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AM\1348825EN.docx PE791.123v02-00 EN United in diversity EN European Parliament 2024-2029 Committee on the Environment, Climate and Food Safety 2025/0394(COD) 28.7.2026 AMENDMENTS 264 - 465 Draft report Susana Solís Pérez (PE787.998v01-00) Amending Directives 2008/98/EC, 2010/75/EU, (EU) 2015/2193 and (EU) 2024/1785 of the European Parliament and of the Council as regards simplification of some requirements and reduction of administrative burden Proposal for a directive (COM(2025)0986 – 2025/0394(COD)) PE791.123v02-00 2/158 AM\1348825EN.docx EN AM_Com_LegReport AM\1348825EN.docx 3/158 PE791.123v02-00 EN Amendment 264 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 3 Present text Amendment (1a) In Article 15, paragraph 3 is replaced by the following: 3. The competent authority shall set the strictest achievable emission limit values by applying BAT in the installation, considering the entire range of the emission levels associated with the best available techniques (“BAT-AELs”) to ensure that, under normal operating conditions, emissions do not exceed the BAT-AELs as laid down in the decisions on BAT conclusions referred to in Article 13(5). The emission limit values shall be based on an assessment by the operator of the entire BAT-AEL range, analysing the feasibility of meeting the strictest end of the BAT-AEL range and demonstrating the best overall performance that the installation can achieve by applying BAT as described in BAT conclusions, having regard to possible cross-media effects. The emission limit values shall be set through either of the following:(a)setting emission limit values expressed for the same or shorter periods of time and under the same reference conditions as the BAT-AELs; or(b)setting emission limit values different from those referred to in point (a) in terms of values, periods of time and reference conditions.Where the emission limit values are set in accordance with point (b), the competent authority shall, at least annually, assess the results of emission monitoring in order to ensure that emissions under normal operating conditions have not exceeded the BAT-AELs.General binding rules referred to in Article 6 may be applied while setting relevant emission limit values in accordance with this ‘3. The competent authority shall set appropriate, technically achievable emission limit values by applying BAT in the installation, considering the applicable best available techniques (“BAT-AELs”) to ensure that, under normal operating conditions, emissions do not exceed the BAT-AELs as laid down in the decisions on BAT conclusions referred to in Article 13(5). The emission limit values shall be based on an assessment by the operator of the entire BAT-AEL range and demonstrating the best overall performance that the installation can achieve by applying BAT as described in BAT conclusions, having regard to possible cross-media effects. The emission limit values shall be set through either of the following:(a)setting emission limit values expressed for the same or shorter periods of time and under the same reference conditions as the BAT-AELs; or(b)setting emission limit values different from those referred to in point (a) in terms of values, periods of time and reference conditions.Where the emission limit values are set in accordance with point (b), the competent authority shall, at least annually, assess the results of emission monitoring in order to ensure that emissions under normal operating conditions have not exceeded the BAT-AELs.General binding rules referred to in Article 6 may be applied while setting relevant emission limit values in accordance with this Article. The general binding rules shall be established by the Member State, based on PE791.123v02-00 4/158 AM\1348825EN.docx EN Article.If general binding rules are adopted, the strictest achievable emission limit values by applying BAT shall be set for categories of installations having similar characteristics that are relevant in determining the lowest emission levels achievable, considering the entire range of the BAT-AELs. The general binding rules shall be established by the Member State, based on the information in the BAT conclusions, analysing the feasibility of meeting the strictest end of the BAT-AEL range and demonstrating the best performance that those categories of installations can achieve by applying BAT as described in BAT conclusions. the information in the BAT conclusions and demonstrating the best performance that those categories of installations can reasonably achieve by applying BAT as described in BAT conclusions.’ Or. en ((https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804)) Amendment 265 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 3 – subparagraph 1 – first sentence Present text Amendment (1b) in Article 15(3), first subparagraph, the first sentence is replaced by the following: 3. The competent authority shall set the strictest achievable emission limit values by applying BAT in the installation, considering the entire range of the emission levels associated with the best available techniques (“BAT-AELs”) to ensure that, under normal operating conditions, emissions do not exceed the BAT-AELs as laid down in the decisions on BAT conclusions referred to in Article 13(5). ‘3. The competent authority shall set emission limit values based on the relevant BAT, considering the entire range of the emission levels associated with the best available techniques (“BAT-AELs”) to ensure that, under normal operating conditions, emissions do not exceed the BAT-AELs as laid down in the decisions on BAT conclusions referred to in Article 13(5).’ AM\1348825EN.docx 5/158 PE791.123v02-00 EN Or. en (EU/2010/75/EU) Justification Article 15 (3) of Directive 2010/75/EU should only require competent authorities to set emission limit values (ELVs) within the relevant BAT AEL range in permits to better reflect the local and site-specific conditions of each installation. Amendment 266 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 4 Text proposed by the Commission Amendment (1b) In Article 15, paragraph 4 is deleted. Or. fr Amendment 267 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 - paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 4 Present text Amendment (1a) in Article 15, paragraph 4 is deleted Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment removes binding environmental performance ranges which would add complexity beyond the core BAT-based emission limit framework. This ensures that PE791.123v02-00 6/158 AM\1348825EN.docx EN permitting remains focused on measurable emission control, reduces administrative burden and avoids disproportionate requirements. Amendment 268 Daniel Buda Proposal for a directive Article 2– paragraph 1 – point 1 a (new) Directive 2010/75 Article 15 – paragraph 4 Present text Amendment (1a) in Article 15, paragraph 4 is deleted. Or. en Justification Requiring competent authorities to set water, waste and resource performance values for all installations, regardless of their relevance to the sector, would undermine this process, create inconsistent requirements across Member States and impose unnecessary administrative burdens without delivering additional environmental benefits. Amendment 269 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1a (new) Directive 2010/75/EC Article 15 – paragraph 4 Present text Amendment (1a) in Article 15, paragraph 4 is deleted: Or. en (2010/75/EU) Justification AEPLs are obsolete because of several provisions in the special legislative acts such as Water Framework Directive, Ambient Air Quality Directive, Waste Framework Directive. AM\1348825EN.docx 7/158 PE791.123v02-00 EN Amendment 270 Elżbieta Katarzyna Łukacijewska, Krzysztof Hetman Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EC Article 15 – paragraph 4 – point a Text proposed by the Commission Amendment (1b) in Article 15(4), point (a) is deleted Or. en Justification Environmental performance limit values should be deleted as they create an additional layer of binding permitting and compliance obligations for operators, including operators of large combustion plants. Consumption levels, resource efficiency concerning materials, water and energy, and waste generation are already addressed through other EU and national legal frameworks, including energy efficiency, water, waste and resource-efficiency legislation. Introducing binding environmental performance limit values under the IED would therefore risk duplicating existing requirements and increasing administrative complexity, contrary to the simplification objective of the Omnibus package. Removing this obligation would preserve the focus of the IED on emissions control and integrated pollution prevention, while avoiding disproportionate administrative and operational burdens in areas already regulated elsewhere. Amendment 271 Pietro Fiocchi Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 4 – point a Present text Amendment (1b) in Article 15(4), point (a) is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075- 20240804&qid=1783407411429) PE791.123v02-00 8/158 AM\1348825EN.docx EN Amendment 272 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk, Ana Vasconcelos Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 4 – subparagraph 3 Text proposed by the Commission Amendment (1a) in Article 15(4) , the following subparagraph is added: For installations forming part of European semiconductor technology initiatives and strategic projects recognised under Regulation (EU) XXX/XXX [Chips Act 2], as well as integrated production facilities and open EU foundries recognised under Regulation (EU) 2023/1781, competent authorities shall take into account the specific technical characteristics of semiconductor manufacturing when applying this paragraph, including process stability, product quality requirements and the limited availability of technically feasible abatement or substitution alternatives. Or. en Justification Semiconductor manufacturing is essential for Europe’s technological sovereignty and resilience. This amendment ensures that the existing IED derogation mechanism can take account of the specific technical constraints of semiconductor production. Amendment 273 Pietro Fiocchi Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 15 – paragraph 4 – point b AM\1348825EN.docx 9/158 PE791.123v02-00 EN Present text Amendment (1c) in Article 15(4), point (b) is replaced by the following: (b) set, for normal operating conditions, indicative environmental performance levels concerning waste and resources other than water, which are not less strict than the binding ranges referred to in the first subparagraph. ‘(b) set, for normal operating conditions, indicative environmental performance levels concerning water, waste and resources, which are consistent with the indicative ranges referred to in the first subparagraph.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075- 20240804&qid=1783407411429) Justification Indicative values would provide the necessary flexibility to adapt resource consumption or waste generation to site-specific constraints. This would ensure that environmental efforts are focused where they have a real impact, rather than meeting disproportionate and rigid targets. Amendment 274 François-Xavier Bellamy Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 4 Present text Amendment (1b) In Article 15, paragraph 4 is replaced by the following: 4. Without prejudice to Article 9(2), the competent authority shall set, for normal operating conditions, binding ranges for environmental performance that are not to be exceeded during one or more periods, as laid down in the decisions on BAT conclusions referred to in Article 13(5). 4. Without prejudice to Article 9(2), the competent authority shall set, for normal operating conditions, indicative ranges for environmental performance that are not to be exceeded during one or more periods, as laid down in the decisions on BAT conclusions referred to in Article 13(5). In addition, the competent authority shall: In addition, the competent authority shall: (a) set, for normal operating conditions, environmental performance limit values (a) set, for normal operating conditions, environmental performance limit values PE791.123v02-00 10/158 AM\1348825EN.docx EN concerning water, having regard to possible cross-media effects, that are not to be exceeded during one or more periods, and which are not less strict than the binding ranges referred to in the first subparagraph; concerning water, having regard to possible cross-media effects, that are not to be exceeded during one or more periods, and which are not less strict than the indicative ranges referred to in the first subparagraph; (b) set, for normal operating conditions, indicative environmental performance levels concerning waste and resources other than water, which are not less strict than the binding ranges referred to in the first subparagraph. (b) set, for normal operating conditions, indicative environmental performance levels concerning waste and resources other than water, which are not less strict than the indicative ranges referred to in the first subparagraph. Or. fr Amendment 275 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 1 - paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 5 – subparagraph 2 Present text Amendment The competent authority shall document in an annex to the permit conditions the reasons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed. The competent authority may grant temporary derogations from the requirements of paragraphs 2 and 3 of this Article and from Article 11, points (a) and (b), for the testing and use of emerging techniques for a total period of time not exceeding 9 months, pro vided that after the period specified, either the technique is stopped or the activity achieves at least the emission levels asso ciated with the best available techniques. Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 276 Anna Zalewska AM\1348825EN.docx 11/158 PE791.123v02-00 EN Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 5 Present text Amendment (1b) Article 15, paragraph 5 is replaced by the following: 5. By way of derogation from paragraph 3, and without prejudice to Article 18, the competent authority may, in specific cases, set emission limit values higher than the BAT-AELs. Such a derogation may apply only where an assessment shows that the achievement of BAT-AELs as described in BAT conclusions would lead to disproportionately higher costs compared to the environmental benefits due to:(a)the geographical location or the local environmental conditions of the installation concerned; or(b)the technical characteristics of the installation concerned. The competent authority shall document in an annex to the permit conditions the reasons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed.The emission limit values set in accordance with the first subparagraph shall, however, not exceed the emission limit values set out in the Annexes to this Directive, where applicable.Derogations granted in accordance with this paragraph shall respect the principles set out in Annex II. The competent authority shall ensure that the operator provides an assessment of the impact of the derogation on the concentration of the pollutants concerned in the receiving environment and in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. Derogations shall not be granted where they could put at risk compliance with environmental quality standards referred to in Article 18.The competent authority shall ‘5. By way of derogation from paragraph 3, and without prejudice to Article 18, the competent authority may set emission limit values higher than the BAT-AELs. Such a derogation may apply where an assessment reasonably demonstrates that the achievement of BAT-AELs as described in BAT conclusions would result in disproportionately higher costs compared to the environmental benefits due to:(a)the geographical location or the local environmental conditions of the installation concerned; (b)the technical characteristics of the installation concerned; c) the economic viability, strategic importance or security of supply of the installation concerned. The competent authority shall document in an annex to the permit conditions the reasons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed.The emission limit values set in accordance with the first subparagraph shall, however, not exceed the emission limit values set out in the Annexes to this Directive, where applicable.Derogations granted in accordance with this paragraph shall respect the principles set out in Annex II. The competent authority shall ensure that the operator provides an assessment of the impact of the derogation on the concentration of the pollutants concerned in the receiving environment and in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. Derogations shall not be granted where they could put at risk compliance with PE791.123v02-00 12/158 AM\1348825EN.docx EN re-assess whether derogations granted in accordance with this paragraph are justified, every four years or as part of each reconsideration of the permit conditions pursuant to Article 21, where such reconsideration occurs earlier than four years after the derogation was granted.The Commission shall adopt an implementing act to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). environmental quality standards referred to in Article 18.The competent authority shall re-assess whether derogations granted in accordance with this paragraph are justified, every eight years or as part of each reconsideration of the permit conditions pursuant to Article 21, where such reconsideration occurs earlier than four years after the derogation was granted.The Commission shall adopt an implementing act to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2).’ Or. en ((https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804)) Amendment 277 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EC Article 15 – paragraph 5 Present text Amendment (1b) in Article 15, paragraph 5 is replaced by the following: By way of derogation from paragraph 3, and without prejudice to Article 18, the competent authority may, in specific cases, set emission limit values higher than the BAT-AELs. Such a derogation may apply only where an assessment shows that the achievement of BAT-AELs as described in BAT conclusions would lead to disproportionately higher costs compared to the environmental benefits due to: ‘By way of derogation from paragraph 3, and without prejudice to Article 18, the competent authority may, in specific cases, set emission limit values higher than the BAT-AELs. Such a derogation may apply only where an assessment shows that the achievement of BAT-AELs as described in BAT conclusions would lead to disproportionately higher costs compared to the environmental benefits due to: AM\1348825EN.docx 13/158 PE791.123v02-00 EN (a) the geographical location or the local environmental conditions of the installation concerned; or (a) the geographical location or the local environmental conditions of the installation concerned; or (b) the technical characteristics of the installation concerned. (b) the technical characteristics of the installation concerned. The competent authority shall document in an annex to the permit conditions the rea- sons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed. The competent authority shall document in an annex to the permit conditions the rea- sons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed. The emission limit values set in accordance with the first subparagraph shall, however, not exceed the emission limit values set out in the Annexes to this Directive, where applicable. The emission limit values set in accordance with the first subparagraph shall, however, not exceed the emission limit values set out in the Annexes to this Directive, where applicable. Derogations granted in accordance with this paragraph shall respect the principles set out in Annex II. The competent authority shall ensure that the operator provides an assessment of the impact of the derogation on the concentration of the pollutants concerned in the receiving environment and in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. Derogations shall not be granted where they could put at risk compliance with environmental quality standards referred to in Article 18. The competent authority shall in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. The competent authority shall re-assess whether derogations granted in accordance with this paragraph are justified, every four years or as part of each reconsideration of the permit conditions pursuant to Article 21, where such reconsideration occurs earlier than four years after the derogation was granted. The competent authority shall re-assess whether derogations granted in accordance with this paragraph are justified, every four years or as part of each reconsideration of the permit conditions pursuant to Article 21, where such reconsideration occurs earlier than four years after the derogation was granted. On the basis of information provided by Member States in accordance with Article 72(1), in particular concerning the application of this paragraph, the Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the application of this paragraph.’ PE791.123v02-00 14/158 AM\1348825EN.docx EN The Commission shall adopt an implementing act to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). The Commission shall adopt an implementing act to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). Or. en (2010/75/EU) Justification This proposal intends to change the new requirements of Annex II, which authorities must consider when granting exemptions and which are overly ambitious and burdensome. Furthermore, the implementing act – introduced in 2024 - which in turn creates additional bureaucracy, is unnecessary when a guideline can serve the same purpose. Amendment 278 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 6 Text proposed by the Commission Amendment (1b) in Article 15, paragraph 6 is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment is consequential to the deletion of binding environmental performance ranges. Removing the related derogation mechanism avoids redundant procedures, simplifies the legal framework and ensures that competent authorities and operators are not subject to unnecessary administrative steps. AM\1348825EN.docx 15/158 PE791.123v02-00 EN Amendment 279 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 15 – paragraph 6 Present text Amendment (1c) in Article 15, paragraph 6 is deleted; Or. en (2010/75/EU) Justification AEPLs are obsolete because of several provisions in the special legislative acts such as Water Framework Directive, Ambient Air Quality Directive, Waste Framework Directive. Amendment 280 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 15 – paragraph 7 Present text Amendment (1c) in Article 15, paragraph 7 is replaced by the following: 7. By way of derogation from paragraphs 3 and 4, and provided that no significant pollution is caused and all measures resulting in less pollution have been exhausted, the competent authority may set less strict emission limit values or environmental performance limit values in the event of a crisis due to extraordinary circumstances beyond the control of the operator and Member States, leading to a severe disruption or shortage of: (a) energy supplies, provided that there is an overriding public interest in security of ‘7. By way of derogation from paragraphs 3 and 4, the competent authority may set less strict emission limit values in the event of a crisis due to extraordinary circumstances beyond the control of the operator and Member States, leading to a severe disruption or shortage of: (a) energy supplies, provided that there is an overriding public interest in security of energy supply; (b) resources, materials or equipment essential for the operator to perform activities of public interest, in compliance with the applicable emission PE791.123v02-00 16/158 AM\1348825EN.docx EN energy supply; (b) resources, materials or equipment essential for the operator to perform activities of public interest, in compliance with the applicable emission limit values or environmental performance limit values; or (c) essential resources, materials or equipment where the production output compensates for such shortage or disruption, for reasons of public health or public safety or for other imperative reasons of overriding public interest. The derogation shall not be granted for more than three months. If the reasons justifying the granting of a derogation persist, the derogation may be prolonged for a maximum period of three months. As soon as the supply conditions are restored or where there is an alternative to the energy supplies, resources, materials or equipment, the Member State shall ensure that the decision to set less strict emission limit values and environmental performance limit values ceases to have effect, and the installation shall comply with permit conditions set in accordance with paragraphs 3 and 4. The Member States shall take measures to ensure that emissions resulting from the derogation referred to in the first subparagraph are monitored. The competent authority shall make information on the derogation and the conditions imposed publicly available in accordance with Article 24 (2). The Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the appli cation of this paragraph. Member States shall notify the Commission of any derogation granted under this paragraph, including the reasons justifying the granting of the derogation and the conditions imposed. The Commission shall assess whether the derogation granted is justified having due regard to the criteria set in this paragraph. If the Commission raises objections within 2 months of the notification by the Member limit values; or (c) essential resources, materials or equipment where the production output compensates for such shortage or disruption, for reasons of public health or public safety or for other imperative reasons of overriding public interest. The derogation shall not be granted for more than six months. If the reasons justifying the granting of a derogation persist, the derogation may be prolonged for a maximum period of six months. As soon as the supply conditions are restored or where there is an alternative to the energy supplies, resources, materials or equipment, the Member State shall ensure that the decision to set less strict emission limit values ceases to have effect, and the installation shall comply with permit conditions set in accordance with paragraphs 3 and 4. The Member States shall take measures to ensure that emissions resulting from the derogation referred to in the first subparagraph are monitored. The competent authority shall make information on the derogation and the conditions imposed publicly available in accordance with Article 24 (2). The Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the appli cation of this paragraph. Member States shall notify the Commission of any derogation granted under this paragraph, including the reasons justifying the granting of the derogation and the conditions imposed. ’; AM\1348825EN.docx 17/158 PE791.123v02-00 EN State, the Member States shall without delay revise the derogation accordingly. Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment ensures that crisis derogations are workable in extraordinary circumstances affecting energy supply, critical resources or activities of public interest. Extending the time limits provides greater operational realism, while maintaining monitoring, transparency and notification requirements and ensuring that derogations cease once supply conditions are restored. Amendment 281 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 15 – paragraph 7 Present text Amendment (1d) in Article 15, paragraph 7 is replaced by the following: 7. By way of derogation from paragraphs 3 and 4, and provided that no significant pollution is caused and all measures resulting in less pollution have been exhausted, the competent authority may set less strict emission limit values or environmental performance limit values in the event of a crisis due to extraordinary circumstances beyond the control of the operator and Member States, leading to a severe disruption or shortage of: ‘7. By way of derogation from paragraph 3, and provided that no significant pollution is caused and all measures resulting in less pollution have been exhausted, the competent authority may set less strict emission limit values in the event of a crisis due to extraordinary circumstances beyond the control of the operator and Member States, leading to a severe disruption or shortage of: (a) energy supplies, provided that there is an overriding public interest in security of energy supply; (a) energy supplies, provided that there is an overriding public interest in security of energy supply; (b) resources, materials or equipment essential for the operator to perform activities of public interest, in compliance with the applicable emission limit values or (b) resources, materials or equipment essential for the operator to perform activities of public interest, in compliance with the applicable emission limit values or PE791.123v02-00 18/158 AM\1348825EN.docx EN environmental performance limit values; or (c) essential resources, materials or equipment where the production output compensates for such shortage or disruption, for reasons of public health or public safety or for other imperative reasons of overriding public interest. (c) essential resources, materials or equipment where the production output compensates for such shortage or disruption, for reasons of public health or public safety or for other imperative reasons of overriding public interest. The derogation shall not be granted for more than three months. If the reasons justifying the granting of a derogation persist, the derogation may be prolonged for a maximum period of three months. The derogation shall not be granted for more than three months. If the reasons justifying the granting of a derogation persist, the derogation may be prolonged for a maximum period of three months. As soon as the supply conditions are restored or where there is an alternative to the energy supplies, resources, materials or equipment, the Member State shall ensure that the decision to set less strict emission limit values and environmental performance limit values ceases to have effect, and the installation shall comply with permit conditions set in accordance with paragraphs 3 and 4. As soon as the supply conditions are restored or where there is an alternative to the energy supplies, resources, materials or equipment, the Member State shall ensure that the decision to set less strict emission limit values ceases to have effect, and the installation shall comply with permit conditions set in accordance with paragraph 3. The Member States shall take measures to ensure that emissions resulting from the derogation referred to in the first subparagraph are monitored. The Member States shall take measures to ensure that emissions resulting from the derogation referred to in the first subparagraph are monitored. The competent authority shall make information on the derogation and the conditions imposed publicly available in accordance with Article 24 (2). The competent authority shall make information on the derogation and the conditions imposed publicly available in accordance with Article 24 (2). The Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the application of this paragraph. The Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the application of this paragraph. Member States shall notify the Commission of any derogation granted under this paragraph, including the reasons justifying the granting of the derogation and the conditions imposed.’; Member States shall notify the Commission of any derogation granted under this paragraph, including the reasons justifying the granting of the derogation and the conditions imposed. AM\1348825EN.docx 19/158 PE791.123v02-00 EN Or. en (2010/75/EU) Justification AEPLs are obsolete because of several provisions in the special legislative acts such as Water Framework Directive, Ambient Air Quality Directive, Waste Framework Directive. Amendment 282 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 7 a (new) Text proposed by the Commission Amendment (1a) in Article 15, the following paragraph is inserted: ‘7a. For the purposes of paragraph 7, activities, investments or production outputs necessary for defence readiness, defence-critical production, the secure supply of ammunition, munitions, military equipment, or other defence-critical materials, or the protection of national security may be considered to serve public safety or imperative reasons of overriding public interest, where the conditions set out in that paragraph are fulfilled.’; Or. en Justification Derogations already exist in Union environmental legislation on grounds such as overriding public interest, public safety or crisis situations. In the current security environment, it should be clear that such grounds may also cover defence readiness activities and investments, including the continuity of defence-critical production and the secure supply of ammunition, munitions, military equipment and other essential materials. This amendment clarifies the application of the existing IED crisis derogation to defence-related situations, without creating a general exemption from the Directive and while maintaining the existing safeguards on pollution prevention, proportionality and time limitation. PE791.123v02-00 20/158 AM\1348825EN.docx EN Amendment 283 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 16 – paragraph 2 Present text Amendment (1b) In Article 16, paragraph 2 is replaced by the following: 2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in a permit for each individual installation or in general binding rules. 2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in general binding rules. Monitoring requirements may be replaced by equivalent monitoring or technical measures ensuring an equivalent level of environmental protection. The monitoring frequency may be reduced if the emission levels are proven to be sufficiently stable. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination.’; Or. en Justification Installations experience huge increases in monitoring requirements being introduced in the BAT conclusions, which result in large administrative burdens with no real environmental effect. The environmental authorities do not have possibilities to alter the frequency of the monitoring or approve alternative methods for measurements and monitoring. Amendment 284 Jessica Polfjärd AM\1348825EN.docx 21/158 PE791.123v02-00 EN Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) Directive (EU) 2010/75/EU Article 16 – paragraph 2 Present text Amendment (1a) in Article 16, paragraph 2 is replaced by the following: 2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in a permit for each individual installation or in general binding rules. ‘2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in general binding rules. Monitoring requirements may be replaced by equivalent monitoring or technical measures ensuring an equivalent level of environmental protection. The monitoring frequency may be reduced if the emission levels are proven to be sufficiently stable. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination.’; Or. en (02010L0075-20240804) Amendment 285 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 16 – paragraph 2 PE791.123v02-00 22/158 AM\1348825EN.docx EN Present text Amendment (1c) In Article 16, paragraph 2 is replaced by the following: 2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in a permit for each individual installation or in general binding rules. ‘2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in general binding rules. Monitoring requirements may be replaced by equivalent monitoring measures or technical measures ensuring an equivalent level of environmental protection. The monitoring frequency may be reduced if the emission levels are proven to be sufficiently stable. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination.’ Or. fr Amendment 286 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 16 – paragraph 4 Present text Amendment (1b) in Article 16, paragraph 4 is replaced by the following: 4. Where the assessment referred to in Article 15(5) demonstrates that the derogation will have a quantifiable or measurable effect on the environment, ‘4. Where the assessment referred to in Article 15(5) demonstrates that the derogation will have a measurable and significant effect on the environment, AM\1348825EN.docx 23/158 PE791.123v02-00 EN Member States shall ensure that the concentration of the pollutants concerned is monitored in the receiving environment. Where relevant, monitoring and measuring methods for each pollutant concerned which are set out in other relevant Union legislation shall be used for the purpose of the monitoring referred to in this paragraph. Member States shall ensure that the concentration of the pollutants concerned is monitored in the receiving environment. Where relevant, monitoring and measuring methods for each pollutant concerned which are set out in other relevant Union legislation shall be used for the purpose of the monitoring referred to in this paragraph.’; Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Justification If a technical study identifies only a negligible contribution, for example to the existing background pollution, there is no need to introduce monitoring of the pollutant concerned in the receiving environment. Amendment 287 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 18 Present text Amendment (1d) Article 18 is replaced by the following: Environmental quality standards Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures shall be included in the permit, with a view to reducing the specific contribution of the installation to the pollution occurring in the relevant area, without prejudice to other measures which may be taken to comply with environmental quality standards. Where stricter conditions have been included in the permit in accordance with the first paragraph, the competent authority shall ‘Environmental quality standards Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures may be included in the permit, without prejudice to other measures which may be taken to comply with environmental quality standards.’ PE791.123v02-00 24/158 AM\1348825EN.docx EN assess the impact of the stricter conditions on the concentration of the pollutants concerned in the receiving environment. Where the load of pollutants emitted by the installation has a quan tifiable or measurable effect on the environment, Member States shall ensure that the concentration of the pollutants concerned in the receiving environment is monitored. The results of such monitoring shall be transmitted to the competent authority. Where monitoring and measurement methods for the pollutants concerned are set out in other relevant Union legislation, such methods, including effect-based methods as appropriate, shall be used for the purpose of the monitoring referred to in the third paragraph. Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment ensures a more proportionate application of additional permit conditions where environmental quality standards require stricter measures than those achievable through BAT. It avoids automatic additional burdens where other measures may be more effective. Amendment 288 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 18 Present text Amendment (1c). Article 18 is replaced by the following: Article 18 ‘Article 18 Environmental quality standards Environmental quality standards AM\1348825EN.docx 25/158 PE791.123v02-00 EN Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures shall be included in the permit, with a view to reducing the specific contribution of the installation to the pollution occurring in the relevant area, without prejudice to other measures which may be taken to comply with environmental quality standards. Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures may be included in the permit, without prejudice to other measures which may be taken to comply with environmental quality standards.’; Where stricter conditions have been included in the permit in accordance with the first paragraph, the competent authority shall assess the impact of the stricter conditions on the concentration of the pollutants concerned in the receiving environment. Where the load of pollutants emitted by the installation has a quantifiable or measurable effect on the environment, Member States shall ensure that the concentration of the pollutants concerned in the receiving environment is monitored. The results of such monitoring shall be transmitted to the competent authority. Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Amendment 289 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1- point 1 b (new) Directive 2010/75/EU Article 18 Present text Amendment (1b) Article 18 is replaced by the following: PE791.123v02-00 26/158 AM\1348825EN.docx EN Where an environmental quality standard requires stricter condi tions than those achievable by the use of the best available tech niques, additional measures shall be included in the permit, without prejudice to other measures which may be taken to com ply with environmental quality standards. ‘Following the failure to achieve an environmental quality standard, the competent authority shall consider including additional conditions in the authorisation to reduce the specific contribution of the installation to pollution occurring in the relevant area, without prejudice to other measures that may be taken to comply with environmental quality standards and taking into account the technical- economic feasibility of such additional conditions. Where stricter conditions have been included in the permit in accordance with the first paragraph, the competent authority shall assess the impact of the stricter conditions on the concentration of the pollutants concerned in the receiving environment. Where the load of pollutants emitted by the installation has a quantifiable or measurable effect on the environment, Member States shall ensure that the concentration of the pollutants concerned in the receiving environment is monitored. The results of such monitoring shall be transmitted to the competent authority. Where monitoring and measurement methods for the pollutants concerned are set out in other relevant Union legislation, such methods, including effect-based methods as appropriate, shall be used for the purpose of the monitoring referred to in the third paragraph.’; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 290 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) AM\1348825EN.docx 27/158 PE791.123v02-00 EN Directive 2010/75/EU Article 20 – paragraph 2 – subparagraph 3 (new) Text proposed by the Commission Amendment (1a) In Article 20(2), the following subparagraph is added: ‘Member States shall establish shortened procedures for updating permits in the case of substantial changes to installations that have positive environmental impacts.’ Or. es Justification Member States should provide for fast-track procedures for installations that provide for substantial changes with the aim of improving their environmental performance. Amendment 291 Elżbieta Katarzyna Łukacijewska, Krzysztof Hetman Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 21 – paragraph 3 a (new) Text proposed by the Commission Amendment (1c) in Article 21, the following paragraph is inserted: 3a. For installations for which a decommissioning date has been set by law, the obligation to update the permit referred to in paragraph 3 shall not apply, provided that the remaining operating period is limited and that the competent authority considers that such update would be disproportionate in view of the remaining lifetime of the installation and the expected environmental benefits. Or. en PE791.123v02-00 28/158 AM\1348825EN.docx EN Justification For installations with a statutory closure date, full permit updates and related retrofits may be disproportionate where they would deliver only limited environmental benefits during the remaining operating period. A targeted clause would reduce unnecessary burden while preserving the competent authority’s assessment role. Amendment 292 François-Xavier Bellamy Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 21 – paragraph 3 – introductory part Text proposed by the Commission Amendment (1c) In Article 21(3), the introductory part is replaced by the following: 3. Within 4 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, the competent authority shall ensure that: ‘3. Within 8 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, the competent authority shall ensure that:’ Or. fr Amendment 293 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 21 – paragraph 3 Present text Amendment (1c) in Article 21, paragraph 3 is replaced by the following: 3. Within 4 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to ‘3. Within 8 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to AM\1348825EN.docx 29/158 PE791.123v02-00 EN the main activity of an installation, the competent authority shall ensure that: the main activity of an installation, the competent authority shall ensure that:’ (a) all the permit conditions for the installation concerned are reconsidered and, if necessary, updated to ensure compliance with this Directive, in particular, with Article 15(3), (4) and (5), where applicable; (a) all the permit conditions for the installation concerned are reconsidered and, if necessary, updated to ensure compliance with this Directive, in particular, with Article 15(3) and (4), where applicable; (b) the installation complies with those permit conditions. (b) the installation complies with those permit conditions. The reconsideration shall take into account all the new or updated BAT conclusions applicable to the installation and adopted in accordance with Article 13(5) since the permit was granted or last reconsidered. The reconsideration shall take into account all the new or updated BAT conclusions applicable to the installation and adopted in accordance with Article 13(5) since the permit was granted or last reconsidered." Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 294 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 2 – paragraph 1 – point 1a (new) Directive 2010/75/EU Article 21 – paragraph 3 Present text Amendment (1a) in Article 21, paragraph 3 is replaced by the following: 3. Within 4 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, the competent authority shall ensure that: ‘3. Within 8 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, the competent authority shall ensure that: (a) all the permit conditions for the installation concerned are reconsidered and, if necessary, updated to ensure compliance with this Directive, in particular, with Article 15(3), (4) and (5), where applicable; (a) all the permit conditions for the installation concerned are reconsidered and, if necessary, updated to ensure compliance with this Directive, in particular, with Article 15(3) and (5), where applicable; PE791.123v02-00 30/158 AM\1348825EN.docx EN (b) the installation complies with those permit conditions. (b) the installation complies with those permit conditions. The reconsideration shall take into account all the new or updated BAT conclusions applicable to the installation and adopted in accordance with Article 13(5) since the permit was granted or last reconsidered. The reconsideration shall take into account all the new or updated BAT conclusions applicable to the installation and adopted in accordance with Article 13(5) since the permit was granted or last reconsidered.’ Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Amendment 295 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 21 – paragraph 5 Present text Amendment (1d) In Article 21, paragraph 5 is replaced by the following: 5. The permit conditions shall be reconsidered and, where necessary, updated at least in the following cases: ‘"5. The permit conditions shall be reconsidered and, where necessary, updated at least in the following cases : (a) the pollution caused by the installation is of such significance that the existing emission limit values of the permit need to be revised or new such values need to be included in the permit; (a) the pollution caused by the installation is of such significance that the existing emission limit values of the permit need to be revised or new such values need to be included in the permit; (b) the operational safety requires other techniques to be use; (b) the operational safety requires other techniques to be use ; (c) where it is necessary to comply with an environmental quality standard referred to in Article 18, including in the case of a new or revised quality standard or where the status of the receiving environment requires a revision of the permit, in the context of the procedure referred to in Article 20 and Article 21, paragraph 3, in order to achieve compliance with plans (c) where it is necessary to comply with a new or revised environmental quality standard in accordance with Article 18.’ AM\1348825EN.docx 31/158 PE791.123v02-00 EN and programmes set under Union legislation; (d) in the case of a request from the operator to extend the duration of the operation of an installation undertaking the activity referred to in Annex I, point 5.4." Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 296 Pietro Fiocchi Proposal for a directive Article 2 – paragraph 1 – point 1 d(new) Directive 2010/75/EU Article 24 – paragraph 1 – point d Present text Amendment (1d) in Article 24(1), point (d) is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075- 20240804&qid=1783407411429) Justification Extending public participation to all procedures for adapting installations to the state of the art (BAT) is disproportionate. Existing permitting procedures already adequately incorporate public consultation for substantial changes. Generalising this obligation to all new permits resulting from IED reviews would significantly prolong permit delivery times. Amendment 297 Pietro Fiocchi Proposal for a directive Article 2 – paragraph 1 – point 1 e(new) Directive 2010/75/EU Article 24 – paragraph 1 – point e PE791.123v02-00 32/158 AM\1348825EN.docx EN Present text Amendment (1e) in Article 24(1), point (e) is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075- 20240804&qid=1783407411429) Justification Extending public participation to all procedures for adapting installations to the state of the art (BAT) is disproportionate. Existing permitting procedures already adequately incorporate public consultation for substantial changes. Generalising this obligation to all new permits resulting from IED reviews would significantly prolong permit delivery times. Amendment 298 Elżbieta Katarzyna Łukacijewska, Krzysztof Hetman Proposal for a directive Article 2 – paragraph 1 – point 1d (new) Directive 2010/75/EU Article 24 – paragraph 2 – point a Present text Amendment 1 d. in Article 24(2), point (a) is replaced by the following: (a) the content of the decision, including a copy of the permit and any subsequent updates, including consolidated permit conditions where relevant; ‘(a) the content of the decision, including a copy of the permit and any subsequent updates;’; Or. en Justification The wording “including consolidated permit conditions where relevant” is unclear and may create additional administrative burden for competent authorities and operators. It should remain for competent authorities to decide whether consolidation is appropriate in a given case. Amendment 299 Anna Zalewska AM\1348825EN.docx 33/158 PE791.123v02-00 EN Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 24 – paragraph 3 Present text Amendment (1c) in Article 24, paragraph 3 is replaced by the following: ‘3. The competent authority shall also make available to the public, including systematically via the internet, on a webpage which is easy to find, free of charge and without restricting access to registered users, the following:(a)relevant information on the measures taken by the operator upon definitive cessation of activities in accordance with Article 22;(b)the results of emission monitoring as required under the permit conditions and held by the competent authority;(c)the results of the monitoring referred to in Article 16(4) and in Article 18.’ ‘3. The competent authority shall ensure access to the following information, based on aggregated data:(a)relevant information on the measures taken by the operator upon definitive cessation of activities in accordance with Article 22;(b)the summary of emission monitoring as required under the permit conditions and held by the competent authority, excluding commercially confidential information;(c)the summary of the monitoring referred to in Article 16(4) and in Article 18.’ Or. en ((https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804)) Amendment 300 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1 e (new) Directive 2010/75/EU Article 27a – paragraph 3 – point g Present text Amendment (1e) in Article 27a(3), point (g) is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) PE791.123v02-00 34/158 AM\1348825EN.docx EN Justification The amendment streamlines the composition of the centre by focusing its assistance on public institutions, research bodies, industry, farmers, technology providers, Member States and the Commission. This strengthens technical and implementation-oriented expertise, reduces procedural complexity and supports the deployment of innovative and emerging techniques. Amendment 301 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Roman Haider, Viktória Ferenc Proposal for a directive Article 2 c– paragraph 1 – point 1b (new) Directive 2010/75/EU Article 27a – paragraph 3 – point g Present text Amendment " (1b) in Article 27a(3), point (g) is deleted; Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Amendment 302 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 27a – paragraph 3 – point e Present text Amendment (1d) In Article 27a(3), point (e) is replaced by the following: (e) representatives of the industries and farmers concerned; ‘(e) representatives of the industries concerned;’ Or. fr Amendment 303 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout AM\1348825EN.docx 35/158 PE791.123v02-00 EN Proposal for a directive Article 2 d – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 27c Present text Amendment (1d) Article 27c is replaced by the following: Article 27c ‘Article 27c Emission levels and indicative environmental performance values associated with emerging techniques Emission levels and indicative environmental performance values associated with emerging techniques By way of derogation from Article 21(3), the competent authority may set: By way of derogation from Article 21(3), the competent authority may set: (a) emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions do not, under normal operating conditions, exceed emission levels associated with emerging techniques as laid down in the decisions on BAT conclusions; (a) indicative emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions do not, under normal operating conditions, exceed emission levels associated with emerging techniques as laid down in the decisions on BAT conclusions.’ (b) indicative environmental performance values consistent with the decisions on BAT conclusions. (b) indicative environmental performance values consistent with the decisions on BAT conclusions. Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Amendment 304 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1a (new) Directive 2010/75/EU Article 27c Present text Amendment PE791.123v02-00 36/158 AM\1348825EN.docx EN (1a) Article 27c is replaced by the following: Emission levels and indicative environmental performance values associated with emerging techniques By way of derogation from Article 21(3), the competent authority may set: ‘Emission levels and indicative environmental performance values associated with emerging techniques By way of derogation from Article 21(3), the competent authority may set: (a) emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions do not, under normal operating conditions, exceed emission levels associ ated with emerging techniques as laid down in the decisions on BAT conclusions; (a) indicative emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions do not, under normal operating conditions, exceed emission levels associ ated with emerging techniques as laid down in the decisions on BAT conclusions.’ (b) indicative environmental performance values consistent with the decisions on BAT conclusions. Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment ensures that emerging techniques are promoted as innovation pathways rather than converted prematurely into binding benchmarks. Indicative emission limit values provide flexibility for first-of-a-kind technologies, reduce investment risk and support industrial transformation. Amendment 305 Martin Günther, Sebastian Everding, Per Clausen Proposal for a directive Article 2 – paragraph 1 – point 2 Directive 2010/75/EU Article 27d Text proposed by the Commission Amendment (2) Article 27d is deleted; deleted Or. en AM\1348825EN.docx 37/158 PE791.123v02-00 EN Amendment 306 Jutta Paulus Proposal for a directive Article 2 – paragraph 1 – point 2 Directive 2010/75/EU Article 27d Text proposed by the Commission Amendment (2) Article 27d is deleted; (2) In Article 27d(3), the second subparagraph is replaced by the following: ‘Where elements of the transformation plans have already been developed in accordance with other Union legislation and are compliant with this Article, a reference may be made in the transformation plan to the relevant documents. By 1 July 2028, the Commission shall adopt an implementing act specifying the circumstances in which operators may consider that elements of the transformation plans are developed in accordance with other Union legislation and may therefore only include a reference in transformation plans to the relevant documents. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2).’; Or. en Amendment 307 Martin Günther, Sebastian Everding, Per Clausen Proposal for a directive Article 2 – paragraph 1 – point 3 Directive 2010/75/EU Article 27e Text proposed by the Commission Amendment PE791.123v02-00 38/158 AM\1348825EN.docx EN (3) Article 27e is amended as follows: deleted (a) in paragraph 1, first subparagraph, the introductory sentence is replaced by the following: ‘Without prejudice to Article 18, in the event of deep industrial transformation of the installation, the competent authority may extend the period for the installation to comply with the updated permit conditions referred to in Article 21(3) up to a total of eight years maximum, provided that:;’ ‘Without prejudice to Articles 18 and 22, in the event of deep industrial transformation consisting of the closure of an installation and its replacement by a new installation to be completed within eight years of publication of decisions on BAT conclusions, in accordance with Article 13(5), relating to the main activity of the existing installation, the competent authority may waive the obligation of updating the permit in accordance with Article 21(3), provided that all the following conditions are met:;’ Or. en Amendment 308 Jutta Paulus Proposal for a directive Article 2 – paragraph 1 – point 3 Directive 2010/75/EU Article 27e Text proposed by the Commission Amendment (3) Article 27e is amended as follows: deleted (a) in paragraph 1, first subparagraph, the introductory sentence is replaced by the following: ‘Without prejudice to Article 18, in the event of deep industrial transformation of the installation, the competent authority AM\1348825EN.docx 39/158 PE791.123v02-00 EN may extend the period for the installation to comply with the updated permit conditions referred to in Article 21(3) up to a total of eight years maximum, provided that:;’ ‘Without prejudice to Articles 18 and 22, in the event of deep industrial transformation consisting of the closure of an installation and its replacement by a new installation to be completed within eight years of publication of decisions on BAT conclusions, in accordance with Article 13(5), relating to the main activity of the existing installation, the competent authority may waive the obligation of updating the permit in accordance with Article 21(3), provided that all the following conditions are met:;’ Or. en Amendment 309 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 2 – paragraph 1 – point 3 – point a Directive 2010/75/EU Article 27e – paragraph 1 – subparagraph 1 – introductory part Text proposed by the Commission Amendment Without prejudice to Article 18, in the event of deep industrial transformation of the installation, the competent authority may extend the period for the installation to comply with the updated permit conditions referred to in Article 21(3) up to a total of eight years maximum, provided that: Without prejudice to Article 18, in the event of deep industrial transformation of the installation, the competent authority may extend the period for the installation to comply with the updated permit conditions referred to in Article 21(3) up to a total of ten years maximum, provided that: Or. en Amendment 310 Anna Zalewska PE791.123v02-00 40/158 AM\1348825EN.docx EN Proposal for a directive Article 2 – paragraph 1 – point 3 – point a a (new) Directive 2010/75/EU Article 27e – paragraph 1 – subparagraph 3 (new) Text proposed by the Commission Amendment (aa) in paragraph 1, the following subparagraph is added: ‘The period referred to in the first subparagraph may be extended for such period as is strictly necessary, where compliance within eight years cannot reasonably be achieved due to the scale, technical complexity, investment cycle, construction schedule, permitting requirements, or dependency on enabling infrastructure of the deep industrial transformation provided that the delay is not attributable to circumstances within the operators control.’ Or. en Amendment 311 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 2 – paragraph 1 – point 3 – point b Directive 2010/75/EU Article 27e – paragraph 2 – subparagraph 1 – introductory part Text proposed by the Commission Amendment Without prejudice to Articles 18 and 22, in the event of deep industrial transformation consisting of the closure of an installation and its replacement by a new installation to be completed within eight years of publication of decisions on BAT conclusions, in accordance with Article 13(5), relating to the main activity of the existing installation, the competent authority may waive the obligation of updating the permit in accordance with Without prejudice to Articles 18 and 22, in the event of deep industrial transformation consisting of the closure of an installation and its replacement by a new installation to be completed within ten years of publication of decisions on BAT conclusions, in accordance with Article 13(5), relating to the main activity of the existing installation, the competent authority may waive the obligation of updating the permit in accordance with AM\1348825EN.docx 41/158 PE791.123v02-00 EN Article 21(3), provided that all the following conditions are met: Article 21(3), provided that all the following conditions are met: Or. en Amendment 312 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk, Ana Vasconcelos, Katri Kulmuni Proposal for a directive Article 2 – paragraph 1 – point 3 – point b a (new) Directive 2010/75/EU Article 27e – paragraph 2a (new) Text proposed by the Commission Amendment (ba) the following paragraph is added: ‘2a. Where a deep industrial transformation referred to in paragraphs 1 or 2 is materially dependent on the timely availability of external enabling infrastructure that is outside the control of the operator, including hydrogen infrastructure, carbon dioxide transport or storage infrastructure, low-carbon electricity supply or electricity grid capacity, the competent authority may extend the period referred to in paragraph 1 up to a total of ten years. Such an extension may be granted only where the operator demonstrates that the transformation remains technically and economically credible, that the delay is primarily caused by the lack of such external enabling infrastructure, and that the installation will apply interim measures to prevent or, where that is not practicable, minimise emissions and other environmental impacts. The competent authority shall include appropriate milestones, monitoring requirements and review clauses in the permit. This paragraph shall be without prejudice to Articles 14, 15, 18 and 22 and shall not allow a deterioration of local environmental quality or compliance with PE791.123v02-00 42/158 AM\1348825EN.docx EN applicable environmental quality standards.’; Or. en Justification Deep decarbonisation of energy-intensive industry often depends on external infrastructure that operators cannot deliver alone, such as hydrogen networks, CO₂ infrastructure or sufficient electricity grid capacity. Operators should not be penalised for infrastructure delays outside their control, provided the transformation remains credible and interim safeguards are applied. Amendment 313 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk Proposal for a directive Article 2 – paragraph 1 – point 3 – point b b (new) Directive 2010/75/EU Article 27e – paragraph 2b (new) Text proposed by the Commission Amendment (bb) the following paragraph is inserted: ‘2b. For installations, or clearly separable parts of installations, whose purpose is linked to defence or national security, the competent authority may set emission limit values derogating from BAT- associated emission levels where strict application of those levels would demonstrably and directly affect essential security interests, operational defence readiness, or the continuity of defence- critical production. Any such derogation shall be limited to the specific pollutant, process and period for which it is strictly necessary, shall be reviewed regularly and shall be accompanied by proportionate alternative measures to prevent or, where that is not practicable, minimise emissions and other environmental impacts. Member States shall document the reasons for such AM\1348825EN.docx 43/158 PE791.123v02-00 EN derogation, without requiring the disclosure of classified information.’; Or. en Justification Certain defence-critical installations may face exceptional operational or security constraints. A narrowly framed possibility to derogate from BAT-associated emission levels is justified where strict application would directly affect essential security interests or operational defence readiness. This does not create a general exemption from the IED, but ensures that environmental requirements are applied in a way that remains compatible with national security, while maintaining safeguards for human health and the environment. Amendment 314 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Articles 70a, 70b, 70c, 70d, 70e, 70f, 70g, 70h, 70i Text proposed by the Commission Amendment (3a) Articles 70a, 70b, 70c, 70d, 70e, 70f, 70g, 70h and 70i are deleted. Or. fr Amendment 315 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Articles 70a Text proposed by the Commission Amendment (3a) Article 70a is deleted Or. en PE791.123v02-00 44/158 AM\1348825EN.docx EN Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 316 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70a Present text Amendment Article 70a (3a) Article 70a is deleted Or. en Amendment 317 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70aa (new) Text proposed by the Commission Amendment (3a) the following article is inserted: ‘Article 70aa Overriding public interest Member States shall ensure that, in permitting procedures, as well as in the planning, construction and operation of livestock installations pursuant to Chapter VIa, including related infrastructures and installations, these activities are presumed AM\1348825EN.docx 45/158 PE791.123v02-00 EN to be in the overriding public interest, in particular serving food production, security of supply and sustainable agricultural management. Member States shall ensure that permitting procedures for such activities are conducted efficiently and without undue delay. Member States may, in duly justified individual cases, restrict the application of this paragraph to specific parts of their territory, specific categories of livestock installations or installations with specific technical characteristics. Member States shall inform the Commission of such restrictions and provide justification therefore.’; Or. en Justification Livestock farming makes an essential contribution to food production and security of supply in the Union. In a context of growing uncertainty and increasing requirements, maintaining a viable and sustainable production capacity is of particular importance.Classifying such activities as being in the overriding public interest strengthens legal certainty and enables more efficient procedures without undermining the objectives of Directive 2010/75/EU. It ensures an appropriate balance between environmental protection and food security. Amendment 318 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová, Antonín Staněk Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70b Text proposed by the Commission Amendment (3a) Article 70b is deleted. Or. fr PE791.123v02-00 46/158 AM\1348825EN.docx EN Justification Precise details on the aggregation rule introduced by the revision of the directive are not given at this stage and the rule is not suitable for livestock activities that are not industrial, when a company or group has numerous sites. The rule is a potential source of additional administrative complexity. Amendment 319 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70b Present text Amendment (3a) Article 70b is deleted Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Amendment 320 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Articles 70b Text proposed by the Commission Amendment (3b) Article 70b is deleted Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate AM\1348825EN.docx 47/158 PE791.123v02-00 EN administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 321 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70 b Present text Amendment (3a) Article 70b is deleted; Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 322 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70b – paragraph 1 Text proposed by the Commission Amendment (3a) In Article 70b, paragraph 1 is replaced by the following: Member States shall adopt measures to ensure that if two or more installations engaged in livestock rearing activities are located close to each other and if their operator is the same or if the installations are under the control of operators who are engaged in an economic or legal relationship, the competent authority may consider those installations to be a single unit for the purpose of calculating the capacity threshold referred to in Article 70a. Member States shall adopt measures to ensure that if two or more installations are engaged in livestock rearing activities, they are located very close to each other and if their operator is the same or they are under the control of operators who are engaged in an economic or legal relationship, the competent authority may consider those installations to be a single unit for the purpose of calculating the capacity threshold referred to in Article 70a. PE791.123v02-00 48/158 AM\1348825EN.docx EN Member States shall ensure that the rule referred to in the first subparagraph is not used to circumvent the obligations set out in this Directive. Member States shall ensure that the rule referred to in the first subparagraph is not used to circumvent the obligations set out in this Directive. Or. es Justification This amendment aims to make the wording of the Directive more precise and to give legal certainty to operators by clearly setting out the conditions for the application of the installation aggregation rule. It is also specified that installations must be ‘very’ close, which is a prerequisite for counting several installations as one. Otherwise, the distance between two pollution points would not justify the aggregation of installations from an environmental point of view. Amendment 323 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive (EU) 2010/75/EU Article 70b – paragraph 1 – subparagraph 1 Present text Amendment (3a) in Article 70b(1), the first subparagraph is deleted; Or. en (02010L0075-20240804) Amendment 324 Michal Wiezik, Martin Hojsík Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive (EU) 2024/1785 Article 70b – paragraph 1 – subparagraph 1 Present text Amendment AM\1348825EN.docx 49/158 PE791.123v02-00 EN (3a) in Article 70(b)(1), the first subparagraph is replaced with the following: Member States shall adopt measures to ensure that if two or more installations engaged in livestock rearing activities are located close to each other and if their operator is the same or if the installations are under the control of operators who are engaged in an economic or legal relationship, the competent authority may consider those installations to be a single unit for the purpose of calculating the capacity threshold referred to in Article 70a. ‘Member States shall adopt measures to ensure that if two or more installations engaged in livestock rearing activities are located close to each other or at any part of the area of land which drains into waters of the respective catchment and contributes to its pollution, and if their operator is the same or if the installations are under the control of operators who are engaged in an economic or legal relationship, or are under the control of different operators but belong to the same company, the competent authority may consider those installations to be a single unit for the purpose of calculating the capacity threshold referred to in Article 70a.’ Or. en (Directive (EU) 2024/1785) Justification While the EC will prepare guidance in 2028 for MS on the criteria to consider, the basic act can still use more precision- in particular the term used in other part of the Directive is inserted ''or are under the control of different operators but belong to the same company''. In the EU region where citizens won a court case related to livestock pollution in 2025, large number of installations pertain to the same company. Company is having more control over the thresholds and redistribution of installations than individual operators and in order to prevent circumvention of this rule, and to target all the subjects which are relevant for an application of this rule, this wording might better encompass the existing realities. Amendment 325 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive 2010/75/EU Articles 70c Text proposed by the Commission Amendment PE791.123v02-00 50/158 AM\1348825EN.docx EN (3c) Article 70c is deleted; Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 326 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70 c – paragraph 1 Present text Amendment (3b) In Article 70c, paragraph 1 is replaced by the following: Member States shall take the necessary measures to ensure that no installation falling within the scope of this Chapter operates without a permit or without being registered and that the operation of all installations within the scope of this Chapter complies with the uniform conditions for operating rules referred to in Article 70i. Member States shall take the necessary measures to ensure that no installation falling within the scope of this Chapter operates without a permit or without being registered and that the operation of all such installations complies with the uniform rules for operating conditions referred to in Article 70i. Member States may use any similar pre- existing procedure for the registration of installations in order to avoid creating an administrative burden. Member States may apply a permitting procedure to the intensive rearing of poultry and pigs: Member States may apply a permitting procedure to the rearing of poultry and pigs: (a) with more than 40 000 places for poultry; (a) with more than 40 000 places for poultry; AM\1348825EN.docx 51/158 PE791.123v02-00 EN (b) with more than 2 000 places for production pigs over 30 kg; or (b) with more than 2 000 places for production pigs (over 30 kg); (c) with more than 750 places for sows. (c) with more than 750 places for sows. Member States may include requirements for certain categories of installations falling within the scope of this Chapter in the general binding rules referred to in Article 6. Member States may include requirements for certain categories of installations falling within this Chapter in the general binding rules referred to in Article 6. Member States shall specify the procedure for registration or granting a permit in respect of installations falling within the scope of this Chapter. Those procedures shall include at least the information listed in paragraph 2. Member States shall specify the procedure for registration or permitting applicable to installations falling within this Chapter. Those procedures shall include, at a minimum, the information listed in paragraph 2. Or. fr Amendment 327 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70c – paragraph 2 – point c Text proposed by the Commission Amendment (3b) In article 70c(2), point (c) is deleted; Or. fr Amendment 328 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70c – paragraph 1 – subparagraph 1 Present text Amendment PE791.123v02-00 52/158 AM\1348825EN.docx EN (3b) in Article 70c(1), the first subparagraph is replaced by the following Member States shall take the necessary measures to ensure that no installation falling within the scope of this Chapter operates without a permit or without being registered and that the operation of all installations within the scope of this Chapter complies with the uniform conditions for operating rules referred to in Article 70i. ‘Member States shall take the necessary measures to ensure that no installation falling within the scope of this Chapter operates without a permit or without being registered and that the operation of all installations within the scope of this Chapter complies with the uniform conditions for operating rules referred to in Article 70i. This obligation shall apply only to installations newly constructed after the entry into force of this Chapter.’; Or. en (Directive 2010/75/EU) Amendment 329 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive 2010/75/EU Article 70c – paragraph 1 – subparagraph 3 Present text Amendment (3c) in Article 70c(1), the third subparagraph is deleted; Or. en (Directive 2010/75/EU) Amendment 330 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70d Text proposed by the Commission Amendment AM\1348825EN.docx 53/158 PE791.123v02-00 EN (3d) Article 70d is deleted; Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 331 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová, Antonín Staněk Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive 2010/75/EU Article 70d Text proposed by the Commission Amendment (3c) Article 70d is deleted; Or. fr Justification Given the reporting obligations already introduced by the Emissions Portal Regulation, this obligation seems redundant. Amendment 332 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) PE791.123v02-00 54/158 AM\1348825EN.docx EN Directive 2010/75/EU Article 70d Present text Amendment (3b) In Directive (EU) 2010/75, Article 70d is amended as follows: 1. Member States shall ensure that the operator carries out monitoring of emissions and of associated environmental performance levels in accordance with the uniform conditions for operating rules referred to in Article 70i. Member States shall ensure that the operator monitors emissions and associated environmental performance levels in accordance with the uniform operating rules referred to in Article 70i. Monitoring data shall be obtained by means of measurement methods or, where not practicable, by calculation methods such as the use of emission factors. The methods used for obtaining the monitoring data shall be described in the operating rules. Monitoring data shall be obtained by means of measurement methods or by calculation methods, including the use of emission factors. The methods used for obtaining the monitoring data shall be described in the operating rules. 2. In the event of non-compliance with the emission limit values and environmental performance limit values set out in the uniform conditions for operating rules referred to in Article 70i, Member States shall require the operator to take the measures necessary to ensure that compliance is restored within the shortest possible time. In the event of non-compliance with the emission limit values and environmental performance limit values set out in the uniform operating rules, Member States shall require the operator to take the measures necessary to ensure that compliance is restored within a compatible timeframe, taking account of the specificities of the agricultural sector. Or. fr Amendment 333 Michal Wiezik, Martin Hojsík Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70d – paragraph 3 a (new) Text proposed by the Commission Amendment (3b) in Article 70(d), the following paragraph is added: ‘3a. Member States may use the data on the use of veterinary antimicrobial medicinal products for which data on use AM\1348825EN.docx 55/158 PE791.123v02-00 EN shall be collected from data providers in accordance with Commission Delegated Regulation (EU) 2021/578 supplementing Regulation (EU) 2019/6, including from farmers, when selecting representative monitoring stations for the purpose of monitoring indicators of antimicrobial resistance on groundwater and surface water watch list in accordance with Directive (EU) 2026 /805. Where a monitoring station for indicators of antimicrobial resistance is located in the vicinity of a livestock installation covered by this Directive where this has a potential to affect the quality of water relevant for the monitoring in question, the respective operator of the livestock installation shall be given prior notice. The respective monitoring of indicators present on the surface and groundwater watch list comes at a no cost to the operator.’; Or. en Amendment 334 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70d Text proposed by the Commission Amendment (3d) Article 70d is amended as follows: (a) the third subparagraph of paragraph 1 is deleted; (b) paragraph 2 is replaced by the following: ‘2. In the event of non-compliance with the emission values and environmental performance limit values set out in the uniform conditions for operating rules PE791.123v02-00 56/158 AM\1348825EN.docx EN referred to in Article 70i, Member States shall require the operator to take the measures necessary to ensure that compliance is restored within deadlines compatible with the specificities of the agricultural sector.’ Or. fr Justification Livestock farming is based on biological cycles. Unlike the industrial sector, adjustments are constrained by unavoidable time factors. If limit values are exceeded as a result of production factors that are already in place (genetic type, working methods, production system, etc.), lowering those values may require an adaptation time that is considerably different from ‘simple’ technological adjustments. Amendment 335 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Articles 70e Text proposed by the Commission Amendment Article 70e (3e) Article 70e is deleted Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 336 François-Xavier Bellamy, Céline Imart AM\1348825EN.docx 57/158 PE791.123v02-00 EN Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70e Present text Amendment (3d) Article 70e is replaced by the following: 1.Member States shall ensure that suitable monitoring is carried out in accordance with the uniform conditions for operating rules referred to in Article 70i. 1. Member States shall ensure that suitable monitoring is carried out in accordance with the uniform operating rules referred to in Article 70i. 2.All monitoring results shall be recorded, processed and presented in such a way as to enable the competent authority to verify compliance with the operating conditions, emission limit values and environmental performance limit values which are included in the general binding rules referred to in Article 6 or in the permit. 2. All monitoring results shall be recorded, processed and presented in such a way as to enable the competent authority to verify compliance with the operating conditions, emission limit value ranges and environmental performance limit values which are set in the general binding rules referred to in Article 6 or in the permit. 3.The operator shall, without delay, make available the data and information listed in paragraph 2 to the competent authority upon request. The competent authority may make such a request in order to verify compliance with the uniform conditions for operating rules. The competent authority shall make that request if a member of the public requests access to the data or information listed in paragraph 2. 3. The operator shall make available the data and information referred to in paragraph 2 to the competent authority upon request. Or. fr Amendment 337 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70e – paragraph 2 Present text Amendment PE791.123v02-00 58/158 AM\1348825EN.docx EN (3e) In Article 70e, paragraph 2 is replaced by the following: 2. All monitoring results shall be recorded, processed and presented in such a way as to enable the competent authority to verify compliance with the operating conditions, emission limit values and environmental performance limit values which are included in the general binding rules referred to in Article 6 or in the permit. ‘2. All monitoring results shall be recorded, processed, and presented in such a way as to enable the competent authority to verify compliance with the operating conditions, emission limit values and environmental performance limit value ranges which are included in the general binding rules referred to in Article 6 or in the permit.’ Or. fr (DIRECTIVE 2010/75/EU) Justification Disclosing sensitive data on operations at each facility can leave farmers seriously exposed. Only the competent authority responsible for controls should have access to this information. Allowing anyone, even without any standing, to request such disclosure appears to be wholly disproportionate. Amendment 338 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 f (new) Directive 2010/75/EU Article 70e – paragraph 3 Present text Amendment (3f) In Article 70e, paragraph 3 is replaced by the following: 3. The operator shall, without delay, make available the data and information listed in paragraph 2 to the competent authority upon request. The competent authority may make such a request in order to verify compliance with the uniform conditions for operating rules. The competent authority shall make that request if a member of the public requests access to the data or information listed in paragraph 2. ‘3. The operator shall make available the data and information listed in paragraph 2 to the competent authority upon request. The competent authority may make such a request in order to verify compliance with the uniform conditions for operating rules.’ AM\1348825EN.docx 59/158 PE791.123v02-00 EN Or. fr (DIRECTIVE 2010/75/EU) Justification Disclosing sensitive data on operations at each facility can leave farmers seriously exposed. Only the competent authority responsible for controls should have access to this information. Allowing anyone, even without any standing, to request such disclosure appears wholly disproportionate. Amendment 339 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 f(new) Directive 2010/75/EU Articles 70f Text proposed by the Commission Amendment (3f) Article 70f is deleted Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 340 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70f – paragraph 3 – subparagraph 1 Present text Amendment PE791.123v02-00 60/158 AM\1348825EN.docx EN (3e) In Article 70f(3), the first subparagraph is replaced by the following: 3. In the event of non-compliance with the requirements set out in this Chapter, Member States shall ensure that the competent authority requires the operator to take any measures, in addition to the measures taken by the operator under Article 70d, that are necessary to ensure that compliance is restored without delay. ‘3. In the event of non-compliance with the requirements set out in this Chapter, Member States shall ensure that the competent authority requires the operator to take any measures, in addition to the measures taken by the operator under Article 70d, that are necessary to ensure that compliance is restored within a reasonable deadline which takes account of the specificities of the sector.’ Or. fr Amendment 341 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová, Antonín Staněk Proposal for a directive Article 2 – paragraph 1 – point 3 g (new) Directive 2010/75/EU Article 70f – paragraph 3 – subparagraph 1 Present text Amendment (3g) In Article 70f, paragraph 3, the first subparagraph is replaced by the following: 3. In the event of non-compliance with the requirements set out in this Chapter, Member States shall ensure that the competent authority requires the operator to take any measures, in addition to the measures taken by the operator under Article 70d, that are necessary to ensure that compliance is restored without delay. ‘3. In the event of non-compliance with the requirements set out in this Chapter, Member States shall ensure that the competent authority requires the operator to take any measures, in addition to the measures taken by the operator under Article 70d, that are necessary to ensure that compliance is restored within a reasonable deadline which takes account of the specificities of the sector.’ Or. fr (DIRECTIVE 2010/75/EU) AM\1348825EN.docx 61/158 PE791.123v02-00 EN Amendment 342 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70f – paragraph 3 – subparagraph 2 Present text Amendment (3b) In Article 70f, the second subparagraph of paragraph 3 is replaced by the following: Where non-compliance causes a significant degradation of local air, water or soil conditions, or where it poses, or risks posing, a significant danger to human health, the operation of the installation shall be suspended by the competent authority until compliance is restored. Where non-compliance causes a significant degradation of local air, water or soil conditions, or where it poses, or risks posing, a significant danger to human health, the competent authority may adopt relevant measures to ensure compliance, including suspending the operation of the installation until compliance is restored. Or. es Justification The Directive should provide for the possibility of not applying the suspension of activity directly in case of non-compliance. The avenues for cooperation between the administration and the company responsible should be exhausted before resorting to drastic measures. Amendment 343 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 f (new) Directive 2010/75/EU Article 70g Text proposed by the Commission Amendment (3f) Article 70g is replaced by the following: 1. Member States shall ensure that the public concerned are given early and effective opportunities to participate in the following procedures: ‘1. Member States shall ensure that the public directly concerned are given, at an early and effective stage, the opportunity to participate in the following procedures: PE791.123v02-00 62/158 AM\1348825EN.docx EN (a) preparation of general binding rules as referred to in Article 6 on permits for installations falling within the scope of this Chapter; (a) preparation of general binding rules as referred to in Article 6 on permits for installations falling within this Chapter; (b) the granting of a permit for a new installation falling within the scope of this Chapter; (b) the granting of a permit for a new installation; (c) the granting of an updated permit in accordance with Article 70c(4) for any substantial change to an existing installation falling within the scope of this Chapter; or (c) the granting of an updated permit in accordance with Article 70c(4) for any substantial change to an existing installation; (d) the procedure for registration, in the event that general binding rules are not adopted, and the Member States allow the installation only to be registered. (d) the procedure for registration, in the event that general binding rules are not adopted, and the Member State allows only registration. 