CELEX: 32022D0465
Language: en
Date: 2022-03-21 00:00:00
Title: Commission Implementing Decision (EU) 2022/465 of 21 March 2022 amending Implementing Decision (EU) 2019/570 as regards rescEU mobile laboratory capacities and rescEU CBRN detection, sampling, identification and monitoring capacities (notified under document C(2022) 1831) (Text with EEA relevance)

23.3.2022   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 94/6
               
            
         COMMISSION IMPLEMENTING DECISION (EU) 2022/465
         of 21 March 2022
         amending Implementing Decision (EU) 2019/570 as regards rescEU mobile laboratory capacities and rescEU CBRN detection, sampling, identification and monitoring capacities
         
            
               (notified under document C(2022) 1831)
            
         
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (1), and in particular Article 32(1), point (g), thereof,
         Whereas:
         
                     (1)
                  
                  
                     Decision No 1313/2013/EU sets out the legal framework of rescEU, which is a reserve of capacities at Union level aiming to provide assistance in overwhelming situations where overall existing capacities at national level and those committed by Member States to the European Civil Protection Pool are not able to ensure an effective response to natural and man-made disasters.
                  
               
                     (2)
                  
                  
                     In accordance with Article 12(2) of Decision No 1313/2013/EU, rescEU’s capacities are to be determined by taking into account identified and emerging risks, overall capacities and gaps at Union level. There are four areas on which rescEU should particularly focus, namely aerial forest firefighting, chemical, biological, radiological and nuclear (‘CBRN’) incidents, emergency medical response, as well as transport and logistics.
                  
               
                     (3)
                  
                  
                     Commission Implementing Decision (EU) 2019/570 (2) sets out the initial composition of rescEU in terms of capacities and quality requirements. The rescEU reserve so far consists of aerial forest firefighting capacities, medical aerial evacuation capacities, emergency medical teams, stockpiling of medical equipment or personal protective equipment, or both, CBRN decontamination capacities, CBRN stockpiling capacities, temporary shelter capacities and transport and logistics capacities.
                  
               
                     (4)
                  
                  
                     An analysis of identified and emerging risks as well as of capacities and gaps at Union level reveals a need to support civil protection activities by providing in-field CBRN detection, sampling, identification and monitoring capacities for the response to emergencies (i.e. to mitigate adverse consequences for human life or health resulting from CBRN substances), for search activities (i.e. to determine the location of CBRN substances out of regulatory control), for the response to security events (i.e. to respond to potentially criminal or intentional unauthorized acts involving or directed at CBRN substances), and for the surveillance of major events (i.e. to prevent criminal or intentional unauthorized acts involving CBRN substances).
                  
               
                     (5)
                  
                  
                     The capacity should include reach back technical assessment support for CBRN detection, sampling, identification and monitoring activities implemented under the Union Mechanism. That reach back component should also be made available to national authorities. The reach back could be provided by a single institution or a pool of specialised institutions.
                  
               
                     (6)
                  
                  
                     The capacity is envisaged to be a single package with a high degree of internal scalability and modularity; making it possible, if needed, to separately deploy its individual components tailored to emergency response, search, security response or surveillance activities, as well as tailored to the specific chemical, biological, radiological or nuclear hazard or threat.
                  
               
                     (7)
                  
                  
                     The analysis of identified and emerging risks as well as of capacities and gaps at Union level also revealed the need for mobile laboratory capacities. The main goal of the mobile laboratory capacities is to provide flexible and adaptable support where Member States are overwhelmed in their capacity to detect, analyse or verify pathogens or CBRN substances. The mobile laboratory capacities could focus on different specialisations with a high degree of scalability, modularity and interoperability.
                  
               
                     (8)
                  
                  
                     In accordance with Article 12(4) of Decision No 1313/2013/EU, quality requirements under rescEU should be based on established international standards, where such standards already exist. The quality requirements for the biological component of the mobile laboratories should therefore be based on the Rapid response mobile laboratories classifications (3)provided by the World Health Organization.
                  
