2. 4. 90 Official Journal of the European Communities No C 84/29 
Proposal for a Council Regulation (EEC) laying down the health conditions for the production and the 
placing on the market of live bivalve molluscs 
COM(89) 648 final 
(Submitted by the Commission on 6 February 1990) 
(90/C 84/03) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 43 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas, in order to ensure the smooth operation of the 
common market and more in particular the common 
organization of the market in products of fisheries, it is 
essential that the placing on the market of live bivalve 
molluscs should no longer be hindered by disparities existing 
in the Member States in respect of health requirements; 
whereas this will enable the production and the placing on 
the market to be better harmonized and bring about 
competition on equal terms while assuring consumers of a 
quality product; 
Whereas Council Directive 79/923/EEC of 30 October 
1979 on the quality of shellfish waters (1) lays down that it is 
necessary to establish the health requirements to be observed 
for shellfish products; 
Whereas requirements should be laid down for all stages 
during harvesting, handling, storage, transport and 
distribution of live bivalve molluscs in order to safeguard the 
public health of consumers; whereas these requirements shall 
apply equally to echinoderms and tunicates; 
Whereas it is important, would a health problem occur after 
the placing on the market of live bivalve molluscs to be able to 
trace back the establishment of dispatch and the harvesting 
area of origin; whereas it is therefore necessary to introduce a 
registration and labeling system which will enable to follow 
the flow of a batch after harvesting; 
Whereas it is important that the public health standards for 
the final product must be specified; whereas, however, 
scientific and technological knowledge is not always 
advanced enough to lay down definitive solutions for certain 
health problems and that it is therefore necessary, in order to 
guarantee optimal protection of public health, to fix a 
Community system to ensure rapid adoption and where 
necessary improvement of the health standards to safeguard from virus contamination or other hazards to human 
health; 
Whereas live bivalve molluscs obtained from harvesting 
areas which do not permit direct, safe consumption may be 
rendered safe by submitting them to a purification process or 
by re-laying in clean water over a longer period; whereas it is 
therefore necessary to define harvesting areas from which 
molluscs can be gathered for direct human consumption, or 
from which they have to be purified or re-layed; 
Whereas it is the responsibility of the producers to ensure that 
the bivalve molluscs are produced and placed on the market 
in compliance with the health requirements prescribed; 
whereas the competent authorities must by carrying out 
checks and inspections ensure that producers comply with 
those health requirements; whereas the competent 
authorities must in particular submit harvesting areas to a 
regular control to ensure that molluscs from these harvesting 
areas do not contain microorganisms and toxic substances in 
quantities which are considered to be dangerous to human 
health; 
Whereas control measures organized on a Community level 
must be introduced to guarantee the uniform application in 
all Member States of the standards laid down in this 
Regulation; 
Whereas in the context of trade between the Member States, 
the rules laid down in Council Directive . . ., concerning 
veterinary checks in intra-Community trade, with a view to 
the realization of the internal market (2) should be 
applied; 
Whereas live bivalve molluscs produced in a third country 
and intended to be placed on the market in the Community 
must not qualify for more favourable conditions than those 
applied in the Community; whereas provision must be made 
for a Community procedure for inspecting the conditions in 
third countries of the production and the placing on the 
market in order to allow the Community to apply a common 
import regime based on terms of equivalence; 
Whereas it is possible that, due to some particular situations, 
some establishments in function before 1 January 1992 will 
not be able to fulfil all the rules laid down in this Regulation; 
whereas it is opportune to settle the matter of granting 
limited and temporary derogations for those establishments 
in the general framework laid down in Council Decision 
.../.. ./EEC (on the granting of temporary limited 
(M OJ No L 281, 10. 11. 1979, p. 47. (2) COM(88) 383 final of July 1988. 
No C 84/30 Official Journal of the European Communities 2. 4. 90 
derogations from specific Community health rules on the 
production and marketing of products of animal 
origin)!1); 
Whereas it is appropriate to emphasize that any exceptions 
from the health rules laid down in this Regulation are 
without prejudice to the submission of all operations of 
production and placing on the market of live bivalve molluscs 
to the general health rules laid down by Council Regulation 
(EEC) No .../... (laying down general health rules 
applicable to the production and placing on the market of 
products of animal origin and specific health rules applicable 
to certain products of animal origin) (2); 
Whereas the Commission should be entrusted with the task 
of adopting certain measures for implementing this 
Regulation; whereas to that end, procedures should be laid 
down introducing close and effective cooperation between 
the Commission and the Member States within the Standing 
Veterinary Committee, 
HAS ADOPTED THIS REGULATION: 
CHAPTER I 
General Provisions 
Article 1 
This Regulation lays down the health conditions for the 
production and the placing on the market of live bivalve 
molluscs which are destined for immediate human 
consumption or for further processing before 
consumption. 
This Regulation applies mutatis mutandis also to 
echinoderms and tunicates. 
Article 2 
For the purpose of this Regulation, the following definitions 
shall apply: 
1. Bivalve molluscs: Lamellibranch molluscs which are 
filter-feeders and may be eaten raw or partially cooked, 
and are normally consumed whole including the viscera 
or after removal of selected parts of the viscera. 
2. Marine biotoxins: poisonous substances accumulated 
by bivalve molluscs feeding on plankton containing 
toxin. 
3. Clean seawater: seawater or estuary water which is free 
from microbiological contamination and toxic and 
objectionable substances occurring naturally or after 
discharge in the environment such as those listed in the 
Annex to Directive 79/923/EEC, in such quantities as 
may adversely affect the health quality of bivalve 
(') OJNoL. . . 
