Commission 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)
The competent authority shall prohibit any movements of aquaculture animals from establishments within the surveillance zone for slaughter, further keeping or release into the wild outside the surveillance zone.
The competent authority shall ensure that any transport of aquaculture animals of listed species within or into the surveillance zone shall be carried out in accordance with the conditions laid down in Article 90(2), points (a) to (e), and in Article 91.
The competent authority may order appropriate supplementary biosecurity measures to be applied to transport operations, including the unloading in the designated establishment of destination in order to control and prevent the possible spread of the diseases.
By way of derogation from paragraph 1, and in agreement with the competent authority at the place of destination, the competent authority may authorise movements of aquaculture animals, other than for release into the wild, provided that appropriate biosecurity measures to prevent the spread of the category A disease, are applied.
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
The competent authority shall order without delay that the measures provided for in Articles 98 and 99 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.
In the locations referred to in paragraph 1, the competent authority may apply additional measures adapted to the specific situation in order to prevent the spread of the category A disease within and from the surveillance zone.
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 official confirmation 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.
The competent authority shall immediately inform operators, other relevant competent authorities, relevant veterinarians, and any other natural or legal person concerned, about the outbreak of the diseases and the control measures adopted.
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, within 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.
By way of derogation from paragraph 1(b) and for the purpose of preserving valuable genetic material, the competent authority may authorise movements of wild aquatic animals of listed species from the infected zone to an establishment authorised by the competent authority for that purpose, provided that appropriate biosecurity measures to prevent the spread of the category A disease are applied. The establishment of destination shall be considered as an establishment located in the infected zone for the purposes of Article 108.
Article 105
Additional measures to be applied in the infected zone
After carrying out a risk assessment, the competent authority shall determine the additional measures necessary to control or eradicate the relevant category A disease.
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.
The measures provided for in paragraph 1 shall be implemented after consultations and in cooperation with the operational expert group referred to in Article 107 and other authorities and stakeholders.
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
In the event of a confirmed case of a category A disease in wild aquatic animals of listed species, the competent authority shall establish an operational expert group as referred to in Article 43(2)(d)(iii) of Regulation (EU) 2016/429.
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 the establishments keeping aquaculture animals of listed species within the infected zone, the competent authority shall apply the measures provided for in Article 87.
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.
The competent authority may, after carrying out a risk assessment, limit the prohibition in paragraph 2 to aquaculture animals of listed species.
By way of derogation from paragraph 2, the competent authority may authorise after carrying out a risk assessment and in agreement with the competent authority of the place of destination, the movement of animals of of listed species out of the infected zone or 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
Directives 92/66/EEC, 2001/89/EC, 2003/85/EC and 2005/94/EC as well as the acts adopted on the basis of those Directives, shall cease to apply with effect from 21 April 2021.
Directives 2000/75/EC and 2002/60/EC as well as the acts adopted on the basis of those Directives, shall cease to apply with effect from 14 July 2021.
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
(referred to in Article 3)
A. Sampling procedures
A.1. SAMPLING OF ANIMALS FOR CLINICAL EXAMINATIONS
- 1.Clinical examinations must include, if possible:
- (a) animals showing clinical signs of category A diseases;
- (b) animals likely to have recently died from a suspected or confirmed category A disease;
- (c) animals with an epidemiological link to a suspected or confirmed case of a category A disease;
- (d) animals that obtained positive or non-conclusive results in previous laboratory examinations.
- 2.The animals to be examined must be selected at random, in a number large enough to allow the detection of the category A disease, if present, where there are no obvious signs of disease or post-mortem lesions suggesting the presence of category A diseases.
- 3.The animals to be examined and the sampling method must be chosen in accordance with the instructions of the competent authority, the relevant scientific evidence for the relevant category A disease, and with the relevant contingency plan as referred to in Article 43 of Regulation (EU) 2016/429. The animals to be examined 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 taking into account:
- (i) the likelihood of exposure to the category A disease agent or to the vector;
- (ii) the absence of immunisation of the animals due to vaccination or maternal immunity;
- (iii) the history of residence in the establishment;
- (h) other relevant epidemiological factors.
- 4.The minimum number of animals to be examined 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 be examined must take into account the relevant category A disease profile, and in particular:
- (a) the expected prevalence of the relevant category A disease in the establishment;
- (b) the level of confidence desired of the survey results, which in any case must not be lower than 95 %;
- (c) international standards and the relevant scientific evidence for the relevant category A disease.
A.2. SAMPLING OF ANIMALS FOR LABORATORY EXAMINATIONS
- 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 the 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 relevant category A disease, if present.
