COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(89) 655 final 
Brussels, 2 February 1990 
Proposal for a 
COUNCIL REGULATION (EEC) 
concerning the animal health conditions governing the placing 
on the market of aquaculture animals and products 
(presented by the Commission) 
•"m,39)655 final 
2 -
EXPLANATORY MEMORANDUM 
Farming of fish, crustaceans and molluscs constitutes an important source of 
income for a part of the population working in the fisheries sector. In order 
to ensure a rational development of production, raise the productivity levels 
and help to bring about a single market, it is essential to lay down common 
health criteria regarding the production and the placing on the market of 
aquaculture animals and products. 
This proposal aims to achieve this goal. 
For that purpose, it is intended to designate officially the regions of the 
Community already having a favourable health status and to regulate for the 
movement between regions having a different health status. 
This proposal also provides for Community arrangements in respect of imports 
from third countries and specifies the criteria to be applied to such 
imports. Such rules must be designed to safeguard the health of aquaculture 
animals within the Community. 
For certain applicatory decisions to be taken, the Commission opted for the 
regulatory committee procedure, since it wished to avoid disrupting the 
existing management machinery in the animal health sector. More generally 
however, the Commission continues to prefer the advisory committee procedure. 
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Proposal 
for a 
COUNCIL REGULATION (EEC) No 
concerning the animal health conditions 
governing the placing on the market of 
aquaculture animals and products 
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 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; 
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Whereas there must be laid down criteria and procedures for the approval, the 
suspension and the withdrawal of approval of such zones; 
Whereas it is necessary to define Community provisions applicable to imports 
from third countries; whereas these provisions must provide for adequate 
safeguard measures; 
Whereas a Community inspection system should be established in order to verify 
compliance with this Regulation; 
Whereas provision should be made for a procedure establishing close 
cooperation between the Commission and the Member States within the Standing 
Veterinary Committee, 
HAS ADOPTED THIS REGULATION : 
CHAPTER 1 
GENERAL PROVISIONS 
Article 1 
This Regulation lays down the animal health conditions governing the placing 
on the market of aquaculture animals and products. 
Article 2 
For the purposes of this Regulation : 
1) aquaculture animals : means live fish, crustaceans or molluscs originating 
from a farm; 
2) aquaculture products : means products derived from aquaculture animals 
such as eggs, gametes or products to be placed on the market for human 
consumption; 
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3) fish, crustaceans and molluscs : means any fish, crustacean and mollusc at 
any stage of development belonging to the species referred to in Annex A, 
columns 2 and 3; 
4) farm : means any establishment or, in general, any geographically defined 
installation in which aquaculture animals are reared or kept with a view to 
their being placed on the market; 
5) approved farm : means a farm complying, as the case may be, with the 
requirements of Annex C I or II, and approved as such in accordance with 
the procedure laid down in Article 6; 
6) approved zone : means a zone complying as the case may be, with the 
requirements of Annex B I, II or III and approved as such in accordance 
with the procedure laid down in Article 5; 
7) approved laboratory : means a laboratory located in the territory of a 
Member State, designated by the competent authority, under its 
responsibility, to carry out the diagnostic tests provided for in this 
Regulation; 
8) official service : means one or more services designated by the competent 
authority of the Member State or third country and responsible for carrying 
out the controls provided for in this Regulation; 
9) health inspection : means a visit by an official service or services, for 
the purpose of checking the health status of a farm or a zone. 
CHAPTER 2 
PLACING ON THE MARKET OF ANIMALS AND PRODUCTS 
FROM AQUACULTURE FROM THE COMMUNITY 
Article 3 
1. The placing on the market of aquaculture animals shall be subject to the 
following general requirements : 
a) they must show no clinical signs of disease on the day of loading; 
b) they must not be intended for destruction or slaughter under a national 
scheme for the eradication of a contagious disease; 
c) they must not come from a farm which is subject to a prohibition on animal 
health grounds and must not have been in contact with animals from such a 
farm; 
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2. Aquaculture products being placed on the market, for breeding purposes 
(eggs and gametes) must originate from animals which satisfy the conditions 
laid down in paragraph 1. 
3. Aquaculture products being placed on the market, for human consumption must 
originate from animals which satisfy the conditions laid down in 
paragraph 1(a). 
Article 4 
Live aquaculture animals must be dispatched in the shortest possible period to 
the place of destination, using means of transport that have been cleaned and, 
if necessary, disinfected in advance with a disinfectant that is officially 
authorized in the Member State of dispatch. 
