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(a) the animal health requirements to be applied for the placing on the market, the importation and the transit of aquaculture animals and products thereof; (b) minimum preventive measures aimed at increasing the awareness and preparedness of the competent authorities, aquaculture production business operators and others related to this industry, for diseases in aquaculture animals; (c) minimum control measures to be applied in the event of a suspicion of, or an outbreak of certain diseases in aquatic animals.
Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals
Modified by
- Commission Directive 2008/53/ECof 30 April 2008amending Annex IV to Council Directive 2006/88/EC as regards Spring viraemia of carp (SVC)(Text with EEA relevance), 32008L0053, May 1, 2008
- Commission Implementing Directive 2012/31/EUof 25 October 2012amending Annex IV to Council Directive 2006/88/EC as regards the list of fish species susceptible to Viral haemorrhagic septicaemia and the deletion of the entry for Epizootic ulcerative syndrome(Text with EEA relevance), 32012L0031, October 26, 2012
- Commission Implementing Directive 2014/22/EUof 13 February 2014amending Annex IV to Council Directive 2006/88/EC as regards infectious salmon anaemia (ISA)(Text with EEA relevance), 32014L0022, February 14, 2014
Corrected by
- Corrigendum to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals, 32006L0088R(01), June 1, 2007
- Corrigendum to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals, 32006L0088R(02), September 12, 2007
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(a) ornamental aquatic animals reared in non-commercial aquaria; (b) wild aquatic animals harvested or caught for direct entry into the food chain; (c) aquatic animals caught for the purpose of production of fishmeal, fish feed, fish oil and similar products.
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(a) without any direct contact with natural waters in the Community; or (b) which are equipped with an effluent treatment system reducing the risk of transmitting diseases to the natural waters to an acceptable level.
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(a) "aquaculture" means the rearing or cultivation of aquatic organisms using techniques designed to increase the production of those organisms beyond the natural capacity of the environment and where the organisms remain the property of one or more natural or legal persons throughout the rearing or culture stages, up to and including harvesting; (b) "aquaculture animal" means any aquatic animal at all its life stages, including eggs and sperm/gametes, reared in a farm or mollusc farming area, including any aquatic animal from the wild intended for a farm or mollusc farming area; (c) "aquaculture production business" means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to the rearing, keeping or cultivation of aquaculture animals; (d) "aquaculture production business operator" means any natural or legal person responsible for ensuring that the requirements of this Directive are met within the aquaculture production business under their control; (e) "aquatic animal" means: -
(i) fish belonging to the superclass Agnatha and to the classesChondrichthyes and Osteichthyes ; (ii) mollusc belonging to the Phylum Mollusca ;(iii) crustacean belonging to the Subphylum Crustacea ;
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(f) "authorised processing establishment" means any food business approved in accordance with Article 4 of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal originOJ L 139, 30.4.2004, p. 55 .(g) "authorised processing establishment operator" means any natural or legal person responsible for ensuring that the requirements of this Directive are met within the authorised processing establishment under their control; (h) "farm" means any premises, enclosed area, or installation operated by an aquaculture production business in which aquaculture animals are reared with a view to their being placed on the market, with the exception of those where wild aquatic animals harvested or caught for the purpose of human consumption are temporarily kept awaiting slaughter without being fed; (i) "farming" means the rearing of aquaculture animals in a farm or in a mollusc farming area; (j) "mollusc farming area" means a production area or relaying area in which all aquaculture production businesses operate under a common biosecurity system; (k) "ornamental aquatic animal" means an aquatic animal which is kept, reared, or placed on the market for ornamental purposes only; (l) "placing on the market" means the sale, including offering for sale or any other form of transfer, whether free of charge or not, and any form of movement of aquaculture animals; (m) "production area" means any freshwater, sea, estuarine, continental or lagoon area containing natural beds of molluscs or sites used for the cultivation of molluscs, and from which molluscs are taken; (n) "put and take fisheries" means ponds or other installations where the population is maintained only for recreational fishing by restocking with aquaculture animals; (o) "relaying area" means any freshwater, sea, estuarine or lagoon area with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live molluscs; (p) "wild aquatic animal" means an aquatic animal which is not an aquaculture animal.
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(a) the technical definitions laid down in Annex I; (b) as appropriate, the definitions laid down respectively in: -
(i) Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safetyOJ L 31, 1.2.2002, p. 1 . (ii) Article 2 of Regulation (EC) No 852/2004; (iii) Article 2 of Regulation (EC) No 853/2004; (iv) Article 2 of Regulation (EC) No 882/2004.
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(a) installations other than aquaculture production businesses, where aquatic animals are kept without the intention of being placed on the market; (b) put and take fisheries; (c) aquaculture production businesses which place aquaculture animals on the market solely for human consumption in accordance with of Article 1(3)(c) of Regulation (EC) No 853/2004.
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(a) fulfils the relevant requirements of Articles 8, 9 and 10; (b) has a system in place which enables the operator to demonstrate to the competent authority that those relevant requirements are being fulfilled; and (c) remains under the supervision of the competent authority, which shall perform the duties laid down in Article 54(1).
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(a) all movements of aquaculture animals and products thereof into and out of the farm or mollusc farming area; (b) the mortality in each epidemiological unit as relevant for the type of production; and (c) the results of the risk-based animal health surveillance scheme provided for in Article 10.
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(a) mortality during transport, as practicable for the type of transport and the species transported; (b) farms, mollusc farming areas and processing establishments visited by the means of transport; and (c) any water exchange during transport, in particular the sources of new water and site of release of water.
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(a) any increased mortality in all farms and mollusc farming areas as appropriate for the type of production; and (b) the diseases listed in Part II of Annex IV, in farms and mollusc farming areas were species susceptible to those diseases are present.
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(a) the necessary disease prevention measures are applied during the transport of aquaculture animals in order not to alter the health status of those animals during transport, and to reduce the risk of spreading diseases; and (b) aquaculture animals are transported under conditions which neither alter their health status nor jeopardise the health status of the place of destination, and where appropriate, of places of transit.
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(a) the aquaculture animals being transported; (b) any aquatic animals at the place of water exchange; and (c) aquatic animals at the place of destination.
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(a) farming and restocking purposes; or (b) further processing before human consumption, unless: -
(i) as regards fish, they are slaughtered and eviscerated before dispatch; (ii) as regards molluscs and crustaceans, they are dispatched as unprocessed or processed products.
