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…
The following participate in the national vigilance system implemented by the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail: 1° Health professionals who accept ; 2° The Directorate-General for Competition, Consumer Affairs and Fraud Control, the Directorate-General for Food and the Directorate-General for Health; 3° Producers and distributors under the provisions of article L. 423-3 of the Consumer Code; 4° The Agence Nationale de Santé Publique,…
The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall inform the competent authorities of any adverse reactions of which he is aware. The Director General of Competition, Consumer Affairs and Fraud Control shall inform the producer or distributor concerned of any adverse reactions brought to his attention.
In the event of adverse reactions, the Director General of Competition, Consumer Affairs and Fraud Control shall, at his request, send the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail any information relating to the composition of each of the products mentioned in Article R. 1323-1 that it may require in order to carry out its duties, in particular the exact concentration…
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is a Registered Trademark of
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75001, Paris France
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