- 2026-06-16 “Good afternoon.
First, I would like to thank Minister Charalambides and the Cyprus Presidency for all the hard work they have done over the past six months. This Presidency came with strong commitments, and it has delivered strongly. The last six months have been about delivery, and today's Council has shown both the breadth of the agenda we have been working on and the concrete results achieved.
I would particularly like to congratulate the Cyprus Presidency for the serious work it started from day one on the Critical Medicines Act. Reaching an agreement already in May is a remarkable achievement. This Act addresses a challenge that became very clear during the COVID-19 crisis and that has been long overdue.
I made a personal commitment to present this proposal within the first 100 days. The Cyprus Presidency not only matched that level of ambition; it outperformed it by moving even faster. I want to sincerely thank everyone in the Presidency who worked on this file.
The Critical Medicines Act is essential to strengthen the European Union's resilience and to boost the security of supply of critical medicines. But it is also about medicines more broadly, wherever shortages affect patients. Few Member States can explain better than Cyprus what it means to face supply challenges.
The objective has always been simple: patients in Europe must have better access to the medicines they need, when they need them. Today, that objective has moved significantly closer.
The second point I would like to highlight is the Biotech Act, another key part of our competitiveness agenda and of last year's health package. Today, Member States agreed on the first part of the Biotech Act, the directive, again at record speed. We presented the proposal only at the end of last year, and this rapid progress confirms both the urgency and the necessity of moving quickly in the European Union.
The debate today was very clear: the potential of biotechnology is enormous. Europe remains a leader in many areas of biotechnology, but it will not stay there unless we shift into a higher gear.
Biotechnology matters for our economies and our competitiveness. It also matters for our health systems, if we want to provide the best available therapies to patients. It can bring more precise diagnostics, new treatments for diseases where we currently have none, and more personalised medicine for patients across Europe.
This is very encouraging news. I hope the Irish Presidency will take inspiration from the strong work of the Cyprus Presidency. From what we heard today, including the clear commitments made by the Irish Minister, we have all the necessary ingredients to deliver on the rest of the Biotech Act.
The third element is the medical devices legislation. The Presidency updated ministers on the progress made. This file is also part of the health package, with the aim of supporting innovation, simplifying existing rules, making the regulatory framework more predictable, and keeping patient safety at the highest level.
At the same time, we want to ensure that new treatments and technologies can reach Europe faster. The discussion in Council showed a strong willingness to make rapid progress on this dossier as well.
Together, the pharmaceutical reform, the Critical Medicines Act, the progress on the Biotech Act, and the proposals for the medtech sector are redefining the landscape of European healthcare. They give us the basis for a long-term vision for the healthcare sector in Europe: one that keeps Europe a global leader and ensures universal access to the best therapies available.
Finally, ministers also discussed health security preparedness and response. The Presidency provided an update on Ebola outbreaks and related challenges. Ministers confirmed the solid work being carried out by the ECDC and the Health Security Committee, including raising awareness, building resilience in Europe, and supporting exit control measures on the ground.
The Commission is following the situation very closely. We are deploying every effort to support the ECDC, local partners and international partners, with the aim of containing the outbreak where it is and helping those fighting the virus.
To conclude, Cyprus should be very proud of what it has achieved under its Presidency in the health sector. These are complex and technically demanding files, and the Presidency has managed them with both speed and high quality.
Minister, thank you again for your work.”
Pharma companies manufacturing and production obligations
- 2026-06-10 “Answer given by Mr Várhelyi on behalf of the European Commission 10.6.2026 Written question Regulation (EC) No 396/2005 on maximum residue levels (MRLs) of pesticides [1] imposes Member States to carry out controls to ensure that food placed on the market is compliant with the legal limits. The European Food Safety Authority ( EFSA) collects the information from national and EU-coordinated control programmes and publishes the EU report on pesticide residues in food [2] . In 2024, 86 449 samples were analysed. 96% contained no residues or residues below or equal to the MRLs. Non-compliant samples (1.8%) triggered sanctions or enforcement actions. Out of 38 169 samples analysed for the presence of imazalil, including fruits with their peel [3] , only 35 contained residues above the MRL. This confirms that the food available to EU consumers is safe. The MRLs for imazalil were”
Maximum residue levels · Food labelling harmonisation at EU level
- 2026-06-10 “Answer given by Mr Várhelyi on behalf of the European Commission 10.6.2026 Written question The Commission continuously monitors the animal health situation and recognises the economic impact of animal diseases on the livestock sector. Considering the impact and consequences of disease outbreaks, it supports Member States through financial and technical assistance, including under the Single Market Programme and measures within the Common Agricultural Policy (CAP) [1] , [2] [3] . The implementation of the measures for the control of avian influenza in the affected Member States is evaluated by the audits performed by the Commission. In the recent years, the Commission performed such audits in Italy in 2022 [4] and 2024 [5] . The conclusions of the audits are that the competent authorities took appropriate technical and supervisory measures to ensure the protection of animal welfare during depopulation of poultry establishments to control disease outbreaks. In addition to the findings and conclusions of the audits, the measures implemented by the competent authorities of Italy to manage the outbreaks of highly pathogenic avian influenza are regularly discussed in the Standing Committee on Plants, Animals, Food and Feed ( PAFF Committee) [6] . While the Commission recognises that there is room for improvement, Regulation (EC) No 1099/2009 [7] provides already sufficient provisions to ensure the protection of animals at the time of killing. As a result, the modernisation of the animal welfare legislation focuses on other areas. [1] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2115&qid=1757948393327. [2] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025PC0236. [3] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52025PC0560. [4] https://ec.europa.eu/food/audits-analysis/audit-report/details/4602. [5] https://ec.europa.eu/food/audits-analysis/audit-report/details/4899. [6] https://food.ec.europa.eu/horizontal-topics/committees/paff-committees/animal-health-and-welfare_en. [7] ELI: http://data.europa.eu/eli/reg/2009/1099/oj.”
Agricultural funding · EU requirements on animal welfare for farmers
- 2026-06-04 “Good afternoon.
I am very pleased to be here in Riga today for a very productive and encouraging exchange with the group of 12 smaller countries [WHO Europe 12th high-level meeting of the Small Countries Initiative].
Our discussions focused first on the Critical Medicines Act and how it can help ensure that all regions in Europe have access to the medicines they need and deserve. This is not only about critical medicines, but also about addressing situations where the market does not deliver adequately for patients - challenges we saw very clearly during the COVID-19 crisis.
We also discussed one of the biggest challenges facing our health systems today: workforce shortages in the healthcare sector. Healthcare professionals across Europe are under immense pressure. That is why prevention must be part of the solution. By investing more in prevention, we can reduce the burden on care systems, support healthcare workers, and improve outcomes for patients.
I was encouraged by the strong agreement that prevention needs to play a much greater role in our health policies. It is one of the most effective ways to build more resilient, sustainable and people-centred health systems.
During my visit, I also had the opportunity to meet an innovative start-up here in Riga working on promising new cell-based technologies, including new approaches to testing and potential applications in medical treatments and therapies.
These are exactly the kind of startups that we're all looking at. They're very strong on research and development although they are very young and under invested when it comes to their future.
So here I think we need to help all these European excellent startups to be able to scale themselves up to be European champions.
Thank you.”
Pharmaceuticals regulation in EU — innovation/access axis
- 2026-06-04 “Answer given by Mr Várhelyi on behalf of the European Commission 4.6.2026 Written question The Commission would like to refer the Honourable Member to the reply provided to Question P-469/2026 [1] on the same subject and explaining why the product SILTAC must be considered as a plant protection product according to Article 2(1)(a) of Regulation (EC) No 1107/2009 on the placing on the market of plant protection products (the PPP Regulation) [2] . All documents relating to the regular discussions in the Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals — Legislation on whether products are in the scope of the PPP Regulation and to the particular case of SILTAC have been disclosed following specific requests submitted in accordance with 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 [3] . In accordance with the Commission’s Working Methods, contacts with stakeholders are conducted with transparency and members of the Commission should seek to ensure an appropriate balance and representativeness in the stakeholders they meet. Commissioners, members of their cabinets and all Commission staff holding management functions are required to meet only interest representatives that are registered in the Transparency Register and publish information on and minutes of all such meetings in accordance with Commission Decisions (EU) 2024/3081 [4] and 2024/3082 [5] . [1] https://www.europarl.europa.eu/doceo/document/P-10-2026-000469_EN.html. [2] http://data.europa.eu/eli/reg/2009/1107/oj. [3] http://data.europa.eu/eli/reg/2001/1049/oj. [4] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202403081. [5] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202403082.”
EU restrictions on unfair commercial practices · Transparency requirements of EU institutions
- 2026-05-29 “Answer given by Mr Várhelyi on behalf of the European Commission 29.5.2026 Written question 1. Under the revised Deep and Comprehensive Free Trade Area (DCFTA) [1] , the EU may impose safeguard measures if duty-reduced or duty-free imports cause persistent economic, societal or environmental difficulties. The revised DCFTA also requires Ukraine to adopt certain EU production standards, such as animal welfare rules for laying hens by the end of 2028. Eggs from non-EU countries without equivalence with EU egg marketing standards [2] must be marked with the ISO 3166 country code and labelled as ‘non-EU standard’ (farming method) on packaging. The Commission will ensure that the future animal welfare legislation establishes EU standards for non-EU products compliant with World Trade Organisation rules [3] .The Commission is preparing a modernised animal welfare proposal that includes phasing out cages for certain sectors. 2. The Commission takes food safety risks associated with Ukrainian egg imports very seriously and implements a risk-based approach to address any identified concerns. When a non-compliance is detected through the Rapid Alert System for Food and Feed, contacts are systematically established with Ukrainian authorities to implement corrective actions. For recurring issues, measures including increased intensified testing, suspension of imports, or temporary bans may be introduced. 3. Origin labelling is required for processed products only if omitting it would mislead consumers [4] . If the final food's origin differs from its primary ingredient, that ingredient's origin must be indicated [5] . Farming method is not mandatory for processed food ingredients. The consumer's ‘right-to-know’ must be balanced against tracking complexities and potential increased production costs for EU SMEs [6] . The Commission doesn't plan to extend mandatory origin labelling to these products. [1] The revised DCFTA with Ukraine entered into force on 29 October 2025. [2] Commission Delegated Regulation (EU) 2023/2465 of 17 August 2023 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards marketing standards for eggs, and repealing Commission Regulation (EC) No 589/2008; C/2023/5509; OJ L, 2023/2465, 08.11.2023, ELI: http://data.europa.eu/eli/reg_del/2023/2465/2024-10-14. [3] A s announced in the Vision on Agriculture and Food: COM/2025/75 final. [4] See Article 26(2) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004, OJ L 304, 22.11.2011, pp. 18. [5] Commission Implementing Regulation (EU) 2018/775 of 28 May 2018 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food OJ?, ELI: http://data.europa.eu/eli/reg/2011/1169/oj. [6] Small and Medium Enterprises.”
EU policy on country of origin food labelling · Import of agri-food products in the EU · Agricultural trade: Ukraine imports
- 2026-05-27 “Answer given by Mr Várhelyi on behalf of the European Commission 27.5.2026 Written question The EU import control system operates at several levels. It includes audits in third countries to verify that they have effective controls in place, preventing unsafe goods from being dispatched to the EU. It also provides for risk-based controls at EU borders to detect non-compliances upon entry, and random sampling and testing in the EU. The EU framework ensures that if an issue is detected after import, it is communicated through the EU rapid alert networks and addressed in a coordinated manner across all Member States. In this context, during the Commission audit in Brazil in October 2025 [1] , auditors identified consignments of beef from female cattle treated with a hormone banned in the EU, exported to the EU. Information was swiftly shared with all Member States that received these consignments. The Commission has no confirmation of hormonal residues found by Member States in any of these consignments. In response, the Commission increased the minimum frequency rates of physical check rates for bovine minced meat and meat preparations from Brazil up to 50%, and for other bovine fresh meat up to 30% [2] . Member States were advised to sample these products. None of the laboratory tests revealed unsatisfactory results. Under Regulation (EU) 2022/1646 [3] , Member States must test at least 7% of imported bovine consignments for pharmacologically active substances. Additionally, the Commission evaluates third countries' residue control plans, results of their implementation annually, and audits the execution of residue controls. For 2026 and 2027, the Commission has increased its audits on countries exporting to the EU by 50% and at border control posts by 33%. The EU’s system is designed to respond swiftly and effectively whenever a risk emerges. [1] https://ec.europa.eu/food/audits-analysis/audit-report/details/4975. [2] According to Article 5(3) of Commission Implementing Regulation (EU) 2019/2129 of 25 November 2019 establishing rules for the uniform application of frequency rates for identity checks and physical checks on certain consignments of animals and goods entering the Union. OJ L 321 12.12.2019, p. 122. (http://data.europa.eu/eli/reg_impl/2019/2129/2021-12-26). [3] Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation. OJ L 248, 26.9.2022, pp. 32. (https://eur-lex.europa.eu/eli/reg_impl/2022/1646/oj/eng).”
Import of agri-food products in the EU · Maximum residue levels · Trade relations with Mercosur
- 2026-05-26 “Answer given by Mr Várhelyi on behalf of the European Commission 26.5.2026 Written question The EU legal framework, in particular Regulation (EU) 2016/429 [1] and Commission Delegated Regulations (EU) 2020/687 [2] and 2020/689 [3] , establishes harmonised measures across the Union for eradicating Category A diseases, such as foot and mouth disease (FMD). These include culling infected herds, restricting animal and product movements from affected zones, and, where appropriate, vaccination [4] . Following confirmation of the FMD on Levos, restrictions were immediately imposed [5] under Delegated Regulation (EU) 2020/687, which permits derogations, allowing certain low-risk animal products to leave the restricted zones, provided risk-mitigation measures are applied. The EU co-finances emergency veterinary measures via the Single Market Programme [6] , covering costs for culling, compensating farmers, cleaning and disinfecting the affected premises, and vaccination [7] . The Commission stands ready to deploy vaccines from the EU FMD antigen bank upon Greece’s request. Additionally, under the Common Agricultural Policy Strategic Plans Regulation [8] , Member States may support investments in restoring agricultural potential and introduce crisis payments for farmers affected by catastrophic events. The Commission may also adopt exceptional support measures for market losses linked to restrictions imposed to curb disease spread. [1] ‘Animal Health Law’ OJ L 84, 31.3.2016, pp. 1, ELI: http://data.europa.eu/eli/reg/2016/429/oj. [2] OJ L 174, 3.6.2020, pp. 64–, ELI: http://data.europa.eu/eli/reg_del/2020/687/oj. [3] OJ L 174, 3.6.2020, pp. 211-340, ELI: http://data.europa.eu/eli/reg_del/2020/689/oj. [4] https://food.ec.europa.eu/animals/animal-diseases/diseases-and-control-measures/foot-and-mouth-disease_en [5] OJ L, 2026/732, 24.3.2026, ELI: http://data.europa.eu/eli/dec_impl/2026/732/oj. [6] Single Market Programme: OJ L 153, p. 1, ELI: http://data.europa.eu/eli/reg/2021/690/oj. [7] https://food.ec.europa.eu/document/download/c1ed1748-1b55-4e7b-add0-b7eb41c65a3e_en?filename=cff_animal_emergency-measures_ah-ms-guidelines.pdf. [8] OJ L 435, 6.12.2021, pp. 1, ELI: http://data.europa.eu/eli/reg/2021/2115/oj.”
Direct payments to farmers (pillar 1) · Animal diseases prevention and management in the EU
- 2026-05-26 “Answer given by Mr Várhelyi on behalf of the European Commission 26.5.2026 Written question Active substances (AS) used in plant protection products (PPPs) can, in principle, only be approved where it is demonstrated that at least one representative use of a PPP containing the AS fulfils the approval criteria set out in Regulation (EC) No 1107/2009 [1] . Alternatives are only considered to determine if AS failing approval criteria need a derogation because they're essential for controlling a serious danger to plant health that no other available method can address [2] . In the Vision for Agriculture and Food [3] , the Commission committed to carefully considering any further ban of AS if alternatives are not available, unless the AS in question represents a threat to human health or the environment that agriculture relies upon for its viability. The Food and Feed Simplification Package [4] proposed by the Commission in December 2025 aims to accelerate innovation and market access for new biocontrol AS to provide more sustainable PPPs to farmers to protect their crops. To speed up Member States’ evaluation of biocontrol AS applications, the Commission proposes replacing systematic time-driven renewals for all AS with a flexible system targeting AS that may harm human or animal health or the environment [5] . The Commission has also proposed to allow derogations from existing approval criteria if an AS is essential to protect plant health or plant production and the possibility for Member States to grant longer grace periods to use existing stocks of non-approved substances when no alternatives exist. The Commission receives information on alternatives provided by stakeholders. So far alternatives have always been identified where the approval of an AS has not been renewed [6] . [1] Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj. [2] As set out in Article 4(7) of Regulation (EC) No 1107/2009, such substances may be approved for 5 years [3] Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions A Vision for Agriculture and Food Shaping together an attractive farming and agri-food sector for future generations. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075. [4] https://food.ec.europa.eu/horizontal-topics/simplification-legislation_en. [5] The majority of Member State resources is currently occupied with the systematic renewal process for all active substances meaning that innovative companies applying for the approval of new biocontrol substances often have to wait for several years before a Member State agrees to take on the role of rapporteur (RMS) for the first risk assessment. [6] In addition, various tools to help farmers in finding solutions protecting their crops have been developed for example IPMWORKS project developed based on Horizon 2020 funds or Agrowise supported by the LIFE Program.”
