[:uk]The Commission Delegated Regulation (EU) 2024/2623 of 30 July 2024 supplements the existing Animal Health Law (Regulation (EU) 2016/429) by establishing specific rules and procedures for approving and recognizing disease-free status for compartments keeping terrestrial animals, particularly concerning Category A diseases.
**Purpose and Scope:**
– **Objective:** To set out detailed requirements and procedures for the approval by competent authorities of compartments that are free from Category A diseases, ensuring a high level of animal health and facilitating safe trade within the European Union.
– **Applicability:** The regulation applies to operators who manage compartments (distinct units with a specific health status) keeping terrestrial animals and seek recognition of their disease-free status for Category A diseases as listed in Annex II of Implementing Regulation (EU) 2020/690.
**Key Provisions:**
**1. General Requirements for Disease-Free Compartments (Article 3):**
– **Surveillance Compliance:** Operators must ensure that disease surveillance within the compartment meets specific design requirements to demonstrate the absence of the Category A disease in question. This includes adherence to surveillance plans and sampling schemes.
– **Biosecurity Measures:** Robust biosecurity practices must be in place, complying with general requirements and specific measures outlined in Chapter III of the regulation. This includes preventing the introduction and spread of diseases within the compartment.
– **Approval of Establishments:** All establishments within the compartment must be officially approved and comply with set criteria, excluding certain high-risk establishments such as those keeping free-range animals or conducting assembly operations, which cannot be part of a disease-free compartment.
– **Appointment of Compartment Manager:** Operators must designate a qualified compartment manager responsible for:
– Ensuring compliance with the regulation’s requirements.
– Implementing and overseeing a common biosecurity management system.
– Coordinating among all parties involved, including personnel, service providers, and visitors.
**2. Application for Approval (Article 4):**
– **Submission Requirements:** Operators must submit a comprehensive application to the competent authority, including:
– Detailed information about the compartment and its biosecurity management system.
– Evidence of disease surveillance and absence of the disease over a specified period.
– Declarations that the compartment is not situated within a restricted zone for the disease.
– **Restriction on Applications:** Applications cannot be made if the compartment or any part of it is located in a restricted zone for the relevant Category A disease.
**3. Granting of Approval (Article 5):**
– **Conditions for Approval:** The competent authority will grant disease-free status if:
– The compartment meets all regulatory requirements.
– There are no components within restricted zones for the disease.
– Complete and accurate information is provided.
– The compartment manager has verified effective biosecurity measures through documented audits.
– An on-site inspection confirms compliance.
– **Coordination Between Member States:** If a compartment spans multiple Member States, competent authorities must collaborate to ensure all components comply with the regulation.
– **Record-Keeping and Reporting:** Competent authorities must maintain registers of approved compartments and promptly report any changes in disease status or compartment modifications to the European Commission.
**4. Monitoring, Suspension, and Withdrawal of Approval (Article 6):**
– **Periodic Reviews:** Competent authorities are required to regularly verify ongoing compliance with approval conditions, based on the epidemiological situation and information from the compartment manager.
– **Suspension of Approval:** Approvals can be suspended if:
– Non-compliance with biosecurity measures or surveillance requirements is detected.
– Immediate corrective actions are mandated, and approval is restored upon verification of compliance.
– **Withdrawal of Approval:** Mandatory withdrawal occurs if:
– An outbreak of the Category A disease is confirmed within the compartment.
– Re-approval requires a new application process.
**5. Specific Requirements for Certain Diseases (Article 7 and Annex II):**
– **Applicability:** Additional requirements are stipulated for compartments seeking disease-free status for Highly Pathogenic Avian Influenza (HPAI) and Newcastle Disease Virus (NDV), particularly in poultry compartments.
– **Detailed Descriptions:** Applications must include:
– Comprehensive descriptions of the compartment and biosecurity management systems.
– Specific protection and surveillance measures tailored to HPAI or NDV.
– **Specific Biosecurity Measures:** Enhanced biosecurity protocols are required, such as:
– Strict control of personnel movements and contact with other birds.
– Detailed procedures for cleansing and disinfection.
– Rigorous pest control plans.
– **Surveillance Programs:** Both passive and active surveillance are mandated, with defined sampling frequencies and testing methodologies to ensure early detection and prevention.
– **Early Warning Systems:** Establishment of protocols for rapid reporting and response to potential disease incidents.
**6. Transitional Provisions (Article 8):**
– **Continuation of Existing Approvals:** Poultry compartments previously approved under prior regulations and listed as disease-free will maintain their status temporarily.
– **Deadline for Compliance:** Operators of these compartments must apply for approval under the new regulation within 12 months, or risk withdrawal of their disease-free status.
**Annexes Overview:**
**Annex I – Requirements for Approval:**
– **Part I – Compartment Manager Responsibilities:**
– Overseeing compartment health status and biosecurity.
– Maintaining documentation and ensuring all involved parties comply with requirements.
– Conducting audits and implementing corrective actions.
– **Part II – Common Biosecurity Management System:**
– Elements that must be included, such as risk analysis, traceability systems, and procedures for movement control.
– Documentation of biosecurity plans and measures across all establishments within the compartment.
– **Part III – Description of a Compartment:**
– Detailed information required in the application, including maps, flow charts of activities, and surveillance results.
**Annex II – Specific Requirements for HPAI and NDV:**
– **Detailed Compartment Description:**
– Including types of establishments, infrastructural factors, epidemiological separation, and identified risk factors.
– **Biosecurity Management System for Poultry Compartments:**
– Specific protocols for personnel, visitors, product flows, and contamination prevention.
– Enhanced cleaning, disinfection, and pest control measures.
– **Protection and Surveillance Measures:**
– **For HPAI (Part II, Section 1):**
– Regular testing and surveillance frequencies adjusted based on risk levels.
– Immediate actions and reporting in case of outbreaks within or near the compartment.
– **For NDV (Part II, Section 2):**
– Similar measures tailored to NDV, including specific sampling and testing protocols.
**Conclusion:**
This regulation sets stringent requirements for compartments seeking disease-free status for Category A diseases, emphasizing:
– **Disease Prevention:** Through rigorous biosecurity and surveillance measures.
– **Transparency and Traceability:** Ensuring all movements and activities within compartments are well-documented and controlled.
– **Responsibility and Oversight:** Clear designation of roles, particularly the compartment manager, to maintain high health standards.
– **Adaptability:** Procedures to adjust measures based on changing epidemiological situations, ensuring rapid response to potential threats.
By adhering to these provisions, compartments can contribute to the overall health security within the EU, facilitating safe trade and protecting animal populations from significant disease risks.[:]
