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1.Where the results of the monitoring provided for in Article 59 indicate that the health standards for live bivalve molluscs are not met or that there may otherwise be a risk to human health, the competent authorities shall close the classified production or relaying area concerned, preventing the harvesting of live bivalve molluscs. However, they may reclassify a production or relaying area as being of Class B or C if it meets the relevant criteria set out in Articles 54 and 55 and presents no other risk to human health.
2.Where the results of microbiological monitoring show that the health standards for live bivalve molluscs referred to in Article 53 not met, competent authorities may, on the basis of a risk assessment, and only on a temporary and non-recurring basis, permit continued harvesting without closure or reclassification subject to the following conditions:
(a)the classified production area concerned and all approved establishments receiving live bivalve molluscs from it are under the official control of the same competent authorities;
(b)the live bivalve molluscs concerned are subjected to appropriate restrictive measures such as purification, relaying or processing.
3.The accompanying registration document, as referred to in Chapter I of Section VII of Annex III to Regulation (EC) No 853/2004, shall include all the information concerning the application of paragraph 2.
4.The competent authorities shall establish the conditions under which paragraph 2 can be availed of in order to ensure, for the production area concerned, maintenance of the compliance with the criteria established in Article 53.
1.The competent authorities may re-open a closed production or relaying area only if the health standards for live bivalve molluscs comply once again with the relevant requirements of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004 and present no other risk to human health.
2.Where the competent authorities have closed a production or relaying area because of the presence of plankton or levels of toxins in live bivalve molluscs that exceed the regulatory limit for marine biotoxins laid down in point 2 of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004, they may re-open it only if at least two consecutive analytical results separated by at least 48 hours are below the regulatory limit.
3.When deciding whether to re-open a production or relaying area, the competent authorities may take account of information on phytoplankton trends.
4.Where there are robust data on the dynamic of the toxicity for a given area, and provided that recent data on decreasing trends of toxicity are available, the competent authorities may decide to re-open an area with results below the regulatory limit in point 2 of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004 obtained from a single sampling.
1.The competent authorities shall set up a control system to ensure that products of animal origin harmful to human health are not placed on the market. The control system shall comprise laboratory tests to verify food business operators' compliance with the requirements for the end product, including live bivalve molluscs and any products derived from them, at all stages of production, processing and distribution.
2.This control system shall verify, where applicable, that the levels of marine biotoxins and contaminants do not exceed safety limits and that the microbiological quality of the molluscs does not constitute a hazard to human health.
1.The competent authorities shall act promptly where a production area must be closed or reclassified, or may be re-opened, or where live bivalve molluscs are subject to the application of measures as referred to in Article 62(2).
2.When deciding on the classification, reclassification, opening or closure of production areas in accordance with Articles 52, 62 and 63, competent authorities may take into account the results of checks carried out by food business operators or organisations representing food business operators, only if the laboratory carrying out the analysis is designated by the competent authorities, and the sampling and analysis are performed in accordance with a protocol agreed upon jointly by the competent authorities and food business operators or organisation concerned.