4.5 Declaration

Tattoo and PMU products should contain the following information on the packaging:

• The intended use of the mixture as a tattoo or PMU ink
• the name and address of the manufacturer or the person responsible for placing the product on the market;
• the date of manufacture and minimum durability;
• the warning “Ingredients of this tattoo ink did only undergo basic safety testing. For some of the ingredients data on their carcinogenicity, mutagenicity, reprotoxicity, short- and long-term toxicity are not available due to the renunciation of animal testing for this voluntary procedure” has to be placed on the ink bottle. Safety endpoints that have been provided for all ingredients present in the ink can be deleted from the warning;
• the batch number or other reference used by the manufacturer for batch identification;
• full list of ingredients according to their International Union of Pure and Applied Chemistry (IUPAC) name, CAS number (Chemical Abstract Service of the American Chemical Society) or Colour Index (CI) number. This also accounts for pre-mixed components added to the ink;

The labelling shall be clearly visible, easily legible and appropriately durable. The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market. Where necessary because of the size of the package, the labelling information shall be included in the instructions for use. The information on the label shall be made available to any person before undergoing the tattooing procedure by the person performing the procedure.