LegalizeCommission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (Text with EEA relevance) (Text with EEA relevance)
Following the official confirmation of an outbreak of a category A disease in accordance with Article 77, the competent authority shall in addition to the measures provided for Article 72 and Article 73, order that the following disease control measures are immediately applied under the supervision of the official veterinarians, to the establishment where the official confirmation of an outbreak of a category A disease has occurred:
(a) fish and crustaceans of listed species shall be killed as soon as possible and molluscs of listed species shall be removed from water as soon as possible;
(b) animals referred to in (a) shall by way of derogation from Article 10(i) of Regulation (EC) No 1069/2009 be disposed of as category 1 or category 2 material in accordance with that Regulation;
(c) the measures provided for in point (a) and (b) shall be carried out either: (i) in the establishment where the official confirmation of an outbreak of a category A disease has occurred with subsequent processing on site; or (ii) in a disease control aquatic food establishment, or in a plant approved in accordance with Regulation (EC) No 1069/2009 for processing or disposal in a way that prevents risk of spreading the category A disease;
(d) aquaculture animals of non-listed species shall, as soon as possible, be killed or slaughtered for human consumption or, in case of molluscs, removed from water in accordance with paragraph 1(b);
(e) appropriate measures shall be applied to limit any possible spread of the category A disease to and from any wild aquatic animals that might be in epidemiological contact with the establishment;
(f) all potentially contaminated products, materials or substances shall be isolated until: (i) they are disposed of in accordance with Regulation (EC) No 1069/2009, in the case of animal by-products; (ii) by way of derogation from Article 10(i) of Regulation (EC) No 1069/2009 they are disposed of or processed as category 1 or category 2 material in accordance with that Regulation, in the case of products of animal origin; (iii) cleaning and disinfection measures have been completed in accordance with the provisions in Article 80, in the case of materials and substances which are fit for cleaning and disinfection; and (iv) they are removed from the establishment and disposed of under the supervision of official veterinarians, in the case of feeding stuff and other materials unfit for cleaning and disinfection.
The competent authority shall order and supervise:
(a) the transport from the affected establishment of animal by-products referred to in paragraph 1(f)(i) and of the products of animal origin referred to in paragraph 1(f)(ii) being in compliance with the provisions of Regulation (EC) No 1069/2009; and
(b) the transport from the affected establishment of materials or substances referred to in paragraph 1(f)(iv) being in compliance with its instructions regarding biosecurity and biosafety conditions to prevent the spread of category A disease agent.
Article 79
Specific derogations from control measures in establishments where listed species are kept for scientific purposes or purposes related to conservation of endangered species
The competent authority may grant derogations from the measures provided for in Article 78(1)(a) and (c) in the event of an official confirmation of a category A disease in establishments where listed species are kept for scientific purposes or purposes related to conservation of endangered species, provided that:
(a) the animal health status of the concerned Member State, or of other Member States, is not jeopardised; and
(b) all appropriate biosecurity measures as listed in Article 78 are taken to prevent any risk of spreading of the category A disease agent.
Where a derogation is granted pursuant to paragraph 1, the competent authority shall ensure that aquaculture animals of listed species covered by the derogation are:
(a) kept in premises where appropriate biosecurity measures to avoid spread of the relevant category A disease are implemented; and
(b) subjected to further surveillance and laboratory examination and are not moved from the establishment until the laboratory tests have indicated that they do not pose a risk of further spread of the relevant category A disease.
Article 80
Cleaning and disinfection
The competent authority shall order the operators to carry out, immediately after the completion of the disease control measures provided for in Article 78, the cleaning and disinfection of:
(a) the establishment, as far as the competent authority considers it is technically possible;
(b) any husbandry-related equipment including but not limited to feeding, grading, treatment, vaccination and workboats;
(c) any production-related equipment including but not limited to cages, netting, trestles, bags and long-lines;
(d) any protective clothing or safety equipment used by operators and visitors; and
(e) all means of transport including tanks and other equipment used to move infected animals or personnel who have been in contact with infected animals.
The cleaning and disinfection as provided for in paragraph 1 shall be carried out:
(a) in accordance to a protocol previously agreed between the competent authority and the operator; and
(b) under the supervision of official veterinarians.
Article 81
Fallowing of the affected establishment
The competent authority shall order operators to carry out, after the completion of the cleaning and disinfection provided for in in Article 80, the fallowing of the affected establishment for the period of time laid down in Annex XIII.
Article 82
Extension of disease control measures in the event of confirmation of a category A disease
In order to prevent the spread of a category A disease the competent authority shall conduct an investigation provided for in Article 71 and after carrying out a risk assessment, extend some or all of the measures provided for in Articles 78, 80 and 81 to:
(a) establishments of the same compartment or which due to distance, hydrodynamic conditions or topographic conditions, have an increased risk for contracting the relevant disease agent from the suspected establishment where the disease is confirmed;
(b) any establishment which as a result of the enquiry provided for in Article 57 of Regulation (EU) 2016/429, has shown a direct epidemiological link with the establishment where the disease is confirmed.
Article 83
Placing on the market of products of animal origin from aquaculture animals of listed species produced in infected establishments
When granting a derogation pursuant Article 78(5), the competent authority may allow the placing on the market of products of animal origin only if the following conditions are fulfilled:
(a) fish must be slaughtered and eviscerated before dispatch;
(b) molluscs and crustaceans must be fully traceable and processed to non-viable products unable to survive if returned to the water, before dispatch.
When purification is required before processing and placing on the market, it shall be conducted at a disease control aquatic food establishment or in a bio-secure purification centre.
The products of animal origin referred to in paragraph 1 shall be intended for:
(a) to the final consumer directly; or
(b) for further processing in a disease control aquatic food establishment.
Article 84
Measures to be applied in the event of confirmation of category A diseases in, food and feed businesses, purification centre, dispatch centre, border control posts or any other location of relevance, including means of transport
In the event of confirmation of a category A disease in food and feed businesses, purification centre, dispatch centre, border control posts or any other location of relevance, including means of transport, in accordance with Article 77, the competent authority shall apply:
(a) the measures provided for in Articles 78, Article 80 and Article 81; and
(b) if needed, additional measures adapted to the specific situation in order to prevent the spread of the category A disease from the affected animals and establishments or locations to unaffected animals.
CHAPTER II
Disease control measures for category A diseases of aquaculture animals in the restricted zone
Section 1
General disease control measures in the restricted zone
Article 85
Establishment of a restricted zone
In the event of the official confirmation of an outbreak of a category A disease in an establishment, food and feed business, animal by–products establishment or any other location of relevance, including means of transport, the competent authority shall immediately establish a restricted zone around the affected establishment or location, including:
(a) a protection zone around the establishment or location where the category A disease is confirmed;
(b) a surveillance zone around the protection zone; and
(c) if necessary, on the basis of the criteria set out in Article 64(1) of Regulation (EU) 2016/429, further restricted zones around or adjacent to the protection and surveillance zones.
The extent of the zones shall be set on a case-to-case basis, taking into account factors influencing the risk of spreading the disease. To that end, the the competent authority shall consider the following data and criteria:
(a) data from the epidemiological enquiry in accordance with Article 57 in Regulation (EU) 2016/429;
(b) relevant hydrodynamic data;
(c) criteria listed in Article 64(1) of Regulation (EU) 2016/429; and
(d) criteria provided for in Annex XIV to this Regulation.
