Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals

• (d)a description and demarcation of the geographical and administrative area in which the programme is to be applied.

Article 46

Period of application of programmes

• (a)the requirements laid down in Annex V have been fulfilled, and the Member State, zone or compartment is declared free of the disease; or

• (b)the programme is withdrawn, namely if it no longer fulfils its purpose, by the competent authority of the Member State concerned, or by the Commission.

SECTION 2 Contingency plan for emerging and exotic diseases

Article 47

Contingency plan for emerging and exotic diseases

• (a)provide the competent authority with the authority and means to access all facilities, equipment, personnel and other appropriate materials necessary for the rapid and efficient eradication of an outbreak;

• (b)ensure coordination and compatibility with neighbouring Member States and encourage cooperation with neighbouring third countries; and

• (c)where relevant, give a precise indication of the vaccine requirements and vaccination conditions considered necessary in the event of emergency vaccination.

Every five years, each Member State shall update its contingency plan and submit the updated plan for approval in accordance with that procedure.

SECTION 3 Vaccination

Article 48

Vaccination

Member States may allow such vaccination in parts of their territory not declared free from the diseases in question, or where vaccination is a part of an eradication programme approved in accordance with Article 44(2).

During such studies, Member States shall ensure that the appropriate measures are taken to protect other aquatic animals from any adverse effect of the vaccination carried out within the framework of the studies.

CHAPTER VII DISEASE-FREE STATUS

Article 49

Disease-free Member State

• (a)none of the species susceptible to the disease(s) in question is present in its territory; or

• (b)the pathogen is known not to be able to survive in the Member State, and in its water source; or

• (c)the Member State meets the conditions laid down in Part I of Annex V.

Article 50

Disease-free zone or compartment

• (a)none of the species susceptible to the disease(s) in question is present in the zone or compartment, and where relevant in its water source; or

• (b)the pathogen is known not to be able to survive in the zone or compartment, and where relevant in its water source; or

• (c)the zone or compartment complies with the conditions laid down in Part II of Annex V.

• (a)the declaration shall be supported by evidence in a form to be determined in accordance with the procedure referred to in Article 62(2) and be accessible by electronic means to the Commission and Member States, in accordance with the requirements of Article 59;

• (b)the Commission shall add the notification of the declaration to the agenda of the next meeting of the Committee referred to in Article 62(1) as an information point. The declaration shall take effect 60 days after the date of the meeting;

• (c)within this period, the Commission or Member States may seek clarification or additional information on the supporting evidence from the Member State making the declaration;

• (d)where written comments are made by at least one Member State, or the Commission, within the period referred to in point (b) indicating significant objective concerns related to the supporting evidence, the Commission and the Member States concerned shall together examine the submitted evidence in order to resolve the concerns. In that case, the period referred to in point (b) may be prolonged for 30 days. Such comments shall be submitted to the declaring Member State and to the Commission;

• (e)if the arbitration referred to in point (d) fails, the Commission may decide to make an on-the-spot inspection in accordance with Article 58 to verify the compliance of the declaration submitted with the criteria set out in paragraph 1, unless the declaring Member State withdraws its declaration;

• (f)where necessary in the light of the results achieved, a decision in accordance with the procedure referred to in Article 62(2) shall be taken, to suspend the self-declaration of the disease-free status of the zone or compartment concerned.

Article 51

Lists of disease-free Member States, zones or compartments

Article 52

Maintenance of disease-free status

A Member State that is declared free from one or more non-exotic diseases listed in Part II of Annex IV in accordance with Article 49 may discontinue targeted surveillance and maintain its disease-free status provided that the conditions conducive to clinical expression of the disease in question exist, and the relevant provisions of this Directive are implemented.

However, for disease-free zones or compartments in Member States not declared disease-free, and in all cases where conditions are not conducive to clinical expression of the disease in question, targeted surveillance shall be continued in accordance with the methods provided for in Articles 49(3) or 50(4) as appropriate, but at a level commensurate with the degree of risk.

Article 53

Suspension and restoration of disease-free status

CHAPTER VIII COMPETENT AUTHORITIES AND LABORATORIES

Article 54

General obligations

The competent authorities shall operate and perform their duties in accordance with Regulation (EC) No 882/2004.

Information shall also, to the extent necessary, be exchanged between the competent authorities of the different Member States.

Article 55

Community reference laboratories

Article 56

National reference laboratories

Member States may designate a laboratory situated in another Member State or EFTA Member State, and a single laboratory may be the national reference laboratory for more than one Member State.

Article 57

Diagnostic services and methods

Member States shall ensure that:

• (a)laboratory examinations for the purposes of this Directive are carried out in laboratories designated for such purpose by the competent authority;

• (b)laboratory examinations in the case of suspicion and to confirm the presence of the diseases listed in Part II of Annex IV are carried out by diagnostic methods to be established in accordance with the procedure referred to in Article 62(2); and

• (c)laboratories designated for diagnostic services in accordance with this Article shall comply with the functions and duties laid down in Part III of Annex VI.

CHAPTER IX INSPECTIONS, ELECTRONIC MANAGEMENT AND PENALTIES

Article 58

Community inspections and audits

The Member States in the territory of which such inspections and audits are made shall provide the experts with all the assistance necessary for carrying out their duties.

The Commission shall inform the competent authority of the results of any such inspections and audits.

Where such measures are not taken, or where they are considered to be insufficient, the measures necessary to safeguard animal health shall be adopted in accordance with the procedure referred to in Article 62(3) and the Member State concerned shall be informed thereof.

Article 59

Electronic management

Article 60

Penalties

The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by the date specified in Article 65(1) at the latest and shall notify it without delay of any subsequent amendment affecting them.

CHAPTER X AMENDMENTS, DETAILED RULES AND COMMITTEE PROCEDURE

Article 61

Amendments and detailed rules

Article 62

Committee procedure

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

CHAPTER XI TRANSITIONAL AND FINAL PROVISIONS

Article 63

Repeal

Article 64

Transitional provisions

Transitional provisions may be adopted in accordance with the procedure referred to in Article 62(2) for a period of four years from 14 December 2006.

Article 65

Transposition

They shall apply those provisions from 1 August 2008.

When they are adopted by Member States, these measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

Article 66

Entry into force

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 67

Addressees

This Directive is addressed to the Member States.

ANNEX I

DEFINITIONS

In addition to the definitions in Article 3, the following technical definitions shall apply:

• (a)‘compartment’ means one or more farms under a common biosecurity system containing an aquatic animal population with a distinct health status with respect to a specific disease;

• (b)‘common biosecurity system’ means that the same aquatic animal health surveillance, disease prevention, and disease control measures are applied;

• (c)‘containment area’ means an area around an infected farm or mollusc farming area where disease control measures are applied with the purpose of preventing the spread of the disease;

• (d)‘disease’ means a clinical or non-clinical infection with one or more aetiological agents in aquatic animals;

• (e)‘disease-free zones or compartments’ means zones or compartments declared disease-free in accordance with Articles 49 or 50;

• (f)‘emerging disease’ means a newly identified serious disease, the cause of which may or may not yet be established, that has the potential to be spread within and between populations, such as by way of trade in aquatic animals and/or aquatic animal products. It also means a listed disease identified in a new host species not yet included in Part II of Annex IV as a susceptible species;

• (g)‘epidemiological unit’ means a group of aquatic animals that share approximately the same risk of exposure to a disease agent within a defined location. This risk may be because they share a common aquatic environment, or because management practices make it likely that a disease agent in one group of animals would quickly spread to another group of animals;

• (h)‘fallowing’ means, for disease management purposes, an operation where a farm is emptied of aquaculture animals susceptible to the disease of concern or known to be capable of transferring the disease agent, and, where feasible, of the carrying water;

• (i)‘further processing’ means processing of aquaculture animals before human consumption by any type of measures and techniques affecting anatomical wholeness, such as bleeding, gutting/evisceration, heading, slicing and filleting, which produces waste or by-products and could cause a risk of spreading diseases;

• (j)‘increased mortality’ means unexplained mortalities significantly above the level of what is considered to be normal for the farm or mollusc farming area in question under the prevailing conditions. What is considered to be increased mortality shall be decided in cooperation between the farmer and the competent authority;

• (k)‘infection’ means the presence of a multiplying, or otherwise developing, or latent disease agent in, or on, a host;

• (l)‘infected zone or compartment’ means zones or compartments where the infection is known to occur;

• (m)‘quarantine’ means maintaining a group of aquatic animals in isolation with no direct or indirect contact with other aquatic animals, in order to undergo observation for a specified length of time and, where appropriate, testing and treatment, including proper treatment of the effluent waters;

• (n)‘susceptible species’ means any species in which infection by a disease agent has been demonstrated by natural cases or by experimental infection that mimics the natural pathways;

• (o)‘vector’ means a species that is not susceptible to a disease but which is capable of spreading infection by conveying pathogens from one host to another;

• (p)‘zone’ means a precise geographical area with a homogeneous hydrological system comprising part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals from lower stretches of the water catchment area, an entire water catchment area from its source(s) to its estuary, or more than one water catchment area, including their estuaries, due to the epidemiological link between the catchment areas through the estuary.

ANNEX II

Information required in the official register of aquaculture production businesses and authorised processing establishments

PART I

Authorised aquaculture production business

• 1.The following minimum information on each aquaculture production business shall be kept by the competent authority in a register, as provided for in Article 6: (a)the name and addresses of the aquaculture production business, and contact details (telephone, facsimile, e-mail); (b)the registration number and particulars of the authorisation delivered, (i.e. dates for specific authorisations, identification codes or numbers, specified conditions for production, any other matter relevant to the authorisation(s)); (c)the geographical position of the farm defined by a suitable system of coordinates of all farm-sites (if possible, GIS coordinates); (d)the purpose, type (i.e. type of culture system, or facilities such as land-based facilities, sea cages, earth ponds) and maximum volume of production where this is regulated; (e)for continental farms, dispatch centres and purification centres, details on the farm's water supply and discharges; (f)the species of aquaculture animals reared at the farm (for multi-species farms or ornamental farms, it shall as a minimum be registered whether any of the species are known to be susceptible to diseases listed in Part II of Annex IV, or known vectors of such diseases); (g)updated information on the health status (i.e. if the farm is disease-free (located in a Member State, zone or compartment), where the farm is under a programme with a view of achieving such status, or where the farm is declared infected by a disease referred to in Annex IV).

• 2.Where an authorisation is granted to a mollusc farming area in accordance with the second subparagraph of Article 4(1), the data required pursuant to point 1(a) of this part shall be recorded for all aquaculture production businesses which operate within the mollusc farming area. The data required pursuant to points 1(b) to 1(g) of this part shall be recorded at mollusc farming area level.

PART II

Authorised processing establishments

The following minimum information on each authorised processing establishment shall be kept by the competent authority in a register, as provided for in Article 6:

• (a)the name and addresses of the authorised processing establishment, and contact details (telephone, facsimile, e-mail);

• (b)the registration number and particulars of the authorisation delivered (i.e. dates for specific authorisations, identification codes or numbers, specified conditions for production, any other matter relevant to the authorisation(s));

• (c)the geographical position of the processing establishment defined by a suitable system of coordinates (if possible GIS coordinates);

• (d)details on the authorised processing establishment's water effluent treatment systems;

• (e)the species of aquaculture animals handled in the authorised processing establishment.

ANNEX III

PART A

Health status of aquaculture zones or compartments to be considered for the application of Article 12

Aquaculture animals for farming and restocking

Category	Health status	May introduce animals from	Health certification	Health certification	May dispatch animals to
Category	Health status	May introduce animals from	Introduction	Dispatching	May dispatch animals to
I	Disease-free (Articles 49 or 50)	Only category I	YES	NO when dispatched to category III or V	All categories
I	Disease-free (Articles 49 or 50)	Only category I	YES	YES when dispatched to categories I, II or IV	All categories
II	Surveillance Programme (Article 44(1))	Only category I	YES	NO	Categories III and V
III	Undetermined (not known to be infected but not subject to a programme for achieving disease-free status)	Categories I, II, or III	NO	NO	Categories III and V
IV	Eradication Programme (Article 44(2))	Only category I	YES	YES	Only category V
V	Infected (Article 39)	All categories	NO	YES	Only category V

