Author: MIL OSI Publisher

Question for written answer  E-001584/2025
to the Commission
Rule 144
Emmanouil Fragkos (ECR)

Lavender, oregano, rosemary, sage and mountain tea are among the aromatic and medicinal plants that can have great export potential due to the growing demand for an increasingly advertised – especially on social media – way of life based on natural products. They can be used for drinks, cosmetics, aromatherapy and pharmaceutical preparations, as well as in cooking.

These crops are especially advantageous for Greek farmers due to their xerophytic nature, allowing for cultivation with minimal water – an increasingly critical factor in a region facing growing water scarcity. In addition, semi-mountainous/mountainous soils are not suitable for many intensive crops, but they are ideal for plants such as oregano and mountain tea, as these are inherently organic products that do not require pesticides and fertilisers. Lavender and mountain tea have the highest export value per kilo, especially if standardised or processed (essential oils, premium packaging). Most of them can be grown organically, greatly increasing the final price. The benefit increases significantly if there is drying/standardisation or collaboration with a cooperative. Unfortunately, although there are many opportunities to enhance the value of these products, often producers throughout the province are not effectively informed of these.

What policies would the Commission recommend to the Greek Ministry of Rural Development and local government agencies to increase these Greek crops, especially those of small producers?

Submitted: 21.4.2025

Question for written answer  E-001610/2025
to the Commission
Rule 144
Aurelijus Veryga (ECR)

The application of extended producer responsibility (EPR) to pharmaceuticals under Article 9 of the Urban Waste Water Treatment Directive raises several concerns. Notably, only the pharmaceutical and cosmetic sectors are required to finance the removal of micropollutants, despite contributions to such pollution from various other industries.

The directive’s impact assessment lacks a comprehensive analysis of its implications for the pharmaceutical industry, particularly regarding access to medicines and pricing, at a time when many Member States are already facing shortages of medicinal products and efforts are under way to enhance the EU’s pharmaceutical autonomy.

In the light of these issues:

• 1.Does the Commission plan to conduct a comprehensive assessment of the EPR’s impact on patient access to medicines and on healthcare system costs?
• 2.If so, would the Commission consider pausing the implementation of the directive until such an assessment is completed?
• 3.Does the Commission intend to review the directive and consider expanding the scope of the EPR scheme to include other sectors contributing to water pollution, in order to ensure a fair and equitable application of the ‘polluter pays’ principle?

Submitted: 23.4.2025

Priority question for written answer  P-001645/2025
to the Commission
Rule 144
Dariusz Joński (PPE)

The EU rail freight sector is currently facing a crisis, incurring losses amounting to millions of euros. Given that the Commission is the guardian of the single market and the principles of fair competition, I would like to ask the following questions:

• 1.Does the Commission consider that the granting by the national market regulator of a Member State of a licence to a third-country entity – which is part of a state-owned company of that country – that does not meet the requirements of EU legislation on unbundling and separation of accounts is compatible with EU law? I would like to point out that the non-EU operator has been provided with commercial resources (locomotives and wagons) enabling it to compete with EU operators.
• 2.Does the Commission consider the activities of such an entity on the EU internal market to be compatible with EU law?
• 3.Do such activities not violate the principles of the functioning of the common market, and do they not pose a threat to EU rail companies which are subject to the full gamut of EU rules?

Submitted: 24.4.2025

Question for written answer  E-001627/2025
to the Commission
Rule 144
Rosa Serrano Sierra (S&D)

In recent years, especially after the pandemic, many Spanish cities boosted sustainable mobility measures which received part-funding from EU funds. However, this trend has stopped – and even been reversed – in several places currently administered by Spain’s Popular Party, in many cases in coalition with Vox, which have begun to remove cycle lanes, reopen pedestrian streets to vehicles and prioritise motorised traffic.

These decisions constitute backsliding on sustainable mobility and place an additional obstacle in the way of the future Sustainable Urban Mobility Plans (SUMPs) to be adopted in urban centres such as these by 2027 in conformity with Regulation 2024/1679.