If water is used in transport, the vehicles shall be designed in such a way 
that water cannot escape from the vehicle during transport. Transport shall be 
carried out in such a way as to safeguard effectively the health of the 
animals, in particular by changing the water. Such a change must be carried 
out in places complying with the requirements of Annex D. A list of these 
places must be notified by the Member States to the Commission and to the 
other Member States. 
Article 5 
1. In order to obtain, for the diseases referred to in Annex A, column 1, 
lists I and II, the status of approved zone, Member States shall present to 
the Commission : 
- all appropriate justifications and in particular those concerning the 
conditions laid down, as the case may be, in Annex B under I B, under 
II B or under III B; 
- the national rules ensuring the respect of the conditions laid down, as 
the case may be, in Annex B under I C, under II C or under III C. 
2. The Commission shall scrutinize the information referred to in 
paragraph 1. The Commission may, in accordance with the procedure laid 
down in Article 26, approve or re-approve zones, having regard to that 
information. 
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If in accordance with Annex B under I D 5, under II D or under III D 5 the approval 
of a zone is withdrawn by the official service, the Commission shall revoke the 
decision concerning its approval. 
3. The Commission shall draw up the list of approved zones, and shall amend this 
list in order to take account of new approvals or withdrawal of approvals. 
Article 6 
1. In order to obtain, for the diseases referred to in Annex A, column 1, lists I 
and II, the status of approved farm situated in a non approved zone, the Member 
States shall present to the Commission : 
- all appropriate justifications and in particular those concerning the 
conditions laid down, as the case may be, in Annex C under I A or under II A; 
- the national rules ensuring the respect of the conditions laid down in Annex C 
under I B or under II B. 
2. The Commission shall scrutinize the information referred to in paragraph 1. The 
Commission may, in accordance with the procedure laid down in Article 26, 
approve or re-approve farms, having regard to that information. 
If in accordance with Annex C under I C or under II C, the approval of a farm is 
withdrawn by the official service, the Commission shall revoke the decision 
concerning its approval. 
3. The Commission shall draw up the list of approved farms, and shall amend this 
list in order to take account of new approvals or withdrawal of approvals. 
Article 7 
1. The placing on the market of live fish belonging to the susceptible species 
referred to in Annex A, column 2, lists I and II, their eggs or gametes, shall 
be subject to the following additional requirements : 
a) when they are to be introduced into an approved zone, they must be 
accompanied by a movement document corresponding to Article 10 and to the 
model referred to in Annex E, Chapter I, certifying that they come from a 
zone of the same health status; 
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b) when they are to be introduced into a farm which, although not situated 
in an approved zone, fulfils the conditions of Annex C I, they must be 
accompanied by a movement document corresponding to Article 10 and to 
the model referred to in Annex E, Chapter 2, certifying that they come 
from a farm of the same health status as the farm of destination, or 
they must be accompanied by the document referred to in a), certifying 
that they come from an approved zone. 
2. The Commission, in accordance with the procedure laid down in Article 26 
may adapt or delete the additional requirements referred to in paragraph 1, 
depending on the evolution of the animal health situation in the Community, 
in particular in order to take account of the results of the eradication 
measures for the disease mentioned in Annex A, column 1, list I. 
Article 8 
1. The placing on the market of live molluscs belonging to the species 
referred to in Annex A, column 2, list II shall be subject to the following 
additional requirements : 
a) if they are to be relaid in an approved coastal zone, they must be 
accompanied by a movement document complying with Article 10 and 
corresponding to the model referred to in Annex E, Chapter 3, certifying 
that they come from a coastal zone of the same health status; 
b) if they are to be relaid in a farm which, although not situated in an 
approved coastal zone fulfils the requirements of Annex C II, they must 
be accompanied by a movement document complying with Article 10 and 
corresponding to the model referred to in Annex E, Chapter 4, certifying 
that they come from a farm of the same health status as the farm of 
destination, or they must be accompanied by the document referred to in 
a), certifying that they come from an approved coastal zone. 
2. The Commission, in accordance with the procedure laid down in Article 26 
may adapt or delete the additional requirements referred to in paragraph 1, 
depending on the evolution of the animal health situation in the Community. 
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Article 9 
The placing on the market in an approved zone of aquaculture products for 
direct human consumption originating from a non approved zone shall be subject 
to the following conditions : 
1. fish susceptible to the diseases referred to in Annex A, column 1, lists I 
and II must be slaughtered and eviscerated prior to expedition; 
2. live molluscs susceptible to the diseases referred to in Annex A, column 1, 
list II must be delivered directly for human consumption and shall not be 
returned to water. 
The Commission, in accordance with the procedure laid down in Article 27, 
shall lay down, when considered necessary, the appropriate conditions 
necessary to ensure compliance with this prohibition. 