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(a) movements of aquaculture animals between Member States where animal health certification is required in accordance with paragraphs 1 or 2 of this Article; and (b) all other movements of live aquaculture animals for farming or restocking purposes between Member States where no animal health certification is required under this Directive.
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(a) clinically healthy; and (b) do not come from a farm or mollusc farming area where there is any unresolved increased mortality.
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(a) comply with the requirements in paragraph 1; and (b) come from a farm or mollusc farming area with a health status as referred to in Part A of Annex III, at least equivalent to the health status of the waters in which they are to be released.
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(a) originate from another Member State, zone or compartment declared free of that specific disease; or (b) be held in quarantine facilities in water free of the pathogen in question, for an appropriate period of time, where, in the light of the scientific data or practical experience provided, this proves to be sufficient to reduce the risk of transmission of the specific disease to a level acceptable for preventing the transmission of the disease concerned.
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(a) they originate from another Member State, zone or compartment declared free of the disease in question; (b) they are processed in an authorised processing establishment under conditions which prevent the spreading of diseases; (c) as regards fish, they are slaughtered and eviscerated before dispatch; or (d) as regards molluscs and crustaceans, they are dispatched as unprocessed or processed products.
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(a) they originate from another Member State, zone, or compartment declared free of the disease in question; or (b) they are temporarily kept in dispatch centres, purification centres or similar businesses which are equipped with an effluent treatment system inactivating the pathogens in question, or where the effluent is subject to other types of treatment reducing the risk of transmitting diseases to the natural waters to an acceptable level.
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(a) the legislation of the third country; (b) the organisation of the competent authority and its inspection services in the third country, the powers of these services, the supervision to which they are subject, and the means at their disposal, including staff capacity, to apply their legislation effectively; (c) the aquatic animal health requirements in force that apply to the production, manufacture, handling, storage and dispatch of live aquaculture animals intended for the Community; (d) the assurances which the competent authority of the third country may give regarding compliance or equivalence with the relevant aquatic animal health conditions; (e) any experience of marketing live aquaculture animals from the third country and the results of any import controls carried out; (f) the results of the Community assessment, in particular the results of the assessment carried out by the competent authorities of the third country concerned or, where the Commission so requests, the report submitted by the competent authorities of the third country on any inspections carried out; (g) the health status of farmed and wild aquatic animals in the third country, with particular regard to exotic animal diseases and any aspects of the general aquatic animal health situation in the country which might pose a risk to aquatic animal health in the Community; (h) the regularity, speed and accuracy with which the third country supplies information on the existence of infectious or contagious aquatic animal diseases in its territory, particularly the notifiable diseases, listed by the World Organisation for Animal Health (OIE); and (i) the rules on the prevention and control of aquatic animal diseases in force in the third country and their implementation, including rules on imports from other countries.
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(a) the requirements laid down for such commodities under this Directive; and (b) any special import conditions established in accordance with Article 25(a).
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(a) special import conditions for each third country, parts thereof or group of third countries; (b) the criteria for classifying third countries and parts thereof with regard to aquatic animal diseases; (c) the use of electronic documents; (d) model animal health certificates and other documents; and (e) procedures and certification for transit.
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(a) when there are any reasons to suspect the presence of a disease listed in Part II of Annex IV, or the presence of such disease is confirmed in aquatic animals, the suspicion and/or the confirmation is immediately notified to the competent authority; and (b) when increased mortality occurs in aquaculture animals, the mortality is immediately notified to the competent authority or a private veterinarian for further investigations.
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(a) the owner and any person attending aquatic animals; (b) any person accompanying aquaculture animals during transport; (c) veterinary practitioners and other professionals involved in aquatic animal health services; (d) official veterinarians, senior staff of veterinary or other official or private laboratories; and (e) any other person with an occupational relationship to aquatic animals of susceptible species or to products of such animals.
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(a) an exotic disease listed in Part II of Annex IV; (b) a non-exotic disease listed in Part II of Annex IV where the Member State concerned, zone, or compartment has been declared free of that disease.
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(a) appropriate samples are taken and examined in a laboratory designated in accordance with Article 57; (b) pending the result of the examination provided for in point (a): -
(i) the farm, or mollusc farming area, in which the disease is suspected, is placed under official surveillance and relevant control measures are implemented to prevent the spreading of the disease to other aquatic animals; (ii) no aquaculture animals are allowed to leave or enter the affected farm or mollusc farming area in which the disease is suspected, unless authorised by the competent authority; (iii) the epizootic investigation provided for in Article 29 is initiated.
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(a) an exotic disease listed in Part II of Annex IV in any Member State; or (b) a non-exotic disease listed in Part II of Annex IV in Member States, zones or compartments with a health status of either category I or III, as referred to in Part A of Annex III, for the disease in question.
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(a) determining the possible origin and means of contamination; (b) investigating whether aquaculture animals have left the farm or mollusc farming area during the relevant period preceding the notification of the suspicion provided for in Article 26(1); (c) investigating whether other farms have been infected.
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(a) the farm or mollusc farming area is officially declared infected; (b) a containment area appropriate to the disease in question is established, including a protection zone and surveillance zone, around the farm or mollusc farming area declared infected; (c) no restocking takes place and no aquaculture animals are moved into, within, and out of the containment area unless authorised by the competent authority; and (d) any additional measures necessary to prevent the further spread of the disease are implemented.
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(a) the eradication measures provided for in this Section have been carried out; (b) sampling and surveillance as appropriate for the disease in question and the types of aquaculture production businesses affected has been carried out in the containment area with negative results.
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(a) apply the measures provided for in Section 3 in order to regain such disease-free status, or (b) draw up an eradication programme in accordance with Article 44(2).
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(a) declaring the farm or mollusc farming area to be infected; (b) establishing a containment area appropriate to the disease in question, including a protection zone and surveillance zone around the farm or mollusc farming area declared infected; (c) restricting the movement of aquaculture animals from the containment area to the effect that such animals may only be: -
(i) introduced into farms or mollusc farming areas in accordance with Article 12(2); or (ii) harvested and slaughtered for human consumption in accordance with Article 33(1);
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(d) the removal and disposal of dead fish and crustaceans, under the supervision of the competent authority in accordance with Regulation (EC) No 1774/2002, in an appropriate timeframe taking into account the type of production and the risk such dead animals pose for further spread of the disease.