By way of derogation from paragraph 1, the competent authority may due to specific geographical, hydrodynamic and epidemiological circumstances, and after carrying out a risk assessment taking into account the disease profile:
(a) not establish the restricted zone as provided for in paragraph 1 around the infected establishment or location;
(b) establish a restricted zone consisting of a protection zone without any adjacent surveillance zone; and
(c) not establish a restricted zone when a category A disease is confirmed in food and feed businesses, purification centre, dispatch centre, border control posts, animal by-products establishments or any other location of relevance, including means of transport.
The competent authority may derogate, to the extent necessary and after carrying out a risk assessment taking into account geographical, hydrodynamic, epidemiological circumstances and the disease profile, from the provisions of this Chapter:
(a) in the further restricted zones; and
(b) in the case that the competent authority decides to establish the restricted zone when an outbreak of a category A disease occurs in establishments or any other locations of relevance referred to in paragraph 4(c).
Article 86
Measures to be applied in the restricted zone
Section 2
Disease control measures in the protection zone
Article 87
Measures to be applied in establishments keeping aquaculture animals in the protection zone
The competent authority shall order operators of establishments keeping aquaculture animals of any species in the protection zone, other than the establishment in which the category A disease has been confirmed, to carry out at least the following measures in order to prevent and control the spread of the disease:
(a) without delay update the records of the inventory provided for in Article 73(1);
(b) when practicable, implement appropriate measures to limit any possible spread of the category A disease to and from any wild aquatic animals that might be in epidemiological contact with the establishment;
(c) prevent aquaculture animals from being removed from the establishment in which they are kept unless authorised by the competent authority;
(d) implement appropriate biosecurity measures to any product, piece of equipment, material or substance likely to spread the relevant category A disease;
(e) reduce the number of visitors to those which are strictly necessary to operate the establishment in a proper manner; and
(f) where practicable, implement appropriate means of cleaning and disinfection at the entry and exit of the establishment.
Article 88
Visits by official veterinarians in establishments in the protection zone
When carrying out the visits referred to in paragraph 1, official veterinarians shall perform at least the following activities:
(a) documentary checks and record analysis;
(b) verification of the implementation of the measures intended to prevent the introduction or spread of the relevant category A disease in accordance with to Article 87;
(c) clinical examination of aquaculture animals of listed species; and
(d) if necessary, collection of samples for laboratory examination in order to confirm or rule out the presence of the relevant category A disease.
Article 89
Prohibitions in relation to movements of aquaculture animals, products from aquaculture animals, other substances and material within, from or to the protection zone
The competent authority shall prohibit the following movements within the protection zone:
(a) movement of aquaculture animals of listed species between establishments in the protection zone;
(b) movement of aquaculture animals of listed species from or to the protection zone;
(c) any movements from the establishments within the protection zone of means of transport and any equipment, product, material or substance likely to transmit the relevant category A disease;
(d) transport of aquaculture animals by well-boats through the protection zone; and
(e) dispatch of unprocessed animal by-products from aquaculture animals of any species from establishments in the protection zone.
Article 90
General conditions to grant derogations from prohibitions of movement and transport concerning aquatic animals and products in the protection zone
When granting the authorisations provided for in pargraph 1, the competent authority shall ensure that the following conditions are met:
(a) all movements must be carried out exclusively via designated routes, agreed with the competent authority, without unloading or stopping;
(b) any exchange of water and discharges of water during the transportation must be carried out in areas, establishments or water exchange points approved by the competent authority;
(c) the means of transport must be constructed and maintained in such a way that they can undergo proper cleaning and disinfection;
(d) the means of transport are cleaned and disinfected: (i) prior to the transport operations; and (ii) after transport operations under the supervision of the official veterinarian;
(e) any other supplementary biosecurity measure considered necessary by the competent authority must be taken in relation to transport operations.
Article 91
Specific conditions for slaughter, and movements for slaughter or processing of aquaculture animals from listed species from establishments in the protection zone
Aquaculture animals from establishments keeping listed species in the protection zone may be:
(a) slaughtered within the establishment in compliance with biosecurity measures provided for by the competent authority; or
(b) moved for immediate slaughter for human consumption in a disease control aquatic food establishment; or
(c) in the case of molluscs, removed from water and moved to a disease control aquatic food establishment for purification if necessary and further processing.
When authorising the movements of aquaculture animals referred to in paragraph 1(b), the competent authority responsible for the disease control aquatic food establishment shall:
(a) be informed of the intention to send aquaculture animals of listed species to the disease control aquatic food establishment;
(b) agree to receive the aquaculture animals in question;
(c) supervise and confirm the slaughter of the animals to the competent authority of dispatch;
(d) ensure that the aquaculture animals of listed species originating from the protection zone are kept separately from aquaculture animals of listed species originating from outside the protection zone, and slaughtered or processed separately from those animals;
(e) monitor the slaughtering or processing;
(f) ensure that the cleaning and disinfection of the premises is completed before aquaculture animals from establishments outside the protection zone are slaughtered or processed;
(g) ensure that products of animal origin obtained from the aquaculture animals comply with the specific conditions for placing on the market provided for in Article 92; and
(h) ensure that animal by-products from slaughter or other processes referred to in paragraph 1, are processed or disposed of in accordance with Regulation (EC) No 1069/2009.
Article 92
Specific conditions for placing on the market of products of animal origin from aquaculture animals of listed species produced in non-affected establishments in the protection zone
The competent authority may authorise placing on the market of products of animal origin obtained from aquaculture animals of listed species in non-affected establishments in the protection zone, provided that the following conditions are fulfilled:
(a) fish must be slaughtered and eviscerated before dispatch; and
(b) molluscs and crustaceans must be fully traceable and processed to non viable products unable to survive if returned to the water, before dispatch.
The products of animal origin referred to in paragraph 1 shall be intended:
(a) for direct supply to the final consumer; or
(b) for further processing in a disease control aquatic food establishment.
Article 93
Special conditions for authorising transport of unprocessed animal by-products from establishments located in the protection zone
The competent authority may authorise the transport of unprocessed animal by-products of aquaculture animals of listed species from establishments in the protection zone to a plant for further processing in accordance with Regulation (EC) No 1069/2009.
Article 94
Risk-mitigating measures concerning certain activities related to aquatic animals within the protection zone
The competent authority may, after carrying out a risk assessment, implement risk- mitigating measures as regards:
(a) commercial and recreational fishing activities in the protection zone;
(b) other activities that are related to aquatic animals in the protection zone and that might pose a risk of spreading the disease; and
(c) transport of service boats used for maintenance activities and treatment of aquatic animals in the protection zone.
Article 95
Measures to be applied in food and feed businesses, purification centre, dispatch centres, border control posts, animal by-products establishments or any other location of relevance in the protection zone, including means of transport
Article 96
Removal of aquaculture animals from affected establishments and subsequent risk- mitigating measures
Article 97
Duration of disease control measures in the protection zone, repopulation of establishments covered by the protection zone
The competent authority shall maintain the disease control measures in the protection zone provided for in Section 2 of this Chapter until:
(a) the measures in Article 96 are carried out and completed; and
(b) the competent authority has, based on the outcome of the investigations conducted in accordance with Article 88, ruled out any occurrence of the relevant category A disease in the other establishments within the protection zone.