PART B

Recommended surveillance and inspections on farms and mollusc-farming areas

Species present	Health status as referred to in Part A	Risk level	Surveillance	Recommended inspection frequency by the competent authority (Article 7)	Recommended inspection frequency by qualified aquatic animal health services (Article 10)	Specific requirements for inspections, sampling and surveillance necessary to maintain the health status	Comments
No species susceptible to the diseases listed in Annex IV	Category I Declared disease-free in accordance with Article 49(1)(a) or (b) or Article 50(1)(a) or (b).	Low	Passive	1 every 4 years	1 every 4 years	Specific requirements for the maintenance of the disease-free status in accordance with Article 52.	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category I Declared disease-free in accordance with of Article 49(1)(c) or of Article 50(1)(c).	High	Active, targeted or passive	1 every year	1 every year	Specific requirements for the maintenance of the disease-free status in accordance with Article 52.	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category I Declared disease-free in accordance with of Article 49(1)(c) or of Article 50(1)(c).	Medium	Active, targeted or passive	1 every 2 years	1 every 2 years	Specific requirements for the maintenance of the disease-free status in accordance with Article 52.	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category I Declared disease-free in accordance with of Article 49(1)(c) or of Article 50(1)(c).	Low	Active, targeted or passive	1 every 4 years	1 every 2 years	Specific requirements for the maintenance of the disease-free status in accordance with Article 52.	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category II Not declared disease-free but subject to a surveillance programme approved in accordance with Article 44(1).	High	Targeted	1 every year	1 every year	Specific requirements in accordance with Article 44(1).	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category II Not declared disease-free but subject to a surveillance programme approved in accordance with Article 44(1).	Medium	Targeted	1 every 2 years	1 every 2 years	Specific requirements in accordance with Article 44(1).	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category II Not declared disease-free but subject to a surveillance programme approved in accordance with Article 44(1).	Low	Targeted	1 every 4 years	1 every 2 years	Specific requirements in accordance with Article 44(1).	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category III Not known to be infected but not subject to surveillance programme for achieving disease-free status.	High	Active	1 every year	3 every year		The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category III Not known to be infected but not subject to surveillance programme for achieving disease-free status.	Medium	Active	1 every year	2 every year		The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category III Not known to be infected but not subject to surveillance programme for achieving disease-free status.	Low	Active	1 every 2 years	1 every year		The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category IV Known to be infected but subject to an eradication programme approved in accordance with Article 44(2).	High	Targeted	1 every year	1 every year	Specific requirements in accordance with Article 44(2).	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category IV Known to be infected but subject to an eradication programme approved in accordance with Article 44(2).	Medium	Targeted	1 every 2 years	1 every 2 years	Specific requirements in accordance with Article 44(2).	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category IV Known to be infected but subject to an eradication programme approved in accordance with Article 44(2).	Low	Targeted	1 every 4 years	1 every 2 years	Specific requirements in accordance with Article 44(2).	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category V Known to be infected. Subject to minimum control measures as provided for in Chapter V.	High	Passive	1 every 4 years	1 every year	Specific requirements in accordance with Chapter V.	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category V Known to be infected. Subject to minimum control measures as provided for in Chapter V.	Medium	Passive	1 every 4 years	1 every 2 years	Specific requirements in accordance with Chapter V.	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.
Species susceptible to one or more of the diseases listed in Annex IV	Category V Known to be infected. Subject to minimum control measures as provided for in Chapter V.	Low	Passive	1 every 4 years	1 every 4 years	Specific requirements in accordance with Chapter V.	The recommended inspection frequencies shall apply without prejudice to the specific requirements mentioned for each health status. However, where possible, such inspections and sampling should be combined with the inspections required pursuant to Articles 7 and 10. The aim of inspections by the competent authority is to check compliance with this Directive in accordance with Article 7. The aim of inspections by qualified aquatic animal health services is to check the health status of the animals, to advise the aquaculture production business operator on aquatic animal health issues, and where necessary, undertake the necessary veterinary measures.

Risk levels

A high-risk farm or mollusc farming area is a farm or mollusc farming area which:

• (a)has a high risk of spreading diseases to or contracting diseases from other farms or wild stocks;

• (b)operates under farming conditions which could increase the risk of disease outbreaks (high biomass, low water quality), taking into account the species present;

• (c)sells live aquatic animals for further farming or restocking.

A medium-risk farm or mollusc farming area is a farm or mollusc farming area which:

• (a)has medium risk of spreading diseases to or contracting diseases from other farms or wild stocks;

• (b)operates under farming conditions which would not necessarily increase the risk of disease outbreaks (medium biomass and water quality), taking into account the species present;

• (c)sells live aquatic animals mainly for human consumption.

A low-risk farm of mollusc farming area is a farm or mollusc farming area which:

• (a)has a low risk of spreading diseases to or contracting diseases from other farms or wild stocks;

• (b)operates under farming conditions which would not increase the risk of disease outbreaks (low biomass, good water quality), taking into account the species present;

• (c)sells live aquatic animals for human consumption only.

Types of health surveillance

Passive surveillance shall include mandatory immediate notification of the occurrence or suspicion of specified diseases or of any increased mortalities. In such cases investigation in accordance with Section 2 of Chapter V shall be required.

Active surveillance shall include:

• (a)routine inspection by the competent authority or by other qualified health services on behalf of the competent authorities;

• (b)examination of the aquaculture animal population on the farm or in the mollusc farming area for clinical disease;

• (c)diagnostic samples to be collected on suspicion of a listed disease or observed increased mortality during inspection;

• (d)mandatory immediate notification of occurrence or suspicion of specified diseases or of any increased mortalities.

Targeted surveillance shall include:

• (a)routine inspection by the competent authority or by other qualified health services on behalf of the competent authorities;

• (b)prescribed samples of aquaculture animals to be taken and tested for specific pathogen(s) by specified methods;

• (c)mandatory immediate notification of occurrence or suspicion of specified diseases or of any increased mortalities.

