1991L0067 — EN — 19.07.1993 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of28January1991
concerning the animal health conditions governing the placing on the market of aquaculture
animalsandproducts
(91/67/EEC)
(OJ L 46, 19.2.1991, p. 1)
Amended by:
Official Journal
No page date
►M1Council Directive 93/54/EEC of 24 June 1993 L 175 34 19.7.1993
▼B
COUNCILDIRECTIVE
of28January1991
concerning the animal health conditions governing the placing on
themarketofaquacultureanimalsandproducts
(91/67/EEC)
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 aquaculture animals and products are included in the list in
Annex II to the Treaty;
Whereas the breeding and rearing of aquaculture animals, and the
placing on the market of aquaculture animals and products constitutes
a source of income for persons working in the fisheries sector;
Whereas, in order to ensure the rational development of this sector and
to increase productivity, health rules for this sector must be laid downat Community level;
Whereas in this context it is necessary to contribute to the completion
of the internal market, avoiding the spread of infectious or contagiousdiseases;
Whereas the animal health situation for aquaculture animals is not the
same throughout the territory of the Community; whereas reference
must therefore be made to the concept of zones when dealing with
parts of the territory concerned;
Whereas criteria and procedures should be laid down for the grant,
maintenance, suspension, restoration and withdrawal of approval ofsuch zones;
Whereas reference should also be made to the concept of farms
enjoying a specific animal health status;
Whereas criteria and procedures should be laid down for the grant,
maintenance, suspension, restoration and withdrawal of approval ofsuch farms;
Whereas it is necessary to set Community requirements applicable to
imports of aquaculture animals and products from third countries;
whereas these requirements must provide for adequate protectivemeasures;
Whereas a Community inspection system should be established in order
to verify compliance with this Directive;
Whereas scientific studies should be undertaken so as to be able to
supplement in the future the rules laid down by this Directive;
Whereas provision should be made for a procedure establishing close
and efficient cooperation between the Commission and the MemberStates within the Standing Veterinary Committee,1991L0067 — EN — 19.07.1993 — 001.001 — 2
(1) OJ No C 84, 2. 4. 1990, p. 42.
(2) OJ No C 19, 28. 1. 1991.
(3) OJ No C 332, 31. 12. 1990.
▼B
HAS ADOPTED THIS DIRECTIVE:
CHAPTER 1
General provisions
Article 1
This Directive defines the animal health conditions governing the
placing on the market of aquaculture animals and products.
This Directive shall apply without prejudice to Community or national
provisions on the conservation of species.
Article 2
For the purposes of this Directive:
1. ‘aquaculture animals’ means live fish, crustaceans or molluscs
coming from a farm, including those from the wild intended for afarm;
2. ‘aquaculture products’ means products derived from aquaculture
animals, whether intended for farming, such as eggs and gametes,
or for human consumption;
3. ‘fish, crustaceans or molluscs’ means any fish, crustacean or
mollusc at any stage of development;
4. ‘farm’ means any establishment or, in general, any geographically
defined installation in which aquaculture animals are reared or keptwith a view to their being placed on the market;
5. ‘approved farm’ means a farm complying, as the case may be, with
the requirements of Annex C I, II or III, and approved as such inaccordance with Article 6;
6. ‘approved zone’ means a zone complying, as the case may be, with
the provisions of Annex B I, II or III, and approved as such inaccordance with Article 5;
7. ‘approved laboratory’ means a laboratory located in the territory of
a Member State, designated by the competent authority, under itsresponsibility, to carry out the diagnostic tests provided for in thisDirective;
8. ‘official service’ means the veterinary service or any other service
of equivalent level designated by the competent authority of theMember State or third country and responsible for carrying outthe controls provided for in this Directive;
9. ‘health inspection’ means a visit by an official service or services
for the purpose of conducting health checks on a farm or zone;
10. ‘placing on the market’ means holding or displaying for sale,
offering for sale, selling, delivering, transferring or any other formof placing on the market in the Community, with the exception ofretail sale.
CHAPTER 2
Placing on the market of Community aquaculture animals and
products
Article 3
1. The placing on the market of aquaculture animals shall be subject
to the following general requirements:
(a) they must show no clinical signs of disease on the day of loading;
(b) they must not be intended for destruction or slaughter under a
scheme for the eradication of a disease listed in Annex A;
(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 with1991L0067 — EN — 19.07.1993 — 001.001 — 3
▼M1
▼M1
animals from such a farm, and in particular from a farm which is
subject to control measures in the context of Commission Directive93/53/EEC of 24 June 1993 introducing minimum Community
measures for the control of certain fish diseases(
1).
2. Aquaculture products being placed on the market for breeding
purposes (eggs and gametes) must originate from animals which satisfy
the requirements laid down in paragraph 1.
3. Aquaculture products being placed on the market for human
consumption must originate from animals which satisfy the require-ments laid down in paragraph 1 (a).
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.
Article 4
Aquaculture animals must be dispatched in the shortest possible period
to the place of destination, using means of transport that have been
cleaned and, if necessary, disinfected in advance with a disinfectant
that is officially authorized in the Member State of dispatch.