EU policy on pesticides · Reduction targets for pesticides
- 2026-05-26 “Answer given by Mr Várhelyi on behalf of the European Commission 26.5.2026 Written question According to the Clinical Trials Regulation (CTR) [1] and the principles of good clinical practice [2] , the sponsor has a responsibility to ensure the safety of clinical trial participants and the reliability of data even when activities are delegated to contract research organisations, including when activities are undertaken outside of the EU. There is, however, no legal requirement for activities to be undertaken by EU-based staff. Article 71 of the CTR defines the obligations for clinical trial sponsors and investigators, including the conditions for delegation of tasks. Furthermore, under Article 74 of the CTR, sponsors established in third countries must have a legal representative in the EU. Member States are required to carry out inspections on their territory or in third countries to supervise compliance with the CTR [3] . The detailed arrangements for Good Clinical Practice inspection procedures are laid down in national implementing legislation, including the need for Member States to establish relevant procedures for arranging inspections outside the EU [4] . The European Medicines Agency also has a role in coordinating cooperation between Member States for inspections within and outside the EU. Hence, the necessary means to allow Member States to conduct inspections effectively and in a timely manner both within and outside the EU are in place. [1] 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, pp. 1. [2] https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline. [3] Article 78 of Regulation (EU) No 536/2014. [4] Implementing Regulation (EU) 2017/556 on detailed arrangements for the Good Clinical Practice inspection procedures pursuant to Regulation (EU) No 536/2014. C/2017/1812. OJ L 80, 25.3.2017, pp. 7.”
Pharmaceuticals regulation in EU · Pharma companies manufacturing and production obligations
- 2026-05-26 “Answer given by Mr Várhelyi on behalf of the European Commission 26.5.2026 Written question Nurse shortages and more broadly health workforce shortages are an important challenge, requiring action in line with the division of competences in the EU. According to Article 168(7) of the Treaty on the Functioning of the EU [1] , Member States are responsible for the management of health services, which includes ensuring adequate staffing levels. The Commission supports Member States in addressing health workforce challenges, including those related to nurses, notably through knowledge sharing and technical assistance. For example, the EU4Health Programme funds initiatives addressing workforce challenges [2] , including the Nursing Action [3] implemented in partnership with World Health Organisation/Europe, which supports countries in developing effective recruitment and retention strategies. The technical brief [4] referred to by the Honourable Members is a deliverable of this EU action, highlighting participating countries’ experiences. This work also adds to that of the Commission’s Expert Group on Health Systems Performance Assessment (HSPA) [5] . The group has mapped approaches to safe staffing levels across all health professions, including but not only nurses, and is foreseen to publish a report to further support the exchange of experiences. To facilitate mobility across the EU, the Professional Qualifications Directive [6] sets out the rules on recognition of professional qualifications obtained in the EU and harmonises minimum training requirements for nurses responsible for general care. The upcoming Skills Portability Initiative [7] aims at modernising and speeding up the processes for EU citizens and introducing common rules on recognition to attract talent from third countries [8] . [1] http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=en. [2] https://www.agenas.gov.it/ricerca-e-sviluppo/ricerca-internazionale/personale-sanitario-ri/heroes-health-workforce-to-meet-health-challenges; https://health.ec.europa.eu/publications/2022-eu4health-work-programme_en; https://www.amreducare.eu/; https://eh4future.eu/; https://gesea.eu/; https://digicantrain.turkuamk.fi/contact-us/; https://ddsmap.webbaysolutions.com/; https://ehma.org/projects/transition; https://www.who.int/europe/publications/i/item/WHO-EURO-2025-12709-52483-81031; https://bewell-project.eu/. [3] https://www.who.int/europe/activities/partnering-with-the-eu-to-support-nurses-in-the-european-union-(nursing-action). [4] https://www.who.int/europe/publications/i/item/WHO-EURO-2026-13146-52920-82459. [5] https://health.ec.europa.eu/health-systems-performance-assessment_en. [6] Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (latest consolidated version from 29/10/2025 available here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005L0036-20251029). [7] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15892-Skills-portability-action-1-facilitating-worker-mobility-across-the-EU-through-skills-transparency-and-digitalisation_en. [8] https://employment-social-affairs.ec.europa.eu/news/commission-seeks-views-skills-portability-initiative-2025-12-05_en.”
Public and private sectors role in healthcare services
- 2026-05-22 “Answer given by Mr Várhelyi on behalf of the European Commission 22.5.2026 Written question Plants obtained by new genomic techniques (NGT) and their products can now only be imported into the EU if they meet the Genetically Modified Organisms (GMO) legislation’s requirements [1] . The proposed Regulation for plants obtained by certain NGTs [2] will apply equally to NGT plants and their products originating in the EU and those imported from non-EU countries. Therefore, if the proposed Regulation — as amended by the co-legislators in the provisional agreement on 3 December 2025 — is adopted, NGT plants and products would only be allowed for import if they comply with the provisions of that regulation. It also specifies Member States’ control obligations, also for imports. Operators within and outside the EU bear primary responsibility for ensuring that products placed on the EU market are compliant with EU legislation. Member States are responsible for import controls and enforcement actions, as relevant in accordance with Regulation (EU) 2017/625 [3] . Depending on the goods, they have to be controlled systematically at the first point of arrival in the EU or with appropriate frequency at an appropriate place within the customs territory of the Union. The Commission carries out audits and controls in Member States and third countries and takes action as necessary. For Category c NGT plants, Member States will be responsible for ensuring that before these plants are released or placed on the market, a decision confirming Category c NGT plant status has been taken . Official controls go beyond analytical testing and include a wide range of methods and techniques, as specified in Article 14 of Regulation (EU) 2017/625. Such approaches are widely used and are particularly relevant in areas of EU law where analytical detection is limited or impossible. [1] https://food.ec.europa.eu/plants/genetically-modified-organisms/gmo-legislation_en. [2] COM(2023) 411 final. [3] https://eur-lex.europa.eu/eli/reg/2017/625.”
Import of agri-food products in the EU · New Genomic Techniques
- 2026-05-19 “Answer given by Mr Várhelyi on behalf of the European Commission 19.5.2026 Written question The EU has a programme to support the development of medicines for rare diseases [1] . At present, one medicinal product has received authorisation in the EU for the treatment of Duchenne muscular dystrophy (DMD), while 34 others are undergoing development and possess active orphan designations within the EU [2] , [3] . None of these 34 products has yet reached the stage of assessment by the European Medicines Agency (EMA) for marketing authorisation. The EMA provides monthly updates on the list of medicinal products currently under evaluation [4] . In certain cases, patients who have a disease with no satisfactory authorised therapies or who cannot enter a clinical trial can receive unauthorised medicines. A ‘named-patient basis’ treatment’ allows — if agreed by the national competent authorities and under the personal responsibility of the healthcare professional — the use of a non-authorised medicine for a specific individual patient, to fulfil special needs [5] . Member States may also exceptionally allow under a tool referred to as ‘compassionate use’ the supply of a non-authorised medicine to patients [6] . Compassionate use programmes are generally intended for products under development. They are regulated by national legislation and the way they work varies from country to country [7] . For medicines that have the potential to address unmet medical needs, the EMA provides early and enhanced advice to medicine developers to optimise development plans and speed up the evaluation so that these medicines can reach patients faster [8] . When the EMA accelerates its assessment, the Commission provides for an expedited decision-making process. [1] https://www.ema.europa.eu/en/news/development-medicines-rare-diseases. [2] https://www.ema.europa.eu/en/human-regulatory-overview/orphan-designation-overview. [3] https://ec.europa.eu/health/documents/community-register/html/reg_od_act.htm?sort=n. [4] https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation. [5] Article 5(1) of EU Directive 2001/83/EC. [6] Article 83 of Regulation (EC) No 726/2004. [7] https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compassionate-use. [8] https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessment.”
Joint EU procurement of medicines · Pharmaceuticals regulation in EU
- 2026-05-19 “Answer given by Mr Várhelyi on behalf of the European Commission 19.5.2026 Written question Since 21 January 2026, over 40 000 comments relating to the topic mentioned were received on the Instagram channel of the Commission’s Representation in Germany under posts across all EU topics. In most cases, users only used hashtags without any additional text or questions. They also often posted similar or similarly sounding hashtags multiple times in a row under posts on any topic. The Commission welcomes open debate and participation on its social media channels. In engaging on those channels, some basic rules need to be respected. With the objective of allowing for a genuine dialogue with users wanting to engage in a purposeful conversation, the Representation’s social media team filtered out the repetitive comments that only used hashtags. Some accounts engaging in the most repetitive posting of only hashtags were temporarily blocked and later unblocked. All this is in line with the Commission’s moderation policy [1] , which ensures open and engaging debate on its social media channels, while guaranteeing mutual respect. [1] https://commission.europa.eu/get-involved/social-media-connect-european-commission_en.”
Transparency requirements of EU institutions · Disinformation & online freedoms · EU engagement with civil society
- 2026-05-18 “Answer given by Mr Várhelyi on behalf of the European Commission 18.5.2026 Written question 1. On 10 December 2025, the Commission was alerted about cereulide contamination in products from a Nestlé company in the Netherlands, which recalled the same day 25 batches across 16 European countries, and treated the incident with utmost seriousness. As soon as the Commission was made aware of the voluntary recall linked to the increased levels of cereulide found in infant formulae, the different existing tools were activated to ensure cross-border coordination between the competent food safety authorities of the Member States. Due to the Chinese source of contamination (arachidonic acid oil, used as ingredient in infant formulae) and in absence of robust guarantees provided in the response by China, the Commission adopted reinforced controls on imports of arachidonic acid oil from China on 25 February 2026 which apply as of 26 February 2026 [1] . 2. In response to this incident, the Commission enhanced coordination with Member States by sharing Rapid Alert System for Food and Feed (RASFF) alerts and activating its existing network of crisis coordinators. Once the incident is resolved, the network of food and feed safety crisis coordinators will be reconvened to have a review on lessons learned, with special attention to communication protocols at all levels. 3. While the Commission is currently not planning a comprehensive review of EU infant nutrition rules, it remains committed to maintaining the highest food safety standards through continuous monitoring and improvement of existing measures. [1] https://eur-lex.europa.eu/eli/reg_impl/2026/459/oj.”
Nutrition
- 2026-05-11 “Answer given by Mr Várhelyi on behalf of the European Commission 11.5.2026 Written question 1. As per Article 168(7) of the Treaty on the Functioning of the European Union [1] , Member States are responsible for the organisation and delivery of health services and medical care. EU tools and initiatives support Member States to strengthen health systems via knowledge sharing, technical assistance, funding and policy guidance. For example, the State of Health in the EU cycle [2] includes country-specific analyses, and the European Semester provides country-specific recommendations: (i n 2020, 2022 and 2023, Greece received recommendations to ensure adequate and equal access to healthcare which reflected, among others, the surveyed population reporting unmet medical needs for financial reasons, long waiting lists or distance (29.1% in 2025) [3] ). 2. Under the Recovery and Resilience Facility (RRF), the Greek recovery and resilience plan (RRP) includes reforms and investments to strengthen the healthcare sector. As the Commission explained in its reply to Parliamentary Question E-004260/25 [4] , the implementation of RRPs falls under Member States’ responsibility [5] . The Commission verifies the fulfillment of milestones and targets of measures included and funds are disbursed only after a positive preliminary assessment of payment requests [6] . The Commission services regularly conduct implementation audits, so does the European Court of Auditors. During the discharge procedure, the European Parliament reviews the Commission’s management of RRF funds to ensure accountability for the performance-based disbursement of grants and loans. 3. In its replies to Parliamentary questions E-001242/25 [7] and E-000269/26 [8] , the Commission explains the Commission’s work in workforce shortages and equal access to healthcare. [1] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=en. [2] https://health.ec.europa.eu/state-health-eu_en. [3] Self-reported unmet needs for medical examination due to financial reasons, long waiting list or distance by sex, age and risk of poverty threshold — % of the persons having the same needs: https://ec.europa.eu/eurostat/databrowser/view/hlth_silc_08b/default/table?lang=en. [4] https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. [5] The principal responsibility of taking appropriate measures to protect the EU financial interests and to ensure that the use of funds complies with EU and national law lies with the Member States, as provided by Article 22 of the RRF Regulation. [6] Similarly, measures implemented under the European Social Fund and the European Regional Development Fund are delivered under shared management. [7] https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. [8] https://www.europarl.europa.eu/doceo/document/-ASW_EN.html.”
Public and private sectors role in healthcare services
- 2026-05-11 “Answer given by Mr Várhelyi on behalf of the European Commission 11.5.2026 Written question The equivalence criteria between plants obtained by certain new genomic techniques (NGT) and conventional plants in the Commission’s proposal [1] are based on a literature study on conventional plants and on extensive work of the European Food Safety Authority (EFSA) and of the Commission Joint Research Centre [2] . In a scientific opinion requested by the Parliament [3] , EFSA confirmed that it is scientifically justified to consider NGT plants meeting those criteria (Category c NGT plants) as equivalent to conventional plants as regards genetic modifications and potential risks. In their provisional agreement, the Parliament and the Council amended the criteria for Category c NGT plants in the Commission’s proposal but maintained that proposal’s scientific basis, which excludes from Category c modifications unlikely obtainable by conventional breeding. Scientific evidence [4] , notably from EFSA, confirms that certain NGT plants do not pose new hazards and are therefore equivalent to conventional plants. This justifies exempting those plants and their products from specific risk assessment for genetically modified organism (GMO). However, Category c NGT plants remain subject to EU legislation applicable to conventional plants/products including safeguard measures to protect human, animal health and the environment, and will undergo a monitoring programme including on environmental and health impacts. Category C NGT plants will be identified in a public register and in variety catalogues. In addition, seed must be labelled, enabling supply chains to exclude NGT plants. Consumers wishing to avoid NGT products could rely on these chains. Already today, GMOs obtained by random mutagenesis are exempted from the GMO labelling requirements. [1] COM(2023) 411 final. On 3 December 2025, the European Parliament and the Council provisionally agreed on the proposal. [2] Technical paper on the rationale for the equivalence criteria in Annex I to the proposal for a regulation on plants obtained by certain new genomic techniques, https://food.ec.europa.eu/document/download/f54a2386-e158-4dbb-af78-41361e471b7f_en?filename=gmo_biotech_ngt_proposal_tech-paper.pdf. [3] EFSA Panel on Genetically Modified Organisms, 2024. Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178). EFSA Journal, 22(7), e8894, https://doi.org/10.2903/j.efsa.2024.8894. [4] The impact assessment accompanying the Commission legislative proposal for a regulation on plants obtained by certain NGTs contains the relevant references to the scientific evidence underpinning the proposal: https://food.ec.europa.eu/document/download/f1142e86-43df-4791-9df2-563e696c59cf_en?filename=gmo_biotech_ngt_ia_report.pdf. EFSA’s scientific opinions relating to NGTs are available here: https://www.efsa.europa.eu/en/topics/new-genomic-techniques.”
New Genomic Techniques
- 2026-05-11 “Answer given by Mr Várhelyi on behalf of the European Commission 11.5.2026 Written question 1. Several instruments are available at EU and national level. The Single Market Programme (SMP) [1] co-finances emergency veterinary measures, including compensation for the killing of animals in outbreak farms and, preventive killing in farms at risk. In addition, Article 220 of Regulation (EU) No 1308/2013 [2] may allow support, at Member State’s request, for market losses linked to animal movement restrictions [3] . Under current state aid rules, Member States can grant aid of up to 100% to cover the costs of prevention, control and eradication of animal diseases and aid to compensate animal diseases’ damages. Aid can be granted under the Agricultural Block Exemption Regulation (ABER) [4] or Agricultural state aid Guidelines [5] , and limited support through the Agricultural de minimis Regulation [6] . The Polish CAP Strategic Plan [7] also provides support notably: for biosecurity investments to prevent the spread of African Swine Fever (ASF), on livestock insurance premiums and on co-financing reciprocal funds. Common Agricultural Policy (CAP) Plans may also support the restoration of agricultural potential on infected farms [8] , while the recently approved CAP simplification package [9] provides for crisis payments for farmers facing losses resulting from outbreak events. 2. ASF EU rules are risk- and science-based [10] , aligned with international standards [11] and consider experience while remaining adaptable to local circumstances and epidemiological situations within limits that can ensure an effective eradication. Commission Implementing Regulation (EU) 2023/594 [12] provides for safe derogations for the movement of live animals and products from restricted zones, within or outside those zones and beyond the Member State concerned, following the risk-based approach. [1] Single Market Programme: https://eur-lex.europa.eu/eli/reg/2021/690/oj. [2] https://eur-lex.europa.eu/eli/reg/2013/1308/2024-11-08. [3] These measures are by nature limited in time, for the duration strictly necessary to support the market concerned and they require a clear start and end of the episode, and all losses specifically documented before the Commission can design a measure and propose it for the opinion of the Member States. [4] https://eur-lex.europa.eu/legal-content/EN/TXT/?toc=OJ%3AL%3A2022%3A327%3ATOC&uri=uriserv%3AOJ.L_.2022.327.01.0001.01.ENG. [5] With prior notification; guidelines for state aid in the agricultural and forestry sectors and in rural areas (OJ C 485, 21.12.2022, p. 1). [6] https://eur-lex.europa.eu/eli/reg/2013/1408/oj/eng. [7] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2115&qid=1757948393327. [8] Under Article 73 of Regulation (EU) 2021/2115: http://data.europa.eu/eli/reg/2021/2115/oj. [9] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025PC0236. [10] https://open.efsa.europa.eu/questions/EFSA-Q-2020-00197; https://open.efsa.europa.eu/questions/EFSA-Q-2022-00381. [11] World Organisation for Animal Health (WOAH) Terrestrial Animal Health code 31st Edition, 2023. Volumes I and II ISBN 978-92-95121-74-4: https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/ . [12] http://data.europa.eu/eli/reg_impl/2023/594/oj .”