H OJ No L . . . molluscs or impair their taste and which is to be used 
under the conditions laid down in this Regulation. 
4. Competent authority: the department designated by the 
Member State concerned to monitor the 
implementation of this Regulation. 
5. Conditioning: the temporary wet storage of live bivalve 
molluscs, whose quality does not indicate need for 
re-laying or treatment in a purification plant, in tanks 
or any other installation containing clean seawater or in 
natural sites to remove sand, mud or slime and to 
improve product palatability. 
6. Gatherer: any physical or legal person or legal entity 
who collects live bivalve molluscs by any means from a 
harvesting area for the purpose of handling and the 
placing on the market. 
7. Harvesting area: sea, estuarine or lagoon areas with 
sites of re-laid beds or natural deposits of bivalve 
molluscs, or those sites used for cultivation of bivalve 
molluscs from which live bivalve molluscs are taken for 
their placing on the market. 
8. Establishment: any on-shore or off-shore construction 
or area in which live bivalve molluscs are handled and 
stored after harvesting and before placing on the 
market. 
9. Purification: the process of holding contaminated live 
bivalve molluscs in clean seawater for a time sufficient 
to permit removal of microbiological contamination 
through normal filter-feeding processes so making them 
suitable for human consumption. 
10. Expedition centre: an establishment for the reception, 
conditioning, washing, cleaning, calibration and 
wrapping of live bivalve molluscs which conform to the 
requirements of this Regulation. 
11. Purification plant: an establishment where live bivalve 
molluscs are kept for purification under suitable 
conditions using clean seawater or seawater which is 
treated to remove contamination so causing the 
reduction of harmful microorganisms to an acceptable 
level. 
12. Re-laying: transfer of live bivalve molluscs to suitable 
natural sea or estuarine areas under the supervision of 
the competent authority in order for purification to 
occur. It does not include the specific operation of 
transferring bivalve molluscs to more suitable areas for 
further growth or fattening. 
13. Means of transport: those parts set aside for goods in 
automobile vehicles, rail vehicles and aircraft, the holds 
of vessels and containers for transport by land, sea or 
air. 
14. Wrapping: an operation whereby live bivalve molluscs 
are protected from shock and desiccation by placing 
them in packaging material adequate for that 
purpose. 
15. Consignment: quantity of live bivalve molluscs handled 
in an expedition center or treated in a purification plant 
and subsequently bound for one or more customers. 
2. 4. 90 Official Journal of the European Communities No C 84/31 
16. Batch: quantity of live bivalve molluscs collected from a 
harvesting area and subsequently destined for delivery 
to an approved expedition center, purification plant, 
re-laying area or processing establishment as 
appropriate. 
17. Placing on the market: the holding or displaying for 
sale, offering for sale, selling, delivering or any other 
form of placing on the market of live bivalve molluscs 
for human consumption either raw or after processing 
in the Community. 
18. Importation: the introduction of live bivalve molluscs 
into the territory of the Community from third 
countries. 
19. Faecal coliform: facultative, aerobic, gram-negative, 
non-sporeforming, cytochrome oxidase negative, 
rod-shaped bacteria that are able to ferment lactose 
with gas production in the presence of bile salts, or 
other surface active agents with similar 
growth-inhibiting properties, at 44 °C + 0,2°C 
within 24 hours at least. 
20. E. coli: faecal coliforms which also form indole from 
tryptophan at 44 °C ± 0,2 °C within 24 hours. 
CHAPTER II 
Provisions for Community production 2. Live bivalve molluscs intended for further processing 
must comply with the relevant requirements of paragraph 1, 
and be processed in conformity with the requirements of 
Council Regulation (EEC) No . . . laying down the health 
conditions for the production and the placing on the market 
of fishery products (1). 
Article 4 
Persons handling live bivalve molluscs during their 
production and placing on the market shall adopt all 
measures necessary to comply with the requirements of this 
Regulation. 
Persons who operate establishments shall in particular ensure 
that: 
— adequate numbers of samples for laboratory examination 
are taken and analyzed in order to establish an historical 
record of the sanitary quality of the live bivalve molluscs 
both before and after handling at an expedition centre or 
at a purification plant, 
— a register is kept for the permanent record of the results of 
the various health checks and kept for presentation to the 
competent authority. 
Article 3 
1. The placing on the market of live bivalve molluscs for 
immediate human consumption shall be subject to the 
following conditions: 
(a) they must originate from harvesting areas which comply 
with the requirements laid down in Chapter I of the 
Annex; 
(b) they must have been collected and transported from the 
harvesting area to an expedition centre or purification 
plant under the conditions laid down in Chapter II of the 
Annex; 
(c) where provided for in this Regulation, they must have 
been re-layed in suitable sites approved for that purpose 
and complying with the conditions laid down in 
Chapter III of the Annex; 
(d) they must have been handled hygienically, and where 
appropriate, they must have been purified in 
establishments approved for that purpose and 
complying with the requirements of Chapter IV; 
(e) they must comply with the criteria set out in Chapter V 
of the Annex; 
(f) health controls must have been carried out in 
accordance with Chapter VI of the Annex; 
(g) they must have been appropriately wrapped in 
accordance with Chapter VII of the Annex; 
(h) they must have been stored and transported under 
satisfactory hygiene conditions in accordance with 
Chapters VIII and IX of the Annex; 
(i) they must bear a health mark as provided for in 
Chapter X of the Annex. Article 5 
1. (a) The competent authorities shall draw up a list of 
their approved expedition centres and purification 
plants, each of which shall have an official 
number. 
