Section 1: General provisions.

I. – The purpose of food vigilance, known as nutrivigilance, is to monitor, assess and prevent the risk of undesirable effects linked to the consumption of the foodstuffs and foods mentioned in II of this article. II. – Nutrivigilance is carried out on : 1° Novel foods within the meaning of Article 2 of Regulation (EU) No 2015/2283 of the European Parliament and of the Council of 25 November 2015…

The food vigilance provided for in Article R. 1323-1 includes : 1° The reporting of adverse reactions by health professionals to the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail ; 2° The transmission to the same Agency of information on adverse reactions received in the course of their duties by the National Public Health Agency, the National Agency for the Safety of Medicines and Health…

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…