Animal diseases prevention and management in the EU
- 2026-05-11 “Answer given by Mr Várhelyi on behalf of the European Commission 11.5.2026 Written question The Commission has recently finalised a comprehensive evaluation of the Tobacco Products Directive 2014/40/EU and the Tobacco Advertising Directive 2003/33/EC [1] . The Commission intends to propose, in 2026, a revision of the legislative framework on tobacco control and will now carry out an impact assessment and continue the wide-scale consultation process, in view of further policy actions. At this stage, the Commission is not in a position to provide information on future tobacco control measures. The Commission will continue to pursue an evidence-based approach and in particular, in matters of public health, adhere to the highest standard of protection when it comes to tobacco and nicotine products. [1] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13481-Evaluation-of-the-legislative-framework-for-tobacco-control_en.”
Regulation on New Oral Nicotine Products · Smoking regulation
- 2026-05-11 “Answer given by Mr Várhelyi on behalf of the European Commission 11.5.2026 Written question The EU legal framework, in particular Regulation (EU) 2016/429 [1] and Commission Delegated Regulations (EU) 2020/687 [2] and 2020/689 [3] , provides for harmonised measures across the Union, based on the principle of rapid eradication through the stamping-out of confirmed outbreaks, combined with movement restrictions and, where appropriate, the use of vaccination [4] . These measures are designed to be proportionate to the risks posed by the disease and are applied taking into account the epidemiological situation. A recent risk assessment was carried out to ensure the efficacy of those measures for Member States [5] . While the legal framework is harmonised, its implementation allows for a degree of flexibility in the choice and combination of measures, including the use of emergency vaccination, under the responsibility of the competent authorities of the Member States. The Commission is in close contact with the Cypriot authorities and supports them in the application of the appropriate control measures, including through technical assistance [6] and access to the EU foot and mouth disease vaccine bank [7] . The Commission continues to monitor the situation closely in view of the evolving epidemiological situation. [1] 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, pp. 1, ELI: http://data.europa.eu/eli/reg/2016/429/oj). [2] Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, pp. 64–, ELI: http://data.europa.eu/eli/reg_del/2020/687/oj). [3] Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, pp. 211-340, ELI: http://data.europa.eu/eli/reg_del/2020/689/oj). [4] https://food.ec.europa.eu/animals/animal-diseases/diseases-and-control-measures/foot-and-mouth-disease_en. [5] Scientific Opinion on the assessment of the control measures for category A diseases of Animal Health Law: Foot and Mouth Disease, First published: 08 June 2021, https://doi.org/10.2903/j.efsa.2021.6632. [6] https://food.ec.europa.eu/animals/animal-diseases/veterinary-emergency-team_en. [7] https://food.ec.europa.eu/animals/animal-diseases/diseases-and-control-measures/foot-and-mouth-disease/support-cy_en.”
Animal diseases prevention and management in the EU
- 2026-05-11 “Answer given by Mr Várhelyi on behalf of the European Commission 11.5.2026 Written question The Commission does not envisage establishing standards to monitor waiting times. According to Article 168(7) of the Treaty on the Functioning of the European Union [1] , Union action shall respect the responsibilities of the Member States for the organisation of health services. This includes the management of waiting times and booking systems. That said, the implementation of the primary use aspects of the European Health Data Space Regulation [2] can lead to efficiency gains in healthcare systems, freeing up time of health professionals. The Commission supports Member States through EU4Health projects aimed at systemic improvements of accessibility of health systems, especially for vulnerable groups [3] and actions focused on health workforce challenges [4] . In addition, the Commission supports cooperation on measuring performance of health systems through the Health Systems Performance Assessment (HSPA) Expert Group. The 2021 report ‘Improving access to healthcare through more powerful measurement tools’ [5] collected specifically examples of indicators used at national level to measure waiting times. Issues related to access to healthcare are regularly discussed and addressed within the framework of the European Semester, where the Commission analyses national health systems, identifies challenges such as accessibility, effectiveness and resilience. The challenge of waiting times in Italy is stressed in the 2025 European Semester Country Report [6] . Member States can use funding under the Recovery and Resilience Facility [7] , the Technical Support Instrument [8] and the Cohesion Policy [9] to improve access to healthcare. Italy benefits from these funding opportunities. [1] http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=en. [2] Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847, OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj. [3] Guidelines on access to healthcare for people with disabilities: https://op.europa.eu/en/publication-detail/-/publication/c2959f58-d63d-11f0-8da2-01aa75ed71a1/language-en; The role of healthcare in reducing poverty: https://op.europa.eu/en/publication-detail/-/publication/e86e91df-a97a-11f0-89c6-01aa75ed71a1; Affordability of healthcare: WHO Barcelona Office for Health Systems Financing (Spain): https://www.who.int/europe/teams/office-for-health-systems-financing-(barcelona). [4] Joint Action Heroes on health workforce planning https://healthworkforce.eu/; Nursing Action https://www.who.int/europe/news/item/17-06-2025-countries-advance--nursing-action--initiative-to-tackle-nurse-shortages-across-the-eu; BeWell https://bewell-project.eu/. [5] https://health.ec.europa.eu/health-systems-performance-assessment_en. [6] https://economy-finance.ec.europa.eu/publications/2025-european-semester-country-reports_en. [7] Recovery and Resilience Facility: https://commission.europa.eu/business-economy-euro/economic-recovery/recovery-and-resilience-facility_en. [8] Technical Support Instrument (TSI): https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/technical-support-instrument/technical-support-instrument-tsi_en. [9] Cohesion Policy: https://ec.europa.eu/regional_policy/2021-2027_en.”
Public and private sectors role in healthcare services
- 2026-05-11 “Answer given by Mr Várhelyi on behalf of the European Commission 11.5.2026 Written question 1. The Rapid Alert System for Food and Feed (RASFF) notification with regard to Brazilian beef contaminated with oestradiol-17β was registered and circulated on 14 November 2025. It was based on information collected by Commission auditors [1] on amounts of meat from animals treated with oestradiol mixed with that of non-treated animals, exported from Brazil to certain Member States accompanied by corresponding health certificates. An information notification was appropriate and allowed immediate follow-up by Member States. 2. Following the RASFF notification, Member States blocked or traced back imported consignments and withdrew them from the market. The Brazilian authorities suspended the farm where non-compliances were identified but also the farms controlled by the certification body which had certified the non-compliant farm, from the list of farms authorised for export of female bovine meat to the EU. The corrective actions to be implemented by Brazil will be closely monitored by the Commission in order to ensure and maintain the EU high food safety standards. 3. The Commission would like to refer the Honourable Members to its answer to written p riority Question P-000230/2026 [2] , which addresses the same issues. The RASFF notification was related to bovine meat, while, in contrast, Brazil received favourable audit reports (2024-8002 [3] and 2023-7857 [4] ) and compliant results in reinforced checks on poultry meat. Consequently, pre-listing of poultry and egg products establishments was resumed. [1] https://ec.europa.eu/food/audits-analysis/audit-report/details/4975. [2] https://www.europarl.europa.eu/doceo/document/P-10-2026-000230-ASW_EN.html. [3] https://ec.europa.eu/food/audits-analysis/audit-report/details/4815. [4] https://ec.europa.eu/food/audits-analysis/audit-report/details/4750.”
Maximum residue levels · Import of agri-food products in the EU
- 2026-05-11 “Answer given by Mr Várhelyi on behalf of the European Commission 11.5.2026 Written question The Rapid Alert System for Food and Feed (RASFF) notification from November 2025 followed a Commission audit in Brazil. It was during this audit that the Commission’s auditors identified beef consignments containing products from female cattle treated with oestradiol. The Commission promptly shared this information with all Member States that received potentially affected consignments. The Commission conducts regular audits on exporting countries, like Brazil, with publicly available reports describing any non-compliance and prompting corrective actions by the competent authorities. The effectiveness of these actions is followed up by the Commission. In this case, upon Commission’s request, Brazil delisted the farm where non-compliances were identified, from the list of farms authorised for export of bovine meat to the EU. Brazil also suspended the activity of the certification body, until it is proved that all shortcomings have been remedied and effective controls are in place. Consequently, all farms certified by this certification body are also suspended. A follow-up audit will be conducted to verify the effectiveness of the Brazil’s action plan and to ensure and maintain the EU high food safety standards. The EU plans to enhance its controls of compliance with EU requirements by increasing its audits of countries exporting to the EU by 50% over the next two years and of border posts in charge of the control of imported products and animals by 33% [1] . [1] As announced during the Commissioner for Health and Animal Welfare implementation dialogue on import controls: https://food.ec.europa.eu/events/implementation-dialogue-import-controls-commissioner-oliver-varhelyi-2025-12-09_en.”
Trade relations with Mercosur · Import of agri-food products in the EU
- 2026-05-08 “Answer given by Mr Várhelyi on behalf of the European Commission 8.5.2026 Written question 1. The EU’s legal framework, in particular Regulation (EU) 2016/429 [1] and Commission Delegated Regulations (EU) 2020/687 [2] and 2020/689 [3] , provides for harmonised measures across the Union, based on the principle of rapid eradication through stamping out confirmed outbreaks of Category A diseases such as foot and mouth disease (FMD), combined with movement restrictions and, where appropriate, the use of vaccination [4] . 2. Under Article 12(1) of Delegated Regulation (EU) 2020/687, the competent authority is required to order the culling of all animals of listed species in an affected establishment following the confirmation of FMD. Vaccination does not alter that requirement. Article 12(4) provides for limited derogations based on a case-by-case risk assessment, giving flexibility for performing the culling either in other locations or postponing the culling based on the context of emergency vaccination, provided that such measures do not compromise disease control. However, culling remains mandatory also in those cases. Indeed, these derogations do not alter the general principle of rapid eradication through stamping-out, which remains essential given the highly contagious nature of the disease. 3. Since the rules and guidelines remain unchanged, the Commission does not foresee issuing further guidelines. [1] 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, pp. 1, ELI: http://data.europa.eu/eli/reg/2016/429/oj). [2] Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, pp. 64–, ELI: http://data.europa.eu/eli/reg_del/2020/687/oj). [3] Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, pp. 211-340, ELI: http://data.europa.eu/eli/reg_del/2020/689/oj). [4] https://food.ec.europa.eu/animals/animal-diseases/diseases-and-control-measures/foot-and-mouth-disease_en.”
Animal diseases prevention and management in the EU
- 2026-05-07 “Answer given by Mr Várhelyi on behalf of the European Commission 7.5.2026 Written question 1. Mercosur countries have been authorised to export beef to the EU for a number of years. The Commission carries out audits of the official control and certification systems underpinning the guarantees provided by Mercosur countries in the certificate for bovine meat required by the EU. Between 2023 and 2025, a total of nine relevant audits were carried out in Brazil, Argentina, Uruguay and Paraguay. The corresponding audit reports are available at the Commission website [1] , with one still being finalised [2] . The Commission plans to carry out four audits for beef in Mercosur countries in 2026 [3] . 2. Published audit reports contain information about the number of states/regions and establishments visited within each country, though names are not disclosed. Commission audits are system audits and not audits of individual establishments, and establishments are visited to evaluate the performance of the competent authorities. The audit’s objective is to assess and verify the effectiveness and compliance of the authorities’ official control and certification systems in order to support the guarantees provided in the certificate required by the EU. 3. Findings vary according to the scope of the audit and the countries’ official control and certification systems and are detailed in the individual reports. The main findings and conclusions lead to recommendations to the competent authorities which are also published in the report. In response to the Commission’s recommendations, the competent authorities present an action plan. The Commission assesses the action plan and follows up on its implementation as necessary, either administratively or during a subsequent audit. Action plans are published alongside the audit reports. [1] http://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm. [2] https://eur-lex.europa.eu/eli/reg/2017/625/oj. [3] For details on the audits carried out and programmed see the annex.”
Trade relations with Mercosur · Import of agri-food products in the EU
- 2026-05-07 “Answer given by Mr Várhelyi on behalf of the European Commission 7.5.2026 Written question The Commission, in collaboration with the European Medicines Agency and its Medicines Shortages Steering Group, is closely monitoring the situation and potential impact of the conflict in the Middle East on the supply of medical products. As of mid-April, the situation appears to be stable, with minimal disruption to transport of medicines and no impact on manufacturing capacity. European air cargo companies, including commercial carriers, have indicated to have the capacity to support additional or rerouted medical supplies, if necessary. The Commission does not hold current data on price developments in the Member States, since the pricing of medicines is a national competence. However, the Commission is funding the European Integrated Price Information Database (EURIPID) [1] , on which Member States periodically share information on medicine list prices and sales volumes. Stockpiling of medical products at EU level is being initiated through rescEU which represents a critical component of the EU’s strategy to bolster collective preparedness for health emergencies and chemical, biological, radiological, and nuclear (CBRN) threats. rescEU encompasses medical and CBRN stockpiles hosted across 16 Member States with a total investment exceeding EUR 1.6 billion [2] . Fully integrated into the Union Civil Protection Mechanism (UCPM), these stockpiles are designed for rapid deployment, underscoring the EU’s commitment to swift, coordinated crisis response. Under the proposed Critical Medicines Act [3] , Member States would also have access to different collaborative procurement tools to increase the availability of critical medicines and other medicines of common interest. [1] The legal framework for the European Integrated Price Information Database consists of the framework partnership Agreement, the General Terms and Conditions to the framework Partnership Agreement of EURIPID Collaboration (GTC) and the Terms and Conditions of Use of the EURIPID Website (TCU). https://euripid.eu/. [2] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32019D0570&qid=1730378629745. [3] COM(2025) 102 final.”
Government stockpiling of critical medicines · Supply chain diversification requirements in medicine procurement · Joint EU procurement of medicines
- 2026-05-07 “Answer given by Mr Várhelyi on behalf of the European Commission 7.5.2026 Written question Cancer incidence estimates and historical data for European countries are available in the European Cancer Information System (ECIS) [1] . The European Cancer Inequalities Registry [2] , a flagship of Europe’s Beating Cancer Plan [3] , tracks cancer disparities in the EU, Norway and Iceland. Its Data Tool integrates data from ECIS, whilst Country Cancer Profiles [4] and EU Analytical Reports [5] provide national analyses and EU-level comparisons. The reported number of new cancer cases grew across Member States up to 2020. This trend continued until 2022, when 2.78 million new cancer cases were estimated, a 2.4% rise from 2020. Since 2021, cancer incidence is stabilising or increasing moderately, with 2.7 million new cases estimated in 2024. However, data enabling robust analysis from 2021 will become available in the second half of 2026, following the 2026 ECIS update where incidence data for 2021-2024 will be published. Cancer incidence varies between Member States, with Central and Eastern European countries generally showing higher rates. However, in 2024 Denmark was estimated to rank highest for incidence (22% above the EU average) and Bulgaria lowest (26% below), in contrast to the general trend. These disparities likely stem from differences in prevalence of risk factors, population structures and ageing, existence and effectiveness of prevention and screening programmes, quality of diagnosis and treatment. From the data registration perspective, quality and completeness of cancer registries also play a role. Finally, the Commission refers the Honourable Member to the answer to Parliamentary Question E-002078/20257 [6] , detailing that there is no scientific evidence of any increase of cancer occurrence following COVID-19 vaccination. [1] https://ecis.jrc.ec.europa.eu/. [2] https://cancer-inequalities.jrc.ec.europa.eu/. [3] https://commission.europa.eu/topics/public-health/european-health-union/cancer-plan-europe_en. [4] https://cancer-inequalities.jrc.ec.europa.eu/country-cancer-profiles-2025. [5] https://cancer-inequalities.jrc.ec.europa.eu/sites/default/files/oecd-ecir-beating-cancer-inequalities-05022024.pdf; https://cancer-inequalities.jrc.ec.europa.eu/sites/default/files/docs/ar2026/Analytical-report-2026.pdf. [6] https://www.europarl.europa.eu/doceo/document/-ASW_EN.html.”
Vaccination · Pharmaceuticals regulation in EU
- 2026-05-07 “Answer given by Mr Várhelyi on behalf of the European Commission 7.5.2026 Written question The Commission took note of the Court of Auditors’ Special Report, which was prepared with the full collaboration of the Commission. The identified shortcomings were raised as potential risks, rather than instances of inefficient use of funds. The finding of persisting inequalities among Member States, for example in cancer screening, is in line with the analyses from the Cancer Inequalities Registry [1] . These results underline the importance of the Commission’s commitment to tackle inequalities in a cross-cutting manner, as is done through numerous Cancer Plan actions [2] , [3] , [4] which will need more time to evolve and show impact. The Commission has accepted the recommendations from the report to mitigate the identified risks and is currently working on follow-up actions. The Commission is continuously investing in efforts to ensure complementarity and sustainability of Cancer Plan actions and is committed to strengthening these efforts. Discussions on how to improve the governance of the Cancer Plan are ongoing with Member States. In terms of funding, the Commission cannot make any commitments going beyond the current Multiannual Financial Framework (MFF), while negotiations between the co-legislators on the next MFF are still ongoing. As the report notes, due to the complexity and varied nature of the Cancer Plan actions, there is no single end date or unified timeline. The Commission regularly publishes an Implementation Roadmap to track milestones and key deliverables for all actions. The report also acknowledged that the 2025 review [5] improved transparency on progress. The Commission is also working to establish a Cancer Plan-wide monitoring framework by the end of 2027 and will seek to evaluate the results and impact of the actions by 2030. [1] https://cancer-inequalities.jrc.ec.europa.eu/. [2] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2022.473.01.0001.01.ENG. [3] https://health.ec.europa.eu/non-communicable-diseases/cancer/europes-beating-cancer-plan-eu4health-financed-projects/projects/eucanscreen_en. [4] https://cancer-screening-and-care.jrc.ec.europa.eu/en. [5] https://health.ec.europa.eu/latest-updates/review-europes-beating-cancer-plan-2025-02-04_en.”
