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Council Directive 93/54/EEC of 24 June 1993 amending Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and products Official Journal L 175 , 19/07/1993 P. 0034 - 0037 Finnish special edition: Chapter 3 Volume 51 P. 0011 Swedish special edition: Chapter 3 Volume 51 P. 0011

COUNCIL DIRECTIVE 93/54/EEC of 24 June 1993 amending Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and products THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas, in accordance with Article 28 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 (4), it is necessary to review the list of diseases set out in Annex A to the said Directive; whereas this review must take into account both the Commission report on the experience gained and the opinion of the Scientific Veterinary Committee; Whereas, following the opinion of the Scientific Veterinary Committee, the list of diseases must be amended in order to take account of the latest epidemiological findings and of the experience gained; Whereas the situation with regard do diseases which are exotic to the Community needs to be reviewed and whereas current epidemiological data indicate that the susceptibility of certain species to certain diseases which are endemic to the Community and the classification of those diseases in lists II or III of Annex A to Directive 91/67/EEC must be reconsidered; Whereas it is necessary to clarify certain requirements laid down in Directive 91/67/EEC, in particular those concerning the procedure for the approval of zones and concerning the conditions governing the placing on the market of aquaculture animals not belonging to the susceptible species, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 91/67/EEC is hereby amended as follows: 1. in Article 3 (a) paragraph 1 (c) shall be replaced by the following: '(c) they must not come from a farm which is subject to a prohibition for animal health reasons and must not have been in contact with animals from such a farm, and in particular from a farm which is subject to control measures in the context of Commission Directive 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases (*); (*) OJ No L 175, 19. 7. 1993, p. 23.' (b) the following paragraph shall be added: '4. This Article shall apply without prejudice to the provisions of Directive 93/53/EEC with regard to the control of certain fish diseases, in particular the diseases in list I'; 2. in Article 5 (1), the introductory words shall be replaced by the following: '1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, list II, the status of approved zone, Member States shall submit to the Commission:'; 3. Article 5 (2) shall be replaced by the following: '2. The Commission shall scrutinize the information referred to in paragraph 1. The Commission shall use such information as a basis for approving zones in accordance with the procedure laid down in Article 26. If, in accordance with Annex B under I.D.5, II.D or III.D.5, the approval of a zone is withdrawn by the official service, the Commission shall revoke the decision concerning its approval. Re-approval of the zone concerned shall occur in accordance with the procedure laid down in Article 26.'; 4. in Article 6 (1), the introductory words shall be replaced by the following: '1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, list II, the status of approved farm situated in a non-approved zone, Member States shall submit to the Commission:'; 5. in Article 7 (1), the introductory words shall be replaced by the following: '1. The placing on the market of live fish belonging to the susceptible species referred to in Annex A, column 2, list II, their eggs or gametes, shall be subject to the following additional guarantees:'; 6. in Article 8 (1), the introductory words shall be replaced by the following: '1. The placing on the market of live molluscs referred to in Annex A, column 2, list II, shall be subject to the following additional guarantees:'; 7. in Article 9, the first sentence of point 1 shall be replaced by the following: '1. Fish susceptible to the diseases referred to in Annex A, column 1, list II, must be slaughtered and eviscerated prior to dispatch.'; 8. in Article 9, the first sentence of point 2 shall be replaced by the following: '2. Live molluscs susceptible to the diseases referred to in Annex A, column 1, list II, must be delivered either for direct human consumption or to the preserving industry; they shall not be relaid unless:'; 9. Article 14 shall be replaced by the following: 'Article 14 1. Without prejudice to the requirements for diseases referred to in Annex A, column 1, list III, established in accordance with Articles 12 and 13, the placing on the market of live farmed fish not belonging to the susceptible species referred to in Annex A, column 2, list II, as well as their eggs and gametes shall be subject to the following additional requirements: (a) where they are to be introduced into an approved zone, they must, in accordance with Article 11, be accompanied by a movement document corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from a zone of the same health status, from an approved farm in a non-approved zone or from a farm which may be situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters. However, pending the outcome of the review provided for in Article 28, Member States may, under the procedure laid down in Article 26, request a derogation from the preceding subparagraph, in particular so as to prohibit the introduction into an approved zone of fish referred to in this paragraph originating in an approved farm situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters. In order to ensure uniform compliance with that provision, appropriate conditions and measures shall be fixed under the same procedure. Pending those decisions, the relevant national rules shall continue to apply subject to compliance with the general provisions of the Treaty; (b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone, from a farm of the same health status or from a farm which may be situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters. 2. The requirements laid down in paragraph 1 shall apply to the placing on the market of farmed molluscs not belonging to the susceptible species referred to in Annex A, column 2, list II. 3. Without prejudice to the requirements for diseases referred to in Annex A, column 1, list III established in accordance with Articles 12 and 13, the placing on the market of wild fish, molluscs or crustaceans, their eggs or gametes, shall be subject to the following additional requirements: (a) where they are to be introduced into an approved zone, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from a zone of the same health status; (b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone; (c) where such animals are fished in the deep sea and are to be used for breeding in approved zones and approved farms, they must be placed in quarantine under the supervision of the official service in suitable facilities and under appropriate conditions to be determined in accordance with the procedure laid down in Article 26. 4. The requirements laid down in paragraphs 1, 2 and 3 shall not apply where practical experience and/or scientific evidence has shown that there is no passive transmission of the disease when acquacultre animals, their eggs and gametes, not belonging to the susceptible species referred to in Annex A, column 2, list II, are moved from a non-approved zone to an approved zone. In accordance with the procedure laid down in Article 26, the Commission shall establish the list of aquaculture animals to which the derogation referred to in the first subparagraph shall apply and, where necessary, shall amend that list in the light of scientific and technological developments. The special conditions for placing such animals on the market, including the model of the accompanying document required, shall be established and amended according to the same procedure. 5. This Article shall not apply to ornamental tropical fish kept permanently in aquariums.'; 10. the following paragraph shall be added to Article 19: '4. If by 1 January 1994 no decision has been taken with regard to the drawing up of the list referred to in paragraph 1, the requisite transitional measures may be adopted, in accordance with the procedure laid down in Article 26, for a period of three years.'; 11. the following paragraph shall be added to Article 20: '3. Pending establishment of the import conditions provided for in this Directive, Member States shall ensure that imports of aquaculture animals and products from third countries are subject to conditions at least equivalent to those applying to the production and placing on the market of Community products.'; 12. Article 24 shall be replaced by the following: 'Article 24 If an infectious or contagious disease of aquaculture animals, likely to endanger the health of livestock in a Member State breaks out or spreads in a third country or if any other animal health reason so justifies, the rules, procedures and measures laid down in Article 19 of Directive 90/675/EEC shall apply as regards aquaculture products and those laid down in Article 18 of Directive 91/496/EEC shall apply as regards aquaculture animals.'; 13. Annex A shall be replaced by the following: 'ANNEX A LIESTED DISEASES/PATHOGENS OF FISH, MOLLUSCS AND CRUSTACEA 1 2 Disease/pathogen Susceptible species LIST I Fish Infectious salmon aneamia (ISA) Atlantic salmon (Salmo salar) LIST II Fish Viral haemorrhagic septicaemia (VHS) Salmonid species, Grayling (Thymallus thymallus); Whitefish (Coregonus spp.); Pike (Esox lucius); Turbot (Scophthalmus maximus); Infectious haematopoietic necrosis (IHN) Salmonid species Pike fry (Esox lucius) Molluscs Bonamia ostreae Flat oyster (Ostrea edulis) Marteilla refringens Flat oyster (Ostrea edulis) 1 2 Disease/pathogen Susceptible species LIST III Fish Infectious pancreatic necrosis (IPN) Spring viraemia of carp (SVC) Bacterial kidney disease (BKD) (Renibacterium salmonidarum) Furunculosis (Aeromonas salmonicida) (Enteric redmouth disease) (ERM) (Yersinia ruckeri) Gyrodactylus salaris To be specified in the programme referred to in Articles 12 and 13'Crustaceans Crayfish plague (Aphanomyces astaci)' 14. References to 'list I' of Annex A shall be deleted from Annexes B, C and D. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1994; they shall 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 a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States. Done at Luxembourg, 24 June 1993. For the Council The President B. WESTH (1) OJ No C 324, 10. 12. 1992, p. 16.(2) OJ No C 150, 31. 5. 1993.(3) OJ No C 129, 10. 5. 1993, p. 6.(4) OJ No L 46, 19. 2. 1991, p. 1

