02019D0570 — EN — 29.10.2021 — 004.001

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►B 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 (notified under document C(2019) 2644) (Text with EEA relevance) (OJ L 099 10.4.2019, p. 41)

Amended by:





Corrected by:









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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

(notified under document C(2019) 2644)

(Text with EEA relevance)







Article 1

Subject matter

This Decision lays down rules for the implementation of Decision No 1313/2013/EU as regards:

(a) the initial composition of rescEU in terms of capacities and its quality requirements;

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(b) the financing of capacities during the transitional period referred to in Article 35 of Decision No 1313/2013/EU;

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(c) total estimated costs of medical aerial evacuation rescEU capacities;

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(d) total estimated costs of emergency medical team type 3 rescEU capacities;

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(e) total estimated costs of medical stockpiling rescEU capacities;

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(f) the categories of low probability risks with a high impact;

(g) the rescEU capacities established to manage low probability risks with a high impact.

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Article 1a

Definitions

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

(1) ‘medical aerial evacuation capacity (“Medevac”)’ means a response capacity that can be used for aerial evacuation of patients with highly infectious diseases as well as non-infectious diseases, such as patients in need of intensive care, patients who need to be immobilized during transport on stretchers and lightly injured patients;

(2) ‘EMT type 3’ means a deployable emergency team of medical and other key personnel trained and equipped to treat patients affected by a disaster and which provides complex inpatient referral surgical care, including intensive care capacity.

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Article 2

The initial composition of rescEU

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1. rescEU shall consist of the following capacities: — aerial forest firefighting capacities, — medical aerial evacuation capacities, ▼M2 — emergency medical team capacities, ▼M4 — medical stockpiling capacities, ▼M4 — capacities in the area of chemical, biological, radiological and nuclear incidents. ▼M1

2. The capacities referred to in paragraph 1 shall include: (a) aerial forest firefighting capacities using airplanes; (b) aerial forest firefighting capacities using helicopters; (c) medical aerial evacuation capacities for highly infectious disease patients; (d) medical aerial evacuation capacities for disaster victims; ▼M2 (e) emergency medical team type 3 capacities: Inpatient Referral Care; ▼M4 (f) stockpiling of medical countermeasures or personal protective equipment aimed at combatting serious cross-border threats to health, as referred to in Decision No 1082/2013/EU of the European Parliament and of the Council ( 1 ); ▼M5 (g) chemical, biological, radiological, and nuclear (CBRN) decontamination capacities; ▼M5 (h) chemical, biological, radiological, and nuclear (CBRN) stockpiling capacities.

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3. The quality requirements for the capacities referred to in paragraph 2 are set out in the Annex.

Article 3

Financial arrangements for the rescEU capacities referred to in Article 35 of Decision No 1313/2013/EU

1. The Commission shall define in the annual work programme the criteria for awarding direct grants to cover the costs referred to in Article 35 of Decision No 1313/2013/EU which are necessary to ensure rapid access to capacities corresponding to those referred to in Article 2.

2. The costs referred to in Article 35 of Decision No 1313/2013/EU shall include stand-by costs, including if applicable, costs related to maintenance, costs related to staff, costs related to training, including the training of crew and technical staff, costs related to warehousing, costs related to insurance, as well as other costs necessary to ensure the effective availability of such capacities.

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Article 3a

Eligible costs of rescEU medical aerial evacuation capacities, emergency medical team type 3 capacities, medical stockpiling, CBRN decontamination and CBRN stockpiling 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.

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Article 3d

Categories of low probability risks with a high impact

For the purposes of establishing rescEU capacities necessary to respond to low probability risks with a high impact, the Commission shall take the following into account:

(a) the unpredictability or the extraordinary nature of a disaster;

(b) the scale of a disaster, including mass casualties, mass fatalities, and mass displacement;

(c) the protracted duration of a disaster;

(d) the degree of complexity of a disaster;

(e) the potential risk of severely disrupting the functioning of the national government, including the provision of social, environmental, economic and public health services or the disruption of critical infrastructure referred to in Article 2(a) of Council Directive 2008/114/EC ( 2 );

(f) geographical range, including the potential of impacts spreading beyond borders;

(g) other factors such as the activation in full mode of the Integrated Political Crisis Response (IPCR) arrangements of the Council or the invocation of the solidarity clause pursuant to Article 222 of the Treaty on the Functioning of the European Union.

Article 3e

rescEU capacities established to respond to low probability risks with a high impact

1. Capacities corresponding to events characterised by at least two of the categories, as specified in Article 3d, shall be established with the objective of responding to low probability risks with a high impact.