               
                     (9)
                  
                  
                     CBRN detection, sampling, identification and monitoring capacities and mobile laboratory capacities should be established to respond to low probability risks with a high impact, in accordance with the categories referred to in Article 3d of Implementing Decision (EU) 2019/570 and after consultation with the Member States.
                  
               
                     (10)
                  
                  
                     Implementing Decision (EU) 2019/570 should therefore be amended accordingly.
                  
               
                     (11)
                  
                  
                     The measures provided for in this Decision are in accordance with the opinion of the committee referred to in Article 33(1) of Decision No 1313/2013/EU,
                  
               HAS ADOPTED THIS DECISION:
         
            Article 1
            Implementing Decision (EU) 2019/570 is amended as follows:
            
                        (1)
                     
                     
                        in Article 1a, the following point 4 is added:
                        
                           ‘(4)   “reach back” means the process of obtaining support from entities that are not deployed in the field.’;
                        
                     
                  
                        (2)
                     
                     
                        in Article 2, paragraph 2 is amended as follows:
                        
                                    (a)
                                 
                                 
                                    point (j) is replaced by the following:
                                    
                                                ‘(j)
                                             
                                             
                                                transport and logistics capacities;’;
                                             
                                          
                              
                                    (b)
                                 
                                 
                                    the following points are added:
                                    
                                                ‘(k)
                                             
                                             
                                                CBRN detection, sampling, identification and monitoring capacities for the response to emergencies, for search activities, for the response to security events, and for the surveillance of major events;
                                             
                                          
                                                (l)
                                             
                                             
                                                mobile laboratory capacities.’;
                                             
                                          
                              
                  
                        (3)
                     
                     
                        Article 3a is replaced by the following:
                        
                           ‘Article 3a
                           Eligible costs of rescEU medical aerial evacuation, emergency medical team type 2 and type 3, medical stockpiling, CBRN decontamination, CBRN stockpiling, temporary shelter, transport, logistics, CBRN detection, sampling, identification and monitoring, and mobile laboratory capacities
                           All cost categories referred to in Annex Ia to Decision No 1313/2013/EU shall be taken into account when calculating the total eligible cost of rescEU capacities.’;
                        
                     
                  
                        (4)
                     
                     
                        in Article 3e, paragraphs 3 and 4 are replaced by the following:
                        
                           ‘3.   rescEU capacities referred to in points (c) to (l) of Article 2(2) shall be established with the objective of managing low probability risks with a high impact.
                        
                        
                           4.   Where rescEU capacities referred to in points (c) to (l) of Article 2(2) are deployed under the Union Mechanism, Union financial assistance shall cover 100 % of the operational costs, pursuant to Article 23(4b) of Decision No 1313/2013/EU.’;
                        
                     
                  
                        (5)
                     
                     
                        the Annex is amended in accordance with the Annex to this Decision.
                     
                  
         
            Article 2
            This Decision is addressed to the Member States.
         
         
            Done at Brussels, 21 March 2022.
            
               
                  For the Commission
               
               Janez LENARČIČ
               
                  Member of the Commission
               
            
         
         
            (1)  OJ L 347, 20.12.2013, p. 924.
         
            (2)  Commission Implementing Decision (EU) 2019/570 of 8 April 2019 laying down rules for the implementation of Decision No 1313/2013/EU of the European Parliament and of the Council as regards rescEU capacities and amending Commission Implementing Decision 2014/762/EU (OJ L 99, 10.4.2019, p. 41).
         
            (3)  Guidance for rapid response mobile laboratory (RRML) classification. Copenhagen: WHO Regional Office for Europe; 2021.
      