EU competences on health
- 2026-05-05 “Answer given by Mr Várhelyi on behalf of the European Commission 5.5.2026 Written question The Commission is closely monitoring the evolution of the different animal product markets, focusing on the potential impact of animal disease outbreaks [1] . The production of eggs increased in some Member States, in particular in Germany in 2025 compared to 2024. Egg imports also increased in 2025. The EU legislative framework for animal health [2] recognises and enables the use of vaccines to ensure effective prevention and control of category A diseases, including for vaccination against Newcastle disease (ND). In addition, vaccination against ND is required for certain movements within the EU [3] and for entry into the EU [4] from third countries or territories. In some Member States, vaccination against ND is mandatory, but certain are aiming on disease-free status from infection with ND virus without vaccination, as granted in the EU specific legislation [5] . For decades well-designed and properly implemented vaccination against ND, coupled with appropriate biosecurity practices effectively prevented outbreaks. Therefore, in the current context of budget difficulties, it is essential to prioritise the use of budget available for the support of emergency measures envisaged by the Single Market Programme (SMP) [6] to other category A diseases where vaccines are not available or not sufficiently effective to prevent the disease. Hence, in 2025 the Commission phased out co-financing emergency measures for ND under the SMP [7] . Following animal disease outbreaks, Member States may support investments in restoring production potential [8] and introduce crisis payments for affected farmers [9] . At the request of the concerned Member State, the Commission may adopt exceptional support measures to address trade restrictions. [1] https://agriculture.ec.europa.eu/farming/animal-products/eggs_en. [2] 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, ELI: http://data.europa.eu/eli/reg/2016/429/oj). [3] Commission Delegated Regulation (EU) 2020/688 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (OJ L 174, 3.6.2020, pp. 140, ELI: http://data.europa.eu/eli/reg_del/2020/688/oj). [4] Commission Delegated Regulation (Eu) 2020/692 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, pp. 379, ELI: http://data.europa.eu/eli/reg_del/2020/692/oj ). [5] Commission Implementing Regulation (EU) 2021/620 of 15 April 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of the disease-free and non-vaccination status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for those listed diseases (OJ L 131, 16.4.2021, pp. 78, ELI: http://data.europa.eu/eli/reg_impl/2021/620/oj ). [6] Regulation (EU) 2021/690 of the European Parliament and of the Council of 28 April 2021 establishing a programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014 (OJ L 153, 3.5.2021, pp. 1, ELI: http://data.europa.eu/eli/reg/2021/690/oj ). [7] Summary report of the Standing Committee on Plants, Animals, Food and Feed, 16-17 December 2024: https://food.ec.europa.eu/document/download/a1190b22-fb16-4f97-b105-c0c674fe4ba3_en?filename=reg-com_ahw_20241216_sum.pdf. [8] 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 Regulations (EU) No 1305/2013 and (EU) No 1307/2013 (OJ L 435, 6.12.2021, pp. 1, ELI: http://data.europa.eu/eli/reg/2021/2115/oj). [9] Regulation (EU) 2025/2649 of the European Parliament and of the Council of 19 December 2025 amending Regulation (EU) 2021/2115 as regards the conditionality system, types of intervention in the form of direct payment, types of intervention in certain sectors and rural development and annual performance reports and Regulation (EU) 2021/2116 as regards suspensions of payments, annual performance clearance and controls and penalties (OJ L, 2025/2649, 31.12.2025, ELI: http://data.europa.eu/eli/reg/2025/2649/oj).”
Animal diseases prevention and management in the EU
- 2026-05-05 “Answer given by Mr Várhelyi on behalf of the European Commission 5.5.2026 Written question The General Data Protection Regulation (GDPR) [1] lays down rules on personal data protection which apply to the processing of the sensitive personal electronic health data collected by health-tracking apps. Regarding the Honourable Member’s question on specific guidelines on the lawfulness of the processing, transparency and protection of data subjects’ rights, in the context of such apps, the European Data Protection Board (EDPB) is tasked with issuing guidelines, recommendations and best practices for the consistent application of the GDPR. The GDPR fully applies to any processing of personal electronic health data undertaken within the framework of the European Health Data Space (EHDS) Regulation [2] . Furthermore, once applicable, the EHDS Regulation will set strong safeguards of security, confidentiality and personal data protection for the primary and secondary use of personal electronic health data. At Member State’ level, enforcement and oversight of the EHDS in the area of secondary use of personal electronic health data will be ensured through Member States’ health data access bodies (HDABs), which will monitor compliance with the EHDS Regulation and impose enforcement measures in the case where a non-compliance is established. In cases of potential GDPR breaches, HDABs must inform the competent national data protection authorities (DPAs) and share relevant information. DPAs and HDABs cooperate in enforcing the EHDS Regulation within their respective remits. Furthermore, the Commission funds projects dedicated to developing privacy-enhancing technologies and digital health tools [3] . [1] 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), https://eur-lex.europa.eu/legal-content/EN/AUTO/?uri=OJ:L:2016:119:TOC. [2] Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025), https://eur-lex.europa.eu/eli/reg/2025/327/oj [3] Examples of funded projects include: Privacy compliant health data as a service for AI development https://cordis.europa.eu/project/id/101095384. Federated virtual twins for privacy-preserving personalised outcome prediction of type 2 diabetes treatment https://cordis.europa.eu/project/id/101136305.”
Processing of health data · Privacy & digital economy
- 2026-05-05 “Answer given by Mr Várhelyi on behalf of the European Commission 5.5.2026 Written question The Commission’s position draws among others on scientific reports, surveys and other analyses that informed its evaluation [1] of the EU tobacco control legislative framework. The available evidence indicates that novel nicotine products are not harmless or risk-free and raise important public health concerns, notably as regards health effects, addiction, youth uptake and dual use with tobacco products. In its public communication, the Commission seeks to reflect the evolving state of scientific knowledge in a balanced and proportionate manner. The approach to taxing new nicotine products such as liquids for electronic cigarettes and nicotine pouches in the proposal to revise the Tobacco Taxation Directive [2] is driven by not only the need to ensure the proper functioning of the internal market, but also by fiscal considerations, notably tax-driven substitution effects that may affect the sustainability of revenue generation. Indeed, while the public health debate is still ongoing with regard to these relatively new products, none of them have been deemed safe or risk-free. Based on the same assumption used for traditional tobacco products, that higher tobacco taxes and prices are the most effective measure to reduce overall tobacco use, the introduction of taxation on new products aims to contribute to a reduction in their consumption. [1] Evaluation of the legislative framework for tobacco control https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13481-Evaluation-of-the-legislative-framework-for-tobacco-control_en. [2] https://taxation-customs.ec.europa.eu/taxation/excise-duties/excise-duties-tobacco/revision-tobacco-taxation-directive-proposal_en.”
Smoking regulation · Regulation on New Oral Nicotine Products
- 2026-05-04 “Answer given by Mr Várhelyi on behalf of the European Commission 4.5.2026 Written question The Commission would like to inform the Honourable Member that both EU citizens and healthcare professionals receive timely updates on all scientific recommendations taken by the European Medicines Agency (EMA). Following each meeting of the EMA’s safety committee (Pharmacovigilance Risk Assessment Committee — PRAC [1] ), the key outcomes are communicated through the PRAC highlights [2] . Furthermore, during the pandemic, the EMA implemented additional measures for COVID-19 medicinal products to maximise the transparency of its regulatory activities related to COVID-19 medicines [3] . Furthermore, all three extraordinary PRAC meetings (18 December 2020, 4 January 2021 and 22 January 2021) were convened to enable the PRAC to provide advice on the Risk Management Plans (RMPs) for the respective vaccines prior the Committee for Medicinal Products for Human Use (CHMP) plenary meeting on the vaccines marketing authorisation applications aiming at issuing a scientific opinion. The outcome (minutes) of these extraordinary PRAC meetings were subsequently incorporated into the minutes for the following PRAC plenaries, which are publicly available [4] , [5] . Additionally, the PRAC recommendations to the CHMP on the RMP are also included in the marketing authorisation assessment reports. They are therefore reflected in the respective European public assessment reports , in particular in the assessment reports for Vaxzevria [6] , [7] and Spikevax [8] , [9] . The PRAC committee operates under EMA’s responsibility. [1] https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac. [2] https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-march-2026. [3] https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/transparency-exceptional-measures-covid-19-medicines. [4] https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-23-26-november-2020_en.pdf. [5] https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-11-14-january-2021_en.pdf. [6] https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria. [7] https://www.ema.europa.eu/en/documents/assessment-report/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-public-assessment-report_en.pdf. [8] https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax. [9] https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf.”
Pharmaceuticals regulation in EU · Transparency of EU medicines governance process
- 2026-05-04 “Answer given by Mr Várhelyi on behalf of the European Commission 4.5.2026 Written question Post-polio syndrome (PPS) is among the more than 6 000 rare and complex diseases and syndromes [1] . While the Commission does not address individual rare conditions separately, it supports the field of rare diseases through European Reference Networks (ERNs) [2] , which are EU-level networks connecting medical expertise across Member States to improve timely diagnosis and high-quality care for patients with rare or complex conditions. Many rare diseases, including post-polio syndrome, require coordinated input from multiple medical specialties. The ERNs facilitate this by enabling structured, multidisciplinary collaboration and alignment of expertise among healthcare providers across different Member States. In this context, patients with PPS may benefit in particular from the activities of the ERN EURO-NMD [3] (Rare Neuromuscular Diseases), as well as, where relevant, the ERN-RND [4] (Rare Neurological Diseases). Regarding funding, the Commission provides support to the ERNs through the EU4Health programme, allocating EUR 77.4 million to fund their activities until 2027. The Commission also supports the work of Orphanet in developing and maintaining a comprehensive rare disease nomenclature and providing high-quality information for rare disease codification. Collaborative research on rare diseases has been a long-standing priority for the Commission. Most recently, this includes the launch of the European Partnership on Rare Diseases under the European Rare Diseases Research Alliance [5] , which further strengthens support for research and innovation in this field. [1] Classified in the Orphanet nomenclature: https://www.orpha.net/. [2] https://health.ec.europa.eu/rare-diseases-and-european-reference-networks/european-reference-networks_en. [3] https://ern-euro-nmd.eu/. [4] https://www.ern-rnd.eu/. [5] https://erdera.org/.”
Public and private sectors role in healthcare services · EU competences on health
- 2026-04-28 “E-000830/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Commission, together with the European Medicines Agency (EMA) and Member States, monitors the safety of COVID-19 vaccines, including data from the scientific literature, through a robust pharmacovigilance system 1 . Based on the continuous monitoring and assessment of safety data from vaccination campaigns worldwide, there is no scientific evidence of any association between COVID-19 vaccines and impaired fertility in men or women. Detailed information on the continuous safety monitoring of COVID-19 vaccines can be found on the EMA website, including the Periodic Safety Update Reports 2 for each vaccine and the report on pharmacovigilance activities carried out by Member States and the EMA between 2019 and 2022 3 . While there have been some reports about the short-term variation of fertility trends during the pandemic, this was attributed to behavioural changes, as in most of the studied countries the fertility rates returned to pre-pandemic levels and no evidence of effect of COVID-19 vaccinations on fertility trends was found 4,5,6 . Based on the existing scientific evidence, the Commission does not consider a specific study on this matter to be necessary. It should be noted that EU citizens and healthcare professionals are informed in a timely manner about the latest scientific decisions taken by the EMA. Following each meeting of the EMA’s safety committee (Pharmacovigilance Risk Assessment Committee - PRAC 7 ), decisions are communicated through the PRAC highlights 8 . In addition, exceptional measures for COVID-19 medicines were implemented by the EMA to maximise the transparency of its regulatory activities related to COVID-19 medicinal products 9 . 1 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-medicines/safety-covid-19-vaccines. 2 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-medicines#authorised-covid-19-vaccines-14489. 3 https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview/legal-frameworkpharmacovigilance/implementation-pharmacovigilance-legislation#multi-annual-reports-on-pharmacovigilanceactivities-12875. 4 COVID-19 vaccination carries no association with childbirth rates in Sweden: https://www.nature.com/articles/s43856-026-01396-x. 5 Birth rate decline in the later phase of the COVID-19 pandemic: the role of policy interventions, vaccination programmes, and economic uncertainty: https://academic.oup.com/hropen/article/2024/3/hoae052/7754492#google_vignette. 6 Max Planck Institute for Demographic Research - How have Covid-19 vaccinations affected birth rates?: https://www.demogr.mpg.de/en/news_events_6123/news_press_releases_4630/news/how_have_covid_19_vacci nations_affected_birth_rates_14112/. 7 Pharmacovigilance Risk Assessment Committee (PRAC): https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac. 8 https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-912-march-2026. 9 Transparency: exceptional measures for COVID-19 medicines: https://www.ema.europa.eu/en/humanregulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/transparencyexceptional-measures-covid-19-medicines.”
Sexuality and reproduction · Vaccination
- 2026-04-27 “E-000546/2026 Answer given by Mr Várhelyi on behalf of the European Commission On 19 May 2025, the UK and the Commission reached a common understanding and agreed to work towards establishing a Common Sanitary and Phytosanitary Area by way of an EUUK sanitary and phytosanitary (SPS) agreement. On 13 November 2025, the European Council adopted the guidelines 1 for the negotiation by the Commission of an SPS agreement between the EU and the UK that should cover sanitary, phytosanitary, food safety and general consumer protection rules applicable to the production, processing and distribution of agrifood products, the regulation of live animals and pesticides, the rules on organics as well as marketing standards applicable to certain sectors or products. The agreement would require that the UK dynamically aligns to the relevant EU rules and, as a result, movements of animals, including zoo animals, could be undertaken without sanitary checks at the borders and with the same certificates as the ones required for movements between Member States. The guidelines as approved by the Council do not cover CITES 2 requirements and therefore the future SPS agreement will not include them in its scope. As a consequence, permits will still be required to move CITES species to and from Great Britain. 1 Council Decision (EU) 2025/2468 of 13 November 2025 authorising the opening of negotiations between the European Union and the United Kingdom of Great Britain and Northern Ireland on a common sanitary and phytosanitary area between the European Union and the United Kingdom in respect of Great Britain and to link the United Kingdom’s and the Union’s greenhouse gas emissions trading systems (OJ L 149). 2 Convention on International Trade in Endangered Species of Wild Fauna and Flora.”
EU-UK data transfer
- 2026-04-27 “E-000363/2026 Answer given by Mr Várhelyi on behalf of the European Commission Health workforce shortages are an important challenge. In accordance with Article 168(7) of the Treaty on the Functioning of the EU 1 , EU action shall respect Member States’ responsibilities for the management of health services, including staffing levels, and the allocation of the resources assigned to such services. The Commission provides funding to support Member States in addressing health workforce challenges. The EU4Health Programme supports initiatives such as the Joint Action Heroes on health workforce planning 2 , digital skills projects 3 , the Nursing Action 4 , and the mental health survey 5 . Erasmus+ supports the BeWell action 6 . Horizon Europe funds relevant research initiatives 7 . The European Social Fund+ supports the training and reskilling of the healthcare workforce. Member States have allocated EUR 42.7 billion to healthcare in their national recovery and resilience plans, which also support the healthcare workforce. The European Semester highlights health workforce challenges in country reports for all Member States and, in several cases, through country-specific recommendations. The Commission’s proposal for the next multiannual financial framework provides for funding opportunities on health, including for strengthening the health workforce (for example, the specific activities listed in Article 37(1), point (b), of the proposal for the European Competitiveness Fund) 8 . In addition, the Commission’s proposal on national and regional partnership plans (NRPPs) envisions that Member States could use their NRPPs to support health investments addressing challenges identified in the European Semester and in line with the objectives identified in Article 3.1(c)(iv) of the proposal for NRPPs. 1 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=en. 2 https://www.agenas.gov.it/ricerca-e-sviluppo/ricerca-internazionale/personale-sanitario-ri/heroes-healthworkforce-to-meet-health-challenges. 3 EU4Health programme: https://health.ec.europa.eu/publications/2022-eu4health-work-programme_en; AMR EDUCare https://www.amreducare.eu/; e-Hospital4Future: https://eh4future.eu/; GESEA Educational Programme; DigiCanTrain: https://digicantrain.turkuamk.fi/contact-us/; DDS-MAP https://ddsmap.easpd.eu/; TRANSiTION: https://ehma.org/projects/transition/; EHMA: https://hpass.healthworkforce.eu/. 4 EU4Health programme, 2024: https://health.ec.europa.eu/publications/2024-eu4health-work-programme_en. 5 https://www.who.int/europe/publications/i/item/WHO-EURO-2025-12709-52483-81031. 6 BeWell: https://bewell-project.eu/. 7 Under Cluster Health, Destination 4, ‘Ensuring equal access to innovative, sustainable, and high-quality healthcare’ and also via the European Partnership for Transforming Health and Care Systems which runs between 2023-2029. 8 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025PC0555.”