2. The competent authority shall make available to the public, including systematically via the internet, free of charge and without restricting access to registered users, the following documents and information: 2. The competent authority shall make available to the public directly concerned, including via the internet, free of charge and without restricting access to registered users, the following documents and information: (a) the permit or the registration; (a) the permit or the registration; (b) the results of the consultations held in accordance with paragraph 1; (b) the results of the consultations held in accordance with paragraph 1; (c) the general binding rules referred to in Article 6 which are applicable to installations falling within the scope of this Chapter; and (c) the general binding rules referred to in Article 6.’ (d) the reports of inspections of the installations falling within the scope of this Chapter. Or. fr Amendment 344 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive (EU) 2010/75/EU Article 70g – paragraph 1 – introductory part AM\1348825EN.docx 63/158 PE791.123v02-00 EN Present text Amendment (3b) in Article 70g(1), the introductory part is replaced by the following: 1. Member States shall ensure that the public concerned are given early and effective opportunities to participate in the following procedures: ‘1. Member States shall ensure that the public directly affected are given early and effective opportunities to participate in the following procedures:’ Or. en (02010L0075-20240804) Amendment 345 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive (EU) 2010/75/EU Article 70g – paragraph 2 – introductory part Present text Amendment (3c) in Article 70g(2), the introductory part is replaced by the following: 2. The competent authority shall make available to the public, including systematically via the internet, free of charge and without restricting access to registered users, the following documents and information: ‘2. The competent authority shall make available to the public directly affected, including via the internet, free of charge and without restricting access to registered users, the following documents and information:’ Or. en (02010L0075-20240804) Amendment 346 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 70g – paragraph 2 – point d PE791.123v02-00 64/158 AM\1348825EN.docx EN Text proposed by the Commission Amendment (3h) In article 70g(2), point (d) is deleted; Or. fr Justification Checks are the state’s responsibility, and it will take any measures needed to ensure installations operate properly. There is no reason to give open access to these reports. Amendment 347 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 g (new) Directive 2010/75/EU Article 70g Text proposed by the Commission Amendment (3g) Article 70g is amended as follows: (a) in paragraph 1, the introductory part is replaced by the following: ‘Member States shall ensure that the public directly affected are given early and effective opportunities to participate in the following procedures:’ (b) paragrah 2 is replaced by the following: ‘2. The competent authority shall make available to the public directly affected, including via the internet, free of charge and without restricting access to registered users, the following documents and information: (a) the permit; (b) the results of the consultations held in accordance with paragraph 1; (c) the general binding rules referred to in Article 6 applicable to installations falling within the scope of this Chapter.’; AM\1348825EN.docx 65/158 PE791.123v02-00 EN Or. en Justification Only persons with a direct interest in the case should have standing to take part in the permit‑granting or permit‑updating process. Amendment 348 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 70h Text proposed by the Commission Amendment (3h) Article 70h is deleted Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 349 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 g (new) Directive 2010/75/EU Article 70h – paragraph 1 Text proposed by the Commission Amendment (3g) In Article 70h, paragraph 1 is replaced by the following: Member States shall ensure that, in accordance with the relevant national legal Member States shall ensure that, in accordance with the relevant national legal PE791.123v02-00 66/158 AM\1348825EN.docx EN system, members of the public concerned have access to a review procedure before a court of law or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to this Chapter when one of the following conditions is met: system, members of the public directly concerned have access to a review procedure before a court of law, or another independent and impartial body established by law, in order to challenge the substantive or procedural legality of decisions, acts or omissions subject to this Chapter when one of the following conditions is met: (a) they have a sufficient interest; (a) they have a direct interest; (b) they maintain the impairment of a right, where administrative procedural law of a Member State requires this as a precondition. (b) they cite the impairment of a right, where administrative procedural law of a Member State requires this as a precondition. Standing in the review procedure shall not be conditional on the role that the member of the public concerned played during a participatory phase of the decision- making procedures under this Directive. The admissibility of the review procedure shall not be made conditional on the role that the member of the public concerned played during a participatory phase of the decision-making procedures under this Directive. The review procedure shall be fair, equitable, timely and not prohibitively expensive, and shall provide for adequate and effective remedies, including injunctive relief as appropriate. The review procedure shall be equitable, impartial, timely and not prohibitively expensive, and shall provide for adequate and effective redress mechanisms, including injunctive relief as appropriate. Or. fr Amendment 350 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70h – paragraph 1 – introductory part Present text Amendment (3d) in Article 70h(1), the introductory part is replaced by the following: Member States shall ensure that, in accordance with the relevant national legal system, members of the public concerned ‘Member States shall ensure that, in accordance with the relevant national legal system, members of the public directly AM\1348825EN.docx 67/158 PE791.123v02-00 EN have access to a review procedure before a court of law, or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to this Chapter when one of the following conditions is met: affected have access to a review procedure before a court of law, or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to this Chapter when one of the following conditions is met:’ Or. en (02010L0075-20240804) Amendment 351 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70h – paragraph 1 – point a Present text Amendment (3e) in Article 70h(1), point a is replaced by the following: (a) they have a sufficient interest; ‘(a) they have a direct interest;’; Or. en (02010L0075-20240804) Amendment 352 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70h – paragraph 2 a (new) Text proposed by the Commission Amendment (3d) in Article 70h, the following paragraph is added: PE791.123v02-00 68/158 AM\1348825EN.docx EN ‘2a. In the context of judicial proceedings relating to permitting decisions under this Directive, Member States may preclude arguments from being raised before a court of law where they were not raised during the administrative stage, as long as the competent authority made available the necessary information in due time so that those arguments were known or could have been known and reviewed during the administrative stage leading to the authorisation of the project, without prejudice to the right of access to justice.’; Or. en (Directive 2010/75/EU) Amendment 353 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 70i Text proposed by the Commission Amendment (3h) Article 70i is replaced by the following: 1. The Commission shall organise an exchange of information between Member States, the sectors concerned, non- governmental organisations promoting environmental protection and the Commission before establishing uniform conditions for operating rules in accordance with paragraph 2. The exchange of information shall, in particular, address the following: ‘1. The Commission shall organise an exchange of information between Member States, the sectors concerned, non- governmental organisations promoting environmental protection and the Commission before establishing uniform conditions for operating rules in accordance with paragraph 2. The exchange of information shall, in particular, address the following: (a) the emission and environmental performance levels of installations and techniques, and other measures consistent with Annex III; (a) the emission and environmental performance levels of installations and techniques, and other measures consistent with Annex III; AM\1348825EN.docx 69/158 PE791.123v02-00 EN (b) the techniques used, associated monitoring, cross-media effects, economic and technical viability and developments in that regard; (b) the techniques used, associated monitoring, cross-media effects, economic and technical viability and developments in that regard; (c) best available techniques identified after considering the issues mentioned in points (a) and (b); (c) best available techniques identified after considering the issues mentioned in points (a) and (b); (d) emerging techniques. (d) emerging techniques. 1a. The limit values provided for in the uniform conditions for operating rules may be assessed by physiological stage or on an overall holding basis. 2. Before adopting the implementing act establishing uniform rules for operating conditions, the Commission shall carry out an assessment of the economic, financial, social and environmental impacts of the proposed measures. That assessment shall be made public before the draft implementing act is submitted for consultation. 2. The Commission shall adopt by 1 September 2026 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia. 2. The Commission shall adopt by 1 September 2027 an implementing act establishing uniform rules on operating conditions for each of the activities referred to in Annex Ia. The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture-based rearing systems, where animals are only seasonally reared in indoor installations. They shall also include indicative information on emerging techniques, where available. The uniform rules on operating conditions shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds by animal type in mixed farms, and the specificities of outdoor rearing systems, where animals are only seasonally reared indoors. They shall also include, where appropriate, indicative information on emerging techniques. Member States may supplement or replace the emission levels and environmental performance of installations and techniques referred to in point (a) of paragraph 1 with parameters or technical measures that ensure a high level of environmental protection, while taking into account the specific structural, PE791.123v02-00 70/158 AM\1348825EN.docx EN climate and economic features of livestock systems. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). 3. Member States shall ensure that the competent authority follows or is informed of developments in best available techniques and of the publication of any new or updated uniform conditions for operating rules. Member States shall ensure that the competent authority follows or is informed of developments in best available techniques and of the publication of any new uniform rules for operating conditions or updates thereof. 4. The uniform rules on operating conditions adopted under this Article shall constitute fully harmonised requirements for the activities falling under Annex Ia, and Member States shall not adopt or maintain additional or more stringent national measures concerning emission reduction, nutrient and manure management, housing systems, environmental performance obligations or other operational environmental requirements for those activities, unless such derogation is explicitly provided for under Union law. By way of derogation from the first sentence and Article 70c, the competent authority may, in duly justified exceptional cases, set less stringent emission limit values or environmental performance standards where a documented assessment demonstrates that achieving the levels resulting from application of the uniform rules would entail costs that are manifestly disproportionate to the environmental benefits, provided that no significant pollution is caused and that all Union environmental quality standards are followed. The competent authority shall set out, in an annex to the permit conditions, the reasons justifying such a derogation, including the results of the assessment and the justification for the conditions imposed.’ Or. fr AM\1348825EN.docx 71/158 PE791.123v02-00 EN Amendment 354 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive 2010/75/EU Article 70i – paragraph 2 – subparagraph 1 Text proposed by the Commission Amendment (3c) In Article 70i, paragraph 2, subparagraph 1 is replaced by the following: The Commission shall adopt by 1 September 2026 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia. ‘The Commission shall adopt by 1 September 2028 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia.’ Or. es Justification It is necessary to provide for reasonable time frames for establishing uniform conditions for the operation of livestock rearing activities. In line with the approach taken in terms of implementation deadlines, a longer deadline can be envisaged for the adoption of the implementing act, which should be done in dialogue and consultation with the sectors concerned, who will be responsible for making the required investments. Amendment 355 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 i (new) Directive 2010/75/EU Article 70i Text proposed by the Commission Amendment (3i) Article 70i is amended as follows: (a) In paragraph 1, the following points are added: PE791.123v02-00 72/158 AM\1348825EN.docx EN ‘(da) Prior to the adoption of the implementing act to establish uniform conditions for operating rules, the Commission shall carry out an assessment of the economic, financial, social and environmental impacts of the planned measure; (db) The assessment shall be published before the consultation phase for the draft implementing act.’; (b) The following paragraph is inserted: ‘1a. The limit values provided for in the uniform conditions for operating rules may be assessed by physiological stage or on an overall holding basis.’ (c) In paragraph 2, the second subparagraph is replaced by the following: ‘The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture- based rearing systems, where animals are only seasonally reared in indoor installations. They shall also include indicative information on emerging techniques, where available. Member States may supplement or replace the emission levels and environmental performance of installations and techniques referred to in point (a) of paragraph 1 with parameters or technical measures that ensure a high level of environmental protection, while taking into account the specific structural, climate and economic features of livestock systems.’; (d) The following paragraph is added: ‘4. By way of derogation from Article 70c, the competent authority may, in specific cases, set less strict environmental performance or emission limits. Such a AM\1348825EN.docx 73/158 PE791.123v02-00 EN derogation may apply only where an assessment shows that the achievement of emission levels and environmental performance as described in the operating rules referred to in paragraph 1 would lead to disproportionately higher costs compared to the environmental benefits. The competent authority shall document in an annex to the permit conditions the reasons for which the first subparagraph applies, including the result of the assessment and the justification for the conditions imposed, and shall ensure that no significant pollution is caused.’; Or. fr Amendment 356 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70i – paragraph 1 – point b Present text Amendment (3d) In Article 70i, paragraph 1, point (b) is replaced by the following: the techniques used, associated monitoring, cross-media effects, economic and technical viability and developments in that regard; ‘the techniques used, associated monitoring, cross-media effects, economic and technical viability, the value for money of their use in relation to the size of the farm, the climatic and regional conditions, and the availability of sufficiently representative and comparable data;’ Or. es ((02010L0075-20240804)) Amendment 357 Carmen Crespo Díaz, Dolors Montserrat PE791.123v02-00 74/158 AM\1348825EN.docx EN Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70i – paragraph 2 – subparagraph 2 Present text Amendment (3e) In Article 70i, paragraph 2, the second subparagraph is replaced by the following: The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture-based rearing systems, where animals are only seasonally reared in indoor installations. ‘The uniform operating conditions shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of the installations, the size of the farms, the various production systems, the climatic and regional conditions, including Mediterranean climates, and the technical and financial viability of the techniques required. Such conditions shall not impose any emission limit values or environmental performance levels that cannot be achieved using techniques that are available, proportionate and economically viable for the category of farm in question.’ Or. es ((02010L0075-20240804)) Amendment 358 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 f (new) Directive 2010/75/EU Article 70i – paragraph 2 – subparagraph 2 a (new) Present text Amendment (02010L0075-20240804) (3f) In Article 70i, paragraph 2, the following subparagraph is added: ‘Prior to the adoption of the implementing act mentioned in this paragraph, the AM\1348825EN.docx 75/158 PE791.123v02-00 EN Commission shall carry out an assessment of the economic, financial, social and environmental impacts of the proposed measures. That assessment shall consider, in particular, their effects on the viability of livestock farms, production capacity, the competitiveness of the sector, food security, competent administrations and small and medium-sized farms. The assessment shall be published before the submission of the draft implementing act.’ Or. es ((02010L0075-20240804)) Amendment 359 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 g (new) Directive 2010/75/EU Article 70i – paragraph 3 a (new) Present text Amendment (02010L0075-20240804) (3g) In Article 70i, the following paragraph is added: ‘3a. Uniform operating conditions adopted pursuant to this Article shall constitute harmonised requirements for the activities listed in Annex Ia. Member States may not adopt or maintain any additional or more stringent operational environmental requirements as regards the matters regulated by those uniform operating conditions, unless such requirements are demanded by Union law.’ Or. es ((02010L0075-20240804)) PE791.123v02-00 76/158 AM\1348825EN.docx EN Amendment 360 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 70i – paragraph 3 b (new) Present text Amendment (02010L0075-20240804) (3h) In Article 70i, the following paragraph is added: ‘3b. Notwithstanding the provisions in paragraph 2 of this Article and in Article 70c, the competent authority may, in duly justified and exceptional cases, set less stringent emission or environmental performance levels than those derived from the uniform operating conditions in respect of a specific installation, where it is proven by means of a documented assessment that achieving those levels would generate costs that are clearly disproportionate to the environmental benefits owing to: (a) the geographical location of the installation; (b) the local environmental conditions; (c) the climatic or regional conditions; (d) the technical, structural or production-related characteristics of the installation. In such cases, the competent authority shall explicitly justify the decision, including the outcome of the assessment carried out and the justification for the conditions imposed. Application of this derogation may not compromise compliance with the relevant environmental quality standards.’ Or. es ((02010L0075-20240804)) AM\1348825EN.docx 77/158 PE791.123v02-00 EN Amendment 361 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70i – paragraph 2 Present text Amendment (3b) in Article 70i, paragraph 2 is replaced by the following: 2. The Commission shall adopt by 1 September 2026 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia. ‘2 The Commission shall adopt by 1 September 2027 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia. The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture-based rearing systems, where animals are only seasonally reared in indoor installations. They shall also include indicative information on emerging techniques, where available. The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture-based rearing systems, where animals are only seasonally reared in indoor installations. They shall also include indicative information on emerging techniques, where available. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). Before adopting the implementing act referred to in the first subparagraph of this Article, the Commission shall carry out and publish a comprehensive impact assessment. The impact assessment shall evaluate the expected economic, financial, social and environmental impacts of the proposed measures, including their effects on the competitiveness of Union industry and agriculture, the viability of agricultural holdings, food security, investment capacity, innovation, administrative burden, employment, rural PE791.123v02-00 78/158 AM\1348825EN.docx EN areas, security of supply, and the level playing field within the internal market and internationally. The assessment shall also examine the proportionality and cost- effectiveness of the proposed measures, including their cumulative impacts in combination with other relevant Union legislation. The implementing act shall not be adopted before that assessment has been completed and made publicly available.’ Or. en ((https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804)) Amendment 362 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70i Present text Amendment (3e) in Article 70i, the following paragraphs are added: ‘3a. When establishing uniform operating conditions pursuant to this Article, it shall be ensured that the requirements are defined having regard to technical feasibility and the economic viability of the installations concerned. In particular, due account shall be taken of the principle of proportionality, so that the economic burden for operators remains commensurate with the environmental benefit pursued. 3b. When establishing uniform operating conditions pursuant to this Article, it shall be ensured that requirements relating to monitoring, measurements, reporting and documentation do not go beyond what is necessary to ensure a high level of environmental protection overall. The AM\1348825EN.docx 79/158 PE791.123v02-00 EN specific characteristics of agricultural activities and the economic viability of the installations concerned shall be duly taken into account. With regard to small and medium-sized agricultural holdings within the meaning of Commission Recommendation 2003/361/EC, the uniform operating conditions shall respect the principle of proportionality and, where appropriate, allow for the application of simplified and standardised requirements.’; Or. en (Directive 2010/75/EU) Amendment 363 Michal Wiezik, Martin Hojsík Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive (EU) 2024/1785 Article 70i– paragraph 3 Present text Amendment (3c) Article 70i(3) is replaced by the following: Member States shall ensure that the competent authority follows or is informed of developments in best available techniques and of the publication of any new or updated uniform conditions for operating rules.’ ‘Member States shall ensure that the competent authority follows or is informed of developments in best available techniques, and of updated lists of pollutants and their quality standards, where applicable, and of the publication of any new or updated uniform conditions for operating rules. Uniform conditions for operating rules shall in particular follow any update in a potential classification of indicators of antimicrobial resistance as pollutants, following their removal from the watchlist, and propose appropriate measures to ensure high protection of environment and human health. ’ PE791.123v02-00 80/158 AM\1348825EN.docx EN Or. en (DIRECTIVE (EU) 2024/1785) Justification it is opportune to include in this omnibus a future-proof provision that in case indicators of antimicrobial resistance get to the list of priority substances, they might become as well new pollutants to take care of in case of livestock installations covered by this Directive. Amendment 364 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 i (new) Directive 2010/75/EU Article 73 – paragraph 3 Text proposed by the Commission Amendment (3i) In Article 73, paragraph 3 is deleted; Or. fr Amendment 365 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová, Antonín Staněk Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 73 – paragraph 3 Text proposed by the Commission Amendment (3h) In Article 73, paragraph 3 is deleted; Or. fr Justification This report is not useful because it does not take account of mirror clauses and because European cattle farming is in a particularly sensitive situation. It would create a significant AM\1348825EN.docx 81/158 PE791.123v02-00 EN administrative burden and costs at a time when the number of livestock is falling and new rules would exacerbate the considerable challenges of generational renewal. Amendment 366 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 f (new) Directive 2010/75/EU Article 73 Present text Amendment (3f) Article 73 is replaced by the following: Article 73 ‘Article 73 Review Review 1. By 30 June 2028 and every 5 years thereafter, the Commission shall submit to the European Parliament and to the Council a report reviewing the implementation of this Directive. The report shall include information on activities for which BAT conclusions have or have not been adopted pursuant to Article 13(5) of this Directive, take into account the dynamics of innovation, including emerging techniques, the need for further pollution prevention measures and the review referred to in Article 8 of Directive 2003/87/EC. 1. By 30 June 2028 and every 5 years thereafter, the Commission shall submit to the European Parliament and to the Council a report reviewing the implementation of this Directive. The report shall include information on activities for which BAT conclusions have or have not been adopted pursuant to Article 13(5) of this Directive, take into account the dynamics of innovation, including emerging techniques, the need for further pollution prevention measures and the review referred to in Article 8 of Directive 2003/87/EC. That report shall include an assessment of the need for Union action through the establishment or updating of Union-wide minimum requirements for emission limit values and for rules on monitoring and compliance for activities within the scope of the BAT conclusions adopted during the previous five-year period, on the basis of the following criteria: That report shall include an assessment of the need for Union action through the establishment or updating of Union-wide minimum requirements for emission limit values and for rules on monitoring and compliance for activities within the scope of the BAT conclusions adopted during the previous five-year period, on the basis of the following criteria: (a) the impact of the activities concerned on the environment as a whole and on human health; (a) the impact of the activities concerned on the environment as a whole and on human health; PE791.123v02-00 82/158 AM\1348825EN.docx EN (b) the state of implementation of best available techniques for the activities concerned. (b) the state of implementation of best available techniques for the activities concerned. That assessment shall consider the opinion of the forum referred to in Article 13(4). That assessment shall consider the opinion of the forum referred to in Article 13(4). Chapter III and Annex V of this Directive shall be considered to represent the Union- wide minimum requirements in the case of large combustion plants. Chapter III and Annex V of this Directive shall be considered to represent the Union- wide minimum requirements in the case of large combustion plants. The report shall be accompanied by a legislative proposal where appro priate. Where the assessment referred to in the second subparagraph identifies such a need, the legislative proposal shall include provisions establishing or updating Union- wide minimum requirements for emission limit values and for rules on monitoring and compliance assessment for the activities concerned. The report shall be accompanied by a legislative proposal where appro priate. Where the assessment referred to in the second subparagraph identifies such a need, the legislative proposal shall include provisions establishing or updating Union- wide minimum requirements for emission limit values and for rules on monitoring and compliance assessment for the activities concerned. 