COMMISSION OF THE EUROPEAN COMMUNITIES 
C0MC89) 648 final 
Brussels, 31 January 1990 
Proposal for a 
COUNCIL REGULATION (EEC) 
laying down the health conditions for the production and 
the placing on the market of live bivalve molluscs 
(presented by the Commission) 
C0M(89)648 final 
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EXPLANATORY MEMORANDUM 
With the adoption of the Single European Act, the Community has embarked upon 
a programme to eliminate all controls at frontiers. The programme to achieve 
this undertaking in set out in the Commissions White Paper of June 1985, and 
includes the elimination of barriors to trade related to health problems in 
the fisherios sector. 
This proposal aims in particular to lay down the health conditions for the 
production and the placing on the market of live bivalve molluscs (mussels, 
oysters, carpet shells otc.) which, because of their particular way of 
production and consumption, need special attention. 
It defines therefore the obligations to be respected by both professionals and 
the competent authorities, and lays down the measures to be taken to ensure 
that the final product is safe for human consumption. This implies a 
surveillance of the harvesting areas, the obligation to submit the molluscs to 
a purification process, relaying or processing in certain circumstances, a 
contrôle of the final product etc. 
Provision is made for Community checks in the Member States so as to ensure 
the uniform application of the said requirements. This must also allow to 
reinforce the confidence of the Member States in each others inspection 
systems which is necessary to ensure a proper functioning of an internal 
market without frontiers. 
The proposal covers the placing on the market in the whole of the Community 
and lays down a procedure to ensure that products originating from third 
countries are produced and placed on the market under conditions which are 
equivalent to those applied in the Community. 
For certain applicatory decisions to be taken, the Commission opted for the 
Regulatory Committee procedure. This choice, which is justified in this case 
by a desire not to disrupt the management process in the health sector, is 
without prejudice to the Commission's preference for the Advisory Committee 
procedure. 
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PROPOSAL FOR A 
COUNCIL REGULATION 
laying down the health conditions for the production 
and the placing on the market of live bivalve molluscs 
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; 
(1) OJ No L 281, 10.11.1979, p. 47 
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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 relaying 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 relayed; 
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 organised on a Community level must be introduced to 
guarantee the uniform application in all Member States of the standards laid 
down in this Regulation; 
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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 realisation of the internal market 
(1) 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 Lhe Community; whereas provision munt. bo mado 
for a Community procedure for Inspecting Lhe 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 establish 
ments 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 derogations from specific Community health rules 
on the production and marketing of products of animal origin] (2); 
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 hoalth rulos 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] (3); 
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 : 
(1) COM(88)383 Final of July 1988 
(2) OJ No L 
(3) OJ No L 
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 tunlcates. 
. 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 
occuring 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 molluscs or to 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 relaying 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. 
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7) Harvesting area : sea, estuarine or lagoon areas with sites of relaid 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 handlod 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 center : 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 ace 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) Relaying : transfer of live bivalve molluscs to suitable natural oea 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. 
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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. 
16) Batch : quantity of live bivalve molluscs collected from a harvesting area 
and subsequently destined for delivery to an approved expedition center, 
purification plant, relaying 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 24h at least. 
20) E. coll : faecal coliforms which also form indole from tryptophan at 44*C 
+0.2*C within 24h. 
CHAPTER II : PROVISIONS FOR COMMUNITY PRODUCTION 
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; 
(2) 
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c) where provided for in this Regulation, they must have been relayed in 
suitable sites approved for that purpose and complying with the 
conditions laid down in Chapter III of the Annex; 
d) they must havo been handled hygienically, and where appropriate, they 
must have been purified in establishments approved for that purpose and 
complying with Lho 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. 
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 
analysed in order to establish an historical record of the sanitary quality 
of the live bivalve molluscs both before and after handling at an expedition 
center 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. 
(1) 
10 
Article 5 
1. a) The competent authorities shall draw up a list of their approved 
expedition centers and purification plants, each of which shall have an 
official number. 
The competent authority shall approve such centers 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 bounderies 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 expendition 
centers. 
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). 
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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 tho requirements of this Regulation. A Member State in whose 
territory a check is being carried out shall give all necessary assistance 
to the exports in carrying out their duties. The Commission shall inform 
the Mombor States of tho results of such chocks. 
2. The general provisions for implomonting 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 Diroctive , [concerning veterinary controls 
in intra-Communlty trade, with a view to the realisation of the internal 
market], shall apply, in particular with respect to the organisation 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. 
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CHAPTER III : 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. 
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 wether 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 wether 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 organisation 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; 
13 
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. 
