The European Medicines Agency (EMA) has revised the European Pharmacopoeia General Monograph 2619, which is an accepted standard for risk management in regards to the levels of elemental impurities. Since it came into effect in January 2018, manufacturers of products outside of the General Chapter 5.20 and in ICH Q3D, such as veterinary medicinal products, have not elaborated on the scientific principles on which risk assessment/risk management should be based.