(a) prohibitions and restrictions on the use of certain veterinary medicinal products in animals for prevention and control of category A and B diseases; (b) rules on the use of vaccines in animals for prevention and control of category A and certain category B diseases; (c) risk-mitigating measures to prevent the spread of category A diseases through vaccinated animals or products from such animals; (d) rules on surveillance of category A diseases following the use of vaccines in terrestrial animals for their prevention and control.
Commission Delegated Regulation (EU) 2023/361 of 28 November 2022 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases (Text with EEA relevance)
(a) "category A disease" means a listed disease that does not normally occur in the Union and for which immediate eradication measures must be taken as soon as it is detected, as referred to in Article 9(1), point (a), of Regulation (EU) 2016/429; (b) "category B disease" means a listed disease which must be controlled in all Member States with the goal of eradicating it throughout the Union, as referred to in Article 9(1), point (b), of Regulation (EU) 2016/429; (c) "emergency suppressive vaccination" means a vaccination strategy implemented by the competent authority in kept terrestrial animals for the prevention and control of category A diseases in accordance with Article 7(1), point (a)(i); (d) "emergency protective vaccination" means a vaccination strategy implemented by the competent authority in kept terrestrial animals for the prevention and control of category A diseases in accordance with Article 7(1), point (a)(ii); (e) "emergency vaccination in wild terrestrial animals" means a vaccination strategy implemented by the competent authority in wild terrestrial animals for the prevention and control of category A diseases in accordance with Article 7(1), point (a)(iii); (f) "preventive vaccination" means a vaccination strategy implemented by the competent authority for the prevention and control of category A diseases in accordance with Article 7(1), point (b); (g) "vaccination zone" means a zone in which a vaccine is administered to listed species to prevent and control category A diseases; (h) "peri-vaccination zone" means a zone, surrounding the vaccination zone, where vaccination for the purpose of preventing and controlling category A diseases is not allowed and where reinforced surveillance is implemented to detect those diseases. (i) "confirmed outbreak" means an outbreak confirmed in accordance with Article 9(2), (3) and (4) of Delegated Regulation (EU) 2020/689; (j) "recovery period" means the necessary period of time required for a vaccination zone to recover the animal health status prior to the implementation of vaccination against a category A disease, by demonstrating absence of the category A disease after emergency protective vaccination against the disease has been carried out; (k) "protection zone" means a protection zone as established on the basis of Article 21(1), point (a), of Delegated Regulation (EU) 2020/687; (l) "surveillance zone" means a surveillance zone as established on the basis of Article 21(1), point (b), of Delegated Regulation (EU) 2020/687; (m) "bovine animal" means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgeneraBos, Bibos, Novibos, Poephagus ) andBubalus (including the subgenusAnoa ) and the offspring of crossings of those species;(n) "ovine animal" means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species; (o) "caprine animal" means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species; (p) "camelid animal" means an animal of the species of ungulates belonging to the family Camelidae listed in Annex III to Regulation (EU) 2016/429; (q) "porcine animal" means an animal of the species of ungulates belonging to the family Suidae listed in Annex III to Regulation (EU) 2016/429;(r) "equine animal" as an animal of species of solipeds belonging to the genus Equus (including horses, asses, and zebras) and the offspring of crossings of those species;(s) "day-old chicks" means all poultry less than 72 hours old.
(a) as a part of the official measures put in place by the competent authority for prevention and control of those diseases; (b) under the conditions laid down in this Regulation.
(a) immunological veterinary medicinal products to diagnose the state of immunity of animals; (b) hyper-immune serum; (c) inactivated immunological veterinary medicinal products, as referred to in Article 2(3) of Regulation (EU) 2019/6; (d) antimicrobials.
(a) it has carried out an assessment to support this decision considering at least the criteria set out in Part 1 of Annex II, in addition to the criteria provided for in Article 46(2) of Regulation (EU) 2016/429; (b) the vaccines are used in accordance with an official vaccination plan which fulfils the requirements laid down in Article 6.
(a) detail, at least, the information and measures set out in Part 1 of Annex III; (b) be implemented under the control of the competent authority and only for the strictly necessary period of time.
(a) at least the preliminary information set out in Annex IV, at the latest two days before starting the vaccination; (b) the official vaccination plan and its amendments and updates, as soon as possible and at the latest two weeks after starting the vaccination or implementing the amendments or updates of the official vaccination plan.
(a) emergency vaccination, as referred to in Article 69 of Regulation (EU) 2016/429, may be any of the following: (i) emergency suppressive vaccination, implemented in response to an outbreak of a category A disease to control its spread and limited to kept terrestrial animals that are to be killed in accordance with Articles 12(1), point (a), and 18(1), point (b), of Delegated Regulation (EU) 2020/687 but are subject to the derogation provided for in Article 12(4), point (b), of that Regulation; (ii) emergency protective vaccination, implemented in response to an outbreak of a category A disease, which is carried out in any of the following cases: on terrestrial animals at risk of infection that are kept in establishments located in affected Member States or zones thereof, in which category A diseases have not been confirmed nor are suspected in accordance with Article 6(1) and Article 11 of Delegated Regulation (EU) 2020/687, in response to a change in the risk of introduction of a category A disease in a non-affected Member State or zone thereof, on affected equine animals subject to the derogation provided for in point 1 of Annex III to Delegated Regulation (EU) 2020/687;
(iii) emergency vaccination in wild terrestrial animals, implemented in response to an outbreak of a category A disease;
(b) preventive vaccination, where a vaccine against a category A disease is administered to terrestrial animals in non-affected geographic areas for preventive purposes other than the cases covered by emergency protective vaccination.
