PROPOSAL FOR A COUNCIL DECISION CONCERNING THE PROVISIONAL APPLICATION OF THE AGREED MINUTE AMENDING THE AGREEMENT BETWEEN THE EUROPEAN ECONOMIC COMMUNITY AND THE REPUBLIC OF HUNGARY ON TRADE IN TEXTILE PRODUCTS
Date: 1990-12-14
Institutions: European Commission
Subjects: Hungary, agreement (EU), textile product, trading operation

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) 

2 -

•"m,39)655 final 

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. 

-  3 -

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; 

- 4 -

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; 

-  5 -

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; 

- 6 

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. 

-  7 -

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. 

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 : 

Article 7 

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; 

- 8 -

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. 

_ 9 -

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. 

- 11 -

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. 

- 12 

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) 

- 13 

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 : 

- 14 -

- 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. 

-  15 -

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) 

- 16 -

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. 

- 17 -

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. 

- 19 -

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 

- 20 -

ANNEX A 

Disease 

Susceptible  species  Carrier species 

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 III 
Fish 
IPN  (Infectious  pancreatic 
necrosis) 

SVC  (Spring viremia of carp) 

BKD (Bacterial Kidney Disease) 

Furunculosis in 
Atlantic  salmon 

ERM  (Enteric Red Mouth Disease) 

Salmo gairdneri 
Oncorhynchus  nerka 

tschawytscha 

" 
**  rhodurus 

Salmo salar 

) Survivors 
) 
) 
) 
) 

) Survivors 

Salmo gairdneri 
Salmo trutta 
Salmo salar 
Thymallus thymallus 
Coregonus sp. 
Esox lucius  (Fry) 

Ostrea edulis 
Ostrea edulis 

Ostrea edulis 

Ruditapes decussatus 

Ceratoderma edule 
Mytilus  edulis 
Crassostrea 
virginica 
Crassostrea 
virginica 

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) 

Survivors 
All other 
salmonidae 

Several  cyprinidae 
Eels, Perch, Pike 

Survivors 

Survivors 

Survivors 

Survivors 

Gyrodactylosis 
(Gyrodactylus salaris) 

Myxobolosis  (Myxosomiasis) 
(Whirling disease) 

Salmo salar 

Salmo trutta 
Salmo salar 

Salvelinus  fontinalis 

Salmo 
gairdneri 

) Survivors 
) 
) 
) 

Crustaceans 

Aphanomycosis 
(crayfish plague) 

Astacus sp 
Austropotamobius 
pallipes 
Procambarus  clarkii 

Pacifastacus 
Leniusculus 

-  21 -

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. 

-  22 -

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. 

- 23 -

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  B I B. 

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 B ID  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  : 

Live Fish 

Eggs 

Gametes 

: 

: Species 

: Quantity 

Number 
Weight 

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  : 

Live Fish 

Eggs 

Gametes 

: 

: Species 

: Quantity 

Number 
Weight 

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  -

F I N A N C I AL 

S T A T E M E NT 

c o n c e r n i ng 

: 

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: 

III B 

Item: 

382  (1) 

Title: 

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 
1992 
1993 
1994 
1995 
following years 

Total 

0,034 
0,034 
0,034 
0,034 
0,034 

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