Activities of Maria Angela DANZÌ
Plenary speeches (37)
Eliminating violence against Women (debate)
Tackle the cost of living crisis: increase pay, tax profits, stop speculation (topical debate)
Shipments of waste (debate)
Surge of respiratory infections and the shortage of medication in Europe (debate)
CO2 emission standards for cars and vans (debate)
Binding annual greenhouse gas emission reductions by Member States (Effort Sharing Regulation) - Land use, land use change and forestry (LULUCF) - Revision of the Market Stability Reserve for the EU Emissions Trading System (debate)
Conclusions of the European Council meeting of 23-24 March 2023 (debate)
Deforestation Regulation (debate)
Revision of the EU Emissions Trading System - Monitoring, reporting and verification of greenhouse gas emissions from maritime transport - Carbon border adjustment mechanism - Social Climate Fund - Revision of the EU Emissions Trading System for aviation (debate)
EU Global Health Strategy (debate)
Methane emissions reduction in the energy sector (debate)
EU Day for the victims of the global climate crisis (debate)
Nature restoration (debate)
Putting the European economy at the service of the middle class (debate)
Ambient air quality and cleaner air for Europe (debate)
Reviewing the protection status of wolves and other large carnivores in the EU (topical debate)
Decent Housing for All (topical debate)
Urban wastewater treatment (debate)
Water scarcity and structural investments in access to water in the EU (debate)
Mental health at work (debate)
European Citizens' Initiative 'Fur Free Europe' (debate)
Sustainable use of plant protection products (debate)
Packaging and packaging waste (debate)
Reducing regulatory burden to unleash entrepreneurship and competitiveness (topical debate)
EU strategy to assist young people facing the housing and cost of living crisis (topical debate)
Outcome of the UN Climate Change Conference 2023 in Dubai, United Arab Emirates (COP28) (debate)
Conclusions of the European Council meeting of 14-15 December 2023 and preparation of the Special European Council meeting of 1 February 2024 - Situation in Hungary and frozen EU funds (joint debate - European Council meetings)
Addressing urgent skills shortages and finding the right talents to boost job creation (European Year of Skills) (debate)
Recent ecological catastrophe involving plastic pellet losses and its impact on micro plastic pollution in the maritime and coastal habitats (debate)
EU2040 climate target (debate)
EU2040 climate target (debate)
Working conditions of teachers in the EU (debate)
Preventing work-related deaths following the Florence tragedy (debate)
Next steps towards greater patient safety by swiftly ensuring the availability of medical devices through a targeted transitional period (debate)
Substantiation and communication of explicit environmental claims (Green Claims Directive) (debate)
Council and Commission statements - Preparation of the European Council meeting of 21 and 22 March 2024 (debate)
Promised revision of the EU animal welfare legislation and the animal welfare-related European citizens’ initiatives (debate)
Institutional motions (2)
JOINT MOTION FOR A RESOLUTION on suspicions of corruption from Qatar and the broader need for transparency and accountability in the European institutions
JOINT MOTION FOR A RESOLUTION on the humanitarian situation in Gaza, the need to reach a ceasefire and the risks of regional escalation
Oral questions (1)
Medicine shortages and strategic healthcare autonomy in the EU
Written questions (52)
District heating market irregularities
VAT arrangements for heating systems
Rights of rainbow families in Italy
Reducing forced labour and child labour in EU supply chains by 2025
Abolition of guaranteed minimum income in Italy
Lack of generic medicines in Europe
Current state of the fight against endometriosis in the EU
Syrian regime forces blockade of aid convoys of the Kurdish Red Crescent (KRC) directed to the North-West
Migrant boat wreck in Calabria
Question regarding via Cagni, Milan
Information on infringement proceedings against Italy in relation to permanent employment contracts in the public sector
Gas storage plant in Sergnano (Cremona)
Drought in Oromia Region, southern Ethiopia
Commission considering taxing credit institutions’ excess profits
Steps towards recognising 'digital content creator' as a profession
The rights of Rainbow families in Italy
Failure to review the environmental impact assessment and environmental implications assessment in the construction of the Perugia ‘Nodino’ bypass
Violation of the rule of law in the occupied Palestinian territories
Illegal pushbacks in Greece
EU response to the arrest of peaceful protesters in Hong Kong
Transfer of airport slots from Alitalia to ITA: failure to reallocate staff and denial of access to documents
Removing the minimum liver weight requirement for foie gras production
Italian NRRP and student housing
Right to be forgotten: a fundamental right for European citizens
Law on the culling of wolves in the province of Bolzano
Recognition of qualifications in the EU and mobility of citizens
Italy’s failure to implement Directives 89/391/EEC and 2003/88/EC and CJEU Judgment C-55/18
Transparency of voluntary organisations
Misuse of NextGenerationEU funds and felling of almost century-old trees in Pordenone
Imbalance between sales prices and production costs of durum wheat in Italy
Damage caused by the pointless high-speed railway project between Verona and Padua
Commission communication ‘A comprehensive approach to mental health’ and phenylketonuria patients
Compliance of the implementing decrees on renewable energy communities with EU state aid guidelines
Projects in the Venice Lagoon
Rings used on live decoys for hunting
Compatibility of the right of pre-emption with EU law
Trade union rights for military personnel in Italy
Compatibility of Malpensa airport expansion plan with EU regulations
Relocation of a regasification ship off the coast of Vado Ligure (SV)
Measures to prevent and contain swine fever in Lombardy
Concession for the management of the Great St Bernard Tunnel
Serious damage to ‘Parco dello Stelvio’ Natura 2000 site (ZPS IT2040044) and ‘Tresero - Dosso del Vallon’ national nature reserve
Discrepancies in legislation on energy communities
Detention of Ilaria Salis in Hungary
Building an on-shore regasification plant in Porto Empedocle
Creon shortages
Serious environmental damage to the Alpi Veglia e Devero-Monte Giove Natura 2000 SAC/SPA (IT1140016), established in 1995
Systematic human rights violations in Iran, with a focus on the plight of women: a call to step up EU diplomatic engagement and support regime change
Useless high-speed railway project from Grisignano to Padua
Militarisation of migrant centres in Italy
Refusal of entry and expulsion of Stefano Rebora, President of the NGO Music for Peace, by the Egyptian authorities in Cairo
Press freedom at risk in Italy
Individual motions (1)
MOTION FOR A RESOLUTION on an EU Cardiovascular Action Plan
Amendments (452)
Amendment 150 #
2023/2121(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls for disaster prevention and preparedness investments to be guaranteed either through a dedicated policy objective, thematic concentration or a specific enabling condition to ensure investments in local infrastructure and risk management in less developed urban and rural areas, including border regions; believes that targeted financing should focus on climate change adaptation and mitigation by tackling the side effects of climate change locally (slow onset events as well as extreme weather events), including wildfires, floods, landslides, heatwaves, coastal erosion and other events and on prevention and ensuring areas' safety;
Amendment 162 #
2023/2121(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls for the creation of a technical assistance programme specifically designed for areas that in previous years have had difficulties with absorbing earmarked funds, smaller municipalities and cross-border and rural areas that face new challenges such as the green transition and climate change; believes that the support should be in the form 100 % EU financing for administrative capacity- building, including support for the recruitment of professionals to help administrations with managing eligible projects, project design and strategic planning capabilities (including planning instruments), while the allocation criteria should include the number of inhabitants and the needs and challenges of these areas;
Amendment 199 #
2023/2121(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. CBelieves that simplifying administrative procedures to access cohesion policy funds would help to cut project implementation times and boost opportunities to absorb funds; considers that for the allocation of funds for local projects, the focus should be on a smaller number of higher budget, common benefit projects, instead of scattering the limited resources across a high number of low budget projects; calls for guidance and planning support to avoid decommitments and repurposing; calls, in addition, for direct support for staff training and the implementation of monitoring and assessment systems;
Amendment 16 #
2023/2081(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the presence of nutrition or health claims affects consumers’ food choices, along with other characteristics such as price, brand, colour, language and packaging shape; whereas health claims, especially risk reduction claims, have more of an impact on consumers’ attitudes than nutrition claims10 ; whereas consumer understanding of nutrition and health claims is influenced by various factors, including nutritional knowledge and education levels; _________________ 10 Pichierri M, Pino G, Peluso AM, Guido G., ‘The interplay between health claim type and individual regulatory focus in determining consumers’ intentions toward extra-virgin olive oil’, Food Research International. Vol. 136, Elsevier, October 2020, pp. 109467., as well as environmental awareness;
Amendment 57 #
2023/2081(INI)
Motion for a resolution
Recital N
Recital N
N. whereas social media significantly contributes to the advertising and sale of foods and food supplements, while the extent to which the NHCR regulates health-related online communications about foods remains unclear; whereas influencer or celebrity communications on social media are not always clearly commercial or non-commercial12 and can lead to unverified false and misleading claims on food products; whereas influencer or celebrity-driven online communications advertising protein or other supplements to enhance muscle growth are not a substitute of actual food and can lead to nutritional disorders such as body dysmorphic disorders; _________________ 12 Ashwell, M. et al., ‘Nature of the evidence base and strengths, challenges and recommendations in the area of nutrition and health claims: a position paper from the Academy of Nutrition Sciences’, British Journal of Nutrition, 130(2), 12 October 2022, p. 233.
Amendment 125 #
2023/2081(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights that the NHCR was adopted at a time when social media did not yet play such a large role in advertising and the sale of foods and food supplements; is concerned that the extent to which the NHCR effectively governs health-related online communications about foods remains unclear; stresses that claims of these types of products should duly inform that, if taken without moderation, may cause mental health disorders such as body dysmorphia, especially in adolescents;
Amendment 97 #
2023/2076(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes that the existence of different legal and institutional frameworks creates additional obstacles to project implementation; recalls that administrative procedures can be complex and time-consuming, a fact which can discourage local and regional authorities from participating in territorial cooperation; calls on the Commission to simplify these procedures, thereby making them more accessible and transparent;
Amendment 105 #
2023/2076(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Stresses that incompatibilities exist between states when it comes to the competences of authorities, as well as frequent changes in regional authorities, which can cause delays; believes that dialogue between local authorities should be encouraged and the participation of civil society in territorial-cooperation projects should be fostered, involving non-governmental organisations, social enterprises and other stakeholders;
Amendment 160 #
2023/2076(INI)
Motion for a resolution
Paragraph 35
Paragraph 35
35. Stresses that the regional and local authorities should be involved in the implementation of projects; invites the Commission to consider providing local and regional authorities in neighbouring countries with technical and institutional support to help them develop and implement territorial-cooperation projects; calls also for guidelines to be drawn up in this regard;
Amendment 61 #
2023/2075(INI)
Motion for a resolution
Recital B
Recital B
B. whereas premature deaths as a result of cardiovascular diseases (CVDs), cancers, diabetes and chronic respiratory diseases account for 68 % of all premature deaths in Europe; whereas other NCDs include mental and neurological disorders, liver and gastrointestinal diseases, kidney diseases, oral diseases, osteoporosis, osteoarthritis and endometriosis among other conditions;
Amendment 68 #
2023/2075(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas antimicrobial resistance (AMR) significantly disrupts medical procedures like surgeries, dental implants, cancer treatments, and organ transplants; AMR also complicates the management of prevalent NCDs, including cardiovascular diseases, dementias, and tumours1a; whereas the repercussions of AMR on disease incidence, mortality rates, hospital stays, and healthcare expenses; _________________ 1a https://www.europarl.europa.eu/RegData/ etudes/BRIE/2023/740238/EPRS_BRI(20 23)740238_EN.pdf
Amendment 72 #
2023/2075(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas there are about 20 million people who have survived cancer in Europe1a and only seven EU countries recognise the 'right to be forgotten' for former cancer patients therefore continue to experience difficulties in accessing financial services like insurance or mortgages, years after successfully completing treatment; _________________ 1a https://ecpc.org/policy/the-right-to-be- forgotten/
Amendment 88 #
2023/2075(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the increasing burden of NCDs on individuals and societies, and the health needs of ageing populations, 40% of which live with multimorbidity, represent challenges to the health systems of the Member States;
Amendment 99 #
2023/2075(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas NCDs, such as obesity, diabetes and endocrine disorders, also increasingly affect children1, which requires a dedicated approach to prevention and management;
Amendment 114 #
2023/2075(INI)
Motion for a resolution
Recital E
Recital E
E. whereas most NCDs are impacted by fourive preventable risk factors: tobacco use, unhealthy diet, lack of physical activity, and harmful use of alcohollcohol consumption and drug; whereas behavioural risk factors lead to biological risk factors, the most common being overweight and obesity, high blood pressure, high blood glucose and high blood cholesterol 6 ; _________________ 6 World Health Organization, ‘Monitoring noncommunicable disease commitments in Europe 2021’, p. 13, 8 December 2021.
Amendment 133 #
2023/2075(INI)
Motion for a resolution
Recital F
Recital F
F. whereas most NCDs are impacted by environmental risk factors such as air pollutionindoor and outdoor air pollution, and multiple global environmental changes, including climate change and biodiversity loss;
Amendment 145 #
2023/2075(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas most NCDs are impacted by socioeconomic inequalities, notably low socioeconomic status having significant consistent impact on mortality and morbidity caused by NCDs;
Amendment 162 #
2023/2075(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas people living with one or more NCDs were one of the most severely affected population groups during the COVID-19 pandemic1a; whereas investment in NCD prevention and management remains limited, despite access to care, essential complications screening and diagnosis being severely disrupted during the COVID-19 pandemic, potentially leading to severe complications over the longer term; _________________ 1a https://www.who.int/publications/i/item/97 89240057661
Amendment 182 #
2023/2075(INI)
Motion for a resolution
Recital H
Recital H
H. whereas innovation with regard to development of technologies, medicines and healthcare practises is crucial to ensure the elimination or reduction of harm caused by preventable risk factors, early detection, integration of care, improved disease management and new and better treatments for NCDs;
Amendment 186 #
2023/2075(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Amendment 195 #
2023/2075(INI)
Motion for a resolution
Recital H b (new)
Recital H b (new)
Hb. whereas recognising the critical impact of conflict of interest between public health objectives and the interests of industries producing alcohol, tobacco, and poorly nutritious and ultra-processed foods. The undue influence of these industries on health policies and strategies can hinder effective NCD prevention efforts. Just as transparency is vital in maintaining the integrity of public health, it is equally essential to implement stringent measures to mitigate conflicts of interest;
Amendment 226 #
2023/2075(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the Healthier together – EU non-communicable diseases (NCD) initiative, Europe’s Beating Cancer Plan, EU4Health work programme and the Commission Communication entitled ‘A comprehensive approach to mental health’; calls on the Commission to strengthen the ‘Healthier together – EU NCD’ initiative by introducing a holistic and comprehensive EU strategy on NCDs complemented by action plans for specific NCDs with clear targets, benchmarks, indicators and mechanisms to monitor progress; welcomes national plans and actions already taken against NCDs by Member States;
Amendment 257 #
2023/2075(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Acknowledges that tobacco use, physical inactivity, the harmful use of alcoholalcohol consumption, unhealthy diets and environmental factors such as air, food, water and soil pollution and chemical exposure substantially increase the risk of NCDs10 ; _________________ 10 https://www.paho.org/en/topics/noncommu nicable-diseases - :~:text=These%204%20groups%20of%20d iseases,of%20the%20response%20to%20N CDs The Pan American Health Organization, ‘Noncommunicable Diseases’.
Amendment 263 #
2023/2075(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Acknowledges that social, economic, cultural, and commercial determinants of health, and health inequities increase the risk of NCDs and underlines the need to create favourable conditions that address these factors; emphasizes the importance of a more robust implementation of the Health in All Policies principle, in dialogue with the public health community, and with thorough consideration of the health impacts of sectoral policies;
Amendment 269 #
2023/2075(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Recognises that over 150,000 new cases of melanoma every year, accounting for 4% of all new cancer diagnoses in EU-27 countries in 2020, making it the sixth most frequently occurring cancer in Europe; Recognises that over 150,000 new cases of melanoma every year, accounting for 4% of all new cancer diagnoses in EU-27 countries in 2020, making it the sixth most frequently occurring cancer in Europe; Recommends a phasing out of the use of sunbeds as consumer products for non- medical purposes1a; Urges Commission to take measures to facilitate improved registration of melanoma cases across the EU, allocate EU funds and support research into and the development of skin cancer screening methods, particularly with new technologies; _________________ 1a https://www.epsu.org/sites/default/files/art icle/files/EADV-Joint-Statement-Skin- Cancer-FINAL.pdf
Amendment 275 #
2023/2075(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Acknowledges that tobacco use, including second hand smoking, was responsible for 1.6 million deaths in Europe in 2019 and is a high risk factor for developing NCDs such as cancer, cardiovascular diseases and chronic respiratory diseases;
Amendment 283 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – introductory part
Paragraph 5 – introductory part
5. Supports Europe’s Beating Cancer Plan to achieve a Tobacco-Free Generation and prevent tobacco use by reducing tobacco consumption to 5% by 2040, as well as the Commission’s proposals to review the Tobacco Products Directive11 and the Tobacco Taxation Directive12 and the proposal to update the Council recommendation of 30 November 2009 on smoke-free environments13 and prevent any delays in revisions of the legislation; calls for a full implementation of the WHO Framework Convention on Tobacco Control; calls on the Commission and the Member States to: _________________ 11 Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, OJ L 127, 29.4.2014, p. 1. 12 Council Directive 2011/64/EU of 21 June 2011 on the structure and rates of excise duty applied to manufactured tobacco, OJ L 176, 5.7.2011, p. 24. 13 OJ C 296, 5.12.2009, p. 4.
Amendment 296 #
2023/2075(INI)
a. implement measures to help tobacco users quit in line with WHO FCTC guidelines for Article 14;
Amendment 302 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point a a (new)
Paragraph 5 – point a a (new)
aa. strengthen packaging rules by introducing mandatory plain standardised packaging with graphic health warnings covering 80% of the front and the back of all tobacco products and introducing pack inserts;
Amendment 304 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b
Paragraph 5 – point b
b. follow up on the scientific evaluations of the health risks related to electronic cigarettes, heated tobacco products and novel tobacco products including the assessment of the risks of using these products compared to consuming other tobacco products; and follow up of the decisions of the Conference of the Parties to the WHO FCTC to which the EU and Member States are Parties, particularly Decisions of the FCTC COP91a and upcoming COP10 regarding regulation of the novel and emerging tobacco products, depiction of tobacco in entertainment media, protection of public health policies from commercial or other vested interest of the tobacco industry; _________________ 1a https://untobaccocontrol.org/downloads/c op9/main-documents/FCTC- COP9_Report_EN.pdf
Amendment 313 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b a (new)
Paragraph 5 – point b a (new)
ba. Implement the European Ombudsman recommendations ‘a whole- of-Commission approach to complying with the obligations stemming from the FCTC constitutes maladministration’; to keep and make available minutes on all of the Commission’s meetings with tobacco interest representatives constitutes maladministration; ensuring implementation of the guidelines for Article 5.3 of the FCTC that state “Parties should interact with the tobacco industry only when and to the extent strictly necessary to enable them to effectively regulate the tobacco industry and tobacco products”;
Amendment 323 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b b (new)
Paragraph 5 – point b b (new)
bb. bringing the taxation of novel smoking products, such as vapes and heated tobacco, into line with cigarettes;
Amendment 327 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b c (new)
Paragraph 5 – point b c (new)
bc. publish annual reports on the progress towards achieving a tobacco-free generation by 2040;
Amendment 329 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b d (new)
Paragraph 5 – point b d (new)
bd. invite European Commission after consulting Member States to adopt Tobacco 21 policies which raise the minimum age for the sale of tobacco products to 21 years.
