Endocrine Disruptors in Europe

A New Regulation on [Nano] Carbon Black

On July 11th, 2016, the EU Commission published a new piece of legislation (Regulation EU No 2016/1120), which aims to regulate further the use of Carbon Black (both in its normal and nanometer forms) in cosmetic products. This new amendment to the EU Cosmetics Regulation (EC No 1223/2009) will enter into force on August 1st, 2016 and foresees no transitional period meaning that the implementation of the new legal requirements will therefore be immediate.

Until now, Carbon Black was allowed in cosmetic products through Entry 126 of Annex IV and only purity criteria had to be respected as provided by Regulation EU No 231/2012 (see E 153).

This former entry has been split into two new entries:

  • Entry 126 for non-nano Carbon Black: the use of this colorant remains unlimited but the purity criteria are now different (and somehow more stringent):
Purity criteriaFormer requirementsNew requirements
Purity95 %97 %
Ash content≤ 4 %≤ 0.15 %
Benzo(a)pyrene≤ 50 ppb≤ 5 ppb
Arsenic≤ 3 ppmIdem
Lead≤ 2 ppm≤ 10 ppm
Mercury≤ 1 ppm≤ 1 ppm
Cadmium≤ 1 ppmNo specification
Total PAHNo specification≤ 500 ppb
Dibenz(a,h)anthraceneno specification≤ 5 ppb
  • Entry 126a for nano Carbon Black: the use of this colorant is limited at 10 % and the purity criteria outlined above also apply. Two further conditions also have to be fulfilled:
    • Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.
    • Primary particle size ≥ 20 nm.

Any questions?


  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.