BETA

Activities of Christophe CLERGEAU

Plenary speeches (16)

Implementation and delivery of the Sustainable Development Goals (debate)
2023/06/14
Dossiers: 2023/2010(INI)
Nature restoration (debate)
2023/07/11
Dossiers: 2022/0195(COD)
Delivering on the Green Deal: risk of compromising the EU path to the green transition and its international commitments (debate)
2023/07/12
Towards a more disaster-resilient EU - protecting people from extreme heatwaves, floods and forest fires (debate)
2023/09/12
The proposed extension of glyphosate in the EU (debate)
2023/10/04
A true geopolitical Europe now (topical debate)
2023/10/18
Sustainable use of plant protection products (debate)
2023/11/21
Dossiers: 2022/0196(COD)
One-minute speeches on matters of political importance
2024/01/15
One-minute speeches on matters of political importance
2024/02/05
Plants obtained by certain new genomic techniques and their food and feed (debate)
2024/02/06
Dossiers: 2023/0226(COD)
Plants obtained by certain new genomic techniques and their food and feed (debate)
2024/02/06
Dossiers: 2023/0226(COD)
State of play of the implementation of the Global Gateway and its governance two years after its launch (debate)
2024/02/06
Empowering farmers and rural communities - a dialogue towards sustainable and fairly rewarded EU agriculture (debate)
2024/02/07
Resumption of the sitting
2024/04/10
Production and marketing of plant reproductive material - Production and marketing of forest reproductive material (joint debate - Plant and forest reproductive material)
2024/04/23
Resumption of the sitting
2024/04/24

Shadow reports (1)

REPORT on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625
2024/01/29
Committee: ENVI
Dossiers: 2023/0226(COD)
Documents: PDF(379 KB) DOC(163 KB)
Authors: [{'name': 'Jessica POLFJÄRD', 'mepid': 197404}]

Opinions (2)

OPINION Proposal for a regulation of the European Parliament and of the Council on the production and marketing of forest reproductive material, amending Regulations (EU) 2016/2031 and 2017/625 of the European Parliament and of the Council and repealing Council Directive 1999/105/EC (Regulation on forest reproductive material)
2024/03/12
Committee: ENVI
Dossiers: 2023/0228(COD)
Documents: PDF(231 KB) DOC(169 KB)
Authors: [{'name': 'Christophe CLERGEAU', 'mepid': 245018}]
OPINION on the proposal for a regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC (Regulation on plant reproductive material)
2024/03/12
Committee: ENVI
Dossiers: 2023/0227(COD)
Documents: PDF(249 KB) DOC(174 KB)
Authors: [{'name': 'Christophe CLERGEAU', 'mepid': 245018}]

Institutional motions (1)

MOTION FOR A RESOLUTION on Commission Delegated Regulation of 12 March 2024 amending Commission Delegated Regulation (EU) 2022/126 supplementing Regulation (EU) 2021/2115 of the European Parliament and of the Council as regards the rules on the ratio for the good agricultural and environmental condition (GAEC) standard 1
2024/04/17
Documents: PDF(146 KB) DOC(47 KB)

Oral questions (1)

Medicine shortages and strategic healthcare autonomy in the EU
2023/09/05
Documents: PDF(54 KB) DOC(12 KB)

Written questions (16)

Euronews
2023/06/13
Documents: PDF(47 KB) DOC(10 KB)
Arbitrary arrest of prominent Vietnamese environmental defender Hoang Thi Minh Hong
2023/06/14
Documents: PDF(50 KB) DOC(10 KB)
Costs to citizens of different agricultural production methods
2023/07/19
Documents: PDF(44 KB) DOC(10 KB)
Missing neurotoxicity data on several pesticides
2023/08/30
Documents: PDF(42 KB) DOC(10 KB)
Relevance and timetable of a delegated regulation on cider and perry
2023/09/05
Documents: PDF(40 KB) DOC(9 KB)
Follow-up to the Mortler report on strategic food stocks
2023/09/27
Documents: PDF(40 KB) DOC(9 KB)
Definition of an ex ante strategy for the prevention and management of agricultural crises to ensure effective and efficient use of the agricultural reserve
2023/10/30
Documents: PDF(39 KB) DOC(9 KB)
Discrimination on grounds of nationality in the accommodation of people with disabilities in Walloon establishments
2023/11/08
Documents: PDF(40 KB) DOC(9 KB)
Revision of the EU Strategy on Offshore Renewable Energy
2023/11/08
Documents: PDF(40 KB) DOC(9 KB)
Changes to civil status and multiple identities of European citizens with more than one nationality
2023/11/08
Documents: PDF(38 KB) DOC(9 KB)
Opinion of a French independent authority on the substitution of most hazardous pesticides in the EU
2023/12/13
Documents: PDF(51 KB) DOC(10 KB)
Ways of detecting plants derived from new genomic techniques
2024/01/12
Documents: PDF(40 KB) DOC(9 KB)
New genomic techniques: ANSES opinion on the lack of scientific basis for equivalence with non-GM plants
2024/01/12
Documents: PDF(38 KB) DOC(9 KB)
Including pesticides in the future proposal for the universal restriction of PFAS
2024/01/30
Documents: PDF(39 KB) DOC(9 KB)
Practices for purifying contaminated water with the aim marketing it as ‘spring’ or ‘natural mineral’ water in France
2024/02/08
Documents: PDF(48 KB) DOC(9 KB)
Impact of EU’s green taxonomy on the development of sail propulsion for transport vessels
2024/04/25
Documents: PDF(39 KB) DOC(11 KB)

Amendments (314)

Amendment 28 #

2023/2720(RSP)


Recital D a (new)
Da. whereas market withdrawals over four decades of the active substances most harmful to biodiversity used as pesticides have not led to a decline in agricultural production thanks to the competence of farmers using alternatives such as bio- control;
2023/09/25
Committee: ENVI
Amendment 54 #

2023/2720(RSP)


Paragraph 5
5. Emphasises the need to close the gaps in key EU sectoral policies, in particular the common agricultural policy, tackling pollinator decline, and to streamline measures for the protection of pollinators into relevant EU policies; calls for consideration to be given to the budgetary means needed to support the agro-ecological transition of European agriculture while maintaining a high level of self-sufficiency in the key agricultural products;
2023/09/25
Committee: ENVI
Amendment 55 #

2023/2720(RSP)


Paragraph 5 a (new)
5a. Regrets that in 2022 the Commission proposed derogations from GAEC 7 and 8 in relation to the environmental conditionality of the new CAP, given that multicropping and ecological focus areas are positive for insect populations and biodiversity in general; calls on the Commission to propose a genuine forward-looking food security strategy so as not to have to propose such derogations, which are ineffective in terms of increasing production but are harmful to biodiversity protection;
2023/09/25
Committee: ENVI
Amendment 65 #

2023/2720(RSP)


Paragraph 7
7. Underlines the continued need to better protect pollinators from risks resulting from pesticides and biocides by reducing the use of pesticides by 50% by 2030 as set out in the farm to fork strategy, and regrets the delay in taking action to protect pollinators through the 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).
2023/09/25
Committee: ENVI
Amendment 70 #

2023/2720(RSP)


Paragraph 7 a (new)
7a. Is surprised that, in its proposal for a regulation on new GMOs, the Commission is promoting varieties made resistant to systemic herbicides by proposing their deregulation, given that pollen from weed flora is an important food resource for all pollinators;
2023/09/25
Committee: ENVI
Amendment 75 #

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 tolerances for residues of pesticides that are banned in the EU for reasons of human health and biodiversity protection, in order to prevent the import of products that can cause unacceptable harm to pollinators;
2023/09/25
Committee: ENVI
Amendment 80 #

2023/2720(RSP)


Paragraph 9 a (new)
9a. Calls for a ban on the production and export of pesticides whose use is banned in the EU, as we must not be responsible for harm to biodiversity on other continents;
2023/09/25
Committee: ENVI
Amendment 86 #

2023/2720(RSP)


Paragraph 10 a (new)
10a. Recalls that a major obstacle to improving pesticide risk assessment for pollinators is the lack of internationally validated testing methods; welcomes the Commission’s commitment to draw up a work plan to this end; insists that adequate financial support be provided to this end, for example through the EU Framework Programme for Research and Innovation – Horizon Europe;
2023/09/25
Committee: ENVI
Amendment 87 #

2023/2720(RSP)


Paragraph 10 a (new)
10a. Notes the Commission’s commitment to update the guidance document for pesticide risk assessment for non-target arthropods (including wild pollinators other than bees); stresses the urgency of this update and calls for a clear deadline to be set for it;
2023/09/25
Committee: ENVI
Amendment 137 #

2023/2720(RSP)


Paragraph 19
19. Highlights the essential role of farmers in maintaining habitats for pollinators and fostering sustainable agricultural practices that prioritise the well-being of these crucial species and contribute to the preservation of biodiversity; stresses the importance of an independent network of advisors trained in pollinator conservation in agricultural areas in order to ensure the dissemination and effective implementation of pollinator-friendly measures;
2023/09/25
Committee: ENVI
Amendment 158 #

2023/2720(RSP)


Paragraph 23 a (new)
23a. Recalls that one of the obstacles to the effective implementation of citizen science programmes is the lack of taxonomic expertise for data processing and the lack of taxonomic tools; calls on the Commission and the Member States to address these shortcomings;
2023/09/25
Committee: ENVI
Amendment 329 #

2023/2074(INI)

Motion for a resolution
Paragraph 9 a (new)
9a. In view of growing international research and recognition of the challenges relevant to farmers´ psychosocial work environment and mental health1a, supports the Commission´s proposal to focus on people living in rural or remote areas, such as farmers, particularly through targeting CAP funds and other structural funds to tailor to needs of these groups and calls for specific proposals to be put forward in the CAP national action plans. _________________ 1a https://sawee.se/publications/farmers- psychosocial-work-environment-and- mental-health/
2023/09/08
Committee: ENVI
Amendment 457 #

2023/2074(INI)

Motion for a resolution
Paragraph 17
17. Invites the Commission and the Member States to invest in further research on mental health, and to include often overlooked sectors, such as agriculture (farmers, rural areas, etc.) within key target groups to benefit from such research;
2023/09/08
Committee: ENVI
Amendment 1 #

2023/2073(INI)

Motion for a resolution
Citation 1
– having regard to the UN 2030 Agenda for Sustainable Development and the Sustainable Development Goals (SDGs), in particular SDG 1 on poverty eradication, SDG 7 on ensuring access to affordable, reliable, sustainable and modern energy for all, SDG 9 on industry and infrastructure, and SDG 13 on climate action, and SDG 5 on achieving gender equality and empowering all women and girls,
2023/10/17
Committee: DEVE
Amendment 4 #

2023/2073(INI)

Motion for a resolution
Citation 14
– having regard to the 1992 United Nations Framework Convention on Climate Change (UNFCCC) and the Kyoto Protocol thereto, to the 21st Conference of the Parties (COP21) to the UNFCCC in Paris, in December 2015, and to the adoption of the Paris Agreement, the first- ever universal, legally binding global climate deal, and to the IPCC Fifth Assessment Report on Climate Change,
2023/10/17
Committee: DEVE
Amendment 19 #

2023/2073(INI)

Motion for a resolution
Recital A
A. whereas SDG 7 stipulates the aim to achieve sustainable access to affordable and clean energy by 203012, notably by calling for greater international cooperation to facilitate access to clean energy research and technology, including renewable energy, energy efficiency and advanced and cleaner fossil-fuel technology, and promote investment in energy infrastructure and clean energy technology; _________________ 12 UN Department of Economic and Social Affairs, ‘The Sustainable Development Goals Report 2023: Special Edition – July 2023’, New York, USA, 2023.
2023/10/17
Committee: DEVE
Amendment 53 #

2023/2073(INI)

Motion for a resolution
Recital E
E. whereas developing countries have an abundance of renewable energy sources, but often lack an enabling policy and regulatory framework forand industrial and technological ecosystems conducive to the sustainable energy development and use, production and use of such energy sources;
2023/10/17
Committee: DEVE
Amendment 60 #

2023/2073(INI)

Motion for a resolution
Recital F
F. whereas the EU together with its Member States provided the vast majority of Official Development Assistance financing for SDG 7 projects in Africa amounting to EUR 13.8 billion between 2014 and 2020; whereas an estimated 53 % of the disbursements were in the form of loans and therefore debt for beneficiaries, thus reducing their ability to invest in the SDGs, including SDG 7, in future;
2023/10/17
Committee: DEVE
Amendment 62 #

2023/2073(INI)

Motion for a resolution
Recital F a (new)
Fa. whereas in terms of geographical targeting, Morocco (EUR 2.5 billion) and South Africa (EUR 1.2 billion) were the first to be granted funding, and only three least developed countries were among the top 10 first beneficiaries of funding; whereas, priority has thus not been given to directing resources towards access and the fight against energy poverty;
2023/10/17
Committee: DEVE
Amendment 74 #

2023/2073(INI)

Motion for a resolution
Recital I
I. whereas the Africa-EU Energy Partnership was renewed in February 2022 with explicit objectives to promote renewable energy generation and distribution;
2023/10/17
Committee: DEVE
Amendment 92 #

2023/2073(INI)

Motion for a resolution
Recital L
L. whereas the expansion of renewables based on solar and wind power also raises challenges as they require large areas of land, thus interfering with existing land use and local needs, in particular regarding access to water; whereas land and sea areas that could be used for renewable energy production need to be identified, taking into account connection conditions and with respect for biodiversity, the local economy and the consent of indigenous populations;
2023/10/17
Committee: DEVE
Amendment 158 #

2023/2073(INI)

11a. Stresses the significant potential in developing countries for offshore renewable energy production facilities to be installed; emphasises the need for holistic management of maritime areas, involving all stakeholders and respecting the consent of local communities;
2023/10/17
Committee: DEVE
Amendment 173 #

2023/2073(INI)

Motion for a resolution
Paragraph 14
14. Notes, with concern, that Africa hosts an increasing number of fossil fuel projects, which risks preventing it from making a timely leap to renewable energy; also notes, however, that although Africa is home to 18 % of the world’s population, it only accounts for 6 % of global energy consumption; recalls that a major portion of current oil, gas and coal production in Africa is destined for export, while the continent continues to be plagued by energy poverty;
2023/10/17
Committee: DEVE
Amendment 179 #

2023/2073(INI)

Motion for a resolution
Paragraph 15 a (new)
15a. Recommends that a joint energy transition planning exercise be carried out within the framework of the EU-AU partnership, drawing on the ACP-EU Joint Parliamentary Assembly and African civil societies, while respecting the sovereignty of African nations; calls for the objectives of decarbonising cities, mobility and industry, ensuring universal access to energy for local populations, generating renewable energy for export, developing energy transport, distribution and storage infrastructures, and improving the resilience of electricity networks to be combined; recommends that guidelines on the fair sharing of investments, revenues, technologies and skills be drawn up;
2023/10/17
Committee: DEVE
Amendment 184 #

2023/2073(INI)

Motion for a resolution
Paragraph 15 b (new)
15b. Stresses the importance of scientific cooperation in sharing the knowledge and skills needed to successfully carry out the energy transition; calls on the European Union to step up cooperation with developing countries on access to research and renewable energy technologies;
2023/10/17
Committee: DEVE
Amendment 231 #

2023/2073(INI)

Motion for a resolution
Paragraph 26 – point c
(c) implement and strictly apply the rights-based approach providing effective complaint and redress mechanisms, notably in projects under the Global Gateway initiative, and requiring full impact studies for each project, particularly on climate change, inequalities and the displacement of local populations;
2023/10/17
Committee: DEVE
Amendment 233 #

2023/2073(INI)

Motion for a resolution
Paragraph 26 – point d a (new)
da. support local and regional electricity interconnection projects;
2023/10/17
Committee: DEVE
Amendment 3 #

2023/2029(INI)

Motion for a resolution
Citation 4
having regard to various reports of the European Court of Auditors on EU external financing, in particular to Special Report 14/2023, ‘Programming the Neighbourhood, Development and International Cooperation Instrument – Global Europe: comprehensive programmes with deficiencies in the methods for allocating funds and impact monitoring’ and to its report entitled ‘Public Private Partnerships in the EU: Widespread shortcomings and limited benefits’,
2023/09/15
Committee: AFETDEVE
Amendment 16 #

2023/2029(INI)

Motion for a resolution
Recital B
B. whereas the Instrument’s external investment framework brings together blended finance and guarantees under the European Fund for Sustainable Development Plus (EFSD+) External Action Guarantee (EAG), which is to be implemented by eligible partners in an open and collaborative approach, with a specific role for the European Investment Bank (EIB); whereas the EFSD+ considerably expands the financial envelope of its predecessor, the EFSD, and will be able to guarantee operations up to EUR 53.4 billion through EAG; whereas the ‘policy first’ principle must result in a cooperation driven by policy objectives and ensure that the European financial architecture for development is aligned in this regard; proposes for example to refine the broad and vague MSMEs window into sub-windows that should be dedicated to individual entrepreneurs and cooperatives;
2023/09/15
Committee: AFETDEVE
Amendment 22 #

2023/2029(INI)