Amendment 342 #
2023/2075(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. AHighlights that the WHO estimate 1 million deaths annually in European Region due to alcohol consumption1a; acknowledges that the harmful useconsumption of alcohol is a risk factor for multiple NCDs and underlines that the lower the amount of alcohol consumed, the lower the risk is of developing NCDs14 ; _________________ 14 Global burden of disease 2016 Alcohol Collaborators, ‘Alcohol use and burden for 195 countries and territories,1990–2016: a systematic analysis for the Global Burden of Disease Study 2016’, 23 August 2018.re is no safe amount that does not affect health2a ; also acknowledges that International Agency for Research on Cancer (IARC) has classified alcohol as a Group 1 carcinogen, indicating that there is convincing evidence to show that it can cause cancer in humans and calls for the urgent implementation of evidence-based methods, such as reduce the affordability of alcohol, to reduce alcohol consumption in Europe; recognises that alcohol consumption is causally linked to several different types of cancer, including breast, liver, and colorectal cancer; _________________ 1a https://cdn.who.int/media/docs/librariespr ovider2/regional-committee-meeting- reports/rc72/european-framework-for- action-on-alcohol-2022-2025-cheat-sheet- en.pdf?sfvrsn=8e63aef4_4&download=tru e 2a https://www.who.int/europe/news/item/04- 01-2023-no-level-of-alcohol- consumption-is-safe-for-our- health#:~:text=The%20World%20Health %20Organization%20has,that%20does%2 0not%20affect%20health
Amendment 352 #
2023/2075(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Acknowledges the efforts of the European Commission to support Member States in reducing the burden of NCDs with the launch of the ‘Healthier together – EU non-communicable diseases initiative (NCD)’ in December 2021; but calls for more ambitious action at EU level not only to revert the rising number of people living with NCDs but also to improve quality of life and well- being of people affected by NCDs;
Amendment 362 #
2023/2075(INI)
Motion for a resolution
Paragraph 7 – point a
Paragraph 7 – point a
a. Enact more comprehensive restrictions on alcohol advertising targeting minoryoung people and adolescents;
Amendment 371 #
2023/2075(INI)
Motion for a resolution
Paragraph 7 – point b a (new)
Paragraph 7 – point b a (new)
ba. urges the Commission to implement evidence-based alcohol policies -based alcohol policies and put forward a legislative proposal on the introduction of health warnings to alcohol labelling requirements, as Ireland did in Section 12 of the Public Health (Alcohol) Act 2018; including possible interactions with other products - ie. drug, medicines and/or analgesics;
Amendment 379 #
2023/2075(INI)
Motion for a resolution
Paragraph 7 – point b b (new)
Paragraph 7 – point b b (new)
bb. urges the Commission to welcome the introduction of the list of ingredients and the nutrition declaration on all alcoholic products, as announced in 2021, with the adoption of the Europe’s Beating Cancer Plan;
Amendment 389 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – introductory part
Paragraph 8 – introductory part
8. Notes that an unhealthy diet is one of the major risk factors for NCDs, including obesity, cardiovascular diseases, cancer, diabetes and other conditions linked to obesity15 , oral diseases, chronic kidney disease, liver, pancreas and other gastrointestinal diseases; acknowledges that obesity is considered a risk factor for several NCDs and is itself recognized as an NCD; calls on the Commission and the Member States to: _________________ 15 World Health Organization Regional Office for the Eastern Mediterranean, ‘Noncommunicable diseases’.
Amendment 401 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point a
Paragraph 8 – point a
a. encourage and help consumers to make informed and healthy choices about food products; promote behavioural changes via communication and mass media campaigns for healthy diets; encourage public food procurement and service policies for healthy and sustainable diets; implement considerable restrictions on advertising of ultra-processed foods, particularly those aimed at children, and encouraging obligatory front-of-pack food labelling;
Amendment 427 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b
Paragraph 8 – point b
b. propose a Nnew Acomprehensive and integrated action Pplan for child obesity, with clear binding targets, benchmarks, indicators and mechanisms to monitor and ensure advancements;
Amendment 431 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b a (new)
Paragraph 8 – point b a (new)
ba. propose the implementation of taxation on unhealthy foods and sugary beverages, while subsidizing affordable access to minimally processed nutritious foods for socioeconomically disadvantaged populations;
Amendment 437 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b b (new)
Paragraph 8 – point b b (new)
bb. implement restrictions on advertising of ultra-processed food during child-focused TV and digital media, at cinemas and in locations that attract a high proportion of children;
Amendment 444 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b c (new)
Paragraph 8 – point b c (new)
bc. enhance the availability, affordability, and accessibility of nutritional care provided by dietitians and nutritionists;
Amendment 445 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b d (new)
Paragraph 8 – point b d (new)
bd. establish and nurture food environments that seamlessly promote the selection of healthy and sustainable food options, ensuring they become the default choices due to their ease of access and affordability; enable a shift in focus from individual responsibility to enhancing the environments where choices are made; counter industry-driven narratives and foster a broader understanding of the commercial and social determinants of dietary behaviour;
Amendment 449 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b e (new)
Paragraph 8 – point b e (new)
be. drive transformative shifts in nutritionally poor food availability through limiting the density of fast-food outlets, especially in proximity to schools and underserved areas. Acknowledge that encouraging behavioural change is intrinsically linked to an individual's socioeconomic status, geographical location, and available opportunities;
Amendment 451 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
Amendment 488 #
2023/2075(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission and the Member States to accelerate the transition to sustainable energy and transport sectors and to ensure a shift towards sustainable food systems through an ambitious proposal for the Framework for Sustainable Food Systems (FSFS);
Amendment 502 #
2023/2075(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that per- and polyfluorinated alkyl substances (PFAS) can lead to health problems such as diabetes, obesity and cancer16 ; calls on the Commission to implement the PFAS restriction proposal submitted to European Chemicals Agency on 13 January 202317 ; _________________ 16 European Environment Agency, ‘What are PFAS and how are they dangerous for my health?’. 17 European Chemicals Agency, ‘ECHA publishes PFAS restriction proposal’, 2023.
Amendment 510 #
2023/2075(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Regrets the slow implementation of the Chemicals Strategy for Sustainability, and, in particular, expects the REACH Regulation18 to be revised in order to be able to identify all substances of concern manufactured or imported in the EU; including endocrine disruptors; calls for the need for more comprehensive identification and regulation of these substances that can interfere with the hormonal system and have been associated with adverse health effects; _________________ 18 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 396, 30.12.2006, p. 1.
Amendment 538 #
2023/2075(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Encourages the Commission and the Member States to achieve the UN Sustainable Development Goals that target communicable diseases in order to promote the prevention of NCDs such as cancer related to infectious diseases; welcomes vaccination programmes in this regard such as in the fight against human papillomavirus transmission; (HPV), including vaccinations for all adolescents and young adults;
Amendment 546 #
2023/2075(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Recognises the impact that the permacrisis, including the COVID-19 pandemic, war, climate change, and the energy crisis, have on the insufficient actions taken on NCDs; calls on the Commission and Member States to prioritise NCD prevention and management as this would strengthen the resilience of healthcare systems and prepare for future shocks;
Amendment 557 #
2023/2075(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the importance of identifying people with a high risk of developing NCDs and diagnosing people as early as possible to improve disease management, prevent life-altering complications and save downstream costs for healthcare systems; calls for the implementation of accessible and equitable self-management tools, including peer support networks, collaborative care platforms, and mental health services, considering factors like technology access;
Amendment 587 #
2023/2075(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Encourages Member States to reduce undiagnosed NCDs by introducing targeted health checks for high-risk individuals addressing the main shared metabolic risk factors, ensuring timely access to high-quality care and support NCD patients’ self- management;
Amendment 591 #
2023/2075(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Notes that some NCDs are closely linked such as diabetes, renal diseases and cardiovascular diseases and that important synergies can be achieved by improving diagnosis and integrated care19 ; calls on Member States to develop, implement and monitor national NCD prevention plans that include risk reduction and secondary screening programmes for at-risk populations; _________________ 19 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 30, June 2022.
Amendment 601 #
2023/2075(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
Amendment 605 #
2023/2075(INI)
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Recognizing that NCDs operate within a broader context, calls for a systemic perspective that acknowledges the interconnected challenges faced by high-risk populations, such as limited access to education, green spaces, healthy foods, physical activity opportunities, healthcare systems, proper air quality, and decent, sustainable, affordable and adequately air-conditioned housing;
Amendment 616 #
2023/2075(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Stresses that nurses, doctors, general practitioners and other primary care professionals, dietitians and nutritionists, dental health professionals and other primary care professionals, as well as patient organisations and the third sector at large, have a significant role in referring patients for diagnostic tests, supporting and/or treating NCDs; encourages the Member States to offer training to healthcare professionals to better identify and support high-risk individuals and treat NCDs according to the latest evidence-based studies;
Amendment 631 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Expresses support for the creation of an EU Network of Comprehensive Cancer Centres, as a good case study for pan European action to improve access to high quality care and to deliver next level cooperation across borders in combating inequalities in access and improved research cooperation;
Amendment 640 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Urges the Commission to speed up the procedures to adopt a code of conduct for financial intermediaries, which recognises the right to be forgotten, cancer patients as a fundamental right for all European citizens, allowing former cancer patients access to financial services throughout Europe without discrimination;
Amendment 643 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 c (new)
Paragraph 18 c (new)
Amendment 644 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 d (new)
Paragraph 18 d (new)
18d. Recognises that health workforce shortage was a pertinent element of the Covid-19 pandemic crisis and therefore recommends that that the European Health Emergency Response Authority (HERA) be provided with explicit mandate to map and propose remedial measures to combat health workforce shortage;
Amendment 648 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 e (new)
Paragraph 18 e (new)
18e. Encourages the Commission and Member States to embed engagement with patient organisations and people living with NCDs into all activities and initiatives related to the design and implementation of prevention and care activities; emphasises the need to deploy person-centred and fully integrated care across the entire chronic diseases care pathway and to strengthen community and priority care, with a focus on chronic diseases requiring access to care across specialties and care levels such as diabetes;
Amendment 649 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 f (new)
Paragraph 18 f (new)
18f. Calls to provide free and quality diagnostic services and checks and drugs for patients attending the NCD clinics for all NCD patients and give as a priority to the healthcare facility that provided the oncological and/or surgical treatment;
Amendment 652 #
2023/2075(INI)
19. Believes that every patient is different and no NCD is the same; calls for NCDs to be prevented and treated as effectively as possible, with a personalised and integrated approach tailored to the patient and the disease and in compliance with human rights obligations, which include meaningful engagement of users in every decision that impacts on them;
Amendment 664 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Recommends funding support for pan-European public health literacy initiatives, such as the suggestion of creating a European Atlas of Early Warning Signs for Cancer, building on the model for cancer prevention created by the European Code Against Cancer;
Amendment 678 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Calls on the Commission to support Member States in reviewing national models of care with a focus on prevention-oriented primary care systems and the upskilling of primary care professionals, even through the Recovery and Resilience Facility, guided by the European Semester process, to reduce inequities across Member States, and improve the resilience of national health systems;
Amendment 690 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19c. Urges Member States to provide training to healthcare professionals on the social and environmental determinants of health, including racism, as well as on inter-sectoral collaboration, integrated service provision, and human rights;
Amendment 695 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 d (new)
Paragraph 19 d (new)
19d. Highlights the increased vulnerability of people living with NCDs effected by extreme weather events and other impacts of climate change and therefore calls for targeted measures in climate change mitigation and adaptation policies;
Amendment 712 #
2023/2075(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Notes the need to focus on the quality of life of NCD patients whose illnesses cannot be cured but may be stabilised for a number of years; emphasises the importance of specific EU recommendations to improve the quality of life of patients including by integrating comprehensive supportive care into psychological care into the comprehensive healthcare, starting with the diagnosis and continuing over the course of the disease and by granting access to specialised support centres;
Amendment 740 #
2023/2075(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls for the incorporation of an equitable approach for digital healthcare strategies: quality and safety of technology should be ensured and inequities in access be addressed, technology as an option should be discussed and agreed upon by the main healthcare professional and the patient in a process of shared decision-making;
Amendment 758 #
2023/2075(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes public-private partnerships as a way of strengthening innovation in healthcare; highlights the European Health Innovation Collaborative, which promotes entrepreneurship and innovation in the healthcare sector and brings together academia, research, and industry to foster collaboration and investment in health technologies; encourages the Commission and the Member States to foster and accelerate public-private partnerships with the caveat of measures to protect public interest;
Amendment 766 #
2023/2075(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the Commission to ensuring access to existing medical devices and strengthen support and investment in the development of, and access to, new innovative medical devices, and to support the digitalisation of health services; believes that new technologies and digitalisation can lead to new and better treatments formanagement and treatments for NCDs as well as improved quality of life for people living with NCDs;
Amendment 778 #
2023/2075(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Believes that good quality data and evidence are important and that correlating health data with social, economic, and environmental data, and strengthening the equity elements of existing health monitoring systems, such as European Health Data Space, will support development of evidence-based and targeted policies and interventions for improved health equity;
Amendment 797 #
2023/2075(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Believes that further economic data collection at national level is needed in order to achieve a better understanding of the associated costs and burden in the Member States;
Amendment 798 #
2023/2075(INI)
Motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25b. Acknowledges the great disparity in the level of funding between different NCDs and the need to evaluate funding priorities to ensure that those diseases which are underfunded despite their high burden, especially among disadvantaged groups, (such as alcohol-related liver disease, pancreatitis, and irritable bowel syndrome) attract more funding;
Amendment 809 #
2023/2075(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Express support for EU level exercises and projects such as the European Cancer Inequities Registry and recommend its expansion into further areas of attention such as inequities related to race-ethnicity, age, gender, LGBTIQ+, vulnerable groups, such as people living with a disability, impairment or (multiple) chronic conditions, and concerns about medical deserts;
Amendment 811 #
2023/2075(INI)
Motion for a resolution
Paragraph 26 b (new)
Paragraph 26 b (new)
26b. calls on the European Commission to encourage, including with targeted funding, research into autoimmune diseases, which afflict 5 to 10 per cent of the global population;
Amendment 814 #
2023/2075(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Commission to create a European NCD Health Knowledge Centre to improve data collection and research on NCDs; stresses the need for further research in NCD co-morbidities and management, and the need for open and FAIR (findable, accessible, interoperable, and reusable) data, as well as the promotion and implementation of existing initiatives, including the European Open Science Cloud, to foster research;
Amendment 834 #
2023/2075(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Address the urgent need to tackle regional disparities in healthcare access, striving for equitable availability of quality NCD management across diverse geographical areas within Member States. Explore innovative methods to enhance access to NCD healthcare, such as mobile clinics, trauma-informed teams, and peer advocates. This strategy aims to not only bridge gaps in healthcare access but also to foster a patient-centred and personalized approach to NCD prevention and treatment;
Amendment 11 #
2023/2074(INI)
Motion for a resolution
Citation 4 d (new)
Citation 4 d (new)
– having regard to its resolution of 12 July 2023 on the COVID-19 pandemic: lessons learned and recommendations for the future (2022/2076(INI)),
Amendment 20 #
2023/2074(INI)
Motion for a resolution
Citation 4 c (new)
Citation 4 c (new)
– having regard to its resolution of 16 February 2022 on Strengthening Europe in the fight against cancer (2020/2267(INI)),
Amendment 38 #
2023/2074(INI)
Motion for a resolution
Citation 4 b (new)
Citation 4 b (new)
– having regard to the report “Mental Health in All Policies – Situation analysis and recommendations for action” by the Joint Action on Mental Health and Well-being, of 2017,
Amendment 39 #
2023/2074(INI)
Motion for a resolution
Citation 4 a (new)
Citation 4 a (new)
– having regard to the definition of mental health by the World Health Organization (WHO),
Amendment 42 #
2023/2074(INI)
Motion for a resolution
Citation 4 e (new)
Citation 4 e (new)
– having regard to the WHO European framework for action on mental health 2021–2025,
Amendment 50 #
2023/2074(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the World Health Organization (WHO) defines mental health as ‘a state of mental well-being that enables people to cope with the stresses of life, realize their abilities, learn well and work well, and contribute to their community’1 ; whereas the mental Health in All Policies (MHiAP) approach makes mental health as a psychological resource of importance for the wellbeing of individuals, families and societies, according to the WHO definition, where Mental health is not just the absence of illness, but is rather conceptualised as a state of wellbeing in which the individual realises her own abilities, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to his/her community; _________________ 1 WHO, fact sheet on mental health, 17 June 2022.