2. For every defined rescEU capacity under Article 2(2), the Commission shall consider whether the capacity can be established to respond to low probability risks with a high impact.

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3. rescEU capacities referred to in points (c) to (h) 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 (h) 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.

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Article 4

Amendment to Implementing Decision 2014/762/EU

Chapter 7 of Implementing Decision 2014/762/EU is deleted.

Article 5

Addressees

This Decision is addressed to the Member States.









ANNEX

QUALITY REQUIREMENTS FOR RESCEU CAPACITIES

1. Aerial forest firefighting capacities using airplanes







Tasks — Contribute to the extinction of large forest and vegetal fires by performing aerial firefighting. Capacities — 2 airplanes with a minimum capacity of 3 000 litres each or 1 airplane with a minimum capacity of 8 000 litres (1). — Ability to perform continuous operations. Main components — Airplane. — Minimum of two crews. — Technical staff. — Field maintenance kit. — Communication equipment allowing air-to-air and air-to-ground communication. Self-sufficiency — Equipment storage and maintenance of the equipment of the module; — Equipment for the communication with the relevant partners, notably those in charge of the coordination on site. Deployment — Availability for departure maximum 3 hours after the acceptance of the offer in the case of a rapid intervention response (2). — Ability to be deployed in a range of 2 000 km within maximum 24 hours. ( 1 ) Such requirements may be subject to review based on possible developments on the market of aerial forest firefighting capacities, including in relation to the availability of spare parts. ( 2 ) Rapid intervention response is a response operation lasting maximum one day including the flight to and from the site where the rescEU capacity is positioned.

2. Aerial forest firefighting capacities using helicopters







Tasks — ►C1 Contribute to the extinction of large forest and vegetal fires by performing aerial firefighting ◄ . Capacities — 1 helicopter with a minimum capacity of 3 000 litres (1) — Ability to perform continuous operations. Main components — Helicopter with minimum two crews. — Technical staff. — Water bucket or releasing kit. — 1 maintenance set. — 1 spare parts set. — Rescue hoists. — Communication equipment allowing air-to-air and air-to-ground communication. Self-sufficiency — Equipment storage and maintenance of the equipment of the module; — Equipment for the communication with the relevant partners, notably those in charge of the coordination on site. Deployment — Availability for departure maximum 3 hours after the acceptance of the offer in the case of a rapid intervention response (2). — Ability to be deployed in a range of 2 000 km within maximum 24 hours. ( 1 ) For the purposes of implementing Article 35 of Decision No 1313/2013/EU and when justified based on assessment of regional vulnerability, aerial forest firefighting capacities using helicopters may be composed of maximum 3 helicopters with a total minimum capacity of 3 000 litres. ( 2 ) Rapid intervention response is a response operation lasting maximum one day including the flight to and from the site where the rescEU capacity is positioned.

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3. Medical aerial evacuation capacities for highly infectious disease patients







Tasks — Aerial transport, including in-flight treatment of highly infectious disease (HID) patients to specialised health facilities in the Union. Capacities — Aircraft with a capacity to transport one or more HID patient per flight; — Ability to fly day and night. Main components — System for safe in-flight medical treatment of HID patients, including intensive care (1): — — Appropriately trained medical personnel to provide care for one or more HID patient; — Dedicated on-board technical and medical equipment to provide care to HID patients during the flight; — Appropriate procedures ensuring isolation and treatment of HID patients during the aerial transport. — Support: — — Aircrew adapted to the number of HID patients and the timeframe of the flight; — Appropriate procedures ensuring the handling of equipment and waste as well as decontamination according to established international standards, including, where applicable, relevant Union legislation. Self-sufficiency — Equipment storage and maintenance of the equipment of the module; — Equipment for communication with the relevant partners, notably those in charge of the coordination on site. Deployment — Availability for departure maximum 24 hours after the acceptance of the offer; — For intercontinental evacuations, ability to perform a 12-hour flight without refuelling. ( 1 ) Such system may include the containerised approach.

4. Medical aerial evacuation capacities for disaster victims







Tasks — Aerial transport of disaster victims to health facilities in the Union. Capacities — Aircraft with an overall capacity to transport at least six patients in need of intensive care and with a capacity to transport patients on stretchers or sitting patients, or both; — Ability to fly day and night. Main components — In-flight medical treatment, including intensive care: — — Appropriately trained medical personnel capable of providing on-board medical treatment for the different types of patients; — Dedicated on-board technical and medical equipment to provide continuous appropriate care for the different types of patients during the flight; — Appropriate procedures ensuring transport and in-flight treatment of patients. — Support: — — Aircrew and medical personnel adapted to the number and types of patients and the timeframe of the flight. Self-sufficiency — Equipment storage and maintenance of the equipment of the module; — Equipment for communication with relevant partners, notably those in charge of the coordination on site. Deployment — Availability for departure maximum 24 hours after the acceptance of the offer; — For airplanes, an ability to perform a 6-hour flight without refuelling.

