2008/896/EC: Commission Decision of 20 November 2008 on guidelines for the purpose of the risk-based animal health surveillance schemes provided for in Council Directive 2006/88/EC (notified under document number C(2008) 6787) (Text with EEA relevance)
Date: 2008-11-20
Institutions: European Commission
Subjects: customs tariff, import, maize, rye, sorghum, wheat

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(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 20 November 2008

on guidelines for the purpose of the risk-based animal health surveillance schemes provided for in
Council Directive 2006/88/EC

(notified under document number C(2008) 6787)

(Text with EEA relevance)

(2008/896/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

guidelines
to be drawn up in accordance with the
procedure referred to in Article 10(4) of that Directive.

Having regard to the Treaty
Community,

establishing the European

Having regard to 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
and in particular
Article 10(4) thereof,

animals (1),

in aquatic

Whereas:

(1)

(2)

Directive 2006/88/EC lays down minimum control
measures to be applied in the event of suspicion of, or
an outbreak of certain diseases in aquatic animals.
In
addition, Part
II of Annex IV to that Directive lists
certain exotic and non-exotic diseases.

Article 10(1) of Directive 2006/88/EC provides that
Member States are to ensure that a risk-based animal
health surveillance scheme is applied in all farms and
mollusc farming areas, as appropriate for the type of
production. Such schemes are to take account of

(1) OJ L 328, 24.11.2006, p. 14.

(3)

(4)

Pursuant to Directive 2006/88/EC, the aim of the animal
health surveillance schemes is to detect any increased
farms and mollusc farming areas, as
mortality in all
appropriate for the type of production, as well as to
detect the diseases listed in Part II of Annex IV to that
in farms and mollusc farming areas where
Directive,
species susceptible to those diseases are present.
In
addition, pursuant to Part B of Annex III to Directive
2006/88/EC,
inspections carried out as part of such
schemes also aim at advising the aquaculture production
business operators on aquatic animal health issues, and
where needed, at undertaking the necessary veterinary
measures.

Due to the diversity of the aquaculture industry in the
Community,
the risk-based animal health surveillance
schemes need to be adapted to the structure of that
industry and to the animal health situation in each
Member State. The guidelines to be taken into account
by the Member States for the purpose of such schemes
should therefore be limited to giving general guidance.

(5)

It is therefore appropriate to lay down the guidelines to
be taken into account for the purpose of the risk-based
animal health surveillance schemes in this Decision.

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(6)

The measures
accordance with
Committee on the Food Chain and Animal Health,

laid down in this Decision are

opinion

in
Standing

the

the

of

HAS ADOPTED THIS DECISION:

Article 1

The guidelines to be taken into account for the purpose of the
risk-based animal health surveillance schemes, provided for in
Article 10(1) of Directive 2006/88/EC, are set out in the Annex
to this Decision.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 20 November 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

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ANNEX

GUIDELINES TO BE TAKEN INTO ACCOUNT FOR THE PURPOSE OF THE RISK-BASED ANIMAL HEALTH
SURVEILLANCE SCHEMES PROVIDED FOR IN ARTICLE 10(1) OF DIRECTIVE 2006/88/EC

1.

Purpose of these guidelines

The purpose of these guidelines is to provide Member States with guidance on the risk-based animal health
surveillance schemes provided for in Article 10(1) of Directive 2006/88/EC (the risk-based animal health
surveillance schemes).

2.

Content of inspections

2.1.

CHECKING OF RECORDS AND CLINICAL EXAMINATIONS

Each inspection of a farm or mollusc farming area should consist of an analysis of the records provided for in
Article 8 of Directive 2006/88/EC, with particular attention being paid to the mortality records, in order to enable
an assessment to be made of the health status track-record of the farm or mollusc farming area.

A representative selection of all epidemiological units should be inspected.

If available, a representative selection of recently dead and moribund aquaculture animals should be examined
clinically, both externally and internally, for major pathological changes. That examination should, in particular,
aim at detecting any infection with a disease listed in Part II of Annex IV to Directive 2006/88/EC (a listed disease).

If the outcome of that examination leads to any suspicion of the presence of such a disease, the aquaculture
animals in the farm or mollusc farming area should be subjected to laboratory examination.