(a) vaccinate the animals subject to the derogation provided for in Article 12(4), point (b), of Delegated Regulation (EU) 2020/687 without delay after the confirmation of the relevant outbreak(s); (b) order and supervise the killing of all vaccinated animals as soon as possible, in accordance with the rules laid down in either Article 12(1), point (a), or Article 12(4), point (a), of Delegated Regulation (EU) 2020/687 and under the biosecurity measures provided for in Articles 12(1), point (c), and Article 12(2) of that Delegated Regulation.
(a) specify the type of vaccine to be used or prioritised, the minimum vaccine coverage and the targeted animals/species; (b) establish geographically: (i) a vaccination zone, in which vaccination is carried out, in order to prevent spreading of the category A disease from affected areas to non-affected areas; (ii) a peri-vaccination zone, surrounding the vaccination zone, in which vaccination is not allowed, covering a distance width from the perimeters of the vaccination zone;
(c) implement reinforced clinical and laboratory surveillance in the vaccination and peri-vaccination zones referred to in point (b): (i) to assess vaccination effectiveness in the vaccination zone; (ii) to detect any possible new outbreak of the disease in the vaccination and peri-vaccination zones; (iii) in accordance with Annex I to Delegated Regulation (EU) 2020/687 as regards the sampling procedures, diagnostic methods and transport of samples; (iv) selecting the diagnostic methods depending on the type of vaccine administered.
(a) specify the type of vaccine to be used or prioritised; (b) implement reinforced clinical and laboratory surveillance;
(a) distribution and administration of the vaccine; (b) returning of any residual quantities of the vaccine to the point of distribution or to any other designated point with a record on the vaccinated establishments, the number of vaccinated animals and the number of doses used.
(a) the movements of animals and products thereof laid down in Part 3, point 1, of Annexes VII to XIV; (b) the collection of the following germinal products from animals of listed species, laid down in Part 3, point 2, of Annexes VII to XIV: (i) semen; (ii) oocytes; (iii) embryos;
(c) in the absence of disease-specific conditions laid down in Part 3, of Annexes VII to XIV, movements of: (i) vaccinated animals from the establishment where they were vaccinated; (ii) products from vaccinated animals from the production and/or processing establishments.
(a) they are subject to compulsory killing after vaccination, in accordance with the official vaccination plan referred to in Article 5(1), point (b), and they are moved to be killed at the nearest suitable place; or (b) they are not subject to compulsory killing after vaccination, in accordance with the official vaccination plan referred to in Article 5(1), point (b), and they are either: (i) not subject to prohibitions of movements; or (ii) they are subject to prohibitions of movements but they comply with the relevant conditions and the competent authority has authorised their movement in accordance with the conditions laid down in Part 3, point 3, of Annexes VII to XIV.
(a) they are not subject to prohibitions of movements; or (b) the competent authority has authorised their movement in accordance with the conditions laid down in Part 3, point 3, of Annexes VII to XIV.
(a) they are not subject to prohibition of collection; or (b) the competent authority has authorised their collection in accordance with the conditions laid down in Part 3, point (3), of Annexes VII to XIV.
(a) protection and surveillance zones and further restricted zones where applicable, established in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687 in the event of an outbreak of a category A disease in kept terrestrial animals, until they are lifted in accordance with Articles 39 and 55 of that Regulation; (b) infected zones established in accordance with Article 63(1) of Delegated Regulation (EU) 2020/687 in the event of an outbreak of a category A disease in wild animals, until they are lifted in accordance with Article 67 of that Regulation; (c) restricted zones established under emergency measures provided for in Articles 71, 257 and 258 of Regulation (EU) 2016/429, and any rules adopted pursuant to Article 71(3) and Article 259 of that Regulation until those measures are lifted.
(a) they are not included in the list of animals and products subject to prohibitions of movements; (b) they are subject to prohibitions of movements but they comply with the relevant conditions and the competent authority has authorised their movement;
(a) Article 149(1) of Regulation (EU) 2016/429 for kept terrestrial animals; (b) Article 161(4) of Regulation (EU) 2016/429 for germinal products; (c) Article 167(3) of Regulation (EU) 2016/429 for products of animal origin; (d) Article 22(5) and (6) of Delegated Regulation (EU) 2020/687 for animal by-products;
(a) in accordance with: (i) the disease-specific conditions set out in Part 4 of Annexes VII to XIV; (ii) Annex I to Delegated Regulation (EU) 2020/687, as regards the sampling procedures, diagnostic methods and transport of samples;
(b) taking into account the type of vaccine administered.
1. Annex I on category A and B diseases for which the use of vaccines shall be prohibited by Member States and on the use of certain veterinary medicinal products, other than vaccines, for prevention and control of category A and B diseases. 2. Annex II on the criteria for the use of a vaccine to prevent and control a category A disease in animals. 3. Annex III on the information to be included in the official vaccination plan. 4. Annex IV on the preliminary information to be provided to other Member States and the Commission prior to vaccination. 5. Annex V on the minimum records on vaccination. 6. Annex VI on the minimum information to be provided by the competent authority to other Member States and the Commission on the implementation of vaccination. 7. Annex VII on vaccination against foot and mouth disease (FMD). 8. Annex VIII on vaccination against infection with Rift Valley Fever virus (RVF). 9. Annex IX on vaccination against infection with lumpy skin disease virus (LSD). 10. Annex X on vaccination against infection with peste des petits ruminants virus (PPR). 11. Annex XI on vaccination against African horse sickness (AHS). 12. Annex XII on vaccination against classical swine fever (CSF). 13. Annex XIII on vaccination against highly pathogenic avian influenza (HPAI). 14. Annex XIV on vaccination against infection with Newcastle disease virus (NCD).
