Activities of Erik POULSEN
Reports (1)
REPORT on non-communicable diseases (NCDs)
Shadow reports (5)
REPORT on the proposal for a directive of the European Parliament and of the Council amending Directive 2013/36/EU as regards supervisory powers, sanctions, third-country branches, and environmental, social and governance risks, and amending Directive 2014/59/EU
REPORT on the proposal for a directive of the European Parliament and of the Council amending Directive 2014/59/EU and Regulation (EU) No 806/2014 as regards certain aspects of the minimum requirement for own funds and eligible liabilities
REPORT on the proposal for a directive of the European Parliament and of the Council amending Directives 2009/65/EU, 2013/36/EU and (EU) 2019/2034 as regards the treatment of concentration risk towards central counterparties and the counterparty risk on centrally cleared derivative transactions
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) No 648/2012, (EU) No 575/2013 and (EU) 2017/1131 as regards measures to mitigate excessive exposures to third-country central counterparties and improve the efficiency of Union clearing markets
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) No 1092/2010, (EU) No 1093/2010, (EU) No 1094/2010, (EU) No 1095/2010 and (EU) 2021/523 as regards certain reporting requirements in the fields of financial services and investment support
Shadow opinions (2)
OPINION on the proposal for a directive of the European Parliament and of the Council on Corporate Sustainability Due Diligence and amending Directive (EU) 2019/1937
OPINION on the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Europe's net-zero technology products manufacturing ecosystem (Net Zero Industry Act)
Oral questions (1)
Ukrainian women fleeing the war lack access to abortion
Written explanations (9)
An EU strategy to boost industrial competitiveness, trade and quality jobs (B9-0085/2023, B9-0086/2023, B9-0087/2023, B9-0088/2023, B9-0089/2023, B9-0090/2023, B9-0091/2023, B9-0104/2023, B9-0105/2023, RC-B9-0107/2023, B9-0107/2023, B9-0108/2023, B9-0110/2023, B9-0111/2023, B9-0115/2023)
I Venstre anerkender vi, at der er behov for at kigge på målrettede ændringer for statsstøtte i lyset af den øgede grønne konkurrence fra USA og Kina. Derfor har vi også stemt for EP’s fælles beslutning om en EU-industristrategi, der skal styrke Europas konkurrenceevne. Det er helt centralt for os, at disse tilpasninger er midlertidige, målrettes grønne teknologier og finansieres via omprioritering af eksisterende fonde og budgetter. Ligeledes skal vi være meget påpasselige med, at tilpasningerne ikke medfører et statsstøtteræs internt mellem medlemsstaterne eller med USA og Kina. Derfor er det afgørende, at lempelser i statsstøttereglerne kun adresserer strategisk vigtige værdikæder eller klare markedsfejl. De balancer skal være på plads i en endelig aftale. Derfor er det heller ikke alle dele af EP’s beslutning, vi kan støtte. For eksempel er vi imod henvisninger til behovet for nye midler til finansiering af suverænitetsfonden, at der skal udarbejdes suverænitetstest i alle konsekvensanalyser relateret til EU-lovgivning og fonde, og generelt de henvisninger, der trækker i en protektionistisk retning. På trods af dette anerkender vi vigtigheden af, at vi fra EU’s side responderer proportionalt på den øgede grønne konkurrence fra USA og Kina, hvorfor vi stemte for den fælles beslutning.
Energy performance of buildings (recast) (A9-0033/2023 - Ciarán Cuffe)
Venstre i Europa-Parlamentet bakker op om et ambitiøst bygningsdirektiv og for en hurtig vedtagelse af Parlamentets holdning, så trilogforhandlingerne kan igangsættes. Det er vigtigt, at der sættes nye ambitiøse standarder for renoveringen af EU's bygninger, som står for 40 % af EU's energiforbrug og for 38 % af EU's CO2-udledninger. Vi har valgt at bakke op om Parlamentets samlede kompromis, da det både afspejler et højt ambitionsniveau og samtidig giver fleksibilitet til de enkelte medlemslande i implementeringen. Vi forventer desuden, at den endelige lovtekst tager højde for medlemsstaternes forskellige bygningsmasser.
Strengthening the application of the principle of equal pay for equal work or work of equal value between men and women (A9-0056/2022 - Kira Marie Peter-Hansen, Samira Rafaela)
Venstre ønsker at støtte tiltag, som skaber bedre muligheder for ligeløn og lønåbenhed i Danmark og EU. Samtidig ønsker vi at passe på vores danske model, hvor både arbejdstagers og -givers rettigheder kommer til orde. Det er derfor en helt afgørende del, at lovteksten giver mulighed for dette. Det er vigtigt, at vi sikrer, at løndannelsen stadig er decentraliseret og uden statslig indblanding. Med denne betænkning kan vi skabe bedre incitament for at forbedre forholdene, når det kommer til kønsbestemte lønforskelle, og samtidig sikre, at virksomhederne stadig har de bedste vilkår i forhold til løndannelseVi valgte oprindeligt at stemme imod, at teksten skulle gå direkte fra udvalg til trilogforhandlinger, men grundet de store forbedringer i teksten, særligt i forhold til hensynet til nationale modeller og fokusset på medlemsstaternes implementering, støtter Venstre betænkningen.
Social Climate Fund (A9-0157/2022 - David Casa, Esther de Lange)
Venstre støtter i høj grad op om Fit for 55-pakken og dens mange lovforslag, der skal sikre, at medlemslandene nedbringer deres udledninger af drivhusgasser med 55 % i 2030. Venstre støtter især op om udvidelsen af kvotehandelssystemet, hvorved vi sætter en markedsbaseret pris på virksomheders aftryk på klimaet. Venstre kan dog ikke støtte op om forslaget om Den Sociale Klimafond, da vi ikke går ind for en overførselsindkomst på EU-niveau. Den Sociale Klimafond skal blandt andet gå til direkte overførselsindkomster, som i Venstres øjne ikke hjælper med den grønne omstilling, men derimod fastholder borgere i nogle EU-lande i en tilværelse afhængig af fossile brændstoffer, som er stik modsat formålet med udvidelsen af kvotehandelssystemet. Derfor stemte Venstre imod Den Sociale Klimafond.
Deforestation Regulation (A9-0219/2022 - Christophe Hansen)
Venstre går grundlæggende ind for at forhindre unødvendig afskovning. Særligt i skrøbelige områder som regnskove.Derfor støtter Venstre fælles EU-regler for afskovningsfri importer. Det er dog afgørende, at disse regler ikke bliver for byrdefulde og bureaukratiske. Det er vi en smule bekymret for med denne lovgivningstekst. Derfor er vi meget opmærksomme på implementeringen af reglerne.
Corporate Sustainability Due Diligence (A9-0184/2023 - Lara Wolters)
Venstre støtter op om et harmoniseret sæt regler for due diligence, som sikrer, at virksomheder ikke risikerer fragmenterede regler i hvert medlemsland. Det bidrager til et endnu stærkere indre marked, samtidig med at vi sikrer ensartede regler for, hvordan virksomheder tager højde for deres aftryk i deres værdikæde.Forslaget og Europa-Parlamentets kompromistekst om virksomheders due diligence i forbindelse med bæredygtighed indeholdt mange elementer, som Venstre ikke støtter op om. At kræve due diligence på tværs af en virksomheds værdikæde vil pålægge virksomheder for mange byrder, og derfor stemte Venstre for de ændringsforslag, som ændrede "værdikæde" til "forsyningskæde".Ligeledes forsøgte Parlamentets tekst også at indføre nye bestemmelser om selskabsledelse samt offentlig indgriben i aflønning af virksomheders ledelse. Dette er noget, som Venstre har kæmpet imod siden forslaget blev fremlagt, og Venstre stemte ligeledes for alle ændringsforslag, som forsøgte at udvande eller fjerne disse bestemmelser.Venstre stemte for den endelige tekst, velvidende at et enstemmigt Ministerråd har fjernet de problematiske elementer om selskabsledelse. Parlamentets relativt svage mandat taget i betragtning er vi derfor overbeviste om, at trilogforhandlingerne formår at fjerne disse bestemmelser.
Interim report on the proposal for a mid-term revision of the Multiannual Financial Framework 2021-2027 (A9-0273/2023 - Jan Olbrycht, Margarida Marques)
I takt med at EU næsten hver dag får nye opgaver, er Venstre åben over for debatten om EU’s budget skal stige, og Venstre er ligeledes åben overfor at hæve EU’s budget, set i lyset af de mange udfordringer vi står overfor som f.eks. Ruslands invasion af Ukraine, optagelse af nye medlemslande og den grønne omstilling.Som følge af Kommissionens forslag til at udvide den flerårige finansielle ramme med 100 milliarder euro har Parlamentet foreslået at øge denne med 10 milliarder euro til en samlet sum af 110 milliarder euro. Disse 10 ekstra milliarder foreslås at blive brugt på budgetlinjer, hvor der allerede er ubrugte midler. Derudover skulle 3 af de 10 milliarder euro blandt andet gå til industripolitiske formål, hvilket Venstre ikke ser er en legitim årsag til at hæve EU’s budget.Venstre i Parlamentet er ikke modstander af at øge budgettet, så det modsvarer EU’s nye opgaver. Der skal dog være en balance. Hvorfor at Venstre valgte at stemme blankt til betænkningen.
Situation in Nagorno-Karabakh after Azerbaijan’s attack and the continuing threats against Armenia (B9-0405/2023, RC-B9-0393/2023, B9-0393/2023, B9-0397/2023, B9-0399/2023, B9-0400/2023, B9-0402/2023, B9-0404/2023)
I Venstre fordømmer vi, at Aserbajdsjan har foretaget et planlagt uberettiget militært angreb på Nagorno-Karabakh, som har medført betydelige tab af menneskeliv og har tvunget over 100.000 armeniere fra Nagorno-Karabakh på flugt. Vi støtter både Armenien og Aserbajdsjans suverænitet og territoriale integritet. I lyset af den eskalerede konflikt støtter vi, at EU’s afhængighed af gaseksport fra Aserbajdsjan skal reduceres, samt at vi, såfremt Aserbajdsjan udfører militær aggression mod Armeniens territoriale integritet, søger at suspendere al import af olie og gas fra Aserbajdsjan. Vi forholder os neutralt til, hvorvidt det på nuværende tidspunkt er nødvendigt at suspendere det eksisterende aftalememorandum om strategisk partnerskab på energiområdet mellem EU og Aserbajdsjan. Udviser Aserbajdsjan yderligere aggression mod Armensk territorie, kan dette revurderes.
Instant payments in euro (A9-0230/2023 - Michiel Hoogeveen)
Venstre støtter op om et betalingssystem i EU som muliggør straksbetalinger. Desværre pålægger den endelige tekst også, at banker i ikke-eurolande skal udbyde disse, selvom efterspørgslen på denne service er lav. De ekstra udgifter for banker i ikke-eurolande, som straksbetalinger medfører, står ikke mål med fordelene ved denne service. Derfor stemte Venstre hverken for eller imod
Written questions (5)
Pharmaceutical legislation
Temporary recognition of the equivalence of central clearing parties located in the United Kingdom
Removing the minimum liver weight requirement for foie gras production
Biosolutions
Biological pest control
Amendments (839)
Amendment 8 #
2023/2720(RSP)
Recital A a (new)
Aa. whereas according to the European Red List, the population of around one in three bee, butterfly and hoverfly species is declining; moreover, one in ten bee and butterfly species, and one in three hoverfly species are threatened with extinction; at regional level, insect population losses of up to 75% have been observed over the last three decades.
Amendment 11 #
2023/2720(RSP)
Recital A b (new)
Ab. whereas annual collection of objective, reliable and comparable data on the species richness and abundance of pollinator species in the field is fundamental for assessing the state of pollinator populations and for assessing whether the EU and its Member States make progress in reversing their decline.
Amendment 46 #
2023/2720(RSP)
Paragraph 3
3. Recognises the contribution made by the first EU Pollinators Initiative and appreciates its results; calls on the Commission to incorporate the results of the Initiative in the future Biodiversity Strategy, including also other key ecosystem services which insects provide;
Amendment 49 #
2023/2720(RSP)
Paragraph 3 b (new)
3b. Emphasizes the need to address all main drivers of pollinators decline;
Amendment 52 #
2023/2720(RSP)
Paragraph 4
4. Recalls that the European Green Deal was adopted as a new holistic strategy enabling the Union to tackle climate and environment-related challenges while leaving no one behind; recalls that the objectives of the Green Deal, including the EU Biodiversity Strategy and the Farm to Fork Strategy, will be met only when the main goal of the EU Pollinators Initiative, namely to reverse pollinator decline, is effectively achieved;
Amendment 56 #
2023/2720(RSP)
Paragraph 5 a (new)
5a. Emphasises that dedicated national and/or regional pollinators’ protection strategies are essential tools to mobilise all relevant parties and manage all the actions needed to reverse pollinator decline; appreciates the efforts of Member States which have adopted dedicated national or regional strategies to protect pollinators and calls on the remaining ones to do so as soon as possible in order to jointly address all drivers of decline in a coordinated manner, taking into account national, regional and local specificities and conditions;
Amendment 58 #
2023/2720(RSP)
Paragraph 5 c (new)
5c. Calls on the Commission and Member States to ensure that current and future governance mechanisms and platforms are fully functional in order to reach, by agreed deadlines, the goals of the Pollinators Initiative and more broadly the Biodiversity Strategy; calls, in this respect, on the Commission to take necessary legislative and non-legislative measures that will lead towards closing existing governance gaps and removing obstacles to meet objectives and targets agreed on the Union level;
Amendment 66 #
2023/2720(RSP)
Paragraph 7
7. Underlines the continued need to better protect pollinators from risks resulting from pesticides and biocides, and regrets the delay in taking actionwelcomes the publication of the new bee guidance document which is essential in order to improtect pollinators through theve the assessment of adverse effects on pollinators within the approval and authorisation procedures laid down in Regulation (EC) 1107/20097 and Regulation (EU) 528/20128 ; _________________ 7 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
Amendment 76 #
2023/2720(RSP)
Paragraph 9
9. Calls for an end to the importation of agricultural products produced using pesticides that are banned in the EU and can causehave not been approved or re-approved in the EU due to unacceptable harm torisks for pollinators;
Amendment 85 #
2023/2720(RSP)
Paragraph 10
10. Takes note ofWelcomes the European Food Safety Authority’s revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees) and calls on the Commission and the Member States to implement it swiftly;
Amendment 89 #
2023/2720(RSP)
Paragraph 12
12. Takes note of the European Chemicals Agency’s draft guidance on the assessment of risks to bees from the use of biocides; underlines the need to swiftly finalize the guidance document, so that it starts to be used in the authorization process under Regulation (EU) 528/2012 at EU or Member State level and for the approval at EU level, respectively;
Amendment 90 #
2023/2720(RSP)
Paragraph 12 a (new)
12a. Calls on the Commission and Member States to address all pending calls by the European Parliament within the adopted report on Union's authorization procedure for pesticides (P8_TA(2019)0023);
Amendment 106 #
2023/2720(RSP)
Paragraph 14
14. Regrets the lack of coordinated efforts to address light pollution, with some countries adopting national policies and others taking no action; underlines that metrics that record and report on light pollution levels in the EU and Member States are needed in order to be able to set pollution reduction targets against agreed baselines, and to monitor progress; encourages the use of Copernicus services to establish a diagnosis of the current light pollution in the European Union;
Amendment 108 #
2023/2720(RSP)
Paragraph 15
15. Underlines the need to incorporate the conservation of biodiversity and ecosystem services into urban planning practices in order to protect pollinator populations, contribute to their diversity and create new and well-connected habitats; calls on the Member States and local authorities to widely apply the guidance on pollinator-friendly cities;
Amendment 109 #
2023/2720(RSP)
Paragraph 15 a (new)
15a. Is alarmed by the ongoing habitat loss and fragmentation and their adverse effects on many pollinating insects; welcomes, in this respect, the commitment of the Commission to prepare a blueprint for a network of ecological corridors for pollinators, or ‘Buzz Lines', jointly with Member States; underlines the necessity to agree on a plan of actions with deadlines and calls on the Members States to support its implementation;
Amendment 122 #
2023/2720(RSP)
Paragraph 17
17. Calls on the Commission and the Member States to develop a standardised EU pollinator monitoring scheme to improve the gathering of data about the pollinator population; underlines that the granularity of the collected data should enable detection of annual population changes which are meaningful for policy actions and conservation measures; calls on the Member States to support training and capacity building in order to rapidly obtain the human resources required for pollinator monitoring;
Amendment 124 #
2023/2720(RSP)
Paragraph 17 a (new)
17a. Underlines the importance of an appropriate design and statistical power to detect changes within the future monitoring efforts; believes, in this regard, that the monitoring needs to be underpinned inter alia by adequately high number of sites in each Member State to detect changes in abundance and species´ richness of various pollinator groups; believes that these elements are key to ensure the necessary representativeness, accuracy, credibility and acceptance of resulting data as indicators of change;
Amendment 127 #
2023/2720(RSP)
Paragraph 17 b (new)
17b. Believes that high quality annual monitoring and information on the state of pollinator populations, assessed at least every three years, is essential to support and improve decision-making processes, ensure more effective public spending, and increase accountability and understanding of the impact of policies and legislation;
Amendment 128 #
2023/2720(RSP)
Paragraph 17 c (new)
Amendment 130 #
2023/2720(RSP)
Paragraph 17 e (new)
17e. Calls on Member States to support and provide adequate funding to the Long-Term Ecosystem Research in Europe (eLTER)2a, and facilitate the integration of the EMBAL and INSIGNIA, as well as the future EU Pollinator Monitoring Scheme, into the eLTER framework. _________________ 2a https://elter-ri.eu
Amendment 135 #
2023/2720(RSP)
Paragraph 18 a (new)
18a. Appreciates the commitments to finalise the EU-wide mapping of key pollinator areas by 2025 and the Red List assessments for key insect pollinator groups by 2024; calls, in this regard, on the Commission to adopt action plans for the recovery of key species with concrete measures and targets as soon as possible following their Red List assessment;
Amendment 142 #
2023/2720(RSP)
Paragraph 20 a (new)
20a. Calls on the relevant Commission´s Directorate Generals and on the EEA, EFSA, ECHA to intensify cooperation to fill the identified data and policy gaps; believes that the Commission, agencies and Member States need to improve collection, sharing, management and generation of new biodiversity data in order to improve policy making and ensure policy coherence at all levels;
Amendment 152 #
2023/2720(RSP)
Paragraph 23
23. Recognises the importance of citizen scientists and taxonomists, who need to be supported further so that they can strengthen their expertise and good practices and share them across Member States; calls on the Member States to support existing and new Butterfly Monitoring Schemes, inter alia by providing long-term financial assistance to their appointed coordinators; appreciates the successful work of Pollinator Ambassadors in motivating citizens and businesses; engagement and calls on the Commission and Member States for their support;
Amendment 161 #
2023/2720(RSP)
Paragraph 23 b (new)
23b. Calls on the Commission and Member States to ensure all necessary means in order to maintain and improve the recently expanded European Butterfly Monitoring Scheme database and to launch and maintain a public EU- database required for the future EU pollinator monitoring scheme;
Amendment 163 #
2023/2720(RSP)
Paragraph 24 a (new)
24a. Underlines the importance of open, constructive and genuine dialogues among EU institutions and representatives of relevant authorities on all governance levels, experts, beekeepers and citizens, which can pave the way towards new partnerships, actions and commitments and stronger engagement, such as during the EU Pollinator Week 2021: A New Deal for Pollinators; believes that knowledge sharing, awareness raising, capacity building and engagement of all relevant stakeholders, such as farmers, beekeepers, foresters, businesses, landscape architects, taxonomists, citizen scientists and young people in pollinator protection is a precondition for successful implementation of this Initiative;
Amendment 14 #
2023/2109(INI)
Aa. (new) whereas the EU will experience increasing demand for electricity in achieving the green transition;
Amendment 19 #
2023/2109(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the EU must mitigate its own risks of external dependence, ensure its strategic autonomy and enhance its supply chain resilience in terms of energy supplies;
Amendment 23 #
2023/2109(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. Whereas the EU energy mix and future electricity market shall ensure constant, reliable and carbon-free power to EU industries and citizens;
Amendment 32 #
2023/2109(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the innovative developments in nuclear power technology, particularly small modular reactors (SMRs), represent a promising pathway towards achieving the Union’s energy and climate objectives and offer considerable opportunities in terms of electricity production, industrial heat, hard-to-abate industries decarbonisation, hydrogen generation and, district heating, cooling and water desalination;
Amendment 46 #
2023/2109(INI)
D. whereas SMRs offer a lower initial capital investment, greater scalability and siting flexibility for locations unable to accommodate more traditional larger reactors, and now have the potential for enhanced safety and security compared to earlier designand more sustainable waste management compared to earlier designs, while also benefitting from feedback from existing large-power reactors;
Amendment 52 #
2023/2109(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. Whereas EU competitors and trade partners are massively investing domestically and abroad to gain leadership in next generation nuclear; whereas continued R&D in nuclear energy provision will be decisive for the European nuclear industry to regain global leadership;
Amendment 60 #
2023/2109(INI)
Ga. Whereas the deployment of SMRs can largely contribute to the decarbonisation of hard-to-abate industries;
Amendment 71 #
2023/2109(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Underlines the potential of nuclear power and SMRs in contributindispensable role of nuclear power in reaching to the EU’'s clean energy goalsimate goals, as well as enhancing the energy independence of the EU;
Amendment 86 #
2023/2109(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls for the development of a comprehensive strategy for the deployment of SMRs in the EU, taking into account the specific needs and circumstances of different regions, including remote and sparsely populated areas, and sectors;
Amendment 97 #
2023/2109(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Acknowledges that SMRs have the potential to play a significantcrucial role in replacing fossil fuels17 ; _________________ 17 https://ec.europa.eu/eusurvey/runner/Europ eanSMRPrePartnership.
Amendment 103 #
2023/2109(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Encourages the use of SMRs for low-carbon hydrogen production, as global hydrogen demand is expected to massively expand by 2050;
Amendment 105 #
2023/2109(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Recognises the potential role of SMRs for industrial heat production, in particular in hard-to-abate industries such as cement, pulp, chemical, and steel;
Amendment 113 #
2023/2109(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Acknowledges the potential of SMRs for district heating and cooling; highlights that SMRs can provide decarbonized, low temperature heat to district heating systems;
Amendment 124 #
2023/2109(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Emphasises that so far, no SMRs have been commercially operated in the world, but that more than 80 SMR designs are currently at different stages of development and deployment in 18 countries; stresses that the EU should therefore not get left behind in the global race for leadership in the future SMR marketstrive for global leadership in the future SMR market; underlines that competition around SMRs is intense with strong political and commercial initatives already launched;
Amendment 128 #
2023/2109(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Emphasises that the European nuclear sector is a strongkey asset and recognises that the EU already has a high degree of expertise and experience in nuclear technologies that can be applied to the development and deployment of SMRs, in particular in the fuel cycle, with a supply chain that could generate most of the added value within Europe;
Amendment 136 #
2023/2109(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Recognises that a growing number of Member States are considering nuclear for their energy mix, emphasises the need for nuclear energy to achieve the climate goals of climate neutrality by 2050;
Amendment 138 #
2023/2109(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Highlights that nuclear power can provide stability and predictability to energy grids thanks to the continued operation of exisiting plants, the construction of new large reactors and the development of SMRs in the EU;
Amendment 145 #
2023/2109(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Welcomes the creation of the so- called ‘European SMR partnership’ in the form of a collaboration scheme involving industrial stakeholders, research and technological organisations, interested customers, European regulators and the Commission; calls on the Commission to bring it to a full partnership by the end of 2023;
Amendment 147 #
2023/2109(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. (new) Recognises the important role of nuclear energy in limiting our dependence on third countries and achieving energy security and stable energy prices within the European Union;
Amendment 156 #
2023/2109(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Recognises that a basic condition for SMRs to develop in the EU is to ensure that a conducive policy preferably based on technological neutrality and a regulatory framework isare in place;
Amendment 213 #
2023/2109(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Recognises the need to sufficiently explore and identify all possible options for financing European SMR production, which has very high capital costs; calls in this regard on the EIB to align its energy lending policy with EU taxonomy and support investment in SMR production;
Amendment 217 #
2023/2109(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
Amendment 220 #
2023/2109(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Expresses the need to place nuclear and SMRs among the technologies recognised by the Net Zero Industry Act, the Strategic Technologies for Europe Platform and the future Sovereignty Fund;
Amendment 231 #
2023/2109(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Calls for inclusive access to EU funding beyond Euratom funds, thereby allowing the nuclear sector to participate in broader EU funding initiatives it is currently excluded from;
Amendment 236 #
2023/2109(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls for the establishment of a new joint undertaking for SMRsEuropean Alliance for SMRs and the creation of a SMR ICPEI;
Amendment 269 #
2023/2109(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Emphasises that R&D should support all different generations of SMRs and not only focus on the needs of the first generation of SMR light water reactors, expected by the beginning of the 2030s, but should also further support fourth- generation types of reactors, the so-called ‘advanced modular reactors’;
Amendment 277 #
2023/2109(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Recognises the need to develop training in key nuclear construction skills all along the value chain;
Amendment 282 #
2023/2109(INI)
Motion for a resolution
Paragraph 31 a (new)
Paragraph 31 a (new)
31a. Emphasizes the importance of strategic workforce planning, which should be forward-looking and adaptable to potential shifts in skill requirements for the deployment of SMRs;
Amendment 41 #
2023/2077(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that additional public and private investment will be needed to face new challenges; underlines that a European Sovereignty Fund financed by additional fresh money will address the fragmentation of the internal market, support the EU’s industrial strategy, reduce our critical dependencies and ensure our open strategic autonomy;
Amendment 15 #
2023/2075(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
– having regard to the European Parliament resolution of 12 July 2023 on the COVID-19 pandemic entitled 'Lessons learned and recommendations for the future' (2022/2076(INI)),
Amendment 54 #
2023/2075(INI)
Motion for a resolution
Recital A
Recital A
A. whereas non-communicable diseases (NCDs) are diseases that are not passed from person to person; whereas non-communicable diseases (NCD’s) cause 90 % of all deaths in the EU4 ; and NCDs continue to grow across the EU; _________________ 4 World Health Organization, ‘Monitoring noncommunicable disease commitments in Europe 2021’, 8 December 2021.
Amendment 56 #
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 health problems and neurological disorders, liver diseases, kidney diseases, oral diseases, osteoporosis, osteoarthritis and endometriosis among other conditionsallergy and auto-immune diseases, oral diseases, rheumatologic diseases and endometriosis among other conditions; whereas data gaps in specific disease areas can result in a misjudgment of the prevalence of these diseases and their burden;
Amendment 77 #
2023/2075(INI)
Motion for a resolution
Recital C
Recital C
C. whereas NCDs account for the largest share of countries’ healthcare expenditures, costing EU economies and are predicted to lead to the loss of potential productive years among employees impacted by such conditions, resulting in a cost of EUR 115 billion, or 0.8 % of GDP annually as well as entailing other societal costs such as loss of productivity and workforce; whereas in 2018, no more than 2.8 % of total health expenditure in the EU was spent on prevention, whereas the costs of treating NCDs remains high5 ; _________________ 5 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 15, June 2022.
Amendment 89 #
2023/2075(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the increasing burden of NCDs affecting individuals and societies and the health needs of ageing populations represent challenges to the health systems of the Member States;
Amendment 96 #
2023/2075(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas NCDs such as type 2 diabetes increasingly affect children; whereas many people living with NCDs such as diabetes are often diagnosed too late and many people already show signs of complications; 1a _________________ 1a https://link.springer.com/article/10.1007/s 11892-014-0508-y Diabetes Research and Clinical Practice, Volume 183, 2022, 109118, ISSN 0168-8227 https://doi.org/10.1016/j.diabres.2021.109 118.
Amendment 102 #
2023/2075(INI)
Motion for a resolution
Recital D b (new)
Recital D b (new)
Amendment 121 #
2023/2075(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas smoking increases the risk of being hospitalised with a mental illness by 250 per cent; 1a _________________ 1a https://tech.au.dk/en/about-the- faculty/news/show/artikel/smoking- significantly-increases-the-risk-of- depression
Amendment 124 #
2023/2075(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Amendment 132 #
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, chemical exposure as well as food, water and soil pollution; whereas most NCDs are impacted by socioeconomic inequalities;
Amendment 166 #
2023/2075(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas antimicrobial resistance (AMR) is a challenge for medical procedures such as surgeries and cancer treatments; whereas AMR leads to increased disease incidence, hospitalisations, mortality rates and healthcare expenses; 1a _________________ 1a https://www.thelancet.com/journals/lancet /article/PIIS0140-6736(21)02724- 0/fulltext
Amendment 169 #
2023/2075(INI)
Motion for a resolution
Recital G b (new)
Recital G b (new)
Gb. whereas not all NCDs can be prevented as some factors are not modifiable such as age, family history, genetics, gender, auto-immunity (e.g. type 1 diabetes) and/or not known such as some neurological disorders;
Amendment 180 #
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, improved disease management, integration of care and new and better treatments for NCDs;
Amendment 189 #
2023/2075(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas people suffering from NCDs run a higher risk of being affected by communicable diseases such as COVID-19; whereas data shows that people suffering from NCD’s run a higher risk of complications and dying from COVID-19; 1a _________________ 1a https://health.ec.europa.eu/system/files/20 22-06/eu-ncd- initiative_publication_en_0.pdf page 57
Amendment 199 #
2023/2075(INI)
Motion for a resolution
Recital H b (new)
Recital H b (new)
Hb. whereas WHO has set a goal to reduce premature deaths from NCDs by 25% by 2025 and world leaders reaffirmed their commitment at the G20 Health Ministers meeting to achieving the UN’s Sustainable Development Goal (UNSDG) 3.4: to reduce premature deaths from NCDs by one-third by 2030; 1a _________________ 1a https://www.who.int/teams/noncommunic able-diseases/on-the-road-to-2025
Amendment 220 #
2023/2075(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 287 #
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 support 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 ; 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 396 #
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 cardiovascular diseases, cancer, diabetes, oral diseases and other conditions linked to obesity15 ; acknowledges that obesity is considered a risk factor for several NCDs; calls on the Commission and the Member States to: _________________ 15 World Health Organization Regional Office for the Eastern Mediterranean, ‘Noncommunicable diseases’.
Amendment 498 #
2023/2075(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that some per- and polyfluorinated alkyl substances (PFAS) can lead to health problems such as obesity, diabetes 1a and cancer16 ; calls on the Commission to implement the PFAS restriction proposal submitted to European Chemicals Agency on 13 January 202317 ; _________________ 1a https://www.clinicaltrialsarena.com/comm ent/high-exposure-pfas-diabetes-women/ 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 549 #
2023/2075(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Stresses that primary prevention is crucial for reducing the occurrence of many types of NCDs; notes that secondary prevention is key for the optimal management of NCDs and contributes to reduce the risk of complications, comorbidities and death;
Amendment 562 #
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 for example through the implementation of health checks and early detection programmes in order to improve disease management, prevent complications and save downstream costs for healthcare systems;
Amendment 568 #
2023/2075(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Welcomes the European Beating Cancer Plan; stresses the importance of early detection and that 25 Member States had introduced population-based screening programmes for breast cancer, 22 for cervical cancer and 20 for colorectal cancer in their National Cancer Control Plans in 2020; welcomes the 2022 Council Recommendation on strengthening prevention through early detection: A new EU approach on cancer screening which include strategies for earlier detection of breast, cervical, colorectal cancer and extend recommended screenings in Europe for lung, prostate and gastric cancers; 1a _________________ 1a https://health.ec.europa.eu/system/files/20 22-02/eu_cancer-plan_en_0.pdf: page 14
Amendment 580 #
2023/2075(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Encourages Member States to reduce undiagnosed NCDs by introducing joint targeted health checks for high-risk individuals addressing the main shared metabolic risk factors, ensuring such as high blood pressure, high blood glucose, high BMI and high LDL cholesterol as well incentivising self-tests such as stool collection to detect colorectal cancer and self-test for cervical cancer, ensuring timely access to quality care and support NCD patients’ self- management;
Amendment 590 #
2023/2075(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Highlights the importance of early intervention in the case of mental health problems; stresses that daycares, schools and workplaces can play an important role in recognising mental health problems at early stages and that timely support can be provided; 1a _________________ 1a https://health.ec.europa.eu/system/files/20 23-06/com_2023_298_1_act_en.pdf
Amendment 595 #
2023/2075(INI)
17. Notes that some NCDs are closely linked such as diabetes and cardiovascular diseases and cancer and depression and that important synergies can be achieved by improving diagnosis and integrated care19 ; 1a _________________ 1a https://www.ejcancer.com/article/S0959- 8049(16)32595-3/fulltext 19 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 30, June 2022.
Amendment 620 #
2023/2075(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Stresses that nurses, doctors, general practitioners. dental health professionals, dietitians and nutritionists and other primary healthcare professionals have a significant role in referring patients for diagnostic tests and treating NCDs; encourages the Member States to offer training to healthcare professionals to better identify high-risk individuals, prevent and treat NCDs;
Amendment 674 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Highlights the importance of addressing social determinants, health literacy, and digital literacy to reduce the overall burden of NCDs;
Amendment 681 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Strongly welcomes digital health solutions such as telemedicine, which can enable better accesses to healthcare in rural areas as well protect immunosuppressed NCD patients from exposure to infectious diseases;
Amendment 716 #
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 care, starting with the diagnosis and continuing over the course of the disease and by granting access to specialised support centres;
Amendment 723 #
2023/2075(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
Amendment 734 #
2023/2075(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Welcomes the pharmaceutical package and calls for the strengthening of the European medicines market to ensure access to medicines and alleviate medicine shortages, reduce barriers to cross-border business, while strengthening incentives for investment in innovation; underlines that data protection and intellectual property rights are crucial to ensure competitiveness in the EU by incentivising innovators to develop new products and further ongoing research efforts; notes that a narrow definition of unmet medical need can harm development of important therapies for people living with NCDs;
Amendment 824 #
2023/2075(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Stresses that good quality data are important to support development of evidence-based and targeted policies for improved health; notes that correlating health data with environmental, social and economic data and strengthening elements of existing health monitoring systems such as European Health Data Space is important in this regard;
Amendment 835 #
2023/2075(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Belives that the EU has a role in supporting global health, including in respect to the international rise of NCDs;
Amendment 18 #
2023/2074(INI)
Motion for a resolution
Citation 2 f (new)
Citation 2 f (new)
– having regard to its resolution from 21 January 2021 on The right to disconnect 2019/2181(INL),
Amendment 19 #
2023/2074(INI)
Motion for a resolution
Citation 2 g (new)
Citation 2 g (new)
– having regard to the 2022 European Parliament Report on Mental Health in a Changing World of Work,
Amendment 24 #
2023/2074(INI)
Motion for a resolution
Citation 2 a (new)
Citation 2 a (new)
– having regard to the Council conclusions of 24 October 2019 on the economy of well-being, calling for a comprehensive EU mental health strategy,
Amendment 26 #
2023/2074(INI)
Motion for a resolution
Citation 2 c (new)
Citation 2 c (new)
– having regard to the 2008 European Pact for Mental health and wellbeing,
Amendment 33 #
2023/2074(INI)
Motion for a resolution
Citation 2 h (new)
Citation 2 h (new)
– having regard to the 2022 European Care Strategy,
Amendment 48 #
2023/2074(INI)
Motion for a resolution
Citation 2 d (new)
Citation 2 d (new)
– having regard to the EU-OSHA report of 7 October 2011 entitled ‘Mental health promotion in the workplace – a good practice report’,
Amendment 49 #
2023/2074(INI)
Motion for a resolution
Citation 2 e (new)
Citation 2 e (new)
– having regard to the 2017 EU Framework for Action on Mental Health,
Amendment 56 #
2023/2074(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas mental health should have equal parity with physical health;
Amendment 63 #
2023/2074(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the urgent need for better and wider awareness and understanding of mental health and for effective action to prevent and address mental ill health has increasingly being recognised in recent years, with the COVID19 pandemic highlighting this crucial need;
Amendment 139 #
2023/2074(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1 EU Strategy and Year on Mental health Welcomes the recent Communication on a "Comprehensive Approach to Mental Health" and calls on the Commission to come forward with a comprehensive and integrated EU Strategy on mental health to address the full spectrum of mental health, i.e. prevention, promotion, support, care, treatment and cure by bringing together and engaging relevant stakeholders through a bottom-up approach; coordinated by a dedicated internal and formal Commission structure, backed with sufficient resources, such a Strategy should ensure the development of national mental health action programmes, building on the outcome of past EU actions on mental health and have clear and measurable objectives, which should be assessed and adapted if required; Stresses that a European Year for Mental Health could be a useful tool to raise awareness of the importance of mental health and contribute to combatting stigma and discrimination while functioning as a stepping stone towards the abovementioned EU Strategy; calls on the Commission to designate such a Year in the near future;
Amendment 145 #
2023/2074(INI)
Motion for a resolution
Subheading 2
Subheading 2
Preventing mental health conditions and promoting mental health among vulnerable groups in societyfor all
Amendment 152 #
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;find themselves in a vulnerable situation; underlines the need to prioritise mental health as a public health problem, stresses that addressing mental health conditions requires a thorough understanding of the different determinants of mental health and that; calls for an intersectional approach is necessary to prevent and mitigate the impacts on individuals, communities and societies through a mental-health-in-all- policies approach;
Amendment 158 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Understands the broader societal implications of declining mental health, including its economic, social, and political repercussions for the EU.
