No C 84/42 Official Journal of the European Communities 2. 4. 90 
CHAPTER X 
MARKING OF CONSIGNMENTS 
1. All parcels in a consignment of live bivalve molluscs must be provided with a health mark so enabling at all 
times during transport and distribution until retail, the identification of their original expedition centre. 
Without prejudice to Council Directive 79/112/EEC on the approximation of laws of the Member States 
relating to the labelling, presentation and advertising of foodstuffs^), as last amended by Directive 
89/395/EEC (2), the mark must contain the following information: 
— the country of dispatch, 
— species of bivalve mollusc (common name and scientific name), 
— the identification of the expedition centre by the approval number granted by the competent 
authority, 
— the date of wrapping. 
2. The health mark may be printed on the wrapping material or be put on a separate tag which is then fixed on the 
wrapping material or put inside the wrapping. They may also be of a twist-tie or staple design; self-adhesive 
health marks must not be used. All types of health marks must be designed for single use and be not 
transferable. 
3. The health mark must be durable and waterproof and the information presented as legible, indelible and in 
easily decipherable characters. 
4. The health mark attached to consignments of live bivalve molluscs which are not wrapped as consumer size 
parcels must be kept for at least 60 days by the retailer after splitting up the content of the consignment. 
H OJ No L33, 8. 2. 1979, p. 1. 
(2) OJ No L 186, 30. 6. 1989, p. 17. 
Proposal for a Council Regulation (EEC) concerning the animal health conditions governing the 
placing on the market of aquaculture animals and products 
COM(89) 655 final 
(Submitted by the Commission on 9 February 1990) 
(90/C 84/04) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 43 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas aquaculture animals and products are included in 
the list in Annex II to the Treaty; Whereas the breeding and rearing of aquaculture animals, 
and the placing on the market of aquaculture animals and 
products constitutes a source of income for persons working 
in the fisheries sector; 
Whereas, in order to ensure the rational development of this 
sector and to increase productivity, health rules for this 
sector must be laid down at Community level; 
Whereas in this context it is necessary to contribute to the 
completion of the internal market, avoiding the spread of 
contagious diseases; 
Whereas the animal health situation for aquaculture animals 
is not the same throughout the territory of the Community, 
whereas reference must therefore be made to zones when 
dealing with parts of the Community; 
2. 4. 90 Official Journal of the European Communities No C 84/43 
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; 
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; 
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. 
No C 84/44 Official Journal of the European Communities 2. 4. 90 
Article 5 
1. In order to obtain, for the diseases referred to in 
Annex A, column 1, lists 1 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. 
If in accordance with Annex B under I D 5, under II D or 
under II 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; 
(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 re-laid 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 re-laid 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. 
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: 
2. 4. 90 Official Journal of the European Communities No C 84/45 
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: 
— 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 procedure under which the programme 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 into 
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 HI, 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. 
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. 
No C 84/46 Official Journal of the European Communities 2. 4. 90 
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. 
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 (J) 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. 
(>) OJNoL... 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: 
— 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, 
2. 4. 90 Official Journal of the European Communities No C 84/47 
— 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. 
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 sh all 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 Regulation (EEC) 
No . . . laying down the principles relating to the 
organization of veterinary control for products arising from 
third countries with a view to the completion of the internal 
market (l) and No . . ., laying down the principles relating to 
the organization 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. 
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. 
(') OJNoL... (2) OJ No L . . . 
No C 84/48 Official Journal of the European Communities 2. 4. 90 
Article 25 
1. The Commission shall be assisted by the Standing 
Veterinary Committee set up by the Council Decision 
68/361/EEC (*), 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. 
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. 
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. 
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. 
(i) OJ No L . . . 
2. 4. 90 Official Journal of the European Communities No C 84/49 
ANNEX A 
1 
Disease 
LIST I 
Fish 
IHN (infectious hematopoetic necrosis) 
LIST II 
Fish 
Viral haemorrhagic septicaemia (VHS) 
Molluscan shellfish 
Bonamia ostreae 
Marteilia sp. 
Haplosporidum sp. 
Perkinsus sp. 
LIST HI 
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) 2 
Susceptible species 
Salmo gairdneri 
Oncorhynchus nerka 
Oncorhynchus tschawytscha 
Oncorhynchus rhodurus 
Salmo salar 
Salmo gairdneri 
Salmo trutta 
Salmo salar 
Thymallus thymallus 
Coregonus sp. 
Esox lucius (Fry) 
Ostrea edulis 
Ostrea edulis 
Ostrea edulis 
Ruditapes decussatus 
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 anguilla, 
Psetta maxima (turbot), 
Notropis atherinoides 
(bait minnow) 
Salmo salar 
Salmo gairdneri 
Salmo trutta 
Salmo salar 
Salvelinus fontinalis 
Astacus sp. 
Austropotamobius pallipes 
Procambarus clarkii 3 
Carrier species 
• Survivors 
> Survivors 
Ceratoderma edule 
Mytilus edulis 
Crassostrea virginica 
Crassostrea virginica 
Survivors 
All other salmonidae 
Several cyprinidae 
eels, perch, pike 
[ Survivors 
\ Survivors 
1 s • 
Y Survivors 
Salmo gairdneri 
} s.™ 
Pacifastacus Leniusculus 
No C 84/50 Official Journal of the European Communities 2. 4. 90 
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 programme 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. 
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 least 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 zones. 
2. Each fish farm must undergo two health inspections annually in accordance with point B2, however, 
samples will be taken by rotation in 50% of the fish farms in the continental zone each year. 
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. 
2. 4. 90 Official Journal of the European Communities No C 84/51 
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 I, lists I and II. 
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. 
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 ID. 
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 H. 
No C 84/52 Official Journal of the European Communities 
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. Laboratoy 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. 
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 B2 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. 
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 a 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. 
2. 4. 90 Official Journal of the European Communities No C 84/53 
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 IC. 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 HI C, points 1 to 4. 
C. Suspension, re-establishment and withdrawal of approval 
The requirements for suspension, re-establishment and withdrawal of approval as laid down in Annex B 
III D shall apply, mutatis mutandis. 
ANNEXD 
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. 
No C 84/54 Official Journal of the European Communities 2. 4. 90 
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) 
Stamp of the official service Function of subscriber 
Signature: 
2. 4. 90 Official Journal of the European Communities No C 84/55 
CHAPTER 2 
MODEL 
MOVEMENT DOCUMENT FOR LIVE FISH, EGGS OR GAMETES FROM AN 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, certifiy 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 
Stamp of the official service 
Signature: Name (in capitals) 
Function of subscriber 
No C 84/56 Official Journal of the European Communities 2. 4. 90 
CHAPTER 3 
MODEL 
MOVEMENT DOCUMENT FOR MOLLUSCS FROM AN APPROVED COASTAL ZONE 
I. Country of origin: 
Approved zone: 
II. Farm of origin (name and address): 
III. Animals: 
Species 
Quantity Number 
Weight Molluscs 
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 cf Council Regulation (EEC) No 
Done at , on 
Name of the official service 
Stamp of the official service 
Signature: Name (in capitals) 
Function of subscriber 
2. 4. 90 Official Journal of the European Communities No C 84/57 
CHAPTER 4 
MODEL 
FOR MOLLUSCS FROM AN APPROVED FARM 
I. Country of origin: 
II. Farm of origin (name and address): 
III. Animals: 
Species 
Quantity Number 
Weight Molluscs 
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) 
Stamp of the official service Title of subscriber 
Signature: