Tattoo inks consist of pigments and carrier combined with additives and impurities. They are widely used in tattoos, permanent make-up, corrective medicine and other such activities.
Since the status of tattoo inks is quite complex and controversial (borderline products, side effects, application area…), the regulatory and toxicological landscape and associated tests vary from one country to another, with the main concern being their risks to health.
Substances or mixtures for tattooing purposes must be compliant with the REACH Regulation [entry 75 of Annex XVII of the REACH Regulation (Regulation (EC) No 1907/2006)]. However, there are currently no binding criteria according to which a safety assessment of tattoo inks should be carried out. Tattooing products are not subject to authorisation prior to their commercialisation. There is also a lack of suitable testing methods and data for health risk assessments.
The Eurofins testing strategy follows the general approach of initially collecting and evaluating existing data and then providing missing information through analytical, microbiological, in vitro and clinical testing.
1. Analytical Testing
Specifications of the ingredients of tattoo inks and the identification of the impurities, heavy metals, MOSH, and nanomaterials present are essential for risk assessment. This data is also needed for the planning of toxicological studies and their evaluation.
2. Microbiological Testing – Sterility Testing
Tattoo inks contaminated with microorganisms can cause infections and lead to serious health issues when introduced to the skin during tattooing.
3. In vitro studies
These are based on the EDQM document ‘Safer Tattooing’ of 201734 and on the REACH and CLP Regulations. For tattoo pigments, tests shall be carried out for the following endpoints: eye irritation/eye damage, skin irritation/skin corrosion, phototoxicity, skin sensitisation, genotoxicity, photogenotoxicity, cytotoxicity, carcinogenicity, etc…. Our experts also have the skills required to direct your test plan on non-cosmetic products.
4. Clinical studies
These are primarily used to mimic the consumer’s response to the tattoo inks and compare the safety requirements to the typical local and systemic consumer exposure to the product. Our experts will guide you in selecting the most appropriate tests.
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