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Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (repealed)
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This Annex applies to live bivalve molluscs and, by analogy, to live echinoderms, live tunicates and live marine gastropods.
make an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area;
examine the quantities of organic pollutants which are released during the different periods of the year, according to the seasonal variations of both human and animal populations in the catchment area, rainfall readings, waste water treatment, etc.;
determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area; and
establish a sampling programme of bivalve molluscs in the production area which is based on the examination of established data, and with a number of samples, a geographical distribution of the sampling points and a sampling frequency which must ensure that the results of the analysis are as representative as possible for the area considered.
that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;
the microbiological quality of live bivalve molluscs in relation to the production and relaying areas;
for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs; and
for the presence of chemical contaminants in live bivalve molluscs.
the likely variation in faecal contamination, and
the parameters referred to in paragraph 6 of Part A.
periodic sampling to detect changes in the composition of plankton containing toxins and their geographical distribution. Results suggesting an accumulation of toxins in mollusc flesh must be followed by intensive sampling;
periodic toxicity tests using those molluscs from the affected area most susceptible to contamination.
The competent authority must:
establish and keep up to date a list of approved production and relaying areas, with details of their location and boundaries, as well as the class in which the area is classified, from which live bivalve molluscs may be taken in accordance with the requirements of this Annex. This list must be communicated to interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres;
immediately inform the interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres, about any change of the location, boundaries or class of a production area, or its closure, be it temporary or final; and
act promptly where the controls prescribed in this Annex indicate that a production area must be closed or reclassified or can be re-opened.
To decide on the classification, opening or closure of production areas, the competent authority may take into account the results of controls that food business operators or organisations representing food business operators have carried out. In that event, the competent authority must have designated the laboratory carrying out the analysis and, if necessary, sampling and analysis must have taken place in accordance with a protocol that the competent authority and the food business operators or organisation concerned have agreed.
Official controls on pectinidae harvested outside classified production areas are to be carried out in fish auctions, dispatch centres and processing establishments. Such official controls are to verify compliance with the health standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter V, to Regulation (EC) No .../2004(3) as well as compliance with other requirements of Annex III, Section VII, Chapter IX, to that Regulation.
Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food of animal origin (see recital 1, 2nd Regulation).
OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation (EC) No 655/2004 (OJ L 104, 8.4.2004, p. 48).
Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food of animal origin (see recital 1, 2nd Regulation).
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