Amendment 66 #
2023/2074(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas Mental Health disorders rank second (2nd) among the most common disabling non-communicable diseases;
Amendment 68 #
2023/2074(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas approximately 4% of all deaths are caused by mental and behavioral disorders in Europe
Amendment 69 #
2023/2074(INI)
Motion for a resolution
Recital B c (new)
Recital B c (new)
Bc. whereas 9 million adolescents in Europe (aged 10 to 19) are living with mental disorders, with anxiety and depression accounting for more than half of all cases; whereas 50% of mental health problems are established by age 14 and 75% by age 24, 10% of children and young people (aged 5 to 16 years) have a clinically diagnosable mental problem, 19 % (almost one in five) European boys aged 15 to 19 suffer from mental disorders, followed by more than 16 per cent of girls the same age, yet 70% of children and adolescents who experience mental health problems have not had appropriate interventions at a sufficiently early age;
Amendment 72 #
2023/2074(INI)
Motion for a resolution
Recital B d (new)
Recital B d (new)
Bd. whereas in the EU, the annual value of lost mental health, in children and young people is estimated at EUR 50 billion;
Amendment 97 #
2023/2074(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas minority stress describes chronically high levels of stress faced by members of stigmatized minority groups, including racial and sexual minority groups, victims of prejudice, hostility, persecution, bullying, exclusion, and physical and verbal aggression; whereas minority stress remains pervasive in various aspects of life among LGBT +, especially adolescents, whose psycho- emotional stability is being challenged by homo-trans-phobia manifested by peers but also frequently their family;
Amendment 99 #
2023/2074(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas, according to the WHO, the data show that violence against women has become a public health problem of epidemic proportions, and the national health services of various countries can and must do more to support women who suffer physical violence or sexual abuse;
Amendment 108 #
2023/2074(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas the omnipresence of smartphones, online messaging and social networks favours online socialisation at the expense of in-person socialisation, and increases the risk of progression from bullying to cyberbullying; whereas cyberbullying victims are at higher risk of depression and suicidal ideation;
Amendment 111 #
2023/2074(INI)
Motion for a resolution
Recital C c (new)
Recital C c (new)
Amendment 118 #
2023/2074(INI)
Motion for a resolution
Recital C d (new)
Recital C d (new)
Cd. whereas EU-OSHA reports that 45% of employed persons consider stress and other risk factors that can adversely affect mental wellbeing to be common in their workplace
Amendment 120 #
2023/2074(INI)
Motion for a resolution
Recital C e (new)
Recital C e (new)
Amendment 123 #
2023/2074(INI)
Motion for a resolution
Recital C f (new)
Recital C f (new)
Cf. whereas a key element of the community model or paradigm is the role of patients and their families –duly organized through their associations and federations– in the debate and planning of the healthcare network; whereas according to the community care paradigm, it is a priority to empower patients as much as possible and turn them into active agents of their own therapeutic process (“health in the first person”); whereas taking advantage of the experience and knowledge of users and their environment is essential to plan and develop healthcare services; whereas dialogue with patients is undoubtedly one of the most stimulating, revealing and rewarding elements in the process of building this community model;
Amendment 151 #
2023/2074(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Highlights that, at any point in their life, any person can become more susceptible to poorer mental health and thus become part of a vulnerable group in society; stresses that addressing mental health conditions requires a thorough understanding of the different determinants of mental health and that an intersectional approach including the EU, Member States, civil society and professional actors, from the healthcare sector in particular, is necessary to prevent and mitigate the impacts on individuals, communities and societies;
Amendment 157 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Calls on the Commission and Member States to prioritise mental health and well-being among young people, by recognising mental health problems as one of the most significant health concerns for young people;
Amendment 159 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Stresses that this report wishes to follow the Mental Health in All Policies (MHiAP), which should apply to all policy levels (e.g. national, regional and local), and in all policy sectors; considers that in order to achieve uptake of the Mental Health in All Policies approach, it is important to demonstrate mutual benefits by pointing out existing win-win situations of mental health promotion, and co-incidence of objectives of non- health policy areas with outcomes of mental health promotion actions are strong drivers of the Mental Health in All Policies approach;
Amendment 201 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
Amendment 209 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Emphasises that mental health and behavioural disorders are an important driver of suicide among individuals, especially younger age groups with male adolescents aged 15–19 reported higher suicide rates;
Amendment 220 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Urges all the public administrations to focus especially on domestic violence, and within it, with a special focus on violence against women and girls, whose trauma inflicted upon them might be life-enduring and a long- lasting scar;
Amendment 248 #
2023/2074(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Considers mental health information systems an important tool to collect data and measure the effectiveness of mental health interventions, and calls for them to be systematically improved and updated; urges the Commission to make an European surveillance study on mental health disorders;
Amendment 259 #
2023/2074(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to assist the Member States and the regions with health competences in collecting and spreading best practice, via the EU Best Practice Portal, with regard to targeted campaigns for supporting vulnerable groups, particularly marginalised communities;
Amendment 261 #
2023/2074(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on Commission and Member States to improve the comprehensiveness, quality and timeliness of their suicide- related data including vital registration of suicide, hospital-based registries of suicide attempts and nationally representative surveys collecting information about self-reported suicide attempts;
Amendment 264 #
2023/2074(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Calls on all the public administrations to focus on preventing use of addictive substances, especially those harmful such as Cannabis Sativa, genetically modified Cannabis Sativa, cocaine and derived substances; calls on the public administrations to focus also on detecting and preventing behavioural additions towards tobacco and alcohol, as well as prescribed opioids; urges the Commission to reform the Tobacco Products Directive (Directive 2014/40/EU on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products);
Amendment 275 #
2023/2074(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Is deeply concerned that, despite progress in some countries, people with mental health conditions frequently experience discrimination and stigma and often do not have access to adequate healthcare, work place or housing, which can lead to severe human rights violations;
Amendment 286 #
2023/2074(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls for the EU and the Member States, Member States, civil society and professional actors, from the healthcare sector in particular, to raise awareness of the importance of mental health in a coordinated and timely manner, through a mental-health-in- all-policies approach;
Amendment 312 #
2023/2074(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls for the EU and the Member States to ensure training and certification schemes for qualified professionals to increase the number of qualified professionals and reduce waiting times including specialists on cultural sensitive counselling and specific contexts and needs such as trauma caused by war and conflict, and natural disasters;
Amendment 330 #
2023/2074(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Urges the Member States to guarantee the access to quality, free of charge and tailored mental health services and programmes focusing on specific needs of children and young people and provide specific support including financially to young adults facing high levels of mental health pressure and in situations of vulnerability including adults who have left alternative care;
Amendment 334 #
2023/2074(INI)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. calls on the Commission to develop effective tools for a uniform and integrated system of child and adolescent neuropsychiatry health services to be implemented in the Member States;
Amendment 336 #
2023/2074(INI)
Motion for a resolution
Paragraph 9 c (new)
Paragraph 9 c (new)
Amendment 341 #
2023/2074(INI)
Motion for a resolution
Paragraph 9 d (new)
Paragraph 9 d (new)
9d. emphasises that WHO recognises suicide as a public health priority; calls on the Commission and Member States to implement WHO evidence-based interventions in the Suicide Prevention Programmes by limiting access to the means of suicide, interacting with the media for responsible suicide communication, promoting social- emotional competencies of adolescents, and early identification, assessment, management and follow-up of anyone affected by suicidal behaviour;
Amendment 344 #
2023/2074(INI)
Motion for a resolution
Paragraph 9 e (new)
Paragraph 9 e (new)
9e. Urges the Member States to incorporate more specialists – psychologists and psychiatrists– in primary care centres, increase the frequency of follow-up visits in mental health centres, whether for adults or child and youth mental health, open new specialised devices (e.g., in dual pathology or in adapted treatment of the homeless population);
Amendment 350 #
2023/2074(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers that mental health conditions are underdiagnosed in the EU; especially among healthcare professionals; recommends the Commission to make a mental health epidemiological assessment or study;
Amendment 356 #
2023/2074(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Underlines the importance of recognition early diagnosis and, intervention and constant monitoring for mental health conditions;
Amendment 360 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. urges Member States to invest in early intervention and maternal mental health services, including prevention, screening and support programmes for all women, including refugee and undocumented migrant women and women faced ill-treatment, sexual abused;
Amendment 393 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Highlights the need to address and take in duly consideration the mental health of healthcare professionals to ensure better mental health conditions to all;
Amendment 395 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. stresses, moreover, that the situation of healthcare workers is increasingly worrying because of challenging working conditions, shortages of the workforce, insufficient resources, and in some cases even physical and verbal aggression; emphasises that addressing mental health workforce shortages is critical for improving service accessibility and future pandemic preparedness;
Amendment 400 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. calls on the Commission to support Member States in the process of developing and delivering systems that are person-centred and human rights compliant;
Amendment 401 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
Amendment 407 #
2023/2074(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Member States in close cooperation with healthcare professionals and hospital management to improve access to treatment and support for mental health conditions by implementing multidisciplinary care;
Amendment 412 #
2023/2074(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. emphasises the need to reprioritise mental healthcare to be evidence-based and patient-first, a system that not only reduces mental illness via curative and rehabilitative care but also improves mental well-being via promotive and preventive care;
Amendment 413 #
2023/2074(INI)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Calls on the Member States to ensure access to psychological first aid, counselling and therapy in culturally sensitive contexts for children in the context of migration, regardless of residence status;
Amendment 431 #
2023/2074(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls Member States to reduce the age of consent to psychosocial counselling and therapy, including access to professionals with expertise on the effects of recreational substance misuse, including cannabis and mental health, to allow children and young people to receive effective mental health support if they wish, irrespective of consent of their parents;
Amendment 441 #
2023/2074(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Urges the Member States to ensure that people on medical leave because of mental health conditions do not face discrimination; urges the Member States and competent bodies to implement national plans that promote the integration of people with mental health conditions into the labour market, in order to reduce inequities and tackle social determinants and provide financial incentives targeted at companies, especially to support small- and medium-sized enterprises, to recruit and retain to recruit the people with mental health conditions;
Amendment 460 #
2023/2074(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Invites the Commission and the Member States to invest in further research on mental health, including the development of distance based, ICT- supported, psychosocial treatments;
Amendment 466 #
2023/2074(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Invites the Commission to accelerate the research of narcissistic personality disorder, development of advanced treatments and medications;
Amendment 468 #
2023/2074(INI)
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. calls on the Commission to develop research on interactions between alcohol, painkillers and drug use cannabis variants with high concentration on THC and its different mode of consumption and information on interaction;
Amendment 488 #
2023/2074(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls for the EU and the Member States professional, in particular from the healthcare sector to urgently develop psychosocial mental health support structures, especially treatments for post- traumatic stress disorder, aimed specifically at victims of natural, climate, humanitarian, geopolitical and conflict- related disasters, asylum seekers and migrants from all backgrounds;
Amendment 502 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission to add, as further support for students who, during the implementation of the programme, are located in EU Member States or in other countries belonging to the Erasmus+ programme, a further category of expenditure relating to the costs of psychological support and assistance for students, and to ensure that this category of expenditure is declared eligible, starting with the next call for proposals for the 2025 programming year;
Amendment 504 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls Commission and Member States to develop or strengthen comprehensive suicide prevention strategies and optimise school-based suicide prevention programs, such as digital and face to face educational programs on the effects of substance misuse and the danger of seeking relief from psychological stress in self- administration of drugs like cannabis;
Amendment 512 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. calls on the Commission to come forward with a proposal for Member States to put in place national action programmes on mental health and well- being;
Amendment 513 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 c (new)
Paragraph 21 c (new)
Amendment 514 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 d (new)
Paragraph 21 d (new)
21d. Calls on the Commission and Member States to monitor progress on children’s overall health and wellbeing, including mental health, as part of their reporting on health in the European Semester process;
Amendment 515 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 e (new)
Paragraph 21 e (new)
21e. Underlines that the Commission should ensure the reduction of harmful psychosocial risk factors at work and to guarantee the right to the same level of protection of workers, regardless of their status and where in the EU they live and work;
Amendment 516 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 f (new)
Paragraph 21 f (new)
21f. Urges the Commission to revise its 2003 recommendation concerning the European schedule of occupational diseases with additions such as work- related mental health disorders, in particular depression, burnout, anxiety and stress; retire its call to transform this recommendation into a directive creating a minimum list of occupational diseases and setting out minimum requirements for their recognition and adequate compensation for individuals concerned;
Amendment 517 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 g (new)
Paragraph 21 g (new)
21g. calls on the Commission to maintain dialogue with EU Member States as an imperative and open the European Commission’s Expert Group on Public Health subgroup on Mental Health to sub-national and civil society actors;
Amendment 31 #
2023/2061(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas the development and use of new technologies will cause a short- term rise in vehicle prices, which could make it harder to renew the car fleet and penalise poorer households;
Amendment 33 #
2023/2061(INI)
Motion for a resolution
Recital F
Recital F
F. whereas the current regulatory framework does not provide specific support and training measures and funding for European regions whose GDP is mainly generated by the automotive sector; whereas many industry associations consider measures to boost demand that do not reduce resources for reindustrialisation to be indispensable;
Amendment 65 #
2023/2061(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls for the future generation of the European Social Fund to explicitly include measures to strengthen social safety nets and vocational training in order to invest in the new skills needed to accompany the transition;
Amendment 92 #
2023/2061(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Believes it necessary to set up specific instruments to support the value chain, with a policy of providing support for the manufacture and procurement of all components related to the ecological transition for vehicles; in particular, considers it necessary to support the sectors of semiconductors, batteries and components necessary for electric motors, autonomous driving, digitisation and connectivity;
Amendment 104 #
2023/2061(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls on the Commission to put forward the necessary proposal to ensure the continuity of the Just Transition Mechanism and that it is endowed with sufficient funds to include support for regions that are dependent on the automotive and parts-supply industry, in particular in the relevant Just Transition Fund mainstreamed within the cohesion policy, so that synergies and spillover effects can be promoted with various European funds and programmes to address the regional transformation process; further takes the view that a specific fund should be established in the next Multiannual Financial Framework for a reindustrialisation policy in the sector to mitigate the impact on jobs;
Amendment 59 #
2023/2048(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Welcomes the Handbook of territorial and development strategies and the Handbook of Sustainable Urban Development Strategies as guides for the design, implementation and monitoring of territorial and urban development strategies; believes the dissemination of good practices must be fostered with a view to ensuring that projects are effective and sustainable;
Amendment 65 #
2023/2048(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Stresses the need for a paradigm shift in the involvement of local and regional authorities in the implementation and management of territorial tools; believes, further, that the public must be involved in the territorial development process with a view to ensuring that projects address their needs and aspirations; calls on the Commission to encourage the public to participate actively in the planning and implementation processes for territorial development projects;
Amendment 71 #
2023/2048(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls for territorial or local development strategies funded by more than one programme to merge into a single track in order to prevent delays and administrative obstacles; calls on the Commission, in that regard, to provide local and regional authorities with technical and financial support with a view to helping them to implement territorial development projects;
Amendment 101 #
2023/2048(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Believes that businesses could play an essential role in territorial development strategies; calls on the Commission to support arrangements for collaboration between companies and local and regional authorities with a view to developing territorial development projects that foster job creation and economic growth;
Amendment 85 #
2023/2044(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Recalls that the right to housing is one of the EU’s social pillars; believes that incentives should be provided in order to ensure that decent affordable housing is available to prevent exoduses and for talented individuals who decide to return to their place of origin;
Amendment 95 #
2023/2044(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Points out that minimum wages have failed to keep pace with other wages in many Member States, exacerbating in- work poverty, wage inequality and the ability of low-wage earners to cope with economic difficulties; believes that establishing a European guaranteed minimum wage could limit talent drain;
Amendment 100 #
2023/2044(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Encourages the financing of specific measures through the multiannual financial framework to address the demographic challenges, with a specific budget for regions with severe and permanent demographic difficulties; in this context, considers it necessary to reformulate the specific instruments of the cohesion policy by assigning greater weight to depopulation for the allocation of funds with a view to developing an economic environment conducive to the expansion of businesses and the creation of jobs with the aim of ensuring that talent remains;
Amendment 148 #
2023/2044(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Acknowledges that direct financial support to regions in or at risk of a talent development trap will be provided under existing instruments; regrets nonetheless that no specific and dedicated financial support has been established for this purpose; suggests that the new programming period should include the creation of a dedicated fund addressing the brain drain and providing incentives for talent to return through programmes that encourage talented individuals that have gone away to come back, offering them tax breaks and attractive career opportunities;
Amendment 173 #
2023/2044(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Considers it essential to prioritise measures to facilitate work-life balance, guaranteeing access to childcare, working time flexibility and decent wages and working conditions; takes the view that investment in research and development, technology and infrastructure is essential to attracting tech companies and start- ups, industries which tend to require highly skilled talent; calls on the Member States and the Commission to provide tax incentives, relief and advisory services to support local businesses hiring young people with a view to fostering the creation of new jobs;
Amendment 70 #
2023/0266(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Different types of input data, including primary and secondary data, can be used to calculate greenhouse gas emissions of transport services. The use of primary data leads to most reliable and accurate results, and therefore should be prioritisedmade compulsory to provide for the gradual uptake of these data in greenhouse gas emissions calculation processes. However, primary data might be unattainable or prohibitively expensive for certain stakeholders, especially SMEs, which should be exempted from that obligation. Therefore, the use by SMEs of secondary data should be allowed under clear conditions.
Amendment 184 #
2023/0266(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Entities referred to in Article 2 shall prioritise the, with the exception of SMEs, shall use of primary data for calculating greenhouse gas emissions of a transport service.
Amendment 179 #
2023/0234(COD)
Proposal for a directive
Recital 19
Recital 19
(19) The household textile and apparel clothing comprise the largest share of Union textile consumption and the biggest contributor to unsustainable patterns of over production and overconsumption. Household tTextiles and apparel are also the focus of all existing separate collection systems in Member States along with other post-consumer apparel and accessories and footwear that are not primarily composed of textiles. Therefore, the scope of the established extended producer responsibility scheme should cover household textile products and other articles of apparel, clothing accessories and footwear. In order to ensure the legal certainty for the producers on the products subject to the extended producer responsibility, the products in scope should be identified by reference to the Combined Nomenclature codes pursuant to Annex I to Council Regulation (EEC) No 2658/8778 . _________________ 78 OJ L 256, 7.9.1987 p. 1.
Amendment 183 #
2023/0234(COD)
Proposal for a directive
Recital 20
Recital 20
(20) The textile sector is resource intensive. While, in relation to both the production of raw materials and textiles, most of the pressures and impacts related to the consumption of clothing, footwear and household textiles in the Union occur in third countries, they also affect the Union due to their global impact on climate and the environment. Therefore, preventing, preparing for re-use and recycling textile waste can help reduce the global environmental footprint of the sector, including in the Union. In addition, the current resource-inefficient waste management of textile waste is not in line with the waste hierarchy and leads to environmental harm both in the Union and in third countries, including through greenhouse gas emissions from incineration and landfilling.
Amendment 184 #
2023/0234(COD)
Proposal for a directive
Recital 20 a (new)
Recital 20 a (new)
(20a) Implementing the requirements, systems, objectives and additional obligations laid down in this Directive is key to the Member States achieving a circular economy in order to create new jobs, strengthen their economies and bring about greater stability. Implementing the separate collection, at source, of all fractions of recyclable waste mentioned in this Directive, while keeping all stakeholders constantly informed, is key to achieving a circular economy.
Amendment 191 #
2023/0234(COD)
Proposal for a directive
Recital 24
Recital 24
(24) Used and waste textiles, textile- related and footwear products should be collected separately from other waste streams, such as metals, paper and cardboard, glass, plastics, wood and bio- waste from 1 January 2025 to maintain their reusability and potential for high- quality recycling. Considering the environmental impact and the loss of materials due to used and waste textiles not being separately collected, and consequently not treated in an environmentally sound manner, the collection network of used and waste textiles, textile-related and footwear products should cover the whole territory of Member States including the outermost regions, be close to the end-user and not target only areas and products where the collection is profitable. The collection network should be organised in cooperation with other actors active in the waste management and re-use sectors, such as municipallocal authorities and social enterprises. In view of the significant environmental and climate benefits associated with re-use, the primary and secondary purpose of the collection network should be the collection of re-usable and recyclable textile, textile- related and footwear products accordingly. Since the consumer is not trained to distinguish between re-usable and recyclable items, the collection systems should, including for logistical efficiency purposes, provide for thededicated collection receptacles that collect both used and waste items together. High collection rates would drive high re-use performance and quality recycling in the textile supply chains, boost the uptake of quality secondary raw materials and support the investment planning in the textile sorting and processing infrastructure. In order to verify and improve the effectiveness of the collection network and the information campaigns, regular compositional surveys at least at NUTS 2 level should be carried out on mixed municipal waste collected to determine the amount of waste textiles and footwear therein. In addition, information on the performance of the separate collection systems and the attained annual separate collection rate should be calculated and made publicly available annually by the producer responsibility organisations.
Amendment 215 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Directive 2008/98/EC
Article 3
Article 3
4ba. ‘unsold textile product’ means any textile product listed in Annex IVc that is suitable for consumption or sale and has not been sold, including surpluses, overstock and gross stock, as well as any textile product that has been returned by a consumer based on their right to withdraw under Article 9 of Directive (EU) 2011/83/EU.
Amendment 233 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Directive 2008/98/EC
Article 9 a
Article 9 a
(a) developing and supporting behavioural change interventions to reduce food waste and discarded food, and information campaigns to raise awareness about food waste prevention;
Amendment 240 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Directive 2008/98/EC
Article 9 a
Article 9 a
(d) supporting training and skills development as well as facilitating access to funding opportunities, in particular for small and medium sized enterprises and social economy actors, as well as local authorities.
Amendment 295 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Directive 2008/98/EC
Article 11 – paragraph 1
Article 11 – paragraph 1
Subject to Article 10(2) and (3), Member States shall set up separate collection at least for bio-waste, paper, metal, plastic and glass.;
Amendment 301 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 a (new)
Article 22 a (new)
Prevention of textile waste 1. Member States shall apply prevention measures along the whole value chain (production, manufacturing and processing, retail, families and other enterprises) to achieve a 50 % target for the separate collection of textile waste products. 2. Member States shall communicate data relating to the implementation of paragraph 1 to the Commission and the European Environment Agency on an annual basis.