The competent authority shall approve such centres 
or plants only where they can be sure that they meet 
the requirements of this Regulation. Member States 
shall withdraw approval if the requirements cease to 
be met. 
(b) The inspection and monitoring of these 
establishments shall be carried out regularly on the 
responsibility of the competent authority, which 
shall at all times have free access to all parts of the 
establishments, in order to ensure compliance with 
the requirements of this Regulation. 
If such inspections reveal that not all the 
requirements of this Regulation are being met, the 
competent authority shall take the appropriate 
action. 
2. (a) The competent authorities shall establish a list of 
harvesting areas with indication of their location and 
boundaries from which live bivalve molluscs may be 
taken in conformity with this Regulation, and in 
particular, with Chapter I of the Annex. 
This list must be communicated to those affected by 
this Regulation such as harvesters and operators of 
purification plants and expedition centres. 
i1) OJNoL 
No C 84/32 Official Journal of the European Communities 2. 4. 90 
(b) The monitoring of the harvesting areas shall be 
carried out on the responsibility of the competent 
authority in accordance with the requirements of this 
Regulation. 
If such monitoring reveals that the requirements of 
this Regulation are not being met, the competent 
authority shall close the harvesting area concerned 
until the situation has been restored. 
3. The competent authorities concerned shall take all 
measures necessary to take account of the results referred 
to in Article 6 (1). 
Article 6 
1. Experts from the Commission may make on-the-spot 
checks in so far as is necessary to ensure the uniform 
application of this Regulation. They may check whether 
establishments and harvesting sites are in effect complying 
with the requirements of this Regulation. A Member State in 
whose territory a check is being carried out shall give all 
necessary assistance to the experts in carrying out their 
duties. The Commission shall inform the Member States of 
the results of such checks. 
2. The general provisions for implementing paragraph 1 
shall be determined in accordance with the procedure laid 
down in Article 16. If necessary, and in accordance with the 
same procedure, a code shall be established containing the 
rules to be followed for the purpose of the checks provided 
for in paragraph 1. 
3. The Commission, in accordance with the procedure 
laid down in Article 16, may draw up recommendations 
containing guidelines on good manufacturing practices 
applicable at the different stages of production and placing 
on the market. 
Article 7 
The rules laid down in Directive . . ., (concerning veterinary 
controls in intra-Community trade, with a view to the 
realization of the internal market) (*), shall apply, in 
particular with respect to the organization of the checks 
carried out by the Member State of destination, and the 
subsequent action and the safeguard measures to be 
applied. 
However, the definitions to be applied are the ones laid down 
in this Regulation. Article 9 
In order to ensure the uniform application of the provision 
laid down in Article 8, the following procedure shall 
apply: 
1. Inspections shall be carried out on the spot by experts of 
the Commission and the Member States to verify 
whether the conditions of production and placing on the 
market can be considered as being equivalent to those 
applied in the Community. 
The experts from the Member States who are to be 
entrusted with these inspections shall be appointed by the 
Commission, acting on a proposal from the Member 
States. 
These inspections shall be made on behalf of the 
Community, which shall bear the cost of any expenditure 
in this connection. 
The frequency and the procedure for these inspections 
shall be determined in accordance with the procedure 
laid down in Article 16. 
2. In deciding whether the conditions of production and 
placing on the market of live bivalve molluscs in a third 
country can be deemed equivalent to those of the 
Community, particular account shall be taken of: 
(a) the legislation of the third country; 
(b) the organization of the competent authority of the 
third country and of its inspection services, the 
powers of such services and the supervision to which 
they are subject, as well as their facilities for 
monitoring the implementation of their 
legislation; 
(c) the actual health conditions during the production 
and placing on the market of live bivalve molluscs 
and in particular the surveillance of harvesting areas 
in relation to microbiological and environmental 
contamination, and to the presence of marine 
biotoxins; 
(d) the regularity and the rapidity of the information by 
the third country on the presence of plankton 
containing toxin in the harvesting areas; 
(e) the assurances a third country can give on the 
compliance of the molluscs with the standards laid 
down in Chapter V of the Annex. 
CHAPTER HI 
Imports from third countries 
Article 8 
Provisions applied to imports of live bivalve molluscs from 
third countries shall be equivalent to those governing the 
placing on the market of Community products. 
OJ No L . The Commission, following the procedure laid down in 
Article 14 shall decide on: 
(a) the third countries fulfilling the conditions of 
equivalence referred to in paragraph 2; 
(b) for each third country, the conditions for the 
importation of live bivalve molluscs. These 
conditions may include in particular: 
(i) the supplying of a health certificate which must 
accompany consignments when forwarded to 
the Community; 
2. 4. 90 Official Journal of the European Communities No C 84/33 
(ii) the definition of the harvesting areas from 
which live bivalve molluscs may be collected 
and imported; 
(iii) the obligation of immediate information to the 
Community on every possible change of the 
approval of harvesting areas; 
(iv) possibly the mandatory purification after 
arrival at the territory of the Community. 
(c) a list of establishments from which the importation 
of live bivalve molluscs is authorized. For that 
purpose, one or more lists of such establishments 
shall be established. An establishment may not 
appear on a list unless it is officially approved by the 
competent authority of the third country exporting 
to the Community. Such approval shall be subject to 
observance of the following requirements: 
— compliance with requirements equivalent to 
those laid down in this Regulation, 
— supervision by an official inspection service of 
the third country. 
4. The Decisions referred to in point 3 may be modified or 
supplemented in accordance with the procedure laid 
down in Article 15. 
These Decisions and the amendments thereto shall be 
published in the Official journal of the European 
Communities, series L. 