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(a) the measures provided for in this chapter are found not to be suited to the epidemiological situation; or (b) the disease appears to be spreading despite the measures taken in accordance with this chapter.
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(a) a description of the epidemiological situation of the disease before the date of commencement of the programme; (b) an analysis of the estimated costs and the anticipated benefits of the programme; (c) the likely duration of the programme and the objective to be attained by the completion date of the programme; and (d) a description and demarcation of the geographical and administrative area in which the programme is to be applied.
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(a) the requirements laid down in Annex V have been fulfilled, and the Member State, zone or compartment is declared free of the disease; or (b) the programme is withdrawn, namely if it no longer fulfils its purpose, by the competent authority of the Member State concerned, or by the Commission.
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(a) provide the competent authority with the authority and means to access all facilities, equipment, personnel and other appropriate materials necessary for the rapid and efficient eradication of an outbreak; (b) ensure coordination and compatibility with neighbouring Member States and encourage cooperation with neighbouring third countries; and (c) where relevant, give a precise indication of the vaccine requirements and vaccination conditions considered necessary in the event of emergency vaccination.
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(a) none of the species susceptible to the disease(s) in question is present in its territory; or (b) the pathogen is known not to be able to survive in the Member State, and in its water source; or (c) the Member State meets the conditions laid down in Part I of Annex V.
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(a) none of the species susceptible to the disease(s) in question is present in the zone or compartment, and where relevant in its water source; or (b) the pathogen is known not to be able to survive in the zone or compartment, and where relevant in its water source; or (c) the zone or compartment complies with the conditions laid down in Part II of Annex V.
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(a) the declaration shall be supported by evidence in a form to be determined in accordance with the procedure referred to in Article 62(2) and be accessible by electronic means to the Commission and Member States, in accordance with the requirements of Article 59; (b) the Commission shall add the notification of the declaration to the agenda of the next meeting of the Committee referred to in Article 62(1) as an information point. The declaration shall take effect 60 days after the date of the meeting; (c) within this period, the Commission or Member States may seek clarification or additional information on the supporting evidence from the Member State making the declaration; (d) where written comments are made by at least one Member State, or the Commission, within the period referred to in point (b) indicating significant objective concerns related to the supporting evidence, the Commission and the Member States concerned shall together examine the submitted evidence in order to resolve the concerns. In that case, the period referred to in point (b) may be prolonged for 30 days. Such comments shall be submitted to the declaring Member State and to the Commission; (e) if the arbitration referred to in point (d) fails, the Commission may decide to make an on-the-spot inspection in accordance with Article 58 to verify the compliance of the declaration submitted with the criteria set out in paragraph 1, unless the declaring Member State withdraws its declaration; (f) where necessary in the light of the results achieved, a decision in accordance with the procedure referred to in Article 62(2) shall be taken, to suspend the self-declaration of the disease-free status of the zone or compartment concerned.
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(a) laboratory examinations for the purposes of this Directive are carried out in laboratories designated for such purpose by the competent authority; (b) laboratory examinations in the case of suspicion and to confirm the presence of the diseases listed in Part II of Annex IV are carried out by diagnostic methods to be established in accordance with the procedure referred to in Article 62(2); and (c) laboratories designated for diagnostic services in accordance with this Article shall comply with the functions and duties laid down in Part III of Annex VI.
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(a) "compartment" means one or more farms under a common biosecurity system containing an aquatic animal population with a distinct health status with respect to a specific disease; (b) "common biosecurity system" means that the same aquatic animal health surveillance, disease prevention, and disease control measures are applied; (c) "containment area" means an area around an infected farm or mollusc farming area where disease control measures are applied with the purpose of preventing the spread of the disease; (d) "disease" means a clinical or non-clinical infection with one or more aetiological agents in aquatic animals; (e) "disease-free zones or compartments" means zones or compartments declared disease-free in accordance with Articles 49 or 50; (f) "emerging disease" means a newly identified serious disease, the cause of which may or may not yet be established, that has the potential to be spread within and between populations, such as by way of trade in aquatic animals and/or aquatic animal products. It also means a listed disease identified in a new host species not yet included in Part II of Annex IV as a susceptible species; (g) "epidemiological unit" means a group of aquatic animals that share approximately the same risk of exposure to a disease agent within a defined location. This risk may be because they share a common aquatic environment, or because management practices make it likely that a disease agent in one group of animals would quickly spread to another group of animals; (h) "fallowing" means, for disease management purposes, an operation where a farm is emptied of aquaculture animals susceptible to the disease of concern or known to be capable of transferring the disease agent, and, where feasible, of the carrying water; (i) "further processing" means processing of aquaculture animals before human consumption by any type of measures and techniques affecting anatomical wholeness, such as bleeding, gutting/evisceration, heading, slicing and filleting, which produces waste or by-products and could cause a risk of spreading diseases; (j) "increased mortality" means unexplained mortalities significantly above the level of what is considered to be normal for the farm or mollusc farming area in question under the prevailing conditions. What is considered to be increased mortality shall be decided in cooperation between the farmer and the competent authority; (k) "infection" means the presence of a multiplying, or otherwise developing, or latent disease agent in, or on, a host; (l) "infected zone or compartment" means zones or compartments where the infection is known to occur; (m) "quarantine" means maintaining a group of aquatic animals in isolation with no direct or indirect contact with other aquatic animals, in order to undergo observation for a specified length of time and, where appropriate, testing and treatment, including proper treatment of the effluent waters; (n) "susceptible species" means any species in which infection by a disease agent has been demonstrated by natural cases or by experimental infection that mimics the natural pathways; (o) "vector" means a species that is not susceptible to a disease but which is capable of spreading infection by conveying pathogens from one host to another; (p) "zone" means a precise geographical area with a homogeneous hydrological system comprising part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals from lower stretches of the water catchment area, an entire water catchment area from its source(s) to its estuary, or more than one water catchment area, including their estuaries, due to the epidemiological link between the catchment areas through the estuary.