Motion for a resolution
Recital B a (new)
Ba. whereas inequalities are amongst the root causes of instability, insecurity and violence;
2023/09/15
Committee: AFETDEVE
Amendment 23 #

2023/2029(INI)

Motion for a resolution
Recital B b (new)
Bb. whereas the promotion of human rights is a cornerstone of the EU’s external action;
2023/09/15
Committee: AFETDEVE
Amendment 24 #

2023/2029(INI)

Motion for a resolution
Recital B c (new)
Bc. whereas human development remains a key area for the EU’s external and development policies; whereas investments in health care, education, nutrition and social protection are paramount to ensure universal access to these services which constitute basic human rights;
2023/09/15
Committee: AFETDEVE
Amendment 28 #

2023/2029(INI)

Motion for a resolution
Recital C
C. whereas due to limited resources, the external financing instruments have often been stretched to their limits; whereas, since the adoption of the Regulation establishing the Instrument, events such as the Russian war of aggression against Ukraine (which triggered a food, energy and cost of living crisis) and the impact ofand the COVID-19 pandemic have exacerbated the situationfood, energy and debt crises in particular to such a degree that an early mid-term evaluation (MTE) of the Instrument and a mid-term revision (MTR) of the multiannual financial framework (MFF) are necessary, and that crisis anticipation and resilience need to be built into these;
2023/09/15
Committee: AFETDEVE
Amendment 55 #

2023/2029(INI)

Motion for a resolution
Paragraph 4
4. Welcomes the consolidation of most of the EU’s external action in a single Instrument, gradually streamlining and harmonising the numerous previous instruments; is of the opinion, however, that although this simplification has enhanced flexibility and efficiency, it has not been accompanied by sufficient levels of effective accountability; underlines in this regard that measures can only be considered effective when this can be proven by clear and comparable monitoring and evaluation mechanisms; reminds of the findings of the 2023 ECA special report on programming of the Instrument, which points out that baseline and target indicators as well as data sources in MIPs where fragmented or missing; calls on the Commission to make the use of ‘Global Europe Results Framework’ (GERF) indicators compulsory for all measures throughout the entire programming cycle of MIPs, that is planning, implementation and reporting of results and for considerably increasing EU delegations capacities; emphasises that the Instrument should provide an efficient, effective, coherent and inclusive implementation, underpinned by the ‘policy first’ principle and in line with the strategic interests and values of the EU; reiterates its call on the Commission to publish, at least biannually, an aid effectiveness progress report, that consistently includes standardized, comprehensible and comparable indicators, covering joint planning, joint implementation and joint results frameworks; calls on the Commission to present this progress report to Parliament;
2023/09/15
Committee: AFETDEVE
Amendment 94 #

2023/2029(INI)

Motion for a resolution
Paragraph 9
9. Stresses the importance of meeting all the Instrument’s spending targets and calls for detailed information on the progress made in this regard; regrets, in particular, the substantial deficit in reaching the Instrument’s climate target and the biodiversity target; recalls that biodiversity is a crucial factor in combatting climate change; calls for a detailed plan outlining how the Commission intends to meet the climatespending targets by the end of the MFF;
2023/09/15
Committee: AFETDEVE
Amendment 98 #

2023/2029(INI)

Motion for a resolution
Paragraph 10
10. Reaffirms the commitment set out in the Instrument to eradicating poverty, fighting inequalities and discrimination and promoting human development; recalls that actions under the Instrument are expected to contribute at least 20 % of the ODA funded under the Instrument to social inclusion and human development; underlines that the EFSD+ should aim to support investments as a means of contributing to the achievement of the SDGs by fostering sustainable and inclusive economic, environmental and social development; calls in this regard for the full implementation of the EU Gender Action Plan III, as well as the operationalisation of the EU Global Health Strategy and the Youth Action Plan in EU external action; underlines the need to enhance the Union’s efforts to promote and protect human rights in its external action, in view of the mid-term review of the implementation of the EU Action Plan on Human Rights and Democracy;
2023/09/15
Committee: AFETDEVE
Amendment 100 #

2023/2029(INI)

Motion for a resolution
Paragraph 10
10. Reaffirms the commitment set out in the Instrument to eradicating poverty, fighting inequalities and discrimination and promoting human development; recalls the commitment made by the EU and the Member States to increase their official development assistance (ODA) to 0.7 % of gross domestic product by 2030, including 20 % of the EU’s ODA for social inclusion and human development, and 0.2 % of the EU’s gross national income for ODA to the least-developed countries;
2023/09/15
Committee: AFETDEVE
Amendment 103 #

2023/2029(INI)

Motion for a resolution
Paragraph 10
10. Reaffirms the commitment set out in the Instrument to eradicating poverty, fighting inequalities and discrimination and promoting human development; emphasises the importance of following a holistic approach to human security as a new guiding paradigm;
2023/09/15
Committee: AFETDEVE
Amendment 109 #

2023/2029(INI)

Motion for a resolution
Paragraph 10 a (new)
10a. Underlines the importance of guaranteeing an effective needs-based and people-centred approach in the EU’s external action; highlights the essential role that local partners and civil society should have in the design, implementation, monitoring and evaluation of the programmes;
2023/09/15
Committee: AFETDEVE
Amendment 132 #

2023/2029(INI)

Motion for a resolution
Paragraph 12
12. Stresses that under no circumstances should the 2024 MTR of the MFF result in the Instrument’s funds being cut or reallocated between programmes; underlines the key role of the Instrument, the EFSD+ and the EAG in providing a strategic framework for blended finance, de-risking investments and guarantees and in mobilising resources from the private sector with the support of the EU budget, particularly in the light of increasing geopolitical and economic competition; calls for the impact of these investments on achieving the Sustainable Development Goals (SDGs) to be systematically assessed, in particular in terms of combating poverty and inequality, especially on the basis of gender; calls for the EFSD+ not to finance investments that have a negative impact on the SDGs, particularly as regards combating climate change and protecting aquatic fauna and flora,
2023/09/15
Committee: AFETDEVE
Amendment 142 #

2023/2029(INI)

Motion for a resolution
Paragraph 14
14. Notes the specific role played by the EIB in the European financial architecture for development, as set out in Article 209 of the TFEU and in Article 36 of the Regulation establishing the Instrument, and acknowledges the EIB’s potential to mobilise additional funding that contributes to the Instrument’s objectives; welcomes the creation of EIB Global, which has been operational since 1 January 2022 and sets out to increase the bank’s presence and expertise in developing countries; notes that, since the setting up of the new development branch, the EIB Global has made record use of the dedicated investment window provided by the Instrument, delivering over EUR 10 billion in 2022, notably in support of Ukraine and the Global Gateway; recalls the importance of the EU budget as the sole guarantor for the EIB’s to provide loans outside the EU in support of EU policies; calls for an increase in the guarantees granted to the EIB by the EU budget in order to allow the EU bank to continue to deliver vital public and private sector operations in Ukraine and to expand its activities in the Global South; calls on the EIB to use its position to mobilise investments for sustainable development in line with the purpose and criteria established by the EFSD+; highlights the important role of the EIB in partnering with the Commission to deliver EUR 100 billion of the 300 billion commitment under the Global Gateway strategy; calls on the EIB to continue to strengthen its presence in the field by building on the current approach of co- location within EU delegations, while further exploiting possible synergies with the EBRD and other European DFIs; underlines that EU investment projects should be subject to evaluation, monitoring and reporting, in order to avoid unintended negative impacts; in this regard, calls on the Commission, together with EIB, EBRD and other European DFIs to develop standardised procedures, including ex ante and ex post evaluations and by applying the Commission’s Result Management Framework (ReMF); urges the Commission to publish this Framework and to make sure that DFIs using their own indicators to clearly define them and explain their application and comparability with the ReMF; calls for the introduction of standardised complaint mechanisms for all DFIs that are sufficiently staffed and resourced and easily accessible; calls on the Commission to follow-up environmental, social and governance (ESG) standards of all investment projects; encourages the EIB to continue to actively engage in developing planning, monitoring and evaluation at country level, hand in hand with the EU delegations and through co- financing with development finance institutions; calls for stronger coordination between the Commission and the EEAS and EU delegations to facilitate discussions and cooperation with relevant actors on the ground in order to identify projects which best meet development effectiveness objectives;
2023/09/15
Committee: AFETDEVE
Amendment 146 #

2023/2029(INI)

Motion for a resolution
Paragraph 14
14. Notes the specific role played by the EIB in the European financial architecture for development, as set out in Article 209 of the TFEU and in Article 36 of the Regulation establishing the Instrument, and; acknowledges the EIB’s potential to mobilise additional funding that contributes to the Instrument’s objectives; welcomes the creation of EIB Global, which has been operational since 1 January 2022 and sets out to increase the bank’s presence and expertise in developing countries; recommends that these financial instruments not be implemented in investment-recipient countries that lack suitable institutional and legal frameworks for EU-backed public-private partnership projects
2023/09/15
Committee: AFETDEVE
Amendment 155 #

2023/2029(INI)

Motion for a resolution
Paragraph 15
15. Wwelcomes the ‘open architecture’ of the EFSD+, which was established to support private-sector investments, and; calls on the Commission, the EIB, the Member States and development finance institutions (DFIs) to fully utilise the options provided by the EAG and the relevant investment windows to promote sustainable private- sector investments; recalls Parliament's power of scrutiny and the need for transparency in the implementation of the EFSD+, including by the EIB,
2023/09/15
Committee: AFETDEVE
Amendment 164 #

2023/2029(INI)

Motion for a resolution
Paragraph 16
16. Welcomes the Team Europe approach and its aim of increasing the coherence, impact and visibility of EU development projects, and calls for more joint actions with the Member States, in particular Team Europe Initiatives (TEIs); recalls however that individual Member States’ contributions have to be indicated in MIPs in order to ensure certainty over the Member States’ financial support; calls on the Commission to review the effectiveness of the approach including Member States’ compliance, and to inform Parliament of its findings;
2023/09/15
Committee: AFETDEVE
Amendment 167 #

2023/2029(INI)

Motion for a resolution
Paragraph 16
16. Welcomes the Team Europe approach and its aim of increasing the coherence, impact and visibility of EU development projects, and calls for more joint actions with the Member States, in particular Team Europe Initiatives (TEIs); calls on the Commission to review the effectiveness of the approach and to inform Parliament of its findings; calls on the Commission to clarify the roles surrounding the Team Europe approach and to propose a mechanism that increases the transparency and democratic scrutiny of the initiative;
2023/09/15
Committee: AFETDEVE
Amendment 168 #

2023/2029(INI)

Motion for a resolution
Paragraph 16
16. Wwelcomes the Team Europe approach and its aim of increasing the coherence, impact and visibility of EU development projects, and; calls for more joint actions with the Member States, in particular Team Europe Initiatives (TEIs) and in cooperation with the countries receiving the funds, in particular Team Europe Initiatives (TEIs), while respecting the consent of local and, in particular, indigenous populations, especially for infrastructure projects; calls on the Commission to review the effectiveness of the approach and to inform Parliament of its findings;
2023/09/15
Committee: AFETDEVE
Amendment 188 #

2023/2029(INI)

Motion for a resolution
Paragraph 19
19. Recalls Parliament’s functions of political control and consultation and stresses the role of the high-level geopolitical dialogue in providing general orientations for the implementation of the Instrument; powers of political and budgetary control and consultation; underlines that the Parliament needs full and timely access to documents and has to be able to monitor the impact and progress of projects, which is, why it needs full access to standardised baseline and target indicators as well as data sources; regrets that decision- making processes in particular in the framework of the Global Gateway are still undefined and not fully transparent; points out that the overlap of financial instruments, for example in the context of guarantees, makes scrutiny difficult; calls on the Commission to provide after consultations with the Parliament a comprehensible, clear and complete overview in a single document about the financial instruments their relations with each other and the different actors as well as a complete and precise overview about grants and guarantees and how they are covered; furthermore, calls on the Commission to provide regular information about the Global Gateway steering group and to make the Result Management Framework (ReMF) fully available; calls for an oversight of the complaint mechanisms and for regular information about complaints; calls on the Parliament to establish a sufficiently staffed and resourced parliamentary oversight body for the Instrument including EFSD+ and Global Gateway projects and calls on the Commission to provide a consistent inter-institutional information flow with the European Parliament being kept informed about investment projects including Global Gateway projects; is of the opinion that the format of the high-level geopolitical dialogue alone cannot fully provide general orientations for the implementation of the Instrument; reiterates that Parliament’s positions need to be fully taken into consideration; also reiterates that European Parliament resolutions constitute part of the overall policy framework for the implementation of the Instrument;
2023/09/15
Committee: AFETDEVE
Amendment 215 #

2023/2029(INI)

Motion for a resolution
Paragraph 26
26. Stresses that the MTE should be accompanied by the necessary legislative changes to the Instrument and the IPA III so that the relevant regulations reflect Ukraine and Moldova’s new status as EU candidate countries, and by a new delegated act setting out the specific objectives and priority areas of cooperation for each region; underlines the importance of providing funding via development finance institutions and the EIB that targets, in particular, access to essential primary materials, to renewable energies and to the economy, as part of shared planning for the development of renewable energies between Europe and its partners, in particular in Latin America, Africa and the Maghreb countries, as part of a shared strategic vision responding to the needs of local populations and not solely those of European countries;
2023/09/15
Committee: AFETDEVE
Amendment 220 #

2023/2029(INI)

Motion for a resolution
Paragraph 27
27. Considers that the geopolitical challenges that emerged with the Russian war of aggression against Ukraine require the Instrument’s budget to be increased considerably so that support for Ukraine can be provided alongside the support for people in developing countries, with priority currently being given to our African and Southern Mediterranean partners; highlights that the challenges are spread all over the world, meaning the EU must increase its geopolitical influence and prioritise the implementation of the post- Cotonou agreements; stresses that it will only be possible to respond to these challenges in a balanced way if the proportion of allocations for each area of the Instrument is kept the same;
2023/09/15
Committee: AFETDEVE
Amendment 230 #

2023/2029(INI)

Motion for a resolution
Paragraph 28
28. Iinsists that Parliament is part of Team Europe and should be treated as such, and therefore expects more frequent, detailed and meaningful information about the implementation of the Instrument, including the list of the EIB's investments involving the Instrument's funds;
2023/09/15
Committee: AFETDEVE
Amendment 233 #

2023/2029(INI)

Motion for a resolution
Paragraph 28 a (new)
28a. Notes that pilot projects and preparatory actions are new initiatives that might turn into EU funding programmes when they turned out to be successful; underlines that they are an opportunity for the European Parliament to introduce programmes that would otherwise not have been financed; highlights that the Insrtument, when interpreted broadly, constitutes in theory a legal basis for all initiatives, which prevents eligibility and therefore makes de-facto initiatives from the European Parliament impossible; calls on the Commission to provide a legislative proposal that enables pilot projects and preparatory actions to be proposed by the Parliament, provided, the proposals are considered useful by the EU delegations and provided additional benefits as they would otherwise not have been financed in praxis;
2023/09/15
Committee: AFETDEVE
Amendment 2 #

2023/2000(INI)

Motion for a resolution
Citation 9 a (new)
– having regard the Humanitarian Partnership 2021-2027 and its goal to improving the effectiveness and efficiency of humanitarian aid;
2023/07/19
Committee: DEVE
Amendment 9 #

2023/2000(INI)

Motion for a resolution
Citation 14 a (new)
– having regard to the UN Security Council Resolution 2664 (2022) on a Humanitarian Exemption to asset freeze measures imposed by United Nations Sanctions Regimes;
2023/07/19
Committee: DEVE
Amendment 10 #

2023/2000(INI)

Motion for a resolution
Citation 15
– having regard to the Grand Bargain agreement signed on 23 May 2016, to the annual independent reports thereon, in particular the 2021 report, and to the Grand Bargain 2.0 framework and the annexes thereto presented at the Grand Bargain annual meeting of 15-17 June 2021, as well as the renewed commitments at the Grand Bargain annual meeting of 19-20 June 2023;
2023/07/19
Committee: DEVE
Amendment 12 #

2023/2000(INI)

Motion for a resolution
Citation 17 a (new)
– having regard to the Climate and Environment Charter for humanitarian organizations and the Donors’ Declaration on climate and the environment of March 2022;
2023/07/19
Committee: DEVE
Amendment 18 #

2023/2000(INI)

Motion for a resolution
Recital B
B. whereas humanitarian crises are becoming more protracted and complex, and are causing global spillover effects; whereas increasing numbers of conflicts, climate change hazards and their impacts and the COVID-19 pandemic have created more economic vulnerability and displacement, resulting in even greater needs; whereas these crises have significantly risen inequalities;
2023/07/19
Committee: DEVE
Amendment 26 #

2023/2000(INI)

Motion for a resolution
Recital D
D. whereas innovative structural solutions are needed to address global humanitarian challenges and ensuring the humanitarian system is more agile, prepared for and responsive to humanitarian crisis, more gender- inclusive, locally-led and accountable; whereas these solutions should focus on ensuring sufficient and quality funding, implementing effectively the humanitarian- development-peace nexus (triple nexus) approach and creating an enabling humanitarian environment for humanitarian workers and organisations; whereas efforts to address current and future humanitarian challenges must be guided by a people-centred approach, especially with regard to women, children and persons with disabilities; whereas the role and participation of local actors and first responders in humanitarian responses must be recognised and supported; whereas it is estimated that over 40% of the half a million humanitarian workers who provide frontline care during emergencies, wars and disasters, are women;
2023/07/19
Committee: DEVE
Amendment 40 #