Public and private sectors role in healthcare services · EU competences on health
- 2026-04-27 “E-000879/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Food Information to Consumers Regulation 1 sets out the principles and requirements governing food information, ensuring consumers can make informed choices. Voluntary information, like ‘vegan’ or ‘vegetarian’, must be accurate, clear, scientifically based where appropriate, and not misleading as to the food’s nature, identity, properties, or composition. Allergens 2 (e.g. milk) must be declared and emphasised in the ingredients list, when they are intentionally present in the finished food, even in an altered form. Food business operators bear the primary responsibility for compliance with applicable rules, including preventing cross-contamination by allergens via robust food safety practices 3 . Unintentional and possible presence of allergens (e.g. due to cross-contamination) may be indicated voluntarily, in accordance with the above rules on voluntary information. Under the General Food Law 4 , unsafe food, including that lacking proper consumer information on the label, must not be placed on the market. Member States must enforce food law, monitor and verify that the relevant requirements are fulfilled by food business operators at all stages of production, processing and distribution. While the Regulation mandates an implementing act on voluntary ‘vegan’/‘vegetarian’ information, no legal deadline has been set, and the Commission has currently prioritised pursuing work to harmonise rules on the provision of information on the unintentional and possible allergen presence. This prioritisation is aligned with the recommendations in the recent report of the European Court of Auditors 5 . 1 OJ L 304 22.11.2011, p. 18. 2 Listed in Annex II to the Regulation (EC) No 1169/2011. 3 Commission Notice on the implementation of food safety management systems covering Good Hygiene Practices and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses (2022/C 355/01). 4 OJ L 31, 1.2.2002, p. 1. 5 Special report 23/2024: Food labelling in the EU – Consumers can get lost in the maze of labels. Accessible at: https://www.eca.europa.eu/en/publications/SR-2024-23.”
Nutrition · Food labelling harmonisation at EU level
- 2026-04-27 “E-000507/2026 Answer given by Mr Várhelyi on behalf of the European Commission Food products from third countries, regardless of their origin, must comply with EU food safety requirements laid down in EU legislation. According to Regulation (EU) 2017/625 1 , Member States must carry out risk based official controls and enforcement activities among others at the stage of distribution, including for imports. Where food of non-animal originating from third countries poses a risk, the Commission may adopt measures through Commission Implementing Regulation (EU) 2019/1793 2 , including increased control frequency, sampling and laboratory analysis and special conditions governing their entry into the EU. Several products originating from Türkiye are listed in Annexes of Regulation (EU) 2019/1793. Each consignment of goods listed in Annex II to that Regulation must be accompanied by an official certificate and the results of laboratory analyses issued by the Turkish competent authority. These measures are reviewed at least twice a year and adjusted as necessary, considering new information related to risks and instances of non-compliance, including information from Rapid Alert System for Food and Feed (RASFF) notifications, and other available information provided by the Member States. The Commission performs audits in Member States and in third countries to ensure that their official control systems guarantee that goods intended for export to the EU comply with the applicable EU rules 3 . On 9 December 2025 the Commission announced a series of measures to strengthen import controls at EU borders and in third countries, among them (i) 50% increase of audits in nonEU countries, (ii) 33% increase of audits in EU border control posts, and (iii) training for over 600 national authority staff. 1 https://eur-lex.europa.eu/eli/reg/2017/625/oj. 2 https://eur-lex.europa.eu/eli/reg_impl/2019/1793/oj. 3 Health and Food Audits and Analysis https://food.ec.europa.eu/horizontal-topics/official-controls-andenforcement/health-and-food-audits-and-analysis_en.”
Import of agri-food products in the EU · Maximum residue levels · Pesticides & trade
- 2026-04-27 “E-000860/2026 Answer given by Mr Várhelyi on behalf of the European Commission The authorisations referred to by the Honourable Member aim to address exceptional circumstances related to animal or public health. These are only granted where the benefit of their immediate availability outweighs the risks linked to the absence of certain documentation. These authorisations are only valid for one year and subject to re-examination to confirm that i) the exceptional circumstances remain, and ii) the benefit-risk balance remains positive 1 . The outcome of their assessment as regards their quality, efficacy, risks to humans, animals and food safety, is reflected in the assessment reports prepared by the European Medicines Agency. These reports are publicly available in the EU Product Database 2 , ensuring full transparency. In accordance with the assessment 3 of the European Food Safety Authority, poultry holding density should be considered a major contributing factor for large highly pathogenic avian influenza (HPAI) epidemics. Member States should consider this risk factor when designing their prevention strategy against HPAI. Vaccination may be used as a complementary tool that, added to biosecurity and other measures, can help prevention against infection and spread of HPAI in poultry. Currently, France is the only Member State implementing preventive vaccination against HPAI in poultry and only a few trading partners continue applying trade restrictions, limited to certain products of vaccinated poultry. 1 Articles 25 to 27 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products. 2 https://medicines.health.europa.eu/veterinary/select-language?destination=/node/210934. 3 https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2017.4991.”
Animal diseases prevention and management in the EU
- 2026-04-27 “E-000298/2026 Answer given by Mr Várhelyi on behalf of the European Commission Sheep pox and goat pox (SPGP) vaccines are available in the EU vaccine bank, and their safety have been assessed by the European Union Reference Laboratory for Capripox viruses and are documented. To support the Greek authorities, the Commission requested the European Food Safety Authority to provide a scientific report 1 assessing the safest and most effective vaccines for SPGP, as well as appropriate vaccination strategies. The report confirmed that, if properly implemented, vaccination is suitable and effective under conditions such as those currently observed in Greece. While no SPGP vaccines are currently authorised within the EU according to the Regulation on Veterinary Medicinal Products (VMPs) 2 , competent authorities in Member States may, in specific circumstances, allow the use of vaccines that are not authorised in the EU. According to the VMPs Regulation, vaccines receive marketing authorisations through applications submitted by pharmaceutical companies. Applicants may apply for a marketing authorisation under exceptional circumstances, if the conditions of Article 25 of the VMPs Regulation are met. Assessment timelines vary but are generally shorter under exceptional circumstances than for standard marketing authorisation applications. The Commission continues to work with Greece to ensure effective enforcement of control measures such as movement restrictions, and it recommends consideration of vaccination as part of an integrated strategy to contain further spread and achieve disease eradication. 1 https://www.efsa.europa.eu/en/efsajournal/pub/9928. 2 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, pp. 43–167. ELI: http://data.europa.eu/eli/reg/2019/6/oj.)”
Animal diseases prevention and management in the EU
- 2026-04-23 “P-000777/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Commission took the following necessary measures: monitor the foot and mouth disease (FMD); adopt immediate FMD regionalisation measures 1 and protect the EU internal market; ensure EU coordination 2 ; after a request from Cyprus, the EU FMD antigen bank shipped vaccine doses to Cyprus 3 ; provide support to all Member States, including training 4 and dispatch the EU Veterinary Emergency Team 5 on-site; regularly inform Member States and trading partners 6 on the evolution of the epidemiological situation and maintain constant dialogue with trading partners to avoid unjustified trade bans. EU co-financing of emergency veterinary measures is available under the Single Market Programme 7 . This includes costs related to the culling of animals on affected farms, compensating their owners, and cleaning and disinfecting the affected premises as well as the costs of purchase, storage and administration of vaccines 8 . Under Article 73 of CAP Strategic Plans Regulation 9 , MS may support investments in restoration of agricultural production potential following animal disease outbreaks. Under Article 78a 10 , Member States may amend their plans to introduce crisis payments for farmers affected by animal diseases, subject to formal recognition of the outbreak and the applicable loss threshold. Cyprus implements an animal welfare intervention 11 which includes biosecurity measures in pig and ruminant holdings. The Commission may also adopt exceptional support measures to address trade restrictions arising from measures implemented to combat the spread of animal diseases. 1 The Commission adopted Commission Implementing Decision (EU) 2026/484 of 25 February 2026 concerning certain interim emergency measures relating to foot and mouth disease in Cyprus, http://data.europa.eu/eli/dec_impl/2026/484/oj. 2 Through European Commission comitology as provided by the Standing Committee on Plants, Animals, Food and Feed: https://food.ec.europa.eu/horizontal-topics/committees/paff-committees_en. 3 https://food.ec.europa.eu/animals/animal-diseases/diseases-and-control-measures/foot-and-mouthdisease/support-cy_en. 4 Better Training for Safer Food (BTSF) resources: https://better-training-for-saferfood.ec.europa.eu/training/?lang=en. 5 https://food.ec.europa.eu/animals/animal-diseases/veterinary-emergency-team_en. 6 https://food.ec.europa.eu/document/download/77095016-118f-4792-a0fc4c89327c2d43_en?filename=ad_control-measures_fmd_chron-cyp.pdf. 7 http://data.europa.eu/eli/reg/2021/690/oj). 8 https://food.ec.europa.eu/document/download/c1ed1748-1b55-4e7b-add0b7eb41c65a3e_en?filename=cff_animal_emergency-measures_ah-ms-guidelines.pdf. 9 Common Agricultural Policy (CAP) 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) http://data.europa.eu/eli/reg/2021/2115/oj.. 10 Regulation (EU) 2025/2649 of the European Parliament and of the Council of 19 December 2025 amending Regulation (EU) 2021/2115 and Regulation (EU) 2021/2116, http://data.europa.eu/eli/reg/2025/2649/oj. 11 In its CAP Strategic Plan 2023–2027, of a total public allocation of EUR 9.7 million.”
Agricultural funding
- 2026-04-23 “P-000703/2026 Answer given by Mr Várhelyi on behalf of the European Commission Under Regulation (EC) No 1107/2009 1 active substances used in plant protection products (PPPs) can only be approved if a comprehensive scientific assessment conducted by Member States and the European Food Safety Authority demonstrates their use is not expected to have harmful effects on human or animal health nor unacceptable effects on the environment. The Food and Feed Safety Omnibus does not propose to change the strict approval criteria for active substances or the requirements for PPPs. It intends to increase procedural efficiency by replacing periodic renewal procedures for most active substances with reviews, when there are indications for its need, via the work programmes for full renewals or targeted reassessments 2 . Under the current legal framework, most substances are approved for a period of up to 15 years. However, due to resource constraints in the Member States, many renewal procedures are greatly delayed, resulting in extensions of existing approvals for sometimes considerable periods. New scientific guidance is only applied at the time of renewal. With the proposed targeted reassessments, substances can be reviewed earlier when new science becomes available. The Commission’s proposal does not affect the ongoing procedures to review the approval of 25 of 30 currently approved PFAS 3 active substances, another will start soon 4 . Decisions on the approval period for these substances will only be taken after completion of these renewal procedures. The study results on PFAS pollution societal costs cannot be directly compared to economic impacts in each sector. The Commission thus considers that the Food and Feed Simplification Package maintains and even improves the current high level of protection. 1 Regulation (EC) No 1107/2009 of the European Parliament and the Council concerning the placing of plant protection products on the market, OJ L 309, 24.11.2009, p. 1. 2 See the amended Article 18 and new Article 18a, proposed for Regulation (EC) No 1107/2009 in the Food and Feed Simplification Package. 3 Per- and polyfluoroalkyl substances. 4 Application for renewal of approval is due in April 2026.”
EU policy on pesticides · Reduction targets for pesticides
- 2026-04-21 “E-000491/2026 Answer given by Mr Várhelyi on behalf of the European Commission Directive 2009/128/EC 1 provides an overall prohibition of aerial spraying. However, Member States may grant derogations for special situations and under defined conditions. Considering that application of plant protection products (PPP) by drones can reduce the risks on human health (e.g. operators) and the environment, the Commission prepared a proposal to amend Directive 2009/128/EC through the Food and Feed Safety Simplification Package 2 adopted on 15 December 2025. It proposes to allow Member States to grant a general derogation from the prohibition on aerial spraying for certain types of drones identified by the Commission in a delegated act as applying PPP under equivalent or lower level of risks. The Commission will adopt a delegated act listing the types of drones that could be used for aerial spraying. The proposed specific rules would complement the requirements set in Regulations (EU) 2019/945 3 and 2019/947 4 , including on the competence of pilots, the operational limitations, and technical and operational parameters. EU-funded projects have tested the potential of unmanned aerial vehicles solutions, including drones, for pesticide spraying and other uses in agriculture, with combined investment of over EUR 17 million. Through their Common Agricultural Policy Strategic Plans, Member States may support a wide range of investments. Investments in precision farming can contribute to the competitiveness and profitability of farms by reduced production costs and improved environmental performance by reduced inputs (e.g., water, energy, fertilizer or PPPs), leading to greater environmental benefits. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009L0128-20190726. 2 https://food.ec.europa.eu/document/download/f08402e6-de66-4082-bf8dec3aff7787bb_en?filename=horiz_omnibus_dir_com-2025-1021-1part1.pdf. 3 https://eur-lex.europa.eu/eli/reg_del/2019/945/oj/eng. 4 https://eur-lex.europa.eu/eli/reg_impl/2019/947/oj/eng.”
Digital and precision farming · EU policy on pesticides
- 2026-04-21 “E-00842/2026 Answer given by Mr Várhelyi on behalf of the European Commission As set out in the Commission’s replies to questions P-004478/2025 1 and P-004688/2025 2 , infection with Lumpy Skin Disease (LSD) is categorised as a Category A disease under the Animal Health Law (AHL, Regulation (EU) 2016/429 3 ). Therefore, it requires Union-level intervention, and immediate eradication measures must be taken upon its detection due to the seriousness of its impact on animal health, the economy, society, and the environment. The appropriateness of this categorisation has been assessed in light of the disease profile and impact criteria laid down in Articles 5 and 7 of the AHL and supported by scientific evidence from the European Food Safety Authority 4 , the EU Reference laboratory and the World Organisation for Animal Health. Based on this assessment, the Commission has concluded that the current categorisation is appropriate and proportionate to the identified risk. No recategorisation is deemed necessary. The Commission continuously monitors the animal health situation in the Union territory and recognises the economic impact of animal diseases on the livestock sector. Considering the impact and consequences of disease outbreaks, it supports Member States through financial and technical assistance, including under the Single Market Programme and measures within the Common Agricultural Policy 5,6,7 . 1 Action protocols for new outbreaks of lumpy skin disease: https://www.europarl.europa.eu/doceo/document/P10-2025-004478_EN.html. 2 Spread of lumpy skin disease (LSD): https://www.europarl.europa.eu/doceo/document/E-10-2025004688_EN.html. 3 OJ L 84, 31.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/429/oj. 4 https://doi.org/10.2903/j.efsa.2022.7121. 5 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2115&qid=1757948393327. 6 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025PC0236. 7 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52025PC0560.”
Animal diseases prevention and management in the EU
- 2026-04-21 “PE784.580v01-00 EN E-000385/2026 Answer given by Mr Várhelyi on behalf of the European Commission Any food product placed on the EU market domestically produced or imported must comply with the EU’s sanitary and phytosanitary requirements 1 . These apply regardless of trade agreements with third countries such as the EU-Mercosur agreement. The EU prohibits the use of hormones for growth promotion, also to imported meat products. From 3 September 2026 2 stricter rules will apply. Food-producing animals and products derived therefrom exported to the EU must originate from animals that have never been administered antimicrobials for promoting growth or increasing yield, nor those reserved in the EU for the treatment of certain infections in humans. This requirement is applicable throughout the animal’s lifetime. For pesticides residues, the Commission established a principle that the most hazardous pesticides banned in the EU for health and environmental reasons are not allowed in the EU through imports. Several actions were already taken for this. A study informing an impact assessment was launched last year. The Food and Feed Safety Simplification package adopted on 16 December 2025 3 operationalises this principle. Updates to maximum residue levels are also continuously based on developments in international standards. These rules are enforced through rigorous border controls and regular audits on third countries. When a shortcoming is identified, the third country is required to place the necessary corrective measures. If these measures prove insufficient and there is a serious risk to human and/or animal health, the goods’ import from the third country may be suspended. EU food labelling rules apply also to all food products, including imports, and require mandatory origin labelling for certain products. On 9 December 2025 4 the Commission announced a 50% increase of audits in third countries over the next two years as well as the establishment of a Task Force to further strengthen controls on imports. 1 https://food.ec.europa.eu/horizontal-topics/official-controls-and-enforcement/import-controls-food-and-feedqas_en. 2 https://eur-lex.europa.eu/eli/reg_del/2023/905/oj. 3 COM(2025) 1021 final; COM(2025) 1030 final. 4 This was announced at the Commissioner for Health and Animal Welfare’s Implementation Dialogue on import controls. https://food.ec.europa.eu/events/implementation-dialogue-import-controls-commissioner-olivervarhelyi-2025-12-09_en.”
EU policy on pesticides · Pharmaceuticals regulation in EU
- 2026-04-21 “E-000625/2026 Answer given by Mr Várhelyi on behalf of the European Commission The preparatory action PIGSTUN 1 aimed to encourage EU pig slaughterhouses using carbon dioxide (CO 2 ) at high concentration for stunning pigs to convert to more human alternatives. It delivered concrete results and proposed alternatives to enhance existing practices and mitigate welfare and operational challenges. The alternatives evaluated by PIGSTUN, as well as methods including lower CO 2 concentrations, are already included in the positive list in Annex I of EU Regulation 1099/2009 2 and are authorised for use at EU level without requiring regulatory changes. For this reason, the Commission encourages the sector to explore the use of all authorised methods at this stage. 1 https://eurcaw-pigs.eu/dossier/pigstun. 2 http://data.europa.eu/eli/reg/2009/1099/oj.”
