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

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (the ‘Animal Health Law’) (1), and in particular Article 37(5) thereof,

Whereas:

(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 (2) 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 (3) 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 free-range 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 diseasesdue 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 Council Directive 2005/94/EC (4), with regard to avian influenza. Compartments that had been approved in accordance with that Directive and Commission Regulation (EC) No 616/2009 (5), 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 (6). 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 (7). That disease-free status should be maintained for the time necessary for operators to apply for approval of the disease-free 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,

HAS ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter and scope

(a) general requirements for granting disease-free status to such compartments;

(b) responsibilities and duties of the operators and the compartment managers of such compartments;

(c) common biosecurity management systems for such compartments;

(d) procedures for the approval by the competent authority of the disease-free status of such compartments, including for compartments that are located in the territory of more than one Member State.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘biosecurity plan’ means a plan that identifies potential pathways for the introduction and spread of disease in an establishment, and describes the biosecurity to be applied to mitigate the risks of specific disease introduction and spread;

(2) ‘common biosecurity management system’ means the common rules governing the functioning of a compartment designed to ensure the disease-free status of all establishments forming part of it; it includes the functional relations between all the compartment components and the overall biosecurity measures implemented in the establishments, in accordance with their biosecurity plans;

(3) ‘compartment manager’ means an appointed person responsible for the common biosecurity management system of the compartment;

(4) ‘compartment component’ means any establishment forming part of the compartment or any premises, food or feed business, animal by-products establishments or other plants belonging to the compartment;

(5) ‘all involved parties’ means the operator of the compartment, the compartment manager and food and feed business operators, animal professionals, transporters, veterinarians, pharmaceutical producers or retailers, or operators of other industries providing services for, delivering animals, products or other commodities to, or receiving animals, products or other commodities from, the compartment;

(6) ‘early warning system’ means a system for the timely detection, reporting and communication of the occurrence, incursion or emergence of category A diseases.

CHAPTER II

REQUIREMENTS AND PROCEDURES FOR THE APPROVAL OF DISEASE-FREE STATUS FOR CATEGORY A DISEASES OF COMPARTMENTS KEEPING TERRESTRIAL ANIMALS

Article 3

Requirements for granting disease-free status for category A diseases to compartments keeping terrestrial animals

(a) compliance with the requirements set out in Part I of Annex I;

(b) that all establishments forming part of the compartment, as well as all other compartment components, are managed under a common biosecurity management system, which complies with the requirements set out in Part II of Annex I;

(c) that all involved parties comply with the requirements of the common biosecurity management system.

Article 4

Applications for approval of disease-free status for category A diseases of compartments keeping terrestrial animals

(a) the information required by Article 96(1) of Regulation (EU) 2016/429 for establishments;

(b) the information referred to in Part III of Annex I to this Regulation.

Article 5

Granting approval of disease-free status for a category A disease of a compartment keeping terrestrial animals

(a) none of the compartment components are situated in a restricted zone or restricted zones for the category A disease;

(b) the information required in accordance with Article 96(1) of Regulation (EU) 2016/429 and referred to in Part II of Annex I to this Regulation, regarding disease surveillance demonstrating the absence of the category A disease, is complete, up-to-date and accurate;

(c) the compartment manager has checked that the common biosecurity management system is in place and is sufficient to ensure a distinct health status, through documented internal and external audits referred to in Part I, point (d), of Annex I;

(d) the procedure for granting approval by the competent authority laid down in Article 99 of Regulation (EU) 2016/429 has been completed, including an on-site inspection by the competent authority or a delegated body to verify compliance with the requirements laid down in Article 3 of this Regulation, and the requirements laid down in points (a), (b) and (c) of this paragraph.

(a) keep registers of approved compartments and their approval files in accordance with the procedure laid down in Article 101 of Regulation (EU) 2016/429;

(b) report to the Commission without delay of any modifications in the components or the animal health status of compartments already recognised by the Commission.

Article 6

Review, suspension and withdrawal of approval of disease-free status of compartments keeping terrestrial animals

CHAPTER III

SPECIFIC REQUIREMENTS FOR THE APPROVAL OF THE DISEASE-FREE STATUS OF COMPARTMENTS KEEPING TERRESTIAL ANIMALS AS REGARDS CATEGORY A DISEASES LISTED IN ANNEX II TO IMPLEMENTING REGULATION (EU) 2020/690

Article 7

Specific requirements related to category A diseases listed in Annex II to Implementing Regulation (EU) 2020/690 for compartments of the relevant listed species and categories of terrestrial animals

(a) a detailed description of the poultry compartment, as set out in Part I, Section 1, of Annex II;