When the conditions set out in paragraph 1 are met:
(a) the competent authority shall apply the measures provided for in Section 3 of this Chapter in the protection zone for the period of time set out in Article 101; and
(b) the establishments referred to in Article 96(1) and (2) and previously covered by the protection zone may be repopulated.
Section 3
Disease control measures in the surveillance zone
Article 98
Measures to be applied in establishments in the surveillance zone
Article 99
Measures in relation to the movement and transport of aquaculture animals within from or to the surveillance zone
Article 100
Measures to be applied in food and feed businesses, purification centre, dispatch centres, border control posts, animal by-products establishments or any other location of relevance in the surveillance zone, including means of transport
Article 101
Duration of disease control measures in the surveillance zone
The competent authority shall lift the disease control measures provided for in this Section when the period of surveillance, set out in point 2 of Annex XV, for the relevant category A disease has elapsed with favourable results.
CHAPTER III
Disease control measures in wild aquatic animals
Article 102
Measures in the event of a suspect case of a category A disease in wild aquatic animals of listed species
In the event of a suspect case of a category A disease in wild aquatic animals of listed species in accordance with Article 9(1), (3) and (4) in Delegated Regulation (EU) 2020/689, the competent authority shall:
(a) immediately conduct an investigation of wild aquatic animals of listed species fished, caught, collected or found dead to confirm or rule out the presence of the category A disease in accordance with Article 71(2);
(b) ensure that all animal by-products obtained from the wild aquatic animals of listed species suspected to be infected, including molluscs shells with meat, are processed or disposed of as category 1 or category 2 material in accordance with Regulation (EC) No 1069/2009;
(c) ensure that, where practicable any material or substance likely to be contaminated by animals suspected to be affected or by the animal by-products obtained from those animals undergoes cleaning and disinfection or is disposed of following the instructions and under the supervision of official veterinarians; and
(d) provide relevant information to the operators or authorities in charge of the management of the relevant animal population.
Article 103
Measures in the event of an outbreak of a category A disease in wild aquatic animals of listed species
In the event of an officially confirmed case of a category A disease in wild aquatic animals of listed species, the competent authority shall determine an infected zone on the basis of:
(a) relevant hydrodynamic, topographic and epidemiological conditions;
(b) the disease profile and the estimated population of aquatic animals of listed species; and
(c) the risk factors contributing to the spread of the relevant category A disease, in particular those associated with the risk of introducing the disease into establishments keeping aquatic animals of listed species.
The competent authority may adapt the boundaries of the initial infected zone:
(a) in order to control the further spread of the relevant category A disease; and
(b) in the case of confirmation of further outbreaks of the category A disease in wild animals.
Article 104
Measures to be applied in the infected zone
In the infected zone established in accordance with Article 103 the competent authority shall:
(a) implement risk mitigation and reinforced biosecurity measures, in order to prevent the spread of the category A disease from the affected animals and infected zone to unaffected animals and areas;
(b) prohibit any movement by humans of wild aquatic animals of listed species and products of animal origin obtained from those animals from the infected zone;
(c) by way of derogation from Article 10(i) of Regulation (EC) No 1069/2009 ensure that all animal by-products obtained from the wild aquatic animals of listed species in the infected zone including molluscs shells, with meat are processed or disposed of as category 1 or category 2 material in accordance with that Regulation;
(d) ensure, where practicable, that any material or substance likely to be contaminated by wild aquatic animals of listed species in the infected zone or animal by-products obtained from those animals undergoes cleaning and disinfection or is disposed of following the instructions and under the supervision of official veterinarians; and
(e) prohibit bringing into establishments keeping aquaculture animals of listed species both within and outside the infected zone or to water catchment or coastal areas outside the infected zone any parts of aquatic animals of listed species whether, fished, caught, collected or found dead in the infected zone as well as any product, material or substance which is likely to be contaminated with a category A disease in the infected zone.
Article 105
Additional measures to be applied in the infected zone
As part of the control or eradication of the relevant category A disease the competent authority may:
(a) suspend restocking, fishing, collecting and catching activities;
(b) order mandatory cleaning and disinfection of fishing equipment and boats and other equipment likely to be contaminated; and
(c) increase fishing, collecting and catching activities or implement other relevant measures to eradicate the disease.
Article 106
Extension of measures
The competent authority may decide that relevant measures in Articles 102 to 105 also apply to aquatic animals of non-listed species.
Article 107
Operational expert group
The operational expert group shall assist the competent authority in:
(a) assessing the epidemiological situation and its evolution;
(b) determining the infected zone; and
(c) establishing the appropriate measures to be applied in the infected zone and their duration.
Article 108
Measures in the establishments within the infected zone
In addition to the measures provided for in Article 87, the competent authority shall prohibit the movement of aquaculture animals kept in establishments within the infected zone:
(a) out of the infected zone; or
(b) to other establishments in the infected zone.
Article 109
Duration of the measures in the infected zone
The competent authority shall maintain the measures provided for in this Chapter until the epidemiological information indicates that the relevant wild population no longer poses a risk of spreading the disease and the operational group recommends lifting the measures.
CHAPTER IV
Disease control measures for category B and C diseases of aquatic animals
Article 110
Preliminary disease control measures to be applied when a category B or C disease is suspected by the competent authority in Member States, zones or compartments that have been granted a disease free status
The competent authority shall apply the measures laid down in Articles 55, Article 56 and Article 57 of Delegated Regulation (EU) 2020/689 in the event of suspicion of a category B or C disease in accordance with Article 9(1), (3) or (4) of Delegated Regulation (EU) 2020/689, in Member States, zones or compartments that have been granted a disease free status as provided for in Article 36(4) and Article 37(4) of Regulation (EU) 2016/429, or Article 83, Article 84(1)(h) to (m) or Article 84(2)(b) to (g) of Delegated Regulation (EU) 2020/689.
Article 111
Disease control measures to be applied when a category B or C disease is confirmed
The competent authority shall apply the measures laid down in the Articles 58 to 65 of Delegated Regulation (EU) 2020/689 in the event of confirmation of a category B or C disease in accordance with Article 9(2), (3) or (4) of Delegated Regulation (EU) 2020/689 in Member States or zones or compartments that have been granted the disease free status as provided for in Article 36(4) and Article 37(4) of Regulation (EU) 2016/429, or Article 83, Article 84(1)(h) to (m) or Article 84(2)(b) to (g) of Delegated Regulation (EU) 2020/689:
PART IV
FINAL PROVISIONS
Article 112
Repeals
Article 113
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 21 April 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
CLINICAL EXAMINATIONS, SAMPLING PROCEDURES, DIAGNOSTIC METHODS OF CATEGORY A DISEASES AND TRANSPORT OF SAMPLES
(as referred to in Article 3 of this Regulation)
A. Sampling procedures
1.Clinical examinations must include, if possible:
(a) animals showing clinical signs of category A diseases;
(b) animals likely to have recently died from the suspected/confirmed disease;
(c) animals with epidemiological link to a suspected or confirmed case; and
(d) animals that obtained positive or non-conclusive results in previous laboratory examinations.
