Content regulations

Substance regulations and sterility requirements

Tattoo inks placed on the market or used on the market are not allowed to contain concentrations of hazardous substances that exceed the concentration limits pursuant to entry 75 of Annex XVII of the REACH Regulation.

This entry limits:

• the substances listed in Appendix 13 of the annex
• the substances listen in Annex II, and
• certain substances in Annex IV of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, and
• substances with a harmonised classification for certain hazard classes and hazard categories in Annex VI of the CLP Regulation.

There are currently around 4,000 substances in tattoo ink subject to restrictions in entry 75, however all of these are not necessarily present in tattoo ink. The number of restricted substances will be increased to include new substances that receive a harmonised classification pursuant to the CLP Regulation.

Responsibility

Manufacturers of tattoo ink within the EU/EEA and importers of tattoo inks to the EU/EEA are responsible for verifying that the products do not exceed the concentration limits for substances in entry 75, point 1 a–h in Annex XVII of the REACH Regulation.

Those who distribute or use tattoo ink also have a responsibility to ensure that the tattoo inks meet this requirement. For more information on responsibilities of different companies for content regulations is found on page.

Concentration limits

Substances listed in Appendix 13 of Annex XVII of the REACH Regulation

Persuant to entry 75, point 1 h of Annex XVII of the REACH Regulation, substances presentin tattoo ink may not exceed the concentration limits for the substances listed in Appendix 13 of the annex. Appendix 13 lists various substances such as lead, colour pigments, chromium, nickel, aromatic amines and polycyclic aromatic hydrocarbons.

In some cases, concentration limits only regulate certain forms of substances, such as hexavalent chromium (chromium VI) and copper in soluble form. Concentration limits for polycyclic aromatic hydrocarbons apply only to substances with certain harmonized classifications.

For nickel, the concentration limit is 0.0005% in tattoo ink, which means that nickel levels that are equal to or above this value are prohibited.

Nickel concentrations below 0.0005% (the equivalent of 5 ppm or 5 mg/kg) are accepted in tattoo ink and such products shall be equipped with a warning about the nickel contents pursuant to entry 75, point 7 e, column 2 of Annex XVII of the REACH Regulation. For tattoo inks on the Swedish market such warning has to be written in Swedish.

For hexavalent chromium, the concentration limit is 0.00005% in tattoo ink, which means that levels that are equal to or above this value are prohibited.

A hexavalent chromium concentration below 0.00005% (the equivalent of 0,5 ppm or 0,5 mg/kg) are acceptable in tattoo ink and such products shall be equipped with a warning about the chromium contents pursuant to item 75, point 7 f of Annex XVII of the REACH Regulation. For tattoo inks on the Swedish market such warning has to be written in Swedish.

Substances with a harmonised classification pursuant to the CLP Regulation

Entry 75, points 1 a, b, c, and d of Annex XVII of the REACH Regulation contains concentration limits for substances with a harmonised classification for certain hazard classes and hazard categories pursuant to Annex VI of the CLP Regulation.

This concerns substances classified as:

• carcinogenic
• toxic for reproduction
• mutagenic
• sensitising
• corrosive/irritant.

For example, the substance isopropanol has a harmonised classification as “eye irritant, category 2” according to Annex VI of the CLP Regulation. This means that the concentration limits according to point 1 d in entry 75 of Annex XVII apply to isopropanol, i.e. concentrations equal to or higher than the limit for the substance in question are prohibited from use in the tattoo ink.

To find out whether a substance has a harmonised classification which entails that the substance has a concentration limit in tattoo inks, you can search for the substance in the European Chemicals Agency’s (ECHA) classification and labelling register.

Substances listed in Annex II and IV of the EC-regulation on cosmetic products

Entry 75, points 1 e, f, and g of Annex XVII of the REACH regulation covers concentration limits for the substances listed in Annex II and the colourants listed in Annex IV (with restrictions pursuant to column g) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Regulation on Cosmetic Products).

To find out whether a substance in your tattoo ink is listed in Annex II or in Annex IV (with restrictions pursuant to column g) in the Regulation on Cosmetic Products, you can search the European Commission’s database CosIng or the Regulation on Cosmetic Products itself.

The colour pigments pigment blue 15:3 (CI 74160) and pigment green 7 (CI 74260) are listed in Annex II of Regulation (EC) No 1223/2009. Pigment green 7 is also listed with restrictions in column g in Annex IV of Regulation (EC) No 1223/2009. According to point 4, entry 75 of Annex XVII of the REACH Regulation, the concentration limits for pigment blue 15:3 and pigment green 7 pursuant to points 1 e and f do not apply until 4 January 2023.

This means that pigment blue 15:3 (CI 74160) and pigment green 7 (CI 74269) are allowed for use until 4 January 2023.

Sterility requirements

According to förordning (2012:503) om tatueringsfärger, tattoo inks placed on or used on the Swedish market must be sterile. Sterile means the absence of microorganisms and viruses.

According to Läkemedelsverkets föreskrifter (HSLF-FS 2022:16) om tatueringsfärger:

• a tattoo ink’s packaging must maintain the ink’s sterility until it is used.
• tattoo inks must bear a label verifying their sterility.

Tattoo ink manufactures must use raw materials of sufficient microbiological quality.

It is also important to prevent the product from being contaminated during production. The manufactured and sealed product must also be sterilised using appropriate method. Radiation is often used to sterilise tattoo inks.

In order for the tattoo ink to retain its sterility, it also needs to be packed in a sealed container that does not leak. There are different ISO standards on sterilisation of products which may be of use for manufacturers.

Since tattoo inks often contain water, this normally requires preservatives to be added to counteract prevent microbiological growth. 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. If you have any question, please contact the Swedish Chemicals Agency.

The European Commission’s warning system RAPEX

If checks carried out by authorities within the EU/EEA show that tattoo inks on the market do not comply with the concentration limits pursuant to entry 75 of Annex XVII of the REACH Regulation, they are to report the products in the European Commission’s warning system called “Rapid alert system for dangerous non-food products” – RAPEX.