2023/2000(INI)

Motion for a resolution
Paragraph 1
1. Calls urgently on the Commission and the Member States to substantially increase their humanitarian aid budgets to respond to humanitarian needs, which are at a record high, without compromising on the development budget; reiterates its call on the Member States to allocate a fixed share of their gross national incomes to humanitarian aid; supports, in this regard, the Council conclusions of 22 May 2023 encouraging the Member States to devote 10 % of their official development assistance to humanitarian action and calls for their swift implementation; calls on the Commission and Member States to set ambitious targets and to create roadmaps for gradually increasing official development assistance to meet the final target;
2023/07/19
Committee: DEVE
Amendment 44 #

2023/2000(INI)

Motion for a resolution
Paragraph 2
2. Notes that closing the funding gap is a global responsibility; reiterates, therefore, the need to expand the humanitarian resource base by promoting the greater involvement of non-traditional donor countries with major economic potential and by mobilising private funding, accompanied by follow-up mechanisms, in full respect of humanitarian principles; of humanity, neutrality, impartiality and independence;
2023/07/19
Committee: DEVE
Amendment 56 #

2023/2000(INI)

Motion for a resolution
Paragraph 4
4. Is concerned about the imbalances in funding between crises and within sectors and warns of the consequences of chronic underfunding on the most vulnerable; notes that in 2022, only 27.7 % of the humanitarian appeal for El Salvador was funded compared to 94.5 % of the humanitarian appeal for the Central African Republic, reflecting that funding imbalances can result in some appeals receiving as much as three times more funding than others; notes the critical and continuous underfunding of the protection and gender based violence sectors, which highly impacts on access to services of people in need; calls for more equitable, needs-based distribution of funding to ensure that no one is left behind; calls on the Commission to develop a more harmonised approach to forgotten crises and to report on its commitment to allocate 15 % of its initial annual humanitarian budget to forgotten crises and prevent the transfer of resources from already underfunded crises; calls on the Council to better coordinate the Member States’ attention and support for these crises;
2023/07/19
Committee: DEVE
Amendment 60 #

2023/2000(INI)

Motion for a resolution
Paragraph 4 a (new)
4a. Calls on the Commission and the Member States to support and implement the G7 foreign ministers statement on anticipatory action and invest an increased part of the humanitarian funding for early warning and anticipatory action ; invites the Commission and the Member States to strengthen existing and currently developed early warning systems (IPC, FEWSNET and local ones) to enhance and disseminate the evidence base for a political warning and triggering of an adequate government, donor and partner response to prevent IPC 2 levels deteriorating into IPC 3, 4 or 5;
2023/07/19
Committee: DEVE
Amendment 64 #

2023/2000(INI)

Motion for a resolution
Paragraph 5
5. Calls on the Commission and the Member States to provide more quality funding through flexible, unearmarked, softly earmarked and multiannual funding that is tailored to local contexts, prioritising protracted crises where predictability is critical, needs-based and people-centred; highlights the need to harmonise and simplify donors’ contracting procedures; applications, contracting, grants management and reporting procedures; calls on the Commission and Member States to allocate increased direct funding to NGOs who are able to more efficiently and cost-effectively utilise funding; calls for greater transparency regarding the recipients and amounts of funding on the ECHO website;
2023/07/19
Committee: DEVE
Amendment 73 #

2023/2000(INI)

Motion for a resolution
Paragraph 5 a (new)
5a. Welcomes the Commission commitment to allocate 25% of humanitarian funding to local and national actors and responders; calls on the EC and Member States to monitor and report on the implementation of this commitment;
2023/07/19
Committee: DEVE
Amendment 80 #

2023/2000(INI)

Motion for a resolution
Paragraph 6
6. Notes that the triple nexus is key to addressing context-specific needs in complex and protracted crises, and in building resilience to future crises, in order to improve coherence and complementary of responses in line with humanitarian principles; insists on more visibilitynexus-specific funding, visibility, coordination, and knowledge-sharing among stakeholders when applying the triple nexus approach, including through better involvement of local actors;
2023/07/19
Committee: DEVE
Amendment 85 #

2023/2000(INI)

Motion for a resolution
Paragraph 7
7. Calls on the Commission to ensure the effective implementation of the triple nexus across its policies and structures and to regularly report on its implementation; calls for the promotion of more joint assessments, analysis and planning across different funding instruments, especially at country level; notes the potential of the Neighbourhood, Development and International Cooperation – Global Europe instrument (NDICI-GE) to put the triple nexus approach into practice; calls for better coordination between the Commission’s Directorate-General for International Partnerships and, the Directorate- General for European Civil Protection and Humanitarian Aid Operations and the European External Action Service in implementing the rapid response pillar of NDICI-GE, in order to ensure that their responses complement one another;
2023/07/19
Committee: DEVE
Amendment 88 #

2023/2000(INI)

Motion for a resolution
Paragraph 7 a (new)
7a. Calls on the Commission to respond to and implement the recommendations from the INTPA- commissioned study on the nexus entitled “HDP nexus: challenges and opportunities for its implementation,” particularly on the recommendation to monitor the implementation of the nexus across the relevant services;
2023/07/19
Committee: DEVE
Amendment 101 #

2023/2000(INI)

Motion for a resolution
Paragraph 9
9. Calls for climate funding to be scaled up in order to prevent, mitigate and respond to the alarming impact of climate change on humanitarian crises; is concerned that NDICI-GE expenditure with a climate objective falls far short of the commitment that such expenditure should represent 30 % of NDICI-GE’s overall financial envelope; calls on the Commission to scale this up without delay, focusing in particular on locally-led adaptation in least developed countries;
2023/07/19
Committee: DEVE
Amendment 107 #

2023/2000(INI)

Motion for a resolution
Paragraph 10
10. Stresses the need to localise disaster risk reduction, climate preparedness, adaptation and response, build, recognise and utilise the capacities of local actors and communities and ensure the climate resilience of the most vulnerable groups;
2023/07/19
Committee: DEVE
Amendment 109 #

2023/2000(INI)

Motion for a resolution
Paragraph 10 a (new)
10a. Calls for donors and Member States to adopt and implement the Humanitarian Aid Donors’ Declaration on Climate and the Environment by increasing their funding for disaster prevention, preparedness, anticipatory action, and response; calls for humanitarian actors to sign onto and implement the Climate Charter for humanitarian organisations, to maximise the environmental sustainability of their work;
2023/07/19
Committee: DEVE
Amendment 114 #

2023/2000(INI)

Motion for a resolution
Paragraph 12
12. Stresses the importance of building human resilience by enhancing protection and minimizing the risks people face in a crisis and ensuring full respect of their rights while supporting access to education and health services and pre-crisis capacity building; emphasises the need to involve the affected people and local communities inand local/national humanitarian actors in coordination structures, implementing early warning systems, conducting needs assessments and determining and monitoring the humanitarian response;
2023/07/19
Committee: DEVE
Amendment 118 #

2023/2000(INI)

Motion for a resolution
Paragraph 12 a (new)
12a. Highlights the role and importance of local formal and informal civil society organisations in the humanitarian response; calls on the Commission and Member States to guarantee their inclusion and participation in all processes in line with the Guidelines on Promoting Equitable Partnerships with Local Responders in Humanitarian Settings published by the Commission;
2023/07/19
Committee: DEVE
Amendment 123 #

2023/2000(INI)

Motion for a resolution
Paragraph 13
13. Asks the Commission to better address the needs of vulnerable groups in humanitarian responses, including minorities, children, women, the elderly, and particularly persons with disabilities and intersectional vulnerabilities; encourages the use of the Organisation for Economic Co-operation and Development’s disability marker to track the progress made in humanitarian action; calls on the Commission to support the External Action Service in order to update the EU guidelines on children and armed conflict and ensure their implementation;
2023/07/19
Committee: DEVE
Amendment 129 #

2023/2000(INI)

Motion for a resolution
Paragraph 14
14. Notes that the number of forcibly displaced persons worldwide is at a record high; calls for the EU and the global community to support refugees, internally displaced people and their host communities, including those forced to flee due the impacts of climate change, and to work for durable solutions, in particular in forgotten crises; calls on the Commission and Member States to report on and reiterate the commitments made under the Global Compact for Refugees to ensure that the global responsibility to host refugees is shared more fairly;
2023/07/19
Committee: DEVE
Amendment 132 #

2023/2000(INI)

Motion for a resolution
Paragraph 14 a (new)
14a. Underlines that existing structural gender inequalities are exacerbated during crises and that therefore, women and girls, as well as the most marginalised groups that suffer different and intersecting forms of discrimination are disproportionately affected by conflicts, natural disasters or climate change hazards; deplores the increase in gender- based violence in humanitarian settings and stresses the need to prevent it; underlines that the specific needs and rights of these groups should be addressed in all humanitarian responses;
2023/07/19
Committee: DEVE
Amendment 137 #

2023/2000(INI)

Motion for a resolution
Paragraph 15
15. Calls for the EU and the Member States to take positive action on gender mainstreaming in humanitarian action, given that women and girls are the most likely victims of conflicts and natural disasters but also agents of change; underlines the need to accelerate the implementation of the EU Gender Action Plan; deplores the increase in gender-based violence in humanitarian settings and stresses the need to prevent it;
2023/07/19
Committee: DEVE
Amendment 145 #

2023/2000(INI)

Motion for a resolution
Paragraph 16
16. Insists on the need to reinforce the centrality and protection of international humanitarian law, international human rights law and humanitarian principles in the EU’s external action; invites the Commission to develop a humanitarian diplomacy strategy together with the Member States, ensuring that this strategy advocates the protection of civilians, compliance with international humanitarian law and respect for humanitarian principles;
2023/07/19
Committee: DEVE
Amendment 147 #

2023/2000(INI)

Motion for a resolution
Paragraph 16 a (new)
16a. Calls on the European Union and the Member States to use all of their political influence to promote and uphold IHL, protect civilians and support humanitarian access to allow disaster affected people to access humanitarian aid as civilians must be better protected and not become intentional, accidental, or collateral victims of conflicts;
2023/07/19
Committee: DEVE
Amendment 152 #

2023/2000(INI)

Motion for a resolution
Paragraph 17
17. Strongly condemns war crimes and serious violations of international humanitarian law; calls for all perpetrators to be held accountable and for victims to receive reparations; deplores the rise in attacks on civilians, humanitarian personneland medical personnel and critical infrastructure, inlcuding hospitals and schools, worldwide and insists on the need to increase protection measures for civilians, humanitarian and medical workers, critical infrastructures and preventing sexual exploitation and abuse within the humanitarian workers; condemns discriminatory policies, such as the ban on female humanitarian workers in Afghanistan;
2023/07/19
Committee: DEVE
Amendment 162 #

2023/2000(INI)

Motion for a resolution
Paragraph 18
18. Welcomes the adoption of UN Security Council Resolution 2664 (201622) introducing a humanitarian exemption in UN sanction regimes; calls for the EU to further align with the global standard set by UN Security Council Resolution 2664 (2016) and to22); calls the Commission to carry out analysis of the impact of sanctions on the delivery of humanitarian aid and subsequently adopt standing humanitarian exemptions in its autonomous sanction regimes in order to facilitate humanitarian activities in contexts affected by armed conflict, as required by international humanitarian law; furthermore insists on the need to include a standing humanitarian exemption in the future Directive on the definition of criminal offences and penalties for the violation of Union restrictive measures in order to ensure that humanitarian activities are not criminalized under EU sanction regimes and that humanitarian workers are protected in the contexts where EU sanctions apply; calls on the European Commission to work closely with financial institutions and humanitarian actors to ensure that administrative barriers including de-risking over- compliance are addressed to enable the delivery of humanitarian aid;
2023/07/19
Committee: DEVE
Amendment 174 #

2023/2000(INI)

Motion for a resolution
Paragraph 19
19. Underlines the importance of supporting local actors in line with the Grand Bargain commitment to making principled humanitarian action as local as possible; invitpraises the Commission and the Member States to furole that local and national organisations and first responders play in humanitarian responses and the support they provide to people in the most acute needs; welcomes the EC guidance note on equitable parthner developships and ECHO’s commitment to advance their localisation strategies in close collaboration with humanitarian partners, and to ensure an adequate sharing of riskagenda in the Grand Bargain discussions; calls on the European Commission and Member States for the full and meaningful implementation of the commitments enshrined in guidance note, ensuring accountability for the commitments made, a proper support to its partners as well as a fair sharing of risks with intermediate and local partner organisations;
2023/07/19
Committee: DEVE
Amendment 104 #

2023/0228(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 47 a (new)
(47 a) ‘One Health Approach’ means an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, plants and ecosystems. It recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent.
2024/01/22
Committee: ENVI
Amendment 106 #

2023/0228(COD)

Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 6
The basic material for all categories shall be assessed for its sustainability characteristics in line with the One Health approach as set out in Annexes II to V, to take into account the climatic and ecological conditions.
2024/01/22
Committee: ENVI
Amendment 92 #

2023/0227(COD)

Proposal for a regulation
Recital 49
(49) In order to contribute to the sustainability of agricultural production and food systems while recognising that sustainability cannot be reduced to a single trait or variety but can only apply to a cultivated system as a whole, and in order to serve economic, environmental and broader societal needs, new varieties of all genera or species should show an improvement compared to the other varieties of the same genera or species registered in the same national variety register, concerning certain aspects. Among those aspects are their yield, including yield stability and yield under low input conditions; tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses, insects and other pests; tolerance/resistance to abiotic stresses, including adaptation to climate change conditions; more efficient use of natural resources, such as water and nutrients; reduced need for external inputs, such as plant protection products and fertilisers; characteristics that enhance the sustainability of storage, processing and distribution; and quality or nutritional characteristics (‘value for sustainable cultivation and use’). For the purpose of deciding on the variety registration and in order to provide sufficient flexibility to register varieties with the most desirable characteristics, those aspects should be considered for a given variety as a whole.
2024/02/02
Committee: ENVI
Amendment 95 #

2023/0227(COD)

Proposal for a regulation
Recital 64
(64) Regulation (EU) 2018/848 should be amended to align the definitions of ‘plant reproductive material’ and ‘heterogeneous material’ with the definitions provided for by this Regulation. Moreover, the empowerment for the Commission to adopt specific provisions for the marketing of PRM of organic heterogeneous material should be excluded from Regulation (EU) 2018/848, as all rules concerning the production and marketing of PRM should be set out in this Regulation for reasons of legal clarity.deleted
2024/02/02
Committee: ENVI
Amendment 101 #

2023/0227(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point e
(e) to contribute to sustainable agricultural production, adapted to a diversity of climatic and soil conditions, currently and in the perspective of future projected climatic conditions;
2024/02/02
Committee: ENVI
Amendment 106 #

2023/0227(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point f
(f) to contribute to food security and food sovereignty
2024/02/02
Committee: ENVI
Amendment 116 #

2023/0227(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 2 – point c
(c) maintenance or multiplication of varieties;
2024/02/02
Committee: ENVI
Amendment 137 #

2023/0227(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 35 a (new)
(35a) ‘conservation and sustainable use of plant genetic resources and agro- biodiversity’ means the preservation of the genetic diversity within and between cultivated plant species, and includes both the in situ dynamic conservation, whether on farm or in garden, the ex situ conservation outside of their natural habitat, and the sustainable use of plant genetic resources and agro-biodiversity in a way and at a rate that does not lead to the long-term decline of biological diversity, thereby maintaining its potential to meet the needs and aspirations of present and future generations.
2024/02/02
Committee: ENVI
Amendment 139 #

2023/0227(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 35 b (new)
(35b) 'One Health Approach’ means an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, plants and ecosystems. It recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent ;
2024/02/02
Committee: ENVI
Amendment 152 #

2023/0227(COD)

Proposal for a regulation
Article 8 – paragraph 4 – introductory part
4. The Commission is empowered to adopt delegated acts, in accordance with Article 75, in order to amend Annex III, to adapt the requirements referred to in paragraphs 1 and 2 to the scientific and technical developments and to the applicable international standards in line with the One Health approach. Those amendments shall concern the following:
2024/02/02
Committee: ENVI
Amendment 181 #

2023/0227(COD)

Proposal for a regulation
Article 22 – paragraph 1 – subparagraph 1 – point c a (new)
(ca) it is not covered by an intellectual property right limiting its use for conservation purposes
2024/02/02
Committee: ENVI
Amendment 182 #

2023/0227(COD)

Proposal for a regulation
Article 22 – paragraph 1 – subparagraph 1 – point c b (new)
(cb) it does not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) or of a category 1 or 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation ...).
2024/02/02
Committee: ENVI
Amendment 183 #

2023/0227(COD)

Proposal for a regulation
Article 26 – paragraph 1
1. By way of derogation from Article 20, PRM of all genera or species listed in Annex I belonging to a conservation variety registered in a national variety register referred to in Article 44(1), point (b), may be produced and marketed in the Union as standard seed or material, if it complies with all the requirements concerning standard seed and material for the respective species, as referred to in Article 8.
2024/02/02
Committee: ENVI
Amendment 184 #