2.Animals to examine must be selected at random, in a number large enough to allow the detection of the disease, if present, where there are no obvious signs of disease or post-mortem lesions suggesting category A diseases.
3.The animals to examine and the sampling method must be chosen in accordance with the instructions of the competent authority and with the relevant contingency plan as referred to in Article 43 of Regulation (EU) 2016/429. The animals to examine and the sampling method must take into account the disease profile and:
(a) the purpose of the sampling;
(b) the listed species kept in the establishment;
(c) the number of animals of listed species kept in the establishment;
(d) the category of the kept animals;
(e) the available production, health and traceability records of the kept animals relevant for the investigation;
(f) the type of establishment and the husbandry practices;
(g) the level of exposure risk: (i) likelihood of exposure to the disease agent or to the vector; (ii) absence of immunisation of the animals due to vaccination or maternal immunity; and (iii) history of residence in the establishment;
(h) other relevant epidemiological factors.
4.The minimum number of animals to examine must be in accordance with the instructions of the competent authority and with the relevant contingency plan as referred to in Article 43 of Regulation (EU) 2016/429. The minimum number of animals to examine must take into account the disease profile and in particular:
(a) the expected prevalence in the establishment;
(b) the level of confidence desired of the survey results, which in any case must not be lower than 95 %; and
(c) international standards and available scientific evidence.
1.Sampling for laboratory examinations must take into account the outcome of the clinical examinations referred to in point A.1 and, if possible, must include animals referred to in paragraph 1 of point A.1.
2.If there are no obvious signs of disease or post-mortem lesions suggesting category A diseases, samples must be collected at random in each epidemiological unit of the establishment and must allow the detection of the disease, if present.
3.The animals to sample, the nature of the samples to collect and the sampling method must be in accordance with the instructions of the competent authority and with the relevant contingency plan as referred to in Article 43 of the Regulation (EU) 2016/429. The animals to sample, the nature of the samples to collect and the sampling method must take into account the disease profile and the criteria set out in paragraph 3 of point A.1.
4.The minimum number of animals to sample must be in accordance with the instructions of the competent authority and the relevant contingency plan as referred to in Article 43 of the Regulation (EU) 2016/429. The minimum number of animals to sample must take into account the criteria set out in paragraph 4 of point A.1 and the performance of the tests used.
5.In the case of wild animals, samples must be collected from animals shot, found dead or purposely trapped or must be obtained on the basis of non-invasive methods such as salt licks and chewing ropes or baits. The minimum number and the nature of the samples must take into account the estimated size of the wild population and the relevant criteria set out in paragraph 3 and 4 of point A.1.
1.The choice of establishments to sample and the sampling method must be in accordance with the instructions of the competent authority and with the relevant contingency plan as referred to in Article 43 of the Regulation (EU) 2016/429. The choice of establishments to sample and the sampling method must take into account the disease profile and the criteria set out in paragraph 3 of point A1.
2.The minimum number of establishments to visit must be in accordance with the instructions of the competent authority and with the relevant contingency plan, as referred to in Article 43 of the Regulation (EU) 2016/429.
B. Diagnostic methods
The techniques, reference materials, their standardisation and the interpretation of the results of tests carried out using the relevant diagnostic methods for category A diseases must comply with Article 6 and Part III of Annex VI to Delegated Regulation (EU) 2020/689.
The diagnostic methodology must aim to maximise the sensitivity of the surveillance. In certain circumstances this surveillance may include the use of laboratory examinations in order to assess previous exposure to disease.
C. Transport of samples
1.All samples taken to confirm or rule out the presence of a category A disease must be sent, with a proper labelling and identification, to an official laboratory which has been informed of their arrival. These samples must be accompanied by the appropriate forms, in accordance with the requirements established by the competent authority and the laboratory receiving the samples. These forms must include at least:
(a) the establishment of origin of the sampled animals;
(b) information on the species, age and category of the sampled animals;
(c) the clinical history of the animals, if available and relevant;
(d) the clinical signs and post-mortem findings; and
(e) any other relevant information.
2.All samples must be:
(a) stored in watertight and unbreakable containers and packages and in accordance with applicable international standards;
(b) kept at the most appropriate temperature and other conditions during transport taking into account the factors that may affect the sample quality.
3.The exterior of the package must be labelled with the address of the recipient laboratory and the following message must be prominently displayed:
‘ Animal pathological material; perishable; fragile; do not open outside the laboratory of destination. ’
4.The person responsible in the official laboratory receiving the samples must be informed in due time of the arrival of the samples.
ANNEX II
MONITORING PERIOD
(as referred to in Articles 8, 17, 27, 32, 48, 57 and 59 of this Regulation)
| Category A diseases | Monitoring period |
|---|---|
| Foot and mouth disease (FMD) | 21 days |
| Infection with rinderpest virus (RP) | 21 days |
| Infection with Rift Valley fever virus (RVFV) | 30 days |
| Infection with lumpy skin disease virus (LSD) | 28 days |
| Infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia) (CBPP) | 45 days |
| Sheep pox and goat pox (SPGP) | 21 days |
| Infection with peste des petits ruminants virus (PPR) | 21 days |
| Contagious caprine pleuropneumonia (CCPP) | 45 days |
| African horse sickness (AHS) | 14 days |
| Infection with Burkholderia mallei (Glanders) | 6 months |
| Classical swine fever (CSF) | 15 days |
| African swine fever (ASF) | 15 days |
| Highly pathogenic avian influenza (HPAI) | 21 days |
| Infection with Newcastle disease virus (NCD) | 21 days |
ANNEX III
CONDITIONS FOR CERTAIN DEROGATIONS FROM ARTICLE 12(1)(a) IN EQUINE ANIMALS
(as referred to in Article 13(4))
1.In the event of an outbreak of African horse sickness the competent authority may derogate from Article 12(1)(a) the affected and the unaffected animals, provided that:
(a) the affected animals subject to the derogation are isolated in vector-protected premises which avoid any transmission of the disease agent from the animals to the relevant vectors until 40 days, corresponding to the infective period established in the relevant Chapter of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), have elapsed after the entry of the animals into the vector protected premises; and
(b) surveillance, including if needed laboratory examinations, carried out by the competent authority, indicates that none of the animals in the vector protected premises poses a risk of virus transmission.
2.In the event of an outbreak of infection with Burkholderia mallei (Glanders) the competent authority may derogate from Article 12(1)(a) the unaffected animals, provided that the animals subject to the derogation are quarantined until:
(a) the affected animals have been killed and destroyed;
(b) after the killing, the cleaning and disinfection of the establishment has been completed as provided for in Article 15; and
(c) the remaining animals have been subjected to a complement fixation test carried with negative result at a serum dilution of 1 in 5 on samples taken at least 6 months after the cleaning and disinfection referred to in point (b).
