Although leachables data is the gold standard, and extractables data is arguably the silver standard; toxicological safety risk assessment of packaging, extractables and leachables profiling, may not be possible or appropriate at every stage of the packaging’s development and registration. In such situations, “safe for use” can be inferred through a “preponderance of evidence” approach, where the preponderant evidence is auxiliary information. In this presentation, the types of auxiliary information are explained. Also, the use of auxiliary information to evaluate and choose candidate materials during material selection and how to manage the AET gap during extractables and leachables safety assessments is discussed.
This presentation was recorded on March 24 and is part of a series.