What changed

OPINION

The Committee on the Environment, ClimateCulture and Food SafetyEducation calls on the Committee on Budgetary Control, as the committee responsible, to incorporate the following into its proposalmotion for a decision:resolution:

General considerations

Discharge in respect of the implementation of the budget of the Translation Centre for the Bodies of the European Union

1. Welcomes the constructive cooperation between the European Parliament and the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) (the Agencies), illustrated, inter alia, by the annual exchanges of views that took place in 2023 in the Committee on the Environment, Public Health and Food Safety (ENVI);

1. Notes the efforts of the Translation Centre for the Bodies of the European Union (‘the Centre’) to enable and promote multilingualism in the Union, for example as regards communications of the Union agencies and the development of terminology in specialised subject areas to improve the quality of translations;

2. Considers that regular visits to and from the Agencies are a key aspect of the scrutiny exercised by the European Parliament over them; notes in this regard the success of the ENVI delegation to the EMA in February 2023 and to the ECHA in April 2023, which facilitated constructive dialogue, enhanced transparency, and strengthened the Parliament's oversight role.

2. Welcomes the setting up of a working group on artificial intelligence (AI) in June 2023 and the decision to take the work of that group further in a new advisory group on AI;

3. Expresses its satisfaction that the European Court of Auditors (ECA) has confirmed the legality and regularity, in all material respects, of the transactions underlying the Agencies' annual accounts for the financial year 2023, as well as the fair representation of their financial position as of 31 December 2023;

3. Is pleased with the Centre’s multi-engine machine translation strategy, which allows for clients’ documents to be translated on site in combination with the intervention of human translators, which is essential for delivering high-quality translations; encourages the Centre to continue its efforts in that area;

4. Welcomes the measures taken by the agencies in light of the European Parliament recommendations in its discharge for the financial year 2022; stresses the importance of increasing the Agencies’ efforts in terms of cooperation with other agencies and international organisations, digitalisation, and gender and geographical balance in senior management positions;

4. Welcomes the fact that the Court of Auditors, in its annual report on EU agencies for the financial year 2023, confirms the legality and regularity of the revenue and payments underlying the Centre’s accounts;

5. Welcomes the fact that the Agencies have implemented effective corrective actions in response to most of the 2022 observations from the ECA; takes note of the 2023 observations regarding the Agencies, particularly those related to ex-ante checks, and emphasises the importance of addressing these issues promptly and thoroughly; calls on the Agencies to maintain their commitment to transparency and accountability through an effective and timely follow-up process;

5. Observes with concern the Court’s findings with regard to various public procurement procedures, which led to irregular payments; encourages the Centre to continue its efforts in improving its monitoring of contracts and its procurement procedures; recommends the establishment of robust oversight mechanisms and regular training for staff to ensure compliance and mitigate risks;

6. Acknowledges the importance of localized initiatives that strengthen health systems and environmental initiatives, while increasing collaboration with Member States and Agencies.

6. Notes that the Centre has still three open observations that have not yet been remedied; encourages the Centre to comply with the ECA's recommendation for corrective action;

7. Calls for improvement in the funding distribution approach, prioritizing the reduction of administrative burdens and channelling resources directly to final recipients by simplifying procedures to enhance accessibility to economic players on the ground.

7. Notes with concern the underrepresentation of women in senior and middle management positions as well as on the management board; urges the Centre to implement a comprehensive gender balance strategy, including measurable targets and proactive recruitment initiatives, to ensure equitable representation at all levels;

Part I – Discharge in respect of the implementation of the budget of the European Centre for Disease Prevention and Control (ECDC) for the financial year 2023

8. Welcomes the fact that the Centre approved its 2023-2024 internal control and anti-fraud action plan, with a focus on raising awareness among staff with regard to identifying and registering exemptions and non-compliance events, on the prevention of fraud and on ethics;

1. Acknowledges the key role of the ECDC in identifying and assessing current and emerging threats to human health from communicable diseases and related special health issues, in order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans and related special health issues;

9. Notes the fact that the Centre has contracted a specialist consultancy to design and implement an EMAS-compliant environment management system; strongly encourages the Centre to pursue its efforts to obtain an EMAS certificate.

2. Notes that the ECDC mandate was extended following the adoption of Regulation (EU) 2022/2370 which entered into force on 13 December 2022 in order to strengthen the Union's health security framework in the fields of epidemiological surveillance; invites the Commission to strengthen investments in the public health workforce and enhance coordination mechanisms for responding to emerging threats, such as infectious disease outbreaks​; welcomes the fact that the ECDC began to implement its new mandate by reviewing the modalities of collaboration with its main partners and stakeholders, as well as the structure and content of its Strategy 2021-2027, while emphasising the importance of ensuring accountability and transparency throughout this process; emphasizes the importance of maintaining the annual declarations of interest of all management board members, advisory forum members and their alternates updated and accessible;

3. Welcomes the continued development of the One Health Framework and the creation of the One Health Task Force to strengthen collaboration with EMA, EFSA, EEA and ECHA; considers these important steps to further strengthen the One Health approach ensuring the inclusion of human, animal and plant health, as well as their interactions with the environment; highlights the importance of ensuring good and fair cooperation between the Agencies and increased collaboration with Member States, while cautioning against inefficiencies, duplication of efforts, and overlapping mandates;

4. Welcomes, following the observations in the 2022 discharge, the signing of the Working Arrangements between the ECDC and Health Emergency Preparedness and Response Authority (HERA) in order to avoid overlaps and duplication of efforts;

5. Stresses that gender balance in the composition of the top management of our agencies and institutions must be a guideline; notes that the Agency's senior management is currently composed of 67% men and 33% women, according to the figures communicated; calls on the Agency to take this into consideration in future recruitments;

6. Notes that 22,7 % of the Agency's staff are nationals of the Member State where it is located; recalls the importance of geographical balance and encourages the Agency to continue to take the necessary measures to have a balanced and fair geographical representation;

7. Acknowledges the lessons learnt during the COVID-19 pandemic, calling for the need for pandemic preparedness and a unified EU response strategy, that utilises digital early warning systems for prompt and efficient decision making.

8. Welcomes the agency's efforts towards an Eco-Management and Audit Scheme (EMAS) certification, which was finally granted in January 2024;

9. Welcomes the fact that the ECDC was able to deliver 90% of the outputs planned in its Single Programming Document 2023−2025, with 5% of the planned outputs postponed, and 4% cancelled, delayed, not implemented or not applicable by the end of the year.

Part II – Discharge in respect of the implementation of the budget of the European Chemicals Agency (ECHA) for the financial year 2023

1. Acknowledges that the ECHA is key in implementing a growing number of Union legislation that regulates chemicals for the benefit of protecting public health and the environment, as well as for innovation and competitiveness; recognises that the ECHA collects, evaluates, and disseminates extensive information on chemicals, assists companies in complying with legislation, and promotes the safe use of chemicals;

2. Observes that the Agency's budget relies on collected fees and a contribution from the Union’s general budget; highlights the need to ensure full transparency of collected fees; takes note with concern that after a rise in 2022, in 2023 the ECHA’s fee income has again decreased, increasing the reliance on the Union to finance its operations; stresses the need to address the lack of predictability of the ECHA’s fee income and reiterates its previous calls to the Commission to improve the ECHA’s budgetary certainty by presenting its proposal to strengthen the governance of ECHA in line with its commitment expressed in the Chemicals Strategy for Sustainability;

3. Recalls the importance of prioritizing efficient resource allocation over increasing staffing levels and stresses the need to allocate staff primarily to scientific roles critical to achieving ENVI objectives, while avoiding unnecessary expansion of the Agency’s workforce;

4. Cautions against overburdening the ECHA with additional regulatory tasks introduced by new directives and regulations, and emphasizes the importance of maintaining focus on its primary responsibilities under REACH and CLP;

5. Acknowledges that in 2023 the ECHA delivered its regulatory tasks under the Union chemicals legislation, in particular REACH and CLP, provided scientific-technical support to the Commission in the implementation of the Chemicals Strategy for Sustainability, as well as preparing and starting work on the implementation of new regulatory tasks under the Drinking Water Directive, the Batteries Regulation and the Serious Cross-Border Threats to Health Regulation;

