Guideline for making application dossiers for novel proteins; Novel food dossiers: from black box to tool box

This document describes when a new protein intended to market for human consumption is considered to be a novel food protein (novel protein) and when it is not, when an application dossier for authorisation must be made and when, in general, an application dossier for notification might be sufficient. It describes in detail the items to be addressed in these application dossiers and gives references to guidance documents of CAs (competent authorities) and provides examples. It also provides guidelines of what information for each item might consider being sufficient by CAs.