Regulation (EC) No 854/2004 of the European Parliament and of the Council (repealed)Show full title

CHAPTER II: OFFICIAL CONTROLS CONCERNING LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AREAS

A. CLASSIFICATION OF PRODUCTION AND RELAYING AREAS

1. The competent authority must fix the location and boundaries of production and relaying areas that it classifies. It may, where appropriate, do so in cooperation with the food business operator.

2. The competent authority must classify production areas from which it authorises the harvesting of live bivalve molluscs as being of one of three categories according to the level of faecal contamination. It may, where appropriate, do so in cooperation with the food business operator.

3. The competent authority may classify as being of Class A areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve molluscs taken from these areas must meet the health standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter V, of Regulation (EC) No .../2004(1).

4. The competent authority may classify as being of Class B areas from which live bivalve molluscs may be collected, but placed on the market for human consumption only after treatment in a purification centre or after relaying so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three dilution Most Probable Number (MPN) test of 4 600E.coli per 100 g of flesh and intravalvular liquid.

5. The competent authority may classify as being of Class C areas from which live bivalve molluscs may be collected but placed on the market only after relaying over a long period so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three dilution MPN test of 46 000 E.coli per 100 g of flesh and intravalvular liquid.

6. If the competent authority decides in principle to classify a production or relaying area, it must:

(a)

make an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area;

(b)

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.;

(c)

determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area; and

(d)

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.

B. MONITORING OF CLASSIFIED RELAYING AND PRODUCTION AREAS

1. Classified relaying and production areas must be periodically monitored to check:

(a)

that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;

(b)

the microbiological quality of live bivalve molluscs in relation to the production and relaying areas;

(c)

for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs; and

(d)

for the presence of chemical contaminants in live bivalve molluscs.

2. To implement paragraph 1(b), (c) and (d), sampling plans must be drawn up providing for such checks to take place at regular intervals, or on a case-by-case basis if harvesting periods are irregular. The geographical distribution of the sampling points and the sampling frequency must ensure that the results of the analysis are as representative as possible for the area considered.

3. Sampling plans to check the microbiological quality of live bivalve molluscs must take particular account of:

(a)

the likely variation in faecal contamination, and

(b)

the parameters referred to in paragraph 6 of Part A.

4. Sampling plans to check for the presence of toxin-producing plankton in production and relaying waters and for biotoxins in live bivalve molluscs must take particular account of possible variations in the presence of plankton containing marine biotoxins. Sampling must comprise:

(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;

(b)

periodic toxicity tests using those molluscs from the affected area most susceptible to contamination.

5. The sampling frequency for toxin analysis in the molluscs is, as a general rule, to be weekly during the periods at which harvesting is allowed. This frequency may be reduced in specific areas, or for specific types of molluscs, if a risk assessment on toxins or phytoplankton occurrence suggests a very low risk of toxic episodes. It is to be increased where such an assessment suggests that weekly sampling would not be sufficient. The risk assessment is to be periodically reviewed in order to assess the risk of toxins occurring in the live bivalve molluscs from these areas.

6. When knowledge of toxin accumulation rates is available for a group of species growing in the same area, a species with the highest rate may be used as an indicator species. This will allow the exploitation of all species in the group if toxin levels in the indicator species are below the regulatory limits. When toxin levels in the indicator species are above the regulatory limits, harvesting of the other species is only to be allowed if further analysis on the other species shows toxin levels below the limits.

7. With regard to the monitoring of plankton, the samples are to be representative of the water column and to provide information on the presence of toxic species as well as on population trends. If any changes in toxic populations that may lead to toxin accumulation are detected, the sampling frequency of molluscs is to be increased or precautionary closures of the areas are to be established until results of toxin analysis are obtained.

8. Sampling plans to check for the presence of chemical contaminants must enable the detection of any overshooting of the levels laid down in Commission Regulation (EC) No 466/2001(2).

C. DECISIONS AFTER MONITORING

1. Where the results of sampling show that the health standards for molluscs are exceeded, or that there may be otherwise a risk to human health, the competent authority must close the production area concerned, preventing the harvesting of live bivalve molluscs. However, the competent authority may reclassify a production area as being of Class B or C if it meets the relevant criteria set out in Part A and presents no other risk to human health.

2. The competent authority may re-open a closed production area only if the health standards for molluscs once again comply with Community legislation. If the competent authority closes a production because of the presence of plankton or excessive levels of toxins in molluscs, at least two consecutive results below the regulatory limit separated at least 48 hours are necessary to re-open it. The competent authority may take account of information on phytoplankton trends when taking this decision. When 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 authority may decide to re-open the area with results below the regulatory limit obtained from one single sampling.

D. ADDITIONAL MONITORING REQUIREMENTS

1. The competent authority is to monitor classified production areas from which it has forbidden the harvesting of bivalve molluscs or subjected harvesting to special, conditions, to ensure that products harmful to human health are not placed on the market.

2. In addition to the monitoring of relaying and production zones referred to in paragraph 1 of Part B, a control system must be set up comprising laboratory tests to verify food business operators' compliance with the requirements for the end product at all stages of production, processing and distribution. This control system is, in particular, to Verify 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.

E. RECORDING AND EXCHANGE OF INFORMATION

The competent authority must:

(a)

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;

(b)

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

(c)

act promptly where the controls prescribed in this Annex indicate that a production area must be closed or reclassified or can be re-opened.

F. FOOD BUSINESS OPERATORS' OWN-CHECKS

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.

(1)

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food of animal origin (see recital 1, 2nd Regulation).

(2)

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).