3. 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, 
ii) the definition of the harvesting areas from which live bivalve 
molluscs may be collected and imported, 
iii) the obligation of immedate 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 sorvico of tho third country. 
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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 tho 
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 organisation of health controls for products 
arising from third countries with a view to the completion of the internal 
market (1) 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. 
(1) 
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Article 12 
1. If a 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/EECU) (hereinafter called "the Committee) 
by its chairman on his initiative or at the request of a Member State. 
(1) 
16 
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 roquired to adopt on a proposal from tho Commission. Tho 
votes of the represent ativeu of Un» Member States within the committ.e shall 
be weighted in the manner 3ot out in that Article. The chairman shall not 
vote. 
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. 
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 15 
1. Where the procedure laid down in this Article is to be applied, the 
chairman shall rc»for tho mattor 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. 
13) 
17 
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. 
If, on the expiry of a period of fifteon working days from the date of 
referral to the Council, the Council has not acted, the proposed measures 
shall be adopted by the Commission. 
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 doiivorod by the 
Committee. It shall inform the Committee of the mannor in which its opinion 
liHti boon taken Into account. 
Article _17 
This Regulation shull enter into force on 1 January 199T. 
This Regulation shall be binding in its entirety and directly applicable in 
all Member States. 
Done at Brussels, For the Council 
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ANNEX 
CHAPTER I 
CONDITIONS FOR HARVESTING AREAS 
1. 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 relaying or after processing 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. 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 g of flesh or 4.600 E. Coli per 100 g of flesh in 95 % 
of samples. After purification, relaying or processing, the 
requirements set out in Chapter V shall be met. 
c) can be collected but only placed on the market after relaying over a 
long period or after relaying combined with purification to meet the 
requirements under (a). Processing of these molluscs by a heat 
treatment sufficient to kill micro organisms 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 out 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 centers. 
-- 19 
CHAPTER II 
REQUIREMENTS FOR HARVESTING AND TRANSPORTATION 
OF BATCHES TO AN EXPEDITION CENTER 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 relaying. 
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 center, purification plant or relaying site, the means of 
transport must be equiped in such a way as to ensure the best survival 
conditions possible, and in particular must they comply with the 
requirements laid down in Chapter IX, point 2. 
- 20 -
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, relaying site or processing plant is 
issued by the competont 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, relaying 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 center, purification plant relaying 
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 center, purification plant, relaying 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. 
21 -
CHAPTER III 
CONDITIONS FOR RELAYING LIVE BIVALVE MOLLUSCS 
The following conditions must be mot : 
1. live bivalve molluscs must be gathered and transported in accordance with 
the requirements of Chaptor II; 
2. techniques for handling live bivalve molluscs destined for relaying must 
permit the resumption of filter feeding activity after immersion in natural 
waters; 
3. live bivalve molluscs must not be relaid at a density which does not permit 
purification; 
4. live bivalve molluscs must be immersed in seawater at the relaying 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 relaying* must, where necessary, 
be determined and announced by the competent authority for each species of 
live bivalve mollusc and approved relay site; 
6. sites for relaying live bivalve molluscs must be approved by the competent 
authority. The boundaries of the sites must be clearly identified; 
7. sites within a relaying area must be woll separated to prevent mixing of 
batches; 
8. permanent records of the source of live bivalve molluscs, relaying period, 
relaying site and subsequent destination of the batch after relaying must 
be maintained by tho operators of relaying sites for inspection by the 
competent authority; 
22 
after harvesting from the relaying site, the batches must during transport 
from the relaying site to the approved expedition center, purification 
plant or processing plant be accompanied by the registration document 
referred to in Chaptor II, point 6, except in the case where tho samo staff 
is operating both the relaying site and the expedition center, 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 spaco to allow for aatlal'actory performance of all 
operations; 
23 -
d) durable walls which are easy to clean; 
e) adequate natural or artificial lighting. 
2. Access to an appropriate numbor of changing rooms, wash basins and 
lavatories; there must be a sufficient numbor 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 80/7 78/EEC of 15 July 1980 relating the quality of water 
intended for human consumption (1) 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 resists corrosion. 
(1) OJ No L 229, 30.08.1980, p 11. 
- 24 -
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 illlness 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 
then 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. 
25 -
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 impermoable surface and be 
easy to clean by scrubbing or use of pressurised 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 sea water 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 sea water per hour and per tonne of live bivalve molluscs 
treated. 
4. Clean sea water 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; the procedure for 
sanitizing the sea water 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. 