6. Welcomes the progress made on the Integrated Regulatory Strategy and the Joint Evaluation Action Plan; recognises the advancements in identifying substances and substance groups as candidates for regulatory action; regrets that the ECHA has, however, fallen short on fulfilling key indicators for identification and prioritisation of hazardous substances; stresses the need to complete the identification of hazardous substances to ensure their safe use;

7. Notes that, despite falling short of fulfilling key indicators for the identification and prioritisation of hazardous substances, the Agency's 2023 annual report highlights that ECHA screened 61 groups covering approximately 1,380 substances, surpassing its initial target, and identified 320 substances for potential risk management, 280 requiring further data, and 540 requiring no further action; furthermore, acknowledges that by the end of 2023, ECHA had assessed 92% of substances registered above 100 tonnes, leaving fewer than 400 high-tonnage substances still to be evaluated;

8. Welcomes the ECHA’s efforts to promote the use of alternatives to animal testing for the regulatory assessment of chemicals and to foster understanding of the opportunities and challenges in moving away from animal testing while ensuring a high level of protection of human health and the environment and encourages ECHA to promote the use of non-animal testing methods;

9. Notes with concern the difficulty to recruit sufficient experts from Member States to the ECHA’s Scientific Committees, posing a risk to the ECHA’s ability to meet legal deadlines and targets in regulatory processes that are dependent on the Committees’ outputs, in particular in the light of increasing tasks being attributed to the ECHA; identifies a need for increased localised collaboration with universities, research centers and specialised national services from the Member States;

10. Stresses that gender balance in the composition of the top management of our Agencies and institutions must be a guideline; notes that the Agency's senior management is currently composed of 73% men and 27% women, according to the figures communicated; calls on the Agency to take this into consideration in future recruitments;

11. Notes that 29.1 % of its staff are nationals of the Member State where the Agency is located; recalls the importance of geographical balance and encourages the Agency to continue to take the necessary measures to have a balanced and fair geographical representation;

12. Welcomes the ECHA Strategy Statement for 2024 - 2028 adopted in December 2023, which sets out the priorities for the ECHA in implementing its evolving mandate and calls for its implementation to prioritize efficiency, financial sustainability, and a reduction in regulatory burdens on businesses and Member States, in order to improve effectiveness in delivering ENVI-related objectives;

Part III – Discharge in respect of the implementation of the budget of the European Environment Agency (EEA) for the financial year 2023

1. Stresses that the EEA provides sound, independent and up-to-date scientific information on the environment; commends the quality of its outputs released in 2023, such as Pathways towards circular plastics in Europe — good practice examples from countries, business and citizens, Assessing the costs and benefits of climate change adaptation and European forest ecosystems: key allies in sustainable development, acknowledges the outmost importance of the EEA to reach the Union’s climate goals; appreciates the EEA’s support of members of the ENVI committee by providing excellent, up-to-date data and information;

2. Acknowledges the adaptability of the EEA, which, in addition to its planned publications for 2023, produced additional works on topics ranging from extreme weather to human health, including The Importance of Restoring Nature in Europe, demonstrating its capacity to inform and contribute to policy debates arising from evolving circumstances;

3. Notes that the EEA is tasked with tracking progress towards the 8th Environment Action programme (‘8th EAP’), which builds on the European Green Deal and sets the framework for Union environmental policy until 2030, with a long-term priority objective for 2050 of living well within planetary boundaries, while investing in competitiveness as outlined in the Draghi report; welcomes the release of its first annual monitoring report in December 2023, on the basis of a set of 28 headline indicators and corresponding targets such as climate change mitigation and adaptation, circular economy and biodiversity;

4. Takes note that, in June 2023 and following a pre-selection by the Commission, a selection by the Management Board and a hearing in ENVI, Leena Ylä-Mononen took over as EEA Executive Director from Hans Bruyninckx, who had served in the role for 10 years; welcomes the swift and effective process which led to this appointment;

