The provisions of articles R. 1322-70 to R. 1322-72 and III of article R. 1322-73 do not apply to the production of clean seawater used in contact with live bivalve molluscs or for feeding shellfish and fish tanks, or to water pumped offshore for use on board ships.
I. – Any production of clean seawater is subject to authorisation from the Prefect of the département in which the production facility is located. The authorisation is issued on the basis of a file containing in particular: 1° The name of the person responsible for production at the facility concerned, if this person is not the author of the application for authorisation; 2° Information enabling the water quality to be…
I. – The clean seawater produced must comply with quality limits and standards, relating to microbiological and physico-chemical parameters, set by joint order of the Minister for Health and the Minister for Agriculture, issued after consultation with the National Agency for Food, Environmental and Occupational Health Safety. The ministerial order mentioned in the first paragraph also defines the additional quality limits and references which the Prefect may, as part of…
I. – When the quality limits mentioned in article R. 1322-71 are not respected for the clean seawater produced, or in the event of a danger likely to compromise the safety of the clean seawater, the person responsible for the production of clean seawater must : – immediately stop the production and distribution of clean seawater as long as these quality limits are not complied with; – take the necessary…
I. – The use of clean seawater in contact with foodstuffs is authorised only for the uses referred to : – Chapter VII of Annex II to Regulation (EC) No 852/2004 ; – Section VIII of Annex III to Regulation (EC) No 853/2004. II. – The use of this water is carried out under the responsibility of the food business using it. The burden of proving the harmlessness of the…
In the event of non-compliance with the provisions of articles R. 1322-70 to R. 1322-73 or the individual decisions taken for their application, the Prefect will send the person responsible for the production of clean seawater formal notice to put an end to the shortcomings observed within a time limit that he will set. This formal notice specifies the measures to be implemented and sets a deadline for submitting observations….
Without prejudice to the provisions of article R. 1322-72 and whether or not the quality limits and references have been complied with, the Prefect may, when the clean seawater produced or used presents an imminent risk to public health, order the production, distribution or use of clean seawater to be stopped without prior formality.
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…
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