Article 10 
1. The movement document referred to in Articles 7 and 8 must be drawn up by 
the official service at the place of origin within 48 hours before loading, 
in the official language or languages of the place of destination. It must 
be drawn up on a single sheet of paper, be made out for a single consignee, 
and shall be valid for 10 days. 
2. Each consignment of aquaculture animals and products must be clearly 
identified in order to be able to trace back to the farm of origin, and to 
verify where appropriate the correlation of the animals or products with 
the information contained in the accompanying movement document. This 
information may figure directly on the container or on a label fixed to it 
or on the transport documents. 
Article 11 
1. Where a Member State draws up or has drawn up a voluntary or compulsory 
control programme for one of the diseases referred to in Annex A, column 1, 
list III, it shall present the programme to the Commission, outlining in 
particular : 
10 
- the distribution of the disease in the Member State; 
- the reasons for which the programme should be implemented, including the 
importance of the disease and the programme's likely benefit in relation 
to its cost; 
- the geographical areas in which the programme will be implemented; 
- the categories of farms to be established, and the standards which must 
be achieved by the farms in each category, including test procedures; 
- the rules applicable for entry of animals of a lower health status into 
the farm; 
- the action to be taken if, for any reason, a farm loses its status; 
- the procedures under which the programm shall be monitored. 
2. The Commission shall scrutinize the programmes presented by the Member 
States. Programmes as referred to in paragraph 1 may be approved in 
accordance with the procedure laid down in Article 26. The additional 
guarantees, general or specific, which may be required for the introduction 
of aquaculture animals and products in to officially checked farms or zones 
may be defined in accordance with the same procedure. 
3. Programmes submitted by Member States may be amended or supplemented in 
accordance with the procedure laid down in Article 26. Under the same 
procedure, the Commission may approve an amendment or addition to a 
programme which has been approved or to guarantees which have been defined 
in accordance with paragraph 2. 
Article 12 
1. Where a Member State considers that its territory or part of its territory 
is free from one of the diseases listed in Annex A, column 1, List III, it 
shall present to the Commission appropriate justification, setting out in 
particular : 
- the name of the disease and the previous history of its occurrence in 
that Member State; 
- the results of surveillance testing based on serological, virological, 
microbiological or pathological findings, as appropriate, and on the fact 
that the disease must by law be notified to the competent authorities; 
- the period over which the surveillance was carried out; 
- the control arrangements for verifying that the area concerned remains 
free from the disease. 
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2. The Commission shall examine such justification. The additional 
guarantees, general or specific, which may be required for the introduction 
of aquaculture animals and products into farms or areas may be defined in 
accordance with the procedure provided for in Article 26. 
3. The Member State concerned shall notify the Commission of any change in the 
particulars specified in paragraph 1 which relate to the disease. The 
guarantees defined as laid down in paragraph 2 may, in the light of such 
notification, be amended or withdrawn in accordance with the procedure 
provided for in Article 26. 
Article 13 
The Commission, in accordance with the procedure laid down in Article 26, 
shall lay down : 
1. the conditions for the placing on the market of ornamental fish; 
2. the conditions for the placing on the market of wild species and products 
thereof; until such conditions are established, the rules laid down in this 
Regulation shall apply, mutatis mutandis. 
3. the conditions for the placing on the market of fish which, although not 
susceptible to the diseases referred to in Annex A, column 1, Lists I and 
II, can transfer by mechanical means those diseases. 
Article 14 
Sampling plans and diagnostic methods to be applied for the detection and 
confirmation of the presence of the disease referred to in Annex A, column 1 
shall be established in accordance with the procedure laid down in 
Article 26. These sampling plans must take account of the presence of wild 
fish, wild crustaceans and wild molluscs in the aquatic environment. 
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Article 15 
The rules laid down in Council Directive concerning veterinary 
checks in intra-Community trade with a view to the completion of the internal 
market (1) shall apply, in particular as regards the organization of and the 
action to be taken following the inspections to be carried out by the Member 
State of destination, and the safeguard measures to be implemented. 
Article 16 
1. Commission veterinary experts may, where it is necessary for the uniform 
application of the Regulation, carry out on-site inspections. The Member 
State in whose territory an inspection is carried out shall provide the 
experts with all the assistance necessary to complete their task. The 
Commission shall notify the Member States of the outcome of such 
inspections. 
2. General provisions for the application of this Article shall be adopted in 
accordance with the procedure laid down in Article 27. 
The rules to be followed during the inspection provided for in this Article 
shall be drawn up in accordance with the same procedure. 
CHAPTER 3 
RULES GOVERNING IMPORTS FROM THIRD COUNTRIES 
Article 17 
Aquaculture animals and products imported into the Community shall satisfy the 
conditions laid down in Articles 18 to 20. 