Given this situation, can Commission answer the following questions:

• 1.Is sustainable urban mobility still a priority for the Commission?
• 2.Does the Commission not consider that promoting active mobility through concrete measures to improve walking and cycling can have positive repercussions on the accessibility of functional urban areas in the EU?
• 3.Does the Commission not believe that local-level decisions to dismantle cycling infrastructure, remove pedestrian areas and give preference to vehicle use clash with the SUMP objectives of switching towards more sustainable forms of mobility and reducing air and noise pollution?

Submitted: 23.4.2025

Question for written answer  E-001581/2025
to the Commission
Rule 144
Emmanouil Fragkos (ECR)

Following the campaigns of Alexander the Great, Greek influence spread to parts of present-day Pakistan and northern India. The Indo-Greek kingdoms (c. 180 BC – 10 AD) established Greek settlements and cultural monuments, reflecting the cultural cross-pollination between Greece and India.

In 2015, the Dawn newspaper reported on the deteriorating condition of the Bazira (Barikot) archaeological site in Swat (Pakistan), an ancient city associated with Alexander the Great and the Indo-Greek period. Despite its importance, the site suffered from inadequate protection measures. Similarly, The Express Tribune reported in 2010 that the ancient seat of the Gandhara civilisation in Swat was in poor condition due to neglect by the authorities, especially after vandalism by religious extremists. A 2016 article in The Diplomat described how Pakistan’s 2,000-year-old historical treasures, including those from the Indo-Greek period, are under threat from religious extremists and smugglers. The lack of adequate protection and preservation measures has exacerbated the situation. The US has supported 35 cultural heritage preservation projects across Pakistan, contributing over USD 8.4 million.

In light of the above:

• 1.How does the Commission monitor Pakistan’s compliance with international standards for the protection of Indo-Greek culture, in view of the country’s assessment for GSP+ status?
• 2.In which bilateral meetings has the Commission raised the issue with the Government of Pakistan and in what way?

Submitted: 21.4.2025

Question for written answer  E-001582/2025
to the Commission
Rule 144
Emmanouil Fragkos (ECR)

The lack of rainfall in Greece, as in all of southern Europe, over the past two years has exacerbated the problem of water scarcity.

Attica mainly gets its water from the artificial lake of Marathon, which functions as a reservoir, and the drop in its level has led to consideration of the scenario of transferring water from Lake Kremasta (Aetolia-Acarnania). This is the largest lake in Greece and is planned to become the main source of water for transfer to the capital.

However, the artificial lake of Kremasta has seen the creation of a proverbial wetland with many types of birds and intense vegetation – in addition to the natural beauty of the area. The rate of water absorption from there for transfer to the capital is planned to be 5% of the water, but this may increase, as the problem has not been definitively resolved. The channelling of water from there to Athens, which will require significant investment, also carries the risk of disturbing the ecosystem that has formed, disrupting the whole lake.

In light of the above:

• 1.Does the Commission intend to monitor the requirements of the studies and the possible execution of the project, which carries the risk of disrupting the ecosystem?
• 2.Does a framework exist for an artificial lake to become a protected area?
• 3.How can the Commission ensure that the ecological balance is not disrupted by such actions, even if their aim is to resolve such a serious issue as water scarcity?

Submitted: 21.4.2025

The Commission is committed to further harmonising EU legislation on food contact materials (FCMs), as indicated in its announcement to revise the legislation[1]. The Commission has recognised the need to significantly reduce the current EU limits for lead and cadmium allowed to transfer into food from ceramic materials, to widen the scope to other types of materials including glass and enamels, and to consider limits for other metals to safeguard public health.

The Commission has already carried out a significant body of work on this initiative, including the development of adequate methodologies for testing[2], an inception impact assessment[3] and direct stakeholder dialogue as well as technical discussions with Member States.