If water is used in overland transport, the vehicles shall be designed in
such a way that water cannot escape from the vehicle during transport.Transport shall be carried out in such a way as to safeguard effectivelythe health of the animals, in particular by changing the water. Changesof water must be carried out in places complying with the requirements
of Annex D. A list of these places and any subsequent amendments
thereto must be notified by each Member State to the Commission,which shall forward that information to the other Member States.
Article 5
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 Statesshall submit to the Commission:
— all appropriate justifications concerning the conditions laid down, as
the case may be, in Annex B under I B, II B or III B,
— the national rules ensuring compliance with the conditions laid
down, as the case may be, in Annex B under I C, II C or III C.
2. The Commission shall scrutinize the information referred to in
paragraph 1. The Commission shall use such information as a basisfor approving zones in accordance with the procedure laid down inArticle 26. If, in accordance with Annex B under I.D.5, II.D orIII.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 theprocedure laid down in Article 26.
3. The Commission shall draw up the list of approved zones. It shall
amend this list in order to take account of new approvals or withdrawalof approvals. The Commission shall forward the list and any amend-ments thereto to the Member States.1991L0067 — EN — 19.07.1993 — 001.001 — 4
(1) OJ No L 175, 19. 7. 1993, p. 23.▼B
▼M1
▼B
▼M1
▼B
▼M1
▼B
▼B
Article 6
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 anon-approved zone, Member States shall submit to the Commission:
— all appropriate justifications concerning the conditions set out, as
the case may be, in Annex C under I A, II A or III A,
— the national rules ensuring compliance with the conditions set out in
Annex C under I B, II B or III B.
2. On receipt of the file relating to the request for approval or re-
approval of a farm in a non-approved zone, the Commission shallhave a month within which to examine that file. That examination shallbe carried out in the light of the information mentioned in paragraph 1and, where appropriate, of on-site inspections undertaken in accordance
with the provisions set out in Article 17.
Should that examination lead to favorable conclusions, the Commission
shall forward such conclusions to the Member States. The Member
States shall have a period of two weeks within which to make knowntheir remarks.
After expiry of that period, if no remarks have been made or if the
Member States' remarks are not contrary to the Commission's conclu-sions, the Commission shall approve or re-approve the farm.
Should there exist major differences between the Commission's conclu-
sions and the Member States' remarks, or should the Commission, afterexamining the file, consider that the approval or re-approval ought notbe granted, the Commission shall have two months within which torefer the matter to the Standing Veterinary Committee and obtain its
opinion. In that case, the approval or re-approval shall be granted in
accordance with the procedure laid down in Article 26.
If in accordance with Annex C under I C, II C or III C, the approval of
a farm is withdrawn by the official service, the Commission shallrevoke the approval decision.
3. The Commission shall draw up the list of approved farms. It shall
amend that list in order to take account of new approvals or withdrawalof approvals. The Commission shall forward the list and any amend-ments thereto to the Member States.
Article 7
1. The placing on the market of live fish belonging to the suscep-
tible species referred to in Annex A, column 2, list II, their eggs or
gametes, shall be subject to the following additional guarantees:
(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 set out in Annex E, Chapter1 or 2, certifying that they come from an approved zone or anapproved farm. Pending the outcome of the review provided for inArticle 28, additional guarantees to be met for the introduction intoan approved zone of fish coming from an approved farm situated in
a non-approved zone shall be fixed in accordance with the proce-
dure laid down in Article 26. Pending that decision, national rulesshall continue to apply subject to compliance with the generalprovisions of the Treaty;
(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
C I, they must in accordance with Article 11, be accompanied by amovement document corresponding to the model set out in AnnexE, Chapter 1 or 2, certifying that they come respectively from anapproved zone or from a farm of the same health status as thefarm of destination.1991L0067 — EN — 19.07.1993 — 001.001 — 5
▼M1
▼B
▼M1
▼B
▼B
2. The Commission may, in accordance with the procedure laid
down in Article 26, adapt or delete the additional guarantees referredto in paragraph 1, depending on the evolution of the animal health
situation in the Community, in particular in order to take account of
the results of the eradication measures for the disease referred to inAnnex A, column 1 of list I.
Article 8
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 guaran-tees:
(a) if they are to be relaid in an approved coastal zone, they must, in
accordance with Article 11, be accompanied by a movement docu-ment corresponding to the model set out in Annex E, Chapter 3 or
4, certifying that they come from an approved coastal zone or from
an approved farm in a non-approved coastal zone, as the case maybe;
(b) if they are to be relaid in a farm which although not situated in an
approved coastal zone fulfils the conditions set out in Annex C III,they must, in accordance with Article 11, be accompanied by amovement document corresponding to the model set out in AnnexE, Chapter 3 or 4, certifying that they come from an approvedcoastal zone or from a farm of the same health status as the farm
of destination.
2. The Commission may, in accordance with the procedure laid
down in Article 26, adapt or delete the additional guarantees referredto in paragraph 1, on the basis of the animal health situation existingin the Community.