Amendment 160 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Stresses that mental health is shaped by a blend of socio-economic, environmental, and genetic factors and is influenced by early life experiences which have an important role in forming and conditioning the wellbeing of every person;
Amendment 162 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Underlines that a comprehensive approach to mental health requires a thorough understanding of the different determinants of mental health to prevent and mitigate the impacts on individuals, communities and societies;
Amendment 164 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Emphasizes that mental health recovery is not just the alleviation of symptoms, but a personal journey towards leading a meaningful life with values, purposes, and relationships, despite the challenges posed by a mental health problem;
Amendment 167 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Acknowledges that gender plays a pivotal role in shaping mental health experiences with disparities in prevalence, types of disorders, and access to mental health care being largely influenced by gender;
Amendment 168 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 f (new)
Paragraph 1 f (new)
1f. Is aware that families and caregivers of individuals with mental health problems bear unique burdens and should be afforded comprehensive, multidisciplinary support, tailored to their distinct needs;
Amendment 173 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 h (new)
Paragraph 1 h (new)
1h. Acknowledges both the benefits and risks of digital technologies, from connectivity and access to information to potential digital addiction and reduced real-world interactions;
Amendment 175 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 i (new)
Paragraph 1 i (new)
1i. Appreciates the important role of the workplace with regard to mental health;
Amendment 197 #
2023/2074(INI)
2. HighlightAcknowledges the complex interconnections between physical health and mental health; whereas mental health stigma and discrimination remain prevalent in society and lead people to disregard mental health compared to physical health, impacting the quality and accessibility of mental health care, as well as the allocation of funds to mental health services; Notes that mental health conditions are the leading cause of years of healthy life loss due to disability in the EU and that people who are diagnosed with severe mental health conditionproblems are likelier to die prematurely;
Amendment 200 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 – subparagraph 1 (new)
Paragraph 2 – subparagraph 1 (new)
Preventing mental health conditions and promoting mental health among vulnerable groups
Amendment 204 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Highlights that some people might be more at risk of experiencing poor mental health and less likely to access tailored mental health care. This is the case of people living in vulnerable situations or people experiencing intersectional discrimination; Notes that the links between these identity or socio- economic factors and mental health need to be clearly taken into consideration to develop tailored support and preventive measures;
Amendment 213 #
2023/2074(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the importance of social policies that tackle social exclusion,risk factors for social exclusion, including but not limited to poverty, homelessness, substance-related disorders, unemployment and economic vulnerabilities in order to prevent mental health conditions and address their root causes; underlines the need to provide better instrumentand accessible instruments and services to help people to cope with problems;
Amendment 235 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 d (new)
Paragraph 3 d (new)
3d. Alarmingly notes the high number of young Europeans aged 10-19 diagnosed with a mental disorder, and that suicide rates among this demographic are notably high;
Amendment 240 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 f (new)
Paragraph 3 f (new)
3f. Acknowledges that psychiatric comorbidity is highly prevalent among people who use substances (up to over 80% of people in drug treatment) and is associated with increased levels of clinical and social severity. The relevance of the comorbidity of substance use and mental health disorders is related not only to its high prevalence, but also to its difficult management and its association with poor outcomes for those affected;
Amendment 243 #
2023/2074(INI)
Motion for a resolution
Subheading 3
Subheading 3
Amendment 245 #
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,collect data, in adherence to the principles of transparency, legitimate purpose and proportionality, and measure the prevalence, clinical severity and effectiveness of mental health interventions; calls for the EU to facilitate the collection and routinely reporting of comparable, disaggregated mental health data across Europe; stresses indicators should factor in people's actual experiences to better reflect the social determinants of mental health and calls for them to be systematically implemented, improved and updated;
Amendment 252 #
2023/2074(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission to introduce a mental health impact assessment to evaluate the effect of different EU actions, policies and funding programmes on mental health;
Amendment 255 #
2023/2074(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Underlines the need for a detailed mapping of the state of mental health care across the EU as a basis for action and priority setting;
Amendment 272 #
2023/2074(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Is deeply concerned that, despite progress in some countries, peopleindividuals with mental health conditionshallenges, including those with psychosocial disabilities, frequently experienface discrimination and stigma and often. Often, they do not have access to adequate healthcare, which cantimely, accessible, affordable, and adequate healthcare and health services, leading to severeinsufficient promotion and protection of their rights and potential human rights violations;
Amendment 277 #
2023/2074(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Recognises the need to use language and terminology that frames the topic in an inclusive and non-stigmatising way and reflects the variety of mental health experiences;
Amendment 279 #
2023/2074(INI)
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Calls on the EU and Member States to invest in mental health literacy and include mental health in school curricula and the curricula of teaching staff; Calls on the European Commission and the Member States to promote training and re-training of professionals to comply with the standards and obligations of the UN CRPD;
Amendment 295 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls for specific programmes to improve mental health literacy as these will contribute to fighting stigma as well as to increasing empowerment and resilience;
Amendment 302 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 d (new)
Paragraph 7 d (new)
7d. Calls on Member States to step up investments in mental health, not just by securing appropriate funds and human resources across health and other sectors to meet mental health needs, but also through committed leadership, pursuing evidence-based policies and practice;
Amendment 331 #
2023/2074(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Underlines the need to effectively respond to the coexistence of mental health and other disorders; dual disorders represent a challenge for treatment services; often patients are referred from one service to the other, making their treatment access more difficult;
Amendment 348 #
2023/2074(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers that mental health conditions are underdiagnosed in the EUUnderlines the importance of early diagnosis and intervention for mental health problems, access to controlled medicines while preventing their diversion, hazardous overmedication or self-medication and considers that the current state of under-, late- and misdiagnosis of mental health conditions need urgent attention; underlines that every diagnosis must be individual, adapted to the person and that every mental health condition is different for each person; reminds that every diagnosis and treatment must be patient-centred;
Amendment 359 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Recognises that many mental health needs are unmet. Underlines the importance of identifying these needs at their onset. Early intervention may prevent these risks from escalating, with also potential benefits in terms of healthcare system costs;
Amendment 366 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Reminds the key role of the prevention of mental health within the digital space and social medias; calls on the Member States to fully implement the Digital Services Act in order to prevent, tackle and avoid any online hate and harassment, especially for young and vulnerable people, such as women; calls for the reinforcement of support, listening and alert platforms for victims of gender- based and sexual violence; Calls on the Commission –primary regulator for very large online platforms and very large online search engines under the DSA –to move towards a safer and healthier digital space for all, by guaranteeing an upward convergence and setting the highest/safest benchmarks;
Amendment 378 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 d (new)
Paragraph 11 d (new)
11d. Acknowledges people with mental health problems and psychosocial disabilities have the right to lead full and meaningful lives;
Amendment 379 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 e (new)
Paragraph 11 e (new)
Amendment 385 #
2023/2074(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Highlights the essential role of a multidisciplinary health workforce and the clinical, financial and organisational benefits of community-based healthcare; recognises the importance of ensuring suitable standards of training and regulation for mental health care providers;
Amendment 410 #
2023/2074(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Calls on the EU and the Member states to increase efforts to ensure more meaningful cooperation with civil society and the communities they represent, experts and particularly persons with lived experience; highlights holistic approaches to mental health prevention, support and services should be developed alongside affected communities, including meaningful involvement of people with psychosocial disabilities, through co- creation and in a non-tokenistic manner;
Amendment 418 #
2023/2074(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Acknowledges that social prescribing is a useful, practical, holistic and effective approach that can be integrated into the primary care setting within a national health serviceystem, as pointed out by the WHO in its toolkit on how to implement social prescribing3 ; _________________ 3 https://apps.who.int/iris/rest/bitstreams/142 4690/retrieve.
Amendment 461 #
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 brain and mental health, in consultation with relevant stakeholders regarding priority topics;
Amendment 476 #
2023/2074(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
Amendment 478 #
2023/2074(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Emphasises the need to integrate mental health into the routine health information systems and identify, collate, routinely report and use core mental health data disaggregated by gender, age and other grounds to properly capture intersectionality issues. Indicators on determinants of mental health should also be available in population (mental) health information and monitoring systems (as recommended by WHO);
Amendment 499 #
2023/2074(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Invites the Commission to further develop its Mental Health Strategy and draw upbuild upon its Communication on a Comprehensive Approach to Mental Health to draw up a comprehensive and integrated EU Strategy on mental health with concrete targets and goals for the future, including more in-depth initiatives, from in consultation with all relevant stakeholders following a bottom-up perspectiveapproach;
Amendment 89 #
2023/0379(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)
Article 1 – paragraph 1 – point 7 a (new)
Regulation (EU) 2016/1011
Article 18 – paragraph 1 – subparagraph 2
Article 18 – paragraph 1 – subparagraph 2
Amendment 113 #
2023/0363(COD)
Proposal for a regulation
Article 2 - paragraph 1 – point 6 a (new)
Article 2 - paragraph 1 – point 6 a (new)
Regulation (EU) No 1093/2010
Article 80 a
Article 80 a
(6a) the following Article is inserted: "Article 80a The Authority shall, by 31 June 2025, report to the Commission on the appropriateness of the following legislation: – Regulation 2019/2088 (SFDR) – Regulation 575/2013(CRR) – Regulation 596/2014 (MAR) More specifically, the Authority shall, where relevant, assess whether the above- mentioned legislation conforms with the following principles: – Whether the data required of the financial institution for the use by the competent authority is strictly necessary for supervisory purposes – Whether the data required of the financial institution for the use by the competent authority respects the principle of proportionality as regards the size and nature of the activities of the financial institution – Whether the same data is requested by different legislations and whether this data is communicated uniformly to the competent authority – Whether the cumulative impact of the reporting requirements is strictly necessary for consumer protection For the purpose of this report, the Authority shall take due account of input from relevant stakeholders. On the basis of that report, the Commission shall, by 31 December 2025, submit to the Parliament and the Council a legislative proposal to reduce excessive reporting requirements"
Amendment 123 #
2023/0363(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 6 a (new)
Article 3 – paragraph 1 – point 6 a (new)
Regulation (EU) No 1094/2010
Article 80 a new
Article 80 a new
Amendment 136 #
2023/0363(COD)
Proposal for a regulation
Article 5 – paragraph -1 (new)
Article 5 – paragraph -1 (new)
Regulation (EU) No 2021/523
Article 8 – paragraph 6 – introductory part
Article 8 – paragraph 6 – introductory part
Amendment 141 #
2023/0363(COD)
Proposal for a regulation
Article 5 – paragraph -1 a (new)
Article 5 – paragraph -1 a (new)
Regulation (EU) No 2021/523
Article 13 – paragraph 7 – subparagraph 2
Article 13 – paragraph 7 – subparagraph 2
Amendment 212 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
Directive 2008/98/EC
Article 3 – paragraph 4aa (new)
Article 3 – paragraph 4aa (new)
(4aa) ‘food wastage’ means edible food that has been prepared for consumption, but has been discarded and as a result become waste;
Amendment 250 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Directive (EU) 2008/98/EC
Article 9 a – paragraph 3 a (new)
Article 9 a – paragraph 3 a (new)
3a. To support Member States in implementing the targets outlined in Article 9(4)(a) by products, in applying the waste hierarchy principle and in determining whether goods not intended for human consumption should be categorised as by products or waste, the Commission shall develop by 2024 guidelines, including definitions and delineations of food waste, by products, and animal by products used at the processing and manufacturing stage;
Amendment 376 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive (EU) 2008/98/EC
Article 22 c – paragraph 3 – point a
Article 22 c – paragraph 3 – point a
(a) are based on the weight of the products concerned and, for textile products listed in Part 1 of Annex IVc, are modulated on the basis of the ecodesign requirements adopted pursuant to the Regulation .../... of the European Parliament and of the Council [P.O. insert the serial number for the Ecodesign for Sustainable Products Regulation when adopted]** that are most relevant for the prevention of textile waste and for the treatment of textiles in line with the waste hierarchy and the corresponding measurement methodologies for those criteria adopted pursuant to that Regulation or on the basis of other Union law establishing harmonised sustainability criteria and measurement methods for textile products, and that ensure the improvement of environmental sustainability and circularity of textiles;
Amendment 385 #
2023/0234(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive (EU) 2008/98/EC
Article 22 c – paragraph 4
Article 22 c – paragraph 4
4. Where necessary to avoid distortion of the internal market and ensure consistency with the ecodesign requirements adopted pursuant to Article 4 read in conjunction with Article 5 of Regulation.../... [P.O. insert the serial number for Ecodesign for Sustainable Products Regulation when adopted], the Commission mayshall adopt implementing acts laying down the fee modulation criteria for the application of paragraph 3, point (a), of this Article. That implementing act shall not concern the precise determination of the level of the contributions and shall be adopted in accordance with the examination procedure referred to in Article 39(2) of this Directive.
Amendment 147 #
2023/0232(COD)
Proposal for a directive
Recital 23
Recital 23
(23) The long-term objective of the Directive is to aim to achieve healthy soils by 2050. As an intermediate step, in light of the limited knowledge about the condition of soils and about the effectiveness and costs of the measures to regenerate their health, the directive takes a staged approach. In the first stage the focus will be on setting up the soil monitoring framework and assessing the situation of soils throughout the EU. It also includes requirements to lay down measuresfor Member States to put forward recommendations on how to manage soils sustainably and to regenerate unhealthy soils once their condition is established, but without imposing an obligation to achieve healthy soils by 2050 neither intermediate targets. This proportionate approach will allow sustainable soil management and regeneration of unhealthy soils to be well prepared, incentivised and set in motion. In a second stage, as soon as the results of the first assessment of soils and trends analysis are available, the Commission will take stock of the progress towards the 2050 objective and the experience thereof, and will propose a review of the directive if necessary to accelerate progress towards 2050.
Amendment 152 #
2023/0232(COD)
Proposal for a directive
Recital 24
Recital 24
(24) Addressing the pressures on soils and identifying the appropriate measures to maintain or regenerate soil health requires that the variety of soil types, the specific local and climatic conditions and the land use or the land cover is taken into account. It is therefore appropriate that Member States consider to establish soil districts. Soil districts should constitute the basic governance units to manage soils and to take measures to comply with the requirements laid down in this Directive, in particular with regard to the monitoring and assessment of soil health. The number, geographic extent and boundaries of soil districts for each Member State should be determined in order to facilitate the implementation of Regulation (UE) …/…. of the European Parliament and of the Council48 . There should be a minimum number of soil districts in each Member State taking into account the size of the Member State. This minimum number of soil districts for each Member State shall correspond to the number of NUTS 1 territorial units established in Regulation (EC) No 1059/2003 of the European Parliament and of the Council49 . _________________ 48 +OP please insert in the text the number of the Regulation on the carbon removal certification contained in document COM(2022) 672 final and insert the number, date, title and OJ reference of that Directive in the footnote. 49 Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1).
Amendment 156 #
2023/0232(COD)
Proposal for a directive
Recital 26
Recital 26
(26) In order to have a common definition of healthy soil condition, there is a need to define a minimum common set of measurable criteria, which, if not respected leads to a critical loss in the soil’s capacity to function as a vital living system and to provide ecosystem services. Such criteria should reflect and be based on the existing soil monitoring systems and level of soil science.
Amendment 157 #
2023/0232(COD)
Proposal for a directive
Recital 27
Recital 27
(27) In order to describe soil degradation it is necessary to establish soil descriptors that can be measured or estimated. Even if there is significant variability between soil types, climatic conditions and land uses, the current scientific knowledge allows to set criteria at Union level for some of those soil descriptors. However, Member States should be able to adapt the criteria for some of these soil descriptors based on specific national or local conditions and define the criteria for other soil descriptors for which common criteria at EU level cannot be established at this stage. For those descriptors for which clear criteria that would distinguish between healthy and unhealthy condition cannot be identified now, only monitoring and assessment are required. This will facilitate the development of such criteria in future.
Amendment 161 #
2023/0232(COD)
Proposal for a directive
Recital 28
Recital 28
(28) In order to create incentives, Member States should set up mechanisms to recognize the efforts of landowners and land managers to maintain the soil in healthy condition, including in the form of soil health certification coto help with the implementary totion of the Union regulatory framework for carbon removals, and supporting the implementation of the renewable energy sustainability criteria set out in article 29 of Directive (EU) 2018/2001 of the European Parliament and of the Council50 . The Commission should facilitate soil health certification by inter alia exchanging information and promoting best practices, raising awareness and assessing feasibility of developing recognition of certification schemes at Union level. Synergies between different certification schemes should be exploited as much as possible to reduce administrative burden for those applying for relevant certifications. _________________ 50 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 (recast) (OJ L 328, 21.12.2018, p. 82).
Amendment 165 #
2023/0232(COD)
Proposal for a directive
Recital 30
Recital 30
(30) Soil is a limited resource subject to an ever-growing competition for different uses. Land take is a process often driven by economic development needs, that transforms natural and semi-natural areas (including agricultural and forestry land, gardens and parks) into artificial land development, using soil as a platform for constructions and infrastructure, as a direct source of raw material or as archive for historic patrimony. This transformation may cause the loss, often irreversibly, of the capacity of soils to provide other ecosystem services (provision of food and biomass, water and nutrients cycling, basis for biodiversity and carbon storage). In particular, land take often affects the most fertile agricultural soils, putting food security in jeopardy. Sealed soil also exposes human settlements to higher flood peaks and more intense heat island effects. Therefore, it is necessary to monitor land take and soil sealing and their effects on soil’s capacity to provide ecosystem services. It is also appropriate to lay down certain principles to mitigate the impacts of land take as part of sustainable soil management.
Amendment 169 #
2023/0232(COD)
Proposal for a directive
Recital 32
Recital 32
(32) TAs a complement to already existing national inventories, the Commission shouldmay assist and support Member States’ monitoring of soil health by continuing to carry out and enhancing regular in-situ soil sampling and related soil measurements (LUCAS soil) as part of the Land Use/Cover Area frame statistical Survey (LUCAS) Programme. For that purpose, the LUCAS Programme shall be enhanced and upgraded to fully align it with the specific quality requirements to be met for the purpose of this Directive. In order to alleviate the burden, Member States should be allowed to take into account the soil health data surveyed under the enhanced LUCAS soil. The Member States thus supported should take the necessary legal arrangements to ensure that the Commission can carry out such in-situ soil sampling, including on privately owned fields, and in compliance with applicable national or Union legislation.
Amendment 170 #
2023/0232(COD)
Proposal for a directive
Recital 33
Recital 33
(33) The Commission is developing remote sensing services in the context of Copernicus as a user-driven programme, hereby also supporting Member States. In order to increase the timeliness and effectiveness of soil health monitoring, and where relevant, Member States shouldmay use remote sensing data including outputs from the Copernicus services for monitoring relevant soil descriptors and for assessing soil health. The Commission and the European Environment Agency should support exploring and developing soil remote sensing products, to assist the Member States in monitoring the relevant soil descriptors.
Amendment 180 #
2023/0232(COD)
Proposal for a directive
Recital 37
Recital 37
(37) To maintain or enhance soil health, soils need to be managed sustainably. Sustainable soil management will enable the long-term provision of soil services, including improved air and water quality and food security. It iscan therefore be appropriate to lay downfor Member States to recommend sustainable soil management principles in order to guide soil management practicers.
Amendment 187 #
2023/0232(COD)
Proposal for a directive
Recital 40
Recital 40
(40) In order to ensure that the best sustainable soil management practices are implerecommentded, Member States should be required to closely monitor the impact of soil management practices and adjust practices and recommendations as necessary, taking into account new knowledge from research and innovation. Valuable contributions are expected in this respect from the Horizon Europe Mission ‘A Soil Deal for Europe’ and in particular its living labs and activities to support soil monitoring, soil education and citizen engagement.
Amendment 195 #
2023/0232(COD)
Proposal for a directive
Recital 46
Recital 46
(46) Flexibility for the management of potentially contaminated sites and contaminated sites is needed to take account of costs, benefits and local specificities. Member States should therefore at least adopt a risk-based approach for managing potentially contaminated sites and contaminated sites, taking into account the difference between these two categories, and which allows to allocate resources taking account of the specific environmental, economic and social context. Decisions should be taken based on the nature and extent of potential risks for human health and the environment resulting from exposure to soil contaminants (e.g. exposure of vulnerable populations such as pregnant women, persons with disabilities, elderly people and children). The cost-benefit analysis of undertaking remediation should be positive. The optimum remediation solution should be sustainable and selected through a balanced decision-making process that takes account of the environmental, economic and social impacts. The management of potentially contaminated sites and contaminated sites should respect the polluter-pays, precautionary and proportionality principles. Member States should lay down the specific methodology for determining the site-specific risks of contaminated sites. Member States should also define what constitutes an unacceptable risk from a contaminated site based on scientific knowledge, the precautionary principle, local specificities, and current and future land use. In order to reduce the risks of contaminated sites to an acceptable level for human health and the environment, Member States should take adequate risk reduction measures including remediation. It should be possible to qualify measures taken under other Union legislation as risk reduction measures under this Directive when those measures effectively reduce risks posed by contaminated sites.
Amendment 210 #
2023/0232(COD)
Proposal for a directive
Recital 51
Recital 51
(51) In order to ensure the necessary adaptation of the rules on soil health monitoring, sustainable soil management and management of contaminated sites, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending this Directive to adapt to technical and scientific progress the methodologies for monitoring soil health, the list of sustainable soil management principles, the indicative list of risk reduction measures, the phases and requirements for the site-specific risk assessment and the content of the register of contaminated and potentially contaminated sites. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 201672 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 72 Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making of 13 April 2016 (OJ L 123, 12.5.2016, p. 1).
Amendment 211 #
2023/0232(COD)
Proposal for a directive
Recital 53
Recital 53
(53) The Commission should carry out an evidence-based evaluation and, where relevant, a revision of this Directive, 6 years after its entry into force on the basis of the results of the soil health assessment. The evaluation should assess in particular the need to set more specific requirements to make sure unhealthy soils are regenerated and the objectivewhether the aim to achieve healthy soils by 2050 is achieved. The evaluation should also assess the need to adapt the definition of healthy soils to scientific and technical progress by adding provisions on certain descriptors or criteria based on new scientific evidence relating to the protection of soils or on the grounds of a problem specific to a Member State arising from new environmental or climatic circumstances. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making, that evaluation should be based on the criteria of efficiency, effectiveness, relevance, coherence and EU value added and should provide the basis for impact assessments of possible further measures.
Amendment 223 #
2023/0232(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. The objective of the Directive is to put in place a solid, flexible and coherent soil monitoring framework for allrelevant soils across the EU and to continuously improve soil health in the Union with the viewaim to achieve healthy soils by 2050 and maintain soils in healthy condition, so that they can supply multiple ecosystem services at a scale sufficient to meet environmental, societal and economic needs, prevent and mitigate the impacts of climate change and biodiversity loss, increase the resilience against natural disasters and for food security and that soil contamination is reduced to levels no longer considered harmful to human health and the environment.
Amendment 241 #
2023/0232(COD)
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
This Directive applies to allrelevant soils in the territory of Member States.
Amendment 258 #
2023/0232(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) ‘sustainable soil management’ means soil management practices that maintain or enhance the productivity of the soil and the ecosystem services provided by the soil without impairing the functions enabling those services, or being detrimental to other properties of the environment;
Amendment 282 #
2023/0232(COD)
(20) ‘soil contamination’ means the presence of a chemical or substance in the soil in a concentration that may bare harmful to human health or the environment;
Amendment 285 #
2023/0232(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 23
Article 3 – paragraph 1 – point 23
(23) ‘risk’ means the possibility of harmful effects to human health or the environment resulting from real world exposure to soil contamination;
Amendment 297 #
2023/0232(COD)
Proposal for a directive
Article 4 – paragraph 1 – subparagraph 1
Article 4 – paragraph 1 – subparagraph 1
Member States shallmay establish soil districts throughout their territory.
Amendment 300 #
2023/0232(COD)
Proposal for a directive
Article 4 – paragraph 1 – subparagraph 2
Article 4 – paragraph 1 – subparagraph 2
Amendment 308 #
2023/0232(COD)
Proposal for a directive
Article 4 – paragraph 2 – introductory part
Article 4 – paragraph 2 – introductory part
2. When establishing the geographic extent of soil districts, Member States mayshall take into account existing land use and administrative units and shall seek homogeneity within each soil district regarding the following parameters:
Amendment 331 #
2023/0232(COD)
Member States shall, if needed, designate one competent authority for each soil district established in accordance with Article 4.
Amendment 336 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Member States shall establish a monitoring framework, that may be based on the soil districts established in accordance with Article 4(1), to ensure that regular and accurate monitoring of soil health is carried out in accordance with this Article and Annexes I and II.
Amendment 338 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. Member States should make use of the expertise of national research institutes and existing national monitoring systems.
Amendment 340 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 3 – point a a (new)
Article 6 – paragraph 3 – point a a (new)
(a a) existing soil monitoring frameworks;
Amendment 341 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 3 – point a b (new)
Article 6 – paragraph 3 – point a b (new)
(a b) available data and assessments of soil health in Member States;
Amendment 343 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 3 – point d
Article 6 – paragraph 3 – point d
(d) therustworthy and scientifically robust remote sensing data and products referred to in paragraph 5 of this Article, if any;
Amendment 348 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
Amendment 358 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The Commission shallmay, subject to agreement from Member States concerned, carry out regular soil measurements on soil samples taken in-situ, based on the relevant descriptors and methodologies referred to in Articles 7 and 8, to support Member States’ monitoring of soil health. Where a Member State provides agreement in accordance with this paragraph, it shall ensure that the Commission can carry out such in-situ soil sampling.
Amendment 360 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 6 – introductory part
Article 6 – paragraph 6 – introductory part
6. The Commission and the EEA shall, on the basis of existing data and within two years of the entry into force of this Directive, establish a digital soil health data portal that shall provide access in georeferenced spatial format, in line with the regulation 223/2009 of the European Parliament and of the Council, to at least the available soil health data resulting from:
Amendment 362 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 6 – introductory part
Article 6 – paragraph 6 – introductory part
6. The Commission and the EEA shall, on the basis of existing data and within two years of the entry into force of this Directive, establish a digital soil health data portal that shall provide access in georeferenced spatial format to at leasto the available soil health data resulting from:
Amendment 370 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 1 – subparagraph 1
Article 7 – paragraph 1 – subparagraph 1
When monitoring and assessing soil health, Member States shall apply the relevant soil descriptors and soil health criteria listed in Annex I, while taking into account national, local, climatic and soil type specificites.
Amendment 371 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States may adapt the soil descriptors and the soil health criteria referred to in part A of Annex I, in accordance withbased on the specifications referred to in the second and third columns in part A of Annex I, taking into account national, local, climatic and soil type specificites.
Amendment 378 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. If relevant, Member States shall determine the organic contaminants for the soil descriptor related to soil contamination referred to in part B of Annex I.
Amendment 380 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States shall set soil health criteria for the soil descriptors listed in part B of Annex I in accordance with the provisions set out in the third column in part B of Annex I, taking into account national, local, climatic and soil type specificites.
Amendment 389 #
2023/0232(COD)
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Member States shall determine sampling points by applying the methodology set out in part A of Annex II, taking into account risk assessments based on existing monitoring systems.
Amendment 390 #
2023/0232(COD)
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Member States shall, based on a risk-based assessment and existing monitoring systems, determine sampling points by applying the methodology set out in part A of Annex II.
Amendment 397 #
2023/0232(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1
Article 8 – paragraph 5 – subparagraph 1
Member States shall ensure that new soil measurements are performed at least every 5 yearin regular, risk-based, intervals.
Amendment 405 #
2023/0232(COD)
Proposal for a directive
Article 8 – paragraph 6
Article 8 – paragraph 6
Amendment 408 #
2023/0232(COD)
Proposal for a directive
Article 8 – paragraph 6
Article 8 – paragraph 6
6. The Commission is empowered to adopt delegated acts in accordance with Article 20 to amend Annex II in order to adapt the reference methodologies mentioned in it to scientific and technical progress, in particular where values of soil descriptors can be determined by remote sensing referred to in Article 6(5).
Amendment 413 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 1 – subparagraph 1
Article 9 – paragraph 1 – subparagraph 1
Member States shall assess the soil health in all their soil districts based on the data collected in the context of the monitoring referred to in Articles 6, 7 and 8 for each of the soil descriptors referred to in Parts A and B of Annex I and and taking into account documented changes in the sampling areas.
Amendment 414 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 1 – subparagraph 1
Article 9 – paragraph 1 – subparagraph 1
Member States shall assess the soil health in all their soil districts based on the data collected in the context of the monitoring referred to in Articles 6, 7 and 8 for each of the relevant soil descriptors referred to in Parts A and B of Annex I.
Amendment 417 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 1 – subparagraph 3
Article 9 – paragraph 1 – subparagraph 3
Member States shall ensure that soil health assessments are performed at least every 5 yearson a regular, risk-based, interval and that the first soil health assessment is performed by … (OP: please insert the date = 5 years after date of entry into force of the Directive).
Amendment 426 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 1 – introductory part
Article 9 – paragraph 2 – subparagraph 1 – introductory part
A soil is considered healthy in accordance with this Directive where the following cumulative conditions are fulfilled, or when there are harmless or acceptable deviation from the target values, taking national, local, climatic and soil specific conditions into account:
Amendment 434 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 1 – point a
Article 9 – paragraph 2 – subparagraph 1 – point a
(a) the values for allthe relevant soil descriptors listed in part A of Annex I meet the criteria laid down therein and, where applicable, adapted in accordance with Article 7;
Amendment 440 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 1 – point b
Article 9 – paragraph 2 – subparagraph 1 – point b
(b) the values for allthe relevant soil descriptors listed in part B of Annex I meet the criteria set in accordance with Article 7 (‘healthy soil’).
Amendment 449 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 3
Article 9 – paragraph 2 – subparagraph 3
Soil is unhealthy where at least one of the relevant criteria referred to in subparagraph 1 is not met (‘unhealthy soil’)to a significant degree and one other relevant criteria is not met (‘unhealthy soil’). If one relevant critera is not met to a significant degree, while all other criteria are met, the competent authority should assess if this can justify that the soil is deemd to be unhealty, taking into account national, local, climatic and soil specifities.
Amendment 466 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 4
Article 9 – paragraph 4
4. Based on the assessment of soil health carried out in accordance with this Article, the competent authority shall, where relevant in coordination with local, regional, national authorities, identify, if relevant in each soil district, the areas which present unhealthy soils and inform the public in accordance with Article 19.
Amendment 472 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 5
Article 9 – paragraph 5
Amendment 497 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1 – point a
Article 10 – paragraph 1 – subparagraph 1 – point a
(a) defining sustainable soil management practices respectingbased upon the sustainable soil management principles listed in Annex III, to be gradually implemented on all managed soils and, on the basis of the outcome of the soil assessments carried out in accordance with Article 9, regeneration practices to be gradually implemented on the unhealthy soils in the Member Staterecommended to soil managers;
Amendment 502 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1 – point a
Article 10 – paragraph 1 – subparagraph 1 – point a
(a) defining sustainable soil management practices respectingtaking into account the sustainable soil management principles listed in Annex III to be gradually implemented on all managed soils and, on the basis of the outcome of the soil assessments carried out in accordance with Article 9, regeneration practices to be gradually implemented on the unhealthy soils in the Member States;
Amendment 506 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1 – point b
Article 10 – paragraph 1 – subparagraph 1 – point b
(b) defining soil management practices and other practices affecting negativelythat significantly affecting the soil health negatively, to be avoided by soil managers.
Amendment 525 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
Amendment 527 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
Amendment 532 #
2023/0232(COD)
Proposal for a directive
Article 11
Article 11
Amendment 638 #
2023/0232(COD)
Proposal for a directive
Article 18 – paragraph 1 – subparagraph 1 – point c – point i
Article 18 – paragraph 1 – subparagraph 1 – point c – point i
(i) implementing sustainabledefining soil management principles in accordance with Article 10;
Amendment 664 #
2023/0232(COD)
Proposal for a directive
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 8, 10, 15 and 16 shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Directive.
Amendment 667 #
2023/0232(COD)
Proposal for a directive
Article 20 – paragraph 3
Article 20 – paragraph 3
3. The delegation of power referred to in Articles 8, 10, 15 and 16 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 674 #
2023/0232(COD)
Proposal for a directive
Article 22 – paragraph 2
Article 22 – paragraph 2
Member States shall determine what constitutes a sufficient interest and impairment of a right, consistently with the objective of providing the public with wide access to justice. For the purposes of paragraph 1, any non-governmental organisation promoting environmental protection and meeting any requirements under national law shall be deemed to have rights capable of being impaired and their interest shall be deemed sufficient.
Amendment 677 #
2023/0232(COD)
Proposal for a directive
Article 23
Article 23
Amendment 703 #
2023/0232(COD)
Proposal for a directive
Article 24 – paragraph 1 – introductory part
Article 24 – paragraph 1 – introductory part
1. By (OP :please insert the date = 6 years after the date of entry into force of the Directive), the Commission shall carry out an evaluation of this Directive to assess the progress towards its objectives and the need to amend its provisions in order to set more specific requirements to ensure that unhealthy soils are regenerated and that all soils willare aimed to be healthy by 2050. This evaluation shall take into account, inter alia, the following elements:
Amendment 727 #
2023/0232(COD)
Proposal for a directive
Annex III – paragraph 1 – introductory part
Annex III – paragraph 1 – introductory part
The following principles shall applycould be taken into account:
Amendment 730 #
2023/0232(COD)
Proposal for a directive
Annex III – paragraph 1 – point a
Annex III – paragraph 1 – point a
(a) when possible, avoid leaving soil bare by establishing and maintaining vegetative soil cover, especially during environmentally sensitive periods;
Amendment 732 #
2023/0232(COD)
Proposal for a directive
Annex III – paragraph 1 – point b
Annex III – paragraph 1 – point b
(b) minimise unnecessary physical soil disturbance;
Amendment 734 #
2023/0232(COD)
Proposal for a directive
Annex III – paragraph 1 – point c
Annex III – paragraph 1 – point c
(c) avoid inputs or release of non- certified substances into soil that may harm human health or the environment, or degrade soil health;
Amendment 736 #
2023/0232(COD)
Proposal for a directive
Annex III – paragraph 1 – point d
Annex III – paragraph 1 – point d
(d) ensure that machinery use is adapted to the strength of the soil, and that the number and frequency of operations on soils are limited so that they over time do not compromise soil health;
Amendment 741 #
2023/0232(COD)
Proposal for a directive
Annex III – paragraph 1 – point g
Annex III – paragraph 1 – point g
(g) ensure soil proteductionvity by the creation and maintenance of adequate landscape features at the landscape level;109 _________________ 109 This principle does not apply to forest soils
Amendment 742 #
2023/0232(COD)
Proposal for a directive
Annex III – paragraph 1 – point i
Annex III – paragraph 1 – point i
(i) ensure optimised water levels in organic soils so that the structure and composition of such soils or the productivity are not negatively affected;110 _________________ 110 This principle does not apply to urban soils
Amendment 49 #
2023/0228(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) The aim of this Regulation is to ensure the production and marketing of high-quality FRM. To help create resilient forests and restoreand productive forests and to increase the functioning of forest ecosystems, users should be informed prior to the purchase of FRM about the suitability of that FRM for the climatic and ecological conditions of the area where it will be used.
Amendment 59 #
2023/0228(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) Genetically modified FRM may only be placed on the market if it is safe for human health and the environment and has been authorised for cultivation pursuant to Directive 2001/18/EC of the European Parliament and of the Council27 or Regulation (EC) 1829/200328 and if that FRM belongs to the tested category. FRM obtained by certain new genomic techniques could deliver benefits to the sector and to the environment with potential to contribute to the Union's innovation and sustainability goals. FRM obtained by certain new genomic techniques may only be placed on the market if it complies with the requirements of Regulation (EU) [Publications Office, please insert reference to Regulation (EU) of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed29 and if that FRM belongs to the tested category. _________________ 27 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1). 28 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1). 29 Regulation (EU) …/… of the European Parliament and of the Council …. (OJ …, p.).
Amendment 71 #
2023/0228(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) help create productive and resilient forests, conservenhance biodiversity and restore forest ecosystemsthe functioning of forest ecosystems, in order to underpin sustainable forestry;
Amendment 73 #
2023/0228(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) support wood, timber and biomaterials production, climate adaptation, climate mitigation and the conservation and sustainable use of forest genetic resources.
Amendment 77 #
2023/0228(COD)
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 2 – point c
Article 2 – paragraph 3 – subparagraph 2 – point c
(c) are considered important for their contribution to adaptation to climate change, andny of the objective listed in article 2(2), point (b) and (c).
Amendment 79 #
2023/0228(COD)
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 2 – point d
Article 2 – paragraph 3 – subparagraph 2 – point d
Amendment 84 #
2023/0228(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – introductory part
Article 3 – paragraph 1 – point 1 – introductory part
(1) ‘forest reproductive material’ (‘FRM’) means cones, infructescenses, fruits and seeds intended for the production of aseed units, parts of plants and planting stock, that belong to tree species and artificial hybrids thereof listed in Annex I to this Regulation and used for afforestation, reforestation and, other tree planting and direct seeding on land classified as forest for any of the following purposes:
Amendment 85 #
2023/0228(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point a
Article 3 – paragraph 1 – point 1 – point a
(a) wood, timber and biomaterials production;
Amendment 87 #
2023/0228(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point b
Article 3 – paragraph 1 – point 1 – point b
(b) biodiversity conservationenhancement;
Amendment 88 #
2023/0228(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point c
Article 3 – paragraph 1 – point 1 – point c
(c) restorasupporting the functioning of forest ecosystems;
Amendment 183 #
2023/0228(COD)
Proposal for a regulation
Article 23 – paragraph 3 – point a – point ii
Article 23 – paragraph 3 – point a – point ii
(ii) the protection of the environment: adaptation to climate change or the contribution to the protection of biodiversity, restora, enhancement of biodiversity, or supporting the functioning of forest ecosystems;
Amendment 104 #
2023/0227(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
(e) to contribute to sustainable and productive agricultural production, adapted to current and future projected climatic conditions;
Amendment 223 #
2023/0227(COD)
Proposal for a regulation
Article 52 – title
Article 52 – title
Value for sustainable and productive cultivation and use
Amendment 226 #
2023/0227(COD)
Proposal for a regulation
Article 52 – paragraph 1 – subparagraph 1
Article 52 – paragraph 1 – subparagraph 1
For the purposes of Article 47(1), point (c), the value of a variety for sustainable and productive cultivation and use of a variety shall be considered as satisfactory if, compared to other varieties of the same species registered in the national variety register of the respective Member State, its characteristics, taken as a whole, offer a clear improvement for the sustainable and productive cultivation and the uses which can be made of the crops, other plants or the products derived therefrom.
Amendment 233 #
2023/0227(COD)
Proposal for a regulation
Article 52 – paragraph 1 – subparagraph 2 – point f
Article 52 – paragraph 1 – subparagraph 2 – point f
(f) characteristics that enhance the sustainability of storage, processing and distributioand productivity across the agrifood value chain;
Amendment 97 #
2023/0226(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) It is therefore necessary to adopt a specific legal framework for GMOCategory 1 NGT plants and products obtained by targeted mutagenesis and cisgenesis and related products when deliberatelyshall not be subject to the reuleased into the environment or placed on s and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. Targeted mutagenesis Category 1 NGT plants and products shall be exempted in Directive 2001/18/EC Annex 1 B like other marketutagenecis methods.
Amendment 109 #
2023/0226(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is more limited. For other organisms, such as microorganisms, the available knowledge will be reviewed in view of a future proposal. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time wider GMO legislation should be examined in view of the Commission conclusion that it is no longer fit purpose to ensure that requirements are science-based and proportional to the risk.
Amendment 158 #
2023/0226(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) In view of the high complexity of plant genomes, the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants should reflect the diversity of plants genomic size and their characteristics. Polyploid plants contain more than two homologous chromosomes. Within this, tetraploid, hexaploid, and octoploid have 4, 6 and 8 sets of chromosomes respectively. Polyploid plants tend to exhibit greater numbers of genetic modifications compared to monoploid plants. Based on this any limit to the total number of individual modifications per plant should reflect the plants “ploidy”, meaning the number of chromosomes set in a plant.
Amendment 209 #
2023/0226(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned in order to ensure transparency and traceability of such plants when they are listed in the database and for the purpose of labe. The information listed shall ing of plant reproductive material derived from themclude information on the technique(s) used to obtain the trait(s).
Amendment 222 #
2023/0226(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47 ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibiAs category 1 NGT plants could also have been obtained with conventional breeding techniques, their use should be permitted in organic production. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).
Amendment 240 #
2023/0226(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Provision should be made to ensure transparency as regards the use of category 1 NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. NGT plants that have obtained a category 1 NGT plant status declaration should be listed in a publicly available database including information on the technique(s) used to obtain the trait(s). To ensure traceability, transparency and choice for operators, during research and plant breeding, when selling seed to farmers or making plant reproductive material available to third parties in any other way, plant reproductive material of category 1 NGT plants should be labelled as category 1 NGT.
Amendment 329 #
2023/0226(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To achieve the goal of ensuring the effective functioning of the internal market, for NGT plants and related products should benefit from, the free movement of goods should be ensured, provided they comply with the requirements of other Union law.
Amendment 335 #
2023/0226(COD)
(40) Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of NGT plants and products and evaluate any accompanying impact on human and animal health, the environment and environmental, economic and social sustainability. Information should be collected regularly andongoing development of new genomic techniques, the Commission should carry out an evaluation within five years after the adoption of the first decision allowing the deliberate release or the marketing of NGT plants or NGT products in the Union, the Commission should carry out an evaluation of this Regulation to. This evaluation should measure the progress made towards the availability of NGT plants or NGT products containing such characteristics or properties on the EU market, with the aim of further improving this Regulation.
Amendment 392 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT plant;
Amendment 401 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precisetargeted locations in the genome of an organism;
Amendment 429 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b
Article 3 – paragraph 1 – point 7 – point b
(b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, on the condition that there are no further modifications that would make it subject to Directive 2001/18/EC orr progeny that has undergone further modifications and fulfils the criteria of equivalence to conventional plants, as set out in Annex I of this Regulation 1829/2003;
Amendment 431 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b a (new)
Article 3 – paragraph 1 – point 7 – point b a (new)
(ba) products for which it is not possible to provide an analytical method to detect, identify and quantify a genetic change made by an new genomic technique.