Infection with Rinderpest virus
Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis)
| Disease | Type of veterinary medicinal product | Conditions |
|---|---|---|
| Infection with | Immunological veterinary medicinal products to diagnose the state of immunity of animals: brucelin | Their use shall be allowed only in accordance with Delegated Regulation (EU) 2020/688, Delegated Regulation (EU) 2020/689, Delegated Regulation (EU) 2020/686 and Regulation (EU) No 853/2004, or for export purposes |
| Infection with | Immunological veterinary medicinal products to diagnose the state of immunity of animals: tuberculin | Their use shall be allowed only in accordance with Delegated Regulation (EU) 2020/688, Delegated Regulation (EU) 2020/689, Delegated Regulation (EU) 2020/686 and Regulation (EU) No 853/2004, or for export purposes |
1. Number of establishments where the category A disease has been confirmed or suspected; 2. Type of establishments where the category A disease has been confirmed or suspected; 3. Number of animals kept in the establishments where the category A disease has been confirmed or suspected; 4. Species affected and risk of disease spread to humans; 5. Presence of the disease in wild animals; 6. Density of animals of listed species in the areas where the disease is present; 7. Density of establishments keeping animals of listed species in the areas where the disease is present; 8. Origin of the outbreak(s); 9. Traceability and possibility to perform contact tracing; 10. Incidence slope of outbreaks; 11. Simulation models used to assess when and if vaccination is relevant, if such information is available; 12. Capacity of killing and killing and disposal schedule in establishments where animals are killed; 13. Movement of potentially infected animals or products out of the restricted zone established pursuant to Delegated Regulation (EU) 2020/687; 14. Rate of airborne or vector-borne spread of the disease agent from the establishments or area where the category A disease has been confirmed; 15. Effectiveness of other disease control measures taken and available resources to implement them; 16. Level of preparedness and capacity of the competent authorities and other personnel concerned; 17. Economic assessment: cost–benefit analysis; 18. Trade concerns: consequences on disease freedom status of the Member State concerned and trade restrictions likely to be imposed by third countries or territories as a consequence of vaccination.
1. mortality in wild animals due to the category A disease; 2. knowledge of the population and ecological dynamics of the affected wild animals; 3. size of the affected area (where animals affected are found); 4. the risk of spread of the disease to additional listed species of wild animals or beyond the above area; 5. the risk of spread of the category A disease to kept animals or to humans; 6. the availability of vaccines and vaccination systems to distribute the vaccine among the target population; 7. the possibility to control the vaccination and to establish a surveillance system to detect the specific disease agent and to assess the effectiveness of vaccination.
1. Number of establishments where the category A disease has been confirmed or suspected; 2. Type of establishments where the category A disease has been confirmed or suspected; 3. Number of animals kept in the establishments where the category A disease has been confirmed or suspected; 4. Species affected; 5. Capacity of killing and killing and disposal schedule in establishments where animals are killed; 6. Rate of airborne or vector-borne spread of the disease agent from the establishments or area where the category A disease has been confirmed.
(a) the description and the results of the assessment performed in accordance with Annex II, including the epidemiological situation and the relevant information used as a basis for the assessment; (b) the main objectives and targets with the chosen vaccination strategy and the official vaccination plan; (c) the detailed geographic description of the vaccination zone in which vaccination is to be carried out and the location of establishments keeping animals to be vaccinated, when available and applicable, including maps; (d) where relevant, the detailed geographic description of the peri-vaccination zone surrounding the vaccination zone, and the location of establishments keeping animals of listed species, when available, including maps; (e) the number of establishments keeping animals of listed species located in the vaccination zone and the number of establishments in which vaccination is to be carried out, if different; (f) the estimated number of kept animals of listed species to be vaccinated, their categories and, when relevant, their age; (g) intended final use of vaccinated animals and products; (h) categories of animals exempted from vaccination and reasoning; (i) the arrangements to administer the vaccine and the system to supervise the administration of the vaccine; (j) the envisaged duration of the vaccination, from the start of the vaccination to the end of the surveillance carried out after vaccination; (k) the summary of the characteristics of the vaccine, including the name of the product(s) and the name of the manufacturer(s), and routes of administration; (l) indication if the vaccine is used in accordance with Article 110(2) of Regulation (EU) 2019/6; (m) the details of the reinforced clinical and laboratory surveillance referred to in Article 9, point 1(c) and Article 10, point 2(b); (n) the hygiene and biosecurity rules to be applied; (o) the record keeping system on the vaccination; (p) the restrictions on movements of vaccinated animals and products thereof and other risk-mitigating measures to control the potential spread of disease to be put in place and their duration in addition to those provided for in this Regulation; (q) communication campaign to be put in place to inform operators and the public about the vaccination, including the safety for human consumption of products of animal origin from vaccinated animals of listed species; (r) other matters deemed appropriate to the situation by the competent authority.
(a) the detailed geographic description of the vaccination zone and the peri-vaccination zone, where relevant; (b) the estimated number of wild animals of listed species to be vaccinated; (c) the measures to be adopted to avoid a high number of movements of wild animals; (d) the vaccination periods or seasons where relevant; (e) the vaccine delivery system.
(a) The description and the results of the assessment performed in accordance with Annex II, including the epidemiological situation and the relevant information used as a basis for the assessment; (b) the main objectives and targets with the chosen vaccination strategy and the official vaccination plan; (c) the number of establishments keeping animals of listed species to be vaccinated; (d) the estimated number of kept animals of listed species to be vaccinated, their categories and, when relevant, their age; (e) categories of animals exempted from vaccination and reasons for exempting them; (f) the system to supervise the administration of the vaccine; (g) the summary of the characteristics of the vaccine, including the name of the products and the name of the manufacturers;
(a) brief reasoning to start the vaccination; (b) chosen strategy and motivation; (c) species of animals that will be vaccinated, specifying if wild animals will be included; (d) estimated number of animals that will be vaccinated; (e) estimated duration of the vaccination; (f) type and commercial name of the vaccine applied, including the indication if the vaccine will be used in accordance with Article 110(2) of Regulation (EU) 2019/6; (g) description of the estimated vaccination zone.