ANNEX IV
PROCEDURES FOR CLEANING, DISINFECTION AND WHEN NECESSARY CONTROL OF INSECTS AND RODENTS
(as referred to in Articles 12, 15, 16, 39, 45 and 57 of this Regulation)
A. General requirements
1.The choice of biocidal products and procedures for cleaning and disinfection operations must take into account:
(a) the causal agent of infection;
(b) the nature of the establishments, vehicles, objects and materials which are to be treated; and
(c) the applicable legislation.
2.The conditions under which biocidal products are used must ensure that their efficacy is not impaired. In particular technical parameters provided by the manufacturer, such as pressure, temperature, required contact time or storage must be observed. The activity of the disinfectant must not be compromised by interaction with other substances.
3.Re-contamination of the previously cleaned parts must be avoided, in particular where washing is carried out with liquids applied under pressure.
4.The water used for cleaning operations must be contained and disposed of in a way that avoids any risk of spreading category A disease agents.
5.Biocidal products must be used in a way that reduces as much as possible any adverse impact on the environment and on public health that may arise from their use.
B. Preliminary cleaning and disinfection
For preliminary cleaning and disinfection under Article 15, to avoid spreading the category A disease:
(a) entire bodies or parts of dead kept animals of listed species must be sprayed with disinfectant and removed from the establishment, in closed and leak-proof vehicles or containers for processing and disposal;
(b) any tissue or blood which may have been spilled during killing, slaughter or post-mortem examination must be carefully collected and disposed of;
(c) as soon as the entire bodies or parts of dead kept animals of listed species have been removed for processing or disposal, the parts of the establishment in which these animals were kept and any parts of other buildings, surfaces or equipment contaminated during killing or post-mortem examination must be sprayed with disinfectant;
(d) manure, including litter and used bedding, must be thoroughly soaked with disinfectant;
(e) the disinfectant must remain on the treated surface for at least 24 hours;
(f) equipment, containers, consumption utensils, surfaces or any material likely to be contaminated after the washing and disinfecting must be destroyed.
C. Final cleaning and disinfection:
For final cleaning and disinfection for the purpose of Article 57:
Manure, including litter and used bedding, must be removed and treated as follows:
(a) the solid phase of manure, including litter and used bedding, must either: (i) undergo a steam treatment at a temperature of at least 70 °C; (ii) be destroyed by burning; (iii) be buried deep enough to prevent access by animals; or (iv) be stacked to heat, sprayed with disinfectant and left for at least 42 days, during which the stack must be either covered or re-stacked to ensure thermic treatment of all layers; (b) the liquid phase of manure must be stored for at least 42 days, and in the case of highly pathogenic avian influenza 60 days, after the last addition of infective material.
Buildings, surfaces and equipment must be thoroughly washed and cleaned by removing the remaining grease and dirt and sprayed with disinfectants.
After 7 days the establishments must be cleaned and disinfected again.
ANNEX V
MINIMUM RADIUS OF PROTECTION AND SURVEILLANCE ZONES
(as referred to in Article 21 of this Regulation)
Indicated as radius of a circle centred on the establishment
| Category A diseases | Protection Zone | Surveillance Zone |
|---|---|---|
| Foot and mouth disease | 3 km | 10 km |
| Infection with rinderpest virus | 3 km | 10 km |
| Infection with Rift Valley fever virus | 20 km | 50 km |
| Infection with lumpy skin disease virus | 20 km | 50 km |
| Infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia) | Establishment | 3 km |
| Sheep pox and goat pox | 3 km | 10 km |
| Infection with peste des petits ruminants virus | 3 km | 10 km |
| Contagious caprine pleuropneumonia | Establishment | 3 km |
| African horse sickness | 100 km | 150 km |
| Infection with Burkholderia mallei (Glanders) | Establishment | Establishment |
| Classical swine fever | 3 km | 10 km |
| African swine fever | 3 km | 10 km |
| Highly pathogenic avian influenza | 3 km | 10 km |
| Infection with Newcastle disease virus | 3 km | 10 km |
ANNEX VI
PROHIBITIONS IN THE RESTRICTED ZONE
(as referred to in Article 27 of this Regulation)
Table: Prohibitions of activities concerning animals of listed species and products from those animals
| PROHIBITIONS OF ACTIVITIES CONCERNING ANIMALS AND PRODUCTS RELATED TO CATEGORY A DISEASES (1) | FMD | RP | RVFV | LSD | CBPP | SPGP | PPR | CCPP | CSF | ASF | AHS | GLAND | HPAI | NCD | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Movements of kept animals of listed species from establishments in the restricted zone | X | X | X | X | X | X | X | X | X | X | X | NA | X | X | |
| Movements of kept animals of listed species to establishments in the restricted zone | X | X | X | X | X | X | X | X | X | X | X | NA | X | X | |
| Restocking of game animals of listed species | X | X | X | X | X | X | X | X | X | X | X | NA | X | X | |
| Fairs, markets, shows and other gatherings of kept animals of listed species including collection and dispersion of those species | X | X | X | X | X | X | X | X | X | X | X | NA | X | X | |
| Movements of semen, oocytes and embryos obtained from kept animals of listed species from establishments in the restricted zone | X | X | X | X (2) | X | X | X | X | X | X | X | NA | NA | NA | |
| Collection of semen, oocytes and embryo from kept animals of listed species | X | X | X | X | X | X | X | X | X | X | NP | NA | NA | NA | |
| Itinerant artificial insemination of kept animals of listed species | X | X | X | X | X | X | X | X | X | X | X | NA | NA | NA | |
| Itinerant natural service of kept animals of listed species | X | X | X | X | X | X | X | X | X | X | X | NA | NA | NA | |
| Movements of hatching eggs to and from establishments in the restricted zone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | X | X | |
| Movements of fresh meat excluding offal from kept and wild animals of listed species from slaughterhouses or game handling establishments in the restricted zone | X | X | X | NP | NP | X | X | NP | X | X | NP | NA | X | X | |
| PROHIBITIONS OF ACTIVITIES CONCERNING ANIMALS AND PRODUCTS RELATED TO CATEGORY A DISEASES (1) (cont.) | FMD | RP | RVFV | LSD | CBPP | SPGP | PPR | CCPP | CSF | ASF | AHS | GLAND | HPAI | NCD | |
| Movements of offal from kept and wild animals of listed species from slaughterhouses or game handling establishments in the restricted zone | X | X | X | X | X | X | X | X | X | X | NP | NA | X | X | |
| Movements of meat products obtained from fresh meat of listed species from establishments in the restricted zone | X | X | X | NP | NP | NP | X | NP | X | X | NP | NA | X | X | |
| Movements of raw milk and colostrum obtained from kept animals of listed species from establishments in the restricted zone | X | X | X | X | NP | X | X | NP | NA | NA | NP | NA | NA | NA | |
| Movements of dairy products and colostrum based products from establishments in the restricted zone | X | X | X | X | NP | X | X | NP | NA | NA | NP | NA | NA | NA | |
| Movements of eggs for human consumption from establishments in the restricted zone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | X | X | |
| Movements of animal by-products from kept animals of listed species from establishments in the restricted zone, except entire bodies or parts of dead animals | Manure, including litter and used bedding | X | X | X | X | NP | X | X | NP | X | X | NP | NA | X | X |
