4.2 Safety of Ingredients

Notwithstanding, and in addition to the requirements set out in paragraph 4.1, tattoo and PMU products must only be used if they comply with all the following requirements. Tattoo inks shall not contain the following substances:

• carcinogenic and mutagenic substances category 1A, 1B or 2 excluding those substances classified only with the hazard statements H350 (inhalation) (may cause cancer by inhalation), H351 (inhalation) (suspected of causing cancer by inhalation), H340(inhalation) (may cause genetic defects via inhalation) and H341 (inhalation) (suspected of causing genetic defects by inhalation) which are classified under Regulation (EC) 1907/2006 [REACH] or in Part 3 of Annex VI to Regulation (EC) 1272/2008 [harmonized substances, CLP]. Unless specific concentrations are defined in Table 1, the concentrations should be as low as technical achievable;