Amendment 304 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 a
Article 22 a
1. Member States shall ensure that producers have extended producer responsibility for household textile products, articles of apparel, clothing accessories and footwear, apparel and clothing accessories listed in Annex IVc (“textile, textile-related and footwear products”), including unsold textile products, that they make available on the market for the first time within the territory of a Member State, in accordance with Articles 8 and 8a.
Amendment 314 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 a
Article 22 a
3. Member States shall define in a clear way the roles and responsibilities of relevant actors involved in the implementation,ensure that local public authorities are involved in the decision-making process of the extended producer responsibility scheme and in the monitoring and verification of the extended producer responsibility scheme referred to in paragraph 1.
Amendment 316 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 a
Article 22 a
(1) the collection of those used products for re-use and the separate collection of waste products for preparation for re-use and recycling in accordance with Articles 22c and 22d, including appropriate information campaigns aimed at citizens;
Amendment 324 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 a
Article 22 a
(4a) collection, transport and treatment of textile products, textile-related and footwear products listed in Annex IVc that are disposed of through mixed municipal waste.
Amendment 326 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 a
Article 22 a
(4b) allocation of a proportion of the EPR tariffs, which is to be decided by the Member States, to a fund for re-use and repair operations carried out by social economy actors.
Amendment 327 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 a
Article 22 a
(4c) incentives for staff of the competent authorities performing the audits and for spending on the recruitment of qualified staff with a view to boosting the staffing levels of these authorities, which are in charge of carrying out inspections and controls stemming from this Directive.
Amendment 332 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 a
Article 22 a
(ea) inspection and control-related tasks, including spending on training for the staff of the competent authorities who are working on tasks stemming from this Directive.
Amendment 388 #
2023/0234(COD)
(c) ensure full coordination between social enterprises and producer responsibility organisations to guarantee the collection, free of charge, of waste generated by social enterprises and other non-waste operators from such textile, textile-related and footwear products collected through the connected collection points.
Amendment 392 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7 Directive 2008/98/EC
Article 1 – paragraph 1 – point 7 Directive 2008/98/EC
(ca) ensure that collection is uniform at regional level, efficient and adapted to local circumstances, avoiding the use of too many different containers.
Amendment 394 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 c
Article 22 c
5a. Producers of textile, textile-related and footwear products listed in Annex IVc cannot use unsold textile products to meet their re-use obligations.
Amendment 401 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 c
Article 22 c
8. The separate collection rate referred to in paragraph 6, point (c) shall be calculated as the percentage obtained by dividing the weight of waste textile, textile- related and footwear products listed in Annex IVc collected separately in accordance with paragraph 5 in a given calendar year in a Member State by the weight of such waste textile, textile-related and footwear products that is generated and collected as mixed municipal waste.
Amendment 404 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 c
Article 22 c
10. Member States shall ensure that producer responsibility organisations are not allowed to refuse the participation of social enterprises and otherlocal public authorities, of social enterprises as well as of other preparation for re-use and re-use operators in the separate collection system established pursuant to paragraph 5.
Amendment 411 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7 Directive 2008/98/EC
Article 1 – paragraph 1 – point 7 Directive 2008/98/EC
11. Without prejudice to paragraph 5, points (a) and (b), and paragraph 6, point (a), Member States shall ensure that local public authorities and social enterprises are allowed to maintain and operate their own separate collection points and that they are given equal or preferential treatment in the location of the separate collection points. Member States shall ensure that local public authorities, social enterprises and social economy entities that are part of the connected collection points in accordance with paragraph 6, point (a) are not required to hand over collected used and waste textiles, textile-related and footwear products listed in Annex IVc to the producer responsibility organisation.
Amendment 418 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 c
Article 22 c
12. Member States shall ensure that collection points set up in accordance with paragraphs 5, 6 and 11 are not subject to the registration orand permit requirements of this Directive.
Amendment 419 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 c
Article 22 c
(b) the re-use and repair arrangements available for textiles and footwear, including the location of collection points and details of how to properly donate textile products;
Amendment 463 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 d
Article 22 d
3a. Member States shall ensure that producer responsibility organisations manage unsold textile products properly in order to fulfil their extended producer responsibilities under Articles 8, 8a, 22a and 22d.
Amendment 468 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 d
Article 22 d
(a) the sorting operation is to generate textiles for re-use and preparation for re- use, giving priority to local re-use and preparation for re-use networks;
Amendment 472 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 d
Article 22 d
(aa) the sorting operation must follow the principle of proximity, giving priority to local sorting and avoiding transport- related environmental impacts;
Amendment 481 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2008/98/EC
Article 22 d
Article 22 d
5a. Member States should put in place separate preparation, re-use and recycling targets for textiles and textile waste, taking appropriate measures to ensure that fulfilment of the targets is closely monitored. The targets should be drawn up in consultation with stakeholders. The European Commission shall be empowered to adopt delegated acts, in accordance with Article 38, to provide guidelines for the definition and monitoring of these targets.
Amendment 516 #
2023/0234(COD)
Proposal for a directive
Annex I – Part 1 – paragraph 1
Annex I – Part 1 – paragraph 1
Amendment 191 #
2023/0232(COD)
Proposal for a directive
Recital 43 a (new)
Recital 43 a (new)
(43a) whereas if there is a project to be built on a Natura 2000 site, it is obligatory for a preliminary Commission assessment of its location to be carried out before any further development takes place;
Amendment 214 #
2023/0232(COD)
Proposal for a directive
Recital 55 a (new)
Recital 55 a (new)
(55a) whereas it is essential to establish a mandatory estimate of the status of abandoned buildings/structures, new EU funds should be earmarked for the financing of the possible cost difference for carrying out new work using virgin land;
Amendment 215 #
2023/0232(COD)
Proposal for a directive
Recital 55 b (new)
Recital 55 b (new)
(55b) whereas it should be appropriate to ban the use of virgin (unused) land for public infrastructure if an equivalent abandoned infrastructure can be recovered, even if recovery or restructuring is less cost effective;
Amendment 539 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
Member States shall ensure that the following principles are respected in case of land takeadopt legislative acts and programmes that give effect to the following principles:
Amendment 541 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – point a – introductory part
Article 11 – paragraph 1 – point a – introductory part
(a) avoid or reduce as much as technically and economically possible, as a result of human activities, the loss of theareas' capacity of the soil to provide multiple ecosystem services, including food production, by: for that purpose, the aforementioned acts:
Amendment 543 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – point a – point i
Article 11 – paragraph 1 – point a – point i
(i) reducing the area affected by the land take to the extent possible andpursuing net-zero land take within 24 months of the entry into force of this Directive;
Amendment 546 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – point a – point ii
Article 11 – paragraph 1 – point a – point ii
(ii) selecting areas where the loss of ecosystem services would be minimizproviding that, until the end of the aforementioned period, land consumption shall be limited to cases of strict necessity only, for the construction of public infrastructure and services or for the establishment of other human functions if, in the latter case, the non- existence of alternative solutions, based on the conversion of areas that have already been urbanised or have been compromised by human activities, can be proved, and appropriate compensatory measures shall be taken;
Amendment 548 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – point a – point iii
Article 11 – paragraph 1 – point a – point iii
(iii) performing the land take in a way that minimizes the negative impact on soilsingling out areas of intrinsic agricultural, environmental, natural or scenic value, in which the loss of ecosystem services is prohibited, and it is therefore impossible for land to be used for other purposes;
Amendment 556 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
(b) compensate as much as possible the loss of soil capacity to provide multiple ecosystem services.gricultural or natural areas which, having been subject to transformation projects approved before the date of entry into force of this Directive and still in progress on that date, are converted into areas designated for human functions;
Amendment 560 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – point b a (new)
Article 11 – paragraph 1 – point b a (new)
Amendment 679 #
2023/0232(COD)
Proposal for a directive
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Without prejudice to the obligations of Member States under Directive 2008/99/EC of the European Parliament and of the Council, Member States shall lay down the rules on penalties applicable to violations, particularly with regard to soil consumption and contamination, by natural and legal persons, of the national provisions adopted pursuant to Article 11 and Chapter IV of this Directive and shall ensure that those rules are implemented. The penalties provided for shall be effective, proportionate and dissuasive.
Amendment 680 #
2023/0232(COD)
Proposal for a directive
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Without prejudice to the obligations of Member States under Directive 2008/99/EC of the European Parliament and of the Council, Member States shall lay down the rules on penalties applicable to violations by natural and legal persons, of the national provisions adopted pursuant toof the provisions adopted pursuant to Article 11 and to Chapter IV of this Directive and shall ensure that those rules are implemented. The penalties provided for shall be effective, proportionate and dissuasive.
Amendment 24 #
2023/0171(COD)
Proposal for a directive
Recital 13
Recital 13
(13) The existing satellite-based service ‘CleanSeaNet’ which notifies Member States authorities on potential illegal discharges, should be further enhanced to include information on the additional polluting substances under the scope of Directive 2005/35/EC. Information relating to potential or actual discharges reported by Member States in accordance with Directive 2005/35/EC and to other Union maritime safety databases, such as the Union Maritime Information and Exchange System established by Directive 2002/59/EC of the European Parliament and of the Council27 (‘SafeSeaNet’) and the Inspection Database set up by Directive 2009/16/EC of the European Parliament and of the Council28 (‘THETIS’) should be integrated and disseminated in a user- friendly electronic format to the national authorities involved in the enforcement chain in order to facilitate their timely response. Such information, when relating to an actual or potential discharge of Exhaust Gas Cleaning System residue from a ship, should further be automatically disseminated to the dedicated module of THETIS set up by under Commission Implementing Decision 2015/253 (‘THETIS-EU’), in order to assist Member States with enforcement actions undertaken in accordance with the provisions of Directive (EU) 2016/802. In order to ensure the effective monitoring of the Directive’s implementation by all Member States, a verification rate of 160% per year of the alerts sent by CleanSeaNet should be ensured by each Member State within the first three years form the transposition of this Directive. Access to this information should be granted to the authorities of other Member States having an interest in it under their roles as port States of the next port of call, coastal States affected by the potential discharge or flag States of the ship in order to facilitate effective and timely cross-border cooperation, minimise the administrative burden of enforcement activities and ultimately effectively penalise offenders for infringements of Directive 2005/35/EC. _________________ 27 Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system and repealing Council Directive 93/75/EEC (OJ L 208, 5.8.2002, p. 10). 28 Directive 2009/16/EC of the European Parliament and of the Council of 23 April 2009 on port State control (recast) (OJ L 131, 28.5.2009, p. 57).
Amendment 36 #
2023/0171(COD)
Proposal for a directive
Recital 18
Recital 18
(18) In order to increase public awareness in ship-source pollution discharges and, improve environmental protection and strengthen enforcement action against pollution, information provided by the Member States on the application of Directive 2005/35/EC and Directive (EU) 2016/802 should be made publicly available through a Union-wide overvUnion-wide in the form of detailed information on checks, warnings and penaltiews and include the information listed in Annex II of Directive 2005/35/EC. as well as in-depth checks and infringements available to the public under the EU Sulphur Directive 2016/802 and the provisions of Annex VI to Marpol on NOx. . Directive 2003/4/EC of the European Parliament and of the Council30 aims to guarantee the right of access to environmental information in the Member States in line with the Convention on access to information, public participation in decision-making and access to justice in environmental matters (Aarhus Convention), to which the Union is a party. The Commission should protect the confidentiality of information received by the Commission from the Member States, is without prejudice to the provisions of Directive 2003/4/EC. _________________ 30 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).
Amendment 39 #
2023/0171(COD)
Proposal for a directive
Recital 18 a (new)
Recital 18 a (new)
(18a) On the basis of the information provided by the Member States under Article 10(a) and Directive 802/2016, the Commission shall make regularly updated data on the implementation and application of this Directive publically available EU-wide, thus ensuring transparency of information on the checks carried out, the entities checked and infringements established. The overview shall include the information listed in Annex II to this Directive.
Amendment 89 #
2023/0171(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive 2005/35/EC
Article 10
Article 10
(d) within three years from the date of transposition of this Directive, ensure that competent authorities verify at least 160% of the alerts sent by CleanSeaNet every year.
Amendment 102 #
2023/0171(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Directive 2005/35/EC
Article 10
Article 10
1. Based on information reported by Member States in accordance with Article 10a, the Commission shall make publicly available a regularly updated Union-wide overview broken down per Member State on the implementation and enforcement of this Directive. The overview shall include the information listed in Annex II to this Directive.
Amendment 125 #
2023/0171(COD)
Proposal for a directive
Annex II – point 2 – point c a (new)
Annex II – point 2 – point c a (new)
Directive 2005/35/EC
Article 10
Article 10
(ca) Monitoring data concerning implementation of Directive 892/2016 uploaded on to THETIS system;
Amendment 137 #
2023/0135(COD)
Proposal for a directive
Recital 1
Recital 1
(1) Corruption remains a significant problem at the Union level, threatening the stability and security of societies, including by enabling organised and other serious crime. Corruption undermines democratic institutions and universal values on which the Union is founded, particularly the rule of law, democracy, equality and the protection of fundamental rights. It jeopardises development, prosperity and the sustainability and inclusiveness of our economies by facilitating the infiltration of the licit economy by organised crime, including through the award of public procurement contracts and public concessions, and by undermining the proper functioning of the market, underpinned by competition. In order to effectively prevent and combat corruption, a comprehensive and multidisciplinary approach is required. The purpose of this Directive is to tackle corruption by means of criminal law, allowing for better cross- border cooperation between competent authorities.
Amendment 156 #
2023/0135(COD)
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9a) With a view to further strengthening the European anti- corruption framework and to effectively preventing corruption offences, the notion of conflict of interest needs to be clearly defined and as broadly as possible. This notion should cover all situations in which the impartial and objective exercise of the duties of a person involved in the performance of public functions is compromised for reasons of family, emotional, political or national affinity, economic interest or any other direct or indirect personal interest, whether real or potential, which conflicts with the public functions that the official is entrusted to perform.
Amendment 161 #
2023/0135(COD)
Proposal for a directive
Recital 9 b (new)
Recital 9 b (new)
(9b) It is also necessary to strengthen transparency and to avoid the phenomenon of the 'revolving door' between the public and private sectors, by imposing restrictions on the exercise of professional activities by former public officials, whether appointed, elected or employed under contract, and on the employment by the private sector of public officials after their resignation or retirement, when such activities or employment are directly related to the duties that they had performed or overseen during their term in office.
Amendment 164 #
2023/0135(COD)
Proposal for a directive
Recital 9 c (new)
Recital 9 c (new)
(9c) This Directive should lay down minimum standards to increase transparency and bring the laws of the Member States in line with reporting obligations concerning the income and assets of public officials.
Amendment 178 #
2023/0135(COD)
Proposal for a directive
Recital 15
Recital 15
(15) Corruption feeds off the motivation for undue economic and other advantages. ÌIn order to reduce the incentive for individuals and criminal organisations to commit new criminal acts and deter individuals from consenting to becoming fake property owners enrichment by corruption offences should be criminalised. This should, in turn, complicate the concealment of illicitly acquired property and reduce the spread of corruption as well as the damage done to society. Transparency helps competent authorities to detect possible illicit enrichment. For example, in jurisdictions whereIt is necessary to ensure maximum transparency as this is crucial to enable the competent authorities to detect possible illicit enrichment. To enable the authorities to assess whether declared assets match declared income, public officials are required tomust declare their assets at regular intervals, including particular when taking up and completing duties, authorities can assess whether the declared assets correspond to declared incomesleaving office.
Amendment 181 #
2023/0135(COD)
Proposal for a directive
Recital 19
Recital 19
(19) The competent authorities should be able to impose, in addition or as an alternative to imprisonment, supplementary sanctions or measures, that are not necessarily of a criminal nature, such as the temporary or permanent disqualification from holding public office or the exclusion from public procurement, a ban on holding elected or governmental office or the exclusion from public procurement and the voiding of contracts and appointments awarded in breach of anti-corruption rules. Such measures have a general dissuasive effect and may reduce the recidivism of convicted offenders. Member States should also consider establishing procedures for the suspension or temporary reassignment of a public official accused of a criminal offence as referred to in this Directive, bearing in mind the need to respect the principle of the presumption of innocence and the right to an effective remedy.
Amendment 186 #
2023/0135(COD)
Proposal for a directive
Recital 27
Recital 27
(27) In order to ensure that the competent authorities have sufficient time to conduct complex investigations and prosecutions, this Directive provides for a minimum limitation period that enables the detection, investigation, prosecution and judicial decision of corruption offences for a sufficient period of time after the commission of such offences, without affecting those Member States which do not set limitation periods for investigation, prosecution and enforcement. That limitation period should in any event be suspended from the date of issuance of the conviction concluding the first instance of the proceedings or of the conviction order, until the effective date of the judgment concluding the proceedings or the date on which the criminal decree becomes final.
Amendment 187 #
2023/0135(COD)
Proposal for a directive
Recital 28
Recital 28
(28) Corruption offences are a difficult category of crime to identify and investigate, as they mostly occur as part of a conspiracy between two or more willing parties and lack an immediate and obvious victim who could complain. Thus, a significant proportion of corruption crime remains undetected, and the criminal parties are able to benefit from the proceeds of their corruption. The longer it takes to detect a corruption offence, the more difficult it is to uncover evidence. Therefore, it should be ensured that law enforcement and prosecutors have appropriate investigative tools to gather relevant evidence of corruption offences which often affect more than one Member State, including wiretaps and evidence collected by undercover agents. Furthermore, Member States should allocate sufficient training, in close coordination with the European Union Agency for Law Enforcement Training (CEPOL), also on the use investigative tools to successfully carry out proceedings and the identification and quantification of proceeds of corruption in the context of freezing and confiscation. In addition, this Directive facilitates the gathering of information and evidence by setting out mitigating circumstances for offenders that help the authorities.
Amendment 215 #
2023/0135(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 – point b
Article 2 – paragraph 1 – point 3 – point b
(b) any other person assigned and exercising a public service function or providing a public service in Member States or third countries, for an international organisation or for an international court.
Amendment 218 #
2023/0135(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 – point b a (new)
Article 2 – paragraph 1 – point 3 – point b a (new)
(ba) any other individual entrusted with public powers or a public service mission or holding an elected public office,
Amendment 234 #
2023/0135(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 8 a (new)
Article 2 – paragraph 1 – point 8 a (new)
8a. ‘Conflict of interest' shall mean any situation in which situation the impartial and objective exercise of the functions of a public official is compromised for reasons of family, emotional, political or national affinity, economic interest or any other direct or indirect, potential or actual personal interest in conflict with the public interest the official is entrusted to serve.
Amendment 237 #
2023/0135(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 8 b (new)
Article 2 – paragraph 1 – point 8 b (new)
8b. ‘The revolving door’ shall mean the taking-up, receipt or holding, directly or indirectly, by a public official of any interest in an undertaking or transaction for which, at the time of the act, he or she is wholly or partly responsible for the monitoring, administration, liquidation or payment.
Amendment 245 #
2023/0135(COD)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall take measures to ensure the highest degree of transparency and accountability in public administration and public decision-making with a view to prevent corruption. These measures include a system of staff recruitment and promotion or assignment based on transparent and meritocratic procedures.
Amendment 248 #
2023/0135(COD)
Proposal for a directive
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2a. Member States shall take the necessary measures to limit the use of trustee assignments for personnel entrusted with responsibility for oversight or verification of compliance with the law.
Amendment 270 #
2023/0135(COD)
Proposal for a directive
Article 3 – paragraph 4 – point b a (new)
Article 3 – paragraph 4 – point b a (new)
(ba) Effective rules addressing the interaction between the public and private sectors, including the regulation of lobbying and the revolving door. In particular the setting of minimum standards concerning lobbying, including: (i) the concepts of lobbying, lobbyists and public officials subject to the law; (ii) common minimum information to be disclosed regarding lobbyists' meetings with officials; (iii) common minimum requirements to ensure that such information is publicly available.