Article 10 
Should an inspection as referred to in Article 9(1) bring to 
light serious facts which may render the placing on the 
market of live bivalve molluscs unsafe for human 
consumption, the Commission shall immediately inform the 
Member States and forthwith adopt a decision to change the 
import conditions or to suspend the importation from a 
particular establishment, harvesting area or from a part or 
the whole of the third country concerned. 
A final decision shall be taken in accordance with the 
procedure provided for in Article 15. 
Article 11 
1. The rules laid down in Council Regulation (EEC) 
No . . ., laying down the principles relating to the 
organization of health controls for products arising from 
third countries with a view to the completion of the internal 
market 0) will apply. 
2. The importation of live bivalve molluscs shall be 
prohibited if the conditions laid down in this Regulation have 
not been observed, and in particular when it is ascertained 
that: 
— the consignment does not comply with the conditions for 
importation laid down for the third country 
concerned, 
— the consignment constitutes a hazard to human health. 
(i) OJ No L . . . Article 12 
1. Ha disease capable of being conveyed to humans by 
live bivalve molluscs and therefore liable to be a serious 
hazard to public health, breaks out or spreads in a third 
country or if other considerations of public health so 
warrant, the Commission acting in accordance with the 
procedure laid down in Article 15, or a Member State may 
prohibit or subject to specific conditions the importation of 
those live bivalve molluscs directly or indirectly from the 
whole or part of the territory of the third country. 
2. Measures taken by the Member States under 
paragraph 1 and withdrawal of such measures, shall be 
notified immediately to the other Member States and the 
Commission, together with the reasons therefor. 
3. The Commission shall as soon as possible appraise the 
situation and take the requisite decisions in accordance with 
the procedure laid down in Article 15. 
4. The Commission shall monitor the situation and, in 
accordance with the procedure laid down in Article 15, shall 
amend or repeal the decisions referred to in paragraphs 1 and 
3, having regard to such situation. 
CHAPTER IV 
Final Provisions 
Article 13 
The Annex to this Regulation shall be amended in 
accordance with the procedure laid down in Article 14. 
Article 14 
1. Where the procedure laid down in this Article is to be 
applied, the matter shall be referred forthwith to the Standing 
Veterinary Committee set up by the Council Decision 
68/361/EEC (2) (hereinafter called 'the Committee') by its 
Chairman on his initiative or at the request of a Member 
State. 
2. The representative of the Commission shall submit to 
the Committee a draft of the measures to be taken. The 
Committee shall deliver its opinion on the draft within a time 
limit which the Chairman may lay down according to the 
urgency of the matter. The opinion shall be delivered by the 
majority laid down in Article 148 (2) of the Treaty in the case 
of decisions which the Council is required to adopt on a 
proposal from the Commission. The votes of the 
representatives of the Member States within the committee 
shall be weighted in the manner set out in that Article. The 
Chairman shall not vote. 
No C 84/34 Official Journal of the European Communities 2. 4. 90 
The Commission shall adopt the measure envisaged if they 
are in accordance with the opinion of the Committee. 
If the measures envisaged are not in accordance with the 
opinion of the Committee, or if no opinion is delivered, the 
Commission shall, without delay, submit to the Council a 
proposal relating to the measures to be taken. The Council 
shall act by a qualified majority. Commission shall, without delay, submit to the Council a 
proposal relating to the measures to be taken. The Council 
shall act by a qualified majority. 
If, on the expiry of a period of fifteen working days from the 
date of referral to the Council, the Council has not acted, the 
proposed measures shall be adopted by the Commission. 
If, on the expiry of a period of three months from the date of 
referral to the Council, the Council has not acted, the 
proposed measures shall be adopted by the Commission. 
Article IS 
1. Where the procedure laid down in this Article is to be 
applied, the Chairman shall refer the matter without delay on 
his own initiative or at the request of a Member State to the 
Committee. 
2. The representative of the Commission shall submit to 
the Committee a draft of the measures to be taken. The 
Committee shall deliver its opinion on the draft within two 
days. The opinion shall be delivered by the majority laid 
down in Article 148 (2) of the Treaty in the case of decisions 
which the Council is required to adopt on a proposal from the 
Commission. The votes of the representatives of the Member 
States within the Committee shall be weighted in the manner 
set out in that Article. The Chairman shall not vote. 
The Commission shall adopt the measures envisaged if they 
are in accordance with the opinion of the Committee. Article 16 
Where the procedure laid down in this Article is to be 
applied, the following rules shall apply. 
The representative of the Commission shall submit to the 
Committee a draft of the measures to be taken. The 
Committee shall deliver its opinion on the draft within a 
time-limit which the Chairman may lay down according to 
the urgency of the matter, if necessary by taking a vote. 
The opinion shall be recorded in the minutes; in addition, 
each Member State shall have the right to ask to have its 
position recorded in the minutes. 
The Commission shall take the utmost account of the 
opinion delivered by the Committee. It shall inform the 
Committee of the manner in which its opinion has been taken 
into account. 
Article 17 
This Regulation shall enter into force on 1 January 1993. 
If the measures envisaged are not in accordance with the 
opinion of the Committee, or if no opinion is delivered, the This Regulation shall be binding in its entirety and directly 
applicable in all Member States. 
