51996PC0279(01)

Proposal for a Council Directive amending, with regard to Gyrodactylus salaris, Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and products

(96/C 242/08)

(Text with EEA relevance)

COM(96) 279 final - 96/0157(CNS)

(Submitted by the Commission on 20 June 1996)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,

Having regard to the proposal of the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the Economic and Social Committee,

Whereas Gyrodactylus salaris is a fresh water parasite of salmonids which is capable of causing serious mortalities in Salmo salar (Atlantic salmon);

Whereas the disease has a serious economic impact would it occur in regions containing wild riverine stocks of Salmo salar previously free of the disease;

Whereas experience has shown that the disease can spread from infected regions through commercial transfers of salmon and other salmonids;

Whereas it is therefore necessary to prevent the spread of the disease from regions in the Community where the absence of the disease can not be certified, towards regions with a documented history of absence of the parasite;

Whereas prevention of spread of the disease can be achieved under the procedures applicable to diseases of list II of Annex A of 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), as last amended by Directive 95/22/EC (2);

Whereas Salmo salar being the species most susceptible to Gyrodactylus salaris, the measures must apply to that species;

Whereas however the parasite can be transferred by other salmonid species and measures must therefore be extended to such species;

Whereas the criteria to certify the absence of Gyrodactylus salaris must be established;

Whereas it is necessary to ensure that the placing on the market of fish from a non approved zone does not prejudice the health status of non infected farms situated in a non approved zone; whereas this can be achieved through certification of consignments;

Whereas it is necessary to adapt the sampling and testing requirements for fish diseases to international standards,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 91/67/EEC is amended as follows:

1. in Article 7:

(a) the introductory sentence of paragraph 1 is replaced by the following text:

'1. The placing on the market of live fish belonging to the species susceptible to IHN and VHS as listed in Annex A, column 2, list II, their eggs and gametes, shall be subject to the following additional guarantees:`;

(b) the following paragraph is added to paragraph 1:

'(c) where they are to be introduced into a non approved farm situated in a non approved zone, they must be accompanied, in accordance with Article 11, by a movement document corresponding to a model to be drawn up in accordance with the procedure laid down in Article 26, certifying that:

- they comply with the requirements of article 3 and come from a farm which is not infected with IHN or VHS, or

- they come from an approved zone with regard to IHN and/or VHS, or

- they come from an approved farm situated in a non approved zone with regard to IHN and/or VHS.`;

(c) paragraph 2 is replaced by the following paragraphs:

'2. The placing on the market of live fish belonging to the species susceptible to gyrodactylosis as listed in Annex A, column 2, list II shall be subject to the following additional guarantees:

(a) where they are to be introduced into an approved zone with regard to Gyrodactylus salaris, they must, in acordance with Article 11, be accompanied by a movement document corresponding to a model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone with regard to Gyrodactylus salaris;

(b) where they are to be introduced into a farm which, although not situated in an approved zone, fulfils the conditions set out in Annex CI, they must in accordance with Article 11, be accompanied by a movement document corresponding to a model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone or from an approved farm with regard to Gyrodactylus salaris.

3. The Commission may in accordance with the procedure laid down in Article 26, adapt or delete the additional guarantees referred to in paragraphs 1 and 2, depending on the evolution of the animal health situation in the Community or in accordance with scientific evolution.`;

2. in Article 9, the first sentence of point 1 is replaced by the following text:

'Fish susceptible to IHN and VHS must be slaughtered and eviscerated prior to dispatch.`;

3. in Annex A:

(a) the following is added to columns 1 and 2 of list II under the heading 'fish`:

>TABLE>

(b) in list III, under 'Fish`, the words 'Gyrodactylus salaris` in column 1 are deleted;

4. in Annex B, point I, B is replaced by the following text:

'B. Grant of approval

1. In order to obtain approval status with regard to IHN and/or VHS, a continental zone must meet the following requirements:

(a) all fish are free for at least four years from any clinical or other sign of IHN and/or VHS.

(b) all farms in the continental zone are placed under the supervision of the official services. Two health inspections per year for two years must have been carried out.

The health inspections must have been carried out at the time of the year when the water temperature favours the development of these diseases. The health inspection must at least consist of:

- an inspection of fish showing abnormalities,

- the taking of samples in accordance with a programme established under the procedure provided for in Article 15, which are to be sent as quickly as possible to an approved laboratory to be tested for the pathogens in question.