ANNEX IV

Disease listing

PART I

Criteria for listing diseases

• A.Exotic diseases shall meet the following criteria laid down in point 1 and either point 2 or 3. 1.The disease is exotic to the Community, i.e. the disease is not established in Community aquaculture, and the pathogen is not known to be present in Community waters. 2.It has potential for significant economic impact if introduced into the Community, either by production losses in Community aquaculture or by restricting the potential for trade in aquaculture animals and products thereof. 3.It has potential for detrimental environmental impact if introduced into the Community, to wild aquatic animal populations of species, which are an asset worth protecting by Community law or international provisions.

• B.Non-exotic diseases shall meet the following criteria laid down in points 1, 4, 5, 6, 7, and 2 or 3. 1.Several Member States, or regions in several Member States, are free of the specific disease. 2.It has potential for significant economic impact if introduced into a Member State free of the disease, either by production losses, and annual costs associated with the disease and its control exceeding 5 % of the value of the production of the susceptible aquaculture animal species production in the region, or by restricting the possibilities for international trade in aquaculture animals and products thereof. 3.The disease has shown, where it occurs, to have a detrimental environmental impact if introduced into a Member State free of the disease, to wild aquatic animal populations of species that is an asset worth protecting under Community law or international provisions. 4.The disease is difficult to control and contain at farm or mollusc farming area level without stringent control measures and trade restrictions. 5.The disease may be controlled at Member State level, experience having shown that zones or compartments free of the disease may be established and maintained, and that this maintenance is cost-beneficial. 6.During placing on the market of aquaculture animals, there is a risk that the disease will establish itself in a previously uninfected area. 7.Reliable and simple tests for infected aquatic animals are available. The tests must be specific and sensitive and the testing method harmonised at Community level.

PART II

Listed diseases

Exotic diseases	Exotic diseases	Exotic diseases
	Disease	Susceptible species
Fish	Epizootic haematopoietic necrosis	Rainbow trout (Oncorhynchus mykis) and redfin perch (Percha fluviatilis)
Molluscs	Infection with Bonamia exitiosa	Australian mud oyster (Ostrea angasi) and Chilean flat oyster (O. chilensis)
Molluscs	Infection with Perkinsus marinus	Pacific oyster (Crassostrea gigas) and Eastern oyster (C. virginica)
Molluscs	Infection with Microcytos mackini	Pacific oyster (Crassostrea gigas), Eastern oyster (C. virginica), Olympia flat oyster (Ostrea conchaphila) and European flat oyster (O. edulis)
Crustaceans	Taura syndrome	Gulf white shrimp (Penaeus setiferus), Pacific blue shrimp (P. styrlirostris), and Pacific white shrimp (P. vannamei)
Crustaceans	Yellowhead disease	Gulf brown shrimp (Penaeus aztecus), Gulf pink shrimp (P. duoranum), Kuruma prawn (P. japonicas), black tiger shrimp (P. monodon), Gulf white shrimp (Penaeus setiferus), Pacific blue shrimp (P. styrlirostris), and Pacific white shrimp (P. vannamei)
---	---	---
Non-exotic diseases	Non-exotic diseases	Non-exotic diseases
Fish	Viral haemorrhagic septicaemia (VHS)	Herring (Cupea spp.), whitefish (Coregonus sp.), pike (Esox Lucius), haddock (Gadus aeglefinus), Pacific cod (G. macrocephalus), Atlantic cod (G. morhua), Pacific salmon (Onchorhynchus spp.), rainbow trout (O. mykiss), rockling (Onos mustelus), brown trout (Salmo trutta), turbot (Schophtalmus maximus), sprat (Sprattus sprattus), grayling (Thymallus thymallus) and olive flounder (Paralichthys olivaceus)
Fish	Infectious haematopoetic necrosis (IHN)	Chum salmon (Oncorchynchus keta), coho salmon (O. kisutch), Masou salmon (O. masou), rainbow or steelhead trout (O. mykiss), sockeye salmon (O. nerka), pink salmon (O. rhodurus), Chinook salmon (O. tshawytscha), and Atlantic salmon (Salmo salar)
Fish	Koi herpes virus (KHV) disease	Common carp and koi carp (Cyprinus carpio)
Fish	Infectious salmon anaemia (ISA): infection with genotype HPR-deleted of the genus Isavirus (ISAV)	Rainbow trout (Oncorhynchus mykiss), Atlantic salmon (Salmo salar), and brown and sea trout (Salmo trutta)
Molluscs	Infection with Marteilia refringens	Australian mud oyster (Ostrea angsi), Chilean flat oyster (O. chilensis), European flat oyster (O. edulis), Argentinian oyster (O. pelchana), blue mussel (Mytilus edulis) and Mediterranean mussel (M. galloprovincialis)
Molluscs	Infection with Bonamia ostrea	Australian mud oyster (Ostrea angasi), Chilean flat oyster (O. chilensis), Olympia flat oyster (O. conchaphila), Asiatic oyster (O. denselammellosa), European flat oyster (O. edulis) and Argentinian oyster (O. puelchana)
Crustaceans	White spot disease	All decapod crustaceans (order Decapoda)