      
         
            ANNEX
            In the Annex to Implementing Decision (EU) 2019/570, the following Sections 11 and 12 are added:
            
               ‘11.   CBRN detection, sampling, identification and monitoring capacity, for the response to emergencies, for search activities, for the response to security events and for the surveillance of major events
               
               
                           
                                        
                                    
                                    
                                       Tasks
                                    
                                 
                        
                           
                                       —
                                    
                                    
                                       Deployable and reach back CBRN detection, sampling, identification and monitoring capacity, for the response to emergencies, for search activities, for the response to security events and for the surveillance of major events (1).
                                    
                                 
                     
                           
                                        
                                    
                                    
                                       Capacities
                                    
                                 
                        
                           
                                       —
                                    
                                    
                                       Ability to provide operational support for the response to emergencies (2), through in-field CBRN detection, sampling, identification and monitoring.
                                    
                                 
                                       —
                                    
                                    
                                       Ability to support search activities, through in-field CBRN detection, sampling, identification and monitoring.
                                    
                                 
                                       —
                                    
                                    
                                       Ability to provide operational support for the response to security events, through in-field CBRN detection, sampling, identification and monitoring. This shall include the ability to support the competent authority of the requesting Member State or third country (3) in its effort to preserve and gather forensic evidence, to secure the chain of custody and to protect classified information.
                                    
                                 
                                       —
                                    
                                    
                                       Ability to support surveillance operations for major events through in-field CBRN detection, sampling, identification and monitoring.
                                    
                                 
                                       —
                                    
                                    
                                       Ability to provide non-deployed reach back technical assessment support for CBRN detection, sampling, identification and monitoring activities, as well as to address safety concerns related to these activities.
                                    
                                 
                                       —
                                    
                                    
                                       Ability to prepare for and address operational challenges to implement CBRN detection, sampling, identification and monitoring activities in the requesting Member State or third country, considering the hazard and threat assessments, plans, procedures and protocols of the requesting Member State or third country.
                                    
                                 
                                       —
                                    
                                    
                                       Ability to operate under the direction of the requesting Member State, as referred to in Article 12(6) and (7) of Decision No 1313/2013/EU, and to provide effective operational liaison and coordination abilities with the relevant authorities of the requesting Member State. (4)
                                       
                                    
                                 
                     
                           
                                        
                                    
                                    
                                       Main components
                                    
                                 
                        
                           
                                       —
                                    
                                    
                                       Pool of experts capable of assessing and planning CBRN detection, sampling, identification and monitoring activities, based on hazard and threat assessments of the Member State or third country.
                                    
                                 
                                       —
                                    
                                    
                                       Deployable pool of experts capable to perform CBRN detection, sampling, identification and monitoring, for the response to emergencies, for search activities, for the response to security events and for surveillance activities.
                                    
                                 
                                       —
                                    
                                    
                                       Deployable CBRN detection, sampling, identification and monitoring equipment and tools, as well as all required supporting equipment, tools, resources, vehicles, consumables, secured communication, data exchange and information technologies, and small field laboratories (5), as deemed necessary to ensure the capacity’s functionality.
                                    
                                 
                                       —
                                    
                                    
                                       Deployable equipment, tools, resources and consumables, as well as an appropriate management system, to handle the contaminated waste caused by the detection, sampling, identification and monitoring activities.
                                    
                                 
                                       —
                                    
                                    
                                       Operational reach back capability for technical and operational assessment, especially in the area of identification, sampling and safety.
                                    
                                 
                                       —
                                    
                                    
                                       Appropriate equipment, procedures, tools, resources and consumables to ensure the safety of the personnel while operating in a hazardous environment, such as appropriate detectors, personal protective equipment or decontamination components, in accordance with existing applicable legal requirements and applicable international standards.
                                    
                                 
                     
                           
                                        
                                    
                                    
                                       Self-sufficiency
                                    
                                 
                        
                           
                                       —
                                    
                                    
                                       Article 12 of Implementing Decision 2014/762/EU applies.
                                    
                                 
                     
                           
                                        
                                    
                                    
                                       Deployment
                                    
                                 
                        
                           
                                       —
                                    
                                    
                                       Availability for departure of the deployable components and availability to provide reach back technical assessment support maximum 12 hours after the acceptance of the offer.
                                    