ANNEX 
CHAPTER I 
CONDITIONS FOR HARVESTING AREAS 
The location and the boundaries of harvesting areas must be fixed by the competent authority in such a way as 
to identify the areas from which live bivalve molluscs: 
(a) can be collected for direct human consumption; live bivalve molluscs taken from these areas shall meet the 
requirements set out in Chapter V; 
(b) can be collected but only placed on the market after treatment in a purification system, after re-laying or 
after processing by a heat treatment sufficient to kill microorganisms as described in Chapter HI, 
Section III, 4 of the Annex to Regulation (EEC) No . . . (') concerning the health conditions governing the 
production and the placing on the market of fishery products. Live bivalve molluscs from these areas must 
not exceed the limits of a 5-tube-3-dilution MPN-test of 6 000 faecal coliforms per 100 grams of flesh or 
(«) OJNoL... 
2. 4. 90 Official Journal of the European Communities No C 84/35 
4 600 E. Coli per 100 grams of flesh in 95 % of samples. After purification, re-laying or processing, the 
requirements set out in Chapter V shall be met; 
(c) can be collected but only placed on the market after re-laying over a long period or after re-laying 
combined with purification to meet the requirements under (a). Processing of these molluscs by a heat 
treatment sufficient to kill microorganisms as described in Chapter III, Section III, 4 of the Annex to 
Regulation (EEC) No . . . concerning the health conditions governing the production and the placing on 
the market of fishery products may be carried our if the limits laid down under (b) are met. 
2. Any change in the delimitation of harvesting areas and the temporary or definite closure thereof shall be 
immediately announced by the competent authorities to those affected by this Regulation and in particular to 
producers and operators of purification plants and expedition centres. 
CHAPTER II 
REQUIREMENTS FOR HARVESTING AND TRANSPORTATION OF BATCHES TO AN EXPEDITION 
CENTRE OR PURIFICATION PLANT 
1. Harvesting techniques must not cause excessive damage to the shells or tissues of live bivalve molluscs. 
2. Live bivalve molluscs must be adequately protected from excessive crushing, abrasion or vibration after 
harvesting and must not be exposed to extremes of hot or cold temperature. 
3. Techniques for harvesting, transporting, landing and handling live bivalve molluscs must not result in 
additional contamination of the product, nor in a significant reduction of the keeping quality of the product, 
nor in any changes significantly affecting the ability to be treated by purification or processing or 
re-laying. 
4. Live bivalve molluscs must not be reimmersed in water which could have additional contamination between 
harvesting and landing onshore. 
5. Means of transport used for transporting live bivalve molluscs must be used under conditions which protect 
against additional contamination and crushing of shells. They must permit adequate drainage and 
cleaning. 
In the event of bulk transport over long distances of live bivalve molluscs to an expedition centre, purification 
plant or re-laying site, the means of transport must be equiped in such a way as to ensure the best survival 
conditions possible, and in particular they must comply with the requirements laid down in Chapter IX, 
point 2. 
6. A registration document for the identification of batches of live bivalve molluscs during transport from the 
harvesting area to an approved expedition centre, purification plant, re-laying site or processing plant is issued 
by the competent authority upon request of the gatherer. For each batch, the gatherer must complete the 
relevant sections of the registration document legibly and indelibly and which must contain the following 
information: 
— the gatherer's identity and signature, 
— the date of harvesting, 
— the location of the harvesting area in as precise detail as is practicable, 
— the shellfish species and quantity in as precise detail as is practicable, 
— the approval number and place of destination for wrapping, re-laying or purification or processing. 
The registration documents must be permanently and sequentially numbered. The competent authority shall 
keep a register indicating the number of the registration documents together with the names of the persons 
collecting live bivalve molluscs to whom they have been issued. The registration document for each batch of 
live bivalve molluscs must be date-stamped upon delivery of a batch to an expedition centre, purification plant, 
re-laying site or processing plant and must be kept available by operators of these sites or establishments for at 
least 60 days. 
However, if the gathering is carried out by the same person operating the expedition centre, purification plant, 
re-laying site or processing plant of destination, the registration document may be replaced by a permanent 
derogation granted by the competent authority. 
7. In case any harvesting area is closed temporarily, the competent authority shall refrain from issuing 
registration documents for that area and immediately suspend the validity of all registration documents already-
issued. 
No C 84/36 Official Journal of the European Communities 2. 4. 90 
CHAPTER III 
CONDITIONS FOR RE-LAYING LIVE BIVALVE MOLLUSCS 
The following conditions must be met: 
1. live bivalve molluscs must be gathered and transported in accordance with the requirements of 
Chapter II; 
2. techniques for handling live bivalve molluscs destined for re-laying must permit the resumption of filter-feeding 
activity after immersion in natural waters; 
3. live bivalve molluscs must not be re-laid at a density which does not permit purification; 
4. live bivalve molluscs must be immersed in seawater at the re-laying site for an appropriate period which must 
exceed the time taken for levels of faecal bacteria to become reduced to the levels permitted in this Regulation, 
and taking into account that the standards of Chapter V have to be compted with; 
5. the minimum water temperature for effective re-laying must, where necessary, be determined and announced 
by the competent authority for each species of live bivalve molluscs and approved re-lay site; 
6. sites for re-laying live bivalve molluscs must be approved by the competent authority. The boundaries of the 
sites must be clearly identified; 
7. sites within a re-laying area must be well separated to prevent mixing of batches; 
8. permanent records of the source of live bivalve molluscs, re-laying period, re-laying site and subsequent 
destination of the batch after re-laying must be maintained by the operators of re-laying sites for inspection by 
the competent authority; 
9. after harvesting from the re-laying site, the batches must during transport from the re-laying site to the 
approved expedition centre, purification plant or processing plant be accompanied by the registration 
document referred to in Chapter II, point 6, except in the case where the same staff is operating both the 
re-laying site and the expedition centre, purification plant or processing plant. 
