ANTONIO CONTO

Founder and Managing director, ChemSafe, Italy

The great theme of the environmental risk assessment of medicinal products has been developed since the 1990s when some Institutions posed their attention to the possible impact of a number of active pharmaceutical substance into the environment. Residues of pharmaceutical active principles (APIs) and their potential toxic effects have been recognized as one of the emerging concerns in the scientific community as well as and, more and more, in the general public. The increasing attention on pharmaceuticals as potential pollutants is due to the fact that they can have similar physico-chemical behavior than other xenobiotics which are persistent and/or can produce adverse effects in environmental species. Additionally, we have to consider that APIs are continuously introduced into the environment as released by patients after use; this condition may lead to a huge persistence and/or bioccumulation in some cases.

The first piece of EU regulation is the 2006 guidance EMEA/CHMP/SWP/4447/00 followed by Q&A EMA/CHMP/SWP/44609/2010-2011. The guidance describes a tiered approach starting from a pre-screening approach up to an extended testing phase and a full E ...