(1) 
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Article 18 
1. Aquaculture animals and products shall come from third countries or parts 
thereof appearing on a list drawn up by the Commission in accordance with 
the procedure laid down in Article 26. This list may be supplemented or 
amended in accordance with the same procedure. 
2. In deciding whether a third country or part thereof may appear on the list 
referred to in paragraph 1, particular account shall be taken of : 
a) the state of health of the aquaculture animals, particular attention 
being paid to exotic diseases and the environmental health situation in 
the third country which might endanger animal health in the Community; 
b) the regularity and rapidity of the information supplied by the third 
country relating to the existence of infectious or contagious diseases 
of aquaculture animals in its territory, in particular those diseases 
mentioned in list B of the International Office of Epizootic Diseases; 
c) the rules of the third country on the prevention and control of diseases 
of aquaculture animals; 
d) the structure of the official services in the third country and their 
powers ; 
e) the organization and implementation of measures to prevent and control 
infectious or contagious diseases of aquaculture animals; 
f) assurances which the third country may provide concerning the rules laid 
down in this Regulation. 
3. The list referred to in paragraph 1 and all amendments thereto shall be 
published in the Official Journal of the European Communities. 
Article 19 
1. For each third country, animals and products from aquaculture shall satisfy 
the health conditions adopted in accordance with the procedure laid down in 
Article 26. 
2. Depending on the animal health situation in the third country concerned, 
the conditions may include in particular : 
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- restriction to imports from a part of the third country, 
- restriction to certain species at any stage of development, 
- the prescription of a treatment to be applied to the products such as the 
disinfection of eggs, 
- prescription of the use to which these animals or products are to be put, 
- the measures to apply following importation, such as quarantine or the 
disinfection of eggs. 
Article 20 
1. Aquaculture animals and products shall be accompanied by a certificate 
drawn up by the official services of the exporting third country. This 
certificate must : 
a) be issued on the day of loading of the consignment for dispatch to the 
Member State of destination; 
b) accompany the consignment in the original; 
c) attest that the aquaculture animals and products meet the requirements 
of this Regulation and those laid down pursuant to this Regulation with 
regard to importation from the third country; 
d) be valid for 10 days; 
e) consist of a single sheet of paper; 
f) be made out for a single consignee. 
2. This certificate must comply with a model established in accordance with 
the procedure laid down in Article 27. 
Article 21 
Inspections shall be carried out on the spot by veterinary experts of the 
Member States and the Commission to verify whether the provisions of this 
Regulation, and in particular Articles 18 and 19, are being applied in 
practice. 
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The experts from the Member States who are to be entrusted with the task of 
carrying out 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 
any expenditure incurred in this connection. 
The frequency of and the procedure for these inspections shall be determined 
in accordance with the procedure laid down in Article 27. 
Article 22 
1. The rules laid down in Council Regulations (EEC) No laying 
down the principles relating to the organisation of veterinary control for 
products arising from third countries with a view to the completion of the 
internal market (1) and No laying down the principles 
relating to the organisation of veterinary control for animals arising from 
third countries with a view to the completion of the internal market (2), 
shall apply. 
2. Importation of aquaculture animals and products shall be prohibited if it 
is found that : 
- consignments do not originate from the territory of a third country, or 
a part thereof, appearing on the list drawn up in accordance with 
Article 18, paragraph 1; 
- they are, or are suspected of being, infected with or contaminated by a 
contagious disease; 
- the conditions laid down in this Regulation have not been complied with 
by the exporting third country; 
- the certificate accompanying them does not comply with the conditions 
set out in Article 20. 
(1) 
(2) 
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Article 23 
1. If an infectious or contagious disease of aquaculture animals, liable to 
endanger the health of livestock in a Member State, breaks out or spreads 
in a third country or if any other reason connected with animal health 
justifies it, the Member State concerned or the Commission shall prohibit 
importation directly or indirectly from either the whole of the third 
country or from part of its territory. 
2. Measures taken by Member States under paragraph 1 and notice of the 
withdrawal of such measures must be communicated immediately to the other 
Member states and the Commission, together with the reasons therefore. 
3. The measures referred to in paragraph 1 may be amended in accordance with 
the procedure laid down in Article 25, in particular in order to ensure 
their coordination with measures adopted by the other Member States, or may 
be withdrawn. 
4. If the situation envisaged in paragraph 1 arises and if it appears 
necessary that other Member States should also apply the measures taken 
pursuant to that paragraph, appropriate measures shall be adopted under the 
procedure laid down in Article 25. 
5. Resumption of importation from the third country concerned shall be 
authorized in accordance with the same procedure. 