| Hides, skins, wool, bristles and feathers | X | X | X | X | NP | X | X | NP | X | X | NP | NA | X | X | |
| Animal by-products other than manure, including litter and used bedding, and other than hides, skins, wool, bristles and feathers | X | X | X | X | X | X | X | X | X | X | X | NA | X | X | |
| PROHIBITIONS OF ACTIVITIES CONCERNING ANIMALS AND PRODUCTS (cont.) RELATED TO CATEGORY A DISEASES (1) | FMD | RP | RVFV | LSD | CBPP | SPGP | PPR | CCPP | CSF | ASF | AHS | GLAND | HPAI | NCD | |
| Movements of feed materials of plant origin and straw obtained in the restricted zone | X | X | NP | NP | NP | NP | NP | NP | NP | NP | NP | NA | NP | NP | |
| (1) Abbreviations for Category A diseases in accordance with Annex II (2) Only oocytes and embryo NA = Not applicable X = prohibition NP = Not prohibited |
ANNEX VII
RISK-MITIGATING TREATMENTS FOR PRODUCTS OF ANIMAL ORIGIN FROM THE RESTRICTED ZONE
(as referred to in Articles 27, 33 and 49 of this Regulation)
| Treatment | FMD (1) | RP | RVFV | LSD | CBPP | SPGP | PPR | CCPP | CSF | ASF | AHS | HPAI | NCD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MEAT | |||||||||||||
| Heat treatment in an hermetically sealed container, to achieve a minimum F0 (2) value of 3 | x | X | X | X | X | X | |||||||
| Heat treatment to achieve a core temperature of 80 °C | X | X | X | X | X | X | |||||||
| Heat treatment to achieve a core temperature of 70 °C | X | X | X | X | X | ||||||||
| Heat treatment (to meat previously de-boned and defatted) to achieve a core temperature of 70 °C for a minimum of 30 minutes | X | X | X | X | |||||||||
| In an hermetically sealed container, applying 60 °C for a minimum of 4 hours | X | X | X | X | |||||||||
| Core temperature of 73,9 °C for a minimum of 0,51 seconds (3) | X | X | X | ||||||||||
| Core temperature of 70,0 °C for a minimum of 3,5 seconds (3) | X | X | |||||||||||
| Core temperature of 65,0 °C for a minimum of 42 seconds (3) | X | X | |||||||||||
| Core temperature of 60 °C for a minimum of 507 seconds (3) | X | X | |||||||||||
| Heat treatment to achieve desiccation to maximum values of Aw of 0,93 and pH of 6 | |||||||||||||
| Heat treatment to achieve a core temperature of 65 °C for a period of time to achieve a minimum pasteurisation value of 40 | X | ||||||||||||
| Natural fermentation and maturation for bone-in meat: minimum 9 months, to achieve maximum values of Aw of 0,93 and pH of 6 | X | X | |||||||||||
| Natural fermentation and maturation for de-boned meat: minimum 9 months, to achieve maximum values of Aw of 0,93 and pH of 6 | X | X | X | ||||||||||
| Natural fermentation for loins: minimum 140 days to achieve maximum values of Aw of 0,93 and pH of 6 (4) | X | X | |||||||||||
| Natural fermentation for hams: minimum 190 days to achieve maximum values of Aw of 0,93 and pH of 6 (4) | X | X | |||||||||||
| Drying after salting Italian style bone-in hams: minimum 313 days (4) | X | ||||||||||||
| Drying after salting Spanish style bone-in hams and loins (4): — Iberian hams: minimum 252 days — Iberian shoulders: minimum 140 days — Iberian loins: minimum 126 days — Serrano hams: minimum 140 days | X | X | X | ||||||||||
| Maturation of carcasses at a minimum temperature of 2 °C for a minimum of 24 hours following slaughter | X | ||||||||||||
| Removal of offal | X | X | X | X | |||||||||
| CASINGS | |||||||||||||
| Salting with sodium chloride (NaCl) either dry or as saturated brine (Aw < 0,80), for a continuous period of 30 days or longer at an ambient temperature of 20 °C or above | X | SC (5) | X | X | X | ||||||||
| Salting with phosphate supplemented salt 86,5 % NaCl, 10,7 % Na2HPO4 and 2,8 % Na3PO4 either dry or as saturated brine (Aw < 0,80) for a continuous period of 30 days or longer at an ambient temperature of 20 °C or above | X | X | X | X | |||||||||
| Salting with sodium chloride (NaCl) minimum 30 days (6) | |||||||||||||
| Bleaching (6) | |||||||||||||
| Drying (6) | |||||||||||||
| MILK | |||||||||||||
| Heat treatment (sterilization process) to achieve a minimum F0 value of 3 | X | SC (5) | SC (5) | ||||||||||
| Heat treatment UHT (Ultra high temperature): Minimum 132 °C for a minimum of 1 second | X | X | |||||||||||
| Heat treatment UHT (Ultra high temperature): Minimum 135 °C for a suitable holding time | X | ||||||||||||
| Heat treatment HTST (High temperature short time pasteurisation) if milk pH is lower than 7, minimum 72 °C for a minimum of 15 seconds | X | X | |||||||||||
| Heat treatment HTST (High temperature short time pasteurisation) if milk pH is 7 or higher, minimum 72 °C for a minimum of 15 seconds, applied twice | X | X | |||||||||||
| Heat treatment HTST (High temperature short time pasteurisation) combined with a physical treatment to achieve pH value below 6 for a minimum of 1 hour or to achieve a minimum of 72 °C, combined with desiccation | X | ||||||||||||
| Pasteurisation consisting in a single heat treatment with an effect at least equivalent to that achieved by applying 72 °C for 15 seconds | X | X | X | X | |||||||||
| (1) Disease abbreviations in accordance with Annex II. (2) F0 is the calculated killing effect on bacterial spores. An F0 value of 3 means that the coldest point in the product has been heated sufficiently to achieve the same killing effect as 121 °C (250oF) in three minutes with instantaneous heating and chilling. (3) Only for poultry meat. (4) Only for porcine animals. (5) Safe commodity. (6) Not for bovine, ovine, caprine and porcine casings. | |||||||||||||
| Treatment | HPAI | NCD | |||||||||||
| --- | --- | --- | |||||||||||
| EGGS | |||||||||||||
| Heat treatment: — Whole egg: — — 60,0 °C – 188 sec. — completely cooked — Whole egg blends: — — 60 °C – 188 sec. — completely cooked — 61,1 °C – 94 sec. — Liquid egg white: — — 55,6 °C – 870 sec. — 56,7 °C – 232 sec. — Plain or pure egg yolk: — — 60 °C – 288 sec. — 10 % salted yolk: — — 62,2 °C – 138 sec. — Dried egg white: — — 67 °C – 20 hours — 54,4 °C – 50,4 hours — 51,7 °C – 73,2 hours | X | ||||||||||||
| Heat treatment: — Whole egg: — — 55 °C – 2 521 sec. — 57 °C – 1 596 sec. — 59 °C – 674 sec. — completely cooked — Liquid egg white: — — 55 °C – 2 278 sec. — 57 °C – 986 sec. — 59 °C – 301 sec. — 10 % salted egg yolk: — — 55 °C – 176 sec. — Dried egg white: — — 57 °C – 54,0 hours | X |
ANNEX VIII
RISK-MITIGATING TREATMENTS FOR PRODUCTS NOT OF ANIMAL ORIGIN FROM THE RESTRICTED ZONE
(as referred to in Articles 36 and 52 of this Regulation)
| Treatment | FMD (1) | RP |
|---|---|---|
| Heat treatment, minimum temperature of 80 °C and for a minimum of 10 minutes, steam in a closed chamber | X | X |
| Storage in package or bales under shelter at premises situated not closer than 2 km to the nearest outbreak and releasing from the premises do not take place before at least three months have elapsed following the completion of cleaning and disinfection according to Article 15 | X | X |
| (1) Disease abbreviations in accordance with Annex II. |
ANNEX IX
MARKING OF FRESH MEAT FROM THE PROTECTION ZONE
(as referred to in Articles 33 and 49 of this Regulation)
1.The mark to be applied to fresh meat of poultry originating in the protection zone and not intended to another Member State pursuant to Article 33(1)(b) must comply with the following:
(a) shape and content: Where ‘XY’ means the relevant country code provided for in point 6 of Part B of Section I of Annex II of Regulation (EC) No 853/2004 and ‘1234’ means the approval number of the establishment referred to in point 7 of Part B of Section I of Annex II of Regulation (EC) No 853/2004;
(b) dimensions: — ‘XY’ width of 8 mm, — ‘1234’ width of 11 mm, — width outer diameter of not less than 30 mm, — line thickness of square of 3 mm.
