WRITTEN QUESTION E-2744/02 by Ian Hudghton (Verts/ALE) to the Commission. Infectious Hematopoietic Necrosis.
Date: 2002-09-30
Institutions: European Parliament, Provisional data
Subjects: fish disease, medical research, research project, veterinary legislation, veterinary medicine

C 52 E/208

Official Journal of the European Union

EN

6.3.2003

Answer given by Mr Byrne on behalf of the Commission

(28 October 2002)

The Commission is still discussing internally a draft for a Commission Directive amending the annexes of
the seed marketing Directives in particular in respect of purity criteria, by including thresholds to allow for
the adventitious or technically unavoidable presence of genetically modified seeds in seed lots of non-
genetically modified varieties. The proposed thresholds for authorised genetically modified organisms
(GMOs) are 0,3, 0,5 and 0,7 %.

The Commission considers it to be of utmost importance that thresholds be established in the seed
legislation in order to take into account the reality which is that traces of genetically modified seeds can be
found in non-genetically modified seed lots, as other impurities are found and are regulated for. A legal
text is thus needed as soon as possible to address such an adventitious presence in seeds in a harmonised
way.

When the internal discussions within the Commission will be completed, the opportunity will be given to
Member States and also, as the Member of the Commission in charge of Health and Consumer Protection
has already announced, to the Parliament, to scrutinise the proposal.

(2003/C 52 E/231)

WRITTEN QUESTION E-2744/02

by Ian Hudghton (Verts/ALE) to the Commission

(30 September 2002)

Subject: Infectious Hematopoietic Necrosis

Can the Commission indicate whether there have been any cases of Infectious Hematopoietic Necrosis
(IHN) within the EU and, if so, when and how many? What research has been carried out in relation to
this disease? What measures are being taken against IHN, is it similar to ISA, and in what fish species does
it occur?

Answer given by Mr Byrne on behalf of the Commission

(25 October 2002)

The disease situation as regards IHN within the Community is variable, as IHN is endemic in certain parts
and absent in other areas. Cases are regularly occurring in particular in Germany, France and Italy. During
2001, IHN was officially reported to the Commission from Germany (eleven cases), France (eight cases),
Italy (seven cases) and Austria (one case).

Several projects and important research have been carried out in relation to IHN.

Projects, of which some have been financed or co-financed by Community funds, that can be mentioned
are:

(cid:1) epidemiological survey, in the early 1990s, to assess the rate of IHN infection in the Community (six

Member States took part);

(cid:1) experimental study of interaction between other fish viruses and IHN virus (IHNV);

(cid:1) experimental study of the pathogenicity of different IHNV isolates for young rainbow trout;

(cid:1) demonstration of the role of Salmo trutta as an asymptomatic carrier of the IHNV;

(cid:1) standardisation of serological techniques in order to be able to detect antibodies against IHNV in

farmed and wild fish.

6.3.2003

EN

Official Journal of the European Union

C 52 E/209

Control measures to be taken against IHN, and other diseases included in list II of Annex A to Council
Directive 91/67/EEC of 28 January 1991, concerning the animal health conditions governing the placing
on the market of aquaculture animals and products (1), are laid down in particular in Council Directive 93/
53/EEC of 24 June 1993,
introducing minimum Community measures for the control of certain fish
diseases (2). In principle, this Directive imposes that in case of IHN being suspected or confirmed within
any area of the Community, certain movement restrictions must be applied and investigations carried out.
The legislation also gives tools for Community approval of programmes and status for zones and farms
with regard to IHN. Specific requirements, as regards sampling, movements and eradication measures
apply to such zones and farms.

The entire territory of Denmark, Ireland, Sweden and the United Kingdom, as well as several zones and
farms in Germany, Spain, France and Italy have approved status for IHN (3). In other zones and farms,
programmes (cid:1) with a view to achieve approved status (cid:1) are applied (4).

As regards infectious salmon anemia (ISA), it is included in list I of the above-mentioned annex. The rules
applying to list I diseases are more stringent than those for list II diseases. Obligatory control measures that
apply when ISA is suspected or confirmed throughout Europe are laid down in Directive 93/53/EEC.

The species listed in Directive 91/67/EEC as susceptible to IHN are salmonid species and Pike fry (Esox
lucius).

(1) OJ L 46, 19.2.1991.
(2) OJ L 175, 19.7.1993.
(3) Commission Decision 2002/308/EC of 22 April 2002, OJ L 106, 23.4.2002.
(4) Commission Decision 2002/304/EC of 19 April 2002, OJ L 104, 20.4.2002.

(2003/C 52 E/232)

WRITTEN QUESTION E-2745/02

by Ian Hudghton (Verts/ALE) to the Commission

(30 September 2002)

Subject: Vaccine to combat infectious Salmon Anaemia

Can the Commission confirm recent reports that an application for approval of a vaccine to combat
Infectious Salmon Anaemia has been submitted to the EU?

If so, can the Commission further indicate when it expects to take a decision on this crucial vaccine and
what the details are of the vaccine, which is reputed to provide a protection level of more than 90 per
cent? Can the Commission confirm that this is being considered as a matter of urgency because of the
severe adverse impact that ISA has had on salmon farmers and of the urgent need for a vaccine?

Upon approval, can the Commission indicate whether funding will be made available to salmon farmers in
order to allow the vaccine to be properly distributed and to ensure that ISA is eradicated?

Answer given by Mr Byrne on behalf of the Commission

(24 October 2002)

legislation on granting of marketing authorisations at Community level (1),

the
Due to the present
Commission is not in the position to give any information regarding possible applications submitted to the
European Agency for the Evaluation of Medicinal Products (EMEA) since such documents are regarded as
falling under the intellectual property rights of the company. Equally the Commission cannot take a
position on any possible future marketing authorisation on Community level for a veterinary medicinal
product including vaccines.