5. Emergency medical team type 3 capacities: Inpatient Referral Care







Tasks — Provide inpatient referral care and complex surgery as described by the WHO global EMT initiative. Capacities — Minimum treatment capability in accordance with the standards of the WHO global EMT initiative; — Day and night services (covering 24/7 if necessary). Main components — In accordance with the standards of the WHO global EMT initiative. Self-sufficiency — The team should ensure self-sufficiency during the entire deployment time. Article 12 of Implementing Decision 2014/762/EU applies and, in addition, the standards of the WHO global EMT initiative. Deployment — Availability for departure in maximum 48-72 hours after the acceptance of the offer, and ability to be operational on site within 5-7 days. — Ability to be operational for at least 8 weeks outside the Union and for at least 14 days inside the Union.

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6. Stockpiling of medical countermeasures and/or personal protective equipment aimed at combatting serious cross-border threats to health







Tasks — Stockpiling of medical countermeasures, comprising of vaccines or therapeutics, intensive care medical equipment, personal protective equipment, or laboratory supplies, for the purpose of preparedness and response to a serious cross-border threat to health (1). Capacities — Adequate number of doses of vaccines necessary for individuals considered to be at risk (2) linked to one or more cases of serious cross-border threats to health. — Adequate number of doses of therapeutics necessary to treat one or more cases of serious cross-border threats to health. — Vaccines and therapeutics shall fulfil one of the following requirements: — — Marketing authorisation from EMA; — A positive recommendation for compassionate or emergency use from EMA or a national regulatory agency of a Member State; — A positive recommendation for expanded or emergency use from WHO and acceptance by at least one National Regulatory Agency of a Member State. — Adequate intensive care medical equipment (3), to provide supportive care to one or more cases of serious cross-border threats to health, in accordance with WHO standards. — Adequate number of sets of personal protective equipment (4) for individuals considered to be at risk (5) linked to one or more cases of serious cross-border threats to health, in accordance with the standards of the ECDC and the WHO. — Adequate number of laboratory supplies, including sampling material, laboratory reagents, equipment and consumables (6), to ensure laboratory diagnosis capacity for one or more cases of serious cross-border threats to health. Main components — Appropriate storage facilities in the Union (7) and adequate stockpiling monitoring system. — Appropriate procedures ensuring the adequate packaging, transport and delivery of the products referred to under capacities, where needed. — Appropriately trained personnel to handle, and administer the products referred to under capacities. Deployment — Availability for departure maximum 12 hours after the acceptance of the offer. ( 1 ) As defined in Decision No 1082/2013/EU. ( 2 ) Individuals considered at risk may comprise: high risk potential contacts, first responders, laboratory workers, health care workers, family members and other defined vulnerable groups. ( 3 ) This may comprise, but is not limited to, intensive care ventilators. ( 4 ) Covering the following categories: (i) eye protection; (ii) hand protection; (iii) respiratory protection; (iv) body protection; and (v) foot protection. ( 5 ) See footnote 2. ( 6 ) This may include, but is not limited to, RT-PCR reagents, such as enzymes, RNA extraction reagents, RNA extraction machine time, PCR machine time, primer and probe reagents, positive control reagents, PCR laboratory consumables (e.g. tubes, plates) and disinfectants. ( 7 ) For the purposes of the logistics of storage facilities, ‘in the Union’ encompasses the territories of Member States and Participating States of the Union Civil Protection Mechanism.

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7. Chemical, biological, radiological and nuclear decontamination







