Article R1323-3 of the French Public Health Code
For the purposes of this chapter, the following definitions shall apply 1° Adverse reaction means a noxious reaction occurring under normal conditions of use of a foodstuff in humans or resulting from use which does not comply with its intended purpose, its usual use or its instructions for use or the special precautions for use indicated on its labelling; 2° Serious adverse reaction: an adverse reaction which warrants hospitalisation or…