2023/0227(COD)

Proposal for a regulation
Article 26 – paragraph 2 a (new)
2a. A variety of conservation, its parts and/or its genetic components may not be covered by an intellectual property right limiting its use for conservation, research, breeding and/or training, including on- farm participatory research and breeding.
2024/02/02
Committee: ENVI
Amendment 185 #

2023/0227(COD)

Proposal for a regulation
Article 26 – paragraph 2 b (new)
2b. A variety of conservation does not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) or of a category 1 or 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… .
2024/02/02
Committee: ENVI
Amendment 186 #

2023/0227(COD)

Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 2
Those amendments shall be adopteddeveloped in consultation with respective multi actor stakeholders involved in heterogeneous material in order to adapt to the development of the respective technical and scientific evidence, and the international standards, and to follow up on the experience gained by the application of this Article concerning all or certain genera or species only.
2024/02/02
Committee: ENVI
Amendment 187 #

2023/0227(COD)

Proposal for a regulation
Article 27 – paragraph 4
4. Any professional operator producing and/or intending to market PRM of heterogeneous material shall submit a notification to the competent authority prior to marketing. If no further information is requested by the national competent authority within a time determined by the competent authority3 months, the PRM of heterogeneous material may be marketed.
2024/02/02
Committee: ENVI
Amendment 205 #

2023/0227(COD)

Proposal for a regulation
Article 38 – paragraph 1 – subparagraph 1
By way of derogation from Articles 2, 5, 6, 7, 8 and 20, the Commission may, by means of implementing acts, decide onThe Commission may financially support the organisation of temporary experiments to seek improved alternatives to provisions of this Regulation concerning the genera and species it applies to, the requirements for belonging to a registered variety, the production and marketing requirements for pre-basic, basic, certified and standard material or seed, and the obligation to belong to pre-basic, basic and certified material or seed.
2024/02/02
Committee: ENVI
Amendment 206 #

2023/0227(COD)

Proposal for a regulation
Article 38 – paragraph 1 – subparagraph 2
Those experiments may take the form of technical or scientific trials examining the feasibility and appropriateness of new requirements compared to the ones set out in Articles 2, 5, 6, 7, 8 and 20 of this Regulation. Multi actor stakeholders shall be involved in the framing of these temporary experiments financed by the Commission.
2024/02/02
Committee: ENVI
Amendment 207 #

2023/0227(COD)

Proposal for a regulation
Article 38 – paragraph 2 – subparagraph 1 – introductory part
The implementing acexperiments referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 76(2) and shall specify one or more of the following elements:
2024/02/02
Committee: ENVI
Amendment 208 #

2023/0227(COD)

Proposal for a regulation
Article 38 – paragraph 2 – subparagraph 2
Those acexperiments shall adapt to the evolution of techniques for production of the PRM concerned, as shall be based on any comparative trials carried out by the Member States.
2024/02/02
Committee: ENVI
Amendment 212 #

2023/0227(COD)

Proposal for a regulation
Article 44 – paragraph 2
2. PRM belonging to a variety registered in at least one national variety register may be produced and marketed in the Union, in accordance with this Regulation unless it consists on a plant covered by an opt-out possibility given to Member States as defined in the GMO Directive 2001/18/EC of the European Parliament and of the Council and in the NGT plant Regulation (EU) .../... of the European Parliament and of the Council.
2024/02/02
Committee: ENVI
Amendment 213 #

2023/0227(COD)

Proposal for a regulation
Article 46 – paragraph 2
2. The Commission is empowered to adopt a delegated act in accordance with Article 75, in order to amend Annex VII only to further add elements that need to be included in the variety registers, taking into account the technical and scientific developments, and on the basis of gained experience indicating the need of competent authorities or professional operators to obtain more precise information about the registered varieties.
2024/02/02
Committee: ENVI
Amendment 219 #

2023/0227(COD)

Proposal for a regulation
Article 47 – paragraph 1 – subparagraph 1 – point f
(f) where the varieties are tolerant to herbicides, they are subject to cultivation conditions for the production of PRM and for any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for registration, to avoid the development of herbicide resistance in weeds due to their use. These conditions will be subject to a public consultation process by the competent authority before they are adopted;
2024/02/02
Committee: ENVI
Amendment 220 #

2023/0227(COD)

Proposal for a regulation
Article 47 – paragraph 1 – subparagraph 1 – point g
(g) where the varieties have particular characteristics other than the ones referred to in point (f) that may lead to undesirable agronomic effects, they are subject to cultivation conditions for the production of PRM and any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for their registration, to avoid those particular undesirable agronomic effects, such as the development of resistance of pests to the respective varieties or undesirable effects on pollinators. These conditions will be subject to a public consultation process by the competent authority before they are adopted;
2024/02/02
Committee: ENVI
Amendment 240 #

2023/0227(COD)

Proposal for a regulation
Article 53 – paragraph 1 – point b
(b) it has an indication of its initial region of origin or the local conditions to which has been bred for ;
2024/02/02
Committee: ENVI
Amendment 245 #

2023/0227(COD)

Proposal for a regulation
Article 56 – paragraph 1 – point l a (new)
(la) the existence of intellectual property rights other than granted plant variety right on the variety as a whole or its components;
2024/02/02
Committee: ENVI
Amendment 247 #

2023/0227(COD)

Proposal for a regulation
Article 56 – paragraph 1 – point m
(m) in case the variety contains or consists of a category 1 NGT as defined in Article 3(7) of Regulation (EU) …/… of the European Parliament and of the Council50 (Office of Publications, please insert referrence to NGT Regulation), evidence that the plant has obtained a declaration of category 1 NGT plant status pursuant to Article 6 or 7 of that Regulation or is progeny of such plant(s); as well as information allowing their detection ; _________________ 50 Regulation (EU) …./…. of the European Parliament and of the Council of … (….., p….).
2024/02/02
Committee: ENVI
Amendment 249 #

2023/0227(COD)

Proposal for a regulation
Article 56 – paragraph 1 – point n
(n) in case the variety contains or consists of a category 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation), indication of that fact as well as information allowing their detection ;
2024/02/02
Committee: ENVI
Amendment 252 #

2023/0227(COD)

Proposal for a regulation
Article 61 – paragraph 1 a (new)
1a. Paragraph 1 does not apply in the cases where the variety: (a) contains or consists of a genetically modified organism, in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003; (b) contains or consists of a category 1 NGT as defined in Article 3(7) of Regulation (EU) …/… of the European Parliament and of the Council ; (c) contains or consists of a category 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… ; (d) is tolerant to herbicides pursuant to Article 47(1)(f) or has particular characteristics that may lead to undesirable agronomic effects pursuant to Article(1)(g).
2024/02/02
Committee: ENVI
Amendment 253 #

2023/0227(COD)

Proposal for a regulation
Article 66 – paragraph 1
After the formal examination of the application provided for in Article 57, and prior to the registration of a variety in a national variety register pursuant to Article 67, the competent authority shall consult the CPVO onrelevant stakeholders at national level, as well as the Committee mentioned in Article 76(1) on the suitability of the variety denomination proposed by the applicant in light of the requirements of Article 54.
2024/02/02
Committee: ENVI
Amendment 254 #

2023/0227(COD)

Proposal for a regulation
Article 66 – paragraph 2
Thet CPVO competent authority may also consult the CPVO, which shall submit to the competent authority a recommendation on the suitability of the variety denomination proposed by the applicant, in accordance with Article 54. The competent authority shall inform the applicant on that recommendation.
2024/02/02
Committee: ENVI
Amendment 261 #

2023/0227(COD)

Proposal for a regulation
Annex VI – Part B – point 2 – point c a (new)
(ca) Heterogeneous material must not be derived from genetic engineering nor from parental material derived from genetic engineering. This excludes GMO as defined in Directive 2001/18/EC art. 2 (2) detailed in Annex 1A part I and NGT I and NGT II as defined in the regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques
2024/02/02
Committee: ENVI
Amendment 262 #

2023/0227(COD)

Proposal for a regulation
Annex VI – Part B – point 2 – point c b (new)
(cb) Heterogeneous material must not be derived from parental material covered by patents nor be protected by patents.
2024/02/02
Committee: ENVI
Amendment 266 #

2023/0227(COD)

Proposal for a regulation
Annex VII – paragraph 1 – point t a (new)
(ta) disclose which breeding techniques have been applied for the development of the plant (e.g., cell fusion, genetic engineering, chemical or irradiation mutation breeding, microspore culture, etc.)
2024/02/02
Committee: ENVI
Amendment 268 #

2023/0227(COD)

Proposal for a regulation
Annex VII – paragraph 1 – point t b (new)
(tb) disclose if the respective variety is covered by existing patents
2024/02/02
Committee: ENVI
Amendment 42 #

2023/0226(COD)

Proposal for a regulation
Recital 1
(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations. Major advances in genetic engineering have already contributed to the widespread use of marker-assisted selection, which makes it possible to identify and mobilise interesting genes that are present in biodiversity. _________________ 32 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).
2023/11/19
Committee: ENVI
Amendment 53 #

2023/0226(COD)

Proposal for a regulation
Recital 2
(2) NGTs constitute a diverse group of genomic techniques, and each of them can be used in various ways to achieve different results and products. They can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods or by means of genetic modification techniques referred to in Annex IB to Directive 2001/18/EC, but also in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) introduceshould bring about genetic modifications without inserting genetic material from non- crossable species (transgenesis). They rely only on the breeders’ gene pool, i.e. the total genetic information that is available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniques, provided that the latter do not lead to the introduction of genetic material from non-crossable species. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool. Modifications made at precise locations may result in the interruption of endogenous genes and may also be accompanied by unintentional genetic modifications at the targeted location or elsewhere in the genome.
2023/11/19
Committee: ENVI
Amendment 68 #

2023/0226(COD)

Proposal for a regulation
Recital 3
(3) There is ongoing public and private research using NGTs or other techniques such as marker-assisted selection on a wider variety of crops and traits compared to those obtained through transgenic techniques authorised in the Union or globally(33). This includes plants with improved tolerance or resistance to plant diseases and pests, plants with improved tolerance or resistance to climate change effects and environmental stresses, improved nutrient and water-use efficiency, plants with higher yields and resilience and improved quality characteristics. TIn spite of the difficulty in generating complex multifactorial traits, these types of new plants, coupled with the fairly easy and speedy applicability of those new techniques, could deliver benefits to farmers, consumers and to the environment which are at least equal to those that marker-assisted selection already offers. Thus, NGTs have the potential to contribute to the innovation and sustainability goals of the European Green Deal (34) and of the ‘Farm to Fork’ (35), Biodiversity (36) and Adaptation to Climate Change(37) Strategies, to global food security (38), and the Bioeconomy Strategy (39), and to the Union’s strategic autonomy (40)lthough it is more the socio- economic conditions of production and consumption that determine sustainability transition pathways. _________________ 33 Insights and solutions stemming from EU-funded research and innovation projects on plant breeding strategies may contribute to address detection challenges, ensure traceability and authenticity, and promote innovation in the area of new genomic techniques. More than 1,000 projects were funded under the Seventh Framework Programme and successor Horizon 2020 programme with an investment of over 3 billion Euros. Horizon Europe support to new collaborative research projects on plant breeding strategies is also ongoing, SWD(2021) 92. 34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final. 35 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally friendly food system, COM/2020/381 final. 36 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030: Bringing nature back into our lives, COM/2020/380 final. 37 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions forging a Climate-Resilient Europe - The New EU Strategy on Adaptation to Climate Change, COM(2021) 82 final 38 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, Safeguarding food security and reinforcing the resilience of food systems, COM (2022) 133 final; Food and Agriculture Organisation of the United Nations (FAO), 2022, Gene editing and agrifood systems, Rome, ISBN 978-92-5- 137417-7. 39 European Commission, Directorate- General for Research and Innovation, A sustainable bioeconomy for Europe – Strengthening the connection between economy, society and the environment: updated bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.2777/792130. 40 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Trade Policy Review - An Open, Sustainable and Assertive Trade Policy, COM(2021)66 final.
2023/11/19
Committee: ENVI
Amendment 73 #

2023/0226(COD)

Proposal for a regulation
Recital 3 a (new)
(3a) The development of NGTs will lead to increased control over plant reproductive material by a few multinationals which will exercise the patents they have been granted on genetic processes and extending them to the plants obtained. This development is not without risk for the sustainability of the plant breeding system operating in the European Union, which has allowed joint management of plant genetic resources that ensures that innovation is spread among a number of breeders of different sizes. The Commission has acknowledged the importance of this issue, into which there will need to be an additional investigation in order to assess the impact of patents on NGTs in terms of strategic autonomy for the European Union, concentration on the seed sector and preservation of cultivated biodiversity, but also the cost of food for consumers. In so far as all plant reproductive material that has been genetically modified may be the subject of one or more patents, traceability and labelling measures should be made compulsory for category 1 and 2 NGT plants and products in order, on the one hand, to enforce the rights of patent holders and, on the other, to ensure that other breeders, farmers and other economic agents are fully informed, since they might otherwise be led to make use of patented plants or products without their knowledge and risk being required by patent holders to pay royalties.
2023/11/19
Committee: ENVI
Amendment 83 #

2023/0226(COD)

Proposal for a regulation
Recital 6
(6) TRather than applying the Court of Justice judgment, by making NGT varieties subject to Directive 2001/18, the Council, in Decision (EU) 2019/190444, requested the Commission to submit, by 30 April 2021, a study in light of that judgment regarding the status of novel genomic techniques under Union law, and a proposal (accompanied by an impact assessment), if appropriate, depending on the conclusions of the study. _________________ 44 Council Decision (EU) 2019/1904 of 8 November 2019 requesting the Commission to submit a study in light of the Court of Justice’s judgment in Case C- 528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study (OJ L 293, 14.11.2019, p. 103).
2023/11/19
Committee: ENVI
Amendment 88 #

2023/0226(COD)

Proposal for a regulation
Recital 7
(7) The Commission’s study on new genomic techniques (45) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate. The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products in the absence of sufficient investment to upgrade the European Network of GMO Laboratories (ENGL). In certain cases, genetic modifications introduced by these techniques are incurrently regarded as not being easily distinguishable with analytical methods normally used from natural mutations or from genetic modifications introduced by conventional breeding techniques or by genetic modification techniques referred to in Annex IB to Directive 2001/18/EC, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and bENGL network considers that the provision by notifiers of information (as provided for in Regulation (EC) No 1829/2003) and of reference material would make it possible to detect and trace NGT products. The matrix approach devised and used by ENGL also makes it possible to determine the natural or artificial origin of genefticial products that could contribute to sust or epigenetic modifications. More effective detection methods are being developed thanks to growing research efforts that were begun recently (late 2022). At all events, the avainlability, food security and resilience of the agri-food chain of detection methods cannot be regarded as a prerequisite for the establishment of appropriate traceability arrangements, which, moreover, may involve documentary traceability, as is the case for many products of high quality and with different designations. _________________ 45 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C- 528/16, SWD(2021) 92 final.
2023/11/19
Committee: ENVI
Amendment 91 #

2023/0226(COD)

Proposal for a regulation
Recital 7 a (new)
(7a) In a statement in October 2022, the EFSA proposed six criteria for conducting a risk assessment for plants produced by targeted mutagenesis, cisgenesis and intragenesis. The first four criteria relate to the molecular characterisation of the genetic modification to the NGT plant: presence or absence of an exogenous DNA sequence (criterion 1), whether or not the DNA sequence derives from the breeders’ gene pool (criterion 2), type of integration (criterion 3), and whether or not any endogenous gene is interrupted (criterion 4). According to those criteria, the plant may be regarded as a plant with no exogenous DNA sequence or a cisgenic or intragenetic plant as a result of targeted insertion with or without interruption of endogenous genes. In the case of endogenous-gene interruption, two additional criteria round off the assessment: history of safe use (criterion 5) and the structure and function of the new allele (criterion 6). Where the history of safe use is not sufficiently established, the function and structure of the allele introduced should be carefully assessed. Ultimately, risk assessment cannot be based on the number of genetic modifications intentionally carried out; rather, it should be based on the impact of genetic modifications on the expression of the plant's genes, whether endogenous or exogenous.
2023/11/19
Committee: ENVI
Amendment 96 #

2023/0226(COD)

Proposal for a regulation
Recital 8
(8) It is therefore necessary to adopt a specific legal framework for GMOs obtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market, while maintaining the central principles of GMO legislation that has been in place for over 20 years: sound information and freedom of choice for consumers and farmers, risk assessment and monitoring by health authorities, precautionary principle and reversibility, and coexistence of sectors.
2023/11/19
Committee: ENVI
Amendment 103 #

2023/0226(COD)

Proposal for a regulation
Recital 9
(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation shouldmust 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 even more limited. For the same reason, this Regulation shouldmust 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 domust 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 and any contaminating technique such as passaging through bridge species allowing foreign sequences into the genome of the target species) must remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgeneforeign sequences and their unintended effects. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.
2023/11/19
Committee: ENVI
Amendment 116 #