Tasks — Decontaminate from chemical, biological, radiological and nuclear agents of infrastructure, buildings, vehicles, equipment, critical evidence or affected persons, including fatalities. Capacities — Adequate decontamination capability for infrastructure, buildings, vehicles, equipment and critical evidence; — If the capacity covers the decontamination of persons, adequate decontamination capability for at least 200 ambulant persons per hour and 20 non-ambulant persons per hour as well as fatalities; — Ability to decontaminate from common toxic industrial chemicals, recognised warfare agents, biological infectious agents (pathogens) and toxins, and radionuclides; — Ability to erect temporary decontamination facilities within a safe radius, to monitor the decontamination area in order to keep the work environment safe and to evaluate the decontamination effectiveness. Main components — Appropriate equipment, technology and solutions to decontaminate from common toxic industrial chemicals, recognised warfare agents, biological infectious agents (pathogens) and toxins and, radionuclides; — Appropriate equipment to monitor progress of decontamination operations; — Appropriate equipment and personnel to perform decontamination of infrastructure, buildings, vehicles, equipment, critical evidence and capabilities; — If the capacity covers the decontamination of persons, appropriate equipment and personnel to perform decontamination of ambulant and non-ambulant persons; — Appropriate capability and procedures to monitor the decontamination area to keep the work environment safe and to verify the decontamination effectiveness; — Appropriate personal protective equipment to operate safely in a contaminated environment for the complete period of deployment; — Adequate pumping system and containers to take-up water locally; — Secure and safe waste management system and procedures during and after decontamination, including containment solutions to temporarily and safely store contaminated waste, pumps, waste combustion remains, contaminated water and wastewater treatment equipment. The management of hazardous waste, including contaminated water and other by-products, will be carried out in accordance with relevant Union or international regulations, or the legislation of the host nation, whichever is more stringent and with support from the host nation. Self-sufficiency — Article 12(1) and (2) of Implementing Decision 2014/762/EU applies; — Ability to decontaminate the capacity’s own personnel. Deployment — Availability for departure maximum 12 hours after the acceptance of the offer; — Ability to maintain operations for at least 14 continuous days.

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8. Stockpiling of chemical, biological, radiological and nuclear countermeasures and/or personal protective equipment aimed at assistance in the area of CBRN







Tasks — Stockpiling of CBRN countermeasures, comprising though not limited to, personal protective equipment, devices, laboratory supplies and logistics elements, as well as complementing and supporting other rescEU capacities, such as the CBRN decontamination and detection, surveillance and monitoring capacities for the purpose of preparedness and response to a CBRN event, including in response to cross-border threats to health (1). Capacities — Materials and systems (2) for decontaminating persons, infrastructure, buildings, vehicles, sensitive equipment and/or critical evidence, including from potential contamination with toxic industrial chemicals, recognised warfare agents, biological infectious agents (pathogens), biotoxins and radionuclides; — materials and devices necessary for detection, sampling, identification, surveillance and monitoring in order to keep safe an environment potentially exposed to CBRN agents; — materials and systems necessary for the containment of contamination and the management of waste and harmful by-products, including for contaminated water and clothes; — materials and systems necessary for fire containment and suppression in a CBRN event; — medical first line treatments, vaccines (3), relevant generic rapid diagnostic kits and antidotes against CBRN agents (e.g. atropine and iodine tablets); — support and disposable materials such as discharges and consumables that are complementary for CBRN response, tools needed for maintenance and stand-by (e.g. air bottle filler), containers for polluted or contaminated material of different agents; — CBRN related logistics support elements such as, but not limited to, tents, logistic containers, equipment for transporting victims, and decontamination tents at hospitals; — personal protective equipment (4) and their regeneration or refill systems, if applicable, for individuals considered to be at risk (5) both as front line workers and population; — laboratory supplies, including sampling material, laboratory reagents, equipment and consumables (6), to ensure laboratory capacity for CBRN-related risks; — body bags for CBRN contaminated fatalities; — any other items as needed, according to the identified risk. Main components — Appropriate storage facilities in the Union (7) and adequate stockpiling monitoring system; — appropriate procedures ensuring the adequate packaging, transport and delivery of the products referred to under capacities, where needed; — appropriately trained personnel to oversee and handle the products referred to under capacities; — appropriate level of compliance with international standards and operation models, such as EU, WHO or NATO standards, including, where applicable, relevant Union legislation. Deployment — Availability for departure maximum 12 hours after the acceptance of the offer. ( 1 ) As defined in Decision No 1082/2013/EU. ( 2 ) Such as PPE regeneration and refill systems. ( 3 ) The quality requirements for vaccines should be those under point 6 above. ( 4 ) Covering the following categories: (i) eye protection; (ii) hand protection; (iii) respiratory protection; (iv) body protection; and (v) foot protection, in different sizes. ( 5 ) See footnote 2. ( 6 ) This may include, but is not limited to, RT-PCR reagents, such as enzymes, RNA extraction reagents, RNA extraction machine time, PCR machine time, primer and probe reagents, positive control reagents, PCR laboratory consumables (e.g. tubes and plates) and disinfectants. ( 7 ) For the purposes of the logistics of storage facilities, ‘in the Union’ encompasses the territories of Member States and Participating States of the Union Civil Protection Mechanism.