CHAPTER 4 
FINAL PROVISIONS 
Article 24 
The Annexes to this Regulation may be amended in accordance with the procedure 
laid down in Article 26. 
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Article 25 
1. The Commission shall be assisted by the Standing Veterinary Committee set 
up by the Council Decision 68/361/EEC(l), hereinafter called "the 
Committee". 
2. Where the procedure laid down in this Article is to be applied, the 
following provisions 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. 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. 
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 fifteen days from the date of referral to 
the Council, the Council has not acted, the proposed measures shall be 
adopted by the Commission. 
Article 26 
Where the procedure laid down in this Article is to be applied, the following 
provisions shall apply. 
(1) 
••/ - 18 -
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 requred to adopt on a proposal from the Commission. The votes of 
the representatives fo 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 thé 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 27 
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. 
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Article 28 
This Regulation shall enter into force on the thirtieth day following that of 
its publication in the Official Journal of the European Communities. 
It shall apply from 1 January 1993. 
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 A 
Disease Susceptible species Carrier species 
LIST I 
Fish 
IHN (Infectious Hematopoetic 
Necrosis) Salmo gairdneri 
Oncorhynchus nerka 
" tschawytscha 
** rhodurus 
Salmo salar ) Survivors 
) 
) 
) 
) 
LIST II 
Fish 
Viral Haemorrhagic Septicaemia 
(VHS) 
Molluscan shellfish 
Bonamia ostreae 
Marteilia sp. 
Haplosporidum sp. 
Perkinsus sp. Salmo gairdneri 
Salmo trutta 
Salmo salar 
Thymallus thymallus 
Coregonus sp. 
Esox lucius (Fry) 
Ostrea edulis 
Ostrea edulis 
Ostrea edulis 
Ruditapes decussatus ) Survivors 
Ceratoderma edule 
Mytilus edulis 
Crassostrea 
virginica 
Crassostrea 
virginica 
LIST III 
Fish 
IPN (Infectious pancreatic 
necrosis) 
SVC (Spring viremia of carp) 
BKD (Bacterial Kidney Disease) 
Furunculosis in 
Atlantic salmon 
ERM (Enteric Red Mouth Disease) 
Gyrodactylosis 
(Gyrodactylus salaris) 
Myxobolosis (Myxosomiasis) 
(Whirling disease) 
Crustaceans 
Aphanomycosis 
(crayfish plague) Salmo gairdneri 
Salmo trutta 
Salvelinus fontinalis 
Oncorhynchus 
(2 species) 
Cyprinus carpio 
Ctenopharyngodon 
idella 
Hypophtalmichtys sp 
All salmonids. 
Oncorhynchus in 
particular 
Salmo salar and all 
other salmonids 
Salmonidae, Anguilla 
anguille. Psetta 
maxima (turbot), 
Notropis atherinoides 
(bait minnow) 
Salmo salar 
Salmo trutta 
Salmo salar 
Salvelinus fontinalis 
Astacus sp 
Austropotamobius 
pallipes 
Procambarus clarkii Survivors 
All other 
salmonidae 
Several cyprinidae 
Eels, Perch, Pike 
Survivors 
Survivors 
Survivors 
Survivors 
Salmo 
gairdneri 
) Survivors 
) 
) 
) 
Pacifastacus 
Leniusculus 
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ANNEX B 
APPROVED ZONES 
I. Continental zones for fish 
A. A continental zone consists of a part of the territory comprising an 
entire catchment area from the sources of the waterways to the sea, or 
more than one catchment area, in which fish is reared, kept or caught. 
The size and the geographical situation of a continental zone must be 
such that possibilities for recontamination, e.g. by migrating fish, is 
reduced to a minimum. This may require the establishment of a 
bufferzone in which a monitoring programm is carried out without 
obtaining the status of approved zone. 
B. Achievement of status 
In order to obtain the approved status, a continental zone must meet the 
following requirements : 
1. All fish are free for at least four years from any clinical or other 
sign of the diseases referred to in Annex A, column 1, lists I and II 
2. All farms in the continental zone are placed under the supervision of 
the official services. Two health inspections per year for four 
years must have been carried out. 
The inspection must have been made at the times of year when the 
water temperature favours the development of the diseases. However, 
rearing ponds must have been inspected only when they are being 
emptied or filled. 
The health inspection must consist at least of : 
- an inspection of fish showing abnormalities; 
- the taking of samples which are to be sent as quickly as possible 
to the approved laboratory to be tested for the diseases referred 
to in Annex A, column 1, lists I and II. 