2023/0226(COD)

Proposal for a regulation
Recital 10
(10) The legal framework for NGT plants shouldmust share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment and the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants. This legal framework shouldmust enable the development and, health and environmental assessment and orderly placing on the market of labelled plants, food and feed containing, consisting of or produced from NGT plants and other products labelled as containing or consisting of NGT plants (‘NGT products’) s. So as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world level, the legal framework applicable to NGT plants must differentiate NGT plants having positive sustainability characteristics from those that induce increased consumption of herbicides because they have been made resistant to them and those that produce their own insecticides or pesticides.
2023/11/19
Committee: ENVI
Amendment 127 #

2023/0226(COD)

Proposal for a regulation
Recital 11
(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. It introduces specific provisderogations for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products (including food and feed) obtained from them shouldmust remain subject to the requirements of the Union GMO legislation and the rules on GMOs in sectoral legislation, such as Regulation (EU) 2017/625 on official controls or the legislation on certain products like plant and forest reproductive material.
2023/11/19
Committee: ENVI
Amendment 130 #

2023/0226(COD)

Proposal for a regulation
Recital 12
(12) The potential risks of NGT plants vary, ranging from risk profiles potentially similar to conventionally-bred plants or plants obtained by the genetic modification techniques referred to in Annex 1B of Directive 2001/18/EC to various types and degrees of hazards and risks that might be similar to those of plants obtained by transgenesis. This Regulation shouldmust therefore lay down special rules to adjust the risk assessment and risk management requirements according to the potentialactually assessed risks or lack thereof posed by NGT plants and NGT products.
2023/11/19
Committee: ENVI
Amendment 137 #

2023/0226(COD)

Proposal for a regulation
Recital 13
(13) This Regulation shouldmust distinguish between two categories of NGT plants.
2023/11/19
Committee: ENVI
Amendment 149 #

2023/0226(COD)

Proposal for a regulation
Recital 14
(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniquesor through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC and their progeny when it respects the same criteria (‘category 1 NGT plants’) shouldmust be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equival or through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC, when they have a similar unmodified parent and thatwhen their risks are comparable, thereby derogating in fullpart from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, tThis Regulation should sets out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants or those obtained through the genetic modifications listed in Annex 1B to Directive 2001/18/EC, and lays down a procedure for competent authorities to verify and take a decision on the fulfillment of those criteria, prior to the release or placing on the market of NGT plants or NGT productson a case-by-case basis and on the basis of the unique characteristics of each NGT plant and not on ex ante criteria, in accordance with the principles of the Cartagena Protocol. Those criteria should be transparent, objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowermust be based on the OMICS approach in order to verify equivalence with conventional plants using standard biochemistry techniques in particular. They must also be based ion accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional breedingthe six criteria set out by EFSA, in particular the presence of exogenous DNA sequences and the disruption of endogenous genes.
2023/11/19
Committee: ENVI
Amendment 168 #

2023/0226(COD)

Proposal for a regulation
Recital 16
(16) Category 1 NGT plants and products should not be subject to all the rules and requirements of the Union GMO legislation and to all provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency for the competent authorities responsible for the assessment of the associated risks, the environmental assessment and monitoring, and in order to allow freedom of choice for both producers and consumers, a declaration of the category 1 NGT plant status shouldmust be obtained prior to deliberate release, including the placing on the market.
2023/11/19
Committee: ENVI
Amendment 174 #

2023/0226(COD)

Proposal for a regulation
Recital 17
(17) This declaration shouldmust be obtained prior to any deliberate release of any category 1 NGT plants for any other purpose than placing on the market, such as for field trials that are to take place in the territory of the Union, since the criteria are based on data that is available before the field trials and on tests in closed environments and does not depend on these field trials. When no field trials are to take place in the territory of the Union, operators shouldmust obtain that declaration before placing the category 1 NGT product on the market.
2023/11/19
Committee: ENVI
Amendment 181 #

2023/0226(COD)

Proposal for a regulation
Recital 18
(18) Since the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants are unrelated to the type of activity that requires the deliberate release of the NGT plant, a declaration of the category 1 NGT plant status made prior to its deliberate release for any other purpose than placing on the market in the territory of the Union should also be valid for the placing on the market of related NGT products. In view of the high uncertainty existing at the field trial stage about the product reaching the market and the likely involvement of smaller operators in such releases, the verification procedure of category 1 NGT plant status prior to field trials should be conducted by national competent authorities in close cooperation with the European Food Safety Authority (‘the Authority’) as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.
2023/11/19
Committee: ENVI
Amendment 194 #

2023/0226(COD)

Proposal for a regulation
Recital 19
(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to strict appropriate deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.
2023/11/19
Committee: ENVI
Amendment 203 #

2023/0226(COD)

(20) The verification of category 1 NGT plant status is of technical nature and does not involve any risk assessment or risk management considerations and the decision on the status is only declaratory. Therefore, when the procedure is conducted at Union level, such implementing decisions should be adopted by the advisory procedure, supported by scientific and technical assistance by the Authority.
2023/11/19
Committee: ENVI
Amendment 213 #

2023/0226(COD)

Proposal for a regulation
Recital 22
(22) Category 1 NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants or to plants obtained through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, category 1 NGT food featuring a significantly changed composition or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46) and will be risk assessed in that context. NGT plants or products presented as having properties for treating or preventing disease in human beings or as being suitable to be used or administered to human beings with a view to restoring, correcting or modifying physiological functions through pharmacological, immunological or metabolic action within the meaning of Article 1(2)(a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use should not benefit from the derogation for Category 1 NGTs. _________________ 46 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).
2023/11/19
Committee: ENVI
Amendment 226 #

2023/0226(COD)

Proposal for a regulation
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 necess based on the record of safe use and the limited knowledge available at the time with regaryd to clarify the status of category 1 NGT plants for the purposes ofidentification. As a result, NGT plants are banned in organic production. The use of new genomic techniques is currently incompatible with the conceptprinciples 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 prohibited 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).
2023/11/19
Committee: ENVI
Amendment 236 #

2023/0226(COD)

Proposal for a regulation
Recital 24
(24) Provision should be made to ensure transparencceability 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. TIn order to ensure traceability, transparency and choice ofor 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 at all stages between production and consumption of the final products, including processing, category 1 NGT plants and products must be labelled and traced. Traceability measures should make it easier to both withdraw products in the event of unforeseen effects on human health, animal health or the environment, and monitor the environmental effects. Traceability must also facilitate the implementation of crisis management measures in line with the precautionary principle.
2023/11/19
Committee: ENVI
Amendment 250 #

2023/0226(COD)

Proposal for a regulation
Recital 25
(25) Category 2 NGT plants shouldmust remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed. Special rules should be provided in order to adapt the procedures and certain other rules laid down in Directive 2001/18/EC and Regulation (EC) No 1829/2003 to the specific nature of category 2 NGT plants and the differing levels of risk that they may pose.
2023/11/19
Committee: ENVI
Amendment 258 #

2023/0226(COD)

(27) Requirements on the content of notifications for consent for the placing on the market of products containing or consisting of GMOs other than food or feed and on the content of applications for authorisation for the placing on the market of genetically modified food and feed are laid down in different pieces of legislation. To ensure consistency between the notifications for consent and applications for authorisation for category 2 NGT products, the content of such notifications and applications should be the same, except those concerning the assessment of food and feed safety assessment as these are only relevant to category 2 NGT food and feed.
2023/11/19
Committee: ENVI
Amendment 267 #

2023/0226(COD)

Proposal for a regulation
Recital 28
(28) The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis51. When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the systematic differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier or the applicant, the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted. _________________ 51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)
2023/11/19
Committee: ENVI
Amendment 277 #

2023/0226(COD)

Proposal for a regulation
Recital 29
(29) Directive 2001/18/EC requires a monitoring plan for environmental effects of GMOs after their deliberate release or placing on the market but provides for flexibility as to the design of the plan taking into account the environmental risk assessment, the characteristics of the GMO, of its expected use and of the receiving environment. Genetic modifications in category 2 NGT plants may range from changes only needing a limited risk assessment to complex alterations requiring a more thorough analysis of potential risks. Therefore, post- market monitoring requirements for environmental effects of category 2 NGT plants should be adapted in the light of the environmental risk assessment and the experience in field trials, the characteristics of the NGT plant concerned, the characteristics and scale of its expected use, in particular any history of safe use of the plant and the characteristics of the receiving environment. Therefore, athe monitoring plan for environmental effects should not be required ifalthough it may be adapted depending on whether or not the category 2 NGT plant is unlikely to pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.
2023/11/19
Committee: ENVI
Amendment 293 #

2023/0226(COD)

Proposal for a regulation
Recital 33
(33) Regulatory incentives should be offered to potential notifiers or applicants for category 2 NGT plants and products containing traits with the potential to contribute to a sustainable agri-food system, in order to steer the development of category 2 NGT plants towards such traits. The criteria to trigger these incentives should focus on broad trait categories with the potential to contribute to sustainability (such as those linked to tolerance or resistance to biotic and abiotic stresses, improved nutritional characteristics or increased yield) and should be based on the contribution to the value for sustainable cultivation and use as defined in [Article 52(1) of the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union52]. The applicability of the criteria across the EU does not allow a narrower definition of traits to focus on specific issues or address local and regional specificities. _________________ 52 COM (2023) 414 final.deleted
2023/11/19
Committee: ENVI
Amendment 298 #

2023/0226(COD)

Proposal for a regulation
Recital 34
(34) Incentives should consist in an accdelerated procedure for risk assessment as regards applications handled by a fully centralised procedure (food and feed products) and enhanced pre-submission advice to help developers prepare the dossier for the purpose of the environmental and food and feed safety assessments, without affecting the general provisions on pre-submission advice, notification of studies and consultation of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 178/2002(53). _________________ 53 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1).
2023/11/19
Committee: ENVI
Amendment 303 #

2023/0226(COD)

Proposal for a regulation
Recital 35
(35) Additional incentives should be afforded when the notifier or applicant is a small or medium-sized enterprise (SME), to promote access to the regulatory procedures by these enterprises, support diversification of developers of NGT plants and encourage the development by small breeders of crop species and traits by means of NGTs, by granting fee waivers for the validation of detection methods to SMEs and more extensive pre-submission advice covering also the design of studies to be carried out for the purpose of risk assessment.deleted
2023/11/19
Committee: ENVI
Amendment 309 #

2023/0226(COD)

Proposal for a regulation
Recital 36
(36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides or to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, NGT plants featuring herbicide-tolerant traits should not be eligible for incentives under this framework. However, this Regulation should not take other specific measures on herbicide tolerant NGT plants, because such measures are taken horizontally in [the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union]fall under category 1. The same applies to NGT plants whose genetic modification has enabled them to produce insecticides or other pesticides.
2023/11/19
Committee: ENVI
Amendment 310 #

2023/0226(COD)

Proposal for a regulation
Recital 37
(37) In order to enable NGT plants to contribute to the sustainability objectives of the Green Deal and the Farm to Fork and Biodiversity Strategies, cultivation of NGT plants in the Union should be facilitated. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of category 2 NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC would undermine those goals.deleted
2023/11/19
Committee: ENVI
Amendment 322 #

2023/0226(COD)

Proposal for a regulation
Recital 38
(38) The special rules laid down in this Regulation concerning the authorisation procedure for category 2 NGT plants are expected to result in more cultivation in the Union of category 2 NGT plants compared to the situation so far under the current Union GMO legislation. That renders necessary for Member States’ public authorities to define coexistence measures to balance the interests of producers of conventional, organic and GM plants and thereby allow producers a choice between different types of production, in line with the Farm to Fork Strategy’s target of 25 % of agricultural land under organic farming by 2030. In order to ensure that the coexistence measures are consistent, the Commission should draw up an implementing act to cover, in particular, the size of buffer strips between conventional plants and NGT plants, for each type of crop.
2023/11/19
Committee: ENVI
Amendment 352 #

2023/0226(COD)

Proposal for a regulation
Recital 45
(45) In order to ensure uniform conditions for the implementation of this Regulation, implementingdelegated powers should be conferred on the Commission as regards the information required to demonstrate that a NGT plant is a category 1 NGT plant, as regards the preparation and the presentation of the notification for that determination, and as regards the methodology and information requirements for the environmental risk assessments of category 2 NGT plants and of NGT food and NGT feed, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council55. _________________ 55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
2023/11/19
Committee: ENVI
Amendment 398 #

2023/0226(COD)

(3a) 'conventional plants' means plants obtained by conventional breeding techniques excluding genetic modifications and techniques of genetic modification listed in Annex IB to Directive 2001/18/EC like mutagenesis and cell fusion;
2023/11/19
Committee: ENVI
Amendment 409 #

2023/0226(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene pool’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crossesnaturally be cross-pollinated;
2023/11/19
Committee: ENVI
Amendment 412 #

2023/0226(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene pool’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, and induced polyploidy and bridge crosses;
2023/11/19
Committee: ENVI
Amendment 423 #

2023/0226(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point a
(a) fulfils the criteria of equivalence to conventional plants, set out in Annex I and Annex IV, and has at least one of the intended characteristic(s) conveyed by the genetic modification that is contained in Part 1 of Annex III and does not have any one of those listed in Part 2 of Annex III, or
2023/11/19
Committee: ENVI
Amendment 428 #

2023/0226(COD)

Proposal for a regulation
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 tha criteria of equivalence set would make it subject to Directive 2001/18/EC or Regulation 1829/2003t in Annex 1 and Annex 4 are still satisfied;
2023/11/19
Committee: ENVI
Amendment 432 #

2023/0226(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b a (new)
(ba) is not presented as having properties for treating or preventing diseases in human beings and may not be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2.(a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use.
2023/11/19
Committee: ENVI
Amendment 456 #

2023/0226(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 15 a (new)
(15a) 'variety' means a variety as defined in Article 5(2) of Regulation (EC) 2100/94.
2023/11/19
Committee: ENVI
Amendment 471 #

2023/0226(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
(b) is progeny of plant(s) referred to in point (a) on the condition that the criteria of equivalence set out in Annex 1 and Annex 4 are still satisfied ; or
2023/11/19
Committee: ENVI
Amendment 477 #

2023/0226(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 2 a (new)
(2a) an extended producer responsibility (EPR) scheme has been settled at European or national level to ensure the financing of risks and possible future damages of human health, animal health or the environment or cross- contamination of organic food and non GMO-food are financed in line with the polluter pays principle.
2023/11/19
Committee: ENVI
Amendment 498 #

2023/0226(COD)

Proposal for a regulation
Article 5 – paragraph 3
3. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I in order to adapt them to scientific and technological progress as regards the types and extent of modifications which can occur naturally or through conventional breeding.
2023/11/19
Committee: ENVI
Amendment 518 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 1
1. To obtain the declaration of category 1 NGT plant status referred to in Article 4(1), point (a), before undertaking a deliberate release of a NGT plant for any other purpose than placing on the market, the person intending to undertake the deliberate release shall submit a request to verify whether the criteria set out in Annex I are met (‘verification request’) to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the implementingdelegated act adopted in accordance with Article 27, point (b)6.
2023/11/19
Committee: ENVI
Amendment 523 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 2
2. Where a person intends to undertake such a deliberate release simultaneously in more than one Member State, that person shall submit the verification request to the competent authority of one of thoseeach Member States.
2023/11/19
Committee: ENVI
Amendment 525 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point b a (new)
(ba) the denomination of the variety;
2023/11/19
Committee: ENVI
Amendment 526 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point c
(c) a description of the trait(s) and characteristics which have been introduced or modified, including disclosure of the sequence of the genetic modification;
2023/11/19
Committee: ENVI
Amendment 529 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point c a (new)
(ca) a declaration on possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2. (a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use;
2023/11/19
Committee: ENVI
Amendment 530 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point c b (new)
(cb) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;
2023/11/19
Committee: ENVI
Amendment 532 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point d – point i
(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementingdelegated act adopted in accordance with Article 27, point (a)6;
2023/11/19
Committee: ENVI
Amendment 541 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point d – point ii a (new)
(iia) the results of the in-door safety assessment set out in Annex IV.
2023/11/19
Committee: ENVI
Amendment 547 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point e
(e) in the cases referred to in paragraph 2, an indication of the Member States in which the requester intends to undertake the deliberate release;deleted
2023/11/19
Committee: ENVI
Amendment 549 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point e a (new)
(ea) an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);
2023/11/19
Committee: ENVI
Amendment 550 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point e b (new)
(eb) a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;
2023/11/19
Committee: ENVI
Amendment 551 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point e c (new)
(ec) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph;
2023/11/19
Committee: ENVI
Amendment 552 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point e d (new)
(ed) samples of the category 1 NGT plant and their control samples, and information as to the place where the reference material can be accessed;
2023/11/19
Committee: ENVI
Amendment 555 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point f a (new)
(fa) a declaration on the non- applicability of Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, or on the correct application of possible obligations arising from this Regulation;
2023/11/19
Committee: ENVI
Amendment 556 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point f b (new)
(fb) any other relevant information relating to the file, including possible refusal, withdrawal or acceptance of previous requests or national or European decisions;
2023/11/19
Committee: ENVI
Amendment 558 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 5
5. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working day2 months within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.
2023/11/19
Committee: ENVI
Amendment 559 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 6
6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working dayAnnex IV. For that purpose, the competent authority shall forward the request to the European Food Safety Authority (“The Authority”) without undue delay. Within 6 months, the Authority shall make a statement on whether the plant is a NGT plant fulfilling the criteria set out in Annex I, including whether it contains any genetic material originating from outside the breeders’ gene pool. The statement shall be forwarded to all Member States, to the Commission, and shall be made public. After receiving this statement, the competent authority shall prepare a verification report within 3 months from the date of receipt of athe verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.
2023/11/19
Committee: ENVI
Amendment 570 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 7
7. The other Member States and the Commission may make comments to the verification report within 20 day3 months from the date of receipt of that report.
2023/11/19
Committee: ENVI
Amendment 583 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 8
8. In the absence of any comments from a Member State or the Commission, within 10 working daysone month 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.
2023/11/19
Committee: ENVI
Amendment 591 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 9
9. In cases where a comment 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 Commission and to the other Member States, without undue delay.
2023/11/19
Committee: ENVI
Amendment 600 #