Amendment 443 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12
Article 3 – paragraph 1 – point 12
(12) ‘NGT product’ means a product, other than food and feed, containing or, consisting of aor produced from NGT plants and food and feedother products containing, or consisting of or produced from such a plants;
Amendment 474 #
2023/0226(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
(2) the plant is a category 2 NGT plant, and has been granted consent or has been authorised in accordance with Chapter III.
Amendment 487 #
2023/0226(COD)
Proposal for a regulation
Article 5 – title
Article 5 – title
Status of category 1 NGT plants and products
Amendment 490 #
2023/0226(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plantsCategory 1 NGT plants should be included in the techniques referred to in Annex 1B of Directive 2001/18.
Amendment 495 #
2023/0226(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 527 #
2023/0226(COD)
(c) a description of the trait(s) and characteristics which have been introduced or modified including information on the technique(s) used to obtain the trait(s);
Amendment 565 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentreasoned objections to the verification report within 20 days from the date of receipt of that report regard to the fulfilment of the criteria set out in Annex I, within 20 days from the date of receipt of that report. A reasoned objection by a Member State shall be science-based and shall directly refer to the criteria as set out in Annex I.
Amendment 579 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any commentsreasoned objection from a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.
Amendment 590 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a commentreasoned objection is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the comment(s) to the Commissionreasoned objection to the Commission and the other Member States without undue delay.
Amendment 598 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the commentreasoned objection(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 617 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
(c) a description of the trait(s) and characteristics which have been introduced or modified including information on the technique(s) used to obtain the trait(s);
Amendment 718 #
2023/0226(COD)
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 (new)
Article 10 – paragraph 1 – subparagraph 1 (new)
It shall be prohibited to label consumer products as containing NGT products or having been developed using NGT. It shall furthermore be prohibited to use ‘negative labelling’ by labelling products as not containing NGT products (non- NGT, free of NGT etc)
Amendment 792 #
2023/0226(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point l
Article 14 – paragraph 1 – point l
(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2)plant should be considered as category 1 NGT plant in accordance with Article 3(7)(c) of this Regulation;
Amendment 885 #
2023/0226(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. The incentives in this Article shall apply to category 2 NGT plants and category 2 NGT products, where at least one of the intended trait(s) of the NGT plant conveyed by the genetic modification is contained in Part 1 of Annex IIIArticle 51(1) of Regulation (2023/0227) and it does not have any traits referred to in Part 2 of that Annex.
Amendment 1009 #
2023/0226(COD)
Proposal for a regulation
Article 30 – paragraph 4
Article 30 – paragraph 4
4. No sooner than two years after the publication of the first report referred to in paragraph 1 the Commission shall carry out an evaluation of the implementation of this Regulation and its impact on human and animal health, the environment, consumer information, the functioning of the internal market herein the organic production, and economic, environmental and social sustainability.
Amendment 1012 #
2023/0226(COD)
Proposal for a regulation
Article 30 – paragraph 5 a (new)
Article 30 – paragraph 5 a (new)
5a. Every three years, the Commission shall review the criteria listed in Annex I and Annex III of this Regulation and, where appropriate, amend them by means of a delegated act, in order to ensure adaptation to the latest scientific and technological progress.
Amendment 1013 #
2023/0226(COD)
Proposal for a regulation
Article 30 – paragraph 5 a (new)
Article 30 – paragraph 5 a (new)
5a. By 2024, the Commission shall produce a report evaluating the specificities and needs for other sectors not covered in this legislation, such as microorganisms, including a proposal for further policy action.
Amendment 1054 #
2023/0226(COD)
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 230 genetic modifications per haploid genome of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.
Amendment 1075 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3 – introductory part
Annex I – point 3 – introductory part
(3) on the condition that the genetic modification does not interrupt an endogenous genecreate a chimeric protein:
Amendment 1083 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3 – point a
Annex I – point 3 – point a
(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool;
Amendment 1092 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3 a (new)
Annex I – point 3 a (new)
(3a) On the condition that NGTs are not used with the purpose of developing herbicide tolerant plants as described in recital 36;
Amendment 1169 #
2023/0226(COD)
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – introductory part
Annex III – Part 1 – paragraph 1 – introductory part
Traits justifying the incentives referred to in Article 22: are listed in Article 52(1) of Regulation (EU) 2023/0227.
Amendment 1172 #
2023/0226(COD)
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 1
Annex III – Part 1 – paragraph 1 – point 1
Amendment 1175 #
2023/0226(COD)
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 2
Annex III – Part 1 – paragraph 1 – point 2
Amendment 1176 #
2023/0226(COD)
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 3
Annex III – Part 1 – paragraph 1 – point 3
Amendment 1179 #
2023/0226(COD)
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 4
Annex III – Part 1 – paragraph 1 – point 4
Amendment 1181 #
2023/0226(COD)
Amendment 1183 #
2023/0226(COD)
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 6
Annex III – Part 1 – paragraph 1 – point 6
Amendment 1184 #
2023/0226(COD)
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 7
Annex III – Part 1 – paragraph 1 – point 7
Amendment 105 #
2023/0210(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) To achieve comparability, the estimated currency conversion charges for credit transfers and remittances carried out within the Union and from the Union to a third country should be expressed in the same way, namely as a percentage mark- up over the latest available euro foreign exchange reference rates issued by the European Central Bank (ECB)charge in the currency in which the transaction is initiated. This currency conversion charge is made up of any mark-up over the mid- market exchange rate offered by neutral, independent and credible providers, expressed in a monetary value. When reference is made to ‘charges’ in this Regulation, it should also cover, where applicable, ‘currency conversion’ charges.
Amendment 180 #
2023/0210(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32
Article 3 – paragraph 1 – point 32
(32) ‘reference exchange rate’ means the exchange rate which is used asby the basis to calculate any currency conversion cost and which is disclosed by the payment service provider or comes from a publicly available sourcepayment service provider for a currency conversion service and is compared against the mid-market exchange rate to calculate the currency conversion cost;
Amendment 181 #
2023/0210(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32 a (new)
Article 3 – paragraph 1 – point 32 a (new)
(32 a) ‘mid-market exchange rate’ means the exchange rate which is used as the basis for comparison against the reference exchange rate to calculate any currency conversion cost and which is aggregated by neutral and credible providers;
Amendment 202 #
2023/0210(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Where a currency conversion service is offered prior to the initiation of the payment transaction and where that currency conversion service is offered at an ATM, at the point of sale or by the payee, the party offering the currency conversion service to the payer shall disclose to the payer all charges, including any mark-ups over the aggregated mid-market exchange rate offered by neutral and credible providers, and the exchange rate to be used for converting the payment transaction.
Amendment 212 #
2023/0210(COD)
Proposal for a regulation
Article 13 – paragraph 1 – introductory part
Article 13 – paragraph 1 – introductory part
1. Payment service providers shall provide in an easily understandable way or make available to payment service users the following information and conditions:
Amendment 216 #
2023/0210(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point f
Article 13 – paragraph 1 – point f
(f) where applicable, the estimated charges for currency conversion in relation to credit transfers and money remittance transactions, expressed as a percentage mark-up over the latest available applicable foreign exchange reference rate issued by the relevin a monetary value in the payer's currency over the mid-market exchange rate offered by neutral antd central bankredible providers;
Amendment 222 #
2023/0210(COD)
Proposal for a regulation
Article 20 – paragraph 1 – introductory part
Article 20 – paragraph 1 – introductory part
The payment service provider shall provide in an easily understandable way the following information and conditions to the payment service user:
Amendment 228 #
2023/0210(COD)
Proposal for a regulation
Article 20 – paragraph 1 – point c – point v
Article 20 – paragraph 1 – point c – point v
(v) where applicable, the estimated charges for currency conversion services in relation to a credit transfer expressed as a percentage mark-up over the latest available applicable foreign exchange reference rate issued by the relevmark-up in a monetary value in the payer's currency over the mid-market exchange rate offered by neutral antd central bankredible providers;
Amendment 7 #
2023/0199(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Directive 2003/87/EC54 should be amended to allow for additional financing with a financial envelope for the period 2024-2027 of EUR 5 billion. The Innovation Fund supports investments in innovative low-carbon technologies, which is a scope that is to be covered by the STEP. The increase in volume of the Innovation Fund should therefore allow to provide financing responding to the objective of supporting the development or manufacturing in the Union of critical clean technologies. In line with the objectives of ensuring cohesion and promoting the Single Market, and in order to support the green transition and the development of clean technologies throughout the Union, the additional financial envelope should be made available through calls for proposals open to entities from all Member States whosile average GDP per capita is below the EU average of the EU-27 measured in purchasing power standards (PPS) and calculated on the basis of Union figures for the period 2015-2017iming at a geographical balance of financial support taking into account the amount of state aid that has been allocated for these technologies by Member States under the Temporary Crisis Framework. _________________ 54 Directive 2003/87/EC establishing a scheme for greenhouse gas emission allowance trading (OJ L 275, 25.10.2003, p. 32).
Amendment 15 #
2023/0199(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point 1
Article 9 – paragraph 1 – point 1
Directive 2003/87/EC
Article 10a(8)
Article 10a(8)
In addition to the allowances referred to in the first to fifth subparagraphs of this paragraph, the Innovation Fund shall also implement a financial envelope for the period from 1 January 2024 to 31 December 2027 of EUR 5 000 000 000 in current prices for supporting investments contributing to the STEP objective referred to in Article 2, point (a)(ii) of Regulation .../...63 [STEP Regulation]. This financial envelope shall be made available to support investments only inin all Member States, whosile average GDP per capita is below the EU average of the EU-27 measured in purchasing power standards (PPS) and calculiming at a geographical balance of financial support taking into account the amount of state aid that has been allocated onfor the basis of Union figures for the period 2015-2017se technologies by Member States under the Temporary Crisis Framework. _________________ 63 Regulation …/… of the European Parliament and of the Council … [insert full title and OJ reference].
Amendment 152 #
2023/0177(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) ESG ratings produced by regulated financial undertakings in the Union that aremay be, inter alia: (i) used for internal purposes; or for providing in-house financial services and products; (ii) provided externally as, or as part of, a product or service that is regulated by existing EU regulations or third country equivalents, such as Regulation (EU) 2019/2088 (SFDR), Regulation (EU) No 596/2014 (MAR), Directive 2014/65/EU (MiFID II), Regulation (EU) 2019/2089 (Low Carbon Benchmark Regulation), Directive 2009/65/EC (UCITS) and Directive 2011/61/EU (AIFMD); or (iii) used for providing in-house financial services and products; or (iv) provided to intra-group entities included in the accounting consolidated group or to the assets under management of the group;
Amendment 461 #
2023/0177(COD)
Proposal for a regulation
Article 49 – paragraph 1 a (new)
Article 49 – paragraph 1 a (new)
1 a. At the latest [2 years after entry into force of this Regulation], the Commission shall, in close cooperation with ESMA, publish a report considering whether the scope of this Regulation is sufficient to ensure confidence in the market and reach its objectives, including the need to extend the scope to ESG data providers. The report may be accompanied, if appropriate, by a legislative proposal.
Amendment 133 #
2023/0167(COD)
Proposal for a directive
Recital 10
Recital 10
(10) The level of costs and charges, as well as other more qualitative elements, such as environmental, social and governance (ESG) factors, participating in the real economy, and financial guarantees, that are associated with investment and insurance- based investment products can have a significant impact on investment returns, something that may not always be evident for retail investors. To ensure that products offer Value for Money for retail investors, Member States should ensure that firms authorised under Directive (EU) 2014/65 or Directive (EU) 2016/97 to manufacture or distribute investment products have clear pricing processes that enable a clear identification and quantification of all costs charged to retail investors and are designed to ensure that the costs and charges that are included in investment products or that are linked to their distribution are justified and proportionate in respect of the characteristics, objectives, strategy and expected performance of the product.
Amendment 140 #
2023/0167(COD)
Proposal for a directive
Recital 13
Recital 13
Amendment 143 #
2023/0167(COD)
Proposal for a directive
Recital 13 a (new)
Recital 13 a (new)
(13a) Embedded in the product governance process, the Value for Money concept could be a consideration of reasonable benefit(s) expected to be provided by the investment, when considering the risk/reward profile and the total costs to the customers as defined in MIFID Delegated Regulation 565/2017, article 50 and annex 2. The benefit(s) should be reasonable, relevant and of a qualitative and/or quantitative nature, meaning that a benefit is not necessarily a return expectation after costs but could also be services.
Amendment 148 #
2023/0167(COD)
Proposal for a directive
Recital 15
Recital 15
Amendment 153 #
2023/0167(COD)
Proposal for a directive
Recital 17
Recital 17
Amendment 182 #
2023/0167(COD)
Proposal for a directive
Recital 34
Recital 34
(34) To ensure that, in the context of advised services, due consideration is given to portfolio diversification, financial advisors should be systematically required to consider the needs of such diversification for their clients or customers, as part of the suitability assessments, including on the basis of information provided by those clients or customers on their existing portfolio of financial and non-financial assets.
Amendment 194 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Directive 2014/65/EU
Article 4 – paragraph 1 – point 66 a (new)
Article 4 – paragraph 1 – point 66 a (new)
(66a) ‘Offers’ means actively marketing and providing services and financial instruments without giving a personal recommendation to an investor. However, it is a financial instrument is always offered, if the financial instrument (i) is produced by the investment firm, or (ii) is produced by any enterprise having a close relationship with the investment firm, and (iii) entails that the investment firm receives and retains any benefit, monetary or non-monetary, in relation to the financial instrument. It is a prerequisite for an investment firm willing to provide execution services in financial instruments, which it does not “offer” or “recommend” that the investment firm as part of its product governance arrangements for its investment services has defined which types of financial instruments it is willing to provide execution services in without having defined a target market. However, the investment firm must still ensure that the financial instrument is not sold to the negative target market.
Amendment 213 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7 a (new)
Article 1 – paragraph 1 – point 7 a (new)
Directive 2014/65/EU
Article 9 – paragraph 3 – subparagraph 1 and 2
Article 9 – paragraph 3 – subparagraph 1 and 2
"3. Member States shall ensure that the management body of an investment firm defines, oversees and is accountable for the implementation of the governance arrangements that ensure effective and prudent management of the investment firm including the segregation of duties in the investment firm and the prevention of conflicts of interest, and in a manner that promotes the integrity of the market and the interest of clients. Without prejudice to the requirements established in Article 88(1) of Directive 2013/36/EU, those arrangements shall also ensure that the management body define, approve and oversee: (a) the organisation of the firm for the provision of investment services and activities and ancillary services, including the skills, knowledge and expertise required by personnel, the resources, the procedures and the arrangements for the provision of services and activities, taking into account the nature, scale and complexity of its business and all the requirements the firm has to comply with; (b) a policy as to services, activities, products and operations offered or provided, in accordance with the risk tolerance of the firm and the characteristics and needs of the clients of the firm to whom they will be offered or provided, including carrying out appropriate stress testing, where appropriate. The policy must ensure that the intended benefits to the clients are taken into consideration; (c) a remuneration policy of persons involved in the provision of services to clients aiming to encourage responsible business conduct, fair treatment of clients as well as avoiding conflict of interest in the relationships with clients. "
Amendment 228 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 1 – point e
Article 16–a – paragraph 1 – point e
Amendment 238 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 1 – point e a (new)
Article 16–a – paragraph 1 – point e a (new)
(ea) a clear description and assessment of any benefits related to the financial instruments ensuring that they are reasonable and relevant for the intended target market under due consideration to the identified target market’s needs, characteristics and objectives.
Amendment 244 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 1 – subparagraph 3
Article 16–a – paragraph 1 – subparagraph 3
Amendment 250 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 1 – subparagraph 3 a (new)
Article 16–a – paragraph 1 – subparagraph 3 a (new)
Further, the product approval process shall ensure that the investment firm takes the clients best interest into consideration in the manufacturing of the financial instruments and takes into account the benefits to the customer – both monetary and non-monetary – that the financial instruments intent to create.
Amendment 252 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 1 – subparagraph 4
Article 16–a – paragraph 1 – subparagraph 4
Amendment 260 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 1 – subparagraph 4 (new)
Article 16–a – paragraph 1 – subparagraph 4 (new)
Member States shall require investment firms to ensure that the management body has effective control over the firm's product approval process. Investment firms shall ensure that the compliance reports to the management body systematically include information about the financial instruments manufactured by the firm, including information on the distribution strategy and the intended benefits to the clients related to the financial instruments. Investment firms shall make the reports available to their competent authority on request.
Amendment 262 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 1 – subparagraph 5
Article 16–a – paragraph 1 – subparagraph 5
Amendment 266 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 1 – subparagraph 5 (new)
Article 16–a – paragraph 1 – subparagraph 5 (new)
Member States shall require investment firms, when deciding the range of financial instrument and services that they offer or recommend and the respective target markets, to maintain procedures and measures to ensure compliance with all applicable requirements under this directive including those relating to disclosure, assessment of suitability or appropriateness, inducements and proper management of conflicts of interest. The management of conflicts of interest includes assessing whether the intended benefit(s) are reasonable, relevant and of a sufficient qualitative and/or quantitative nature taking into account both monetary and non-monetary benefits when compared to the costs and charges incurred by the client.
Amendment 267 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Amendment 275 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 2a (new)
Article 16–a – paragraph 2a (new)
2a. Member States shall require investment firms as part of the product approval process to undertake a scenario analysis of their financial instruments falling under the definition of packaged retail investment products in accordance with Article 4(1) of Regulation (EU) No 1286/2014 of the European Parliament and of the Council, which shall assess the risks of poor outcomes for end clients posed by the product and in which circumstances these outcomes may occur. The scenario analysis shall take all costs and charges into consideration including estimated reasonable cost linked to distribution of the financial instruments.
Amendment 276 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65
Article 16–a – paragraph 3
Article 16–a – paragraph 3
Amendment 279 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 3 a (new)
Article 16–a – paragraph 3 a (new)
3a. Member States shall require investment firms to determine whether the financial instrument's risk/reward profile is consistent with the target market and whether the financial instrument design is driven by features that benefit the client
Amendment 280 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 4 – subparagraph 1
Article 16–a – paragraph 4 – subparagraph 1
An investment firm shall regularly review financial instruments it offers or recommends, taking into account any event or risk that could materially affect the identified target market, to assess whether the financial instrument remains consistent with the objectives and needs of the identified target market and whether the benefits are still relevant for the identified target market and reasonable compared to the costs and charges. The firm must also consider whether the intended distribution strategy remains appropriate.
Amendment 282 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 4 (new)
Article 16–a – paragraph 4 (new)
Member States shall ensure that investment firms consider the charging structure proposed for the financial instrument, including by examining the following: (a) financial instrument's costs and charges are compatible with the needs, objectives and characteristics of the target market; (b) charges do not undermine the financial instrument's return expectations, such as where the costs or charges equal, exceed or remove almost all the expected tax advantages linked to a financial instrument; (c) the charging structure of the financial instrument is appropriately transparent for the target market, such as that it does not disguise charges or is too complex to understand, and (d) an assessment of the expected return of the financial instruments after all costs and charges including estimated reasonable cost linked to distribution.
Amendment 283 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 4 – subparagraph 2
Article 16–a – paragraph 4 – subparagraph 2
Amendment 297 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 4 – subparagraph 3
Article 16–a – paragraph 4 – subparagraph 3
Amendment 303 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65
Article 16–a – paragraph 4 – subparagraph 4
Article 16–a – paragraph 4 – subparagraph 4
Amendment 312 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65
Article 16–a – paragraph 5 – subparagraph 1
Article 16–a – paragraph 5 – subparagraph 1
Amendment 320 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 6
Article 16–a – paragraph 6
Amendment 330 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 6 a (new)
Article 16–a – paragraph 6 a (new)
6a. An investment firm that offers or recommends financial instruments which it does not manufacture, shall have in place adequate arrangements to obtain the information referred to in paragraph 1 and to understand the characteristics and identified target market of each financial instrument including the benefits assessed to be reasonable and relevant for the identified target market.
Amendment 334 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 7 – introductory part
Article 16–a – paragraph 7 – introductory part
7. An investment firm shall document all assessments made and shall, upon request, provide such assessments to a relevant competent authority, including the following:which offers or recommends financial instruments it does not manufacture shall have in place adequate product governance arrangements that ensures that the investment firm take into account the best interest of the target market and assesses the benefits to the identified target market of the financial instruments as well as the investment services the investment firm offers to clients. When assessing whether the products offered or recommended are compatible with the needs, characteristics and objectives of the identified target market, the investment firm should, when taking into account the product costs as well as service costs, and the benefit(s) provided to the client, make an assessment of whether the products and services cumulatively provide benefits to the client, also taking into consideration the expected investment horizon of the client.
Amendment 339 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65
Article 16–a – paragraph 7 – point a
Article 16–a – paragraph 7 – point a
Amendment 342 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65
Article 16–a – paragraph 7 – point b
Article 16–a – paragraph 7 – point b
Amendment 348 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 8
Article 16–a – paragraph 8
8. An investment firm which manufactures and offers or recommends the financial instrument may establish one pricing process relating to both manufacturing and distribution stagthat provides investment advice shall define a range of financial instruments for which it provides investment advice. The range of financial instruments shall be defined taking into consideration the best interests of the target market. When deciding the range of financial instruments to include when providing investment advice, the investment firm should include complexity, risk and the need for diversification, and the investment firm may decide a range for different groups of clients within the same client category based on client-relationship and interaction and client needs and preferences.
Amendment 352 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 9
Article 16–a – paragraph 9
Amendment 368 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 11
Article 16–a – paragraph 11
Amendment 376 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65
Article 16–a – paragraph 12 – subparagraph 1
Article 16–a – paragraph 12 – subparagraph 1
Amendment 391 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2014/65/EU
Article 16–a – paragraph 12 – subparagraph 2
Article 16–a – paragraph 12 – subparagraph 2
Amendment 404 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point a
Article 1 – paragraph 1 – point 12 – point a
Directive 2014/65/EU
Article 24 – paragraph 1
Article 24 – paragraph 1
1. Member States shall require that, when providing investment services or, where appropriate, ancillary services to clients, an investment firm act honestly, fairly and professionally in accordance with the best interests of its clients and comply, in particular, with the principles set out in this Article and Articles 24a to Article 25.;
Amendment 407 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2014/65/EU
Article 24 – paragraph 1 a – introductory part
Article 24 – paragraph 1 a – introductory part
1a. Member States shall ensure that, in order to act in the best interest of the client, when providing investment advice to retail clients for which inducements are received and retained, investment firms are under the obligation of the following:
Amendment 410 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2014/65/EU
Article 24 – paragraph 1 a – point a
Article 24 – paragraph 1 a – point a
(a) to provide advice on the basis of an assessment of an appropriate range of financial instruments; clearly inform the client before the suitability assessment is initiated and before any investment advice is provided: (1) whether the investment advice is provided taking into account a broad range of investment products, including from manufactures not having any close ties with the investment firm, or (2) whether the investment advice is based on a narrow range of financial instruments, including: (i) whether investment advice is only or predominately provided in connection with investment products manufactured by the investment firm, (ii) whether it only includes products manufactured by manufactures with a close relationship to the investment firm, and (iii) whether the investment advice is only or predominately done for investment products providing the investment firm with inducements unless these are of a minor non-monetary character.
Amendment 415 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2014/65/EU
Article 24 – paragraph 1 a – point b
Article 24 – paragraph 1 a – point b
Amendment 421 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2014/65
Article 24 – paragraph 1 a – point b a (new)
Article 24 – paragraph 1 a – point b a (new)
Amendment 425 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2014/65/EU
Article 24 – paragraph 1 a – point c
Article 24 – paragraph 1 a – point c
Amendment 429 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2014/65/EU
Article 24 – paragraph 1 a – point c a (new)
Article 24 – paragraph 1 a – point c a (new)
(ca) if the client asks to have assessed whether a specific financial instrument is suitable, the investment firm shall still inform the client of one or more other relevant financial instruments in accordance with subparagraph b.
Amendment 434 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b – point i (new)
Article 1 – paragraph 1 – point 12 – point b – point i (new)
Directive 2014/65/EU
Article 24 – paragraph 1 a a (new)
Article 24 – paragraph 1 a a (new)
1aa. The cost efficiency referred to in the first subparagraph, point (b), shall be determined on the basis of the investment firm’s assessment of the instrument’s net return expectations after all costs and charges performed under Article 16-a(4), point d with due consideration to the assessment performed according to Article 16-a(7) of the benefits provided to the client.
Amendment 435 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point c
Article 1 – paragraph 1 – point 12 – point c
Directive 2014/65/EU
Article 24 – paragraph 2 – introductory part
Article 24 – paragraph 2 – introductory part
Amendment 436 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point c
Article 1 – paragraph 1 – point 12 – point c
Directive 2014/65/EU
Article 24 – paragraph 2 – subparagraph 1 – point a
Article 24 – paragraph 2 – subparagraph 1 – point a
Amendment 437 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point c
Article 1 – paragraph 1 – point 12 – point c
Directive 2014/65/EU
Article 24 – paragraph 2 – subparagraph 1 – point b
Article 24 – paragraph 2 – subparagraph 1 – point b
Amendment 438 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point c
Article 1 – paragraph 1 – point 12 – point c
Directive 2014/65/EU
Article 24 – paragraph 2 – subparagraph 1 – point c
Article 24 – paragraph 2 – subparagraph 1 – point c
Amendment 486 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13
Article 1 – paragraph 1 – point 13
Directive 2014/65
Article 24 – paragraph 2
Article 24 – paragraph 2
Amendment 494 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13
Article 1 – paragraph 1 – point 13
Directive 2014/65
Article 24 – paragraph 3
Article 24 – paragraph 3
Amendment 507 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13
Article 1 – paragraph 1 – point 13
Directive 2014/65
Article 24a – paragraph 4 – subparagraph 1
Article 24a – paragraph 4 – subparagraph 1
Amendment 511 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13
Article 1 – paragraph 1 – point 13
Directive 2014/65
Article 24a – paragraph 4 – subparagraph 2
Article 24a – paragraph 4 – subparagraph 2
Amendment 645 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14 – point a
Article 1 – paragraph 1 – point 14 – point a
Directive 2014/65
Article 25 – paragraph 2 – subparagraph 1
Article 25 – paragraph 2 – subparagraph 1
Subject to the second subparagraph, when providing investment advice or portfolio management services, the investment firm shall obtain the necessary information regarding the client or potential client’s knowledge and experience in the investment field relevant to the specific type of product or service, that client’s financial situation, including the composition of any existing portfolios, its ability to bear full or partial losses, investment needs and objectives including sustainability preferences, if any, and risk tolerance, so as to enable the investment firm to recommend to the client or potential client the investment services or financial instruments that are suitable for that person, and, in particular, are in accordance with its risk tolerance, ability to bear losses and need for portfolio diversification.
Amendment 649 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14 – point a
Article 1 – paragraph 1 – point 14 – point a
Directive 2014/65
Article 25 – paragraph 2 – subparagraph 2
Article 25 – paragraph 2 – subparagraph 2
When providing independent investment advice to retail clients restricted to well- diversified, non- complex, and cost- efficient financial instruments, the independvestment firm shall be under no obligation to obtain information on the retail client or potential retail client’s knowledge and experience about the considered financial instruments or investment services or on the retail client’s existing portfolio composition.
Amendment 652 #
2023/0167(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14 – point a
Article 1 – paragraph 1 – point 14 – point a
Member States shall ensure that investment firms, when providing investment services other than those referred to in paragraph 2, ask the client or potential client to provide information regarding their knowledge and experience in the investment field relevant to the specific type of product or service offered or demanded, and for the retail client or potential retail client, the capacity to bear full or partial losses and risks tolerance so as to enable the investment firm to assess whether the investment service(s) or financial instrument(s) envisaged is appropriate for the client.
Amendment 324 #
2023/0138(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) ‘'net expenditure’ means government expenditure net of interest expenditure, discretionary revenue measures and other budgetary variables outside the control of the government as set out in Annex II, point (a);, expenditure on programmes of the Union fully matched by Union funds revenue and cyclical elements of unemployment benefit expenditure.
Amendment 499 #
2023/0138(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point e a (new)
Article 6 – paragraph 1 – point e a (new)
(e a) the fiscal adjustment necessary to put or keep public debt ratio on a plausibly declining path with debt reductions of 1-1.5% of GDP annually on average over the 4 years following the adjustment period, depending on debt levels and sustainability and the business cycle.
Amendment 510 #
2023/0138(COD)
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Article6a Requirements for setting the technical trajectory When designing the technical trajectory for each Member State, the Commission shall ensure that: (a) by the end of the adjustment period, at the latest, the 10-year debt trajectory in the absence of further budgetary measures is on a credibly downward path or stays at prudent levels; (b) the government deficit is brought and maintained below the 3% of GDP reference value in the absence of further budgetary measures over the same 10- year period; (c) for the years that the Member State concerned is expected to have a deficit above the 3% of GDP reference value, and the excess is not close and temporary, the technical trajectory is also consistent with the benchmark referred to under Article 3 of Regulation (EC) No 1467/97 as amended by Regulation (EU) [on the corrective arm]; (d) the public debt ratio stabilises over the adjustment period and is reduced over the projection period. The Commission will set out the minimum annual average adjustment figure for each Member State within a range of [x] p.p of debt to GDP and [y] p.p of debt to GDP, depending on that Member State's debt levels and sustainability and the business cycle, for the whole projection period. The technical trajectories shall be differentiated for each Member State.
Amendment 218 #
2023/0132(COD)
Proposal for a directive
Recital 47
Recital 47
(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory data protection for market launch shall take place in the Pharmaceutical Committee. The Commission may 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 220 #
2023/0132(COD)
Proposal for a directive
Recital 48
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, cooperation in this area is essential in order to avoid that decisions in one Member State create shortages in other Member States. For this reason, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. While the price paid within a given Member State reflects the preference of a national health system, more coordination on pricing and procurement could contribute to more equal and timely access to medicines, including for Member States with lower purchasing power. The Commission may support joint price negotiation with pharmaceutical companies, as per the Beneluxa Initiative on Pharmaceutical Policy and the Valletta Declaration. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on national pricing, reimbursment and public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
Amendment 222 #
2023/0132(COD)
Proposal for a directive
Recital 48
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, tcooperation and dialogue with all stakeholders in this areas could help to avoid that decisions in one Member State contribute to unavailability in other Member States. The Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
Amendment 225 #
2023/0132(COD)
Proposal for a directive
Recital 49
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases, antibiotics and generic and biosimilar medicinal products. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
Amendment 237 #
2023/0132(COD)
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, 'negative impact on quality of life', ‘'relevant patient population’ following scientific assessment by the Agency and with input from patient organisations and other relevant stakeholders. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 252 #
2023/0132(COD)
Proposal for a directive
Recital 54
Recital 54
(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to marketsubmit an application for pricing and reimbursement for a medicinal product in the Member States where a Member State has requested it and the marketing authorisation is valid for the purposes of receiving additional regulatory data protection.
Amendment 256 #
2023/0132(COD)
Proposal for a directive
Recital 55
Recital 55
(55) When applying the provisions on market launch incentives, mMarketing authorisation holders and Member States should do their utmost to achieve a mutually agreed supply of medicinal products in accordance with the needs of the Member State concerned, without unduly delaying or hindering the other party from enjoying its rights under this Directive.
Amendment 308 #
2023/0132(COD)
Proposal for a directive
Recital 67
Recital 67
(67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States who. Member States should ensure appropriate collection system for all medicinal products.
Amendment 316 #
2023/0132(COD)
Proposal for a directive
Recital 69 a (new)
Recital 69 a (new)
(69 a) A progressive reform towards unitary packaging of medicines, in particular in hospital pharmacies, could result in a decrease of the materials used for the packaging of medicines, a reduction of the carbon footprint of the transport of medicines, a reduction in medicines waste, a better management of pollution from pharmaceutical waste, a prevention of tension and shortages of medicines, and an innovative tool to fight against antimicrobial resistance. The use of single dose unit containing all usefull information, in hospital environnement, could represent an improvement in favor of minimizing the risk of medication errors and therefore increased patient protection.
Amendment 321 #
2023/0132(COD)
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refusedcould be refused. Refusal of a marketing authorization should not be considered if the medicinal product can be authorized under the conditional marketing authorization process or the Temporary Emergency Marketing Authorization in order to not prohibit or delay patient access to medicines. The ERA should be updated when new data or knowledge about relevant risks become available.
Amendment 357 #
2023/0132(COD)
Proposal for a directive
Recital 123
Recital 123
(123) Certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorised to supply medicinal products to the public certain public service obligations. Those Member States should be able to continue to impose those obligations on wholesalers established within their territory. They should also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those that they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection. Member States should also impose certain obligations of public services to wholesalers within the limits of their responsibilities to ensure that medicinal products made available on one market are not placed on another market to avoid creating a shortage for patients.
Amendment 359 #
2023/0132(COD)
Proposal for a directive
Recital 123 a (new)
Recital 123 a (new)
(123 a)Pharmacists have always had a role in primary care, particularly to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and to support patients suffering of acute and chronic illnesses. As responsible for dispensing the medicinal products, pharmacists also monitor their proper use and compliance by the patient, provide advice in particular to avoid the risks of iatrogenics (all the undesirable effects caused by taking one or more medications) and carry out medication reviews. In an hospital environment, hospital pharmacists are even setting up pharmaceutical consultations and designing personalised pharmaceutical plans, in cooperation with health professionals, patients and carers. Hospital pharmacists and community pharmacists could play a major role in the progressive use of electronic package leaflets.
Amendment 363 #
2023/0132(COD)
Proposal for a directive
Recital 128
Recital 128
(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. Based on the findings from hospital pilots, the obligation to provide a paper leaflet should be lifted for medicinal products not intended for self- administration by the patient.
Amendment 367 #
2023/0132(COD)
Proposal for a directive
Recital 130
Recital 130
(130) The use of multi-language packages can be a tool for access to medicinal products, in particular for small markets and in public health emergencies. Where multi-language packages are used, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi- language package is marketed. While electronic medicinal product information will facilitate their redistribution between Member States, language requirements on labels will remain a challenge. Removing the obligation for an official language and introducing the obligation to use the international non-proprietary name for medicinal products not intended for self- administration by the patient, in addition to providing electronic product information, could improve the availability of medicinal products and enable easier redistribution between Member States.
Amendment 395 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 5 – point c a (new)
Article 1 – paragraph 5 – point c a (new)
(c a) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’). Hospital formulae are supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department.
Amendment 396 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 5 – point c b (new)
Article 1 – paragraph 5 – point c b (new)
(c b) radiopharmaceuticals, prepared in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such process, or in accordance with a pharmacopoeia and if the radiopharmaceutical is intended to be used in-house, for diagnostic as well as therapeutic applications.
Amendment 400 #
2023/0132(COD)
6. Medicinal products referred to in paragraph 5, point (a), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven daysaccording to appropriate stability.
Amendment 419 #
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 and a hospital pharmacist, 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’).
Amendment 430 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2 a. Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of shortages of critical medicines or to ensure the treatment of patients affected by rare diseases, in the absence of other solutions.
Amendment 434 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to thegood pharmacy preparation practices that are adapted to hospital proceesses and based on good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1).
Amendment 497 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 22
Article 4 – paragraph 1 – point 22
(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antiparasitics and antifungals;
Amendment 593 #
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 corresponding to the duration of treatment. If an antimicrobial can not be dispensed per unit, the marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.
Amendment 596 #
2023/0132(COD)
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 1 (new)
Article 17 – paragraph 3 – subparagraph 1 (new)
Pharmacists should play a role in antimicrobial stewardship, including advising on the prudent use of antibiotics and other antimicrobials, as well as their correct disposal.
Amendment 618 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment. When necessary, it shall also include information on available techniques and on the techniques that will be used to reduce the discharges and emissions of the medicinal product, in particular those occuring in manufacturing effluents before these effluents leave the manufacturing sites.
Amendment 632 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including also by the healthcare professionnals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
Amendment 668 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 4 a (new)
Article 23 – paragraph 4 a (new)
4 a. The Agency shall ensure that the ERA is followed by clear recommandations to the marketing authorisation holders on how to respect the guidelines and to fulfill the requirements in the future.
Amendment 763 #
2023/0132(COD)
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 October 2005 to avoid restricting patients' access to existing treatments;
Amendment 764 #
2023/0132(COD)
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant in cases where the medicinal product does not qualify for conditional marketing authorization or the Temporary Emergency Marketing Authorization;
Amendment 1383 #
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 healthcare professionals.
Amendment 1474 #
2023/0132(COD)
Proposal for a directive
Article 177 – paragraph 1 – subparagraph 1 (new)
Article 177 – paragraph 1 – subparagraph 1 (new)
Member States shall monitor the digital market services or products, websites, applications likely to broadcast advertising for prescription medicinal products for which advertising is prohibited according to article 177, paragraph 1.
Amendment 1545 #
2023/0132(COD)
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments.
Amendment 1555 #
2023/0132(COD)
Proposal for a directive
Article 196 – paragraph 1 – point f
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments.
Amendment 1565 #
2023/0132(COD)
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
Article 200 – paragraph 4 – subparagraph 1
The competent authority of the Member State may process personal health data from sources other than clinical studies, including real world data, to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder.
Amendment 1588 #
2023/0132(COD)
Proposal for a directive
Article 207 – paragraph 1 – subparagraph 1 (new)
Article 207 – paragraph 1 – subparagraph 1 (new)
Member States shall promote awareness- raising and educational campaigns for the general public on the environmental risks of pharmaceuticals and on how to improve disposal practices.
Amendment 1598 #
2023/0132(COD)
Proposal for a directive
Article 216 – paragraph 1
Article 216 – paragraph 1
By [OP please insert the date = 10 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it, in particular regarding the prolongation of data protection period to take into account the evolution of scientific knowledge and innovation.
Amendment 212 #
2023/0131(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Addressing unequal patient access of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe as has been highlighted by the Council and the European Parliament. Member States and the Parliament have called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring patient access and availability of medicinal products in all Member States.
Amendment 230 #
2023/0131(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Promising medicinal products that have the potential to significantly address patients’ unmet medical needs should benefit from early and enhanced scientific support, including through supporting innovative patient-relevant in vitro and in silico technologies which are key to the development of these products. Such support will ultimately help patients benefit from new therapies as early as possible.
Amendment 272 #
2023/0131(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients and their caregivers, healthcare professionals, industry, associations representing payers, or other stakeholders, as relevant.
Amendment 306 #
2023/0131(COD)
Proposal for a regulation
Recital 60
Recital 60
(60) Regulatory decision-making on the development, authorisation and supervision of medicinal products may be supported by access and analysis of health data, including real world data, where appropriate, i.e. health data generated outside of clinical studies and/or through the use of in silico methods, such as computational modelling and simulation (CM&S) which includes PBPK, molecular modelling and mechanistic modelling, digital twin & artificial intelligence (AI). The Agency should be able to use such data, including via the Data Analysis and Real World Interrogation Network (DARWIN) and the European Health Data Space interoperable infrastructure. Through these capabilities the Agency may take advantage of all the potential of supercomputing, artificial intelligence and big data science to fulfil its mandate, without compromising privacy rights. Where necessary the Agency may cooperate with the competent authorities of the Member States towards this objective.
Amendment 318 #
2023/0131(COD)
Proposal for a regulation
Recital 73
Recital 73
(73) To optimise the use of resources for both applicants for marketing authorisations and competent authorities assessing such applications, a single assessment of an active substance master file should be introduced. The outcome of the assessment should be issued through a certificate. To avoid duplication of assessment, the use of an active substance master file certificate should be mandatory for subsequent applications or marketing authorisations for medicinal products for human use containing that active substance from an active substance master file certification holder. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to extend the certification scheme to additional quality master files, e.g. in case of novel excipients, adjuvantsmaster files, such as quality master files for active substances other than chemical active substances or for other substances present or used in the manufacture of a medicinal product e.g. in case of novel excipients, adjuvants, raw materials, viral vectors and other starting materials, growth media, radiopharmaceutical precursors and, active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance and conjugates, or such as platform technology master files for platform technologies used in the manufacturing process of one or more medicinal products.
