ISSN 1977-0677

Official Journal

of the European Union

L 20

European flag  

English edition

Legislation

Volume 65
31 January 2022


Contents

 

I   Legislative acts

page

 

 

REGULATIONS

 

*

Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices ( 1 )

1

 

 

II   Non-legislative acts

 

 

INTERNATIONAL AGREEMENTS

 

*

Council Decision (EU) 2022/124 of 25 January 2022 on the conclusion, on behalf of the European Union, of the Protocol to amend the Air Transport Agreement between the United States of America and the European Community and its Member States

38

 

 

REGULATIONS

 

*

Commission Delegated Regulation (EU) 2022/125 of 19 November 2021 amending Annexes I to V to Regulation (EU) No 691/2011 of the European Parliament and of the Council on European environmental economic accounts ( 1 )

40

 

*

Commission Delegated Regulation (EU) 2022/126 of 7 December 2021 supplementing Regulation (EU) 2021/2115 of the European Parliament and of the Council with additional requirements for certain types of intervention specified by Member States in their CAP Strategic Plans for the period 2023 to 2027 under that Regulation as well as rules on the ratio for the good agricultural and environmental condition (GAEC) standard 1

52

 

*

Commission Delegated Regulation (EU) 2022/127 of 7 December 2021 supplementing Regulation (EU) 2021/2116 of the European Parliament and of the Council with rules on paying agencies and other bodies, financial management, clearance of accounts, securities and use of euro

95

 

*

Commission Implementing Regulation (EU) 2022/128 of 21 December 2021 laying down rules for the application of Regulation (EU) 2021/2116 of the European Parliament and of the Council on paying agencies and other bodies, financial management, clearance of accounts, checks, securities and transparency

131

 

*

Commission Implementing Regulation (EU) 2022/129 of 21 December 2021 laying down rules for types of intervention concerning oilseeds, cotton and by-products of wine making under Regulation (EU) 2021/2115 of the European Parliament and of the Council and for the information, publicity and visibility requirements relating to Union support and the CAP Strategic Plans

197

 

*

Commission Implementing Regulation (EU) 2022/130 of 24 January 2022 entering a name in the register of protected designations of origin and protected geographical indications Bračko maslinovo ulje (PDO)

206

 

*

Commission Implementing Regulation (EU) 2022/131 of 24 January 2022 entering a name in the register of protected designations of origin and protected geographical indications Carne Ramo Grande (PDO)

207

 

*

Commission Regulation (EU) 2022/132 of 28 January 2022 amending Regulation (EC) No 1099/2008 of the European Parliament and of the Council on energy statistics, as regards the implementation of updates for the annual, monthly and short-term monthly energy statistics ( 1 )

208

 

 

DECISIONS

 

*

Council Implementing Decision (EU) 2022/133 of 25 January 2022 authorising France to introduce a special measure derogating from Articles 218 and 232 of Directive 2006/112/EC on the common system of value added tax

272

 

*

Decision (EU) [2022/134] of the European Central Bank of 19 January 2022 laying down common rules on the transmission by the European Central Bank of supervisory information to authorities and bodies for the purpose of carrying out the tasks conferred on it by Council Regulation (EU) No 1024/2013 (ECB/2022/2)

275

 

 

Corrigenda

 

*

Corrigendum to Commission Delegated Regulation (EU) 2022/1 of 20 October 2021 amending Regulation (EU) 2021/821 of the European Parliament and of the Council as regards the list of dual-use items ( OJ L 3, 6.1.2022 )

282

 


 

(1)   Text with EEA relevance.

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


I Legislative acts

REGULATIONS

31.1.2022   

EN

Official Journal of the European Union

L 20/1


REGULATION (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 25 January 2022

on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4), point (c), thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

(1)

Pursuant to Articles 9 and 168 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), the Union is to ensure a high level of human health protection in the definition and implementation of all Union policies and activities.

(2)

The COVID-19 pandemic has highlighted the interconnectedness of human, animal, and ecosystem health and the risks posed by the loss of biodiversity on Earth. As recognised by the World Health Organization, many of the same microbes infect animals and humans, so efforts that focus only on human health or only on animal health cannot prevent or eliminate the problem of disease transmission. Diseases may be transmitted from humans to animals or vice versa and therefore need to be tackled in both humans and animals, taking advantage of potential synergies in research and treatments. Approximately 70 % of emerging diseases, and almost all known pandemics, namely influenza, HIV/AIDS and COVID-19, are zoonoses. Those diseases have increased globally over the past 60 years. Changes in land use, deforestation, urbanisation, agricultural expansion and intensification, wildlife trafficking and consumption patterns are factors that have contributed to that increase. Zoonotic pathogens can be bacterial, viral or parasitic, and can include unconventional agents that are able to spread to humans through direct contact or through food, water or the environment. The COVID-19 pandemic is a clear example of the need to reinforce the application of the One Health approach in the Union to achieve better public health outcomes, since, as stated in Regulation (EU) 2021/522 of the European Parliament and of the Council (4), ‘human health is connected to animal health and to the environment and … actions to tackle threats to health must take into account those three dimensions’.

(3)

The unprecedented experience of the COVID-19 pandemic has also highlighted the difficulties of the Union and the Member States in addressing such a public health emergency. In that regard, it has demonstrated the need to strengthen the Union’s role in order to be more effective in managing the availability of medicinal products and the availability of medical devices and in vitro diagnostic medical devices and their respective accessories (collectively ‘medical devices’) and in developing medical countermeasures to address the threats posed to public health at an early stage in a harmonised way that ensures cooperation and coordination between Union, national and regional competent authorities, medicinal products and medical devices industry and other actors in the supply chains for medicinal products and medical devices, including healthcare professionals. While the Union needs to give a higher priority to health, its ability to ensure the continued provision of high quality healthcare services and to be prepared to address pandemics and other health threats has been severely impeded by the absence of a clearly defined legal framework for managing its response to pandemics and by the limited mandates and resources of its health agencies, as well as by the limited degree of Union and Member States preparedness for public health emergencies that impact a majority of the Member States.

(4)

Shortages of medicinal products and medical devices have different and complex root causes which need to be further mapped, understood and analysed together with the different stakeholders in order to be comprehensively addressed. A better understanding of those shortages should include identification of vulnerabilities in the supply chain. In the specific case of the COVID-19 pandemic, the shortage of treatments for the disease had a variety of causes, ranging from production difficulties in third countries to logistical or production difficulties within the Union, where the shortage of vaccines was due to inadequate manufacturing capacity.

(5)

Disruptions to the often complex supply chains for medicinal products and medical devices, national export restrictions and bans, border closures impeding the free movement of such goods, uncertainty related to the supply for and demand of such goods in the context of the COVID-19 pandemic, and the lack of production in the Union of certain medicinal products or active substances, have led to significant impediments to the smooth functioning of the internal market and to addressing the serious threats to public health across the Union, with serious consequences for the Union’s citizens.

(6)

Addressing the issue of shortages of medicinal products has been a long-standing priority for the Member States and European Parliament as illustrated by several reports from the European Parliament such as the European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (5), as well as by discussions within the Council of the European Union. However, that issue has remained, to date, unaddressed.

(7)

Shortages of medicinal products represent a growing threat to public health, with a serious impact on healthcare systems and on the right of patients to access appropriate medical treatment. Increased global demand for medicinal products, which was exacerbated by the COVID-19 pandemic, has led to further shortages of medicinal products, weakening the healthcare systems in Member States and posing significant risks to patients’ health and to the care of patients, particularly in terms of disease progression and worsening of symptoms, longer delays or interruptions in care or therapy, longer periods of hospitalisation, increased risk of exposure to falsified medicinal products, medication errors, adverse effects resulting from the substitution of unavailable medicinal products with alternative ones, significant psychological distress for patients and increased costs for healthcare systems.

(8)

The COVID-19 pandemic has exacerbated the problem of shortages of certain medicinal products considered to be critical to addressing the pandemic, and has highlighted the Union’s external dependence in terms of domestic production of medicinal products and medical devices, the lack of coordination and the structural limitations in the Union’s and Member States’ ability to rapidly and effectively react to such challenges during public health emergencies. It has also highlighted the need to support and strengthen the industrial capacities to produce those medicinal products and medical devices through appropriate policies, as well as the need for more active and extensive involvement of the Union institutions, bodies, offices and agencies in protecting the health of Union citizens.

(9)

The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators, surgical masks, and COVID-19 test kits, while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices led to severe supply difficulties and, at certain times, serious shortages of medical devices. It has also led Member States competing with each other when they respond to the legitimate needs of their citizens, thereby contributing to uncoordinated actions at national level, such as national hoarding and stockpiling. Those issues further resulted in new entities being involved in the expedited production of such medical devices, which subsequently resulted in delays in conformity assessments and the prevalence of medical devices that were over-priced, non-compliant, unsafe, and, in some cases, counterfeits. It is therefore appropriate and a matter of urgency that long-term structures be established within the European Medicines Agency (the ‘Agency’), established by Regulation (EC) No 726/2004 of the European Parliament and of the Council (6), to ensure more solid and effective monitoring of shortages of medical devices that can occur during a public health emergency and coordination of the management of those shortages, as well as increased and early dialogue with the medical devices industry and healthcare professionals to prevent and mitigate those shortages.

(10)

The COVID-19 pandemic and the subsequent public health emergency revealed the need for a more coordinated Union approach in crisis management. Although the lack of an impact assessment accompanying the Commission proposal for this Regulation was due to the emergency-like nature of the situation, sufficient allocation of resources in terms of staff and funding should be secured, taking into account the specificities of the health sector in the different Member States.

(11)

Uncertainty of supply and demand and the risk of shortages of medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions among Member States and other national protective measures, which can seriously impact the functioning of the internal market, thereby exacerbating the consequences for public health, as well as leading to the need for temporary export transparency and export authorisation mechanisms. Furthermore, shortages of medicinal products can result in serious risks to the health of patients in the Union due to their lack of availability, which can result in medication errors, increased duration of hospital stays, adverse reactions and increased risk of fatalities caused by the administration of unsuitable medicinal products used as a substitute for unavailable medicinal products. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures or to a disease deteriorating or not being treated, and may also prevent health professionals from adequately carrying out their tasks or being protected when doing so, as evidenced during the COVID-19 pandemic, with serious consequences for their health. Such shortages, for example, insufficient supply of COVID-19 test kits, can also have a significant impact on control of the spread of a given pathogen. It is therefore important to have an appropriate framework at Union level to coordinate the Union response to shortages of medicinal products and medical devices and to reinforce and formalise the monitoring of critical medicinal products and medical devices in the most efficient way and in a way that avoids creating unnecessary burdens for stakeholders which can place a strain on resources and cause additional delays.

(12)

Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be identified, developed, notably through joint efforts by public authorities, the private sector and academia, and made available to Union citizens as soon as possible during such emergencies. The COVID-19 pandemic has also highlighted the need to coordinate assessments and conclusions on multinational clinical trials, in line with what was done on a voluntary basis by clinical trials experts of Member States prior to the date of application of Regulation (EU) No 536/2014 of the European Parliament and of the Council (7), and the need for Union-level advice on the use of medicinal products in national compassionate use programmes or the use of medicinal products for indications that are not covered by the marketing authorisation in the Union, in order to avoid delays in the implementation of results of research and in the development and availability of new or repurposed medicinal products.

(13)

During the COVID-19 pandemic, ad hoc solutions, such as contingent arrangements between the Commission, the Agency, marketing authorisation holders, manufacturers or other actors in the supply chain for medicinal products, on the one side, and Member States, on the other, had to be found in order to make available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and in order to facilitate and speed up the development and marketing authorisation of treatments and vaccines.

(14)

In order to ensure the better functioning of the internal market for safe and efficacious medicinal products for the treatment of COVID-19 or prevention of its spread and to contribute to a high level of human health protection, it is therefore appropriate to approximate and strengthen the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products which have the potential to treat, prevent or diagnose diseases that cause public health emergencies, with a view to strategically complementing the efforts of the Commission, including the Health Emergency Preparedness and Response Authority (‘HERA’), established by Commission Decision of 16 September 2021 (8), and Union agencies, to that end.

(15)

In order to support the assessment of the crisis-preparedness and crisis-management framework provided for in this Regulation with regard to shortages of medicinal products and medical devices, the Commission should be able to use the outcomes of targeted stress tests performed by the Commission, the Agency, Member States or other relevant actors. Such stress tests entail a simulation of a public health emergency or major event in which some or all segments of the processes and procedures laid down in this Regulation are tested.

(16)

This Regulation aims to ensure a high level of protection for human health by ensuring the smooth functioning of the internal market as regards medicinal products and medical devices. Moreover, this Regulation aims to ensure the quality, safety and efficacy of medicinal products that have the potential to address public health emergencies. Both objectives are being pursued simultaneously and are inseparably linked, without one being secondary to the other. As regards Article 114 TFEU, this Regulation establishes a framework for the monitoring and reporting of shortages of medicinal products and medical devices during public health emergencies and major events. As regards Article 168(4), point (c), TFEU, this Regulation should provide for a strengthened Union framework for ensuring the quality and safety of medicinal products and medical devices.

(17)

This Regulation should establish a framework to address the issue of shortages of medicinal products and medical devices during public health emergencies and major events. However, those shortages are a persistent problem that has been increasingly affecting the health and lives of Union citizens for decades. Therefore, this Regulation should be a first step towards improving the Union response to that persistent problem. The Commission should subsequently assess the expansion of that framework to ensure that the issue of shortages of medicinal products and medical devices is addressed.

(18)

In order to improve crisis preparedness and management with respect to medicinal products and medical devices and to increase resilience and solidarity across the Union, the procedures and the respective roles and obligations of the different entities concerned should be clarified. The framework established by this Regulation should build on the ad hoc solutions identified to date in the response to the COVID-19 pandemic that have proven effective, and should build on experience, best practices and examples from third countries, while remaining flexible enough to tackle any future public health emergency and major event in the most efficient way to the benefit of public health and patients.

(19)

A harmonised system of monitoring shortages of medicinal products and medical devices should be established. This would facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which can have a serious impact on public health. That system should be complemented by improved structures for ensuring the appropriate management of public health emergencies and major events and for coordinating and providing advice on research and development relating to medicinal products which have the potential to mitigate public health emergencies or major events. In order to facilitate the monitoring and reporting of actual or potential shortages of medicinal products and medical devices, the Agency should be able to request and obtain information and data from the marketing authorisation holders concerned, manufacturers and Member States through designated single points of contact, while avoiding any duplication of the information requested and submitted. This should not interfere with the obligation on marketing authorisation holders under Article 23a of Directive 2001/83/EC of the European Parliament and of the Council (9) to notify a Member State when a product ceases to be placed on the market of that Member State or the obligation under Article 81 of that Directive on marketing authorisation holders and wholesale distributors to ensure appropriate and continued supplies of that medicinal product to persons and legal entities that are authorised or entitled to supply medicinal products, so that the needs of patients in the Member State in question are met.

(20)

In order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, the Agency should set up an information technology (IT) platform, to be known as the European shortages monitoring platform (‘ESMP’), that is capable of processing information on the supply of and demand for critical medicinal products during public health emergencies or major events and, outside of those situations, to allow for reporting on shortages of medicinal products that are likely to lead to public health emergencies or major events. To facilitate the development of the ESMP, existing IT systems should be leveraged and used where possible. The ESMP should allow national competent authorities to submit and monitor information on unmet demand, including information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public, in order to anticipate shortages of medicinal products. The ESMP could also process additional information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public in order to avert a public health emergency or a major event. The ESMP, once it is fully implemented, should act as the sole portal for marketing authorisation holders to provide the information required during public health emergencies and major events, with a view to increasing efficiency and predictability during public health emergencies and major events, and to accelerating the decision-making process while avoiding duplication of efforts and unjustified burdens on stakeholders. In order to facilitate the coordination role of the Agency, the interoperability of data with existing Member States’ IT platforms for monitoring shortages and other systems, as appropriate, is essential to allow the sharing of relevant information with the ESMP, which should be managed by the Agency.

(21)

In the event that the actual future demand is unknown due to a public health emergency or major event, it is important to make pragmatic predictions as to demand for certain medicinal products on the basis of the best available information. In that context, information and data on available stocks and planned minimum stocks should be collected by Member States and the Agency and taken into account in identifying the demand as far as possible. Those information and data are essential for making correct adjustments in the manufacturing of medicinal products to avoid or at least mitigate the impact of shortages of medicinal products. However, when data on stocks are not available or cannot be provided due to national security interests, Member States should provide the Agency with estimated data on volumes of demand.

(22)

With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products (the ‘Medicine Shortages Steering Group – MSSG’). The MSSG should establish lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice and recommendations on the necessary action to take to safeguard the quality, safety and efficacy of medicinal products as well as to safeguard the supply of medicinal products and to ensure a high level of human health protection.

(23)

To facilitate appropriate communication between patients and consumers, on the one hand, and the MSSG, on the other, Member States could collect data on the impact of shortages of medicinal products on patients and consumers, and share relevant information with the MSSG in order to inform approaches to management of shortages of medicinal products.

(24)

In order to ensure the inclusivity and transparency of the work of the MSSG, there should be appropriate engagement between the MSSG and relevant third parties, including representatives of medicinal product interest groups, marketing authorisation holders, wholesale distributors, any other appropriate actors in the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers.

(25)

The MSSG should benefit from the Agency’s extensive scientific expertise as regards the evaluation and supervision of medicinal products and should further develop the Agency’s leading role in coordinating and supporting the response to shortages of medicinal products during the COVID-19 pandemic.

(26)

In order to ensure that high quality, safe and efficacious medicinal products, which have the potential to address public health emergencies, can be developed and made available within the Union as soon as possible during public health emergencies, an emergency task force should be established within the Agency to provide advice on such medicinal products (the ‘Emergency Task Force – ETF’). The ETF should provide advice on scientific questions related to the development of treatments and vaccines and on clinical trial protocols free of charge to those entities involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their role in the development of such medicinal products. Decisions on clinical trial applications should remain within the competence of the Member States, in accordance with Regulation (EU) No 536/2014.

(27)

The work of the ETF should be separate from the work of the scientific committees of the Agency and should be carried out without prejudice to the scientific assessments of those committees. The ETF should provide advice and recommendations with regard to the use of medicinal products in the fight to overcome public-health emergencies. The Committee for Medicinal Products for Human Use (‘CHMP’) established by Article 5 of Regulation (EC) No 726/2004 should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation. The MSSG could also draw on the work of the ETF when developing the critical medicines lists.

(28)

The establishment of the ETFshould build on the support provided by the Agency during the COVID-19 pandemic, in particular as regards scientific advice on clinical trials design and product development as well as the ‘rolling’ review of emerging evidence, i.e. on an on-going basis, to allow a more efficient assessment of medicinal products including vaccines during public health emergencies, while guaranteeing a high level of human health protection.

(29)

In order to ensure the better functioning of the internal market for medicinal products and to contribute to a high level of human-health protection, it is appropriate for the ETF to coordinate and provide advice to developers involved in the research and development of medicinal products that have the potential to treat, prevent or diagnose diseases causing the public health emergency.

(30)

The ETF should provide advice on clinical trial protocols and to developers of clinical trials that are conducted in the Union, providing guidance on clinically relevant endpoints and targets for vaccines and treatments in order to facilitate clinical trial design meeting the criteria for effective public health interventions.

(31)

Experience with clinical trials during the COVID-19 pandemic revealed a tremendous amount of duplication of investigations on the same interventions, a high number of small trials, under-representation of important population subgroups, based on gender, age, ethnicity or medical comorbidities, and a lack of collaboration, leading to a risk that research will be wasted. International regulators pointed out the need to improve the clinical research agenda in order to generate robust evidence on quality, safety and efficacy of medicinal products. The main way of obtaining reliable evidence is through coordinated, well-designed, and adequately powered large randomised controlled trials. Clinical trial results and clinical data produced after the relevant marketing authorisation has been granted should be made publicly available in a timely manner. The publication of the trial protocol at the start of the clinical trial would allow public scrutiny.

(32)

Whenever necessary, considering that medicinal products for human use may impact the veterinary sector, a close liaison with the national competent authorities for veterinary medicinal products should be envisaged.

(33)

Although individual research entities may agree with each other or with another party to act as a sponsor in order to prepare a single harmonised Union-wide clinical trial protocol, experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that is able to take up all the responsibilities and activities of a sponsor within the Union as well as interact with multiple Member States. To address that problem, a new Union-wide and Union-funded vaccine trial network called VACCELERATE was launched following the Commission communication of 17 February 2021 entitled ‘HERA Incubator: Anticipating together the threat of COVID-19 variants’. The Agency should identify and facilitate such initiatives by giving advice on the possibilities for acting as a sponsor or, where applicable, for allocating respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) No 536/2014 and coordinate the development of clinical trial protocols. Such an approach would strengthen the research environment in the Union, would promote harmonisation and would avoid subsequent delays in availability of results of research for marketing authorisation files. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as from existing clinical trial networks to facilitate the development, application, submission, and running of trials. This may be particularly valuable for trials established by Union or international public health or research organisations.

(34)

The Agency publishes European Public Assessment Reports (EPARs) for medicinal products authorised in accordance with Regulation (EC) No 726/2004 which provide information on the assessment of those medicinal products by describing the data assessed and the reasons for recommending whether a medicinal product should be authorised. The EPAR includes detailed information with regard to all relevant pre-submission activities under that Regulation, including the names of the coordinators and experts involved, and, where a medicinal product developer requests scientific advice during the pre-submission phase, an overview of the scientific topics discussed in view to that advice.

(35)

With respect to medical devices, an executive steering group on shortages of medical devices should be established to coordinate urgent actions within the Union in relation to the management of supply and demand issues of medical devices, and to establish a list of critical medical devices in the case of a public health emergency (the ‘Medical Device Shortages Steering Group – MDSSG’). To ensure such coordination, the MDSSG should also liaise with the Medical Devices Coordination Group (‘MDCG’) established by Article 103 of Regulation (EU) 2017/745 of the European Parliament and of the Council (10), where appropriate. In that respect, Member States should be able to appoint the same representatives to both the MDSSG and the MDCG.

(36)

The operational phase of the work of the MSSG, the MDSSG and the ETF should be triggered by the recognition of a public health emergency in accordance with Decision No 1082/2013/EU of the European Parliament and of the Council (11) and, as regards the MSSG, also by the recognition of a major event. The continuous monitoring of risks to public health from major events, including manufacturing issues, natural disasters and bioterrorism that have the potential to affect the quality, safety, efficacy, or supply of medicinal products should also be ensured. In addition, such monitoring should follow the One Health approach.

(37)

It is understood that all recommendations, advice, guidance and opinions provided for in this Regulation are inherently non-binding. Each of those instruments is intended to allow the Commission, the Agency, the MSSG, the MDSSG and the ETF to make their views known and to suggest a line of action without imposing any legal obligation on the addressees of those instruments.

(38)

It is imperative to have in place robust transparency measures and standards regarding the Agency’s regulatory activities in relation to medicinal products and medical devices that fall under the scope of this Regulation. Those measures should include the timely publication of all relevant information on approved medicinal products and medical devices and of clinical data, including clinical trial protocols. The Agency should be highly transparent as regards the membership, recommendations, opinions and decisions of the MSSG, the MDSSG and the ETF. Members of the MSSG, the MDSSG and the ETF should not have financial or other interests in the medicinal products or medical device industries which could affect their impartiality.

(39)

In order to establish the list of categories of critical medical devices and to facilitate the process of monitoring shortages, the manufacturers of those medical devices, or their authorised representatives and, where necessary, relevant notified bodies should provide information requested by the Agency. In specific situations, namely where a Member State considers the need to provide for temporary exemptions pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 of the European Parliament and of the Council (12) with a view to mitigating actual or potential shortages of medical devices, the importer and distributor should also play a role in providing the requested information if the non-EU manufacturer has not designated an authorised representative.

(40)

This Regulation should provide the Agency with a role in supporting the expert panels on medical devices designated in accordance with Article 106(1) of Regulation (EU) 2017/745 (the ‘expert panels’) in providing independent scientific and technical assistance to the Member States, the Commission, the MDCG, notified bodies and manufacturers, while upholding maximum transparency as a condition for fostering trust and confidence in the Union regulatory system.

(41)

In addition to their role in clinical evaluation assessments and performance evaluations regarding certain high risk medical devices in accordance with Regulations (EU) 2017/745 and (EU) 2017/746, respectively, as well as in providing opinions in response to consultation by manufacturers and notified bodies, the expert panels are to provide scientific, technical, and clinical assistance to the Member States, the Commission and the MDCG. In particular, the expert panels are to contribute to the development of guidance on a number of points, including clinical and performance aspects of specific medical devices, categories, or groups of medical devices or specific hazards related to a category or group of medical devices, develop clinical evaluation and performance evaluation guidance in line with the state of the art, and contribute to the identification of concerns and emerging issues on safety and performance. In that context, the expert panels could play a relevant role in preparedness for and the management of public health emergencies relating to medical devices, particularly those of high risk including those medical devices which have the potential to address public health emergencies, without prejudice to tasks and obligations under Regulations (EU) 2017/745 and (EU) 2017/746.

(42)

Given the Agency’s long-standing and proven record of expertise in the field of medicinal products and considering the Agency’s experience from working with a multitude of groups of experts, it is appropriate to establish suitable structures within the Agency to monitor potential shortages of medical devices in the context of a public health emergency and provide that the Agency provide the secretariat for the expert panels. This would ensure that the expert panels operate sustainably in the long term and would provide clear synergies with related crisis-preparedness work in the area of medicinal products. Those structures would in no way change the regulatory system or decision-making procedures in the area of medical devices that are already in place in the Union, which should remain clearly distinct from those for medicinal products. To ensure a smooth transition to the Agency, the Commission should provide support for the expert panels until 1 March 2022.

(43)

In order to facilitate the work and exchanges of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and to create synergies with other existing IT systems and IT systems under development, including the European database on medical devices (Eudamed) provided for in Article 33 of Regulation (EU) 2017/745, alongside enhanced protection of data infrastructure and deterrence from possible cyber attacks. Within Eudamed, the European Medical Device Nomenclature provided for in Article 26 of Regulation (EU) 2017/745 and in Article 23 of Regulation (EU) 2017/746 should be used to help the gathering of relevant information on categorisation of medical devices. That work could also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as by data from the Union Space Programme established by Regulation (EU) 2021/696 of the European Parliament and of the Council (13), such as from the Galileo geolocation services, and Copernicus Earth observation data.

(44)

In order to ensure the completeness of information and data obtained by the Agency and considering the specific characteristics of the medical device sector, until Eudamed is fully functional, it should be possible to constitute the list of single points of contact for monitoring the shortages of medical devices included on the public health emergency critical devices list using as a source of information the relevant databases or medical device associations at Union or national level.

(45)

Rapid access to and exchanges of health data, including real world data, i.e. health data generated outside of clinical studies, are essential to ensuring the effective management of public health emergencies and major events. This Regulation should allow the Agency to use and facilitate such exchanges and to be part of the establishment and operation of the European Health Data Space interoperable infrastructure, taking advantage of all the potential of supercomputing, artificial intelligence and big data science to develop predicting models and take better and more timely and effective decisions, without compromising privacy rights.

(46)

In order to facilitate the reliable exchange of information on medicinal products in a robust and consistent manner, the identification of medicinal products should be based on the standards developed by the International Organization for Standardization for the identification of medicinal products for human use.

(47)

The handling of sensitive data, crucial for dealing with potential public health emergencies, requires a high level of protection against cyber attacks. Healthcare organisations have also been facing heightened cybersecurity threats in the midst of the COVID-19 pandemic. The Agency itself was the target of a cyber attack that resulted in some documents related to COVID-19 medicinal products and vaccines belonging to third parties being illegally accessed and some of those documents then being leaked on the internet. It is therefore necessary for the Agency to be equipped with a high level of security controls and processes against cyber attacks to ensure that the Agency operates normally at all times and especially during public health emergencies and major events. To that end, the Agency should establish a plan to prevent, detect, mitigate and respond to cyber attacks so that its operations are secure at all times, while preventing any illegal access to documentation held by the Agency.