CHAPTER IV 
CONDITIONS FOR THE APPROVAL OF ESTABLISHMENTS 
I. General conditions relating to premises and equipment 
Establishments must be located in areas which are free from 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. 
Establishments must have at least: 
1. In areas where live bivalve molluscs are handled or stored: 
(a) buildings or facilities of sound construction and designed and maintained adequately for the purpose 
of preventing contamination of live bivalve molluscs with any type of waste, dirty water, fumes, dirt 
or by the presence of rodents or other animals; 
(b) flooring which is easy to keep clean and is laid in such a way as to facilitate adequate drainage; 
(c) adequate working space to allow for satisfactory performance of all operations; 
(d) durable walls which are easy to clean; 
(e) adequate natural or artificial lighting. 
2. 4. 90 Official Journal of the European Communities No C 84/37 
2. Access to an appropriate number of changing rooms, wash basins and lavatories; there must be a sufficient 
number of hand wash basins close to the lavatories. 
3. Adequate equipment for washing tools, containers and equipment. 
4. Facilities for the supply and, where appropriate, adequate storage and distribution 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 consumption (') or facilities for the supply of clean sea water. 
Facilities supplying non-potable water may be authorized. The water concerned may not come into 
contact with live bivalve molluscs or be used for cleaning or disinfecting containers, plant or equipment 
which come into contact with the live bivalve molluscs. Pipes and outlets carrying non-potable water must 
be clearly distinguished from those carrying potable water. 
5. Equipment and instruments or their surfaces which are intended to come into contact with live bivalve 
molluscs must be made of material which is easy to wash and clean repeatedly and resist corrosion. 
II. General hygiene requirements 
A high degree of cleanliness and hygiene shall be required of staff, premises, equipment and working 
conditions: 
1. Staff who treat or handle live bivalve molluscs must in particular wear clean working clothes and, where 
appropriate, clean gloves which are suitable for the work in which the person is engaged. 
2. It is forbidden for staff to apply types of 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 
products. 
3. Any rodents, insects or other vermin found must be destroyed and further infestation prevented. Domestic 
animals must not enter the facilities. 
4. Premises, equipment and instruments used for production of live bivalve molluscs shall 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 or at such other times as may be appropriate. 
5. Premises, instruments and equipment must not be used for purposes other than the production of live 
bivalve molluscs unless authorization by the competent authority. 
6. Waste products must be stored hygienically in a separate area and, where appropriate, in covered 
receptacles suitable for the purpose intended. Waste material must be removed from the vicinity of the 
establishment at suitable periods. 
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. 
III. Requirements for purification plants 
In addition to the requirements under I and II, the following conditions must be met: 
1. The floors and walls of the purification system 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 system must be sufficiently sloped and be equipped with drains sufficient for the volume 
of work. 
2. Live bivalve molluscs must be washed free of mud with pressurized clean seawater or potable water 
before purification. The initial washing may also be carried out in the purification system 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. 
3. The purification system must be supplied with sufficient seawater or flow of seawater per hour and per 
tonne of live bivalve molluscs treated. 
4. Clean seawater must be used for purifying live bivalve molluscs; the distance between the seawater intake 
point and the waste water outlets must be sufficient to avoid contamination; the procedure for sanitizing 
the seawater shall be authorized once its effectiveness has been verified by the competent authority; 
potable water used to prepare seawater from its major constituent chemicals shall conform to the 
meaning of Council Directive 80/778/EEC. 
(') OJ No L 229, 30. 8. 1980, p. 11. 
NoC 84/38 Official Journal of the European Communities 2. 4. 90 
5. Operation of the purification system must be in accordance with instructions issued by the competent 
authority to ensure that live bivalve molluscs rapidly resume filter-feeding activity, remove sewage 
contamination, do not become recontaminated and are able to remain alive in a suitable condition after 
purification for wrapping, storage and transport before placing on the market. 
6. The quantity of live bivalve molluscs shall not exceed the capacity of the purification system; 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 system are adequately covered by the water until the moment when water is 
drained away before removal from the said system. The establishment operator must take account of the 
data relating to the raw materials (the type of bivalve molluscs, 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. 
7. A purification tank shall not contain more than one batch of molluscs during the period of 
purification. 
8. Containers used to hold live bivalve molluscs in purification system must have a mesh-type construction 
which allows seawater to flow through; the depth of layers of live bivalve molluscs should not impair the 
opening of shells during purification; containers of live bivalve molluscs should be placed at densities 
recommended by the competent authorities. 
9. No crustaceans, fish or other marine species must be kept in a purification system in which live bivalve 
molluscs are undergoing purification. 
10. After completion of purification, the shells of live bivalve molluscs can be washed thoroughly by hosing 
with potable water or clean seawater, this may take place in the purification system if necessary, the 
washing water must not be recirculated. 
11. The purification plants must have their own laboratory or secure the services, or access to data of, a 
laboratory equipped with the necessary facilities for checking the efficiency of purification by use of 
microbiological specifications. Laboratory facilities must be approved by the competent authority. 
12. Purification plants must regularly keep record of the following data: 
— results of microbiological tests on purification system water entering the purification tanks, 
— results of microbiological tests on unpurified live bivalve molluscs, 
— results of microbiological tests on purified live bivalve molluscs, 
— date and quantity of live bivalve molluscs delivered to the purification plant and appropriate 
registration document number, 
— the times of filling and emptying of purification systems (purification times), 
— dispatch details of consignments after purification. 
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. 
13. Purification plants must only accept batches of live molluscs which are accompanied by the registration 
document referred to in Chapter II; 
purification establishments dispatching batches of live bivalve molluscs to expedition centres must 
provide for the registration document referred to in Chapter II, point 6. 
