Supervision of tattoo inks and dyes 2024
Tattoo dyes can cause health problems. To protect consumers, the European Union imposes strict requirements on inks and pigments used in tattoos and permanent make-up. In 2024, the NVWA initiated a European enforcement action. Together with 13 other countries, we examined whether the inks and pigments available on the market complied with the legal requirements.
In short: European enforcement action
The Netherlands introduced national legal requirements for tattoo dyes in 2003. However, since many inks are sourced from outside the Netherlands, and in certain cases from distant countries, it was difficult to enforce compliance with national regulations. This changed in 2022 with the entry into force of EU legislation concerning tattoo dyes. The relevant EU rules are set out in Annex XVII of the REACH Regulation.
Manufacturers were given a transitional period to adjust their working practices to comply with the new European rules. By 2023, these periods had lapsed, allowing market surveillance authorities to begin enforcement. The NVWA launched a European enforcement action that included participation from 13 other European market surveillance authorities.
We analysed 52 samples from 14 countries at our product safety laboratory in Groningen. In 37 of these samples, we identified 1 or more non-compliances, including administrative non-compliances without significant risk. However, there were also more serious non-compliances, such as the presence of prohibited substances.
Inspection results
We compiled a list of the different brands of tattoo dyes, based on information from inspections and indications from the Municipal Health Services (GGD). Participating market surveillance authorities from other countries added to the list to ensure the most representative random sample of the market could be taken. Next, in the first quarter of 2024, samples were taken across Europe.
In the second and third quarters of 2024, we analysed 52 tattoo dyes of 26 different brands at the NVWA laboratory in Groningen. We examined the composition of the dyes and labels.
Analysis findings
From the analysis, we identified the following:
- In the case of 27 samples, the composition was found to be non-compliant with the requirements. This means the samples contained a prohibited substance, or an excessive amount of a prohibited substance. It is possible that the labelling of these samples was also non-compliant, although this was not separately documented.
- In the case of 10 samples, the labelling was found to be non-compliant with the requirements, due to a missing or incorrect list of ingredients, for example. This also constitutes a safety risk, e.g. for consumers with allergies.
- In the case of 15 samples, we identified zero non-compliances.
Analysis findings
| Findings | Number |
|---|---|
| Compliant | 15 |
| Label non-compliance | 10 |
| Chemical non-compliance | 27 |
Which requirements were not complied with?
The following table shows which non-compliances we identified and in what percentage of the 52 samples this occurred.
| Analysis parameter | Non-compliant quantity | Non-compliant percentage |
|---|---|---|
| Polycyclic Aromatic Hydrocarbons (PAHs) | 7 | 13% |
| Primary Aromatic Amines (PAAs) | 4 | 8% |
| Heavy metals | 17 | 33% |
| Preservatives | 15 | 29% |
| Volatile Organic Compounds (VOCs) | 48 | 92% |
| Microbiological | 4 | 8% |
| Labelling | 25 | 48% |
No quantitative determination took place for VOCs. We only determined whether a VOC was present in a sample, not whether the VOC was present in quantities that would constitute a regulatory breach.
Fewer PAAs and PAHs
In the past, we often found primary aromatic amines (PAAs) and polycyclic aromatic hydrocarbons (PAHs) in dyes: PAAs especially among bright colours, and PAHs in black dyes. These substances are prohibited due to their potential to be carcinogenic.
We detected far fewer PAAs and PAHs in this analysis than in earlier ones conducted before European regulations came into effect. They were detected in fewer products, and when present, their concentrations were lower.
VOCs and preservatives still present
The presence of volatile organic compounds (VOCs), such as solvents, remains a concern. Many of these substances are sensitising, meaning they can trigger allergies. For this reason, many VOCs are not permitted in high concentrations in tattoo dyes. Of the 52 samples, 92% contained one or more VOCs. No quantitative determination was performed, in contrast to the other analyses.