Amendment 399 #
2023/0131(COD)
Proposal for a regulation
Recital 92 a (new)
Recital 92 a (new)
(92 a) Significant benefit should remain the main determining factor for eligibility for orphan status when assessing an orphan medicinal product that meets the incidence threshold.
Amendment 401 #
2023/0131(COD)
Proposal for a regulation
Recital 92 b (new)
Recital 92 b (new)
(92 b) What constitutes significant benefit in a patient population can change over time, therefore, the concept should remain sufficiently flexible to ensure a future-proof regulatory framework while ensuring predictability through additional guidance developped in consultation with patient organisations.
Amendment 405 #
2023/0131(COD)
(93) If a satisfactory method of diagnosis, prevention or treatment of the condition in question has already been authorised in the Union, the orphan medicinal product will have to be of significant benefit to those affected by that condition. In this context, a medicinal product authorised in one Member State is generally deemed as being authorised in the Union. It is not necessary for it to have Union authorisation or to be authorised in all Member States to be considered as a satisfactory method. In addition, commonly used methods of diagnosis, prevention or treatment that are not subject to a marketing authorisation may be considered satisfactory if there is scientific evidence of their efficacy and safety. In certain cases, medicinal products prepared for an individual patient in a pharmacy according to a medical prescription, or according to the prescriptions of a pharmacopoeia and intended to be supplied directly to patients served by the pharmacy, may be considered as satisfactory treatment if they are well known and safe and this is a general practice for the relevant patient population in the Union. This only applies to medicinal products that are not advanced therapy medicinal products and that do not otherwise contain complex active substances.
Amendment 411 #
2023/0131(COD)
Proposal for a regulation
Recital 96 a (new)
Recital 96 a (new)
Amendment 428 #
2023/0131(COD)
Proposal for a regulation
Recital 104
Recital 104
(104) To maximise the potential benefit of clinical research, continued exploration of new indications should be encouraged. 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 two indications). To continue incentivising innovation, especially in underserved areas, while also allowing generic entry, any subsequent new orphan marketing authorisations granted to the marketing authorisation holder should receive three years of market exclusivity bound to the indication, not the active substance. This will allow generic competition in the first two orphan indications, while allowing for continued research for those patients who could still benefit.
Amendment 433 #
2023/0131(COD)
Proposal for a regulation
Recital 105 a (new)
Recital 105 a (new)
(105 a)One of the overarching goals of this Regulation is to help meeting the medical needs of patients with rare diseases, to improve the affordability of orphan medicinal products and the patient access to orphan medicinal products across the Union, and to encourage innovation in areas of need. While other Union programmes and policies also contribute to these goals, people living with a rare disease continue to face common challenges that are many and multifactorial, including delayed diagnoses, lack of available transformative treatments, and difficulties to access treatments where they live, reflecting the fragmentation of the market across the Member States. The European added value to addressing the needs of people living with a rare disease being exceptionally high due to the rarity of patients, experts, data, and resources, it is appropriate for the Commission to develop, to complement this Regulation, a dedicated framework for rare diseases to bridge relevant legislation, policies and programmes, and support national strategies with a view to better meet the unmet needs of people living with rare diseases and their carers. This framework should be needs driven and goals based, and developped in consultation with the Member States and patient organisations as well as, where relevant, other interested parties.
Amendment 438 #
2023/0131(COD)
(126) It is necessary to take measures for the supervision of medicinal products authorised by the Union, and in particular for the intensive supervision of undesirable effects of these medicinal products, and the collection of real-world data within the framework of Union pharmacovigilance activities, so as to ensure the rapid withdrawal from the market of any medicinal product presenting a negative benefit-risk balance under normal conditions of use.
Amendment 440 #
2023/0131(COD)
Proposal for a regulation
Recital 129
Recital 129
(129) Scientific and technological progresses in data analytics and data infrastructure are essential for the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data- driven and multiplying the possibilities to access evidence and real-world data, across the life cycle of a medicinal product. This Regulation recognises the Agency’s experience and capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On this basis, the Agency should take initiative to update the summary of product characteristics in case new efficacy or safety data has an impact on the benefit- risk balance of a medicinal product. In such case, the Agency and the marketing authorisation holder should collaborate to determine the particulars of any such update.
Amendment 457 #
2023/0131(COD)
Proposal for a regulation
Recital 134
Recital 134
(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, as well as legal certainty, a level playing field and fair competition always need to be ensured and existing levels of protection need to be respected. Whenever possible, priority should be given to the use of non-animal approaches.
Amendment 470 #
2023/0131(COD)
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment, including longer delays or interruptions in care or therapy, longer periods of hospitalisation, increased risks of exposure to falsified medicinal products, medication errors, adverse effects resulting from the substitution of unavailable medicinal products with alternative ones, significant psychological distress for patients and increased costs for healthcare systems. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.
Amendment 477 #
2023/0131(COD)
Proposal for a regulation
Recital 137
Recital 137
(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation, while allowing Member States to adopt or maintain legislation ensuring a higher degree of protection against medicine shortages, in respect of the commitments taken in the framework of the "Voluntary Solidarity Mechanism for medicines". It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe.
Amendment 484 #
2023/0131(COD)
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. The MSSG should develop in coordination with the Agency a Voluntary Solidarity Mechanism to allow Member States where stocks of important medicines are critically low and where other available options have been exhausted to send out on a voluntary basis a notification, to which other Members States may respond on a voluntary basis to provide temporary relief. This mechanism should leverage existing structures, including the European Shortages Monitoring Platform (‘ESMP’), established by Regulation (EU) 2022/123, and should invite manufacturers and wholesalers to participate where relevant. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 508 #
2023/0131(COD)
Proposal for a regulation
Recital 145
Recital 145
(145) Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, including some advanced therapy medicinal products, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental risk assessment and consent by the competent authority of a Member State is complex and can take a significant amount of time.
Amendment 521 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘orphan medicineal product sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);
Amendment 531 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 7 a (new)
Article 2 – paragraph 2 – point 7 a (new)
(7 a) 'adverse reaction' means a response to a medicinal product that is noxious and unintended, and includes medication errors and uses outside of the terms of the marketing authorisation, including the misuse and abuse of the medication product;
Amendment 549 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) ‘demand’ means the request for a medicinal product or a medical device by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product or the medical device is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients;
Amendment 550 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) ‘demand’ means the request for a medicinal product or a medical device by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product or the medical device is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients;
Amendment 559 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet the demand for that medicinal product in that Member State.or medical device at a national level, whatever the cause
Amendment 560 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet the demand for that medicinal product or medical device in that Member State, whatever the cause.
Amendment 564 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12 a (new)
Article 2 – paragraph 2 – point 12 a (new)
(12 a) ‘supply’ means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;
Amendment 565 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12 a (new)
Article 2 – paragraph 2 – point 12 a (new)
(12 a) ‘supply’ means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;
Amendment 572 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 14 a (new)
Article 2 – paragraph 2 – point 14 a (new)
(14 a) 'Healthcare professionals’ organisations’ means not-for-profit organisations that have an interest in patient care, and where healthcare professionals represent a majority of members in governing bodies.
Amendment 574 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 14 b (new)
Article 2 – paragraph 2 – point 14 b (new)
(14 b) ‘Patients’ organisations’ means as not-for-profit organisations which are patient focused, and where patients and/or carers (the latter when patients are unable to represent themselves) represent a majority of members in governing bodies.
Amendment 599 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment, including with regard to the quality of life of a relevant patient population or subpopulation, of a life- threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 607 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Where appropriate, the application may include an active substance master file certificate or an application for an active substance master file or any other quality master file certificate or application as referred to in Article 25 and Article 26 of [revised Directive 2001/83/EC].
Amendment 616 #
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 621 #
2023/0131(COD)
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Article6a Parallel application for one or more new indications (1) During the scientific assessment of an initial marketing authorisation application of a medicinal product by the Agency, the applicant may submit to the Agency a separate parallel application for one or more new indications concerning the same medicinal product. (2) The parallel application shall be assessed by the Agency as a marketing authorisation application in accordance with this Regulation, subject to the following: (a) To the extent the Committee for Medicinal Products for Human Use can assess the parallel application within the timeframe applicable to the initial marketing authorisation application, leading to the same outcome for both applications it shall group the applications and issue a single opinion. (b) To the extent the said Committee cannot issue an opinion on the parallel application within the timeframe applicable to the initial marketing authorisation application the parallel application shall be converted to a Type II variation application in accordance with Commission Regulation (EC) No 1234/2008. (c) If the initial marketing authorisation application is withdrawn or receives a negative opinion from the Committee for Medicinal Products for Human Use, the Committee will pursue the assessment of the parallel application as a standalone marketing authorisation application.
Amendment 643 #
2023/0131(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point h
Article 12 – paragraph 4 – point h
(h) where appropriate, details of any recommended obligation to conduct any other post-authorisation studies, including post-authorisation treatment optimisation studies, to improve the safe and effective use of the medicinal product;
Amendment 667 #
2023/0131(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant in cases where the medicinal product does not qualify for conditional marketing authorization or the Temporary Emergency Marketing Authorization;
Amendment 668 #
2023/0131(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments;
Amendment 724 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit- risk balance is favourable. After consultation with the marketing authorisation holder, the Agency shall lay down deadlines and criteria for the fulfilment of these conditions, and make them publicly available.
Amendment 756 #
2023/0131(COD)
Proposal for a regulation
Article 25 – paragraph 1 – subparagraph 2 – point a
Article 25 – paragraph 1 – subparagraph 2 – point a
(a) if one of its indications or, posologies, pharmaceutical forms, methods or routes of administration or any other element is protected by a patent or a supplementary protection certificate in one or more Member States;
Amendment 762 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. When applying paragraph 1, the Member State shall notify the Agency, which shall make the notification publicly available.
Amendment 766 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 4 – subparagraph 2
Article 26 – paragraph 4 – subparagraph 2
In the preparation of the opinion, the Committee for Medicinal Products for Human Use may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The Committee may also make use of health data generated outside of clinical studies, including real world data, where available, taking into account the reliability of those data.
Amendment 770 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. The Agency shall keep an up-to- date list of the opinions adopted in accordance with paragraph 4 and shall publish it in a central repository for compassionate use on its website.
Amendment 775 #
2023/0131(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with this Regulation shall benefit from the periods of regulatory protection set out in Chapter VII of [revised Directive 2001/83/EC]. The granting of periods of regulatory protection shall be published and updated where appropriate by the Agency in a designated registry.
Amendment 782 #
2023/0131(COD)
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
During a public health emergency, the Commission may grant a temporary emergency marketing authorisation (‘TEMA’) or a new temporary emergency therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life- threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non-clinical, clinical data and environmental data and information.
Amendment 786 #
2023/0131(COD)
Proposal for a regulation
Article 31 – paragraph 1 – introductory part
Article 31 – paragraph 1 – introductory part
A temporary emergency marketing authorisation or a temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, may be granted only after the recognition of a public health emergency at Union level in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council67 and where the following requirements are met: _________________ 67 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26).
Amendment 789 #
2023/0131(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point a
Article 31 – paragraph 1 – point a
(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation of the medicinal productr temporary emergency therapeutic indication of the medicinal product, including when grouped with an extension of the marketing authorisation, will contribute to address the public health emergency;
Amendment 799 #
2023/0131(COD)
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation.
Amendment 801 #
2023/0131(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. On the basis of the scientific opinion of the Agency referred to in paragraph 1, the Commission shall set specific conditions with respect to the temporary emergency marketing authorisation, in particular the conditions for manufacturing, use, supply and safety monitoring and the compliance with related good manufacturing, and pharmacovigilance practices. If necessary, the conditions may specify the batches of the medicinal product concerned by the temporary emergency marketing authorisation, after consultation with the applicant or marketing authorisation holder.
Amendment 803 #
2023/0131(COD)
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Those specific conditions and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation and shall be reviewed annually by the Agency, in consultation with the applicant or marketing authorisation holder.
Amendment 805 #
2023/0131(COD)
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
The temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, shall cease to be valid when the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371.
Amendment 809 #
2023/0131(COD)
Proposal for a regulation
Article 34 – paragraph 1 a (new)
Article 34 – paragraph 1 a (new)
1a. When the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, ceases to be valid in accordance with paragraph 1 of this Article, the Agency may set a transitional period after consultation with the marketing authorisation holder in order to avoid any disruption in supply of the medicinal product concerned.
Amendment 814 #
2023/0131(COD)
Proposal for a regulation
Article 35 – paragraph 2 a (new)
Article 35 – paragraph 2 a (new)
2a. Where the Commission adopts any such implementing act, the provisions of Article 34, paragraph 1a shall apply.
Amendment 817 #
2023/0131(COD)
Proposal for a regulation
Article 36 – paragraph 2
Article 36 – paragraph 2
For the purpose of regulatory data protection, the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, and any subsequent marketing authorisation, as referred to in subparagraph 1, shall be considered as part of the same global marketing authorisation.
Amendment 975 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 3
Article 48 – paragraph 3
3. Article 81(2), point (c) of [revised Directive 2001/83/EC] shall notmay apply for variations under this Article.
Amendment 979 #
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, or a new therapeutic indication, including when grouped with an extension of the 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, the Agency shall inform the Commission accordingly.
Amendment 984 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 1 – subparagraph 2
Article 58 – paragraph 1 – subparagraph 2
Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC], and for medicinal products used with an in vitro diagnostic medical device.
Amendment 1010 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Agency mayshall 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 the following conditions:
Amendment 1022 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
(b) are orphan medicinal products and are likely to address a high unmetlisted on the register of designated orphan medicinal need aproducts referred to in Aarticle 70(1); 67 (1) of this Regulation;
Amendment 1077 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
Amendment 1083 #
2023/0131(COD)
Amendment 1090 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
Amendment 1125 #
2023/0131(COD)
Proposal for a regulation
Article 70
Article 70
Amendment 1282 #
2023/0131(COD)
Proposal for a regulation
Article 73 a (new)
Article 73 a (new)
Article 73a European Framework for Rare Diseases By (OP: 24 months after the date of entry into force of this Regulation), the Commission shall, following appropriate consultation with the Member States, patient organisations and, where relevant, other interested parties, propose a needs driven and goals based European Framework for Rare Diseases with a view to bridge relevant Union legislation, policies and programmes, and support national strategies to better meet the unmet needs of people living with rare diseases, and their carers.
Amendment 1293 #
2023/0131(COD)
Proposal for a regulation
Article 75 – paragraph 1 – point c
Article 75 – paragraph 1 – point c
(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatments for paediatric patients.
Amendment 1294 #
2023/0131(COD)
Proposal for a regulation
Article 75 – paragraph 1 a (new)
Article 75 – paragraph 1 a (new)
1 a. The Agency shall, after consultation with the Commission and relevant interested parties, draw up guidelines for the application of this Article.
Amendment 1302 #
2023/0131(COD)
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.
Amendment 1341 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2 a (new)
Article 87 – paragraph 2 a (new)
2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant.
Amendment 1344 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2 b (new)
Article 87 – paragraph 2 b (new)
2 b. Within 20 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re- examination. Within 30 days following receipt of a request for re-examination pursuant to paragraph 2b, the Agency shall confirm or revise its previous scientific conclusions.The Agency shall be able to question the applicant directly.The applicant may also offer to be questioned.Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re- examining the above mentioned scientific conclusions. If, within the 15-day period referred to in paragraph 4, the applicant does not request re-examination, the scientific conclusions shall become definitive. The Agency shall adopt a decision within a period not exceeding 15 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions.
Amendment 1354 #
2023/0131(COD)
Proposal for a regulation
Article 88 – paragraph 1
Article 88 – paragraph 1
Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4, is discontinued, the applicant shall notify the Agency of its intention to discontinue the conduct of the paediatric investigation plan and provide the reasons for such discontinuation no less than six months before the discontinuation or as soon as possible.
Amendment 1390 #
2023/0131(COD)
Proposal for a regulation
Article 111 – paragraph 1
Article 111 – paragraph 1
The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems capable of achieving, including those that record adverse reactions including medication errors, processes and standards for medication safety, and implement digital technologies, with a view to achieve high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.
Amendment 1399 #
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 adequately develop the medicinal product 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 1430 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 5
Article 113 – paragraph 5
5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations, including, where relevant, of HTA bodies, patients and their caregivers, clinicians, sponsors, developers and academia. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.
Amendment 1511 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 1
Article 118 – paragraph 1 – subparagraph 1
Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 and the notification made pursuant to Article 116(1), points (a) to (d), the competent authority concerned as referred to in Article 116(1) shall continuously monitor any potential or actual shortage of those medicinal products through their national IT surveillance systems or data bases.
Amendment 1515 #
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, where this has not already been requested following paragraph 9 of article 127. The competent authority concerned mayshall set a deadline for the submission of the information requested.
Amendment 1533 #
2023/0131(COD)
Proposal for a regulation
Article 120 – paragraph 2
Article 120 – paragraph 2
2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.
Amendment 1543 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point b a (new)
Article 121 – paragraph 1 – point b a (new)
(b a) establish an accessible and easily understandable system for patients and patient organisations to report shortages of medicinal products;
Amendment 1552 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(c a) address recommandations to health professionals and patients on the alternative medicinal products to use to pursue treatments;
Amendment 1554 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point c b (new)
Article 121 – paragraph 1 – point c b (new)
(c b) launch information campaign to discourage hoarding or to avoid waste, at any level of the supply chain, from wholesalers to patients.
Amendment 1606 #
2023/0131(COD)
Proposal for a regulation
Article 123 – paragraph 4 – subparagraph 1 (new)
Article 123 – paragraph 4 – subparagraph 1 (new)
Member States, within the MSSG, may decide to activate the “Voluntary Solidarity Mechanism for medicines” to (a) notify a critical shortage of a medicinal product at national level to other Member States and the Commisison, (b) identify, with the support of the Agency, the availabilities of the medicinal product in other Member States, (c) organise, with the support of the Agency, meetings with the issuing Member States, the donating part and other relevant parties to discuss operational requirements, (d) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicines.
Amendment 1619 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actualll notified critical shortages of medicinal products in cases in whichas soon as the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b).
Amendment 1622 #
2023/0131(COD)
Proposal for a regulation
Article 125 – paragraph 1 – point a
Article 125 – paragraph 1 – point a
(a) provide any additional information that the Agency may request, including regular information on the available stocks of medicines;
Amendment 1634 #
2023/0131(COD)
Proposal for a regulation
Article 127 – paragraph 1
Article 127 – paragraph 1
1. The competent authority of the Member State shall identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a), following a consultation with national health professionals and patients organisations.
Amendment 1637 #
2023/0131(COD)
Proposal for a regulation
Article 127 – paragraph 3
Article 127 – paragraph 3
3. For the purposes of the identification of critical medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information including the shortage prevention plan referred to in Article 117 and information on the available stocks of medicines from the marketing authorisation holder as defined in Article 116(1).
Amendment 1647 #
2023/0131(COD)
Proposal for a regulation
Article 129 – paragraph 1
Article 129 – paragraph 1
For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.
Amendment 1654 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with patient organisations and the working party referred to in Article 121(1), point (c), ensure the following:
Amendment 1669 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 5
Article 130 – paragraph 5
5. Following the adoption of the Union list of critical medicinal products in accordance with Article 131, the Agency shall assess and report to the MSSG on any relevant information received from the marketing authorisation holder pursuant to Article 133 and the competent authority of the Member State in accordance with Article 127, paragraphs 7 and 8.
Amendment 1693 #
2023/0131(COD)
Proposal for a regulation
Article 132 – paragraph 1 b (new)
Article 132 – paragraph 1 b (new)
1 b. The MSSG shall set up a Voluntary Solidarity Mechanism to allow Member States to request assistance in obtaining stocks of a medicine during critical shortages. The MSSG shall specify the procedures and criteria to launch the Voluntary Solidarity Mechanism in consultation with the Member States, the Agency and the Commission.
Amendment 1705 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 a (new)
Article 134 – paragraph 1 a (new)
1 a. The Commission shall also work with the European Centre for Disease prevention and Control on building reliable forecasts of potentiel threats and potential shortages.
Amendment 162 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 34 – introductory part
Article 2 – paragraph 1 – point 34 – introductory part
(34) ‘batchmodel’ means a defined quantity of finished products that meets the following conditions:specific type of detergent or surfactant, which includes a product name and a unique formula, according to the Unique Formula Identifier (UFI).
Amendment 203 #
2023/0124(COD)
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Amendment 287 #
2023/0124(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point a
Article 18 – paragraph 2 – point a
(a) it shall correspond to a specific batchmodel of the detergent or surfactant;
Amendment 28 #
2023/0113(COD)
Proposal for a directive
Recital 8
Recital 8
(8) Where the resolution authorityn preparing resolution plans and assessing the resolvability of resolution groups, resolution authorities are able to considers that an entity that is part of a resolution group qualifies as a liquidation entity, intermediate entities should not be required to deduct from their internal MREL capacity their holdings of own funds or other liabilities that would meet the conditions for compliance with the internal MREL and that are issued by liquidation entities. In such a case, the liquidation entity is no longer required to comply with the MREL, and therefore there is no indirect subscription of internal MREL eligible resources through the chain formed by the resolution entity, the intermediate entity and the liquidation entity group entity qualifies as a liquidation entity as the exercise of the write-down and conversion powers is not envisaged in respect of that entity. Where that is the case, the group entity might not need to hold own funds and eligible liabilities in excess of its own funds requirements. In those circumstances, intermediate entities should not be required to deduct from their internal MREL capacity their holdings of own funds or other liabilities that would meet the conditions for compliance with the internal MREL and that are issued by liquidation entities. In case of failure, the resolution strategy does not envisage that the liquidation entity would be supportrecapitalised by the resolution entity. That means that the upstreaming of losses above the existing own funds requirements from the liquidation entity to the resolution entity, via the intermediate entity, would not be expected, and neither would the downstreaming of capital in the opposite direction. That adjustment to the scope of the holdings to be deducted in the context of the indirect subscription of internal MREL eligible resources would thus not affect the prudential soundness of the framework.
Amendment 32 #
2023/0113(COD)
Proposal for a directive
Recital 10
Recital 10
(10) There are liquidation entities for which the MREL does exceed the amount of the own funds requirements, in which case resolution authorities should be able to set the MREL. That MREL should be set at an amountresolution authorities may consider that MREL should exceeding the amount for loss absorption. That is the case where the resolution authorities consider that such a higher amount is necessary to protect financial stability or address the risk of contagion to the financial system. In those situations, the liquidation entityresolution authorities should determine a MREL for the liquidation entity consisting of an amount sufficient to absorb losses, increased by the amount necessary to properly address the potential risks identified by the resolution authorities. The liquidation entity concerned should comply with the MREL and should not be exempted from the prior permission regime laid down in Articles 77(2) and 78a of Regulation (EU) No 575/2013. Any intermediate entities belonging to the same resolution group as the liquidation entity concerned should continue to be required to deduct from their internal MREL capacity their holdings of internal MREL eligible resources issued by that liquidation entity. In addition, since liquidation proceedings take place at the level of the legal entity, liquidation entities still subject to MREL should comply with the requirement on an individual basis only. Lastly, certain eligibility requirements related to the ownership of the liability concerned are not relevant, as there is no need to ensure the transfer of losses and capital from the liquidation entity to awithout the exercise of the write-down and conversion powers there would be no need to preserve the control of the subsidiary by the resolution entity, and should therefore not apply.
Amendment 37 #
2023/0113(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Directive 2014/59/EU
Article 2 – paragraph 1 – point 83aa
Article 2 – paragraph 1 – point 83aa
(83aa) ‘liquidation entity’ means a legal person established in the Union in respect of which the group resolution plan or, for entities that are not part of a group, the resolution plan, provides that the entity is to be wound up in an orderly manner in accordance with the applicable national law;; or with regard to an entity within a resolution group other than a resolution entity, the group resolution plan does not envisage the exercise of the write-down and conversion powers with respect to that entity;
Amendment 43 #
2023/0113(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive 2014/59/EU
Article 45c – paragraph 2a – subparagraph 2 – introductory part
Article 45c – paragraph 2a – subparagraph 2 – introductory part
By way of derogation from the first subparagraph, and where necessary for the objectives of protecting financial stability or limiting potential contagion to the financial system, resolution authorities may exceptionallythe resolution authority may assess whether it is justified to determine the requirement referred to in Article 45(1) for liquidation entities on an individual basis an amount exceeding the amount sufficient to absorb losses in accordance with paragraph 2, point (a), of this Article, increased to the amount that is necessary for the achievement of those objectives. The assessment by the resolution authority shall consider the possible consequences of the failure of the liquidation entity concerned and shall, in particular, take into account any possible impacts on financial stability and on the risk of contagion to the financial system, and shall provide justification as to why the entity concerned should nonetheless remain identified as a liquidation entity. In those cases, liquidation entities shall meet the requirement referred to in Article 45(1) by using one or more of the following:
Amendment 48 #
2023/0113(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive 2014/59/EU
Article 45f – paragraph 1 – subparagraph 3a – introductory part
Article 45f – paragraph 1 – subparagraph 3a – introductory part
By way of derogation from the first and second subparagraphs, when intermediate entities would be disproportionately affected by the deduction rules set out in Article 72e(5) of Regulation (EU) No 575/2013, resolution authorities may decide to determine the requirement laid down in Article 45c of this Regulation on a consolidated basis for a subsidiary as referred to in this paragraph where all of the following conditions are met:
Amendment 55 #
2023/0113(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive 2014/59/EU
Article 45f – paragraph 1 – subparagraph 3a – point a – point ii
Article 45f – paragraph 1 – subparagraph 3a – point a – point ii
(ii) the subsidiary is subject to the requirement referred to in Article 104a of Directive 2013/36/EU or to the combined buffer requirementnly on a consolidated basis;
Amendment 60 #
2023/0113(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive 2014/59/EU
Article 45f – paragraph 1 – subparagraph 3a – point b
Article 45f – paragraph 1 – subparagraph 3a – point b
(b) compliance with the requirement laid down in Article 45c on a consolidated basis does not negatively affect in a significantmaterial way the resolvability of the resolution group, or the write down or conversion, in accordance with Article 59, of relevant capital instruments and eligible liabilities of the subsidiary concerned or of other entities in the resolution group.;
Amendment 68 #
2023/0113(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 2 – point b
Article 2 – paragraph 1 – point 2 – point b
Regulation (EU) No 806/2014
Article 12d – paragraph 2a – subparagraph 2 – introductory part
Article 12d – paragraph 2a – subparagraph 2 – introductory part
By way of derogation from the first subparagraph, and where necessary for the objectives of protecting financial stability or limiting potential contagion to the financial system, the Board may exceptionallythe Board may assess whether it is justified to determine the requirement referred to in Article 12a(1) for liquidation entities on an individual basis an amount exceeding the amount sufficient to absorb losses in accordance with paragraph 2, point (a), of this Article, increased to the amount that is necessary for the achievement of those objectives. The assessment by the Board shall consider the possible consequences of the failure of the liquidation entity concerned and shall, in particular, take into account any possible impacts on financial stability and on the risk of contagion to the financial system, and shall provide justification as to why the entity concerned should nonetheless remain identified as a liquidation entity. In those cases, liquidation entities shall meet the requirement referred to in Article 12a(1) by using one or more of the following:
Amendment 73 #
2023/0113(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 – point a
Article 2 – paragraph 1 – point 3 – point a
Regulation (EU) No 806/2014
Article 12g – paragraph 1 – subparagraph 3a – introductory part
Article 12g – paragraph 1 – subparagraph 3a – introductory part
By way of derogation from the first and second subparagraphs, when the intermediate entities would be disproportionately affected by the deduction rules set out in Article 72(e)(5) of Regulation (EU) 575/2013, the Board may decide to determine the requirement laid down in Article 12d on a consolidated basis for a subsidiary as referred to in this paragraph where all of the following conditions are met:
Amendment 78 #
2023/0113(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 – point a
Article 2 – paragraph 1 – point 3 – point a
Regulation (EU) No 806/2014
Article 12g – paragraph 1 – subparagraph 3a – point a – point ii
Article 12g – paragraph 1 – subparagraph 3a – point a – point ii
(ii) the subsidiary is subject to the requirement referred to in Article 104a of Directive 2013/36/EU or to the combined buffer requirementnly on a consolidated basis;
Amendment 82 #
2023/0113(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 – point a
Article 2 – paragraph 1 – point 3 – point a
Regulation (EU) No 806/2014
Article 12g – paragraph 1 – subparagraph 3a – point b
Article 12g – paragraph 1 – subparagraph 3a – point b
(b) compliance with the requirement laid down in Article 12d on a consolidated basis does not negatively affect in a significantmaterial way the resolvability of the resolution group, or the write down or conversion, in accordance with Article 21, of relevant capital instruments and eligible liabilities of the institution or subsidiary concerned or of other entities in the resolution group.;
Amendment 40 #
2023/0105(COD)
Proposal for a directive
Recital 3
Recital 3
(3) In light of the close link between the quality of honey and its origin and the need for the consumer not to be misled regarding the quality of the product, Directive 2001/110/EC lays down rules on the labelling of the origin where the honey has been harvested. In particular, Article 2(4) of that Directive requires the country or countries of origin where the honey has been harvested to be indicated on the label and provides that, if honey originates in more than one Member State or third country, the mandatory indication of the countries of origin may be replaced by one of the following, as appropriate: ‘blend of EU honeys’, ‘blend of non-EU honeys’, ‘blend of EU and non-EU honeys’. The different rules adopted on this basis by Member States may have misled consumers and may have hindered the functioning of the internal market. In the light of the Farm to Fork Strategy’s objective of strengthening consumers in making informed choices, including on the origin of their food, and in the interest to preserve the efficient functioning of the internal market throughout the Union through a harmonisation of the labelling rules, it is appropriate to revise the rules for honey origin labelling and provide that the country or countries of origin should be mentioned on the packaging. In light of the reduced size of the packs containing only a single portion of honey (breakfast packs) and the resulting technical difficulties, it is therefore appropriate to exempt those packs from the obligation of listing all individual countries of origin, where the honey originates in more than one country. To ensure the accuracy of the information on the country or countries of origin of honey that consumers are provided with, the placing on the market of honey should be conditional upon the accuracy of the composition of the product with its indicated country or countries of origin. To ensure the compliance of products with the requirements set out in this Directive, checks should be performed by competent authorities.
Amendment 48 #
2023/0105(COD)
Proposal for a directive
Recital 3
Recital 3
(3) In light of the close link between the quality of honey and its origin and the need for the consumer not to be misled regarding the quality of the product, Directive 2001/110/EC lays down rules on the labelling of the origin where the honey has been harvested. In particular, Article 2(4) of that Directive requires the country or countries of origin where the honey has been harvested to be indicated on the label and provides that, if honey originates in more than one Member State or third country, the mandatory indication of the countries of origin may be replaced by one of the following, as appropriate: ‘blend of EU honeys’, ‘blend of non-EU honeys’, ‘blend of EU and non-EU honeys’. The different rules adopted on this basis by Member States may have misled consumers and may have hindered the functioning of the internal market. In the light of the Farm to Fork Strategy’s objective of strengthening consumers in making informed choices, including on the origin of their food, and in the interest to preserve the efficient functioning of the internal market throughout the Union through a harmonisation of the labelling rules, it is appropriate to revise the rules for honey origin labelling and provide that the country or countries of origin should be mentioned on the packaging in descending order of their share in weight. In light of the reduced size of the packs containing only a single portion of honey (breakfast packs) and the resulting technical difficulties, it is therefore appropriate to exempt those packs from the obligation of listing all individual countries of origin, where the honey originates in more than one country. In order to increase transparency and to meet consumer expectations, the geographical origin of the honey should be indicated on the label in the same visual field as the indication of the product.
Amendment 52 #
2023/0105(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) Following the "From the Hive" action carried out by the European Commission's Directorate-General for Health and Food Safety (DG SANTE), together with the national authorities of 18 countries belonging to the European Food Fraud Network, the European Anti- Fraud Office (OLAF) and the European Commission's Joint Research Centre (JRC), a very high percentage of imported honeys were found to be adulterated with cheap ingredients, such as sugar syrups and water, to artificially increase the product's volume. Directive 2001/110, amended by Directive 2014/63, empowers the European Commission to establish the most appropriate methods of analysis to ensure that honey marketed in the European Union complies with the requirements of the legislation. These methods are now obsolete, and there is an urgent need to update them regularly in the light of the latest scientific developments, in collaboration with the Commission's Joint Research Centre, in order to prevent fraudulent practices and to ensure a level-playing field between EU and non-EU operators.
Amendment 54 #
2023/0105(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) Following the "From the Hive" action carried out by the European Commission's Directorate-General for Health and Food Safety (DG SANTE), together with the national authorities of 18 countries belonging to the European Food Fraud Network, the European Anti- Fraud Office (OLAF) and the European Commission's Joint Research Centre (JRC), a very high percentage of imported honeys were found to be adulterated with cheap ingredients, such as sugar syrups and water, to artificially increase the product's volume. Directive 2001/110/EC empowers the European Commission to establish the most appropriate methods of analysis to ensure that honey marketed in the European Union complies with the requirements of the legislation. These methods are now obsolete, and there is an urgent need to update them regularly in the light of the latest scientific developments, in collaboration with the Commission's Joint Research Centre, in order to prevent fraudulent practices.
Amendment 62 #
2023/0105(COD)
Proposal for a directive
Recital 3 b (new)
Recital 3 b (new)
(3b) It is also essential to improve traceability from the beekeeper to the consumer, with a minimum of compulsory, harmonised rules. At present, traceability rules do not make it possible to link the various operators who come into contact with the product, which encourages fraud. Given the difficulties involved in tracing the origin of honey, a specific traceability system needs to be set up for this sector, while limiting administrative burden for beekeepers to a minimum.
Amendment 63 #
2023/0105(COD)
Proposal for a directive
Recital 3 b (new)
Recital 3 b (new)
(3b) In addition to verifiability of the origin of honey thanks to the testing of its composition, the traceability of the product or batch should be ensured. At present, traceability rules do not make it possible to link the various operators who come into contact with the product, which encourages fraud. Given the difficulties involved in tracing the origin of honey, a specific traceability system needs to be set up for this sector.
Amendment 69 #
2023/0105(COD)
Proposal for a directive
Recital 3 c (new)
Recital 3 c (new)
(3c) To ensure accurate information for consumers and guarantee the traceability and verifiability of honey authenticity and honey origins, ultrafiltered honey, referred to in Directive 2001/110/EC as "filtered honey", should no longer be allowed to be marketed and labelled as "honey". Ultrafiltration refers to filtration processes using a filter mesh of a size under 100 µm thus removing the majority of the pollen from honey. Since pollen is the key element present in honey used to trace its origin when analysed, the absence of pollen in honey makes it almost impossible to verify the data provided regarding its country or countries of origin. Ultrafiltration thus alters honey by depriving it of one of its main components and characteristics, and prevents its traceability, thus enabling for fraud and misleading indications for consumers. If, when tested, a product marketed as honey presents little or no trace of pollen, it should be prohibited from being placed on the market as well as the batch it is part of, if applicable.
Amendment 70 #
2023/0105(COD)
Proposal for a directive
Recital 3 c (new)
Recital 3 c (new)
(3c) In order to avoid any ambiguity for the consumer and to ensure the traceability of honey, ultrafiltered honey, referred to in Directive 2001/110/EC as "filtered honey", should no longer be allowed to be marketed under the name of honey. While beekeepers commonly use wide-mesh honey sieves to remove any plant debris or pieces of wax, ultrafiltration removes much, if not almost all, of the pollen from honey. Pollen is the most important element present in honey on which analyses are based to verify its floral and geographical origin. The absence of pollen in honey by ultrafiltration therefore removes one of the essential components and prevents verification of the country or countries of origin.
Amendment 75 #
2023/0105(COD)
Proposal for a directive
Recital 3 d (new)
Recital 3 d (new)
(3d) Heat treatment above 40-50°C degrades the sensitive components of honey. However, the hydroxymethylfurfural (HMF) content and the diastase index can only be used to assess the gross degradation of honeys. A minimum threshold should be defined for the presence of invertase, a much more sensitive enzyme, which degrades rapidly at high temperatures. To ensure that consumers are properly informed, the term "virgin honey", referring to the absence of significant heat treatment, may be included on the label on the front of the commercial packaging of the honey if no heat treatment has degraded highly sensitive enzymes such as invertase, from harvesting to potting.
Amendment 76 #
2023/0105(COD)
Proposal for a directive
Recital 3 d (new)
Recital 3 d (new)
(3d) Considering the direct link between information of consumers and the reliability of the information indicated on honey, it is impossible to inform consumers unless the accuracy of the information on the label is guaranteed. Traceability and verifiability of the composition should therefore be ensured in order to guarantee the origin and the quality of honey, including in the case of honey contained in other products. Ensuring traceability and verifiability of the honey's country or countries of origin will also ensure a level-playing field between all operators by making sure that they all comply with the same obligations.
Amendment 78 #
2023/0105(COD)
Proposal for a directive
Recital 3 e (new)
Recital 3 e (new)
(3e) The commercialisation of honeys that are not naturally matured by bees, most of which are imported from third countries, distorts competition on the Union market. In most cases, this involves vacuum evaporation of the water contained in the honey, which results in a depletion of the aromas naturally present. The rapid and artificial evaporation of water from honey competes with the slow dehumidification process carried out naturally by bees in the hive. Artificial evaporation should therefore be prohibited.
Amendment 138 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 b (new)
Article 1 – paragraph 1 – point 1 b (new)
(1b) In Article 2, paragraph 2, subparagraph 1 is replaced by the following: "2. the product names referred to in Annex I, points 2 and 3, shall apply only to the products defined therein and shall be used in trade to designate them. These names may be replaced by the simple product name "honey", except in the case of filtered honey, comb honey, chunk honey or cut comb in honey and baker's honey. comb honey, honey with pieces of comb and industrial honey." Or. en (02001L0110)
Amendment 144 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Directive 2001/110/EC
Article 2 – paragraph 2 – point b a (new)
Article 2 – paragraph 2 – point b a (new)
In Article 2, paragraph 2, the following point ba is added: "(ba) except for honeys intended for industrial use, the term "virgin honey" may be included on the label on the front of the commercial packaging of the honey, provided that no heat treatment has degraded highly sensitive enzymes such as invertase, from harvesting to potting, and that the conditions referred to in Annex II, points 6 (diastase index and hydroxymethylfurfural content) and 7 (invertase index) are met."
Amendment 150 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Directive 2001/110/EC
Article 2 – paragraph 4 – point a
Article 2 – paragraph 4 – point a
(a) The country of origin where the honey has been harvested shall be indicated on the label. If the honey originates in more than one country, the countries of origin where the honey has been harvested shall be indicated on the label of packs. All countaining more than 25 g;ries of origin shall be written in full and listed in descending order of importance and their respective percentages shall be clearly indicated on the front-of-pack label of the product, close to the product's trade name. This shall also apply to products containing industrial honey, which shall indicate on their front-of-pack label the country or countries of origin of the honey they contain.
Amendment 171 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 Directive 2001/110/EC
Article 1 – paragraph 1 – point 2 Directive 2001/110/EC
(b) For the purpoExcept in the cases of Regulation (EU) No 1169/2011 and in particular Articles 12 to 15 thereof, the particulars to be indicated according to point (a) of this paragraph shall be considered as mandatory particulars in accordance with Article 9 of that Regulation.honey intended for industry, these names may be supplemented by indications relating to: - floral or vegetable origin, if the product comes entirely or essentially from the origin indicated and has the organoleptic, physico-chemical and microscopic characteristics thereof, - regional, territorial or topographical origin, if the product comes entirely from the origin indicated, - specific quality criteria.