(48)

Due to the sensitive nature of health data, the Agency should safeguard its processing operations and ensure that they respect the data protection principles of lawfulness, fairness and transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. Where the processing of personal data is necessary for the purposes of this Regulation, such processing should be done in accordance with Union law on the protection of personal data. Any processing of personal data under this Regulation should take place in accordance with Regulations (EU) 2016/679 (14) and (EU) 2018/1725 (15) of the European Parliament and of the Council.

(49)

The credibility of the Agency and public trust in its decisions depend on a high degree of transparency. Therefore, the use of adequate communication tools to proactively engage with the general public should be provided for. In addition, the rapid strengthening of transparency standards and measures regarding the Agency’s working bodies and clinical data that has been assessed for the evaluation and surveillance of medicinal products and medical devices are paramount to gain and uphold public trust. This Regulation should establish a framework for those strengthened transparency standards and measures, on the basis of the transparency standards and measures adopted by the Agency during the COVID-19 pandemic.

(50)

During public health emergencies or major events, the Agency should ensure cooperation with the European Centre for Disease Prevention and Control (‘ECDC’) established by Regulation (EC) No 851/2004 of the European Parliament and of the Council (16) and other Union agencies, as appropriate. Such cooperation should include the sharing of data, including data on epidemiological forecasting, regular communication at an executive level, and inviting representatives of the ECDC and other Union agencies to attend meetings of the ETF, the MSSG and the MDSSG, as appropriate. Such cooperation should also include strategic discussions with relevant entities of the Union that are in a position to assist research and development regarding appropriate solutions and technologies for mitigating the effects of the public health emergency or major event or preventing future similar public health emergencies or major events.

(51)

In cases of public health emergencies, or in relation to major events, it should be possible for the Agency to enable regular exchanges of information with Member States, marketing authorisation holders, relevant actors of the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers, to ensure early discussions on potential shortages of medicinal products in the market and on supply constraints, so as to allow better coordination and synergies to mitigate and respond to the public health emergency or major event.

(52)

Given that the COVID-19 pandemic has not come to an end, and that the duration and evolution of public health emergencies, such as pandemics, are uncertain, provision should be made for a review of the effectiveness of the functioning of the structures and mechanisms established in accordance with this Regulation. In light of that review, those structures and mechanisms should be adjusted, if appropriate.

(53)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member States alone due to the cross-border dimension of public health emergencies and major events but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(54)

In order to ensure that sufficient resources, including appropriate staffing and adequate expertise, are available for carrying out the tasks provided for under this Regulation, expenditure of the Agency should be covered by the contribution from the Union to the Agency’s revenue. That expenditure should include remuneration for rapporteurs who are appointed to provide scientific services in relation to the ETF and, in line with usual practice, reimbursement of travel, accommodation and subsistence expenses related to meetings of the MSSG, the MDSSG, the ETF and their working parties.

(55)

The EU4Health Programme established by Regulation (EU) 2021/522 or the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (17) are some of the tools to provide additional support to national competent authorities in relation to shortages of medicinal products, including through the implementation of actions to mitigate shortages of medicinal products and improve the security of supply. Member States should be able to request financial support from the Union specifically for the implementation of their obligations set out in this Regulation.

(56)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered formal comments on 4 March 2021.

(57)

In accordance with Article 168(7) TFEU, this Regulation fully respects the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care as well as the fundamental rights and principles recognised by the Charter including the protection of personal data.

(58)

One of the aims of this Regulation is to ensure a strengthened framework for monitoring of and reporting on shortages of medicinal products during public health emergencies and major events. As announced in the communication of the Commission of 25 November 2020 entitled ‘Pharmaceutical Strategy for Europe’, the Commission will propose to revise the pharmaceutical legislation to enhance the security of supply and address shortages of medicinal products through specific measures. That legislation could cover a further coordinating role for the Agency in monitoring and managing shortages of medicinal products. If, as a result of that revision, strengthened measures regarding monitoring of and reporting on supply of and demand for medicinal products at Union level are required, the ESMP should be considered as a suitable system to facilitate any new provisions relating to monitoring of and reporting on shortages of medicinal products. As part of the reporting on this Regulation, the Commission should consider the need to extend the scope of this Regulation to include veterinary medicinal products and personal protective equipment, to amend definitions and to introduce measures at Union or national level to strengthen compliance with the obligations set out in this Regulation. That review should include consideration of the remit and functioning of the ESMP. The extension of the functioning of the ESMP and the need for national shortages monitoring systems should be considered if necessary. In order to prepare for shortages of medicinal products during public health emergencies and major events and to support the monitoring of such shortages, capacity building that is supported by Union funding mechanisms should be considered in order to enhance cooperation among Member States. This could include the exploration of best practices and the coordination of the development of IT tools for monitoring and managing shortages of medicinal products in Member States and for connecting to the ESMP. To ensure that the ESMP is used to its full potential and to identify and forecast problems relating to supply of and demand for medicinal products, where appropriate, the ESMP should facilitate the use of big data techniques and artificial intelligence.

(59)

In order to allow for the prompt application of the measures provided for in this Regulation, it should enter into force on the day following that of its publication in the Official Journal of the European Union,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject Matter

Within the European Medicines Agency (the ‘Agency’),this Regulation provides for a framework for and the means of:

(a)

preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products and on medical devices at Union level;

(b)

monitoring, preventing, and reporting on shortages of medicinal products and on shortages of medical devices;

(c)

setting up an interoperable information technology (IT) platform at Union level to monitor and report on shortages of medicinal products;

(d)

providing advice on medicinal products that have the potential to address public health emergencies;

(e)

providing support for the expert panels provided for in Article 106(1) of Regulation (EU) 2017/745.

Article 2

Definitions

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

(a)

‘public health emergency’ means a situation of public health emergency recognised by the Commission in accordance with Article 12(1) of Decision No 1082/2013/EU;

(b)

‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State, which concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin, or a serious incident that can affect the supply of or demand for medicinal products, or quality, safety or efficacy of medicinal products, which may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection;

(c)

‘medicinal product’ means a medicinal product as defined in Article 1, point (2), of Directive 2001/83/EC;

(d)

‘veterinary medicinal product’ means a veterinary medicinal product as defined in Article 4, point (1), of Regulation (EU) 2019/6 of the European Parliament and the Council (18);

(e)

‘medical device’ means a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745 or an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746, and includes accessories for such devices within the meaning of Article 2, point (2), of Regulation (EU) 2017/745, and Article 2, point (4), of Regulation (EU) 2017/746, respectively;

(f)

‘supply’ means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;

(g)

‘demand’ means the request for a medicinal product or a medical device by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product or the medical device is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients;

(h)

‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet demand for that medicinal product or medical device at a national level, whatever the cause;

(i)

‘developer’ means any legal or natural person seeking to generate scientific data with regard to the quality, safety and efficacy of a medicinal product as part of the development of that product.

CHAPTER II

MONITORING AND MITIGATING SHORTAGES OF CRITICAL MEDICINAL PRODUCTS AND MANAGEMENT OF MAJOR EVENTS

Article 3

Executive Steering Group on Shortages and Safety of Medicinal Products

1.   The Executive Steering Group on Shortages and Safety of Medicinal Products (the ‘Medicine Shortages Steering Group – MSSG’) is hereby established within the Agency.

The MSSG shall be responsible for fulfilling the tasks referred to in Article 4(3) and (4) and Articles 5 to 8.

The MSSG shall meet regularly and also whenever the situation requires, either in person or remotely, in preparation for or during a public health emergency or when an issue of concern has been raised with the MSSG or when the Commission has recognised a major event in accordance with Article 4(3).

The Agency shall provide the secretariat of the MSSG.

2.   The members of the MSSG shall consist of a representative of the Agency, a representative of the Commission and one representative appointed by each Member State.

Members of the MSSG may be accompanied to meetings of the MSSG by experts in specific scientific or technical fields.

The list of the members of the MSSG shall be published on the Agency’s web portal.

A representative of the Agency’s Patients’ and Consumers’ Working Party (‘PCWP’) and a representative of the Agency’s Healthcare Professionals’ Working Party (‘HCPWP’) may attend meetings of the MSSG as observers.

3.   The MSSG shall be co-chaired by the representative of the Agency and by one of the representatives of the Member States, who shall be elected by and from among the representatives of the Member States in the MSSG.

The co-chairs of the MSSG, on their own initiative or at the request of one or more members of the MSSG, may invite, as observers and to provide expert advice, representatives of national competent authorities for veterinary medicinal products, representatives of other relevant competent authorities and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, wholesale distributors, any other appropriate actor in the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers, to attend its meetings, as necessary.

4.   The MSSG, in coordination with the national competent authorities for medicinal products, shall facilitate appropriate communication with marketing authorisation holders or their representatives, manufacturers, other relevant actors of the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers, with a view to receiving relevant information on actual or potential shortages of medicinal products considered to be critical during a public health emergency or a major event as provided for in Article 6.

5.   The MSSG shall establish its rules of procedure, including procedures relating to the working party referred to in paragraph 6 of this Article and procedures for adoption of the critical medicines lists, sets of information and recommendations referred to in Article 8(3) and (4).

The rules of procedure referred to in the first subparagraph shall enter into force once the MSSG has received a favourable opinion from the Commission and the Management Board of the Agency.

6.   The MSSG shall be supported in its work by a working party established in accordance with Article 9(1), point (d).

The working party referred to in the first subparagraph shall consist of representatives of the national competent authorities for medicinal products, who shall be the single points of contact in relation to shortages of medicinal products.

7.   The MSSG may consult with the Committee for Medicinal Products for Veterinary Use (‘CVMP’) established by Article 56(1), point (b), of Regulation (EC) No 726/2004 whenever the MSSG deems necessary to do so, in particular, in order to deal with public health emergencies or major events related to zoonoses or diseases that only affect animals and that have or may have a major impact on human health or where the use of active substances for veterinary medicinal products may be useful in addressing the public health emergency or major event.

Article 4

Monitoring of events and preparedness for public health emergencies and major events

1.   The Agency, in collaboration with Member States, shall continuously monitor any event that is likely to lead to a public health emergency or major event. As necessary, the Agency shall cooperate with the European Centre for Disease Prevention and Control (‘ECDC’) and, where relevant, other Union agencies.

2.   To facilitate the monitoring referred to in paragraph 1, the national competent authorities for medicinal products, acting through the single points of contact referred to in Article 3(6), or the platform referred to in Article 13 (the ‘ESMP’), once it is fully functional, shall report in a timely manner to the Agency on any event that is likely to lead to a public health emergency or major event, including an actual or potential shortage of a medicinal product in a given Member State. Such reporting shall be based on the reporting methods and criteria pursuant to Article 9(1), point (b).

Where a national competent authority informs the Agency of a shortage of a medicinal product as referred to in the first subparagraph, it shall provide the Agency with any information that it has received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC, if that information is not available in the ESMP.

Where the Agency receives a report of an event from a national competent authority for medicinal products, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(6), in order to evaluate the impact of the event in other Member States.

3.   Where the Agency considers that an actual or imminent major event needs to be addressed, it shall raise the issue of concern with the MSSG.

Following a positive opinion of the MSSG, the Commission may recognise the major event.

The Commission or at least one Member State may raise the issue of concern with the MSSG on its own initiative.

4.   The MSSG shall inform the Commission and the Executive Director of the Agency once the MSSG considers that the major event has been sufficiently addressed and considers that its assistance is no longer needed.

On the basis of the information referred to in the first subparagraph or on its own initiative, the Commission or the Executive Director may confirm that the major event has been sufficiently addressed and therefore that the assistance of the MSSG is no longer needed.

5.   Following the recognition of a public health emergency or the recognition of a major event in accordance with paragraph 3 of this Article, Articles 5 to 12 apply as follows:

(a)

where the public health emergency or the major event may affect the quality, safety or efficacy of medicinal products, Article 5 applies;

(b)

where the public health emergency or the major event may lead to shortages of medicinal products in more than one Member State, Articles 6 to 12 apply.

Article 5

Evaluation of information and provision of recommendations on action in relation to the quality, safety and efficacy of medicinal products related to public health emergencies and major events

1.   Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the MSSG shall evaluate information related to the public health emergency or the major event and consider the need for urgent and coordinated action with regard to the quality, safety and efficacy of the medicinal products concerned.

2.   The MSSG shall provide recommendations to the Commission and Member States on any appropriate action that it believes needs to be taken at Union level on the medicinal products concerned in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004.

3.   The MSSG may consult with the CVMP whenever the MSSG deems necessary to do so, in particular, in order to deal with public health emergencies or major events related to zoonoses or diseases that only affect animals and that have or may have a major impact on human health, or where the use of active substances for veterinary medicinal products may be useful in addressing the public health emergency or the major event.

Article 6

Lists of critical medicinal products and information to be provided

1.   Without prejudice to paragraph 2, the MSSG shall establish a list with the main therapeutic groups of medicinal products that are necessary for emergency care, surgery and intensive care, in order to inform the preparation of the critical medicines lists as referred to in paragraphs 2 and 3 to be used to respond to a public health emergency or major event. The list shall be established by 2 August 2022 and updated annually and whenever necessary.

2.   Immediately following the recognition of a major event in accordance with Article 4(3) of this Regulation, the MSSG shall consult the working party referred to in Article 3(6) of this Regulation. Immediately following that consultation, the MSSG shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers to be critical during the major event (the ‘major event critical medicines list’).

The MSSG shall update the major event critical medicines list whenever necessary until the major event has been sufficiently addressed and it has been confirmed that the assistance of the MSSG is no longer needed pursuant to Article 4(4) of this Regulation.

3.   Immediately following the recognition of a public health emergency, the MSSG shall consult the working party referred to in Article 3(6) of this Regulation. Immediately following that consultation, the MSSG shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers to be critical during the public health emergency (the ‘public health emergency critical medicines list’). The MSSG shall update the public health emergency critical medicines list whenever necessary until the termination of the recognition of the public health emergency. The public health emergency critical medicines list may be updated to take into account the results of the review process under Article 18 of this Regulation, where appropriate. In such cases, the MSSG shall liaise with the Emergency Task Force referred to in Article 15 of this Regulation (‘ETF’).

4.   For the purposes of Article 9(2), the MSSG shall adopt and make publicly available the set of information referred to in Article 9(2), points (c) and (d), that is necessary to monitor the supply of and demand for medicinal products included on the lists referred to in paragraphs 2 and 3 of this Article (the ‘critical medicines lists’) and shall inform the working party referred to in Article 3(6) of that set of information.

5.   Following the adoption of critical medicines lists in accordance with paragraphs 2 and 3, the Agency shall immediately publish those lists and any updates to those lists on its web portal as referred to in Article 26 of Regulation (EC) No 726/2004.

6.   The Agency shall establish within its web portal a publicly accessible webpage that provides information on actual shortages of medicinal products included in the critical medicines lists in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. The webpage shall provide at least the following information:

(a)

the name and common name of the medicinal product on the critical medicines lists;

(b)

the therapeutic indications for the medicinal product on the critical medicines lists;

(c)

the reason for the shortage of the medicinal product on the critical medicines lists;

(d)

the start and end dates of the shortage of the medicinal product on the critical medicines lists;

(e)

the Member States affected by the shortage of the medicinal product on the critical medicines lists;

(f)

other relevant information for healthcare professionals and patients, including information on whether alternative medicinal products are available.

The webpage referred to in the first subparagraph shall also provide references to national registries on shortages of medicinal products.

Article 7

Monitoring shortages of medicinal products on the critical medicines lists

Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the MSSG shall monitor the supply of and demand for medicinal products included on the critical medicines lists, with a view to identifying any actual or potential shortages of those medicinal products. The MSSG shall conduct such monitoring using the critical medicines lists and the information and data provided, in accordance with Articles 10 and 11, and available through the ESMP, once it is fully functional.

For the purposes of the monitoring referred to in the first paragraph of this Article, where relevant, the MSSG shall liaise with the Health Security Committee established by Article 17 of Decision No 1082/2013/EU (‘HSC’) and, in the case of a public health emergency, with any other relevant advisory committee on public health emergencies established pursuant to Union law and with the ECDC.

Article 8

Reporting and recommendations on shortages of medicinal products

1.   For the duration of a public health emergency, or following the recognition of a major event as referred to in Article 4(3) until it has been confirmed that the major event has been sufficiently addressed pursuant to Article 4(4), the MSSG shall regularly report the results of the monitoring referred to in Article 7 to the Commission and the single points of contact referred to in Article 3(6), and, in particular, shall signal any actual or potential shortages of medicinal products included on the critical medicines lists or any event that is likely to lead to a major event.

The reports referred to in the first subparagraph may also be made available to other actors in the supply chain for medicinal products, where appropriate, in accordance with competition law.

2.   Where requested by the Commission or one or more single point of contact as referred to in Article 3(6), the MSSG shall provide aggregated data and demand forecasts to support its findings and conclusions. In that regard, the MSSG shall:

(a)

use data from the ESMP, once it is fully functional;

(b)

liaise with the ECDC to obtain epidemiological data, models and development scenarios to help forecast medicinal product needs; and

(c)

liaise with the Executive Steering Group on Shortages of Medical Devices referred to in Article 21 (‘MDSSG’) where medicinal products included on the critical medicines lists are used jointly with a medical device.

The aggregated data and demand forecasts referred to in the first subparagraph may also be made available to other actors in the supply chain for medicinal products, where appropriate, in accordance with competition law, with a view to better preventing or mitigating actual or potential shortages of medicinal products.

3.   As part of the reporting referred to in paragraphs 1 and 2, the MSSG may provide recommendations on measures that the Commission, Member States, marketing authorisation holders and other entities, including representatives of healthcare professionals and of patients, could take to prevent or mitigate actual or potential shortages of medicinal products.

Member States may request the MSSG to provide recommendations on measures referred to in the first subparagraph.

For the purposes of the second subparagraph, the MSSG shall liaise, as relevant, with the HSC and, in the case of a public health emergency, with any other relevant advisory committee on public health emergencies established pursuant to Union law.

4.   The MSSG, on its own initiative or at the request of the Commission or a Member State, may provide recommendations on measures that the Commission, Member States, marketing authorisation holders, representatives of healthcare professionals and other entities could take to ensure preparedness for dealing with actual or potential shortages of medicinal products caused by public health emergencies or major events.

5.   Where requested by the Commission, the MSSG may coordinate measures taken by the national competent authorities, the marketing authorisation holders and other entities, including representatives of healthcare professionals and of patients, as relevant, to prevent or mitigate actual or potential shortages of medicinal products in the context of a public health emergency or major event.

Article 9

Working methods and provision of information on medicinal products

1.   In order to prepare for the fulfilment of the tasks referred to in Articles 4 to 8, the Agency, shall:

(a)

specify the procedures and criteria for establishing and reviewing the critical medicines lists;

(b)

specify the methods of and criteria for the monitoring, data collection and reporting provided for in Articles 4, 7 and 8, with a basic minimum data set;

(c)

develop streamlined IT monitoring and reporting systems, in coordination with the relevant national competent authorities, that facilitate interoperability with other existing IT systems and IT systems under development until the ESMP is fully functional, on the basis of data fields that are harmonised across Member States;

(d)

establish the working party referred to in Article 3(6) and ensure that each Member State is represented on that working party;

(e)

establish and maintain a list of single points of contact for marketing authorisation holders for all medicinal products authorised in the Union, through the database provided for in Article 57(1), point (l), of Regulation (EC) No 726/2004;

(f)

specify the methods for the provision of recommendations referred to in Article 5(2) and Article 8(3) and (4) and for the coordination of measures referred to in Article 8(5);

(g)

publish information covered by points (a), (b) and (f) on a dedicated webpage on its web portal.

For the purposes of the first subparagraph, point (a), Member States, marketing authorisation holders, other relevant actors in the supply chain for medicinal products and representatives of healthcare professionals, of patients and consumers, may be consulted as necessary.

2.   Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the Agency shall:

(a)

establish a list of single points of contact for the marketing authorisation holders for the medicinal products included on the critical medicines lists;

(b)

maintain the list of single points of contact referred to in point (a) for the duration of the public health emergency or major event;

(c)

request relevant information on medicinal products on the critical medicines lists from the single points of contact referred to in point (a) and set a deadline for the submission of that information, if that information is not available in the ESMP;

(d)

request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6) on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.

3.   The information referred to in paragraph 2, point (c), shall include at least:

(a)

the name of the marketing authorisation holder of the medicinal product;

(b)

the name of the medicinal product;

(c)

the identification of active manufacturing sites for finished products and active substances of the medicinal product;

(d)

the Member State in which the marketing authorisation is valid and the marketing status of the medicinal product in each Member State;

(e)

details of the actual or potential shortage of the medicinal product, such as actual or estimated start and end dates and suspected or known cause;

(f)

sales and market share data of the medicinal product;

(g)

available stocks of the medicinal product;

(h)

the forecast of supply for the medicinal product, including information on potential vulnerabilities in the supply chain, quantities already delivered and projected deliveries;

(i)

demand forecasts for the medicinal product;

(j)

details of available alternative medicinal products;

(k)

shortage prevention and mitigation plans that include, at a minimum, information on production and supply capacity and approved production sites of the finished medicinal product and of active substances, potential alternative production sites and minimum stock levels of the medicinal product.

4.   In order to supplement the shortage prevention and mitigation plans for critical medicinal products referred to in paragraph 3, point (k), the Agency and national competent authorities for medicinal products may request information from wholesale distributors and other relevant actors regarding any logistical challenges incurred in the wholesale supply chain.

Article 10

Obligations on marketing authorisation holders

1.   Marketing authorisation holders for medicinal products authorised in the Union shall provide the information for the purposes of Article 9(1), point (e), of this Regulation by 2 September 2022, in the form of an electronic submission to the database referred to in Article 57(1), point (l), of Regulation (EC) No 726/2004. Those marketing authorisation holders shall provide updates when necessary.

2.   In order to facilitate the monitoring referred to in Article 7, the Agency may request marketing authorisation holders for medicinal products included on the critical medicines lists to submit the information referred to in Article 9(2) point (c).

The marketing authorisation holders referred to in the first subparagraph of this paragraph shall submit the requested information by the deadline set by the Agency, through the single points of contact referred to in Article 9(2), point (b), using the monitoring and reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively. Those marketing authorisation holders shall provide updates where necessary.

3.   The marketing authorisation holders referred to in paragraphs 1 and 2 shall justify any failure to provide any requested information and any delays in providing requested information by the deadline set by the Agency.

4.   Where the marketing authorisation holders referred to in paragraph 2 indicate that the information that they submitted at the request of the Agency or the national competent authorities for medicinal products contains information of a commercially confidential nature, they shall identify the relevant parts of that information having such nature and explain why that information is of a commercially confidential nature.

The Agency shall assess the merits of each indication of information as being of a commercially confidential nature and protect such commercially confidential information against unjustified disclosure.

5.   Where the marketing authorisation holders referred to in paragraph 2 or other relevant actors in the supply chain for medicinal products have any information in addition to that required under paragraph 2, second subparagraph, which provides evidence of an actual or potential shortage of medicinal products, they shall immediately provide such information to the Agency.

6.   Following the reporting on the results of the monitoring referred to in Article 7 and any recommendations on preventive or mitigating measures provided in accordance with Article 8(3) and (4), the marketing authorisation holders referred to in paragraph 2 shall:

(a)

provide any comments they have to the Agency;

(b)

take into account any recommendations referred to in Article 8(3) and (4) and any guidelines referred to in Article 12, point (c);

(c)

comply with any measures taken at Union or Member State level pursuant to Articles 11 and 12;

(d)

inform the MSSG of any measures taken and report on the monitoring and results of those measures, including providing information on the resolution of the actual or potential shortage of medicinal products.

Article 11

Role of Member States in the monitoring and mitigation of shortages of medicinal products

1.   In order to facilitate the monitoring referred to in Article 7, unless the information concerned is available on the ESMP, the Agency may request a Member State to:

(a)

submit the set of information referred to in Article 6(4) including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6) and using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;

(b)

indicate the existence of any commercially confidential information and explain why that information is of a commercially confidential nature, in accordance with Article 10(4);

(c)

indicate any failure to provide requested information, and whether there are any delays in providing that information by the deadline set by the Agency in accordance with Article 10(3).

Member States shall comply with the Agency’s request by the deadline set by the Agency.

2.   For the purposes of paragraph 1, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products included on the critical medicines lists to the public shall provide that Member State with relevant information and data, including information and data on the levels of stock of those medicinal products at the request of that Member State.

3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article on volumes of sales of and volumes of prescriptions for medicinal products which provides evidence of an actual or potential shortage of a medicinal product included on the critical medicines lists, including data referred to in Article 23a, third paragraph, of Directive 2001/83/EC, they shall immediately provide such information to the MSSG through their respective single points of contact referred to in Article 3(6) of this Regulation.

4.   Following the reporting on the results of the monitoring referred to in Article 7 and any recommendations on preventive or mitigating measures provided in accordance with Article 8(3) and (4), Member States shall:

(a)

take into account any recommendations and guidelines referred to in Article 12, point (c), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);

(b)

inform the MSSG of any measures taken and report on the results of the actions referred to in point (a), including providing information on the resolution of the actual or potential shortage of medicinal products.

For the purposes of the first subparagraph, points (a) and (b), Member States that take an alternative course of action at national level shall share the reasons for doing so with the MSSG in a timely manner.

The recommendations, guidelines and actions referred to in the first subparagraph, point (a), and a summary report of the lessons learned, shall be made publicly available via the web portal referred to in Article 14.

Article 12

Role of the Commission regarding the monitoring and mitigation of shortages of medicinal products

The Commission shall take into account the information from and recommendations of the MSSG referred to in Article 8(1) and (2) and in Article 8(3) and (4), respectively, and shall:

(a)

take all necessary action within the limits of the powers conferred on the Commission, with a view to mitigating actual or potential shortages of medicinal products included on the critical medicines lists;

(b)

facilitate the coordination between marketing authorisation holders and other relevant entities to address demand surges, where necessary;

(c)

consider the need for guidelines and recommendations to be addressed to Member States, marketing authorisation holders, and other entities, including relevant entities from the supply chain for medicinal products, where relevant;

(d)

inform the MSSG of any measures taken by the Commission and report on the results of those measures;

(e)

request the MSSG to provide recommendations or coordinate measures as provided for in Article 8(3), (4) and (5);

(f)

consider the need for medical countermeasures in accordance with Decision No 1082/2013/EU and other applicable Union law;

(g)

liaise with third countries and relevant international organisations, as appropriate, to mitigate actual or potential shortages of medicinal products included on the critical medicines lists or their active substances, where those medicinal products or active substances are imported into the Union and where such actual or potential shortages have international implications, and report on any related actions as well as the results of those actions to the MSSG, where relevant.

Article 13

European shortages monitoring platform

1.   The Agency shall set up, maintain, and manage an IT platform to be known as the European shortages monitoring platform (‘ESMP’), which shall be linked to the database referred to in Article 57(1), point (l), of Regulation (EC) No 726/2004.

The ESMP shall be used to facilitate the collection of information on shortages of, supply of, and demand for medicinal products, including information on whether the medicinal product is placed or ceases to be placed on the market in a Member State.

2.   The information collected through the ESMP shall be used to monitor, prevent, and manage:

(a)

actual or potential shortages of medicinal products on the critical medicines lists during public health emergencies and major events; and

(b)

actual or potential shortages of medicinal products that are likely to lead to a public health emergency or a major event in accordance with Article 4(2).

3.   For the purposes of paragraph 2, during public health emergenciesand major events:

(a)

marketing authorisation holders shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(2), point (a), in accordance with Articles 9 and 10;

(b)

Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(1), point (d), in accordance with Articles 9 and 11.

The reporting referred to in the first subparagraph, point (b), shall include information in addition to that referred to in that point received from marketing authorisation holders and wholesale distributors, or other persons or legal entities that are authorised or entitled to supply to the public medicinal products included on the critical medicines lists, where relevant.

