One particularly interesting group of chemical products from a safety perspective is tattoo inks. Data cited by the European Chemicals Agency (ECHA) indicate that at least 12% of Europeans have a tattoo, while in the 18–35 age group the proportion may be as high as twice that.

Considering also the way tattoo inks are used—through direct and long-term contact with the human body—it is hardly surprising that there is a need to control the safety of this product group. For a long time, however, tattoo inks were not regarded under EU law as a separate product category and were treated as “ordinary chemicals”. Although this may seem surprising, they do not meet the definition of a cosmetic product and therefore were not regulated in a similar manner.

In practice, this meant that placing such products on the market required compliance with requirements comparable to those applicable to printing inks.

This situation understandably raised concerns among both consumers and authorities, which resulted in the introduction in 2020 of a REACH restriction on substances that may be used in tattoo inks. While the legal classification of tattoo inks did not change, their safety level was significantly increased by eliminating from the market products containing hazardous or toxic substances.

Of course, the question arises as to how serious the problem actually was and whether tattoo inks available on the market prior to the restriction were genuinely harmful to human health, or whether this was primarily a “regulatory” move.

Australia: Toxic Substances in Tattoo Inks

 

In a recently conducted study of 15 tattoo ink samples, Australian researchers found that none of them would meet the standards applicable to such products in the European Union.

The study analysed 8 black and 7 coloured inks, all purchased from Australian suppliers. All samples were assessed against the limits introduced in the EU, as similar restrictions do not currently apply in Australia.

The results were unambiguous: in every sample, the level of at least one metal exceeded the safety limits established in the EU. Antimony was present in all samples at concentrations above the permitted values.

Further analyses revealed the presence of toluidine, which is considered carcinogenic, as well as sulfanilic acid, which is suspected of having such properties.

The test results alarmed researchers, who are now calling for higher safety standards for tattoo inks on the Australian market.

Regulation (EU) 2020/2081

 

The restriction concerning tattoo inks and permanent make-up in the EU was introduced by Regulation (EU) 2020/2081. It prohibited the use in tattoo inks of a very broad range of substances, including those that may cause allergic reactions, skin irritation or eye irritation. Although tattoo inks are still not classified as cosmetic products, the REACH restriction also indicates that they may not contain substances that are regulated under the Cosmetics Regulation as prohibited for use in cosmetic products. The restriction also imposed strict controls on the presence of toxic metals in tattoo inks.

Additional labelling requirements were introduced as well, such as the statement “Mixture for use in tattoos or permanent make-up”, the inclusion of a list of ingredients, and the obligation to provide a reference number on the label to enable clear identification of the batch.

CLP and REACH Requirements for Tattoo Inks

 

For most products, the provisions began to apply on 4 January 2022, significantly affecting the regulatory framework and safety of tattoo inks on the EU market. It should be remembered, however, that this product group is still not classified as cosmetics. This means that, in addition to verifying compliance with the requirements set out in Regulation (EU) 2020/2081, the following documentation obligations applicable to other chemical products must also be met (where required):

• a safety data sheet in the language of the country where the product is placed on the market;
• CLP classification;
• CLP-compliant labelling;
• submission of a PCN notification;
• for products imported from outside the EU – submission of a C&L notification.

 

Summary

 

For many years, tattoo inks remained in a regulatory limbo, which may have adversely affected user safety. With the introduction of the REACH restriction, the level of control over this product group has increased significantly. For businesses, this means additional obligations and the need for a proper assessment of their products before placing them on the market. If your company requires support in this area, we invite you to contact us.