14. Every package containing purified live bivalve molluscs must be provided with a label certifying that all 
molluscs have been purified. 
IV. Requirements for expedition centres 
1. In addition to meeting the requirements under I and II, the following conditions must be met: 
(a) conditioning must not cause any deleterious microbiological contamination of the product; 
(b) instructions for the use of conditioning facilities shall be issued by the competent authority and will 
have special regard to the bacteriological and chemical quality of the seawater used in the 
facilities; 
(c) equipment and containers in the conditioning facilities do not constitute a source of 
contamination; 
2. 4. 90 Official Journal of the European Communities No C 84/39 
(d) procedures for calibration of live shellfish must not result in additional contamination of the product 
or in any changes afecting the ability of the product to be transported and stored after 
wrapping; 
(e) any washing or cleaning of live bivalve molluscs must be carried out using pressurized clean seawater 
or potable water — cleaning water may not be recycled. 
2. Expedition centres must only accept batches of live shellfish which are accompanied by the registration of 
documents referred to in Chapter II, point 6 and coming from an approved harvesting area, re-laying site 
or purification plant. 
3. The expedition centres must have their own laboratory or secure the services of a laboratory equipped 
with the necessary facilities for checking if the molluscs comply with the microbiological standards of 
Chapter V. Laboratory facilities must be approved by the competent authority. 
However, this requirement is invalid if the expedition centres get their molluscs from a purification plant 
where they have been examined after purification. 
CHAPTER V 
REQUIREMENTS CONCERNING LIVE BIVALVE MOLLUSCS 
Live bivalve molluscs destined for immediate human consumption shall comply with the following 
requirements: 
1. The possession of visual characteristics associated with freshness and viability including shells free of dirt, an 
adequate response to percussion, and normal amounts of intravalvular liquid. 
2. They shall contain less than 300 faecal coliforms or less than 230 E. Coli per 100 grams of mollusc flesh and 
intravalvular liquid based on a 5-tube, 3 dilution MPN-test or any other bacteriological procedure shown to be 
equivalent in degree of precision. 
3. Absence of salmonella in 25 grams mollusc flesh. 
4. Live bivalve molluscs are not contaminated with toxic or objectionable compounds occurring naturally or 
added to the environment such as those listed in the Annex to Directive 79/923/EEC in such quantities that 
the calculated dietary intake exceeds the acceptable daily intake (ADI), or that the taste of the molluscs is 
impaired. 
5. The upper limits as regards the radionuclide contents shall not exceed the limits for foodstuffs as laid down by 
the Community. 
6. The total Paralytic Shellfish Poison (PSP) content shall not exceed 80 micrograms per 100 grams of mollusc 
flesh. 
7. The Diarrhetic Shellfish Poison (DSP) content of the flesh shall not exceed levels which may be considered 
dangerous to human health. 
8. In the absence of routine virus testing procedures and establishment of virological standards sanitary 
evaluation must use counts of faecal bacteria. 
Examinations for checking the compliance with the requirements of this Chapter must be carried out in 
accordance with proven methods which are scientifically recognized. 
Where necessary for the uniform application of this Regulation, sampling plans as well as the methods and 
analytical tolerances to be applied in order to check compliance with the requirements of this Chapter shall be 
established in accordance with the procedure laid down in Article 14. 
The effectiveness of the faecal indicator bacteria and their numerical limits as well as the other parameters laid 
down in this Chapter shall constantly be kept under review and, where scientific evidence proves the need to do 
so, be revised following the procedure laid down in Article 15. 
When there is scientific evidence indicating the need to introduce other parameters to safeguard public health 
such as the possible contamination with Neurotoxin-Shellfish Poison (NSP), this shal be done applying the 
same procedure. 
^oC^^O COtnci^l]ourn^otrric^nro^^nCornrnuninc^ ^^ ^0 
Ct^A^T8^Vl 
^U8L^^^ALT^^O^T^^LA^O^U^^V^^ 
Apublic health control system shall be established by the competent authorities in order to verify whether the 
requirements laid down in this regulation are complied with. This control system shall included 
L periodic supervision oflive bivalve molluscs relaying and harvesting areas in order. 
^a^ to avoid any abuse of the origin and destination of the live bivalve molluscs^ 
d^ to check the microbiological quality ofthe live bivalve molluscs in relation to the area ofharvestmg as laid 
down in Chapters 
^ to check the possible presence of to^mDproducing plankton 
f^or that purposed sampling plans shall be established by the competent authorities for checking at regular 
intervals or onacaseby^case basis in the situation of irregular periods of harvesting. 
sampling plans must in particular take account of^ 
^ likely variations in faecal contamination at each harvesting area^ 
^ possible variations of the presenceofplanktoncontaimngmarmebioto^ins^ the sampling must be 
designed as follows^ 
^ ^^^B^^^. penodicsamplingorgam^edtodetectchangesin thecomposition of theplankton 
containing toxins and the geographical distribution thereof. Information leading toasuspicion of 
accummulation of toxins in muscle flesh must be followed by 
— control of the plankton in the growing and fishing waters by increasing the number of sampling 
points and the number of samples^ and 
— tonicity tests on molluscs from the affected ^one and most susceptible to the contamination. 
This intensive sampling plan must be continued until the results of tonicity tests permit again the 
placing on the market of the molluscs^ 
^ possible contamination of the molluscs in the harvesting area.If the result ofasampling plan shows that 
the placing on themarketoflivebivalvemolluscs may constituteaha^ard to humanhealth^thecompetent 
authority shall close the harvesting area until the situation has been restored. 
