4. Results and conclusion

4.1 Control objects and inks

In this project, a total of 211 tattoo inks sourced from 64 different economic operators were examined. The inspections covered various business ventures, including stores, tattoo shops, web pages, web page marketplaces, and private importers. Among the inspected enterprises, 35 were users of tattoo inks, 29 were suppliers, and two operated as both user and supplier.

Figure 1 Number of controlled economic operators/marketplaces and inks per country

Origin of inks

More than half of the controlled inks originated from the US. Approximately a quarter were manufactured within the EU, while the rest have origins in China, UK, other non-EU countries. Two inks had unknown origin.

Ink brands

A total of 48 different brands were controlled, 12 of the brands were found in several countries.

Figure 2 Brands and number of countries they were controlled in. The number of countries the tattoo ink was controlled in is stated behind the brand name.

* Premium Tattoo ink Tattoo Tomato is red black

4.2 Compliance for content and labelling

4.2.1 Restricted substances or substances above limit value

All inks were checked for content of restricted substances. Forty-six of the controlled inks (22%) contained one restricted substance, and 6 inks (3%) contained two restricted substances:

10 inks (5%) contained carcinogenic substances
1 ink (0.5%) contained a skin corrosive/irritating substance
4 inks (2%) contained substances prohibited by Cosmetic Regulation (Annex II to EC 1223/2009)
37 inks (18%) contained restricted substances listed in appendix 13 to REACH Annex XVII

Thirty of the restricted substances were detected via analysis, while the rest (22 substances) were detected by checking the list of ingredients on the tattoo ink label. 23 out of 67 analysed inks (34%) contained one or more substance above the permitted concentration limits.

The largest percentage of inks containing restricted substances originated from other non-EU countries, China, and the UK:

Figur 3 Percentage distribution of inks containing restricted substances, and origin

4.2.2 Labelling

Of the 211 controlled inks, 194 (92%) were missing mandatory labelling items.

Figure 4 Compliance for labelling items in percent

All tattoo inks controlled in this project were checked for labelling of reference number, list of ingredients and safety instruction. More than half of the inks featured this labelling on their packaging. Notably, the highest compliance rate was observed for reference numbers, approaching 90%.

Two hundred and nine inks were checked for labelling of the obligatory statement “Mixture for use in tattoos or permanent make-up”. Approximately a quarter of the controlled inks included this obligatory statement on their packaging. However, nearly three quarters of the inks lacked this labelling. Specifically, 102 inks (49%) were completely missing the statement, and 44 inks (21%) had the correct statement but not in the required national language. This shows that the most common non-compliance in labelling was a lack of the obligatory statement “Mixture for use in tattoos or permanent make-up”.

None of the inks imported from China and the UK had the correct labelling.

Figure 5 Overview of origin of inks and compliance for labelling, in percent

4.3 Results Norway

A total of 18 controls were conducted across tattoo shops and stores. 16 were users of tattoo inks and 2 were suppliers.

Inks and origins:

58 inks from 16 different brands were subject to control.
Origin of the inks:
- 23 originated from the EU, 1 was from the UK and 34 were from the USA.

Content:

Restricted substances or substances exceeding limit values:
- 4 inks (7%) contained substances listed Reach annex XVII item 75 number 1, e) annex II in EU 1223/20009 (cosmetic regulation)

Labelling:

30 inks (52%) featured the mandatory statement “Mixture for use in tattoos or permanent make-up". 26 inks lacked this required statement: 6 were completely missing it, 2 lacked information on the packaging and 18 inks had the statement but not in Norwegian.
All inks had a reference number on their packaging.
39 inks (67%) provided a list of ingredients.
Correct labelling of safety instructions was present on the packaging of 18 inks (31%). Another 36 of the inks had the labelling, but not in the correct language. 4 inks were missing safety instructions entirely.

Compliance summary:

Overall, only 3 inks (5%) were compliant.

Comments

The Norwegian Environment Agency also investigated whether tattoo artists conveyed packaging information to their clients. Out of 16 tattoo artists, only three informed customers about the ink’s labelling details.