Also, several samples contained preservatives which are not permitted. These are also sensitising substances which can cause allergic reactions. Since the concentrations were very low and the substances concerned were often not listed as ingredients on the packaging, we suspect that they were not intentionally added. They may have been present in a base material.
Both the VOCs and the presence, unintentional or otherwise, of preservatives are important indicators for the industry. Manufacturers should critically review or reassess their formulations and production process against the REACH restriction.
Microbiological condition
We also examined whether the inks were sterile. The REACH Regulation does not specify requirements for the microbiological condition of tattoo ink. We therefore determined any non-compliances on the basis of the Netherlands’ national legislation.
In the Netherlands, inks must be sterile. This means no bacteria, pathogens or other infectious agents are present in the inks. This ensures that no pathogens or other infectious agents are introduced into the skin during the tattooing process, which could result in inflammation, for example. This national legislation enables us to take enforcement action in the Netherlands if an ink is not sterile.
Of the inks which were analysed, four were found to be non-sterile. None of these inks were sampled in the Netherlands. We therefore shared the results with our colleagues, but did not take any enforcement action ourselves.
What enforcement steps did we take?
We shared the results with the European authorities who participated in this project. Each country is responsible for enforcement within its own borders, based on its own sanctions policies. For information purposes, we shared the signal advice from the Office for Risk Assessment & Research (BuRO) of the NVWA with our European colleagues. BuRO studied the health risks of tattoo dye ingredients. The signal advice can help determine the seriousness of a regulatory breach.
We continue to work closely with European colleagues to monitor the impact of any corrective actions. Together, we examine how to improve regulatory compliance.
Enforcement in the Netherlands
In the Netherlands, seven samples were taken of inks available on the market in the Netherlands. Non-compliances were identified in six of these samples.
- Four samples contained a minor or very minor amount above the permitted limit of a prohibited substance.
- Two samples contained chromium and nickel, without these allergens being indicated on the label.
Based on the signal advice from BuRO concerning the health risks of tattoo dye ingredients (2023) and the intervention policy of NVWA, we undertook the following interventions:
- 4 verbal notifications: the risk to consumers was limited/very limited in the case of these non-compliances
- 2 official warnings: a potential health risk was identified in these cases
The 6 products may no longer be sold. Entrepreneurs must also take action to prevent any recurrence. In 2025, we will monitor this through targeted business inspections. Furthermore, we will ensure that entrepreneurs based in the Netherlands cooperate in interventions by our European colleagues.
Next steps
Although this project shows that many tattoo dyes do not yet comply with the requirements of the REACH restriction, there is evidence of improved compliance. No non-compliances were identified in 15 inks.
To enhance regulatory compliance, we are committed to a joint approach to European market surveillance of tattoo dyes. To this end, we aim to cooperate with the REACH Enforcement Forum, among other organisations and initiatives. We also closely follow European Commission initiatives such as Coordinated Activities on the Safety of Products (CASP). Furthermore, we are exploring how European inspection results can be made public, allowing us to publicise which brands do not comply with the legal requirements.
The NVWA also continues to work at a national level to make tattoos and piercings as safe as possible. This is done in cooperation with colleagues from the Municipal Health Services (GGD) and their European partners. We continue to carry out our unannounced hygiene inspections. We are also conducting research into tattoos and health problems among the Dutch population in 2024. This research was developed in cooperation with the Ministry of Health, Welfare and Sport (VWS), the National Institute for Public Health and the Environment (RIVM), the Tattoo poli and BuRO. The results of this research are due in fourth quarter of 2024.
Advice to consumers
Are you thinking about getting a tattoo or piercing? Or are you planning to have permanent make-up applied? You can check which studios are licensed on veiligtatoeerenenpiercen.nl. These studios have all been inspected by the GGD for safe and hygienic working practices. Want to be certain that safe ink is used? Ask the tattoo artist for information, and use our infographic to check the label.