5. Welcomes the fact that, following the Discharge Authority’s recommendations of 2022, the EEA has established regular progress monitoring processes for both the implementation of key reports and assessments and recently with a stronger focus on indicators, and has consecutively reached a budget execution rate of 100% of the annual budget, a 100% delivery rate of key reports and assessments, and high engagement with key stakeholders and network partners throughout the year;

6. Stresses that gender balance in the composition of the top management of our Agencies and institutions must be a guideline; welcomes the fact that the Agency's senior management is currently composed of 50% men and 50% women, according to the figures communicated;

7. Notes that 20.1 % of its staff are nationals of the Member State where the Agency is located; recalls the importance of geographical balance and encourages the Agency to continue to take the necessary measures to have a balanced and fair geographical representation;

8. Takes note with concern that despite the multi-year nature of the EEA’s tasks, an imbalance exists concerning the numbers of permanent versus contractual posts in the Agency, as well as operational staff versus support staff, leading to a constant need for reskilling as well as an overload of administrative work for scientists; considers that taking into account the substantial increase of workload, and in order to properly perform the required tasks linked to the Union’s goals for, inter alia, climate neutrality, circular economy and nature restoration, the EEA’s staff number should continue to substantially grow in the years to come and this should be reflected in the financial resources allocated to the Agency.

9. Cautions against overburdening the EEA with additional tasks arising from new directives and regulations, emphasizing the need to focus on its primary responsibilities; stresses the importance of ensuring that resources are not diluted by attempting to address an overly broad range of objectives, which could compromise the quality and impact of its outputs;

Part IV – Discharge in respect of the implementation of the budget of the European Food Safety Authority (EFSA) for the financial year 2023

1. Welcomes the EFSA's' contribution to the safety of the Union food and feed chain, and its considerable efforts in providing risk managers with comprehensive, independent and up-to-date scientific advice on questions linked to the food chain, communicating clearly to the public on its outputs and the information on which they are based, and cooperating with interested parties and institutional partners to promote coherence and trust in the food safety system;

2. Welcomes the involvement of the EFSA in ENVI’s work and more generally the engagement of EFSA with initiatives related to the Farm to Fork and the Union Chemical strategies, with a particular emphasis on pesticides, nutrition, animal welfare, and chemical risk assessment; stresses the need for these efforts to remain firmly grounded in robust, evidence-based policy-making, including the establishment of a Union chemicals data platform, to ensure that decisions are informed by the best available scientific data and promote effective and balanced regulatory outcomes;

3. Cautions against overburdening the EFSA with additional tasks linked to broader initiatives such as the Farm to Fork and Union Chemical strategies, emphasizing that its primary focus should remain on food safety and core chemical risk assessments;

4. Notes that the EFSA closed 660 scientific questions in 2023, slightly below the target of 673 but better than the result achieved since 2020; highlights the need to decrease the amount of questions in stock; welcomes the measures put in place to increase the speed of the Risk Assessment process;

5. Notes with concern that, according to the Annual Strategy Survey launched by the EFSA asking for feedback from its customers, partners, and stakeholders who are directly or indirectly involved in the delivery of the EFSA’s scientific opinions, the EFSA’s ability to provide its advice in a timely manner remains a point of attention as in the previous year; calls on the EFSA to implement the necessary measures to improve this aspect;

6. Highlights the need for the EFSA to develop strong cooperation with all its stakeholders, including the other Agencies for better connection and outputs dissemination; welcomes the fact that the EFSA developed cooperation with Member States, including with the increased support of the Focal Points Network, mainly focusing on support in the area of data collection and communication; encourages EFSA to even further increase its efforts to protect animal welfare and promote the use of non-animal testing methods, also in its cooperation with other institutions;

7. Stresses that gender balance in the composition of the top management of our Agencies and institutions must be a guideline; notes that the EFSA's senior management is currently composed of 63% men and 38% women, according to the figures communicated; calls on the Agency to take this into consideration in future recruitments;

8. Notes that 41.8 % of its staff are nationals of the Member State where the Agency is located; recalls the importance of geographical balance and encourages the Agency to continue to take the necessary measures to have a balanced and fair geographical representation;

9. Highlights that the European Parliament adopted two resolutions at the beginning of the mandate to object to Maximum Residues Levels (MRLs) for pesticides due to cumulative and synergistic effects not having been taken into account in EFSA’s reasoned opinion;

10. Welcomes the fact that the EFSA continued implementing its new organisational structure that was put in place in 2022 to reflect the Transparency Regulation; notes that the Transparency Regulation required the Commission to develop and adopt a ‘General Plan for Risk Communication’, which has not been presented by the Commission despite the preparatory work completed by the EFSA; highlights the need to continuously improve efficiency and transparency in the EFSA’s process architecture.

