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Regulations for tattoo inks

  • Published: May 25, 2022
  • Last updated: May 25, 2022

The regulations for tattoo inks impose requirements on the contents and labelling of the products, as well as requirements on those using the products. Your responsibilities will vary depending on your company’s role in the supply chain. A single company can have several different roles.

Tattoo inks for tattooing and permanent makeup are examples of chemical products. As such, they must comply with the requirements for chemical products listed in the follow EU legislation, among others.

  • Regulation (EC) No 1907/2006 of the European Parliament concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
  • Regulation (EC) No 1272/2008 of the European Parliament and the Council on classification, labelling and packaging of substances and mixtures.
  • Regulation (EU) No 528/2012 of the European Parliament and the Council concerning the making available on the market and use of biocidal products.

Restrictions in entry 75 in Annex XVII of the REACH Regulation applies to tattoo inks placed on the market and used after 4 January 2022. The REACH Regulation also contains regulations regarding safety data sheets.

Tattoo inks are chemical products that must be classified, labelled, and packaged in accordance with the requirements of the CLP Regulation.

The use of preservatives in tattoo inks are regulated by 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.

Sweden also has national legislation that imposes requirements on tattoo inks on the Swedish market through förordning (2012:503) om tatueringsfärger and Läkemedelsverkets föreskrifter (HSLF-FS 2022:16) om tatueringsfärger.

This Swedish legislation requires that:

  • Tattoo inks must be sterile and packed in packages that maintain the sterility of the tattoo inks.
  • Tattoo inks must have specific labelling.
  • Manufacturers of tattoo inks in Sweden or importers of tattoo inks to Sweden must notify the tattoo inks to the Swedish Medical Products Agency.

Answers to questions about the regulations

The Swedish Medical Products Agency and the Swedish Chemicals Agency are responsible for guidance regarding the various parts of the legislation that apply to tattoo inks.

For questions about restrictions on tattoo inks in entry 75 in Annex XVII of the REACH Regulation, förordning (2012:503) om tatueringsfärger or Läkemedelsverkets föreskrifter (HSLF-FS 2022:16) om tatueringsfärger, please contact the Swedish Medical Products Agency.

For question regarding other requirements in the REACH Regulation, CLP Regulation and biocidal products Regulation, please contact the Swedish Chemicals Agency.

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