Labelling regulations

Tattoo ink released and used in the EU/EEA shall meet the labelling requirements pursuant to:

• entry 75, point 7, column 2 of Annex XVII of the REACH Regulation
• the CLP Regulation
• HSLF‍-‍FS 2022:16.

Sweden has language requirements regarding tattoo inks through the Swedish Medical Products Agency regulations (HSLF‍-‍FS 2022:16) on tattoo inks. Sweden has language requirements regarding the labeling of tattoo inks through Läkemedelsverkets föreskrifter (HSLF‍-‍FS 2022:16) om tatueringsfärger.

Labelling requirements

According to the REACH Regulation

The labelling required according to entry 75, point 7, column 2 of Annex XVII of the REACH Regulation is:

• The statement “blandning för användning i tatueringar eller permanent makeup” or the corresponding labeling in English “mixture for use in tattoos or permanent make‍-‍up”, which must be displayed on the packaging (the bottle) (point 7 a).
• A reference number (batch number) used to unambiguously identify the batch (point 7 b).
• A list of the ingredients (see point 7 c for details).
• The additional statement “pH‍-‍reglerare” or the corresponding labeling in English ” for substances used solely for this purpose (point 7 d).
• The statement “Innehåller nickel. Kan framkalla en allergisk reaktion.” if the mixture contains a concentration of nickel below the concentration limit specified in Appendix 13 (point 7 e). Note that the statement must be written in Swedish.
• The statement “Innehåller krom (VI). Kan framkalla en allergisk reaktion.” if the mixture contains a concentration of chromium (VI) below the concentration limit specified in Appendix 13 (point 7 e). Note that the statement must be written in Swedish.
• Safety instructions for use insofar as they are not already required to be stated on the label by Regulation (EC) No 1272/2008 (CLP Regulation) (point 7 g). Note that the instructions must be written in Swedish

This labelling shall be clearly visible, easily legible and marked in a way that is indelible. Where necessary because of the size of the package, the information according to point 7, except for point a, shall be included instead in the instructions for use.

If the tattoo ink bottle is very small, it may therefore be permissible to provide some of the information according to point 7 in the instructions for use. However, the Swedish Medical Products Agency believes that information about batch number always should be provided on the bottle. If the tattoo ink bottles does not have batch numbers, there is a risk mixing up different batches of tattoo inks.

Also keep in mind that tattooists before tattooing are obligated to provide their customer with information about tattoo inks according to point 7, which includes the batch number of the tattoo ink.

According to the CLP Regulation

Tattoo inks are chemical products which may need to be labelled pursuant to the CLP Regulation. If a tattoo ink on the Swedish market needs to be labelled pursuant to the CLP Regulation, this labelling shall be written in Swedish.

More information about the CLP Regulation is available from the Swedish Chemicals Agency.

According to Swedish legislation

Tattoo ink placed or used on the Swedish market shall be labelled pursuant to 7 § HSLF‍-‍FS 2022:16. This labelling must be printed on the packaging or in the instructions for use:

• Name or company name and address or registered place of business for the party manufacturing the tattoo ink in Sweden or imports the tattoo ink to Sweden, provided that the contact information in the form of name, address, and telephone number within the EU has not already been provided in the labelling pursuant to the CLP Regulation.
• Expiry date.
• A guarantee that the contents are sterile until its packaging is opened.

Language requirements for labelling

For tattoo inks released or used on the Swedish market, certain parts of the labelling shall be written in Swedish, while other parts of the labelling may be written in Swedish or English. Sweden’s language requirements for tattoo ink labelling are described in the table below:

Manufacturers and importers

Those who manufacture or import tattoo inks to Sweden from countries outside the EU/EEA are responsible for that:

• the tattoo inks being labelled pursuant to entry 75, point 7, column 2 of Annex XVII of the REACH Regulation
• the tattoo inks being labelled pursuant to the provisions in the CLP Regulation
• the tattoo inks being labelled pursuant to 7 § HSLF‍-‍FS 2022:16
• ensuring that the labelling on the tattoo inks comply with the Swedish language requirements in 8 § HSLF‍-‍FS 2022:16

Knowledge about ingredients and impuritites are crucial for manufacturers and importers of tattoo inks to be able to correctly label the tattoo inks.. Ingredients are to be listed in the list of ingredients pursuant to entry 75, point 7 c, column 2 of Annex XVII of the REACH Regulation.

Impurities are not regarded as ingredients and shall therefore not be included in list of ingredients. Tattoo inks containing the impurities nickel and chromium (VI) should however be marked with warnings pursuant to entry 75, points 7 e and f, column 2 of Annex XVII of the REACH Regulation.

Distributors

As a distributor, you are responsible for:

• ensuring that the products you sell are correctly labelled and packaged pursuant to the REACH and CLP Regulations
• ensuring that the tattoo inks being labelled pursuant to 7 § HSLF‍-‍FS 2022:16
• ensuring that the labelling on the tattoo inks comply with the Swedish language requirements in 8 § HSLF‍-‍FS 2022:16.

Choose an established supplier that is aware of and complies with the rules. Ask the supplier questions to make sure the rules are followed. These questions and the answers thereto should be documented. Also verify that the products have the required labelling. If there is no labelling or the labelling does not meet the Swedish language requirements, the label needs to be corrected.

Tattooist

As a tattooist, you are responsible for:

• verifying that the tattoo ink you intend to use for tattoos are labelled “blandning för användning i tatueringar eller permanent makeup” or “mixture for use in tattoos or permanent make‍-‍up”. According to 8 § HSLF‍-‍FS 2022:16, this label may be written in Swedish or English (products lacking this label may not be used for tattooing purposes)
• verifying that the products you intend to use have the correct labelling information pursuant to entry 7, column 2 of entry 75 of Annex XVII of the REACH Regulation
• providing the customer with labelling information pursuant to point 7, column 2 in post 75 of Annex XVII of the REACH Regulation for the tattoo ink/inks you intend to use in the tattoo prior to the start of the tattooing
• verifying that the product have the correct labelling information pursuant to 7 § HSLF‍-‍FS 2022:16 pursuant entry 7, column 2 of entry 75 of Annex XVII of the REACH Regulation
• verifying that the product labelling and the information intended to be provided to the customer meets the Swedish language requirements pursuant to 8 § HSLF‍-‍FS 2022:16
• using tattoo inks in accordance with the labelling, instructions and safety data sheets attached to the product.

Choose an established supplier that is aware of and complies with the rules. Ask the supplier questions to make sure the rules are followed. These questions and the answers thereto should be documented. Also verify for yourself that the products have the required labelling. If there is no labelling or the labelling does not meet the Swedish language requirements, the label needs to be corrected.