COUNCIL DIRECTIVE 93/54/EEC of 24 June 1993 amending Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and products

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

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

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas, in accordance with Article 28 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 (4), it is necessary to review the list of diseases set out in Annex A to the said Directive; whereas this review must take into account both the Commission report on the experience gained and the opinion of the Scientific Veterinary Committee;

Whereas, following the opinion of the Scientific Veterinary Committee, the list of diseases must be amended in order to take account of the latest epidemiological findings and of the experience gained;

Whereas the situation with regard do diseases which are exotic to the Community needs to be reviewed and whereas current epidemiological data indicate that the susceptibility of certain species to certain diseases which are endemic to the Community and the classification of those diseases in lists II or III of Annex A to Directive 91/67/EEC must be reconsidered;

Whereas it is necessary to clarify certain requirements laid down in Directive 91/67/EEC, in particular those concerning the procedure for the approval of zones and concerning the conditions governing the placing on the market of aquaculture animals not belonging to the susceptible species,

HAS ADOPTED THIS DIRECTIVE:

Directive 91/67/EEC is hereby amended as follows:

1. in Article 3

(a) paragraph 1 (c) shall be replaced by the following:

'(c) they must not come from a farm which is subject to a prohibition for animal health reasons and must not have been in contact with animals from such a farm, and in particular from a farm which is subject to control measures in the context of Commission Directive 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases (*);

(*) OJ No L 175, 19. 7. 1993, p. 23.'

(b) the following paragraph shall be added:

'4. This Article shall apply without prejudice to the provisions of Directive 93/53/EEC with regard to the control of certain fish diseases, in particular the diseases in list I';

2. in Article 5 (1), the introductory words shall be replaced by the following:

'1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, list II, the status of approved zone, Member States shall submit to the Commission:';

3. Article 5 (2) shall be replaced by the following:

'2. The Commission shall scrutinize the information referred to in paragraph 1. The Commission shall use such information as a basis for approving zones in accordance with the procedure laid down in Article 26. If, in accordance with Annex B under I.D.5, II.D or III.D.5, the approval of a zone is withdrawn by the official service, the Commission shall revoke the decision concerning its approval. Re-approval of the zone concerned shall occur in accordance with the procedure laid down in Article 26.';

4. in Article 6 (1), the introductory words shall be replaced by the following:

'1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, list II, the status of approved farm situated in a non-approved zone, Member States shall submit to the Commission:';

5. in Article 7 (1), the introductory words shall be replaced by the following:

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

6. in Article 8 (1), the introductory words shall be replaced by the following:

'1. The placing on the market of live molluscs referred to in Annex A, column 2, list II, shall be subject to the following additional guarantees:';

7. in Article 9, the first sentence of point 1 shall be replaced by the following:

'1. Fish susceptible to the diseases referred to in Annex A, column 1, list II, must be slaughtered and eviscerated prior to dispatch.';

8. in Article 9, the first sentence of point 2 shall be replaced by the following:

'2. Live molluscs susceptible to the diseases referred to in Annex A, column 1, list II, must be delivered either for direct human consumption or to the preserving industry; they shall not be relaid unless:';

9. Article 14 shall be replaced by the following:

'Article 14

1. Without prejudice to the requirements for diseases referred to in Annex A, column 1, list III, established in accordance with Articles 12 and 13, the placing on the market of live farmed fish not belonging to the susceptible species referred to in Annex A, column 2, list II, as well as their eggs and gametes shall be subject to the following additional requirements:

(a) where they are to be introduced into an approved zone, they must, in accordance with Article 11, be accompanied by a movement document corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from a zone of the same health status, from an approved farm in a non-approved zone or from a farm which may be situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters.

However, pending the outcome of the review provided for in Article 28, Member States may, under the procedure laid down in Article 26, request a derogation from the preceding subparagraph, in particular so as to prohibit the introduction into an approved zone of fish referred to in this paragraph originating in an approved farm situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters. In order to ensure uniform compliance with that provision, appropriate conditions and measures shall be fixed under the same procedure. Pending those decisions, the relevant national rules shall continue to apply subject to compliance with the general provisions of the Treaty;

(b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone, from a farm of the same health status or from a farm which may be situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters.