2023/0226(COD)

Proposal for a regulation
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 day3 months from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
2023/11/19
Committee: ENVI
Amendment 604 #

2023/0226(COD)

Proposal for a regulation
Article 6 – paragraph 11
11. The Commission shall publish a summary of the decisions referred to in paragraphs 8 and 10 in the Official Journal of the European UnionWithin 15 days following their submission or issuance, the competent authority of the Member State where the verification request was submitted to and, where relevant, the Commission shall make public the verification request, the verification report referred to in paragraph 6, the comments referred to in paragraph 7 and the decisions referred to in paragraphs 8 and 10.
2023/11/19
Committee: ENVI
Amendment 614 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 1
1. Where a declaration of category 1 NGT plant status referred to in Article 4(1), point (a), has not already been made in accordance with Article 6, to obtain such a declaration bBefore placing on the market a NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraph 2 and the implementing act adopted in accordance with Article 27, point (b).
2023/11/19
Committee: ENVI
Amendment 616 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point b a (new)
(ba) the denomination of the variety;
2023/11/19
Committee: ENVI
Amendment 618 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point c
(c) a description of the trait(s) and characteristics which have been introduced or modified, including disclosure of the sequence of genetic modification ;
2023/11/19
Committee: ENVI
Amendment 620 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point c a (new)
(ca) a declaration on possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2. (a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use;
2023/11/19
Committee: ENVI
Amendment 621 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point c b (new)
(cb) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;
2023/11/19
Committee: ENVI
Amendment 629 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point d – point ii a (new)
(iia) the results of the in-door safety assessment set out in Annex IV
2023/11/19
Committee: ENVI
Amendment 631 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point d a (new)
(da) an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);
2023/11/19
Committee: ENVI
Amendment 633 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point d b (new)
(db) a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;
2023/11/19
Committee: ENVI
Amendment 634 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point d c (new)
(dc) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph;
2023/11/19
Committee: ENVI
Amendment 637 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point d d (new)
(dd) samples of the category 1 NGT plant and their control samples, and information as to the place where the reference material can be accessed;
2023/11/19
Committee: ENVI
Amendment 641 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point e a (new)
(ea) a declaration on the non- applicability of Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, or on the correct application of possible obligations arising from this Regulation;
2023/11/19
Committee: ENVI
Amendment 642 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 2 – point e b (new)
(eb) any other relevant information relating to the file, including possible refusal, withdrawal or acceptance of previous requests or national or European decisions.
2023/11/19
Committee: ENVI
Amendment 645 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 4
4. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 360 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.
2023/11/19
Committee: ENVI
Amendment 646 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 5
5. If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 30 working day6 months from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States without undue delay. Member States may make comments on the statement within 2 months from the date of receipt of that statement. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement, and where relevant, comments made by Member States, public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.
2023/11/19
Committee: ENVI
Amendment 651 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 6
6. The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 30 working day months from the date of receipt of the statement of the Authority, taking the latter into account. The decision shall be adoptedMember States may make comments on the draft decision within 2 months from the date of receipt of that draft decision. The decision shall be adopted within the 3 following months, in accordance with the procedure referred to in Article 28(2).
2023/11/19
Committee: ENVI
Amendment 654 #

2023/0226(COD)

Proposal for a regulation
Article 7 – paragraph 7
7. The Commission shall publish a summary of themake public its draft decision in, the Official Journal of the European Uncomments referred to in paragraph 6, and its decision.
2023/11/19
Committee: ENVI
Amendment 668 #

2023/0226(COD)

Proposal for a regulation
Article 9 – title
Database of decisions declaring the category 1 NGT plant statuInformation and public access
2023/11/19
Committee: ENVI
Amendment 670 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1
The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6)register for the purpose of recording the information related to all products consisting of, made of, or containing Cat.1 NGT plant.
2023/11/19
Committee: ENVI
Amendment 671 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – introductory part
The databaseregister shall contain the following information:
2023/11/19
Committee: ENVI
Amendment 672 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point b
(b) the designation and specification of the category 1 NGT plant;
2023/11/19
Committee: ENVI
Amendment 673 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point b a (new)
(ba) the denomination of the variety ;
2023/11/19
Committee: ENVI
Amendment 674 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d
(d) a description of the trait(s) and characteristics which have been introduced or modified, including possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action;
2023/11/19
Committee: ENVI
Amendment 676 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d a (new)
(da) a copy of the studies, which have been carried out and any other available material to demonstrate that: (i) the plant is a NGT plant; (ii) the NGT plant meets the criteria set out in Annex I; (iii) the results of the in-door safety assessment set out in Annex IV;
2023/11/19
Committee: ENVI
Amendment 680 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d b (new)
(db) the sequence of the genetic modification;
2023/11/19
Committee: ENVI
Amendment 682 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d c (new)
(dc) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;
2023/11/19
Committee: ENVI
Amendment 683 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d d (new)
(dd) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant;
2023/11/19
Committee: ENVI
Amendment 685 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point e a (new)
(ea) the opinion or statement of EFSA, as referred to in Article 6 (10) and Article 7(5), and
2023/11/19
Committee: ENVI
Amendment 697 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 2
2. The databaseregister shall be publicly available.
2023/11/19
Committee: ENVI
Amendment 704 #

2023/0226(COD)

Proposal for a regulation
Article 10 – title
Labelling of category 1 NGT plant reproductive material, including breedTraceability and labelling requirement for products consisting of or containing mcaterialgory 1 NGT products
2023/11/19
Committee: ENVI
Amendment 711 #

2023/0226(COD)

Proposal for a regulation
Article 10 – paragraph 1
Plant reproductive material, including for breeding and scientific purposes, that contains orTraceability and labelling requirements defined in Directive 2001/18, Regulation 1829/2003 and Regulation 1830/2003 should apply for all plants and products consisting of or containing Category 1 NGT. For products consistsing of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge,, the words "This product consists of [name of the product] obtained by new genetic technique " shall bappear aon the label indicating the words ‘catof the product. For products containing category 1 NGT, followed by the identification number of the NGT plant(s) it has been derived from. the words "This product contains [name of the product] obtained by new genetic technique" shall appear on the label of the product.
2023/11/19
Committee: ENVI
Amendment 731 #

2023/0226(COD)

Proposal for a regulation
Article 11 – paragraph 3 – point b
(b) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the genetic modification ; and
2023/11/19
Committee: ENVI
Amendment 735 #

2023/0226(COD)

Proposal for a regulation
Article 11 – paragraph 6 a (new)
6 a. Notwithstanding paragraphs 3, 5 and 6 of this Article: (a) where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the competent authority may disclose the information referred to in paragraph 3; and (b) information which forms part of the opinions or statements of the Authority or the conclusions of the assessment reports and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply.
2023/11/19
Committee: ENVI
Amendment 736 #

2023/0226(COD)

Proposal for a regulation
Article 11 – paragraph 7 a (new)
7 a. Third parties may submit request to the National competent authority, to the Commission or to the Authority to access confidential information with substantiated argumentation, such as significant concerns about the environment, animal or human health.
2023/11/19
Committee: ENVI
Amendment 737 #

2023/0226(COD)

Proposal for a regulation
Article 11 a (new)
Article11a Measures to avoid the unintended presence of category 1 NGT plants 1. Member States shall take appropriate measures to avoid the unintended presence of category 1 NGT plants in other products on the basis of a delegated act proposed by Commission in accordance with Article 26 to define notably the size of the buffer strip for each sort of crops and the obligation of NGT growers to inform organic and certified non-GMO growers with field plots next to those where NGT plants are grown. Member States shall develop the definition of crop specific and adapted measures as a matter of subsidiarity, based on the latest scientific and experimental knowledge, to avoid the unintended presence of category 1 NGT plants. 2. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination in accordance with the principal of the extended producer responsibility. 3. The Commission shall gather and coordinate information based on the studies at EU and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of NGT, conventional and organic crops.
2023/11/19
Committee: ENVI
Amendment 739 #

2023/0226(COD)

Proposal for a regulation
Article 11 b (new)
Article 11b Duration of the validity of the declaration If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.
2023/11/19
Committee: ENVI
Amendment 770 #

2023/0226(COD)

Proposal for a regulation
Article 13 – paragraph 1 – point d a (new)
(da) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC;
2023/11/19
Committee: ENVI
Amendment 786 #

2023/0226(COD)

Proposal for a regulation
Article 14 – paragraph 1 – point h
(h) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the notifiercompetent authority considers thatif the NGT plant does not need a monitoring plan, the notifier may propose not to submit ashould require a lighter monitoring plan;
2023/11/19
Committee: ENVI
Amendment 807 #

2023/0226(COD)

Proposal for a regulation
Article 15 – paragraph 1
The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) or state that monitoring is not requiredcould be lighter. The written consent shall provide the adequate grounds that justifies that a monitoring plan is lighter. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.
2023/11/19
Committee: ENVI
Amendment 820 #

2023/0226(COD)

Proposal for a regulation
Article 17 – paragraph 1
1. The consent granted under Part C of Directive 2001/18/EC shall, after the firsteach renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an unlimited period, unles10 years, unless after three renewal rounds the decision referred to in Article 17(6) or (8) provides that the renewal is for a n unlimited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent.
2023/11/19
Committee: ENVI
Amendment 824 #

2023/0226(COD)

Proposal for a regulation
Article 17 – paragraph 2 a (new)
2a. If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.
2023/11/19
Committee: ENVI
Amendment 846 #

2023/0226(COD)

Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2
In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant orand concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), 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);
2023/11/19
Committee: ENVI
Amendment 854 #

2023/0226(COD)

Proposal for a regulation
Article 19 – paragraph 3 – point b
(b) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan. This duration may be different from the duration of the authorisation. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessmeIn case the application is a request for renewal and if based on the results of the monitoring report or regarding the findings of the environmental risk assessment of any released Cat 2 NGT plant or food or feed containing or consisting of Cat 2 NGT plant, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the applicant considers that the NGT plant does need a monitoring plan, the applicant may propose not to submit acompetent authority may propose not require the continuation of the monitoring plan.
2023/11/19
Committee: ENVI
Amendment 860 #

2023/0226(COD)

Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1
By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall deliver an opinion onassent the application for authorisation referred to in Article 19 of this Regulation within six months as from the receipt of a valid application.
2023/11/19
Committee: ENVI
Amendment 864 #

2023/0226(COD)

Proposal for a regulation
Article 20 – paragraph 4
4. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by. If the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph, the Union reference laboratory shall proceed to his own research and analyses to confirm the claimed unfeasibility. In that case, the decision of the Union reference laboratory shall be motivated and be made public.
2023/11/19
Committee: ENVI
Amendment 869 #

2023/0226(COD)

By way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, after the first renewal, the authorisation shall be valid for an unlimited period, unless the Commission decides to renew the authorisation for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.deleted
2023/11/19
Committee: ENVI
Amendment 875 #

2023/0226(COD)

Proposal for a regulation
Article 21 – paragraph 1 a (new)
1. The authorisation shall be valid for a limited period of 10 years, unless the Commission decides after three renewal rounds by way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) N° 1829/2003 to renew the authorisation for an unlimited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.
2023/11/19
Committee: ENVI
Amendment 876 #

2023/0226(COD)

Proposal for a regulation
Article 21 – paragraph 1 b (new)
If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis or if the , the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.
2023/11/19
Committee: ENVI
Amendment 884 #

2023/0226(COD)

Proposal for a regulation
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 III and it does not have any traits referred to in Part 2 of that Annex.deleted
2023/11/19
Committee: ENVI
Amendment 889 #

2023/0226(COD)

Proposal for a regulation
Article 22 – paragraph 2
2. The following incentives shall apply to applications for authorisation submitted in accordance with Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19: (a) by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 4 months from the receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 20(1). The time limit shall be extendable under the conditions set out in Article 20(1), subsection (2); (b) where the applicant is a SME, it shall be exempted from the payment of the financial contributions to the Union Reference Laboratory and to the European Network of GMO Laboratories referred to in Article 32 of Regulation (EC) No 1829/2003.deleted
2023/11/19
Committee: ENVI
Amendment 893 #

2023/0226(COD)

Proposal for a regulation
Article 22 – paragraph 3
3. The following pre-submission advice for the purposes of the risk assessment conducted in accordance with Annex II shall, in addition to Article 32a of Regulation (EC) No 178/2002, apply prior to notifications submitted in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and to applications for authorisation submitted in accordance with Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19: (a) the staff of the Authority shall, at the request of a potential applicant or notifier, provide advice on plausible risk hypotheses that the potential applicant or notifier has identified based on the properties of a plant, product or hypothetical plant or product, that need to be addressed by providing the information under Parts 2 and 3 of Annex II. The advice shall not, however, cover the design of studies to address the risk hypotheses; (b) where the potential applicant or notifier is a SME, it may notify the Authority of how it intends to address the plausible risk hypotheses referred to in point (a) that it has identified based on the properties of a plant, product or hypothetical plant or product, including the design of the studies it intends to perform in accordance with the requirements laid down Parts 2 and 3 of Annex II. The Authority shall provide advice on the notified information, including on the design of the studies.deleted
2023/11/19
Committee: ENVI
Amendment 896 #

2023/0226(COD)

Proposal for a regulation
Article 22 – paragraph 4
4. The pre-submission advice referred to in paragraph 3 shall comply with the following requirements: (a) it shall be without prejudice and non- committal as to any subsequent assessment of applications or notifications by the Panel on Genetically Modified Organisms of the Authority. The staff of the Authority providing the advice shall not be involved in any preparatory scientific or technical work that is directly or indirectly relevant to the application or notification that is the subject of the advice; (b) for potential notifications in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and for potential applications under Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19 concerning a category 2 NGT plant to be used as seeds or other plant reproductive material, the pre-submission advice shall be provided by the Authority together, or in close collaboration with the competent authority of the Member State to which the notification or application is going to be submitted; (c) the Authority shall make public without delay a summary of the pre- submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis; (d) potential applicants or notifiers demonstrating that they are a SME can request the pre-submission advice referred to in paragraph 3, point (a), at different points in time.deleted
2023/11/19
Committee: ENVI
Amendment 900 #

2023/0226(COD)

Proposal for a regulation
Article 22 – paragraph 5
5. Any request for the incentives shall be submitted to the Authority at the time of request of advice referred to in paragraph 3 or the application referred to in Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19, and accompanied by the following information: (a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the category 2 NGT plant meet the conditions referred to in paragraph 1; (b) where applicable, the information necessary to demonstrate the (potential) applicant or notifier is a SME; (c) for the purpose of paragraph 3, information on the aspects listed in Part 1 of Annex II as far as it can already be provided and any other relevant information.deleted
2023/11/19
Committee: ENVI
Amendment 904 #

2023/0226(COD)

Proposal for a regulation
Article 22 – paragraph 6
6. Article 26 of Directive 2001/18/EC and Article 30 of Regulation (EC) No 1829/2003 shall apply to information submitted under this article to the Authority, as appropriate.deleted
2023/11/19
Committee: ENVI
Amendment 905 #

2023/0226(COD)

Proposal for a regulation
Article 22 – paragraph 7
7. The Authority shall lay down the practical arrangements to implement paragraphs (3) to (6).deleted
2023/11/19
Committee: ENVI
Amendment 908 #

2023/0226(COD)

Proposal for a regulation
Article 22 – paragraph 8
8. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the lists of traits of NGT plants laid down in Annex III in order to adapt them to scientific and technological progress and to new evidence relating to the impact on sustainability of those traits, subject to the following conditions: (a) the Commission shall take into account the monitoring of the impacts of this Regulation in accordance with Article 30(3); (b) the Commission shall conduct an up- to-date scientific literature review of the impact on environmental, social and economic sustainability of the trait(s) it intends to add to or delete from the list in Annex III; (c) where applicable, the Commission shall take into account the results of monitoring which was carried out in accordance with Article 14, point (h), or Article 19(3), of NGT plants harbouring the trait(s) conveyed by their genetic modification.
2023/11/19
Committee: ENVI
Amendment 926 #

2023/0226(COD)

1. Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003on the basis of a delegated act proposed by Commission in accordance with Article 26 to define notably the size of the buffer strip for each sort of crops and the obligation of NGT growers to inform organic and certified non-GMO growers with field plots next to those where NGT plants are grown. Member States shall develop the definition of crop specific and adapted measures as a matter of subsidiarity, based on the latest scientific and experimental knowledge, to avoid the unintended presence of category 2 NGT plants. 2. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination in accordance with the principal of the extended producer responsibility. 3. The Commission shall gather and coordinate information based on the studies at EU and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of NGT, conventional and organic crops.
2023/11/19
Committee: ENVI
Amendment 947 #

2023/0226(COD)

Proposal for a regulation
Article 25 – paragraph 1
Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plantNGT plants. Article 23 of Directive 2001/18/EC shall apply for all NGT mutatis mutandis.
2023/11/19
Committee: ENVI
Amendment 958 #

2023/0226(COD)

Proposal for a regulation
Article 26 – paragraph 2
2. The power to adopt the delegated acts referred to in Article 5(3)6(1), Article 6(3), Article 11a and Article 22(8)4 shall be conferred on the Commission for a period of 5 years from [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.
2023/11/19
Committee: ENVI
Amendment 963 #

2023/0226(COD)

Proposal for a regulation
Article 26 – paragraph 3
3. The delegations of power referred to in Article 5(3)6(1), Article 6(3), Article 11a and Article 22(8)4 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.
2023/11/19
Committee: ENVI
Amendment 968 #

2023/0226(COD)

Proposal for a regulation
Article 26 – paragraph 6
6. A delegated act adopted pursuant to Articles 6(1), Article 56(3), Article 11a and Article 22(8)4 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.
2023/11/19
Committee: ENVI
Amendment 972 #

2023/0226(COD)

Proposal for a regulation
Article 27 – paragraph 1 – point a
(a) the information required to demonstrate that a plant is a NGT plant;deleted
2023/11/19
Committee: ENVI
Amendment 975 #

2023/0226(COD)

Proposal for a regulation
Article 27 – paragraph 1 – point b
(b) the preparation and the presentation of the verification requests referred to in Articles 6 and 7;deleted
2023/11/19
Committee: ENVI
Amendment 989 #

2023/0226(COD)

Proposal for a regulation
Article 27 – paragraph 2
Before adopting the implementing acts referred to in points (a) to (d), the Commission shall consult the Authority. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).
2023/11/19
Committee: ENVI
Amendment 993 #

2023/0226(COD)

Proposal for a regulation
Article 29 – title
Guidance and ex ante evaluation
2023/11/19
Committee: ENVI
Amendment 994 #

2023/0226(COD)

Proposal for a regulation
Article 29 – paragraph 2 a (new)
2a. Before the date of application of this Regulation, the European Commission shall provide an evaluation of this Regulation on the strategic autonomy of the European Union, on the concentration of the breeding sector, on the future of the European Plant Variety Rights system, on the safety measures to preserve the genetic diversity currently maintain by little and medium breeders and on the rise of food costs for European consumers due to the patents on new genomic techniques controlled by a few multinational firms.
2023/11/19
Committee: ENVI
Amendment 1030 #

2023/0226(COD)

Proposal for a regulation
Article 32 a (new)
Article 32a Penalties and withdrawal of the decision Member States shall lay down the rules on penalties applicable in case of failure to disclose any information requested in the verification procedure or in the authorisation procedure. The competent authority may withdraw its decision. The penalties provided for shall be effective, proportionate and dissuasive. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter. Member States shall without delay notify the Commission of those rules and any subsequent decision of penalties or withdrawal.
2023/11/19
Committee: ENVI
Amendment 1035 #

2023/0226(COD)

Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 1
It shall apply from [24when delegated acts referred to in Article 6(1), Article 6(3), Article 11a, Article 24 and all implementing acts required according to article 27 are adopted but no sooner than [36 months from the date of entry into force of this Regulation].
2023/11/19
Committee: ENVI
Amendment 1044 #

2023/0226(COD)

Proposal for a regulation
Annex I – title
Criteria of equivalence of NGT plants to conventional plants 1. 1. A NGT plant is considered equivalent to conventional plants when it differs from the unedited parent plant by no more than 20 genetic modifications of the types referred to in points 1 to 2 within the whole genome of the host plant. (1) substitution or insertion of no more than 20 nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ; (2) deletion of target inversion of any number of nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ; 2. Alongside these process-based criteria, equivalence shall be verified on the basis of the results the genetic modifications produce on the plant. When compared to the unedited parent of the same species grown in the same conditions, result- based criteria shall be set out as follows : (1) the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and (2) the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; and (3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired.
2023/11/19
Committee: ENVI
Amendment 1045 #

2023/0226(COD)

Proposal for a regulation
Annex I – title
Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants if, when compared to the unedited parent of the same species grown in the same conditions : - the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and - the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; provided any alteration of biochemical pathways, examined through gene ontology analysis, does not give rise to any adverse compositional consequences, and - biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired; provided any novel biochemicals or proteins produced by the plant does not present adverse effects on the plant itself, on any other forms of life it is known to interact with or bound to consume it.
2023/11/19
Committee: ENVI
Amendment 1046 #

2023/0226(COD)

Proposal for a regulation
Annex I – title
Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants if, when compared to the unedited parent of the same species grown in the same conditions : - the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and - the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; and - biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired.
2023/11/19
Committee: ENVI
Amendment 1058 #

2023/0226(COD)

Proposal for a regulation
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plants when it differs from the recipient/unedited parental plant by no more than 20 genetic modifications 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 tools2 within the whole genome of the host plant.
2023/11/19
Committee: ENVI
Amendment 1060 #

2023/0226(COD)

Proposal for a regulation
Annex I – point 1
(1) substitution or insertion of no more than 20 nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded;
2023/11/19
Committee: ENVI
Amendment 1070 #

2023/0226(COD)

Proposal for a regulation
Annex I – point 2
(2) deletion of target inversion of any number of nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ;
2023/11/19
Committee: ENVI
Amendment 1072 #

2023/0226(COD)

Proposal for a regulation
Annex I – point 3
(3) on the condition that the genetic modification does not interrupt an endogenous gene: (a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool; (b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool;deleted
2023/11/19
Committee: ENVI
Amendment 1094 #

2023/0226(COD)

Proposal for a regulation
Annex I – point 4
(4) targeted inversion of a sequence of any number of nucleotides;deleted
2023/11/19
Committee: ENVI
Amendment 1099 #

2023/0226(COD)

Proposal for a regulation
Annex I – point 5
(5) any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points (1) and/or (2)) in a species from the breeders’ gene pool.deleted
2023/11/19
Committee: ENVI
Amendment 1145 #

2023/0226(COD)

Proposal for a regulation
Annex II – Part 1 – paragraph 5
Any information on hazard identification and characterisation specified under Parts 2 and 3 shall only be required if the specific characteristics and the intended use of the category 2 NGT plant or category 2 NGT food or feed give rise to a plausible risk hypothesis that can be addressed utilising the specified information.deleted
2023/11/19
Committee: ENVI
Amendment 1190 #

2023/0226(COD)

Proposal for a regulation
Annex III – Part 2 – paragraph 1
Traits excluding the application of the incentives referred to in Article 22: - tolerance to herbicides. - plants producing insecticides and pesticides
2023/11/19
Committee: ENVI
Amendment 1193 #

2023/0226(COD)

Proposal for a regulation
Annex III a (new)
ANNEX IIIa In-door safety assessment A Cat.1 NGT plant is considered safe, without having to go through field trials, if the following confined experiments have been undertaken and provide evidence that: (1) the whole genome sequencing and profiling shows the intended and unintended genetic modifications have not adversely modified the function of one or more genes; and (2) the whole transcriptome sequencing realized on the relevant part of the plant shows the intended and unintended genetic modifications have not adversely modified biochemical pathways, leading in particular to adverse compositional consequences, verified e.g. through gene ontology analysis; and (3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the intended and unintended genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of toxic or allergenic novel biochemicals or proteins for the plant itself, any other forms of life it is known to interact with or bound to consume it.
2023/11/19
Committee: ENVI
Amendment 86 #

2023/0199(COD)

Proposal for a regulation
Recital 2
(2) The EU industry has proven its inbuilt resilience but is being challenged. High inflation, labour shortages, post- COVID supply chains disruptions, rising interest rates, and spikes in energy costs and input prices are weighing on the competitiveness of the EU industry. This is paired with strong, but not always ese difficulties are accompanied by strong, sometimes unfair, competition oin thea fragmented global market and difficulties structuring local value chains around networks of industrial stakeholders capable of carrying out projects. The EU has already put forward several initiatives to support its industry, such as the Green Deal Industrial Plan40, the Critical Raw Materials Act41, the Net Zero Industry Act42, the new Temporary Crisis and Transition Framework for State aid43, and REPowerEU44. While these solutions provide fast and targeted support, the EU needs a more structural answer to the investment needs of its industries, safeguarding cohesion and the level playing field in the Single Market and to reduce the EU’s strategic dependencies. _________________ 40 Communication on A Green Deal Industrial Plan for the Net-Zero Age, COM(2023) 62 final. 41 COM(2023) 160 final. 42 COM(2023) 161 final. 43 Communication on a Temporary Crisis and Transition Framework for State Aid measures (OJ C 101, 17.3.2023, p. 3). 44 Regulation (EU) 2023/435 as regards REPowerEU (OJ L 63, 28.2.2023, p. 1).
2023/09/08
Committee: BUDGITRE
Amendment 93 #

2023/0199(COD)

Proposal for a regulation
Recital 3
(3) The uptake and scaling up in the Union of deep and digital technologies, clean technologies, and biotechnologies will be essential to seize the opportunities and meet the objectives of the green and digital transitions, thus promoting the competitiveness of the European industry, its structure and its sustainability. Therefore, immediate action is required to support the development or manufacturing in the Union of such technologies, safeguarding and strengthening their value chains thereby reducing the Union’s strategic dependencies, and addressing existing labour and skills shortages in those sectors through trainings and apprenticeships and the creation of attractive, quality jobs accessible to all.
2023/09/08
Committee: BUDGITRE
Amendment 103 #

2023/0199(COD)

Proposal for a regulation
Recital 4
(4) There is a need to support critical technologies in the following fields: deep and digital technologies, clean technologies, and biotechnologies (including the respective critical raw materials value chains), in particular projects, companies and sectors with a critical role for EU’s competitiveness and resilience and its value chains. By way of example, deep technologies and digital technologies should include microelectronics, high-performance computing, quantum technologies (i.e., computing, communication and sensing technologies), cloud computing, edge computing, and artificial intelligence, cybersecurity technologies, robotics, 5G and advanced connectivity and virtual realities, including actions related to deep and digital technologies for the development of defence and aerospace applications. Clean technologies should include, among others, renewable energy; electricity and heat storage; heat pumps; electricity grid; renewable fuels of non- biological origin; sustainable alternative fuels; electrolysers and fuel cells; carbon capture, utilisation and storage; energy efficiency; hydrogen and its related infrastructure; smart energy solutions; technologies vital to sustainability such as water purification and desalination; advanced materials such as nanomaterials, composites and future clean construction materials, and technologies for the sustainable extraction and processing of critical raw materials. Biotechnology should be considered to include technologies such as biomolecules and its applications, pharmaceuticals and medical technologies vital for health security, crop biotechnology, and industrial biotechnology, such as for waste disposal, and biomanufacturing. The Commission may, at the latest one month after the entry into force of this regulation, issue guidance to further specify the scope of the technologies in these three fields considered to be critical in accordance with this Regulation, in order to promote a common interpretation of the projects, companies and sectors to be supported under the respective programmes in light of the common strategic objective. Moreover, technologies in any of these three fields which are subjects of an Important Project of Common European Interest (IPCEI) approved by the Commission pursuant to Article 107(3), point (b) TFEU should be deemed to be critical, and individual projects within the scope of such an IPCEI should be eligible for funding, in accordance with the respective programme rules, to the extent that the identified funding gap and the eligible costs have not yet been completely covered.
2023/09/08
Committee: BUDGITRE
Amendment 114 #

2023/0199(COD)

Proposal for a regulation
Recital 5 a (new)
(5a) In order to strengthen the EU industry’s manufacturing capacities, regional and local industrial actors must have resilient ecosystems. The development of value chains comprising a large number of VSEs/SMEs is key for the reindustrialisation of Europe but a suitable approach is needed. This ecosystem of VSEs/SMEs finds it difficult to mobilise European funding instruments and access public contracts. It is therefore necessary to strengthen these local value chains and their structures, and set up local and regional platforms to support their projects and facilitate access to finance.
2023/09/08
Committee: BUDGITRE
Amendment 158 #

2023/0199(COD)

Proposal for a regulation
Recital 13
(13) In order to extend support possibilities for investments aimed at strengthening industrial development and reinforcement of value chains in strategic sectors, the scope of support from the ERDF should be extended by providing for new specific objectives under the ERDF, without prejudice to the rules on eligibility of expenditure and climate spending as set out in Regulation (EU) 2021/106055 and Regulation (EU) 2021/105856. In strategic sectors, it should also be possible to support productive investments in enterprises other than SMEs, which can make a significant contribution to the development of less developed and transition regions, as well as in more developed regions of Member States with a GDP per capita below the EU average. Managing authorities are encouraged to promote collective structures of VSEs/SMEs and the collaboration between large enterprises and local SMEs, supply chains, innovation and technology ecosystems. This would allow reinforcing Europe’s overall capacity to strengthen its position in those sectors through providing access to all Member States for such investments, thus counteracting the risk of increasing disparities. _________________ 55 Regulation (EU) 2021/1060 laying down common provisions (OJ L 231, 30.6.2021, p. 159). 56 Regulation (EU) 2021/1058 on the European Regional Development Fund and on the Cohesion Fund (OJ L 224, 24.6.2021, p. 31).
2023/09/08
Committee: BUDGITRE
Amendment 191 #

2023/0199(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point a – introductory part
(a) supporting the development or manufacturing throughout the Union, or safeguarding and, strengthening and structuring the respective value chains at local, regional and national level, of critical technologies in the following fields:
2023/09/08
Committee: BUDGITRE
Amendment 207 #

2023/0199(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point b a (new)
(ba) strengthening Europe's economic, social and territorial cohesion and reducing disparities between the level of development of the various regions.
2023/09/08
Committee: BUDGITRE
Amendment 243 #

2023/0199(COD)

Proposal for a regulation
Article 3 – paragraph 2 a (new)
2a. Non-associated third-country entities are not eligible for support under this regulation, i.e. legal entity that is established in a non-associated third country or, where it is established in the Union or in an associated country that has its executive management structures in a non-associated third country.
2023/09/08
Committee: BUDGITRE
Amendment 244 #

2023/0199(COD)

Proposal for a regulation
Article 3 – paragraph 2 b (new)
2b. By way of derogation from the preceding paragraph, a legal entity established in the Union or in an associated country and controlled by a non-associated third country or a non- associated third-country entity shall be eligible to be a recipient or subcontractor involved in an action only if guarantees approved by the Member State or the associated country in which it is established in accordance with its national procedures are made available to the Commission. Those guarantees may refer to the legal entity’s executive management structure established in the Union or in an associated country. If considered to be appropriate by the Member State or associated country in which the legal entity is established, those guarantees may also refer to specific governmental rights in the control over the legal entity. The guarantees provide assurances that participation in an action of such a legal entity is not contrary to the objectives set out in Article 2 of this Regulation.
2023/09/08
Committee: BUDGITRE
Amendment 246 #

2023/0199(COD)

Proposal for a regulation
Article 4 – paragraph 1
1. The Commission shall award a Sovereignty Seal to any action contributing to any of the Platform objectives, provided the action has been assessed and complies with the minimum quality requirements, in particular eligibility, exclusion and award criteria, provided by a call for proposals under Regulation (EU) 2021/695, Regulation (EU) 2021/694, Regulation (EU) 2021/697, Regulation (EU) 2021/522, or Commission Delegated Regulation (EU) 2019/856. In particular, the Commission shall take into account the action’s ability to strengthen and provide a structure for local networks of industrial actors, and preserve and generate employment.
2023/09/08
Committee: BUDGITRE
Amendment 274 #

2023/0199(COD)

Proposal for a regulation
Article 5 – paragraph 3
3. The Commission shall report on the expenditure financed by the Platform. It shall, as appropriate, report on the achievements related to each of the specific Platform objectives and in particular on objective 2(1)(c) (new) to ensure that the implementation of the Platform does not harm cohesion.
2023/09/08
Committee: BUDGITRE
Amendment 281 #

2023/0199(COD)

Proposal for a regulation
Article 6 – paragraph 1 – point d a (new)
(da) organisations and actors responsible for networks of industrial actors at local level that help to achieve the Platform’s objectives.
2023/09/08
Committee: BUDGITRE
Amendment 287 #

2023/0199(COD)

Proposal for a regulation
Article 7 – paragraph 2
2. The annual report shall include consolidated information on the progress made in implementing the Platform objectives under each of the programmes and funds. It shall include qualitative and quantitative information on how Europe's social, economic and territorial cohesion is being reinforced.
2023/09/08
Committee: BUDGITRE
Amendment 291 #