Amendment 286 #
2023/0135(COD)
Proposal for a directive
Article 3 – paragraph 6 a (new)
Article 3 – paragraph 6 a (new)
6a. Member States shall take the necessary measures to ensure that a specialised body as defined in Article 4 or another competent authority regularly examines public officials' declarations of assets and financial interests and compares these declarations with what they have declared to the tax authorities. If these examinations reveal the existence of assets undeclared by the public official, Member States shall take the appropriate measures to identify their origin.
Amendment 287 #
2023/0135(COD)
Proposal for a directive
Article 3 – paragraph 6 b (new)
Article 3 – paragraph 6 b (new)
6b. Member States shall take the necessary measures to ensure that cash contributions in excess of EUR 500 per year per donor, or other forms of support of equivalent value, made to political parties and movements are made public and include the identity of the donor, the size of the contribution or the value of the benefit or other form of support and the date of payment by means of an entry in a special register maintained at the registered office of the political party or movement, inclusion in financial statements and publication on the official website of the political party or movement.
Amendment 297 #
2023/0135(COD)
Proposal for a directive
Article 4 – paragraph 3 – point a
Article 4 – paragraph 3 – point a
(a) are functionally independent ofrom the government in accordance with the fundamental principles of the legal system of the Member State and have a sufficient number of qualified staff and the financial, technical and technological resources, as well as the powers and tools necessary to ensure the proper administration of their tasks and to implement the provisions necessary to comply with Articles 3 to 6;
Amendment 329 #
2023/0135(COD)
Proposal for a directive
Article 7 – paragraph 1 – point b a (new)
Article 7 – paragraph 1 – point b a (new)
(ba) The fact that a public official takes up, receives or retains, directly or indirectly, an interest in an undertaking or transaction undermining his or her impartiality, independence or objectivity for which, at the time of the event, he or she is wholly or partly responsible for the supervision, administration, liquidation or payment.
Amendment 330 #
2023/0135(COD)
Proposal for a directive
Article 7 – paragraph 1 – point b b (new)
Article 7 – paragraph 1 – point b b (new)
(bb) The fact that a public official, in the course of his or her duties relating either to the supervision and/or control of a private undertaking, or to the conclusion of contracts of any kind with a private undertaking or to the giving of an opinion on such contracts, or to having proposed directly to the competent authority decisions relating to the operations carried out by a private undertaking or to having given an opinion on such decisions, acquired or received an interest by way of employment, advice or capital in one of those undertakings before the expiry of a period of three years from the date on which those duties ceased.
Amendment 384 #
2023/0135(COD)
Proposal for a directive
Article 15 – paragraph 4 – point d
Article 15 – paragraph 4 – point d
(d) deprivation of the right to stand for elections, proportionate to the seriousness of the offence committed; and;
Amendment 395 #
2023/0135(COD)
Proposal for a directive
Article 17 – paragraph 2 – point f
Article 17 – paragraph 2 – point f
(f) the possibility for public authorities to annul or rescind a contractannulment or rescinding of the contract concluded and the assignments conferred with them, in the context of which the offence was committed;
Amendment 425 #
2023/0135(COD)
Proposal for a directive
Article 21 – paragraph 2 a (new)
Article 21 – paragraph 2 a (new)
2a. Member States shall take the necessary measures to ensure that the limitation period referred to in paragraph 1 is suspended from the date of issuance of the conviction concluding the first instance of the proceedings or of the conviction order, until the effective date of the judgment concluding the proceedings or the date on which the sentencing order becomes final.
Amendment 443 #
2023/0135(COD)
Proposal for a directive
Article 23 – paragraph 1
Article 23 – paragraph 1
Member States shall take the necessary measures to ensure that effective investigative tools, such as those used in countering organised crime or other serious crimes, are available to persons, units or services responsible for investigating or prosecuting the criminal offences referred to in this Directive. These tools shall also include the use of wiretapping or electronic devices and the possibility of conducting undercover police operations.
Amendment 465 #
2023/0135(COD)
Proposal for a directive
Article 26 – paragraph 1
Article 26 – paragraph 1
1. Member States shall collect disaggregated statistical data on each of the criminal offences as referred to in Articles 7 to 14 of this Directive.
Amendment 504 #
2023/0135(COD)
Proposal for a directive
Article 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3a. The provisions of this Directive shall not affect the right of Member States to apply or introduce more stringent laws, regulations or administrative provisions with regard to transparency requirements and applicable penalties than those laid down in this Directive.
Amendment 152 #
2023/0132(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3 a) In the interest of public health and for the wellfunctioning EU regulatory framework, the innovative medicinal product should be understood as one that meets a previously unmet or inadequately met, substantive health need and offers enhanced effectiveness or other incremental benefit relative to existing therapeutic alternatives.
Amendment 277 #
2023/0132(COD)
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal relevant product, without this being considered patent or Supplementary Protection Certificate (SPC) infringement. The application of this limited exemption is however fragmented across the Union and ithe objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rel, on day one a reference medicinal product,fter loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ands, obtaining pricing and reimbursement request, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member Stateof the patent or SPC of, for the reference medicinal product, there can be no commercial uslevant product or process, there can be placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 290 #
2023/0132(COD)
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studactivities to support pricing and reimbursementto support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toaforementioned purposes, contributing to the timely market entry medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.
Amendment 301 #
2023/0132(COD)
Proposal for a directive
Recital 65
Recital 65
(65) The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal productAvoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions and a resolution of the European Parliament. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC
Amendment 356 #
2023/0132(COD)
Proposal for a directive
Recital 118
Recital 118
(118) It is therefore appropriate to harmonise the basic principles applicable to the prescription status of medicinal products in the Union or in the Member State concerned, while taking as a starting point the principles already established on this subject by the Council of Europe as well as the work of harmonisation completed within the framework of the United Nations, concerning psychotropic or narcotic substances - the United Nations Single Convention of 1961 on narcotic drugs and Convention on Psychotropic Substances of 1971. Therefore, research on interactions between alcohol, painkillers and psychoactive substances, in particular the high- THC concentration cannabis, should be developed.
Amendment 415 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). A non-routine basis entails a treatment scale that does not exceed the treatment capacity of a hospital. Member States shall ensure that only hospitals are granted hospital exemption approvals. A transition period of 5 years is granted to holders of a hospital exemption (public and private) that exceed preparation on a nonroutine basis to obtain a centralised marketing authorisation. During the transition period, deviations from a non- routine basis guarantee patient access. Member States shall ensure that the scope for use is centred around targeting unmet medical need, in situations when similar treatment is not available and/or affordable.
Amendment 428 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2 a. Member States may allow for cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of unmet medical needs, if preparation on a non-routine basis is maintained. Competent authorities should share with each other information on hospital exemption approvals and the evidence used for such approvals upon request. In case of deviations between national laws, the authorities of the importing country should indicate that these deviations are acceptable. Requirements in Article 2(3-6) should be maintained.
Amendment 455 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data. The Agency shall ensure that an overview of approved advanced therapy medicinal products prepared under hospital exemption is made public.
Amendment 583 #
2023/0132(COD)
Proposal for a directive
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) an antimicrobial stewardshipresistance mitigation plan as referred to in Annex I;
Amendment 591 #
2023/0132(COD)
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
2. The competent authority may impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardshipresistance mitigation plan unsatisfactory.
Amendment 594 #
2023/0132(COD)
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
3. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities described on the prescription. If an antimicrobial can not be dispensed per unit, the marketing authorization holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.
Amendment 745 #
2023/0132(COD)
Proposal for a directive
Article 44 – paragraph 2
Article 44 – paragraph 2
2. The marketing authorisation shall lay down deadlines for the fulfilment of the conditions referred to in paragraph 1, first subparagraph, where necessary.
Amendment 770 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial; orbiotic or systemic antiviral or systemic antifungal;
Amendment 778 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 1 – point e a (new)
Article 51 – paragraph 1 – point e a (new)
(e a) is an antiparasitic; or
Amendment 786 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
Amendment 792 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 2 a (new)
Article 51 – paragraph 2 a (new)
2 a. Wherever possible, Member States shall provide that prescriptions and dispensation shall be aligned with the number of units required for the treatment or therapy concerned.
Amendment 796 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 1 a (new)
Article 56 – paragraph 1 a (new)
1 a. The marketing authorisation holder shall, in good faith, file for pricing and reimbursement in the Member States in which the marketing authorisation is valid within 4 months after the marketing authorisation was granted.The marketing authorisation holder shall be exempt from this obligation provided the competent authority of the Member State grants a product specific waiver. The obligation referred to in the first subparagraph shall exclude medicinal products defined in Article 4.1 (13), Article 10, Article 11, Article 12. Member States representatives may request the Commission to discuss issues related to this obligation in the Committee established by Council Decision 75/320/EEC (“Pharmaceutical Committee"). The Commission might invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.
Amendment 800 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Amendment 804 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 2
Article 56 – paragraph 3 – subparagraph 2
The arrangements for implementing the first subparagraph should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of suc be based on the high level of human health protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.
Amendment 1253 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
Amendment 1265 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities conducted to generate data for an application, forfor the purpose of :
Amendment 1276 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) applying for a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and forand subsequent variations;
Amendment 1285 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 1294 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement. approval;
Amendment 1301 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;
Amendment 1308 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.
Amendment 1321 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) tThe activities conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation andfalling within the first subparagraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 1337 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activitiin a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products manufactured for the aforementioned purposes.
Amendment 1341 #
2023/0132(COD)
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article 85a Ban of patent linkage 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of medicinal products or to determine their inclusion within the scope of public health insurance systems or the public and private procurement of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. 4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.
Amendment 1380 #
2023/0132(COD)
Proposal for a directive
Article 105 – paragraph 2
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or other relevant persons, such as family members, or healthcare professionals.
Amendment 1605 #
2023/0132(COD)
Proposal for a directive
Annex I – point 21 – point a – introductory part
Annex I – point 21 – point a – introductory part
a) an antimicrobial stewardshipresistance mitigation plan which shall in particular outline:
Amendment 1617 #
2023/0132(COD)
Proposal for a directive
Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part
Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part
Amendment 214 #
2023/0131(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) In the interests of public health and with a view to the proper functioning of the EU regulatory framework, an innovative medicinal product should be understood as a medicinal product that satisfies a substantial health need that was previously unsatisfactorily or inadequately met and offers greater efficacy or other incremental benefits than existing therapeutic alternatives.
Amendment 223 #
2023/0131(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) To prevent influence on the development or implementation of pharmaceutical policies or legislation or the decision-making processes of the Agency and the other EU institutions, the Executive Director, the Deputy Executive Director, the members of the Management Board and the members of the Committees may not, for two years after leaving office, hold any office or accept posts or engage in any activity whether remunerated or free of charge, on behalf of any person over whom they have exercised regulatory, negotiating or authorising powers.
Amendment 252 #
2023/0131(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) The simplification of procedures should not have an impact on standards or the quality of scientific evaluation of the medicinal products to guarantee the quality, safety and efficacy of medicinal products. It should also allow for the reduction of the scientific evaluation period from 210 days to 1850 days.
Amendment 260 #
2023/0131(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. The CHMP and PRAC consists of experts from all Member States while working parties consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. What is more, with regard to the scientific assessment and the agreement of the paediatric investigation plans and other issues of paediatric interest not falling under the responsibilities of the PRAC and the CHMP, the expertise and experience of the Paediatric Committee will be retained in a paediatric working group that will provide a contribution to the Agency on paediatric issues. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.
Amendment 299 #
2023/0131(COD)
Proposal for a regulation
Recital 56 a (new)
Recital 56 a (new)
(56a) To prevent delays in treatment and to provide timely access for patients to medicines undergoing clinical trials, the EU body responsible for centralised procurement of medicinal products shall use the framework agreement, as regulated by Directive 2014/24/EU, for the purchase of experimental drugs, as soon as the first phase of Regulation (EU) No 536/2014 has been completed. It is also recommended that the Member States use that institution.
Amendment 335 #
2023/0131(COD)
Proposal for a regulation
Recital 78 a (new)
Recital 78 a (new)
Amendment 337 #
2023/0131(COD)
Proposal for a regulation
Recital 78 b (new)
Recital 78 b (new)
(78b) Member States, the Union, third countries, international organisations and agencies have identified the key areas of priority pharmaceutical research, including novel antibiotics and antivirals, improved diagnostics and treatments for emerging infectious diseases, affordable and efficacious medicinal products in the areas of oncology and neurodegenerative diseases and other areas of unmet medical need for which the development of orphan medicinal products is needed. However, while Member States and the Union offer generous corporate R&D subsidies as well as R&D tax incentives to stimulate pharmaceutical research, there is little evidence to suggest, and no obligation to ensure, that the composition of R&D portfolios of pharmaceutical companies is determined by such direct or indirect subsidies. It is therefore increasingly evident that effective public health policy is undermined by shortcomings in transparency and accountability in public expenditure on health.
Amendment 341 #
2023/0131(COD)
Proposal for a regulation
Recital 78 c (new)
Recital 78 c (new)
(78b) Those market failures highlight the need for a paradigm shift in both the Member States’ and the Union’s approach to generating pharmaceutical R&D in key areas of priority and in public expenditure directed towards health.The establishment at EU of mission-oriented R&D infrastructure which acts in the public interest is a tool to alleviate those market failures.This public law infrastructure must be able to carry out research and development activities concerning novel antimicrobials, and in other sectors where unmet medical needs are common. What is more, with a view to overcoming market failures of that kind, more preliminary purchasing agreements must be concluded and joint procurement must be carried out, with the aim of providing the EU and its Member States with greater flexibility in line with their needs and of ensuring that medicines are available for all EU residents, irrespective of their Member State of origin.
Amendment 345 #
2023/0131(COD)
Proposal for a regulation
Recital 78 d (new)
Recital 78 d (new)
(78d) To prevent overlapping of competences and with a view to better coordination and efficiency of the use of public resources, the Commission must present a proposal, where necessary, to streamline and restore the competences of the European Medicines Agency (EMA), the Health Emergency Preparedness and Response Authority (HERA) and the European Centre for Disease Prevention and Control (ECDC).
Amendment 349 #
2023/0131(COD)
Proposal for a regulation
Recital 79
Recital 79
Amendment 357 #
2023/0131(COD)
Proposal for a regulation
Recital 80
Recital 80
Amendment 363 #
2023/0131(COD)
Proposal for a regulation
Recital 81
Recital 81
Amendment 367 #
2023/0131(COD)
Proposal for a regulation
Recital 82
Recital 82
Amendment 371 #
2023/0131(COD)
Proposal for a regulation
Recital 83
Recital 83
Amendment 376 #
2023/0131(COD)
Proposal for a regulation
Recital 84
Recital 84
Amendment 415 #
2023/0131(COD)
Proposal for a regulation
Recital 102
Recital 102
(102) In order to incentivise investment and innovation, research and development of orphan medicinal products addressing for whigch unmet needs, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; orphan medicinal products addressing high unmet medical needs benefit from the longest market exclusivity, while mno other therapies exist or, where they already exist, would be a significant benefit for the target population, a modulation of market exclusivity has been introduced. This modulation is based on the science and principles that guide research, with incentives based on practical obstacles, unique attributes and the development needs of new therapies that address patients' needs; the Regulation provides for four main archetypes of incentives, each addressing unique needs and knowledge gaps in research. Market exclusivity for well- established use orphan medicinal products, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.
Amendment 429 #
2023/0131(COD)
Proposal for a regulation
Recital 104
Recital 104
(104) To reward research into and development of new therapeutic indications, an additional period of one year of market exclusivity is provided for a new therapeutic indication (with a maximum of twoUndertaking research and clinical trials for a rare disease is a complex and time-consuming activity, mainly because of the small patient population and the lack of knowledge typical of many rare diseases without authorised treatment. Knowledge and experience acquired with clinical trials in an indication is not immediately transferable to a new indication, but may provide important guidance. Therefore, research into new therapeutic indications should be rewarded. Industry must be provided with sufficient incentives to continue exploring new indications and to ensure that patients benefit from incremental innovation and to support new technologies to move to other indications).;
Amendment 434 #
2023/0131(COD)
Proposal for a regulation
Recital 106
Recital 106
(106) Before a medicinal product for human use is placed on the market in one or more Member States, it has to have undergone extensive studies, including non-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population. It is importanterative that such studies are undertaken also on the paediatric population in order to ensure that medicinal products are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric population. It is also important that medicinal products are presented in dosages and formulations adequate for the use in children.
Amendment 436 #
2023/0131(COD)
Proposal for a regulation
Recital 112
Recital 112
(112) With a view to ensuring that research is conducted only when safe and ethical and that the requirement for study data in the paediatric population does not block or delay the authorisation of medicinal products for other populations, the Agency may defer the initiation or completion of some or all of the measures contained in a paediatric investigation plan for a limited period of time. Such deferral should be extended only in duly justified casesThe length of the deferral shall be specified in a decision of the Agency and shall ensure that the PIP is completed no more than two years after the marketing authorisation for other populations is granted.
Amendment 451 #
2023/0131(COD)
Proposal for a regulation
Recital 133
Recital 133
(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especially in the context of non-pharmacological therapies, digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products, including where medical devices or in vitro diagnostics are used as combined products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.
Amendment 513 #
2023/0131(COD)
Proposal for a regulation
Recital 155
Recital 155
(155) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the rights of the child, respect for private and family life, the protection of personal data and the freedom of art and science. To this end, specific actions will be established to reduce the gap between paediatric medicinal products, including speeding up the development and marketing of paediatric medicinal products, providing funds for paediatric research and setting which paediatric medicinal products are a priority with a view to covering unmet needs.
Amendment 515 #
2023/0131(COD)
Proposal for a regulation
Recital 156
Recital 156
(156) The objective of this Regulation is to ensure the authorisation of high quality medicinal products, including for paediatric patients and patients suffering from rare diseases throughout the Union. Where this objective cannot be sufficiently achieved by the Member States, such as in the case of the development of paediatric medicinal products, but can rather, by reason of its scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Amendment 537 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 9 a (new)
Article 2 – paragraph 2 – point 9 a (new)
(9a) 'Paediatric population' means the proportion of the population aged between infancy and 18.
Amendment 538 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 9 b (new)
Article 2 – paragraph 2 – point 9 b (new)
(9b) 'Paediatric investigation plan' means a research and development programme designed to ensure that the requisite data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population;
Amendment 539 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 9 c (new)
Article 2 – paragraph 2 – point 9 c (new)
(9c) 'Medicinal product authorised for a paediatric indication' means a medicinal product authorised for use in all or part of the paediatric population and for which the details of the indication authorised are specified in the summary of product characteristics drawn up in accordance with Article 4 of the [revised directive];
Amendment 611 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 1
Article 6 – paragraph 6 – subparagraph 1
The Agency shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 1850 days after receipt of a valid application. In the case of a medicinal product for human use containing or consisting of genetically modified organisms, the opinion of that Committee shall take into account the evaluation of the environmental risk assessment in accordance with Article 8.
Amendment 618 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 1520 days.
Amendment 619 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 7 a (new)
Article 6 – paragraph 7 a (new)
7a. An application for a marketing authorisation submitted pursuant to this Regulation for a medicinal product for human use that has not been granted a paediatric derogation shall be considered valid only if it includes the results of all paediatric studies performed and other information collected in accordance with an agreed paediatric investigation plan, as laid down in Article 6 of the revised [Directive 2001/83/EC];
Amendment 719 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.
