Content checks for tattoo ink carried out by companies

The companies’ responsibilities vary depending on their role. Companies that sell and use tattoo ink on the Swedish market are also responsible for ensuring that the products are sterile until they are to be used.

The concentration limits for substances in tattoo ink are set in entry 75, points 1 a–h of Annex XVII of the REACH Regulation. These regulations apply to all companies, regardless of their role.

Checks to be conducted by manufacturers

Tattoo ink manufacturers are responsible for ensuring that the substances used in their products do not exceed the concentration limits. In order to verify that this is the case, they need to find out whether the tattoo inks contain limited substances and in what concentrations.

Ingredients are substances that are added during the manufacturing process for tattoo inks. These shall be declared in the list of ingredients of the tattoo ink. Ingredients such as colour pigments may contain contaminants that are subject to concentration limits for substances in tattoo inks.

Contaminants are not considered ingredients and do not need to be declared in the list of ingredients. Chemical analyses must have been conducted to check whether the restricted substances or contaminants are included in the final product (the tattoo ink), and in what concentrations.

The REACH Regulation covers concentration limits for around 4,000 substances in in tattoo inks, but it is not reasonable nor relevant to analyse all of them. Different ingredients have different problems with contaminants. Checks of certain limited substances can be more relevant for one ingredient but not for another. It is important to select and check the relevant substances that are specific to the ingredients of the tattoo ink in question.

Examples of concentration-restricted contaminants which may be present in tattoo ink include arsenic, lead, aromatic amines, and polycyclic aromatic hydrocarbons (PAH).

Tattoo inks on the Swedish marked must be sterile and must not contain living organisms (such as bacteria or fungi) or viruses.

In order to comply with the concentration limits for substances, as well as the Swedish requirement regarding sterility, you must, as a manufacturer:

• select and purchase raw materials of sufficient purity in order to comply with the concentration limits of the REACH Regulation (request analysis certificates for the raw materials you purchase or, when necessary, conduct an analysis of the raw materials to check if they contain restricted substances)
  
• select and purchase raw materials of sufficient microbiological quality and use good manufacturing practice to avoid microbiological contamination of the tattoo ink
  
• use packaging materials that are compatible with the tattoo ink being manufactured that do not contaminate the product, that do not leak, and that maintains the product sterility until the product is to be used (see requirements in 2 § Läkemedelsverkets föreskrifter (HSLF-FS 2022:16) om tatueringsfärger
  
• use cleaned manufacturing equipment (without residues from cleaning agents/disinfectants) made from materials that will not contaminate the tattoo ink (certain materials can release substances that are subject to restrictions)
  
• have the manufactured and sealed product sterilised using an appropriate method (e.g. radiation).
  

Tattoo inks on the Swedish market shall also be labelled according to HSLF-FS 2022:16, such as expiry date. In order for manufacturers to be able to provide the products with a expiry date label, they need to test how long the products last before expiring. A product’s expiration date is influenced by the product content, among other things.

As a tattoo ink manufacturer, you also need information about the substances present in the product in order to classify the product pursuant to the CLP Regulation.

Checks to be conducted by importers

Tattoo ink importers are responsible for ensuring that the substances present in their products do not exceed the concentration limits. In order to verify that this is the case, they need to find out whether the tattoo inks contain limited substances and in what concentrations. Since importers do not manufacture the tattoo inks themselves, they need access to the relevant documentation from manufacturers outside the EU/EEA.

The documentation from the manufacturer is needed to check that concentration limits for restricted substances, relevant to the product ingredients, are not exceeded. If the manufacturer states that neither the tattoo ink or the ingredients have been analysed, the importer need to conduct analyses of their own.

Tattoo inks placed or used on the Swedish market by the importer must also meet the sterility requirement pursuant to förordning (2012:503) om tatueringsfärger. Sterile means that the products do not contain any living organisms (such as bacteria or fungi) or viruses.

The packaging of the tattoo inks must also maintain the product’s sterility until they are used pursuant to HSLF-FS 2022:16. Documentation from the manufacturer needs to show that the products have been sterilised. The importer should also check that the tattoo inks are not leaking (leaking products are not sterile).

As a tattoo ink importer, you also need information about the substances present in the product in order to classify the product pursuant to the CLP Regulation.

Checks to be conducted by distributors and tattooists

Distributors who purchase tattoo inks from EU/EEA countries to sell and tattooists who use tattoo inks are also responsible for ensuring that the tattoo ink complies with the restriction.

In order to verify compliance with the restriction, distributors and tattooists can, for example, establish agreements with their suppliers so that the products meet the concentration limits in the restriction.

They can also direct specific questions to the supplier in order to confirm compliance with the restriction. The questions and answers should be documented.

Distributors placing tattoo inks on the Swedish market and Swedish tattooists who use tattoo ink also need to verify that the tattoo inks meet the sterility requirement and the requirement that the packaging shall maintain the sterility of the product until it is used.

Specific questions can also be directed at the supplier to confirm that the tattoo ink has been sterilised. The questions and answers should be documented. They must also verify that the tattoo ink has labelling about sterility pursuant to HSLF-FS 2022:16 and that they are not leaking (leaking products are not sterile).