Individual identification, where relevant in accordance with Regulation (EU) 2019/2035, species and category, Registration number of the establishment, number of vaccinated animals, number of vaccine doses administered, type and name of the vaccine, date of vaccination, date of killing (where applicable), date and method of disposal of the carcass (where applicable).
Regions or zones where wild animals are vaccinated, vaccine delivery system, period of vaccination, type and name of the vaccine, number of vaccine doses distributed, methods to monitor vaccination effectiveness and methods of disease surveillance in vaccinated zones.
| Emergency vaccination strategy | Preventive vaccination strategy | |||
|---|---|---|---|---|
| Suppressive vaccination | Protective vaccination | In wild animals | ||
| Description of vaccination and peri-vaccination zones | WHERE APPLICABLE | YES | YES | WHERE APPLICABLE |
| Total number of establishments and total number of establishments in each vaccination zone (where applicable) | YES | YES | NO | YES |
| Total number of animals to be vaccinated, (by species) and total number of animals in each vaccination zone (where applicable). | YES | YES | NO | YES |
| Total number of vaccinated establishments (in each vaccination zone where applicable) | YES | YES | NO | YES |
| Total number of vaccinated animals, by species, (in each vaccination zone, where applicable) | YES | YES | NO | YES |
| Total number of doses administered or distributed | YES | YES | YES | YES |
| Expected date for completing the vaccination | NO | YES | YES | YES |
| Total number of vaccinated animals killed. | YES | WHERE APPLICABLE | NO | NO |
| Dates of killing of the vaccinated animals (suppressive vaccination) or expected date of completion of killing (protective vaccination, where applicable) | YES | WHERE APPLICABLE | NO | NO |
| Emergency vaccination strategy | Preventive vaccination | ||
|---|---|---|---|
| Suppressive vaccination | Protective vaccination | In wild animals | |
| Within 7 days from the end of the administration of the vaccine to all animals included in the official vaccination plan | At least once every two weeks for the first month of vaccination and once a month for the rest of the duration of the vaccination for one-year or shorter vaccination campaigns | At least once a month for one-year or shorter vaccination campaigns | Once a year |
| At least once at the end of the annual vaccination for multi-year vaccination campaigns | At least every 6 months for multi-year vaccination campaigns | ||
1. a clinical examination of one of the following types: (a) clinical examination of all animals of listed species kept in all establishments in the vaccination zone; (b) clinical examination targeted at particular species likely to exhibit clear clinical signs, if the competent authority decides so, based on the positive outcome of a risk assessment;
2. laboratory examination in line with the following conditions: (a) for antibodies against non-structural proteins of the FMD virus carried out on samples taken from vaccinated animals of listed species and their non-vaccinated offspring in all establishments in the vaccination zone; (b) to detect infection with the FMD virus, either by an assay for antibodies against non-structural proteins of the FMD virus, or by another approved method, carried out on samples collected in accordance with Annex I to Delegated Regulation (EU) 2020/687 from all establishments in the vaccination zone in which vaccination was not carried out; (c) carried out for each establishment tested under point (a) according to a sample size that shall be calculated to detect a within-establishment animal prevalence of 5 % or less, with a 95 % confidence, in both vaccinated and non-vaccinated animals; (d) where the competent authority uses in addition sentinel animals introduced in affected establishments as part of their repopulation, the conditions for repopulation of affected establishments provided for in Delegated Regulation (EU) 2020/687 shall be taken into account.
(a) animals of listed species from establishments located in the vaccination zone; (b) fresh meat, raw milk and colostrum obtained from vaccinated animals; (c) dairy products and colostrum-based products produced from milk and colostrum obtained from vaccinated animals;
(a) movements for slaughter of kept animals of listed species from establishments located in the vaccination zone to a slaughterhouse located within or as close as possible to the vaccination zone, within the same Member State, under the same conditions as those laid down in Article 24, Article 28(2), (3), (4), (5) and (7) and Article 29(1) and (2) of Delegated Regulation (EU) 2020/687; (b) movements of fresh meat and raw milk obtained from vaccinated animals under the same conditions as those provided for in Article 24, Article 28(2), (3), (4), (6) and (7) and Article 33(1), point (a), and Article 33(2) of Delegated Regulation (EU) 2020/687; (c) movements of dairy products produced from milk obtained from vaccinated animals if they have undergone an effective treatment for FMD in accordance with Annex VII to Delegated Regulation (EU) 2020/687 and only if during the production process, storage and transport they have been separated from products not eligible for dispatch outside the vaccination zone pursuant to this Regulation; (d) collection of semen for artificial insemination from donor animals of listed species kept in approved germinal product establishments located in the vaccination zone for the production of frozen semen, under the following conditions: (i) it is ensured that the semen collected during this period is stored separately for at least 30 days; (ii) prior to dispatch of the semen, either: the donor animal has not been vaccinated and the same conditions as those set out in Article 32, points (b) and (c), of Delegated Regulation (EU) 2020/687 are fulfilled, or the donor animal has been vaccinated following a negative result to a laboratory examination for the detection of antibodies against the FMD virus carried out prior to vaccination, and a negative result has been achieved in a laboratory examination for the detection of either virus or viral genome, or in an approved test for the detection of antibodies against non-structural proteins of the FMD virus, carried out at the end of the quarantine period for the semen on samples taken from all animals of listed species present at that time in the approved germinal product establishment, and the semen complies with the conditions set out in Part 5, Chapter I, point 3, of Annex II to Delegated Regulation (EU) 2020/686.