- 3.The animals to be sampled, the nature of the samples to be collected and the sampling method must be in accordance with the instructions of the competent authority, the relevant scientific evidence for the relevant category A disease, the relevant details and guidance of the European Union Reference Laboratories (EURL) and of the Commission, and with the relevant contingency plan referred to in Article 43 of Regulation (EU) 2016/429. The animals to be sampled, the nature of the samples to be collected and the sampling method must take into account the relevant category A disease profile and the criteria set out in paragraph 3 of point A.1.
- 4.The minimum number of animals to be sampled must be in accordance with the instructions of the competent authority, the relevant scientific evidence for the relevant category A disease, the relevant details and guidance of the EURL and of the Commission, and the relevant contingency plan referred to in Article 43 of Regulation (EU) 2016/429. The minimum number of animals to be sampled 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.
A.3. SAMPLING OF ESTABLISHMENTS FOR VISITS
The choice of establishments where the samples are to be taken, the minimum number of establishments to be visited and the sampling method must be in accordance with the instructions of the competent authority, the relevant scientific evidence for the relevant category A disease, and with the relevant contingency plan referred to in Article 43 of Regulation (EU) 2016/429. The choice of establishments where samples are to be taken and the sampling method must take into account the relevant category A disease profile and the criteria set out in paragraph 3 of point A1.
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 with 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 the 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;
- (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) | 90 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) | 25 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
(referred to in Articles 12, 15, 16, 39, 45, 55 and 57)
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, except otherwise authorised by the competent authority considering the minimum required contact time as indicated by the manufacturer;
- (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 for a minimum period of 60 minutes;
- (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, or earlier if the buildings, surfaces and equipment have completely dried out after the completion of activities required in accordance with point 2, the establishments must be cleaned and disinfected again.
ANNEX V
MINIMUM RADIUS OF PROTECTION AND SURVEILLANCE ZONES
(referred to in Article 21)
Indicated as the 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 | 4 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) | 1 km | 3 km |
| Sheep pox and goat pox | 5 km | 20 km |
| Infection with peste des petits ruminants virus | 5 km | 20 km |
| Contagious caprine pleuropneumonia | 1 km | 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
(referred to in Article 27)
Table
Prohibitions of activities concerning animals of listed species and products thereof
| Prohibitions of activities concerning animals and products related to category A diseases [^E0009] | Prohibitions of activities concerning animals and products related to category A diseases [^E0009] | FMD | RP | RVFV | LSD | CBPP | SPGP | PPR | CCPP | CSF | ASF | AHS | GLANDERS | HPAI | NCD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Movements of kept animals of listed species from establishments in the restricted zone | 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 | 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 | 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 | 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 | Movements of semen, oocytes and embryos obtained from kept animals of listed species from establishments in the restricted zone | X | X | X | X | X | X | X | X | X | X | X | NA | NA | NA |
| Collection of semen, oocytes and embryo from kept animals of listed species | 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 | 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 for breeding of kept animals of listed species | Itinerant natural service for breeding 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 | 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 | 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 | NP | X | NP | X | X | NP | NA | X | X |
| Movements of offal from kept and wild animals of listed species from slaughterhouses or game handling establishments in the restricted zone | 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 | 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 |
| Movement of raw milk and colostrum obtained from kept animals of listed species from establishments in the restricted zone | Movement 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 |
| Movement of dairy products and colostrum-based products from establishments in the restricted zone | Movement of dairy products and colostrum-based products from establishments in the restricted zone | X | X | X | NP | NP | NP | X | NP | NA | NA | NP | NA | NA | NA |
| Movement of eggs for human consumption from establishments in the restricted zone | Movement 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 |
| 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 | Hides, skins, wool, bristles and feathers | X | X | NP | X | NP | X | X | NP | X | X | NP | 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 | 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 | NP | NA | X | X |
| Movement feed materials of plant origin and straw obtained in the restricted zone | Movement 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 |
| NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited | NA = Not applicable X = Prohibition NP = Not prohibited |
Abbreviations for Category A diseases in accordance with Annex II.
ANNEX VII
PART I
RISK MITIGATING TREATMENTS FOR PRODUCTS OF ANIMAL ORIGIN FROM THE RESTRICTED ZONE
(referred to in Articles 27, 33 and 49)
1. Treatments for foot-and-mouth disease
Meat
Heat treatment in a hermetically sealed container, to achieve a minimum F0 ([^E0010]) value of 3;
Heat treatment to achieve a core temperature of at least 80 °C;
Heat treatment to achieve a core temperature of 70 °C for a minimum of 30 min;
Heat treatment in a hermetically sealed container, applying at least 60 °C for a minimum of 4 hours;
Natural fermentation and maturation for a minimum period of 9 months, to achieve maximum values of Aw of 0,93 and pH of 6 throughout the product;
Drying after salting for a minimum period of 182 days, for porcine meat only.