Amendment 177 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
The following Article 2a is added : "Article 2a Honey and products containing honey placed on the Union market shall be part of a traceability system such as an identification code or a blockchain system. Competent authorities shall be able to trace the honey’s journey back to its country of origin. Operators placing honey and products containing honey on the market shall be able to trace it, via an identification number or blockchain system, to its previous operator and country of origin. This number shall be written on the product's label and/or documentation. This traceability system shall be supported by the traceability requirements established pursuant to Article 18 of Regulation (EC) No 178/2002."
Amendment 178 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 g (new)
Article 1 – paragraph 1 g (new)
Directive 2001/110/EC
Article 3
Article 3
Article 3 In the case of filtered honey and baker's honeis replaced by the following: "Article 3 In the case of honey intended for industry, bulk containers, packs and tradeaging and sales documentsation shall clearly indicate the full product name, as referred to in Annex I, point 2(b)(viii), and point 3. set out in point 3 of Annex I." Or. en (02001L0110)
Amendment 195 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 b (new)
Article 1 – paragraph 1 b (new)
Directive 2001/110/EC
Article 4 a (new)
Article 4 a (new)
The following Article 4a is added: "Article 4a A traceability system for honey shall be set up, complementing the horizontal rules already applicable to the agri-food sector in accordance with Article 18 of Regulation (EC) No 178/2002. The Commission is empowered to adopt, no later than 12 months after the entry into force of this Directive, a delegated act introducing a harmonised traceability system enabling competent authorities to trace the entire history of the honey produced and imported into the Union back to the harvesting beekeepers or, in the case of imported honey, to the operators."
Amendment 196 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
Annexes I and II are amended in accordance with Annex Ia to this Directive;
Amendment 202 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
Directive 2001/110/EC
Annex I – paragraph 2 – point b – point viii
Annex I – paragraph 2 – point b – point viii
Amendment 209 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 b (new)
Article 1 – paragraph 1 b (new)
Directive 2001/110/EC
Annex II – paragraph 2
Annex II – paragraph 2
In Annex II, paragraph 2 is replaced by the following: "When placed on the market as honey or used in any product intended for human consumption, honey shall not have added to it any food ingredient, including food additives, nor shall any other additions be made other than honey. Honey must, as far as possible, be free from organic or inorganic matters foreign to its composition. With the exception of point 3 of Annex I, it must not have any foreign tastes or odours, have begun to ferment, have an artificially changed acidity or have been heated in such a way that the natural enzymes have been either destroyed or significantly inactivated. , or have been exposed to vacuum evaporation. Honey, when marketed as such or used in any product intended for human consumption, must comply with the compositional characteristics set out in points 1 to 6. In addition, when marketed as "virgin honey" it must also comply with the compositional characteristics set out in point 6a." Or. en (02001L0110)
Amendment 210 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
In Annex II, paragraph 2 is replaced by the following: "When placed on the market as honey or used in any product intended for human consumption, honey shall not have added to it any food ingredient, including food additives, nor shall any other additions be made other than honey. Honey must, as far as possible, be free from organic or inorganic matters foreign to its composition. With the exception of point 3 of Annex I, iIt must not have any foreign tastes or odours, have begun to ferment, have an artificially changed acidity or have been heated in such a way that the natural enzymes have been either destroyed or significantly inactivated. , or have been exposed to vacuum evaporation. The category "products containing honey" therefore does not include honey blended with food ingredients or other additional ingredients." Or. en (02001L0110)
Amendment 217 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 c (new)
Article 1 – paragraph 1 c (new)
Directive 2001/110/EC
Annex II – paragraph 3
Annex II – paragraph 3
Amendment 218 #
2023/0105(COD)
Amendment 228 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 d (new)
Article 1 – paragraph 1 d (new)
Directive 2001/110/EC
Annex II – paragraph 6 a (new)
Annex II – paragraph 6 a (new)
In Annex II, the following paragraph 6a is added: "6a. Invertase index (Gontarski unit) for "virgin honeys". Determined after processing and blending. - generally, not less than 50 U/kg - honeys with a low natural enzyme content, not less than 25 U/kg."
Amendment 79 #
2023/0085(COD)
Proposal for a directive
Recital 16
Recital 16
(16) The assessment made to substantiate explicit environmental claims needs to consider the life-cycle of the product or of the overall activities of the trader and should not omit any relevant environmental aspects or environmental impacts. The benefits claimed should not result in an unjustified transfer of negative impacts to other stages of the life cycle of a product or trader, or to the creation or increase of other negative environmental impacts and should be done in an EU harmonized and standardized way in order to minimize the risk of greenwashing, and to create predictability and a cost-efficient structure for the companies producing the products and traders.
Amendment 94 #
2023/0085(COD)
Proposal for a directive
Recital 21
Recital 21
(21) Climate-related claims have been shown to be particularly prone to being unclear and ambiguous and to mislead consumers. This relates notably to environmental claims, as addressed in thate products or entities are “climate neutral”, “carbon neutral”, “100% CO2 compensated”, or will be “net-zero” by a given year, or similar. Such statements are often based on “offsetting” of greenhouse gas emissions through “carbon credits” generated outside the company’s value chain, for example from forestry or renewable energy projects. The methodologies underpinning offsets vary widely and are not always transparent, accurate, or consistent. This leads to significant risks of overestimations and double counting of avoided or reduced emissions, due to a lack of additionality, permanence, ambitious and dynamic crediting baselines that depart from business as usuposal for a Directive on empowering consumers for the green transition. This relates notably to environmental claims that products or entities are “climate neutral”, and accurate accounting. These factors result in offset credits of low environmental integrity and credibility that mislead consumers when they are relied upon in explicit environmental claims. Offsetting can also deter traders from emissions reductions in their own operations and value chains“carbon neutral”, “100% CO2 compensated”, or will be “net-zero” by a given year, or similar. In order to adequately contribute to global climate change mitigation targets, traders should prioritise effective reductions of emissions across their own operations and value chains instead of relying on offsets. Any resulting residual emissions will vary by sector-specific pathway in line with the global climate targets and will have to be addressed through removals enhancements. When offsets are used nonetheless, i, and via the use of carbon removal technologies and carbon farming solutions. It is deemed appropriate to address climate- related claims, including claims on future environmental performance, based on offsets in a transparent manner. Therefore, the substantiation of climate- related claims should consider any greenhouse gas emissions offsets used by the traders separately from the trader’s or the product’s greenhouse gas emissions. In addition, this information should also specify the share of total emissions that are addressed through offsetting, whether these offsets relate to emission reductions or removals enhancement, and the methodology applied. The climate-related claims that include the use of offsets have to be substantiated by methodologies that ensure the integrity and correct accounting of these offsets and thus reflect coherently and transparently the resulting impact on the climateways contain certificate of carbon removal credits or carbon farming credits, proving in compliance with the Carbon Removal Certification Framework (2022/0394).
Amendment 126 #
2023/0085(COD)
Proposal for a directive
Recital 32
Recital 32
(32) The Commission Recommendation (EU) 2021/2279 contains guidance on how to measure the life cycle environmental performance of specific products or organisations and how to develop Product Environmental Footprint Category Rules (PEFCRs) and Organisation Environmental Footprint Sectorial Rules (OEFSRs) that allow comparison of products to a benchmark. Such category rules for specific products or traders can be used to support the substantiation of claims in line with the requirements of this Directive. Therefore, the Commission should be empowered to adopt delegated acts to establish product group or sector specific rules where this may have added value. However, in case the Product Environmental Footprint method does not yet cover an impact category, which is relevant for a product group, the adoption of PEFCR may take place only once these new relevant environmental impact categories have been added. For example, as regards marine fisheries, the PEFCR should for example reflect the fisheries- specific environmental impact categories, in particular the sustainability of the targeted stock. Concerning space, the PEFCR should reflect defence and space- specific environmental impact categories, including the orbital space use. As regards food and agricultural products, biodiversity and nature protection, as well as farming practices, including positive externalities of extensive farming and animal welfare, should, for example, also be integrated before the adoption of PEFCR could be considered. As regards textiles, the PEFCR should for example reflect the microplastics release, before the adoption of PEFCR could be considered. To further develop the current PEF methodology and address its limitations, the Commission shall regularly update the methodology in order to reflect scientific progress.
Amendment 139 #
2023/0085(COD)
Proposal for a directive
Recital 40
Recital 40
(40) In cases where an environmental label involves a commercial communication to consumers that suggests or creates the impression that a product has a positive or no impact on the environment, or is less damaging to the environment than competing products without the label, that environmental label also constitutes an explicit environmental claim. The content of such environmental label is therefore subject to the requirements on substantiation and communication of explicit environmental claims. Ecolabels that demonstrate in line with EN ISO 14024 Type I a systematic lifecycle approach, as well as an independent decision-making body and product specific absolute requirements should not be subject for the requirements on substantiation and communication of explicit environmental claims since the governance of these ecolabels will mean that they are already in line with the intention of the provisions.
Amendment 196 #
2023/0085(COD)
Proposal for a directive
Article 1 – paragraph 2 – introductory part
Article 1 – paragraph 2 – introductory part
2. This Directive does not apply to environmental labelling schemes or to explicit environmental claims or to sustainability reporting regulated by or substantiated by rules established in:
Amendment 198 #
2023/0085(COD)
Proposal for a directive
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) Regulation (EC) No 66/2010 of the European Parliament and of the Council95 , including other officially recognized ISO 14024 type 1 ecolabels. _________________ 95 Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (OJ L 27, 30.1.2010, p. 1).
Amendment 210 #
2023/0085(COD)
Proposal for a directive
Article 1 – paragraph 2 – point o a (new)
Article 1 – paragraph 2 – point o a (new)
(o a) Directive (EU) 2022/2464 of the European Parliament and of the Council (CSDR);
Amendment 261 #
2023/0085(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 15 a (new)
Article 2 – paragraph 1 – point 15 a (new)
(15 a) ‘widely recognized scientific evidence’ means evidence based on an international or national standard or on a scientifically valid reasoning which has either been subject to peer review and publication or has received widespread acceptance within a relevant scientific community with proven expertise on the topic;
Amendment 286 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) rely on widely recognised scientific evidence, use accurate information and take into account relevant international standards such as the Environmental Footprint (PEF and OEF) based on PEFCRs or OEFSRs;
Amendment 357 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
(i) include primary information available for a product or to the trader for environmental impacts, environmental aspects or environmental performance, which are subject to the claim;
Amendment 471 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – introductory part
Article 5 – paragraph 6 – subparagraph 2 – introductory part
That information shall include at least the following, while protecting sensitive information and business secrets:
Amendment 493 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point f
Article 5 – paragraph 6 – subparagraph 2 – point f
(f) for climate-related explicit environmental claims that relying on greenhouse gas emission offsets, information to which extent they rely on offsets and whether these relate to emissions reductions or removals;carbon removals, the certificates of corresponding units according to Regulation 2022/0394.
Amendment 540 #
2023/0085(COD)
Proposal for a directive
Article 8 – paragraph 2 – point d
Article 8 – paragraph 2 – point d
(d) the requirements for the environmental labelling scheme have been developed by experts that can ensure their scientific robustness and have been submitted, where relevant and necessary, for consultation to a heterogeneous group of stakeholders that has reviewed them and ensured their relevance from a societal perspective;
Amendment 594 #
2023/0085(COD)
Proposal for a directive
Article 8 – paragraph 7
Article 8 – paragraph 7
7. The Commission shall publish and keep-up-to date a list of officially recognised environmental labels thatenvironmental labelling schemes that comply with this Directive and are allowed to be used on the Union market after [OP: Please insert the date = the date of transposition of this Directive] pursuant to paragraphs 3, 4 and 5.
Amendment 606 #
2023/0085(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
Member States shall ensure that the information used for substantiation of explicit environmental claims is reviewed and updated by traders when there are circumstances that may affect the accuracy of a claim, and no later than 5 years from the date when the information referred to in Article 5(6) is provided. In the review, the trader shall revise the used underlying information to ensure that the requirements of Articles 3 and 4 are fully complied with. The trader shall not be obliged to review the substantiation nor reapply for certification in case of minor changes to the text of the claim without major impact on the nature of the claim.
Amendment 635 #
2023/0085(COD)
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
4. The verification shall be undertaken by a verifier fulfilling the requirements set out in Article 11, in accordance with the procedures referred to in paragraphs 1 and 2, before the environmental claim is made public or the environmental label is displayed by a trader. The verification process can take a maximum of 8 weeks. After this period, a claim is permitted to be placed on the market.
Amendment 642 #
2023/0085(COD)
Proposal for a directive
Article 10 – paragraph 5
Article 10 – paragraph 5
5. For the purposes of the verification the verifier shall take into account the nature and content of the explicit environmental claim or the environmental label. In case of environmental claims and environmental labels based on product specific and sectoral category rules developed pursuant to Article 3(4)(c) and 5(8), where such rules already foresee third-party verification, simplified requirements to obtain the certificate of conformity shall be set out in those delegated acts.
Amendment 691 #
2023/0085(COD)
Proposal for a directive
Article 11 – paragraph 3 a (new)
Article 11 – paragraph 3 a (new)
3 a. Member States shall ensure that measures adopted in accordance with this Directive are without prejudice to the protection of business information (trade secrets) foreseen in Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016.
Amendment 725 #
2023/0085(COD)
Proposal for a directive
Article 15 – paragraph 3
Article 15 – paragraph 3
3. Where, further to the evaluation referred to in the first subparagraph, the competent authorities find that the substantiation and communication of the explicit environmental claim or the environmental labelling scheme does not comply with the requirements laid down in this Directive, they shall notify the trader making the claim about the non- compliance prior to publishing the report mentioned in Article 15(1) and require that trader to take all appropriate corrective action within 30 days to bring the explicit environmental claim or the environmental labelling scheme into compliance with this Directive or to cease the use of and references to the non-compliant explicit environmental claim. Such action shall be as effective and rapid as possible, while complying with the principle of proportionality and the right to be heard.
Amendment 744 #
2023/0085(COD)
Proposal for a directive
Article 16 – paragraph 6 a (new)
Article 16 – paragraph 6 a (new)
6 a. The Commission shall [6 months months from the date of entry into force of this Directive] adopt delegated acts according to Article 18 of this Directive establishing a Notice and Action mechanism allowing for citizens to raise red flag alerts regarding possible unsubstantiated green claims and potential greenwashing, including its applicable rules and criteria.
Amendment 762 #
2023/0085(COD)
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
Amendment 767 #
2023/0085(COD)
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 1 – point b
Article 17 – paragraph 3 – subparagraph 1 – point b
Amendment 769 #
2023/0085(COD)
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 1 – point c
Article 17 – paragraph 3 – subparagraph 1 – point c
Amendment 775 #
2023/0085(COD)
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 2
Article 17 – paragraph 3 – subparagraph 2
For the purposes of point (a), Member States shall ensure that when penalties are to be imposed in accordance with Article 21 of Regulation (EU) 2017/2394115 , the maximum amount of such fines being at least at 42 % of the trader’s annual turnover in the Member State or Member States concerned. _________________ 115 OJ L 345, 27.12.2017, p. 1.
Amendment 803 #
2023/0085(COD)
Proposal for a directive
Article 21 – paragraph 3 a (new)
Article 21 – paragraph 3 a (new)
3 a. As part of the evaluation referred to in paragraph 1, and in order to ensure a level playing field, the Commission shall carry out an impact assessment on the measures established for micro and small enterprises in Articles 4, 5, 10 and 12, and consider their review after this Directive is implemented.
Amendment 804 #
2023/0085(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 1
Article 25 – paragraph 1 – subparagraph 1
Member States shall adopt and publish by [OP please insert the date = 1830 months after the date of entry into force of this Directive] the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate the text of those measures to the Commission.
Amendment 817 #
2023/0085(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 2
Article 25 – paragraph 1 – subparagraph 2
They shall apply those measures from [OP please insert the date = 2436 months after the date of entry into force of this Directive].
Amendment 31 #
2023/0081(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The net-zero transformation is already causing huge industrial, economic, and geopolitical shifts across the globe, which will become ever more pronounced as the world advances in its decarbonisation efforts. The road to net zero translates into strong opportunities for the expansion of Union’s net-zero industry, making use of the strength of the Single Market, by promoting investment in technologies in the field of renewable energy technologies , electricity and heat storage technologies, heat pumps, grid technologies, renewable fuels of non- biological origin technologies, electrolysers and fuel cells, fusion, small modular reactors and related best-in-class fuels, carbon capture, utilisation, and storage technologies, biosolutions and energy-system related energy efficiency technologies, and efficient water technology and their supply chains, allowing for the decarbonisation of our economic sectors, from energy supply to transport, buildings, and industry. A strong net zero industry within the European Union can help significantly in reaching the Union’s climate and energy targets effectively, as well as in supporting other Green Deal objectives, while creating jobs and growth.
Amendment 37 #
2023/0081(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) To meet the 2030 climate and energy targets, energy efficiency needs to be prioritised. Saving energy is the cheapest, safest and cleanest way to meet those targets. ‘Energy efficiency first’ is an overall principle of EU energy policy and is important in both its practical applications in policy and investment decisions. Therefore, it is essential to expand the Union’s manufacturing capacity for energy efficient technologies, such as heat pumps and smart grid technologies, that help the EU reduce and control its energy consumption. Additionally, in view of the water-energy nexus, it will be critical to ensure the uptake of technologies facilitating a reduction of the water footprint within net-zero strategic projects.
Amendment 42 #
2023/0081(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
Amendment 62 #
2023/0081(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) To achieve the 2030 objectives a particular focus is needed on some of the net-zero technologies, also in view their significant contribution towards the path to net zero by 2050. These technologies include solar photovoltaic and solar thermal technologies, onshore and offshore renewable technologies, battery/storage technologies, heat pumps and geothermal energy technologies, electrolysers and fuel cells, sustainable biofuels including sustainable biogas/biomethane, carbon capture and storage technologies and grid technologies. These technologies play a key role in the Union’s open strategic autonomy, ensuring that citizens have access to clean, affordable, secure energy. Given their role, these technologies should benefit from even faster permitting procedures, obtain the status of the highest national significance possible under national law and benefit from additional support to crowd-in investments.
Amendment 73 #
2023/0081(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The development of carbon capture and storage solutions for industry is confronted with a coordination failure. On the one hand, despite the growing CO2 price incentive provided by the EU Emissions Trading System, for industry to invest into capturing CO2 emissions making such investments economically viable, they face a significant risk of not being able to access a permitted geological storage site. On the other hand, investors into first CO2 storage sites face upfront costs to identify develop and appraise them even before they can apply for a regulatory storage permit. Transparency about potential CO2 storage capacity in terms of the geological suitability of relevant areas and existing geological data, in particular from the exploration of hydrocarbon production sites, can support market operators to plan their investments. Member State should make such data publicly available and report regularly in a forward-looking perspective about progress in developing CO2 storage sites and the corresponding needs for injection and storage capacities above, in order to collectively reach the Union-wide target for CO2 injection capacity. To ensure that injection capacity will deliver the expected CO2 removals and to avoid stranded assets, CCS value chains including capture-transport and storage need to be established by 2030.
Amendment 81 #
2023/0081(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) A key bottleneck for carbon capture investments that are today increasingly economically viable is the availability of operating CO2 storage sites in Europe, which underpin the incentives from Directive 2003/87/EC. To scale up the technology and expand its leading manufacturing capacities, the EU needs to develop a forward-looking supply of permanent geological CO2 storage sites permitted in accordance with Directive 2009/31/EU36 . By defining a Union target of 560 million tonnes of annual operational CO2 injection capacity by 2030, in line with the expected capacities needed in 2030, the relevant sectors can coordinate their investments towards a European Net- Zero CO2 transport and storage value chain that industries can use to decarbonise their operations. This initial deployment will also support further CO2 storage in a 2050 perspective. According to the Commission’s estimates, the Union could need to capture up to 550 million tonnes of CO2 annually by 2050 to meet the net zero objective37 , including for carbon removals. Such a first industrial-scale storage capacity will de-risk investments into the capturing of CO2 emissions as important tool to reach climate neutrality. When this regulation is incorporated into the EEA Agreement, the Union target of 50 million tonnes of annual operational CO2 injection capacity by 2030 will be adjusted accordingly. _________________ 36 Directive 2009/31/EC of the European Parliament and of the Council of 23 April 2009 on the geological storage of carbon dioxide and amending Council Directive 85/337/EEC, European Parliament and Council Directives 2000/60/EC, 2001/80/EC, 2004/35/EC, 2006/12/EC, 2008/1/EC and Regulation (EC) No 1013/2006 (Text with EEA relevance), (OJ L 140, 5.6.2009, p. 114). 37 In depth analysis in support of the Commission Communication (2018/773) A Clean Planet for all. A European long-term strategic vision for a prosperous, modern, competitive and climate neutral economy.
Amendment 82 #
2023/0081(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) To reach the Union’s target of 60 million tonnes of annual operational CO2 injection capacity by 2030 it is necessary to support cross-border transportation of CO2 and to overcome the limitations set by the London Protocol. The Commission should develop a CO2 infrastructure plan with actions towards creating a regulatory and financial framework to establish a unified CCS market in the EU.
Amendment 84 #
2023/0081(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) By defining CO2 storage sites that contribute to the Union’s 2030 target as net-zero strategic projects, the development of CO2 storage sites can be accelerated and facilitated, and the increasing industrial demand for storage sites can be channelled towards the most-cost-effective storage sites. An increasing volume of depleting gas and oil fields that could be converted in safe CO2 storage sites are at the end of their useful production lifetime. In addition, the oil and gas industry has affirmed its determination to embark on an energy transition and possesses the assets, skills and knowledge needed to explore and develop additional storage sites. To reach the Union’s target of 560 million tonnes of annual operational CO2 injection capacity by 2030, the sector needs to pool its contributions to ensure that carbon capture and storage as a climate solution is available ahead of demand. In order to ensure a timely, Union-wide and cost- effective development of CO2 storage sites in line with the EU objective for injection capacity, licensees of oil and gas production in the EU should contribute to this target pro rata of their oil and gas manufacturing capacity, while providing flexibilities to cooperate and take into account other contributions of third parties.
Amendment 88 #
2023/0081(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) After the entry into force of this regulation, the Commission shall assess the introduction of post-2030 targets for CO2 storage to contribute to the Union´s 2035, 2040 and 2045 climate targets and to the objective to reach climate neutrality at the latest by 2050.
Amendment 148 #
2023/0081(COD)
Proposal for a regulation
Recital 51
Recital 51
(51) Given their role in ensuring the Union’s security of supply for net-zero technologies, and their contribution to the Union’s open strategic autonomy and the green and digital transition, responsible permitting authorities should considerpresume Net- Zero Strategic Projects to be in the public interest. Based on its case-by-case assessment, a responsible permitting authority may conclude that the public interest served by the project overrides the public interests related to nature and environmental protection and that consequently the project mayshould be authorised, provided that all relevant conditions set out in Directive 2000/60/EC, Directive 92/43/EEC and Directive 2009/147/EC63and time limits are met. _________________ 63 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7–25).
Amendment 164 #
2023/0081(COD)
Proposal for a regulation
Recital 57
Recital 57
(57) The environmental assessments and authorisations required under Union law, including in relation to water, air, ecosystems, habitats, biodiversity and birds, are an integral part of the permit granting procedure for a net zero technologies manufacturing project and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit granting procedures for net zero technologies manufacturing projects are predictable and timely, a they should not exceed the pre-set time limit for any stage in the permitting process. Any potential to streamline the required assessments and authorisations while not lowering the level of environmental protection should be realised. In that regard, it should be ensured that the necessary assessments are bundled to prevent unnecessary overlap and it should be ensured that project promoters and responsible authorities explicitly agree on the scope of the bundled assessment before the assessment is carried out to prevent unnecessary follow-up.
Amendment 172 #
2023/0081(COD)
Proposal for a regulation
Recital 58
Recital 58
(58) Land use conflicts can create barriers to the deployment of net zero technologies manufacturing projects. Well- designed plans, including spatial plans and zoning, that take into account the potential for implementing net-zero technologies manufacturing projects and whose potential environmental impacts are assessed, have the potential to help balance public goods and interests, decreasing the potential for conflict and accelerating the sustainable deployment of net-zero technologies manufacturing projects in the Union. Responsible national, regional and local authorities should therefore consider the inclusion ofinclude, where relevant, provisions for net-zero technologies manufacturing projects when developing relevant plans.
Amendment 179 #
2023/0081(COD)
Proposal for a regulation
Recital 62
Recital 62
(62) Net-zero regulatory sandboxes can be an important tool to promote innovation in the field of net-zero technologies ands well as regulatory learning and should include all technologies with potential to enable the transition to a climate neutral, clean economy and reduce strategic dependencies. Innovation needs to be enabled through experimentation spaces as scientific outcomes need to be tested in a controlled real-word environment. Regulatory sandboxes should be introduced to test innovative net-zero technologies in a controlled environment for a limited amount of time It is appropriate to strike a balance between legal certainty for participants in the Net- Zero regulatory sandboxes and the achievement of the objectives of Union law. As Net-Zero regulatory sandboxes must in any case comply with the essential requirements on Net-Zero technology laid out in Union and national law, it is appropriate to provide that participants , who comply with the eligibility requirements for Net-Zero regulatory sandboxes and who follow, in good faith, the guidance provided by the competent authorities and the terms and conditions of the plan agreed with those authorities, are not subject to any administrative fines or penalties. This is justified as the safeguards in place will, in principle, ensure effective compliance with Union or Member State law on the Net-Zero technology supervised in the regulatory sandboxes. The Commission will publish a Guidance for Sandboxes document in 2023 as announced in the New European Innovation Agenda to support Member States in preparing the net zero technology sandboxes. Those innovative technologies could eventually be essential to achieve the Union’s climate neutrality objective, ensure the security of supply and resilience of the Union’s energy system, and consequently enter the scope of strategic net-zero technologies.
Amendment 208 #
2023/0081(COD)
Proposal for a regulation
Article 1 – paragraph 2 a (new)
Article 1 – paragraph 2 a (new)
2a. The Commission shall, if necessary, review and update the list of net-zero technologies and the annex of strategic net-zero technologies by means of delegated acts in accordance with Article 33 one year after the date of entry into force of this Regulation and every year thereafter;
Amendment 209 #
2023/0081(COD)
Proposal for a regulation
Article 1 – paragraph 2 b (new)
Article 1 – paragraph 2 b (new)
2b. The yearly review and update of the list of net-zero technologies and the annex of strategic net-zero technologies shall be based on the following criteria and an assessment of: 1. Technology neutrality with the aim of including relevant technologies that meet the criteria for substantial contribution to climate change mitigation in accordance with article 10 of Regulation (EU) 2020/852; 2. Technology that is critical for meeting EU's climate neutrality target; 3. Technology with an untapped potential as well as technologies facing market failures due to insufficient funding and regulation;
Amendment 227 #
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; biosolutions; and energy-system related energy efficiency technologies and efficient water technology. 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 240 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point c
Article 3 – paragraph 1 – point c
(c) ‘innovative net-zero technologies’ means technologies which satisfy the definition of ‘net-zero technologies’, except that they have not reached a tith potential to enable the transition to a climate neutral, clean echonology readiness level of at least 8my and reduce strategic dependencies, and that comprise genuine innovation which are not currently available on the market and are advanced enough to be tested in a controlled environment.
Amendment 318 #
2023/0081(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where an environmental impact assessment must be carried out in accordance with Articles 5 to 9 of Directive 2011/92/EU, the project promoter concerned shall request an opinion to the competent authority referred to in Article 4 on the scope and level of detail of the information to be included in the environmental impact assessment report pursuant to Article 5(1) of that Directive. The national competent authority shall ensure that the opinion referred to in the first subparagraph is issued as soon as possible and within a period of time not exceeding 3015 days from the date on which the project promoter submitted its request.
Amendment 334 #
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 337 #
2023/0081(COD)
Proposal for a regulation
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3a. In exceptional cases, where the nature, complexity, location or size of the proposed project so requires, the national competent authority may extend the time limits referred to in paragraph 3 by a maximum of 1 month, before their expiry and on a case-by-case basis. In that event, the national competent authority shall inform the project promoter of the reasons justifying the extension and of the date when the reasoned conclusion is expected in writing.
Amendment 338 #
2023/0081(COD)
Proposal for a regulation
Article 7 – paragraph 3 b (new)
Article 7 – paragraph 3 b (new)
3b. The lack of a reasoned conclusion by the competent authority within the applicable time limits referred to in paragraph 3 shall result in a positive conclusion of the assessment procedure.
Amendment 340 #
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 45 days. In cases falling under the second sub-paragraph of Article 6(4), this period shallcan be extended to 90 daysmaximum 90 days. In that event, the national competent authority shall inform the project promoter of the reasons justifying the extension.
Amendment 374 #
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 and all the necessary infrastructure, 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. When there is a need for an assessment according to this Article these assessments shall be conducted in such a way that they do not lead to a prolongation of the time limits referred to in Article 13(1) and 13(2).
Amendment 384 #
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 12 and 13 shall be made publicly available in an easily understandable manner and all decisions concerning one project shall be presented in the same place.
Amendment 461 #
2023/0081(COD)
Proposal for a regulation
Article 12 – paragraph 3
Article 12 – paragraph 3
3. Net-zero strategic projects shall be considered to contribute to the security of supply of strategic net-zero technologies in the Union and therefore to be in the public interest. With regard to the environmental impacts addressed in Articles 6(4) and 16(1)I of Directive 92/43/EEC, Article 4(7) of Directive 2000/60/EC and Article 9(1)(a) of Directive 2009/147/EC, net-zero strategic projects in the Union shall, until climate neutrality is achieved, be considered as being of public interest and may be considershall be presumed as havbeing ain the overriding public interest provided that all the conditions set out in those Directives are fulfilled.
Amendment 487 #
2023/0081(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. National competent authorities shall ensure that the lack of reply of the relevant administrative bodies within the applicable time limits referred to in this Article results in the specific intermediary steps to be considered as approved, except where the specific project is subject to an environmental impact assessment pursuant to Council Directive 92/43/EEC or Directive 2000/60/EC, Directive 2008/98/EC, Directive 2009/147/EC, Directive 2010/75/EU, 2011/92/EU or Directive 2012/18/EU or a determination of whether such environmental impact assessment is necessary and the relevant assessments concerned have not yet been carried out, or where the principle of administrative tacit approval does not exist in the national legal system. The need for such an impact assessment shall be decided on and communicated to the project promoter within 14 days. When this is not done within this time limit it shall be considered that such an impact assessment is not needed. This provision shall not apply to final decisions on the outcome of the process, which are to be explicit. All decisions shall be made publicly available.
Amendment 512 #
2023/0081(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
An annual injection capacity of at least 560 million tonnes of CO2 shall be achieved by 2030, in storage sites located in the territory of the European Union, its exclusive economic zones or on its continental shelf within the meaning of the United Nations Convention on the Law of the Sea (UNCLOS) and which are not combined with Enhanced Hydrocarbon Recovery (EHR). Of the annual injection capacity of at least 60 million tonnes of CO2, at least 20 million tonnes shall be reserved for the permanent removal of CO2 through the injection of biogenic and/or atmospheric CO2.
Amendment 522 #
2023/0081(COD)
Proposal for a regulation
Article 16 a (new)
Article 16 a (new)
Amendment 525 #
2023/0081(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) make publicly available data on areas where CO2 storage spermites can be permittor exploration permits have been issued con their territorysidering the full scope of viable options and geologies.
Amendment 563 #
2023/0081(COD)
Proposal for a regulation
Article 18 – title
Article 18 – title
18 Contribution of authorised oil and gas producerfrom Member States
Amendment 564 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. Each entity holding an authorisation as defined in Article 1, point 3, of Directive 94/22/ECMember States shall be subject to an individual contribution to the Union- wide target for available CO2 injection capacity set in Article 16. Those individualMember State contributions shall be calculated pro-rata on the basis of each entity’Member States share in the Union’s coal, crude oil and natural gas production from 1 January 2020 to 31 December 2023 and shall consist of CO2 injection capacity in a storage site permitted in accordance with Directive 2009/31/EC on the geological storage of carbon dioxide and available to the market by 2030.
Amendment 570 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Within three months of the entry into force of this Regulation, Member States shall, identify and report to the European Commission the entities referred to in paragraph 1 and their volumes in coal, crude oil and natural gas that are productioned from 1 January 2020 to 31 December 2023.
Amendment 574 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 3
Article 18 – paragraph 3
3. Following the receipt of the reports submitted pursuant to Article 17 (2), the Commission after having consulted Member States and interested parties, shall specify the share of the contribution to the Union CO2 injection capacity objective by 2030 from entitiMember States referred to in paragraph 1.
Amendment 579 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 4 – introductory part
Article 18 – paragraph 4 – introductory part
4. Within twelve months of the entry into force of the Regulation, the entities referred to in paragraph 1Member States shall submit to the Commission a plan detailing how they intend to meet their contributione to Union CO2 injection capacity objective by 2030. Those plans shall:
Amendment 581 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 4 – point a
Article 18 – paragraph 4 – point a
(a) confirm the entity'Member States contribution, expressed in terms of targeted volume of new CO2 storage and injection capacity commissioned by 2030;
Amendment 593 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 5 – introductory part
Article 18 – paragraph 5 – introductory part
5. To meet their targeted volumes of available injection capacity, entitiMember States referred to in paragraph 1 can do any of the following:
Amendment 595 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 5 – point a
Article 18 – paragraph 5 – point a
(a) develop CO2 storage projects alone or in co-operation with private companies;
Amendment 597 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 5 – point b
Article 18 – paragraph 5 – point b
(b) enter into agreements with other entitiMember States referred to in paragraph 1;
Amendment 601 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 5 – point c
Article 18 – paragraph 5 – point c
(c) enter into agreements with third party storage project developers or investors to fulfil their contribution.
Amendment 606 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 6
Article 18 – paragraph 6
6. Two years after the entry into force of the Regulation and every year thereafter, the entitiMember States referred to in paragraph 1 shall submit a report to the Commission detailing their progress towards meeting their contribution. In line with Directive 2009/31/EC, this report shall include details on new injection capacity commissioned, how much of that capacity is being utilised, and the sources of CO2 that is stored. The Commission shall make these reports public.
Amendment 735 #
2023/0081(COD)
Proposal for a regulation
Annex – row 6
Annex – row 6
6. Sustainable biofuels including biogas/biomethane technologies
Amendment 99 #
2023/0042(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The Union fleet-wide targets are to be complemented by the necessary roll-out of recharging and refuelling infrastructure as set out in the Commission Proposal for a regulation on the deployment of alternative fuel infrastructure16 . Strengthened CO2 emission reduction requirements should also incentivise additional investments in infrastructure, beyond the legally required minimum, enabling a large infrastructure roll-out. To that end, the European Commission should present a report by (6 month after the entry into force of this regulation) setting out actions to reduce the duration of the permit granting process for recharging infrastructure. __________________ 16 Proposal for a Regulation of the European Parliament and of the Council on the deployment of alternative fuels infrastructure, and repealing Directive 2014/94/EU of the European Parliament and of the Council, 14.7.2021, COM/2021/559 final.
Amendment 116 #
2023/0042(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) Extra Heavy Combinations (EHC) are vehicles with a maximum permissible mass over 60 tonnes, compared to the EU- average of 40 tonnes. As the formula for calculating CO2 emissions assumes the same payload as for significantly smaller heavy-duty vehicles, the formula should be modified to take into account the increased energy efficiency of these extra heavy combinations to better reflect the real life emissions.
Amendment 141 #
2023/0042(COD)
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21a) Heavy-duty vehicles intended for use as abnormal transport, such as windmill transports, car transporters and contractor vehicles, should be exempted from having to meet the CO2 targets before, during and after the transport. That a vehicle is intended for the use of abnormal transport can be verified by a certificate issued by national authorities.
Amendment 231 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point i
Article 1 – paragraph 1 – point 3 – point i
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 23 a (new)
Article 3 – paragraph 1 – point 23 a (new)
(23a) 'Renewable fuels eligible for CCF' means advanced biofuels and biogas (as defined in Directive (EU) 2018/2001 Annex IX parta) and renewable fuels of non-biological origin. These eligible fuels need to meet sustainability and greenhouse gas emissions saving criteria as given in Directive (EU) 2018/2001 of the European Parliament and of the Council;
Amendment 237 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point i
Article 1 – paragraph 1 – point 3 – point i
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 23 b (new)
Article 3 – paragraph 1 – point 23 b (new)
(23b) 'Carbon Correction Factor (CCF)' means a factor which applies a correction to the tailpipe CO2 emissions of vehicles for compliance assessment, to reflect the GHG emission intensity and the share of renewable fuels eligible for CCF, as defined in Article 3 (23a new) of this Regulation;
Amendment 316 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3ab (new)
Article 3ab (new)
3c. Article 3ab - Additional measures to support the transition to zero-emission vehicles in the Union market By [6 months entry into force of this Regulation], the Commission shall adopt a delegated act in accordance with Article 17 to harmonise the type-approval rules for vehicles with internal combustion engines converted to battery, fuel cell electric drive or hydrogen combustion engine, in order to allow for series approval. The Commission shall also assess the introduction of a rule for calculating the CO2 equivalents of combustion engine vehicles converted to zero emission vehicles in the context of the application of this regulation.
Amendment 338 #
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
Member States may decide to exclude from the obligation under this Article a limited share of the urban buses, city buses and inter-urban buses registered in each reporting period, confirming that the purpose of the vehicle cannot be equally served by a zero-emission vehicle and it is thus in the public interest to register a non- zero emission vehicle to fulfil that purpose, due to socio-economic cost-benefit in view of specific territorial morphology or meteorological circumstances. This exemption shall cease by 2030.
Amendment 365 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EU) 2019/1242
Article 4 – paragraph 1 – point a a (new)
Article 4 – paragraph 1 – point a a (new)
Amendment 433 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 16
Article 1 – paragraph 1 – point 16
Regulation (EU) 2019/1242
Article 13 d – paragraph 1
Article 13 d – paragraph 1
1. The Commission shall monitor, where available, the results of on-road tests performed within the framework of Regulation (EC) No 595/2009ance during a periodic roadworthiness test to verify the CO₂ emissions and fuel consumption of new heavy-duty vehicles. Access shall only be granted to authorised inspectors during the periodic roadworthiness testing under standardised and safe conditions.
Amendment 449 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 18
Article 1 – paragraph 1 – point 18
Regulation (EU) 2019/1242
Article 15
Article 15
The Commission shall, in 2028, review the effectiveness and impact of this Regulation and submit a report to the European Parliament and to the Council with the result of the review. By 31 December 2027, and every year thereafter, the Commission shall report to the European Parliament and to the Council, on the state of the enabling conditions for the market adoption of zero-emission heavy-duty vehicles in the Union. In this report, the Commission shall assess all relevant elements, in particular the following: (a) registrations of zero-emission heavy- duty vehicles in Member States ; (b) the deployment of charging and refuelling infrastructure suitable for heavy-duty vehicles in Member States; (c) the implementation of road user charges differentiated by CO2 emissions in Member States; (d) the level of the average price of allowances under the new the emissions trading system covering road transport (e) other measures that support the uptake of zero-emission heavy-duty vehicles; If the report concludes that enabling conditions, especially under paragraphs (b), (c) or (d) are found to be not in line with the targets for vehicle manufacturers in Art. 3a and b of this Regulation, the findings of the report shall be taken into account for future revisions of the Directive 2014/94/EU of the European Parliament and of the Council, the Directive (EU) 2022/362 of the European Parliament and of the Council, and the Directive 2003/87/EC of the European Parliament and of the Council.
