Tattoo Product Testing & Regulatory Expertise

The importance of regulating the products used in the tattooing process rises. Due to recent apprehensions surrounding tattoo safety, very rigid regulations define the composition, hygiene and quality of tattoo and permanent make-up products.

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Compliance Verification

We conduct in-depth analyses of tattoo inks and permanent make-up products to verify compliance with global and regional regulatory requirements

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Regulatory Testing Solutions

Our tailored testing solutions meet evolving compliance needs: tracking legal updates, adjusting testing protocols, guiding clients on market access

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Risk Assessments

We conduct comprehensive toxicity evaluations, assessing health risks: allergenic potential, carcinogenicity and bioaccumulation of harmful substances

Is your tattoo ink safe and REACH/FDA compliant?

The tattoo industry is rising closer under the microscope for product safety, ingredient transparency, hygiene, health, and regulatory compliance. EU REACH Annex XVII and FDA impose strict guidelines over-the-ink composition and processes of manufacturing. Manufacturers must ensure their products are poison-free and meet the latest safety standards.

Eurofins provides testing and regulatory support for tattoo and permanent makeup inks to ensure compliance with global safety standards. We will justify regulatory compliance for FDA oversight in the U.S., the REACH regulation in Europe, France's additional national laws on tattoo ink safety, and any other potential international requirements. Our team also offers labelling and compliance review, toxicological risk assessment, and preparation of regulatory dossier.

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What Sets Eurofins Apart?

Effective scientific knowledge and safety product design services are what Eurofins delivers beyond compliance.

Our highly sophisticated laboratories use advanced analyzers to achieve standardized impurity detection to support new and developing regulatory frameworks for brands in the area of tattoo and permanent makeup products in enhancing their safety and quality.

With Eurofins, manufacturers can safely and confidently manufacture compliant tattoo and permanent makeup products according to global safety standards.

Global Regulatory Expertise

Compliance with EU, FDA, and worldwide regulations. 

State-of-the-art testing facilities

Advanced analytical techniques of impurity and trace analysis.

Risk Assessment & Testing Solutions

We identify potential safety concerns—arising from the presence of prohibited substances—before market introduction. With fast and reliable testing services, these solutions ensure rapid product launches while assuring compliance and safety.

Full-fledged Testing & Regulatory Expertise for Tattoo Related Products

 

Tattoo and permanent makeup products are now at the forefront of beauty products all over the world. However, their use, safety, and compliance with regulations are critical issues in their respective sectors. Eurofins Cosmetics & Personal Care provides the best platform for testing inks, pigments, needles, equipment used by tattoo artists, and all other tattoo-related products as per international safety standards and regulatory requirements. Our comprehensive services optimize manufacturers to keep abreast with the evolving global regulations and introduce in the market cost-effective and safe products.

 

The EU estimates that up to 12% of Europeans have tattoos, and double that number in the 18-35 age group. Approximately 33% of Americans have tattoos, while 21% have two or more tattoos.

 

Tattoo and permanent make-up inks consist of a mix of several chemicals, obviously including pigments and diluents. These mixtures may contain hazardous substances and contaminants exposing clients to health risks, including infections and allergic reactions, with dire consequences in rare instances such as genetic changes and cancers. Tattoo and permanent make-up ink chemicals may remain in the body for life, there is the possibility for long-term exposure to the potentially harmful ingredients.

 

Eurofins provides specialized testing and regulatory support for tattoo or permanent makeup ink products to ensure compliance with global safety standards. It includes:

  • Analytical Testing: Our laboratories conduct comprehensive testing for heavy metals, polycyclic aromatic hydrocarbons (PAHs), aromatic amines, colourants, phthalates, and other restriction substances.
  • Microbiological & Stability Testing: Eurofins performs ink evaluation for long-term product safety and performance through stability, sterility and contamination risk studies.
  • In Vitro & Clinical Studies: Our safety and efficacy testing involves skin irritation, sensitization, allergenic potential, and biocompatibility evaluations.
  • Labelling & Compliance Review: We ensure regional compliance with product labels and the safety of ingredient listing.
  • Regulatory & Toxicology Compliance: Our professional team delivers toxicological risk assessments, regulatory dossier preparations, ingredient safety evaluations for EU REACH and FDA compliance:
    • United States: The FDA designates inks for tattoos and permanent makeup as cosmetics, so now they fall under the purview of regulation. Nevertheless, the FDA has not approved any pigments for injection into the skin. The FDA looks at adverse reactions and takes remedial steps, as warranted. OSHA regulates tattoo workplaces in terms of safety; thus, tattoo operators must be trained in bloodborne pathogens and sterilization procedures. Nevertheless, there are no standardized test methods for tattoo inks, raising concerns about product quality and safety.
    • European Union: The EU has tighter restrictions resulting from REACH Regulation No. 1907/2006, amendments or new regulations, such as 2020 Regulation No. 2081, which introduce fresh limitations on tattoo inks. REACH's Annex XVII, Entry 75 puts concentration limits on hazardous materials that include heavy metals, aromatic amines, and preservatives. The rationale here is to decrease incidents of chronic allergic reactions and other health risks, all the while enhancing the safety of inks.
    • France: France enforces the REACH regulation together with its own national legislation, which includes the law of tattoo products manufacturing and selling (Law No. 2014-201). French regulations stipulate that the manufacturer should declare the product, comply with Good Manufacturing Practices (GMP), and upon conclusion of safety assessment, release for the market. The European Chemicals Agency (ECHA) administers ingredient restrictions so that harmful substances are not incorporated in tattoo inks.