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1. The following minimum information on each aquaculture production business shall be kept by the competent authority in a register, as provided for in Article 6: -
(a) the name and addresses of the aquaculture production business, and contact details (telephone, facsimile, e-mail); (b) the registration number and particulars of the authorisation delivered, (i.e. dates for specific authorisations, identification codes or numbers, specified conditions for production, any other matter relevant to the authorisation(s)); (c) the geographical position of the farm defined by a suitable system of coordinates of all farm-sites (if possible, GIS coordinates); (d) the purpose, type (i.e. type of culture system, or facilities such as land-based facilities, sea cages, earth ponds) and maximum volume of production where this is regulated; (e) for continental farms, dispatch centres and purification centres, details on the farm's water supply and discharges; (f) the species of aquaculture animals reared at the farm (for multi-species farms or ornamental farms, it shall as a minimum be registered whether any of the species are known to be susceptible to diseases listed in Part II of Annex IV, or known vectors of such diseases); (g) updated information on the health status (i.e. if the farm is disease-free (located in a Member State, zone or compartment), where the farm is under a programme with a view of achieving such status, or where the farm is declared infected by a disease referred to in Annex IV).
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2. Where an authorisation is granted to a mollusc farming area in accordance with the second subparagraph of Article 4(1), the data required pursuant to point 1(a) of this part shall be recorded for all aquaculture production businesses which operate within the mollusc farming area. The data required pursuant to points 1(b) to 1(g) of this part shall be recorded at mollusc farming area level.
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(a) the name and addresses of the authorised processing establishment, and contact details (telephone, facsimile, e-mail); (b) the registration number and particulars of the authorisation delivered (i.e. dates for specific authorisations, identification codes or numbers, specified conditions for production, any other matter relevant to the authorisation(s)); (c) the geographical position of the processing establishment defined by a suitable system of coordinates (if possible GIS coordinates); (d) details on the authorised processing establishment's water effluent treatment systems; (e) the species of aquaculture animals handled in the authorised processing establishment.
| Category | Health status | May introduce animals from | Health certification | May dispatch animals to | |
|---|---|---|---|---|---|
| Introduction | Dispatching | ||||
| I | Only category I | YES | NO when dispatched to category III or V | All categories | |
| YES when dispatched to categories I, II or IV | |||||
| II | Only category I | YES | NO | Categories III and V | |
| III | Categories I, II, or III | NO | NO | Categories III and V | |
| IV | Only category I | YES | YES | Only category V | |
| V | All categories | NO | YES | Only category V | |
| Species present | Health status as referred to in Part A | Risk level | Surveillance | Recommended inspection frequency by the competent authority (Article 7) | Recommended inspection frequency by qualified aquatic animal health services (Article 10) | Specific requirements for inspections, sampling and surveillance necessary to maintain the health status | Comments |
|---|---|---|---|---|---|---|---|
| No species susceptible to the diseases listed in Annex IV | Low | Passive | 1 every 4 years | 1 every 4 years | Specific requirements for the maintenance of the disease-free status in accordance with Article 52. | ||
| Species susceptible to one or more of the diseases listed in Annex IV | High | Active, targeted or passive | 1 every year | 1 every year | |||
| Medium | 1 every 2 years | 1 every 2 years | |||||
| Low | 1 every 4 years | 1 every 2 years | |||||
| High | Targeted | 1 every year | 1 every year | Specific requirements in accordance with Article 44(1). | |||
| Medium | 1 every 2 years | 1 every 2 years | |||||
| Low | 1 every 4 years | 1 every 2 years | |||||
| High | Active | 1 every year | 3 every year | ||||
| Medium | 1 every year | 2 every year | |||||
| Low | 1 every 2 years | 1 every year | |||||
| High | Targeted | 1 every year | 1 every year | Specific requirements in accordance with Article 44(2). | |||
| Medium | 1 every 2 years | 1 every 2 years | |||||
| Low | 1 every 4 years | 1 every 2 years | |||||
| High | Passive | 1 every 4 years | 1 every year | Specific requirements in accordance with Chapter V. | |||
| Medium | 1 every 4 years | 1 every 2 years | |||||
| Low | 1 every 4 years | 1 every 4 years |
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(a) has a high risk of spreading diseases to or contracting diseases from other farms or wild stocks; (b) operates under farming conditions which could increase the risk of disease outbreaks (high biomass, low water quality), taking into account the species present; (c) sells live aquatic animals for further farming or restocking.
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(a) has medium risk of spreading diseases to or contracting diseases from other farms or wild stocks; (b) operates under farming conditions which would not necessarily increase the risk of disease outbreaks (medium biomass and water quality), taking into account the species present; (c) sells live aquatic animals mainly for human consumption.
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(a) has a low risk of spreading diseases to or contracting diseases from other farms or wild stocks; (b) operates under farming conditions which would not increase the risk of disease outbreaks (low biomass, good water quality), taking into account the species present; (c) sells live aquatic animals for human consumption only.
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(a) routine inspection by the competent authority or by other qualified health services on behalf of the competent authorities; (b) examination of the aquaculture animal population on the farm or in the mollusc farming area for clinical disease; (c) diagnostic samples to be collected on suspicion of a listed disease or observed increased mortality during inspection; (d) mandatory immediate notification of occurrence or suspicion of specified diseases or of any increased mortalities.
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(a) routine inspection by the competent authority or by other qualified health services on behalf of the competent authorities; (b) prescribed samples of aquaculture animals to be taken and tested for specific pathogen(s) by specified methods; (c) mandatory immediate notification of occurrence or suspicion of specified diseases or of any increased mortalities.
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A. Exotic diseases shall meet the following criteria laid down in point 1 and either point 2 or 3. -
1. The disease is exotic to the Community, i.e. the disease is not established in Community aquaculture, and the pathogen is not known to be present in Community waters. 2. It has potential for significant economic impact if introduced into the Community, either by production losses in Community aquaculture or by restricting the potential for trade in aquaculture animals and products thereof. 3. It has potential for detrimental environmental impact if introduced into the Community, to wild aquatic animal populations of species, which are an asset worth protecting by Community law or international provisions.
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B. Non-exotic diseases shall meet the following criteria laid down in points 1, 4, 5, 6, 7, and 2 or 3. -
1. Several Member States, or regions in several Member States, are free of the specific disease. 2. It has potential for significant economic impact if introduced into a Member State free of the disease, either by production losses, and annual costs associated with the disease and its control exceeding 5 % of the value of the production of the susceptible aquaculture animal species production in the region, or by restricting the possibilities for international trade in aquaculture animals and products thereof. 3. The disease has shown, where it occurs, to have a detrimental environmental impact if introduced into a Member State free of the disease, to wild aquatic animal populations of species that is an asset worth protecting under Community law or international provisions. 4. The disease is difficult to control and contain at farm or mollusc farming area level without stringent control measures and trade restrictions. 5. The disease may be controlled at Member State level, experience having shown that zones or compartments free of the disease may be established and maintained, and that this maintenance is cost-beneficial. 6. During placing on the market of aquaculture animals, there is a risk that the disease will establish itself in a previously uninfected area. 7. Reliable and simple tests for infected aquatic animals are available. The tests must be specific and sensitive and the testing method harmonised at Community level.