EU requirements on animal welfare for farmers
- 2026-04-21 “E-000750/2026 Answer given by Mr Várhelyi on behalf of the European Commission The size and minimum duration of restricted zones established in accordance with Union law 1 for outbreaks of highly pathogenic avian influenza (HPAI) are based on scientific evidence published by the European Food Safety Authority 2 . The international standards of the Terrestrial Code 3 of the World Organisation for Animal Health (WOAH) require cleaning and disinfection as condition for the recovery of free status when stamping out policy as defined in Chapter 4.2. of that Code is implemented. The procedures of cleaning and disinfection to be implemented for the eradication of outbreaks of category A disease, including HPAI, are described in EU rules and are composed of preliminary and final cleaning and disinfection. Completion of final cleaning and disinfection is, among other conditions, required by Article 68(1) of Regulation (EU) 2016/429 4 (Animal Health Law) before lifting the disease control measures in restricted zones. Therefore, Union law is aligned with the international standards ensuring guarantees for third countries accepting the regionalisation by the Union and the continuation of the trade from non-affected areas of the EU. In accordance with applicable Union law, the lifting of a restricted zone established for outbreaks of category A disease is not automatic. Such a zone can only be lifted after a minimum period (30 days in case of HPAI) only if all required measures, including enhanced surveillance in establishments located in the protection and surveillance zones, have been completed within that period. This approach remains unchanged by the revised Delegated Regulation (EU) 2020/687 5 . 1 Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, pp. 64, ELI: http://data.europa.eu/eli/reg_del/2020/687/oj). 2 https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.6372. 3 https://www.woah.org/en/what-we-do/standards/codes-and-manuals/. 4 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, pp. 1, ELI: http://data.europa.eu/eli/reg/2016/429/oj. 5 http://data.europa.eu/eli/reg_del/2020/687/oj.”
Animal diseases prevention and management in the EU
- 2026-04-21 “E-000719/2026 Answer given by Mr Várhelyi on behalf of the European Commission According to Article 168(7) of the Treaty on the Functioning of the European Union 1 , Member States are responsible for organising and delivering health services and medical care. The EU supports Member States with tools and initiatives such as technical assistance, knowledge sharing, funding and policy guidance. The European Semester provides a framework to identify and address policy challenges in Member States, ensuring coordination at EU level while safeguarding the principle of subsidiarity. The latest European Semester Polish country report’s health annex 2 shows that Poland’s health system is comparatively hospital-centred. Poland had one of the highest numbers of hospital beds per 1000 population in 2023, 6.3 vs 5.1 for the EU, with concurrent low occupancy rates. However, Poland has not received a country specific recommendation regarding the closure of maternity wards. The findings in the health annex are analytical in nature and do not, in themselves, entail a recommendation to close facilities. Decisions on the organisation of hospital networks, including maternity wards, remain a national competence. To the Commission’s knowledge, there is no direct link between analyses presented under the European Semester and the closure of maternity wards in Poland as raised by the Honourable Member. 1 eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=en. 2 https://economy-finance.ec.europa.eu/publications/2025-european-semester-country-reports_en.”
Public and private sectors role in healthcare services · EU competences on health
- 2026-04-17 “E-000732/2026 Answer given by Mr Várhelyi on behalf of the European Commission The scientific advice from the European Food Safety Authority (EFSA) serves multiple purposes, including identifying and assessing relevant negative welfare consequences by using animal-based measures associated with on-farm conditions and providing recommendations to prevent or mitigate the identified welfare consequences. The Commission is engaged in an impact assessment with a view to modernising the existing legislation on the welfare of animals on-farm, with a sector-by-sector approach, based on the latest scientific evidence and taking into account the different economic, social and environmental impacts of envisaged changes. No decision has been taken yet concerning the scope of the proposal as the impact assessment is still ongoing. The European Partnership on animal health and welfare 1 , co-funded under Horizon Europe, with EFSA as a member, is already performing some research on welfare of turkeys, including on animal-based indicators, and more may be performed where necessary. 1 https://www.eupahw.eu/.”
EU requirements on animal welfare for farmers
- 2026-04-17 “E-000634/2026 Answer given by Mr Várhelyi on behalf of the European Commission 1. The proposals put forward by the Honourable Members mentioned were assessed and replied to by the Commission 1 , referring to the work of the European Centre for Disease Prevention and Control (ECDC) with the Member States through the Emerging and Vectorborne Diseases Network (EVD-Net) 2 and the newly designated EU Reference Laboratory (EURL) for public health on high risk, emerging and zoonotic bacterial pathogens 3 , which covers Lyme borreliosis. There are no current plans to set up a European patient testing registry, but the Commission noted the suggestion. 2. Borrelia tests would typically fall into risk class C under Regulation (EU) 2017/746 4 . They are subject to assessment by notified bodies, which certify the quality management system of the manufacturer and assess technical documentation on a sampling basis or, for self-tests, of every device prior to its placement on the market. There are also post-market surveillance, market surveillance and vigilance requirements applicable when the device is on the market. Therefore, Regulation (EU) 2017/746 provides a framework for independent oversight of these tests. 3. Under the existing EU legislative framework, EU institutions do not have a mandate to perform an evaluation of medical devices. The work of the ECDC and the relevant EURL designated by the Commission is described in point 1. Moreover, as part of demonstrating conformity with Regulation (EU) 2017/746 the manufacturer must ensure that the device is state-of-the-art. An assessment of medical technologies is also performed by health technology assessment bodies at national level. The joint clinical assessment under Regulation (EU) 2021/2282 5 is limited to certain class D devices and therefore would not cover Borrelia tests. 1 Further reply from the Commission, received by the European Parliament on 3 November 2025: https://www.europarl.europa.eu/doceo/document/PETI-CM-760964_EN.pdf. 2 https://www.ecdc.europa.eu/en/about-ecdc/what-we-do/partners-and-networks/disease-and-laboratorynetworks/european-emerging-and. 3 https://www.rki.de/EN/Institute/International-activities/eu-reference-laboratory/EURL-PH-HEZB/eurl-publichealth-high-risk-bacterial-pathogens-node.html. 4 MDCG guidance on IVD classification: https://health.ec.europa.eu/document/download/12f9756a-1e0d-4aed9783-d948553f1705_en. 5 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282.”
Pharmaceuticals regulation in EU · Medical devices
- 2026-04-17 “E-000840/2026 Answer given by Mr Várhelyi on behalf of the European Commission 1. The Commission monitors the official controls performed on honey imported into the EU to verify compliance with the EU food safety legislation in general, and with Directive 2001/110/EC 1 in particular. Every consignment of honey is subject to official controls at the border control post of first arrival, including documentary and identity checks at a frequency of 100%, as well as physical checks on 15% of consignments 2 . During 2025, two coordinated measures of intensified official controls were launched at EU level 3 , with 22 consignments controlled under these measures, none of them related to Greece. 2. Directive (EU) 2024/1438 4 introduced mandatory origin labelling for honey blends and new provisions on traceability and authenticity. From June 2026, the countries of origin will have to be labelled for blends, including the percentage share represented by each country. By June 2029, the Commission will adopt delegated acts laying down methods and criteria to determine the place where honey has been harvested and EU-wide traceability requirements 5 . The Commission is also working to reinforce the capacity to detect honey adulterated with sugar syrups thanks to a project, running until end of 2026, that aims to harmonise analysis methods. The Commission has until June 2028 to adopt implementing acts laying down methods of analysis to detect adulterated honey 6 . 3. The Commission supports efforts to strengthen short supply chains and promote the consumption of local honey through the Common Agricultural Policy, which provides funding for advisory services, technical assistance, investments and actions aimed at supporting local beekeepers to improve production and quality of honey and enhance consumer confidence in local products. 1 ELI: http://data.europa.eu/eli/dir/2001/110/oj. 2 Pursuant to Implementing Regulation (EU) 2019/2129. 3 Pursuant to Implementing Regulation (EU) 2019/1873. 4 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32024L1438. 5 Pursuant to Article 4a (1), point (e) of Directive 2001/110/EC, as amended by Directive (EU) 2024/1438. 6 Pursuant to Article 4, second paragraph of Directive 2001/110/EC, as amended by Directive (EU) 2024/1438.”
EU policy on country of origin food labelling · Food labelling harmonisation at EU level
- 2026-04-17 “E-000744/2026 Answer given by Mr Várhelyi on behalf of the European Commission Sheep pox and goat pox control measures at EU level are laid down in Regulation (EU) 2016/429 1 and Delegated Regulation (EU) 2020/687 2 . Additional EU rules for control measures and movement restrictions relating to sheep pox and goat pox in Greece are laid down in Commission Implementing Decision 2024/2207 3 . Under Implementing Decision (EU) 2024/2207, movements of live sheep and goats from Greece to other Member States or to destinations outside the Union are prohibited. That Decision also prohibits movements of sheep and goats to restricted zones, except movements for immediate slaughter that are authorised by the competent authority. The Decision does not prohibit movements of animals from other Member States into non-restricted areas of Greece, nor does it restrict movements to any part of Greece for immediate slaughter. The EU has in place harmonised rules for movements of animals between Member States that are not affected by diseases listed in Regulation (EU) 2016/429 and Commission Delegated Regulation (EU) 2020/688 4 . Member States may adopt national measures that go beyond the referred Union legislation, under condition that such measures do not hinder the movement between Member States. The Commission has not been informed of any general suspension of imports of live sheep and goats from Member States to Greece. The Commission continues to closely monitor the situation to ensure that the measures applied remain consistent with Union animal health legislation and allow the safe operation of the EU single market. 1 http://data.europa.eu/eli/reg/2016/429/oj. 2 http://data.europa.eu/eli/reg_del/2020/687/oj. 3 http://data.europa.eu/eli/dec_impl/2024/2207/oj. 4 http://data.europa.eu/eli/reg_del/2020/688/oj.”
Animal diseases prevention and management in the EU
- 2026-04-17 “P-000417/2026 Answer given by Mr Várhelyi on behalf of the European Commission EU food safety standards apply to all products placed on the EU market, regardless of their origin and regardless of the existence of a free trade agreement with the trade partner. The Commission is dedicated to strictly enforcing these standards to ensure that imported food meets EU requirements. In accordance with the Communication on ‘A Vision for Agriculture and Food 1 ’, the Commission will notably increase the number of audits in third countries by 50% and works closely with the Member States to further strengthen border controls. During a recent Commission audit in Brazil, the Brazilian competent authority informed the auditors about beef consignments containing products from female cattle treated with oestradiol. The Commission promptly shared all necessary information with the Member States so that, if needed, they can take appropriate action both at borders and within their markets. The Brazilian competent authority has confirmed the delisting of the concerned establishment for EU export, and the suspension of the activity of the concerned certification body. The Rapid Alert System for Food and Feed (RASFF) system operated effectively. Member State authorities issued appropriate notifications upon detecting non-compliant products, enabling coordinated precautionary measures across the EU. The Commission oversees this system and continues to track actions taken by the Member States. 1 COM/2025/75 final.”
Import of agri-food products in the EU · EU policy on country of origin food labelling
- 2026-04-17 “E-000591/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Food Information to Consumers Regulation (‘the FIC Regulation) 1 sets out the principles and requirements for food information, ensuring that consumers can make informed choices. Food additives must be indicated in the list of ingredients by their functional class, followed by either their specific name or E-number. The use of E-numbers is not mandatory; operators may choose between the specific name or E-number. Substances or products causing allergies or intolerances listed in the Annex to the FIC Regulation must be clearly indicated and emphasised in the ingredients list. This also applies to food additives listed in the Annex as well as to food additives derived from substances listed in the Annex. If an allergen from which a food additive is derived is present in the finished food, even in an altered form, it must be declared, ensuring adequate consumer protection without the need to specify the raw material source. The EU allergens list is based on scientific opinions 2 by the European Food Safety Authority. These substances represent the most common food allergens, and there is ample evidence for their inclusion. This list may be re-examined and, when necessary, updated considering the most recent scientific knowledge. Allergic consumers are primarily concerned by specific allergens rather than broader source categories of additives. Therefore, the Commission considers that the current legal framework adequately addresses allergenic concerns and does not necessitate the introduction of mandatory E-numbers or the disclosure of raw material sources. 1 OJ L 304 22.11.2011, p. 18: https://eur-lex.europa.eu/eli/reg/2011/1169/oj/eng. 2 The EFSA Journal (2004) 32, 1-197 and EFSA Journal 2014;12(11):3894.”
Food labelling harmonisation at EU level
- 2026-04-15 “E-000473/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Commission is working closely with the World Health Organization (WHO) to implement the global HIV 1 strategy. The Commission supports the WHO in monitoring surveillance data and progress towards international targets including the Sustainable Development Goals. Projects funded under the EU4Health Programme 2 focus on supporting outreach and care for HIV patients with comorbidities, along with funding for research activities in this domain through Horizon Europe 3 . The Commission intends to contribute to a planned UN General Assembly declaration on HIV in 2026. The Cohesion Policy (2021–2027) supports the modernisation of screening and diagnostic infrastructure, deployment of e-health and community-based care models, and strengthening of the health workforce to improve prevention, early detection and equitable access to quality treatment, including in high-incidence Member States. The EU Facility, a component of the National and Regional Partnership Fund under the 20282034 Multiannual Financial Framework 4 , offers flexible implementation and funding, allowing quick responses, including support for health and safety policy. National and Regional Partnership Plans can focus on investments to reduce health disparities, ensuring equal access to quality healthcare. The Commission discusses communicable diseases regularly in the Health Security Committee 5 , which includes discussions on the challenges and prioritisation for response with the support of the European Centre for Disease Prevention and Control 6 . 1 Human immunodeficiency virus (HIV). 2 https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en. 3 https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-opencalls/horizon-europe_en. 4 COM (2025) 565. 5 https://health.ec.europa.eu/health-security-and-infectious-diseases/crisis-management_en#health-securitycommittee. 6 https://www.ecdc.europa.eu/en/hiv-infection-and-aids.”
Vaccination · EU competences on health
- 2026-04-15 “E-000250/2026 Answer given by Mr Várhelyi on behalf of the European Commission 1. The Study on smoke-free environments and advertising of tobacco and related products 1 was carried out under the Specific contract 2019 71 01, implementing framework contract N°SANTE/2016/A1/39 – Lot 1. The contracted amount was EUR 179,995. 2. Figures as regards the time and EU money spent on the drafting of the Commission Staff Working Document 2 accompanying the document Proposal for Council Recommendation on Smoke- and Aerosol-Free Environments replacing Council Recommendation 2009/C 296/02 are not available. 3. The competence of the EU to act in the field of excise duty is conferred by Article 113 of the Treaty on the Functioning of the European Union, which empowers the Council to adopt harmonised rules, necessary to ensure the proper functioning of the internal market and to avoid distortions of competition. Apart from harmonising excise duty for manufactured tobacco, Directive 2011/64/EU 3 ensures a high level of health protection. In the evaluation of Directive 2011/64/EU and in the preparation of the proposal for its revision 4 , the Commission followed the Better Regulation principles. Comprehensive and up-to-date impact assessments and external studies have been used in order to support the policy cycle, and to gather evidence on all relevant impacts. 1 https://op.europa.eu/en/publication-detail/-/publication/68ce81fc-5d55-11ec-9c6c-01aa75ed71a1/language-en. 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52024SC0055. 3 https://eur-lex.europa.eu/eli/dir/2011/64/oj/eng. 4 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025PC0580.”
Smoking regulation · EU competences on health
- 2026-04-15 “P-000590/2026 Answer given by Mr Várhelyi on behalf of the European Commission 1. In accordance with Article 168(7) of the Treaty on the Functioning of the European Union 1 , Union action must respect the responsibilities of the Member States for the organisation and delivery of their health services and medical care, including for migrants. Under the Healthier Together initiative 2 , the Commission supports Member States and stakeholders in implementing actions addressing non-communicable diseases (NCDs) with funding from the EU4Health programme 3 . The actions include a health inequalities dimension and address the needs of vulnerable populations. 2. The Commission supports Member States in reducing health inequalities through the European Cancer Inequalities Registry 4 , which provides data to guide investments at EU and national level. Under the Safe Hearts Plan 5 , the Commission intends to develop an EU cardiovascular health inequalities dashboard to help identify gaps in access to and availability of care across the EU. 1 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=en. 2 https://health.ec.europa.eu/non-communicable-diseases/healthier-together-eu-non-communicable-diseasesinitiative_en. 3 https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en. 4 https://cancer-inequalities.jrc.ec.europa.eu/. 5 https://health.ec.europa.eu/non-communicable-diseases/cardiovascular-health_en.”
Public and private sectors role in healthcare services · EU competences on health
- 2026-04-14 “E-000515/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Commission is aware of certain problems and challenges related to the implementation of Regulations (EU) 2017/745 on medical devices 1 and (EU) 2017/746 on in vitro diagnostic medical devices 2 . It has been taking decisive actions to improve the situation, aiming to ensure more timely patients’ access to medical technologies. Specifically, on 16 December 2025 the Commission adopted a legislative proposal for a revision of the current regulations 3 . The proposed revision aims to simplify the rules for medical devices and in vitro diagnostics to make them easier, faster and more effective, while keeping the highest standards for patient safety. It will make the sector more competitive in the internal market and globally by supporting innovation. The Commission counts on the European Parliament and the Council to prioritise this proposal and ensure a swift adoption. In addition, the Commission is finalising an Implementing Regulation laying down certain procedural requirements for the conformity assessment activities carried out by notified bodies 4 . The main elements of this Implementing Act are maximum timelines for notified bodies to complete the certification procedure. This will enhance the predictability of the process, speed up access of medical devices to the market and guarantee their continuous supply. The act was supported by the Medical Device Committee in March 2026 and will be adopted in April. The Commission has also prepared Delegated Regulations to expand the lists of wellestablished technologies referred to in Regulation on medical devices to make the application of some legal requirements for these technologies more proportionate, without compromising health and safety. These acts have been adopted in March 2026 5 . 1 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). 2 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/EEC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). 3 Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I, COM(2025) 1023 final, 2025/0404 (COD); https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#simpler-and-more-effective-rules-formedical-devices--commission-proposal-for-a-targeted-revision-of-the-medical-devices-regulations. 4 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14471-Medical-devices-uniformapplication-of-the-requirements-for-notified-bodies_en. 5 Currently under the scrutiny procedure by the European Parliament and the Council until June 2026, see https://webgate.ec.europa.eu/regdel/#/delegatedActs/2643 and https://webgate.ec.europa.eu/regdel/#/delegatedActs/3061.”