Amendment 502 #
2023/0042(COD)
Proposal for a regulation
Annex I – point 2 – point 2.7 – paragraph 2 – point 2.7.2 – paragraph 1
Annex I – point 2 – point 2.7 – paragraph 2 – point 2.7.2 – paragraph 1
Regulation (EU) 2019/1242
Annex I – point 2 – point 2.7
Annex I – point 2 – point 2.7
CO2(NO) = ∑sg sharesg × MPWsg × (avgCO2sg × (1 - sharesgEHC) + αsg x avgCO2sg × sharesgEHC)
Amendment 503 #
2023/0042(COD)
Proposal for a regulation
Annex I – point 2 – point 2.7 – paragraph 2 – point 2.7.2 – paragraph 14 a (new)
Annex I – point 2 – point 2.7 – paragraph 2 – point 2.7.2 – paragraph 14 a (new)
Regulation (EU) 2019/1242
Annex I – point 2 – point 2.7
Annex I – point 2 – point 2.7
sharesgEHC is the share in subgroup sg of the manufacturer's new heavy duty category N3 vehicles that are permitted to be used in an EHC αsg is the compensation factor to adjust the effect of the higher payload of a EHC on the manufacturer's trucks, depending on the average in service maximum permissible combination mass, using the weighted value of the result of the following formulae: αsg = 1 + (-3/5*avgGVWsg comb 8x4-30)/100, for 8x4 EHC trucks αsg = 1 + (-3/5*avgGVWsg comb other+19)/100, for other EHC trucks avgGVWsg comb is the manufacturer- specific average in the country of registration for the in service maximum permissible combination mass (tonnes) for EHC trucks in question in the subgroup sg, when the following condition is met: For the purposes of the calculation of CO2 emissions, a truck covered by this Regulation shall be considered part of an EHC if the truck is in category N3 and the in service maximum permissible mass of the vehicle combination in the country of registration is over 60 tonnes and has been reported in accordance with point (qa) of Part A of Annex IV.
Amendment 508 #
2023/0042(COD)
Proposal for a regulation
Annex IV – Part A – point q a (new)
Annex IV – Part A – point q a (new)
Regulation (EU) 2019/1242
Annex IV
Annex IV
(qa) maximum mass for a category N3 truck in an EHC referred to in Annex I, paragraph 2.7.2. in the truck’s country of registration when the truck is coupled to one or more semi-trailers/drawbar trailers;
Amendment 517 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 1 – subparagraph 1.1 – table 1.2
Annex I – paragraph 1 – subparagraph 1.1 – table 1.2
1.2. Vocational vehicles are defined by the following criteria: Vehicle category Chassis Criteria for vocational vehicles configuration N Rigid One of the following digits, as listed in Appendix 2 of Annex I to Regulation (EU) 2018/858, is used to supplement the code for bodywork indicated in entry 38 of the certificate of conformity: 09, 10, 12, 13, 14, 15, 16, 17, 18, 19, 20, 23, 24, 25, 26, 27, 28, 31; Tractor Maximum speed not exceeding 79 km/h
Amendment 522 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 2 – subparagraph 2.1
Annex I – paragraph 2 – subparagraph 2.1
2.1. Calculation of the specific CO2 emissions of a new heavy-duty vehicle The specific emissions in g/km of a new heavy-duty vehicle v attributed to a sub-group sg or of its primary vehicle shall be calculated in accordance with the following formula: 𝐶𝑂2𝑣 = ∑𝑊 𝑚𝑝 𝑠𝑔,𝑚𝑝 × 𝐶𝑂2𝑣,𝑚𝑝 × (𝟏 ― 𝐂𝐂𝐅𝐢) 𝐶𝑂2p𝑣 = ∑𝑊 𝑚𝑝 𝑠𝑔,𝑚𝑝 × 𝐶𝑂2p𝑣,𝑚𝑝 × (𝟏 ― 𝐂𝐂𝐅𝐢) Where, ∑𝑚𝑝 is the sum over all mission profiles mp listed in Table 2; sg is the sub-group to which the new heavy-duty vehicle v has been attributed according to Section 1 of this Annex; Wsg,mp, is the mission profile weight specified in points 2.1.1 to 2.1.3; CO2v,mp is the CO2 emissions in g/km of the new heavy-duty vehicle v determined for a mission profile mp, reported in accordance with Articles 13a and 13b and normalised pursuant to Annex III; CO2pv,mp is the CO2 emissions in g/km of the primary vehicle of the new heavy-duty vehicle v, determined for a mission profile mp, reported in accordance with Articles 13a and 13b; CCFi is the Carbon Correction Factor for the fuel or blend of fuels in use i, as defined in article 3 point (23b new) and calculated according to paragraph 7 of this Annex, to be applied from 2030 onwards.. For zero-emissions motor vehicles the values of CO2v,mp and CO2pv,mp shall be set to 0.
Amendment 589 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 6 a (new)
Annex I – paragraph 6 a (new)
Amendment 26 #
2022/2172(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Strongly opposes any new own resource based on the financial or corporate sector; notes that the percentage that the ETS contributes to the EU’s own resources could be increased before introducing any new own resources;
Amendment 52 #
2022/2172(INI)
Draft opinion
Paragraph 5
Paragraph 5
Amendment 26 #
2022/2146(INI)
Motion for a resolution
Recital A
Recital A
A. whereas Member States are free to decide on their own economic policies, in particular their own tax policies within the boundaries of the EU Treaties; whereas a well-functioning tax system is in the interest of Member States in order to ensure proper tax collection; whereas, although tax policy largely remains a responsibility of the Member States, the single market requires coordination in setting tax policy in order to further single market integration;
Amendment 38 #
2022/2146(INI)
Motion for a resolution
Recital B
Recital B
B. whereas a number of European companies are battling strong headwinds as a result of the current adverse economic and social situations;
Amendment 51 #
2022/2146(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the BEPS action plan managed to establish a global consensus on many issues regarding the fight against tax avoidance and aggressive tax planning;
Amendment 56 #
2022/2146(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the EU led by example in transposing international agreements into a high number of tax directives improving coordination and the EU’s fight against tax fraud, tax avoidance and aggressive tax planning;
Amendment 62 #
2022/2146(INI)
Motion for a resolution
Recital E
Recital E
E. whereas as of 16 December 2022, 138 statejurisdictions, including all EU Member States, had agreed on the reform of the international tax system through a two- pillar solution;
Amendment 67 #
2022/2146(INI)
Motion for a resolution
Recital F
Recital F
F. whereas tax policy fragmentation createsontributes to creation of various obstacles for citizens and companies in the single market, particularly small and medium- sized enterprises (SMEs); whereas these obstacles discourage cross-border economic activity and can distort the single market;
Amendment 69 #
2022/2146(INI)
Motion for a resolution
Recital F
Recital F
F. whereas tax policy fragmentation creates various obstacles for citizens and companies in the single market, particularly small and medium-sized enterprises (SMEs); whereas these obstacles discourage cross-border economic activity and can distort the single market; whereas Member States continue to lose tax revenue due to harmful tax practices enabled by loopholes between Member States’ legislation, or between Member States and third countries, and estimates of revenue lost as a result of harmful tax practices range from EUR 36-37 billion to EUR 160-190 billion per year; whereas policy fragmentations might increase the cost of enforcement for tax authorities;
Amendment 110 #
2022/2146(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Underlines that EU Member States have a full responsibility for proper tax collection and they are entitled to decide on their own tax systems;
Amendment 111 #
2022/2146(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Highlights that well-functioning tax systems and national tax administrations play a key role in tax collection and that sustainable tax revenue in the Member States´ public budgets is important in the current challenging economic climate;
Amendment 128 #
2022/2146(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Takes note of the numerousWelcomes different tax directives since 2011 that have led to fairer, simpler and more effective corporate taxation in the EU, andbut also to a high number of tax compliance obligations on companies within the EU21 ; _________________ 21 See notably the Anti-Tax Avoidance Directives (ATAD I and ATAD II), the amendments of the Directive on administrative cooperation in the field of taxation (DAC 1 to DAC 7), the revision of the Parent Subsidiary Directive, the EU Dispute Settlement Directive, the Public Country-by-Country Reporting Directive, or the Pillar Two Directive.
Amendment 135 #
2022/2146(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Deplores the fact that in certain cases the Member States have implemented and applied tax directives in a divergent manner, which may undermininge the proper functioning of the single market and leading to misalignment in tax bases, more red tape and higher compliance costs;
Amendment 159 #
2022/2146(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission to present an overall evaluation of actions taken on corporate taxation since 2011 and to immediatelywith the aim to ease the burden on businesses by invoking a regulatory moratorium and to delaying those tax acts that would unnecessarily increase costs for businesses already under strain; calls on the Commission to carry out competitiveness checks for new legislative tax proposals, as requested by the European Council for all new proposals on 22 March 2023;
Amendment 162 #
2022/2146(INI)
7. Calls on the Commission to present an overall evaluation of actions taken on corporate taxation since 2011 and to immediately ease the burden on businesses by invoking a regulatory moratorium and delaying those tax acts that would unnecessarily increase costs for businesses already under strain; calls on the Commission to carry out competitiveness checks for new legislative tax proposals, as requested by the European Council for all new proposals on 22 March 2023, and to ensure that the submission of any new proposal, if necessary, is essential for the smooth functioning of the single market ;
Amendment 173 #
2022/2146(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Takes note of the renewed debate on tax incentives following the US Inflation Reduction Act; calls on the Commission to allow fornalyse experimentation with tax credits; insists, nevertheless, that all decisions should be taken in a coordinated manner to preserve the functioning of the single market;
Amendment 180 #
2022/2146(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls on the Member States to consider engageing in policies of full expensing for capital investments and to make capital allowance provisions permanent in order to improve real investments and to assist Europe’s competitiveness;
Amendment 195 #
2022/2146(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Takes note ofWelcomes the two-pillar solution reached at the OECD/G20 Inclusive Framework on the allocation of taxing rights and the application of a minimum effective tax rate of 15 % on the global profits of MNEs; welcomes the adoption of the Pillar Two Directive implementing the international agreement in the EU law;
Amendment 208 #
2022/2146(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Observes that, in addition to coping with a volatile business environment and an increasing number of EU tax directives, companies are focusing their financial and human resources on applying the Pillar Two rules; calls on the Commissioninvites the Commission to assess effectiveness and impact of the Pillar Two rules, namely in the context of expected aims, cost-benefits analysis, fight against tax evasion and avoidance, fair tax competition and higher tax revenue, and thus to give companies breathing space and enough time to prepare for the possible new BEFIT rules;
Amendment 227 #
2022/2146(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to guidesuggest measures for all the Member States towards a simplified tax system to reduce the administrative burden for companies, especially SMEs; acknowledges that simplifying refund procedures, deductions and litigation are other solutions to reduce the administrative burden, especially for SMEs;
Amendment 231 #
2022/2146(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Welcomes that the EU has developed peer review procedures within the Code of Conduct Group for business taxation; underlines that in this framework Member States re-examine, amend or abolish their existing tax measures that constitute harmful tax competition, as well as refrain from introducing new ones in the future; welcomes in this regard the 2022 Council agreement to broaden the scope of the tax measures under scrutiny when examining harmful tax practices within the EU;
Amendment 241 #
2022/2146(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the Commission’s plan to work on a BEFIT proposal, expected in the third quarter of 2023, with a view to designing a new and single EU corporate tax rulebook, based on a fair, comprehensive and effective formulary apportionment and a common tax base of income taxation for businesses, which wil. In this context, calls on the Commission to ensure that the new proposal provides clarity and predictability for companies;
Amendment 249 #
2022/2146(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Reiterates its consideration that the BEFIT initiative should be supported by the political process in building political support for change, including consideration of next steps in the absence of such political support, and that the initiative shouldmust be accompanied by a thorough impact assessment;
Amendment 256 #
2022/2146(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Takes note of the intended BEFIT objectives, as addressed in the Commission’s call for evidence for an impact assessment, to increase businesses’ resilience by reducing the complexity of tax rules and the compliance costs faced by EU businesses with cross-border operations, to remove obstacles to cross- border investment and make the single market a more attractive location for international investment, to create an environment conducive to fair and sustainable growth by paving the way for administrative simplification, and to provide sustainable tax revenue for the national budgets of the EU Member States, which is particularly important in the current challenging economic climate;
Amendment 274 #
2022/2146(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Takes note of the Commission proposal of 11 May 2022 addressing the debt-equity bias; deplores and the Council decision of 6 December 2022 to suspend the examination of the proposal; calls on the Council to relaunchassess negotiations on this proposal; within a broader context after other proposals in the area of corporate income taxation announced by the Commission have been put forward ;
Amendment 28 #
2022/2142(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Recalls that Article 48(7) of the Treaty on European Union provides for two general passerelle clauses that allow the decision-making procedures to be changed in order to adopt measures in Council through qualified majority voting (QMV) in areas that are currently subject to unanimity; regrets the fact that these passerelle clauses have never been used; recalls that activating the passerelle clauses would in any case require unanimity in the European Council and Parliament’s consent;
Amendment 36 #
2022/2142(INI)
Draft opinion
Paragraph 4
Paragraph 4
Amendment 2 #
2022/2062(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
— having regard to Articles 2 and 3 of the Treaty on European Union,
Amendment 21 #
2022/2062(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas the EIB eligibility list currently excludes equipment and infrastructure for military use; whereas investments for dual use are not excluded1a; _________________ 1a https://www.eib.org/en/publications/eib- eligibility-excluded-activities-and- excluded-sectors-list
Amendment 39 #
2022/2062(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Emphasises the importance of adherence to the rule of law in the European Union, as enshrined in the EU Treaty; invites the EIB to align its activities with the Rule of Law conditionality mechanism;
Amendment 54 #
2022/2062(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Welcomes the EIB Strategic European Security Initiative (SESI), which will make available up to 6 billion euros by 2027 for dual-use research, RDI, civilian security infrastructure and cutting-edge technology projects;
Amendment 58 #
2022/2062(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
Amendment 59 #
2022/2062(INI)
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10 c. Regrets the exclusion of ammunition, weapons, equipment and infrastructure for military use from the list of eligible investments, given that investment in these areas is critical in order to sustain European security; considers that any military product is not unethical in and of itself and that its use should always be aligned with international law; calls on the EIB to include investments in defence products and activities in its eligibility list;
Amendment 67 #
2022/2062(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Welcomes the fact that in 2022, the EIB provided financing amounting to a total investment of EUR 16.35 billion for SMEs and mid-caps; calls on the EIB to reflect on ways to facilitate its support to SME's further, especially for smaller financing projects;
Amendment 95 #
2022/2062(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Emphasises the importance of investing in low carbon energy sources such as hydrogen, CCS and nuclear energy; welcomes in this regard the EIB's contribution to REPowerEU in the form of an additional 30 billion euros in investments; highlights that nuclear energy is free of CO2 emissions and taxonomy-aligned; welcomes in this regard the EIB's activities in this field and encourages the bank to step up its efforts;
Amendment 101 #
2022/2062(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes the introduction of the EIB’s new transport lending policy in July 2022 and calls for its swift implementation; calls on the EIB to finance all projects that align with the EU Taxonomy, as well as other projects that aim to lower the carbon footprint of the maritime sector, such as Green Corridor projects;
Amendment 115 #
2022/2062(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Welcomes the fact that EIB Global supported EUR 9.1 billion in global investment outside the EU in 2022; expects EIB investments in non-EU countries to be fully aligned with EU and EU external action policies and objectives;
Amendment 117 #
2022/2062(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24 a. Considers that the EIB should contribute to the EU’s objective of enhancing its strategic autonomy; welcomes in this regard the launch of the Global Gateway Fund, which will principally support investments in infrastructure and SME's;
Amendment 103 #
2022/2061(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that the EU should fairly and fully implement the Basel III reform in a timely manner; in a way that recognises European specificities such as unrated corporates and low-risk mortgages;
Amendment 125 #
2022/2061(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Notes that the ECB has decided to raise its main interest rates from 0 % to 2 .5 % for the main refinancing operation rate;
Amendment 297 #
2022/2061(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
Amendment 299 #
2022/2061(INI)
Motion for a resolution
Paragraph 24 b (new)
Paragraph 24 b (new)
24 b. Recognises risk reduction as a precondition for the establishment of risk- sharing mechanisms such as EDIS;
Amendment 178 #
2022/0411(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6 – point c
Article 1 – paragraph 1 – point 6 – point c
Regulation (EU) 2017/1129
Article 6 – paragraphs 4 and paragraph 5
Article 6 – paragraphs 4 and paragraph 5
Amendment 202 #
2022/0411(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10 – point a – point i
Article 1 – paragraph 1 – point 10 – point a – point i
Regulation (EU) 2017/1129
Article 13 – paragraph 1 – subparagraph 1
Article 13 – paragraph 1 – subparagraph 1
The Commission shall adopt delegated acts in accordance with Article 44 to supplement this Regulation regarding the standardised format and standardised sequence of the prospectus, the base prospectus and the final terms, and the schedules defining the specific information to be included in a prospectus, including LEIs and ISINs, avoiding duplication of information when a prospectus is composed of separate documents.; The format for the standardised prospectus shall follow international market practices.
Amendment 256 #
2022/0411(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point c
Article 2 – paragraph 1 – point 5 – point c
Regulation (EU) No 596/2014
Article 17 – paragraph 4 – subparagraph 2
Article 17 – paragraph 4 – subparagraph 2
Amendment 80 #
2022/0406(COD)
Proposal for a directive
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) ‘company’ means a legal entity incorporated as one of the types of companies listed in Annex II to Directive (EU) 2017/1132 which may under national law issue shares and seek admission to trading of the shares on an SME growth market;
Amendment 89 #
2022/0406(COD)
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall ensure that companies that do not have shares that are admitted to trading on a trading venue have the right to adopt multiple-vote share structures for the admission to trading of shares on an SME growth market in one or more Member States. Member States shall ensure that the company’s decision to adopt a multiple-vote share structure is taken by the general meeting by at least a qualified majority as specified in national law. Member States shall not make the adoption of such a structure conditional upon the provision of enhanced economic rights for shares without enhanced voting rights. For the purposes of the first subparagraph, where there are several classes of shares, the decision to adopt a multiple-vote share structure shall also be subject to a separate vote within each class of shares whose rights are affected. Member States shall not prevent the admission to trading of shares of a company on an SME growth market on the ground that the company has adopted a multiple-vote share structure.
Amendment 108 #
2022/0406(COD)
Proposal for a directive
Article 5 – paragraph 1 – point b – introductory part
Article 5 – paragraph 1 – point b – introductory part
(b) limit the voting weight ofimpact of the multiple- vote shares on the exercise of other shareholders’ rights, in particular duringdecision-making process at the general meetings, by introducing eitherat least one of the following:
Amendment 116 #
2022/0406(COD)
Proposal for a directive
Article 5 – paragraph 1 – point b – point i
Article 5 – paragraph 1 – point b – point i
(i) a maximum weighted voting ratio and a requirement on the maximum percentage of the outstanding share capital that the total amount of multiple- vote shares can represent;
Amendment 127 #
2022/0406(COD)
Proposal for a directive
Article 5 – paragraph 1 – point b – point ii
Article 5 – paragraph 1 – point b – point ii
(ii) a restriction on the exercise of the enhanced voting rights attached to multiple-vote shares for voting on matters to be decided at the general meeting of shareholders and that require the approval by a qualified majorityquirement that decisions by the general meeting subject to qualified majority, excluding appointment and dismissal of directors as well as operational decisions to be taken by directors and that are submitted to the general meeting for approval, are to be adopted by either: - a qualified majority, as specified in national law, both of the votes cast and either of the share capital represented at the meeting or of the number of shares represented at the meeting or; - a qualified majority, as specified in national law, of the votes cast, and are subject to a separate vote within each class of shares the rights of which are affected.
Amendment 139 #
2022/0406(COD)
Proposal for a directive
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Member States may provide for further safeguards to ensure adequate protection of shareholders and of the interests of the company. Those safeguards may include in particular:
Amendment 145 #
2022/0406(COD)
Proposal for a directive
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
Amendment 153 #
2022/0406(COD)
Proposal for a directive
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
Amendment 155 #
2022/0406(COD)
Proposal for a directive
Article 5 – paragraph 2 – point c
Article 5 – paragraph 2 – point c
Amendment 165 #
2022/0406(COD)
Proposal for a directive
Article 5 – paragraph 2 – point d
Article 5 – paragraph 2 – point d
Amendment 5 #
2022/0404(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Directive 2009/65/EU
Article 52 – paragraph 1 − subparagraph 2
Article 52 – paragraph 1 − subparagraph 2
The risk exposure to a counterparty of the UCITS in a derivative or repurchase agreement transaction that is not centrally cleared through a CCP authorised in accordance with Article 14 of Regulation (EU) No 648/2012 or recognised in accordance with Article 25 of that Regulation, shall not exceed either:;
Amendment 7 #
2022/0404(COD)
Proposal for a directive
Article 2
Article 2
Articles 74, 76, 81, 100 and 104 Directive 2013/36/EU
[...] d e [...] l e t e d
Amendment 218 #
2022/0403(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) To ensure that clients are aware of their options and can take an informed decision as where to clear their derivative contracts, clearing members and clients that provide clearing services in both Union and recognised third-country CCPs should inform their clients about the option to clear a derivative contract in a Union CCP so that clearing in those services identified as of substantial systemic importance is reduced in Tier 2 CCPs in order to ensure the financial stability of the Union. Clearing members must respect the wishes of the clients on where to clear the clients' derivatives.
Amendment 238 #
2022/0403(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) To mitigate potential risks for the financial stability of the Union, or of one or more of its Member States, CCPs and clearing houses should not be allowed to be clearing members of other CCPs nor should CCPs be able to accept to have other CCPs as clearing members or indirect clearing members. This exclusion should not affect interoperability arrangements, or other arrangements such as cross- margining and sponsored-memberships or sponsored access, between CCPs.
Amendment 243 #
2022/0403(COD)
Proposal for a regulation
Recital 50 a (new)
Recital 50 a (new)
(50a) (51) To further enhance the attractiveness of CCPs established in the Union, the opening hours of TARGET2 should be extended beyond the current constraints. This will allow clearing members established in the Union to fulfil their margin obligations in EUR, lowering the current dependency on USD for margin calls occurring beyond the closing time of TARGET2.
Amendment 255 #
Amendment 446 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 – point e – introductory part
Article 1 – paragraph 1 – point 21 – point e – introductory part
Regulation (EU) No 648/2012
Article 25 – paragraph 7
Article 25 – paragraph 7
(e) the following paragraphs 7a, 7b, 7c and 7cd are added:
Amendment 447 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 – point e
Article 1 – paragraph 1 – point 21 – point e
Regulation (EU) No 648/2012
Article 25 – paragraph 7 – subparagraph 1
Article 25 – paragraph 7 – subparagraph 1
7a. Where ESMA has not yet determined the tiering of a CCP or where ESMA has determined that all or some CCPs in a relevant third country are Tier 1 CCPs, the cooperation arrangements referred to in paragraph 7 shall take into account the risk the provision of clearing services by those CCPs entails and shall specify:
Amendment 448 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 – point e
Article 1 – paragraph 1 – point 21 – point e
Regulation (EU) No 648/2012
Article 25 – paragraph 7 – subparagraph 3
Article 25 – paragraph 7 – subparagraph 3
(b) exceptionally, the mechanism for the exchange of information on a quarterly basis requiring detailed information covering the aspects referred to in paragraph 2a and in particular information on significant changes to risk models and parameters, extension of CCP activities and services and changes in the client account structure, with the aim to detect if a CCP is potentially close to becoming or is potentially likely to become systemically importantmonitor and detect risks for the financial stability of the Union or one or more of its Member States.
Amendment 449 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 – point e
Article 1 – paragraph 1 – point 21 – point e
Regulation (EU) No 648/2012
Article 25 – paragraph 7 – subparagraph 3 – point c (new)
Article 25 – paragraph 7 – subparagraph 3 – point c (new)
(c a) the mechanism for prompt notification to ESMA by the third-country competent authority where a third- country CCP intends to extend and reduce its activities and services;
Amendment 451 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 – point e
Article 1 – paragraph 1 – point 21 – point e
Regulation (EU) No 648/2012
Article 25 – paragraph 7 – point f
Article 25 – paragraph 7 – point f
(f) the procedures for third-country authorities to assure the effective enforcement of decisions adopted by ESMA in accordance with Articles 25f, 25k(1), point i, 25j, 25k(1)(b), 25l, 25m and 25p;
Amendment 452 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 – point e
Article 1 – paragraph 1 – point 21 – point e
Regulation (EU) No 648/2012
Article 25 – paragraph 7 – point e
Article 25 – paragraph 7 – point e
(e) the procedures for third-country authorities to promptly inform ESMA of the following with a focus on aspects relevant for the Union or one or more of its Member Stcooperate with ESMA when drawing up recovery plans and any subsequent changes to such plans and the procedures for third-country authorities to cooperate with ESMA when recovery plans are activates:d
Amendment 454 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 – point e
Article 1 – paragraph 1 – point 21 – point e
Regulation (EU) No 648/2012
Article 25 – paragraph 7 – point e – point i
Article 25 – paragraph 7 – point e – point i
Amendment 455 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 – point e
Article 1 – paragraph 1 – point 21 – point e
Regulation (EU) No 648/2012
Article 25 – paragraph 7 – point e – point i i
Article 25 – paragraph 7 – point e – point i i
(ii) if a Tier 2 CCP intends to activate its recovery plan orthe procedures for third countries to promptly inform ESMA where the third- country authorities have determined that there are indications of an emerging crisis situation that could affect the operations of that CCP, in particular, its ability to provide clearing services or where the third-country authorities envisage to take a resolution action in the near future.
Amendment 456 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 – point e a (new)
Article 1 – paragraph 1 – point 21 – point e a (new)
Regulation (EU) No 648/2012
Article 25 – paragraph 7 – point d
Article 25 – paragraph 7 – point d
(e a) 7d. Where ESMA has determined that at least one CCP in a relevant third country is a Tier 2 CCP, ESMA shall establish effective cooperation arrangements with the relevant resolution authority of that third country. The cooperation arrangements shall specify in relation to those Tier 2 CCPs at least the following: (a) the procedures for the third-country resolution authority to consult ESMA when drawing resolution plans and any subsequent material changes to such plans; (b) the procedures for the third-country resolution authority to inform ESMA when the resolution plan is activated and when the third-country resolution authority intends to deviate from the resolution plan.’;
Amendment 457 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 a (new)
Article 1 – paragraph 1 – point 21 a (new)
Regulation (EU) No 648/2012
Article 25a
Article 25a
(21 a) Article 25a is replaced by the following: "Article 25a Comparable compliance 1. A CCP referred to in Article 25(2b) may submit a reasoned request that ESMA assesses whether in its compliance with the applicable third-country framework, taking into account the provisions of the implementing act adopted in accordance with Article 25(6), that CCP may be deemed to satisfy compliance with the requirements set out in Article 16 and Titles IV and V. ESMA shall immediately transmit the request to the third-country CCP college. 2. The reasoned request referred to in paragraph 1 shall provide the factual basis for a finding of comparability and the reasons why compliance with the requirements applicable in the third country satisfies the requirements set out in Article 16 and Titles IV and V. 3. The Commission, in order to ensure that the assessment referred to in paragraph 1 effectively reflects the regulatory objectives of the requirements set out in Article 16 and Titles IV and V and the Union's interests as a whole, shall adopt a delegated act specifying the following: (a) the minimum elements to be assessed for the purposes of paragraph 1of this Article; (b) the modalities and conditions to carry out the assessment. The Commission shall adopt the delegated act referred to in the first subparagraphbe submitted either within the deadline set by ESMA in the notification informing the third-country CCP that it is not considered to be a Tier 1 CCP or at any moment after a third- country CCP has been recognised by ESMA as a Tier 2 CCP in accordance with Article 25(2b). 3. The reasoned request referred to in paragraph 1 shall: (a) specify the requirements for which the Tier 2 CCP requests comparable compliance; (b) provide the factual basis for a finding of comparability and the reasons why compliance with the requirements applicable in the third country satisfies the requirements set out in Article 16 and Titles IV and V; (c) specify the way in which the Tier 2 CCP complies with any conditions set out in the implementing act referred to in Article 25(6). (d) a statement from its competent authority confirming that the Tier 2 CCP is of good repute and standing; and (e) where necessary, with regard to the requirements set out in Article 16 and Title V of this Regulation, a translation of the relevant applicable third-country framework into a language commonly used in finance. 4. ESMA shall assess, within 30 working days of receipt of a reasoned request submitted in accordance with paragraph 1, whether that reasoned request is complete. ESMA shall set a deadline by which the Tier 2 CCP has to provide additional information where the request is incomplete. 5. ESMA shall assess whether the Tier 2 CCP’s compliance with the applicable third-country framework, following an outcomes-based and risk-based approach, is comparable to the requirements set out in Article 16 and Titles IV and V of this Regulation. ESMA shall also take into account the supervisory outcomes achieved by the relevant third-country competent authority, as well as the level and depth of cooperation by the relevant third-country competent authority with ESMA. 6. ESMA shall decide whether to grant comparable compliance for the requirements included in the reasoned request within 90 working days from the receipt of a complete reasoned request submitted in accordance with paragraph 4. 7. ESMA may postpone that decision where the reasoned request or the additional information referred to in paragraph 4 are not submitted in time and the assessment of that request could, as a result, delay ESMA’s decision on the recognition of the third-country CCP or the review of its recognition. 8. A Tier 2 CCP for which ESMA has not granted comparable compliance for one or more requirements may not submit a new reasoned request as referred to in paragraph 1 regarding those requirements, unless there has been a relevant change to the applicable third- country framework or to the way in which that CCP complies with that framework. 9. A Tier 2 CCP that has been granted comparable compliance shall notify ESMA of any change to its applicable third-country framework, to the way in which it complies with the applicable third-country framework and to its internal rules and procedures. ESMA shall inform the Commission of those notifications. 10. Where ESMA has granted comparable compliance to a Tier 2 CCP, ESMA shall review the decision on a regular basis. 11. ESMA shall withdraw comparable compliance from a Tier 2 CCP where ESMA finds that the CCP’s compliance with the applicable thirdcountry framework, following an outcomes-based and risk-based approach, is no longer comparable to the requirements set out in Article 16 and Titles IV and V of this Regulation. ESMA shall also take into accordance with Article 82 by 2 January 2021. unt the supervisory outcomes achieved by the relevant third-country competent authority, as well as the level and depth of cooperation by the relevant third-country competent authority with ESMA.’ " Or. en (02012R0648-20220812)
Amendment 458 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 b (new)
Article 1 – paragraph 1 – point 21 b (new)
Regulation (EU) No 648/2012
Article 25f
Article 25f
(21 b) Article 25f is replaced by the following: " Article 25f Request for information 1. ESMA may by simple request or by decision require recognised CCPs and related third parties to whom those CCPs have outsourced operational functions or activities to provide all necessary information to enable ESMA to carry out its duties under this Regulation. 2. WThen sending a simple request for information information referred to in paragraph 1 may be of a periodic or one- off nature. 3. When requiring that information is provided under paragraph 1, ESMA shall indicate all of the following: (a) the reference to this Article as the legal basis of the request; (b) the purpose of the request; (c) the information required; (d) the time limit to provide the information; (e) inform the person from whom the information is requested that there is no obligation to provide the information but that in the case of a voluntary reply to the request the information provided must not be incorrect or misleading; (f) the fine provided for in Article 25j in conjunction with point (a) of Section V of Annex III, where the answers to questions asked are incorrect or misleading. 3. When requiring that information is provided under paragraph 1 by decision, ESMA shall indicate all of the following: (a) the reference to this Article as the legal basis of the request; (b) the purpose of the request; (c) the information required; (d) the time limit to provide the informationwhere the information is of a periodic nature, the periodicity at which the information should be provided; (ef) the periodic penalty payments provided for in Article 25k where the production of the required information is incomplete; (f(g) the fine provided for in Article 25j in conjunction with point (a) of Section V of Annex III, for failing to provide the required information or where the answers to questions asked are incorrect or misleading; and (g) the right to appeal the decision before ESMA's Board of Appeal and to have the decision reviewed by the Court of Justice of the European Union (‘Court of Justice’) in accordance with Articles 60 and 61 of Regulation (EU) No 1095/2010. 4. The persons referred to in paragraph 1 or their representatives and, in the case of legal persons or associations having no legal personality, the persons authorised to represent them by law or by their constitution shall supply the information requested. Lawyers duly authorised to act may supply the information on behalf of their clients. The latter shall remain fully responsible if the information supplied is incomplete, incorrect or misleading. 5. ESMA shall, without delay, send a copy of the simple request or of its decisionrequest to the relevant third-country competent authority where the persons referred to in paragraph 1 concerned by the request for information are domiciled or established. " Or. en (02012R0648-20220812)
Amendment 459 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21 c (new)
Article 1 – paragraph 1 – point 21 c (new)
Regulation (EU) No 648/2012
Article 25fa (new)
Article 25fa (new)
Amendment 461 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 25
Article 1 – paragraph 1 – point 25
Regulation (EU) No 648/2012
Article 26
Article 26
1. A CCP shall have robust governance arrangements, which include a clear organisational structure with well- defined, transparent and consistent lines of responsibility, effective processes to identify, manage, monitor and report the risks to which it is or might be exposed, and adequate internal control mechanisms, including sound administrative and accounting procedures. AWithout prejudice to interoperability arrangements, or other arrangements such as cross- margining and sponsored-memberships or sponsored access, between CCPs, a CCP shall not be or become a clearing member, a client, or establish indirect clearing arrangements with a clearing member with the aim to undertake clearing activities at a CCP.;
Amendment 463 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 29 – point a
Article 1 – paragraph 1 – point 29 – point a
Regulation (EU) No 648/2012
Article 37
Article 37
1. A CCP shall establish, where relevant per type of product cleared, the categories of admissible clearing members and the admission criteria, upon the advice of the risk committee pursuant to Article 28(3). Such criteria shall be non- discriminatory, transparent and objective so as to ensure fair and open access to the CCP and shall ensure that clearing members have sufficient financial resources and operational capacity to meet the obligations arising from participation in a CCP. Criteria that restrict access shall be permitted only to the extent that their objective is to control the risk for the CCP. TWithout prejudice to interoperability arrangements, or other arrangements such as cross- margining and sponsored- memberships or sponsored access, between CCPs, the criteria shall ensure that CCPs or clearing houses cannot be clearing members, directly or indirectly, of the CCP.;
Amendment 470 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 30 – point a a (new)
Article 1 – paragraph 1 – point 30 – point a a (new)
Regulation (EU) No 648/2012
Article 38 – paragraph 7
Article 38 – paragraph 7
(a a) "7. A CCP shall provide its clearing members with information on the initial margin models it uses. That information shall: (a) clearly explain the design of the initial margin models and how ithey operates; (b) clearly describe the key assumptions and limitations of the initial margin model and the circumstances under which those assumptions are no longer valid; (c) be documented. " Or. en (02012R0648-20220812)
Amendment 482 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 33 – point a
Article 1 – paragraph 1 – point 33 – point a
Regulation (EU) No 648/2012
Article 46 – paragraph 1
Article 46 – paragraph 1
1. A CCP shall accept highly liquid collateral with minimal credit and market risk to cover its initial and ongoing exposure to its clearing members. A CCP may accept public guarantees or public bank or uncollateralised commercial bank guarantees, provided that they are unconditionally available upon request within the liquidation period referred to in Article 41. Where bank guarantees are provided to a CCP, that CCP shall take them into account when calculating its exposure to the bank that is also a clearing member. The CCP shall apply adequate haircuts to asset values and guarantees to reflect the potential for their value to decline over the interval between their last revaluation and the time by which they can reasonably be assumed to be liquidated. It shall take into account the liquidity risk following the default of a market participant and the concentration risk on certain assets that may result in establishing the acceptable collateral and the relevant haircuts. When revising the level of the haircuts it applies to the assets it accepts as collateral, the CCP shall take into account any potential procyclicality effects of such revisions.;
Amendment 487 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EU) No 648/2012
Article 48 – paragraph 6
Article 48 – paragraph 6
(33 a) Paragraph 6 is amended: "6. Where assets and positions are recorded in the records and accounts of a CCP as being held for the account of a defaulting clearing member’s client in accordance with Article 39(3), the CCP shall, at least, contractually commit itself to trigger the procedures for the transfer of the assets and positions held by the defaulting clearing member for the account of the client to another clearing member designated by the client, on the client’s request or unless the client objects before the transfer of assets and positions is concluded and without the consent of the defaulting clearing member. That other clearing member shall be obliged to accept these assets and positions only where it has previously entered into a contractual relationship with the client by which it has committed itself to do so. When designating a clearing member, the client shall contractually designate an alternative clearing member to be used in case their positions need to be transferred in the event of default. If the transfer to that other clearing member has not taken place for any reason within a predefined transfer period specified in its operating rules, the CCP may take all steps permitted by its rules to actively manage its risks in relation to those positions, including liquidating the assets and positions held by the defaulting clearing member for the account of the client. " Or. en (02012R0648-20220812)
Amendment 488 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 33 b (new)
Article 1 – paragraph 1 – point 33 b (new)
Regulation (EU) No 648/2012
Article 48 – paragraph 6
Article 48 – paragraph 6
(33 b) A subparagraph is added to Article 48(6) "6. Where assets and positions are recorded in the records and accounts of a CCP as being held for the account of a defaulting clearing member’s client in accordance with Article 39(3), the CCP shall, at least, contractually commit itself to trigger the procedures for the transfer of the assets and positions held by the defaulting clearing member for the account of the client to another clearing member designated by the client, on the client’s request and without the consent of the defaulting clearing member. That other clearing member shall be obliged to accept these assets and positions only where it has previously entered into a contractual relationship with the client by which it has committed itself to do so. If the transfer to that other clearing member has not taken place for any reason within a predefined transfer period specified in its operating rules, the CCP may take all steps permitted by its rules to actively manage its risks in relation to those positions, including liquidating the assets and positions held by the defaulting clearing member for the account of the client. client. a. In the case of default of an existing clearing member and for the purposes of porting clients from the defaulting clearing members towards an alternative clearing member, such alternative clearing member, the client subject to porting and the CCP shall be temporary waived from the requirements of Directive (EU) 2015/849, Directive (EU) 2018/843 and Directive (EU) 2019/1153. The alternative clearing member shall we temporarily waived from the requirements of capital for clearing members towards clients under Regulation (EU) No 575/2013. " Or. en (02012R0648-20220812)
Amendment 489 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 33 c (new)
Article 1 – paragraph 1 – point 33 c (new)
Regulation (EU) No 648/2012
Article 47 – paragraph 9 (new)
Article 47 – paragraph 9 (new)
Amendment 490 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 -a (new)
Article 1 – paragraph 1 – point 34 -a (new)
Regulation (EU) No 648/2012
Article 48 – paragraph 5
Article 48 – paragraph 5
(34 a) "5. Where assets and positions are recorded in the records and accounts of a CCP as being held for the account of a defaulting clearing member’s clients in accordance with Article 39(2), the CCP shall, at least, contractually commit itself to trigger the procedures for the transfer of the assets and positions held by the defaulting clearing member for the account of its clients to another clearing member designated by all of those clients, on their request or unless all clients object before the transfer of assets and positions is concluded and without the consent of the defaulting clearing member. That other clearing member shall be obliged to accept those assets and positions only where it has previously entered into a contractual relationship with the clients by which it has committed itself to do so. When designating a clearing member, clients shall contractually designate an alternative clearing member to be used in case their positions need to be transferred in the event of default. If the transfer to that other clearing member has not taken place for any reason within a predefined transfer period specified in its operating rules, the CCP may take all steps permitted by its rules to actively manage its risks in relation to those positions, including liquidating the assets and positions held by the defaulting clearing member for the account of its clients. " Or. en (02012R0648-20220812)
Amendment 495 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 – point a
Article 1 – paragraph 1 – point 34 – point a
Regulation (EU) No 648/2012
Article 49 – paragraph 1 a – subparagraph 2
Article 49 – paragraph 1 a – subparagraph 2
Where a CCP considers that the change to the models referred to in paragraph 1 it intends to adopt is not significant as referred to paragraph 1gin the below list, the CCP shall request that the application be subject to a non-objection procedure under paragraph 1b. In that case, the CCP may start applying such change before the decision of the CCP’s competent authority and ESMA pursuant to paragraph 1b. A change shall be considered as non- significant where one of the following conditions is met: a) the change leads to a decrease or increase of the margin requirements greater than 10% and lower than 20%; b) The CCP intends to offer a new clearing member access model, or to offer clearing services with a non-materially different risk profile and characteristics than the current ones, c) The list of eligible collateral is extended to accept collateral with a materially different risk profile: a. new asset class; b. new category of issuer, such as corporate or sovereign, or level of credit risk.
