3. Inspection procedures

The framework for the Joint Control of Tattoo Inks project, along with the project plan, was established during a group meeting held in Oslo in February 2023. Prior to this meeting, each country had developed its own plan for controlling tattoo inks, drawing advantage of the fact that Sweden had already initiated their controls. However, the group collectively agreed on a set of common checklist items that were controlled and reported on. Subsequent communication in the group occurred through an online communication platform, and several digital meetings.

The Norwegian Environment Agency performed 18 controls at selected stores and tattoo shops. The controlled stores are the two largest suppliers of tattoo inks in Norway. The tattoo shops mainly consisted of two or more tattoo artists who shared shop space but run their own separate enterprises. The tattoo artists were all users according to the Reach definition.

The control objects were chosen based on information from the Norwegian Food Safety Authority's registry of tattoo ink importers, internet research and general knowledge of the inspectors. Most of the control objects were located in the greater Oslo area.

A press release about the controls along with information about the new regulation, was announced at the Norwegian Environment Agency's web page prior to the inspections: Tatoveringskjemikalier kontrolleres - miljodirektoratet.no

A press release with inspections results was announced after the completion of the inspections: Informerer ikkje godt nok om innhald i tatoveringsblekk - miljodirektoratet.no

Two to seven inks were selected for control at each controlled economic operator. The inks were selected from different brands/suppliers and in a variety of colours. The ink labels were inspected according to the requirements in points 7 a-g to Annex XVII, entry 75 of Reach and pictures were taken for documentation. The lists of ingredients were controlled for legal content according to point 1 a-h back at the office.

No analyses of the inks were performed. The requirement for inks users (tattoo artist) to give the information on the ink label to their customers was also controlled.

Any non-compliance regarding labelling or content was followed up with the suppliers. 

The Swedish Medical Product Agency (the Swedish MPA) performed a risk-based selection of 46 tattoo inks (incl. permanent make up) for the  market surveillance. Out of these 46 inks, 31 inks were from traditional economic operators

Traditional economic operator means a natural or legal person subject to obligations regarding the content, labeling and/or use of tattoo inks (e.g. manufacturer, importer, distributor or professional user of an ink).

and 15 were from online marketplaces (CDON.se, Amazon.se, Fruugo.com and Fyndiq.se). The selection of economic operators was based on information in the Agency’s product registry over tattoo inks

According to the Swedish regulation (2012:503) on tattoo inks, anyone who professionally manufactures a tattoo ink or brings such an ink into Sweden shall notify the Swedish Medical Products Agency for registration in the product register referred to in section 4. The notifier shall provide the information required for registration. If the information changes, the notifier shall inform the Agency of this.

and was based on tattoo inks that were available on the Swedish market, either by webpages or online marketplaces. 

The 46 inks were chemically analysed by the Netherlands Food and Consumer Product Safety Authority (NVWA) with focus on a selection of aromatic amines, polycyclic aromatic hydrocarbons (PAH) and heavy metals.

The labelling of the 46 inks was also controlled in regard to points 7 a-g to Annex XVII, entry 75 of Reach and 7 § points a-c to the Swedish MPA’s provision (HSLF-FS 2022:16) for tattoo inks.

Suppliers placing a tattoo ink on the market is responsible for ensuring that their ink(s) have all the mandatory labelling, while tattoo artist who only use the inks (neither import, sell or otherwise supply the products to third parties) do not have the same extensive requirements. However, the lack of certain information can prevent the tattoo artist to fulfil the obligation under point 8 to Annex XVII, entry 75 of Reach (the information to be provided to the customer before tattooing). Where applicable, the Swedish MPA has informed the user of tattoo inks about deficiencies in the labelling. 

A list of the included substances in the analysis and a list of selected tattoo inks in the Swedish project can be found in the published report on the Swedish MPA’s webpage (see Annex 1 and 2, referred as “bilaga 1” and “bilaga 2”): Kontroll av tatueringsfärger på den svenska marknaden 2022–2023 | Läkemedelsverket (lakemedelsverket.se)

The Danish Chemical Inspection Service performed a nationwide control which consisted of a combination of physical inspections and border controls.

The Danish Chemical Inspection Service performed five physical inspections located all over the country. Two inspections were carried out at tattoo shops (downstream users), one inspection at the manufacturer of PMU-colours (permanent makeup) and two inspections were located at the largest distributors in Denmark.

In cooperation with The Danish Customs Controls shipments were detained. The Inspection had prepared a fact sheet for The Danish Customs Controls to clarify the rules of restriction nr 75. This initiative was taken to support The Danish Customs Controls in which products should be detained for further inspection. We consider the factsheet being particular useful, as mostly non-compliance products have been taken out for inspection.

The physical inspections were notified in advance and the companies were selected based on the following criteria:

August 2023, an inspector from The Danish Chemical Inspection Service participated in a stakeholders' meeting from the tattoo business and gave a presentation on the project as well as the requirements for labelling and ingredients. Examples of some non-compliant products were also shown.

The Danish Chemicals Inspection Service primary found compliant products during the physical inspections. All physical inspections had focus on guidance. It seems that the industry was familiar with the new restriction.

During collaboration with The Danish Customs, 13 shipments were taken out for inspection. Three  of these shipments were released with a guidance paper. A total of 86 products were detained by the border, and 71 products turned out as non-compliant and were seized and destroyed.

The majority of the products were imported from outside the EU.

Only labelling on the ink was controlled, none of the inks were analysed.

The Finnish Safety and Chemicals Agency (Tukes) selected 7 tattoo inks and 14 permanent make up pigments for the market surveillance. 19 of these samples from traditional online web shops and two of the samples were from online marketplaces.

 The selection of economic operators was based on information in the Agency’s product registry (KemiDigi) and was based on information on the tattoo inks that were available on the Finnish market either by webpages or online webstores.

The inspected products were purchased from online stores. The inks were chemically analysed by the Netherlands Food and Consumer Product Safety Authority (NVWA) with regards to a selection of aromatic amines, polycyclic aromatic hydrocarbons (PAH) and heavy metals. 10 of the inks were also microbiologically analysed by the Finnish Customs laboratory.

The labelling of the inks was controlled in regard to points 7 a-g to Annex XVII, entry 75 of Reach regulation.

Upon observation of a non-compliance, the economic operators which were controlled were made aware of the non-compliances with the law and requested to give their opinion on the issue. In all cases, the economic operators took the necessary corrective actions without coercive actions.

The agency organized a webinar for industry stakeholders about the content of the new restriction before launching the monitoring project and updated its website regarding the restriction. A press release about the results was published after agency's web page after the inspections: Tukes testautti tatuointi- ja kestopigmentointivärejä: tulokset parantuneet merkittävästi | Turvallisuus- ja kemikaalivirasto (Tukes)

Seven of the samples were compliant by the chemical analysis and labelling. Three of the inks exceeded the concentration limits of the Reach restriction.  One of the inks included restricted PAHs and two of the inks included heavy metals such as copper and lead over the concentration limits. One of these three also contained a significant amount of microbes.

All the inks which had exceeded the concentration limits were voluntary withdrawn from the market by the economic operator.

12 inks didn’t contain all the labelling required. Most of the non-compliance with labelling requirements were missing frames in Swedish which is required to have in the inks placed on the market in Finland since Finland is bilingual country.

One economic operator stopped selling the non-compliant inks and rest of the economic operators added the missing labelling to the inks.