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However, zones having a historical record of absence of the diseases 
referred to in Annex A, column 1, lists I and II, may obtain the 
approved status if : 
a) their geographical situation does not permit easy introduction of 
diseases; 
b) an official disease control system has been in place for an 
extended period of time of at leats 20 years during which : 
- there has been regular monitoring of all fish farms, 
- a disease notification system has been applied, 
- diseases have not been reported, 
- no live fish from infected zones has been introduced. 
3. If there is no farm in a continental zone to be approved the official 
services must have subjected fish from the lower part of the 
catchment area to a health inspection twice a year for two years, in 
accordance with paragraph 2. 
4. The laboratory examinations of fish taken during health inspections 
have produced negative results as regards the pathogens referred to 
in Annex A, column 1, lists I and II. 
C. Maintenance of status 
The maintenance of the status is subject to the following requirements : 
1. Fish introduced into the zone must come from other approved zone. 
2. Each fish farm must undergo two health inspections annually in 
accordance with point B, 2, however, samples will be taken by 
rotation in 50 % of the fish farms in the continental zone each year. 
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In the case of zones having a historical record of absence of the 
diseases referred to in Annex A, column 1, lists I and II, the 
frequency of sampling may be reduced in function of the period 
during which such zones are free of diseases. However, this 
frequency shall not be less than 20 % of the farms per year. 
3. The results of the laboratory examinations on the fish sampled 
during the health inspections must have been negative as regards 
the pathogens referred to in Annex A, column 1, lists I and II. 
4. A register must be kept by the farmers or the persons responsible 
for the introducing of fish, containing all the information 
necessary to enable the state of health of the fish to be 
monitored constantly. 
D. Suspension, re-establishment and withdrawal of the approval 
1. Any abnormal death or other symptom that might constitute grounds 
for suspecting an outbreak of a disease of Annex A, column I, 
Lists I and II must be notified as quickly as possible to the 
official service. The latter shall immediately suspend the 
approval of the zone. 
2. A sample of at least 10 sick fish must be sent to the approved 
laboratory in order to be tested for the diseases of Annex A, 
column 1, Lists I and II. 
The results of the tests must be communicated immediately to the 
official service. 
3. Where the results are negative for the pathogens in question but 
positive for another cause, the official service shall 
re-establish the approval. 
4. However when no diagnosis can be made a further health inspection 
must be made within 15 days of the first taking of a sample and a 
sufficient number of sick fish must be taken and forwarded to the 
approved laboratory in order to be tested for the diseases of 
Annex A, column 1, lists I and II. 
- 24 -
If the results are again negative or if there are no more sick 
fish, the official service will re-establish the approval. 
5. Where the results are positive, approval must be withdrawn by the 
official service. 
6. Re-establishment of the approval of a zone is subject to the 
following requirements : when an outbreak occurs, 
- all fish in the infected farms must have been slaughtered, and 
infected or contaminated fish must have been destroyed, 
- facilities and equipment must have been disinfected in 
accordance with a procedure approved by the official services. 
After elimination of the outbreak, the requirements referred to 
in point B must be again complied with. 
7. The Central competent authority shall inform the Commission and 
the other Member States about the suspension, re-establishment 
and withdrawal of the approval of zones. 
II. Coastal zones for fish 
A. A coastal zone consists of a part of the coast or an estuary with a 
precise geographical delimitation which consists of a homogeneous 
hydrological system. 
B. Achievement of status of approved zone 
In order to obtain the approved status, a coastal zone for fish must 
meet the requirements laid down for continental zones referred to in 
I, B. 
C. Maintenance of status 
The maintenance of the approval for a coastal zone is subject to the 
requirements referred to in I C. 
25 -
D. Suspension, re-establishment and withdrawal of approval 
The rules laid down for suspension, re-establishment or withdrawal of 
approval are those referred to in I D. 
III. Coastal zones for molluscs 
A. A coastal zone must comply with the definition laid down in point II A. 
B. Achievement of status of approved zone 
In order to be approved, a continental zone must meet the following 
requirements : 
1. All molluscs have for at least four years shown no clinical or 
other sign of the diseases of Annex A, column 1, list II. 
2. All farms in the coastal zone are placed under the supervision of 
the official services. Health inspections are carried out at 
intervals adapted to the development of the pathogen in question. 
During these inspections samples are taken and sent without delay 
to the approved laboratory to be tested for the diseases of 
Annex A, column 1, List II. 
3. If there is no farm in the continental zone, the official service 
must have submitted molluscs to a health inspection in accordance 
with paragraph 2, at intervals adapted to the development of the 
pathogens in question. 
4. Laboratory examinations of molluscs taken during health inspections 
.by the official services have produced negative results as regards 
the pathogens of Annex A, column 1, List II. 