4.   For the purposes of paragraph 2, and as regards ensuring preparedness for public health emergencies and major events:

(a)

marketing authorisation holders shall use the ESMP to report to the Agency:

(i)

the information referred to in Article 13(4) of Regulation (EC) No 726/2004 for authorisations granted in accordance with that Regulation;

(ii)

information based on the categories set out in Article 9(3) that relate to actual or potential shortages of medicinal products that are likely to lead to a public health emergency or major event, where appropriate;

(b)

Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 9(1), point (e).

5.   The reporting referred to in paragraph 4, point (b):

(a)

shall include the information referred to in Article 23a of the Directive 2001/83/EC that was reported to national competent authorities for medicinal products for authorisations granted in accordance with that Directive;

(b)

may include additional information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public.

6.   To ensure the optimal use of the ESMP, the Agency shall:

(a)

develop the technical and functional specifications of the ESMP, including the data exchange mechanism for exchanging with the existing national systems and the format for electronic submissions, in collaboration with the MSSG;

(b)

require that data submitted to the ESMP comply with the standards developed by the International Organization for Standardization for the identification of medicinal products and be based on the domains of master data in pharmaceutical regulatory processes, namely substance, product, organisation, and referential data, where relevant;

(c)

develop standardised reporting terminology to be used by marketing authorisation holders and Member States when reporting to the ESMP, in collaboration with the MSSG;

(d)

establish relevant guidance for reporting through the ESMP, in collaboration with the MSSG;

(e)

ensure that data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without any duplication of reporting;

(f)

ensure that the Commission, the Agency, national competent authorities and the MSSG have appropriate levels of access to the information contained in the ESMP;

(g)

ensure that commercially confidential information submitted to the system is protected against unjustified disclosure;

(h)

ensure the ESMP is fully operational by 2 February 2025 and draw up a plan for the implementation of the ESMP.

Article 14

Communication regarding the MSSG

1.   The Agency shall provide information to the public and interest groups with regard to the work of the MSSG in a timely manner and shall respond to disinformation targeting the work of the MSSG as appropriate, via a dedicated webpage on its web portal and other appropriate means, in cooperation with national competent authorities.

2.   Proceedings of the MSSG shall be transparent.

The summaries of the agenda and of the minutes of the meetings of the MSSG, as well as its rules of procedure referred to in Article 3(5) and recommendations referred to in Article 8(3) and (4), shall be documented and made publicly available on a dedicated webpage on the Agency web portal.

Where the rules of procedure referred to in Article 3(5) allow members of the MSSG to have divergent opinions recorded, the MSSG shall make such divergent opinions, and the grounds on which they are based, available to national competent authorities for medicinal products at their request.

CHAPTER III

MEDICINAL PRODUCTS WITH THE POTENTIAL TO ADDRESS PUBLIC HEALTH EMERGENCIES

Article 15

Emergency Task Force

1.   The Emergency Task Force (‘ETF’) is hereby established within the Agency.

The ETF shall be convened in preparation for and during public health emergencies, either in person or remotely.

The Agency shall provide the secretariat of the ETF.

2.   During public health emergencies, the ETF shall undertake the following tasks:

(a)

in liaison with the scientific committees, working parties, and scientific advisory groups of the Agency, providing scientific advice and reviewing the available scientific data on medicinal products that have the potential to address the public health emergency, including requesting data from developers and engaging with them in preliminary discussions;

(b)

providing advice on the main aspects of clinical trial protocols, and providing advice to developers on clinical trials for medicinal products intended to treat, prevent or diagnose the disease causing the public health emergency, in accordance with Article 16 of this Regulation without prejudice to the tasks of the Member States as regards the assessment of submitted clinical trial applications to be conducted within their territories in accordance with Regulation (EU) No 536/2014;

(c)

providing scientific support to facilitate clinical trials for medicinal products intended to treat, prevent or diagnose the disease causing the public health emergency;

(d)

contributing to the work of the scientific committees, working parties and scientific advisory groups of the Agency;

(e)

in liaison with the scientific committees, working parties, and scientific advisory groups of the Agency, providing scientific recommendations with regard to the use of any medicinal product which have the potential to address public health emergencies, in accordance with Article 18;

(f)

cooperating with national competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations, on scientific and technical issues that relate to the public health emergency and to medicinal products which have the potential to address public health emergencies, as necessary.

The support referred to in the first subparagraph, point (c), shall include advice to sponsors of similar or linked planned clinical trials on the establishment of joint clinical trials and may include advice on establishing agreements to act as a sponsor or as co-sponsor in accordance with Article 2(2), point (14), and Article 72 of Regulation (EU) No 536/2014.

3.   The members of the ETF shall consist of:

(a)

chairs or vice chairs, or both, of the scientific committees of the Agency, and other representatives of those committees;

(b)

representatives of the working parties of the Agency, including representatives of the PCWP and representatives of the HCPWP;

(c)

staff members of the Agency;

(d)

representatives of the coordination group established in accordance with Article 27 of Directive 2001/83/EC;

(e)

representatives of the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) No 536/2014; and

(f)

other clinical trial experts who represent national competent authorities for medicinal products.

The members of the ETF shall be nominated by the entities they represent.

External experts may be appointed to the ETF on an ad hoc basis, as necessary, especially in the cases referred to in Article 5(3).

Representatives of other Union bodies and agencies shall be invited on an ad hoc basis, as necessary, to participate in the work of the ETF, especially in the cases referred to in Article 5(3).

The ETF shall be chaired by the representative of the Agency and co-chaired by the chair or vice-chair of the CHMP.

4.   The composition of the ETF shall be approved by the Management Board of the Agency, taking into account specific expertise relevant to the therapeutic response to the public health emergency.

The Executive Director of the Agency or the representative of the Executive Director, as well as representatives of the Commission and of the Management Board of the Agency, shall be entitled to attend all meetings of the ETF.

The composition of the ETF shall be made publicly available.

5.   The co-chairs of the ETF may invite other representatives of Member States, members of scientific committees and working parties of the Agency, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers, clinical trial sponsors, representatives of clinical trial networks, independent clinical trial experts and researchers, and representatives of healthcare professionals and of patients to attend its meetings.

6.   The ETF shall establish its rules of procedure, including rules on the adoption of recommendations.

The rules of procedure referred to in the first subparagraph shall enter into force once the ETF has received a favourable opinion from the Commission and the Management Board of the Agency.

7.   The ETF shall perform its tasks as an advisory and support body separate from, and without prejudice to, the tasks of the scientific committees of the Agency as regards the authorisation, supervision and pharmacovigilance of the medicinal products concerned and related regulatory actions to ensure the quality, safety and efficacy of those medicinal products.

The CHMP and other relevant scientific committees of the Agency shall take the ETF recommendations into consideration when adopting their opinions.

The ETF shall take account of any scientific opinion issued by the committees referred to in the second subparagraph of this paragraph in accordance with Regulation (EC) No 726/2004 and Directive 2001/83/EC.

8.   Article 63 of Regulation (EC) No 726/2004 applies to the ETF as regards transparency and the independence of its members.

9.   The Agency shall publish information regarding the medicinal products that the ETF considers to have the potential to address public health emergencies and any updates on its web portal. The Agency shall inform Member States and the HSC, as appropriate, of any such publication without undue delay and, in any case, prior to such publication.

Article 16

Advice on clinical trials

1.   During a public health emergency, the ETF shall provide advice on the main aspects of clinical trials and clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers as part of an accelerated scientific advice process, without prejudice of the responsibility of the Member State or States concerned under Regulation (EU) No 536/2014.

2.   Where a developer engages in an accelerated scientific advice process, the ETF shall provide the advice referred to in paragraph 1 free of charge at the latest 20 days after the developer submits a complete set of the requested information and data to the Agency. The advice shall be endorsed by the CHMP.

3.   The ETF shall establish procedures and guidance for requesting and submitting of the set of information and data required, including information on the Member State or States where an application for authorisation of a clinical trial is submitted or is intended to be submitted.

4.   The ETF shall involve representatives of the Member States with clinical trial expertise in the preparation of the scientific advice, in particular in cases where an application for authorisation of a clinical trial is submitted or is intended to be submitted.

5.   When authorising a clinical trial application for which the ETF has provided scientific advice, Member States shall take that advice into consideration. The scientific advice provided by the ETF shall be without prejudice to the ethical review provided for in Regulation (EU) No 536/2014.

6.   Where a developer is the recipient of the scientific advice referred to in paragraph 5 of this Article, that developer shall subsequently submit the data resulting from clinical trials to the Agency if the Agency makes a request for those data pursuant to Article 18.

7.   Without prejudice to paragraphs 1 to 6 of this Article, the scientific advice referred to in paragraph 5 of this Article shall otherwise be provided in accordance with the procedures established pursuant to Article 57 of Regulation (EC) No 726/2004.

Article 17

Public information regarding clinical trials and marketing authorisation decisions

1.   For the duration of a public health emergency, the sponsors of clinical trials conducted in the Union shall, in particular, make the following information publicly available through the EU portal and EU database established respectively by Articles 80 and 81 of Regulation (EU) No 536/2014:

(a)

the clinical trial protocol, at the start of each trial for all trials authorised under Regulation (EU) No 536/2014 that examine medicinal products which have the potential to address the public health emergency;

(b)

the summary of the results, within a timeline set by the Agency that is shorter than the timeline laid down in Article 37 of Regulation (EU) No 536/2014.

2.   Where a medicinal product of relevance to the public health emergency receives a marketing authorisation, the Agency shall publish, in particular:

(a)

the product information with details of the conditions of use at the time of the marketing authorisation;

(b)

the European Public Assessment Reports as soon as possible and, where possible, within seven days of the marketing authorisation;

(c)

the clinical data submitted to the Agency in support of the application, where possible within two months of the marketing authorisation by the Commission;

(d)

the entire risk management plan referred to in Article 1, point 28c, of Directive 2001/83/EC, and any updated versions thereof.

For the purposes of the first subparagraph, point (c), the Agency shall anonymise all personal data and redact commercially confidential information.

Article 18

Review of medicinal products and recommendations on their use

1.   Following the recognition of a public health emergency, the ETF shall undertake a review of the available scientific data on medicinal products which have the potential to be used to address the public health emergency. That review shall be updated whenever needed during the public health emergency, including where the ETF and the CHMP agree on the preparation of the assessment of a marketing authorisation application.

2.   In the preparation of the review referred to in paragraph 1, the ETF may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The ETF may also make use of health data generated outside of clinical studies, where available, taking into account the reliability of those data.

The ETF may liaise with the third country agencies for medicinal products with respect to additional information and data exchanges.

3.   Following a request from one or more Member States, or the Commission, the ETF shall provide recommendations to the CHMP for an opinion in accordance with paragraph 4 on:

(a)

the compassionate use of medicinal products falling under the scope of Directive 2001/83/EC or Regulation (EC) No 726/2004; or

(b)

the use and distribution of an unauthorised medicinal product in accordance with Article 5(2) of Directive 2001/83/EC.

4.   Following receipt of a recommendation provided pursuant to paragraph 3, the CHMP shall adopt its opinion on the conditions to be imposed on the use and distribution of the medicinal product concerned and on the patients targeted. That opinion shall be updated where necessary.

5.   Member States shall take account of the opinions referred to in paragraph 4 of this Article. Article 5(3) and (4) of Directive 2001/83/EC applies to the use of such an opinion.

6.   In the preparation of its recommendations provided pursuant to paragraphs 3, the ETF may consult the Member State concerned and request it to provide any available information or data that the Member State used for its decision to make the medicinal product available for compassionate use. Following such a request, the Member State shall provide all of the requested information and data.

Article 19

Communication regarding the ETF

The Agency shall provide information to the public and relevant interest groups with regard to the work of the ETF in a timely manner and shall respond to disinformation targeting the work of the ETF, as appropriate, via a dedicated webpage on its web portal and other appropriate means, in cooperation with national competent authorities.

The Agency shall regularly publish on its web portal the list of the members of the ETF, the rules of procedure referred to in Article 15(6) and the list of medicinal products under review, as well as the opinions adopted pursuant to Article 18(4).

Article 20

IT tools and data

In preparation for and to support the work of the ETF during public health emergencies, the Agency shall:

(a)

develop and maintain IT tools, including an interoperable IT platform, for the submission of information and data, including electronic health data generated outside of clinical studies, that facilitate interoperability with other existing IT tools and with IT tools under development, and provide adequate support to national competent authorities;

(b)

coordinate independent monitoring studies on the use, effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related to the public health emergency, using relevant data, including, where relevant, data held by public authorities;

(c)

as part of its regulatory tasks, make use of digital infrastructures or IT tools in order to facilitate rapid access to or analysis of available electronic health data generated outside of clinical studies and to facilitate the exchange of such data between Member States, the Agency and other Union bodies;

(d)

provide the ETF with access to external sources of electronic health data to which the Agency has access, including health data generated outside of clinical studies.

For the purposes of the first paragraph, point (b), coordination as regards vaccines shall be conducted in conjunction with the ECDC, in particular, through a new vaccine monitoring IT platform.

CHAPTER IV

MONITORING AND MITIGATING SHORTAGES OF CRITICAL MEDICAL DEVICES AND SUPPORT FOR EXPERT PANELS

Article 21

Executive Steering Group on Shortages of Medical Devices

1.   The Executive Steering Group on Shortages of Medical Devices (the ‘Medical Device Shortages Steering Group – MDSSG’) is hereby established within the Agency.

The MDSSG shall be responsible for fulfilling the tasks referred to in Articles 22, 23 and 24.

The MDSSG shall meet regularly and also whenever the situation requires, either in person or remotely, in preparation for or during a public health emergency.

The Agency shall provide the secretariat of the MDSSG.

2.   The members of the MDSSG shall consist of a representative of the Agency, a representative of the Commission and one representative appointed by each Member State.

The representatives of the Member States shall have expertise in the field of medical devices, as relevant. Those representatives may be the same as the representatives appointed to the Medical Devices Coordination Group established by Article 103 of Regulation (EU) 2017/745 (‘MDCG’), where appropriate.

Members of the MDSSG may be accompanied to meetings of the MDSSG by experts in specific scientific or technical fields.

The list of the members of the MDSSG shall be published on the Agency’s web portal.

A representative of the PCWP and a representative of the HCPWP may attend meetings of the MDSSG as observers.

3.   The MDSSG shall be co-chaired by the representative of the Agency and by one of the representatives of the Member States, who shall be elected by and from among the representatives of the Member States in the MDSSG.

The co-chairs of the MDSSG, on their own initiative or at the request of one or more members of the MDSSG, may invite, as observers and to provide expert advice, third parties, including representatives of medical device interest groups, such as representatives of manufacturers and notified bodies, or any other relevant actor in the supply chain for medical devices, and representatives of healthcare professionals, of patients and consumers, to attend its meetings, as necessary.

4.   The MDSSG shall establish its rules of procedure, including procedures relating to the working party referred to in paragraph 5 of this Article, and procedures for adoption of the lists referred to in Article 22, sets of information and recommendations referred to in Article 24(3) and (4).

The rules of procedure referred to in the first subparagraph shall enter into force once the MDSSG has received a favourable opinion from the Commission and the Management Board of the Agency.

5.   The MDSSG shall be supported in its work by a working party established in accordance with Article 25(1).

The working party referred to in the first subparagraph shall consist of representatives of the national competent authorities responsible for shortage monitoring and management of medical devices, who shall be the single points of contact in relation to shortages of medical devices.

Article 22

List of critical medical devices and information to be provided

1.   Immediately following the recognition of a public health emergency, the MDSSG shall consult the working party referred to in Article 21(5). Immediately following that consultation, the MDSSG shall adopt a list of categories of critical medical devices which it considers to be critical during the public health emergency (‘public health emergency critical devices list’).

To the extent possible, relevant information on critical medical devices and related manufacturers shall be gathered from Eudamed, once it is fully functional. The information shall also be gathered from importers and distributors, as appropriate. Until Eudamed is fully functional, available information may also be gathered from national databases or other available sources.

The MDSSG shall update the public health emergency critical devices list whenever necessary until the termination of the recognition of the public health emergency.

2.   For the purposes of Article 25(2), the MDSSG shall adopt and make publicly available the set of information referred to in Article 25(2), points (b) and (c), that is necessary to monitor the supply of and demand for medical devices included on the public health emergency critical devices list, and inform the working party referred to in Article 21(5) of that set of information.

3.   The Agency shall publish on a dedicated webpage on its web portal:

(a)

the public health emergency critical devices list, as well as any updates to that list; and

(b)

information on actual shortages of critical medical devices included on the public health emergency critical devices list.

Article 23

Monitoring shortages of medical devices on the public health emergency critical devices list

1.   During a public health emergency the MDSSG shall monitor the supply of and demand for medical devices included on the public health emergency critical devices list, with a view to identifying any actual or potential shortages of those medical devices. The MDSSG shall conduct such monitoring using the public health emergency critical devices list and the information and data provided in accordance with Articles 26 and 27.

For the purposes of the monitoring referred to in the first subparagraph of this paragraph, where relevant, the MDSSG shall liaise with the MDCG, the HSC and any other relevant advisory committee on public health emergencies established pursuant to Union law.

2.   For the purposes of the monitoring referred to in paragraph 1 of this Article, the MDSSG may make use of data from device registries and databases where such data is available to the Agency. In so doing, the MDSSG may take into account the data generated pursuant to Article 108 of Regulation (EU) 2017/745 and Article 101 of Regulation (EU) 2017/746.

Article 24

Reporting and recommendations on shortages of medical devices

1.   For the duration of the public health emergency, the MDSSG shall regularly report the results of the monitoring referred to in Article 23 to the Commission and the single points of contact referred to in Article 25(2), point (a), and, in particular, shall signal any actual or potential shortages of medical devices included on the public health emergency critical devices list.

2.   Where requested by the Commission, Member States or one or more single point of contact referred to in Article 25(2), point (a), the MDSSG shall provide aggregated data and demand forecasts to support its findings and conclusions.

For the purposes of the first subparagraph, the MDSSG shall liaise with the ECDC to obtain epidemiological data to help forecast medical device needs, and with the MSSG where medical devices included on the public health emergency critical devices list are used jointly with a medicinal product.

The findings and conclusions of the MDSSG referred to in the first subparagraph may be made available to other actors in the medical device sector, where appropriate, in accordance with competition law, with a view to better preventing or mitigating or actual or potential shortages.

3.   As part of the reporting referred to in paragraphs 1 and 2, the MDSSG may provide recommendations on measures that the Commission, Member States, medical device manufacturers, notified bodies and other entities could take to prevent or mitigate actual or potential shortages of medical devices.

For the purposes of the first subparagraph, the MDSSG shall liaise, where relevant, with the MDCG, with the HSC and with any other relevant advisory committee on public health emergencies established pursuant to Union law.

4.   The MDSSG, on its own initiative or at the request of the Commission, may provide recommendations on measures that the Commission, Member States, manufacturers of medical devices, notified bodies and other entities could take to ensure preparedness for dealing with actual or potential shortages of medical devices caused by public health emergencies.

5.   Where requested by the Commission, the MDSSG may coordinate measures taken by the national competent authorities for medical devices, manufacturers of medical devices, notified bodies, and other entities, as relevant, to prevent or mitigate actual or potential shortages of medical devices in the context of a public health emergency or major event.

Article 25

Working methods and provision of information on medical devices

1.   In order to prepare for the fulfilment of the tasks referred to in Articles 22, 23 and 24, the Agency shall:

(a)

specify the procedures and criteria for establishing and reviewing the public health emergency critical devices list.;

(b)

develop streamlined IT monitoring and reporting systems, in coordination with the relevant national competent authorities, that facilitate interoperability with existing IT tools and Eudamed, once it is fully functional, and provide the adequate support to national competent authorities for monitoring and reporting;

(c)

establish the working party referred to in Article 21(5) and ensure that each Member State is represented on that working party;

(d)

specify the methods for the provision of recommendations referred to in Article 24(3) and (4) and for the coordination of measures referred to in Article 24.

For the purposes of the first subparagraph, point (a), the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and consumers may be consulted as necessary.

2.   Following the recognition of a public health emergency, the Agency shall:

(a)

establish a list of single points of contact for the manufacturers of medical devices, or their authorised representatives, importers and notified bodies, for the medical devices included on the public health emergency critical devices list;

(b)

maintain the list of single points of contact referred to in point (a) for the duration of the public health emergency;

(c)

request relevant information on medical devices included on the public health emergency critical devices list from the single points of contact referred to in point (a) on the basis of the set of information adopted by the MDSSG and set a deadline for the submission of that information;

(d)

request relevant information on medical devices included on the public health emergency critical devices list from the single points of contact referred to in Article 21(5), second subparagraph, on the basis of the set of information adopted by the MDSSG in accordance with Article 22(2) and set a deadline for the submission of that information.

The Agency may use sources other than those referred to in the first subparagraph, including existing databases and databases in development, to gather information required under paragraph 3.

For the purposes of the first subparagraph, point (a), where it is considered relevant, national or Union databases, including Eudamed, once it is fully functional, or medical device associations may be used as sources of information.

3.   The information referred to in paragraph 2, point (c), shall include at least:

(a)

the name of the manufacturer of the medical device and, if applicable, the name of its authorised representative;

(b)

the information identifying the medical device and the intended purpose and where necessary, specific characteristics of the medical device;

(c)

if applicable, the name and number of the notified body and information regarding the relevant certificate or certificates;

(d)

details of the actual or potential shortage of the medical device, such as actual or estimated start and end dates and the suspected or known cause;

(e)

sales and market share data of the medical device;

(f)

available stocks of the medical device;

(g)

the forecast of supply of the medical device, including information on the potential vulnerabilities in the supply chain;

(h)

quantities already delivered and projected deliveries of the medical device;

(i)

the demand forecasts for the medical device;

(j)

shortage prevention and mitigation plans that include, at a minimum, information on production and supply capacity;

(k)

information from relevant notified bodies regarding their capacity to process applications and carry out and complete conformity assessments in relation to medical devices included in the public health emergency critical devices list, within an appropriate period of time considering the emergency;

(l)

information on the number of applications received by relevant notified bodies in relation to medical devices included in the public health emergency critical devices list and on the relevant conformity assessment procedures;

(m)

where conformity assessments are ongoing, the status of the conformity assessment by the relevant notified bodies in relation to medical devices included in the public health emergency critical devices list and possible critical issues on the final outcome of the assessment and which need to be considered in order to complete the conformity assessment process.

For the purposes of the first subparagraph, point (k), the relevant notified bodies shall communicate the date by which the assessment is expected to be completed. In that regard, notified bodies shall prioritise conformity assessments of medical devices included in the public health emergency critical devices list.

Article 26

Obligations on manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies

1.   In order to facilitate the monitoring referred to in Article 23, the Agency may request manufacturers of medical devices, or their authorised representatives, as applicable, and, if appropriate, importers and distributors, included on the public health emergency critical devices list and, where necessary, relevant notified bodies, to submit the information requested by a deadline set by the Agency.

The manufacturers of medical devices, or their authorised representatives, as applicable, and, if appropriate, importers and distributors, referred to in the first subparagraph, shall submit the requested information through the single points of contact referred to in Article 25(2), point (a), using the monitoring and reporting systems established pursuant to Article 25(1), point (b). They shall provide updates where necessary.

2.   Manufacturers of medical devices, or their authorised representatives, as applicable, notified bodies and, if appropriate, importers or distributors shall justify any failure to provide requested information and any delays in providing requested information by the deadline set by the Agency.

3.   Where manufacturers of medical devices, or their authorised representatives, notified bodies, or, if appropriate, importers or distributors indicate that the information that they submitted contains information of a commercially confidential nature, they shall identify the relevant parts of that information having such nature and explain why that information is of a commercially confidential nature.

The Agency shall assess the merits of each indication of information as being of a commercially confidential nature and protect such commercially confidential information against unjustified disclosure.

4.   Where manufacturers of medical devices, or their authorised representatives, notified bodies, or, if appropriate, importers or distributors have any information in addition to that required under paragraph 1, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the Agency.

5.   Following the reporting on the results of the monitoring referred to in Article 23 and any recommendations on preventive or mitigating measures provided in accordance with Article 24, manufacturers of medical devices, or their authorised representatives, and, if appropriate, importers and distributors referred to in paragraph 1, shall:

(a)

provide any comments they have to the Agency;

(b)

take into account any recommendations referred to in Article 24(3) and (4) and any guidelines referred to in Article 28, point (b);

(c)

comply with any measures taken at Union or Member State level pursuant to Article 27 or 28;

(d)

inform the MDSSG of any measures taken and report on the results of those measures, including providing information on the resolution of the actual or potential shortage of medical devices.

6.   Where manufacturers of medical devices referred to in paragraph 1 are established outside the Union, the information requested in accordance with this Article shall be provided by the authorised representatives, or, if appropriate, by importers or distributors.

Article 27

Role of Member States in the monitoring and mitigation of shortages of medical devices

1.   In order to facilitate the monitoring referred to in Article 23, the Agency may request a Member State to:

(a)

submit the set of information referred to in Article 22(2), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 25(2), point (a), and using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);

(b)

indicate the existence of any commercially confidential information and explain why that information is of a commercially confidential nature, in accordance with Article 26(3);

(c)

indicate any failure to provide requested information and whether there are any delays in providing that information by the deadline set by the Agency in accordance with Article 26(2).

Member States shall comply with the Agency’s request by the deadline set by the Agency.

2.   For the purposes of paragraph 1, Member States shall gather information from manufacturers of medical devices and their authorised representatives, healthcare providers, importers and distributors, as applicable, and notified bodies on medical devices included on the public health emergency critical devices list.

3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the MDSSG through their respective single point of contact referred to in Article 25(2), point (a).

4.   Following the reporting on the results of the monitoring referred to in Article 23 and any recommendations on preventive or mitigating measures provided in accordance with Article 24, Member States shall:

(a)

consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list while ensuring a high level of patient and product safety;

(b)

take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);

(c)

inform the MDSSG of any measures taken and report on the results of the actions referred to in point (b), including providing information on the resolution of the actual or potential shortage of medical devices concerned.

For the purposes of the first subparagraph, points (b) and (c), Member States that take an alternative course of action at national level shall share the reasons for doing so with the MDSSG.

The recommendations, guidelines and actions referred to in the first subparagraph, point (b), of this paragraph, and a summary report of the lessons learned shall be made publicly available via the web portal referred to in Article 29.

Article 28

Role of the Commission regarding the monitoring and mitigation of shortages of medical devices

The Commission shall take into account the information from and recommendations of the MDSSG and shall:

(a)

take all necessary action within the limits of the powers conferred on the Commission, with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while respecting the conditions set out in those Articles and seeking to ensure both patient and product safety;

(b)

consider the need for guidelines and recommendations to be addressed to Member States, manufacturers of medical devices, notified bodies, and other entities, where relevant;

(c)

request the MDSSG to provide recommendations or coordinate measures provided for in Article 24(3), (4) and (5);

(d)

consider the need for medical countermeasures in accordance with Decision No 1082/2013/EU and other applicable Union law;

(e)

liaise with third countries and relevant international organisations, as appropriate, to mitigate actual or potential shortages of medical devices included on the public health emergency critical devices list or their component parts, where those devices or parts of such devices are imported into the Union, and where such actual or potential shortages have international implications, and report on any related actions as well as the results of those actions to the MDSSG, where relevant.

Article 29

Communication regarding the MDSSG

1.   The Agency shall provide information to the public and relevant interest groups with regard to the work of the MDSSG in a timely manner and shall respond to disinformation targeting the work of the MDSSG, as appropriate, via a dedicated webpage on its web portal and other appropriate means, in cooperation with national competent authorities.

2.   Proceedings of the MDSSG shall be transparent.

The summaries of the agenda and of the minutes of the meetings of the MDSSG, as well as its rules of procedure referred to in Article 21(4) and recommendations referred to in Article 24(3) and (4), shall be documented and made publicly available on the dedicated webpage on the Agency web portal.

