20 Amendments of Pär HOLMGREN related to 2024/2030(DEC)
Amendment 2 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Welcomes the involvement of the EU Agencies in establishing a common data platform on chemicals as proposed by the Commission; regrets, however, the special treatment proposed for EMA to include only data submitted to it after the entry into force of the new Regulation, and only on certain substances, thus withholding the very large majority of data that it holds on chemicals from the common data platform; stresses that inclusion of all chemicals-related data that EMA holds would greatly help to develop predictive toxicity testing and thus to develop alternatives to animal testing; calls on the EMA and the Commission to reconsider their position accordingly;
Amendment 14 #
Draft opinion
Paragraph 2
Paragraph 2
2. Notes that the ECDC mandate was extended following the adoption of Regulation (EU) 2022/23701 which entered into force on 13 December 2022 in order to strengthen the Union's health security framework in the fields of epidemiological surveillance; invites the Commission to strengthen investments in the public health workforce and enhance coordination mechanisms for responding to emerging threats, such as infectious disease outbreaks; welcomes the fact that the ECDC began to implement its new mandate by reviewing the modalities of collaboration with its main partners and stakeholders, as well as the structure and content of its Strategy 2021-2027; emphasizes the importance of maintaining the annual declarations of interest of all management board members, advisory forum members and their alternates updated and accessible ; _________________ 1 Regulation (EU) 2022/2370 of the European Parliament and of the Council of 23 November 2022 amending Regulation (EC) No 851/2004 establishing a European centre for disease prevention and control (OJ L 314, 6.12.2022, p. 1–25 ELI: http://data.europa.eu/eli/reg/2022/2370/oj)
Amendment 29 #
Draft opinion
Paragraph 2
Paragraph 2
2. Observes that the Agencies budget relies on collected fees and a contribution from the Union’s general budget; takes note with concern that after a rise in 2022, in 2023 the ECHA’s fee income has again decreased, increasing the reliance on the Union to finance its operations; stresses the need to address the lack of predictability of the ECHA’s fee income andwhich is hindering its ability to implement its Work Programme effectively; reiterates its previous calls to the Commission to improve the ECHA’s budgetary certainty by urgently presenting its proposal to strengthen the governance of ECHAfor a founding regulation for the ECHA to strengthen the governance of ECHA and to secure sustainable financing, in line with its commitment expressed in the Chemicals Strategy for Sustainability;
Amendment 32 #
Draft opinion
Paragraph 3
Paragraph 3
3. Recalls the necessity of ensuring adequate staffing reflecting the needs of the European Green Deal and the Union Chemical Strategy for Sustainability, Circular Economy Action Plan and, in particular, the zero pollution target, and the associated increase in tasks; highlights that ECHA's expanding workload, coupled with delays in the REACH revision process, can potentially jeopardize its capacity to fulfil its central role in ensuring science-based regulation and a high level of protection while supporting the single market;
Amendment 38 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the ECHA to enhance its communication strategies to prevent the misinterpretation of its progress on the PFAS restriction process; stresses the urgent need to address the growing evidence of health and environmental harm caused by PFAS, including their presence in human tissues, and to ensure these risks are fully considered in the socio-economic assessment of the restriction;
Amendment 39 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Reaffirms the importance of the precautionary principle as a cornerstone of EU chemicals regulation and calls on ECHA to prioritize precautionary approaches when scientific evidence indicates potential risks to human health or the environment; calls on the ECHA to further refine its stakeholder engagement processes to achieve a more proportional balance between industry, civil society, and independent scientific expertise, ensuring that the voices of all stakeholders are adequately represented and that public and environmental health are not subordinated to economic interests;
Amendment 46 #
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses that the EEA provides sound, independent information on the environment; commends the quality of its outputs released in 2023, such as Pathways towards circular plastics in Europe — good practice examples from countries, business and citizens, Assessing the costs and benefits of climate change adaptation and European forest ecosystems: key allies in sustainable development; appreciates the EEA’s support of members of the ENVI committee by providing excellent, up-to- date data and information;
Amendment 49 #
Draft opinion
Paragraph 2
Paragraph 2
2. Acknowledges the adaptability of the EEA, which, in addition to its planned publications for 2023, released additional works on topics ranging from extreme weather to human health, such as The importance on restoring nature in Europe, demonstrating its capacity to inform and fuel current policy debates arising from evolving circumstances; emphasizes that, as climate and environment have become horizontal priorities with the European Green Deal, the EEA provides further added value through its broad and interconnected knowledge base; notes that, through its Eionet network and digitalisation work, the EEA is well- placed to support the implementation of the European Green Deal on the ground;
Amendment 54 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Notes that the work of the EEA is by nature trans-boundary and that the quality and usefulness of the EEA research and activities is significantly enhanced by the inclusion of non-EU EEA member countries and non-EU EEA cooperating countries, for example demonstrated by the excellent standing cooperation with the Western Balkan countries; hopes in the context of enlargement that the EEA will soon be able to welcome Moldova and Ukraine as cooperating or member countries; regrets also in this context that the United Kingdom has not yet returned as an EEA member or cooperating country following its exit from the European Union;
Amendment 55 #
Draft opinion
Paragraph 5
Paragraph 5
5. Welcomes the fact that, following the Discharge Authority’s recommendations of 2022, the EEA has established regular progress monitoring processes for both the implementation of key reports and assessments and recently with a stronger focus on indicators, and has consecutively reached a budget execution rate of 100% of the annual budget, a 100% delivery rate of key reports and assessments, and high engagement with key stakeholders and network partners throughout the year; notes the need for more actionable recommendations and enhanced coordination with national agencies to ensure the effective application of EU environmental policies;
Amendment 58 #
Draft opinion
Paragraph 6
Paragraph 6
6. Takes note with concern that despite the multi-year nature of the EEA’s tasks, an imbalance exists concerning the numbers of permanent versus contractual posts, as well as operational staff versus support staff, leading to a constant need for reskilling as well as an overload of administrative work for scientists; takes note that the growing number of collaborations between Directorates- General in implementing the Green Deal has created a complex patchwork of agreements that results in heavy administrative burden for the EEA, whereby some tasks which are long-term in nature are funded by short-term financial agreements; considers that taking into account the substantial increase of workload, and in order to properly perform the tasks on the Union’s goals for, inter alia, climate neutrality, circular economy and nature restoration, the EEA’s staff number should continue to substantially grow in the years to come and the EEA budget needs to increase in proportion in order to keep up with the necessary increase in staff numbers.