Detailed rules on actions to be taken in cases of suspicion and/or confirmation of a listed disease are laid down in
Chapter V of Directive 2006/88/EC.

2.2.

SAMPLING AND LABORATORY EXAMINATION

The taking of samples for laboratory examination is not necessary in all cases. In determining whether sampling is
necessary, the information gained when checking the records of the farm or mollusc farming area and when
inspecting the aquaculture animals, as well as other relevant information should be taken into account.

3.

Choosing between the competent authority, private veterinarians and other qualified aquatic animal
health service for carrying out the inspections

Member States should determine whether the inspections which are part of
the risk-based animal health
surveillance schemes are to be carried out by the competent authority or whether private veterinarians or other
qualified aquatic animal health services should also be permitted to carry them out.

4.

Frequency of inspections

Part B of Annex III to Directive 2006/88/EC sets out recommended frequencies for inspections of farms and
mollusc farming areas. Those frequencies are determined by two factors:

(a) the health status of the concerned Member State, zone or compartment in relation to non-exotic diseases listed

in Part II of Annex IV to that Directive (listed non-exotic diseases);

(b) the risk level of the farm or mollusc farming area in relation to the contracting and spreading of diseases.

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5.

The health status of the farms and mollusc farming areas

Part B of Annex III to Directive 2006/88/EC differentiates between the following health status categories:

Category I

(a) Declared disease-free in accordance with Article 49(1)(a) or (b) or Article 50(1)(a) or (b) of

Directive 2006/88/EC. Such status is determined by the fact that:

(i) none of the species susceptible to the disease(s) in question is present in the Member State,
zone or compartment, and where relevant in the water source of that Member State, zone
or compartment; or

(ii) the pathogen is known not

to be able to survive in the Member State, zone or
compartment, and where relevant in the water source of that Member State, zone or
compartment.

(b) Declared disease-free in accordance with Article 49(1)(c) or Article 50(1)(c) of Directive
2006/88/EC. The status is based on targeted surveillance complying with the conditions laid
down in Part II of Annex V to Directive 2006/88/EC.

Category II

Not declared disease-free but subject to a surveillance programme approved in accordance with
Article 44(1) of Directive 2006/88/EC.

Category III

Not known to be infected but not subject to surveillance programme for achieving disease-free
status.

Category IV

Known to be infected but subject to an eradication programme approved in accordance with
Article 44(2) of Directive 2006/88/EC.

Category V

Known to be infected. Subject to minimum control measures as provided for in Chapter V of
Directive 2006/88/EC.

Where appropriate, inspections carried out in the framework of a risk-based animal health surveillance scheme
may be combined with:

(a)

inspections carried out in the framework of surveillance or eradication programmes approved in accordance
with Directive 2006/88/EC (for zones or compartments falling within categories II or IV);

(b) any surveillance carried out to maintain the disease-free status (for zones or compartments falling within
category I – declared disease-free in accordance with Article 49(1)(a) or (b) or Article 50(1)(a) or (b) of
Directive 2006/88/EC);

(c) any surveillance carried out as part of control measures pursuant to Chapter V of Directive 2006/88/EC (for

zones or compartments falling within category V).

When drawing up risk-based animal health surveillance schemes, Member States should take account of the
following:

(a)

for farms or mollusc farming areas situated in areas which have a health status falling within categories II and
IV, the inspection frequency required by surveillance or eradication programmes approved in accordance with
Directive 2006/88/EC is higher than the frequency recommended by Part B of Annex III to that Directive; it is
therefore not necessary for Member States to lay down specific requirements concerning the inspection
frequency for farms and mollusc farming areas situated in areas covered by such programmes;

(b) the need for Member States to lay down specific requirements on the frequency of inspections under a risk-
based animal health surveillance scheme exists mainly for farms or mollusc farming areas situated in areas
which have a health status falling within categories I, III and V, depending on the particular circumstances and
national measures;

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(c) consideration should be given to the fact that a farm or mollusc farming area may have a different health
status in relation to different diseases; this may be the case for farms and mollusc farming areas keeping species
which are susceptible to more than one of the listed non-exotic diseases (1).