For zones having a historical record of absence of the diseases 
referred to in Annex A, column 1, list II, this information may be 
taken into account for achievement of the status of approved zone. 
- 26 -
c. Maintenance of status 
The maintenance of approved status is subject to the following 
requirements : 
1. Molluscs introduced into the coastal zone must come from other 
approved zones. 
2. Each farm must undergo a health inspection in accordance with 
point B, 2 at intervals adapted to the development of the pathogens 
in question. 
3. The results of the laboratory examinations on the molluscs sampled 
during the health inspections must have been negative as regards the 
pathogens referred to in Annex A, column 1, Chapter II. 
4. A register must be kept by the farmers or the persons responsible for 
the introduction of molluscs, containing all information necessary to 
enable the state of health of the molluscs to be monitored constantly. 
D. Suspension, re-establishment and withdrawal of the approval 
1. Any abnormal death or other symptom that might constitute grounds for 
suspecting an outbreak of a disease of Annex A, column 1, list II 
must be notified as quickly as possible to the official service. The 
latter shall immediately suspend the approval of the zone. 
2. A sample of molluscs must be sent to the approved laboratory in order 
to be tested for the diseases of Annex A, column 1, list II. 
The results of the tests must be communicated immediately to the 
official service. 
3. Where the results are negative for the pathogens in question, but 
positive for another cause, the approval shall be re-established. 
- 27 -
4. However, when no diagnosis can be made a further health inspection 
must be made within 15 days of the first taking of samples and a sick 
mollusc must be taken and forwarded to the approved laboratory in 
order to be tested for the diseases of Annex A, column 1, list II. 
If the results are again negative or if there are no longer any sick 
molluscs, the official service will re-establish the approval. 
5. Where the results are positive, approval must be withdrawn by the 
official service. 
6. Re-establishment of the approval of a zone is subject to the 
following requirements : 
a) when an outbreak occurs : 
- infected or contaminated molluscs must have been destroyed, 
- facilities and equipment must have been disinfected in 
accordance with a procedure approved by the official service; 
b) after elimination of the outbreak, the requirements referred to in 
B must again be complied with. 
7. The central competent authority shall inform the Commission and the 
other Member States about the suspension, re-establishment and 
withdrawal of the approval of zones. 
- 28 -
ANNEX C 
APPROVED FARMS IN A NON-APPROVED ZONE 
I. Continental farms for fish 
A. Achievement of status of approved farm 
In order to be approved, a farm must meet the following requirements : 
1. Water must be supplied by a well or a borehole. 
2. There must be a natural or artificial barrier for anadromic fish 
situated downstream. 
3. It must comply with the relevant requirements laid down in 
Annex BIB. 
B. Maintenance of status 
The maintenance of the approval shall be subject to the requirements 
laid down in Annex B I C. However, the sampling for laboratory 
examination must be carried out once a year. 
C. Suspension, re-establishment and withdrawal of approval 
The requirements laid down in Annex BID shall apply. 
II. Continental farms for molluscs 
A. Achievement of status of approved farm 
In order to be approved, a farm must meet the following requirements : 
1. It must be supplied with water by means of a system which allows the 
killing of the pathogens of Annex A, column 1, list II. 
2. It must comply, mutatis mutandis, with the requirements for the 
achievement of status as laid down in Annex B III B, points 1, 2 and 
4. 
B. Maintenance of status 
The maintenance of the approval shall, mutatis mutandis, be subject to 
the requirements for maintenance of status as laid down in 
Annex B III C, points 1 to 4. 
C. Suspension, re-establishment and withdrawal of approval 
The requirements for suspension, re-establishment and withdrawal of 
approval as la?.d down in Annex B III D shall apply, mutatis mutandis. 
- 29 -
ANNEX D 
Renewal of water during the transportation of aquaculture animals shall be 
carried out in places which meet the following requirements : 
1. the hygienic properties of the water available for changing must be such as 
not to alter the health situation of the species transported with regard to 
the pathogens of the diseases of Annex A, column I, lists I and II. 
2. the location of these places and the facilities provided at them must be 
such as to prevent any contamination of neighbouring farms : 
- either by facilitating disinfection of the water used, for example, by 
collecting it in a tank where it can be disinfected, or 
- by ensuring that the release of this water does not under any 
circumstances entail its direct discharge into the open sea or 
free-flowing waterways. 
- 30 -
ANNEX E 
CHAPTER 1 
MODEL 
MOVEMENT DOCUMENT 
FOR LIVE FISH. EGGS AND GAMETES FROM AN APPROVED ZONE 
I. Country of origin : 
Approved zone : 
II. Farm of origin (name and address) : 
III. Animals or products : 
: Species 
: Quantity Number 
Weight Live Fish Eggs Gametes : 
IV. Destination 
Country of destination :...... 