(a) movements for slaughter of kept animals of listed species kept in the vaccination zone to a slaughterhouse located within or outside the vaccination zone but within the same Member State, under the same conditions as those provided for in Article 24 and Article 28(5) of Delegated Regulation (EU) 2020/687; (b) movements of fresh meat, excluding offal, obtained from vaccinated ungulates of listed species, other than porcine animals, if the fresh meat: complies with the same conditions as those set out in Article 28(6) of Delegated Regulation (EU) 2020/687, has been de-boned and the main accessible lymph nodes have been removed, is, or has been obtained from, carcasses that have been subjected to a maturation process at a temperature of more than 2 °C for at least 24 hours and the pH value recorded in the middle of the Longissimus dorsi muscle was less than 6,0;
(c) movements of fresh meat obtained from ungulates of listed species, other than porcine animals, kept and slaughtered outside the vaccination zone; (d) movements of fresh meat, excluding offal, obtained from vaccinated porcine animals slaughtered in this period, if the fresh meat was produced under the conditions provided for in Article 24, Article 28(2), (3), (4), (6) and (7) and Article 33(1), point (a), and Article 33(2) of Delegated Regulation (EU) 2020/687; (e) movements of raw milk obtained from vaccinated animals under the same conditions as those provided for in Article 24, Article 28(2), (3), (4), (6) and (7) and Article 33(1), point (a), and Article 33(2), point (b), of Delegated Regulation (EU) 2020/687; (f) movements of dairy products obtained from vaccinated animals if those dairy products have undergone an effective treatment against FMD in accordance with Annex VII to Delegated Regulation (EU) 2020/687 and only if during the production process, storage and transport have been separated from products not eligible for dispatch outside the vaccination zone pursuant to this Regulation. (g) collection of semen for artificial insemination from donor animals of listed species kept in approved germinal product establishments located in the vaccination zone under the conditions set out in point 3.1, subpoint (d).
(a) movements for slaughter of animals of listed species kept in the vaccination zone to a slaughterhouse located within or out of the vaccination zone, but within the same Member State, under the same conditions as those set out in Article 24 and Article 28(5) of Delegated Regulation (EU) 2020/687; (b) movements of unvaccinated animals of listed species in accordance with the following provisions: (i) within 24 hours preceding loading, all animals of listed species on the establishment have been subjected to clinical examination and have not shown clinical signs of FMD, (ii) the animals have completed a standstill on the establishment of origin of at least 30 days during which no animal of listed species has been introduced into the establishment, (iii) the animals intended for transport were either individually subjected, with negative results, to tests for the detection of antibodies against the FMD virus at the end of the isolation period, or a serological survey was completed on that establishment irrespective of the species concerned; (iv) the animals were not exposed to any source of infection during their transportation from the establishment of origin to the place of destination, that shall be located in the same Member State;
(c) movements of non-vaccinated calves, offspring of vaccinated cows to: (i) an establishment within the vaccination zone of the same health status as the establishment of origin; (ii) a slaughterhouse for immediate slaughter; (iii) an establishment designated by the competent authority, from which the offspring are to be sent directly to a slaughterhouse; (iv) any establishment, after having obtained a negative result in a serological test for the detection of antibody against the FMD virus carried out on a sample of blood taken prior to dispatch from the establishment of origin;
(d) movements of fresh meat, meat products, raw milk, dairy products in accordance with point 3.2, points (b) to (f); (e) collection of semen in accordance with point 3.1, point (d)
| Recovery period | Type of surveillance to demonstrate the absence of occurrence of FMD |
|---|---|
| 3 months after the last remaining vaccinated animal in the vaccination zone has been killed or slaughtered, excluding animals referred to in Article 13(2) of Regulation (EU) 2020/687 | Clinical and laboratory |
| The relevant recommendations in the FMD Chapter, 30th edition 2022, of the WOAH Terrestrial Animal Health Code are met | |
1.1. Vaccination zone I: vaccination zone where emergency protective vaccination is implemented in areas where LSD has not been confirmed; 1.2. Vaccination zone II: vaccination zone where emergency protective vaccination is implemented in areas where outbreaks of LSD have been confirmed.
(a) bovine animals; (b) germinal products from bovine animals; (c) unprocessed animal by-products from bovine animals other than milk, colostrum, dairy products and colostrum-based products intended for animal feed.
(a) vaccination zones I or II of the same or another Member State provided that all of the following conditions are fulfilled: (i) the bovine animals in the consignment must have been vaccinated against LSD at least 28 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on that date; (ii) all the other bovine animals kept in the same establishment of origin as the bovine animals in the consignment must have been vaccinated against LSD at least 28 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on that date or remain within the immunity period induced by previous vaccination or maternal immunity on the date of dispatch; (iii) the bovine animals in the consignment must have been kept in their establishment of origin since birth or for a continuous period of at least 28 days prior to the date of dispatch; and a clinical examination was carried out, with favourable results, of all bovine animals kept in the establishment of origin of such consignments, including the bovine animals in such consignments, if necessary, a laboratory examination was carried out, with favourable results, of bovine animals kept in the establishment of origin of such consignments, including the bovine animals in such consignments;
(b) any destination, in the same Member State or in other Member States, if, in addition to the conditions laid down in point (a) (ii) and (iii), all of the following conditions are fulfilled: (i) the bovine animals in the consignment must have been vaccinated against LSD at least 60 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on the date of dispatch; (ii) within a radius of at least 20 km around the establishment of origin of such consignments, there have been no outbreaks of LSD during a period of at least three months prior to the date of dispatch; and (iii) all bovine animals kept in 50 km around the establishment of origin of the consignment must have been vaccinated or revaccinated against LSD at least 60 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on that date or within the immunity period induced by maternal immunity;
(c) any destination, in other Member States or territories in third countries, if, in addition to the conditions laid down in point (a), the following conditions are fulfilled: (i) the animals must comply with any animal health guarantee, based on the favourable outcome of a risk assessment of measures against the spread of LSD required by the competent authority of the Member State of origin and approved by the competent authority of the Member States of passage and destination, prior to the date of dispatch; (ii) there must have been no confirmed outbreaks of LSD within a radius of at least 20 km around the establishment of origin of such consignments for a period of at least three months prior to the date of dispatch; and (iii) all bovine animals kept in 50 km around the establishment of origin of the consignment must have been vaccinated or revaccinated against LSD at least 60 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on that date or within the immunity period induced by maternal immunity.