6.

The determination of the risk level of farms and mollusc farming areas

6.1.

INTRODUCTION

The risk level of farms and mollusc farming areas varies, not only between areas having a different health status,
but also within areas with the same health status (2).

Section 6.2 gives guidance on the risk factors to be taken into account when determining the risk level of farms
and mollusc farming areas.

Section 6.3 sets out a model which may be used for the classification of farms and mollusc farming areas as
having a high, medium or low risk level. Member States may use other models to determine the risk level of farms
and mollusc farming areas, if such models are considered more suited in a given situation.

These guidelines do not provide information concerning the way Member States should apply the model set out in
Section 6.3. Member States may:

(a) apply that model to each individual farm and mollusc farming area to determine its individual risk level; or

(b) use the model to catalogue the different types of farms and mollusc farming areas on their territory and, on
that basis, define which categories of farms and mollusc farming areas should be regarded as having a low,
medium or high risk level.

6.2.

RISK FACTORS

A wide range of factors are relevant in determining the risk level of a farm or mollusc farming area. Such factors
may include, but are not limited to the following:

(a)

the direct spread of disease via water;

(b) the movements of aquaculture animals;

(c)

the type of production;

(d) the species of aquaculture animals kept;

(e)

the bio-security system, including staff competence and training;

(f)

the density of farms and mollusc farming areas and processing establishments in the area around the farm or
mollusc farming area concerned;

(g) the proximity of farms and mollusc farming areas having lower health status to the farm or mollusc farming

area concerned;

(h) the health status track record of the farm or mollusc farming area concerned and of other farms and mollusc

farming areas situated in the area;

(1) For example, a rainbow trout farm might be free of infectious salmon anaemia (Category I), be under Category II (under an approved
surveillance programme) for viral haemorrhagic septicaemia and have unknown status as regards infectious haematopoietic necrosis
(Category III).

(2) For example, a farm which is declared free of a listed non-exotic disease, in general presents a low risk of spreading such a disease.
However, a farm producing its own juveniles presents a much lower risk than a farm buying all its juveniles from one or more different
suppliers.

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(i)

the presence of disease pathogens in wild aquatic animals in the area around the farm or mollusc farming area
concerned;

(j)

the risk posed by human activities in the proximity of the farm or mollusc farming area concerned (1);

(k) predators or birds with access to the farm or mollusc farming area concerned.

The use of a complex system for the assessment of risk levels of farms and mollusc farming areas, taking into
account all relevant risk factors, may provide a precise classification of farms and mollusc farming areas according
to their risk level. However, such a system may also be time-consuming and not cost-efficient. In addition, the
weighting of different factors in order to asses the overall risk is a complicated operation.

In view of the difficulties of using a complex system to classify farms and mollusc farming areas according to their
risk level, it is appropriate in most cases to focus on the following risk factors:

(a) the direct spread of disease via water and due to the geographical proximity of the farms and mollusc farming

areas;

(b) the movements of aquaculture animals.

Those two risk factors are relevant regardless of the type of production, of the species of aquaculture animals kept
on the farm or mollusc farming area and of the diseases concerned.

6.3. MODEL TO DETERMINE THE RISK LEVEL OF FARMS AND MOLLUSC FARMING AREAS

This model to determine the risk level (high/medium/low) of farms or mollusc farming areas comprises three steps:

Step I: Approximation of the likelihood of the contraction of disease on the farm or in the mollusc farming area;

Step II: Approximation of the likelihood of the spread of disease from the farm or mollusc farming area;

Step III: Combining the estimates of risk levels resulting from steps I and II.

Approximation of the likelihood of the contraction of disease on the farm or in the mollusc farming area

Step I

Likelihood of the contraction of disease via
water and due to the geographical proximity
of farms and mollusc farming areas

Likelihood of the contraction of disease
through movements of aquaculture
animals

High

High

Low

Low

High

Low

High

Low

Level of risk

High

Medium

Medium

Low

(1) Such as transport routes, ports (ballast water), angling.

