4.1 General Safety

When applied and used as intended, tattoo and PMU products must not endanger the health or safety of persons or the environment. To this end, the manufacturer or person responsible for placing the product on the market should perform a risk evaluation for each ingredient and the total ink based on recent toxicological data and knowledge. This evaluation has to be sent to the competent authorities before placing the ink on the market. Each health complaint reported to the manufacturer or the person responsible for placing the product on the market has to be reported to the competent authorities.