5. Operation of the purification system must be in accordance with 
instructions issued by the competent authority to ensure that live 
bivalve molluscs rapidly rosume filter feeding activity, removo sewago 
contamination, do not bocomo rocontaminated and are able to remain 
alive in a suitable condition after purification for wrapping, storage 
and transport before placing on the market. 
- 26 -
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 tho 
moment when water is drained away before removal from the said 
system. The establishment operator must tako account of the data 
relating to the raw materials (the type of bivalve mollusc, its area 
of origin, microbe content, otc.) 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. 
27 -
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 tosts 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 conters 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. 
28 
IV. REQUIREMENTS FOR EXPEDITION CENTERS 
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; 
d) procedures for calibration of live shellfish 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. 
e) any washing or cleaning of live bivalve molluscs must be carried out 
using pressurised clean seawater or potable water - cleaning water 
may not be recycled. 
2. Expedition centers 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, relaying site or 
purification plant. 
3. The expedition centers must have their own laboratory or secure the 
services of a laboratory equiped 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 requirements is invalid if the expedition centers get 
their molluscs from a purification plant where they have been examined 
after purification. 
29 -
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 g 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 g 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 (ADD, 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 g 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. 
- 30 -
Examinations for checking the compliance with the requirements of this Chapter 
must be carried out in accordance with proven methods which are scientifically 
recognised. 
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-Shelfish Poisson (NSP), this shall be done applying the same 
procedure. 
CHAPTER VI 
PUBLIC HEALTH CONTROL AND SUPERVISION OF PRODUCTION 
A public 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 include : 
1. Periodic supervision of live bivalve mollusc relaying and harvesting areas 
in order : 
a) to avoid any abuse of the origin and destination of the live bivalve 
molluscs; 
b) to check the microbiological quality of the live bivalve molluscs in 
relation to the area of harvesting as laid down in Chapter I; 
c) to check the possible presence of toxin-producing plankton. 
31 -
For that purpose, sampling plans shall be established by the competent 
authorities for checking at regular intervals or on a case-by-case basis in 
the situation of irregular periods of harvesting. 
Sampling plans must in particular take account of : 
a) likely variations in faecal contamination at each harvesting area; 
b) possible variations of the presence of plankton containing marine 
biotoxins; the sampling must be designed as follows : 
(i) surveillance : periodic sampling organised to detect changes in 
the composition of the plankton containing toxins and the 
geographical distribution thereof. Information leading to a 
suspicion of accumulation of toxins in muscle flesh must be 
followed by 
(ii) intensive sampling : 
- control of the plankton in the growing and fishing waters by 
increasing the number of sampling points and the number of 
samples and 
- toxicity tests on molluscs from the affected zone and most 
susceptible to the contamination. 
This intensive sampling plan must be continued until the results 
of toxicity tests permit again the placing on the market of the 
molluscs; 
c) possible contamination of the molluscs in the harvesting area. 
If the result of a sampling plan shows that the placing on the market of 
live bivalve molluscs may constitute a hazard to human health, the 
competent authority shall close the harvesting area untill the situation 
has been restored. 
2. Laboratory tests in order to check the respect of the requirements for the 
end product as laid down in Chapter V of this Annex. 
There shall in particular be established a control system to verify that 
the level of marine biotoxins do not exceed the safe levels required by 
this Regulation. 
- 32 
3. An inspection at regular intervals of establishments. These inspections 
shall include in particular checks : 
a) to verify whether the approval conditions are still being complied with; 
b) on the cleanliness of the premises, facilities, equipment and of staff 
hygiene; 
c) to verify whether the live bivalve molluscs are handled and treated 
correctly; 
d) on the correct application and functioning of purification or 
conditioning systems; 
e) of the record books referred to in Chapter IV under III, 12; 
f) the correct use of health marks. 
These checks may include the taking of samples for laboratory tests; the 
results of these tests shall be notified to the persons responsible for the 
establishments. 
4. Checks on the storage and transport conditions of the consignments of live 
bivalve molluscs. 
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. 
33 
2. Oysters must be wrapped with the concave shell downwards. 
3. All wrappings of live bivalve molluscs must be sealed and remain sealed 
from tho expedition centre until delivery to the consumer or retailer. 
CHAPTKR 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 center except in the case of 
retail sale at the expedition centre. 
CHAPTER IX 
TRANSPORT FROM THE EXPEDITION CENTER 
1. Consignments of live bivalve molluscs destined for human consumption must 
be transported wrapped as a sealed parcel from the expedition center 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 : 
34 
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 bo sultubly equipped to provide efficient protection of tho 
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 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 sea water. 
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 center. 