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;
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.
Milk
Heat treatment, namely a sterilisation process, to achieve a minimum F0 value of 3;
Heat treatment Ultra High Temperature (UHT) at a minimum of 132 °C for a minimum of one second;
If milk pH is lower than 7, heat treatment High temperature short time (HTST) pasteurisation at a minimum of 72 °C for a minimum of 15 seconds;
If milk pH is 7 or higher, heat treatment HTST pasteurisation at a minimum of 72 °C for a minimum of 15 seconds, applied twice;
Heat treatment HTST pasteurisation at a minimum of 72 °C combined with a physical treatment to achieve pH value below 6 for a minimum of one hour;
Heat treatment HTST pasteurisation at a minimum of 72 °C combined with desiccation.
2. Treatments for Rinderpest
There is no risk mitigating treatment for Rinderpest.
3. Treatments for Rift Valley fever
Meat without offal
Maturation of carcasses at a minimum temperature of 2 °C for a minimum of 24 hours following slaughter.
Offal and meat from carcasses not matured
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3.
Milk
Heat treatment, namely a sterilisation process, to achieve a minimum F0 value of 3;
Heat treatment High temperature short time (HTST) pasteurisation at a minimum of 72 °C for a minimum of 15 seconds.
4. Treatments for lumpy skin disease
Offal
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3.
Casings
Safe commodity.
Milk
Heat treatment, namely a sterilisation process, to achieve a minimum F0 value of 3;
Heat treatment Ultra High Temperature (UHT) at a minimum of 132 °C for a minimum of one second;
Heat treatment High temperature short time (HTST) pasteurisation at a minimum of 72 °C for a minimum of 15 seconds;
Treatment to achieve a pH value below 6 for a minimum of one hour.
5. Treatments for contagious bovine pleuropneumonia
Offal
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3.
6. Treatments for Sheep Pox and Goat Pox
Offal
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3.
Milk
Heat treatment, namely a sterilisation process, to achieve a minimum F0 value of 3;
Heat treatment Ultra High Temperature (UHT) at a minimum of 132 °C for a minimum of one second;
Heat treatment High temperature short time (HTST) pasteurisation at a minimum of 72 °C for a minimum of 15 seconds;
Treatment to achieve a pH value below 6 for a minimum of one hour.
7. Treatments for Peste des Petits ruminants
Meat
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3;
Heat treatment to achieve a core temperature of at least 80 °C;
Heat treatment to achieve a core temperature of 70 °C for a minimum of 30 min;
Heat treatment to achieve a core temperature of 65 °C for a period of time to achieve a minimum pasteurisation value of 40;
Heat treatment in a hermetically sealed container, applying at least 60 °C for a minimum of 4 hours.
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;
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.
Milk
Heat treatment, namely a sterilisation process, to achieve a minimum F0 value of 3;
Heat treatment Ultra High Temperature (UHT) at a minimum of 132 °C for a minimum of one second;
If milk pH is lower than 7, heat treatment High temperature short time (HTST) pasteurisation at a minimum of 72 °C for a minimum of 15 seconds;
If milk pH is 7 or higher, heat treatment HTST pasteurisation at a minimum of 72 °C for a minimum of 15 seconds, applied twice;
Heat treatment HTST pasteurisation at a minimum of 72 °C combined with a physical treatment to achieve pH value below 6 for a minimum of one hour;
Heat treatment HTST pasteurisation at a minimum of 72 °C combined with desiccation.
8. Treatments for contagious caprine pleuropneumonia
Offal
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3.
9. Treatments for classical swine fever
Meat
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3;
Heat treatment to achieve a core temperature of at least 80 °C;
Heat treatment to achieve a core temperature of 70 °C for a minimum of 30 min;
Heat treatment in a hermetically sealed container, applying at least 60°C for a minimum of 4 hours;
Natural fermentation and maturation for a minimum period of 9 months, (except for loins: a minimum period of 140 days and for hams: a minimum period of 190 days), to achieve maximum values of Aw of 0,93 and pH of 6;
Drying after salting for a minimum period of 182 days.
