Tattoo inks

Tattoo and permanent make-up inks are intended to make a symbol or picture on a person’s body. The ink is injected or inserted into the person’s skin, mucous membrane or sclera using any applicable method. These methods include permanent pigmentation, cosmetic tattooing, microblading and micropigmentation.

The use of thousands of hazardous substances in tattoo and permanent make-up inks will be restricted in the EU from January 2022. Non-compliant tattoo and permanent make-up inks cannot be sold or used for tattooing purposes.

What substances contained by tattoo and permanent make-up inks does the restriction apply to?

The restriction applies to substances that:

  • are carcinogenic 
  • are mutagenic 
  • are toxic to reproduction
  • cause skin sensitisation 
  • cause skin corrosion or irritation, can cause serious eye damage or eye irritation
  • are prohibited in cosmetic products 
  • are colourants permitted only in rinse-off cosmetic products
  • are prohibited colourants in cosmetic products intended for mucous membranes 
  • are prohibited colourants in cosmetic products intended for eyes 
  • are permitted colourants in cosmetic products, but for which a maximum concentration or other restriction
  • has been listed in entry 13 in Annex XVII to the REACH regulation.

Where can you check whether a tattoo ink contains restricted substances?

Companies can contact the ink manufacturer or importer to identify whether the ink contains any restricted substances. Information is also available in the ink’s safety data sheet and any list of ingredients included in the packaging. 

Safety data sheets regarding hazardous inks can always be obtained from the ink supplier. You can also request a safety data sheet regarding non-hazardous inks, and it must be provided for you if the ink contains any harmful or hazardous ingredients. Section 3.2 of the safety data sheet includes information about ingredients and Section 15 about restrictions.

Where are restricted substances listed?

Marking requirements

The packaging of a tattoo and permanent make-up ink must include: 

  • the text “Mixture for use in tattoos or permanent make-up”
  • batch number
  • list of ingredients
  • the additional text “pH control agent” for pH control agents, whose concentration must be less than 0.1%
  • safety instructions for use
  • the text “Contains nickel. Can cause allergic reactions.” if the nickel content is less than 0.0005%
  • the text “Contains chromium (VI). Can cause allergic reactions.” if the chromium (VI) content in the mixture is less than 0.00005%   

The customer  receiving the tattoo must be provided with the information indicated on the packaging and included in the instructions for use of the tattoo ink. For example, the customer can use the list of ingredients to identify any substances they have been advised to avoid (e.g. due to allergies).

If an ink has been classified as hazardous in accordance with the CLP Regulation, or it contains certain harmful or hazardous substances, a warning label must be attached to the packaging. 

Inks sold in Finland must include markings in Finnish and Swedish.

If an ink does not contain the text “Mixture for use in tattoos or permanent make-up”, it cannot be used for tattooing.

Preservatives

Preservatives used in tattoo and cosmetic tattoo inks must be compliant with biocide legislation, approved in the EU or under evaluation. For more information, please search for “Product type 6” chemicals from the ECHA register of biocidal active substances. 

Notification to Tukes’ Chemical Products Register and the Finnish Poison Information Centre

Companies must use a chemical notification to submit information on the tattoo ink they have placed on the market to the relevant authority. The chemical notification must be submitted through the KemiDigi system. Information must be submitted to the Finnish Poison Information Centre through the submission portal maintained by the European Chemicals Agency (ECHA).

Legislation

See also