ANNEX V

Requirements for declaring a Member State, zone or compartment disease-free

PART I

Disease-free Member State

• 1.On historical grounds 1.1.A Member State where susceptible species are present, but where there has not been any observed occurrence of the disease for at least for a period of 10 years before the date of application for the disease-free status despite conditions that are conducive to its clinical expression may be considered disease-free where: (a)basic biosecurity measure conditions have been in place continuously for at least a period of 10 years before the date of application for the disease-free status; (b)infection is not known to be established in wild populations; (c)the implementation of trade and imports conditions to prevent the introduction of the disease into the Member State is effective. A Member State wishing to benefit from a disease-free status, shall submit an application in accordance with Article 49 before 1 November 2008. After this date, disease-free status may only be granted in accordance with Part I.2. 1.2.The basic biosecurity measures referred to in point 1.1(a) shall consist, as a minimum, of the following: (a)the disease is compulsorily notifiable to the competent authority, including notification of suspicion; (b)an early detection system is in place throughout the Member State, enabling the competent authority to undertake effective disease investigation and reporting, and ensuring in particular: (i)the rapid recognition of any clinical signs consistent with the suspicion of a disease, emerging disease, or unexplained mortality in farms or molluscs farming areas, and in the wild; (ii)the rapid communication of the event to the competent authority with the aim to activating diagnostic investigation with minimum delay. 1.3.The early detection system referred to in point 1.2(b) shall include at least the following: (a)broad awareness, among the personnel employed in aquaculture businesses or involved in the processing of aquaculture animals, of any signs consistent with the presence of a disease, and training of veterinarians or aquatic animal health specialists in detecting and reporting unusual disease occurrence; (b)veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease occurrence; (c)access by the competent authority to laboratories with the facilities for diagnosing and differentiating listed and emerging diseases.

• 2.Based on targeted surveillance A Member State where the last known clinical occurrence was within 10 years before the date of application for the disease-free status or where the infection status prior to targeted surveillance was unknown, for example because of the absence of conditions conducive to clinical expression, may be considered free of the specific disease where: (a)the Member State meets the basic disease control conditions laid down in point 1.2; and (b)targeted surveillance in accordance with methods adopted pursuant to Article 49(3), has been in place for at least a period of two years without detection of the disease agent on farm, or in mollusc farming areas that rears any of the susceptible species. Where there are parts of the Member State in which the number of farms, or molluscs farming areas is limited, and consequently targeted surveillance in these parts do not provide sufficient epidemiological data, but in which there are wild populations of any of the susceptible species, those wild populations shall be included in the targeted surveillance.

PART II

Disease-free zone or compartment

• 1.Zones 1.1.A zone may comprise: (a)an entire water catchment area from its source to its estuary; or (b)part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals from lower stretches of the water catchment area; or (c)more than one water catchment area, including their estuaries, due to the epidemiological link between the catchment areas through the estuary. The geographical demarcation of the zone shall be clearly identified on a map. 1.2.Where a zone extends over more than one Member State, it may not be declared a disease-free zone unless the conditions outlined in points 1.3, 1.4 and 1.5 apply to all areas of that zone. In that case both Member States concerned shall apply for approval for the part of the zone situated in their territory. 1.3.A zone where susceptible species are present, but where there has not been any observed occurrence of the disease for at least a period of 10 years before the date of application for the disease-free status, despite conditions that are conducive to its clinical expression, may be considered disease-free if it complies mutatis mutandis with the requirements laid down in Part I.1. A Member State wishing to benefit from a disease-free status shall notify its intention in accordance with Article 50(2) before 1 November 2008. After this date, disease-free status may only be granted in accordance with Part I.2. 1.4.A zone where the last known clinical occurrence was within a period of 10 years before the date of application for the disease-free status or where the infection status prior to targeted surveillance was unknown, for example because of the absence of conditions conducive to clinical expression, may be considered disease-free where it complies mutatis mutandis with the requirements laid down in Part I.2. 1.5.A buffer zone in which a monitoring programme is carried out shall be established, as appropriate. The demarcation of the buffer zones shall be such that it protects the disease-free zone from passive introduction of the disease.