Amendment 502 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 – point b
Article 1 – paragraph 1 – point 34 – point b
Regulation (EU) No 648/2012
Article 49 – paragraph 1 g – point a
Article 49 – paragraph 1 g – point a
(a) the change leads to a decrease or increase of the total pre-funded financial resources, including margin requirements, default fund and skin-in-the-game, greater than 1520 %;
Amendment 506 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 – point b
Article 1 – paragraph 1 – point 34 – point b
Regulation (EU) No 648/2012
Article 49 – paragraph 1 g – point b
Article 49 – paragraph 1 g – point b
Amendment 508 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 – point b
Article 1 – paragraph 1 – point 34 – point b
Regulation (EU) No 648/2012
Article 49 – paragraph 1 g – point c
Article 49 – paragraph 1 g – point c
Amendment 511 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 – point b
Article 1 – paragraph 1 – point 34 – point b
Regulation (EU) No 648/2012
Article 49 – paragraph 1 g – point d
Article 49 – paragraph 1 g – point d
(d) the methodology for defining and calibrating stress test scenarios for the purpose of determining default fund exposures, is changed, leading to a decrease or increase greater than 20 % of a default fund, or greater than 50 % of any individual default fund contribution;
Amendment 513 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 – point b
Article 1 – paragraph 1 – point 34 – point b
Regulation (EU) No 648/2012
Article 49 – paragraph 1 g – point e
Article 49 – paragraph 1 g – point e
(e) the methodology applied to assess liquidity risk and monitor concentration risk, is changed, leading to a decrease or increase of the estimated liquidity needs in any currency greater than 20 % or the total liquidity needs greater than 10 %;
Amendment 515 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 – point b
Article 1 – paragraph 1 – point 34 – point b
Regulation (EU) No 648/2012
Article 49 – paragraph 1 g – point f
Article 49 – paragraph 1 g – point f
(f) the methodology applied to value collateral, or calibrate collateral haircut or set concentration limits, is changed, such that the total value of non- cash collateral decreases or increases by more than 120 %; provided that the CCP’s proposed change does not fulfil any criteria for the extension of CCP’s authorisation specified in Article 2(1);
Amendment 517 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 – point b
Article 1 – paragraph 1 – point 34 – point b
Regulation (EU) No 648/2012
Article 49 – paragraph 1 g – point g
Article 49 – paragraph 1 g – point g
Amendment 523 #
2022/0403(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 34 – point d a (new)
Article 1 – paragraph 1 – point 34 – point d a (new)
Regulation (EU) No 648/2012
Article 49 – paragraph 7 (new)
Article 49 – paragraph 7 (new)
(d a) the following paragraph 7 is added: Where a CCP intends to adopt a change that does not qualify as non-significant pursuant to paragraph 1a of Article 49 and does not qualify significant under paragraph 1g of Article 49, such change shall be directly implemented by the CCP and shall not be subject to the procedures referred to in paragraph 49.
Amendment 450 #
2022/0396(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) To incentivise waste prevention, a new concept of ‘refill’ should be introduced. Refill should be considered as a specific waste prevention measure that counts towards and is necessary for meeting of the re-use and refill targets. However, containers owned by the consumer, performing a packaging function in the context of refill, such as reusable cups, mugs, bottles or boxes are not packaging in the sense of this Regulation. Only refill happening via a system for refill shall count towards the reuse and refill targets. Such system for refill can for example be a system for refill found in the premises of an economic operator or a product dispenser for home consumption.
Amendment 665 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 28
Article 3 – paragraph 1 – point 28
(28) ‘refill’ means an operation entailing a system for refill by which an end user fills its owna container, which fulfils the packaging function, with a product or several products offered by the final distributor in the context of a commercial transactionpurchased through a final distributor;
Amendment 1098 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. From 1 January 2030, the plastic part in packaging shall containeconomic operators shall ensure the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unit of packaging as an average of the overall portfolio of plastic packaging placed on the Union market by the economic operator:
Amendment 1104 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. From 1 January 2030, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unit of packaginglastic waste:
Amendment 1156 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. From 1 January 2040, the plastic part in packaging shall containeconomic operators shall ensure the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unit of packaging as an average of the overall portfolio of plastic packaging placed on the Union market by the economic operator:
Amendment 1163 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. From 1 January 2040, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unit of packaginglastic waste:
Amendment 1234 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. Compliance with the requirements set out in paragraphs 1 and 3 shall be demonstrated by economic operates in the technical information concerning the packaging referred to in Annex VII. or through the yearly reporting to the Producer Responsibility Organizations (PRO's).
Amendment 1270 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. By 31 December 2026, the Commission is empowered toshall adopt implementing acts establishing the methodology for the calculation and verification of the percentage of recycled content recovered from post-consumer plastic waste, per unit of plastic packaginglastic waste, based on a mass balance approach, and the format for the technical documentation referred to in Annex VII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1282 #
2022/0396(COD)
By 1 January 2028, the Commission shall assess the need for derogations from the minimum percentage laid down in paragraph 1, points a, b and d, and in paragraph 2, points a, b and c for specific plastic packaging, or for the revision of the derogation established under paragraph 3 for specific plastic packaging. The assessment shall be based on market availability and prices of recycled plastics on an annual basis from the year of entry into force of this Regulation, considering Eurostat data for the EU-27 achieved plastic packaging recycling levels. Such assessment shall also be based on the uptake of new recycling technologies and their impact on available market volumes.
Amendment 1305 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 2 – point a
Article 7 – paragraph 9 – subparagraph 2 – point a
(a) provide for derogations from the scope, timing or level of minimum percentage laid down in paragraph 1, points a, b and d, and in paragraph 2, points a, b and c for specific plastic packaging, and, as appropriate,
Amendment 1324 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 10
Article 7 – paragraph 10
10. Where justified by the lack of availability or excessive prices of specific recycled plastics that may have adverse effects on human or animal health, security of food supply or the environment, making compliance with the minimum percentages of recycled content set out in paragraphs 1 and 2 excessively difficult, the Commission shall be empowered to adopt a delegated act in accordance with Article 58 totargets in paragraphs 1 and 2 of this Article shall be suspended until the Commission by means of an urgency procedure amend paragraphs 1 and 2 by adjusting the minimum percentages accordingly. In evaluating the justification of such adjustment, the Commission shall assess requests from natural or legal persons to be accompanied by relevant information and data on the market situation for this post- consumer plastic waste and best available evidence regarding the related risks to human or animal health, to the security of food supply or to the environment.
Amendment 1442 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – introductory part
Article 9 – paragraph 4 – subparagraph 1 – introductory part
Compliance with the requirements set out in paragraphs 1 and 2 shall be demonstrated on request from the relevant authority in the technical documentation referred to in Annex VII, which shall contain the following elements:
Amendment 1501 #
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 containing information on its material composition. The label shall be based on pictograms and be easily understood without the need for text written in national language. This obligation does not apply to transport packaging. However, it applies to e- commerce packaging.
Amendment 1589 #
2022/0396(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
By 1 January 2028, labels that enable the separate collection of each material specific fraction of packaging waste that is intended to be discarded in separate receptacles shall be affixed, printed or engraved visibly, legibly and indelibly on all waste receptacles for collection of packaging waste. The label can be provided with a national text describing the material composition.
Amendment 1868 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 4 – introductory part
Article 26 – paragraph 4 – introductory part
4. The manufacturer and the final distributor making available on the market within the territory of a Member State in sales packaging alcoholic beverages, calculated as an average by volume of the products placed on the market, in the form of beer, carbonated alcoholic beverages, fermented beverages other than wine, aromatised wine products and fruit wine, products based on spirit drinks, wine or other fermented beverages mixed with beverages, soda, cider or juice, non- alcoholic beverages in the form of water, water with added sugar, water with other sweetening matter, flavoured water, soft drinks, soda lemonade, iced tea and similar beverages which are immediately ready to drink, pure juice, juice or must of fruits or vegetables and smoothies without milk and non-alcoholic beverages containing milk fatshall ensure that:
Amendment 2112 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15 a (new)
Article 26 – paragraph 15 a (new)
15a. Economic operators in a Member State shall be exempted from the obligation to meet the targets in paragraphs 4 to 6 if: (a) the Member State have a deposit and return system, as defined in article 44 of this regulation, with a collection rate of at least 90 % of the weight of the packaging, listed in paragraphs 4 to 6, placed on the market, and, (b) the Member State can show a high rate of recycling of the collected packaging.
Amendment 87 #
2022/0394(COD)
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a Union certification framework for carbon removals and carbon farming
Amendment 93 #
2022/0394(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) Under the Paris Agreement adopted under the United Nations Framework Convention on Climate Change22 ('the Paris Agreement'), the international community has agreed to hold the increase in the global average temperature well below 2° C above pre-industrial levels and to pursue efforts to limit the temperature increase to 1.5° C above pre-industrial levels. The Union and its Member States are Parties to the Paris Agreement and are strongly committed to its implementation by reduction of greenhouse gas emissions and increase in carbon removals and carbon farming. __________________ 22 Approved by Council Decision (EU) 2016/1841 of 5 October 2016 on the conclusion, on behalf of the European Union, of the Paris Agreement adopted under the United Framework Convention on Climate Change (OJ L 282, 19.10.2016, p. 1).
Amendment 99 #
2022/0394(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) At a global scale, the latest report23 by the International Panel on Climate Change (IPCC) points towards a decreasing likelihood of limiting global warming to 1.5 °C unless rapid and deep cuts in global greenhouse gas (GHG) emissions occur throughout the forthcoming decades. The IPCC report also clearly states that ‘the deployment of carbon dioxide removal to counterbalance hard-to-abate residual emissions is unavoidable if net-zero carbon dioxide (CO2) or GHG emissions are to be achieved’. This will require the large-scale deployment of sustainable activities for capturing CO2 from the atmosphere and durably storinge it in geological reservoirs, terrestrial and marine ecosystems, or productfor several centuries. Today and with current policies, the Union is not on track to deliver the required carbon removals: carbon removals in terrestrial ecosystems have been decreasing in recent years, and no significant industrial carbon removals are currently taking place in the Union. __________________ 23 IPCC Working Group III (2022), Technical Summary. In: Climate Change 2022: Mitigation of Climate Change. Sixth Assessment Report (link).
Amendment 109 #
2022/0394(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The aim of this Regulation is to develop a voluntary Union certification framework for carbon removals and carbon farming, with the view to incentivise the uptake of high- quality carbon removals and carbon farming activities, in full respect of the biodiversity and the zero-pollution objectives. It is a tool to support the achievement of the Union objectives under the Paris Agreement, notably the goal of collective climate neutrality by 2050 laid down in Regulation (EU) 2021/1119 of the European Parliament and of the Council24 . The Union also committed to generate negative emissions after 2050. An important instrument to enhance carbon removals in terrestrial ecosystems is Regulation (EU) 2018/841 of the European Parliament and of the Council25 , which is currently under review. The objective of the review is to set out a Union net removals target of 310 Mt CO2 eq by 2030, and to allocate respective targets to each Member State. __________________ 24 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 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1). 25 Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1).
Amendment 127 #
2022/0394(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Union certification framework will support the development of carbon removal activities as well as carbon farming activities in the Union that result in an unambiguous net carbon removal benefit, while avoiding greenwashing. In the case of carbon farming, such certification framework should also encourage the uptake of carbon removal activities that generate co-benefits for biodiversity, therefore achievingat least have an overall neutral impact on biodiversity, contributing to the nature restoration targets set out in Union law on nature restoration. The Union certification framework will be instrumental in meeting the Union climate change mitigation objectives set in international agreements and in the Union legislation.
Amendment 135 #
2022/0394(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to support operators willing to make additional efforts to increase carbon removals and carbon farming in a sustainable way, the Union certification framework should take into account the different types of carbon removal activities, carbon farming activities, their specificities and related environmental impacts. Therefore, this Regulation should provide clear definitions of carbon removal, carbon removal activities, carbon farming, carbon farming activities and other elements of the Union certification framework.
Amendment 148 #
2022/0394(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) This Regulation should set out the requirements under which carbon removals and carbon farming should be eligible for certification under the Union certification framework. To this end, carbon removals and carbon farming should be quantified in an accurate and robust way; and they should be generated only by carbon removal activities or carbon farming activities that generate a net carbon removal benefit or a net carbon farming benefit, are additional, aim to ensure long- term or permanent storage of carbon, and have an overall neutral impact or co-benefit on sustainability objectives. Furthermore, carbon removals and carbon farming should be subject to independent third- party auditing in order to ensure the credibility and reliability of the certification process. Mandatory Union carbon pricing rules established through Directive 2003/87/EC of the European Parliament and of the Council26 are in place which regulate the treatment of emissions from activities covered by that Directive. This Regulation should be without prejudice to Directive 2003/87/EC, except in relation to the certification of removals of emissions from sustainable biomass which are zero-rated in accordance with Annex IV thereto. __________________ 26 Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32).
Amendment 155 #
2022/0394(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) A carbon removal activity or a carbon farming activity should result in a net carbon removal benefit or a net carbon farming benefit showing that it delivers a positive climate impact. The net carbon removal benefit or net carbon farming benefit should be computed following two steps. First, operators should quantify the amount of additional carbon removals or carbon farming that a carbon removal activity or a carbon farming activity has generated in comparison to a baseline. A standardised baseline reflecting the standard performance of comparable activities in similar social, economic, environmental and technological circumstances and geographical locations should be preferred because it ensures objectivity, minimises compliance and other administrative costs, and positively recognises the action of first movers who have already engaged in carbon removal activities or carbon farming activities. In the context of carbon farming, the use of national forest inventories and available digital technologies, including electronic databases and geographic information systems, remote sensing, drones, satellites, novel in-field carbon quantification systems, artificial intelligence and machine learning, and of electronic maps should be promoted to decrease the costs of establishing baselines and of monitoring carbon removal activities. However, where it is not possible to set such a standardised baseline, a project-specific baseline based on the operator’s individual performance may be used. In order to reflect the social, economic, environmental and technological developments and to encourage ambition over time in line with the Paris Agreement, baselines should be periodically updated.
Amendment 170 #
2022/0394(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The second step for quantifying the net carbon removal benefit or the net carbon farming benefit should consist of subtracting any increase in greenhouse gas emissions related to the implementation of the carbon removal activity. Relevant greenhouse gas emissions that should be taken into consideration include direct emissions, such as those resulting from the use of more fertilisers, chemicals, fuel or energy, or indirect emissions, such as those resulting from materials or land use change, with consequent risks for food security due to displacement of agricultural production or displacement of forestry. A reduction in greenhouse gas emissions resulting from the implementation of the carbon removal activity should not be taken into account to quantify the net carbon removal benefit, but it should be taken into account when quantifying the net carbon farming benefit. A reduction in greenhouse gas emissions should be considered as a co-benefit towards the sustainability objective of climate change mitigation; by being reported on the certificates, decreases in greenhouse gas emissions (like the other sustainability co- benefits) can increase the value of the certified carbon removals.
Amendment 175 #
2022/0394(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) A carbon removal activity or a carbon farming activity delivers a net carbon removal benefit or a net carbon farming benefit when the carbon removals or carbon farming above the baseline outweigh any increase in greenhouse gas emissions due to the implementation of the carbon removal activity and carbon farming activity. For instance, in the case of activities that deliver permanent carbon storage by injecting carbon underground, the amount of permanently stored carbon should outweigh the energy- related greenhouse gas emissions from the industrial process. In the case of carbon farming, the carbon captured by an afforestation activity or the carbon kept in the ground by a peatland re-wetting activity should outweigh the emissions from the machinery used to carry out the carbon removal activity or the indirect land use change emissions that can be caused by carbon leakage.
Amendment 184 #
2022/0394(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Carbon removals and carbon farming should be quantified in a relevant, accurate, complete, consistent and comparable manner. Uncertainties in the quantification should be duly reported and accounted in order to limit the risk of overestimating the quantity of carbon dioxide removed from the atmosphere. Carbon removals generated by carbon farming should be quantified with a high level of accuracy to assure the highest quality and minimise uncertainties. Moreover, in order to incentivise synergies between Union climate and biodiversity objectives, enhanced monitoring of land needs to be required, thereby helping to protect and enhance the resilience of nature-based carbon removals throughout the Union. The satellite and on-site monitoring and reporting of emissions and removals need to closely reflect those approaches, and make the best use of advanced technologies available under Union programmes, such as Copernicus, making full use of already existing tools, and ensure consistency with the national greenhouse gas inventories.
Amendment 189 #
2022/0394(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) In order to ensure that the Union certification framework channels incentives toward carbon removals and carbon farming that go beyond the standard practice, carbon removal activities as well as carbon farming activities should be additional. Therefore, these activities should go beyond statutory requirements, that is, operators should carry out activities that are not already imposed upon them by the applicable law. Moreover, carbon removal activities shouldand carbon farming activities should at least partly take place due to the incentive effect provided by the certification. Such effect is present when the incentive created by the potential revenues, resulting from the certification, changes the behaviour of operators in such a way that they engage in the additional carbon removal activity or carbon farming activity to achieve additional carbon removals and carbon farming.
Amendment 202 #
2022/0394(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Atmospheric and biogenic carbon that is captured and stored through a carbon removal activity or a carbon farming activity risks being released back into the atmosphere (e.g. reversal) due to natural or anthropogenic causes. Therefore, operators should take all relevant preventive measures to mitigate those risks and duly monitor that carbon continues to be stored over the monitoring period laid down for the relevant carbon removal activity. The validity of the certified carbon removals and carbon farming should depend on the expected duration of the storage and the different risks of reversal associated with the given carbon removal activity and carbon farming activity. Activities that store carbon in geological formations provide enough certainties on the very long-term duration of several centuries for the stored carbon and can be considered as providing permanent storage of carbon. Carbon farming or carbon storage in products are more exposed to the risk of voluntary or involuntary release of carbon into the atmosphere. To account for this risk, the validity of the certified carbon removals generated by carbon farming and carbon storage in productscarbon farming certification should be subject to an expiry date matching with the end of the relevant monitoring period. Thereafter, the carbon should be assumed to be released into the atmosphere, unless the economic operator proves the maintenance of the carbon storage through uninterrupted monitoring activities. A carbon farming activity shall not lead to a decreased carbon sink, as defined in regulation (EU) 2018/841, compared to a baseline beyond the monitoring period.
Amendment 211 #
2022/0394(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In addition to measures taken to minimise the risk of carbon release into the atmosphere during the monitoring period, appropriate liability mechanisms should be introduced to address cases of reversal. Such mechanisms could include e.g. discounting of carbon removal units and carbon farming units, collective buffers or accounts of carbon removal units or carbon farming units, and up-front insurance mechanisms. Since liability mechanisms in respect of geological storage and CO2 leakage, and relevant corrective measures have already been laid down by Directive 2003/87/EC and Directive 2009/31/EC of the European Parliament and of the Council27 , those liability mechanisms and corrective measures should apply to avoid double regulation. __________________ 27 Directive 2009/31/EC of the European Parliament and of the Council of 23 April 2009 on the geological storage of carbon dioxide and amending Council Directive 85/337/EEC, European Parliament and Council Directives 2000/60/EC, 2001/80/EC, 2004/35/EC, 2006/12/EC, 2008/1/EC and Regulation (EC) No 1013/2006 (OJ L 140, 5.6.2009, p. 114).
Amendment 223 #
2022/0394(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Carbon removal activities and carbon farming activities have a strong potential to deliver win-win solutions for sustainability, even if trade- offs cannot be excluded. Therefore, it is appropriate to establish minimum sustainability requirements to ensure that carbon removal activities have a neutral impact or generate co-benefits forand carbon farming activities at least have an overall neutral impact on the sustainability objectives of climate change mitigation and adaptation, the protection and restoration of biodiversity and ecosystems, the sustainable use and protection of water and marine resources, the transition to a circular and bio-based economy, and pollution prevention and control. Those sustainability requirements should, as appropriate, and taking into consideration local conditions, build on the technical screening criteria for Do Not Significant Harm concerning forestry activities andfor underground permanent geological storage of CO2, build on the criteria laid down in Commission Delegated Regulation (EU) 2021/213928 , and on the sustainability criteria for forest and agriculture biomass raw material build on the sustainability criteria laid down in Article 29 of Directive (EU) 2018/2001 of the European Parliament and of the Council29 . Practices, such as forest monocultures, that produce harmful effects for biodiversity that are not in line with sustainable forest management practices should not be eligible for certification. __________________ 28 Commission Delegated Regulation (EU) 2021/2139 of 4 June 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to climate change mitigation or climate change adaptation and for determining whether that economic activity causes no significant harm to any of the other environmental objectives (OJ L 442, 9.12.2021, p. 1). 29 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 (OJ L 328, 21.12.2018, p. 82).
Amendment 233 #
2022/0394(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Farming practices that remove CO2 from the atmosphere can contribute to the climate neutrality objective if they are used appropriately and should be rewarded, either via the Common Agricultural Policy (CAP) or other public or private initiatives. Specifically, this Regulation should tak, such as sustainable private finto acance, count farming practices as referenced in the Communication on Sustainable Carbon Cycles30 . __________________ 30 Communication from the Commission, Sustainable Carbon Cycles, COM (20221) 800ractual arrangements along supply chains, voluntary carbon markets and product claims.
Amendment 240 #
2022/0394(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Operators or groups of operators may report co-benefits that contribute to the sustainability objectives beyond the minimum sustainability requirements. To this end, their reporting should comply with the certification methodologies tailored to the different carbon removal activities or carbon farming activities, developed by the Commission. Certification methodologies should, as much as possible, incentivise the generation of at least have an overall neutral impact on co- benefits for biodiversity going beyond the minimum sustainability requirements. These additional co-benefits willmay give more economic value to the certified carbon removals and willcarbon farming and may result in higher revenues for the operators. In the light of these considerations, it is appropriate for the Commission to prioritise the development of tailored certification methodologies onfor active carbon farming activities that provide significant co-benefits forhave a large impact on climate mitigation and that at least have an overall neutral impact on biodiversity.
Amendment 245 #
2022/0394(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) It is appropriate to develop detailed certification methodologies for the different carbon removal activities and carbon farming activities in order to apply, in a standardised, verifiable and comparable way, the quality criteria laid down in this Regulation. Those methodologies should ensure the robust and transparent certification of the net carbon removal benefit generated by the carbon removal activity and of the net carbon farming benefit generated by the carbon farming activity, while avoiding disproportionate administrative burden for operators or group of operators, in particular for small farmers and forest holders. To this end, the Commission should be empowered to supplement this Regulation by adopting delegated acts establishing detailed certification methodologies for the different carbon removal activities and different carbon farming activities. Those methodologies should be developed in close consultation with the Expert Group on Carbon Removals and all other interested actors. They need to be based on the best available scientific evidence, build upon existing public and private schemes and methodologies for carbon removal certification and carbon farming certification, and take into account any relevant standard and rules adopted at national and Union level.
Amendment 250 #
2022/0394(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure a credible and reliable certification process, carbon removal activities should be subject to independent third-party auditing. In particular, carbon removal activities and carbon farming activities should be subject to an initial certification audit before their implementation, verifying their compliance with the quality criteria set out in this Regulation, including the correct quantification of the expected net carbon removal benefit and net carbon farming benefit. Carbon removal activities and carbon farming activities should also be subject to periodic re- certification audits to verify the compliance of the generated carbon removals. To this end, the Commission should be empowered to adopt implementing acts to set out the structure, technical details, and the minimum information to be contained in the description of the carbon removal activity and carbon farming activity, and in the certification and re- certification audit reports.
Amendment 258 #
2022/0394(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Providing land managers with improved knowledge, tools and methods for a better assessment and optimisation of the carbon removalsfarming is key for cost- efficient implementation of mitigation actions and for securing their engagement in carbon farming. This is particularly relevant for Union small farmers or forest holders that often lack the know-how and the expertise required to implement carbon removalfarming activities and to comply with the required quality criteria and related certification methodologies. Therefore, it is appropriate to require that producer organisations facilitate the provision of relevant advisory services through technical advice to their members. The Common Agricultural Policy and national State aid can support financially the provision of advisory services, knowledge exchange, training, information actions or interactive innovation projects with farmers and foresters.
Amendment 265 #
2022/0394(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) It is appropriate thatimportant to differ between carbon removal certificates and carbon farming certificates, and underpin different end- uses, such as the compilation of national and corporate greenhouse gas inventories, including with regard to Regulation (EU) 2018/841 of the European Parliament and of the Council31 , the proof of climate- related and other environmental corporate claims (including on biodiversity), or the exchange of verified carbon removal units or carbon farming units through voluntary carbon offsetting markets. To this end, the certificates should contain accurate and transparent information on the carbon removal activity and carbon farming activity, including the total removals and total carbon farming and net carbon removal benefit and net carbon farming benefit that comply with the quality criteria set out in this Regulation. The two types of certificates can not be traded with each other at a 1:1 ratio, as a carbon removal certificate is the proof of a much more secure and permanent carbon removal than what a carbon farming certificate is proof of. The Commission should be also empowered to adopt delegated acts to further specify or amend Annex II which lists the minimum information to be contained in the certificates. __________________ 31 Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1).
Amendment 274 #
2022/0394(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) To ensure an accurate, robust and transparent verification, certification bodies responsible for performing the certification of carbon removal activities and carbon farming activities should have the required competences and skills and should be accredited by national accreditation authorities pursuant to Regulation (EC) No 765/2008 of the European Parliament and of the Council32 . To avoid possible conflicts of interest, the certification bodies should also be completely independent from the operator carrying out the carbon removal activity or carbon farming activity that is subject to the certification. In addition, Member States should contribute towards ensuring the correct implementation of the certification process by supervising the operation of certification bodies that are accredited by national accreditation authorities, and by informing the certification schemes about relevant non- conformity findings. __________________ 32 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
Amendment 280 #
2022/0394(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Certification schemes should be used by operators to demonstrate compliance with this Regulation. Therefore, certification schemes should operate on the basis of reliable and transparent rules and procedures and should ensure accuracy, reliability, integrity and non-repudiation of origin, and protection against fraud of information and of data submitted by operators. They should also ensure the correct accounting of the verified carbon removal units or verified carbon farming units, notably by avoiding double counting. To this end, the Commission should be empowered to adopt implementing acts, including adequate standards of reliability, transparency, accounting and of independent auditing to be applied by certification schemes, so as to ensure the necessary legal certainty as regards the rules applicable to operators and to certification schemes. To ensure a cost- effective certification process, those technical harmonised rules on certification should also have the objective of reducing unnecessary administrative burden for operators, or group of operators, in particular for Small and Medium Enterprises (SMEs), including small farmers and foresters.
Amendment 292 #
2022/0394(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Certification schemesThe Commission should establish and maintain an interoperable and public EU Negative Carbon registriesy in order to ensure transparency and full traceability of carbon removal certificates and carbon farming certificates, and to avoid the risk of fraud and double counting. Fraud may occur if more than one certificate is issued for the same carbon removal activity or carbon farming activity because the activity has been registered under two different certification schemes or has been registered twice under the same scheme. Fraud may also occur when the same certificate is used several times to make the same claim based on a carbon removal activity or a carbon removal unit, or on a carbon farming activity or a carbon farming unit. The registriesy should store the documents resulting from the certification process of carbon removals and carbon farming, including summaries of certification audits and re-certification audit reports, the certificates and updated certificates, and make them publicly available in electronic form. The registriesy should also record the certified carbon removal units and carbon farming units that meet the Union quality criteria. In order to ensure a level playing field within the single market, the Commission should be empowered to adopt implementing rules setting out standards and technical rules on the functioning and the inter-operability of thoseset up this EU Negative Carbon registries. y.
Amendment 298 #
2022/0394(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Certification schemes play an important role in providing evidence of compliance with the quality criteria for carbon removals and carbon farming. It is therefore appropriate for the Commission to require certification schemes to report regularly on their activity. Such reports should be made public, in full or where appropriate in an aggregated format, in order to increase transparency and to improve supervision by the Commission. Furthermore, such reporting would provide the necessary information for the Commission to report on the operation of the certification schemes with a view to identifying best practices and submitting, if appropriate, a proposal to further promote such best practices. In order to ensure comparable and consistent reporting, the Commission should be empowered to adopt implementing acts setting out the technical details on the content and format of the reports drawn up by the certification schemes.
Amendment 301 #
2022/0394(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) To enable operators to apply the quality criteria set out in this Regulation in a standardised and cost-effective way, while taking into account the specific characteristics of different carbon removal activities and different carbon farming activities, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to supplement this Regulation by establishing detailed certification methodologies for different types of carbon removal activities and for different types of carbon farming activities. The Commission should also be able to amend Annex II listing the minimum information to be contained in the certificates. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making34 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. __________________ 34 OJ L 123, 12.5.2016, p. 1
Amendment 305 #
2022/0394(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) The Commission should review the implementation of this Regulation 3 years following the entry into force of this Regulation, and subsequently not later than six months after the global stocktake agreed under Article 14 of the Paris Agreement.. Those reviews should take into account the relevant developments concerning the Union legislation, technological and scientific progress, market developments in the field of carbon removals and carbon farming and food security including food availability and affordability, and should be informed by the results of the global stocktake of the Paris Agreement.
Amendment 307 #
2022/0394(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) The objectives of this Regulation, namely to promote the deployment of high quality carbon removals and carbon farming while minimising the risk of greenwashing, cannot be sufficiently achieved by the Member States alone, and by reason of the scale and effects of the proposed action, those objectives can be better achieved at Union level. Therefore, 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 to achieve those objectives,
Amendment 313 #
2022/0394(COD)
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. The objective of this Regulation is to facilitate the deployment of carbon removals and carbon farming by operators or groups of operators, while ensuring that those removals do not undermine the greenhouse gas reductions required pursuant to Article 4(1) of Regulation (EU) 2021/1119. To that end, this Regulation establishes a voluntary Union framework for the certification of carbon removals and carbon farming by laying down:
Amendment 322 #
2022/0394(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) quality criteria for carbon removal and carbon farming activities that take place in the Union;
Amendment 327 #
2022/0394(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) rules for the verification and certification of carbon removals and carbon farming;
Amendment 348 #
2022/0394(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This voluntary Union framework for the certification of carbon removals and carbon farming does not apply to emissions falling within the scope of Directive 2003/87/EC, with the exception of the storage of carbon dioxide emissions from sustainable biomass that are zero- rated in accordance with Annex IV thereto.
Amendment 357 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) ‘carbon removal’ means either the permanent storage of atmospheric or biogenic carbon within geological carbon pools, biogenic carbon pools, long-lasting products and matfor severials, and the marine environment, or the reduction of carbon release from a biogenic carbon pool to the atmosphere centuries;
Amendment 371 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
(b) ‘carbon removal activity’ means one or more practices or processes carried out by an operator resulting in permanent carbon storage, enhancing carbon capture in a biogenic carbon pool, reducing the release of carbon from a biogenic carbon pool to the atmosphere, or storing atmospheric or biogenic carbon in long-lasting products or materithat, under normal circumstances and appropriate management, results in carbon removals;
Amendment 387 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) ‘operator’ means any legal or physical person who operates or controls a carbon removal or carbon farming activity, or to whom decisive economic power over the technical functioning of the activity has been delegated;
Amendment 394 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) ‘monitoring period’ means a period, the duration of which is determined in accordance to the type of carbon removal activity, over which the storage of carbon is monitored by the operator or the groups of operators;
Amendment 401 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g
Article 2 – paragraph 1 – point g
Amendment 418 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h
Article 2 – paragraph 1 – point h
(h) ‘carbon farming’ means a carbon removalstorage or reduction activity related to land managementor coastal management, agriculture or forestry that results in the increase of carbon storage in living biomass, dead organic matter and soils by enhancing carbon capture and/or reducing the release of carbon to the atmosphere, while at the same time achieving biogenic emission reduction, such as methane and nitrous oxide reduction;
Amendment 425 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h a (new)
Article 2 – paragraph 1 – point h a (new)
(ha) ‘carbon farming activity’ means one or more practices or processes carried out by an operator resulting in carbon storage or emission reductions from carbon farming;
Amendment 428 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h b (new)
Article 2 – paragraph 1 – point h b (new)
(hb) ‘carbon farming storage’ means a carbon farming activity that stores atmospheric and biogenic carbon in living biomass, soils and dead organic matter as defined per carbon farming activity in the certification methodology;
Amendment 432 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point i
Article 2 – paragraph 1 – point i
Amendment 452 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point o a (new)
Article 2 – paragraph 1 – point o a (new)
(oa) ‘carbon farming storage unit’ means one tonne of certified net carbon farming storage benefit generated by a carbon farming activity and registered by a certification scheme.
Amendment 458 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point o b (new)
Article 2 – paragraph 1 – point o b (new)
(ob) ‘carbon farming greenhouse gas reduction unit’ means one tonne of certified net greenhouse gas reduction benefit generated by a carbon farming activity and registered by a certification scheme;
Amendment 466 #
2022/0394(COD)
Proposal for a regulation
Article 3 – paragraph 1 – introductory part
Article 3 – paragraph 1 – introductory part
Carbon removals shall be eligible for certificationand carbon farming shall respectively be eligible for certification under separate certification frameworks under this Regulation where they meet both of the following conditions:
Amendment 472 #
2022/0394(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) they are generated from a carbon removal activity or carbon farming activity that complies with the quality criteria set out in Articles 4 to 7;
Amendment 479 #
2022/0394(COD)
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
For carbon farming, Annex III provides a non-exhaustive list of examples of measures that might be eligible for certification, if managed correctly. The Commission shall review the list periodically and is empowered to adopt delegated acts in accordance with Article 16 to include further examples to the list in order to ensure that new and innovative practices are promoted.
Amendment 499 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 2 – point c
Article 4 – paragraph 1 – subparagraph 2 – point c
(c) GHGincrease is the increase in direct and indirect greenhouse gas emissions, other than those from biogenic carbon pools in the case of carbon farming, which are due to the implementation of the carbon removal activity which are due to the implementation of the carbon removal activity. This includes both domestic and international impacts (such as direct and indirect land use change), and emissions related to energy, transportation, land, materials etc. used.
Amendment 504 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. In the case of carbon farming, CRbaseline andA carbon farming activity shall provide a net carbon farming benefit, which shall be quantified using the following formula: Net carbon farming benefit = (CSbaseline – CStotal) + (GHGbaseline - GHGreduction) - GHGincrease > 0, where: (a) CSbaseline is the carbon storage under the baseline, (b) CRStotal shall be understood as net greenhouse gas removals or emissions in accordance with the accounting rules laid down in Regulation (EU) 2018/841. is the total carbon storage of the carbon farming activity, (c) GHGbaseline is the release of greenhouse gases under the baseline; (d) GHGreduction is the emission reduction of GHG emissions accounted for in CO2 equivalent, achieved through the implementation of the carbon farming activity, (e) GHGincrease is the direct and indirect greenhouse gas emissions, other than those from biogenic carbon pools, which are due to the implementation of the carbon farming activity. This includes both domestic and international impacts (such as direct and indirect land use change), and emissions related to energy, transportation, land, materials etc. used. Where the activity only stores carbon and thus only generates carbon farming storage units, then (GHGbaseline – GHGreduction) is equal to zero. Where the activity only reduces greenhouse gas release and thus only generates carbon farming greenhouse gas reduction units, then (CSbaseline – CStotal) is equal to zero. Where the activity generates both carbon storage and greenhouse gas emission reductions, the registry referred to in Article 12 shall ensure that a distinction is made between the corresponding carbon farming storage units and carbon farming greenhouse gas reduction units.
Amendment 515 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Quantities referred to in paragraph 1, points (a), (b) and (c) and referred to in paragraph 2 points (a), (b), (c) and (cd), shall be designated with a negative sign (-) if they are net greenhouse gas removals, or in the case of carbon farming, storage or reductions, and with a positive sign (+) if they are net greenhouse gas emissions ;, they shall be expressed in tonnes of carbon dioxide equivalent.
Amendment 518 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Carbon removals and carbon farming shall be quantified in a relevant, accurate, complete, consistent, comparable and transparent manner. Uncertainties in the quantification of carbon removals and carbon farming shall be duly reported and taken into account in a manner that is conservative and proportionate to the level of uncertainty.
Amendment 528 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
5. The standardised baseline shall correspond to the standbe highly representative of the state-of-the- ardt carbon removal or carbon farming performance of comparable activities in similar social, economic, environmental, natural and technological circumstances and take into account the geographical context.
Amendment 537 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 6
Article 4 – paragraph 6
6. By way of derogation from paragraph 5, where duly justified, the baseline may be based on the individual carbon removal or carbon farming performance of that activity.
Amendment 546 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 7
Article 4 – paragraph 7
7. The baseline shall be periodically updated, but for legal clarity stay constant throughout the monitoring period once a carbon removal activity or carbon farming activity has started.
Amendment 550 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 8
Article 4 – paragraph 8
8. The quantification of the carbon removals and carbon farming shall account for uncertainties in accordance with recognised statistical approaches.
Amendment 554 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 9
Article 4 – paragraph 9
9. To support the quantification of carbon removals generated by carbon farming, the operator or group of operators shall gather data on carbon removalsfarming and greenhouse gas emissions in a manner compatible with national greenhouse gas inventories under Regulation (EU) 2018/841 and Part 3 of Annex V to Regulation (EU) 2018/1999.
Amendment 559 #
2022/0394(COD)
Proposal for a regulation
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. A carbon removal activity and a carbon farming activity shall be additional. To that end, the carbon removal activity shall meet both of the following criteria:
Amendment 568 #
2022/0394(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) it goes beyond Union and national statutory requirements placed on the operator;
Amendment 572 #
2022/0394(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) it takes place at least partly due to the incentive effect of the certification.
Amendment 587 #
Amendment 594 #
2022/0394(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. An operator or group of operators shall demonstrate that a carbon removal activity aims at ensuring the long-termpermanent storage of carbon.
Amendment 597 #
2022/0394(COD)
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
1a. An operator or group of operators shall demonstrate that a carbon farming activity aims at ensuring the long-term storage and/or reduction of greenhouse gas emissions.
Amendment 599 #
2022/0394(COD)
Proposal for a regulation
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. For the purposes of paragraph 1 and 1a, an operator or group of operators shall comply with both of the following criteria:
Amendment 614 #
2022/0394(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. For carbon farming and carbon storage in products, the carbon stored by a carbon removalthe purpose of paragraph 1(a), the carbon stored shall be considered released to the atmosphere at the end of the permanence assessment period included in the certification methodology, provided the minimum monitoring period is respected, unless the operator or the group of operators renew the period by proving the continued and uninterrupted maintenance of carbon farming activity and monitoring. However, a carbon farming activity shall be consinot lead to a decred released to the atmosphere at the end ofased carbon sink, as defined in Regulation (EU) 2018/841, compared to the baseline beyond the monitoring period.;
Amendment 627 #
2022/0394(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. A carbon removal activity shall have aor a carbon farming activity shall at least have an overall neutral impact on or generate co- benefits for all the following sustainability objectives:
Amendment 633 #
2022/0394(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) climate change mitigation beyond the net carbon removal benefit referred to in Article 4(1) or the net carbon farming benefit referred to in 4(2), (b) other carbon removal activities or carbon farming activities, in particular permanent removals, (c) the avoidance of the risk for carbon leakage or land use changes in third countries;
Amendment 638 #
2022/0394(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point d
Article 7 – paragraph 1 – point d
(d) transition to a circular economyand bio- based economy, such as replacement of fossil-based products with bio-based products;
Amendment 641 #
2022/0394(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point f
Article 7 – paragraph 1 – point f
(f) protection and restoration of biodiversity and ecosystems, as defined in the national restoration plans.