Where the rules of procedure referred to in Article 21(4) allow members of the MDSSG to have divergent opinions recorded, the MDSSG shall make such divergent opinions, and the grounds on which they are based, available to national competent authorities at their request.

Article 30

Support for the expert panels on medical devices

From 1 March 2022, on behalf of the Commission, the Agency shall provide the secretariat for the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745 (the ‘expert panels’) and shall provide the support necessary to ensure that those expert panels can efficiently perform the tasks set out in Article 106(9) and (10) of that Regulation.

The Agency shall:

(a)

provide administrative and technical support to the expert panels for the provision of scientific opinions, views and advice;

(b)

facilitate and manage remote and physical meetings of the expert panels;

(c)

ensure that the work of the expert panels is carried out in an independent manner in accordance with Article 106(3), second subparagraph, and Article 107 of Regulation (EU) 2017/745 and with the systems and procedures established by the Commission pursuant to that Regulation to actively manage and prevent potential conflicts of interest in accordance with Article 106(3), third subparagraph, of that Regulation;

(d)

maintain and regularly update a webpage for the expert panels and make all necessary information not already publicly available in Eudamed publicly available on that webpage in order to ensure the transparency of the activities of the expert panels, including providing the justifications of notified bodies where those bodies did not follow the advice of the expert panels provided pursuant to Article 106(9) of Regulation (EU) 2017/745;

(e)

publish the scientific opinions, views and advice of the expert panels while ensuring confidentiality in accordance with Article 106(12), second subparagraph, and Article 109 of Regulation (EU) 2017/745;

(f)

ensure that remuneration and expenses are provided to the experts in accordance with implementing acts adopted by the Commission pursuant to Article 106(1) of Regulation (EU) 2017/745;

(g)

monitor compliance with the expert panels’ common rules of procedure and available guidelines and methodologies relevant to the functioning of the expert panels;

(h)

provide annual reports to the Commission and the MDCG on the work of the expert panels, including information on the number of opinions delivered and the views and advice provided by the expert panels.

CHAPTER V

FINAL PROVISIONS

Article 31

Cooperation between the MSSG, the MDSSG, the ETF and the expert panels

1.   The Agency shall ensure that the MSSG and the MDSSG cooperate in relation to measures to address public health emergencies and major events.

2.   Members of the MSSG and MDSSG, and members of the working parties referred to in Article 3(6) and in Article 25(2), point (a), respectively, may attend one another’s meetings and working parties and, where appropriate, cooperate on monitoring exercises, reporting and the preparation of opinions.

3.   With the agreement of the respective chairs or co-chairs, joint meetings of the MSSG and the MDSSG may be held.

4.   Where relevant, the Agency shall ensure that the ETF and the expert panels cooperate in relation to preparedness and management of public health emergencies.

Article 32

Transparency and conflicts of interest

1.   The MSSG and the MDSSG shall carry out their activities in an independent, impartial and transparent manner.

2.   The members of the MSSG and of the MDSSG and, where relevant, observers, shall not have any financial or other interests in the medicinal products industry or medical devices industry which could affect their independence or impartiality.

3.   The members of the MSSG and the MDSSG and, where relevant, observers, shall make a declaration of their financial and other interests and shall update those declarations of interest annually and whenever necessary.

The declarations referred to in the first subparagraph shall be made publicly available on the Agency’s web portal.

4.   The members of the MSSG and the MDSSG and, where relevant, observers, shall disclose any other facts of which they become aware that might reasonably be expected in good faith to involve or give rise to a conflict of interest.

5.   Before each meeting, the members of the MSSG and the MDSSG and, where relevant, observers who participate in meetings of the MSSG and the MDSSG shall declare any interests which could be considered to be prejudicial to their independence or impartiality with respect to the items on the agenda.

6.   Where the Agency decides that an interest declared in accordance with paragraph 5 constitutes a conflict of interest, the member or observer concerned shall not take part in any discussions or decision making, or obtain any information, concerning the item of concern on the agenda.

7.   The declarations and the decisions of the Agency referred to in paragraphs 5 and 6, respectively, shall be recorded in the summary minutes of the meeting.

8.   The members of the MSSG and the MDSSG and, where relevant, observers, shall be subject to a requirement of professional secrecy, even after their duties have ceased.

9.   Members of the ETF shall update the annual declaration of their financial or other interests provided for in Article 63 of Regulation (EC) No 726/2004 whenever a relevant change to their declaration occurs.

Article 33

Protection against cyber attacks

The Agency shall equip itself with a high level of security controls and processes against cyber attacks, cyber espionage and other data breaches to ensure the protection of health data and the normal functioning of the Agency at all times, especially during public health emergencies or major events at Union level.

For the purposes of the first paragraph, the Agency shall actively identify and implement cybersecurity best practices adopted within Union institutions, bodies, offices and agencies for preventing, detecting, mitigating, and responding to cyber attacks.

Article 34

Confidentiality

1.   Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/2001 of the European Parliament and of the Council (19) and Directive (EU) 2019/1937 of the European Parliament and of the Council (20), and existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council (21), including intellectual property rights.

2.   Without prejudice to paragraph 1, all parties involved in the application of this Regulation shall ensure that no commercially confidential information is shared in a way which has the potential to enable undertakings to restrict or distort competition within the meaning of Article 101 TFEU.

3.   Without prejudice to paragraph 1, information exchanged on a confidential basis between national competent authorities and between national competent authorities and the Commission and the Agency shall not be disclosed without the prior agreement of the authority from which that information originates.

4.   Paragraphs 1, 2, and 3 do not affect the rights and obligations of the Commission, the Agency, Member States or other actors identified in this Regulation with regard to the exchange of information and the dissemination of warnings, nor do they affect the obligations of the persons concerned to provide information under criminal law.

5.   The Commission, the Agency, and Member States may exchange commercially confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.

Article 35

Personal data protection

1.   Transfers of personal data under this Regulation shall be subject to Regulations (EU) 2016/679 and (EU) 2018/1725, as applicable.

2.   As regards transfers of personal data to a third country, in the absence of an adequacy decision or appropriate safeguards as referred to in Article 46 of Regulation (EU) 2016/679 and Article 48 of Regulation (EU) 2018/1725 respectively, the Commission, the Agency, and Member States may carry out certain transfers of personal data to regulatory authorities of third countries with which they have put in place confidentiality arrangements where those transfers are necessary for important reasons of public interest, such as the protection of public health. Such transfers shall be made in conformity with the conditions laid down in Article 49 of Regulation (EU) 2016/679 and Article 50 of Regulation (EU) 2018/1725.

Article 36

Reporting and review

1.   By 31 December 2026, and every fourth year thereafter, the Commission shall present a report to the European Parliament and the Council on the application of this Regulation. In particular, that report shall review:

(a)

the crisis preparedness and management framework for medicinal products and medical devices, including the outcomes of periodic stress tests;

(b)

instances of non-compliance with the obligations set out in Articles 10 and 26 by marketing authorisation holders, manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies;

(c)

the remit and functioning of the ESMP.

2.   Notwithstanding paragraph 1, following a public health emergency or a major event, the Commission shall present, in a timely manner, a report to the European Parliament and the Council on the instances referred to in paragraph 1, point (b).

3.   Based on the report referred to in paragraph 1, the Commission shall, where appropriate, present a legislative proposal in order to amend this Regulation. In particular, the Commission shall consider the need for:

(a)

extending the scope of this Regulation to veterinary medicinal products and to personal protective equipment for medical use;

(b)

amending Article 2;

(c)

introducing measures to strengthen at Union or national level compliance with the obligations established in Articles 10 and 26; and

(d)

expanding the remit of the ESMP, the need for further facilitating the ESMP interoperability with national and Union IT systems, the need for national shortage monitoring platforms, and the need for meeting any additional requirements to address structural shortages of medicinal products that may be introduced in the context of a revision of Directive 2001/83/EC and Regulation (EC) No 726/2004.

Article 37

Union financing

1.   The Union shall provide the financing of the Agency’s activities in support of the work of the MSSG and the MDSSG, the ETF, the working parties referred to in Article 3(6) and in Article 25(1), point (c), and the expert panels, that involve its cooperation with the Commission and the ECDC.

The Union’s financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (22).

2.   The Agency shall remunerate the assessment activities of the rapporteurs in relation to the ETF under this Regulation, in addition to reimbursing the expenses incurred by Member States’ representatives and experts in relation to the meetings of the MSSG, the MDSSG, the ETF and the working parties referred to in Article 3(6) and in Article 21(5), in accordance with financial arrangements established by the Management Board of the Agency. Such remuneration shall be paid to the relevant national competent authorities.

3.   The Union contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall cover the tasks of the Agency provided for under this Regulation, and shall cover the full amount of remuneration paid to national competent authorities for medicinal products where fee exemptions apply in accordance with Council Regulation (EC) No 297/95 (23).

Article 38

Entry into Force and date of application

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

It shall apply from 1 March 2022.

However, with the exception of Article 30, Chapter IV shall apply from 2 February 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 25 January 2022

For the European Parliament

The President

R. METSOLA

For the Council

The President

C. BEAUNE


(1)   OJ C 286, 16.7.2021, p. 109.

(2)   OJ C 300, 27.7.2021, p. 87.

(3)  Position of the European Parliament of 20 January 2022 (not yet published in the Official Journal) and decision of the Council of 25 January 2022.

(4)  Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1).

(5)   OJ C 385, 22.9.2021, p. 83.

(6)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

(7)  Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).

(8)   OJ C 393 I, 29.9.2021, p. 3.

(9)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

(10)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

(11)  Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

(12)  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

(13)  Regulation (EU) 2021/696 of the European Parliament and of the Council of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU (OJ L 170, 12.5.2021, p. 69).

(14)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(15)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

(16)  Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1).

(17)  Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17).

(18)  Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).

(19)  Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

(20)  Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305, 26.11.2019, p. 17).

(21)  Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).

(22)  Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).

(23)  Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 35, 15.2.1995, p. 1).


II Non-legislative acts

INTERNATIONAL AGREEMENTS

31.1.2022   

EN

Official Journal of the European Union

L 20/38


COUNCIL DECISION (EU) 2022/124

of 25 January 2022

on the conclusion, on behalf of the European Union, of the Protocol to amend the Air Transport Agreement between the United States of America and the European Community and its Member States

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2), in conjunction with Article 218(6)(a) thereof,

Having regard to the proposal from the European Commission,

Having regard to the consent of the European Parliament (1),

Whereas:

(1)

In accordance with Decision 2010/465/EU of the Council and the Representatives of the Governments of the Member States of the European Union, meeting within the Council (2), the Protocol to amend the Air Transport Agreement between the United States of America and the European Community and its Member States, signed on 25 and 30 April 2007 (the ‘Protocol’), was signed on 24 June 2010, subject to its conclusion at a later date.

(2)

The Protocol has been ratified by all Member States, except for the Republic of Croatia. The Republic of Croatia is to accede to the Protocol in accordance with Article 6(2) of the 2012 Act of Accession.

(3)

The Protocol should be approved.

(4)

As Article 5 of Decision 2010/465/EU, on the provision of information by the Member States, is no longer necessary, that Article should cease to apply from the date of entry into force of this Decision,

HAS ADOPTED THIS DECISION:

Article 1

The Protocol to amend the Air Transport Agreement between the United States of America and the European Community and its Member States, signed on 25 and 30 April 2007 (the ‘Protocol’), is hereby approved on behalf of the European Union (3).

Article 2

The President of the Council shall proceed, on behalf of the Union, to the exchange of diplomatic notes provided for in Article 10 of the Protocol.

Article 3

Article 5 of Decision 2010/465/EU shall cease to apply from the date of entry into force of this Decision.

Article 4

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 25 January 2022.

For the Council

The President

C. BEAUNE


(1)  Consent of 14 December 2021 (not yet published in the Official Journal).

(2)  Decision 2010/465/EU of the Council and the Representatives of the Governments of the Member States of the European Union, meeting within the Council of 24 June 2010 on the signing and provisional application of the Protocol to Amend the Air Transport Agreement between the United States of America, of the one part, and the European Community and its Member States, of the other part (OJ L 223, 25.8.2010, p. 1).

(3)  The text of the Protocol has been published in OJ L 223, 25.8.2010, p. 3, together with the decision on signature.


REGULATIONS

31.1.2022   

EN

Official Journal of the European Union

L 20/40


COMMISSION DELEGATED REGULATION (EU) 2022/125

of 19 November 2021

amending Annexes I to V to Regulation (EU) No 691/2011 of the European Parliament and of the Council on European environmental economic accounts

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 691/2011 of the European Parliament and of the Council of 6 July 2011 on European environmental economic accounts (1), and in particular Article 3(3) thereof,

Whereas:

(1)

To carry out its tasks under the Treaties, especially those related to the environment, sustainability and climate change, the Commission requires access to full, up-to-date and reliable information. Regulation (EU) No 691/2011 establishes a common framework for European environmental economic accounts, including lists of characteristics for which data are to be compiled and transmitted, and rules on the frequency and transmission deadlines for the compilation of the accounts.

(2)

The lists of characteristics of environmental accounts are essential to ensure comparability of statistical data across Member States. They now need to be updated to align to updates in the data sources for the accounts and to keep relevance for users.

(3)

To better monitor progress towards a green, competitive and resilient circular economy (2) and progress towards the sustainable development goals relevant to the EU, additional up-to-date data concerning the links of the environment and the economy is required.

(4)

The lists of characteristics of environmental accounts are essential to ensure comparability of statistical data across Member States.

(5)

The list of air pollutants in Annex I to Regulation (EU) No 691/2011 should be updated to align to the list of greenhouse gases that are reported under the United Nations Framework Convention on Climate Change (UNFCCC), which was revised after the second commitment period of the Kyoto Protocol, as well as to the guidelines for emission inventories under the Convention on long-range transboundary air pollution (CLRTAP) and definitions of Directive (EU) 2016/2284 of the European Parliament and of the Council on the reduction of national emissions of certain atmospheric pollutants (National Emissions Ceilings Directive) (3).

(6)

To better serve climate policies, Member States should be required to provide a breakdown of taxes recorded for government revenue arising from the EU Emissions Trading System (EU ETS) and other CO2 taxes. Those taxes should therefore be included in the list of characteristics in Annex II to Regulation (EU) No 691/2011.

(7)

The information in Tables C and E of Annex III to Regulation (EU) No 691/2011 is no longer necessary to produce Union aggregates, as Eurostat has developed a new method based on other readily available data. Those tables should therefore be deleted.

(8)

To better serve thematic environmental policies for the European Green Deal, the environmental accounts protection expenditure accounts must distinguish for all sectors the environmental purposes of Protection of ambient air and climate (Classification of environmental protection activities (CEPA) 1), Wastewater management (CEPA 2), Waste management (CEPA 3), Protection and remediation of soil, groundwater and surface water (CEPA 4), Noise and vibration abatement (CEPA 5), Protection of biodiversity and landscapes (CEPA 6), Protection against radiation, R & D and other environmental protection activities (CEPA 7–9). Annex IV to Regulation (EU) No 691/2011 should therefore be updated to reflect those changes.

(9)

Information on the marketed share of the environmental goods and services sector is not sufficient to serve environmental policies. Annex V to Regulation (EU) No 691/2011 should therefore be updated to require Member States to provide information on the total size of the sector.

(10)

To make it easier for users to interpret data and to allow Member States to assure quality during data compilation, Member States should provide information on all components of national expenditure on environmental protection. This includes estimates and information on the intermediate consumption of environmental protection services. Eurostat’s experience with validating Member States’ data demonstrates that, based on the accounting relations between other mandatory reporting categories, Eurostat cannot derive the data on the intermediate consumption of environmental protection services, such as costs of waste disposal or wastewater treatment services incurred by corporations, with sufficient quality for all Member States. Annex IV to Regulation (EU) No 691/2011 should therefore be updated so that Member States compile and report data for this item, undertaking all relevant quality assurance measures.

(11)

To accurately measure the total national expenditure on environmental protection, there is a need to identify all expenditure for environmental protection services that have been incurred for the purpose of producing other environmental protection services, and thus have already been covered in the value of relevant final products. Therefore, it is essential that Member States report all intermediate consumption of environmental protection services for the production of environmental protection services, whether by specialist producers or not.

(12)

Reporting deadlines for European environmental economic accounts should be reduced, to improve the usefulness of the accounts for policy making purposes.

(13)

To reduce the reporting burden for the Member States, the required level of detail of the classification NACE should be reduced for the environmental goods and services sector accounts and for the environmental protection expenditure accounts for NACE category ‘Manufacturing’. That is a cost-effective measure which also enhances data availability to users, by reducing the number of confidentiality flags and data disclosure restrictions. Annexes IV and V to Regulation (EU) No 691/2011 should therefore be updated.

(14)

To offset the additional burden imposed by shorter reporting deadlines and updated lists of characteristics, a burden reduction should be introduced in the form of a threshold of 1 % for breakdowns by economic activity in the environmental protection expenditure account.

(15)

The first reference year for the updated data must be established.

(16)

Regulation (EU) No 691/2011 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I to V to Regulation (EU) No 691/2011 are amended in accordance with the Annex to this Regulation.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in the Member States.

Done at Brussels, 19 November 2021.

For the Commission

The President

Ursula VON DER LEYEN


(1)   OJ L 192, 22.7.2011, p. 1.

(2)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: A new Circular Economy Action Plan For a cleaner and more competitive Europe, COM(2020)98 final.

(3)  Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1).


ANNEX

Annexes I to V to Regulation (EU) No 691/2011 are amended as follows:

(1)

Annex I is amended as follows:

(a)

Section 3 is replaced by the following:

‘Section 3

LIST OF CHARACTERISTICS

Member States shall produce statistics on the emissions of the following air pollutants:

Name

Symbol

Reporting unit

Carbon dioxide without emissions from biomass

CO2

1 000 tonnes (Gg)

Carbon dioxide from biomass

Biomass CO2

1 000 tonnes (Gg)

Nitrous oxide

N2O

tonnes (Mg)

Methane

CH4

tonnes (Mg)

Perfluorocarbons

PFCs

tonnes (Mg) CO2-equivalents

Hydrofluorocarbons

HFCs

tonnes (Mg) CO2-equivalents

Sulphur hexafluoride and nitrogen trifluoride

SF6 NF3

tonnes (Mg) CO2-equivalents

Nitrogen oxides

NOX

tonnes (Mg) NO2-equivalents

Non-methane volatile organic compounds

NMVOCs

tonnes (Mg)

Carbon monoxide

CO

tonnes (Mg)

Particulate matter < 10 μm

PM10

tonnes (Mg)

Particulate matter < 2,5 μm

PM2,5

tonnes (Mg)

Sulphur oxides

SOX

tonnes (Mg) SO2-equivalents

Ammonia

NH3

tonnes (Mg)

All data shall be reported to one decimal place.’;

(b)

Section 5 is replaced by the following:

‘Section 5

REPORTING TABLES

1.

For each of the characteristics referred to in Section 3, data shall be produced by a hierarchical classification of economic activities, NACE Rev. 2 (A*64 aggregation level), fully compatible with ESA 95. In addition, data shall be produced for:

Household air emissions,

Bridging items, by which is meant reporting items which clearly reconcile the differences between the air emissions accounts reported under this Regulation and those data reported in official national air emission inventories.

2.

The hierarchical classification referred to in paragraph 1 is as follows:

Air emissions by industry – NACE Rev. 2 (A*64)

Household air emissions

Transport

Heating/cooling

Other

Bridging items

Total air emission accounts (production activities + households) for each of the characteristics referred to in Section 3

Less national residents abroad

National fishing vessels operating abroad

Land transport

Water transport

Air transport

Plus non-residents on the territory

+

Land transport

+

Water transport

+

Air transport

(+ or –)

Other adjustments and statistical discrepancies

=

Total emissions of pollutant X as reported to UNFCCC (1)/CLRTAP (2)’;

(2)

in Annex II, Sections 3 and 4 are replaced by the following:

‘Section 3

LIST OF CHARACTERISTICS

Member States shall produce statistics on environmentally related taxes according to the following characteristics:

energy taxes,

transport taxes,

pollution taxes,

resource taxes,

Member States shall also report, as a distinct characteristic, government tax revenue recorded in the European System of Accounts in relation to their participation in the EU Emissions Trading System.

Member States shall also report, as a distinct characteristic, other environmentally related taxes which have been included in total energy, transport, pollution or resource taxes and are levied on carbon content of fuels (other CO2 taxes).

All data shall be reported in million national currency.

Section 4

FIRST REFERENCE YEAR, FREQUENCY AND TRANSMISSION DEADLINES

1.

Statistics shall be compiled and transmitted on a yearly basis.

2.

Statistics shall be transmitted within 16 months of the end of the reference year. This applies from the reference year 2020.

3.

In order to meet user needs for complete and timely datasets, the Commission (Eurostat) shall produce, as soon as sufficient country data becomes available, estimates for the EU-27 totals for the main aggregates of this module. The Commission (Eurostat) shall, wherever possible, produce and publish estimates for data that have not been transmitted by Member States within the deadline specified in point 2.

4.

The first reference year is the year 2020.

5.

In each data transmission to the Commission, Member States shall provide annual data for the years n-4, n-3, n-2, n-1 and n, where n is the reference year. Member States may provide any available data for the years preceding 2016.’;

(3)

in Annex III, Sections 4 and 5 are replaced by the following:

‘Section 4

FIRST REFERENCE YEAR, FREQUENCY AND TRANSMISSION DEADLINES

1.

Statistics shall be compiled and transmitted on a yearly basis.

2.

Statistics shall be transmitted within 16 months of the end of the reference year. This applies from the reference year 2021.

3.

In order to meet user needs for complete and timely datasets, the Commission (Eurostat) shall produce, as soon as sufficient country data becomes available, estimates for the EU-27 totals for the main aggregates of this module. The Commission (Eurostat) shall, wherever possible, produce and publish estimates for data that have not been transmitted by Member States within the deadline specified in point 2.

4.

The first reference year is 2021.

5.

In each data transmission to the Commission, Member States shall provide annual data for the years n-4, n-3, n-2, n-1 and n, where n is the reference year. Member States may provide any available data for the years preceding 2017.

Section 5

REPORTING TABLES

Data, expressed in mass units, shall be produced for the characteristics listed in the following tables.

Table A – Domestic extraction

MF.1

Biomass

MF.1.1

Crops (excluding fodder crops)

MF.1.1.1

Cereals

MF.1.1.2

Roots, tubers

MF.1.1.3

Sugar crops

MF.1.1.4

Pulses

MF.1.1.5

Nuts

MF.1.1.6

Oil-bearing crops

MF.1.1.7

Vegetables

MF.1.1.8

Fruits

MF.1.1.9

Fibres

MF.1.1.A

Other crops (excluding fodder crops) n.e.c.

MF.1.2

Crop residues (used), fodder crops and grazed biomass

MF.1.2.1

Crop residues (used)

MF.1.2.1.1

Straw

MF.1.2.1.2

Other crop residues (sugar and fodder beet leaves, etc.)

MF.1.2.2

Fodder crops and grazed biomass

MF.1.2.2.1

Fodder crops (including biomass harvest from grassland)

MF.1.2.2.2

Grazed biomass

MF.1.3

Wood

MF.1.3.1

Timber (industrial roundwood)

MF.1.3.2

Wood fuel and other extraction

MF.1.4

Wild fish catch, aquatic plants and animals, hunting and gathering

MF.1.4.1

Wild fish catch

MF.1.4.2

All other aquatic animals and plants

MF.1.4.3

Hunting and gathering

MF.2

Metal ores (gross ores)

MF.2.1

Iron

MF.2.2

Non-ferrous metal

MF.2.2.1

Copper

MF.2.2.2

Nickel

MF.2.2.3

Lead

MF.2.2.4

Zinc

MF.2.2.5

Tin

MF.2.2.6

Gold, silver, platinum and other precious metals

MF.2.2.7

Bauxite and other aluminium

MF.2.2.8

Uranium and thorium

MF.2.2.9

Other non-ferrous metals

MF.3

Non-metallic minerals

MF.3.1

Marble, granite, sandstone, porphyry, basalt, other ornamental or building stone (excluding slate)

MF.3.2

Chalk and dolomite

MF.3.3

Slate

MF.3.4

Chemical and fertiliser minerals

MF.3.5

Salt

MF.3.6

Limestone and gypsum

MF.3.7

Clays and kaolin

MF.3.8

Sand and gravel

MF.3.9

Other non-metallic minerals n.e.c.

MF.3.A

Excavated earthen materials (including soil), only if used (optional reporting)

MF.4

Fossil energy materials/carriers

MF.4.1

Coal and other solid energy materials/carriers

MF.4.1.1

Lignite (brown coal)

MF.4.1.2

Hard coal

MF.4.1.3

Oil shale and tar sands

MF.4.1.4

Peat

MF.4.2

Liquid and gaseous energy materials/carriers

MF.4.2.1

Crude oil, condensate and natural gas liquids (NGL)

MF.4.2.2

Natural gas

Tables B (Imports – Total trade) and D (Exports – Total trade)

MF.1

Biomass

MF.1.1

Crops (excluding fodder crops)

MF.1.1.1

Cereals

MF.1.1.2

Roots, tubers

MF.1.1.3

Sugar crops

MF.1.1.4

Pulses

MF.1.1.5

Nuts

MF.1.1.6

Oil-bearing crops

MF.1.1.7

Vegetables

MF.1.1.8

Fruits

MF.1.1.9

Fibres

MF.1.1.A

Other crops (excluding fodder crops) n.e.c.

MF.1.2

Crop residues (used), fodder crops and grazed biomass

MF.1.2.1

Crop residues (used)

MF.1.2.1.1

Straw

MF.1.2.1.2

Other crop residues (sugar and fodder beet leaves, etc.)

MF.1.2.2

Fodder crops and grazed biomass

MF.1.2.2.1

Fodder crops (including biomass harvest from grassland)

MF.1.3

Wood

MF.1.3.1

Timber (industrial roundwood)

MF.1.3.2

Wood fuel and other extraction

MF.1.4

Wild fish catch, aquatic plants and animals, hunting and gathering

MF.1.4.1

Wild fish catch

MF.1.4.2

All other aquatic animals and plants

MF.1.5

Live animals and animal products (excluding wild fish, aquatic plants and animals, hunted and gathered animals)

MF.1.5.1

Live animals (excluding wild fish, aquatic plants and animals, hunted and gathered animals)

MF.1.5.2

Meat and meat preparations

MF.1.5.3

Dairy products, birds, eggs and honey

MF.1.5.4

Other products from animals (animal fibres, skins, furs, leather, etc.)

MF.1.6

Products mainly from biomass

MF.2

Metal ores (gross ores)

MF.2.1

Iron

MF.2.2

Non-ferrous metal

MF.2.2.1

Copper

MF.2.2.2

Nickel

MF.2.2.3

Lead

MF.2.2.4

Zinc

MF.2.2.5

Tin

MF.2.2.6

Gold, silver, platinum and other precious metals

MF.2.2.7

Bauxite and other aluminium

MF.2.2.8

Uranium and thorium

MF.2.2.9

Other non-ferrous metals

MF.2.3

Products mainly from metals

MF.3

Non-metallic minerals

MF.3.1

Marble, granite, sandstone, porphyry, basalt, other ornamental or building stone (excluding slate)

MF.3.2

Chalk and dolomite

MF.3.3

Slate

MF.3.4

Chemical and fertiliser minerals

MF.3.5

Salt

MF.3.6

Limestone and gypsum

MF.3.7

Clays and kaolin

MF.3.8

Sand and gravel

MF.3.9

Other non-metallic minerals n.e.c.