2.The mark to be applied to fresh meat intended for treatment in a processing plant pursuant to Article 33(2)(a) shall consist in, either:
(a) the identification mark provided for in Regulation (EC) No 853/2004 with an additional diagonal cross consisting of two straight lines intersecting at the centre of the stamp and enabling the information thereon to remain legible; or
(b) a single oval stamp, 6,5 cm wide by 4,5 cm high, in which the following information must appear in perfectly legible characters: — on the upper part, the full name or ISO code of the Member State in capitals, — in the centre, the approval number of the slaughterhouse, — on the lower part, one of the following sets of initials CE, EC, EF, EG, EK, EY, EO, ES, EU, EB, WE or EZ, — two straight lines crossing at the centre of the stamp in such a way that the information is not obscured, — the letters must be at least 0,8 cm high and the figures at least 1 cm high.
ANNEX X
DURATION OF THE MEASURES IN THE PROTECTION ZONE
(as referred to in Article 39 of this Regulation)
| Category A diseases | Minimum period of duration of measures in the protection zone (Article 39(1)) | Additional period of duration of surveillance measures in the protection zone (Article 39(3)) |
|---|---|---|
| Foot and mouth disease | 15 days | 15 days |
| Infection with rinderpest virus | 21 days | 9 days |
| Infection with Rift Valley fever virus | 30 days | 15 days |
| Infection with lumpy skin disease virus | 28 days | 17 days |
| Infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia) | 45 days | Not applicable |
| Sheep pox and goat pox | 21 days | 9 days |
| Infection with peste des petits ruminants virus | 21 days | 9 days |
| Contagious caprine pleuropneumonia | 45 days | Not applicable |
| African horse sickness | 12 months | Not applicable |
| Infection with Burkholderia mallei (Glanders) | 6 months | Not applicable |
| Classical swine fever | 15 days | 15 days |
| African swine fever | 15 days | 15 days |
| Highly pathogenic avian influenza | 21 days | 9 days |
| Infection with Newcastle disease virus | 21 days | 9 days |
ANNEX XI
DURATION OF THE MEASURES IN THE SURVEILLANCE ZONE
(as referred to in Articles 55 and 56 of this Regulation)
| Category A diseases | Minimum period of duration of measures in the surveillance zone |
|---|---|
| Foot and mouth disease | 30 days |
| Infection with rinderpest virus | 30 days |
| Infection with Rift Valley fever virus | 45 days |
| Infection with lumpy skin disease virus | 45 days |
| Infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia) | 45 days |
| Sheep pox and goat pox | 30 days |
| Infection with peste des petits ruminants virus | 30 days |
| Contagious caprine pleuropneumonia | 45 days |
| African horse sickness | 12 months |
| Infection with Burkholderia mallei (Glanders) | Not applicable |
| Classical swine fever | 30 days |
| African swine fever | 30 days |
| Highly pathogenic avian influenza | 30 days |
| Infection with Newcastle disease virus | 30 days |
ANNEX XII
SAMPLING PROCEDURES AND DIAGNOSTIC METHODS FOR CATEGORY A DISEASES IN AQUATIC ANIMALS
1.The following procedures apply to the clinical examination and collection of samples:
(a) the clinical examination and the sampling for laboratory examinations must include: (i) aquaculture animals of listed species showing clinical signs of the relevant category A disease; and (ii) aquaculture animals likely to have recently died from the suspected/confirmed category A disease; and (iii) aquaculture animals with an epidemiological link to a suspected or confirmed case of a category A disease;
(b) the minimum number of samples to be collected is: Scenario Type of animals Report of increased mortality Introduction of infected animals Post-mortem or clinical signs observed Suspicion based on other circumstances Molluscs (the whole animal) 30 30 — 150 Crustaceans 10
10 150 Fish — — 10 30
(c) the following additional criteria apply to the sampling of molluscs: (i) animals suspected to be infected must be selected for sampling. If listed species are present in the population of animals concerned by the suspicion, those must be selected for sampling; (ii) if weak, gaping or freshly dead but not decomposed molluscs are present, those must be selected first. If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs; (iii) if the establishment uses more than one water source for mollusc production, molluscs representing all water sources must be included for sampling to ensure that all parts of the establishment are proportionally represented in the sample; (iv) when sampling from a group of mollusc farming establishments which apparently have identical epidemiological status, molluscs from a representative number of sampling points must be included in the sample. The main factors to be considered when selecting those sampling points must be stocking density, water currents, the presence of listed species, both susceptible and vector species, bathymetry and management practices. Natural beds within or adjacent to the mollusc farming establishment(s) must be included in the sample;
(d) the following additional criteria apply when sampling crustaceans: (i) if weak or moribund crustaceans of listed species are present in the production units, those crustaceans must be selected first. If such animals are not present, the crustaceans selected must include crustaceans of different year classes, proportionally represented in the sample; (ii) if more than one water source is used for crustacean production, crustaceans of listed species representing all water sources must be included in the sample to ensure that all parts of the establishment are proportionally represented in the sample; (iii) when collection of samples from wild populations of listed species is required under Article 102(a) of this Regulation, the number and geographical distribution of the sampling points must be determined in a way that ensures a reasonable coverage of the area suspected to be infected. The sampling points must be representative for the different ecosystems where the wild populations of susceptible species are located such as marine, estuary, river and lake systems;
(e) the following additional criteria apply for sampling fish: (i) if weak, abnormally behaving or freshly dead but not decomposed fish are present, those fish must be selected. If such animals are not present, the fish selected must include fish of listed species, belonging to different year classes, proportionally represented in the sample; (ii) if more than one water source is used for fish production, listed species representing all water sources must be included for sampling to ensure that all parts of the establishment are proportionally represented in the sample; (iii) if rainbow trout (Onchorynchus mykiss) or European perch (Perca fluviatilis) are present, only fish of those species may be selected for sampling. If neither rainbow trout nor European perch are present, the sample must be representative of all other listed species present, following the criteria in points (a) to (d); (iv) when collection of samples from wild populations of listed species is required under Article 102(a) of this Regulation, the number and geographical distribution of the sampling points must be determined in a way that ensures a reasonable coverage of the area suspected to be infected. The sampling points must also be representative of the different ecosystems where the wild populations of susceptible species are located such as marine, estuary, river and lake systems;
(f) the selection of organs to be sampled, preparation, storage and shipment of the samples to the laboratory must be carried out in compliance with recommendations from the European Union reference laboratory for the relevant disease.