2. The Commission shall, by 31 December 2012, review the need to control emissions from: 2. The Commission shall, by 31 December 2012, review the need to control emissions from: (a) the combustion of fuels in installations with a total rated thermal input below 50 MW; (a) the combustion of fuels in installations with a total rated thermal input below 50 MW; (b) the intensive rearing of cattle; and (b) the intensive rearing of cattle; and (c) the spreading of manure. (c) the spreading of manure. The Commission shall report the results of that review to the European Parliament and to the Council accompanied by a legislative proposal where appropriate. The Commission shall report the results of that review to the European Parliament and to the Council accompanied by a legislative proposal where appropriate. 3. The Commission shall, using an evidence-based methodology and taking into account the specificities of the sector, assess the need for Union action to: 3. The Commission shall, using an evidence-based methodology and taking into account the specificities of the sector, assess the need for Union action to: (a) comprehensively address the emissions from the rearing of livestock within the Union, in particular from cattle; and (b) further achieve the objective of global environmental protection with respect to products placed on the Union market, through the prevention and control of emissions from livestock farming, and in a (b) further achieve the objective of global environmental protection with respect to products placed on the Union market, through the prevention and control of emissions from livestock farming, and in a AM\1348825EN.docx 83/158 PE791.123v02-00 EN manner consistent with the Union’s international obligations. manner consistent with the Union’s international obligations; and (c) keep the economic impacts on the holdings concerned as limited as possible. The Commission shall report the results of that assessment by 31 December 2026 to the European Parliament and the Council. The report shall be accompanied by a legislative proposal where appropriate. The Commission shall report the results of that assessment by 31 December 2026 to the European Parliament and the Council. The report shall be accompanied by a legislative proposal where appropriate. 4. With regard to Chapter VIa, the Commission shall review: (a) the economic impacts on holdings, differentiated by size, type of production and regional conditions, with particular regard to family-run holdings and small and medium-sized enterprises; (b) administrative burdens, in particular reporting obligations as well as measurement and documentation requirements, and their costs, with the objective of reducing bureaucracy; (c) the appropriateness of thresholds and scope of application, in particular with regard to structurally disadvantaged regions and extensive or site-adapted farming systems; (d) the practical feasibility and technical availability of emission reduction measures as well as their cost- effectiveness; (e) potential distortions of competition within the internal market and in international trade, including the risk of production relocation; (f) coherence with other Union policies and legal acts, in particular the Common Agricultural Policy, in order to avoid double burdens; (g) impacts on security of supply, price development and the long-term viability of agricultural production in the Union. The Commission shall submit a report on the outcome of this review to the European Parliament and the Council PE791.123v02-00 84/158 AM\1348825EN.docx EN within five years of the entry into force of this Directive. That report shall, where appropriate, be accompanied by a legislative proposal. 5. A Member State may apply to the Commission for a derogation from specific provisions of Chapter VIa, provided that it demonstrates that: (a) an at least equivalent or higher level of environmental protection is achieved through national measures; (b) the functioning of the internal market is not adversely affected; and (c) no unjustified distortions of competition arise. The application shall be duly reasoned and accompanied by an impact assessment. The Commission shall decide on the application by means of an implementing act in accordance with the examination procedure referred to in Article [X]. That implementing act may lay down conditions, time limits or reporting obligations. The authorisation shall be granted for a maximum period of five years and may be extended, upon request by the Member State concerned, provided that the conditions continue to be fulfilled. 4. The Commission shall review: 6. The Commission shall review: (a) the need to control emissions from onshore and offshore explo ration and production of mineral oil and gas; (a) the need to control emissions from onshore and offshore explo ration and production of mineral oil and gas; (b) the need to control emissions from the on-site treatment and extraction of non- energy industrial minerals used in industry other than for construction, as well as the need to control emissions from the on-site treatment and extraction of ores which are newly carried out in the Union; (b) the need to control emissions from the on-site treatment and extraction of non- energy industrial minerals used in industry other than for construction, as well as the need to control emissions from the on-site treatment and extraction of ores which are newly carried out in the Union; (c) the need to revise the activity threshold in Annex I for the production of hydrogen by electrolysis of water. (c) the need to revise the activity threshold in Annex I for the production of hydrogen by electrolysis of water. AM\1348825EN.docx 85/158 PE791.123v02-00 EN The Commission shall include the results of that review in the first of the reports to the European Parliament and to the Council required under the first paragraph. The Commission shall include the results of that review in the first of the reports to the European Parliament and to the Council required under the first paragraph.’ Or. en (Directive 2010/75/EU) Amendment 367 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 i (new) Directive 2024/1785 Article 73 – paragraph 3 Text proposed by the Commission Amendment (3i) in Article 73, paragraph 3 is deleted. Or. en Justification Livestock farming is fundamentally different from industrial activities. Cattle production is land-based, highly dependent on biological processes and local conditions, and cannot be effectively regulated through an installation-based framework such as the IED. Including livestock farms within the Directive would create disproportionate administrative burdens and legal uncertainty without delivering clear environmental benefits. Amendment 368 Jutta Paulus Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 73 – paragraph 3 – point (a) Present text Amendment (3a) In Article 73(3), point (a) is replaced by the following: PE791.123v02-00 86/158 AM\1348825EN.docx EN (a) comprehensively address the emissions from the rearing of livestock within the Union, in particular from cattle; and ‘(a) comprehensively address the emissions from the rearing of livestock within the Union, in particular from cattle, and evaluate options for ensuring greater coherence in the regulatory framework covering organic rearing activities as well as possible adjustments to the calculation of installation capacity under Annex Ia;' Or. en Amendment 369 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 73 – paragraph 3 – subparagraph 2 Present text Amendment (3b) In Article 73(3), the second subparagraph is replaced by the following: The Commission shall report the results of that assessment by 31 December 2026 to the European Parliament and the Council. The report shall, if appropriate, be accompanied by a legislative proposal. ‘The Commission shall report the results of that assessment by 31 December [7 years after the entry into force of the implementing act referred to in Article70i(2)] to the European Parliament and the Council.’ Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 370 Letizia Moratti, Massimiliano Salini, Flavio Tosi Proposal for a directive Article 2 – paragraph – 3 a (new) Directive 2010/75/EU Article 73 – paragraph 3 – point a AM\1348825EN.docx 87/158 PE791.123v02-00 EN Text proposed by the Commission Amendment (3a) In Article 73(3), point (a) is deleted; Or. en (In Directive (EU) 2024/1785, Article 73, paragraph (3) a)) Amendment 371 Jutta Paulus Proposal for a directive Article 2 – paragraph 1 – point 4 Directive 2010/75/EU Article 76 Text proposed by the Commission Amendment (4) Article 76 is amended as follows: deleted (i) in paragraph 2, the first sentence is replaced by the following: ‘The power to adopt delegated acts referred to in Article 48(5), and Article 74 shall be conferred on the Commission for a period of 5 years from 1 August 2024.;’ ‘The delegation of power referred to in Article 48(5), and Article 74 may be revoked at any time by the European Parliament or by the Council.;’ ‘A delegated act adopted pursuant to Article 48(5) or Article 74 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 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.;’ Or. en PE791.123v02-00 88/158 AM\1348825EN.docx EN Amendment 372 Martin Günther, Sebastian Everding, Per Clausen Proposal for a directive Article 2 – paragraph 1 – point 4 Directive 2010/75/EU Article 76 Text proposed by the Commission Amendment (4) Article 76 is amended as follows: deleted (i) in paragraph 2, the first sentence is replaced by the following: ‘The power to adopt delegated acts referred to in Article 48(5), and Article 74 shall be conferred on the Commission for a period of 5 years from 1 August 2024.;’ ‘The delegation of power referred to in Article 48(5), and Article 74 may be revoked at any time by the European Parliament or by the Council.;’ ‘A delegated act adopted pursuant to Article 48(5) or Article 74 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 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.;’ Or. en Amendment 373 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 4 a (new) Directive 2010/75/EU Article 79 – paragraph 3 a (new) Text proposed by the Commission Amendment AM\1348825EN.docx 89/158 PE791.123v02-00 EN (4a) In Article 79, the following paragraph is inserted: ‘3a. Member States shall ensure that, in relation to the activities cited in Annex Ia, the penalties laid down in this Article take due account of the following criteria: (a) the nature of the livestock-rearing activity; (b) the nature of the infringement; (c) the economic scale of the livestock farm; (d) the degree of negligence or intentionality; and (e) the economic capacity of the operator. The provisions of the second subparagraph of paragraph 2, relating to the maximum levels of penalty linked to turnover, shall not apply automatically to activities listed in Annex Ia where this could give rise to clearly disproportionate outcomes.’ Or. es ((02010L0075-20240804)) Amendment 374 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 4 a (new) Directive 2010/75/EU Article 79 – paragraph 4 a (new) Text proposed by the Commission Amendment (4a) In Article 79, the following paragraph is added: ‘4a. The activities referred to in Annex Ia fall exclusively under paragraph 1.’ Or. fr PE791.123v02-00 90/158 AM\1348825EN.docx EN Amendment 375 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 4 a (new) Directive 2010/75/EU Article 79 – paragraph 4 a (new) Text proposed by the Commission Amendment (4a) In Article 79, the following paragraph is added: ‘4a. Paragraphs 2 and 3 of this Article shall not apply to the activities listed in Annex Ia.’; Or. fr Amendment 376 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 4 b (new) Directive 2010/75/EU Article 79a – paragraph 3 a (new) Text proposed by the Commission Amendment (4b) In Article 79a, the following paragraph is added: ‘3a. The provisions of this Article shall not apply to the activities referred to in Annex Ia.’ Or. fr Amendment 377 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive AM\1348825EN.docx 91/158 PE791.123v02-00 EN Article 2 – paragraph 1 – point 4 b (new) Directive 2010/75/EU Article 79a – paragraph 3 a (new) Text proposed by the Commission Amendment (4b) In Article 79a, the following paragraph is added: ‘3a. The provisions of this article shall not apply to the activities listed in Annex Ia.’; Or. fr Amendment 378 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Text proposed by the Commission Amendment 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: deleted (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope PE791.123v02-00 92/158 AM\1348825EN.docx EN of this Directive in the version in force on 3 August 2024, shall comply with that version. Or. en Justification Livestock farms should not be treated in the same way as industrial installations and should be removed from this Directive. Amendment 379 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Text proposed by the Commission Amendment 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: deleted (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on AM\1348825EN.docx 93/158 PE791.123v02-00 EN 3 August 2024, shall comply with that version. Or. en Amendment 380 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Text proposed by the Commission Amendment 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: deleted (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on 3 August 2024, shall comply with that version. Or. en PE791.123v02-00 94/158 AM\1348825EN.docx EN Amendment 381 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – introductory part Text proposed by the Commission Amendment In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within four years from the entry into force of the implementing act referred to in Article 70 decies, paragraph 2. Or. en Amendment 382 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – point a Text proposed by the Commission Amendment (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; deleted Or. en Amendment 383 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – subparagraph 1 – point b AM\1348825EN.docx 95/158 PE791.123v02-00 EN Text proposed by the Commission Amendment (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; deleted Or. en Amendment 384 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – subparagraph 1 – point c Text proposed by the Commission Amendment (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. deleted Or. en Amendment 385 Michal Wiezik, Martin Hojsík Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – subparagraph 3 Text proposed by the Commission Amendment ‘By way of derogation from the first subparagraph of this paragraph, an installation which first falls within the scope of this Directive after the entry into force of the implementing act referred to in Article 70i(2), shall not be obliged to apply the rules of this Directive where it, on the day of it falling into scope, is in the PE791.123v02-00 96/158 AM\1348825EN.docx EN process of a transition towards resilient production systems, including conversion to organic farming and extensification of livestock production systems pursuant Article 10(1), point (b), of [CAP Regulation ], where the transition plan approved by the Member State details and solemnly declares that upon completion of the implementation of the transition action plan the installation ceases to fall within the scope of this Directive.’ Or. en (Directive 2010/75/EC) Justification In the industrial part of the IED there is a specific derogation from the obligation of updating the permit in case of a planned closure of the installation with a view to implement deep industrial transformation. while the provision presented herewith is of a different nature, it could be seen as analogous in that it prevents the sunk cost of an operator of a livestock installation which would first fall within the scope of the Directive in hte future, but is in the meantime started a transformation in accordance with the transition scheme as proposed in the CAP Regulation 2025/0241 (COD). Amendment 386 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Text proposed by the Commission Amendment 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: ‘14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive by: (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (a) 2032, if the plant has a capacity of 600 LSU or more; AM\1348825EN.docx 97/158 PE791.123v02-00 EN (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (b) 2036, if the plant has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. (c) 2040 for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on 3 August 2024, shall comply with that version. Until the relevant date of application as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on 3 August 2024, shall comply with that version.’ Or. es Justification It is necessary to provide for adequate transitional periods to allow the intensive livestock rearing sector to adapt to the standards of the Directive. Amendment 387 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Present text Amendment In Article 82, paragraph 14 is amended as follows 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: ‘14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within 6 years of the entry into force of the implementing act referred to in Article 70i(2). PE791.123v02-00 98/158 AM\1348825EN.docx EN (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of Directive 2010/75/EU in the version in force on the day before this Directive enters into force, shall comply with Directive 2010/75/EU in that version. Until the relevant date of application as referred to in the first subparagraph the installations mentioned in that subparagraph, which fall within the scope of Directive 2010/75/EU, in the version in force on the day before this Directive enters into force, shall comply with Directive 2010/75/EU in that version.’ Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 388 Letizia Moratti, Massimiliano Salini, Flavio Tosi Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Present text Amendment In Article 82, paragraph 14 is replaced by the following: 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within six years from the entry into force of the implementing act referred to in Article 70 decies(2). AM\1348825EN.docx 99/158 PE791.123v02-00 EN (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2) for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on 3 August 2024, shall comply with that version. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of Directive 2010/75/EU in the version in force on the day before … [entry into force of this amending Directive], shall comply with Directive 2010/75/EU in that version. Or. en (Directive (EU) 2024/1785) Amendment 389 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 15 Text proposed by the Commission Amendment 15. Derogations granted by the competent authority in accordance with Article 15(5) before 1 July 2026 shall remain valid until the competent authority reassesses whether the derogation is justified under Article 15(5). The reassessment shall be carried out 4 years from 1 July 2026 or as part of the reconsideration of the permit conditions 15. Derogations granted by the competent authority in accordance with Article 15(5) before 1 July 2026 shall remain valid until the competent authority reassesses whether the derogation is justified under Article 15(5). The reassessment shall be carried out 6 years from 1 July 2026 or as part of the reconsideration of the permit conditions PE791.123v02-00 100/158 AM\1348825EN.docx EN pursuant to Article 21, whichever is the earlier. pursuant to Article 21, whichever is the earlier. Or. en Amendment 390 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk, Ana Vasconcelos Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 16 a (new) Text proposed by the Commission Amendment ‘16a. For installations, or clearly separable parts of installations, whose purpose is linked to defence or national security, Member States may adjust the timetable or modalities for the application of the requirements referred to in paragraphs 10 to 14, where their application would demonstrably and directly affect essential security interests, operational defence readiness, or the protection of classified information. Any such adjustment shall be limited to what is strictly necessary and proportionate, shall not constitute a general exemption from the obligations of this Directive, Member States shall document the reasons for such adjustment, without requiring the disclosure of classified information.’ Or. en Justification Certain defence-related installations may face specific operational or security constraints, including the protection of classified information. A narrowly framed derogation, solely for defence and national security, within the transitional provisions ensures legal certainty without creating a general exemption from the Directive or lowering the level of protection of human health and the environment. Amendment 391 AM\1348825EN.docx 101/158 PE791.123v02-00 EN Ondřej Knotek, Jana Nagyová, Antonín Staněk, Roman Haider, Viktória Ferenc, Anne- Sophie Frigout Proposal for a directive Article 4 a (new) Text proposed by the Commission Amendment Article 4a Anti-gold-plating clause Member States shall not require economic operators to submit information, reports, notifications or registrations that duplicate obligations established under Union law in the areas covered by this Directive. Where a Member State considers additional requirements necessary to address a specific national circumstance, it shall demonstrate that such requirements are proportionate, non- discriminatory and cannot be satisfied through information already available under Union law. Or. en Amendment 392 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 4 b (new) Text proposed by the Commission Amendment Article 4b Report-Once"-Principle Member States shall ensure that economic operators are not required to provide the same information more than once to public authorities under the legal acts covered by this Directive. Competent authorities shall make use of information already submitted under Union or national legislation where such PE791.123v02-00 102/158 AM\1348825EN.docx EN information is available through electronic means and may be reused for regulatory purposes. Or. en Amendment 393 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 4 c (new) Text proposed by the Commission Amendment Article 4c Review of remaining reporting obligations By … [three years from the entry into force of this amending Directive], the Commission shall assess whether reporting, monitoring, registration and notification obligations under the legal acts covered by this Directive can be further simplified without reducing environmental protection. The assessment shall quantify the administrative costs borne by undertakings, with particular attention to small and medium-sized enterprises, and shall, where appropriate, be accompanied by legislative proposals. Or. en Amendment 394 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 a (new) Directive (EU) 2024/3019 Article 9 – paragraph 1 Present text Amendment AM\1348825EN.docx 103/158 PE791.123v02-00 EN Article 4a Amendment to Directive (EU) 2024/3019 (1a) In Article 9(1), the first subparagraph is replaced by the following: 1. Member States shall take measures to ensure that by 31 December 2028, producers who place any of the products listed in Annex III on the market have extended producer responsibility. ‘1. Member States shall take measures to ensure that by 31 December 2030, producers who place any of the products listed in Annex III on the market have extended producer responsibility.’ Or. es Justification In view of the imminent implementation of extended producer responsibility obligations and with the aim of ensuring adequate legal certainty for the sectors concerned and preserving the production of medicines in the EU, an initial delay of 2 years is proposed for the implementation of these obligations. Amendment 395 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 b (new) Directive (EU) 2024/3019 Article 9 – paragraph 1 – subparagraph 2 a (new) Text proposed by the Commission Amendment Article 4a Amendment to Directive (EU) 2024/3019 (1b) in Article 9(1), the following subparagraph is added: ‘The European Commission shall produce as soon as possible a new impact assessment to ascertain the list of substances present in urban wastewater, verify the costs of quaternary treatment, review the attribution of responsibility to the relevant sectors under the polluter pays principle, and determine the impact on the availability, affordability and accessibility of medicines, in particular PE791.123v02-00 104/158 AM\1348825EN.docx EN generic and critical medicines and their active substances. If the results demonstrate a risk to the affordability, availability and accessibility of those medicines and active substances, the Commission shall propose measures to address those risks, including legislative proposals and, in particular, the temporary suspension of extended producer responsibility obligations.’ Or. es Justification The attribution by the Commission of most of the micro-pollutant load to pharmaceutical and cosmetic products has been questioned on methodological and scientific grounds. If a new impact assessment identifies significant risks to the production of medicines and active substances in the EU, the Commission should propose a temporary suspension of these obligations. Amendment 396 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 c (new) Directive (EU) 2024/3019 Article 9 – paragraph 2 – point b a (new) Text proposed by the Commission Amendment Article 4a Amendment to Directive (EU) 2024/3019 (1c) In Article 9, paragraph 2, the following point is inserted: ‘(ba) in relation to investment costs, there are no approved plans and milestones, independent audits of costs and compensation or claw-back mechanisms in relation to the date of entry into operation of the infrastructure;’ Or. es AM\1348825EN.docx 105/158 PE791.123v02-00 EN Justification In relation to extended producer responsibility obligations, safeguards should be provided for in case quaternary treatments are not in place or they are not functioning efficiently. Amendment 397 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 d (new) Directive (EU) 2024/3019 Article – paragraph 2 – point b b (new) Text proposed by the Commission Amendment Article 4a Amendment to Directive (EU) 2024/3019 (1d) In Article 9, paragraph 2, the following point is inserted: ‘(bb) in relation to operational costs, the infrastructure is not operational or it is not operating efficiently.’ Or. es Justification In relation to extended producer responsibility obligations, safeguards should be provided for in case quaternary treatments are not in place or they are not functioning efficiently. Amendment 398 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 a (new) Council Directive 92/43/EEC Article 2 – paragraph 3a (new) Text proposed by the Commission Amendment Article 4a Amendments to Council Directive 92/43/EEC PE791.123v02-00 106/158 AM\1348825EN.docx EN In Article 2 of Council Directive 92/43/EEC, the following paragraph is added: ‘3a. By way of derogation from paragraphs 1 and 2, and until 31 December 2035 and in order to achieve the climate neutrality objective and intermediate climate targets referred to in Articles 2 and 4 of Regulation (EU) 2021/1119, the following overarching objectives shall take precedence over the conservation objectives set out in those paragraphs: (a) the industrial transformation and decarbonisation of the Union economy; (b) the energy transition of the Union; (c) the digital transition of the Union. The conservation of natural habitats and of wild fauna and flora as provided for in this Directive shall not constitute an obstacle to the pursuit or achievement of the objectives referred to in the first subparagraph. By 31 December 2034, the Commission shall submit a report to the European Parliament and to the Council on the application of this paragraph, accompanied, where appropriate, by a legislative proposal.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01992L0043-20250714) Justification The amendment supports the Directive’s objective of targeted simplification and more proportionate environmental permitting by introducing a clear legal basis for Member States to apply limited derogations from certain requirements where this is necessary and proportionate for the achievement of climate neutrality, security of energy supply and digital sovereignty. It reflects the strategic importance of accelerating Europe’s industrial transformation as well as the energy and digital transition, while preserving the overall objectives and safeguards of the Directive. In light of the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. AM\1348825EN.docx 107/158 PE791.123v02-00 EN Amendment 399 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 b (new) Council Directive 92/43/EEC Article 6 – paragraph 4 Present text Amendment Article 4b Amendments to Council Directive 92/43/EEC In Article 6 of Council Directive 92/43/EEC, paragraph 4 is replaced by the following: 4. If, in spite of a negative assessment of the implications for the site and in the absence of alternative solutions, a plan or project must nevertheless be carried out for imperative reasons of overriding public interest, including those of a social or economic nature, the Member State shall take all compensatory measures necessary to ensure that the overall coherence of Natura 2000 is protected. It shall inform the Commission of the compensatory measures adopted. Where the site concerned hosts a priority natural habitat type and/or a priority species, the only considerations which may be raised are those relating to human health or public safety, to beneficial consequences of primary importance for the environment or, further to an opinion from the Commission, to other imperative reasons of overriding public interest. ‘4. If, in spite of a negative assessment of the implications for the site and in the absence of alternative solutions, a plan or project must nevertheless be carried out for imperative reasons of overriding public interest, including those of a social or economic nature, the Member State shall take proportional compensatory measures to ensure that the overall coherence of Natura 2000 is protected. The compensatory measures may be implemented through geographically separate sites or areas. Compensatory measures shall be implemented as soon as practicable and shall be operational no later than five years after the commencement of the plan or project to which they relate. It shall inform the Commission of the compensatory measures adopted. Where the site concerned hosts a priority natural habitat type and/or a priority species, the only considerations which may be raised are those relating to human health or public safety, to beneficial consequences of primary importance for the environment or, further to an opinion from the Commission, to other imperative reasons of overriding public interest. By way of derogation from the second subparagraph, and until 31 December 2035, the objectives referred to in Article PE791.123v02-00 108/158 AM\1348825EN.docx EN 2(4) shall constitute imperative reasons of overriding public interest within the meaning of the first subparagraph of this paragraph, including where the plan or project concerned affects a site hosting a priority natural habitat type and/or a priority species. No opinion from the Commission shall be required in such cases.