• 2.Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is dependent on the health status regarding that disease of surrounding natural waters 2.1.A compartment may comprise one or more farms, a group or cluster of farms or a mollusc farming area that may be considered as one epidemiological unit due to its geographical localisation and distance from other groups or clusters of farms or mollusc farming areas, provided that all farms comprising the compartment fall within a common biosecurity system. The geographical demarcation of a compartment shall be clearly identified on a map. 2.2.A compartment where susceptible species are present, but where there has not been any observed occurrence of the disease for at least a period of 10 years before the date of application for the disease-free status despite conditions that are conducive to its clinical expression, may be considered disease-free if it complies mutatis mutandis with the requirements in Part I.1 of this Annex. Member States wishing to benefit from this provision shall notify their intention in accordance with Article 50(2) before 1 November 2008. After this date, disease-free status may only be granted in accordance with Part I.2. 2.3.A compartment where the last known clinical occurrence was within 10 years before the date of application for the disease-free status, or where the infection status in the compartment or in the waters surrounding the compartment prior to targeted surveillance was unknown, for example because of the absence of conditions conducive to clinical expression, may be considered disease-free if it complies mutatis mutandis with the requirements laid down in Part I.2. 2.4.Each farm or mollusc farming area in a compartment shall be subject to additional measures imposed by the competent authority, when considered necessary to prevent the introduction of diseases. Such measures may include the establishment of a buffer zone around the compartment in which a monitoring programme is carried out, and the establishment of additional protection against the intrusion of possible pathogen carriers or vectors.

• 3.Compartments comprising one or more individual farms where the health status regarding a specific disease is independent of the health status regarding that disease of the surrounding natural waters. 3.1.A compartment may comprise: (a)an individual farm which may be considered a single epidemiological unit, as it is not influenced by the animal health status in the surrounding waters; or (b)more than one farm where each farm in the compartment complies with the criteria laid down in point 3.1(a) and points 3.2 to 3.6, but, due to extensive movement of animals between farms, shall be considered as a single epidemiological unit, provided that all farms are under a common biosecurity system. 3.2.A compartment shall be supplied with water: (a)through a water treatment plant inactivating the relevant pathogen in order to reduce the risk of the introduction of the disease to an acceptable level; or (b)directly from a well, a borehole or a spring. Where such water supply is situated outside the premises of the farm, the water shall be supplied directly to the farm, and be channelled through a pipe. 3.3.There shall be natural or artificial barriers that prevent aquatic animals from entering each farm in a compartment from the surrounding watercourses. 3.4.The compartment shall, where appropriate, be protected against flooding and infiltration of water from the surrounding watercourses. 3.5.The compartment shall comply, mutatis mutandis, with the requirements laid down in Part I.2. 3.6.A compartment shall be subject to additional measures imposed by the competent authority, when considered necessary to prevent the introduction of diseases. Such measures may include the establishment of additional protection against the intrusion of possible pathogen carriers or vectors. 3.7.Implementing measures concerning point 3.2(a) shall be laid down in accordance with the procedure referred to in Article 62(2).

• 4.Special provisions for individual farms which commence or recommence their activities 4.1.A new farm, which meets the requirements referred to in points 3.1(a) and 3.2 to 3.6, but which commences its activities with aquaculture animals from a compartment declared disease-free may be considered disease-free without undergoing the sampling required for approval. 4.2.A farm which recommences its activities after a break with aquaculture animals from a compartment declared disease-free, and meets the requirements referred to in points 3.1(a) and 3.2 to 3.6, may be considered disease-free without undergoing the sampling required for approval, provided that: (a)the health history of the farm over the last four years of its operation is known to the competent authority; however, if the farm concerned has been in operation for less than four years, the actual period in which it has been in operation will be taken into account; (b)the farm has not been subject to animal-health measures in respect of the diseases listed in Part II of Annex IV and there have been no antecedents of those diseases on the farm; (c)prior to the introduction of the aquaculture animals, eggs or gametes, the farm is cleaned and disinfected, followed, as necessary, by a period of fallowing.

ANNEX VI

Functions and duties of laboratories

PART I

Community reference laboratories

• 1.In order to be designated as a Community reference laboratory in accordance with Article 55, laboratories shall fulfil the following requirements. They must: (a)have suitably qualified staff with adequate training in diagnostic and analytical techniques applied in their area of competence, including trained personnel available for emergency situations occurring within the Community; (b)possess the equipment and products needed to carry out the tasks assigned to them; (c)have an appropriate administrative infrastructure; (d)ensure that their staff respect the confidential nature of certain subjects, results or communications; (e)have sufficient knowledge of international standards and practices; (f)have available, as appropriate, an updated list of available reference substances and reagents and an updated list of manufacturers and suppliers of such substances and reagents; (g)take account of research activities at national and Community level.

