safety, Security and Health / TUTO, Wellbeing and Health Protection Unit / HYT Telephone:0295163041 Email Address: [email protected]