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01992L0043-20250714) Justification The rebalancing is necessary to support the Directive’s objective of targeted simplification and more proportionate application of Union environmental legislation. Projects which are essential for Europe’s industrial transformation, energy security and digital transition must be capable of being delivered in practice and without disproportionate delays. Recognising such authorised projects as being in the overriding public interest provides greater legal certainty, accelerates permitting and helps ensure that environmental procedures remain efficient, effective and aligned with the Union’s strategic objectives, including climate neutrality and competitiveness. Amendment 400 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 c (new) Council Directive 92/43/EEC Article 16 Present text Amendment Article 4c Amendments to Council Directive 92/43/EEC Article 16 of Council Directive 92/43/EEC is replaced by the following: 1. Provided that there is no satisfactory alternative and the dero gation is not detrimental to the maintenance of the populations of the species concerned at a favourable conservation status in their ‘1. Provided that there is no satisfactory alternative and the dero gation is not detrimental to the maintenance of the populations of the species concerned at a favourable conservation status in their AM\1348825EN.docx 109/158 PE791.123v02-00 EN natural range, Member States may derogate from the provisions of Articles 12, 13, 14 and 15 (a) and (b): (a) in the interest of protecting wild fauna and flora and conserving natural habitats; (b) to prevent serious damage, in particular to crops, livestock, forests, fisheries and water and other types of property; (c) in the interests of public health and public safety, or for other imperative reasons of overriding public interest, including those of a social or economic nature and beneficial consequences of primary importance for the environment; (d) for the purpose of research and education, of repopulating and re- introducing these species and for the breedings operations necessary for these purposes, including the artificial propagation of plants; (e) to allow, under strictly supervised conditions, on a selective basis and to a limited extent, the taking or keeping of certain specimens of the species listed in Annex IV in limited numbers specified by the competent national authorities. natural range, Member States may derogate from the provisions of Articles 12, 13, 14 and 15 (a) and (b): (a) in the interest of protecting wild fauna and flora and conserving natural habitats; (b) to prevent serious damage, in particular to crops, livestock, forests, fisheries and water and other types of property; (c) in the interests of public health and public safety, or for other imperative reasons of overriding public interest, including those of a social or economic nature, those set out in Article 2(4), and beneficial consequences of primary importance for the environment; (d) for the purpose of research and education, of repopulating and re- introducing these species and for the breedings operations necessary for these purposes, including the artificial propagation of plants; (e) to allow, under strictly supervised conditions, on a selective basis and to a limited extent, the taking or keeping of certain specimens of the species listed in Annex IV in limited numbers specified by the competent national authorities. 1a. Incidental capture, killing or disturbance of specimens of species listed in Annex IV(a), resulting from the planning, construction, repowering, operation or maintenance of energy infrastructure projects authorised in accordance with Union and national law, shall not be considered deliberate within the meaning of Article 12(1), provided that appropriate mitigation measures are applied and that the project does not jeopardise the maintenance of the populations of the species concerned at a favourable conservation status in their natural range. 2. Member States shall forward to the Commission every two years a report in accordance with the format established by the Committee on the derogations applied under paragraph 1. The Commission shall give its opinion on these derogations within a maximum time limit of 12 months 2. Member States shall forward to the Commission every two years a report in accordance with the format established by the Committee on the derogations applied under paragraph 1. The Commission shall give its opinion on these derogations within a maximum time limit of 12 months PE791.123v02-00 110/158 AM\1348825EN.docx EN following receipt of the report and shall give an account to the Committee. following receipt of the report and shall give an account to the Committee. 3. The reports shall specify: (a) the species which are subject to the derogations and the reason for the derogation, including the nature of the risk, with, if appropriate, a reference to alternatives rejected and scientific data used; (b) the means, devices or methods authorized for the capture or killing of animal species and the reasons for their use; (c) the circumstances of when and where such derogations are granted; (d) the authority empowered to declare and check that the required conditions obtain and to decide what means, devices or methods may be used, within what limits and by what agencies, and which persons are to carry out the task; (e) the supervisory measures used and the results obtained. 3. The reports shall specify: (a) the species which are subject to the derogations and the reason for the derogation, including the nature of the risk, with, if appropriate, a reference to alternatives rejected and scientific data used; (b) the means, devices or methods authorized for the capture or killing of animal species and the reasons for their use; (c) the circumstances of when and where such derogations are granted; (d) the authority empowered to declare and check that the required conditions obtain and to decide what means, devices or methods may be used, within what limits and by what agencies, and which persons are to carry out the task; (e) the supervisory measures used and the results obtained.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01992L0043-20250714) Justification The amendment supports the Directive’s objective of targeted simplification and more proportionate environmental permitting. It clarifies that incidental capture, killing or disturbance linked to authorised climate-neutrality projects should not be considered deliberate where appropriate mitigation measures are applied and the conservation status of the species concerned is maintained. This strengthens legal certainty while preserving species protection and enabling the timely deployment of strategic projects necessary for the Union’s industrial transformation, energy security, digital transition and climate-neutrality objective. Amendment 401 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 a (new) Directive (EU) 2019/904 Article 6 – paragraph 1 Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 AM\1348825EN.docx 111/158 PE791.123v02-00 EN (1a) in Article 6, paragraph1 is deleted. Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 402 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 b (new) Directive (EU) 2019/904 Article 6 – paragraph 3 Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 (1b) in Article 6, paragraph 3 is deleted. Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 403 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 c (new) Directive (EU) 2019/904 Article 6 – paragraph 4 PE791.123v02-00 112/158 AM\1348825EN.docx EN Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 (1c) in Article 6, paragraph 4 is deleted. Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 404 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 d (new) Directive (EU) 2019/904 Article 15 – paragraph 3 – point a Present text Amendment Article 4a Amendments to Directive (EU) 2019/904 (a) an assessment of the need to review the Annex listing single-use plastic products, including as regards caps and lids made of plastic which are used for glass and metal beverage containers; (1d) in Article 15(3), point (a) is replaced by the following: ‘(a) an assessment of the need to review the Annex listing single-use plastic products;’ Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. AM\1348825EN.docx 113/158 PE791.123v02-00 EN Amendment 405 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 e (new) Directive (EU) 2019/904 Annex – Part B – point 4 Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 ‘(1e) in the Annex, Part B, point 4 is deleted.’ Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 406 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 f (new) Directive (EU) 2019/904 Annex – Part C Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 (1f) in the Annex, Part C is deleted. Or. en PE791.123v02-00 114/158 AM\1348825EN.docx EN Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 407 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 d (new) Directive 2009/147/EC Article 5 – paragraph 1 a (new) Text proposed by the Commission Amendment Article 4d Directive 2009/147/EC is amended as follows: In Article 5, the following paragraph is added: ‘1a. By way of derogation from paragraph 1, and until 31 December 2035, the prohibitions set out in that paragraph shall not apply to activities, plans or projects that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC. Member States shall keep records of determinations made pursuant to this paragraph and shall communicate a summary thereof to the Commission annually. By 31 December 2034, the Commission shall submit a report to the European Parliament and to the Council on the application of this paragraph, accompanied, where appropriate, by a legislative proposal.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009L0147-20190626) AM\1348825EN.docx 115/158 PE791.123v02-00 EN Justification The amendment supports the Directive’s objective of targeted simplification and more proportionate environmental permitting by introducing a clear legal basis for Member States to apply limited derogations from certain requirements where this is necessary and proportionate for the achievement of climate neutrality, security of energy supply and digital sovereignty. It reflects the strategic importance of accelerating Europe’s industrial transformation as well as the energy and digital transition, while preserving the overall objectives, safeguards and existing framework of this Directive. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 408 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 e (new) Directive 2009/147/EC Article 9 – paragraph 1 – pont c a (new) Text proposed by the Commission Amendment Article 4e Directive 2009/147/EC is amended as follows: In Article 9(1), the following point is inserted: ‘(ca) until 31 December 2035, in order to achieve climate neutrality, to support activities, plans or projects that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009L0147-20190626) Justification Extending the possibility for Member States to apply limited and proportionate derogations from certain requirements of this Directive to climate-neutrality projects necessary for Europe’s industrial transformation, energy security and digital transition. Amendment 409 PE791.123v02-00 116/158 AM\1348825EN.docx EN Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 4 b (new) Directive 2000/60/EC Article 4 – paragraph 4 a (new) Text proposed by the Commission Amendment Article 4b In Article 4 of Directive 2000/60/EC, the following paragraph is added: ‘4a. By way of derogation from paragraph 4, point (c), the deadlines set out in paragraph 1 may be extended a third time through a further update of the river basin management plans in those Member States seriously affected by climate change and with very arid conditions. To measure the impact of climate change and aridity, an aridity index shall be used, which shall be calculated as the ratio of average annual evapotranspiration to average annual precipitation over a reference period of 30 years. Member States showing an aridity index higher than 1 shall be considered to have very arid conditions. That third extension shall only be possible if all the other conditions set out in paragraph 4 are also met.’ Or. es Justification La Directiva Marco de Aguas fue aprobada en un momento en el que los efectos del cambio climático no estaban completamente integrados en las políticas de la UE. El cumplimiento de los objetivos ambientales fijados en los primeros planes hidrológicos de cuenca es muy complicado en las regiones de la ribera del Mar Mediterráneo, el mar que más rápidamente se está calentando en el mundo, que sufren de forma directa las consecuencias del cambio climático y una aridez extrema que impide la recuperación de las masas de agua con peor calidad, especialmente las aguas subterráneas. Se propone una tercera prórroga para el cumplimiento de los objetivos ambientales de la Directiva, hasta 2033, para evitar impactos económicos y sociales en los países de la UE más afectados por el cambio climático. Mas información sobre el índice de aridez: Aridity Actual | Indicators | Discover the key services, thematic features and tools of Climate-ADAPT Climate-ADAPT AM\1348825EN.docx 117/158 PE791.123v02-00 EN Amendment 410 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 f (new) Directive 2000/60/EC Article 4 – paragraph 8 a (new) Text proposed by the Commission Amendment Article 4f Amendments to Directive 2000/60/EC In Article 4 of Directive 2000/60/EC, the following paragraph is inserted: ‘8a. By way of derogation from paragraph 7, and until 31 December 2035, Member States shall not be in breach of this Directive where failure to achieve or maintain the objectives set out in paragraph 1 results from activities, plans or projects that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC, provided that the reasons for the modification or deterioration are specifically set out and explained in the relevant river basin management plan or, where the relevant river basin management plan has not yet been updated, in a standalone notification submitted to the Commission within twelve months of the authorisation of the activity, plan or project concerned. The condition set out in paragraph 7(c) requiring demonstration of overriding public interest and the condition set out in paragraph 7(d) requiring demonstration that the beneficial objectives cannot be achieved by other means shall not apply to activities, plans or projects falling within the scope of this paragraph. For the purposes of applying the deterioration standard under paragraph 1(a)(i), a deterioration of the status of a surface water body shall be deemed to occur only where the overall ecological status PE791.123v02-00 118/158 AM\1348825EN.docx EN classification of the water body declines by one class or more. By 31 December 2034, the Commission shall submit a report to the European Parliament and to the Council on the application of this paragraph, accompanied, where appropriate, by a legislative proposal’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02000L0060-20260510) Justification The amendment introduces a clear legal basis for Member States to apply limited and proportionate derogations from certain requirements of this Directive where necessary to achieve climate neutrality, security of energy supply and digital sovereignty. It supports the acceleration of Europe’s industrial transformation as well as the energy and digital transition, while preserving the Directive’s overall objectives, safeguards and existing framework. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 411 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 g (new) Directive (EU) 2024/2881 Article 13 – paragraph 3 a (new) Text proposed by the Commission Amendment Article 4g In Article 13 of Directive (EU) 2024/2881, the following paragraph is inserted: ‘3a. By way of derogation from paragraph 1 and until 31 December 2035, Member States shall not be considered to have failed to fulfil their obligations under this Article where exceedances of the limit values set out in Annex I are attributable, in whole or in material part, to activities, plans or projects contributing to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC. The AM\1348825EN.docx 119/158 PE791.123v02-00 EN Member State concerned shall notify the Commission of the exceedance and its causes. By 31 December 2034, the Commission shall submit a report to the European Parliament and to the Council on the application of this paragraph, accompanied, where appropriate, by a legislative proposal.’; Or. en (https://eur-lex.europa.eu/eli/dir/2024/2881/oj/eng) Justification The amendment supports targeted simplification and more proportionate permitting by introducing a clear legal basis for Member States to apply limited and proportionate derogations from certain requirements of this Directive where necessary to achieve climate neutrality, security of energy supply and digital sovereignty. It reflects the strategic importance of accelerating Europe’s industrial transformation as well as the energy and digital transition, while preserving the Directive’s overall objectives, safeguards and existing framework. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 412 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 h (new) Directive 2011/92/EU Article 4 – paragraph 4 a (new) Text proposed by the Commission Amendment Article 4h Amendments to Directive 2011/92/EU In Article 4 of Directive 2011/92/EU, the following paragraph is inserted: ‘4a. Activities, plans and pProjects that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC shall, for the purposes of screening under this Article, be presumed not to have significant effects on the PE791.123v02-00 120/158 AM\1348825EN.docx EN environment within the meaning of paragraph 3.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0092-20140515) Justification The amendment introduces a clear legal basis for Member States to apply limited and proportionate derogations from certain requirements of this Directive where necessary to achieve climate neutrality, security of energy supply and digital sovereignty. It supports the timely deployment of projects essential for Europe’s industrial transformation and the energy and digital transition, while preserving the Directive’s overall objectives and safeguards. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 413 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 i (new) Directive 2008/56/EC Article 14 – paragraph 1 Present text Amendment Article 4i Amendments to Directive 2008/56/EC In Article 14 of Directive 2008/56/EC, paragraph 1 is replaced by the following: 1. A Member State may identify instances within its marine waters where, for any of the reasons listed under points (a) to (d), the envi ronmental targets or good environmental status cannot be achieved in every aspect through measures taken by that Member State, or, for reasons referred to under point (e), they cannot be achieved within the time schedule concerned: ‘1. A Member State may identify instances within its marine waters where, for any of the reasons listed under points (a) to (d) and (f), the environmental targets or good environmental status cannot be achieved in every aspect through measures taken by that Member State, or, for reasons referred to under point (e), they cannot be achieved within the time schedule concerned: (a) action or inaction for which the Member State concerned is not responsible; (a) action or inaction for which the Member State concerned is not responsible; (b) natural causes; (b) natural causes; AM\1348825EN.docx 121/158 PE791.123v02-00 EN (c) force majeure; (c) force majeure; (d) modifications or alterations to the physical characteristics of marine waters brought about by actions taken for reasons of overriding public interest which outweigh the negative impact on the environment, including any transboundary impact; (d) modifications or alterations to the physical characteristics of marine waters brought about by actions taken for reasons of overriding public interest, including activities, actions or projects, in order to achieve climate neutrality, that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC, which outweigh the negative impact on the environment, including any transboundary impact; (e) natural conditions which do not allow timely improvement in the status of the marine waters concerned. (e) natural conditions which do not allow timely improvement in the status of the marine waters concerned; (f) activities, actions or projects, in order to achieve climate neutrality, that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC. The Member State concerned shall identify such instances clearly in its programme of measures and shall substantiate its view to the Commission. In identifying instances a Member State shall consider the consequences for Member States in the marine region or subregion concerned. However, the Member State concerned shall take appropriate ad-hoc measures aiming to continue pursuing the environmental targets, to prevent further deterioration in the status of the marine waters affected for reasons identified under points (b), (c) or (d) and to mitigate the adverse impact at the level of the marine region or subregion concerned or in the marine waters of other Member States. The Member State concerned shall identify such instances clearly in its programme of measures and shall substantiate its view to the Commission. In identifying instances a Member State shall consider the consequences for Member States in the marine region or subregion concerned. However, the Member State concerned shall take appropriate ad-hoc measures aiming to continue pursuing the environmental targets, to prevent further deterioration in the status of the marine waters affected for reasons identified under points (b), (c) or (d) and to mitigate the adverse impact at the level of the marine region or subregion concerned or in the marine waters of other Member States.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02008L0056-20170607) Justification The amendment introduces a clear legal basis for Member States to apply limited and proportionate derogations from certain requirements of this Directive where necessary to achieve climate neutrality, security of energy supply and digital sovereignty. It supports the PE791.123v02-00 122/158 AM\1348825EN.docx EN timely deployment of projects essential for Europe’s industrial transformation and the energy and digital transition, while preserving the Directive’s overall objectives and safeguards. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 414 Jutta Paulus Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Text proposed by the Commission Amendment Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 24 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1(2), point (a), of this Directive by … [six months from date of entry into force of this amending Directive] at the latest. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the other provisions of this Directive by [ 24 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Or. en Justification The use of the new standards for suppliers to notify substances of very high concern in articles to ECHA should be transposed within six months from the date of entry into force of this Directive so as to accelerate the simplification. Amendment 415 François-Xavier Bellamy Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Text proposed by the Commission Amendment AM\1348825EN.docx 123/158 PE791.123v02-00 EN Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 24 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive amending Directive 2010/75/EU by [36 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Or. fr Amendment 416 Anna Zalewska Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Text proposed by the Commission Amendment Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 24 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 36 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Or. en Amendment 417 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 5 – paragraph 2 a (new) Text proposed by the Commission Amendment 2a. In relation to installations carrying out activities referred to in Annex Ia to Directive 2010/75/EU, Member States shall apply the laws, regulations and administrative provisions PE791.123v02-00 124/158 AM\1348825EN.docx EN adopted in accordance with this Directive within four years of the entry into force of the implementing act referred to in Article 70i(2). Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of Directive 2010/75/EU in the version in force on the day before this Directive enters into force shall comply with Directive 2010/75/EU. Or. fr Amendment 418 Daniel Buda Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2 In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is deleted A )Point 2 is complemented with a third sentence as follows:’ ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. Or. en (Annex Ia of Directive 2010/75/EU) AM\1348825EN.docx 125/158 PE791.123v02-00 EN Justification Farmers should not be placed in the same category as heavy industrial polluters. Such provisions are disproportionate and lead to a loss of competitiveness of the agricultural sector Amendment 419 François-Xavier Bellamy, Céline Imart Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: (a) Point 2 is complemented with a third sentence as follows: ‘Rearing of poultry or pigs: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ (a) with more than 85 000 places for poultry; (b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. (b) with more than 2 000 places for production pigs (over 30 kg); (c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. (c) with more than 750 places for sows.’ Or. fr Amendment 420 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia PE791.123v02-00 126/158 AM\1348825EN.docx EN Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: (a) Point 2 is complemented with a third sentence as follows: ‘Installations fall within the scope of this annex if they come under one of the following activity categories: Intensive rearing of poultry or pigs: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ (a) with more than 40 000 places for poultry; (b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. (b) with more than 2 000 places for production pigs (over 30 kg); or (c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. (c) with more than 750 places for sows.’ Or. fr Justification With the new thresholds, too many pig and poultry holdings would have to make additional investments that would be disproportionate to the very limited emissions benefits. We therefore call for a return to the same thresholds and number of places in force under the 2010 directive and for cattle farms to be excluded. Amendment 421 Jessica Polfjärd Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: AM\1348825EN.docx 127/158 PE791.123v02-00 EN a) Point 2 is complemented with a third sentence as follows: ‘Installations fall within the scope of this annex if they fall within one or more of the following activity categories: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ 1. Rearing of pigs with more than 2,000 production pig places for pigs over 30 kg or with more than 750 sow places. b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’ 2.Rearing of poultry with more than 40,000 poultry places.’; c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. Or. en(02010L0075-20240804) Amendment 422 Letizia Moratti, Massimiliano Salini, Flavio Tosi Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: a) Point 2 is complemented with a third sentence as follows: ‘Installations fall within the scope of this annex if they fall within one or more of the following activity categories: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ 1.Rearing of pigs with more than 2,000 production pig places for pigs over 30 kg or with more than 750 sow places. b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’ 2.Rearing of poultry with more than 40,000 poultry places.’; c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. PE791.123v02-00 128/158 AM\1348825EN.docx EN Or. en(02010L0075-20240804) Amendment 423 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex I a Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: (a) Point 2 is complemented with a third sentence as follows: ‘Activities referred to in Article 70a ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’; Installations fall within the scope of this annex if they fall within one or more of the following activity categories: (b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’; 1. Rearing of pigs with more than 2 000 places for production pigs over 30 kg, or with more than 750 places for sows. (c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. 2. Rearing of poultry with more than 40 000 places for poultry.’ Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 424 Alexander Bernhuber Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia is replaced by the following: AM\1348825EN.docx 129/158 PE791.123v02-00 EN a) Point 2 is complemented with a third sentence as follows: ‘Activities referred to in Article 70a ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ Installations carrying out organic production in accordance with Regulation (EU) 2018/848, as well as installations applying animal welfare measures exceeding applicable Union minimum requirements, shall be excluded from the scope of this Annex. Installations fall within the scope of this annex if they fall within one or more of the following activity categories: b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. 