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

1 This Regulation lays down rules supplementing those laid down in Article 37(1) of Regulation (EU) 2016/429 as regards the requirements and procedures for the approval by the competent authority of the disease-free status, for listed diseases referred to in Article 9(1), point (a), of that Regulation (category A diseases), of compartments keeping terrestrial animals.

2 Chapter II of this Regulation lays down the following requirements and procedures for the approval of the disease-free status of compartments keeping terrestrial animals referred to in Article 37(1) of Regulation (EU) 2016/429: (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.

3 Chapter III of this Regulation lays down specific requirements for the approval of the disease-free status of compartments keeping terrestrial animals as regards the category A diseases listed in Annex II to Implementing Regulation (EU) 2020/690 for the relevant listed species and categories of animals.

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.

1 Operators that apply to the competent authority for approval of the disease-free status for a category A disease of a compartment keeping terrestrial animals shall ensure that: (a) the surveillance in the compartment for the category A disease complies with: (i) the requirements on the design of surveillance laid down in Article 3(1) of Delegated Regulation (EU) 2020/689; (ii) the specific surveillance requirements laid down in Chapter III of this Regulation; (b) the biosecurity measures in place in the compartment comply with: (i) the requirements laid down in Article 10 of Regulation (EU) 2016/429; (ii) the specific biosecurity requirements laid down in Chapter III of this Regulation; (c) establishments forming part of the compartment: (i) are approved in accordance with Article 94(1), points (b) to (e), of Regulation (EU) 2016/429; and (ii) comply with Article 97(1) of Regulation (EU) 2016/429; (d) establishments forming part of the compartment are not: (i) establishments keeping: free-range animals; more than one animal species in the same epidemiological unit; (ii) establishments for assembly operations, markets, exhibition places, fairs, animal shelters, confined establishments, zoos, and wildlife sanctuaries.

2 Operators that apply to the competent authority for approval of the disease-free status for a category A disease of a compartment keeping terrestrial animals shall appoint an appropriately qualified compartment manager who shall ensure: (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.

1 Operators applying to the competent authority for approval of the disease-free status for a category A disease of a compartment keeping terrestrial animals shall submit an application for approval to the competent authority that contains the following information: (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.

2 Operators of compartments keeping terrestrial animals shall not submit an application for approval of the disease-free status of a compartment for a category A disease, provided for in paragraph 1, while the compartment or any component thereof is situated in a restricted zone for the category A disease.

1 The competent authority shall only grant approval of a disease-free status for a category A disease of a compartment keeping terrestrial animals subject to compliance with the following conditions: (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.

2 Where at least one component of the compartment is situated in the territory of another Member State, the competent authority to which the application was submitted shall liaise with the competent authority of the other Member State to ensure verification of compliance with the conditions referred to in paragraph 1, point (d).

3 The competent authority shall: (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.

1 The competent authority shall check that the compartment continues to comply with the conditions for approval, as laid down in Article 5(1), point (d), at appropriate intervals based on the assessment of the epidemiological situation in the area where the compartment components are situated and based on documents and information received from the compartment manager as set out in Part I, points (f) and (g), of Annex I.

2 The competent authority shall suspend or withdraw approval of disease-free status of compartments keeping terrestrial animals in accordance with the rules laid down in Article 100 of Regulation (EU) 2016/429 and Article 82 of Delegated Regulation (EU) 2020/689.

3 When the competent authority suspends the approval of the disease-free status of a compartment keeping terrestrial animals because it no longer complies with the information submitted in accordance with Article 5(1), points (b) and (c), the compartment approval shall be restored once corrective actions have been verified as effective by the competent authority.

4 The competent authority shall withdraw the approval of disease-free status of a compartment keeping terrestrial animals in the case of an outbreak, within a component of that compartment, of the category A disease for which the disease-free status was granted.

5 When the approval of the disease-free status of a compartment has been withdrawn as provided for in paragraph 4 of this Article, the disease-free status may only be restored following a new application in accordance with Article 4.

1 In addition to the information referred to in Part III of Annex I, applications for approval of disease-free status for highly pathogenic avian influenza (HPAI) of poultry compartments shall contain the following: (a) a detailed description of the poultry compartment, as set out in Part I, Section 1, of Annex II; (b) a detailed description of the common biosecurity management system of the poultry compartment, as set out in Part I, Section 2, of Annex II; (c) a detailed description of the protection and surveillance measures, as set out in Part II, Section 1, of Annex II.

2 In addition to the information referred to in Part III of Annex I, applications for the approval of the disease-free status for infection with Newcastle disease virus (NDV) for poultry compartments shall contain the following: (a) a detailed description of the poultry compartment, as set out in Part I, Section 1, of Annex II; (b) a detailed description of the common biosecurity management system of the poultry compartment, as set out in Part I, Section 2, of Annex II; (c) a detailed description of the protection and surveillance measures, as set out in Part II, Section 2, of Annex II.

Poultry compartments that have been approved in relation to avian influenza in accordance with Regulation (EC) No 616/2009 and that are listed as free from HPAI in Annex XI to Implementing Regulation (EU) 2021/620, shall continue to have their disease-free status with respect to HPAI maintained after the date of entry into force of this Regulation. Operators of those poultry compartments shall apply for approval of disease-free status for HPAI in accordance with Article 4 of this Regulation within a period of 12 months from that date, or the competent authority shall withdraw their approval at the end of that period.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.