Schedule REQUIREMENTS OF CHAPTER IV OF THE ANNEX
| Column (1) Conditions for the approval of dispatch or purification centres | Column (2) Whether derogation possible and limitations |
|---|---|
| Section I. General conditions relating to premises and equipment | |
| Centres must not be located in areas which are close to objectionable odours, smoke, dust and other contaminants. The location must not be subject to flooding by ordinary high tides or run-off from surrounding areas. | no |
| Centres must have at least: 1 on premises where live bivalve molluscs are handled or stored: a) buildings or facilities of sound construction, designed and maintained adequately for the purpose of preventing contamination of live bivalve molluscs by any type of waste, dirty water, fumes, dirt or by the presence of rodents or other animals; | yes, in so far as the construction of buildings or facilities is concerned |
(b) flooring which is easy to keep clean and is laid in such a way as to facilitate drainage; | yes |
(c) adequate working space to allow for satisfactory performance of all operations; | yes |
(d) durable walls which are easy to clean; | yes |
(e) adequate natural or artificial lighting; | yes |
2 access to an appropriate number of changing rooms, wash basins and lavatories; there must be a sufficient number of wash basins close to the lavatories; | yes, in so far as the requirement relates to the number of changing rooms |
3 adequate equipment for washing tools, containers and equipment; | no |
4 facilities for the supply and, where appropriate, storage of exclusively potable water within the meaning of Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumptionf1 or facilities for the supply of clean sea water; | no |
| Facilities supplying non-potable water may be authorised. The water concerned may not come into direct contact with live bivalve molluscs or be used for cleaning or disinfecting containers, plant or equipment which come into contact with live bivalve molluscs. Pipes and outlets carrying non-potable water must be clearly distinguished from those carrying potable water; | no |
5 equipment and instruments or their surfaces which are intended to come into contact with live bivalve molluscs must be made of corrosion-resistant material which is easy to wash and clean repeatedly. | yes |
| Section II. General hygiene requirements | |
| A high degree of cleanliness and hygiene must be required of staff, premises, equipment and working conditions: | no |
1 staff who treat or handle live bivalve molluscs must in particular wear clean working clothes and, where appropriate, gloves which are suitable for the work in which the person is engaged; | no |
2 staff are obliged to refrain from personal behaviour, such as spitting, which could result in contamination of live bivalve molluscs; any person suffering from an illness which can be transmitted by live bivalve molluscs must be temporarily prohibited, until recovery, from working with or handling these products; | no |
3 any rodents, insects or other vermin found must be destroyed and further infestation prevented. Domestic animals must not enter the facilities; | no |
4 premises, equipment and instruments used for handling live bivalve molluscs must be kept clean and in a good state of repair; equipment and instruments must be thoroughly cleaned at the end of the day’s work and at such other times as may be appropriate; | no |
5 premises, instruments and equipment must not be used for purposes other than the handling of live bivalve molluscs without authorisation by the competent authority; | no |
6 waste products must be stored hygienically in a separate area and, where appropriate, in covered containers suitable for the purpose intended. Waste material must be removed from the vicinity of the establishment at appropriate intervals; | yes, in so far as a separate area for the storage of waste products is concerned |
7 the finished products must be stored under cover and must be kept away from the areas where animals other than live bivalve molluscs such as crustaceans, are handled. | yes |
| Section III. Requirements for purification centres | |
| In addition to the requirements under Sections I and II, the following conditions must be met: 1 the floors and walls of the purification tanks and any water storage containers must have a smooth, hard and impermeable surface and be easy to clean by scrubbing or use of pressurized water. The base of the purification tanks must be sufficiently sloped and be equipped with drainage sufficient for the volume of work; | yes, in so far as it relates to water storage containers and the slope of the base of purification tanks |
2 live bivalve molluscs must be washed free of mud with pressurized clean sea water or potable water before purification. The initial washing may also be carried out in the purification tanks before purification commences, the drainage pipes being kept open during the entire initial washing and sufficient time being allowed thereafter for the system to be flushed clean before the purification process begins; | no |
3 the purification tanks must be supplied with a sufficient flow of sea water per hour and per tonne of live bivalve molluscs treated; | no |
4 clean sea water or sea water cleaned by treatment must be used for purifying live bivalve molluscs; the distance between the sea water intake point and the waste water outlets must be sufficient to avoid contamination; if treatment of the sea water is necessary, the process shall be authorised once its effectiveness has been verified by the competent authority; potable water used to prepare sea water from its major constituent chemicals must comply with the requirements laid down in Directive 80/778/EEC; | no |
