The safety assessment of herbals with a new and ethical approach

Abstract

The increasing use of plant medicines (herbals) in Europe needs a shared methodology to determine the toxicity and the daily exposure level to these drugs. For this reason, the European regulatory agencies have undertaken a study that could meet popular uses and toxicological research in different countries of the Union. Here we list some examples of the most used herbal drug classes and we propose a decision-making process based on their characteristics, their content in active principles and on the basis of the present scientific pharmacological and toxicological literature. The proposed decision tree actually makes easier for the assessor to quickly and accurately evaluate the accredited indexes for risk and toxicity assessment based on the preclinical literature data and using the correct classification that some of them may have because they are already present in medicinal products or used as food.

Keywords:

• Herbal drugs
• toxicity
• NOEL
• NOAEL
• regulatory toxicology
• safety assessment

Notes

1. Usually significant NOAELs and LOAELs are obtained directly by the toxicological study rather than calculated.