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 D 
the mark must contain the following information : advertising of foodstuffs as last amended by Directive 89/395/EEC (2), 
(1) OJ No L 33, 08.02.19/9, p. 1 
(2) OJ No L 186, 30.06.1989, p. 17 
35 
- the country of dispatch, 
species of bivalve mollusc (common name and scientific name) 
- the identification of the expedition center 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. 
- 36 -
FINANCIAL STATEMENT concerning : 
Draft proposal for a Council Regulation concerning the health conditions governing 
the production and the placing on the market of live bivalve molluscs 
1. BUDGET HEADING: Item: Title: 
III B 382 (1) Inspection in Agriculture 
2. LEGAL BASIS: Article 43 of the Treaty 
3. CLASSIFICATION : Non-compulsory expenditure 
4. PURPOSE/DESCRIPTION OF THE MEASURE: 
Verification of the application of the Regulation (Art. 6 and 9) 
T! METHOD OF CALCULATION: 
5.1.Form of expenditure: Mission expenses 
5.2.Community contribution: 100 % 
5.3.Calculation: 
300 mission days per year at ECU 170 per day (currant cost of inspection) 
ECU 51.000 per year 
T. FINANCIAL IMPLICATION AS REGARDS OPERATING APPROPRIATIONS 
6.1.Schedule of appropriations (m ECU): 
Year 
1991 
1992 
1993 0,051 
1994 0,051 
1995 0,051 
following years 
Total 0.153 
6.2.Financing during current year: NIL 
7. OBSERVATIONS: 
(1) When the preliminary draft budget is prepared, an examination will be made to 
see where this category of expenditure is to be charged in the budget. 
This proposal also calls for 3 additional A7/6 posts. 
Staff requirements set out above must be met by redeployment within the Commission 
or by the budget procedure for the year concerned. 
- 37 -
STATEMENT OF IMPACT ON BUSINESS 
NAME OF THE PROPOSAL 
Draft proposal for a Council Regulation on the health conditions 
affecting the production and the placing on the market of live bivalve 
moi(uses. 
OBJECTIVES 
The proposal outlines the health requirements to be respected by 
Industry and commerce, as well as by the competent authorities during 
production, handling, storage and distribution of live bivalve 
mo I I uses. 
These requirements replace the different health conditions at present 
applied by the Member States and will help to bring about a single 
market. 
IMPACT ON BUSINESS 
The national rules of the Member States as regards health problems 
related to live bivalve molluscs are not always on an equivalent level 
or are conceived in a different manner. 
Live bivalve mol lues are extremely sensitive as far as health risks are 
concerned. The creation of a single market where bivalve molluscs are 
allowed to be moved freely requires a harmonisation of the conditions 
for production and marketing, based on a high level of protection. 
This will Inevitably require for a certain number of mainly small 
enterprises an effort in order to adapt to the proposed rules as far as 
upgrading of premises and control procedures are concerned. It Is also 
likely that, In order to meet the proposed standards, a number of 
establishments which are situated In zones where the quality of coastal 
waters is not satisfactory will need to provide for purification 
equipment. 
In order to allow smooth adaptation to the proposed rules and in order 
to limit possible influence on business, transitional periods are 
proposed for certain requirements. 
- 38 -
Member States will also be allowed, under the conditions set out In 
Council Decision laying down the conditions for granting 
derogations to the Community health requirements for the production and 
the placing on the market of products of animal origin^), to submit 
to the Commission requests for dorogatlons to the proposed rules If 
those are well grounded and documented. 
It must be further emphasized that the Community Is prepared to assist 
the Member States in achieving higher health standards. For that 
purpose, the Commission has submitted to the Council a proposal for a 
Regulation on the Improvement of the conditions under which fishery 
products and aquaculture products are processed and marketed [COM (89) 
187 final] <2>. 
It must also be carried In mind that Member States are already bound to 
respect certain standards for the shellfish waters by virtue of 
Directive 79/923/EEC on the quality required of shellfish waters^3). 
The respect of these standards will to a large extend help to achieve 
the product standards as envisaged In the present proposal. 
Furthermore, free trade will be ensured once consignments comply with 
the proposed standards: this will be without doubt to the benefit of 
enterprIses. 
<1> O.J. n° 
(2) O.J. n° C 143 of 09.06.89, p. 6 
<3> O.J. n° L 281 of 10.11.79, p. 47 
ISSN 0254-1475 
COM(89) 648 final 
DOCUMENTS 
EN 03 04 05 
Catalogue number : CB-CO-90-057-EN-C 
ISBN 92-77-57297-3 
Office for Official Publications of the European Communities 
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