Medical devices
- 2026-04-13 “P-000720/2026 Answer given by Mr Várhelyi on behalf of the European Commission Food products placed on the EU market must comply with very stringent requirements to protect human, animal and plant health. These requirements apply to all products no matter they are produced in the EU or not. Member States must carry out official controls and enforcement activities according to Regulation (EU) 2017/625 1 , including at the stage of import to ensure that only products in compliance with the applicable legislation are placed on the EU market. Where food of non-animal origin from third countries poses a contamination risk, the Commission may take measures through Commission Implementing Regulation (EU) 2019/1793 2 . These measures may include checks at border control posts at harmonised frequencies, or stricter certification/testing requirements. Tomatoes and tomato products from Egypt are currently not subject to such measures. Under the Vision for Agriculture and Food 3 , the Commission will pursue a stronger alignment of production standards applied to imported products. In addition, on 9 December 2025 4 , the Commission announced a series of measures to strengthen import controls at EU borders and in third countries, among them (i) 50% increase of audits in non-EU countries, (ii) 33% increase of audits in EU border control posts, and (iii) training for over 600 national authority staff. In addition, enterprises active on the EU market will be required to respect the rules provided in Directive (EU) 2024/1760 on corporate sustainability due diligence 5 . 1 https://eur-lex.europa.eu/eli/reg/2017/625/oj. 2 https://eur-lex.europa.eu/eli/reg_impl/2019/1793/oj. 3 https://agriculture.ec.europa.eu/overview-vision-agriculture-food/vision-agriculture-and-food_en. 4 At the Implementation dialogue on import controls. 5 http://data.europa.eu/eli/dir/2024/1760/oj.”
Pesticides & trade · EU policy on labour exploitation in global supply chains · Import of agri-food products in the EU
- 2026-04-13 “P-000725/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Commission will publish a Staff Working Document which will inter alia present a costbenefit analysis of the measures included in the Proposal for a European Biotech Act 1 , including the 12-month Supplementary Protection Certificate (SPC) extension - in line with the requirements of Better Regulation Guidelines of the Commission 2 . 1 COM(2025) 1022 final. 2 SWD(2021) 305 final.”
Pharmaceuticals regulation in EU · Pharma IPRs
- 2026-04-13 “E-000675/2026 Answer given by Mr Várhelyi on behalf of the European Commission The re-evaluation by the European Food Safety Authority (EFSA) of the salt of aspartameacesulfame (E 962), which consists of two components authorised as sweeteners, aspartame (E 951) and acesulfame derived from acesulfame K (E 950), is estimated to be adopted in the plenary session of the Panel on Food Additives and Flavourings of 30 June - 2 July 2026 open for observers 1 . The scientific opinion on the re-evaluation of acesulfame K (E 950), one of the two components of E 962, was published by EFSA on 30 April 2025 2 . As part of the re-evaluation of the salt of aspartame-acesulfame (E 962), EFSA performs an update of the assessment of aspartame (E 951) as second component of the salt E 962. The principles and procedures as outlined in the ‘Revised protocol on hazard identification and characterisation of sweeteners’ 3 apply. A systematic literature search was performed in which EFSA considers all studies fitting the inclusion criteria laid out in the protocol. The search period included studies that have become available on aspartame (E 951) since the last risk assessment conducted in 2013 4 , up to June 2025. All relevant evidence identified through the systematic search must undergo appraisal, synthesis, weighing and integration as described in the revised protocol. Based on the outcome of the critical appraisal of all evidence, EFSA will decide whether a revision of the acceptable daily intake (ADI) of aspartame (E 951) is required. The update of the dietary exposure assessment of aspartame (E 951) is also part of the work on the reevaluation of E 962. 1 https://www.efsa.europa.eu/sites/default/files/2025-09/2026-plenary-meetings-efsa-panels-and-scientificcommitte.pdf. 2 https://www.efsa.europa.eu/en/efsajournal/pub/9317. 3 https://zenodo.org/records/7788969. 4 http://www.efsa.europa.eu/en/efsajournal/pub/3496.”
Nutrition
- 2026-04-09 “P-000230/2026 Answer given by Mr Várhelyi on behalf of the European Commission In 2017, following the identification of serious deficiencies during audits by the Commission, several Brazilian establishments were removed from the list of establishments from which imports into the Union of meat and meat products were permitted. In addition, the Commission asked Brazil not to add any new establishment on this list until further notice. The Commission further conducted several audits to ensure Brazilian authorities had effectively resolved the identified non-compliance issues. Brazil received favourable audit reports 1,2 and compliant results from reinforced checks on poultry meat have been consistent for several years. In addition, Brazil provided a residues control plan for eggs which had been assessed favourably. Therefore, on 24 February 2025, the Commission updated the list of countries authorised to export animal products to the Union 3 . Consequently, based on evidence of compliance with EU requirements, the listing of poultry and egg products establishments resumed 4 . However, Brazil is still required to ensure that all shipments of poultry meat, meat products, and preparations from Brazil undergo systematic pre-export microbiological checks, with physical checks maintained at a 100% rate. Brazilian authorities were contacted 5 about this in November 2025. Member States and stakeholders were updated during several meetings, e.g. Potsdam Council working party, Market Access Working Group. 1 Brazil 2024-8002 - Food Audits and Analysis | Food Safety https://ec.europa.eu/food/audits-analysis/auditreport/details/4815. 2 Brazil 2023-7857 - Food Audits and Analysis | Food Safety https://ec.europa.eu/food/audits-analysis/auditreport/details/4750. 3 Annex -I of Regulation 2021/405 https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=celex%3A32025R0354. 4 The legal basis for requiring the listing of establishments in third countries from which animals and animal products may be exported to the Union is provided in Article 126 of the Official Control Regulation OJ L 95, 7.4.2017, pp. 1–142. 5 By the Directorate-General for Health and Animal Welfare (DG SANTE).”
Trade relations with Mercosur · Import of agri-food products in the EU
- 2026-04-09 “E-000398/2026 Answer given by Mr Várhelyi on behalf of the European Commission mRNA vaccines authorised in the EU against COVID-19 are not genetically modified organisms and do not contain genes as their active substance. They are not used with the aim to restore, correct, or modify human genes. Therefore, they are not considered a gene therapy. mRNA vaccines are biotechnology medicinal products regulated under the EU pharmaceutical legislation to ensure their quality, safety, and efficacy. The definitions and detailed requirements for gene therapy and somatic cell therapy medicinal products were updated in 2009 1 to take into account scientific and technical progress in the field of advanced therapies, as reflected in Regulation (EC) No 1394/2007 2 . Hundreds of millions of people worldwide have received the mRNA COVID-19 vaccines. All EU-authorised medicines, including mRNA vaccines, are continuously and rigorously monitored. According to the European Medicines Agency, enhanced monitoring has found no safety issues related to the distribution of vaccine components 3 . 1 ELI: http://data.europa.eu/eli/dir/2009/120/oj. 2 ELI: http://data.europa.eu/eli/reg/2007/1394/oj. 3 COVID-19 vaccines: key facts: https://www.ema.europa.eu/en/human-regulatory-overview/public-healththreats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-vaccines-key-facts#mrna-covid-19-vaccines7221.”
Pharmaceuticals regulation in EU · Vaccination
- 2026-04-09 “E-000557/2026 Answer given by Mr Várhelyi on behalf of the European Commission To date, most of the Member States have adopted national limits for the use of gametes in their country. These limits are in general covering the distribution of gametes for maximum 12 families. During the recent legislative procedure on the new Regulation on substances of human origin (SoHO) 1 , the European Parliament and the Council did not agree to the introduction of an EUwide limit. However, as of 7 August 2027, the new SoHO Regulation will require Member States’ authorities to enforce all national maximum limits for distribution by gamete banks. Hence these limits will apply even in cases of cross-border distribution to other Member States, and this marks a significant step forward in the control of cross-border distribution of sperm in the EU. 1 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC – see in particular its Article 58(10).”
Sexuality and reproduction
- 2026-04-09 “E-000540/2026 Answer given by Mr Várhelyi on behalf of the European Commission Under the Vision for Agriculture and Food 1 , the Commission announced a dedicated EU Task Force to be established, which will pull expertise and forces from the Commission and Member States together to further strengthen the control on imports. The work of the Task Force on Import Controls 2 was launched at the ministerial meeting that took place in the margins of the 26 January 2026 AGRIFISH Council meeting 3 . The first expert and working groups held under the Task Force took place on 24 February 2026 (on intensification of official controls of food and feed of non-animal origin 4 ), on 4 March 2026 (on plant health) and on 18 March 2026 (on Veterinary Import Controls Legislation). A further meeting is scheduled for 15 April 2026 (on the Official Controls Regulation). Conclusions along with potential recommendations for joint actions or, where appropriate, suggestions of specific regulatory measures, are expected for the second half of 2026. Implementation of these conclusions is foreseen to start in 2027. It should be noted that the Task Force does not replace official controls performed by Member States or create parallel structures; it builds on existing expert and working groups, bringing them together in a more coordinated and strategic way. Its added value lies in improving harmonised implementation across the EU, identifying gaps or inconsistencies, and proposing joint actions where an EU-level approach is most convenient. Finally, the effective and consistent implementation of EU legislation across all Member States is ensured through on-site audits conducted by the Commission (Directorate-General for Health and Food Safety). The frequency of these audits in Member States will be increased by 33% for the 2026-2027 period. 1 https://agriculture.ec.europa.eu/overview-vision-agriculture-food/vision-agriculture-and-food_en. 2 Import controls of food and feed Q&As; Food Safety: https://food.ec.europa.eu/horizontal-topics/officialcontrols-and-enforcement/import-controls-food-and-feed-qas_en. 3 Agriculture and Fisheries Council: https://www.consilium.europa.eu/en/meetings/agrifish/2026/01/26/. 4 ELI: http://data.europa.eu/eli/reg_impl/2019/1793/oj.”
Import of agri-food products in the EU
- 2026-04-09 “E-000448/2026 Answer given by Mr Várhelyi on behalf of the European Commission 1. The protection of individuals with coeliac disease in the EU is governed by two main regulations: the Regulation on Food Information to Consumers 1 , which mandates clear labelling for allergens and gluten, and the Gluten Free Regulation 2 , which sets specific rules for gluten-free products. These regulations create a harmonised framework that facilitates informed consumer choices and ensures a high level of protection across the EU. 2. In line with Article 168 of the Treaty on the Functioning of the European Union, the Commission complements national policies by providing support in reaching health policy objectives, through the framework initiative ‘Healthier Together’ 3 , which addresses noncommunicable diseases, such as coeliac disease. The Expert Group on Public Health 4 advises the Commission on the preparation of policy initiatives and activities addressing key public health challenges. The Commission also supports the exchange of best practices 5 , such as on effective actions to support coeliac patients. The implementation of measures on healthcare delivery and financial support to improve the access to specific foods for coeliac patients rests with the Member States. 3. In addition to possible excess baggage exemptions by airlines, the allocation of financial resources to measures allowing people with coeliac disease to carry gluten-free products on flights, is the responsibility of national authorities. 1 OJ L 304 22.11.2011, p. 18. 2 OJ L 228, 31.7.2014, p. 5. 3 Healthier together – EU non-communicable diseases initiative, https://health.ec.europa.eu/non-communicablediseases/healthier-together-eu-non-communicable-diseases-initiative_en. 4 https://health.ec.europa.eu/non-communicable-diseases/expert-group-public-health_en. 5 https://webgate.ec.europa.eu/dyna/bp-portal/.”
EU competences on health · Nutrition
- 2026-04-09 “E-000739/2026 Answer given by Mr Várhelyi on behalf of the European Commission In March 2025, the Commission proposed the Critical Medicines Act 1 (CMA) to strengthen the availability and security of supply of critical medicines. The CMA proposal follows the ordinary legislative procedure. In this context, the European Parliament proposed an EU coordination mechanism for critical medicines, allowing the Commission to monitor stock levels across the EU and manage stock redistribution between countries in cases of shortages. This redistribution mechanism is not part of the Commission’s proposal. The organisation of healthcare system is a national competence. The Commission’s proposal focuses on national contingency stock requirements, which are obligations imposed on supply chain actors to hold buffer stocks of certain medicines to mitigate the risk of supply chain disruptions. Member States must ensure that these national requirements do not adversely affect the supply to other Member States, are proportionate, and adhere to the principles of transparency and solidarity. Furthermore, the CMA proposes collaborative procurement mechanisms involving the Commission at the request of Member States. 1 Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest and amending Regulation (EU) 2024/795.”
Government stockpiling of critical medicines · EU competences on health
- 2026-04-08 “E-000389/2026 Answer given by Mr Várhelyi on behalf of the European Commission 1. The Commission acknowledges the importance of improving cross-border healthcare in border regions, including emergency care where timely, efficient responses are vital. The Directive 2011/24/EU 1 and Social Security Coordination Regulations 2 (e.g. via the European Health insurance Card, EHIC) both facilitate this process ensuring that citizens can access health services across borders when needed (including in emergency). 2. Through the implementation of Directive 2011/24/EU, the Commission requires Member States to make reimbursement conditions transparent and objective, as well as encourage mutual recognition of prescriptions to avoid administrative barriers. EU social security coordination rules ensure the coordination, not the harmonisation, of national social security systems, protecting individuals’ rights when moving within Europe, while Member States remain competent in defining their own schemes. The EHIC provides those insured under a Member State’s statutory scheme 3 with needed healthcare in other Member States during temporary stays, covering more than just emergencies. 3. The Commission supports Member States in addressing obstacles in cross-border healthcare including in emergency through INTERREG 4 and B solutions 5 . The Commission also provides support for the establishment of Cross-Border Coordination Points (CBCP), in the framework of BRIDGEforEU 6 with dedicated calls for proposals. 1 https://eur-lex.europa.eu/eli/dir/2011/24/oj/eng. 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004R0883-20190731. 3 Article 19 of Regulation 883/2004 juncto Article 25 Regulation 987/2004. 4 https://interreg.eu/. 5 https://www.b-solutionsproject.com/. 6 https://eur-lex.europa.eu/eli/reg/2025/925/oj/eng.”
EU competences on health
- 2026-04-08 “E-000422/2026 Answer given by Mr Várhelyi on behalf of the European Commission With regard to gain-of-function research, the Commission refers the Honourable Member to the answers to Parliamentary Questions E-002369/2025 1 and E-004131/2025 2 , detailing the Commission's risk management measures, eligibility criteria, ethical considerations and security checks to support gain-of-function research on respiratory diseases. It is imperative that all research activities rigorously adhere to established scientific methods, demonstrate measurable scientific excellence, and operate within the bounds of the applicable legal frameworks, including strict compliance with norms, safety regulations, and security standards, particularly when research involves the handling or manipulation of pathogenic viruses. Beyond ensuring compliance with relevant national, EU, and international legislation, research activities funded through Horizon Europe must also strictly follow the principles of research ethics and integrity 3 . Any research activity that presents disproportionate or unmitigated risks to human health, the environment, or society at large is deemed ineligible for funding. This ensures that Horizon Europe upholds the highest standards of responsibility, safety, and societal accountability. With regard to the origin of the COVID-19, the Commission refers the Honourable Member to the answers to Parliamentary Questions E-003628/2025 4 , E-002534/2025 5 , E-001403/2025 6 and E-001040/2025 7 , detailing when and from what source EU institutions became aware of a possible upcoming COVID-19 pandemic and the Commission’s view of the origin of the SARS-CoV2 virus. 1 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 2 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 3 As spelled out in Article 19 of the Horizon Europe Regulation: ELI: http://data.europa.eu/eli/reg/2021/695/oj. 4 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 5 https://www.europarl.europa.eu/doceo/document/P-10-2025-002534-ASW_EN.html. 6 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 7 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html.”
Pharmaceuticals regulation in EU · EU competences on health
- 2026-04-07 “Answer given by Mr Várhelyi on behalf of the European Commission 7.4.2026 Written question 1. The Commission did not issue guidance about the use of ICD-10 codes, — the International Classification of Diseases, Tenth Revision, Clinical Modification [1] — for classifying deaths as due to COVID-19. The European Centre for Disease Prevention and Control (ECDC), in order to facilitate surveillance of the disease at EU-level, issued COVID-19 surveillance guidance [2] . EU-level reporting to the ECDC was carried out by collecting data on the basis of definitions established at national level. 2. The investigation, and correction of doubtful medical diagnoses and statistics in a specific Member State falls within the competence of that Member State. 3. As regards secondary use of personal electronic health data, the European Health Data Space Regulation [3] focuses on making existing data available cross-border, and on making data quality transparent. It does not regulate the collection of data at source. [1] https://www.cdc.gov/nchs/icd/icd-10-cm/index.html. [2] https://www.ecdc.europa.eu/sites/default/files/documents/COVID-19-surveillance-guidance.pdf. [3] Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847, OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj.”