Amendment 745 #
2023/0131(COD)
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
(fa) a decision based on commercial grounds, without prejudice to any commercially-confidential information.
Amendment 753 #
2023/0131(COD)
Proposal for a regulation
Article 24 – paragraph 4
Article 24 – paragraph 4
4. Where the marketing authorisation holder intends to permanently withdraw the marketing authorisation for a critical medicinal product, the marketing authorisation holder shall, prior to the notification referred to in paragraph 1, offer, on fair and reasonable terms, to transfer the marketing authorisation to a third party that has declared its intention to place that critical medicinal product on the market, or to use the pharmaceutical non-clinical and clinical documentation contained in the file of the medicinal product for the purposes of submitting an application in accordance with Article 14 of [revised Directive 2001/83/EC]. A marketing authorisation holder to whom a marketing authorisation is transferred shall notify the Agency of the transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall publish that information.
Amendment 821 #
2023/0131(COD)
Proposal for a regulation
Chapter III – title
Chapter III – title
III ADDRESSING PHARMACEUTICAL MARKET FAILURES IN THE UNION AND GREATER INCENTIVES FOR THE RESEARCH AND DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’
Amendment 824 #
2023/0131(COD)
Proposal for a regulation
Article 40
Article 40
Amendment 882 #
2023/0131(COD)
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Amendment 892 #
2023/0131(COD)
Proposal for a regulation
Article 40 b (new)
Article 40 b (new)
Article 40b Additional measures to incentivise the creation of antimicrobials 1. The Commission shall furthermore establish a Union push and pull incentive scheme to promote and accelerate the development of novel antimicrobials, as well as to promote increased access to existing and newly developed antimicrobials. Member States shall be encouraged to participate in the Union- level scheme. 2. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the scheme and its funding and shall, at the least, include the development of the following incentives in such delegated acts: a) research grants under Union funds with conditionalities linked to the affordability and supply of new and existing antimicrobials; b) milestone prizes for novel antimicrobial developers with conditionalities linked to the affordability and supply of new and existing antimicrobials;
Amendment 899 #
2023/0131(COD)
Proposal for a regulation
Article 41
Article 41
Amendment 926 #
2023/0131(COD)
Proposal for a regulation
Article 42
Article 42
Amendment 940 #
2023/0131(COD)
Proposal for a regulation
Article 43
Article 43
Amendment 982 #
2023/0131(COD)
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
Where the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, including under Article 20, the Agency shall inform the Commission accordingly.
Amendment 1015 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Agency may offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil one of the following conditions:
Amendment 1102 #
2023/0131(COD)
Proposal for a regulation
Article 68 – paragraph 1 – introductory part
Article 68 – paragraph 1 – introductory part
1. The orphan medicine sponsor maywill, prior to the submission of an application for marketing authorisation, request advice from the Agency on the following:
Amendment 1107 #
2023/0131(COD)
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and not-for-profit entities provided for in framework programmes for research and technological development.
Amendment 1119 #
2023/0131(COD)
Proposal for a regulation
Article 70
Article 70
Amendment 1156 #
2023/0131(COD)
(a) nintwelve years for orphan medicinal products other than those referred to in points (b) and (c)for whose indication the Union has not approved a satisfactory treatment method;
Amendment 1178 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) ten years for orphan medicinal products addressing a high unmetif: 1. the Union has authorised fewer than three (3) orphan medicinal products for the indication in question, or; 2. notwithstanding any authorisations for medicinal products for the condition in question, no orphan medicinal need as referred to in Article 70product has received EU authorisation for part of the target population or subsets thereof as regards the therapeutic indication of the new medicinal product, or; 3. the Union has authorised an orphan medicinal product for use according to its indication, but that orphan medicinal product either has a new mechanism of application or is a new technology;
Amendment 1208 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point c a (new)
Article 71 – paragraph 2 – point c a (new)
(ca) eight years for orphan medicinal products that are not referred to in points (a), (b) or (c);
Amendment 1244 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 1236 months for orphan medicinal products referred to in Article 71(2), points (a),(b) and (bc a), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or morea new therapeutic indications for a different orphan condition.
Amendment 1252 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2
Article 72 – paragraph 2 – subparagraph 2
Amendment 1260 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2 a (new)
Article 72 – paragraph 2 – subparagraph 2 a (new)
When the orphan marketing authorisation holder obtains any further marketing authorisations for one or more therapeutic indications relative to different orphan conditions for the same orphan medicinal product, these specific therapeutic indications shall be protected by a separate market exclusivity of three years from the expiry of the market exclusivity for the entire product pursuant to Article 71, where appropriate in accordance with Article 71(1) and (2).
Amendment 1304 #
2023/0131(COD)
Proposal for a regulation
Article 77 – paragraph 1
Article 77 – paragraph 1
1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1)., which is valid in accordance with the provisions of Article 76(2), the Agency shall, after receiving the opinion of its paediatric working party, adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.
Amendment 1310 #
2023/0131(COD)
Proposal for a regulation
Article 77 – paragraph 3 – subparagraph 1
Article 77 – paragraph 3 – subparagraph 1
After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall, after receiving the input of the paediatric working party, review it within 30 days.
Amendment 1314 #
2023/0131(COD)
Proposal for a regulation
Article 78 – paragraph 2 – subparagraph 1
Article 78 – paragraph 2 – subparagraph 1
Following the receipt of a valid application in accordance with the provisions of Article 76(2), the Agency shall, after receiving the input of its paediatric working party, within 90 days adopt a decision as to whether or not a product- specific waiver shall be granted.
Amendment 1315 #
2023/0131(COD)
3. When appropriate, the Agency may, either of its own motion or acting upon the recommendations of the paediatric working party, adopt decisions, on the basis of the grounds set out in Article 75(1), to the effect that a class or a product-specific waiver, as referred to in Article 75(2), should be granted.
Amendment 1316 #
2023/0131(COD)
Proposal for a regulation
Article 78 – paragraph 7
Article 78 – paragraph 7
7. In consultation with the Commission and with interested parties, the Agency and its paediatric working party shall draw up and publish guidelines for the practical application of this Article.
Amendment 1320 #
2023/0131(COD)
Proposal for a regulation
Article 81 – paragraph 3
Article 81 – paragraph 3
3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years and should ensure that the PIP is completed no more than two years after the marketing authorisation for other populations is granted.
Amendment 1334 #
2023/0131(COD)
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 3
Article 84 – paragraph 2 – subparagraph 3
Within 30 days, and after receiving the opinion of its paediatric working party, the Agency shall review these changes and adopt a decision on their refusal or acceptance.
Amendment 1338 #
2023/0131(COD)
Proposal for a regulation
Article 86 – paragraph 1 a (new)
Article 86 – paragraph 1 a (new)
The paediatric experts who are taking part in the CHMP's working parties shall contribute to the conformity assessment.
Amendment 1339 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 1
Article 87 – paragraph 1
1. Decisions referred to in Articles 77, 78, 80, 81, 82 and 84 adopted by the Agency shall be supported by scientific conclusions, which should incorporate the opinion expressed by the paediatric working party and which shall be annexed to the decision.
Amendment 1340 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2
Article 87 – paragraph 2
2. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or and other appropriate working parties when preparing the above mentioned scientific conclusions. The outcome of such consultations shall be annexed to the decision.
Amendment 1358 #
2023/0131(COD)
Proposal for a regulation
Article 91 – paragraph 3
Article 91 – paragraph 3
3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, including the accurate dosage, and may vary the marketing authorisation accordingly.
Amendment 1365 #
2023/0131(COD)
Proposal for a regulation
Article 96 – paragraph 1
Article 96 – paragraph 1
Paediatric medicinal products shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, paediatric medicinal products. These incentives will be granted by means of specific calls for research proposals encompassing the product's entire development phase, from discovery to post-marketing, as outlined in the annual paediatric research plans, which are part of the EU's research programmes concerning health and health products.
Amendment 1380 #
2023/0131(COD)
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point j
Article 104 – paragraph 1 – subparagraph 1 – point j
(j) conclusions of assessments, recommendations, opinions, approvals, obligations deriving from the conditional marketing authorisation and decisions taken by the coordination group, the competent authorities of the Member States and the Commission in the framework of the procedures set out in Articles 16, 106, 107 and 108 of this Regulation and of Chapter IX, Sections 3 and 7 of [revised Directive 2001/83/EC].
Amendment 1398 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 1 – point a
Article 113 – paragraph 1 – point a
(a) it is not possible to develop the medicinal product, even if medical devices or in-vitro diagnostic are used as combined products, or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;
Amendment 1483 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder and of the public authorities no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1520 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned mayshall set a deadline for the submission of the information requested.
Amendment 1539 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish on a publicly available website information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available websitcluding the known reasons for them, where appropriate in accordance with points (a) to (fa) of the second subparagraph of Article 24(1), in cases in which that competent authority has assessed the shortage and provided recommendations to health-care professionals and patients, including on the alternatives available;
Amendment 1600 #
2023/0131(COD)
Proposal for a regulation
Article 123 – paragraph 4
Article 123 – paragraph 4
4. The MSSG mayshall provide recommendations on measures to resolve or to mitigate the critical shortage, as well as on alternatives available, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.
Amendment 1623 #
2023/0131(COD)
Proposal for a regulation
Article 125 – paragraph 1 – point c
Article 125 – paragraph 1 – point c
(c) take into accountcomply with the recommendations referred to in Article 123(4);
Amendment 1626 #
2023/0131(COD)
Proposal for a regulation
Article 125 – paragraph 1 – point f
Article 125 – paragraph 1 – point f
(f) inform the Agency of the causes and the end date of the critical shortage.
Amendment 1643 #
2023/0131(COD)
Proposal for a regulation
Article 128 – paragraph 2 a (new)
Article 128 – paragraph 2 a (new)
2a. The marketing authorisation referred to in Article 116(1) shall also entail the obligation to establish and maintain minimum safety stocks of critical medicinal products set out in Article 131.The minimum safety stocks of critical medicinal products shall be sufficient to cover demand for them for a period of two months in the Member States in which the medicinal product is marketed. The marketing authorisation holder may apply to the relevant authority for an exemption from maintaining minimum safety stocks on the following grounds: (a) the manufacturing process or shelf life of the critical medicinal product is incompatible with the duration of the minimum safety stock; (b) other valid reasons agreed with the relevant authority.
Amendment 1662 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;
Amendment 1666 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 2
Article 130 – paragraph 1 – subparagraph 2
The Agency shall publish the information referred to in points (b), (c) andda(a) to (d) on a dedicated webpage on its web-portal.
Amendment 1695 #
2023/0131(COD)
Proposal for a regulation
Article 133 – paragraph 1 – point c
Article 133 – paragraph 1 – point c
(c) take into accountcomply with the recommendations referred to in Article 132(1);
Amendment 18 #
2023/0081(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The higher energy prices after the unjustified and unlawful military aggression by the Russian Federation against Ukraine, gave a strong impetus to accelerate the implementation of the European Green Deal and reinforce the resilience of the Energy Union by speeding up the clean energy transition and ending any dependence on fossil fuels exported from the Russian Federationird countries. The REPowerEU plan35 plays a key role in responding to the hardships and global energy market disruption caused by the invasion of Ukraine by the Russian Federation. That plan aims to accelerate the energy transition in the European Union, in order to increase the use of renewable energy and to reduce the Union’s gas and electricity consumption and to boost investments in the deployment of energy efficient and low carbon neutral solutions. That plan sets inter alia the targets to double solar photovoltaic capacity by 2025 and to install 600 GW of solar photovoltaic capacity by 2030; to double the rate of deployment of heat pumps; to produce 10 million tonnes of domestic renewable hydrogen and e-fuels, from power-to-gas (P2G) to power-to-liquid (P2L), by 2030; to double the rate of deployment of heat pumps; to produce 10 million tonnes of domestic renewable hydrogen by 2030; and to substantially increase production of biomethane. The plan also sets out that achieving the REPowerEU goals will require diversifying the supply of low carbon energy equipment and of critical raw materials, reducing sectoral dependencies, overcoming supply chain bottlenecks and expanding the Union’s clean energy technology manufacturing capacity. As part of its efforts to increase the share of renewable energy in power generation, industry, buildings and transport, the Commission proposes to increase the target in the Renewable Energy Directive to 45% by 2030 and to increase the target in the Energy Efficiency Directive to 13%. This would bring the total renewable energy generation capacities to 1236 GW by 2030, in comparison to 1067 GW by 2030 envisaged under the 2021 proposal and will see increased needs for storage through batteries to deal with intermittency in the electricity grid. Similarly, policies related to the decarbonisation of the road sector, such as Regulation (EU) 2019/631 and Regulation (EU) 2019/1242 will be strong drivers for a further electrification of the road transport sector and thus increasing demand for batteries. _________________ 35 Communication of 18 May 2022 from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, REPowerEU Plan, COM/2022/230 final, 18.05.2022.
Amendment 118 #
2023/0081(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) In addition, the Communication on the Green Deal Industrial Plan for the Net- Zero Age42 sets out a comprehensive approach to support a clean energy technology scale up based on four pillars. The first pillar aims at creating a regulatory environment that simplifies and fast-tracks permitting for new net-zero technology manufacturing and assembly sites and facilitates the scaling up of the net-zero industry of the Union. The second pillar of the plan is to boost investment in and financing of net-zero technology production, through the revised Temporary Crisis and Transition Framework adopted in March 2023 and the creation of a European Sovereignty fund to preserve the European edge on critical and emerging technologies relevant to the green and digital transitions. The third pillar relates to developing the skills needed to make the transition happen and increase the number of skilled workers in the clean energy technology sector. The fourth pillar focuses on trade and the diversification of the supply chain of critical raw materials. That includes engaging in partnerships with other countries, international organizations, or industry associations to develop joint strategies, share information, and coordinate efforts to enhance supply chain resilience, creating a critical raw materials club, working with like-minded partners to collectively strengthen and map supply chains and, implementing traceability systems and transparency, diversifying away from single suppliers for critical input, encouraging investment in downstream activities, and engaging in market research. _________________ 42 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions: A Green Deal Industrial Plan for the Net-Zero Age, COM/2023/62 final, 01.02.2023.
Amendment 218 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘net-zero technologies’ means renewable energy technologies66 ; electricity and heat storage technologies; heat pumps; grid technologies; renewable fuels of non-biological origin technologies; sustainable alternative fuels technologies67 ; electrolysers and fuel cells; advanced technologies to produce energy from nuclear processes with minimal waste from the fuel cycle, small modular reactors, and related best-in-class fuels; carbon capture, utilisation, and storage technologies; and energy- system related energy efficiency technologies. They refer to the final products, specific components and specific machinery primarily used for the production of those products. They shall have reached a technology readiness level of at least 8. _________________ 66 ‘renewable energy' means ‘renewable energy’ as defined in Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources 67 ‘sustainable alternative fuels’ means fuels covered by the Proposal for a Regulation of the European Parliament and of the Council on ensuring a level playing field for sustainable air transport, COM/2021/561 final and by the Proposal for a Regulation of the European Parliament and Council on the use of renewable and low-carbon fuels in maritime transport COM/2021/562 final.
Amendment 250 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
(i) ‘net-zero regulatory sandbox’ means a scheme that enables undertakings to test innovative net-zero technologies, excluding nuclear fusion, in a controlled real-world environment, under a specific plan, developed and monitored by a competent authority.
Amendment 285 #
2023/0081(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) business support services, including but not limited to corporate tax declaration, local tax laws, labour law with a particular focus on SMEs.
Amendment 332 #
2023/0081(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The national competent authority shall ensure that the authorities concerned issue a reasoned conclusion as referred to in Article 1(2), point (g)(iv) of Directive 2011/92/EU on the environmental impact assessment within threewo months of receiving all necessary information gathered pursuant to Articles 5, 6 and 7 of that Directive and completing the consultations referred to in Articles 6 and 7 of that Directive.
Amendment 345 #
2023/0081(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. The timeframes for consulting the public concerned on the environmental report referred to in Article 5(1) of Directive 2011/92/EU shall not be longer than 4530 days. In cases falling under the second sub-paragraph of Article 6(4), this period shall be extended to 960 days.
Amendment 367 #
2023/0081(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. When preparing plans, including zoning, spatial plans and land use plans, national, regional and local authorities shall, where appropriate, include in those plans provisions for the development of net-zero technology manufacturing projects, including net-zero strategic projects and all the necessary infrastructure. Priority shall be given to artificial and built surfaces, industrial sites, brownfield sites, and, where appropriate, greenfield sites not usable for agriculture and forestry, only by integrating sustainable design, energy efficiency, renewable energy, and responsible resource management practices.
Amendment 376 #
2023/0081(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Where plans include provisions for the development of net-zero technology manufacturing projects, including net-zero strategic projects, are subject to an assessment pursuant to Directive 2001/42/EC and pursuant to Article 6 of Directive 92/43/EEC, those assessments shall be combined. Where relevant, that combined assessment shall also address the impact on potentially affected water bodies and verify whether the plan potentially prevent a water body from achieving good status or good potential or cause deterioration of status or of potential referred to in Article 4 of Directive 2000/60/EC or would potentially hamper that a water body achieves good status or good potential. Where relevant Member States are required to assess the impacts of existing and future activities on the marine environment, including land-sea interactions, as referred to in Article 4 of Directive 2014/89/EU, these impacts shall also be covered by the combined assessment. Where relevant, Member States are required to assess the impacts of potential air emissions from the project, including pollutants such as particulate matter, nitrogen oxides, sulphur oxides, and volatile organic compounds as referred to Directives 2016/2284/EC and 2010/81/EC.
Amendment 389 #
2023/0081(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. All decisions adopted pursuant to this Section and Articles 5, 12 and 13 shall be made publicly available.
Amendment 408 #
2023/0081(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b – point iii
Article 10 – paragraph 1 – point b – point iii
(iii) it puts into place measures to attract, upskill or reskill a workforce required for net-zero technologies, including through apprenticeships, in close cooperation with social partners;by ensuring equal opportunities for individuals from different backgrounds, including gender, race, ethnicity, and socioeconomic status, in close cooperation with social partners; it also puts into place measures to prioritize the health and safety of the workforce by implementing appropriate measures to mitigate workplace hazards and ensure compliance with occupational health and safety regulations.
Amendment 416 #
2023/0081(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b – point iv a (new)
Article 10 – paragraph 1 – point b – point iv a (new)
(iva) it encourages sustainable practices throughout its supply chain including collaborating with suppliers and ensuring similar environmental standards and best practices. It may also include criteria such as responsible sourcing of raw materials and the use of sustainable transportation methods.
Amendment 453 #
2023/0081(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. Without prejudice to obligations provided for in Union law, Member States shall grant net-zero strategic projects the status of the highest national significance possible, where such a status exists in national law, and be treated accordingly in the permit-granting processes including those relating to environmental assessments and if national law so provides, to spatial planning.
Amendment 464 #
2023/0081(COD)
Proposal for a regulation
Article 12 – paragraph 4 a (new)
Article 12 – paragraph 4 a (new)
4a. Net-zero strategic projects shall be considered to contribute to the Union’s 2030 target of reducing net greenhouse gas emissions by at least 55 % relative to 1990 levels and the Union’s 2050 climate neutrality target, as defined by Regulation (EU) 2021/1119, and therefore net-zero strategic projects that produce environmental effects during the construction phase of the project, but reduce emissions when the net-zero strategic projects are in operation, shall be considered to have fulfilled all requirements in Articles 6(4) and 16(1) of Directive 92/43/EEC, Article 4(7) of Directive 2000/60/EC and Article 9(1)(a) of Directive 2009/147/EC) and competent authorities shall not include these temporary construction emissions in the permit granting decision.
