Consultation closes on Chile’s proposed tattoo inks regulation

Chile’s Ministry of Health (MoH) has closed its public consultation on a draft regulation on tattoos and skin piercings. The proposed regulation would ban the use of toxic substances in tattoo inks and pigments. The draft also says they should not contain sensitising and photosensitising substances and must comply with officially permitted lists. Chemicals currently allowed in tattoos are included on a list of permitted colourants for use in pharmaceuticals and cosmetics. This was approved by the 2012 MoH Decree 31 and Technical Standard No 130. However, Chile is working on developing lists of permitted and restricted chemicals in inks for tattoos. For that purpose, the MoH will use as reference substances permitted by the EU, the US FDA and recommendations made by national and international recognised technical organisations. And while the lists are in progress, the cosmetic industry may use the following to determine permitted substances:

  • the EU’s cosmetics Directives;
  • the US FDA’s approved list;
  • the list of products for permanent make-up and tattoos authorised and registered with the Spanish Agency of Medicines and Sanitary Products (AEMPS); and
  • the Council of Europe Resolution (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up

The draft regulation also proposes banning the use of the following in tattoo and permanent make-up inks:

  • aromatic amines (specifically p-phenylenediamine);
  • methanol;
  • ethylene glycol;
  • glutaraldehyde;
  • detergents;
  • benzoates; and
  • nickel.

Products used for tattoos and permanent make-up must be labelled with the name and address of the manufacturer and date of manufacture. The draft regulation provides one-year for the transition following its official publication. During this period the cosmetics industry may still use the 2012 list of permitted colourants. Chile’s Public Health Institute (ISP) will be responsible for monitoring, oversight and control of the inks, pigments and dyes. The MoH will now analyse the comments it has received, and respond before the final regulation is published in the country’s Official Gazette. Potential risks from tattoos include bacterial contamination, allergies and toxic effects. In September the European Academy of Dermatology and Venereology (EADV) said tattoo inks should be “properly tested” and at least meet the same safety standards as cosmetic products. ECHA, Denmark, Italy and Norway are working on a proposal to restrict chemicals in tattoo inks and permanent make-up. Further information is available at:

Chemical Watch, 23 October 2018 ; http://chemicalwatch.com