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Approximation of the likelihood of the spread of disease from the farm or mollusc farming area

Step II

Likelihood of the spread of disease via water
and due to the geographical proximity of
farms and mollusc farming areas

Likelihood of the spread of disease
through movements of aquaculture
animals

High

High

Low

Low

High

Low

High

Low

Step III

Level of risk

High

Medium

Medium

Low

Combining the estimates of risk levels resulting from steps I and II

Step I. Likelihood of the
contraction of disease

High

Medium

Low

M

L

L

H

M

L

H

H

M

Low

Medium

High

Step II. Likelihood of the spread of disease

6.4.

THE RISK LEVEL FOR CERTAIN FARMS AND MOLLUSC FARMING AREAS FALLING WITHIN HEALTH STATUS
CATEGORY I

Farms and mollusc farming areas which do not keep species susceptible to any of the listed non-exotic diseases, or
where the pathogen in question is known not to be able to survive in the Member State, zone or compartment
and, where relevant, in its water source may, pursuant to Part B of Annex III to Directive 2006/88/EC, all be
regarded as having a low risk level. It is therefore not necessary, in principle, for the risk-based animal health
surveillance scheme to include different frequencies of inspections.

However, those farms and mollusc farming areas may have different levels of risk as regards the contraction and
spread of listed non-exotic diseases or emerging diseases. Member States may therefore classify those farms and
mollusc farming areas according to their risk level and thus differentiate their level of surveillance and inspection.
In doing so, Member States may also take into account the need to optimise the use of resources.

6.5. APPROXIMATION OF THE LIKELIHOOD OF THE CONTRACTION AND THE SPREAD OF DISEASE VIA WATER

AND DUE TO GEOGRAPHICAL PROXIMITY OF FARMS AND MOLLUSC FARMING AREAS

6.5.1. Introduction

Farms and mollusc farming areas have a low risk of the contraction and the spread of disease if the sources and
outlet of water or the water environment in which the farm or mollusc farming area is located can be regarded as
giving a certain level of protection from the introduction and spread of pathogens of diseases. The risk of the
contraction and spread of a disease on and from a farm or a mollusc farming area via water and due to
geographical proximity of the farms and mollusc farming areas varies greatly (1).

The model set out in Section 6.3 only distinguishes between high and low likelihoods for the spread of diseases via
water and due to the geographical proximity of farms and mollusc farming areas.

This section provides examples of situations that may be regarded as presenting a low likelihood for the
contraction and spread of disease via water and due to the geographical proximity of
farms and mollusc
farming areas.

(1) For example, from a covered recirculation system with water sourced from a borehole and where the outlet water is disinfected (very

low risk), to a sea cage farm with a large number of farms in its proximity (very high risk).

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The list of examples provided in this section is not exhaustive. It should therefore not be concluded that farms and
mollusc farming areas not covered by any of these examples present a high likelihood for the contraction or
spread of diseases.

6.5.2. Examples of low risk for the contraction of disease via water and due to the geographical proximity of farms and mollusc

farming areas:

(a) farms and mollusc farming areas supplied with water through a borehole or spring;

(b) farms and mollusc farming areas supplied with water which is disinfected or treated in order to prevent the

introduction of pathogens;

(c) farms and mollusc farming areas supplied with water from any other water source which:

(i) are not connected to farms or mollusc farming areas, or processing establishments, keeping or processing
species susceptible to the same diseases as the species kept in the farm or mollusc farming area concerned;

(ii) do not contain wild aquatic animals of susceptible species;

(d) inland water basins, including ponds and lakes, which are isolated from other water sources; in determining
whether the water basin should be regarded as isolated, consideration should be given to seasonal changes such
as the possibility of contact with other water sources through flooding;

(e) coastal farms and mollusc farming areas which are protected by a safe distance from other farms and mollusc
farming areas and from processing establishments keeping or processing species susceptible to the same
diseases as the species kept in the farm or mollusc farming areas concerned; what should constitute a safe
distance needs to be determined by the competent authority, taking into account factors such as the ability of
the relevant pathogens to survive in open waters, the water currents and the length of tidal excursions.