Article 9
The placing on the market in an approved zone of aquaculture animals
and products for human consumption originating in a non-approvedzone shall be subject to the following requirements:
1. Fish susceptible to the diseases referred to in Annex A, column 1,
list II, must be slaughtered and eviscerated prior to dispatch.
However, pending the outcome of the review provided for in Article
28, the obligation to eviscerate shall not be required, if the fishcome from an approved farm in a non-approved zone. Derogationsfrom this principle may be adopted under the procedure provided
for in Article 26.
Pending that decision, national rules shall continue to apply subject
to compliance with the general provisions of the Treaty.
2. Live molluscs susceptible to the diseases referred to in Annex A,
column 1, list II, must be delivered either for direct humanconsumption or to the preserving industry; they shall not be relaidunless:
— they originate in an approved farm in a non-approved coastal
zone, or
— they are temporarily immersed in storage ponds or purification
centres which are specially equipped and approved for thatpurpose by the competent authority and include in particular asystem for the treatment and disinfection of residual water. Theconditions for such approval will be determined by the Commis-sion in accordance with the procedure laid down in Article 26.1991L0067 — EN — 19.07.1993 — 001.001 — 6
▼M1
▼B
▼M1
▼B
▼M1
▼B
▼B
3. The Commission shall, in accordance with the procedure provided
for in Article 26, take, if necessary, appropriate measures to ensureuniform compliance with this Article.
Article 10
1. Where a Member State draws upor has drawn upa p rogramme
designed to enable it subsequently to initiate the procedures provided
for in Article 5 (1) and Article 6 (1), it shall submit its programme tothe Commission specifying in particular:
— the geographical zone and farm or farms concerned,
— the measures to be taken by the official services to ensure that the
programme is properly carried out,
— the procedures followed by the approved laboratories, their number
and location,
— the prevalence of the disease or diseases listed in Annex A, column
1 of lists I and II,
— the measures laid down to combat these diseases where detected.
2. The Commission shall scrutinize the programmes submitted by
the Member States. The programmes shall be approved in accordance
with the procedure laid down in Article 26. After the adoption of the
programmes, the introduction of aquaculture animals and products intozones or farms covered by the programmes shall be subject to the rulesset out in Articles 7 and 8.
3. Programmes submitted by Member States may be amended or
supplemented in accordance with the procedure laid down in Article
26. Under the same procedure the Commission may approve an amend-
ment or addition to a programme which has been approved or toguarantees provided for by the rules referred to in paragraph 2.
Article 11
1. The movement documents referred to in Articles 7 and 8 must be
drawn upby the official service at the p lace of origin within 48 hoursbefore loading, in the official language or languages of the place ofdestination. They must be drawn up on a single sheet of paper, be
made out for a single consignee. They shall be valid for 10 days.
2. Each consignment of aquaculture animals and products must be
clearly identified in order to be able to trace back to the farm of origin,and to verify where appropriate the correlation of the animals orproducts with the information contained in the accompanying move-ment document. This information may figure directly on the container
or on a label fixed to it or on the movement document.
Article 12
1. Where a Member State draws upor has drawn upa voluntary or
compulsory control programme for one of the diseases referred to in
Annex A, column 1 of list III, it shall submit the programme to theCommission, outlining in particular:
— the distribution of the disease in the Member States,
— the justification of the programme, taking into account, the impor-
tance of the disease and the programme's likely benefit in relation
to its cost,
— the geographical area in which the programme will be imple-
mented,
— the status of farms to be established, and the standards which must
be achieved by the farms in each category, including test proce-
dures,
— the rules applicable for entry of animals of a lower health status
into the farm,
— the action to be taken if, for any reason, a farm loses its status,
— the procedures under which the programme is to be monitored.1991L0067 — EN — 19.07.1993 — 001.001 — 7
▼B
2. The Commission shall scrutinize the programme presented by the
Member States. These programmes may be approved in accordancewith the procedure laid down in Article 26. The additional guarantees,
general or specific, which may be required for the introduction of aqua-
culture animals and products into officially checked zones or farmsshall be defined in accordance with the same procedure.
3. Programmes submitted by Member States may be amended or
supplemented in accordance with the procedure laid down in Article
26. Under the same procedure, the Commission may approve anamendment or addition to a programme which has been approved orto guarantees which have been defined in accordance with paragraph 2.
Article 13
1. Where a Member State considers that its territory or part of its
territory is free from one of the diseases listed in Annex A, column 1
of list III, it shall submit to the Commission appropriate justifications,setting out in particular:
— the name of the disease and the previous history of its ocurrence in
that Member State,
— the results of surveillance testing based on serological, virological,
microbiological or pathological findings, as appropriate, and on thefact that the disease is compulsorily notifiable to the competentauthorities,
— the period over which the surveillance was carried out,
— the control arrangements for verifying that the area concerned
remains free from the disease.
2. The Commission shall examine such justifications. The additional
guarantees, general or specific, which may be required for the introduc-tion of aquaculture animals and products into certain areas or farms
shall be defined in accordance with the procedure provided for in
Article 26.
3. The Member State concerned shall notify the Commission of any
change in the particulars specified in paragraph 1 which relate to thedisease. The guarantees defined as laid down in paragraph 2 may, in
the light of such notification, be amended or withdrawn in accordance
with the procedure provided for in Article 27.
Article 14
1. Without prejudice to the requirements for diseases referred to in
Annex A, column 1, list III, established in accordance with Articles12 and 13, the placing on the market of live farmed fish not belongingto the susceptible species referred to in Annex A, column 2, list II, aswell as their eggs and gametes shall be subject to the following addi-
tional requirements:
(a) where they are to be introduced into an approved zone, they must,
in accordance with Article 11, be accompanied by a movementdocument corresponding to the model to be drawn up in accor-dance 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 situatedin a non-approved zone on condition that such a farm contains nofish belonging to the susceptible species referred to in Annex A,column 2, list II, and is not connected with a watercourse or withcoastal 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 approvedzone of fish referred to in this paragraph originating in an approvedfarm situated in a non-approved zone on condition that such a farmcontains no fish belonging to the susceptible species referred to inAnnex A, column 2, list II, and is not connected with a watercourse1991L0067 — EN — 19.07.1993 — 001.001 — 8
▼M1
▼M1
or with coastal or estuarial waters. In order to ensure uniform
compliance with that provision, appropriate conditions andmeasures 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 situ-
ated in a non-approved zone, fulfils the conditions of Annex C,they must, in accordance with Article 11, be accompanied by amovement document, corresponding to the model to be drawn upin accordance with the procedure laid down in Article 26, certi-
fying that they come from an approved zone, from a farm of the
same health status or from a farm which may be situated in anon-approved zone on condition that such a farm contains no fishbelonging 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 suscep-tible 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 12and 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 accor-
dance with the procedure laid down in Article 26, certifying thatthey come from a zone of the same health status;
(b) where they are to be introduced into a farm which, although situ-
ated in a non-approved zone, fulfils the conditions of Annex C,they must, in accordance with Article 11, be accompanied by amovement document, corresponding to the model to be drawn up
in accordance with the procedure laid down in Article 26, certi-
fying that they come from an approved zone;
(c) where such animals are fished in the deepsea and are to be used
for breeding in approved zones and approved farms, they must beplaced in quarantine under the supervision of the official service insuitable facilities and under appropriate conditions to be deter-mined 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 shownthat there is no passive transmission of the disease when acquacultreanimals, 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 Commis-
sion shall establish the list of aquaculture animals to which the
derogation referred to in the first subparagraph shall apply and, wherenecessary, shall amend that list in the light of scientific and technolo-gical developments. The special conditions for placing such animals onthe market, including the model of the accompanying documentrequired, shall be established and amended according to the same
procedure.
5. This Article shall not apply to ornamental tropical fish kept
permanently in aquariums.
Article 15
Sampling plans and diagnostic methods to be applied for the detection
and confirmation of the presence of the diseases referred to in AnnexA, column 1, shall be established in accordance with the procedure laiddown in Article 26. These sampling plans must take account of the1991L0067 — EN — 19.07.1993 — 001.001 — 9
▼B
▼B
presence of wild fish, crustaceans and molluscs in the aquatic environ-
ment.
Article 16
1. The rules laid down in Council Directive 89/662/EEC of 11
December 1989 concerning veterinary checks in intra-Community tradewith a view to the completion of the internal market(
1) as regards
aquaculture products for human consumption and Council Directive90/425/EEC of 26 June 1990 concerning veterinary and zootechnicalchecks applicable in intra-Community trade in certain live animals
and products with a view to the completion of the internal market(
2)
as regards aquaculture animals and products placed on the market shallapply, in particular as regards the organization of and the action to betaken following the inspections to be carried out by the Member Stateof destination, and the protective measures to be implemented.
2. Directive 89/662/EEC is amended as follows:
(a) in Annex A, the following indent is added:
‘— 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 (OJ No L 46, 19.
2. 1991, p. 1)’;
(b) in Annex B the following indent is deleted:
‘— aquaculture products intended for human consumption.’
3. In Annex A, point I, of Directive 90/425/EEC the following refer-
ence is added:
‘Council Directive 91/67/EEC of 28 January 1991 concerning the
animal health conditions governing the placing on the market ofaquaculture animals and products (OJ No L 46, 19. 2. 1991, p. 1)’.
Article 17
1. Commission veterinary experts may, where it is necessary for the
uniform application of this Directive, carry out on-site inspections inconjunction with the competent authorities. The Member State in
whose territory an inspection is carried out shall provide the experts
with all the assistance necessary to complete their task. The Commis-sion shall notify the Member States of the outcome of such inspections.
2. General provisions for the application of this Article shall be
adopted in accordance with the procedure laid down in Article 26.
The rules to be followed during the inspection provided for in this
Article shall be drawn upin accordance with the same p rocedure.
CHAPTER 3
Rulesgoverningimportsfromthirdcountries
Article 18
Aquaculture animals and products imported into the Community shall
satisfy the conditions laid down in Articles 19, 20 and 21.
Article 19
1. Aquaculture animals and products must come from third countries
or parts thereof appearing on a list drawn up by the Commission inaccordance with the procedure laid down in Article 26. That list maybe supplemented or amended in accordance with the same procedure.1991L0067 — EN — 19.07.1993 — 001.001 — 10
(1) OJ No L 395, 30. 12. 1989, p. 13.
(2) OJ No L 224, 18. 8. 1990, p. 29; as amended by Directive 90/539/EEC (OJ
No L 303, 31. 10. 1990, p. 6).
▼B
2. In deciding whether a third country or part thereof may appear on
the list referred to in paragraph 1, particular account shall be taken of:
(a) the state of health of the aquaculture animals, particular attention
being paid to exotic diseases and the environmental health situationin the third country which might endanger the health of livestock in
the Member States;
(b) the regularity and rapidity of the information supplied by the
country relating to the existence of infectious or contagiousdiseases of aquaculture animals in its territory, in particular thosediseases mentioned in list B of the International Office of Epizoo-tics;
(c) the rules of the third country on the prevention and control of
diseases of aquaculture animals;
(d) the structure of the official services in the third country and their
powers;
(e) the organization and implementation of measures to prevent and
control infectious or contagious diseases of aquaculture animals;
(f) assurances which the third country may provide concerning the
rules laid down in this Directive.
3. The list referred to in paragraph 1 and all amendments thereto
shall be published in the Official Journal of the European Commu-
nities.
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 tran-sitional measures may be adopted, in accordance with the procedurelaid down in Article 26, for a period of three years.
Article 20
1. For each third country, aquaculture animals and products shall
satisfy the health conditions adopted in accordance with the procedure
laid down in Article 26.
2. Depending on the animal health situation in the third country
concerned, the conditions referred to in paragraph 1 may include in
particular:
— restriction to imports from a part of the third country,
— restriction to certain species at any stage of development,
— the prescription of a treatment to be applied to the products, such as
the disinfection of eggs,
— prescription of the use to which these animals or products are to be
put,
— the measures to apply following importation, such as quarantine or
the disinfection of eggs.
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 atleast equivalent to those applying to the production and placing on themarket of Community products.
Article 21
1. Aquaculture animals and products shall be accompanied by a
certificate drawn upby the official services of the exp orting thirdcountry. This certificate must:
(a) be issued on the day of loading of the consignment for dispatch to
the Member State of destination;
(b) accompany the consignment in the original;1991L0067 — EN — 19.07.1993 — 001.001 — 11
▼M1
▼B
▼M1
▼B
▼B
(c) attest that the aquaculture animals and certain fishery products
meet the requirements of this Directive and those laid downpursuant thereto with regard to importation from the third country;
(d) be valid for 10 days;
(e) consist of a single sheet of paper;
(f) be made out for a single consignee.
2. The certificate referred to in paragraph 1 must comply with a
model established in accordance with the procedure laid down inArticle 26.
Article 22
Inspections shall be carried out on the spot by veterinary experts of the
Member States and the Commission to verify whether the provisions of
this Directive, and in particular Articles 19 and 20 thereof, are being
applied in practice.
The experts from the Member States who are to be entrusted with the
task of carrying out these inspections shall be appointed by the
Commission, acting on proposals from the Member States.
Those inspections shall be made on behalf of the Community, which
shall bear the expenditure incurred in this connection.
The frequency of and the procedures for these inspections shall be
determined in accordance with the procedure laid down in Article 26.
Article 23
1. The general rules and principles applicable during inspections of
aquaculture products imported from third countries shall be those laiddown in Council Directive 90/675/EEC of 10 December 1990 laying
down the principles governing the organization of veterinary checks
on products entering the Community from third countries(
1).
2. The general rules and principles applicable during inspections of
live aquaculture animals imported from third countries shall be those
laid down by Article 7 of Directive 90/425/EEC.
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 justi-
fies, the rules, procedures and measures laid down in Article 19 ofDirective 90/675/EEC shall apply as regards aquaculture products andthose laid down in Article 18 of Directive 91/496/EEC shall apply asregards aquaculture animals.
CHAPTER 4
Finalprovisions
Article 25
Annexes C and E may be amended in accordance with the procedure
laid down in Article 26.
Annexes A, B and C shall be amended only by the Council acting by a
qualified majority on a proposal from the Commission, with a view inparticular to adapting them to technological progress.1991L0067 — EN — 19.07.1993 — 001.001 — 12
(1) OJ No L 373, 31. 12. 1990, p. 1.▼M1
▼B
▼B
Article 26
1. Where the procedure laid down in this Article is to be followed,
the Chairman shall refer the matter without delay to the Standing
Veterinary Committee set upby Decision 68/361/EEC(1), hereinafter
referred to as ‘the Committee’, either on his own initiative or at therequest of the representative of a Member State.
2. (a) The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee
shall deliver its opinion on the draft within a time limit whichthe Chairman may lay down according to the urgency of thematter. The opinion shall be delivered by the majority laiddown in Article 148 (2) of the Treaty in the case of decisionswhich the Council is required to adopt on a proposal from the
Commission. The votes of the representatives of the Member
States within the Committee shall be weighted in the mannerset out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are
in accordance with the opinion of the Committee.
(b) If the measures envisaged are not in accordance with the opinion
of the Committee, or if no opinion is delivered, the Commission
shall, without delay, submit to the Council a proposal relating tothe measures to be taken. The Council shall act by a qualifiedmajority.
If, on the expiry of a period of three months from the date of
referral to the Council, the Council has not acted, the proposedmeasures shall be adopted by the Commission save where theCouncil has decided against the said measures by a simple
majority.
Article 27
1. Where the procedure laid down in this Article is to be followed,
the Chairman shall without delay, refer the matter to the Committee,either on his own initiative or at the request of the representative of aMember State.
2. (a) The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committeeshall deliver its opinion on the draft within two days. Theopinion shall be delivered by the majority laid down in Article148 (2) of the Treaty in the case of decisions which the Council
is required to adopt on a proposal from the Commission. The
votes of the representatives of the Member States within theCommittee shall be weighted in the manner set out in thatArticle. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are
in accordance with the opinion of the Committee.
(b) If the measures envisaged are not in accordance with the opinion
of the Committee, or if no opinion is delivered, the Commissionshall, without delay, submit to the Council a proposal relating tothe measures to be taken. The Council shall act by a qualifiedmajority.
If, on the expiry of a period of 15 days from the date of referral
to the Council, the Council has not acted, the proposed measuresshall be adopted by the Commission save where the Council has
decided against the said measures by a simple majority.
Article 28
Before 1 July 1992, in respect of the list of diseases set out in Annex
A, and before 1 January 1997, in respect of the health status ofapproved farms in a non-approved zone, the Council shall, on the basisof a report from the Commission on the experience gained, prepared1991L0067 — EN — 19.07.1993 — 001.001 — 13
(1) OJ No L 255, 18. 10. 1968, p. 23.
▼B
following an opinion from the Scientific Veterinary Committee and
accompanied by any proposals, on which it will decide by a qualifiedmajority, review the provisions of this Directive and in particular those
concerning the marketing of live fish coming from approved farms in
non-approved zones.
Article 29
1. The Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this Directivebefore 1 January 1993.
2. When Member States adopt the measures referred to in paragraph
1, they shall contain a reference to this Directive or shall be accompa-nied 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.
Article 30
This Directive is addressed to the Member States.1991L0067 — EN — 19.07.1993 — 001.001 — 14
▼M1
ANNEX A
LIESTEDDISEASES/PATHOGENSOFFISH,MOLLUSCSANDCRUSTACEA
12
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)
LIST III
Fish
Infectious pancreatic necrosis (IPN)
To be specified in the programme referred to in
Articles 12 and 13'Spring viraemia of carp (SVC)
Bacterial kidney disease (BKD)
(Renibacterium salmonidarum)
Furunculosis (Aeromonas salmonicida)
(Enteric redmouth disease) (ERM)
(Yersinia ruckeri)
Gyrodactylus salaris
CrustaceansCrayfish plague (Aphanomyces astaci)1991L0067 — EN — 19.07.1993 — 001.001 — 15
▼B
ANNEX B
APPROVEDZONES
I.Continentalzonesforfish (column 2 of ►M1list◄II in Annex A)
A.Definition of continental zones
A continental zone consists of
— a part of the territory comprising an entire catchment area from the
sources of the waterways to the estuary, or more than one catchment
area, in which fish is reared, kept or caught, or
— a part of a catchment area from the sources of the waterways to a
natural or artificial barrier preventing fish migrating from down-
stream of that barrier.
The size and the geographical situation of a continental zone must be
such that possibilities for recontamination, e.g. by migrating fish, are
reduced to a minimum. That may require the establishment of a buffer-
zone in which a monitoring programme is carried out without obtaining
the status of approved zone.
B.Grant of appeal
In order to obtain approved status, a continental zone must meet the
following requirements:
1. all fish are free for at least four years from any clinical or other sign
of one or more of the diseases referred to in Annex A, column 1 of
►M1list◄II;
2. all farms in the continental zone are placed under the supervision of
the official services. Two health inspections per year for four years
must have been carried out.
The health inspection must have been made at the times of year when
the water temperature favours the development of these diseases.
The health inspection must consist at least of:— an inspection of fish showing abnormalities,
— the taking of samples which are to be sent as quickly as possible
to the approved laboratory to be tested for the pathogens in ques-
tion.
However, zones having a historical record of absence of the diseases
referred to in Annex A, column 1 of ►
M1list◄II, may obtain
approved status if:
(a) their geographical situation does not permit easy introduction of
diseases;
(b) an official disease control system has been in place for an
extended period of time of at least 10 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,
— no live fish from infected zones has been introduced;
3. 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 catch-
ment area to a health inspection twice a year for four years, in
accordance with paragraph 2;
4. the laboratory examinations of fish taken during health inspections
have produced negative results as regards the pathogens in question.
C.Maintenance of approval
Maintenance of approval is subject to the following requirements:
1. fish introduced into the zone must come from another approved zone
or from an approved farm;
2. each farm must undergo two health inspections annually in accor-
dance with point B 2; however, samples will be taken by rotation in
50 % of the fish farms in the continental zone each year;1991L0067 — EN — 19.07.1993 — 001.001 — 16
▼B
3. the results of the laboratory examinations on the fish sampled during
the health inspections must have been negative as regards the agents
of the diseases referred to in Annex A, column 1 of ►M1list◄II;
4. a register must be kept by the farmers or the persons responsible for
the introducing of fish, containing all the information necessary to
enable the state of health of the fish to be monitored constantly.
D.Suspension, re-establishment and withdrawal of approval
1. Any abnormal death or other symptom that might constitute grounds
for suspecting an outbreak amongst fish of a disease referred to in
Annex A, column 1 of ►M1list◄II must be notified as quickly
as possible to the official service. The latter shall immediately
suspend the approval of the zone.
2. A sample of at least 10 sick fish must be sent to the approved labora-
tory in order to be tested for the pathogens in question. The results of
the tests must be communicated immediately to the official service.
3. Where the results are negative for the pathogens in question but posi-
tive for another cause, the official service shall restore approval.
4. However, when no diagnosis can be made, a further health inspection
must be made within 15 days of the first sampling and a sufficient
number of sick fish must be taken and forwarded to the approved
laboratory in order to be tested for the pathogens in question.
If the results are again negative or if there are no more sick fish, the
official service will restore the approval.
5. Where the results are positive, approval must be withdrawn by the
official service.
6. Restoration of the approval of a zone is subject to the following
requirements:
(a) when an outbreak occurs:
— all fish in the infected farms must have been slaughtered, and
infected or contaminated fish must have been destroyed,
— facilities and equipment must have been disinfected in accor-
dance with a procedure approved by the official services;
(b) after elimination of the outbreak, the requirements set upin p oint
B must be again complied with.
7. The central competent authority shall inform the Commission and the
other Member States regarding suspension, restoration and with-
drawal of the approval of zones.
II.Coastalzonesforfish (column 2 of ►M1list◄II of Annex A)
A. A coastal zone consists of a part of the coast or sea water or an estuary
with a precise geographical delimitation which consists of a homoge-
neous hydrological system.
B.Grant of approval
In order to obtain approved status, a coastal zone for fish must meet the
requirements laid down for continental zones referred to in point I B.
C.Maintenance of status
Maintenance of the approval for a coastal zone is subject to the require-
ments set out in point I C.
D.Suspension, restoration and withdrawal of approval
The rules are identical to those set out to in point I D.
III.Coastal zones for molluscs (column 2 of ►M1 ◄II of
Annex A)
A. A coastal zone must comply with the definition laid down in point II A.1991L0067 — EN — 19.07.1993 — 001.001 — 17
▼B
B.Grant of approval
In order to be approved, a coastal zone must meet the following require-
ments:
1. all molluscs have for at least two years shown no clinical or other
sign of one or more of the diseases referred to in Annex A, column
1o f►M1list◄II;
2. all farms in the coastal zone are placed under the supervision of the
official services. Health inspections are carried out at intervals
adapted to the development of the pathogens in question.
During these inspections samples are taken and sent without delay to
the approved laboratory to be tested for the pathogens in question;
3. if there is no farm in the continental zone, the official service must
have submitted molluscs to a health inspection in accordance with
point 2, at intervals adapted to the development of the pathogens in
question. However, if detailed investigations of fauna show that the
zone does not contain anymolluscs belonging to vector, carrier or
susceptible species, the official service may approve the zone before
any molluscs are introduced;
4. laboratory examinations of molluscs taken during health inspections
by the official services have produced negative results as regards the
pathogens in question.
For zones having a historical record of absence of the diseases
referred to in Annex A, column 1 of ►M1list◄II, this informa-
tion may be taken into account for the grant of approval.
C.Maintenance of approval
Maintenance of approval is subject to the following requirements:1. molluscs introduced into the coastal zone must come from other
approved coastal zones or from approved farms in non-approved
coastal zones;
2. each farm must undergo a health inspection in accordance with point
B 2 at intervals adapted to the development of the pathogens in ques-
tion;
3. the results of the laboratory examinations on the molluscs sampled
during the health inspections must have been negative as regards the
agents of the diseases referred to in Annex A, column 1 of
►
M1 ◄II;
4. a register must be kept by the farmers or the persons responsible for
the introduction of molluscs, containing all information necessary to
enable the state of health of the molluscs to be monitored constantly.
D.Suspension, restoration and withdrawal of approval
1. Any abnormal death or other symptom that might constitute grounds
for suspecting an outbreak amongst molluscs of a disease, referred to
in Annex A, column 1 of list II, must be notified as quickly as
possible to the official service. The latter shall immediately suspend
approval of the zone.
2. A sample of sick molluscs must be sent to the approved laboratory in
order to be tested for the pathogens in question.
The results of the tests must be communicated immediately to the
official service.
3. Where the results are negative for the pathogens in question, but
positive for another cause, approval shall be restored.
4. However, when no diagnosis can be made, a further health inspection
must be made within 15 days of the first taking of samples and a
sufficient number of sick molluscs must be taken and forwarded to
the approved laboratory in order to be tested for the pathogens in
question. If the results are again negative or if there are no longer
any sick molluscs, the official service will restore approval.
5. Where the results are positive, approval must be withdrawn by the
official service.
6. Restoration of approval of a zone is subject to the following require-
ments:
(a) when an outbreak occurs:
— infected or contaminated molluscs must have been destroyed,1991L0067 — EN — 19.07.1993 — 001.001 — 18
▼B
— facilities and equipment must have been disinfected in accor-
dance with a procedure approved by the official service;
(b) after elimination of the outbreak, the requirements set out in
point B must again be complied with.
7. The central competent authority shall inform the Commission and the
other Member States regarding suspension, restoration and with-
drawal of the approval of zones.1991L0067 — EN — 19.07.1993 — 001.001 — 19
▼B
ANNEX C
APPROVEDFARMSINANON-APPROVEDZONE
I.Continentalfarmsforfish (Column 2 of ►M1list◄II of Annex A)
A.Grant of approval
In order to be approved, a farm must meet the following requirements:1. Water must be supplied by a well or a borehole.
2. There must be a natural or artificial barrier for anadromic fish situ-
ated downstream.
3. It must comply with the relevant requirements set out in Annex B I
B.
B.Maintenance of approval
Maintenance of approval shall be subject to the requirements set out in
Annex B I C. However, sampling must be carried out once a year.
C.Suspension, restoration and withdrawal of approval
The requirements set out in Annex B I D shall apply.
II.Coastalfarmsforfish (Column 2 of ►
M1list◄II of Annex A)
A.Grant of approval
In order to be approved, a farm must meet the following requirements:
1. It must be supplied with water by means of a system which allows
the destruction of the agents of the diseases referred to in Annex A,
column 1 of ►M1list◄II.
2. It must comply, mutatis mutandis, with the requirements laid down in
Annex B II B.
B.Maintenance of approval
Maintenance of approval shall, mutatis mutandis, be subject to the
requirements laid down in Annex B II C.
C.Suspension, restoration and withdrawal of approval
The requirements laid down in Annex B II D shall apply mutatis
mutandis.
III.Coastalfarmsformolluscs (Column 2 of ►M1list◄II of Annex A)
A.Grant of approval
In order to be approved, a farm must meet the following requirements:1. It must be supplied with water by means of a system which allows
the destruction of the agents of diseases referred to in Annex A,
column 1 of ►
M1list◄II.
2. It must comply, mutatis mutandis, with the requirements as set out in
Annex B III B, points 1, 2 and 4.
B.Maintenance of approval
Maintenance of approval shall, mutatis mutandis, be subject to the guar-
antees laid down in Annex B III C, points 1 to 4.
C.Suspension, restoration and withdrawal of approval
The requirements set out in Annex B III D shall apply mutatis mutandis .1991L0067 — EN — 19.07.1993 — 001.001 — 20
▼B
ANNEX D
RENEWALOFWATER
Renewal of water during the transportation of aquaculture animals shall be
carried out in facilities which are approved by the Member States and meet the
following requirements:
1. The hygienic properties of the water available for changing must be such as
not to alter the health situation of the species transported with regard to the
agents of the diseases referred to in Annex A, column 1 of ►M1list◄II.
2. These facilities shall contain devices designed to prevent any contamination
of the host environment:
— either by facilitating disinfection of the water, or
— by ensuring that release of this water does not under any circumstances
entail direct discharge into the open sea or free-flowing waterways.1991L0067 — EN — 19.07.1993 — 001.001 — 21
▼B
ANNEX E
Modelsofmovementdocuments
CHAPTER 1
MOVEMENT DOCUMENT FOR LIVE FISH, EGGS AND GAMETES FROM AN
APPROVEDZONE
1991L0067 — EN — 19.07.1993 — 001.001 — 22
▼B
CHAPTER 2
MOVEMENTDOCUMENTFORLIVEFISH,EGGSORGAMETESFROMANAPPROVED
FARM
1991L0067 — EN — 19.07.1993 — 001.001 — 23
▼B
CHAPTER 3
MOVEMENTDOCUMENTFORMOLLUSCSFROMANAPPROVEDCOASTALZONE
1991L0067 — EN — 19.07.1993 — 001.001 — 24
▼B
CHAPTER 4
MOVEMENTDOCUMENTFORMOLLUSCSFROMANAPPROVEDFARM
1991L0067 — EN — 19.07.1993 — 001.001 — 25