2023/0199(COD)

Proposal for a regulation
Article 8 – paragraph 2
2. The evaluation report shall, provide an overview of the regions for which the programmes have been amended (including information on relevant aspects of the partnership principle), and in particular, shall assess to which extent the objectives have been achieved, the efficiency of the use of the resources and the European added value. It shall also consider the continued relevance of all objectives and actions, in view of their potential upscaling. It shall be accompanied by a thorough assessment of differentiated territorial impacts and effects on cohesion in the implementation of the Platform.
2023/09/08
Committee: BUDGITRE
Amendment 310 #

2023/0199(COD)

Proposal for a regulation
Article 10 – paragraph 1 – point 3
Regulation (EU) 2021/1058
Article 3 – paragraph 1a
The Commission shall pay 30 % of the ERDF allocation to that priority as set out in the decision approving the programme amendment as exceptional one-off pre- financing in addition to the yearly pre- financing for the programme provided for in Article 90(1) and (2) of Regulation (EU) 2021/1060 or in Article 51(2), (3) and (4) of Regulation (EU) 2021/1059. The exceptional pre-financing shall be paid by 31 December 2024, providedafter the Ccommission has adopted the decision approving the programme amendment by 31 October 2024pletion of the mid-term review of the programs, as provided for in Article 18 of Regulation (EU) 2021/1060.
2023/09/08
Committee: BUDGITRE
Amendment 320 #

2023/0199(COD)

Proposal for a regulation
Article 11 – paragraph 1 – point 2
Regulation (EU) 2021/1056
Article 8 – paragraph 2 – new subparagraph
The JTF may also support productive investments in enterprises other than SMEs contributing to the STEP objectives referred to in Article 2 of Regulation .../...65 [STEPRegulation]. That support may be provided irrespective of whether the gap analysis was carried out in accordance with Article 11(2)(h) and irrespective of its outcome. Such investments shall only be eligible where they do not lead to relocation as defined in point (27) of Article 2 of Regulation (EU) 2021/1060. The provision of such support shall not require a revision of the territorial just transition plan where that revision would be exclusively linked to the gap analysis. _________________ 65 Regulation …/… of the European Parliament and of the Council … [insert full title and OJ reference].
2023/09/08
Committee: BUDGITRE
Amendment 331 #

2023/0199(COD)

Proposal for a regulation
Article 14 – paragraph 1 – point 2 a (new)
Regulation (EU) 1303/2013
Article 24 – paragraph 1 a (new)
(2a) In Article 24 the following paragraph is inserted: "1a. By way of derogation from Article 60(1) and the first and fourth subparagraphs of Article 120(3), a co-financing rate of 100 % may be applied to expenditure declared in the final accounting year for one or more priority axes in a programme supported by the ERDF, the ESF or the Cohesion Fund. By way of derogation from Article 30(1) and (2) and Article 96(10), the application of the co-financing rate of 100 % shall not require a Commission decision approving a programme amendment. The Member State shall notify the revised financial tables to the Commission following approval by the monitoring committee. The co-financing rate of 100 % shall apply only if the financial tables are notified to the Commission before the submission of the final application for an interim payment for the final accounting year in accordance with Article 135(2)."
2023/09/08
Committee: BUDGITRE
Amendment 332 #

2023/0199(COD)

Proposal for a regulation
Article 14 – paragraph 1 a (new)
Regulation (EU) 1303/2013
Article 2 – paragraph 29 a (new)
In Article 2 the following paragraph is inserted: "29a. The last accounting year of the period should be extended until June 30, 2025. "
2023/09/08
Committee: BUDGITRE
Amendment 63 #

2023/0105(COD)

Proposal for a directive
Recital 12 a (new)
(12a) In accordance with Annex I to Directive 2001/112/EC, fruit juices are the fermentable but unfermented products obtained from fruit which is sound and ripe. Other than products derived from the fermentation of grapes, products derived from the fermentation of fruit juices had no legal definition in EU legislation. The purpose of this Directive is to better inform consumers about the absence of added sugar in fruit juices and to promote techniques to reduce the sugar content naturally present in fruit juices. In view of the importance of cider and perry in market outlets for apple juice and pear juice respectively and the objective of promoting a healthier and more sustainable food system in the EU, Annex III to Directive 2001/112/EC should be amended to define the denominations ‘cider’ and ‘perry’ and to restrict them to products derived from the fermentation of, respectively, apple juice and pear juice without the addition of either sugar or alcohol, in order to ensure that consumers are properly informed.
2023/09/25
Committee: AGRI
Amendment 111 #

2023/0105(COD)

Proposal for a directive
Recital 12 a (new)
(12a) In accordance with Annex I to Directive 2001/112/EC, fruit juices are the fermentable but unfermented products obtained from fruit which is sound and ripe. Other than products derived from the fermentation of grapes, products derived from the fermentation of fruit juices had no legal definition in EU legislation. The purpose of this Directive is to better inform consumers about the absence of added sugar in fruit juices and to promote techniques to reduce the sugar content naturally present in fruit juices. In view of the importance of cider and perry in market outlets for apple juice and pear juice respectively and the objective of promoting a healthier and more sustainable food system in the EU, Annex III to Directive 2001/112/EC should be amended to define the denominations ‘cider’ and ‘perry’ and to restrict them to products derived from the fermentation of, respectively, apple juice and pear juice without the addition of either sugar or alcohol, in order to ensure that consumers are properly informed.
2023/10/03
Committee: ENVI
Amendment 200 #

2023/0105(COD)

Proposal for a directive
Annex I – paragraph 1 – point 2
Directive 2001/112/EC
Annex 3 – point a a (new)
(aa) ‘cider’: for the product of the fermentation of apple juice or concentrated apple juice or a mixture of the two products, possibly with the addition of water, without the addition of sugar or alcohol.
2023/09/25
Committee: AGRI
Amendment 201 #

2023/0105(COD)

Proposal for a directive
Annex I – paragraph 1 – point 2
Directive 2001/112/EC
Annex 3 – point a b (new)
(ab) ‘perry’: for the product of the fermentation of pear juice or concentrated pear juice or a mixture of the two products, possibly with the addition of water, without the addition of sugar or alcohol.
2023/09/25
Committee: AGRI
Amendment 291 #

2023/0105(COD)

Proposal for a directive
Annex I – paragraph 1 – point 2
Directive 2001/112/EC
Annex III – point 1 – point a a (new)
aa. ‘cider’: for the product of the fermentation of apple juice or concentrated apple juice or a mixture of the two products, possibly with the addition of water, without the addition of sugar or alcohol.
2023/10/03
Committee: ENVI
Amendment 292 #

2023/0105(COD)

Proposal for a directive
Annex I – paragraph 1 – point 2
Directive 2001/112/EC
Annex III – point 1 – point a b (new)
ab. ‘perry’: for the product of the fermentation of pear juice or concentrated pear juice or a mixture of the two products, possibly with the addition of water, without the addition of sugar or alcohol.
2023/10/03
Committee: ENVI
Amendment 6 #

2023/0038M(NLE)

Draft opinion
Recital B a (new)
Ba. whereas the EU has chosen to develop its open strategic autonomy so that it is less exposed to crises and disruptions in supply;
2023/08/04
Committee: AGRI
Amendment 10 #

2023/0038M(NLE)

Draft opinion
Recital B b (new)
Bb. whereas, with the Green Deal, the EU is embarking on a new development project that is based on raising environmental standards in Europe and around the world;
2023/08/04
Committee: AGRI
Amendment 14 #

2023/0038M(NLE)

Draft opinion
Paragraph 1
1. Welcomes the elimination of tariffs on EU agri-food exports, including key products such as pigmeat (current tariff: 5%) and wine and sparkling wine (current tariff: 5%), thereby opening up new, albeit modest, business opportunities;
2023/08/04
Committee: AGRI
Amendment 22 #

2023/0038M(NLE)

Draft opinion
Paragraph 2
2. Welcomes the protection of geographical indications for EU wines and spirits as well as other food products, as required by the TRIPS Agreement since 1995; notes the efforts being made in relation to EU sensitive agricultural sensitivitieproducts by imposing limited and controlled access to highly sensitive products with the aim of protecting EU farmers through tariff rate quotas (TRQs); notescalls on the Commission to report within the next two years on the progress being made in including sustainability and animal welfare provisions;
2023/08/04
Committee: AGRI
Amendment 29 #

2023/0038M(NLE)

Draft opinion
Paragraph 3
3. Insists, nevertheless, that the Commission carefully manage and monitor the TRQs, and considers that TRQs should be accompanied by minimum entry prices to prevent dumping;
2023/08/04
Committee: AGRI
Amendment 35 #

2023/0038M(NLE)

Draft opinion
Paragraph 4
4. Calls on the EU to implement safeguards, such as seasonality, on the additional TRQs for agricultural products, as permitted by the WTO rules which the Commission very seldom uses to protect European market integrity;
2023/08/04
Committee: AGRI
Amendment 43 #

2023/0038M(NLE)

Draft opinion
Paragraph 4 a (new)
4a. Notes that the New Zealand milk sector benefits from an undertaking with a virtual monopoly over its exports;
2023/08/04
Committee: AGRI
Amendment 45 #

2023/0038M(NLE)

Draft opinion
Paragraph 5
5. Recognises that the EU dairy, beef and sheep sectors are under pressure owing to the market access being given to non-EU countries and the level of international prices, which are never balanced prices, but either dumping prices when surpluses are being dumped, or speculative prices when security of supply is at stake; calls on the Commission to consider the cumulative impacts of past and future trade deals on EU farmers and the need for investment into protect local EU production; when international prices are too low, in order to ensure food security for Europeans;
2023/08/04
Committee: AGRI
Amendment 56 #

2023/0038M(NLE)

Draft opinion
Paragraph 5 a (new)
5a. Calls on the Commission to refrain from proposing tariff concessions that threaten livestock breeding in Europe;
2023/08/04
Committee: AGRI
Amendment 60 #

2023/0038M(NLE)

Draft opinion
Paragraph 6
6. Underlines that it would welcome exchanges between the EU and New Zealand on good practices, in particular regarding regulations on new breeding techniques and attracting young peopleexchanging good regulatory and scientific practices, in particular regarding existing regulations on GMOs and the regulations on new GMOs that are currently being negotiated, in order to take advantage of New Zealand’s long experience in controlling invasive species; considers that this Free Trade Agreement will not help to attract young Europeans into the farming profession;
2023/08/04
Committee: AGRI
Amendment 71 #

2023/0038M(NLE)

Draft opinion
Paragraph 7 a (new)
7a. Calls on the Commission to move towards new and real partnership agreements with States and regional entities that want to cooperate in order to achieve human development goals and the ecological transition, and to organise fair trade; considers that real partnership agreements should be developed by involving civil society in democratic processes and should be implemented with the consent of the local populations affected;
2023/08/04
Committee: AGRI
Amendment 76 #

2023/0038M(NLE)

Draft opinion
Paragraph 7 b (new)
7b. Calls on the Commission to draw inspiration from the history of commodity agreements in order to secure the supply of raw materials through multiannual government-to-government agreements with restricted prices and thereby break the stranglehold of the large international traders;
2023/08/04
Committee: AGRI
Amendment 2 #

2021/2213(INI)

Motion for a resolution
Recital B
B. whereas the multiplication of crises such as the global consequences of the COVID-19 pandemic and the Russian war of aggression against Ukraine call for the forging of stronger alliances and more effective partnerships which deliver tangible results in order to better address emerging needs and global challenges by supporting early warning systems for a swift range of information and early actions in live-saving assistance;
2024/02/05
Committee: DEVE
Amendment 2 #

2021/2213(INI)

Motion for a resolution
Recital B
B. whereas the multiplication of crises such as the global consequences of the COVID-19 pandemic and the Russian war of aggression against Ukraine call for the forging of stronger alliances and more effective partnerships which deliver tangible results in order to better address emerging needs and global challenges by supporting early warning systems for a swift range of information and early actions in live-saving assistance;
2024/02/05
Committee: DEVE
Amendment 6 #

2021/2213(INI)

Motion for a resolution
Recital C
C. whereas the long-standing partnership between the EU and the ACP countries is of great importance given the number of countries it unites and the greater role it could play in the multilateral system, which is currently under strain; whereas this partnership agreement brings together more than half of the UN member states;
2024/02/05
Committee: DEVE
Amendment 6 #

2021/2213(INI)

Motion for a resolution
Recital C
C. whereas the long-standing partnership between the EU and the ACP countries is of great importance given the number of countries it unites and the greater role it could play in the multilateral system, which is currently under strain; whereas this partnership agreement brings together more than half of the UN member states;
2024/02/05
Committee: DEVE
Amendment 7 #

2021/2213(INI)

Motion for a resolution
Recital D
D. whereas the EU and ACP countries must pursue a strengthened partnership between equals in order to generate mutually beneficial outcomes on common and intersecting interests and in a spirit of shared responsibility, solidarity, reciprocity, mutual respect and accountability;
2024/02/05
Committee: DEVE
Amendment 7 #

2021/2213(INI)

Motion for a resolution
Recital D
D. whereas the EU and ACP countries must pursue a strengthened partnership between equals in order to generate mutually beneficial outcomes on common and intersecting interests and in a spirit of shared responsibility, solidarity, reciprocity, mutual respect and accountability;
2024/02/05
Committee: DEVE
Amendment 8 #

2021/2213(INI)

Motion for a resolution
Recital D
D. whereas the EU and ACP countries must pursue a strengthened partnership in order to generate mutually beneficial outcomes on common and intersecting interests and in a spirit of shared responsibility, co-creation, solidarity, reciprocity, mutual respect and accountability;
2024/02/05
Committee: DEVE
Amendment 8 #

2021/2213(INI)

Motion for a resolution
Recital D
D. whereas the EU and ACP countries must pursue a strengthened partnership in order to generate mutually beneficial outcomes on common and intersecting interests and in a spirit of shared responsibility, co-creation, solidarity, reciprocity, mutual respect and accountability;
2024/02/05
Committee: DEVE
Amendment 19 #

2021/2213(INI)

Motion for a resolution
Paragraph 5
5. Reiterates the importance of the parliamentary dimension and the political dialogue as an integral part of the partnership;
2024/02/05
Committee: DEVE
Amendment 19 #

2021/2213(INI)

Motion for a resolution
Paragraph 5
5. Reiterates the importance of the parliamentary dimension and the political dialogue as an integral part of the partnership;
2024/02/05
Committee: DEVE
Amendment 34 #

2021/2213(INI)

Motion for a resolution
Paragraph 11
11. Insists on the need to give greater prominence to the human and social development aspects of the agreement and the need to improve resources for humanitarian aid and to guarantee effective channels of access to its implementation;
2024/02/05
Committee: DEVE
Amendment 34 #

2021/2213(INI)

Motion for a resolution
Paragraph 11
11. Insists on the need to give greater prominence to the human and social development aspects of the agreement and the need to improve resources for humanitarian aid and to guarantee effective channels of access to its implementation;
2024/02/05
Committee: DEVE
Amendment 96 #

2021/2213(INI)

Motion for a resolution
Paragraph 28 a (new)
28 a. Stresses the importance of the parliamentary dimension in this agreement, as representatives of the civil society of four continents and aggregators of the diversity in a parliamentary assembly;
2024/02/05
Committee: DEVE
Amendment 96 #

2021/2213(INI)

Motion for a resolution
Paragraph 28 a (new)
28 a. Stresses the importance of the parliamentary dimension in this agreement, as representatives of the civil society of four continents and aggregators of the diversity in a parliamentary assembly;
2024/02/05
Committee: DEVE
Amendment 98 #

2021/2213(INI)

Motion for a resolution
Paragraph 29
29. Welcomes the commitment to promote a multi-stakeholder approach, enabling the active engagement of a wide variety of actors, including parliaments, local authorities, civil society, especially women and young people, and the private sector; calls for this commitment to be rapidly translated into practice, which will necessitate the creation of an open and transparent mechanism for structured consultation in order to ensure the effective participation of stakeholders;
2024/02/05
Committee: DEVE
Amendment 98 #

2021/2213(INI)

Motion for a resolution
Paragraph 29
29. Welcomes the commitment to promote a multi-stakeholder approach, enabling the active engagement of a wide variety of actors, including parliaments, local authorities, civil society, especially women and young people, and the private sector; calls for this commitment to be rapidly translated into practice, which will necessitate the creation of an open and transparent mechanism for structured consultation in order to ensure the effective participation of stakeholders;
2024/02/05
Committee: DEVE
Amendment 102 #

2021/2213(INI)

Motion for a resolution
Paragraph 31
31. Welcomes the provisions on global alliances and international cooperation included in the new agreement, with commitments to the rules-based international order and to promoting international dialogue and seeking multilateral solutions to drive global action forward, promoting peace and development;
2024/02/05
Committee: DEVE
Amendment 102 #

2021/2213(INI)

Motion for a resolution
Paragraph 31
31. Welcomes the provisions on global alliances and international cooperation included in the new agreement, with commitments to the rules-based international order and to promoting international dialogue and seeking multilateral solutions to drive global action forward, promoting peace and development;
2024/02/05
Committee: DEVE