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;
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;
Salting with citrate supplemented salt 89,2 % NaCl, 8,9 % trisodium citrate dihydrate and 1,9 % citric acid monohydrate (wt/wt/wt) with pH 4,5, for a continuous period of 30 days or longer at an ambient temperature of 20 °C or above.
10. Treatments for African swine fever
Meat
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3;
Heat treatment to achieve a core temperature of at least 80 °C;
Heat treatment to achieve a core temperature of at least 70 °C for a minimum of 30 minutes;
Heat treatment in a hermetically sealed container, applying at least 60 °C for a minimum of 4 hours;
For deboned meat, natural fermentation and maturation of for minimum period of 9 months (except for loins: a minimum of 140 days and for hams: a minimum period of 190 days), to achieve maximum values of Aw of 0,93 and pH of 6;
Drying after salting for a minimum period of 182 days.
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;
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.
11. Treatments for African horse sickness
Meat, casings and milk are safe commodities.
12. Treatments for highly pathogenic avian influenza
Meat
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3;
Heat treatment to achieve a core temperature of at least 70 °C;
Heat treatment to achieve a core temperature of at least 65 °C for a minimum of 42 seconds;
Heat treatment to achieve a core temperature of at least 60 °C for a minimum of 507 seconds.
Eggs
Heat treatment, with temperatures reaching at the core of the product at least the indicated value for a minimum of the time indicated:
Whole egg:
- — Completely cooked;
- — 60 °C – 188 seconds.
Whole egg blends:
- — Completely cooked;
- — 61,1 °C – 94 seconds;
- — 60 °C – 188 seconds.
Liquid egg white:
- — 56,7 °C – 232 seconds;
- — 55,6 °C – 870 seconds.
Plain or pure egg yolk:
- — 60 °C – 288 seconds.
10 % salted yolk:
- — 62,2 °C – 138 seconds.
Dried egg white:
- — 67 °C – 20 hours;
- — 54,4 °C – 513 hours.
13. Treatments for Newcastle disease
Meat
Heat treatment in a hermetically sealed container, to achieve a minimum F0 value of 3;
Heat treatment to achieve a core temperature of at least 70 °C;
Heat treatment to achieve a core temperature of 60 °C for a minimum of 507 seconds;
Heat treatment to achieve a core temperature of 57,8 °C for a minimum of 63 minutes and 18 seconds.
Eggs
Heat treatment, with temperatures reaching at the core of the product at least the indicated value for a minimum of the time indicated:
Whole egg:
- — Completely cooked;
- — 59 °C – 674 seconds;
- — 57 °C – 1 596 seconds;
- — 55 °C – 2 521 seconds.
Fortified egg:
- — 62,2 °C – 3 minutes and 30 seconds;
- — 61,1 °C – 6 minutes and 12 seconds.
Sugared/salted egg:
- — 63,3 °C – 3 minutes and 30 seconds;
- — 62,2°C – 6 minutes and 12 seconds.
Liquid egg white:
- — 59 °C – 301 seconds;
- — 57 °C – 986 seconds;
- — 55 °C – 2 278 seconds.
Plain or pure egg yolk:
- — 61,1 °C – 3 minutes and 30 seconds;
- — 60 °C – 6 minutes and 12 seconds.
10 % salted egg yolk:
- — 55 °C – 176 seconds.
Dried egg white:
- — 57 °C – 50 hours and 24 minutes.
PART II
METHODS TO MITIGATE THE RISK OF THE SPREAD OF CATEGORY A DISEASES FOR ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS FROM THE RESTRICTED ZONE
(referred to in Articles 27, 35, 37, 51 and 53)
The following methods for the treatment, transformation or processing, as described in the following Chapters and Annexes of Regulation (EU) No 142/2011:
-
- Processing of derived products by standard processing methods 1 to 5, referred to in Annex IV, Chapter III.
-
- Transformation or composting by standard transformation parameters for biogas transformation or composting, referred to in Annex V, Chapter III, Section 1.
-
- Double heat treatment for processing of milk-derived or milk-based products, referred to in Annex X, Chapter II, Section 4, Part 1, point B.
-
- Heat treatment for processing of manure, referred to in Annex XI, Chapter I, Section 2 point (b).
-
- Heat treatment for the manufacture of petfood (namely, processed petfood, dog chews and flavouring innards) referred to in Annex XIII, Chapter II, point 3(a) and point 3(b)(i), (ii) and (iii).
-
- Treatment of blood products from Equidae by one of the treatments followed by an effectiveness check, as set out in Annex XIII, Chapter IV, point 2(b)(ii).
-
- Treatment of hides and skins, referred to in Annex I, point 28; and the processing of hides and skins, referred to in Annex XIII, Chapter V, point C2.