5 operation of the purification system must allow live bivalve molluscs to rapidly resume filter feeding activity, remove sewage contamination, not to become recontaminated and be able to remain alive in a suitable condition after purification for wrapping, storage and transport before being placed on the market; | no |
6 the quantity of live bivalve molluscs to be purified must not exceed the capacity of the purification centre; the live bivalve molluscs must be continuously purified for a period sufficient to allow the microbiological standards laid down in Chapter V to be met. This period starts from the moment at which the live bivalve molluscs in the purification tanks are adequately covered by the water until the moment when they are removed. The purification centre must take account of the data relating to the raw materials (the type of bivalve mollusc, its area of origin, microbe content, etc) in case it is necessary to extend the purification period so as to ensure that the live bivalve molluscs meet the bacteriological requirements of Chapter V; | no |
7 should a purification tank contain several batches of molluscs, they must be of the same species and come from the same production area or different areas conforming to the same health conditions. The length of the treatment must be based on the time required by the batch needing the longest period of purification; | no |
8 containers used to hold live bivalve molluscs in purification systems must have a construction which allows sea water to flow through; the depth of layers of live bivalve molluscs should not impede the opening of shells during purification; | no |
9 no crustaceans, fish or other marine species must be kept in a purification tank in which live bivalve molluscs are undergoing purification; | no |
10 after completion of purification, the shells of live bivalve molluscs must be washed thoroughly by hosing with potable water or clean sea water; this may take place in the purification tank if necessary; the washing water must not be recirculated; | no |
11 purification centres must have their own laboratories or secure the services of a laboratory equipped with the necessary facilities for checking the efficiency of purification by use of microbiological specifications. Laboratory facilities outside the centres must be recognised by the competent authority; | no |
12 purification centres must regularly keep a record of the following data:
These records must be complete and accurate, legible and recorded in a permanent ledger book which must be available for inspection by the competent authority; | no |
13 purification centres must accept only those batches of live molluscs which are accompanied by the registration document referred to in Chapter II; | no |
| Purification centres dispatching batches of live bivalve molluscs to dispatch centres must provide the registration document referred to in Chapter II, section 6. | no |
14 every package containing purified live bivalve molluscs must be provided with a label certifying that all molluscs have been purified. | no |
| Section IV. Requirements for dispatch centres | |
1 In addition to the requirements under Sections I and II, the following conditions must be met: (a) conditioning must not cause any contamination of the product, conditioning facilities must be used in accordance with procedures recognised by the competent authorities, with special regard to the bacteriological and chemical quality of the sea water used in those facilities; | no |
(b) equipment and containers in the conditioning facilities must not constitute a source of contamination; | no |
(c) procedures for calibration of live bivalve molluscs must not result in additional contamination of the product or in any changes affecting the ability of the product to be transported and stored after wrapping; | no |
(d) any washing or cleaning of live bivalve molluscs must be carried out using pressurised clean sea water or potable water; cleaning water may not be recycled. | no |
2 Dispatch centres must accept only those batches of live bivalve molluscs which are accompanied by the registration document referred to in Chapter II, section 6 and coming from an approved production area, relaying area or purification centre. | no |
3 Dispatch centres must have their own laboratories or secure the services of a laboratory equipped with the necessary facilities for checking, inter alia, whether the molluscs comply with the microbiological standards of Chapter V. Laboratory facilities outside the centre must be recognised by the competent authority. | no |
| However, these requirements do not apply to dispatch centres obtaining their molluscs exclusively and directly from a purification centre where they have been examined after purification. 4 Dispatch centres must keep the following data at the disposal of the competent authority: | no |
| — results of microbiological tests on live bivalve molluscs from an approved production area or relaying area; — dates and quantities of live bivalve molluscs delivered to the dispatch centre and corresponding registration document numbers; — dispatch details. These data must be classified chronologically and preserved for a period to be laid down by the competent authority, but not less than three months. 5 Dispatch centres situated aboard vessels shall be subject to the conditions laid down in point 1(b), (c) and (d) and in points 3 and 4. The conditions laid down in Section I and II shall apply mutatis mutandis to such dispatch centres although special conditions may be laid down in accordance with the procedure laid down in Article 12 of the Council Directive. | no |
Annotations
Footnotes
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OJ No. L229, 30.8.1980, p11. Directive last amended by the 1985 Act of Accession (OJ No. L302, 15.11.1985, p218).