MF.3.B

Products mainly from non-metallic minerals

MF.4

Fossil energy materials/carriers

MF.4.1

Coal and other solid energy materials/carriers

MF.4.1.1

Lignite (brown coal)

MF.4.1.2

Hard coal

MF.4.1.3

Oil shale and tar sands

MF.4.1.4

Peat

MF.4.2

Liquid and gaseous energy materials/carriers

MF.4.2.1

Crude oil, condensate and natural gas liquids (NGL)

MF.4.2.2

Natural gas

MF.4.2.3

Fuels bunkered (Imports: by resident units abroad; Exports: by non-resident units domestically)

MF.4.2.3.1

Fuel for land transport

MF.4.2.3.2

Fuel for water transport

MF.4.2.3.3

Fuel for air transport

MF.4.3

Products mainly from fossil energy products

MF.5

Other products

MF.6

Waste for final treatment and disposal’;

(4)

in Annex IV, Sections 3, 4 and 5 are replaced by the following:

‘Section 3

LIST OF CHARACTERISTICS

Member States shall produce environmental protection expenditure accounts according to the following characteristics which are defined in accordance with ESA:

output of environmental protection services. Market output, non-market output and output of ancillary activities are distinguished,

intermediate consumption of environmental protection services

intermediate consumption of environmental protection services for production of environmental protection services,

imports and exports of environmental protection services,

valued added tax (VAT) and other taxes less subsidies on products on environmental protection services,

gross fixed capital formation and acquisitions less disposals of non-financial non-produced assets for the production of environmental protection services,

final consumption of environmental protection services,

environmental protection transfers (received/paid).

All data shall be reported in million national currency.

Section 4

FIRST REFERENCE YEAR, FREQUENCY AND TRANSMISSION DEADLINES

1.

Statistics shall be compiled and transmitted on a yearly basis.

2.

Statistics shall be transmitted within 24 months of the end of the reference year. This applies from the reference year 2020.

3.

In order to meet user needs for complete and timely datasets, the Commission (Eurostat) shall produce, as soon as sufficient country data becomes available, estimates for the EU-28 totals for the main aggregates of this module. The Commission (Eurostat) shall, wherever possible, produce and publish estimates for data that have not been transmitted by Member States within the deadline specified in point 2.

4.

The first reference year is 2020.

5.

In each data transmission to the Commission, Member States shall provide annual data for the years n – 2, n – 1 and n, where n is the reference year. Member States may provide any available data for the years preceding 2018.

Section 5

REPORTING TABLES

1.

For the characteristics referred to in Section 3, data shall be reported in a breakdown by:

type of producers/consumers of environmental protection services as defined in Section 2,

classes of the classification of environmental protection activities (CEPA) grouped as follows:

CEPA 1

CEPA 2

CEPA 3

CEPA 4

CEPA 5

CEPA 6

Sum of CEPA 7, CEPA 8 and CEPA 9

The following NACE breakdowns for the ancillary production of environmental protection services: NACE Rev. 2 B, C, D, Division 36. Data for section C shall be presented as follows:

NACE C10-C12 – Manufacture of food products; beverages and tobacco products

NACE C17 – Manufacture of paper and paper products

NACE C19-20 – Manufacture of coke, chemicals and refined petroleum and chemical products

NACE C 21-23 – Manufacture of pharmaceuticals, rubber, plastic and other non-metallic products

NACE C 24 – Manufacture of basic metals

NACE C 25-30 – Manufacture of fabricated metal products, including machinery and equipment

NACE C13-16, 18, 31-33 – other manufacturing activities

Member States where the total amount of the turnover or the number of persons employed in one or more of these NACE breakdowns represents less than 1 % of the Union total do not need to provide data for those NACE breakdowns.

2.

The CEPA classes referred to in point 1 are as follows:

 

CEPA 1 – Protection of ambient air and climate

 

CEPA 2 – Wastewater management

 

CEPA 3 – Waste management

 

CEPA 4 – Protection and remediation of soil, groundwater and surface water

 

CEPA 5 – Noise and vibration abatement

 

CEPA 6 – Protection of biodiversity and landscapes

 

CEPA 7 – Protection against radiation

 

CEPA 8 – Environmental research and development

 

CEPA 9 – Other environmental protection activities.’;

(5)

in Annex V, Sections 3, 4 and 5 are replaced by the following:

‘Section 3

LIST OF CHARACTERISTICS

Member States shall produce statistics on the environmental goods and services sector according to the following characteristics:

output of the total environmental goods and services sector and of market activities,

exports of the total environmental goods and services sector,

value added of the total environmental goods and services sector and of market activities,

employment in the total environmental goods and services sector and of market activities.

All data shall be reported in million national currency, except for the characteristic “employment” for which the reporting unit shall be “full time equivalent”.

Section 4

FIRST REFERENCE YEAR, FREQUENCY AND TRANSMISSION DEADLINES

1.

Statistics shall be compiled and transmitted on a yearly basis.

2.

Statistics shall be transmitted within 22 months of the end of the reference year. This applies from the reference year 2020.

3.

In order to meet user needs for complete and timely datasets, the Commission (Eurostat) shall produce, as soon as sufficient country data becomes available, estimates for the EU-28 totals for the main aggregates of this module. The Commission (Eurostat) shall, wherever possible, produce and publish estimates for data that have not been transmitted by Member States within the deadline specified in point 2.

4.

The first reference year is 2020.

5.

In each data transmission to the Commission, Member States shall provide annual data for the years n – 2, n – 1 and n, where n is the reference year. Member States may provide any available data for the years preceding 2018.

Section 5

REPORTING TABLES

1.

For the characteristics referred to in Section 3, data shall be reported cross-classified by:

classification of economic activities, NACE Rev. 2 grouped as follows:

NACE A

NACE B

NACE C

NACE D

NACE E

NACE F

NACE J

NACE M

NACE O

NACE P

Sum of NACE G+NACE H+NACE I+NACE K+NACE L+ NACE N+NACE Q+NACE R+ NACE S + NACE T + NACE U

classes of the classification of environmental protection activities (CEPA) and the classification of resource management activities (CReMA) grouped as follows:

CEPA 1

CEPA 2

CEPA 3

CEPA 4

CEPA 5

CEPA 6

Sum of CEPA 7, CEPA 8 and CEPA 9

CReMA 10

CReMA 11

CReMA 13

CReMA 13A

CReMA 13B

CReMA 13C

CReMA 14

Sum of CReMA 12, CReMA 15 and CReMA 16

2.

The CEPA classes referred to in point 1 are as set out in Annex IV. The CReMA classes referred to in point 1 are as follows:

 

CReMA 10 – Management of water

 

CReMA 11 – Management of forest resources

 

CReMA 12 – Management of wild flora and fauna

 

CReMA 13 – Management of energy resources:

 

CReMA 13A – Production of energy from renewable resources

 

CReMA 13B – Heat/energy saving and management

 

CReMA 13C – Minimisation of the use of fossil energy as raw materials

 

CReMA 14 – Management of minerals

 

CReMA 15 – Research and development activities for resource management

 

CReMA 16 – Other resource management activities.’.


(1)  United Nations Framework Convention on Climate Change.

(2)  Convention on Long-Range Transboundary Air Pollution.


31.1.2022   

EN

Official Journal of the European Union

L 20/52


COMMISSION DELEGATED REGULATION (EU) 2022/126

of 7 December 2021

supplementing Regulation (EU) 2021/2115 of the European Parliament and of the Council with additional requirements for certain types of intervention specified by Member States in their CAP Strategic Plans for the period 2023 to 2027 under that Regulation as well as rules on the ratio for the good agricultural and environmental condition (GAEC) standard 1

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021 establishing rules on support for strategic plans to be drawn up by Member States under the common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulation (EU) No 1305/2013 of the European Parliament and of the Council and Regulation (EU) No 1307/2013 of the European Parliament and of the Council (1), and in particular Articles 4(8), 13(3), 37(5), 38(5) and 39(3) and Articles 45, points (a) to (i), 56, points (a), (b) and (c), and 84, points (a) and (b), thereof,

Whereas:

(1)

Regulation (EU) 2021/2115 lays down a new legal framework for the common agricultural policy (CAP) to improve its delivery on the Union’s objectives set out in the Treaty on the Functioning of the European Union. That Regulation further specifies these Union objectives to be achieved by the CAP and defines the types of intervention as well as the common Union requirements applicable to Member States, while leaving flexibility for Member States in the design of the interventions to be provided in their CAP Strategic Plans.

(2)

In order to ensure the common nature of the CAP and the internal market, Regulation (EU) 2021/2115 empowers the Commission to adopt additional requirements for the design of the interventions to be specified in the CAP Strategic Plans, in the area of direct payments, of certain agricultural sectors referred to in Regulation (EU) No 1308/2013 of the European Parliament and of the Council (2) and in the area of rural development as well as common rules for these areas as regards the ratio for the good agricultural and environmental condition (GAEC) standard 1. All those additional requirements have to be considered by Member States when designing their CAP Strategic Plans which cover all areas concerned and should therefore be all laid down in this Regulation.

(3)

As regards the interventions to be specified by Member States in their CAP Strategic Plans, in the area of direct payments, additional requirements for the interventions on hemp and cotton should be laid down. The granting of payments should be made conditional upon the use of certified seeds of certain hemp varieties.

(4)

In addition, the procedure for the determination of hemp varieties and the verification of their tetrahydrocannabinol content (THC content) referred to in Article 4(4) second subparagraph, of Regulation (EU) 2021/2115 should be laid down. The verification of the THC content is necessary to protect the financial interests of the Union, but is also strategic to preserve public health, and to ensure coherence with other legislative frameworks, namely criminal law in the field of illicit drug trafficking and the commitments under international obligations such as the Single Convention on Narcotic Drugs (3). It is therefore appropriate to lay down rules harmonising the methods and the procedures used by the Member States for the verification of hemp varieties and for the quantitative determination of the THC content in hemp, in order to ensure comparable results.

(5)

It is necessary to provide for a time period during which hemp grown for fibre may not be harvested after flowering, in order to enable the effective and reliable determination of the THC content in hemp.

(6)

In the interest of clarity and legal certainty, when a variety exceeds the THC content referred to in Article 4(4), second subparagraph, of Regulation (EU) 2021/2115 for 2 consecutive years, the Member States should take the necessary measures to inform timely the operators that the cultivation of that variety would not give the right to direct payments.

(7)

The rules for the verification of hemp varieties and the quantitative determination of the THC content should take into account that hemp may be cultivated either as main crop or as catch crop. In that context, it is appropriate to provide a definition of hemp cultivated as catch crop.

(8)

Title III, Chapter II, Section 3, Subsection 2, of Regulation (EU) 2021/2115 provides for a crop-specific payment for cotton. It is appropriate to lay down the rules and conditions for the authorisation of agricultural land and varieties for the purposes of that payment. Furthermore, additional conditions should be laid down to ensure a minimum activity in line with the support’s objective.

(9)

The Member States referred to in Article 36 of Regulation (EU) 2021/2115 should approve interbranch cotton producing organisations on the basis of objective criteria relating to their scale and internal organisation. The scale of an interbranch organisation should be fixed, taking into account the requirement for the ginner belonging to the organisation to be able to take delivery of sufficient quantities of unginned cotton.

(10)

Specific obligations with regard to the farmers, as members of interbranch organisations, should be laid down. These aim at facilitating the administration and control of farmers’ membership, as well as enhancing the organisations’ potential efficiency gain arising from the number and dedication of their members.

(11)

Additional requirements as regards investments, agri-environment-climate interventions, coaching, promotion, communication and marketing, mutual funds, replanting of orchards, olive groves or vineyards following mandatory grubbing-up, green harvesting and non-harvesting, harvest and production insurance, market withdrawals for destinations other than free distribution and collective storage should be set out for the interventions to be specified by Member States, in their CAP Strategic Plans, in the fruit and vegetables sector, in the apiculture sector, in the wine sector, in the hops sector, in the olive oil and table olives sectors as well as other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115. In addition, provisions regarding forms of support and types of expenditure, including the use of flat-rates and scales of unit costs or lump sums, as well as administrative and personnel costs should be laid down. For reasons of sound financial management and legal certainty, a list of expenditure that may not be covered by the CAP Strategic Plans and a non-exhaustive list of expenditure that may be covered in the fruit and vegetables, the apiculture, the wine, the hops, the olive oil and table olives sectors as well as other sectors should be drawn up.

(12)

Furthermore, specific rules regarding certain sectoral types of intervention, namely, in the fruit and vegetables, the apiculture, the wine, the hops and the livestock sectors should be laid down in order to take into account certain specificities of those sectors.

(13)

Regarding sectoral types of intervention managed by producer organisations, associations of producer organisations, transnational producer organisations, transnational associations of producer organisations, or producer groups through operational programmes, in the fruit and vegetables, olive oil and table olives and other sectors, specific rules should be laid down as regards products coverage and market withdrawals for free distribution, namely transport and conditioning costs, taking into account the potential importance of that intervention. In particular, maximum levels of support for market withdrawals should be fixed in order to ensure that withdrawals do not become a permanent alternative outlet for products compared to placing them on the market. In all cases, for similar reasons, it is appropriate to set a quantitative limit of withdrawals per product per producer organisation. In addition, specific rules should be laid down regarding the destinations for withdrawn products, the conditions for the recipients of withdrawn products and relevant standards to be complied with by withdrawn products.

(14)

To facilitate the use of sectoral interventions through operational programmes, the method of calculation of the value of marketed production of producer organisations should be established, including the use of a flat rate for the purpose of calculating the value of fruit and vegetables intended for processing. The method of calculation of the value of marketed production should attenuate yearly fluctuations or insufficient data for newly recognised organisations or groups. To prevent misuse of the scheme, producer organisations should not be permitted in general to change the methodology for fixing the reference period within the duration of a programme.

(15)

To ensure a good functioning of the types of intervention in the fruit and vegetables sector, it would be appropriate to lay down specific objectives regarding agri-environment-climate interventions.

(16)

Rules should be laid down concerning the national financial assistance that Member States may grant in regions where the degree of organisation of producers of fruit and vegetables is particularly low, including rules on how the degree of organisation is calculated and a low degree of organisation is confirmed.

(17)

To ensure a good functioning of the types of intervention in apiculture sector, rules regarding beehives should be laid down.

(18)

To ensure a good functioning of the types of intervention in the wine sector, it is appropriate to draw up a non-exhaustive list of operators which may be the beneficiaries of the support for the different types of intervention. It is also necessary to provide for some specific eligibility requirements as regards beneficiaries of the types of intervention ‘restructuring and conversion of vineyards’, ‘green harvesting’ and ‘harvest insurance’, bodies governed by public law and private companies. It is further appropriate to exclude from Union support producers farming unlawful plantings or unauthorised planted areas.

(19)

To ensure that Union funds are spent properly, it is necessary to lay down rules on expenditure for the ‘replanting of vineyards for health or phytosanitary reasons’ in the wine sector. In particular, it is appropriate to provide for such expenditure not to exceed a certain amount of the total annual expenditure on restructuring and conversion of vineyards paid by the Member State concerned in any given financial year. It should be also clarified that the costs for grubbing-up and for compensating the income foregone should not constitute eligible expenditure under this intervention, which only aims at supporting the costs for replanting after mandatory phytosanitary measures.

(20)

For the purposes of the ‘restructuring and conversion of vineyards’ and ‘green harvesting’ interventions, it is appropriate to lay down rules on the measurement of areas, in particular to define what corresponds to the area planted with vines, which is of particular importance where support is paid on the basis of area-based standard scales of unit costs.

(21)

To ensure a good functioning of the types of intervention in the hops sector, it is appropriate to lay down rules on the Union financial assistance calculation.

(22)

To ensure a good functioning of the types of intervention in the livestock sector, it is appropriate to lay down rules on the restocking with livestock following compulsory slaughter or because of losses resulting from natural disasters.

(23)

The conditions applicable to commitments to preserve on farm endangered breeds and plant varieties under threat of genetic erosion, and to activities for the conservation, the sustainable use, and the development of genetic resources in agriculture and in forestry, should contribute to the specific environmental and climate-related objectives of the CAP set out in Article 6(1), points (d), (e) and (f), of Regulation (EU) 2021/2115. In particular, they should address the need to ensure the protection, the conservation, and the promotion of genetic diversity.

(24)

Levels of animal welfare should be improved by providing support to farmers who undertake to adopt higher standards of animal husbandry, which go beyond the relevant mandatory requirements. Where animal welfare commitments are made to provide for upgraded standards of production methods, the areas should be defined. In doing so, it should be avoided that those animal welfare commitments overlap with standard farming practices, in particular vaccination to prevent pathologies.

(25)

National recognised quality schemes can provide consumers with assurances on the quality and characteristics of the product or the production process. Criteria about the specificity of the final product, the access to the scheme, the verification of binding product specifications, the transparency of the scheme and the traceability of the products should be laid down with a view to optimising their support under rural development interventions. Given the special characteristics of cotton as a farm product, national quality schemes for cotton should also be covered.

(26)

With a view to supporting voluntary agricultural product certification schemes recognised by the Member States under rural development interventions and being aligned to sectoral interventions, certain objective criteria should be laid down.

(27)

With a view to ensure a level playing field as regards the ratio for the good agricultural and environmental condition (GAEC) standard 1 as referred to in Annex III to Regulation (EU) 2021/2115, rules should be provided for the method to determine both the reference ratio and the annual ratio of permanent grassland, as well as the level at which these can be established.

(28)

With a view to ensuring the protection of the share of permanent grassland, it is also appropriate to lay down that Member States should take steps to ensure reconversion of areas in the case where the share of permanent grassland has decreased below the 5 % limit. However, derogations should be provided for the cases where the absolute area of permanent grassland remain relatively stable or where the decrease of the share below the threshold is the result of conversions of area for environmentally- and climate-friendly objectives, in particular afforestation and rewetting of areas.

(29)

Since Member States need to take the rules laid down in this Regulation into account when developing their CAP Strategic Plans, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

TITLE I

SUBJECT MATTER

Article 1

Subject matter

This Regulation supplements Regulation (EU) 2021/2115 with:

(a)

additional requirements for certain types of intervention, specified by Member States in their CAP Strategic Plans covering the period from 1 January 2023 to 31 December 2027:

(i)

in the form of direct payments for the cultivation of hemp and cotton;

(ii)

in the agricultural sectors referred to in Article 42 of Regulation (EU) 2021/2115;

(iii)

for genetic resources and animal welfare in the framework of environmental, climate and other management commitments and for quality schemes in the area of rural development;

(b)

rules on the ratio for the good agricultural and environmental condition (GAEC) standard 1.

TITLE II

ADDITIONAL REQUIREMENTS FOR CERTAIN TYPES OF INTERVENTION IN THE FORM OF DIRECT PAYMENTS

CHAPTER I

Hemp

Article 2

Additional eligibility requirements

When providing, in their CAP Strategic Plans, the definitions foreseen in Article 4(1) of Regulation (EU) 2021/2115, Member States shall make the granting of payments for the production of hemp conditional upon the use of seeds of hemp varieties which fulfil the following requirements:

(a)

they are listed in the Common Catalogue of Varieties of Agricultural Plant Species on 15 March of the year in respect of which the payment is granted and published in accordance with Article 17 of Council Directive 2002/53/EC (4);

(b)

their Δ9-tetrahydrocannabinol content (hereinafter referred to as ‘THC content’) did not exceed for 2 consecutive years the limit as laid down in Article 4(4), second subparagraph, of Regulation (EU) 2021/2115;

(c)

they are certified in accordance with Council Directive 2002/57/EC (5) or in accordance with Article 10 of Commission Directive 2008/62/EC (6) in the case of conservation varieties.

Article 3

Verification of hemp varieties and quantitative determination of THC content

1.   Member States shall establish a verification system for determining the THC content in hemp varieties which allows them to apply the method for the verification of hemp varieties and quantitative determination of the THC content in hemp varieties set out in Annex I.

2.   The competent authority of the Member State shall keep the records related to findings on the THC content. Such records shall comprise, for each variety, at least the results in terms of THC content from each sample expressed in percentage to two decimal places, the procedure used, the number of tests carried out, an indication of the point at which the sample was taken and measures taken at national level.

3.   If an average of all the samples of a given variety exceeds the THC content laid down in Article 4(4), second subparagraph, of Regulation (EU) 2021/2115, Member States shall use procedure B described in Annex I to this Regulation for the variety concerned in the course of the following claim year. That procedure shall be used in the course of the next claim years unless all the analytical results for the given variety are below the THC content laid down in Article 4(4), second subparagraph, of Regulation (EU) 2021/2115.

4.   If for the second year the average of all the samples of a given variety exceeds the THC content laid down in Article 4(4), second subparagraph, of Regulation (EU) 2021/2115, the Member State shall notify the Commission of the name of the variety concerned by 15 January of the following claim year at the latest. Starting from that claim year, the cultivation of the given variety shall not give a right to direct payments in the Member State concerned.

5.   Member States shall ensure that the hemp producers are timely informed about the names of hemp varieties which are ineligible for direct payment in accordance with Article 4(4), second subparagraph, of Regulation (EU) 2021/2115 following a notification pursuant to paragraph 4 of this Article by making the information notified public not later than the date for submitting the single application.

Article 4

Catch crop

For the purposes of this Chapter, ‘hemp cultivated as catch crop’ means crop of hemp sown after 30 June of a given year.

Article 5

Cultivation requirements

Crops of hemp shall continue to be cultivated under normal growing conditions in accordance with local practice for at least 10 days from the date of the end of flowering so that the checks necessary for the application of this Article can be made.

Hemp cultivated as catch crop shall continue to be cultivated under normal growing conditions in accordance with local practice at least until the end of the vegetation period.

Member States may authorise hemp to be harvested before the end of the 10-day period after the end of flowering, provided that the harvest takes place after flowering has begun and that the inspectors indicate which representative parts of each plot concerned shall continue to be cultivated for at least 10 days following the end of flowering for inspection purposes, in accordance with the method set out in Annex I.

CHAPTER II

Cotton

Article 6

Authorisation of agricultural land for cotton production

The Member States referred to in Article 36 of Regulation (EU) 2021/2115 shall establish, in their CAP Strategic Plans, objective criteria for the authorisation of agricultural land pursuant to Article 37(3) of that Regulation.

Those criteria shall be based on one or more of the following:

(a)

the agricultural economy of those regions where cotton is a major crop;

(b)

the soil and climate in the areas in question;

(c)

the management of irrigation water;

(d)

rotation systems and cultivation methods likely to respect the environment.

Article 7

Authorisation of varieties for sowing

The Member States referred to in Article 36 of Regulation (EU) 2021/2115 shall set out, in their CAP Strategy Plans, which varieties, registered in the Common Catalogue of Varieties of Agricultural Plant Species provided for in Directive 2002/53/EC and adapted to their market needs, are authorised for sowing.

Article 8

Additional conditions for receiving the crop-specific payment for cotton

For the crop-specific payments for cotton referred to in Article 37(1) of Regulation (EU) 2021/2115, the Member States referred to in Article 36 of that Regulation shall set out, in their CAP Strategy Plans, a minimum plant density on the sown area fixed on the basis of the soil and weather conditions and, where appropriate, specific regional characteristics.

Article 9

Approval of interbranch organisations

1.   The approval of an interbranch organisation in the sense of Article 39(1) of Regulation (EU) 2021/2115 shall be granted by the Member State where the ginners are established and for a period of one year starting in due time before the sowing season of that year, provided that the organisation fulfills the following criteria:

(a)

it covers a total area of at least 4 000 ha that meet authorisation criteria as referred to in Article 6 of this Regulation;

(b)

it has adopted internal operating rules, in particular on membership conditions and fees, in accordance with Union and national rules.

2.   Where it is found that an approved interbranch organisation no longer fulfils the criteria for approval provided for in paragraph 1, the Member State that granted the approval shall withdraw the approval, unless the non-compliance is remedied within a deadline to be fixed by the Member State in the withdrawal decision. The competent authority of the responsible Member State shall notify the interbranch organisation of its intention to withdraw an approval, together with the reasons for the withdrawal, in advance. It shall grant the interbranch organisation the opportunity to submit its observations within a period specified in the notification of the planned withdrawal.

Farmers who are members of an approved interbranch organisation whose approval is withdrawn in accordance with the first subparagraph of this paragraph shall not be eligible to receive the increase of the crop-specific payment for cotton pursuant to Article 40(2) of Regulation (EU) 2021/2115.

Article 10

Obligations for farmers producing cotton

1.   A farmer shall not be a member of more than one approved interbranch organisation referred to in Article 39(1) of Regulation (EU) 2021/2115.

2.   A farmer who is a member of an approved interbranch organisation shall deliver cotton only to a ginner belonging to that same organisation.

3.   The participation of farmers in an approved interbranch organisation shall be the result of voluntary membership.

TITLE III

ADDITIONAL REQUIREMENTS FOR CERTAIN TYPES OF INTERVENTION IN THE SECTORS REFERRED TO IN ARTICLE 42 OF REGULATION (EU) 2021/2115

CHAPTER I

Common rules applicable to interventions in the fruit and vegetables sector, in the apiculture sector, in the wine sector, in the hops sector, in the olive oil and table olives sector and in the other sectors referred to in Title III, Chapter III, of Regulation (EU) 2021/2115

Section 1

Common rules on investments, agri-environment-climate related types of intervention, coaching, promotion and communication, mutual funds, replanting, green harvesting and non-harvesting, harvest insurance, market withdrawals and collective storage

Article 11

Investments in tangible and intangible assets

1.   When Member States include, in their CAP Strategic Plans, investments in tangible and intangible assets as foreseen in the fruit and vegetables sector, in the apiculture sector, in the wine sector, in the hops sector, in the olive oil and table olives sector in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, they shall provide for the following:

(a)

the tangible and the intangible assets acquired are used according to the nature, objectives and intended use by the beneficiary, as described in the related interventions of the CAP Strategic Plan and, where relevant, in the approved operational programme;

(b)

without prejudice to paragraph 10, the tangible and the intangible assets acquired remain both in the property and possession of the beneficiary until the end of the fiscal depreciation period or during a period of at least 5 years to be set by Member States taking into account the nature of the assets. Each of these periods shall be calculated as of the date of the asset acquisition or as of the date on which the asset is put at the disposal of the beneficiary.

However, Member States may provide for a shorter period during which the asset shall remain in the property and possession of the beneficiary, but this period shall not be less than 3 years for the purpose of maintenance of investments or jobs created by micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC (7).

The investments in tangible assets referred to in the first subparagraph shall be made at the premises of the beneficiary or, where relevant, at the premises of its producer members or of its subsidiaries complying with the 90 % requirement referred to in Article 31(7) of this Regulation. However, in the apiculture sector, Member States may also provide in their CAP Strategic Plans, for investments in tangible assets made outside the premises of the beneficiary.

Where the investment is made on ground rented under particular national property rules, the requirement of being in the property of the beneficiary may not apply provided the asset have been in the possession of the beneficiary at least for the period required in paragraph (b) of first subparagraph.

2.   Member States may provide in their CAP Strategic Plans that support for investments in tangible and intangible assets, including those under leasing contracts, may be financed in one amount or in instalments that were approved, where relevant, in the operational programme or as so specified by Member States in the relevant interventions.

If the period referred to in paragraph 1, first subparagraph, point (b), for a given investment exceeds the length of the operational programme, Member States shall ensure that it may be carried over to a subsequent operational programme.

When Member States provide, in their CAP Strategic Plans, support for investments in tangible and intangible assets, pursuing the agro-environmental-climate related objectives referred to in Articles 46, points (e) and (f), and 57, point (b), of Regulation (EU) 2021/2115, such investments shall pursue one or more of the objectives listed in Article 12(1) of this Regulation.

3.   Member States may provide, in their CAP Strategic Plans, support for investments in tangible assets consisting of systems which generate energy provided that the amount of energy generated does not exceed the amount of energy that can be used on a yearly basis for the normal activities of the beneficiary.

4.   Member States may provide, in their CAP Strategic Plans, support for investments in irrigation provided that:

(a)

percentages for minimum water savings targets are set up, both in terms of potential and effective reduction in water use, to be reached by the beneficiary of support, and subject to the CAP Strategic Plan demonstrating that such water savings targets have been determined taking into account the needs set out in the river basin management plans referred to in Directive 2000/60/EC of the European Parliament and of the Council (8);

(b)

a water meter system enabling measurement of water use at the level of the holding or the relevant production unit is in place or is put in place as part of the investment;

(c)

in case of specific investments in irrigation referred to in paragraphs 5 to 8 the conditions laid down in those paragraphs are complied with.