Amendment 496 #
2023/0081(COD)
Proposal for a regulation
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
2. The Commission and Member States may provide administrative support to net-zero strategic projects to facilitate their rapid and effective implementation, including by providing:
Amendment 508 #
2023/0081(COD)
Proposal for a regulation
Article 16
Article 16
Amendment 523 #
2023/0081(COD)
Proposal for a regulation
Article 17
Article 17
Amendment 561 #
Amendment 630 #
2023/0081(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point d a (new)
Article 19 – paragraph 2 – point d a (new)
(da) The tender’s sustainability and resilience contribution shall not be used by contracting authorities or contracting entities to favour national providers over providers originating from other EU Member States.
Amendment 683 #
2023/0081(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. The Platform shall be composed Member States, representatives of the European Parliament and of the Commission. It shall be chaired by a representative of the Commission.
Amendment 685 #
2023/0081(COD)
Proposal for a regulation
Article 29 – paragraph 6
Article 29 – paragraph 6
6. The Platform may establish standing or temporary sub-groups dealing with specific questions and tasks including the relevant social partners as well as practitioners from the affected industries.
Amendment 688 #
2023/0081(COD)
Proposal for a regulation
Article 29 – paragraph 8
Article 29 – paragraph 8
8. Where appropriate, the Platform or the Commission may invite experts and other third parties from Net-Zero Industrial Partnerships countries to Platform and sub- group meetings or to provide written contributions.
Amendment 749 #
2023/0081(COD)
Proposal for a regulation
Annex – row 7
Annex – row 7
Amendment 7 #
2023/0079(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) Access to raw materials is essential for the Union economy and the functioning of the internal market. There is a set of non-energy, non-agricultural raw materials that, due to their high economic importance and their exposure to high supply risk, often caused by a high concentration of supply from a few third countries, are considered critical. Given the key role of many such critical raw materials in realising the green and digital transitions, and in light of their use for defence and space applications, demand will increase exponentially in the coming years and decades. At the same time, the risk of supply disruptions is increasing against the background of rising geopolitical tensions and resource competition. Furthermore, if not managed properly, increased demand for critical raw materials could lead to negative environmental, economic and social impacts. Considering these trends, it is necessary to take measures to ensure access to a secure and sustainable supply of critical raw materials to safeguard the Union's economic resilience and open strategic autonomy.
Amendment 16 #
2023/0079(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Firstly, in order to effectively ensure the Union's access to a secure and sustainable supply of critical raw materials, that framework should include measures to decrease the Union's growing supply risks by strengthening Union capacities along all stages of the strategic raw materials value chain, including extraction, refining, processing and recycling, towards benchmarks defined for each strategic raw material. Secondly, as the Union will continue to rely on imports, the framework should include measures to increase the diversification of external supplies of strategic raw materials. Thirdly, is necessary to provide measures to reinforce the Union’s ability to monitor and mitigate existing and future supply risks. Fourthly, the framework should contain measures to increase the circularity and sustainability of the critical raw materials consumed in the Union, including reinforcing research and development of alternative materials and technical solutions as well as extraction, refinement, production and recycling processes.
Amendment 36 #
2023/0079(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) To strengthen Union capacities along the strategic raw materials value chain, benchmarks should be set to guide efforts and track progress. The aim should be to increase capacities for each strategic raw material at each stage of the value chain, while aiming to achieve overall capacity benchmarks for extraction, processing and recycling of strategic raw materials. Firstly, the Union should increase the use of its own geological resources of strategic raw materials and build up capacity to allow it to extract the materials needed to produce at least 10 % of the Union's consumption of strategic raw materials. Keeping in mind that extraction capacity is highly dependent on the availability of Union geological resources, the achievement of this benchmark is dependent on such availability. Secondly, in order to build a full value chain and prevent any bottlenecks at intermediate stages, the Union should in addition increase its processing capacity along the value chain and be able to produce at least 40 % of its annual consumption of strategic raw materials. Thirdly, it is expected that in the coming decades a growing share of the Union's consumption of strategic raw materials can be covered by secondary raw materials, which would improve both the security and the sustainability of the Union’s raw materials supply. Therefore, Union recycling capacity should be able to produce at least 10% for each strategic raw material as well as 25 % of the Union’s annual aggregated consumption of strategic raw materials. These benchmarks refer to the 2030 time horizon, in alignment with the Union's climate and energy targets set under Regulation (EU) 2021/1119 of the European Parliament and of the Council29and the digital targets under the Digital Decade30, which they underpin. Furthermore, quality jobs, including skills development and job-to- job transitions, will address risks in the sectoral labour market and help ensure the EU’s competitiveness. _________________ 29 Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (OJ L 243, 9.7.2021, p. 1). 30 Decision (EU) 2022/2481 of the European Parliament and of the Council of 14 December 2022 establishing the Digital Decade Policy Programme 2030 (OJL 323, 19.12.2022, p. 4–26 )
Amendment 100 #
2023/0079(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) The volatile prices of several strategic raw materials, exacerbated by limited means to hedge them on forward markets, create an obstacle both for project promoters to secure financing for strategic raw material projects as well as for downstream consumers looking to secure stable and predictable prices for key inputs. In an effort to reduce uncertainty over future prices for strategic raw materials, it is necessary to provide for the setting up of a system that enables both interested off- takers and promoters of Strategic Projects, including SMEs, to indicate their buying or selling bids and to bring them in contact if the respective bids are potentially compatible.
Amendment 141 #
2023/0079(COD)
Proposal for a regulation
Recital 55
Recital 55
(55) In order to support the implementation of tasks pertaining to the development of Strategic Projects and their financing, exploration programmes, monitoring capacities or strategic stocks and to advise the Commission appropriately, a European Critical Raw Materials Board should be established. The Board should be composed of Member States and of the Commission, while being able to ensure participation of other parties as observers. To develop the necessary expertise for the implementation of certain tasks, the Board should establish standing sub-groups on financing, exploration, monitoring and strategic stocks, that should act as a network by gathering the different relevant national authorities, economic operators and, when necessary, consult industry, including SMEs, academia, civil society and other relevant stakeholders. TAlthough non-binding, the Board’s advice and opinions should be non-binding andtaken into due consideration and prioritised by the Commission. However, the absence of such an advice or opinion should not prevent the Commission from performing its tasks under this Regulation.
Amendment 149 #
2023/0079(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a – introductory part
Article 1 – paragraph 2 – point a – introductory part
(a) strengthen the different stages of the strategic raw materials value chain with a view to ensure that, by 2030, and in the following decades, Union capacities for each strategic raw material have significantly increased so that, overall, Union capacity approaches or reaches the following benchmarks:
Amendment 152 #
2023/0079(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a – point i
Article 1 – paragraph 2 – point a – point i
(i) Union extractionrecycling capacity, is able to extract the ores, minerals or concentrates neededncluding for all intermediate recycling steps, is able to produce at least 10% of the Union's annual consumption of each strategic raw materials, to the extent that the Union’s reserves allow for this; as well as 25% of the Union's aggregated consumption of strategic raw materials.
Amendment 169 #
2023/0079(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) diversify the Union's imports of strategic raw materials with a view to ensure that, by 2030, the Union's annual consumption of each strategic raw material at any relevant stage of processing can rely on imports from several third countries, none of which provide more than 650% of the Union's annual consumption;
Amendment 185 #
2023/0079(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 4 a (new)
Article 2 – paragraph 1 – point 4 a (new)
Amendment 186 #
2023/0079(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
(6) ‘extraction’ means the primary or secondary extraction of ores, minerals and plant products from their original source, including from a mineral occurrence underground, mineral occurrence under water, sea brine and trees;
Amendment 204 #
2023/0079(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a a (new)
Article 5 – paragraph 1 – point a a (new)
(aa) it contributes to the supply of strategic technologies through the substitution of any of the strategic raw materials outlined in Annex I, Section I within the value chains in order to optmize processes to minimize waste generation, energy consumption, and water usage;
Amendment 216 #
2023/0079(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point c a (new)
Article 5 – paragraph 1 – point c a (new)
(ca) the projects should outline sustainability performance and measure key metrics, such as greenhouse gas emissions, water usage, waste generation, and social impacts;
Amendment 225 #
2023/0079(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
(e) for projects in third countries that are emerging markets or developing economies, the project would be mutually beneficial for the Union and the third country concerned by adding value in that country, reaching the benchmark established in Article 1(2)(b), and should be coherent with the Regulation (EU) 2017/821 (Conflict Minerals Regulation).
Amendment 237 #
2023/0079(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point d
Article 6 – paragraph 1 – point d
(d) a plan containing measures to facilitate public acceptance including, where appropriate, the establishment of recurrent communication channels with the local communities, research institutions and organisations, including social partners, the implementation of awareness- raising and information campaigns about sustainable practices, environmental conservation, and social responsibility and the establishment of mitigation and compensation mechanisms;
Amendment 241 #
2023/0079(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point d a (new)
Article 6 – paragraph 1 – point d a (new)
(da) Information on sustainability performance and key metrics, such as greenhouse gas emissions, water usage, waste generation, and social impacts;
Amendment 270 #
2023/0079(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. By [OP please insert: 3 months after the date of entry into force of this Regulation], Member States shall designate one national competent authority which shall be responsible for facilitating and coordinating the permit-granting process for critical raw material projects, the environmental assessment and provide information on the elements referred to in Article 17.
Amendment 276 #
2023/0079(COD)
Proposal for a regulation
Article 8 – paragraph 7
Article 8 – paragraph 7
7. Member States shall ensure that the national competent authority referred to in paragraph 1 has a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary, including for up- and re-skilling, for the effective performance of its tasks under this Regulation. Where a Member State lacks sufficient resources to comply with this provision, the Commission shall offer technical and financial support.
Amendment 323 #
2023/0079(COD)
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 3
Article 11 – paragraph 2 – subparagraph 3
Under the joint procedure referred to in the first subparagraph, the national competent authority referred to in Article 8(1) shall provide for a single assessment of the environmental impact of a particular project required by the relevant Union legislation. underlying among others aspects of the Strategic project the raw material extraction methods, transportation, processing and waste management.
Amendment 333 #
2023/0079(COD)
Proposal for a regulation
Article 11 – paragraph 3 a (new)
Article 11 – paragraph 3 a (new)
3a. The national competent authority should consider whether the strategic projects adhere to recognized certification schemes or standards related to responsible mining or extraction according to international certifications such as the Initiative for Responsible Mining Assurance (IRMA) or the Responsible Minerals Initiative (RMI).
Amendment 349 #
2023/0079(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Member States shall ensure that national, regional and local authorities responsible for preparing plans, including zoning, spatial plans and land use plans, include in such plans, where appropriate, provisions for the development of critical raw materials projects. Priority shall be given to artificial and built surfaces, industrial sites, brownfield sites, and, where appropriate, greenfield sites not usable for agriculture and forestry and including vulnerable ecosystems.
Amendment 356 #
2023/0079(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. Where plans including provisions for the development of critical raw material projects are subject to an assessment pursuant to Directive 2001/42/EC and pursuant to Article 6 of Directive 92/43/EEC, those assessments shall be combined. Where relevant, this combined assessment shall also address the impact, including the cumulative effects, on potentially affected water bodies and verify whether the plan would cause deterioration of the status or of the potential referred to in Article 4 of Directive 2000/60/EC or would potentially hamper that a water body achieves good status or good potential. Where relevant Member States are required to mitigate poluution risks and assess the impacts of existing and future activities on the marine environment, including land-sea interactions, as referred to in Article 4 of Directive 2014/89/EU, these impacts shall also be covered by the combined assessment.
Amendment 359 #
2023/0079(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. The provisions set out in this Regulation are without prejudice to the obligations under Articles 6 and 7 of the United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters, signed atin Aarhus on 25 June 1998, and under the UNECE Convention on environmental impact assessment in a transboundary context, signed at Espoo on 25 February 1991. The provisions set out in this Regulation are without prejudice to the obligations set out in the Convention on Biological Diversity (CBD) and on the United Nations Convention to Combat Desertification (UNCCD);
Amendment 407 #
2023/0079(COD)
Proposal for a regulation
Article 20 – paragraph 2 – introductory part
Article 20 – paragraph 2 – introductory part
2. Member States, after consulting relevant stakeholders and SMEs representatives, shall identify key market operators along the critical raw materials value chain established in their territory and shall:
Amendment 419 #
2023/0079(COD)
Proposal for a regulation
Article 24 – paragraph 2 – point b
Article 24 – paragraph 2 – point b
(b) set minimum amounts of demanded material without prejudice to the ability of small market actors to participate in the system, taking into account the aggregate needs of SMEs, the expected number of interested participants and the need to ensure a manageable amount of participants.
Amendment 458 #
2023/0079(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point d a (new)
Article 25 – paragraph 1 – point d a (new)
(da) explore innovative recycling techniques to recover critical raw materials from electronic waste, industrial residues, or end-of-life products.
Amendment 459 #
2023/0079(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point d b (new)
Article 25 – paragraph 1 – point d b (new)
(db) promote traceability and certification schemes that ensure the responsible treatment of waste containing critical raw materials and adhere to best practices and environmental standards.
Amendment 460 #
2023/0079(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point e
Article 25 – paragraph 1 – point e
(e) ensure that their workforce is equipped with the skills needed and trained to support circularity of the critical raw materials value chain, with a focus on reusability, repairability, and recyclability and separation of valuable materials from waste materials.
Amendment 463 #
2023/0079(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point e a (new)
Article 25 – paragraph 1 – point e a (new)
(ea) Pay special attention to ensuring the proper management of hazardous waste containing critical raw materials that follow national and international regulations for handling, storage, transportation, and disposal of hazardous waste. Implement appropriate treatment methods, such as encapsulation, neutralization, or secure landfilling, to mitigate environmental and health risks associated with hazardous waste.
Amendment 511 #
2023/0079(COD)
Proposal for a regulation
Article 25 – paragraph 7 – subparagraph 2 – point d
Article 25 – paragraph 7 – subparagraph 2 – point d
(d) particular challenges affecting their collection, separation and waste treatment;
Amendment 692 #
2023/0079(COD)
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Each Member State shall appoint a high-level representative to the Board and the European Parliament shall appoint its representatives to the Board. Where relevant as regards the function and expertise, a Member State may appoint different representatives in relation to different tasks of the Board. Each member of the Board shall have an alternate.
Amendment 703 #
2023/0079(COD)
Proposal for a regulation
Article 35 – paragraph 6 – subparagraph 2 – point d a (new)
Article 35 – paragraph 6 – subparagraph 2 – point d a (new)
(da) a subgroup bringing together industry representatives from the strategic sectors involved, with particular attention to the representatives of national SMEs.
Amendment 716 #
2023/0079(COD)
Proposal for a regulation
Article 45 – paragraph 1
Article 45 – paragraph 1
By 12 months after entry into force of the Regulation, Member States shall lay down common rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented equally. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.
Amendment 718 #
2023/0079(COD)
Proposal for a regulation
Annex I – Section 1 – paragraph 1 – point p a (new)
Annex I – Section 1 – paragraph 1 – point p a (new)
(pa) Aluminum
Amendment 86 #
2023/0042(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Against that background, new strengthened CO2 emission reduction targets should be set for new heavy-duty vehicles for the period 2030 onwards. Those t, and all new heavy-duty vehicles put on the Union margkets should be set at a level that as of 2040 should be zero- emission. Ambitious targets will deliver a strong signal to accelerate the uptake of zero-emission vehicles on the Union market and to, stimulate innovation in zero- emission technologies in a cost- efficient way, ensure European companies maintain a leading position on the global market, and contribute to reduce the running costs for transport companies, while ensuring the Union fulfil its climate and air pollution objectives.
Amendment 114 #
2023/0042(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Due to the heterogeneous structure of the total truck fleet, it is not possible to fully predict whether for all niche uses, technological developments will be quick enough to ensure thasome room should be given in the short ztero-emission tailpipe technology is a viable choice. This may include uses such as long-haul heavy- duty vehicles in specific territorial morphology and meteorological circumstances, coaches and lorrim to account for particular niche uses. This may include uses such as vehicles for critical security and safety applications that cannot be fulfilled by zero-emission tailpipe technologies. The vehicles in question should constitute a limited share of the entire heavy-duty vehicle fleet. In view of such considerations, some margin in the 2040 target should be left to accommodate developments in technology yet to occurThe 2028 review clause should assess the possibility of applying CO2 targets also for niche uses and uncertified vehicles.
Amendment 121 #
2023/0042(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) With the stricter Union fleet-wide targets from 2030 onwards, manufacturers will have to deploy significantly more zero-emission vehicles on the Union market. In that context, the incentive mechanism for zero- and low-emission vehicles (‘ZLEV’) would no longer serve its original purpose and would risk undermining the effectiveness of Regulation (EU) 2019/1242. The ZLEVat incentive mechanism should therefore be amended with a view to only incentivise zero-emission vehicles as of 2025, to be aligned with current market developments, and to have it fully removed as of 2030.
Amendment 129 #
2023/0042(COD)
Proposal for a regulation
Recital 21 – paragraph 4
Recital 21 – paragraph 4
As for certain vehicle groups, which are type-approved, CO2 emissions are not determined yet for technical reasons, these vehicles do not have to meet the CO2 targets set by this Regulation. These are for example special purpose vehicles, such as mobile cranes, carriers of hydraulic multi- equipment or exceptional load transport vehicles, off-road vehicles, such as certain vehicles used for mining, forestry and agricultural purposes, as well as other vehicles with non-standard axle configurations such as vehicles with more than 4 axles or more than 2 driven axles, and small buses with a maximum mass lower than 7,5 t, and small lorries with a maximum mass lower than 5t.
Amendment 131 #
2023/0042(COD)
Proposal for a regulation
Recital 21 – paragraph 5
Recital 21 – paragraph 5
Amendment 146 #
2023/0042(COD)
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) CO2 emissions from vocational vehicles, such as garbage, tippers or concrete mixers, are already certified under VECTO, monitored and reported by vehicle manufacturers and Member States, and several zero-emission vocational vehicles are already commercially available in Europe. CO2 emissions from vocational vehicles represent around 5% of heavy-duty vehicles emissions and around 10% of sales. As they mostly operates in cities, vocational vehicles also significantly impact urban air quality. Most of those vehicles run on low mileage and with predictable routes, and are being stored overnight in depots, thereby making it easier for operators to run zero-emission vehicles. CO2 emissions reduction targets should therefore also apply to those vehicles.
Amendment 150 #
2023/0042(COD)
Proposal for a regulation
Recital 25 b (new)
Recital 25 b (new)
(25b) CO2 emissions from small lorries with a maximum mass lower than 5t and medium lorries with a maximum mass lower than 7,4t which cannot yet be determined under VECTO, but their CO2 emissions are being determined under Regulation (EU) 2018/858 and their registrations reported by Member States to the Commission. Zero-emission technologies for vehicles under that segment are already mature and cost- efficient. That segment includes many urban delivery trucks supplying stores, such as supermarkets in cities, so their decarbonisation will contribute to the improvement of urban air quality. Smaller lorries should therefore also be subject to the same CO2 targets, and be attributed to the respective sub-groups according to their mission profile, mileage and payload.
Amendment 164 #
2023/0042(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The zero- and low-emission factor should last be applied for the reporting period of the year 2029, because it is no longer considered necessary after that time as an incentive to promote the market entrance of zero-emission vehicles.
