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- Point in Time (29/04/2004)
- Original (As adopted by EU)
Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for on the hygiene of foodstuffs
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Version Superseded: 01/01/2010
Point in time view as at 29/04/2004.
There are currently no known outstanding effects for the Regulation (EC) No 853/2004 of the European Parliament and of the Council, SECTION VII: LIVE BIVALVE MOLLUSCS.
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In the case of operations that take place before live bivalve molluscs arrive at a dispatch or purification centre, they supplement the requirements of Annex I to that Regulation.
In the case of other operations, they supplement the requirements of Annex II to that Regulation.
In the case of a batch of live bivalve molluscs sent from a production area, the registration document must contain at least the following information:
the gatherer's identity and address;
the date of harvesting;
the location of the production area described in as precise detail as is practicable or by a code number;
the health status of the production area;
the shellfish species and quantity; and
the destination of the batch.
In the case of a batch of live bivalve molluscs sent from a relaying area, the registration document must contain at least the information referred to in (a) and the following information:
the location of the relaying area; and
the duration of relaying.
In the case of a batch of live bivalve molluscs sent from a purification centre, the registration document must contain at least the information referred to in (a) and the following information:
the address of the purification centre;
the duration of purification; and
the dates on which the batch entered and left the purification centre.
the staff gathering live bivalve molluscs also operate the dispatch centre, purification centre, relaying area or processing establishment receiving the live bivalve molluscs; and
a single competent authority supervises all the establishments concerned,
registration documents are not necessary if that competent authority so permits.
sterilisation in hermetically sealed containers; and
heat treatments involving:
immersion in boiling water for the period required to raise the internal temperature of the mollusc flesh to not less than 90oC and maintenance of this minimum temperature for a period of not less than 90 seconds;
cooking for three to five minutes in an enclosed space where the temperature is between 120 and 160oC and the pressure is between 2 and 5 kg/cm2, followed by shelling and freezing of the flesh to a core temperature of -20oC; and
steaming under pressure in an enclosed space satisfying the requirements relating to cooking time and the internal temperature of the mollusc flesh mentioned under (i). A validated methodology must be used. Procedures based on the HACCP principles must be in place to verify the uniform distribution of heat.
Food business operators harvesting live bivalve molluscs, or handling them immediately after harvesting, must ensure compliance with the following requirements.
adequately protect live bivalve molluscs from crushing, abrasion or vibration;
not expose live bivalve molluscs to extreme temperatures;
not re-immerse live bivalve molluscs in water that could cause additional contamination; and
if carrying out conditioning in natural sites, use only areas that the competent authority has classified as being of class A.
Food business operators relaying live bivalve molluscs must ensure compliance with the following requirements.
use techniques for handling live bivalve molluscs intended for relaying that permit the resumption of filter-feeding activity after immersion in natural waters;
not relay live bivalve molluscs at a density that prevents purification;
immerse live bivalve molluscs in seawater at the relaying area for an appropriate period, fixed depending on the water temperature, which period must be of at least two months' duration unless the competent authority agrees to a shorter period on the basis of the food business operator's risk analysis; and
ensure sufficient separation of sites within a relaying area to prevent mixing of batches; the "all in, all out" system must be used, so that a new batch cannot be brought in before the whole of the previous batch has been removed.
Internal surfaces must be smooth, durable, impermeable and easy to clean.
They must be constructed so as to allow complete draining of water.
Any water intake must be situated in a position that avoids contamination of the water supply.
Food business operators purifying live bivalve molluscs must ensure compliance with the following requirements.
Food business operators operating dispatch centres must ensure compliance with the following requirements.
a class A production area;
a relaying area;
a purification centre; or
another dispatch centre.
In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC) No .../2004(5), food business operators must ensure that live bivalve molluscs placed on the market for human consumption meet the standards laid down in this Chapter.
for Paralytic Shellfish Poison (PSP), 800 micrograms per kilogram;
for Amnesic Shellfish Poison (ASP), 20 milligrams of domoic acid per kilogram;
for okadaic acid, dinophysistoxins and pectenotoxins together, 160 micrograms of okadaic acid equivalents per kilogram;
for yessotoxins, 1 milligram of yessotoxin equivalent per kilogram; and
for azaspiracids, 160 micrograms of azaspiracid equivalents per kilogram.
the species of bivalve mollusc (common name and scientific name); and
the date of packaging, comprising at least the day and the month.
By way of derogation from Directive 2000/13/EC, the date of minimum durability may be replaced by the entry "these animals must be alive when sold".
Food business operators harvesting pectinidae outside classified production areas or handling such pectinidae must comply with the following requirements.
with the documentary requirements of Chapter I, points 3 to 7, where applicable. In this case, the registration document must clearly indicate the location of the area where the pectinidae were harvested; or
as regards packaged pectinidae, and wrapped pectinidae if the wrapping provides protection equivalent to that of packaging, with the requirements of Chapter VII concerning identification marking and labelling.
Official Publications Office is to insert the official number of Regulation on the organisation of official controls.
Official Publications Office is to insert the official number of Regulation on the hygiene of foodstuffs.
Official Publications Office is to insert the official number of Regulation on the organisation of official controls.
Official Publications Office is to insert the official number of Regulation on the hygiene of foodstuffs.
Official Publications Office is to insert the official number of Regulation on the hygiene of foodstuffs.
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