5.   Support for investments in the improvement of an existing irrigation installation or element of irrigation infrastructure may be provided under the following conditions:

(a)

the investments are assessed by the beneficiary ex ante as showing potential water savings reflecting the technical parameters of the existing installations or infrastructures;

(b)

the investments affect bodies of groundwater or surface water whose status have been identified as less than good in the relevant river basin management plan as provided for in Directive 2000/60/EC for reasons related to water quantity, and an effective reduction in water use will be achieved contributing to the achievement of good status of these water bodies, as laid down in Article 4(1) of that Directive.

The conditions set out in the first subparagraph, points (a) and (b), shall not apply to investments, made in support of improvements of an existing irrigation installation or element of irrigation infrastructure, relating to the creation of a reservoir or to the use of reclaimed water which does not affect a body of groundwater or surface water.

6.   Support for investments in irrigation resulting in a net increase of the irrigated area affecting a given body of groundwater or surface water may be provided under the following conditions that:

(a)

the status of the water body has not been identified as less than good in the relevant river basin management plan for reasons related to water quantity;

(b)

an environmental impact analysis shows that there will be no significant negative environmental impact from the investment; that environmental impact analysis shall be either carried out by or approved by the competent authority.

7.   Support for investments in the use of reclaimed water as an alternative water supply may be provided under the condition that the use of such water is compliant with Regulation (EU) 2020/741 of the European Parliament and of the Council (9).

8.   Support for investments in the creation or expansion of a reservoir for the purpose of irrigation may be provided under the condition that it does not lead to significant negative environmental impact.

9.   Member States shall ensure the recovery of the Union financial assistance from the beneficiary, if one of the following situations occurs within the period referred to in paragraph 1, first subparagraph, point (b):

(a)

a cessation of activity of the beneficiary or a transfer to another entity;

(b)

a relocation of a productive activity outside the geographical cultivated area by the beneficiary or, where relevant, its members;

(c)

a change in ownership, in particular where it gives to a firm or a public body an undue advantage; or

(d)

any other significant change affecting the nature, objectives or implementation conditions of the intervention concerned which would result in undermining its original objectives.

In case of non-compliance by the beneficiary with the conditions provided by Member States in their CAP Strategic Plans on the basis of paragraphs 1 to 8 and the first subparagraph of this paragraph, Member States shall ensure the recovery of the Union financial assistance in proportion to the duration of non-compliance.

Member States may choose not to recover the Union financial assistance when the beneficiary ceases a productive activity due to a non-fraudulent bankruptcy.

If a producer member leaves its organisation or producer group, Member States shall ensure that the investment or its residual value is recovered by the beneficiary and that its residual value is added to the operational fund.

In duly justified circumstances, Member States may provide that the beneficiary is not required to recover the investment or its residual value.

10.   Where the assets, for which investments were supported, are replaced, the residual value of the investments replaced shall be:

(a)

added to the operational fund of the producer organisation; or

(b)

subtracted from the cost of the replacement.

Notwithstanding the first subparagraph, Member States cannot provide in their CAP Strategic Plans the mere replacement of investments by identical assets.

11.   Member States shall not provide support for investments specified as interventions in their CAP Strategic Plans, if those interventions receive support pursuant to Article 58(1), first subparagraph, points (h) to (k), of that Regulation.

Article 12

Interventions related to agri-environment-climate objectives

1.   When Member States include, in their CAP Strategic Plans, interventions pursuing agri-environment-climate objectives in the fruit and vegetables sector, in the apiculture sector, in the wine sector, in the hops sector, in the olive oil and table olives sector or in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, they shall provide in their CAP Strategic Plans that the interventions covered pursue one of the following aims:

(a)

achieving a reduction in the current use of production inputs, emission of pollutants or waste from the production process;

(b)

achieving the replacement of the use of energy from fossil fuel sources with renewable energy sources;

(c)

achieving a reduction in the environmental risks linked to the use of certain production inputs or to the production of certain residues, including plant protection products, fertilisers, manure or other animal dejections;

(d)

achieving a reduction in water use;

(e)

being linked to non-productive investments needed to achieve the agri-environment-climate related objectives, in particular where those objectives relate to the protection of habitats and biodiversity;

(f)

achieving an effective and measurable reduction of greenhouse gas emissions or a durable carbon sequestration;

(g)

increasing the resilience of the production to risks linked to climate change, such as soil erosion;

(h)

achieving conservation, sustainable use and development of genetic resources; or

(i)

leading to the protection or an improvement of the environment.

Member States shall ensure that beneficiaries provide evidence of the expected positive contribution to one or more environmental objectives at the moment of the submission for approval of the proposed operational programme, of the intervention or of the amendment of such programme or intervention.

2.   The interventions referred to in paragraph 1, shall be made at the premises of the beneficiary or, where relevant, at the premises of its producer members or at the premises of its subsidiaries complying with the 90 % requirement referred to in Article 31(7) of this Regulation. However, in the apiculture sector, Member States may also provide in their CAP Strategic Plans, for such interventions made outside the premises of the beneficiary. The expected benefit and additional impact of the intervention related to agri-environment-climate objectives has to be demonstrated ex ante through project specifications or other technical documents to be presented by the beneficiary at the moment of the submission for approval of the operation, operational programme or amendment of such a programme or operation, showing the results that could be obtained through the implementation of the intervention.

3.   When determining the expenditure to be covered, Member States shall take into account the additional costs incurred and income foregone resulting from the implemented interventions related to agri-environment-climate objectives, and the targets set.

4.   Member States shall ensure that beneficiaries implementing interventions related to agri-environment-climate objectives have access to the relevant knowledge and information required to implement such interventions, and that appropriate training is made available for those who require it, as well as access to expertise in order to assist farmers who commit to change their production systems.

5.   Member States shall ensure that a revision clause is provided in the operational programmes for operations implemented under interventions related to agri-environment-climate objectives in the fruit and vegetables sector, in the hops sector, in the olive oil and table olives sector, and in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, in order to ensure their adjustment in the case of amendments to any relevant mandatory standards, requirements or obligations.

Article 13

Coaching

1.   When Member States include, in their CAP Strategic Plans, coaching interventions in the fruit and vegetables sector, in the hops sector, in the olive oil and table olives sector, or in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, they shall provide in their CAP Strategic Plans that the interventions covered pursue one of the following objectives:

(a)

exchanging best practices related to crisis prevention and management interventions helping the beneficiary to benefit from experience with implementation of crisis prevention and risk management interventions;

(b)

promoting the setting-up of new producer organisations, merging existing ones or enabling individual producers to join an existing producer organisation as well as advising producers groups on their way to reach the recognition as producer organisation pursuant to Regulation (EU) No 1308/2013;

(c)

creating networking opportunities for coaching providers and recipients, in particular marketing channels as a means of crisis prevention and management.

2.   The coaching provider shall be a producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group. The coaching provider shall benefit from the support for the coaching intervention.

3.   The coaching recipient shall be a producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group, the individual producers members or non-members of a producer organisation, their associations or a producer group.

4.   All eligible costs related to the coaching activity shall be paid to the coaching provider which includes this intervention in its operational programme.

5.   Coaching interventions shall not be outsourced.

Article 14

Promotion, communication and marketing

When Member States include, in their CAP Strategic Plans, promotion, communication and marketing interventions in the fruit and vegetables sector, in the wine sector, in the hops sector, in the olive oil and table olives sector or in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, they shall provide in their CAP Strategic Plans that the interventions covered pursue one of the following objectives:

(a)

increasing awareness of the merits of Union agricultural products and of the high standards applicable to their production methods in the Union;

(b)

increasing the competitiveness and consumption of Union agricultural products and certain processed products produced in the Union and raising their profile both inside and outside the Union for sectors other than wine;

(c)

increasing awareness about Union quality schemes both inside and outside the Union;

(d)

increasing the market share of Union agricultural products and certain processed products produced in the Union, specifically focusing on the markets in third countries that have the highest growth potential;

(e)

contributing, where relevant, to restore the normal market conditions in the Union market in the event of serious market disturbance, loss of consumer confidence or other specific problems;

(f)

increasing awareness of sustainable production;

(g)

increasing consumer awareness of brands or trademarks of producer organisations, associations of producer organisations, transnational producer organisations, transnational associations of producer organisation in the fruit and vegetables sector;

(h)

diversifying, opening and consolidating the markets for Union wines in third countries and increasing awareness of the intrinsic qualities of Union wines on those markets. A reference to wine origin and brands may only be used when it complements the promotion, communication and marketing of Union wines in third countries;

(i)

informing consumers about the responsible consumption of wine. Member States shall ensure that promotional material for generic promotion and promotion of quality labels bears the Union emblem and include the following statement: ‘Funded by the European Union’. The emblem and the funding statement shall be displayed in accordance with the technical characteristics laid down in Commission Implementing Regulation (EU) No 821/2014 (10).

Article 15

Mutual funds

1.   When Member States include, in their CAP Strategic Plans, mutual funds interventions in the fruit and vegetables sector, in the hops sector, in the olive oil and table olives sector or in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, they shall provide the implementing conditions for the administrative cost of setting up, for filling and, where appropriate, the refilling of mutual funds.

2.   The eligible expenditure on administrative cost of setting up mutual funds in the fruit and vegetables sector, in the hops sector, in the olive oil and table olives sector and in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115 shall comprise both the Union financial assistance and the contribution from the beneficiary. The amount of the eligible expenditure shall not exceed 20 %, 16 % or 8 % of the contribution of the beneficiary to the capital of the mutual fund in the first, second and third year of its operation, respectively.

3.   A beneficiary may receive support for the administrative cost of setting up mutual funds in the fruit and vegetables sector, in the hops sector, in the olive oil and table olives sector and in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, only once and only within the 3 first years of the operation of the mutual fund.

Where a beneficiary only applies for that support in the second or the third year of operation of the mutual funds, the support shall be 16 % or 8 % of the contribution of the beneficiary to the capital of the mutual fund in the second and third year of its operation, respectively.

4.   When Member States include, in their CAP Strategic Plans, mutual funds interventions in the wine sector as referred to in Article 58(1), first subparagraph, point (l), of Regulation (EU) 2021/2115, they shall limit the Union support to administrative cost of setting up mutual funds in the wine sector to:

(a)

20 % of the producers’ contribution to the mutual fund in the first year;

(b)

16 % of the producers’ contribution to the mutual fund in the second year;

(c)

8 % of the producers’ contribution to the mutual fund in the third year.

The support period shall not exceed 3 years.

Article 16

Replanting of orchards, olive groves or vineyards following mandatory grubbing-up

1.   When Member States include, in their CAP Strategic Plans, interventions in the fruit and vegetables sector, in the olive oil and table olives sector, in the wine sector or in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, in the form of replanting of orchards, olive groves or vineyards following mandatory grubbing-up for health or phytosanitary reasons or, in the case of orchard and olive groves, to adapt to climate change, they shall ensure that the beneficiaries comply with Regulation (EU) 2016/2031 of the European Parliament and of the Council (11) when implementing these interventions.

2.   The expenditure for replanting of orchards or olives groves shall not exceed 20 % of the total expenditure under each operational programme or relevant intervention.

Article 17

Green harvesting and non-harvesting

1.   When Member States include, in their CAP Strategic Plans, interventions in the fruit and vegetables sector, in the wine sector, in the hops sector, in the olive oil and table olives sector or in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, in the form of ‘green harvesting’ for these sectors and ‘non-harvesting’ for these sectors except for wine, Member States shall ensure that these interventions are additional to and different from normal cultivation practices, and that they concern 100 % of the expected production of the product concerned in a given parcel.

‘Green harvesting’ shall consist of the total harvesting on a given area of unripe non-marketable products which have not been damaged prior to the green harvesting. ‘Non-harvesting’ shall consist of the termination of the current production cycle on the area concerned where the product is well developed and is of sound, fair and of marketable quality.

2.   Member States shall ensure that green harvesting interventions are implemented during the growing seasons in advance of the product reaching a marketable stage and shall not be undertaken in respect of the products for which the normal harvest has already begun.

3.   Member States shall set, in their CAP Strategic Plans, maximum time limits during the production season for the application of the green harvesting interventions for each product subject to such interventions as well as other eligibility conditions for green harvesting and non-harvesting, including varieties and categories of products where relevant.

4.   Member States shall exclude financial compensation for non-harvesting interventions undertaken where commercial production has been taken from the area concerned during the normal production cycle.

5.   Support for green harvesting shall only cover the products which are physically on the fields and which are actually green harvested. For sectors other than the wine sector, compensation amounts, comprising both the Union financial assistance and contribution from the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group for green harvesting and non-harvesting shall be set by the Member State, per hectare payments, at a level corresponding to not more than 90 % of the maximum support level for market withdrawals, other than free distribution, applicable to the same product.

6.   Member States shall provide that the beneficiary has to notify the competent authorities of the Member State in writing or by electronic means in advance of an intention of green harvesting or non-harvesting.

7.   Member States shall set in their CAP Strategic Plans:

(a)

detailed provisions on the implementation of those interventions including their content and deadlines, on the amount of compensation to be paid and on the application of the interventions, as well as the list of products eligible under the interventions;

(b)

provisions to ensure that no negative impact on the environment nor any negative phytosanitary consequences results from the implementation of the interventions;

(c)

a prohibition to grant support in the fruit and vegetables sector in the case of green harvesting, if a significant part of the normal harvest has been carried out and, in the case of non-harvesting, if a significant part of the commercial production has already been taken.

8.   Member States shall ensure that:

(a)

the area concerned has been well maintained, that no harvest has already taken place, that the product is well developed, not damaged and would in general be sound, fair and of marketable quality;

(b)

the harvested products are not denatured;

(c)

there is no negative impact on the environment or any negative phytosanitary consequences resulting from the intervention for which the producer organisation is responsible;

(d)

the area of any vine parcel which has undergone green harvesting is not taken into consideration when calculating the yield limits set in the technical specifications of wines with a protected designation of origin or a protected geographical indication;

(e)

by way of derogation from paragraphs 2 and 4, in the fruit and vegetables sector, where fruit and vegetable plants have a harvesting period exceeding one month, green harvesting might take place after the normal harvest has already begun and non-harvesting might take place even if commercial production has been taken from the area concerned during the normal production cycle. In such cases, the financial compensation shall only compensate for the production that would be harvested in the six weeks following the green harvesting and non-harvesting operation and is not marketed as a result of such operations. Those fruit and vegetable plants shall not be used for further production purposes in the same growing season;

(f)

in the fruit and vegetables sector, except for the case referred to in point (e), green harvesting and non-harvesting interventions cannot apply simultaneously for the same product and the same area in any given year.

Article 18

Harvest and production insurance

When Member States include in their CAP Strategic Plans, harvest and production insurance as an intervention in the fruit and vegetables sector, in the hops sector, in the olive oil and table olives sector, or in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, they may grant additional national financing to support harvest and production insurance actions which are benefiting from the operational fund. The total public support shall not exceed 80 % of the cost of the insurance premiums paid for by producers for insurance against losses.

Harvest and production insurance interventions shall not cover insurance payments which compensate producers for more than 100 % of the income loss suffered, taking into account any compensation the producers obtain from other support or insurance schemes related to the insured risk.

Article 19

Market withdrawals for destinations other than free distribution

When Member States include in their CAP Strategic Plans, interventions in the form of ‘market withdrawals for destinations other than free distribution’, they shall ensure the definitive withdrawal from the market of a certain product in a manner that it cannot be reverted to the market for food purposes.

Member States may only provide in their CAP Strategic Plans, interventions in the form of ‘market withdrawal for destinations other than free distribution’ in the fruit and vegetables sector as well as in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, respectively, and only in respect of perishable products that cannot be durably stored at their normal commercial stage without refrigeration.

Member States shall not provide in their CAP Strategic Plans, interventions in the form of ‘market withdrawals for destinations other than free distribution’ in respect of animal products and products of the sugar sector as referred to in Article 1(2) of Regulation (EU) No 1308/2013.

Article 20

Collective storage

1.   When Member States include, in their CAP Strategic Plans, collective storage interventions as referred to in Article 47(2), point (c), of Regulation (EU) 2021/2115, they shall provide for a temporary withdrawal of a product from the market in period of certain market pressure, and adopt rules to ensure that the product is stored under the responsibility of the beneficiary in such conditions that preserves its normal commercial value and in respect of the applicable sanitary rules. For products with a short shelf-life in their fresh stage, Member States shall provide for the product to be stored frozen or in a processed form. Products for which a certain maturation period is required in their normal production process, or where such maturation process increases the value of the product, are only eligible for collective storage once that maturation period is fully completed.

2.   Member States shall fix, for each product for which this intervention is provided in their CAP Strategic Plans, the minimum storage duration and the maximum amount of compensation per unit of product and per day of storage, as well as the relevant storage conditions. The maximum amount that can be financed with the operational fund shall not be higher than the sum of the cost of the physical storage, in the frozen or processed form where relevant, and the financial cost due to immobilising the value of the product at current market prices. This maximum amount shall not include the possible freezing or processing costs or the possible devaluation of the product. Member States shall fix also the control procedures, including on-the-spot checks, to assure the non-substitution of the products as well as the respect of the storage conditions and of the storage period.

Section 2

Forms of support and types of expenditure

Article 21

Forms of support

1.   In the sectors referred to in Article 42 of Regulation (EU) 2021/2115, Member States shall provide for payments of support on the basis of the actual costs incurred by the beneficiary, supported by documents, such as invoices, submitted by the beneficiaries for the implementation of an intervention specified in their CAP Strategic Plan.

However, Member States may choose to provide for payment of support on the basis of standard flat rates, scales of unit costs or lump sums. When establishing those flat rates, scales and lump sums, Member States shall take into account regional or local specificities and base their calculation on documentary evidence demonstrating that the calculation reflects the market price of the operations or actions covered by the intervention concerned.

2.   In the fruit and vegetables sector, Member States shall respect the maximum amounts of expenditure and the conditioning costs which may be paid in relation to the relevant interventions specified in their CAP Strategic Plans set out in Annexes V and VII.

3.   Where Member States provide, in their CAP Strategic Plans, for payment of support in the form of standard flat rates, scales of unit costs or lump sums, those shall be reviewed periodically in order to take account an indexation or an economic change.

4.   When Member States use the fair, equitable and verifiable calculation method established pursuant to Article 44(2), point (a), of Regulation (EU) 2021/2115, they shall keep all the documentary evidence concerning the establishment of standard flat rates, scales of unit costs or lump sums and their review as referred to in paragraph 3 of this Article.

5.   Where Member States include, in their CAP Strategic Plans, interventions in the wine sector related to the restructuring and conversion of vineyards and investments in tangible and intangible assets, the following rules shall apply:

(a)

if Member States decide to calculate the amount of the support on the basis of standard scales of unit costs based on a surface measurement unit, the amount shall correspond to the actual surface measured in accordance with Article 42 of this Regulation;

(b)

if Member States decide to calculate the amount of the support on the basis of standard scales of unit costs based on other measurement units or on the basis of the actual costs resulting from supporting documents to be submitted by the beneficiaries, they shall lay down rules on appropriate control methods to establish the actual extent of implementation of the operation.

6.   This Article shall not apply to Union financial assistance for the distillation of by-products of wine making carried out in accordance with the restrictions laid down in Part II, Section D, of Annex VIII to Regulation (EU) No 1308/2013.

Article 22

Types of expenditure

1.   Types of expenditure covered by the types of intervention referred to in Title III, Chapter III, of Regulation (EU) 2021/2115 shall not compensate the value added tax of the eligible expenditure incurred by the beneficiary, except where it is non-recoverable under national VAT legislation.

2.   Types of expenditure referred to in paragraph 1 shall not include the types of expenditure listed in Annex II.

3.   The types of expenditure listed in Annex III shall be considered eligible by Member States when defining the relevant interventions and may be covered by the operational programmes or as so specified by Member States in the relevant interventions. Member States may consider eligible other types of expenditure in their CAP Strategic Plans provided they are not listed in Annex II.

4.   Member States shall establish, in their CAP Strategic Plans, the conditions under which expenditures linked to interventions referred to in Articles 11 and 12 may be counted as contributing to the objectives of 15 % and 2 % of expenditure under operational programmes as referred to in Article 50(7), points (a) and (c), of Regulation (EU) 2021/2115, respectively, and of 5 % of expenditure under interventions as referred to in Article 60(4) of that Regulation. Such conditions shall ensure that these interventions pursue effectively the related objectives set out in Articles 46 and 57 of that Regulation, respectively, for the fruit and vegetables and the wine sectors.

Article 23

Administrative and personnel costs

1.   Personnel costs incurred by the beneficiary, subsidiaries within the meaning of Article 31(7) or, subject to Member State’s approval, by a cooperative which is member of a producer organisation shall be considered eligible for support if they are incurred in relation to the preparation, implementation or follow-up of a particular supported intervention.

Such personnel costs shall include, inter alia, costs of personnel contracted by the beneficiary and the costs corresponding to the share of the working hours invested in the implementation of an intervention by its permanent staff.

Member States shall ensure that the beneficiary submits supporting documents setting out the details of the work actually carried out in relation to the particular intervention and that the value of the related personnel cost can be independently assessed and verified. The value of personnel cost related to a particular intervention shall not exceed the costs generally accepted on the market in question for the same kind of service.

For the purpose of determining personnel costs linked to the implementation of an intervention by the permanent personnel of the beneficiary, the hourly rate applicable may be calculated by dividing the last documented annual gross employment costs of the specific employees that have worked in the implementation of the operation by 1 720 hours, or on pro rata basis in case of part-time employees.

For the interventions ‘promotion, communication and marketing’ and ‘communication actions’ referred to in Article 47(1), point (f), and (2), point (l), of Regulation (EU) 2021/2115 and for the actions by interbranch organisations and promotion and communication carried out in third countries as referred to in Article 58(1), first subparagraph, points (i), (j) and (k), of that Regulation, the expenditure paid for administrative and personnel costs directly incurred by the beneficiaries shall not exceed 50 % of the overall cost of the intervention.

2.   Administrative costs incurred by the beneficiary, subsidiaries within the meaning of Article 31(7) or, subject to Member State’s approval, by a cooperative which is member of a producer organisation shall be considered eligible for support if they are incurred in relation to the preparation, implementation or follow-up of a particular supported intervention.

The administrative costs shall be considered eligible if they do not exceed 4 % of the total eligible costs of the implemented intervention.

The costs of external audits shall be considered eligible for support where such audits are performed by an independent and qualified external body.

3.   Member States may provide in their CAP Strategic Plans, for the fruit and vegetables sector, for the hops sector, for the olive oil and table olives sector or for other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, a standard flat rate for the personnel and administrative costs linked to the management of the operational fund or the preparation, implementation and follow-up of the operational programme up to a maximum of 2 % of the operational fund approved, comprising both the Union financial assistance and the contribution of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group.

CHAPTER II

Specific rules applicable to the fruit and vegetables sector, to the olive oil and table olives sector, and to the other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115

Section 1

Products covered and transport costs

Article 24

Products covered

Only products for which the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group is recognised shall be covered by the type of intervention provided that the value of the products covered by the operational programme account for more than 50 % of the value of all products marketed by that organisation in the sector covered by that operational programme. In addition, the products concerned shall come from the producer organisation’s members or producer members of another producer organisation or association of producer organisations.

Article 25

Transport costs and conditioning requirement for free distribution

1.   When Member States include in their CAP Strategic Plans, interventions in the form of ‘market withdrawal for free-distribution or other destinations’ referred to in Article 47(2), point (f), of Regulation (EU) 2021/2115, they shall fix the costs of transport for the free distribution of all products withdrawn from the market under operational programmes on the basis of scale of unit costs set according to the distance between the place of withdrawal and the place of delivery for free distribution. Only transport costs up to a distance of 750 km can be reimbursed.

2.   The transport costs shall be paid to the party that actually bears the financial cost of the transport operation in question. Payment shall be subject to the presentation of supporting documents certifying, in particular:

(a)

the names of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group;

(b)

the quantity of the products concerned;

(c)

acceptance by the recipients as referred to in Article 52(6), point (a), of Regulation (EU) 2021/2115 and the means of transport used;

(d)

the distance between the place of withdrawal and the place of delivery.

3.   Conditioning of products withdrawn from the market for free distribution under operational programmes shall be subject to the following:

(a)

packages of products for free distribution display the Union emblem referred to in Article 15(2), together with one or more of the statements set out in Annex IV; payment is subject to the presentation of supporting documents certifying in particular:

(i)

the names of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations;

(ii)

the quantity of the products concerned;

(b)

acceptance by the recipient as referred to in Article 52(6), point (a), of Regulation (EU) 2021/2115, specifying the presentation.

Section 2

Maximum level of Union financial assistance for market withdrawals

Article 26

Support

1.   For the type of intervention ‘market withdrawal for free distribution or other destinations’ referred to in Article 47(2), point (f), of Regulation (EU) 2021/2115, in relation to products listed in Annex V, the sum of costs of transport, conditioning costs of products withdrawn for free distribution referred to in Article 33 of this Regulation, added to the amount of support for market withdrawals, shall not exceed the average ‘ex-producer organisation’ market price of the product concerned in the previous last 3 years, including after processing where relevant.

2.   For the type of intervention ‘market withdrawal for free distribution or other destinations’ referred to in Article 47(2), point (f), of Regulation (EU) 2021/2115 applicable to products other than those listed in Annex V to this Regulation, Member States shall set maximum amounts of support, comprising the Union financial assistance, the national contribution where relevant and contribution from the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group, at a level not exceeding 40 % of the average ‘ex-producer organisation’ market prices for the previous 5 years in case of free distribution and at a level not exceeding 30 % of the average ‘ex-producer organisation’ market prices for the previous 5 years for destinations other than free distribution.

3.   Where the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group has received compensation from third parties for withdrawn products, the support referred to in the first subparagraph shall be reduced by an amount equivalent to the compensation received. In order to be eligible for support, the products concerned shall not enter again the commercial market.

4.   The share of market withdrawals, other than for free distribution, of any given product of any given producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group undertaken in a given year shall be as follows:

(a)

it shall not exceed 10 % of the average volume of marketed production by that producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group during the 3 previous years;

(b)

and, for fruit and vegetables, in total, the sum of the percentages over 3 consecutive years shall not exceed 15 when adding the share calculated in accordance with point (a) for the current year and the shares of the market withdrawals of the 2 previous years calculated on the basis of the respective volume of marketed production by that producer organisation during those 2 previous years.

If the information on the volume of marketed production of any or all of the previous years is not available, the volume of marketed production for which the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group was recognised shall be used.

However, amounts of withdrawals for free distribution which are disposed of in one of the ways referred to in Article 52(6) of Regulation (EU) 2021/2115 or any other equivalent destination approved by Member States as referred to in Article 27(2) of this Regulation shall not be taken into account in the share of market withdrawals.

5.   In relation to products listed in Annex V, the support for market withdrawals comprising both the Union financial assistance and the producer organisation contribution, shall be no more than the amounts set out in that Annex.

The Union financial assistance in case of market withdrawals of fruit and vegetables which are disposed of by way of free distribution to charitable organisations, foundations and institutions as referred to in Article 52(6) of Regulation (EU) 2021/2115 shall only cover payment for the disposed products in accordance with paragraphs 1 or 2 of this Article where the conditioning costs shall be those referred to in Article 33 of this Regulation.

Article 27

Destinations for withdrawn products

1.   When Member States include in their CAP Strategic Plans interventions in the form of ‘market withdrawal for free distribution or other destinations’ in the fruit and vegetables sector, in the olive oil and table olives sector and in other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115, they shall determine the permissible destinations for products withdrawn from the market and ensure that no negative impact on the environment nor any negative phytosanitary consequences result from the withdrawal or its destination.

2.   Upon request of charitable organisations, foundations or institutions as referred to in Article 52(6), point (a), of Regulation (EU) 2021/2115, Member States may authorise the charitable organisations, foundations or institutions to ask for a contribution from the final recipients of products withdrawn from the market.