2. Laboratory tests inorder to check the respectof the requirementsfor the endproductaslaiddownin 
ChapterVofthisAnne^. 
There shall in particular be establishedacontrol system to verify that the level of marine bioto^ms do not 
exceed the safe levels required by this regulation. 
3. An inspection at regular intervals of establishments. These inspections shall include in particular checks^ 
^ to verify whether the approval conditions are still being complied with^ 
^ on the cleanliness of the premises^ facilities^ equipment and of staff hygienes 
^ to verify whether the live bivalve molluscs are handled and treated correctly^ 
^ on the correct application and functioning of purification or conditioning systems^ 
^ of the record books referred to in Chapter iVunderttpf^ 
^ the correct use of health marks. 
Thesechecksmaymcludethetakingofsamples for laboratorytests^theresultsofthesetestsshall be notified to 
the persons responsible for the establishments. 
^. Checks on the storage and transport conditions of the consignments of live bivalve molluscs. 
2. 4. 90 Official Journal of the European Communities No C 84/41 
CHAPTER VII 
WRAPPING 
1. Live bivalve molluscs shall be wrapped under satisfactory hygiene conditions. 
The wrapping material or container must: 
— not impair the organoleptic characteristics of the live bivalve molluscs, 
— must not be capable of transmitting substances which are harmful to human health to the live bivalve 
molluscs, 
— be strong enough to give adequate protection to the live bivalve molluscs. 
2. Oysters must be wrapped with the concave shell downwards. 
3. All wrappings of live bivalve molluscs must be sealed and remain sealed from the expedition centre until 
delivery to the consumer or retailer. 
CHAPTER VIII 
PRESERVATION AND STORAGE 
1. In any storing rooms, live bivalve molluscs must be kept at a temperature which does not adversely affect their 
quality and viability, the wrapping must not come into contact with the floor of the store room but must be 
placed on a clean, raised surface. 
2. Reimmersion of live bivalve molluscs in seawater must not take place after being wrapped and having left the 
expedition centre except in the case of retail sale at the expedition centre. 
CHAPTER IX 
TRANSPORT FROM THE EXPEDITION CENTRE 
1. Consignments of live bivalve molluscs destined for human consumption must be transported wrapped as a 
sealed parcel from the expedition centre up to the time of being offered for immediate sale to the consumer or 
retailer. 
2. The means of transport used for consignments of live bivalve molluscs must have the following 
characteristics: 
(a) their interior walls and any other parts which might come into contact with the live bivalve molluscs must 
be made of corrosion-resistant materials; the walls must be smooth and easy to clean; 
(b) they must be suitably equipped to provide efficient protection of the live bivalve molluscs against extremes 
of hot and cold, contamination with dirt or dust, and damage to the shells from vibration and 
abrasion; 
(c) the live bivalve molluscs must not be transported with other products which might contaminate 
them. 
3. Consignments of live bivalve molluscs must be transported and distributed using closed vehicles or containers 
which maintain the product at a temperature which does not adversely affect their quality and viability. 
The parcels containing live bivalve molluscs must not be transported in direct contact with the floor of the 
vehicle or container but must be supported on raised surfaces or by some other means which prevents 
contact. 
Where ice is used in transporting consignments of live bivalve molluscs, it must have been made from potable 
water or clean seawater. 
No C 84/42 Official Journal of the European Communities 2. 4. 90 
CHAPTER X 
MARKING OF CONSIGNMENTS 
1. All parcels in a consignment of live bivalve molluscs must be provided with a health mark so enabling at all 
times during transport and distribution until retail, the identification of their original expedition centre. 
Without prejudice to Council Directive 79/112/EEC on the approximation of laws of the Member States 
relating to the labelling, presentation and advertising of foodstuffs^), as last amended by Directive 
89/395/EEC (2), the mark must contain the following information: 
— the country of dispatch, 
— species of bivalve mollusc (common name and scientific name), 
— the identification of the expedition centre by the approval number granted by the competent 
authority, 
— the date of wrapping. 
2. The health mark may be printed on the wrapping material or be put on a separate tag which is then fixed on the 
wrapping material or put inside the wrapping. They may also be of a twist-tie or staple design; self-adhesive 
health marks must not be used. All types of health marks must be designed for single use and be not 
transferable. 
3. The health mark must be durable and waterproof and the information presented as legible, indelible and in 
easily decipherable characters. 
4. The health mark attached to consignments of live bivalve molluscs which are not wrapped as consumer size 
parcels must be kept for at least 60 days by the retailer after splitting up the content of the consignment. 
H OJ No L33, 8. 2. 1979, p. 1. 
(2) OJ No L 186, 30. 6. 1989, p. 17. 
Proposal for a Council Regulation (EEC) concerning the animal health conditions governing the 
placing on the market of aquaculture animals and products 
COM(89) 655 final 
(Submitted by the Commission on 9 February 1990) 
(90/C 84/04) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 43 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas aquaculture animals and products are included in 
the list in Annex II to the Treaty; Whereas the breeding and rearing of aquaculture animals, 
and the placing on the market of aquaculture animals and 
products constitutes a source of income for persons working 
in the fisheries sector; 
Whereas, in order to ensure the rational development of this 
sector and to increase productivity, health rules for this 
sector must be laid down at Community level; 
Whereas in this context it is necessary to contribute to the 
completion of the internal market, avoiding the spread of 
contagious diseases; 
Whereas the animal health situation for aquaculture animals 
is not the same throughout the territory of the Community, 
whereas reference must therefore be made to zones when 
dealing with parts of the Community;