                                 
                                       —
                                    
                                    
                                       Ability to maintain operations for at least 14 continuous days.
                                    
                                 
                                       —
                                    
                                    
                                       The capacity may be pre-positioned in cases of requests of assistance according with Article 15(2) of Decision 1313/2013/EU and based on national threat assessments indicating an exceptional situation of increased risk.
                                    
                                 
                     
            12.   Mobile laboratory capacities
            
            
                        Tasks
                     
                     
                        
                                    —
                                 
                                 
                                    Provide a modular, flexible and adaptable mobile laboratory capable of detecting, analysing or verifying pathogens or CBRN substances.
                                 
                              
                  
                        Capacities
                     
                     
                        
                                    —
                                 
                                 
                                    Ability to manage laboratory activities.
                                 
                              
                                    —
                                 
                                 
                                    Ability to conduct testing and analysis following existing applicable international standards, guidelines and best practices.
                                 
                              
                                    —
                                 
                                 
                                    Ability to handle pathogens or CBRN substances of different risk groups and store, transmit and manage related data and analytical results in a secure and safe manner.
                                 
                              
                                    —
                                 
                                 
                                    Ability to support public health investigation, report results, and perform verification while preserving the chain of custody and protecting classified information.
                                 
                              
                  
                        Main components
                     
                     
                        Experts
                        
                                    —
                                 
                                 
                                    Appropriately trained and adequately equipped personnel to perform the different tasks as defined under tasks.
                                 
                              Logistics
                        
                                    —
                                 
                                 
                                    Develop appropriate operational procedures.
                                 
                              
                                    —
                                 
                                 
                                    Knowledge of custom rules and specific requirements related to border crossing of mobile laboratory equipment, reagents and staff members.
                                 
                              Information management
                        
                                    —
                                 
                                 
                                    Communication system with secure and non-secure IT network (LAN) to ensure internet connection, data management and data exchange, including in remote areas
                                 
                              
                                    —
                                 
                                 
                                    Laboratory information management system.
                                 
                              Equipment
                        
                                    —
                                 
                                 
                                    Appropriate equipment and consumables required to perform essential tasks and functions.
                                 
                              
                                    —
                                 
                                 
                                    Appropriate supporting systems tools and resources to perform essential tasks and functions.
                                 
                              Safety
                        
                                    —
                                 
                                 
                                    Appropriate equipment, procedures, tools, resources and consumables, including appropriate waste management systems, to ensure the safety of the personnel, the surrounding population and the environment while operating with hazardous CBRN substances or pathogens, in accordance with existing applicable legal requirements and applicable international standards.
                                 
                              
                  
                        Self-sufficiency
                     
                     
                        
                                    —
                                 
                                 
                                    The capacity should ensure self-sufficiency for at least 14 days.
                                 
                              
                                    —
                                 
                                 
                                    Article 12(1) and (2) of Implementing Decision 2014/762/EU applies.
                                 
                              
                  
                        Deployment
                     
                     
                        
                                    —
                                 
                                 
                                    Availability for departure in maximum 12 hours after the acceptance of the offer’.
                                 
                              
                  
               (1)  Any event that based on national threat assessments may require CBRN surveillance activities (e.g. large public gatherings, sport events, meetings of heads of state, music concerts, world expositions).
            
               (2)  This shall cover any type of natural or man-made emergency involving hazardous materials or CBRN substances. Examples are emergencies resulting from natural disasters, from industrial, transport or research activities, from criminal or intentional unauthorized acts, terrorist acts or armed conflicts, or from satellite crashes and space debris.
            
               (3)  In accordance with Article 12(10) of Decision 1313/2013/EU, if a disaster outside the Union could significantly affect one or more Member States or their citizens, rescEU capacities may be deployed.
            
               (4)  Such as authorities related to civil protection, law enforcement, intelligence, explosive ordnance disposal or technical support.
            
               (5)  E.g. to support the initial analysis of samples.