However, zones having a historical record of absence of IHN and/or VHS, may obtain approved status if:

(i) their geographical situation does not permit easy introduction of disease;

(ii) an official disease control system has been in place for an extended period of time of at least ten years, during which:

- there has been regular monitoring of all farms,

- a disease notification system has been applied,

- no case of disease has been reported,

- under the rules in force, only fish, eggs or gametes from non-infected zones or farms subject to official checks and presenting equivalent health gurantees, were able to be introduced into the zone.

The period of 10 years referred to above may be reduced to five years as a result of the testing carried out by the official service of the requesting Member State, provided that, in addition to the requirements referred to in the first subparagraph, the regular monitoring of all farms referred to above has included at lest two health inspections per year involving at least:

- an inspection of fish showing abnormalities,

- a taking of samples of at least 30 fish at each visit.

Member States wishing to benefit from the provisions relating to historical records must submit their request no later than 31 December 1996.

(c) 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 four years, in accordance with paragraph b;

(d) the laboratory examinations of fish taken during health inspections have produced negative results as regards the pathogens in question.

(e) Where a Member State has requested approval for a water catchment area originating in a neighbouring Member State, or common to two Member States, the following provisions shall apply:

- the two Member States concerned shall simultaneously submit a request for approval in accordance with the procedures laid down in Articles 5 or 10,

- the Commission, in accordance with the procedure laid down in Article 26, after examining and checking the request and evaluating the health situation, shall if need be, lay down any other provisions necessary for granting such approval.

The Member States, in accordance with Directive 89/608/EEC (¹) shall grant each other mutual assistance for the application of this Directive, and in particular of this paragraph;

(¹) OJ No L 351, 2. 12. 1989, p. 34.

2. In order to obtain approved status with regard to Gyrodactylus salaris, a continental zone must meet approval conditions established in accordance with the procedure provided for in Article 26.

However, where a Member States considers that its territory or part of its territory is free from Gyrodactylus salaris, it may submit to the Commission appropriate justifications, setting out in particular:

(i) the results of surveillance testing carried out over an extended period of time, and based on the identification of the parasite and the fact that the disease is compulsorily notifiable to the official service,

(ii) the period over which the surveillance was carried out.

Based on the above information, and in accordance with the procedure provided for in Article 26, it may be decided to grant the approved status to the territory or a part thereof of the applying Member State.`

5. in Annex B I, C point 2 is replaced by the following text:

'2. (a) each farm must undergo, with regard to IHN and/or VHS, two health inspections annually in accordance with point B, 1 (b); however, samples will be taken by rotation in 50 % of the fish farms in the continental zone each year;

(b) the surveillance programme for maintenance of approved status with regard to gyrodactylosis is established in accordance with the procedure provided for in Article 26.`;

6. in Annex B, II, paragraph B is replaced by the following text:

'B. Grant of approval

In order to obtain approved status with regard to IHN and/or VHS, a coastal zone for fish must meet the requirements laid down for continental zones referred to in point IB, first paragraph.

Where necessary, the requirements for obtaining the approved status with regard to gyrodactylosis for coastal zones are laid down in accordance with the procedure provided for in Article 26.`

7. In Annex C, I, A point 4 is replaced by the following text:

'4. it must comply, mutatis mutandis, with the requirements set out in Annex B, I, B. Furthermore, where approval with regard to IHN and/or VHS is requested on the basis of a historical record with an official control system for a 10-year period, it must have been submitted, at least once a year, to a clinical inspection and the taking of samples to be tested for the pathogens in question in an approved laboratory;`

8. In Annex C, I point B is replaced by the following text:

'B. Maintenance of approval

Maintenance of approval shall be subject to the requirements set out in Annex B I C. However, sampling with regard to IHN and/or VHS must be carried out once a year.`

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1997. They shall forthwith notify the Commission thereof.

When Member States adopt these measures, they 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 the Member States.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.

Article 3

This Directive shall enter in to force 20 days after its publication in the Official Journal of the European Communities.

Article 4

This Directive is addressed to the Member States.

(1) OJ No L 46, 19. 2. 1991, p. 1.

(2) OJ No L 243, 11. 10. 1995, p. 1.