Regarding specific pigments, Pigment Blue 15:3 and Pigment Green 7 did not need to comply with entry 75 before January 5^th, 2023. Therefor Norway has opted for guidance rather than enforcement in this project.

Finally, several tattoo artists reported discontinuing the use of coloured inks following the implementation of the new regulations.

4.4 Results Sweden

46 inks from 22 economic operators and 4 online marketplaces were controlled by analyses and control of the labelling. 13 were suppliers placing on the market (note that some could have dual roles, also being users), 9 were only users and 4 were online marketplaces.

Inks and origins:

46 inks from 32 different brands were subject to control.
Origin of the inks:
- 2 had unknown origins, 6 came from China, 13 originated from the EU, 7 were from other non-EU countries, 3 were from the UK and 15 were from the USA.

Content:

Substances exceeding allowed limit values:
- 20 out of 46 tattoo inks (43%) that were analysed contained one or more substances above the permitted concentration limits. One tattoo ink exceeded the maximum permitted level of isopropyl alcohol, as indicated in the list of ingredients.
- 7 inks (15%) contained carcinogenic or mutagenic substances, 1 ink (2%) contained a corrosive/irritant substance and 19 inks (41%) contained substances listed in appendix 13 to REACH annex XVII

Summary from the analyses

Of the tattoo inks purchased from marketplaces, 11 out of 15 (73%) contained one or more substances above the legal limit. Of the 31 tattoo inks that had a designated EU/EEA economic operator, 9 of these (29%) contained one or more substances above the legal limit.

7 out of 46 tattoo inks (15%) contained one or more polycyclic aromatic hydrocarbons (PAHs) above the permitted levels, with 6 of these containing a total of approximately 3–60 mg/kg PAHs.

18 out of 46 tattoo inks (39%) contained heavy metals above the permitted levels (arsenic, antimony, cobalt, lead or nickel).

None of the tattoo inks contained any of the aromatic amines that were analysed.

Labelling:

27 inks (59%) did not meet the requirement for the mandatory statement "Mixture for use in tattoo or permanent makeup" or its Swedish equivalent. 10 of these 27 inks did not have this label at all and the rest had deficiencies in its wording or that it was stated in, for example, an instruction manual and not on the packaging (bottle and/or outer packaging).
8 inks (17%) did not have a reference number on their packaging (7 of them were from an online marketplace).
4 inks (9%) did not have an ingredient list and 20 inks (43%) had one or more ingredients that were not declared in accordance with the nomenclature to be used.
19 inks (41%) had labelling of safety instruction in English, but the safety instructions were not translated to the correct language (swedish) and 9 inks had a correct labelling of safety instructions. 18 inks had a correct labelling in regard to the economic operator's role and responsibility.

Compliance summary:

Overall, only 4 inks (9%) were compliant.

Conclusions from the Swedish MPA’s project

Compliance regarding chemical content has improved slightly compared with the Swedish MPA's inspection project in 2020, with regard to tattoo inks with a designated supplier with an address in the EU/EEA. Tattoo inks from the marketplaces CDON.se, Amazon.se, Fyndiq.se and Fruugo.com had more serious deficiencies in terms of content and labelling.

The proportion of inks with non-compliant labelling was high and each economic operator should engage with its supplier to increase compliance throughout the chain. Correct labeling is also important as the tattooist has an obligation to provide the person to be tattooed (the customer) with specific information contained on the packaging (the bottle and any outer packaging) and any attached leaflet. In order for the tattooist to fulfill these obligations the information on the tattoo ink must be correct.

4.5 Results Denmark

A total of 13 shipments were taken out for inspection in cooperation with The Danish Customs Controls. Two were suppliers and 12 were users.

Inks and origins:

86 inks from 11 different brands were subject to control.
Origin of the inks:
- 8 had unknown origins, 10 came from China, 1 originated from the EU, 3 were from the UK and 64 were from the USA.

Content:

Restricted substances or substances exceeding limit values:
- 18 ink contained a substance listed in appendix 13 to REACH annex XVII.

Labelling:

70 inks (81%) lacked the mandatory statement “Mixture for use in tattoos or permanent make-up”. 16 inks had the statement but not in Danish.
64 inks (74%) had a reference number on their packaging.
All the inks provided a list of ingredients.
Correct labelling of safety instructions was present on 57 inks (66%). Seven of the inks (8%) was missing safety instructions entirely.