1. Rearing of pigs representing 600 LSU or more, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’ 2. Rearing of only laying hens representing 560 LSU or more, or rearing of only other poultry categories representing 560 LSU or more. In installations rearing a mix of poultry including laying hens, the threshold shall be 560 LSU and the capacity shall be calculated using 0,93 as weighting factor ( 1 ) for laying hens. 3. Rearing of any mix of pigs or poultry representing 600 LSU or more, excluding rearing of pigs in installations operating under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. PE791.123v02-00 130/158 AM\1348825EN.docx EN The LSU level of an installation is calculated using the following conversion rates: Pigs: Breeding sows ≥ 50 kg … 0,500 Piglets ≤ 20 kg … 0,027 Other pigs … 0,300 Poultry: Broilers … 0,007 Laying hens … 0,014 Turkeys … 0,030 Ducks … 0,010 Geese … 0,020 Ostriches … 0,350 Other poultry fowls … 0,001’; Or. en (Directive 2010/75/EU) Amendment 425 Jutta Paulus Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, deleted a) Point 2 is complemented with a third sentence as follows: Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded. b) In the first sentence of point 3, the words ‘or laying hens or other poultry AM\1348825EN.docx 131/158 PE791.123v02-00 EN categories’ are inserted after ‘excluding rearing of pigs’. c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. Or. en Amendment 426 Grégory Allione Proposal for a directive Annex I –point 2 – point (-a) (new) Directive 2010/75/EU Annex Ia – point 1 Present text Amendment (-a) point 1 is replaced by the following: Rearing of pigs representing 350 LSU or more, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. ‘1. Rearing of pigs with more than 2 000 places for production pigs over 30 kg, or with more than 750 places for sows.’_; Or. en Amendment 427 Alexander Bernhuber Proposal for a directive Annex I – point 2 - point -a (new) 2010/75/EU Annex Ia – point 1 Present text Amendment PE791.123v02-00 132/158 AM\1348825EN.docx EN (-a) point 1 is replaced by the following Rearing of pigs representing 350 LSU or more, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. 1. Rearing of pigs with more than 2 000 places for production pigs over 30 kg, or with more than 750 places for sows. Or. en (Directive 2010/75/EU) Amendment 428 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point -a (new) Directive 2010/75/EU Annex I a – paragraph 1 Present text Amendment (-a) paragraph 1 is replaced by the following: 1. Rearing of pigs representing 350 LSU or more, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. ‘1. Rearing of pigs with more than 2 000 places for production pigs of more than 30 kg, or with more than 750 places for sows, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare in nitrate vulnerable zones (ZVN) and 4 LSU/hectare in non-NVZ zones used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside.’ AM\1348825EN.docx 133/158 PE791.123v02-00 EN Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 429 Alexander Bernhuber Proposal for a directive Annex I – point 2 – point a Directive 2010/75/EU Annex Ia – point 2 Text proposed by the Commission Amendment a) Point 2 is complemented with a third sentence as follows: a) Point 2 is replaced by the following: Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded. ‘Rearing of poultry with more than 40 000 places.’; Or. en Amendment 430 Grégory Allione Proposal for a directive Annex I – point 2 – point a Directive 2010/75/EU Annex Ia – point 2 Text proposed by the Commission Amendment a) Point 2 is complemented with a third sentence as follows: a) Point 2 is replaced by the following: Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded. Rearing of poultry with more than 40 000 places. Or. en Amendment 431 PE791.123v02-00 134/158 AM\1348825EN.docx EN Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point a Directive (EU) 2010/75/EU Annex I a – point 2 Text proposed by the Commission Amendment (a) in point 2, the following text is added: (a) point 2 is replaced by the following: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’; ‘2. Rearing of poultry with more than 40 000 places for poultry, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848.’; Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 432 Grégory Allione Proposal for a directive Annex I – point 2 – point b Directive 2010/75/EU Annex Ia – point 3 Text proposed by the Commission Amendment b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. b) point 3 is deleted. Or. en Amendment 433 Alexander Bernhuber Proposal for a directive Annex I – point 2 – point b AM\1348825EN.docx 135/158 PE791.123v02-00 EN Directive 2010/75/EU Annex Ia – point 3 Text proposed by the Commission Amendment b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. deleted Or. en Amendment 434 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point b Directive 2010/75/EU Annex I a – point 3 Text proposed by the Commission Amendment (b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’; (b) Point 3 is deleted; Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 435 Jutta Paulus Proposal for a directive Annex I – point 2 – point b Directive 2010/75/EU Annex Ia – point 3 Text proposed by the Commission Amendment b) In the first sentence of point 3, the deleted PE791.123v02-00 136/158 AM\1348825EN.docx EN words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. Or. en Amendment 436 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point b a (new) Directive 2010/75/EU Annex I a – subparagraph 2 (new) Text proposed by the Commission Amendment (ba) the following subparagraph is inserted after the first subparagraph: ‘By way of derogation from the previous subparagraph, an exclusion applies to rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare in nitrate vulnerable zones (ZVN) and 4 LSU/hectare in non-NVZ zones used only for grazing or growing fodder or forage used for feeding the animals, and the animals are reared outside for a significant amount of time in a year or seasonally reared outside.’; Or. it Amendment 437 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point c Directive 2010/75/EU Annex I a – subparagraph 2 Text proposed by the Commission Amendment AM\1348825EN.docx 137/158 PE791.123v02-00 EN (c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘Weaners ≤ 20 kg … 0,027’. (c) The second subparagraph is replaced by the following: ‘The LSU level of an installation is calculated using the following conversion rates: Pigs: Breeding sows ≥ 100 kg (including farrowing sows) … 0,500 Weaners ≤ 30 kg … 0,027 Other pigs … 0,300 Poultry: Broilers … 0,007 Laying hens … 0,014 Turkeys … 0,030 Ducks … 0,010 Geese … 0,020 Ostriches … 0,350 Other poultry fowls … 0,001’ Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 438 Jutta Paulus Proposal for a directive Annex I – point 2 – point c Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. deleted Or. en PE791.123v02-00 138/158 AM\1348825EN.docx EN Amendment 439 Michal Wiezik, Martin Hojsík Proposal for a directive Annex I – point 2 – point c a (new) Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment ca) in the second paragraph, under the heading “Poultry”, ‘Pullets … 0,007’ is inserted after ‘Laying hens … 0,014’. Or. en Amendment 440 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I – point 3 – point (-a) (new) Directive 2010/75/EU Annex V – Part 1 – point 3 Present text Amendment (-a) in Part 1, point 3 is amended as follows: ANNEX V ‘ANNEX V Technical provisions relating to combustion plants Technical provisions relating to combustion plants PART 1 PART 1 Emission limit values for combustion plants referred to in Article 30(2) Emission limit values for combustion plants referred to in Article 30(2) (...) (...) 3. Emission limit values (mg/Nm 3 ) for SO 2 for combustion plants using gaseous fuels with the exception of gas turbines and gas engines 3. Emission limit values (mg/Nm 3 ) for SO 2 for combustion plants using gaseous fuels other than natural gas with the exception of gas turbines and gas engines (...) (...) Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) AM\1348825EN.docx 139/158 PE791.123v02-00 EN Justification Requiring continuous measurement of emissions of particulate matter and sulfur dioxide is not logical for boilers burning natural gas. Burning natural gas cannot release these pollutants into the air. This is therefore only an unnecessary administrative burden for the operators concerned. Amendment 441 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk, Katri Kulmuni Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EU Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % by volume of hydrogen, or to combustion plants operating under a time-bound fuel- switching trajectory approved by the competent authority to progressively increase the share of hydrogen in the fuel mix. In both cases, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18. The competent authority shall ensure appropriate monitoring of the hydrogen share and the annual NOx load and shall review the applicability of this footnote where the approved fuel-switching trajectory is not implemented.; Or. en PE791.123v02-00 140/158 AM\1348825EN.docx EN Justification The Commission proposal recognises that existing NOx concentration limits may create barriers for hydrogen combustion, while retaining the safeguard that the annual NOx load may not increase. Extending this approach to installations following a credible and approved fuel-switching trajectory avoids a cliff-edge at 20 % hydrogen and supports gradual industrial decarbonisation, while preserving the key environmental safeguard. Amendment 442 Michal Wiezik, Martin Hojsík Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EU Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen provided that the hydrogen is sourced from fossil-free sources, preferably renewable sources; and its use results in a significant reduction in lifecycle greenhouse gas emissions compared to conventional fossil fuel combustion and contributes to the deep industrial transformation referred to in Article 3(9a) of this Directive. Where this is the case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; Or. en Amendment 443 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout AM\1348825EN.docx 141/158 PE791.123v02-00 EN Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EU Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; (5) The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. This without prejudice to stricter measures required pursuant to Article 18.; Or. en Justification It is unclear how it will be possible to meet the condition requiring that the amount of NOx emissions produced under the relevant emission limit when burning natural gas not be exceeded in case when the exemption from the NOx emission limit is applied. Amendment 444 Jutta Paulus Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EU Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, provided the substitution by hydrogen of previously used fuel results in at least 15% total greenhouse gas PE791.123v02-00 142/158 AM\1348825EN.docx EN year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; emissions reduction. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; Or. en Amendment 445 Thomas Bajada, Annalisa Corrado Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EC Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; (5) The emission limit value is not applicable to combustion plants firing gas with more than 30 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; Or. en Amendment 446 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I, point 3, point (aa) (new) Directive 2010/75/EU AM\1348825EN.docx 143/158 PE791.123v02-00 EN Annex V – Part 1 – point 8 Present text Amendment (aa) in Part 1, point 8 is amended as follows: ANNEX V "ANNEX V Technical provisions relating to combustion plants Technical provisions relating to combustion plants PART 1 PART 1 Emission limit values for combustion plants referred to in Article 30(2) Emission limit values for combustion plants referred to in Article 30(2) (...) (...) 8. Emission limit values (mg/Nm 3 ) for SO 2 for combustion plants using gaseous fuels with the exception of gas turbines and gas engines 8. Emission limit values (mg/Nm 3 ) for SO 2 for combustion plants using gaseous fuels other than natural gas with the exception of gas turbines and gas engines (...) (...)" Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Justification Requiring continuous measurement of emissions of particulate matter and sulfur dioxide is not logical for boilers burning natural gas. Burning natural gas cannot release these pollutants into the air. This is therefore only an unnecessary administrative burden for the operators concerned. Amendment 447 Michal Wiezik, Martin Hojsík Proposal for a directive Annex I – point 3 – point b Directive 2010/75/EC Annex V – part 2 – point 6 Text proposed by the Commission Amendment The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, provided that the hydrogen is sourced from fossil-free sources, preferably PE791.123v02-00 144/158 AM\1348825EN.docx EN into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; renewable sources; and its use results in a significant reduction in lifecycle greenhouse gas emissions compared to conventional fossil fuel combustion and contributes to the deep industrial transformation referred to in Article 3(9a) of this Directive. Where this is the case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; Or. en Justification Related to the previous amendment on the footnote. combustion of hydrogen doesnt produce emissions, but also how hydrogen was produced should matter, and the lifecycle emissions of that hydrogen should be taken into account. Amendment 448 Thomas Bajada, Annalisa Corrado Proposal for a directive Annex I – point 3 – point b Directive 2010/75/EC Annex V – Part 2 – point 6 – last subparagraph Text proposed by the Commission Amendment The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; The emission limit value is not applicable to combustion plants firing gas with more than 30 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; AM\1348825EN.docx 145/158 PE791.123v02-00 EN Or. en Amendment 449 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I – point 3 – point b Directive 2010/75/EU Annex V – Part 2 – point 6 – last subparagraph Text proposed by the Commission Amendment The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. This without prejudice to stricter measures required pursuant to Article 18.; Or. en Justification It is unclear how it will be possible to meet the condition requiring that the amount of NOx emissions produced under the relevant emission limit when burning natural gas not be exceeded in case when the exemption from the NOx emission limit is applied. Amendment 450 Jutta Paulus Proposal for a directive Annex I – point 3 – point b Directive 2010/75/EU Annex V – Part 2 – point 6 – last subparagraph Text proposed by the Commission Amendment The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, PE791.123v02-00 146/158 AM\1348825EN.docx EN such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; provided the substitution by hydrogen of the previously used fuel results in at least 15% total greenhouse gas emissions reduction. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; Or. en Amendment 451 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I - point 3 - point ba (new) Directive 2010/75/EU Annex V – Part 2 – point 8 Present text Amendment (ba) in Part 2, point 8 is amended as follows: ANNEX V ‘ANNEX V Technical provisions relating to combustion plants Technical provisions relating to combustion plants PART 2 PART 2 Emission limit values for combustion plants referred to in Article 30(3) Emission limit values for combustion plants referred to in Article 30(3) (...) (...) 8. Emission limit values (mg/Nm 3 ) for dust for combustion plants using gaseous fuels with the exception of gas turbines and gas engines 8. Emission limit values (mg/Nm 3 ) for dust for combustion plants using gaseous fuels other than natural gas with the exception of gas turbines and gas engines (...) (...)’ Or. en AM\1348825EN.docx 147/158 PE791.123v02-00 EN (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Justification Requiring continuous measurement of emissions of particulate matter and sulfur dioxide is not logical for boilers burning natural gas. Burning natural gas cannot release these pollutants into the air. This is therefore only an unnecessary administrative burden for the operators concerned. Amendment 452 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I - point 3 - point ba (new) Directive 2010/75/EU Annex V – Part 3 – point 3 Present text Amendment 3a. in Annex V, Part 3, point 3 is amended as follows ANNEX V "ANNEX V Technical provisions relating to combustion plants Technical provisions relating to combustion plants (...) (...) PART 3 PART 3 Emission monitoring Emission monitoring (...) (...) 3. Where continuous measurements are not required, measurements of SO 2 , NO x , dust and, for gas fired plants, also of CO shall be required at least once every 6 months. 3. Where continuous measurements are not required, measurements of SO 2 , NO x , dust and, for gas fired plants, also of CO shall be required at least once every 6 months. This shall not apply to combustion plants burning natural gas, where only NOx and CO shall be measured. (...) (...)" Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) PE791.123v02-00 148/158 AM\1348825EN.docx EN Justification Continuous measurement of emissions of particulate matter and sulfur dioxide is not mandatory for natural gas combustion sources in the case of turbines and engines. However, these sources still have to measure these pollutants on a one-off basis, even though the combustion of natural gas cannot release these pollutants into the air. This is therefore only an unnecessary administrative burden for the operators concerned. Amendment 453 Jutta Paulus Proposal for a directive Annex I – point 3 – point c Directive 2010/75/EU Annex V – Part 4 – point 5 Text proposed by the Commission Amendment 5. In the case of complete replacement of ambient air with oxygen, the emission limit values referred to in Article 30 shall be regarded as having been complied with if the emissions are not higher than the emissions from the combustion of the given fuel at the standardised O2 content. 5. In the case of complete replacement of ambient air with oxygen, the emission limit values referred to in Article 30 shall be regarded as having been complied with if the emissions are not higher than the emissions from the combustion of the given fuel at the standardised O2 content. In such case, Member States shall ensure that the overall load of pollutants eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with the emission limit values set out under conventional air-firing conditions. Or. en Amendment 454 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 3 a (new) Directive 2010/75/EU Annex VI – Part 4 – paragraph 2.1 AM\1348825EN.docx 149/158 PE791.123v02-00 EN Present text Amendment 3a. in Annex VI, part 4, paragraph 2.1 is replaced by the following: The emission limit values set out in points 2.2 and 2.3 apply as daily average values for total dust, HCl, HF, NOx, SO2 and TOC (for continuous measurements), as average values over the sampling period of a minimum of 30 minutes and a maximum of 8 hours for heavy metals and as average values over the sampling period of a minimum of 6 hours and a maximum of 8 hours for dioxins and furans. ‘The emission limit values set out in points 2.2 and 2.3 apply as daily average values for total dust, HCl, HF, NOx, SO2 and TOC (for continuous measurements), as average values over the sampling period of a minimum of 30 minutes and a maximum of 8 hours for heavy metals and as average values over the sampling period of a minimum of 6 hours and a maximum of 8 hours for dioxins and furans. All values are standardised at 10 % oxygen. All values are standardised at 10 % oxygen. Half-hourly average values shall only be needed in view of calculating the daily average values. Half-hourly average values shall only be needed in view of calculating the daily average values. In the event that the competent authority chooses to set emission limit values in accordance with Art. 15 (3b) of this Directive, these limit values can be set as freight-related values, such as g/t product.’; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 455 Katri Kulmuni Proposal for a directive Annex II – point 1 Directive (EU) 2015/2193 Annex II Text proposed by the Commission Amendment 1. Annex II to Directive (EU) 2015/2193 is amended as follows: deleted (a) In Part 1, tables 1, 2 and 3 as regards the emission limit values for PE791.123v02-00 150/158 AM\1348825EN.docx EN emission of NOx when gaseous fuels other than natural gas are used, the following footnote is inserted after the figures mentioned in the seventh column regarding that pollutant: (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (b) In Part 2, tables 1 and 2, as regards the emission limit values for emission of NOx when gaseous fuels other than natural gas are used, the following footnote is inserted after the figures mentioned in the sixth column regarding that pollutant: (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification The MCP Directive contains specific emission limit values (ELVs) for the category “Other gaseous fuel” and these values are higher than the ELVs for natural gas. Under MCPD AM\1348825EN.docx 151/158 PE791.123v02-00 EN hydrogen is classified as other gaseous fuel. The MCPD contains a mixing rule, which sets weighted ELVs based on the share of each fuel in the combustion process. The ELVS established via mixing rule would be sufficient to take into account the slighthly higher NOx emission originating from the combustion of hydrogen, so the provisions proposed by the Commission are not necessary. Furthermore, the Commission proposal is very combersome to apply in practice and add administrative burden, thus working against the objectives of this proposal. Amendment 456 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex II – point 1 – point a Directive (EU) 2015/2193 Annex II – Part 1 – tables 1, 2 and 3 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. This without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification It is unclear how it will be possible to meet the condition requiring that the amount of NOx emissions produced under the relevant emission limit when burning natural gas not be exceeded in case when the exemption from the NOx emission limit is applied. Amendment 457 Jutta Paulus Proposal for a directive PE791.123v02-00 152/158 AM\1348825EN.docx EN Annex II – point 1 – point a Directive 2015/2193 Annex II – Part 1 – tables 1, 2 and 3 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, provided the substitution by hydrogen of previously used fuel results in at least 15% greenhouse gas emissions reduction. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Amendment 458 Thomas Bajada, Annalisa Corrado Proposal for a directive Annex II – point 1 – point a Directive (EU) 2015/2193 Annex II – Part 1 – tables 1, 2 and 3 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without (*) The emission limit value is not applicable to combustion plants firing gas with more than 30 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without AM\1348825EN.docx 153/158 PE791.123v02-00 EN prejudice to stricter measures required pursuant to Article 6 (9).; prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Amendment 459 Alexander Bernhuber Proposal for a directive Annex II – point 1 – point a Directive (EU) 2015/2193 Annex II – Part 1 – tables 1, 2 and 3 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification The proposed threshold of 20% hydrogen content must be lowered to 5% to ensure regulatory certainty during early application phases and enable hydrogen projects to proceed to implementation more rapidly. Amendment 460 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex II – point 1 – point b Directive (EU) 2015/2193 Annex II – Part 2 – tables 1 and 2 – footnote PE791.123v02-00 154/158 AM\1348825EN.docx EN Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. This without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification It is unclear how it will be possible to meet the condition requiring that the amount of NOx emissions produced under the relevant emission limit when burning natural gas not be exceeded in case when the exemption from the NOx emission limit is applied. Amendment 461 Jutta Paulus Proposal for a directive Annex II – point 1 – point b Directive (EU) 2015/2193 Annex II – PART 2 – tables 1 and 2 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, provided the substitution by hydrogen of previously used fuel results in at least 15% greenhouse gas emissions reduction. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit AM\1348825EN.docx 155/158 PE791.123v02-00 EN prejudice to stricter measures required pursuant to Article 6 (9).; values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Amendment 462 Thomas Bajada, Annalisa Corrado Proposal for a directive Annex II – point 1 – point b Directive (EU) 2015/2193 Annex II – Part 2 – table 1 and 2 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 30 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Amendment 463 Alexander Bernhuber Proposal for a directive Annex II – point 1 – point b Directive (EU) 2015/2193 Annex II – Part 2 – table 1 and 2 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas (*) The emission limit value is not applicable to combustion plants firing gas PE791.123v02-00 156/158 AM\1348825EN.docx EN with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; with more than 5 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification The proposed threshold of 20% hydrogen content must be lowered to 5% to ensure regulatory certainty during early application phases and enable hydrogen projects to proceed to implementation more rapidly. Amendment 464 Michal Wiezik, Martin Hojsík Proposal for a directive Annex II – point 2 – point c Directive (EU) 2015/2193 Annex III – Part 1– point 2 – first indent Text proposed by the Commission Amendment - three times the number of maximum average annual operating hours, applicable pursuant to Article 6(3) or (8), for medium combustion plants with a rated thermal input equal to or greater than 20 MW that meet the requirements applicable to ‘category NRG’ in respect to Stage V controls under Regulation (EU) 2016/1628 of the European Parliament and of the Council1 , - three times the number of maximum average annual operating hours, applicable pursuant to Article 6(3) or (8), for medium combustion plants with a rated thermal input equal to or greater than 20 MW that have adopted measures for the installation of retrofit emission control devices and advanced secondary abatement techniques for particulate pollutants and which meet the requirements applicable to ‘category NRG’ in respect to Stage V controls under Regulation (EU) 2016/1628 of the European Parliament and of the Council1 , _________________ _________________ AM\1348825EN.docx 157/158 PE791.123v02-00 EN 1 Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC 1 Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC Or. en Justification it should be required that the monitoring frequencies are reduced in cases of not only compliance with the limits, which might lack ambition in case of PM, also considering that data centres are increasingly deployed near populated areas and are currently exempted from emission limits on patricle number (PN), but also with the requirement that advanced emission control, also for PM and PN is in place to ensure the hightest possible protection of human heatlh and environmnet. Amendment 465 Jutta Paulus Proposal for a directive Annex II – point 2 – point d Directive (EU) 2015/2193 Annex III – Part 2 – paragraph 6 Text proposed by the Commission Amendment 6. In the case of complete replacement of ambient air with oxygen, the emission limit values referred to in Article 6 shall be regarded as having been complied with if the emissions are not higher than the emissions from the combustion of the given fuel at the standardised O2 content. 6. In the case of complete replacement of ambient air with oxygen, the emission limit values referred to in Article 6 shall be regarded as having been complied with if the emissions are not higher than the emissions from the combustion of the given fuel at the standardised O2 content. In such case, Member States shall ensure that the overall load of pollutants eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with the emission limit values PE791.123v02-00 158/158 AM\1348825EN.docx EN set out under conventional air-firing conditions. Or. en
27.08.2026 Datei PD
Europa: Änderungsantrag zum Umwelt-Omnibus fordert Aufnahme der Kommunalen Abwasserrichtlinie (KARL)
Im Dezember 2025 veröffentlichte die EU-Kommission einen Entwurf für den Umwelt-Omnibus mit dem Ziel, Problemstellungen in bestehenden europäischen Umweltgesetzgebungen anzupassen. Die Überarbeitung der Kommunalen Abwasserrichtlinie (KARL) wurde trotz umfangreicher Forderungen nicht berücksichtigt. Bevor der Umwelt-Omnibus beschlossen werden kann, müssen EU-Rat und EU-Parlament ihre Positionen festlegen und anschließend im Trilog eine gemeinsame Einigung erzielen. Das EU-Parlament arbeitet derzeit an seiner Position und wird diese voraussichtlich im Oktober 2026 im Umweltausschuss beschließen. Mit Änderungsantrag 395 fordern einige Abgeordnete die Aufnahme der KARL in den Umwelt-Omnibus. Die EU-Kommission soll demnach eine neue Folgenabschätzung vorlegen. Diese soll eine vollständige Liste der in städtischen Abwässern enthaltenen Mikroschadstoffe erfassen, die Kosten der 4. Reinigungsstufe überprüfen, die Zuordnung der Verantwortung nach dem Verursacherprinzip bewerten sowie die Auswirkungen der EPR auf die Verfügbarkeit, Erschwinglichkeit und Zugänglichkeit von Arzneimitteln, insbesondere von Generika, kritischen Arzneimitteln und deren Wirkstoffen, untersuchen. Werden Risiken für die Verfügbarkeit, Erschwinglichkeit oder Zugänglichkeit dieser Arzneimittel und Wirkstoffe festgestellt, soll unter anderem eine vorübergehende Aussetzung der Erweiterten Herstellerverantwortung (EPR) über Gesetzgebungsakte der EU-Kommission ermöglicht werden.