Amendment 176 #
2023/0042(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) The existing system of multi-annual emission credits and emission debts should be extended to 2039 as reduction targets keep strengthening beyond 2030 until 2040 and require forward-looking technical developments of manufacturers during that period. Nevertheless, manufacturers should clear all remaining emission debts in the years 2029, 2034 and 2039, and emission credits that are not used within five years after they have been acquired should automatically expire, so as to avoid locking-in a low ambition.
Amendment 208 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point g
Article 1 – paragraph 1 – point 3 – point g
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 11 – point a
Article 3 – paragraph 1 – point 11 – point a
(a) a heavy-duty motor vehicle with not more out an internal combustion engine, or with an 5 g/(t∙km) or 5 g/(p∙km) of CO2 emissionsinternal combustion engine that emits less than 1gCO2/(t.km) or 1gCO2/(p.km) as determined in accordance with Article 9 of Regulation (EU) 2017/2400;
Amendment 212 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point g
Article 1 – paragraph 1 – point 3 – point g
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 11 – point b
Article 3 – paragraph 1 – point 11 – point b
(b) a heavy-duty motor vehicle fulfilling the conditions of point 1.1.4 of Annex I to this Regulationwithout a combustion engine or with a combustion engine emitting not more than 1 gCO2/(t.km) or 1 gCO2/(p.km) as determined in accordance with Regulation (EC) No 715/2007 of the European Parliament and of the Council, if no CO2 emissions have been determined according to Regulation (EU) 2017/2400;
Amendment 215 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point g
Article 1 – paragraph 1 – point 3 – point g
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 11 – point b a (new)
Article 3 – paragraph 1 – point 11 – point b a (new)
(ba) a heavy-duty motor vehicle of category N2 with a maximum mass lower than 7, 4t without an internal combustion engine, or with an internal combustion engine that emits less than 1gCO2/(t.km) as determined in accordance with Regulation (EU) 2018/858 if no CO2 emissions have been determined;
Amendment 254 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – introductory part
Article 3a – paragraph 1 – introductory part
1. The average CO2 emissions of the Union fleet of new heavy-duty motor vehicles, other than special purpose, off- road, and off-road special purpose, and vocational vehicles shall be reduced by the following percentages compared to the average CO2 emissions of the reporting period of the year 2019:
Amendment 265 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – point b
Article 3a – paragraph 1 – point b
(b) for all vehicle sub-groups for the reporting periods of the years 2030 to 2034 by 450 %,
Amendment 268 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – point b
Article 3a – paragraph 1 – point b
(b) for all vehicle sub-groups for the reporting periods of the years 2030 to 2034 by 450 %,
Amendment 279 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3 a – paragraph 1 – point c
Article 3 a – paragraph 1 – point c
(c) for all vehicle sub-groups for the reporting periods of the years 2035 to 2039 by 6590 %,
Amendment 287 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
(c) for all vehicle sub-groups for the reporting periods of the years 2035 to 2039 by 65 90%,
Amendment 292 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – point d
Article 3a – paragraph 1 – point d
(d) for all vehicle sub-groups for the reporting periods of the years 2040 onwards by 9100%.
Amendment 312 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 2
Article 3a – paragraph 2
2. To these CO2 emission targets, the vehicle sub-groups have to contribute as laid down in point 4.3. of Annex I, taking into account the attribution of non- certified vehicles as laid down in Table 1.1.1a of Annex I.
Amendment 334 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3b – paragraph 2
Article 3b – paragraph 2
Amendment 385 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6 – point b
Article 1 – paragraph 1 – point 6 – point b
3. For the reporting periods from 2025 to 2029 the zero- and low-emission factor shall only take into account the number and the CO2 emissions of all zero- emission heavy-duty vehicles of category N in the manufacturer's fleet, and shall be determined on the basis of a 215 % benchmark in accordance with point 2.3.2 of Annex I.;
Amendment 407 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point b a (new)
Article 1 – paragraph 1 – point 9 – point b a (new)
Regulation (EU) 2019/1242
Article 7 – paragraph 1 – subparagraph 2
Article 7 – paragraph 1 – subparagraph 2
(ba) in paragraph 1, the second subparagraph is replaced by the following: (ba) in paragraph 1, the second subparagraph is replaced by the following: ‘Emission[DY1] credits shall be acquired in the reporting periods of the years 2019 to 2039, and shall be taken into account only for the purpose of determining the manufacturer’s compliance with the specific CO2 emissions target of any of the five years following the year during which they have been acquired. However, where the emission credits have been acquired in the reporting periods of the years 2019 to 2024, they shall be taken into account only for the purpose of determining the manufacturer’s compliance with the specific CO2 emissions target of the reporting period of the year 2025.’; [DY1]Limiting lifetime of credits to 5 years to avoid being locked into low ambition;
Amendment 418 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point a
Article 1 – paragraph 1 – point 11 – point a
Regulation (EU) 2019/1242
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
Amendment 420 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point b
Article 1 – paragraph 1 – point 11 – point b
Regulation (EU) 2019/1242
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
Amendment 6 #
2022/2194(INL)
Motion for a resolution
Recital B
Recital B
B. Whereas it was estimated that the setting up of a legislative tool at Union level to address cross-border obstacles, combined with existing tools, could bring about economic benefits of 123 billion euros, while removing all obstacles would bring up benefits up to 460 billion euros; whereas internal border regions cover 40 % of the EU’s territory, account for 30 % of its population (i.e. 150 million people) and are home to almost 2 million cross-border workers; whereas the removal of cross-border obstacles would as well bring about a positive impact on social rights, equal opportunities, and an improved access to high-quality public services for citizens living and working in border regions20, and particularly cross- border workers; _________________ 20 European Parliamentary Research Service (2023). “Mechanism to resolve legal and administrative obstacles in a cross-border context”. European added value assessment, p.48.
Amendment 42 #
2022/2194(INL)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses that regional and local authorities, and the educational, health and safety authorities, as well as NGOs operating on the ground, should be involved in a meaningful and inclusive way in the formulation of measures aimed at removing cross-border obstacles;
Amendment 128 #
2022/2194(INL)
Motion for a resolution
Article 8 – point 2 – point b
Article 8 – point 2 – point b
(b) one or more local or regional authorities, including the educational, health and safety authorities, in a given cross-border region;
Amendment 310 #
2022/0396(COD)
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) In order to ensure the balanced participation of all stakeholders, the Commission should set up an ad hoc forum made up of Member State representatives and the other parties involved, such as industry (including SMEs and craft enterprises), trade unions, traders, retailers, importers, environmental protection groups and the consumer organisation. The Commission should consult this forum to give it a say in preparing detailed design-for-recycling criteria for each packaging category.
Amendment 426 #
2022/0396(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) In order to safeguard the functioning of the internal market, it is necessary to ensure that packaging from third countries entering the Union market comply with this Regulation, whether imported as self-standing packaging or in a packaged product. In particular, it is necessary to ensure that appropriate conformity assessment procedures have been carried out by manufacturers with regard to that packaging. Importers should therefore ensure that the packaging they place on the market comply with those requirements and that documentation drawn up by manufacturers are available for inspection by the competent national authorities. To enable them to meet these obligations, non-professional importers, in particular micro and small enterprises, should be given adequate support.
Amendment 568 #
2022/0396(COD)
Proposal for a regulation
Recital 137
Recital 137
(137) It is necessary to provide for sufficient time for economic operators to comply with their obligations under this Regulation, and for Member States to set up the administrative infrastructure necessary for its application. The application of this Regulation should therefore also be deferred to a date where those preparations can reasonably be finalised. Particular attention should be paid to facilitate compliance by SMEs with their obligations and requirements under this Regulation, including through guidance to be provided by the Commission to facilitate compliance by economic operators, with a focus on SMEmicro- , small and medium-sized enterprises and the sectors that will be heavily impacted by the new obligations.
Amendment 1085 #
2022/0396(COD)
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Article 6a Packaging and packaging waste forum The Commission shall ensure that, when drawing up the delegated and/or implementing acts, it upholds a balanced participation of Member State representatives and all stakeholders, such as industry (including SMEs and craft enterprises), trade unions, traders, retailers, importers, environmental protection groups and consumer organisations. These parties shall, in particular, help to establish design for recycling criteria for the various types of packaging and recycling output criteria based on the criteria and parameters listed in Table 2 of Annex II for the packaging categories listed in Table 1 of that annex. To that end, the Commission shall establish a working group, known as the 'Packaging and packaging waste forum', that brings these parties together.
Amendment 1504 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
From [OP: Please insert the date = 42 months after the entry into force of this Regulation], packaging shall be marked with a label and/or a QR code or other type of digital label containing information on its material composition. This obligation does not apply to transport packaging. However, it applies to e- commerce packaging.
Amendment 1545 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 1
Article 11 – paragraph 4 – subparagraph 1
Labels referred to in paragraphs 1 to 3 and/or the QR code or other type of digital data carrier referred to in paragraph 2s 1 to 3 shall be placed, printed or engraved visibly, clearly legibly and indelibly on the packaging. Where this is not possible or not warranted on account of the nature and size of the packaging, they shall be affixed to the grouped packaging.
Amendment 1553 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 2 a (new)
Article 11 – paragraph 4 – subparagraph 2 a (new)
Where the information referred to in paragraphs 1 to 3 can be communicated digitally via the packaging or a label affixed thereto, the following requirements shall apply: (a) user data must not be collected or traced; (b) the information must not be displayed alongside other sales or marketing information.
Amendment 1628 #
2022/0396(COD)
Proposal for a regulation
Article 16 – paragraph 2 a (new)
Article 16 – paragraph 2 a (new)
2a. In order to meet the obligations laid down in this article, Member States shall provide tools to support non- professional importers, in particular importing micro and small enterprises.
Amendment 1735 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Member States mayshall exempt economic operators from point 3 of Annex V if they comply with the definition of micro-company in accordance with rules set out in the Commission Recommendation 2003/361, as applicable on [OP: Please insert the date = the date of entry into force of this Regulation], or else agricultural holdings carrying out direct sales activities at farmers' markets recognised by national or regional law, and where it is not technically feasible not to use packaging or to obtain access to infrastructure that is necessary for the functioning of a reuse system.
Amendment 1739 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 3 a (new)
Article 22 – paragraph 3 a (new)
3a. 3.Economic operators shall be exempt from the application of point 3 of Annex V if: a) by 2030, they are able to demonstrate a collection and recycling rate for these packaging formats of at least 85% by weight, on the basis of the predominant packaging material;or b) they qualify as a micro or small enterprise in accordance with the rules laid down in Commission Recommendation 2003/361, as applicable on [OP: please insert the date = the date of entry into force of this regulation].
Amendment 1798 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 1 a (new)
Article 26 – paragraph 1 a (new)
1a. Economic operators shall be exempt from the requirement in paragraph 1a, provided that, by 2030, the packaging material listed in Annex II: (a) reaches a minimum recycling rate of 90% at EU level, as calculated in Article 47;and (b) is recycled at scale within the meaning of Article 6(6).
Amendment 1809 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 2 – introductory part
Article 26 – paragraph 2 – introductory part
2. The final distributor, with the exception of the economic operators referred to in Article 22(3), making available on the market within the territory of a Member State in sales packaging cold or hot beverages filled into a container at the point of sale for take-away shall ensure that:
Amendment 1839 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 3 – introductory part
Article 26 – paragraph 3 – introductory part
3. A final distributor, with the exception of the economic operators referred to in Article 22(3), that is conducting its business activity in the HORECA sector and that is making available on the market within the territory of a Member State in sales packaging take- away ready-prepared food, intended for immediate consumption without the need of any further preparation, and typically consumed from the receptacle, shall ensure that:
Amendment 1978 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 8 a (new)
Article 26 – paragraph 8 a (new)
8a. Economic operators shall be exempt from the requirement in paragraph 8, provided that, by 2030, the packaging material listed in Annex II: (a) reaches a minimum recycling rate of 90% at EU level, as calculated in Article 47;and (b) is recycled at scale within the meaning of Article 6(6).
Amendment 2045 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 12 – subparagraph 2
Article 26 – paragraph 12 – subparagraph 2
This obligation applies to pallets, boxes, excluding cardboard, trays, plastic crates, intermediate bulk containers, drums and canisters, of all sizes and materials (excluding paper and cardboard), including flexible formats.
Amendment 2072 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 13 – subparagraph 2
Article 26 – paragraph 13 – subparagraph 2
This obligation applies to pallets, boxes, excluding cardboardtrays, plastic crates, intermediate bulk containers, and drums and canisters, of all sizes and materials (excluding paper and cardboard), including flexible formats.
Amendment 2093 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 13 a (new)
Article 26 – paragraph 13 a (new)
13a. Packaging needed to increase the shelf life of products, and therefore to combat food waste, protect the environment and ensure the efficient use of raw materials, shall be excluded from the scope of this article.
Amendment 183 #
2022/0365(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
2a. It is necessary to ensure that this regulation does not restrict individual mobility and that private vehicles are generally available for purchase by the public. It is also necessary to provide support for manufacturers in the transition to vehicles without internal combustion engines in order to ensure their competitiveness and to protect jobs in this sector. In addition, there is a need to avoid the risk of possible increases in the price of vehicles covered by this regulation driving purchasers towards the second-hand market, thereby effectively undermining the expected emission reduction benefits.
Amendment 243 #
2022/0365(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Non-exhaust emissions consist of particles emitted by tyres and brakes of vehicles. Emissions from tyres is estimated to be the largest source of microplastics to the environment. As shown in the Impact Assessment, it is expected that by 2050, non-exhaust emissions will constitute up to 90 % of all particles emitted by road transport, because exhaust particles will diminish due to vehicle electrification. Those non-exhaust emissions should therefore be measured and limited, in line with the Zero Pollution Action Plan, which provides for a 30 % reduction in micro-plastic emissions by 2030. The Commission should prepare a report on tyre abrasion by the end of 2024 to review the measurement methods and state-of-the- art in order to propose tyre abrasion limits and supplement the requirements outlined in Regulation (EU) 2019/2144 with specific requirements on tyre abrasion and the permitted limits.
Amendment 256 #
2022/0365(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Vehicles with traction batteries, including plugin hybrids and battery electric vehicles, contribute to the decarbonisation of the road transport sector. In order to gain and increase consumer trust in such vehicles, they should be performant and durable. It is therefore important to require that traction batteries retain a good part of their initial capacity after many years of use. That is of particular importance to buyers of second hand electric vehicles to ensure that the vehicle will continue to perform as expected. Monitors of the battery state-of- health should therefore be required for all vehicles that use traction batteries. In addition, minimum performance requirements for battery durability of passenger cars and light commercial vehicles should be introduced, taking into account the UN Global Technical Regulation 2247 . _________________ 47 United Nations Global Technical Regulation on In-vehicle Battery Durability for Electrified Vehicles, UN GTR 22
Amendment 262 #
2022/0365(COD)
(15) Tampering of vehicles to remove or deactivate parts of the pollution control systems is a well-known problem. Such practice leads to uncontrolled emissions and should be prevented. Tampering of the odometer, leads to false mileage and hampers the proper in-service control of a vehicle. It is therefore of the utmost importance to guarantee the highest possible security protection of those systems, complete with security certificates and appropriate anti-tampering protection to ensure that neither pollution control systems nor the vehicle odometer can be tampered with. Provision should also be made for an effective system of penalties for car manufacturers that devise and/or make use of control, diagnostic and monitoring systems that falsify readings, thereby appearing to bring them into line with such legislation. The proceeds thereof should be set aside and earmarked for households living in transport poverty.
Amendment 282 #
2022/0365(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Manufacturers may opt to produce vehicles and replacement parts which comply with lower emission limits or with better battery durability than what is required in this Regulation, or which include advanced options including geofencing and adaptive controls. Consumers and national authorities should be able to identify such vehicles and replacement parts through appropriate documentation. An eEnvironmental vehicle passport (EVP)s should therefore be made available for vehicles (EVP, environmental vehicle passport) and for tyres, consisting of labels certifying that they are in within the permitted tyre abrasion limits.
Amendment 333 #
2022/0365(COD)
1. This Regulation establishes common technical requirements and administrative provisions for the emission type-approval and market surveillance of motor vehicles, systems, replacement parts, components and separate technical units, with regard to their CO2 and pollutant emissions, fuel and energy consumption and battery durability.
Amendment 345 #
2022/0365(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
This Regulation applies to motor vehicles of categories M1, M2, M3, N1, N2 and N3, as well as trailers of O3 and O4 categories as specified in Article 4 of Regulation (EU) No 2018/858, including those designed and constructed in one or more stages, and to systems, replacement parts, components and separate technical units intended for such vehicles. This Regulation also applies to tyres of categories C1, C2 and C3, as specified in UN Regulations 30 and 54.
Amendment 480 #
2022/0365(COD)
Proposal for a regulation
Article 4 – title
Article 4 – title
Article4 Obligations of the manufacturers concerning construction of vehicles, systems, replacement parts, components and separate technical units
Amendment 485 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Manufacturers shall ensure that the new vehicles they manufacture, which are sold, registered or put into service in the Union, are type approved in accordance with this Regulation. Manufacturers shall ensure that the new components or separate technical units, including engines, traction batteries, brake systems, tyres and replacement pollution control systems requiring type- approval which they manufacture and which are sold or put into service in the Union are type approved in accordance with this Regulation.
Amendment 511 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Manufacturers shall design and construct components or separate technical units, including engines, traction batteries, tyres, brake systems and replacement pollution control systems to comply with this Regulation, including complying with the emission limits set out in Annex I.
Amendment 789 #
2022/0365(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. With effect from 1 July 2025, the sale or installation of a system, component or separate technical unit intended to be fitted on an M1, N1 vehicle approved under this Regulation, shall be prohibited if the system, component, tyres and separate technical unit isare not of type approved in compliance with this Regulation.
Amendment 801 #
2022/0365(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. With effect from 1 July 2027, the sale or installation of a system, component or separate technical unit intended to be fitted on an M2, M3, N2, N3 vehicle approved under this Regulation, shall be prohibited if the system, component, tyres and separate technical unit isare not type approved in compliance with this Regulation.
Amendment 809 #
2022/0365(COD)
Proposal for a regulation
Article 11 – paragraph 3 a (new)
Article 11 – paragraph 3 a (new)
3a. The national authorities shall introduce penalties for manufacturers that design, produce and assemble vehicles fitted with defeat devices or mechanisms and for the deliberate falsification of readings to bring them into line with the parameters specified under such legislation. Penalties will also be introduced for manipulating and tampering with control, diagnostics and monitoring systems so as to alter their readings and bring them into line with such legislation. The proceeds thereof shall be set aside and earmarked for households living in transport poverty.
Amendment 815 #
2022/0365(COD)
Proposal for a regulation
Article 12 – paragraph 1 a (new)
Article 12 – paragraph 1 a (new)
1a. Non-compliance or tampering shall incur significant financial penalties of at least 50 % of the list price per vehicle.
Amendment 847 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 3 – point h
Article 14 – paragraph 3 – point h
(h) tyre types in respect to tyre abrasion, no later than 31 December 2024;
Amendment 886 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point h
Article 14 – paragraph 4 – subparagraph 1 – point h
(h) the methods to measure tyre abrasion in order to monitor tyre abrasion rates, no later than 31 December 2024;
Amendment 959 #
2022/0365(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point b
Article 15 – paragraph 2 – point b
(b) setting out abrasion limits for tyre types in Annex I referring to the work performed in the UN World Forum for Harmonisation of Vehicle Regulations (WP29) or to the limits proposed by the Commission in the event that an international agreement is not reached;
Amendment 2398 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 4 a (new)
Article 25 – paragraph 4 a (new)
4a. Member States shall introduce measures to promote participation in programmes of that kind, in particular by microenterprises and small and medium- sized enterprises (SMEs)