Amendment 74 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls on the Commission to increase the budget of EFSA and stresses the necessity of ensuring adequate staffing to reflect the needs of the more systematic implementation of a ‘One Health’ approach to risk assessment;
Amendment 77 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Recalls that since 2015, the Parliament has adopted 83 resolutions objecting to the placing on the market of GMOs for food and feed; highlights that one reason for these objections are gaps in the risk assessment undertaken by the Authority's Panel on Genetically Modified Organisms; urges the Authority to address and close these gaps as a matter of urgency;
Amendment 79 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Notes that a recent report1a highlighted that EFSA’s ‘GMO Panel’, which is responsible for the assessment of genetically engineered organisms, includes a large number of researchers involved in the development of genetically engineered plants, some of whom have links to the industry; urges the Authority to better address conflict of interests and to actively include more independent experts in its panels; _________________ 1a https://www.testbiotech.org/wp- content/uploads/2024/09/Testbiotech_EF SA_GMO_Panel_2024-1.pdf
Amendment 81 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5 c. Highlights that the European Parliament adopted two resolutions at the beginning of the mandate to object to Maximum Residues Levels (MRLs) for pesticides due to cumulative and synergistic effects not having been taken into account in EFSA’s reasoned opinion;
Amendment 82 #
Draft opinion
Paragraph 6
Paragraph 6
6. Welcomes the fact that the EFSA continued implementing its new organisational structure that was put in place in 2022 to reflect the Transparency Regulation; notes that the Transparency Regulation required the Commission to develop and adopt a ‘General Plan for Risk Communication’, which has not been presented by the Commission despite the preparatory work completed by the EFSA; highlights the need to improve efficiency and transparency in the EFSA’s process architecture.
Amendment 85 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Stresses the need to preserve EFSA’s independence by avoiding any ad-hoc future modification to its functioning, such as expanding the scope of pre-submission advice (article 32a of the Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety) to technical matters such as study design and protocols to be tested; notes the potential damage to public trust in EFSA work from ad-hoc changes to its functioning;
Amendment 96 #
Draft opinion
Paragraph 5
Paragraph 5
5. Recalls that the EMA is a fee- funded agency, with 88,21 % of its 2023 revenue stemming from fees for applications for marketing licenses for pharmaceutical products and for post- authorisation activities, 11,43 % stemming from the Union budget and 0,36 % from various other sources; stresses that despite the majority of funding coming from private sources, the EMA is a public authority; underlines that public trust in and guarantee of the Agency’s independence and integrity is crucial and therefore highlights the need to ensure transparency of these revenues and; welcomes the fact that in the future the EMA will have the obligation to publish in its activity report the annual revenue received per type of fee and charge according to Regulation (EU) 2024/5682 ; _________________ 2 Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95 (OJ L, 2024/568, 14.2.2024, ELI: http://data.europa.eu/eli/reg/2024/568/oj).
Amendment 98 #
Draft opinion
Paragraph 6
Paragraph 6
6. Notes that in 2023 the EMA received 6 965 requests for information and 709 requests for access to documents and that the EMA applies a queuing system that leads to delays in the treatment of the requests; emphasises the importance of transparency in the EMA operations, hence the need to ensure a timely access to information and documents in order to reinforce public trust in regulatory decisions and the medicines placed on the EU market;
Amendment 102 #
Draft opinion
Paragraph 7
Paragraph 7
7. Notes that the situation regarding the EMA’s former premises in London became increasingly challenging in 2023, with a need for the EMA to dedicate significant levels of resources to managing commercial real estate in a third country, endangering its core activities; calls on the Commission and the Council to secure a long-term political resolution of this issue and to allow the EMA to fully focus its efforts on its public health missionensure that the EMA has sufficient resources to carry out all of its activities and regulatory mechanisms including facilitating the development and access to medicines, supporting research and innovation and its responsibilities for monitoring and mitigating potential or actual shortages of critical medicines without any delay.