-
- Treatment or processing of game trophies, referred to in Annex XIII, Chapter VI, point C.
-
- Treatment of pig’s bristles, referred to in Annex XIII, Chapter VII, point A2(a).
-
- Treatment of wool and hair, referred to in Annex XIII, Chapter VII, point B, third subparagraph.
-
- Treatment for feather and down, referred to in Annex XIII, Chapter VII, point C.
-
- Processing of fat derivates, referred to in Annex XIII, Chapter XI, points 1 and 2.
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 [^E0011] | 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 the releasing of the feed materials of plant origin and straw from the premises do not take place before at least four months have elapsed following the completion of the cleaning and disinfection in accordance with Article 15 | X | X |
Disease abbreviations in accordance with Annex II.
ANNEX IX
MARKING OF FRESH MEAT FROM THE RESTRICTED ZONE
(Special health or identification marks)
(referred to in Articles 33 and 49)
- 1.The special identification mark to be applied to fresh meat of poultry originating in the protection zone and not intended for another Member State as referred to in Article 33(1), point (b), of this Regulation shall be the identification mark provided for in Article 5(1), point (b), of Regulation (EC) No 853/2004, with two additional diagonal parallel lines enabling the information on it to remain perfectly legible.
- 2.The special health mark or, where relevant, the special identification mark to be applied to fresh meat intended for treatment in a processing establishment in accordance with Articles 33(2), point (a), and 49(2), point (a), of this Regulation shall consist of the health mark provided for in Article 48 and Annex II to Implementing Regulation (EU) 2019/627 or, where relevant, the identification mark provided for in Section I of Annex II to 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 on it to remain perfectly legible.
ANNEX X
DURATION OF THE MEASURES IN THE PROTECTION ZONE
(referred to in Article 39)
| 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) | 90 days | Not applicable |
| Sheep pox and goat pox | 21 days | 9 days |
| Infection with peste des petits ruminants virus | 21 days | 12 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 | 25 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
(referred to in Article 55 and 56)
| 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) | 90 days |
| Sheep pox and goat pox | 30 days |
| Infection with peste des petits ruminants virus | 33 days |
| Contagious caprine pleuropneumonia | 45 days |
| African horse sickness | 12 months |
| Infection with Burkholderia mallei (Glanders) | Not applicable |
| Classical swine fever | 40 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
Periods for the fallowing provided for in Article 81 and for the synchronous fallowing provided for in Article 96(4) and (5) of this Regulation
| 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.
Table 1
Scheme for surveillance comprising health visits and samplings in establishments and groups of establishments for category A diseases in aquatic animals, except epizootic hematopoietic necrosis
| 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 |
Table 2
Specific scheme for surveillance comprising health visits and samplings in establishments for epizootic haematopoietic necrosis (EHN) in aquatic animals [^E0012]
| 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 fish in the sample |
|---|---|---|---|---|
| Type of establishment | Number of health inspections per year (2 years) | Number of samplings per year (2 years) | Number of growing fish | Number of brood stock fish [^E0013] |
| (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 [^E0013] (first or second inspection) |
| (c) Establishments without broodstock | 2 | 2 | 150 (first and second inspection) | 0 |
| Maximum number of fish per pool: 10 | Maximum number of fish per pool: 10 | Maximum number of fish per pool: 10 | Maximum number of fish per pool: 10 | Maximum number of fish per pool: 10 |
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.
[^E0013]: (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.
[^E0001]: 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 origin (OJ L 139, 30.4.2004, p. 55).
[^E0002]: Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products (OJ L 95, 7.4.2017, p. 1).
[^E0003]: Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs (OJ L 314, 5.12.2019, p. 115).
[^E0004]: Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1, ELI: http://data.europa.eu/eli/reg/2011/142/oj).
[^E0005]: Commission Delegated Regulation (EU) 2024/2623 of 30 July 2024 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for approval and recognition of disease-free status of compartments keeping terrestrial animals (OJ L, 2024/2623, 4.10.2024, ELI: http://data.europa.eu/eli/reg_del/2024/2623/oj).
[^E0006]: Commission Implementing Regulation (EU) 2021/620 of 15 April 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of the disease-free and non-vaccination status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for those listed diseases (OJ L 131, 16.4.2021, p. 78, ELI: http://data.europa.eu/eli/reg_impl/2021/620/oj).
[^E0007]: Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
[^E0008]: Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (see page 140 of this Official Journal).
[^E0010]: 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 (250 °F) in three minutes with instantaneous heating and chilling.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.