Tattoo and permanent make up inks Testing

What are tattoo and permanent make-up?

Tattoos are a popular form of body art, made by penetrating the outer layer of the skin with a needle and injecting ink into the area beneath to create a design. 

Permanent make-up is similar to a tattoo, and is used to produce designs that resemble eyeliner, lip liner, eyebrows, or other make-up.

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 are composed of a mix of several chemicals, obviously including pigments and diluents.

These mixtures may contain hazardous substances and contaminants which pose health risks including infections, allergic reactions or even more serious consequences like genetic mutations and cancer. As chemicals used in tattoo and permanent make-up inks may remain in the body for life, there is the possibility for long-term exposure to the potentially harmful ingredients.

Regulatory framework

US: FDA considers the inks used in intradermal tattoos, including permanent make-up, to be cosmetics and regulated as such. Although a number of color additives are approved for use in cosmetics, FDA has not approved any pigments for injection into the skin for cosmetic purposes. Using an unapproved color additive in a tattoo ink makes the ink adulterated.

FDA monitors and investigates adverse reactions associated with cosmetic products, including permanent make-up and tattoo inks. Corrective action is taken according to the severity of the adverse event to prevent injury and illness to consumers. 

EU: On December 2021, the European Union (EU) published the Regulation (EU) No 2020/2081 amending Annex XVII to Regulation (EC) No 1907/2006 of REACH as regards substances in tattoo inks or permanent make-up, which entered in force on 4^th January 2022.

This amendment adds the entry 75 of Annex XVII, which imposes specific restrictions on the manufacture, placing products on the market and use of mixtures for tattooing purposes.Appendix 13 details a list of substances with specific concentration limits related to tattoo inks.

A derogation is applied to Pigment Blue 15:3 and Pigment Green 7 until 4^th January 2023.

The aim of these restrictions is not to ban tattooing but to make the chemicals used in tattoos and permanent make-up safer.

Chronic allergic reactions and other inflammatory skin reactions from tattoo and permanent make-up inks are expected to decrease thanks to the restrictions. More serious effects such as cancer, DNA damages or harm to the reproductive system potentially originating from chemicals used in the inks may also decrease.

Why choose Eurofins?

Eurofins Consumer Product Testing network of laboratories use highly sophisticated instrumental techniques for impurities and traces analysis, with the aim to get the best detection limits achievable by todays technological advancements and restraints.

To guarantee the protection of people and comply with the latest disposition of the law regarding tattoos and permanent make-up, Eurofins can support and help you with:

• Consulting, regulatory & toxicological services: Toxicological risk assessment of chemicals and finished tattoo inks or permanent make-up; Label review.
• Analytical testing:
  • Detection of restricted chemicals listed in Appendix 13 of REACH and in Annex II and IV of Cosmetic Regulation (EC) No 1223/2009:  Heavy Metals (Hg, Ni, Sn, Sb, As, Ba, Cd, Cr, Co, Cu, Zn, Pb, Se); Polycyclic aromatic hydrocarbons (+25 analytes); Aromatic amines (+30 analytes); Colorants (+40 analytes); Phthalates (+10 analytes); Antimicrobial substances; Formaldehyde; Acetaldehyde; Allergens
  • Sterility testing according to USP 71

• Stability study: Evaluation of physical/chemical and organoleptic characteristics