Division III.4.1

Monitoring or exposure data of the pharmacologically active substance shall not be required. However, if available, it may provide valuable additional information in certain cases, i.e. for substances that are already present in the environment (either naturally or as a result of use in the veterinary or other sectors). Such data may be useful in determining background levels to which consumers may already be exposed. If such data are available, whether as published results from official residue monitoring bodies or as results of academic or other research, these shall be provided.