2. The requirements laid down in paragraph 1 shall apply to the placing on the market of farmed molluscs not belonging to the susceptible species referred to in Annex A, column 2, list II.

3. Without prejudice to the requirements for diseases referred to in Annex A, column 1, list III established in accordance with Articles 12 and 13, the placing on the market of wild fish, molluscs or crustaceans, their eggs or gametes, shall be subject to the following additional requirements:

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

(b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone;

(c) where such animals are fished in the deep sea and are to be used for breeding in approved zones and approved farms, they must be placed in quarantine under the supervision of the official service in suitable facilities and under appropriate conditions to be determined in accordance with the procedure laid down in Article 26.

4. The requirements laid down in paragraphs 1, 2 and 3 shall not apply where practical experience and/or scientific evidence has shown that there is no passive transmission of the disease when acquacultre animals, their eggs and gametes, not belonging to the susceptible species referred to in Annex A, column 2, list II, are moved from a non-approved zone to an approved zone.

In accordance with the procedure laid down in Article 26, the Commission shall establish the list of aquaculture animals to which the derogation referred to in the first subparagraph shall apply and, where necessary, shall amend that list in the light of scientific and technological developments. The special conditions for placing such animals on the market, including the model of the accompanying document required, shall be established and amended according to the same procedure.

5. This Article shall not apply to ornamental tropical fish kept permanently in aquariums.';

10. the following paragraph shall be added to Article 19:

'4. If by 1 January 1994 no decision has been taken with regard to the drawing up of the list referred to in paragraph 1, the requisite transitional measures may be adopted, in accordance with the procedure laid down in Article 26, for a period of three years.';

11. the following paragraph shall be added to Article 20:

'3. Pending establishment of the import conditions provided for in this Directive, Member States shall ensure that imports of aquaculture animals and products from third countries are subject to conditions at least equivalent to those applying to the production and placing on the market of Community products.';

12. Article 24 shall be replaced by the following:

'Article 24

If an infectious or contagious disease of aquaculture animals, likely to endanger the health of livestock in a Member State breaks out or spreads in a third country or if any other animal health reason so justifies, the rules, procedures and measures laid down in Article 19 of Directive 90/675/EEC shall apply as regards aquaculture products and those laid down in Article 18 of Directive 91/496/EEC shall apply as regards aquaculture animals.';

13. Annex A shall be replaced by the following:

'ANNEX A

LIESTED DISEASES/PATHOGENS OF FISH, MOLLUSCS AND CRUSTACEA

1 2 Disease/pathogen Susceptible species LIST I Fish Infectious salmon aneamia (ISA) Atlantic salmon (Salmo salar) LIST II Fish Viral haemorrhagic septicaemia (VHS) Salmonid species, Grayling (Thymallus thymallus); Whitefish (Coregonus spp.); Pike (Esox lucius); Turbot (Scophthalmus maximus); Infectious haematopoietic necrosis (IHN) Salmonid species Pike fry (Esox lucius) Molluscs Bonamia ostreae Flat oyster (Ostrea edulis) Marteilla refringens Flat oyster (Ostrea edulis) 1 2 Disease/pathogen Susceptible species LIST III Fish Infectious pancreatic necrosis (IPN) Spring viraemia of carp (SVC) Bacterial kidney disease (BKD) (Renibacterium salmonidarum) Furunculosis (Aeromonas salmonicida) (Enteric redmouth disease) (ERM) (Yersinia ruckeri) Gyrodactylus salaris To be specified in the programme referred to in Articles 12 and 13'Crustaceans Crayfish plague (Aphanomyces astaci)'

14. References to 'list I' of Annex A shall be deleted from Annexes B, C and D.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1994; they shall 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 a reference shall be laid down by the Member States.

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

Article 3

This Directive is addressed to the Member States.

Done at Luxembourg, 24 June 1993.

For the Council

The President

B. WESTH

(1) OJ No C 324, 10. 12. 1992, p. 16.(2) OJ No C 150, 31. 5. 1993.(3) OJ No C 129, 10. 5. 1993, p. 6.(4) OJ No L 46, 19. 2. 1991, p. 1