Processing of health data · EU competences on health
- 2026-04-07 “Answer given by Mr Várhelyi on behalf of the European Commission 7.4.2026 Written question EU sanitary and phytosanitary (SPS) requirements are non-negotiable and apply to all imports irrespective of trade agreements with third countries. The figures mentioned in the question seem to reflect the controls in the context of the regulation 2019/1020 [1] (which do not apply to the importation of meat) and not to the SPS controls. A harmonised, risk-based system of official controls, established under Regulation (EU) 2017/625 [2] , ensures mandatory inspections in all Member States. The Commission monitors the compliance of imports and will reinforce the enforcement in this area through an increase in the number of audits performed on third countries and Member States, closer monitoring of non-compliant commodities and countries (with frequency of checks increased as required), support to Member States carrying out these additional checks and additional training to Member States’ officials [3] . The Commission regularly audits Member States to verify their import controls. Audit reports on Border Control Posts [4] do not identify significant systemic non-compliances on the performance of Member States’ checks. The Commission also established a Task Force on Import Controls [5] to increase the EU’s response to further strengthening the control on imports, in line with its Vision for Agriculture and Food [6] . Where justified, the Commission may assess targeted adjustments to the legal framework. Although the Commission considers that the current legislative framework provides a robust basis for effective border controls, it is also working on the revision of the Union Customs Code, as part of the EU Customs Reform [7] , currently examined by the co-legislators. Through such reform, the Commission aims to improve the capabilities of EU customs . [1] Report on controls on products entering the EU market with regard to product compliance in 2024 https://op.europa.eu/en/publication-detail/-/publication/ea5db20e-840f-11f0-9af8-01aa75ed71a1/language-en. [2] http://data.europa.eu/eli/reg/2017/625/oj. [3] https://ec.europa.eu/commission/presscorner/detail/en/ip_25_2979. [4] Health and Food Audits and Analysis https://food.ec.europa.eu/horizontal-topics/official-controls-and-enforcement/health-and-food-audits-and-analysis_en. [5] Import controls of food and feed Q&As — Food Safety: https://food.ec.europa.eu/horizontal-topics/official-controls-and-enforcement/import-controls-food-and-feed-qas_en. [6] Vision for Agriculture and Food — Agriculture and rural development: https://agriculture.ec.europa.eu/overview-vision-agriculture-food/vision-agriculture-and-food_en. [7] https://taxation-customs.ec.europa.eu/customs/eu-customs-reform_en.”
Import of agri-food products in the EU · EU policy on custom fee on non-EU imports
- 2026-04-01 “P-000755/2026 Answer given by Mr Várhelyi on behalf of the European Commission Immediately after receiving the notification of the foot and mouth disease (FMD) outbreak suspicion by the Cypriot authority, the Commission adopted emergency disease control measures 1 ensuring coordination via the Regulatory Committee. At the request of Cyprus, it also dispatched the EU Veterinary Emergency Team with three separate missions to assist competent authorities with tailor-made recommendations. The EU FMD antigen bank shipped vaccine doses to the island of Cyprus 2 . The EU Reference laboratory for FMD provided on the spot support and confirmed the presence of FMD serotype SAT1. The Commission also regularly informs Member States and trading partners on the epidemiological situation and advocates for recognising EU regionalisation to avoid unjustified trade bans. The Commissioner for Health and Animal Welfare also visited Cyprus on 13 March to express the Commission’s solidarity and support strictly implemented eradication measures by all available tools. EU co-financing of emergency measures is available under the Single Market Programme, including the costs for culling and/or disposal of animals on affected farms, the cleaning and disinfection, compensation for owners and surveillance activities. EU financial support can also be granted under the Common Agricultural Policy (CAP), including for risk management, improved on-farm biosecurity and restoration of production potential following outbreaks. Exceptional support may be requested by Member States for farmers affected by trade restrictions. Finally, the Member States may amend their CAP Plans to introduce crisis payments for farmers severely affected by animal diseases, among others. In its Plan 2023–2027, Cyprus addresses biosecurity measures 3 . 1 http://data.europa.eu/eli/dec_impl/2026/484/oj. 2 https://food.ec.europa.eu/animals/animal-diseases/diseases-and-control-measures/foot-and-mouthdisease/support-cy_en. 3 Total public allocation of EUR 9.7 million in biosecurity measures that include pig, cattle and sheep & goat holdings.”
Animal diseases prevention and management in the EU · Agricultural funding
- 2026-03-31 “Answer given by Mr Várhelyi on behalf of the European Commission 31.3.2026 Written question 1. The EU legislation on the protection of animals during transport is not applicable to transports between third countries and the Commission is not aware of any Member State or an EU operator involved in the case described by the Honourable Member. 2. Incidents related to the suitability of vessels may still occasionally occur. For this reason, in 2023, the Commission adopted tertiary legislation strengthening official controls on transports by livestock vessels [1] , [2] . In 2025-2026, the Commission is carrying out a series of audits on the implementation of this recent legislation. This will contribute to improving transports of animals by sea, as far as such transports departs from the EU. Furthermore, in its 2023 proposal for a new Regulation on animal transport [3] , the Commission proposed stricter rules at export, increasing space allowance, approval of feeding systems for unweaned animals, rules for livestock vessels, and certification bodies. 3. The above-mentioned Commission proposal is currently pending with the co-legislators. The proposal offers the opportunity to modernise technical requirements for animal transport, including transports by sea, to achieve concrete improvements for animals while maintaining the competitiveness of the EU livestock sector. The primary responsibility for the vessel, its safety and operations rests with the flag state. [1] COMMISSION DELEGATED REGULATION (EU) 2023/842 of 17 February 2023 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards rules for the performance of official controls to verify compliance with animal welfare requirements for the transport of animals by livestock vessels. [2] COMMISSION IMPLEMENTING REGULATION (EU) 2023/372 of 17 February 2023 laying down rules on the recording, storing and sharing of written records of official controls performed on livestock vessels, on contingency plans for livestock vessels in the event of emergencies, on the approval of livestock vessels and on minimum requirements applicable to exit points. [3] COM(2023) 770 final.”
EU requirements on animal welfare for farmers
- 2026-03-31 “E-000367/2026 Answer given by Mr Várhelyi on behalf of the European Commission Data on COVID-19 mortality were updated and publicly reported by the European Centre for Disease Prevention and Control (ECDC) on a daily basis at the beginning of the pandemic. Those data reflected the rapid data collected by ECDC from the individual Member States. All countries that made these data available were included in the statistics at any time. The vaccines used during the COVID-19 pandemic 1 went through rigorous testing in clinical trials to prove their safety and efficacy and have been authorised on the basis of a positive risk/benefit balance. The approval process used in the EU is described on the European Medicines Agency (EMA) website 2 . It is estimated that COVID-19 vaccination prevented 2.5 million deaths during the pandemic globally 3 and 1.6 million in Europe 4 , mostly among older adults. The Commission would like to note that the article on ‘Hydrothermotherapy’ referenced in the question is described by the authors as a hypothesis report and not a study of cause and effect 5 . 1 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-medicines/covid-19-vaccines-key-facts. 2 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-vaccines-developmentevaluation-approval-monitoring. 3 https://jamanetwork.com/journals/jama/fullarticle/2837831#250554726. 4 https://pubmed.ncbi.nlm.nih.gov/39127051/. 5 https://pmc.ncbi.nlm.nih.gov/articles/PMC7668174/.”
EU measures on lifestyle-related behaviours (smoking, drinking, eating, etc.) · Vaccination
- 2026-03-31 “E-004804/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission would like to refer the Honourable Member to the answers to Parliamentary Questions P-004688/2025 1 , E-000029/2026 2 , and P-004548/2025/rev.1 3 , which outlines the robust framework for lumpy skin disease (LSD) control established by EU legislation 4 , aligned with the World Organisation for Animal Health standards and supported by European Food Safety Authority assessments 5 . As explained therein, EU legislation provides for surveillance and containment measures, including emergency protective vaccination, ensures the effectiveness and proportionality of control measures, and foresees support from the Union vaccine bank as well as financial assistance and compensation. Those replies also clarify that vaccination is an important complementary tool but does not replace stamping-out once an outbreak is confirmed. Immediate culling of affected outbreak establishment remains essential to prevent further spread and ensure swift eradication. The current framework provides a solid legal basis and regulatory certainty for the livestock sector for the management and containment of the disease. The Commission continuously considers the latest scientific information and field experience when updating these rules. 1 Spread of lumpy skin disease (LSD): https://www.europarl.europa.eu/doceo/document/E-10-2025004688_EN.html. 2 Management of lumpy skin disease: https://www.europarl.europa.eu/doceo/document/E-10-2026000029_EN.html. 3 Lumpy skin disease outbreak in Catalonia – EU preparedness and vaccine availability: https://www.europarl.europa.eu/doceo/document/P-10-2025-004548_EN.html. 4 Regulation (EU) 2016/429 (‘Animal Health Law’), Commission Delegated Regulations (EU) 2020/687 and (EU) 2023/361. 5 https://doi.org/10.2903/j.efsa.2022.7121.”
Animal diseases prevention and management in the EU
- 2026-03-31 “E-000377/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Commission treats this incident with utmost seriousness and is committed to ensuring the highest standards of food safety. 1. On 10 December 2025, the Commission was alerted to cereulide contamination in products from a Nestlé company in the Netherlands, which recalled the same day 25 batches across 16 European countries. As soon as the Commission was made aware of this incident, the different existing tools, in particular the Rapid Alert System for Food and Feed (RASFF), were activated to ensure an efficient cross-border coordination between the competent food safety authorities of the Member States. 2. Since RASFF investigations found that arachidonic acid oil imported from China and subsequently used in infant formula was the very likely contamination source, the Commission has swiftly adopted measures 1 requiring mandatory laboratory analysis, certification, and stricter border controls for this product. Pursuant to Regulation (EC) No 178/2002 2 , food business operators at all stages of production, processing and distribution have the primary responsibility to ensure that their products comply with food law requirements relevant to their activities and to verify that these requirements are met. 1 http://data.europa.eu/eli/reg_impl/2026/459/oj. 2 http://data.europa.eu/eli/reg/2002/178/oj.”
Pharmaceuticals regulation in EU · Pharmaceutical imports & exports rules
- 2026-03-31 “Answer given by Mr Várhelyi on behalf of the European Commission 31.3.2026 Written question EU legislation requires rigorous assessment and authorisation of new treatments ensuring the quality, safety and efficacy of approved medicines. Supply of advanced therapy medicinal products (ATMPs) in the EU requires a marketing authorisation, an approved clinical trial, or a nationally-approved hospital exemption. Patients with severe illnesses may also access unauthorised medicines through compassionate use [1] with Member States required to notify the European Medicines Agency to maintain transparency and coordination, offering controlled early access and mitigating ‘therapy tourism’ risks. While it is concerning that experimental therapies are marketed directly to patients through online platforms and social media, it is important to emphasise that the EU and national regulators are vigilant and actively working to ensure patient safety. The European Medicines Agency and Heads of Medicines Agencies Network have issued joint statements outlining the risks associated with unregulated advanced therapies. The most recent statement, in March 2025 [2] , provides practical guidance for patients and caregivers on how to identify unregulated therapies. The new EU pharmaceutical legislation also clarifies hospital exemption rules for ATMPs, tightening oversight to close loopholes that could be exploited for unproven therapies. The Commission remains fully committed to the implementation of existing actions under Europe’s Beating Cancer Plan [3] , which support better access to high-quality and safe treatments. For example, last year, the Joint Action EUnetCCC launched the EU Network of Comprehensive Cancer Centres [4] with the aim of improving eligible patient access across Europe by 2030. [1] Article 83 of Regulation (EC) No 726/2004. [2] https://www.ema.europa.eu/en/documents/public-statement/unregulated-advanced-therapy-medicinal-products-pose-serious-risks-health_en.pdf. [3] https://health.ec.europa.eu/system/files/2022-02/eu_cancer-plan_en_0.pdf. [4] https://eunetccc.eu/.”
EU competences on health · Pharmaceuticals regulation in EU
- 2026-03-30 “E-000276/2026 Answer given by Mr Várhelyi on behalf of the European Commission Addressing medicine shortages is a priority for the Commission. The Commission’s objective is to ensure that medicines are available to patients across the EU when needed. The European Medicines Agency (EMA) and its Medicines Shortages Steering Group, which includes representatives from Member States, monitor and address ongoing shortages escalated to the EU level by national authorities, including shortages of antivirals. For critical shortages unresolved at the Member State level, the Medicines Shortages Steering Group and the EMA coordinate actions to mitigate their effects as much as possible. Additionally, a Member State may request assistance from others in urgent situations under the Voluntary Solidarity Mechanism. In the past, the procedures under this mechanism have successfully led to redistributing stocks available in other EU countries. The provisions addressing prevention of shortages under the new Pharmaceutical Regulation 1 , on which co-legislators found a political agreement in December 2025, will provide a robust EU framework for managing critical shortages and improving access to medicines. Specifically, the new Regulation will strengthen early notification obligations for shortages by companies and require them to have shortage prevention plans for medicines sold under prescription. This new regulatory framework would be complemented by the Critical Medicines Act 2 , as proposed by the Commission in March 2025, which aims to address upstream supply chain vulnerabilities and offer additional tools to enhance supply security. 1 COM(2023) 193 final. 2 COM(2025) 102 final.”
Government stockpiling of critical medicines · Pharmaceuticals regulation in EU · Joint EU procurement of medicines
- 2026-03-30 “E-000330/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Commission has not issued specific instructions to Greece regarding the control of sheep pox and goat pox (SPGP), including vaccination, as these matters are addressed within the comprehensive EU regulatory framework. This framework includes Regulation (EU) 2016/429 1 , Delegated Regulation 2020/687 2 , Delegated Regulation (EU) 2020/689 3 , and Delegated Regulation (EU) 2023/361 4 , which govern the use of vaccines. Furthermore, to support the Greek competent authorities, a mission by the European Veterinary Emergency Team 5 was carried out on-site in May 2025, concluding that vaccination was highly recommended as a powerful additional tool for the control and eradication of SPGP 6 . As a result, the Commission recommended Greece to consider vaccinating against SPGP and assisted the Greek competent authorities in making an informed decision, as the decision to implement vaccination or not lies with the Member State’s competent authority. It also requested that the European Food Safety Authority (EFSA) provides a scientific report 7 on the safest and most effective vaccines against SPGP, as well as suitable strategies under different epidemiological scenarios. Finally, a Commission audit in March 2025 evaluated the implementation of animal health controls for SPGP in Greece. The audit’s findings will offer guidance for targeted recommendations, with the final report to be published on the Commission’s website 8 . 1 http://data.europa.eu/eli/reg/2016/429/oj. 2 Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed disease, OJ L 174, 3.6.2020, p. 64–139, http://data.europa.eu/eli/reg_del/2020/687/oj. 3 Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance) OJ L 174, 3.6.2020, p. 211–340 ELI: http://data.europa.eu/eli/reg_del/2020/689/oj. 4 Commission Delegated Regulation (EU) 2023/361 of 28 November 2022 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases , OJ L 52, 20.2.2023, ELI: http://data.europa.eu/eli/reg_del/2023/361/oj. 5 https://food.ec.europa.eu/animals/animal-diseases/veterinary-emergency-team_en. 6 https://food.ec.europa.eu/document/download/feb626db-6599-425e-b908-79cf7e3d01ce_en?filename=regcom_ahw_20250521_pres-09.pdf. 7 https://www.efsa.europa.eu/en/efsajournal/pub/9928. 8 https://ec.europa.eu/food/audits-analysis/audit-report.”
Animal diseases prevention and management in the EU
- 2026-03-30 “E-000269/2026 Answer given by Mr Várhelyi on behalf of the European Commission Health workforce shortages are an important challenge for Member States. Analysis identifies persistent shortages and uneven distribution of health professionals in Greece, which hamper access to healthcare 1 . Under Article 168(7) of the Treaty on the Functioning of the European Union 2 , Member States are responsible for the organisation and delivery of health services and medical care. The EU’s role is to support Member States in strengthening their health systems, by encouraging cooperation and exchange of best practices, via technical assistance, funding and policy guidance. In the 2020, 2022 and 2023 cycles of the European Semester, Greece received recommendations to ensure adequate and equal access to healthcare. Reforms under the Greek recovery and resilience plan include the setup of a national health map, to map health workforce needs in real time. This common challenge requires appropriate measures in line with the competences of Member States and the EU, using shared knowledge, such as through the activities of the Expert Group on Health Systems Performance Assessment 3 . The European Semester country reports systematically stress health workforce challenges and Member States can use EU funding instruments such as the Cohesion Policy Funds and the Recovery and Resilience Facility to address them. The Commission also supports Member States through EU4Health initiatives such as the Joint Action HEROES on forecasting and planning of health workforce 4 and the Nursing Action 5 . 1 Country Health Profile: Greece, 2025. https://health.ec.europa.eu/document/download/b9b4092c-b357-4ae38d82-d9a252e7e159_en?filename=2025_chp_gr_english.pdf. 2 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=en. 3 See for instance: https://health.ec.europa.eu/latest-updates/minutes-hspa-expert-group-workshop-staffinglevels-healthcare-16-october-2025-2025-11-06_en. 4 The project – JA HEROES | Health Workforce Planning Project, https://healthworkforce.eu/the-project/. 5 EU4Health programme, https://health.ec.europa.eu/publications/2024-eu4health-work-programme_en.”
EU competences on health · Public and private sectors role in healthcare services