Amendment 663 #
2022/0394(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. For the purposes of paragraph 1, a carbon removal and carbon farming activity shall comply with minimum sustainability requirements laid down in the certification methodologies, set out in the delegated acts adopted pursuant to Article 8. For forest and agriculture biomass, these criteria shall be those laid down in Article 29 of Directive (EU) 2018/2001.
Amendment 670 #
2022/0394(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Where an operator or group of operators report co-benefits that contribute to the sustainability objectives referred to in paragraph 1 beyond the minimum sustainability requirements referred to in paragraph 2, they shall comply with the certification methodologies set out in delegated acts referred to in Article 8. The certification methodologies shall incentivise as much as possible the generation of co-benefits going beyond the minimum sustainability requirements, in particularprioritise climate mitigation, incentivise active management of forest and agricultural land and aim to generate co-benefits for the objectives referred to in paragraph 1, point (f).
Amendment 682 #
2022/0394(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The Commission is empowered to adopt delegated acts in accordance with Article 16 to establish the technical certification methodologies referred to in paragraph 1 for activities related to permanent carbon storage, carbon farming and carbon storage in products. Those certification methodologies shall include at least the elements set out in Annex Icarbon removal and carbon farming. Those certification methodologies shall include at least the elements set out in Annex I. The first such delegated act shall be adopted no later than 12 months after the entry into force of this regulation. The delegated acts shall, based on consultation with market actors and the expert group on carbon removals, include the technical certification methodologies for, at least but not only, the activities listed in annex III. The Commission should for carbon farming prioritise activities that results in active and sustainable management of agricultural land and forests.
Amendment 701 #
2022/0394(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point a
Article 8 – paragraph 3 – point a
(a) the objectives of ensuring the robustness of carbon removals and recognising the protection and restoration of ecosystemcarbon farming activities and recognising the sustainability criteria laid down in article 29 in Directive (EU) 2018/2001 and the national restorations plans;
Amendment 705 #
2022/0394(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
(b) the objective of minimising administrative burden and keeping the certification procedure as simple as possible for operators, particularly for small-scale carbon farming operators;
Amendment 712 #
2022/0394(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point c
Article 8 – paragraph 3 – point c
(c) relevant Union and national binding law;
Amendment 735 #
2022/0394(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. To apply for a certification of compliance with this Regulation, an operator or a group of operators shall submit an application to a certification scheme. Upon acceptance of that application, the operator or a group of operators shall submit to a certification body a comprehensive description of the carbon removal or carbon farming activity, including the certification methodology applied to assess compliance with Articles 4 to 7, the expected total carbon removals and net carbon removalcarbon farming storage and emissions reductions and the net carbon removal benefit and carbon farming benefit. Groups of operators shall also specify how advisory services on carbon removal activities and carbon farming activities are provided, in particular to small-scale carbon farming operatoroperators. For operators or groups of operators involved in cross-border and/or multi-country carbon removal and carbon farming projects is it possible to appoint a single certification body for all cross-border and multi-country carbon removal and carbon farming projects.
Amendment 748 #
2022/0394(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The certification body shall conduct a certification audit to verify the information submitted in accordance with paragraph 1 and to confirm compliance of the carbon removal activity or the carbon farming activity with Articles 4 to 7. As a result of that certification audit, the certification body shall issue a certification audit report, that includes a summary, and a certificate containing, as a minimum, the information set out in Annex II. The certification scheme shall control the certification audit report and the certificate, and make the summary of the certification audit report and the certificate publicly available in athe EU Negative Carbon registry referred to in Article 12.
Amendment 755 #
2022/0394(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The certification body shall carry out periodic re-certification audits to reconfirm compliance of the carbon removal activity or the carbon farming activity with Articles 4 to 7 and verify the generated carbon benefit. As a result of that re-certification audit, the certification body shall issue a re- certification audit report, that includes a summary, and an updated certificate. The certification scheme shall control the re- certification audit report and the updated certificate, and make the summary of the re-certification audit report, the updated certificate and the certified carbon removal units publicly available in aor the carbon farming units publicly available in the EU Negative Carbon registry referred to in Article 12.
Amendment 762 #
2022/0394(COD)
Proposal for a regulation
Article 9 – paragraph 5
Article 9 – paragraph 5
5. The Commission mayshall no later than 12 months after the entry into force of this Regulation adopt implementing acts to set out the structure, format, technical details of the comprehensive description of the carbon removal activity or the carbon farming activity referred to in paragraph 1, and of the certification and re-certification audit reports referred to in paragraphs 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17.
Amendment 767 #
2022/0394(COD)
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Article 9a Use of certificates Where carbon removal or carbon farming units are used to contribute to stated climate objectives, such units shall not be double counted. Any use of certificates shall ensure the highest integrity of climate mitigation, and shall not lead to increased greenhouse gas emissions. Carbon removal units and carbon farming units shall remain distinct from each other. Carbon farming units must not be used to count as compensations or contributions towards any fossil fuel- based greenhouse gas emissions.
Amendment 780 #
2022/0394(COD)
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Member States shall supervise the operation of certification bodies. Certification bodies shall submit, upon request by the national competent authorities, all relevant information necessary to supervise their operation, including date, time and location of the audits referred to in Article 9. Where Member States find issues of non- conformity, they shall inform the certification body and the relevant certification scheme thereof without delay and publish this notice in the EU Negative Carbon registry referred to in Article 12.
Amendment 791 #
2022/0394(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Certification schemes shall operate on the basis of reliable and transparent rules and procedures, in particular with regard to internal management and monitoring, handling of complaints and appeals, stakeholder consultation, transparency and publication of information, appointment and training of certification bodies, addressing non- conformity issues, and development and management of registries.
Amendment 796 #
2022/0394(COD)
Proposal for a regulation
Article 11 – paragraph 4
Article 11 – paragraph 4
4. Certification schemes shall publish, in the EU Negative Carbon registry referred to in Article 12, at least annually, a list of the appointed certification bodies, stating for each certification body by which entity or national public authority it was recognised and which entity or national public authority is monitoring it.
Amendment 804 #
2022/0394(COD)
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. The Commission shall no later than 12 months after this regulation entering into force adopt implementing acts setting out the structure, format, technical details and process referred to in paragraphs 2, 3 and 4, which shall apply to all certification schemes. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17.
Amendment 806 #
Amendment 814 #
2022/0394(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. A certification schemeThe European Commission shall establish and duly maintain a public registry to make publicly accessible the information related to the certification process, including the certificates and updated certificates, and the quantity of carbon removal units and carbon farming units certified in accordance with Article 9. Those registriesy shall use automated systems, including electronic templates, and shall be interoperable. All information and data entering the registry should be publicly available and easily downloadable.
Amendment 819 #
2022/0394(COD)
Proposal for a regulation
Article 12 – paragraph 1 a (new)
Article 12 – paragraph 1 a (new)
1a. A certification scheme shall, at least monthly, submit all relevant data and reporting as specified by the Commission in the implementing acts referred to in Article 9 paragraph 5 and Article 11 paragraph 5.
Amendment 821 #
2022/0394(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. The Commission mayshall no later than 12 months after the entry into force of this Regulation adopt implementing acts setting out the structure, format, and technical details of the publicEU Negative Carbon registriesy, and of the recording, holding or use of carbon removal and carbon farming units, as referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17.
Amendment 831 #
2022/0394(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Only a certification scheme recognised by the Commission by means of a decision may be used by operators or group of operators to demonstrate compliance with this Regulation. Such decision shall be valid for a period of no more than 5 years, and be made public in the EU Negative Carbon Registry.
Amendment 834 #
2022/0394(COD)
Proposal for a regulation
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. The Commission shall inform about its decision for recognition no later than one month after the notification was administered.
Amendment 836 #
2022/0394(COD)
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. The Commission may, after extensive correspondence with the certification scheme, repeal a decision recognising a certification scheme pursuant to paragraph 1 where the certification scheme fails to implement the standards and rules set out in the implementing acts referred to in Article 11(5). Where a Member State raises concerns that a certification scheme does not operate in accordance with the standards and rules set out in the implementing acts referred to in Article 11(5) that constitute the basis for decisions under paragraph 1, the Commission shall investigate the matter and take appropriate action, including repealing the relevant decision.
Amendment 839 #
2022/0394(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. The Commission mayshall no later than 12 months after this regulation entering into force adopt implementing acts setting out the structure, format, and technical details of the notification and recognition processes referred to in paragraphs 1 and 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17.
Amendment 845 #
2022/0394(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Commission mayshall no later than 12 months after this regulation entering into force adopt implementing acts setting out he structure, format, and technical details of the reports referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17.
Amendment 869 #
2022/0394(COD)
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2a. The European Commission shall, as appropriate, no later than 12 months after the entry info force of this Regulation present a proposal for an EU permanent carbon removal target as well as Member States specific carbon removal targets for 2030, 2040 and 2050 to be added to the Effort Sharing Regulation (2018/842) as an integral part of the post- 2030 EU climate framework. The targets allocated to Member States should be based on their accumulated historic emissions during the time period 1890- 1990. The EU-wide carbon removal target for 2030 shall at least be 50 Mt. Member States should be able to buy and sell carbon removal units among themselves in order to ensure cost- effectiveness. Member States should also be able, in the case of overachievement of their carbon removal target, transfer carbon removal units to the LULUCF- sector and count it towards its 2030-target in Regulation (2018/841).
Amendment 873 #
2022/0394(COD)
Proposal for a regulation
Article 18 – paragraph 2 b (new)
Article 18 – paragraph 2 b (new)
2b. The European Commission shall no later than 12 months after the entry info force of this Regulation present a report analysing and identifying an appropriate share of emissions from installations covered by the ETS (Directive 2003/83/EC), which should be covered by an obligation to purchase permanent carbon removal certificates recognised by this Regulation. This mandatory purchase of carbon removal certificates shall be additional and shall not remove any obligations to cancel allowances laid down by the ETS Directive (2003/83/EC).
Amendment 875 #
2022/0394(COD)
Proposal for a regulation
Article 18 – paragraph 2 c (new)
Article 18 – paragraph 2 c (new)
2c. The European Commission shall examine the options for laying down market-based obligations for food refiners and food processors to take greater responsibility for emissions in their food supply chain, and shall, if appropriate, no later than 12 months after the entry into force of this Regulation present a legislative proposal to this effect, setting obligations and criteria for their purchase of certificates generated from carbon farming activities However, this proposal should not, under any circumstances, put any constraint to whom certificates generated from carbon farming activities could be sold to.
Amendment 923 #
2022/0394(COD)
Proposal for a regulation
Annex II a (new)
Annex II a (new)
Amendment 150 #
2022/0345(COD)
Proposal for a directive
Recital 16
Recital 16
(16) The evaluation has also shown that the wastewater treatment sector offers the opportunity to significantly reduce its own energy consumption and to produce renewable energy, for example by better use of the available surfaces in urban wastewater treatment plants for solar energy production or by producing biogas from sludge. The evaluation also illustrated that, without clear legal obligations, only partial progress can be expected in this sector. In this context, Member States should be required to ensure that the total annual energy used by all urban wastewater treatment plants on their national territory treating a load of 10 000 p.e. and above does not exceed the production of energy from renewable sources as defined in Article 2(1) of Directive (EU) 2018/2001 of the European Parliament and of the Council44, by those urban wastewater treatment plants. That objective should be progressively met with interim targets by 31 December 2040. Reaching this energy neutrality target will contribute to reduce the avoidable greenhouse gas (GHG) emissions from the sector by 46 %, while supporting the achievement of the 2050 climate neutrality objectives and related national and Union objectives, [such as the objectives set out in Regulation (EU) 2018/842 of the European Parliament and of the Council45. Encouraging EU-based biogas or solar energy production while enhancing energy efficiency measures in line with the Energy Efficiency First principle46, which means taking utmost account of cost-efficient energy efficiency measures in shaping energy policy and making relevant investment decisions, will also help reduce the Union energy dependence, one of the objectives expressed in the Commission "Repower EU" Plan47. It is also in line with Directive (EU) 2018/844 of the European Parliament and of the Council48and with Directive (EU) 2018/2001 in which urban wastewater treatment sites are qualified as ‘go-to' areas for renewables, meaning a location designated as particularly suitable for the installation of plants for the production of energy from renewable sources. In order to reach the objective of energy neutrality via optimal measures for each urban wastewater treatment plant and for the collection system, Member States should ensure that energy audits are carried out in accordance with Article 8 of Directive 2012/27/EU of the European Parliament and of the Council49every four years accompanied by an action plan with concrete implementation recommendations. Those audits should include an identification of the potential for cost- effective use or, reduction of energy consumption, recovery and use of waste heat andproduction of renewable energy following the criteria set out in Annex VI to Directive 2012/27/EU as well as identify potential improvements in order to reduce methane and nitrous oxide emissions. _________________ 44 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 (OJ L 328, 21.12.2018, p. 82). 45 Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26). 46 Commission Recommendation (EU) 2021/1749 of 28 September 2021 on Energy Efficiency First: from principles to practice — Guidelines and examples for its implementation in decision-making in the energy sector and beyond 47 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: REPowerEU Plan (COM/2022/230 final). 48 Directive (EU) 2018/844 of the European Parliament and of the Council of 30 May 2018 amending Directive 2010/31/EU on the energy performance of buildings and Directive 2012/27/EU on energy efficiency (OJ L 328, 21.12.2018, p. 210). 49 Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1).
Amendment 837 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. Member States shall ensure that energy audits of urban wastewater treatment plants and collecting systems are carried out every four years. Those energy audits should be accompanied by an action plan with concrete implementation recommendations. Those audits shall be carried out in accordance with Article 8 of Directive 2012/27/EU and include an identification of the potential for cost- effective use or, reduction of energy consumption, recovery and use of waste heat onsite or via a district energy system and production of renewable energy, with a particular focus to identify and utilise the potential for biogas production, while and other energy production, while identifying potential improvements in order to reducinge methane and nitrous oxide emissions. The first audits shall be carried out:
Amendment 881 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 2 – point a
Article 11 – paragraph 2 – point a
(a) 50 % of the total annual energy used by such plants and their collecting systems by 31 December 2030;
Amendment 893 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 2 – point b
Article 11 – paragraph 2 – point b
(b) 75 % of the total annual energy used by such plants and their collecting systems by 31 December 2035;
Amendment 907 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 2 – point c
Article 11 – paragraph 2 – point c
(c) 100 % of the total annual energy used by such plants and their collecting systems by 31 December 2040.
Amendment 1113 #
2022/0345(COD)
Proposal for a directive
Article 21 – paragraph 1 – point d
Article 21 – paragraph 1 – point d
(d) the greenhouse gase emissions produced by all operational activities of the urban wastewater treatment plant and the energy used and produced by urban wastewater treatment plants of above 10 000 p.e. The monitoring should also include leak detection;
Amendment 1156 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point e
Article 22 – paragraph 1 – point e
(e) by 31 December 2025, set up a data set containing information on green house gas emissions from all operational activities with a breakdown between different gasses and on the total energy used and renewable energy produced by each urban wastewater treatment plant of 10 000 p.e. and above as well as a calculation of the percentage of achievement of the targets set out in Article 11(2) and update that data set annually thereafter;
Amendment 277 #
2022/0196(COD)
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the sustainable use of plant protection products and ensuring sustainable crop protection, and amending Regulations (EU) 2021/2115 and (EC) 1107/2009 (Text with EEA relevance)
Amendment 298 #
2022/0196(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The European Parliament resolution of 12 February 2019 on the implementation of Directive 2009/128/EC on the sustainable use of pesticides41 noted that the Union must act without delay to transition to a more sustainable use of pesticides and called on the Commission to propose an ambitious Union-wide binding target for the reduction of pesticide use. The European Parliament re-affirmed its call for binding reduction targets in its resolution of 20 October 2021 on a Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system42 ., while stressing that their achievability depends on the availability of safer, effective and efficient alternatives; __________________ 41 P8_TA(2019)0082, 12 February 2019. 42 P9_TA(2021)0425, 20 October 2021.
Amendment 363 #
2022/0196(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Biological control agents are a sustainable control alternative to the use of chemical products for the control of harmful organisms. As noted in Council Decision (EU) 2021/110257 , biological control agents have a growing importance in sustainable agriculture and forestry and have an instrumental role to play in the success of integrated pest management and organic farming. Access to biological controls facilitates moving away from chemical plant protection products. It is appropriate to encourage farmers to switch to low input agricultural methods including organic farming. It is therefore appropriate to define the concept of biological control as a basis for Member States to set indicativend set targets tofor increaseing the percentage of crops on which biological control agents are usedsales of low risk and biological control plant protection products. __________________ 57 Council Decision (EU) 2021/1102 of 28 June 2021 requesting the Commission to submit a study on the Union’s situation and options regarding the introduction, evaluation, production, marketing and use of invertebrate biological control agents within the territory of the Union and a proposal, if appropriate in view of the outcomes of the study (OJ L 238, 6.7.2021, p. 81).
Amendment 367 #
2022/0196(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The objective of the Farm to Fork Strategy is to make substantial progress in the reduction of the use of chemical plant protection products in an economically viable way. In order to achieve that aim, it is necessary to set quantified targets at Union and Member State levels for the reduction in the use and risk of chemical plant protection products and the use of more hazardous plant protection products to monitor progress. National targets should be established by national law in order to ensure adequate progress and accountability in relation to them. These binding national targets should also be achieved by Member States by 2030. The reduction in the use of chemical plant protection products is expected to significantly reduce occupational safety and health risks for professional users. In order to ensure that professional users of plant protection products are still able to adequately protect crops against pests and diseases, this regulation should also ensure that more low risk and biological control plant protection products are available. Considering that a reduction in chemical plant protection products is only sustainable if crop failures in agriculture can continue to be prevented, the reduction targets for chemical plant protection products should only apply if sufficient alternatives are available and new genomic techniques can be used to grow healthier crops. Therefore, this regulation should set Union and national targets to increase the sales of low risk and biological control plant protection products ('replacement targets').
Amendment 388 #
2022/0196(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Given the different levels of historical progress and differences in intensity of pesticide use between Member States, it is necessary to allow Member States some flexibility when setting their own binding national targets (“national 2030 reduction targets”). Intensity of use is best measured by dividing the total quantity of active substances placed on the market, and therefore used, in the form of plant protection products in a particular Member State by the surface area over which the active substances were applied. Intensity in the use of chemical pesticides, and in particular of the more hazardous pesticides, correlates with greater dependency on chemical pesticides, greater risks to human health and the environment and less sustainable farming practices. It is therefore appropriate to allow Member States to take their lower intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. It is also appropriate to require them to take their higher intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. In addition, in order to give recognition to past efforts by Member States, they should also be allowed to take into account historical progress prior to the adoption of the Farm to Fork Strategy when setting national 2030 reduction targets. Conversely, where Member States have increased, or made only limited reductions in, their use and risk of chemical plant protection products, they should now make a greater contribution to the achievement of the Union 2030 reduction targets, while also taking account of their intensity of pesticide use. In order to ensure a fair and collective effort towards the achievement of Union-wide targets and an adequate level of ambition, minimum limits should be laid down for national 2030 reduction targets. Member States should be allowed to justify their inability to meet the national 2030 reduction targets due to a lack of available alternatives to chemical plant protection products or due to taken measures to ensure food security and safety. The EU’s outermost regions, as listed in Article 349 of the Treaty, are located in the Atlantic, Caribbean and Indian Ocean. Due to permanent constraints such as their remoteness to the European continent, insularity and high exposure to climate change, it is appropriate to allow Member States to take into account the specific needs of these regions as regards the use of plant protection products and measures tailored to specific climatic conditions and crops. In order to ensure a fair and collective effort towards the achievement of Union-wide targets, where a Member State reaches the level of its 2030 national reduction target before 2030, it should not be required to undertake additional reduction efforts, but it should closely monitor annual fluctuations in the use and risk of chemical plant protection products and in the use of more hazardous plant protection products to ensure progress towards meeting the respective 2030 national reduction target. In the interests of transparency, Member State responses to any Commission recommendations in relation to the level of ambition of national targets and the annual progress made towards them should be publicly accessible.
Amendment 393 #
2022/0196(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Given the different levels of historical progress and differences in intensity of pesticide use between Member States, it is necessary to allow Member States some flexibility when setting their own binding national targets (“national 2030 reduction targets”), especially for the frontrunners that, due to their historical ambitious work, use significant less plant protection products compared to the EU average . Intensity of use is best measured by dividing the total quantity of active substances placed on the market, and therefore used, in the form of plant protection products in a particular Member State by the surface area over which the active substances were applied. Intensity in the use of chemical pesticides, and in particular of the more hazardous pesticides, correlates with greater dependency on chemical pesticides, greater risks to human health and the environment and less sustainable farming practices. It is therefore appropriate to allow Member States to take their lower intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. It is also appropriate to require them to take their higher intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. In addition, in order to give recognition to past efforts by Member States, they should also be allowed to take into account historical progress prior to the adoption of the Farm to Fork Strategy when setting national 2030 reduction targets. Conversely, where Member States have increased, or made only limited reductions in, their use and risk of chemical plant protection products, they should now make a greater contribution to the achievement of the Union 2030 reduction targets, while also taking account of their intensity of pesticide use. In order to ensure a fair and collective effort towards the achievement of Union-wide targets and an adequate level of ambition, minimum limits should be laid down for national 2030 reduction targets. The EU’s outermost regions, as listed in Article 349 of the Treaty, are located in the Atlantic, Caribbean and Indian Ocean. Due to permanent constraints such as their remoteness to the European continent, insularity and high exposure to climate change, it is appropriate to allow Member States to take into account the specific needs of these regions as regards the use of plant protection products and measures tailored to specific climatic conditions and crops. In order to ensure a fair and collective effort towards the achievement of Union-wide targets, where a Member State reaches the level of its 2030 national reduction target before 2030, it should not be required to undertake additional reduction efforts, but it should closely monitor annual fluctuations in the use and risk of chemical plant protection products and in the use of more hazardous plant protection products to ensure progress towards meeting the respective 2030 national reduction target. In the interests of transparency, Member State responses to any Commission recommendations in relation to the level of ambition of national targets and the annual progress made towards them should be publicly accessible.
Amendment 400 #
2022/0196(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The overall objective of this regulation should be to reduce the environmental impact of plant protection measures. Reduction in the use of chemical plant protection products is only one of multiple measures that can contribute to achieving this goal. Considering that there is currently not enough data at Union level to properly assess the overall environmental impact of plant protection measures, the harmonised risk indicators based on the sales plant protection products are used. However, some Member States have and will continue to develop indicators for the integral assessment of environmental impact of plant protection measures. Member States should be able to fulfil their obligations for national reduction targets by setting and reaching targets on the basis of these new indicators. Member States should be able to include in their national action plan a methodology, baseline reference year and set target, to be approved by the Commission.
Amendment 413 #
2022/0196(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Member States should draft and publish national action plans. In order for the Member State national action plans to be effective, they should contain quantitative objectives, references to binding national 2030 reduction targets as set out in national law, together with related indicative targets set out in the national action plans, measures, timetables and indicators to reduce risks and impacts of pesticide use on human health and the environment and to increase the availability of alternative measures for plant protection. This will allow for a structured approach to the setting of quantitative objectives and targets, with a clear link to the national 2030 reduction targets. In order to monitor compliance with the provisions of this Regulation, Member States should also be required to report annually on targets and precise quantitative data relating to compliance with provisions on use, training, application equipment and integrated pest management.
Amendment 423 #
2022/0196(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) In order to achieve the Union-wide reduction targets (‘Union 2030 reduction targets’) as well as national 2030 reduction targets, it is necessary to increase the availability and use of biological control and other non-chemicallow risk alternatives. Availability of these alternatives will incentivise the adoption of low pesticide- input pest management practices such as organic farming. In order to ensure that sufficient low risk and biological plant protection products are available to meet the Union reduction and replacement targets, it is appropriate to amend Regulation (EC) 1107/2009 to enable provisional authorisation for these products.
Amendment 574 #
2022/0196(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) In order to monitor progress achieved in the reduction of risks and adverse impacts to human health and the environment from the use of plant protection products it is necessary to continue using the system of harmonised risk indicators established under Directive (EU) 2009/128/EC. The Commission should however also publish a report evaluating the feasibility of developing a harmonised Union indicator for the environmental impact of plant protection measures that focusses on more aspects beyond quantity of plant protection products.
Amendment 581 #
2022/0196(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) Statistical data on plant protection products collected in accordance with Regulation (EC) No 1185/2009 of the European Parliament and of the Council74 should be used in calculating these harmonised risk indicators and progress towards achieving binding Union and national targets based on the Farm to Fork Strategy. Given that pesticide use fluctuates between years depending, in particular, on the weather, a three year baseline period is appropriate to take account of such fluctuations. The baseline period for the calculation of harmonised risk indicators 1 and 2 is 2011–2013, as this was the first three year period for which data was received by the Commission under Regulation (EC) No 1185/2009 and coincides with the entry into force of Directive 2009/128/EC. The baseline period for the calculation of progress towards the Union 2030 reduction targets is 2015–3-2017, as this was the three most recent years for which data was available at the time of the announcement of the Farm to Fork Strategy5. The baseline period for the calculation of a new harmonised risk indicator 2a is 2022–2024, as this will be the first three year period for which data on the areas treated under each authorisation for an emergency situation in plant protection will be available. __________________ 74 Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides (OJ L 324, 10.12.2009, p. 1).
Amendment 2152 #
2022/0196(COD)
Proposal for a regulation
Article 18 – paragraph 3 – point a
Article 18 – paragraph 3 – point a
(a) a proven serious and exceptional risk of the spread of quarantine pests or invasive alien species exists;
Amendment 2168 #
2022/0196(COD)
Proposal for a regulation
Article 18 – paragraph 5
Article 18 – paragraph 5
5. The competent authority referred to in paragraph 3 shall decide on the application for a permit for the use of a plant protection product in a timely manner to ensure that the risk as referred to in point (a) of paragraph 3 is avoided, and latest within 21 weeks of its submission.
Amendment 2205 #
2022/0196(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The use of all plant protection products is prohibited on all surface waters and within 3 metres of such waters. This 3 metre buffer zone shall not be reduced by using alternative risk-mitigation techniques, with the exception of low-risk plant protection products and biocontrol products for the 3 metres buffer zone. Deviation of this 3 metre buffer zone shall be justified by the Member State in its National Action Plan, and may be justified if the risk for the sensitive area is negligible, by the use of alternative risk-mitigation techniques or implementation of the buffer zone would require a disproportionate amount of agricultural land.
Amendment 2221 #
2022/0196(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. By … [OP: please insert the date of application of this Regulation], Member States shall have in place appropriate measures to avoid deterioration caused by plant protection products of surface and groundwater status as well as coastal and marine waters and allow achievement of good surface and groundwater status, to protect the aquatic environment and drinking water supplies from the impact of plant protection products with the aim to achieve, at least, the objectives set out in Directives 2000/60/EC, 2006/118/EC, 2008/105/EC, 2008/56/EC and (EU) 2020/2184.
Amendment 2434 #
2022/0196(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. Each professional user shall consult an independent advisor at least once a year for the purposes of receiving the strategic advice referred to in paragraph 4. Where the circumstances of the plant protection measures taken by the professional user have not changed significantly, a shortened version of the strategic advice may be given, and the user does not have to fulfil all the requirements of paragraph 4. The strategic advice shall be designed in such a way that it will not cause disproportionate administrative burden or cost to professional users. Member States may, as part of their National Action Plan, define criteria under which professional users do not have to comply with article 3 and 4 of this paragraph. Such criteria shall ensure that only professional users are excluded for which the benefits of the strategic advice will be negligible.
Amendment 2442 #
2022/0196(COD)
Proposal for a regulation
Article 26 – paragraph 4 – point a
Article 26 – paragraph 4 – point a
(a) application of relevant control techniques to prevent harmful organisms and diseases;
Amendment 2526 #
2022/0196(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. By … [OP please insert the date = first day of the month following 9 months after the date of entry into force of this Regulation], an owner of application equipment in professional use shall enter the fact that he or she is the owner of the application equipment in the electronic register of application equipment in professional use referred to in Article 33, using the form set out in Annex V, unless the Member State in which the owner uses the equipment has exempted that equipment from inspection in accordance with Article 32(3). Member States shall ensure that the registration procedure will not result in disproportionate administrative burdens or costs for professional users.
Amendment 2655 #
2022/0196(COD)
Proposal for a regulation
Article 35 – title
Article 35 – title
Methodology for calculating harmonised risk indicators 1, 2 and 2a, 2a, and new indicators for assessment of the environmental impact of plant protection measures.
Amendment 2659 #
2022/0196(COD)
Proposal for a regulation
Article 35 – paragraph 3 a (new)
Article 35 – paragraph 3 a (new)
3a. The Commission shall by 2027, publish a report evaluating the indicators developed by Member States under article 4a for the environmental impact of plant protection measures. This report shall, on the basis of the indicators developed by Member States, evaluate the feasibility of developing a harmonised Union indicator for the environmental impact of plant protection measures.
Amendment 2699 #
2022/0196(COD)
Proposal for a regulation
Article 39 – paragraph 1
Article 39 – paragraph 1
Member States may recover the costs related to carrying out their obligations under this Regulation by means of fees or charges. Member States shall ensure that funds received from these fees or charges are reserved for the competent authority.
Amendment 2733 #
2022/0196(COD)
Proposal for a regulation
Article 43 a (new)Regulation (EU) 1107/2009
Article 43 a (new)Regulation (EU) 1107/2009
Article 30 a (new)
Amendment 2735 #
2022/0196(COD)
Proposal for a regulation
Article 43 b (new)
Article 43 b (new)
Regulation (EU) 1107/2009
Article 74
Article 74
Article 43b Amendments to Regulation (EU) 1107/2009 Regulation (EC) No 1107/2009 is amended as follows: (1) In Article 74, the following paragraphs are added: '3. Member States shall ensure that funds received from the fees or charges referred to in paragraph 1 are reserved for the competent authority as designated under article 75. 4. Member States shall ensure that sufficient funding is ring-fenced for the competent authority as designated under article 75 to prevent delays in authorisation procedures.'
Amendment 2793 #
2022/0196(COD)
Proposal for a regulation
Annex I – paragraph 1 – subparagraph 1 – point 4
Annex I – paragraph 1 – subparagraph 1 – point 4
4. The baseline for reduction target 1 shall be set at 100, and is equal to the average result of the above calculation for the period 20153-20175.
Amendment 2808 #
2022/0196(COD)
Proposal for a regulation
Annex I – paragraph 1 – subparagraph 2 – point 3
Annex I – paragraph 1 – subparagraph 2 – point 3
3. The baseline for reduction target 2 shall be set at 100, and is equal to the average result of the above calculation for the period 20153-20175.
Amendment 2942 #
2022/0196(COD)
Proposal for a regulation
Annex VI – Section 3 – point 8
Annex VI – Section 3 – point 8
8. With effect from 1 January 2027, the Commission is empowered to adopt delegated acts in accordance with Article 40 to enable that the methodology of harmonised risk indicator 2 shallcan be replaced by the methodology of harmonised risk indicator 2a referred to in section 4 of this Annex.
Amendment 714 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall put in place the restoration measures that are necessary to improve to good condition areas of habitat types within the Natura 2000 areas listed in Annex I which are not in good condition. Such measures shall be in place on at least 30 % of the area of each group of habitat types within the Natura 2000 areas listed in Annex I that is not in good condition, as quantified in the national restoration plan referred to in Article 12, by 2030, on at least 60 % by 2040, and on at least 90 % by 2050.
Amendment 738 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall inside the Natura 2000 areas put in place the restoration measures that are necessary to re-establish the habitat types listed in Annex I in areas not covered by those habitat types. Such measures shall be in place on areas within the Natura 2000 areas representing at least 30 % of the additional overall surface needed to reach the total favourable reference area of each group of habitat types listed in Annex I, as quantified in the national restoration plan referred to in Article 12, by 2030, at least 60 % of that surface by 2040, and 100 % of that surface by 2050.
Amendment 1288 #
2022/0195(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Member States shall by 2030 have put in place measures to reverse the decline of pollinator populations by 2030 and achieve thereafter an increasing trend of pollinator populations, measured every three years after 2030implementing the measures, until satisfactory levels are achieved, as set out in accordance with Article 11(3).
Amendment 1669 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 4
Article 11 – paragraph 4
4. Member States shall put in place methodology and guidelines to identify and map the agricultural and forest areas in need of restoration, in particular the areas that, due to intensification or other management factors, are in need of enhanced connectivity and landscape diversity.
Amendment 1867 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point o a (new)
Article 12 – paragraph 2 – point o a (new)
(oa) the estimated financing needs for the implementation of the restoration measures, which shall include the description of the support to stakeholders and in particularly private landowners affected by restoration measures or other new obligations arising from this Regulation, and the means of intended financing, public or private, including (co-) financing with Union funding instruments as well as a description on how the national plans will respect the private property rights according to national regulation and secure full compensation for economical or property disadvantages and losses;
Amendment 2322 #
2022/0195(COD)
Proposal for a regulation
Annex VII – point 16
Annex VII – point 16
(16) Increase the agricultural area subject to agro-ecological management approaches such as organic agriculture or agro-forestry, regenerative farming, carbon farming, non-tillage farming, multicropping and crop rotation, integrated pest and nutrient management.
Amendment 353 #
2022/0140(COD)
Proposal for a regulation
Recital 40 a (new)
Recital 40 a (new)
(40 a) Clinical trials are of utmost importance for fostering innovation within Europe in the benefit of European patients. In order to incentivise continuous European leadership in this domain, the sharing of the clinical trials data through the EHDS for secondary use should not compromise the scientific integrity of and investment in these clinical trials, in line with Regulation (EU) 536/2014.
Amendment 466 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes the European Health Data Space (‘EHDS’) by providing for rules, common standards and practices, infrastructures and a governance framework for the primary and secondary use of electronic health data. The European Health Data Space (‘EHDS’) shall, with respect for the principle of subsidiarity, complement and not replace Member States' national rules and policy principles for the use of both primary and secondary health data.
Amendment 789 #
2022/0140(COD)
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. For the purpose of paragraph 1, the Commission shall consult and cooperate with relevant stakeholders, including patients’ representatives, healthcare providers, health professionals, industry associations, national competence centres, as well as other Union and national authorities with competence in relevant areas, to encourage and contribute to the elaboration and adoption of a European electronic health record exchange format.
Amendment 1235 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Electronic health data entailing protected intellectual property and trade secrets from private enterprisehealth data holders shall be made available for secondary use. Where such data is made available for secondary use, all technical and organisational measures necessary to preserve the confidentiality of IP rights and confidentiality of trade secrets shall be taken by the health data access body and in consultation with the data holder. This regulation is without prejudice to existing relevant Union legislation, including Directive 2004/48/EC, Directive 2001/29/EC, Directive (EU) 2016/943 and Directive (EU) 2019/790.
Amendment 1241 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 4 a (new)
Article 33 – paragraph 4 a (new)
4 a. Health data holders shall, when making available to health data access bodies relevant electronic health data pursuant to Article 41(1) which contains intellectual property or trade secrets, inform the data access body that this is the case and indicate which parts of the datasets are concerned.
Amendment 1244 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 4 b (new)
Article 33 – paragraph 4 b (new)
4 b. Should the health data access body be in no position to ensure the protection of IP rights and the confidentiality of trade secrets, it shall refuse the granting of the relevant health data access permit to the health data user.
Amendment 1246 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 4 c (new)
Article 33 – paragraph 4 c (new)
4 c. Health data holders and health data users may conclude data sharing agreements with regards to the exchange of data containing IP and trade secrets. Such negotiations shall be overseen by the relevant health data access body.
Amendment 1247 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 4 d (new)
Article 33 – paragraph 4 d (new)
4 d. Public sector bodies or Union institutions, agencies and bodies that obtain access to electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, shall take all specific technical and organisational measures necessary to preserve the confidentiality of such data.
Amendment 1467 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point d
Article 37 – paragraph 1 – point d
(d) process electronic health data for the purposes set outreferred to in Article 343, including gathe collectionring, combination, preparation and disclosure, anonymisation and pseudonymisation of those data for secondary use on the basis of a data permit;
Amendment 1524 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 2 – point a a (new)
Article 37 – paragraph 2 – point a a (new)
(a a) immediately notify the relevant supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of any potential issue related to the processing of personal electronic health data for secondary use to ensure application and enforcement of this Regulation and relevant provisions of the aforementioned Regulations, including penalties.
Amendment 1537 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 4 a (new)
Article 37 – paragraph 4 a (new)
4 a. The EDPB shall provide health data acces bodies with specific guidelines and minimum standards of anonymisation and pseudonymisation for the purposes in this Regulation in order to ensure the same level of quality of anonymisation and pseudonymisation across Member States. The guidelines shall be based on state-of- the-art technology in this regard, which in turn shall be used by the health data access bodies when carrying out their task of anonymisation or pseudonymisation of electronic health data. The guidelines shall be regularly updated, in line with technological progress in this field.
Amendment 162 #
2022/0095(COD)
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) To ensure consistency with the Chemicals Strategy for Sustainability and the Bioeconomy Strategy, the definition of substances of concern must distinguish between synthetic chemicals and bio- based substances. Bio-based substances are key to making the EU economy more circular and sustainable while lowering its dependence on fossil fuels. The use of bio-based substances improves the overall sustainability and environmental performance of products. Therefore, biobased substances should not be preventively labelled as substances of concern to avoid losing their positive impact on the environment. On the contrary, the use of safe bio-based substances in products and processes should be promoted to replace hazardous chemicals.
Amendment 219 #
2022/0095(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) Micro, small and medium-sized enterprises (SMEs) could greatly benefit from an increase in the demand for sustainable products but could also face costs and difficulties with some of the requirements. The Member States and the Commission should, in their respective areas of responsibility, provide adequate information, ensure targeted and specialised training, and provide specific assistance and support, including financial, to SMEs active in the manufacturing of products for which ecodesign requirements are set, including existing funding and financing tools. Those actions should, for example, cover the calculation of a scientifically robust and verifiable life-cycle based standard, such as the product environmental footprint, and the technical implementation of the product passport, and could facilitate SMEs' access to relevant digital tools, software and databases. Member States actions should be taken in respect of applicable State aid rules.
Amendment 342 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 23
Article 2 – paragraph 1 – point 23
(23) ‘environmental footprint’ means a quantification of a product’s environmental impacts, whether in relation to a single environmental impact category or an aggregated set of impact categories based on scientifically robust and verifiable lifecycle-based standards, such as the Product Environmental Footprint method;
Amendment 391 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – point c a (new)
Article 2 – paragraph 1 – point 28 – point c a (new)
(ca) the criteria in point (b) does not apply to biodegradable substances of biological origin or substances identical to them;
Amendment 12 #
2015/0270(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The recent crisis has shown that the functioning of the internal market may be under threat and that there is an increasing risk of financial fragmentation. The failure of a bank that is relatively large compared to the national banking sector or the concurrent failure of a part of the national banking sector may cause national DGSs to be vulnerable to large local shocks, even with the additional funding mechanisms provided by Directive 2014/49/EU of the European Parliament and of the Council12 . This vulnerability of national DGSs to large local shocks can contribute to adverse feedback between banks and their national sovereign undermining the homogeneity of protection for deposits and contributing to a lack of confidence among depositors and resulting in market instability. As a prerequisite for well-functioning EDIS and in order to reduce the risk of adverse feedback loops between banks and national sovereigns, it is necessary to fully acknowledge the risk that large holdings of sovereign debt poses for banks' balance sheets. __________________ 12 Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee schemes (OJ L 173, 12.6.2014, p. 149).
Amendment 100 #
2015/0270(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) No 806/2014
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) credit institutions established in a participating Member State and subject to Regulation (EU) No 575/2013 (CRR regulation);