11. Encourages EFSA to expand its efforts in horizon scanning and early identification of emerging risks in the food and feed chain, particularly in areas linked to climate change and the increasing complexity of global supply chains; stresses the importance of adopting proactive approaches to risk assessment and mitigation to ensure the resilience of the Union’s food system.

12. Underlines the significance of enhancing public engagement and outreach activities, including leveraging digital tools to increase public access to scientific information and the rationale behind EFSA’s decisions; calls for the development of user-friendly platforms that promote greater understanding and foster citizen participation in the food safety dialogue.

13. Notes the growing importance of alternative protein sources and novel foods in achieving the Union’s sustainability goals; calls on the EFSA to prioritize the development of robust scientific frameworks for assessing the safety and nutritional impact of these products, ensuring that innovation is underpinned by rigorous risk assessment standards.

14. Calls for closer collaboration between the EFSA and the ECDC to enhance the monitoring and assessment of zoonotic diseases and antimicrobial resistance; stresses the need for a unified approach to safeguarding public health through a ‘One Health’ perspective.

Part V – Discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2023

1. Reiterates the key role of the EMA in protecting human and animal health by assessing and supervising medicines for human or veterinary use and protecting public health by raising awareness on key issues including antimicrobial resistance and prevention of communicable diseases through vaccination;

2. Notes that in 2023, the EMA recommended for marketing authorisation 77 new human medicines, including 39 new active substances, and 14 new veterinary medicines, including 9 new active substances; welcomes the fact that the EMA confirmed seventeen orphan-status designations under the Union framework for orphan medicines, the purpose of which is to encourage the development and marketing of medicines for patients with rare diseases, adopting an expedited mechanism under special conditions;

3. Notes the EMA decision to lift its COVID-19 business continuity measures, in alignment with the World Health Organisation declaration of the end of COVID-19 as a public health emergency of international concern; welcomes the fact that it enabled the EMA to shift its focus to address other challenges, including the finalisation of the EMA’s extended mandate obligations, of the medical devices and in vitro medical devices regulations (MDR/IVDR), and the first reflections on the EC proposal for the revision of the general Union pharmaceutical legislation for human medicines;

4. Welcomes the EMA’s efforts to contribute to Union priorities, including via inter alia the implementation of the Union Beating Cancer Plan, the Union Chemical Strategy for Sustainability and the European One Health Action Plan against Antimicrobial Resistance; urges the EMA to further cooperate with relevant agencies and actors to combat new, rare and difficult-to-diagnose cancers; reiterates the need to pay special attention to often misdiagnosed conditions among women and girls and to be conscious of class bias in health related issues and pharmacological needs;

5. Recalls that the EMA is a fee-funded agency, with 88,21 % of its 2023 revenue stemming from fees for applications for marketing licenses for pharmaceutical products and for post-authorisation activities, 11,43 % stemming from the Union budget and 0,36 % from various other sources; highlights the need to ensure full transparency of these revenues and welcomes the fact that in the future the EMA will have the obligation to publish in its activity report the annual revenue received per type of fee and charge according to Regulation (EU) 2024/568 ;

6. Notes that in 2023 the EMA received 6 965 requests for information and 709 requests for access to documents and that the EMA applies a queuing system that leads to delays in the treatment of the requests; emphasises the importance of transparency in the EMA operations, hence the need to ensure a timely access to information and documents;

7. Stresses that gender balance in the composition of the top management of our agencies and institutions must be a guideline; notes that the Agency's senior management is currently composed of 60% men and 40% women, according to the figures communicated; calls on the Agency to take this into consideration in future recruitments;

8. Notes that the Agency has concluded an internal environmental audit in 2023 with a view to obtaining EMAS certification in 2024;

9. Recommends the establishment of a formal framework for joint procurement of essential medicines across Member States, modelled on the success of the COVID-19 vaccine procurement process, for ensuring equitable access to high-quality medicines through economies of scale.