2.Samples must be examined in the laboratory using the diagnostic methods and procedures approved by the European Union reference laboratory for the relevant disease.
ANNEX XIII
MINIMUM PERIODS OF FALLOWING OF AFFECTED AQUACULTURE ESTABLISHMENTS
| Category A disease | Minimum period of fallowing of the affected establishment | Minimum period of synchronised fallowing of affected establishments in the same protection zone | Supplementary requirements |
| --- | --- | --- | --- | | Infection with Mikrocytos mackini | 6 months | 4 weeks | Must include the coldest period of the year | | Infection with Perkinsus marinus | 6 months | 4 weeks | Must include the warmest period of the year | | Infection with Taura syndrome virus | 6 weeks | 4 weeks | Must include the warmest period of the year | | Infection with Yellow head syndrome virus | 6 weeks | 3 weeks | Must include the warmest period of the year | | Epizootic haematopoietic necrosis | 8 weeks | 4 weeks | Must include the warmest period of the year |
ANNEX XIV
CRITERIA FOR ESTABLISHING RESTRICTED ZONES AS REGARDS CATEGORY A DISEASES IN AQUATIC ANIMALS
1.Restricted zones as referred to in Article 85 must be defined on a case-by-case basis taking into account at least the following factors:
(a) the accumulated number, the accumulated percentage and the distribution of the mortalities of molluscs/crustaceans/fish in the establishment or group of farming establishments infected with category A diseases;
(b) relevant information regarding movements to and from the infected establishment(s);
(c) the distance to and density of neighbouring establishments;
(d) the presence of wild aquatic animals;
(e) any knowledge concerning mortalities, suspected cases or outbreaks in wild aquatic animals which are, or could be related to the specific category A disease;
(f) the proximity to processing establishments, and the species present at those establishments, especially as regards listed species;
(g) farming practices applied in the affected and neighbouring establishments;
(h) hydrodynamic conditions and other identified factors of epidemiological significance.
2.For the geographical demarcation of the protection and surveillance zones for category A diseases affecting molluscs and crustaceans, the following minimum requirements apply:
(a) the protection zone must be established in the immediate vicinity of an establishment or group of farming establishments officially confirmed as infected with a category A disease and must correspond to an area determined according to appropriate hydrodynamic and epidemiological data;
(b) the surveillance zone must be established outside the protection zone and must correspond to an area surrounding the protection zone, determined according to appropriate hydrodynamic or epidemiological data.
3.For the geographical demarcation of the protection and surveillance zones for category A diseases affecting fish, the following minimum requirements must apply:
(a) the protection zone must be established around an establishment where Epizootic hematopoietic necrosis (EHN) has been confirmed. This zone shall correspond: (i) in coastal areas: to an area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the establishment in which EHN has been officially confirmed, or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; (ii) in inland areas: to the entire water catchment area of the establishment in which EHN has been officially confirmed. The competent authority may limit the extension of the zone to parts of the water catchment area, or the area of the establishment, provided this does not compromise prevention of the spread of the disease;
(b) the surveillance zone must be established by the competent authority outside the protection zone and must:
(i) in coastal areas: correspond to an area, surrounding the protection zone, of overlapping tidal excursion; or an area, surrounding the protection zone, and included in a circle of radius 10 km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; (ii) in inland areas: be an extended area outside the established protection zone.
ANNEX XV
SURVEILLANCE SCHEME AND DURATION OF CONTROL MEASURES IN THE SURVEILLANCE ZONE FOR CATEGORY ADISEASES IN AQUACULTURE ANIMALS
(as referred to in Articles 98 and 101 of this Regulation)
Surveillance scheme
The establishments and groups of aquaculture establishments keeping listed species within a surveillance zone must undergo surveillance as provided for in Article 98 to check for infection with the relevant category A disease. The surveillance must include health visits, including sampling from production units. Those visits must be carried out by the competent authority in accordance with Tables 1 and 2.
The criteria set out in point 1 of Annex XII, as appropriate for the species, apply to sampling.
| Category A disease | Number of health visits per year | Number of laboratory examinations per year | Number of animals in the sample | Period of the year for sampling | Residency period of the sampled animals in the establishment |
|---|---|---|---|---|---|
| Infection with Mikrocytos mackini | 1 | 1 | 150 | When the prevalence of infection is known to be maximal or April–May, after 3–4 months period when seawater temperatures are less than 10 °C | 4 months |
| Infection with Perkinsus marinus | 1 | 1 | 150 | When the prevalence of infection is known to be maximal or in the month of September, October or November | 4 months |
| Infection with Taura syndrome virus | 2 | 2 | 150 | In the period of the year when water temperature is likely to reach its highest annual level | 2 months |
| Infection with Yellow head syndrome virus | 2 | 2 | 150 | In the period of the year when water temperature is likely to reach its highest annual level | 2 months |
| Type of establishment | Number of health inspections per year (2 years) | Number of samplings per year (2 years) | Number of fish in the sample | |
| --- | --- | --- | --- | --- | | Number of growing fish | Number of brood stock fish (2) | | | | | (a) Establishments with broodstock | 2 | 2 | 150 (first and second inspection) | 150 (first or second inspection) | | (b) Establishments with broodstock only | 2 | 1 | 0 | 150 (2) (first or second inspection) | | (c) Establishments without broodstock | 2 | 2 | 150 (first and second inspection) | 0 | | Maximum number of fish per pool: 10 | | | | | | (1) The sampling of fish for laboratory examination must be carried out whenever the water temperature is between 11 and 20 °C. The water temperature requirement must also apply to health inspections. In establishments where the water temperature does not reach 11 °C during the year, sampling and health visits must be carried out when the water temperature is at its highest level. (2) Samples from broodstock must not include gonadal fluids, milt or ova as there is no evidence of EHN causing reproductive tract infection. | | | | |
Duration of the control measures in the surveillance zone
| Category A disease | Minimum periods of surveillance |
|---|---|
| Infection with Mikrocytos mackini | 3 years |
| Infection with Perkinsus marinus | 3 years |
| Infection with Taura syndrome virus | 2 years |
| Infection with Yellow head syndrome virus | 2 years |
| Epizootic haematopoietic necrosis | 2 years |
When the period of surveillance has elapsed and there has been no new detection of infection with the relevant category A disease, the measures in the surveillance zone must be lifted as provided for in Article 101 of this Regulation.
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