6.5.3. Examples of low risk for the spread of disease via water and due to the geographical proximity of farms and mollusc farming

areas:

(a) farms and mollusc farming areas with no discharge into natural waterways (1);

(b) farms and mollusc farming areas which disinfect, or in any other manner treat the water discharge, to prevent

the spread of pathogens;

(c) farms and mollusc farming areas which discharge their water into public sewage systems provided that the
if the sewage water is
public sewage system contains a form of treatment of the sewage water; however,
discharged into natural water ways without any treatment, such farms and mollusc farming areas should not be
regarded as constituting a low likelihood;

(d) farms and mollusc farming areas with no discharge into waters with aquaculture or wild aquatic animals of

species susceptible to the relevant listed disease(s);

(e)

inland water basins, including ponds and lakes, which are isolated from other water sources; in determining
whether the water basin should be regarded as isolated, consideration should be given to seasonal changes such
as the possibility of any contact with other water sources through flooding;

(f) coastal farms and mollusc farming areas which are protected by a safe distance from other farms and mollusc
farming areas keeping species which are susceptible to the same diseases as the species kept in the farm or
mollusc farming areas concerned; what should constitute a safe distance needs to be determined by the
competent authority taking into account factors such as the ability of the relevant pathogens to survive in
open waters, the water currents, and the length of tidal excursions.

(1) For example, inland farms which lead their outlet water into the ground or on the fields.

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6.6. APPROXIMATION OF THE LIKELIHOOD OF THE CONTRACTION AND SPREAD OF DISEASE THROUGH

MOVEMENTS OF AQUACULTURE ANIMALS

6.6.1. Introduction

Movements of live aquaculture animals into and out of farms and mollusc farming areas are a very important
means for the transmission of disease.

In evaluating that factor, the following should be assessed:

(a) the place of origin of the aquaculture animals;

(b) the number of aquaculture animals supplied to the farm or mollusc farming area;

(c)

the number of different suppliers of aquaculture animals;

(d) the frequency of movements of aquaculture animals into and out of farms and mollusc farming areas.

The model set out in Section 6.3 only recommends that farms be grouped together according to their high or low
risk of the contraction and the spread of disease through movements of aquaculture animals. For the purposes of
that model, it is therefore sufficient only to take account of whether the farm or mollusc farming area is supplied
by or delivers live aquaculture animals (including eggs), and the place of origin of those animals.

This section provides examples of situations that may be regarded as presenting a low risk for the contraction and
spread of disease through movements of aquaculture animals.

The list of examples provided in this section is not exhaustive. It should therefore not be concluded that farms and
mollusc farming areas not covered by any of these examples present a high risk of the contraction and the spread
of disease.

6.6.2. Examples of low likelihood of the contraction of disease through the supply of aquaculture animals to farms and mollusc

farming areas:

(a) farms and mollusc farming areas which are self sufficient with eggs or juveniles (1);

(b) cases where the aquaculture animals are supplied only from disease-free zones or compartments. For farms in
health status Categories III and V there is no requirement under existing Community legislation that aqua­
culture animals be supplied from disease-free zones or compartments, and the fact that the farm chooses to
obtain its animals from a disease-free zone or compartment distinguishes the farm from other farms in the
same health status category. Farms in health status Category I should only receive animals from a disease-free
place of origin. For these farms, it should therefore be required instead that the animals are either supplied
from the same disease-free area or that the farm only has a limited number of suppliers of aquaculture animals;

(c) cases where wild aquatic animals, released from quarantine and intended for further farming, are supplied;

(d) cases where disinfected eggs are supplied; this is relevant only where scientific evidence or practical experience
has shown that disinfection effectively reduces the risk of disease transmission to an acceptable level as regards
the listed diseases to which the species on the farm or mollusc farming area are susceptible.

6.6.3. Examples of low likelihood of the spread of disease through the delivery of aquaculture animals to farms or mollusc farming

areas:

(a) farms and mollusc farming areas which do not deliver any animals for further farming, relaying or restocking;

(b) fish farms which only deliver disinfected eggs; this is only relevant where scientific evidence or practical
experience has shown that disinfection effectively reduces the risk of disease transmission to an acceptable
level as regards the listed exotic or non-exotic diseases to which the species on the farm are susceptible.

(1) This could be the case for fish farms keeping their own brood stock and for mollusc farms and mollusc farming areas where the

production is based on natural recruitment of spat.