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| Exotic diseases | ||
|---|---|---|
| Disease | Susceptible species | |
| Fish | Epizootic haematopoietic necrosis | Rainbow trout ( |
| Molluscs | Infection with |
Australian mud oyster ( |
| Infection with |
Pacific oyster ( | |
| Infection with |
Pacific oyster ( | |
| Crustaceans | Taura syndrome | Gulf white shrimp ( |
| Yellowhead disease | Gulf brown shrimp ( | |
| Non-exotic diseases | ||
|---|---|---|
| Fish | Viral haemorrhagic septicaemia (VHS) | Herring ( |
| Infectious haematopoetic necrosis (IHN) | Chum salmon ( | |
| Koi herpes virus (KHV) disease | Common carp and koi carp ( | |
| Infectious salmon anaemia (ISA): infection with genotype HPR-deleted of the genus Isavirus (ISAV) | Rainbow trout ( | |
| Molluscs | Infection with |
Australian mud oyster ( |
| Infection with |
Australian mud oyster ( | |
| Crustaceans | White spot disease | All decapod crustaceans ( |
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1. On historical grounds -
1.1. A Member State where susceptible species are present, but where there has not been any observed occurrence of the disease for at least for a period of 10 years before the date of application for the disease-free status despite conditions that are conducive to its clinical expression may be considered disease-free where: -
(a) basic biosecurity measure conditions have been in place continuously for at least a period of 10 years before the date of application for the disease-free status; (b) infection is not known to be established in wild populations; (c) the implementation of trade and imports conditions to prevent the introduction of the disease into the Member State is effective.
A Member State wishing to benefit from a disease-free status, shall submit an application in accordance with Article 49 before 1 November 2008 . After this date, disease-free status may only be granted in accordance with Part I.2. -
1.2. The basic biosecurity measures referred to in point 1.1(a) shall consist, as a minimum, of the following: -
(a) the disease is compulsorily notifiable to the competent authority, including notification of suspicion; (b) an early detection system is in place throughout the Member State, enabling the competent authority to undertake effective disease investigation and reporting, and ensuring in particular: -
(i) the rapid recognition of any clinical signs consistent with the suspicion of a disease, emerging disease, or unexplained mortality in farms or molluscs farming areas, and in the wild; (ii) the rapid communication of the event to the competent authority with the aim to activating diagnostic investigation with minimum delay.
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1.3. The early detection system referred to in point 1.2(b) shall include at least the following: -
(a) broad awareness, among the personnel employed in aquaculture businesses or involved in the processing of aquaculture animals, of any signs consistent with the presence of a disease, and training of veterinarians or aquatic animal health specialists in detecting and reporting unusual disease occurrence; (b) veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease occurrence; (c) access by the competent authority to laboratories with the facilities for diagnosing and differentiating listed and emerging diseases.
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2. Based on targeted surveillance A Member State where the last known clinical occurrence was within 10 years before the date of application for the disease-free status or where the infection status prior to targeted surveillance was unknown, for example because of the absence of conditions conducive to clinical expression, may be considered free of the specific disease where: -
(a) the Member State meets the basic disease control conditions laid down in point 1.2; and (b) targeted surveillance in accordance with methods adopted pursuant to Article 49(3), has been in place for at least a period of two years without detection of the disease agent on farm, or in mollusc farming areas that rears any of the susceptible species.
Where there are parts of the Member State in which the number of farms, or molluscs farming areas is limited, and consequently targeted surveillance in these parts do not provide sufficient epidemiological data, but in which there are wild populations of any of the susceptible species, those wild populations shall be included in the targeted surveillance. -
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1. Zones -
1.1. A zone may comprise: -
(a) an entire water catchment area from its source to its estuary; or (b) part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals from lower stretches of the water catchment area; or (c) more than one water catchment area, including their estuaries, due to the epidemiological link between the catchment areas through the estuary.
The geographical demarcation of the zone shall be clearly identified on a map. -
1.2. Where a zone extends over more than one Member State, it may not be declared a disease-free zone unless the conditions outlined in points 1.3, 1.4 and 1.5 apply to all areas of that zone. In that case both Member States concerned shall apply for approval for the part of the zone situated in their territory. 1.3. A zone where susceptible species are present, but where there has not been any observed occurrence of the disease for at least a period of 10 years before the date of application for the disease-free status, despite conditions that are conducive to its clinical expression, may be considered disease-free if it complies mutatis mutandis with the requirements laid down in Part I.1.A Member State wishing to benefit from a disease-free status shall notify its intention in accordance with Article 50(2) before 1 November 2008 . After this date, disease-free status may only be granted in accordance with Part I.2.1.4. A zone where the last known clinical occurrence was within a period of 10 years before the date of application for the disease-free status or where the infection status prior to targeted surveillance was unknown, for example because of the absence of conditions conducive to clinical expression, may be considered disease-free where it complies mutatis mutandis with the requirements laid down in Part I.2.1.5. A buffer zone in which a monitoring programme is carried out shall be established, as appropriate. The demarcation of the buffer zones shall be such that it protects the disease-free zone from passive introduction of the disease.