Further preparatory work for the initiative is ongoing, which is highly complex and requires further consultations with all relevant stakeholders to ensure the coherence of requirements across different types of FCMs, in particular the approach to regulating particularly hazardous substances but considering also the potential impacts on small and medium enterprises (SMEs) and producers using traditional production techniques.

• [1] https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/revision-eu-rules_en
• [2] https://publications.jrc.ec.europa.eu/repository/handle/JRC102075
• [3] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/2074-Food-safety-heavy-metals-in-ceramic-glass-and-enameled-table-and-kitchenware_en

Regulation (EU) 2017/745 on medical devices[1] (MDR) defines ‘custom-made devices’ in Article 2(3) and provides for legal exceptions for certain mass-produced devices.

Accordingly, it would depend on the specific case whether clear aligners — also known as invisible braces — may be actually considered as custom-made devices or rather mass-produced devices.

The Medical Device Coordination Group (MDCG) established under Article 103 of the MDR endorsed the guidance document ‘MDCG 2021-3 Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices’[2] where ‘orthotic braces’ are mentioned as examples of ‘mass-produced adaptable medical devices’, not considering them as custom-made devices.

This reflects the situation on the market, where the use of clear aligners is largely extended as adapted devices from mass-produced devices, as well as the views of other international regulatory frameworks[3]^,[4].

Both custom-made devices and mass-produced adaptable medical devices need the prescription of authorised healthcare professionals with respect to their specific characteristics and the needs of patients.

Therefore, the possibility to purchase clear aligners or invisible braces without consulting a healthcare structure or professional may indeed represent a risk for patients as well as a competitive disadvantage for healthcare manufacturers and professionals.

The responsibility for market surveillance and vigilance on the appropriate placing on the market and use of those devices belongs to the national competent authorities of the Member States in the field of medical devices[5].

• [1]  OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj
• [2] https://health.ec.europa.eu/document/download/385d7e20-d8b5-49d0-abd7-8daf269bf1b8_en?filename=mdcg_2021-3_en.pdf
• [3] For instance, the Australian Therapeutic Goods Administration considers aligners as ‘patient-matched medical devices’, not custom-made devices. See https://www.tga.gov.au/resources/guidance/understanding-personalised-medical-devices-rules-including-3d-printed-devices#patientmatched-medical-devices
• [4] See the guidance on ‘Personalized Medical Devices (PMD)’ by the International Medical Device Regulatory Forum (IMDRF) https://www.imdrf.org/working-groups/personalized-medical-devices
• [5] https://health.ec.europa.eu/medical-devices-sector/new-regulations/contacts_en#national-competent-authorities

Article 11 of Directive 2011/95/EU[1] sets out the grounds for considering that a third-country national has ceased to be a refugee or a person eligible for subsidiary protection. This is also provided for by Article 11 of Regulation (EU) 2024/1347[2], which requires that determining authorities also take into account precise and up-to-date information obtained from relevant and available sources. The assessment of whether the conditions for international protection have ceased is to be undertaken on an individual basis, taking into account the specific circumstances of the beneficiary.

Article 31(4) of Directive 2013/32/EU[3] allows Member States to postpone concluding the examination procedure due to an uncertain situation in the country of origin which is expected to be temporary. The Commission is monitoring the situation and has been informed by the relevant Member States about this suspension.

The Commission continues to work closely with the United Nations (UN) High Commissioner for Refugees to ensure that returns are voluntary, safe and dignified, and with other UN partners to help create the conditions inside Syria for people to return.

• [1] Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted, OJ L 337, 20.12.2011, p. 9-26, http://data.europa.eu/eli/dir/2011/95/oj
• [2] Regulation (EU) 2024/1347 of the European Parliament and of the Council of 14 May 2024 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection and for the content of the protection granted, amending Council Directive 2003/109/EC and repealing Directive 2011/95/EU of the European Parliament and of the Council, OJ L, 2024/1347, 22.5.2024, http://data.europa.eu/eli/reg/2024/1347/oj
• [3] Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (recast), OJ L 180, 29.6.2013, p. 60-95, http://data.europa.eu/eli/dir/2013/32/oj