(a) any destination, in the same Member State and other Member States, provided that all of the following conditions are fulfilled: (i) the bovine animals in the consignment shall comply with any animal health guarantee, based on the favourable outcome of a risk assessment of measures against the spread of LSD required by the competent authority of the Member State of origin and approved by the competent authority of the Member States of passage and destination, prior to the date of dispatch; (ii) the bovine animals in the consignment must have been vaccinated against LSD at least 28 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on that date; (iii) all other bovine animals kept in the same establishment of origin as the bovine animals in the consignment must have been vaccinated against LSD at least 28 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on that date or remain within the immunity period induced by previous vaccination or maternal immunity on that date; (iv) the following examinations were carried out: a clinical examination, with favourable results, of all bovine animals kept in the establishment of origin of such consignments, including the bovine animals in such consignments, if necessary, a laboratory examination, with favourable results, of bovine animals kept in the establishment of origin of such consignments, including the bovine animals in such consignments;
(v) the bovine animals must have been resident since birth, or for a period of at least 28 days prior to the date of dispatch, in an establishment where, within a radius of at least 20 km, no outbreak of LSD has been confirmed during the three months prior to the date of dispatch; (vi) all bovine animals in 50 km around the establishment of origin of the consignment must have been vaccinated or revaccinated against LSD, at least 60 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on that date or within the immunity period induced by maternal immunity;
(b) any destination located within another vaccination zone II of the same Member State, provided that all of the following conditions are fulfilled: (i) all other bovine animals kept in the establishment of origin of such consignments must have been vaccinated against LSD at least 28 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on that date or remain within the immunity period induced by previous vaccination or maternal immunity on that date; and (ii) the bovine animals must have been vaccinated against LSD at least 28 days prior to the date of dispatch and remain within the immunity period in accordance with the instructions of the vaccine manufacturer on that date or are unvaccinated offspring less than four months old, born to dams vaccinated at least 28 days prior to parturition that remained within the immunity period according to the vaccine manufacturer on the date of parturition, and may be moved to another establishment.
3.4.1. Movements of consignments of semen, oocytes and embryos of bovine animals may be authorised from approved germinal product establishments or other establishments located in vaccination zone I to: (a) vaccination zones I or II of the same Member State provided that all of the following conditions are fulfilled: (i) the donor animals were either: vaccinated and revaccinated against LSD according to the manufacturer’s instructions of the vaccine used, and the first vaccination must have been administered at least 60 days prior to the date of collection of the semen, oocytes or embryo, or subjected, with negative results, to a serological test to detect specific antibodies against LSD virus on the day of the collection and at least 28 days after the period of collection as regards semen or on the day of collection as regards embryos and oocytes;
(ii) the donor animals were kept, during the 60 days prior to the date of collection of the semen, oocytes or embryos, in an artificial insemination centre or other appropriate establishment where, within a radius of at least 20 km, no outbreak of LSD has been confirmed during the three months prior to the date of collection of the semen, oocytes or embryos; (iii) the donor animals were clinically checked 28 days prior to the date of collection, as well as throughout the entire collection period, and did not show any clinical symptoms of LSD;
(b) any destination located in another vaccination zone I or II of another Member State, provided that, in addition to the conditions laid down in point (a), all of the following conditions are fulfilled: (i) the donor animals were subjected, with negative results, to a polymerase chain reaction (PCR) test to detect LSD conducted on blood samples collected at the commencement of collection of the semen and at least every 14 days thereafter during the semen collection period or on the day of collection for embryos and oocytes; (ii) the semen was subjected, with negative results, to a PCR test to detect LSD;
(c) any destination located in the same or another Member State or, in case of a vaccination zone I, to a third country provided that, in addition to the conditions laid down in point (a), the donor animals comply with any other appropriate animal health guarantees, based on a positive outcome of a risk assessment of the impact of such dispatch and of the measures against the spread of LSD, required by the competent authority of the Member State of the establishment of origin and approved by the competent authorities of the Member States of the places of passage and of destination, prior to the dispatch of such semen, oocytes or embryos.
3.4.2. Movements of consignments of semen, oocytes and embryos of bovine animals, may be authorised from approved germinal product establishments or other establishments located in a vaccination zone II to any destination located in another vaccination zone II of the same Member State.
(a) any destination located in the same Member State or to any destination located in vaccination zones I or II of another Member State; (b) in the case of consignments of hides and skins, any destination located in any area of the same or another Member State or third country provided that one of the following conditions is fulfilled: (i) the treated hides and skins have been subjected to one of the treatments referred to in point 28(b) to (e) of Annex I to Commission Regulation (EU) No 142/2011 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 ).(ii) the treated hides and skin have been subjected to one of the treatments set out in Section XIV, Chapter I, point (4)(b)(ii), of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council 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 ).
(a) in the case of unprocessed animal by-products other than hides and skins, any destination located in the same Member State or any destination located in vaccination zones I or II of another Member State provided that the unprocessed animal by-products are dispatched under the official supervision of the competent authorities for processing or disposal in a plant approved in accordance with Article 24 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1 ).(b) in the case of hides and skins of bovine animals: (i) any destination located in a vaccination zone II of the same or another Member State provided that they are untreated raw hides and skins destined for human consumption or untreated hides and skins not intended for human consumption dispatched under the official supervision of the competent authorities for processing or disposal in a plant approved in accordance with Article 24 of Regulation (EC) No 1069/2009; (ii) any destination located in the same or another Member State provided that the conditions laid down in point 3.5(b), are fulfilled;
(c) in the case of colostrum, milk and dairy products, any destination located in any area of the same or another Member State provided that they have been subjected to a risk-mitigating treatment for LSD, as set out in Annex VII to Delegated Regulation (EU) 2020/687.
(a) in the case of transport of bovine animals, the means of transport: (i) comply with the requirements laid down in Article 24(1) of Delegated Regulation (EU) 2020/687; and (ii) are cleaned and disinfected in accordance with Article 24(2) of Delegated Regulation (EU) 2020/687 under the control or supervision of the competent authority of the Member State;
(b) only include bovine animals or unprocessed animal by-products or untreated hides and skins of the same health status.
| Recovery period | Type of surveillance to demonstrate the absence of occurrence of LSD |
|---|---|
| 14 months after the slaughter or killing of the last case, or after the last vaccination if emergency protective vaccination has been used (in vaccination zone II), whichever occurred last, and during which period clinical and laboratory surveillance has demonstrated no occurrence of LSD | Clinical and laboratory (virological and serological) |
| 26 months after the slaughter or killing of the last case, or after the last vaccination if emergency protective vaccination has been used (in vaccination zone II), whichever occurred last, and during which period clinical surveillance alone has demonstrated no occurrence of LSD | Clinical |
| 8 months after the last vaccination if emergency protective vaccination has been used (in vaccination zone I), and during which period clinical and laboratory surveillance has demonstrated no occurrence of LSD | Clinical and laboratory (virological and serological) |
| Recovery period | Type of surveillance to demonstrate the absence of occurrence of PPR |
|---|---|
| 6 months after the slaughter or killing of the last case and of all vaccinated animals if emergency protective vaccination has been used, and during which period clinical and laboratory surveillance has demonstrated no occurrence of PPR | Clinical and laboratory (virological and serological) |
| 24 months after the slaughter or killing of the last case, or after the last vaccination if emergency protective vaccination has been used, whichever occurred last, and during which period clinical and laboratory surveillance has demonstrated no occurrence of PPR | Clinical and laboratory (virological and serological) |
1. a clinical examination of equine animals every 3 to 7 days, or each day in the case of severe clinical cases, since such cases may need to be euthanised because of animal welfare reasons; 2. a laboratory surveillance of equine animals (testing should be carried out on samples taken at intervals of 3 to 7 days as the minimum time required to capture the minimum incubation period after which an infected animal may test positive), and the diagnostic protocol shall be set up according to the vaccine used (a serological surveillance, in case a DIVA vaccine is used, or a virological surveillance). The surveillance is necessary to detect the AHS virus types circulating to ensure that all circulating serotypes are included in the official vaccination plan; 3. a surveillance of Culicoides.
1. The equine animal to be moved from the establishment where it was kept at the time when the vaccination was carried out, was vaccinated more than 40 days prior to movement; 2. The animal referred to in point (1): (a) has undergone a prior identity check and clinical examination as referred to in Article 91(1), point (a), of Delegated Regulation (EU) 2020/688; (b) showed no clinical symptoms of AHS on the day of the clinical examination; (c) is identified by way of a transponder and a record of vaccination against AHS is kept in its single lifetime document and in the computer database referred to in Article 109(1), point (d), of Regulation (EU) 2016/429; (d) is kept in a vector protected establishment as defined in Article 2(18) of Delegated Regulation (EU) 2020/689 for a period of at least 14 days prior to movement and is subjected to an agent identification test for AHS, at the end of this period, with a negative result, or is kept in a vector protected establishment for at least 40 days prior to movement; (e) is protected from the attack of vectors.
| Recovery period | Type of surveillance to be implemented during the recovery period |
|---|---|
| 12 months, since the last animal was vaccinated and 2 years since the last outbreak | Clinical and serological |
| The relevant recommendations in the AHS Chapter, 30th edition 2022, of the WOAH Terrestrial Animal Health Code | |
(a) vaccinated porcine animals; (b) offspring of seropositive sows; (c) semen, oocytes and embryos for artificial insemination from donor porcine animals kept in approved germinal product establishments; (d) fresh meat obtained from vaccinated porcine animals;
(1) movements of vaccinated porcine animals, directly from the establishment of origin to: (a) a slaughterhouse located as close as possible to the vaccination zone, in the same Member State, under the same conditions as those provided for in Article 24, Article 28(2), (3), (4), (5) and (7) and Article 29(1) and (2) of Delegated Regulation (EU) 2020/687; (b) to an animal by-product approved plant, under the same conditions as those provided for in Article 24, Article 28(2), (3), (4), (5) and (7) and Article 37 of Delegated Regulation (EU) 2020/687;
(2) movement of fresh meat from vaccinated animals in accordance with Article 33(1), point (a), of Delegated Regulation (EU) 2020/687; (3) all movements of animals and products thereof, laid down in point 1, provided that: (a) all the vaccinated porcine animals kept in the vaccination zone have been slaughtered or killed, and the fresh meat obtained from those animals has been disposed or processed in accordance with Article 33(1), point (a), of Delegated Regulation (EU) 2020/687; (b) all the establishments where vaccinated porcine animals had been kept have been cleaned and disinfected in accordance with Article 57(1) of Delegated Regulation (EU) 2020/687; (c) the repopulation of the establishments above has not taken place until at least 10 days after completion of the cleaning and disinfection operations, and after all porcine animals in the establishments where vaccination has been applied have been slaughtered or killed; (d) after repopulation, porcine animals in all establishments of the vaccination zone have undergone clinical and laboratory examinations in accordance with Annex I to Delegated Regulation (EU) 2020/687 in order to detect the possible presence of CSF virus and those examinations have not taken place until at least 40 days have elapsed after the repopulation, during which time porcine animals are not allowed to move from that establishment.
| Recovery period | Type of surveillance to be implemented during the recovery period |
|---|---|
| 3 months after all vaccinated porcine animals have been slaughtered or killed, excluding kept porcine animals referred to in Article 13(2) of Regulation (EU) 2020/687 when there are means, validated in accordance with the Terrestrial Manual of the WOAH, of distinguishing between vaccinated and infected kept porcine animals. | Clinical and serological |
| The relevant recommendations in the CSF Chapter, 30th edition 2022, of the WOAH Terrestrial Animal Health Code | |
| Recovery period | Type of surveillance to be implemented during the recovery period |
|---|---|
| 28 days after completion of the emergency protective vaccination or at the time of the lifting of the restricted zones established in accordance with Article 21 of Delegated Regulation (EU) 2020/687 if this comes later. | Reinforced surveillance in accordance with Article 9(1), point (c) and Part 2. |
2.1. enhanced passive surveillance shall be implemented in the vaccinated establishments by weekly virological testing of a representative sample of dead birds collected within one week; 2.2. after the start of vaccination, the following active surveillance has to be carried out by an official veterinarian in vaccinated establishments at least every 30 days to detect occurrence of infection with HPAI field virus: (a) a clinical examination that shall include a check of the production records and health records of the establishment in each epidemiological unit, including an evaluation of its clinical history and clinical examinations of the poultry or captive birds; (b) a collection of representative samples for laboratory surveillance by serological or virological testing to enable detection of a prevalence of HPAI virus infection in the epidemiological unit of 5 % with a confidence level of 95 %, using appropriate methods and protocols that allow early detection of the virus and taking into account the specific characteristics of the vaccine used;
2.3. Vaccinated captive birds from confined establishments are exempted from the surveillance requested in point 2.2, subpoint (b). 2.4. The measures provided for in points 2.1 and 2.2 shall remain in place in the establishments keeping vaccinated animals as long as they keep vaccinated animals.
(a) They are vaccinated poultry or captive birds for which the results of the reinforced passive and active surveillance, implemented in accordance with point (2) are negative for detection of infection with HPAI field virus or day-old chicks and hatching eggs derived from such poultry or captive birds and (i) in case of poultry, these are moved to a slaughterhouse for immediate slaughter; or they are moved from their establishments to other establishments: (ii) where vaccination is carried out; or (iii) where only vaccinated poultry or captive birds are kept; or (iv) where complete separation between vaccinated and non-vaccinated poultry or captive birds can be ensured; and (v) the moved poultry or captive birds remain in the establishment of destination, referred to in subpoints (ii), (iii) or (iv), for at least 21 days, unless these are poultry moved from the establishment of destination to a slaughterhouse for immediate slaughter; (vi) the poultry or captive birds, including day-old chicks and hatching eggs derived from such poultry or captive birds, referred to in subpoints (i), (ii), (iii) or (iv) are not moved to another Member State;
or (b) they are vaccinated captive birds from confined establishments moved to a confined establishment in another Member State provided that: (i) approval of such type of movements has been granted by the competent authority of the Member State of destination; (ii) they have been subjected to a virological test with negative results within 72 hours before movement;
or (c) they are vaccinated poultry sent for immediate slaughter to another Member State, provided that: (i) the surveillance applied in the establishment of origin in accordance with point (2) has favourable results; (ii) poultry of the consignment to be dispatched were clinically inspected with favourable results by an official veterinarian within 72 hours before the time of loading, and, in case of poultry of Anseriforme species, favourable results were obtained on virological tests performed on samples taken within 72 hours prior to the time of departure from 20 birds from that consignment;
or (d) they are hatching eggs derived from vaccinated poultry or captive birds which: (i) originate from a vaccinated breeding flock for which the reinforced passive and active surveillance in accordance with point (2) has favourable results; (ii) have been disinfected before dispatch in accordance with a method approved by the competent authority; (iii) are transported directly to the hatchery of destination; (iv) are traceable within the hatchery; (v) in case they are moved to another Member State, in addition to the requirements in subpoints (i) to (iv), the Member State of destination has informed the Commission and the other Member States that such movements are authorised;
or (e) they are day-old chicks derived from vaccinated poultry which: (i) originate from a vaccinated breeding flock for which the reinforced passive and active surveillance in accordance with point (2) has favourable results; (ii) are placed in a poultry house or shed where there is no resident poultry; (iii) remain in the establishment of destination for at least 21 days; (iv) in case they are moved to another Member State, in addition to the requirements in subpoints (i) to (iii), the Member State of destination has informed the Commission and the other Member States that such movements are authorised.
(a) The eggs originate from a vaccinated flock for which the surveillance in point (2) has favourable results and are directly transported to: (i) a packing centre designated by the competent authority provided that they are packed in disposable packaging or in a packaging which can be cleaned and disinfected in such way as to inactivate the HPAI virus; (ii) an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004.
(b) The movement of meat obtained from poultry in accordance with the conditions laid down in points 4.1(a)(i), 4.1(a)(v) and 4.1(c) may be authorised without further conditions;
| Recovery period | Type of surveillance to be implemented during the recovery period |
|---|---|
| 3 months after completion of the emergency protective vaccination or at the time of the lifting of the restricted zones established in accordance with Article 21 of Delegated Regulation (EU) 2020/687 if this comes later. | The reinforced surveillance in accordance with Article 9(1), point (c) |