When the charitable organisations, foundations or institutions referred to in Article 52(6), point (a), of Regulation (EU) 2021/2115 concerned have obtained such authorisation, they shall keep financial accounts for the operation in question.

Member States may authorise payment in kind by the beneficiaries of free distribution to processors of products where such payment only compensates for processing costs and where the Member State in which the payment takes place has adopted rules ensuring that processed products are intended for consumption by the final recipients referred to in the second subparagraph.

Member States shall take all the necessary steps to facilitate contacts and cooperation between producer organisations and charitable organisations foundations or institutions as referred to in Article 52(6), point (a), of Regulation (EU) 2021/2115.

3.   Disposal of products withdrawn to the industry for processing into non-food products shall be possible. Member States shall adopt detailed provisions to ensure that no distortion of competition occurs for the industries concerned within the Union or for imported products and that products withdrawn do not enter the commercial food market again. The alcohol resulting from distillation shall be used exclusively for industrial or energy purposes.

Article 28

Conditions for the recipients of withdrawn products

1.   The recipients of withdrawn products for free distribution in the sectors referred to in Articles 42, points (a), (e) and (f), of Regulation (EU) 2021/2115 shall undertake to:

(a)

comply with the rules concerning marketing standards laid down in Regulation (EU) No 1308/2013;

(b)

keep separate stock records for the withdrawal operations in question;

(c)

accept the checks provided for by Union and national law;

(d)

provide the supporting documents on the final destination of each of the products concerned, in the form of a take-over certificate or equivalent document certifying that the withdrawn products have been taken over by a third party with a view to their free distribution.

Member States may decide that recipients do not have to keep records as referred to in the first subparagraph, point (b), if they receive quantities below a maximum to be determined by them based on a documented risk analysis.

2.   The recipients of withdrawn products for destinations other than free distribution shall undertake to:

(a)

comply with the rules concerning marketing standards laid down in Regulation (EU) No 1308/2013;

(b)

keep separate stock records and financial accounts for the operations in question if the Member State considers it as necessary despite the fact that the product has been denatured before delivery;

(c)

accept the checks provided for by Union and national law;

(d)

not request additional aid for the alcohol produced from the products concerned in the case of withdrawn products intended for distillation.

Article 29

Marketing standards of withdrawn products

1.   A product withdrawn from the market for destinations other than free distribution, in the sectors referred to in Articles 42, points (a), (e) and (f), of Regulation (EU) 2021/2115, shall comply with the relevant standard and rules for the marketing of that product as referred to in Regulation (EU) No 1308/2013, except the rules on the presentation and marking of products.

Where fruits and vegetables are withdrawn in bulk, the minimum requirements for class II as defined in Commission Implementing Regulation (EU) No 543/2011 (12) shall be complied with.

However, miniature produce from the fruit and vegetables sector, as defined in the relevant standard, shall comply with the applicable marketing standard, including the provisions on the presentation and marking of products.

2.   If a specific marketing standard is not laid down for a given fruit or vegetable, the minimum requirements set out in Annex VI shall be met. Member States may lay down additional rules supplementing those minimum requirements.

Section 3

Basis for the calculation of Union financial assistance

Article 30

Value of marketed production for newly recognised organisations or groups

Where, during the 3 years following its recognition, historical data on marketed production for a producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations, or producer group in the sectors referred to in Articles 42, points (a), (e) and (f), of Regulation (EU) 2021/2115 is not available for the 3 previous years, Member States shall accept the value of marketed or marketable production during a period of 12 consecutive months communicated by the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations, or producer group for which the organisation concerned or the producer group can prove at the satisfaction of the Member State that it has the actual capacity to market it on behalf of its producer members.

However, if the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group has communicated the value of the marketed production for the purpose of its recognition, only this value shall be accepted by the Member State.

Article 31

Basis for calculation of the value of marketed production

1.   The value of marketed production for a producer organisation, transnational producer organisation, or producer group in the sectors referred to in Article 42, points (a), (e) and (f), of Regulation (EU) 2021/2115 shall be calculated on the basis of the production of the producer organisation, transnational producer organisation, or producer group itself and its producer members that has been put on the market by this organisation or group, and shall only include the production of those products for which the producer organisation, transnational producer organisation, or producer group is recognised. The value of marketed production may include products that are not required to conform to the marketing standards, where those standards do not apply.

The value of marketed production for an association of producer organisation or a transnational association of producer organisations shall be calculated on the basis of the production marketed by the association of producer organisations or transnational association of producer organisations itself and by its member producer organisations, and shall only include the production of those products for which the association of producer organisations or transnational association of producer organisations is recognised. However, where operational programmes are approved for an association of producer organisation or a transnational association of producer organisations and separately for its member producer organisations, the value of marketed production counted for the operational programmes of the members shall not be taken into account for the calculation of the value of the marketed production of the association.

In addition, for sectors listed in Article 42, points (e) and (f), of Regulation (EU) 2021/2115, the value of marketed production may also include the value of the production covered by contracts negotiated by the producer organisation, transnational producer organisation, association of producer organisations, transnational association of producer organisations or producer group on behalf of its members.

2.   The value of marketed production shall be calculated at fresh stage or the first processing stage on which the product is normally marketed, in bulk where products are allowed to be marketed in bulk, and shall not include the cost of further processing or further conditioning or the value of final processed products. Member States shall indicate in their CAP Strategic Plans how the value of marketed production is calculated for each sector.

The value of the marketed production of fruit and vegetables intended for processing, which have been transformed into one of the processed fruit and vegetable products listed in Annex I, Part X, to Regulation (EU) No 1308/2013 or any other processed product referred to in this paragraph, by either a producer organisation, an association of producer organisations or their producer members or subsidiaries complying with paragraph 7 of this Article, either by themselves or through outsourcing, shall be calculated as a flat rate in percentage applied to the invoiced value of those processed products. That flat rate shall be:

(a)

53 % for fruit juices;

(b)

73 % for concentrated juices;

(c)

77 % for tomato concentrate;

(d)

62 % for frozen fruit and vegetables;

(e)

48 % for canned fruit and vegetables;

(f)

70 % for canned mushrooms of Agaricus bisporus and other cultivated mushrooms preserved in brine;

(g)

81 % for fruits provisionally preserved in brine;

(h)

81 % for dried fruits;

(i)

27 % for processed fruit and vegetables other than those referred to in points (a) to (h);

(j)

12 % for processed aromatic herbs;

(k)

41 % for paprika powder.

3.   Member States may allow the beneficiary to include the value of the by-products in the value of marketed production.

4.   The value of marketed production shall include the value of market withdrawals for free distribution. The value of withdrawals for free distribution shall be calculated on the basis of the average price of those products marketed by the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group in the period concerned.

5.   Only the production of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations, producer group, or its producer members which is marketed by that producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group shall be counted in the value of marketed production.

The production of the producer members of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group marketed by another producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group designated by their own organisation shall be counted in the value of marketed production of the organisation, association or group that marketed the production. Double counting shall be prohibited.

6.   Except where paragraph 7 applies, the marketed production of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group shall be invoiced at the ‘ex-producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group’ stage ready for marketing, excluding:

(a)

VAT;

(b)

costs of transport internal to the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group.

7.   However, the value of marketed production may also be calculated at the ‘ex-subsidiary’ stage, on the basis set out in paragraph 6, provided that at least 90 % of the shares or capital of the subsidiary is owned:

(a)

by one producer organisation or association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group; or

(b)

subject to Member State approval, by producer members of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group, if doing so contributes to the objectives listed in Article 152(1), point (c), of Regulation (EU) No 1308/2013.

8.   In case of outsourcing, the value of marketed production shall be calculated at the ‘ex-producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group’ stage and shall include the added economic value of the activity that has been outsourced by the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group to its members, third parties or to another subsidiary than the one referred to in paragraph 7.

9.   Where a reduction in production occurs due to a natural disaster, climatic event, plant or animal diseases or pest infestations, any insurance indemnification received in respect of harvest or production insurance actions referred to in Article 18, or equivalent actions managed by the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group, or its producer members, due to those causes may be included in the value of marketed production of the 12-month reference period in which it is actually paid.

Article 32

Reference period and ceiling on Union financial assistance

1.   Member States shall determine for each producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group a 12-month reference period, starting no earlier than 1 January of the year that is 3 years prior to the year for which the aid is requested and ending no later than 31 December of the year preceding the year for which the aid is requested.

The 12-month reference period shall be the accounting period of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group concerned.

The methodology for fixing the reference period shall not vary during a programme except in duly justified situations.

2.   Member States shall decide whether the ceiling on Union financial assistance to the operational fund is calculated each year, either:

(a)

on the basis of the value of the marketed production during the reference period of the producers who are members of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group on 1 January of the year for which the aid is requested; or

(b)

on the basis of the actual value of the marketed production in the reference period concerned of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group concerned. In that case, the rule shall apply to all non-transnational beneficiaries in that Member State.

3.   Where for a product a reduction of at least 35 % in the value of marketed production for a given year in relation to the average of three previous 12-month reference periods has occurred, the following shall apply:

(a)

if the reduction occurred due to reasons falling outside the responsibility and control of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group, the value of marketed production of that product shall be deemed to represent 65 % of the average value in the three previous 12-month reference periods;

(b)

if the reduction occurred due to natural disasters, climatic events, plant diseases or pest infestations falling outside the responsibility and control of the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group, the value of marketed production of that product shall be deemed to represent 85 % of the average value in the three previous 12-month reference periods.

In both cases, the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group shall prove to the competent authority of the Member State concerned that those reasons were falling outside its responsibility and control.

Where the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations or producer group proves to the Member State concerned that those reasons were falling outside its responsibility and control and that they have taken the necessary preventive measures, the value of marketed production of that product shall be deemed to represent 100 % of its average value in the three previous 12-month reference periods.

CHAPTER III

Fruit and vegetables sector

Article 33

Conditioning costs for free distribution

The payments of expenditure to the producer organisation, association of producer organisations, transnational producer organisation, transnational association of producer organisations related to the costs of conditioning of fruit and vegetables withdrawn from the market for free distribution under operational programmes are set out in Annex VII.

Article 34

Calculation of the degree of organisation of producers for the purpose of the national financial assistance

1.   When determining the level of national financial assistance in the fruit and vegetables sector in accordance with Article 53 of Regulation (EU) 2021/2115, the degree of organisation in a region of a Member State shall be calculated on the basis of the value of fruit and vegetables produced in the region concerned and marketed by the organisations and shall only include those products for which those organisations are recognised. Article 31 of this Regulation shall apply mutatis mutandis.

2.   Only fruit and vegetables produced in the region referred to in paragraph 3 shall be considered for the purposes of this Article.

3.   Member States shall define the regions as a distinct part of their national territory in accordance with objective and non-discriminatory criteria, such as their agronomic and economic characteristics and their regional agricultural or fruit and vegetable potential, or their institutional or administrative structure and for which data are available in order to calculate the degree of organisation referred to in paragraph 1.

The list of regions established by a Member State shall not be amended at least for 5 years unless such amendment is objectively justified, in particular for reasons that are not related to the calculation of the degree of organisation of producers in the region or regions concerned.

4.   Member States shall notify the Commission by 31 January each year of the list of the regions that meet the criteria referred to in Article 53(1) and (2) of Regulation (EU) 2021/2115, and of the amount of national financial assistance granted to the producer organisations in those regions.

Member States shall notify the Commission of any amendment of the list of the regions.

5.   A producer organisation wishing to apply for national financial assistance shall, if necessary, amend its operational programme.

Article 35

3-year average for market withdrawals for free distribution

1.   The limit of 5 % of the volume of marketed production referred to in Article 52(6), point (a), of Regulation (EU) 2021/2115 shall be calculated on the basis of the average of the overall volumes of products for which the producer organisation is recognised and which are marketed through the producer organisation during the 3 previous years.

2.   For newly recognised producer organisations, the data for marketing years prior to recognition shall be:

(a)

where the organisation was a producer group, the equivalent data for that producer group; or

(b)

the volume applicable to the application for recognition.

CHAPTER IV

Apiculture sector

Article 36

Definition of beehive

For the purposes of this Chapter, the term ‘beehive’ means the unit containing a honeybee colony used for the production of honey, other apiculture products or honeybee breeding material, and all the elements necessary for its survival.

Article 37

Method to calculate the number of beehives

The number of beehives ready for wintering in the territory of the Member States between 1 September and 31 December shall be calculated each year according to an established reliable method laid down in the CAP Strategic Plans.

Article 38

Notification of the number of beehives

The annual notification of the number of beehives referred to in Article 55(7) of Regulation (EU) 2021/2115 as calculated in accordance with Article 37 of this Regulation, shall be made by 15 June of each year, starting in 2023.

Article 39

Minimum Union contribution

The minimum Union contribution to the expenditure related to the implementation of the types of intervention in the apiculture sector referred to in Article 55 of Regulation (EU) 2021/2115 and specified by Member States in their CAP Strategic Plans shall be 30 %.

CHAPTER V

Wine sector

Article 40

Beneficiaries

1.   Member States shall establish which operators, may benefit from interventions in the wine sector specified in their CAP Strategic Plans. Those operators shall include beneficiaries as referred to in paragraphs 2, 3 and 4 as well as professional organisations, wine producer organisations, associations of wine producer organisations, temporary or permanent associations of two or more wine producers and interbranch organisations.

2.   Member States shall provide for wine growers to be the sole beneficiaries of the types of intervention ‘restructuring and conversion of vineyards’, ‘green harvesting’ and ‘harvest insurance’ referred to in Article 58(1), first subparagraph, points (a), (c) and (d), of Regulation (EU) 2021/2115, respectively.

3.   A body governed by public law may not benefit from support under the types of intervention in the wine sector. However, Member States may allow a body governed by public law to benefit from the support:

(a)

for actions implemented by interbranch organisations as referred to in Article 58(1), first subparagraph, points (i) and (j), of Regulation (EU) 2021/2115;

(b)

for information actions and promotion and communication carried out in third countries as referred to in Article 58(1), first subparagraph, points (h) and (k), of Regulation (EU) 2021/2115, provided that, it is not the sole beneficiary of the support granted in respect of those interventions.

4.   Private companies may be beneficiaries for the promotion and communications carried out in third countries as referred to in Article 58(1), first subparagraph, point (k), of Regulation (EU) 2021/2115.

5.   No support shall be granted to producers farming unlawful plantings and areas planted with vines without authorisation pursuant to Article 71 of Regulation (EU) No 1308/2013.

Article 41

Replanting of vineyards for health or phytosanitary reasons

The annual expenditure paid by Member States for support to interventions specified in their CAP Strategic Plans in relation to the replanting of vineyards following mandatory grubbing-up shall not exceed 15 % of the total annual expenditure on restructuring and conversion of vineyards under Article 58(1), first subparagraph, point (a), of Regulation (EU) 2021/2115 paid by the Member State concerned during any given financial year.

The grubbing-up costs and the compensation of the income foregone shall not constitute eligible expenditure under this type of intervention.

Article 42

Area planted

1.   For the purposes of Article 58(1), first subparagraph, points (a) and (c), of Regulation (EU) 2021/2115, an area planted with vines is defined by the external perimeter of the vine stocks with the addition of a buffer whose width corresponds to half of the distance between the rows.

2.   Where a Member State decides to verify the eligible costs of operations for the restructuring and conversion of vineyards and green harvesting exclusively on the basis of standard scales of unit costs based on measurement units different from the surface or of supporting documents to be submitted by the beneficiaries, the competent authorities may decide not to measure the area planted as set out in paragraph 1.

CHAPTER VI

Hops sector

Article 43

Union financial assistance

The maximum Union financial assistance to be allocated to each producer organisation or association, as referred to in Article 62(1) of Regulation (EU) 2021/2115, shall be calculated pro rata based on the eligible hop areas of its producer members. To be eligible, the hop areas shall be planted at a uniform density of at least 1 500 plants per hectare in the case of double stringing/wiring, or at least 2 000 plants per hectare in the case of single stringing/wiring.

The areas shall only include areas bounded by a line joining the outer stays of the poles. Where there are hop plants on that line, an additional strip of a width corresponding to the average width of an alleyway within that parcel may be added to each side of that area. The additional strip shall not form part of a public right of way. The two headlands at the ends of the hop rows that are needed for manoeuvring agricultural machinery may be included in the area, provided that the length of neither headland exceeds 8 metres and they are counted only once, and they do not form part of a public right of way.

The areas shall not include areas planted with young hop plants grown chiefly as nursery products.

CHAPTER VII

Livestock sector

Article 44

Restocking with livestock following compulsory slaughter for health reasons or because of losses resulting from natural disasters

1.   Member States shall ensure that the type of intervention ‘restocking with livestock after compulsory slaughter for health reasons or because of losses resulting from natural disasters’ as referred to in Article 47(2), point (e), of Regulation (EU) 2021/2115, is only implemented when disease control measures have been taken in accordance with Regulation (EU) 2016/429 of the European Parliament and of the Council (13).

2.   Expenditure for restocking with livestock shall not exceed 20 % of the total expenditure under operational programmes.

TITLE IV

ADDITIONAL REQUIREMENTS FOR CERTAIN TYPES OF INTERVENTION IN RURAL DEVELOPMENT

Article 45

Conservation, sustainable use and development of genetic resources in agriculture and in forestry

1.   Member States which include, in their CAP Strategic Plans, interventions related to the conservation, sustainable use and development of genetic resources in agriculture and in forestry as referred to in Article 70 of Regulation (EU) 2021/2115 may provide support only as:

(a)

agri-environment-climate commitments for preserving on farm endangered breeds and plant varieties under threat of genetic erosion; or

(b)

support for activities regarding the conservation, the sustainable use and development of genetic resources in agriculture and in forestry.

Activities covered by the type of agri-environment-climate commitments referred to in the first subparagraph, point (a), shall not be eligible for support pursuant to that subparagraph, point (b).

2.   Member States shall ensure that agri-environment-climate commitments for preserving on farm endangered breeds and plant varieties under threat of genetic erosion, referred to in paragraph 1, first subparagraph, point (a), shall require:

(a)

to rear farm animals of local breeds, recognised by a Member State to be endangered, genetically adapted to one or more traditional production systems or environments in that Member State, where the endangered status is scientifically established by a body possessing the necessary skills and knowledge in the area of endangered breeds, as defined in Article 2, point (24), of Regulation (EU) 2016/1012 of the European Parliament and of the Council (14); or

(b)

to preserve plant genetic resources naturally adapted to the local and regional conditions and under threat of genetic erosion.

3.   The following species of farm animals of local breeds referred to in paragraph 2, point (a), may be eligible for support:

(a)

cattle;

(b)

sheep;

(c)

goats;

(d)

equidae (Equus caballus and Equus asinus);

(e)

pigs;

(f)

birds;

(g)

rabbits;

(h)

bees.

4.   Member States shall only consider as eligible for support local breeds referred to in paragraph 2, point (a), if the following requirements are complied with:

(a)

the number, at national level, of breeding females concerned is stated;

(b)

a duly recognised relevant breed society registers and keeps up-to-date the herd or flockbreeding book for the breed.

5.   Member States shall consider plant genetic resources referred to in paragraph 2, point (b), as being under threat of genetic erosion on condition that sufficient evidence of genetic erosion, based upon scientific results or indicators for the reduction of landraces or primitive local varieties, their population diversity and, where relevant, for modifications in the prevailing agricultural practices at local level, is provided.

6.   Member States shall ensure that operations for the conservation, the sustainable use and development of genetic resources in agriculture and in forestry, referred to in paragraph 1, first subparagraph, point (b), include the following:

(a)

targeted actions promoting in situ and ex situ conservation, characterisation, collection and utilisation of genetic resources in agriculture and forestry, including web-based inventories of genetic resources currently conserved in situ, including on-farm or on-forest holding conservation, and ex situ collections and databases;

(b)

concerted actions promoting the exchange of information for the conservation, characterisation, collection and utilisation of genetic resources in Union agriculture or forestry among competent Member State organisations;

(c)

accompanying action: information, dissemination, advice, training, and technical report preparation, involving non-governmental organisations and other stakeholders.

7.   For the purposes of paragraph 1, first subparagraph, point (b), the following definitions shall apply:

(a)

in situ conservation’ in agriculture means the conservation of genetic material in ecosystems and natural habitats and the maintenance and recovery of viable population of species or feral breeds in their natural surroundings and, in the case of domesticated animal breeds or cultivated plant species, in the farmed environment where they have developed their distinctive properties;

(b)

in situ conservation’ in forestry means the conservation of genetic material in ecosystems and natural habitats and the maintenance and recovery of viable population of species in their natural surroundings;

(c)

‘on-farm or on-forest holding conservation’ means in situ conservation and development at farm or forest holding level;

(d)

ex situ conservation’ means the conservation of genetic material for agriculture or forestry outside their natural habitat;

(e)

‘ex situ collection’ means a collection of genetic material for agriculture or forestry maintained outside their natural habitat.

Article 46

Animal welfare

Member States which include in their CAP Strategic Plans interventions related to animal welfare commitments referred to in Article 70 of Regulation (EU) 2021/2115 shall ensure that animal welfare commitments provide upgraded standards of production methods in at least one of the following areas:

(a)

water, feed, and animal care in accordance with the natural needs of animals;

(b)

housing conditions that improve the comfort of animals and their freedom of movement, such as increased space allowances, flooring surfaces, natural light, microclimate control, as well as housing conditions such as free farrowing or group housing, depending on the natural needs of animals;

(c)

conditions allowing for expression of natural behaviour, such as enrichment of living environment or late weaning;

(d)

outdoor access and grazing;

(e)

practices that increase animal robustness and longevity, including slower growing breeds;

(f)

practices to avoid mutilation or castration of animals. In specific cases when mutilation or castration of animals is deemed necessary, anaesthetics, analgesia and anti-inflammatory medication or immunocastration shall be used;

(g)

sanitary measures, preventing non-transmissible diseases, that do not require the use of medical substances such as vaccines, insecticides or anti-parasitic drugs.

Article 47

Quality schemes

Member States which include in their CAP Strategic Plans interventions related to quality schemes, referred to in Article 77(1), point (c), of Regulation (EU) 2021/2115, shall ensure that national recognised quality schemes cover:

(a)

quality schemes, including farm certification schemes, for agricultural products, cotton or foodstuffs, recognised by the Member States as complying with the following criteria:

(i)

the specificity of the final product under such schemes is derived from clear obligations to guarantee any of the following:

specific product characteristics,

specific farming or production methods, or

a quality of the final product that goes significantly beyond the commercial commodity standards as regards public, animal or plant health, animal welfare or environmental protection;

(ii)

the scheme is open to all producers;

(iii)

the scheme involves binding product specifications and compliance with those specifications is verified by public authorities or by an independent inspection body;

(iv)

the scheme is transparent and assures complete traceability of products;

(b)

voluntary agricultural product certification schemes recognised by the Member States as meeting the Union best practice guidelines for the operation of voluntary certification schemes referred to in Commission Communication of 16 December 2010 entitled ‘EU best practice guidelines for voluntary certification schemes for agricultural products and foodstuffs’ (15) relating to agricultural products and foodstuffs.

TITLE V

RULES ON THE RATIO FOR GAEC STANDARD 1

Article 48

Rules on the ratio for GAEC standard 1

1.   For the maintenance of permanent grassland in relation with GAEC standard 1 as listed in Annex III to Regulation (EU) 2021/2115, Member States shall ensure that the ratio of permanent grassland in relation to agricultural area does not decrease by more than 5 % compared to a reference ratio to be established by each Member State in its CAP Strategic Plan by dividing areas of permanent grassland by the total agricultural area.

For the purpose of establishing the reference ratio referred to in the first subparagraph:

(a)

‘areas of permanent grassland’ means permanent grassland declared in 2018 in accordance with Article 72(1), first subparagraph, point (a), of Regulation (EU) No 1306/2013 of the European Parliament and of the Council (16) by farmers receiving direct payments, and determined as referred to in Article 2(1), second subparagraph, point (23), of Commission Delegated Regulation (EU) No 640/2014 (17), where necessary adjusted by Member States to take into account the impact of a possible change, in particular in the definition of permanent grassland to be established by Member States in accordance with Article 4(3), point (c), of Regulation (EU) 2021/2115;

(b)

‘total agricultural area’ means the agricultural area declared in 2018 in accordance with Article 72(1), first subparagraph, point (a), of Regulation (EU) No 1306/2013 by farmers receiving direct payments and determined as referred to in Article 2(1), second subparagraph, point (23), of Delegated Regulation (EU) No 640/2014, where necessary adjusted by Member States, in particular to take into account the impact of a possible change in the definition of agricultural areas to be established by Member States in accordance with Article 4(3) of Regulation (EU) 2021/2115.

2.   The ratio of permanent grassland shall be established each year on the basis of the areas declared for that year by the beneficiaries receiving direct payments pursuant to Title III, Chapter II, of Regulation (EU) 2021/2115 or the annual payments pursuant to Articles 70, 71 and 72 of that Regulation in accordance with Article 67(1) of Regulation (EU) 2021/2116 of the European Parliament and of the Council (18).

Member States may establish the ratio of permanent grassland and the reference ratio at national, regional, sub-regional, group of holdings or holding level.

3.   Where it is established that the ratio referred to in paragraph 2 has decreased by more than 5 % at the level at which the GAEC standard 1 is implemented, the Member State concerned shall impose obligations at holding level to reconvert land into permanent grassland or to establish an area of permanent grassland for some or all of the farmers who have land at their disposal which was converted from permanent grassland into land for other uses during a period in the past.

However, where the area of permanent grassland in a given year is maintained, in absolute, terms within 0,5 % of the areas of permanent grassland established in accordance with paragraph 1, second subparagraph, point (a), the obligation set out in paragraph 1, first subparagraph, shall be considered to have been complied with.

4.   Paragraph 3, first subparagraph, shall not apply where the decrease below the threshold of 5 % is the result of commitments undertaken or obligations, as referred to in Article 4(4), points (b) and (c), of Regulation (EU) 2021/2115 due to which an agricultural activity is no longer performed on the areas in question, and which do not include plantations of Christmas trees or cultivation of crops or trees for energy production.

5.   For the purpose of calculating the ratio referred to in paragraph 2, areas reconverted into permanent grassland or established as permanent grassland in accordance with paragraph 3, or established as permanent grassland as part of the Member States implementation of GAEC standard 1, shall be considered as permanent grassland as of the first day of the reconversion or establishment. Those areas shall be used to grow grasses or other herbaceous forage in compliance with the definition provided for in Article 4(3), point (c), of Regulation (EU) 2021/2115, at least for 5 consecutive years following the reconversion or establishment, or for areas already used to grow grasses or other herbaceous forage, for the remaining number of years to reach 5 consecutive years.

TITLE VI

FINAL PROVISIONS

Article 49

Entry into force

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 7 December 2021.

For the Commission

The President

Ursula VON DER LEYEN


(1)   OJ L 435, 6.12.2021, p. 1.

(2)  Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).

(3)  https://www.unodc.org/unodc/en/treaties/single-convention.html

(4)  Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ L 193, 20.7.2002, p. 1).

(5)  Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (OJ L 193, 20.7.2002, p. 74).

(6)  Commission Directive 2008/62/EC of 20 June 2008 providing for certain derogations for acceptance of agricultural landraces and varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion and for marketing of seed and seed potatoes of those landraces and varieties (OJ L 162, 21.6.2008, p. 13).

(7)  Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

(8)  Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

(9)  Regulation (EU) 2020/741 of the European Parliament and of the Council of 25 May 2020 on minimum requirements for water reuse (OJ L 177, 5.6.2020, p. 32).

(10)  Commission Implementing Regulation (EU) No 821/2014 of 28 July 2014 laying down rules for the application of Regulation (EU) No 1303/2013 of the European Parliament and of the Council as regards detailed arrangements for the transfer and management of programme contributions, the reporting on financial instruments, technical characteristics of information and communication measures for operations and the system to record and store data (OJ L 223, 29.7.2014, p. 7).