Consignee (Name and address) : 
V. Means of transport (Nature and identification) 
VI. Health attestation 
I, the undersigned, certify that the animals or goods of the present 
consignment originate from an approved zone and that they satisfy the 
requirements of Council Regulation (EEC) No 
Done at , on 
NAME OF THE OFFICIAL SERVICE 
NAME (in capitals) 
Function of subscriber 
STAMP OF THE OFFICIAL SERVICE Signature 
- 31 -
CHAPTER 2 
MODEL 
MOVEMENT DOCUMENT 
FOR LIVE FISH. EGGS OR GAMETES FROM AM APPROVED FARM 
I. Country of origin : 
II. Farm of origin (name and address : 
III. Animals or products : 
: Species 
: Quantity Number 
Weight Live Fish Eggs Gametes : 
IV. Destination 
Country of destination : 
Consignee (Name and address) : 
V. Means of transport (Nature and identification) 
VI. Health attestation 
I, the undersigned, certify that the animals or products of the present 
consignment originate from an approved farm and that they satisfy the 
requirements of Council Regulation (EEC) No 
Done at » on 
NAME OF THE OFFICIAL SERVICE 
NAME (in capitals) 
Function of subscriber 
STAMP OF THE OFFICIAL SERVICE Signature 
••*-";».• 
MOPCL 
MOVEMENT DOCUMENT 
FOt MOLLBSCS FROM AN APPROVED COASTAL ZOttE 
I. Country of origin : 
Approved zone : 
II. Farm of origin (name and address : 
TII. Animals : 
Molluscs : 
: Species : : 
: Quantity Number 
Weight 
IV. Destination 
Country of destination : .;... 
Consignee (name and address) : 
V; Means of transport (nature and identification) 
VI. Health certification 
I, the undersigned, certify that the molluscs.of the present consignment 
originate from an approved coastal zone and that they satisfy the 
requirements of Council Regulation (EEC) No. 
Done at , on 
NAME OF THE OFFICIAL SERVICE 
NAME (in capitals) 
Function of subscriber 
STAMP OF THE OFFICIAL SERVICE Signature 
33 -
CHAPTER 4 
MODEL 
FOR MOLLUSCS FROM AN APPROVED FARM 
I. Country of origin : 
TI. Farm of origin (name and address) : 
III. Animals : 
: Molluscs : 
: Species : : 
: Quantity Number : 
: Weight : : 
IV. Destination 
Country of origin : 
Consignee (name and address : 
V. Means of transport (nature and identification) 
VI. Health certification 
I, the undersigned, certify that the animals of the present consignment 
originate from an approved farm and that they satisfy the requirements of 
Council Regulation (EEC) No 
Done at , on 
NAME OF THE OFFICIAL SERVICE 
NAME (in capitals) 
Title of subscriber 
STAMP OF THE OFFICIAL SERVICE Signature 
34 -
FINANCIAL STATEMENT concerning : 
Draft proposal for a Council Regulation concerning the animal health conditions 
governing the placing on the market of aquaculture animals and products 
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. 15 and 20) 
5. METHOD OF CALCULATION: 
5.1.Form of expenditure: Mission expenses 
5.2.Community contribution: 100 % 
5.3.Calculâtion: 
200 mission days per year at ECU 170 per day (currant cost of inspection) 
ECU 34.000 per year 
6. FINANCIAL IMPLICATION AS REGARDS OPERATING APPROPRIATIONS 
6.1.Schedule of appropriations (m ECU): 
Year 
1991 0,034 
1992 0,034 
1993 0,034 
1994 0,034 
1995 0,034 
following years 
Total 0.170 
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 2 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. 
- 35 -
STATEMENT OF IMPACT ON BUSINESS 
Name of the proposa 
Draft proposal for a Council Regulation concerning the animal health 
conditions governing the placing on the market of aquaculture animals 
and products. 
Object ives 
In view of achieving the Internal market, to remove barriers to trade 
In the fish farming sector, avoiding however the spread of contagious 
diseases In particular to the regions In the Community which are free 
of the disease. 
Impact on business 
The proposal is expected not to have impact on business. It is 
directed In first Instance to the authorities of the Member States, 
who have to ensure that aquaculture animals and products do not 
present a risk for the spreading of diseases. 

ISSN 0254-1475 
COM(89) 655 final 
DOCUMENTS 
EN 03 04 05 
Catalogue number : CB-CO-90-060-EN-C 
ISBN 92-77-57324-4 
Office for Official Publications of the European Communities 
L-2985 Luxembourg