10. Notes that the situation regarding the EMA’s former premises in London became increasingly challenging in 2023, with a need for the EMA to dedicate significant levels of resources to managing commercial real estate in a third country, endangering its core activities; calls on the Commission to secure a long-term political resolution of this issue and to allow the EMA to fully focus its efforts on its public health mission.

Conclusion

1. Recommends, based on the facts available, that discharge be granted to the Executive Directors of the Agencies in respect of the implementation of the budget of the European Union Agencies for the financial year 2023.

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The Chair in his capacity as rapporteur for the opinion declares under hisher exclusive responsibility that heshe did not receive input from any entity or person to be mentioned in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.

INFORMATION ON ADOPTION BY COMMITTEE ASKED FOR OPINION

Date adopted

18.2.2025

30.1.2025

Result of final vote

0:

58

20

17

0

7

2

Members present for the final vote

Grégory Allione, Vytenis Povilas Andriukaitis, Pascal Arimont, Bartosz Arłukowicz, Sakis Arnaoutoglou, Anja Arndt, Thomas Bajada, Alexander Bernhuber, Barbara Bonte, Stine Bosse, Lynn Boylan, Delara Burkhardt, Pascal Canfin, Annalisa Corrado, Antonio Decaro, Ondřej Dostál, Pietro Fiocchi, Emma Fourreau, Anne-Sophie Frigout, Heléne Fritzon, Gerben-Jan Gerbrandy, Andreas Glück, Hanna Gronkiewicz-Waltz, Anja Hazekamp, Esther Herranz García, Martin Hojsík, Pär Holmgren, Romana Jerković, Radan Kanev, Stefan Köhler, Ewa Kopacz, András Tivadar Kulja, Katri Kulmuni, Peter Liese, Javi López, César Luena, Elżbieta Katarzyna Łukacijewska, Ignazio Roberto Marino, Tilly Metz, Dolors Montserrat, Dan-Ştefan Motreanu, Jana Nagyová, Rasmus Nordqvist, Jacek Ozdoba, Jutta Paulus, Carola Rackete, Massimiliano Salini, Silvia Sardone, Majdouline Sbai, Lena Schilling, Jonas Sjöstedt, Sander Smit, Claudiu-Richard Târziu, Ingeborg Ter Laak, Beatrice Timgren, Dimitris Tsiodras, Filip Turek, Ana Vasconcelos, Aurelijus Veryga, Kristian Vigenin, Alexandr Vondra, Emma Wiesner, Michal Wiezik, Milan Zver

Nikolaos Anadiotis, Zsuzsanna Borvendég, Alma Ezcurra Almansa, Sunčana Glavak, Catherine Griset, Hannes Heide, Giusi Princi, Emma Rafowicz, Sabrina Repp, Nela Riehl, Sandro Ruotolo, Malika Sorel, Marco Squarta, Eugen Tomac, Zala Tomašič, Bogdan Andrzej Zdrojewski

Substitutes present for the final vote

Stefano Cavedagna, Per Clausen, Valérie Deloge, Gabriella Gerzsenyi, Jens Gieseke, Sunčana Glavak, Nicolás González Casares, Michalis Hadjipantela, Matteo Ricci, Chloé Ridel, André Rodrigues, Bruno Tobback, Raffaele Topo, Laurence Trochu

Maria Guzenina, Erik Marquardt, Carolina Morace, Sabine Verheyen

Members under Rule 216(7) present for the final vote

Salvatore De Meo, Nora Junco García, Alexander Jungbluth, Julien Leonardelli

Paulo Do Nascimento Cabral, Elisabeth Grossmann

FINAL VOTE BY ROLL CALL BY THEIN COMMITTEE ASKED FOR OPINION

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