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2. Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is dependent on the health status regarding that disease of surrounding natural waters -
2.1. A compartment may comprise one or more farms, a group or cluster of farms or a mollusc farming area that may be considered as one epidemiological unit due to its geographical localisation and distance from other groups or clusters of farms or mollusc farming areas, provided that all farms comprising the compartment fall within a common biosecurity system. The geographical demarcation of a compartment shall be clearly identified on a map. 2.2. A compartment where susceptible species are present, but where there has not been any observed occurrence of the disease for at least a period of 10 years before the date of application for the disease-free status despite conditions that are conducive to its clinical expression, may be considered disease-free if it complies mutatis mutandis with the requirements in Part I.1 of this Annex.Member States wishing to benefit from this provision shall notify their intention in accordance with Article 50(2) before 1 November 2008 . After this date, disease-free status may only be granted in accordance with Part I.2.2.3. A compartment where the last known clinical occurrence was within 10 years before the date of application for the disease-free status, or where the infection status in the compartment or in the waters surrounding the compartment prior to targeted surveillance was unknown, for example because of the absence of conditions conducive to clinical expression, may be considered disease-free if it complies mutatis mutandis with the requirements laid down in Part I.2.2.4. Each farm or mollusc farming area in a compartment shall be subject to additional measures imposed by the competent authority, when considered necessary to prevent the introduction of diseases. Such measures may include the establishment of a buffer zone around the compartment in which a monitoring programme is carried out, and the establishment of additional protection against the intrusion of possible pathogen carriers or vectors.
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3. Compartments comprising one or more individual farms where the health status regarding a specific disease is independent of the health status regarding that disease of the surrounding natural waters. -
3.1. A compartment may comprise: -
(a) an individual farm which may be considered a single epidemiological unit, as it is not influenced by the animal health status in the surrounding waters; or (b) more than one farm where each farm in the compartment complies with the criteria laid down in point 3.1(a) and points 3.2 to 3.6, but, due to extensive movement of animals between farms, shall be considered as a single epidemiological unit, provided that all farms are under a common biosecurity system.
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3.2. A compartment shall be supplied with water: -
(a) through a water treatment plant inactivating the relevant pathogen in order to reduce the risk of the introduction of the disease to an acceptable level; or (b) directly from a well, a borehole or a spring. Where such water supply is situated outside the premises of the farm, the water shall be supplied directly to the farm, and be channelled through a pipe.
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3.3. There shall be natural or artificial barriers that prevent aquatic animals from entering each farm in a compartment from the surrounding watercourses. 3.4. The compartment shall, where appropriate, be protected against flooding and infiltration of water from the surrounding watercourses. 3.5. The compartment shall comply, mutatis mutandis , with the requirements laid down in Part I.2.3.6. A compartment shall be subject to additional measures imposed by the competent authority, when considered necessary to prevent the introduction of diseases. Such measures may include the establishment of additional protection against the intrusion of possible pathogen carriers or vectors. 3.7. Implementing measures concerning point 3.2(a) shall be laid down in accordance with the procedure referred to in Article 62(2).
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4. Special provisions for individual farms which commence or recommence their activities -
4.1. A new farm, which meets the requirements referred to in points 3.1(a) and 3.2 to 3.6, but which commences its activities with aquaculture animals from a compartment declared disease-free may be considered disease-free without undergoing the sampling required for approval. 4.2. A farm which recommences its activities after a break with aquaculture animals from a compartment declared disease-free, and meets the requirements referred to in points 3.1(a) and 3.2 to 3.6, may be considered disease-free without undergoing the sampling required for approval, provided that: -
(a) the health history of the farm over the last four years of its operation is known to the competent authority; however, if the farm concerned has been in operation for less than four years, the actual period in which it has been in operation will be taken into account; (b) the farm has not been subject to animal-health measures in respect of the diseases listed in Part II of Annex IV and there have been no antecedents of those diseases on the farm; (c) prior to the introduction of the aquaculture animals, eggs or gametes, the farm is cleaned and disinfected, followed, as necessary, by a period of fallowing.
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1. In order to be designated as a Community reference laboratory in accordance with Article 55, laboratories shall fulfil the following requirements. They must: -
(a) have suitably qualified staff with adequate training in diagnostic and analytical techniques applied in their area of competence, including trained personnel available for emergency situations occurring within the Community; (b) possess the equipment and products needed to carry out the tasks assigned to them; (c) have an appropriate administrative infrastructure; (d) ensure that their staff respect the confidential nature of certain subjects, results or communications; (e) have sufficient knowledge of international standards and practices; (f) have available, as appropriate, an updated list of available reference substances and reagents and an updated list of manufacturers and suppliers of such substances and reagents; (g) take account of research activities at national and Community level.
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2. However, the Commission may designate only laboratories that operate and are assessed and accredited in accordance with the following European Standards, account being taken of the criteria for different testing methods laid down in this Directive: -
(a) EN ISO/IEC 17025 on "General requirements for the competence of testing and calibration laboratories"; (b) EN 45002 on "General criteria for the assessment of testing laboratories"; (c) EN 45003 on "Calibration and testing laboratory accreditation system — General requirements for operation and recognition".
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3. The accreditation and assessment of testing laboratories referred to in paragraph 2 may relate to individual tests or groups of tests. 4. For one or more of the diseases under their responsibility, the Community reference laboratories may take advantage of the skills and capacity of laboratories in other Member States or EFTA Member States, provided that the laboratories concerned comply with the requirements laid down in points 1, 2 and 3 of this Annex. Any intention to take advantage of such cooperation shall be part of the information provided as a basis for the designation in accordance with Article 55(1). However, the Community reference laboratory shall remain the contact point for the National reference laboratories in the Member States, and for the Commission. 5. The Community reference laboratories shall: -
(a) coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing the disease concerned, specifically by: -
(i) typing, storing and, where appropriate, supplying strains of the pathogen of the relevant disease to facilitate the diagnostic service in the Community, (ii) supplying standard sera and other reference reagents to the national reference laboratories in order to standardise the tests and reagents used in each Member State, where serological tests are required, (iii) organising periodic comparative tests (ring tests) of diagnostic procedures at Community level with the national reference laboratories designated by the Member States, in order to provide information on the methods of diagnosis used and the results of tests carried out in the Community; (iv) retaining expertise on the relevant disease pathogen and other pertinent pathogens to enable rapid differential diagnosis;
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(b) assist actively in the diagnosis of outbreaks of the relevant disease in Member States by receiving pathogen isolates for confirmatory diagnosis, characterisation and epizootic studies; (c) facilitate the training or retraining of experts in laboratory diagnosis with a view to harmonising diagnostic techniques throughout the Community; (d) collaborate, as regards methods of diagnosing animal diseases falling within their areas of competence, with the competent laboratories in third countries where those diseases are prevalent; (e) collaborate with the relevant OIE reference laboratories with regard to exotic diseases listed in Part II of Annex IV under their responsibility; (f) collate and forward information on exotic and endemic diseases, that are potentially emerging in Community aquaculture.