(11)  Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4).

(12)  Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (OJ L 157, 15.6.2011, p. 1).

(13)  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 (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1).

(14)  Regulation (EU) 2016/1012 of the European Parliament and of the Council of 8 June 2016 on zootechnical and genealogical conditions for the breeding, trade in and entry into the Union of purebred breeding animals, hybrid breeding pigs and the germinal products thereof and amending Regulation (EU) No 652/2014, Council Directives 89/608/EEC and 90/425/EEC and repealing certain acts in the area of animal breeding (‘Animal Breeding Regulation’) (OJ L 171, 29.6.2016, p. 66).

(15)   OJ C 341, 16.12.2010, p. 5.

(16)  Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549).

(17)  Commission Delegated Regulation (EU) No 640/2014 of 11 March 2014 supplementing Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to the integrated administration and control system and conditions for refusal or withdrawal of payments and administrative penalties applicable to direct payments, rural development support and cross compliance (OJ L 181, 20.6.2014, p. 48).

(18)  Regulation (EU) 2021/2116 of the European Parliament and of the Council of 2 December 2021 on the financing, management and monitoring of the common agricultural policy and repealing Regulation (EU) No 1306/2013 (OJ L 435, 6.12.2021, p. 187).


ANNEX I

Union method for the verification of hemp varieties and the determination of the Δ9-tetrahydrocannabinol content in hemp varieties referred to in Article 3

1.   Scope

The method set out in this Annex seeks to determine the Δ9-tetrahydrocannabinol (hereinafter referred to as ‘THC content’ of varieties of hemp (Cannabis sativa L.). As appropriate, the method involves applying procedure A or B as described in this Annex.

The method is based on the quantitative determination of THC by gas chromatography (GC) after extraction with a suitable solvent.

1.1.   Procedure A

Procedure A shall be used for checks on the production of hemp, where the control sample for on-the-spot checks carried out each year cover at least 30 % of the areas declared for the production of hemp in accordance with Article 4(4), second subparagraph, of Regulation (EU) 2021/2115.

1.2.   Procedure B

Procedure B shall be used where a Member State introduces a system of prior approval for the cultivation of hemp, and the minimum level for the on-the-spot checks covers at least 20 % of the areas declared for the production of hemp in accordance with Article 4(4), second subparagraph, of Regulation (EU) 2021/2115.

2.   Sampling

2.1.   Conditions for taking the samples

The samples shall be taken during the day following a systematic pattern to ensure that the sample is representative of the field, but excluding the edges of the crop.

2.1.1.   Procedure A

In a standing crop of a given variety of hemp, a 30 cm part containing at least one female inflorescence of each plant selected shall be taken. Sampling shall be carried out during the period running from 20 days after the start of flowering to 10 days after the end of flowering.

Member States may authorise sampling to be carried out during the period from the start of flowering to 20 days after the start of flowering provided that, for each variety grown, other representative samples are taken in accordance with the first paragraph during the period from 20 days after the start of flowering to 10 days after the end of flowering.

For hemp cultivated as catch crop, in the absence of female inflorescences, the top 30 cm of the plant stem shall be taken. In that case sampling shall be carried out just before the end of the vegetation period, once the leaves begin presenting the first signs of yellowing, however no later than the onset of a forecast period of frost.

2.1.2.   Procedure B

In a standing crop of a given variety of hemp, the upper third of each plant selected shall be taken. Sampling shall be carried out during the 10 days following the end of flowering or, for hemp cultivated as catch crop, in the absence of female inflorescences, just before the end of the vegetation period, once the leaves begin presenting the first sign of yellowing, but no later than the onset of a forecast period of frost. In the case of dioecious varieties, only female plants shall be taken.

2.2.   Sample size

Procedure A: the sample shall comprise parts of 50 plants per field.

Procedure B: the sample shall comprise parts of 200 plants per field.

Each sample shall be placed in a fabric or paper bag, without crushing it, and be sent to the laboratory for analysis.

Member States may provide for a second sample to be collected for counter-analysis, if required, to be kept either by the producer or by the body responsible for the analysis.

2.3.   Drying and storage of the sample

Drying of the samples shall begin as soon as possible and, in any case, within 48 hours using any method below 70 °C.

Samples shall be dried to a constant weight and to a moisture content of between 8 % and 13 %.

After drying, the samples shall be stored without crushing them at below 25 °C in a dark place.

3.   Determination of THC content

3.1.   Preparation of the test sample

Stems and seeds over 2 mm in size shall be removed from the dried samples.

The dried samples shall be grinded to obtain a semi-fine powder (passing through a 1 mm mesh sieve).

The powder may be stored for 10 weeks at below 25 °C in a dark, dry place.

3.2.   Reagents and extraction solution

Reagents

Δ9-tetrahydrocannabinol, pure for chromatographic purposes,

squalane, pure for chromatographic purposes, as an internal standard.

Extraction solution

35 mg of squalane per 100 ml hexane.

3.3.   Extraction of THC

100 mg of the powdered test sample shall be weighed, be placed in a centrifuge tube and 5 ml of extraction solution shall be added containing the internal standard.

The sample shall be placed in an ultrasound bath and be left for 20 minutes. It shall be centrifuged for 5 minutes at 3 000 r.p.m. and then the supernatant THC solution shall be removed. The solution shall be injected into the chromatograph and a quantitative analysis shall be carried out.

3.4.   Gas chromatography

(a)

Apparatus

gas chromatograph with a flame ionisation detector and a split/splitless injector,

column allowing good separation of cannabinoids, for example a glass capillary column 25 m long and 0,22 mm in diameter impregnated with a 5 % non-polar phenyl-methyl-siloxane phase.

(b)

Calibration ranges

At least three points for procedure A and five points for procedure B, including points 0,04 and 0,50 mg/ml THC in extraction solution.

(c)

Experimental conditions

The following conditions are given as an example for the column referred to in point (a):

oven temperature 260 °C,

injector temperature 300 °C,

detector temperature 300 °C.

(d)

Volume injected: 1 μl.

4.   Results

The findings shall be expressed to two decimal places in grams of THC per 100 grams of analytical sample dried to constant weight. A tolerance of 0,03 g per 100 g shall apply.

Procedure A: one determination per test sample.

However, where the result obtained is above the limit laid down in Article 4(4), second subparagraph, of Regulation (EU) 2021/2115, a second determination shall be carried out per analysis sample and the mean value of the two determinations shall be taken as the result.

Procedure B: the result shall correspond to the mean value of two determinations per test sample.


ANNEX II

List of non-eligible types of expenditure referred to in Article 22(2)

PART I

In the fruit and vegetables sector, the apiculture sector, the hops sector, the olive oil and table olives sector and the other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115

1.

General production costs and, in particular, costs for (even certified) mycelium, seeds and non-perennial plants; plant protection products (including integrated control materials); fertilisers and other inputs; costs of collection or transport (internal or external); storage costs; packaging costs (including use and management of packaging), even as part of new processes; operating costs (in particular electricity, fuel and maintenance).

2.

Reimbursement of loans taken out for an intervention.

3.

Purchase of land not built on costing more than 10 % of all the eligible expenditure on the operation concerned.

4.

Investments in means of transport to be used by the beneficiary in the apiculture sector or for marketing or distribution by the producer organisation.

5.

Operating costs of goods hired.

6.

Expenditure linked to leasing contracts (taxes, interest, insurance costs, etc.) and operating costs.

7.

Subcontracting or outsourcing contracts relating to the operations or expenditure mentioned as not eligible in this list.

8.

Any national or regional taxes or fiscal levies.

9.

Interest on debt except where the contribution is made in a form other than a non-repayable direct assistance.

10.

Investments in shares or capital of companies if the investment represents a financial investment.

11.

Costs incurred by parties other than the beneficiary, producer organisation or its members, associations of producer organisations, or their producer members, or a subsidiary, or an entity within a chain of subsidiaries within the meaning of Article 31(7), or subject to Member State’s approval, by a cooperative which is member of a producer organisation.

12.

Interventions not taking place on the holdings and/or premises of the producer organisation, association of producer organisations, or their producer members, or a subsidiary, or an entity within a chain of subsidiaries within the meaning of Article 31(7), or subject to Member State’s approval, by a cooperative which is member of a producer organisation.

13.

Interventions outsourced or implemented by the beneficiary, the producer organisation outside the Union, except promotion, communication and marketing type of intervention as referred to in Article 47(1), point (f), of Regulation (EU) 2021/2115.

PART II

In the wine sector

1.

Day-to-day management of a vineyard

2.

Protection against damage by game, birds or hail.

3.

Construction of windbreaks and wind protection walls.

4.

Driveways and elevators.

5.

Purchase of tractors or any kind of transport vehicles.

6.

Grubbing-up of infected vineyards and loss of revenue following mandatory grubbing up for health or phytosanitary reasons.

ANNEX III

List of eligible types of expenditure referred to in Article 22(3)

1.

Specific costs for:

quality improvement measures,

biological plant protection materials (such as pheromones and predators) whether used in organic, integrated or conventional production,

agri-environment-climate interventions referred to in Article 12,

organic, integrated or experimental production, including specific costs for organic seeds and seedlings,

monitoring of compliance with the standards referred to in Title II of Implementing Regulation (EU) No 543/2011, with plant-health rules and with maximum level of residues.

Specific costs shall mean the additional costs, calculated as the difference between the conventional production costs and the costs actually incurred, and income foregone resulting from an action excluding additional income and costs savings.

2.

Veterinary medicinal products for the treatment of beehive invaders and diseases affecting bees.

3.

Costs associated with the restocking of beehives and bee breeding.

4.

Purchase of machinery and equipment for the improvement of honey production and collection.

5.

Administrative and personnel costs relating to the implementation of operational programmes or to the relevant interventions, including reports, studies, costs of keeping accounts and the management of accounts, compulsory charges linked to wages and salaries if borne directly by the beneficiary, subsidiaries or an entity within a chain of subsidiaries within the meaning of Article 31(7), or, subject to Member State’s approval, by a cooperative which is member of a producer organisation.

6.

Purchase of land not built on where purchase is necessary to carry out an investment included in the operational programme provided it costs less than 10 % of all the eligible expenditure on the operation concerned. In exceptional and duly justified cases, a higher percentage may be fixed for operations concerning environmental conservation.

7.

Purchase or leasing of tangible assets, including second hand tangible assets provided they have not been purchased with Union or national support in a period of 5 years preceding the purchase or leasing within the limit of the net market value of the tangible asset.

8.

Hire of physical assets where economically justified as an alternative to purchase, at the approval of the Member State.

9.

For the sectors referred to in Article 42, points (a), (d), (e) and (f), of Regulation (EU) 2021/2115, investments in transport vehicles where the producer organisation duly justifies to the Member State concerned that the transport vehicle is used for transport internal to the premises of the producer organisation; and investments in additional on-the-truck facilities for cold-storage or controlled atmosphere transport.

10.

Investments in shares or capital of companies contributing directly to the achievement of the goals of the operational programme.


ANNEX IV

Statement for packaging of products referred to in Article 25(3), point (a)

Продукт, предназначен за безвъзмездно разпределяне (Делегиран регламент (ЕС) 2022/126)

Producto destinado a su distribución gratuita [Reglamento Delegado (UE) 2022/126]

Produkt určený k bezplatné distribuci (nařízení v přenesené pravomoci (EU) 2022/126)

Produkt til gratis uddeling (delegeret forordning (EU) 2022/126)

Zur kostenlosen Verteilung bestimmtes Erzeugnis (delegierte Verordnung (EU) 2022/126)

Tasuta jagamiseks mõeldud tooted [delegeeritud määrus (EL) 2022/126]

Προϊόν προοριζόμενο για δωρεάν διανομή [κατ’εξουσιοδότηση κανονισμός (ΕΕ) 2022/126]

Product for free distribution (Delegated Regulation (EU) 2022/126)

Produit destiné à la distribution gratuite [règlement délégué (UE) 2022/126]

Proizvod za besplatnu distribuciju (Delegirana uredba (EU) 2022/126)

Prodotto destinato alla distribuzione gratuita [regolamento delegato (UE) 2022/126]

Produkts paredzēts bezmaksas izplatīšanai [Deleģētā regula (ES) 2022/126]

Nemokamai platinamas produktas (Deleguotasis reglamentas (ES) 2022/126)

Ingyenes szétosztásra szánt termék ((EU) 2022/126 felhatalmazáson alapuló rendelet)

Prodott għad-distribuzzjoni bla ħlas (Ir-Regolament Delegat (UE) 2022/126)

Voor gratis uitreiking bestemd product (Gedelegeerde Verordening (EU) 2022/126)

Produkt przeznaczony do bezpłatnej dystrybucji [Rozporządzenie delegowane (UE) 2022/126]

Produto destinado a distribuição gratuita [Regulamento Delegado (UE) 2022/126]

Produs destinat distribuirii gratuite [Regulamentul delegat (UE) 2022/126]

Výrobok určený na bezplatnú distribúciu [delegované nariadenie (EÚ) 2022/126]

Proizvod, namenjen za prosto razdelitev (Delegirana uredba (EU) 2022/126)

Ilmaisjakeluun tarkoitettu tuote (delegoitu asetus (EU) 2022/126)

Produkt för gratisutdelning (delegerad förordning (EU) 2022/126)

Táirge lena dháileadh saor in aisce (Rialachán Tarmligthe (AE) 2022/126)


ANNEX V

Maximum amounts of support for market withdrawals referred to in Article 26(1) and (4), first subparagraph

Products

Maximum support (EUR/100 kg)

Free distribution

Other destinations

Cauliflowers

21,05

15,79

Tomatoes (withdrawn from 1 June to 31 October)

7,25

7,25

Tomatoes (withdrawn from 1 November to 31 May)

33,96

25,48

Apples

24,16

18,11

Grapes

53,52

40,14

Apricots

64,18

48,14

Nectarines

37,82

28,37

Peaches

37,32

27,99

Pears

33,96

25,47

Aubergines

31,2

23,41

Melons

48,1

36,07

Watermelons

9,76

7,31

Oranges

21,00

21,00

Mandarins

25,82

19,50

Clementines

32,38

24,28

Satsumas

25,56

19,50

Lemons

29,98

22,48


ANNEX VI

Minimum requirements for withdrawal of products referred to in Article 29(2)

1.   

The products shall be:

whole, when it applies to fresh raw products,

sound; products affected by rotting or deterioration such as to make them unfit for consumption shall be excluded,

clean, practically free from any visible foreign matter,

practically free from pests and damage caused by pests where applicable,

free of abnormal moisture,

free of any foreign taste or smell.

2.   

Products must be suitable for marketing and consumption, sufficiently developed and ripe where applicable, taking account of their normal characteristics.

3.   

Products must be characteristic of the variety or commercial type or quality where applicable.


ANNEX VII

Conditioning costs referred to in Article 33

Product

Sorting and packing costs (EUR/t)

Apples

187,70

Pears

159,60

Oranges

240,80

Clementines

296,60

Peaches

175,10

Nectarines

205,80

Watermelons

167,00

Cauliflowers

169,10

Other products

201,10


31.1.2022   

EN

Official Journal of the European Union

L 20/95


COMMISSION DELEGATED REGULATION (EU) 2022/127

of 7 December 2021

supplementing Regulation (EU) 2021/2116 of the European Parliament and of the Council with rules on paying agencies and other bodies, financial management, clearance of accounts, securities and use of euro

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2021/2116 of the European Parliament and of the Council of 2 December 2021 on the financing, management and monitoring of the common agricultural policy and repealing Regulation (EU) No 1306/2013 (1), and in particular Articles 11(1),23(2), 38(2), 40(3), 41(3), 47(1), 52(1), 54(4), 55(6), 64(3), 76(2), 94(5) and (6) thereof,

Whereas:

(1)

Regulation (EU) 2021/2116 lays down the basic provisions concerning, inter alia, the accreditation of paying agencies and coordination bodies, the obligations of the paying agencies as regards public intervention, the financial management and the clearance procedures, securities and use of euro. In order to ensure the smooth functioning of the new legal framework, certain rules have to be adopted to supplement the provisions laid down by that Regulation in the areas concerned. The new rules should replace the relevant provisions of Commission Delegated Regulation (EU) No 907/2014 (2).

(2)

In accordance with Article 9(2) of Regulation (EU) 2021/2116, paying agencies may only be accredited by Member States if they comply with certain minimum criteria established at Union level. Those criteria are to cover four basic areas: internal environment, control activities, information and communication, and monitoring. Member States should be free to lay down additional accreditation criteria to take account of any specific features of a paying agency.

(3)

In accordance with Article 8(1), point (b), of Regulation (EU) 2021/2116, a competent authority at ministerial level is to be responsible for the issuing, reviewing and withdrawing of the accreditation of the coordinating body referred to in Article 10 of that Regulation. Coordinating bodies should only be accredited by Member States if they comply with certain minimum criteria established at Union level and by the competent authority. Those criteria should cover the specific tasks of the coordinating body as regards the processing of the information of a financial character as referred to in Article 10(1), point (a), and (2) of Regulation (EU) 2021/2116.

(4)

Public intervention measures may be financed only if the expenditure concerned is incurred by the paying agencies designated by the Member States as being responsible for certain obligations with respect to public intervention. However, the performance of tasks relating, in particular, to the administration and checking of intervention measures, with the exception of payment of aid, may be delegated in accordance with Article 9(1), second subparagraph, of Regulation (EU) 2021/2116. It should also be possible for several paying agencies to perform these tasks. It should also be laid down that the management of certain public storage measures may be entrusted to third parties, whether public or private bodies, under the responsibility of the paying agency. It is therefore appropriate to specify the scope of the responsibility of the paying agencies in this context, specify their obligations and determine under what conditions and according to which rules the management of certain public storage measures may be entrusted to third parties, whether public or private bodies. In this case, it should be provided that the bodies concerned have to act under contract on the basis of general obligations and principles which should be laid down.

(5)

Union agricultural legislation includes, for the European Agricultural Guarantee Fund (EAGF) and interventions financed by the European Agricultural Fund for Rural Development (EAFRD) and governed under the integrated administration and control system (IACS), periods for payment of aids to beneficiaries, which have to be complied with by Member States. Payments effected outside those periods are to be regarded as ineligible for Union financing. However, analysis has shown that in a number of cases late payments of aid are made by Member States due to additional checks by Member States related to contentious claims, appeals and other national legal disputes. Therefore and in accordance with the principle of proportionality, a fixed margin related to expenditure should be laid down within which no reductions of payments are to be made for these cases. In addition, once this margin is exceeded, in order to modulate the financial impact in proportion to the delay incurred in payment, provision should be made for the Commission to proportionally reduce the Union payments according to the length of delay in payment recorded.

(6)

Payments of aid before the earliest possible date of payment as laid down by Union law cannot be justified by the same reasons as payments after the latest possible date of payment. Therefore, no proportional reduction should be provided for those early payments. However, an exception should be provided for cases where Union agricultural legislation provides the payment of an advance up to a certain maximum amount.

(7)

The Commission is to make payments to the Member States on the basis of declarations of expenditure sent by the Member States, in accordance with Articles 21 and 32 of Regulation (EU) 2021/2116. The Commission should, however, take into account the revenue received by the paying agencies on behalf of the Union budget. The conditions under which certain types of expenditure and revenue effected under the EAGF and the EAFRD are to be offset should therefore be laid down.

(8)

Pursuant to Article 16(2), third subparagraph, of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (3), if the Union budget has not been adopted by the beginning of the financial year, payments may be made monthly per chapter to a maximum of one twelfth of the allocated appropriations in the relevant chapter of the budget for the preceding financial year. To allocate the available appropriations fairly among the Member States, provision should be made for the monthly payments under the EAGF and the interim payments under the EAFRD to be made in this case as a percentage of the declarations of expenditure submitted by each Member State and for the balance not used in a given month to be reallocated in the subsequent monthly or interim payments.

(9)

It should be provided that the Commission, after having informed the Member States concerned, may defer the compensation of the expenditure and the assigned revenue for the next monthly payments in case there is late submission of the required information or there are discrepancies that needs to be further clarified with the Member State.

(10)

To avoid the application, by the Member States which have not adopted the euro, of different exchange rates in accounts of revenue received or aid paid to beneficiaries and registered in the account of the paying agencies, in a currency other than the euro, on the one hand, and in the declaration of expenditure drawn up by the paying agency, or the accredited coordinating body, on the other, additional requirements need to be laid down.

(11)

For cases where the exchange rate for the operative event have not been established by the Union law it needs be established requirements for the exchange rate that Member States which have not adopted the euro, have to use in their declaration of expenditure and for the purpose of the financial and performance clearance for the assigned revenue resulting from financial consequences of non-recovery.

(12)

In the context of the performance clearance, it is appropriate to lay down rules on the criteria for justifications to be provided by the Member State concerned and the methodology and criteria for applying reductions.

(13)

In order to enable the Commission to verify that Member States respect their obligation to protect the financial interests of the Union and to ensure an efficient application of the conformity clearance procedure provided for in Article 55 of Regulation (EU) 2021/2116, provisions should be laid down concerning the criteria and methodology to apply corrections. The different types of corrections referred to in that Article 55 should be defined and principles should be laid down on how the circumstances of each case will be taken into account to determine the amounts of correction. Moreover, rules should be established on how recoveries made by the Member States from the beneficiaries will be credited to the EAGF and the EAFRD.

(14)

In respect of the specific eligibility rules for the crop-specific payment for cotton set out in Title III, Chapter II, Section 3, Subsection 2, of Regulation (EU) 2021/2115 of the European Parliament and of the Council (4) and support for early retirement as referred to in Article 155(2) of that Regulation, cases of non-compliance need to be assessed under a conformity procedure, which would assess the compliance with legality and regularity at beneficiary level.

(15)

Under the new delivery model, the compliance of the Member States’ systems with the Union rules will be assessed and in cases of serious deficiencies with the governance systems, the Commission will propose to exclude certain expenditure from Union financing in a conformity procedure. The assessment should not extend to cases of non-compliance with the eligibility conditions for individual beneficiaries laid down in the national CAP Strategic Plans and national rules. As the assessment is at systems level, the proposal for exclusion from Union financing should be based on flat-rate corrections. However, where the specific circumstances allow, Member States could provide a detailed calculation or an extrapolated calculation of the risk forthe EAGF or the EAFRD, to be assessed by the Commission in the conformity procedure.

(16)

Numerous provisions in agricultural regulations of the Union require that a security be given to ensure payment of a sum due if an obligation is not met. Therefore, in order to avoid unequal competitive conditions, the conditions applying to that requirement should be laid down.

(17)

In the interest of clarity and legal certainty, Delegated Regulation (EU) No 907/2014 should be repealed. However, Article 5a, Article 7(3) and (4), Article 11(1), second subparagraph, and (2) and Article 13 of that Regulation should continue to apply to the implementation of rural development programmes pursuant to Regulation (EU) No 1305/2013 of the European Parliament and of the Council (5) and to the operational programmes approved under Regulation (EU) No 1308/2013 of the European Parliament and of the Council (6), while Article 13 of that Regulation should continue to apply for ongoing recoveries launched under Article 54 of Regulation (EU) No 1306/2013 of the European Parliament and of the Council (7).

(18)

In the interest of the correct implementation of Regulation (EU) 2021/2116, it is appropriate to specify that where a paying agency, accredited in accordance with Regulation (EU) No 1306/2013, assumes responsibility for expenditure for which it was not previously responsible, it should be accredited with the new responsibilities before 1 January 2023.

(19)

Finally, in view of Point 31 of the Inter-institutional Agreement of 13 April 2016 on Better Law-Making, the Commission considers that there is a substantive link between the empowerments in Regulation (EU) 2021/2116 regarding the rules on paying agencies’ accreditation, financial management, clearance and securities, and there is an interconnection between them in the day-to-day management of the CAP expenditure. It is, therefore, appropriate to lay down those rules in the same delegated act,

HAS ADOPTED THIS REGULATION:

CHAPTER I

Paying agencies and other bodies

Article 1

Conditions for the accreditation of paying agencies

1.   Member States shall accredit as paying agencies departments or bodies, which fulfil the conditions laid down in this paragraph and meet the criteria referred to in paragraphs 2 and 3. Paying agencies carrying out the management and control of expenditure as provided for in Article 9(1) of Regulation (EU) 2021/2116 shall provide, in respect of payments made by them and as regards communicating and keeping information, sufficient guarantees that:

(a)

as regards types of intervention referred to in Regulation (EU) 2021/2115, the expenditure matches the corresponding reported output and that it has been effected in accordance with the applicable governance systems;

(b)

payments are legal and regular as regards the measures laid down in Regulations (EU) No 228/2013 (8), (EU) No 229/2013 (9), (EU) No 1308/2013 and (EU) No 1144/2014 of the European Parliament and of the Council (10);

(c)

accurate and exhaustive accounts are kept of the payments made;

(d)

the checks laid down by Union legislation are made;

(e)

the requisite documents are presented within the time limits and in the form set out by Union rules;

(f)

the documents are accessible and kept in a manner which ensures their completeness, validity and legibility over time, including with regard to electronic documents within the meaning of Union rules.

2.   In order to be accredited, a paying agency shall have an administrative organisation and a system of internal control which comply with the criteria set out in Annex I regarding:

(a)

internal environment;

(b)

control activities;

(c)

information and communication;

(d)

monitoring.

3.   Member States may lay down further accreditation criteria to take account of the size, responsibilities and other specific features of the paying agency.

Article 2

Conditions for the accreditation of coordinating bodies

1.   Where more than one paying agency is accredited, in accordance with Article 10(1) of Regulation (EU) 2021/2116, the Member State concerned shall accredit as coordinating bodies departments or bodies, which fulfil the conditions laid down in paragraph 2 and meet the criteria referred to in paragraphs 3 and 4. That Member State shall, by a formal act at ministerial level, decide on the accreditation of the coordinating body after it has satisfied itself that the administrative arrangements of that body guarantee that it is capable of fulfilling the tasks referred to in that Article.

2.   In order to be accredited, the coordinating body shall ensure that:

(a)

declarations to the Commission are based on information from properly authorised sources;

(b)

the annual performance report referred to in Article 54(1) of Regulation (EU) 2021/2116 and Article 134 of Regulation (EU) 2021/2115 is covered by the scope of the opinion referred to in Article 12(2) of Regulation (EU) 2021/2116 and its transmission is accompanied by a management declaration covering the compilation of the entire report;

(c)

declarations to the Commission are properly authorised before transmission;

(d)

a proper audit trail exists to support the information transmitted to the Commission;

(e)

a record of information received and transmitted is securely stored in computerised format.

3.   In order to be accredited, a coordinating body shall have an administrative organisation and a system of internal control as regards the compilation of the annual performance report, which complies with requirements set by the competent authority as regards the procedures involved, and especially the criteria on information and communication as set out in Annex II.

4.   Member States may lay down further accreditation criteria to take account of the size, responsibilities and other specific features of the coordinating body.

Article 3

Obligations of the paying agency as regards public intervention

1.   The paying agencies referred to in Article 9(1) of Regulation (EU) 2021/2116 shall manage and ensure control of the operations linked to intervention measures relating to public storage for which they are responsible, under the terms laid down in Annex III to this Regulation and, where appropriate, in the sectoral agricultural legislation, in particular on the basis of the minimum checking rates fixed in that Annex.

The paying agencies may delegate their powers in relation to public intervention measures to intervention agencies which meet the conditions of approval laid down in point 1.D of Annex I to this Regulation or act through other paying agencies.

2.   The paying agencies or intervention agencies may, without prejudice to their overall responsibility relating to public storage:

(a)

entrust the management of certain public storage measures to natural or legal persons storing bought-in agricultural products (‘storers’);

(b)

mandate natural or legal persons to carry out certain specific tasks laid down by the sectoral agricultural legislation.

If the paying agencies entrust the management to storers as referred to in the first subparagraph, point (a), such management shall be carried out under storage contracts on the basis of the obligations and general principles set out in Annex IV.

3.   The obligations of paying agencies with regard to public storage shall be, in particular, as follows: