BAKGRUNN (fra kommisjonsforordningen)

(1) Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases referred to in Article 5 thereof, including rules on disease notification and reporting, surveillance, eradication programmes and disease-free status. In particular, Article 37(1) of that Regulation allows Member States to apply to the Commission for the recognition of disease-free status of compartments for listed diseases referred to in Article 9(1), point (a), thereof (category A diseases). 

(2) The compartmentalisation approach provided for in Regulation (EU) 2016/429 is in line with the international standards of the World Organisation for Animal Health (‘WOAH’), and in particular Chapters 4.4. and 4.5. of the Terrestrial Animal Health Code respectively on zoning and compartmentalisation, and on the application of compartmentalisation, which are meant to be used as a basis by WOAH Members for their regulations on animal disease prevention and control. 

(3) While general rules for recognition of the disease-free status of compartments keeping terrestrial animals for category A diseases are laid down in Article 37(1) of Regulation (EU) 2016/429, this Regulation should lay down supplementing rules for the approval by the competent authority of the disease-free status of such compartments. 

(4) For such approval by the competent authority of the disease-free status for category A diseases of compartments keeping terrestrial animals, the rules laid down in this Regulation should include general requirements for such compartments, as well as rules on the responsibilities and duties of the compartment manager, requirements for a common biosecurity management system, and detailed requirements and procedures for the approval of such compartments by the competent authority, including compartments which are located in the territory of more than one Member State. 

(5) Article 2 of Commission Implementing Regulation (EU) 2020/690 provides that the listed diseases for which the disease-free status of compartments may be established, in accordance with Article 37(4), point (b), of Regulation (EU) 2016/429, are set out in Annex II to that Implementing Regulation). Specific requirements for the approval by the competent authority of the disease-free status for those category A diseases should be laid down in this Regulation. 

(6) To prevent the introduction and spread of category A diseases in a compartment keeping terrestrial animals, and for the control of those category A diseases in the Union, detailed requirements should be laid down in this Regulation concerning specific surveillance and strict biosecurity provisions. The rules laid down in this Regulation should also provide that certain establishments, such as those keeping freerange animals or establishment for assembly operations, which even when they have strict biosecurity measures in place still inherently pose a heightened risk for the spread of diseases due to frequent movements and mixing of animals of different categories or a different health status, cannot be part of a compartment for the purposes of the approval of disease-free status for category A diseases. 

(7) Establishing and maintaining specific disease-free compartments for category A diseases is demanding, as when they are established, operators must ensure that the animal population is protected and its distinct health status is preserved in all situations, even and especially where there is a restricted zone for the category A disease in the vicinity of the compartment. Therefore, the strictest biosecurity measures should apply to all components of the compartments, which can only be achieved through a common biosecurity management system. Such a system requires strict management and therefore each compartment operator should appoint for that purpose a compartment manager with defined tasks and responsibilities. 

(8) Operators applying to the competent authority for approval of the disease-free status for category A diseases of compartments keeping terrestrial animals should be aware of the requirements and procedures for such applications. It is therefore necessary to lay down such requirements and procedures in this Regulation. 

(9) An application for approval of the disease-free status for a category A disease of a compartment keeping terrestrial animals should not be allowed, while the compartment or a part thereof is located in a restricted zone for that category A disease, due to the difficulty to establish, maintain and verify effective biosecurity plans when outbreaks of that category A disease are occurring in the vicinity of the compartment. 

(10) Articles 94 to 100 of Regulation (EU) 2016/429 lay down general rules and procedures for the approval of certain types of establishments, notably those referred to in Article 94(1), point (e), thereof, which includes compartments. This Regulation should lay down certain detailed procedures for the competent authority for the approval, suspension, and withdrawal of the disease-free status for category A diseases of compartments keeping terrestrial animals. This is due to the complexity and specificity of biosecurity management measures for compartments and the differences in terms of animal disease risk between breaches in the biosecurity measures and the actual occurrence in the compartment of the category A disease(s) for which it has been granted disease-free status. 

(11) The listed diseases for which the disease-free status of compartments may be established in accordance with Article 37 of Regulation (EU) 2016/429 are set out in Annex II to Implementing Regulation (EU) 2020/690 and include highly pathogenic avian influenza (HPAI) and infection with Newcastle disease virus (NDV). Compartments keeping poultry (poultry compartments) granted disease-free status for HPAI and NDV should fulfil several specific requirements, notably a detailed description of the poultry compartment, a targeted common biosecurity management system, and protection and surveillance systems tailored to address the risk of the introduction into the poultry compartment of those two category A diseases. Such specific technical and detailed requirements should be laid down in this Regulation. 

(12) The rules laid down in this Regulation for the approval of the disease-free status for category A diseases of compartments keeping terrestrial animals differ from the rules in force before the date of application of Regulation (EU) 2016/429. In the case of terrestrial animals, the use of poultry compartments was permitted under Directive 2005/94/EC , with regard to avian influenza. Compartments that had been approved in accordance with that Directive and Commission Regulation (EC) No 616/2009, which have both now been repealed, are deemed to still have an approved disease-free status for HPAI, on the basis of the transitional provisions laid down in Article 280(3) of Regulation (EU) 2016/429, and in Article 84(2), point (a), of Commission Delegated Regulation (EU) 2020/689. Those compartments of the Member States that are recognised as being free from HPAI are listed in Annex XI to Commission Implementing Regulation (EU) 2021/620. That disease-free status should be maintained for the time necessary for operators to apply for approval of the diseasefree status for compartments in accordance with this Regulation. Therefore, appropriate transitional rules should be laid down to ensure a smooth transition for the existing recognised disease-free status of poultry compartments that are listed in Annex XI to Implementing Regulation (EU) 2021/620,