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1. The national reference laboratories designated pursuant to Article 56 shall be responsible for coordinating the diagnostic standards and methods within their field of responsibility in the Member State concerned. These national reference laboratories shall: -
(a) undertake to notify, without delay, the competent authority whenever the laboratory is aware of a suspicion of any of the diseases referred to in Annex IV; (b) coordinate, in consultation with the relevant Community reference laboratory, the methods employed in Member States for diagnosing the diseases concerned under their responsibility; (c) assist actively in the diagnosis of outbreaks of the relevant disease by receiving pathogen isolates for confirmatory diagnosis, characterisation and epizootic studies; (d) facilitate the training or retraining of experts in laboratory diagnosis with a view to harmonising diagnostic techniques throughout the Member State; (e) ensure confirmation of positive results of all outbreaks of exotic diseases listed in Part II of Annex IV, and of primary outbreaks of non-exotic diseases listed in that Annex; (f) organise periodic comparative tests (ring tests) of diagnostic procedures at national level with the laboratories designated by the Member States in accordance with Article 57, in order to provide information on the methods of diagnosis used and the results of tests carried out in the Member State; (g) cooperate with the Community reference laboratory referred to in Article 55 and participate in the comparative tests organised by the Community reference laboratories; (h) ensure a regular and open dialogue with their national competent authorities; (i) operate and be assessed and accredited in accordance with the following European Standards account being taken of the criteria for different testing methods laid down in this Directive: -
(i) EN ISO/IEC 17025 on "General requirements for the competence of testing and calibration laboratories"; (ii) EN 45002 on "General criteria for the assessment of testing laboratories"; (iii) EN 45003 on "Calibration and testing laboratory accreditation system — General requirements for operation and recognition".
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2. The accreditation and assessment of testing laboratories referred to in point 1(i) may relate to individual tests or groups of tests. 3. The Member States may designate national reference laboratories which do not comply with the requirements referred to in point 1(i)(i) of this Part, where operation under EN ISO/IEC 17025 is practically difficult, provided the laboratory operates under quality assurance in line with the guidelines in ISO 9001. 4. Member States may authorise a national reference laboratory situated on their territory to take advantage of the skills and capacity of other laboratories designated pursuant to Article 57, for one or more of the diseases under their responsibility, provided that these laboratories comply with the relevant requirements of this Part. However, the national reference laboratory shall remain the contact point for the central competent authority of the Member State, and for the Community reference laboratory.
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1. The competent authority of a Member State shall designate only laboratories for diagnostic services pursuant to Article 57 that fulfil the following requirements. They must: -
(a) undertake to notify, without delay, the competent authority whenever a laboratory is aware of a suspicion of any of the diseases referred to in Annex IV; (b) undertake to participate in comparative tests (ring-tests) of diagnostic procedures arranged by the national reference laboratory; (c) operate and be assessed and accredited in accordance with the following European Standards account being taken of the criteria for different testing methods laid down in this Directive: -
(i) EN ISO/IEC 17025 on "General requirements for the competence of testing and calibration laboratories"; (ii) EN 45002 on "General criteria for the assessment of testing laboratories"; (iii) EN 45003 on "Calibration and testing laboratory accreditation system — General requirements for operation and recognition".
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2. The accreditation and assessment of testing laboratories referred to in paragraph 1(c) may relate to individual tests or groups of tests. 3. The Member States may designate laboratories which do not comply with the requirements referred to in point 1(c)(i) of this Part, where operation under EN ISO/IEC 17025 is practically difficult, provided that the laboratory operates under quality assurance in line with the guidelines in ISO 9001. 4. The competent authority shall cancel the designation where the conditions referred to in this Annex are no longer fulfilled.
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1. Provision must be made to ensure the legal powers needed to implement contingency plans and put into effect a rapid and successful eradication campaign; 2. Provision must be made to ensure access to emergency funds, budgetary means and financial resources in order to cover all aspects of the fight against exotic diseases listed in Part II of Annex IV; 3. A chain of command must be established to guarantee a rapid and effective decision-making process for dealing with exotic diseases listed in Annex IV or emerging diseases. A central decision-making unit must be in charge of the overall direction of control strategies; 4. Detailed plans must be available for Member States to be prepared for the immediate establishment of local disease control centres in the event of an outbreak of exotic diseases listed in Part II of Annex IV or emerging diseases and to implement disease control and environment protection measures at a local level; 5. Member States must ensure cooperation between the competent authorities and competent environmental authorities and bodies in order to ensure that actions on veterinary and environmental safety issues are properly coordinated; 6. Provision must be made for adequate resources to ensure a rapid and effective campaign, including personnel, equipment and laboratory capacity; 7. An up-to-date operations manual must be available, with a detailed, comprehensive and practical description of all the actions, procedures, instructions and control measures to be employed in handling exotic diseases listed in Part II of Annex IV or emerging diseases; 8. Detailed plans must be available for emergency vaccination, where appropriate; 9. Staff must be regularly involved in training in clinical signs, epidemiological enquiry and control of epizootic diseases, in real-time alert exercises, and in training in communication skills to provide ongoing disease awareness campaigns for authorities, farmers and veterinarians; 10. Contingency plans must be prepared that take into account the resources needed to control a large number of outbreaks occurring within a short period of time; 11. Without prejudice to the veterinary requirements laid down in Regulation (EC) No 1774/2002, contingency plans must be prepared to ensure that, in the event of an outbreak of diseases, any mass disposal of aquatic animal carcases and aquatic animal waste is done without endangering animal and human health, using processes or methods which prevent damage to the environment and in particular: -
(i) with minimum risk to soil, air, surface and groundwater, and to plants and animals; (ii) with minimum nuisance caused by noise or odours; (iii) with minimum adverse effects on the nature or places of special interest;
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12. Such plans must include the identification of appropriate sites and undertakings for the treatment or disposal of animal carcasses and animal waste in the event of an outbreak in accordance with Regulation (EC) No 1774/2002.
| This Directive | Repealed Directives | ||
|---|---|---|---|
| 91/67/EEC | 93/53/EEC | 95/70/EC | |
| Article 1(1)(a) | — | — | |
| Article 1(1)(b) | — | — | — |
| Article 1(1)(c) | — | Article 1 | Article 1 |
| Article 1(2) | — | Article 20(2) | Article 12(2) |
| Article 2(1) | — | — | — |
| Article 2(2) | — | — | — |
| Article 2(3) | — | — | |
| Article 3 | Article 2 | Article 2 | Article 2 |
| Article 4 | — | — | — |
| Article 5 | — | — | — |
| Article 6 | — | — | — |
| Article 7 | — | — | — |
| Article 8(1) | — | Article 3(2) | Article 3(2) |
| Article 8(2) | — | — | — |
| Article 8(3) | — | — | — |
| Article 8(4) | — | — | — |
| Article 9 | — | — | — |
| Article 10 | — | — | Article 4 |
| Article 11 | — | — | — |
| Article 12 | — | — | — |
| Article 13(1) | Article 4, first paragraph | — | — |
| Article 13(2) | Article 4, second paragraph | — | — |
| Article 14(1)(a) | — | — | |
| Article 14(1)(b) | — | — | — |
| Article 14(2) | Article 16(1) | — | — |
| Article 14(3) | Article 16(1), | — | — |
| Article 14(4) | — | — | — |
| Article 15(1) | Article 3(1)(a) and (2) | — | — |
| Article 15(2) | — | — | — |
| Article 15(3) | Article 3(1)(b) and (2) | — | — |
| Article 15(4) | — | — | — |
| Article 16(1) | — | — | |
| Article 16(2) | — | — | — |
| Article 17 | — | — | — |
| Article 18(1) | Article 9 | — | — |
| Article 18(2) | — | — | — |
| Article 19(1) | — | — | — |
| Article 19(2) | Article 9(2) | — | — |
| Article 20 | Article 14(3) | — | — |
| Article 21 | — | — | — |
| Article 22 | Article 19(1) | — | — |
| Article 23(1) | — | — | — |
| Article 23(2) | Article 22 | — | — |
| Article 23(3) | Article 19(2) | — | — |
| Article 23(4) | Article 19(3) | — | — |
| Article 23(5) | — | — | — |
| Article 24 | Article 21 | — | — |
| Article 25(a) | Article 20 | — | — |
| Article 25(b) | — | — | — |
| Article 25(c) | — | — | — |
| Article 25(d) | Article 21(2) | — | — |
| Article 25(e) | — | — | — |
| Article 26 | — | Article 4 | Article 5(1) |
| Article 27 | — | — | Article 5(5) |
| Article 28(a) | — | Article 5(2)(a) | |
| Article 28(b) | — | Article 5(2)(b) | |
| Article 29(1) | — | ||
| Article 29(2) | — | Article 5(2)(i) | Article 5(4), second and fourth subparagraph |
| Article 29(3) | — | — | |
| Article 29(4) | — | Article 5(2)(i), second indent | — |
| Article 30 | — | Article 5(4) | Article 5(3) |
| Article 31 | — | — | — |
| Article 32 | — | Article 5(2), Article 6 | Article 4(1), third subparagraph, second indent, Article 5(2)(b), Article 5(4), third and fourth subparagraph |
| Article 33(1) | Article 3(3) | Article 6(a) fourth indent | — |
| Article 33(2) | — | Article 6(a), fourth indent | — |
| Article 33(3) | — | — | — |
| Article 33(4) | — | — | — |
| Article 34(1) | — | — | |
| Article 34(2) | — | Article 6(a), fourth indent | — |
| Article 35 | — | Article 6(a), second, fifth and sixth indent | — |
| Article 36 | — | — | — |
| Article 37(a) | — | — | — |
| Article 37(b) | — | — | Article 5(3) |
| Article 38(1) | — | Article 9(1), second sentence | — |
| Article 38(2) | — | Article 9(3) | — |
| Article 38(3) | — | — | — |
| Article 39(a) | — | Article 10(1)(c) | Article 4(1), third paragraph, first indent |
| Article 39(b) | — | — | — |
| Article 39(c) | — | Article 10(1)(c) | — |
| Article 39(d) | — | — | — |
| Article 40 | — | Article 7 | — |
| Article 41 | — | — | — |
| Article 42 | — | — | — |
| Article 43 | — | — | — |
| Article 44(1) | Article 10 | Article 10(2) | — |
| Article 44(2) | Article 10 | Article 10(2) | — |
| Article 45 | Article 10(1) | — | — |
| Article 46 | — | — | — |
| Article 47 | — | — | |
| Article 48(1) | — | Article 14(1) | — |
| Article 48(2) | — | Article 14(1) | — |
| Article 48(3) | — | — | — |
| Article 48(4) | — | — | — |
| Article 49(1) | Article 5(1) | — | — |
| Article 49(2) | — | — | — |
| Article 49(3) | Article 15 | — | — |
| Article 50(1) | — | — | |
| Article 50(2) | — | — | — |
| Article 50(3) | Article 5(1) | — | — |
| Article 50(4) | Article 15 | — | — |
| Article 51(1) | — | — | — |
| Article 51(2) | Article 5(2) | — | — |
| Article 52 | — | — | — |
| Article 53(1) | — | — | — |
| Article 53(2) | — | — | — |
| Article 53(3) | — | Article 9(1), second sentence | — |
| Article 54(1) | — | — | — |
| Article 54(2) | — | — | |
| Article 54(3) | — | — | — |
| Article 55(1) | — | Article 13(1) | Article 7(1) |
| Article 55(2) | — | Article 13(2) | Article 7(2) |
| Article 55(3) | — | — | — |
| Article 56(1) | — | ||
| Article 56(2) | — | — | — |
| Article 56(3) | — | Article 12(6) | Article 6(5) |
| Article 56(4) | — | — | — |
| Article 56(5) | — | Article 6(2) | |
| Article 57(a) | — | Article 11(2) | — |
| Article 57(b) | — | Article 11(1) | Article 6(1) |
| Article 57(c) | — | — | — |
| Article 58(1) | Article 17 | Article 16 | Article 8 |
| Article 58(2) | Article 22 | — | — |
| Article 58(3) | Article 17 | — | — |
| Article 59 | — | — | — |
| Article 60 | — | — | — |
| Article 61(1) | — | — | — |
| Article 61(2) | Article 25 | Article 18 | Article 9 |
| Article 61(3) | Article 18a | ||
| Article 62 | Article 19 | Article 10 | |
| Article 63 | — | — | — |
| Article 64 | — | — | — |
| Article 65 | Article 29 | Article 20 | Article 12 |
| Article 66 | — | — | Article 13 |
| Article 67 | Article 30 | Article 21 | Article 14 |