Tattoo Ink and PMU Product Testing

Permanent makeup is a cosmetic technique which employs tattoos (permanent pigmentation of the dermis) as a means of producing designs that resemble makeup, such as eyelining and other permanent enhancing colours to the skin of the face, lips, and eyelids.

The main ingredients of tattoo inks are colourants and related auxiliaries. Risks may be frequently found when polycyclic aromatic hydrocarbons (PAHs),aromatic amines, heavy metals and microorganism that it contains exceed the limit. However, the foregoing substances are usually carcinogenic, mutagenic or have reproductive toxicity. So such notifications are quite common on the EU market.

Resolution ResAP (2008)1

On 20 February 2008, the European Council published Resolution ResAP (2008)1 to regulate the quality and safety of tattoo inks and PMU products. The resolution provides for the components of tattoo inks and PMU products, risk evaluation before their placing on the market, application and notification obligations.


Test Items:

  • Heavy metals
  • PAHs
  • Aromatic amine
  • Pigment
  • Preservatives
  • Stability (UV, laser, enzyme and microbiological)
  • Sterility test
  • Toxicology (corrosion, irritation, phototoxicity, immunotoxicity and genotoxicity in vitro)
  • Other requirements

Limits for Partial Elements or Compounds in the Council of Europe Resolution ResAP(2008)1

Element/compound

Limit

Element/compound

Limit

Arsenic

2 ppm

Mercury

0.2 ppm

Barium

50 ppm

Nickel

As low as technically achievable

Cadmium

0.2 ppm

Lead

2 ppm

Cobalt

25 ppm

Selenium

2 ppm

Chromium (VI)

0.2 ppm

Antimony

2 ppm

Copper soluble

25 ppm

Tin

50 ppm

Zinc

50 ppm

27 aromatic amines

Banned

Polycyclic aromatic hydrocarbons (PAHs)

0.5 ppm

Benzene-a-pyrene (BaP)

5 ppb

 *Remarks: see the original of The Council of Europe Resolution ResAP(2008)1 for the full information

In addition to requirements for heavy metals, organic solvents and certain colourants, the resolution also requires that the packaging of tattoo and PMU products include the following information:

-         Name and address of manufacturers or the person that in charge of placing such products in the market;

-         Validity of such products;

-         Use conditions and warnings;

-         Batch No. or other batch certifications used by manufacturers;

-         The formulation shall bear IUPAC name, CAS No. and CI No.;

-         Guarantee of sterile inclusion.

C&K Testing can provide professional testing for tattoo inks and PMU products as per standards of different countries and regions. Besides, we can render you one-stop solutions integrating consulting, testing and certification. Please feel free to contact test@cirs-group.com or leave us a message if any question. 


Disclaimer:

C&K Testing accepts no responsibility or liability whatsoever with regard to the information on this website. Reproduction for non-commercial purposes of information and documents from the our  website is authorised provided that you acknowledge "C&K Testing" as the source.

Hot news

Subscribe Now

Stay informed on regulatory changes, industry news & events, market trends and services with our email updates.

You subscription will include:
Monthly Technology News: Catch up on breaking news & events, upcoming webinars and seminars on a monthly basis.

Newsletters: Be the first to know about upcoming regulatory requirements.

Subscribe to Our News !