• 2.However, the Commission may designate only laboratories that operate and are assessed and accredited in accordance with the following European Standards, account being taken of the criteria for different testing methods laid down in this Directive: (a)EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’; (b)EN 45002 on ‘General criteria for the assessment of testing laboratories’; (c)EN 45003 on ‘Calibration and testing laboratory accreditation system — General requirements for operation and recognition’.

• 3.The accreditation and assessment of testing laboratories referred to in paragraph 2 may relate to individual tests or groups of tests.

• 4.For one or more of the diseases under their responsibility, the Community reference laboratories may take advantage of the skills and capacity of laboratories in other Member States or EFTA Member States, provided that the laboratories concerned comply with the requirements laid down in points 1, 2 and 3 of this Annex. Any intention to take advantage of such cooperation shall be part of the information provided as a basis for the designation in accordance with Article 55(1). However, the Community reference laboratory shall remain the contact point for the National reference laboratories in the Member States, and for the Commission.

• 5.The Community reference laboratories shall: (a)coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing the disease concerned, specifically by: (i)typing, storing and, where appropriate, supplying strains of the pathogen of the relevant disease to facilitate the diagnostic service in the Community, (ii)supplying standard sera and other reference reagents to the national reference laboratories in order to standardise the tests and reagents used in each Member State, where serological tests are required, (iii)organising periodic comparative tests (ring tests) of diagnostic procedures at Community level with the national reference laboratories designated by the Member States, in order to provide information on the methods of diagnosis used and the results of tests carried out in the Community; (iv)retaining expertise on the relevant disease pathogen and other pertinent pathogens to enable rapid differential diagnosis; (b)assist actively in the diagnosis of outbreaks of the relevant disease in Member States by receiving pathogen isolates for confirmatory diagnosis, characterisation and epizootic studies; (c)facilitate the training or retraining of experts in laboratory diagnosis with a view to harmonising diagnostic techniques throughout the Community; (d)collaborate, as regards methods of diagnosing animal diseases falling within their areas of competence, with the competent laboratories in third countries where those diseases are prevalent; (e)collaborate with the relevant OIE reference laboratories with regard to exotic diseases listed in Part II of Annex IV under their responsibility; (f)collate and forward information on exotic and endemic diseases, that are potentially emerging in Community aquaculture.

PART II

National reference laboratories

• 1.The national reference laboratories designated pursuant to Article 56 shall be responsible for coordinating the diagnostic standards and methods within their field of responsibility in the Member State concerned. These national reference laboratories shall: (a)undertake to notify, without delay, the competent authority whenever the laboratory is aware of a suspicion of any of the diseases referred to in Annex IV; (b)coordinate, in consultation with the relevant Community reference laboratory, the methods employed in Member States for diagnosing the diseases concerned under their responsibility; (c)assist actively in the diagnosis of outbreaks of the relevant disease by receiving pathogen isolates for confirmatory diagnosis, characterisation and epizootic studies; (d)facilitate the training or retraining of experts in laboratory diagnosis with a view to harmonising diagnostic techniques throughout the Member State; (e)ensure confirmation of positive results of all outbreaks of exotic diseases listed in Part II of Annex IV, and of primary outbreaks of non-exotic diseases listed in that Annex; (f)organise periodic comparative tests (ring tests) of diagnostic procedures at national level with the laboratories designated by the Member States in accordance with Article 57, in order to provide information on the methods of diagnosis used and the results of tests carried out in the Member State; (g)cooperate with the Community reference laboratory referred to in Article 55 and participate in the comparative tests organised by the Community reference laboratories; (h)ensure a regular and open dialogue with their national competent authorities; (i)operate and be assessed and accredited in accordance with the following European Standards account being taken of the criteria for different testing methods laid down in this Directive: (i)EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’; (ii)EN 45002 on ‘General criteria for the assessment of testing laboratories’; (iii)EN 45003 on ‘Calibration and testing laboratory accreditation system — General requirements for operation and recognition’.

• 2.The accreditation and assessment of testing laboratories referred to in point 1(i) may relate to individual tests or groups of tests.

• 3.The Member States may designate national reference laboratories which do not comply with the requirements referred to in point 1(i)(i) of this Part, where operation under EN ISO/IEC 17025 is practically difficult, provided the laboratory operates under quality assurance in line with the guidelines in ISO 9001.

• 4.Member States may authorise a national reference laboratory situated on their territory to take advantage of the skills and capacity of other laboratories designated pursuant to Article 57, for one or more of the diseases under their responsibility, provided that these laboratories comply with the relevant requirements of this Part. However, the national reference laboratory shall remain the contact point for the central competent authority of the Member State, and for the Community reference laboratory.

PART III

Designated laboratories in Member States