Compliance summary:

None of the inks were compliant.

A fact sheen was prepared in advance to The Danish Customs Control to clarify the rules of restriction nr 75 (help to spot non-compliance products).

In additional The Danish Chemical Inspection Service performed 5 physical inspections. 2 inspections were carried out at tattoo shops (downstream users), 1 inspection at the manufacturer of PMU colors (permanent makeup) and 2 inspections were located at the largest distributors in Denmark. All the physical inspections had focus on guidance.

4.6 Results Finland

A total of 7 inspections were conducted across stores, web pages and web page-marketplaces. All of the inspected entities were suppliers of tattoo inks.

Inks and origins:

21 inks from 10 different brands were subject to control.
Origin of the inks:
- 13 originated from the EU, 3 were from other non-EU countries and 5 were from the USA.

Content:

Restricted substances or substances exceeding limit values:
- 3 inks contained carcinogenic substances.

Of these, two inks contained both carcinogenic substances and one ink contained heavy metals. One of these three also contained a significant amount of microbes.

Labelling:

9 of the inks (42%) featured the mandatory statement “Mixture for use in tattoos or permanent make-up”. 2 inks lacked this required statement, 10 had the statement but not in Finnish and Swedish.
19 of 21 inks (90%) had a reference number on their packaging.
19 inks (90%) provided a list of ingredients.
Correct labelling of safety instructions was present on the packaging of 12 inks (57%). Another 4 of the inks had the labelling, but not in the correct language. 2 inks were missing safety instructions entirely.

Compliance summary:

Overall, 9 inks (42%) met all labelling requirements
According to the performed chemical analyses, 3 out of 21 tattoo inks (14%) tested contained one or more substances above the permitted concentration limits. Two of the inks (10%) exceeded the concentration limits with PAH substances and one ink (5%) exceeded the concentration limits with heavy metals.

4.7 Compliance summary and conclusion

In total only 14 out of the 211 controlled inks (7%) were compliant regarding content and labelling. These 14 inks came from 9 different brands. Seven of the inks originated in the EU, 5 in the US, and 2 from other non-EU countries.

In summary, it can be said that a large number of non-compliances from the regulations were found among most actors, regardless of where the ink originated from. Some actors have updated themselves on the new regulations, but the introduction of new regulations requires that the entire supply chain follows the current regulatory requirements and stays updated on the rules that apply in the industry they operate in and for the products they use.

Therefore, there will be a need for further follow-up and supervision of this industry and the new Reach regulations. It will still be useful for the Nordic authorities to cooperate on this work and share experiences in the future.

4.8 Follow up on non-compliant tattoo inks

The participating countries in this project conducted their controls over varying time spans and scopes. Additionally, different types of enterprises were controlled, ranging from small operators on online marketplaces to large importers. Various enforcement methods and actions were used. Some countries analysed inks while others did not.

Where applicable, all enterprises have been informed about the results of the controls. Some surveillance authorities opted for guidance for compliant inks or those with minor non-compliances. For inks containing restricted substances, the results were presented to the supplier or user when possible. In some cases, inks with restricted substances were withdrawn from the market, and in other instances, they were seized and destroyed.

In this project, enforcement actions were not pre-determined by the project group. However, in retrospect, it is apparent that the follow-up actions were quite alike for similar findings.

4.9 Remarks

CLP and safety instruction

None of the inks controlled in this project were labelled according to the CLP-regulation (regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures). The requirement for tattoo inks (Reach Annex XVII entry 75, 7 (g) is that safety instructions should be marked on the label, insofar as they are not already required to be stated on the label by the CLP regulation).

The requirements for safety instructions appear somewhat unclear, as there is no specific description of the text that should be included on the label. Consequently, it is challenging to identify deviations in this area, especially since safety instructions are not mandatory for all inks. It is also not possible to determine if CLP-labeling is required solely based on the information provided on the label.

“Reach compliant”

Several inks were labelled with “Reach compliant”, both compliant and non-compliant inks. This information can be misleading for users and should therefore be discontinued.