27.08.2026 Beitrag PD
Fachseminar: Werbung für Arzneimittel am 29. September 2026
Die gezielte Ansprache von Fachkreisen und der Öffentlichkeit ist für pharmazeutische Unternehmen unverzichtbar, um Produkte erfolgreich am Markt zu positionieren. Angesichts eines wachsenden Wettbewerbs und anhaltenden Kostendrucks nimmt die Bedeutung wirksamer Marketingmaßnahmen stetig zu. Gleichzeitig verändern sich das Heilmittelwerbegesetz und das Wettbewerbsrecht kontinuierlich. Um rechtliche Risiken zu vermeiden und vorhandene Spielräume optimal zu nutzen, laden wir Sie herzlich zu unserer praxisorientierten Fachveranstaltung ein. In unserem Seminar vermitteln wir Ihnen fundierte Kenntnisse zu den rechtlichen Grundlagen sowie zu speziellen Detailfragen der Pharmakommunikation. Ein besonderer Schwerpunkt liegt dabei auf aktuellen Trends wie digitalen Werbeformaten und Online-Kampagnen. Das Programm lebt vom Praxistransfer und setzt auf einen interaktiven Aufbau: Bringen Sie Ihre individuellen Fragen ein und tauschen Sie sich im Rahmen moderierter Diskussionen mit Kolleginnen und Kollegen aus. Die Veranstaltung richtet sich branchenspezifisch an: Geschäftsleitungen der pharmazeutischen Industrie Fach- und Führungskräfte aus Recht und Compliance Teams aus Marketing, Vertrieb sowie Medical Affairs Informationsbeauftragte nach dem Arzneimittelgesetz Das Fachseminar findet am 29. September 2026, von 09:30 Uhr bis 15:30 Uhr in digitalem Format statt Fachseminar: Werbung für Arzneimittel Werbung für Arzneimittel rechtssicher gestalten. Anmeldung & Details
27.08.2026 Beitrag
Parlamentarischer Abend zur Primärversorgung in Berlin: "Primärversorgung- Quo Vadis?"
Gemeinsam mit unseren Mitgliedern sowie Vertretern aus Politik, Selbstverwaltung und Wissenschaft möchten wir über die Gestaltung und Chancen eines neuen Primärversorgungssystem diskutieren. Vorab geben uns Expertinnen und Experten Einblick in mögliche Wege, die die einzelnen Akteure im Gesundheitswesen beschreiten können, um die neue Primärversorgung zielgerichtet in das Gesundheitssystem zu verankern. Der Parlamentarische Abend findet in Präsenz am 13. Oktober 2026 ab 18:00 Uhr im DBB Forum Berlin | Friedrichstr. 169 | 10117 Berlin statt. Da die Teilnehmeranzahl begrenzt ist, melden Sie sich zeitnah über unsere Veranstaltungsseite an. Die Plätze werden nach Anmeldung vergeben. Primärversorgung - Quo Vadis? Wie lässt sich ein modernes, effizientes und patientenorientiertes Versorgungssystem für die Zukunft gestalten? Details und Anmeldung
27.08.2026 Beitrag
27.08.2026 – Mittagsausgabe
Quelle: Heilpraxisnet.de Vitamin-D-Mangel & viel Bauchfett erhöhen frühzeitiges Sterberisiko deutlich Übermäßige Fettpolster im Bauchbereich und Vitamin-D-Mangel haben in Kombination offenbar besonders nachteilige gesundheitliche Effekte. So unterliegen Personen, die sowohl an abdominaler Adipositas als auch an einem Vitamin-D-Mangel leiden, einem deutlich erhöhten frühzeitigen Sterberisiko. Originalbeitrag lesen Quelle: Heilpraxisnet.de Bauchspeicheldrüsenkrebs: Diese Pflanzenstoffe zeigen nachweisbar Wirkung Bei Bauchspeicheldrüsenkrebs könnten verschiedene Pflanzenstoffe einen Beitrag zur Therapie leisten. Pflanzliche Wirkstoffe wie Curcumin, Quercetin und Resveratrol zeigen vielversprechende krebshemmende Eigenschaften. Allerdings bedarf es weiterer Untersuchungen für eindeutige Behandlungsempfehlungen. 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27.08.2026 Beitrag
AESGP_Euro_OTC_News_Issue_386.pdf
AESGP Issue 386 | July 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • CMDh MAY minutes & JUN meeting report ___________________________________________________________________ 2 • EMA and DG SANTE sign Working Arrangement with New Zealand MoH ___________________________________________ 4 Herbal News ________________________________________________________________________________________________ 4 • HMPWG Meeting report - FEB 2026 ________________________________________________________________________ 4 Environment ________________________________________________________________________________________________ 6 • ECGT Directive - EU Commission publication - Common Understanding on old stock situations _________________________ 6 FOOD ___________________________________________________________________________________ 7 EFSA ______________________________________________________________________________________________________ 7 • EREN Food Supplement Project Report published _____________________________________________________________ 7 MEDICAL DEVICES ________________________________________________________________________ 8 Post Market Surveillance and Vigilance Medical Devices WG ________________________________________________________ 8 • Publication update of MIR 7.3.1. XSD files ___________________________________________________________________ 8 MDCG Standards WG _________________________________________________________________________________________ 8 • OJEU Publication of MDR Harmonised Standards - Corrigendum to Commission Implementing Decision (EU) 2026/1231 _____ 8 Expansion of the list of well-established technologies ______________________________________________________________ 9 • Delegated acts published in the OJEU ______________________________________________________________________ 9 MDR/IVDR Implementation _____________________________________________________________________________________ 9 • Overview on Applications for Designation as a NB - Update 01 July 2026 ___________________________________________ 9 • Notified Bodies Survey on Certifications & Applications - Data dated 28 February 2026 ________________________________ 9 • Updated list of notified bodies’ standard fees ________________________________________________________________ 10 • Publication of the European Parliament Draft Report __________________________________________________________ 10 Team NB __________________________________________________________________________________________________ 10 • Proposal for risk adaptive surveillance system (MDR) _________________________________________________________ 10 Study on Availability of MDs __________________________________________________________________________________ 10 • 3rd EO Survey - Survey Results __________________________________________________________________________ 10 Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 _______________________________ 11 • Update _____________________________________________________________________________________________ 11 CROSS-SECTORIAL NEWS _________________________________________________________________ 12 COMBINE programme launches phase 2 of the pilot coordinated assessment procedure for combined studies _____________ 12 Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi - Summary conclusions ____________________________________________________________________________________________ 12 DG HERA RAMP UP - Pilot go-live ______________________________________________________________________________ 13 AESGP OTC News | July 2026 2 | 14 Regulatory News CMDh MAY minutes & JUN meeting report The minutes of the CMDh meeting held on 19-20 MAY 2026 have been published. For MDC members, the only relevant item is the COMBO update. Among the items reported, the following may be noted: Safety Outcome Survey (SOS) Working Group • The WG discussed the project on publishing the outcomes of important safety variations for NAPs. Development is planned to start in the second half of 2026 (to be finalised in 2027). • The WG also discussed the new project on publishing the outcomes of PRAC advice to MS on the CMDh website. It was proposed that the PRAC advice should only be brought back to the CMDh for potential publication once the underlying procedure is finalised. The SOS WG will further develop a proposal based on the discussion. • The WG also noted the publication of a new Q&A (Q31) on PSURs on the EMA website, explaining whether MAHs can extrapolate the PRAC recommendation on a PSUSA to medicinal products not included in the procedure. An update of the CMDh Q&As on PhV will be prepared until the next SOS WG meeting to refer to the new EMA Q&A New Pharmaceutical Legislation (NPL) A presentation was given on the NPL, focusing on the main changes in MRP/DCP, CMDh coordination with the EU governance structure, the CMDh roadmap, preliminary impact assessment and topic leads and how the CMDh can engage with industry during the NPL implementation. EC/EMA Operational Group on Combination Products and Consultation Procedures (COMBO) COMBO was established to clarify and streamline applications and assessments concerning combination products and consultation procedures for medical devices. COMBO aims to provide a regular forum for dialogue, sharing experiences, achieving mutual understanding. The group is working on guidance, e.g. to enhance the role of Notified Body Opinions in complementing the quality assessment of MAAs or guidance to standardise and harmonise the assessment of medical devices with ancillary medicinal substances. Electronic Product Information (ePI) EMA and ES presented an update on the ePI, including the use of PLM portal, the provisions in the NPL and the draft implementation roadmap. Additionally, please be informed that the report from the CMDh meeting held on 23-25 JUN has been published. Among the items reported, the following may be noted: Deletion of the requirement to provide cover letters for type IA variations The CMDh has agreed to delete the requirement to provide cover letters for type IA variations, starting from 1 JUL 2026. The following guidance documents have been updated to reflect the change: • Requirements on submissions for variations and renewals within MRP and national procedures • BPG on the use of eCTD in the MRP/DCP • Cover letter for variation applications in MRP • Questions and answers on variations • BPG for the allocation of the MRP variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1) [Track version] Medicines https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_05_CMDh_Minutes.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure-document-tracked-changes_en.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_June_2026.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_291_2013_Rev24_2026_06_clean_-_Chapter_1_-_BPG_for_the_allocation_of_the_MR_number.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_291_2013_Rev24_2026_06_clean_-_Chapter_1_-_BPG_for_the_allocation_of_the_MR_number.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_291_2013_Rev24_2026_06_TC_-_Chapter_1_-_BPG_for_the_allocation_of_the_MR_number.pdf AESGP OTC News | July 2026 3 | 14 • BPG for the processing of Type IA minor variations (notifications) in MRP (Chapter 3) [Track version] • BPG for the processing of grouped applications in MRP (Chapter 6) [Track version] The tick box regarding annual update of type IA variation(s) has been removed from the cover letter template and will be included in the variation application form. The EMA/CMDh explanatory notes on variation application form (Human medicinal products only) have been updated to reflect the change. The document will be published once the updated variation application form is published. In addition, the document is updated to provide further clarification on how products should be listed in section 2 of the application form and to provide further guidance on the information to be included for grouped variations. Updated version of the MAA eAF The updated version 1.28.0.0 of the MAA eAF is now available on the eAF website for applicants and MAHs to familiarise themselves with the changes. The main reason for the changes in the form is to align the product data with the ISO IDMP model. The form can be used for new MAA submissions to the NCAs for NP, MRP and DCP procedures from 1 SEP 2026. It will be mandatory to use the updated form for all new MAA submissions to the NCAs from 1 JAN 2027. Applicants are reminded that the version of the form should not be changed during an ongoing procedure. Update of Q&As on QP declaration The CMDh and CMDv agreed an update of the joint QP declaration [Track version]. The document has been brought in line with the new Variations Guideline. Other minor changes have been included. Answers for human and veterinary medicinal products have been aligned where possible. Best Practice Guide on Variation Worksharing (Chapter 7) The CMDh agreed an update of the BPG on Variation Worksharing (Chapter 7) [Track version]. Further clarifications on the choice of the reference authority and the pre-submission activities have been added. Update of (Public) Assessment Report Templates The CMDh agreed an update of the following (public) assessment report templates: • DCP D70 Overview AR template (incl. instructions) [Track version] • DCP D70 Overview AR template (empty) [Track version] • Instructions for RMS when preparing the PAR based on the FAR [Track version] • PAR template (empty) when prepared based on FAR [Track version] A new standard wording for the non-clinical aspects has been added to be used, where relevant. Update of Q&As – Post-Brexit The CMDh agreed an update of its Post-Brexit [Track version]. The information on reference medicinal products authorised in the UK has been clarified in the document. Meeting with Interested Parties The CMDh convened a meeting with Interested Parties on 25 JUN 2026. The topics on the agenda included the NPL, the CMDh Multi-Annual Workplan, variations, safety label variations, multilingual packs, and trade name challenges. Change in the Presidency of the Council of the EU The June 2026 CMDh meeting was the last one under the Cypriot Presidency of the Council of the European Union. Ireland will take over the Presidency in July 2026. Nicole Kavanagh will be the appointed Presidency vice-chairperson of the CMDh during the Irish Presidency of the Council of the European Union. CMDh June meeting The following documents have been updated to reflect the decisions reached during the last CMDh meeting. The documents are also now available on the HMA website: • Questions and answers on variations [Track version] • Cover letter for Variation Applications in the Mutual Recognition Procedure [Track version] • CMDh Best Practice Guide on the use of eCTD in the MRP/DCP [Track version] • Requirements on submissions for Variations and Renewals within MRP and National Procedures [Track version] https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_293_2013_Rev.28_2026_06_clean_-_Chapter_3_-_BPG_for_the_Processing_of_Type_IA_Minor_Variations_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_293_2013_Rev.28_2026_06_TC_-_Chapter_3_-_BPG_for_the_Processing_of_Type_IA_Minor_Variations_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_296_2013_Rev32_2026_06_clean_-_Chapter_6_-_BPG_for_the_Processing_of_Grouped_Applications_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_296_2013_Rev32_2026_06_TC_-_Chapter_6_-_BPG_for_the_Processing_of_Grouped_Applications_in_MRP.pdf https://esubmission.ema.europa.eu/ https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_340_2015_Rev.9_2026_06_clean_-_QA_on_QP_Declaration.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_340_2015_Rev.9_2026_06_TC_-_QA_on_QP_Declaration.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_297_2013_Rev.36_2026_06_clean_-_Chapter_7_-_BPG_on_Worksharing.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_297_2013_Rev.36_2026_06_TC_-_Chapter_7_-_BPG_on_Worksharing.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_440_2022_Rev6_2026_06_clean_-_Overview_AR_including_instructions.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_440_2022_Rev6_2026_06_TC_-_Overview_AR_including_instructions.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_200_2007_Rev15_2026_06_clean_-_D70_Overview_AR.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_440_2022_Rev6_2026_06_TC_-_Overview_AR_including_instructions.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_454_2025_Rev3_2026_06_clean_-_Instructions_for_RMS_when_preparing_the_PAR_based_on_the_FAR.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_454_2025_Rev3_2026_06_TC_-_Instructions_for_RMS_when_preparing_the_PAR_based_on_the_FAR.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_453_2025_Rev3_2026_06_clean_-_Empty_PAR_template_when_the_PAR_is_prepared_based_on_the_FAR.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_453_2025_Rev3_2026_06_TC_-_Empty_PAR_template_when_the_PAR_is_prepared_based_on_the_FAR.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_457_2025_Rev1_2026_06_clean_-_Q_A_Post-Brexit.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_457_2025_Rev1_2026_06_TC_-_Q_A_Post-Brexit.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_132_2009_Rev66_2026_06_clean_-_QAs_Variations.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_132_2009_Rev66_2026_06_TC_-_QAs_Variations.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/Variations/CMDh_096_2009_Rev9_2026_06_clean_-_Cover_letter_for_Variation_Applications_in_MRP.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/Variations/CMDh_096_2009_Rev9_2026_06_TC_-_Cover_letter_for_Variation_Applications_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_084_2008_Rev8_2026_06_clean_-_BPG_on_the_use_of_eCTD_in_MRP_and_DCP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_084_2008_Rev8_2026_06_TC_-_BPG_on_the_use_of_eCTD_in_MRP_and_DCP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_006_2008_Rev_29_2026_06_clean_-_eSubmission_for_Variations_and_Renewals.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_006_2008_Rev_29_2026_06_clean_-_eSubmission_for_Variations_and_Renewals.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_006_2008_Rev_29_2026_06_TC_-_eSubmission_for_Variations_and_Renewals.pdf AESGP OTC News | July 2026 4 | 14 EMA and DG SANTE sign Working Arrangement with New Zealand MoH The European Commission’s DG SANTE and the European Medicines Agency (EMA) have signed a Working Arrangement with New Zealand Ministry of Health (incorporating the New Zealand Medicines and Medical Devices Safety Authority - Medsafe) this week, to strengthen collaboration and exchange of information on medicinal products. The agreement was signed by DG SANTE Director-General Sandra Gallina and EMA Executive Director Emer Cooke. Director-General Audrey Sonerson signed for the New Zealand Ministry of Health. The purpose of this Working Arrangement is to strengthen cooperation between signatories across a range of areas in public health, while promoting the timely, secure exchange of information. The working arrangement document is available here. Deliverables from the Arrangement will include: • Facilitate exchange of information regarding medicinal products quality, safety and efficacy. • Increase alignment and coordination on topics related to medicinal products for human-use, in-line with the application legislation. • Mutual learning, capacity building and the sharing of best practices in regulatory science and public health. The Arrangement is running from 6 July 2026, and is valid for an indefinite period of time, unless terminated by either party. Herbal News HMPWG Meeting report - FEB 2026 The public report of the 41st meeting of the Heads of Medicines Agencies’ Homeopathic Medicinal Products Working Group (HMPWG), that took place on 26-27 FEB 2026, has been uploaded to the HMA website. Please keep in mind that, since this meeting took place several months ago, some information may not reflect the latest developments. The following topics were discussed: Safety An overview of sub-working group First Safe Dilution (s-WG FSD) reactivated in March 2025, was presented. The group is composed by experts on FSD and HMPWG (secretariat) members. As the main focus of the s-WG FSD is the assessment of FSDs on new stocks, a draft “6th list FSD” is currently being elaborated. In view of the planned updated EMA guidance on the Establishment of Lactose Allergy Threshold in all Medicinal Products, including Homeopathic Medicinal Products (Annex to "Excipients Guideline"), the HMPWG discussed the potential impact on homeopathic products including the consistency of application across regulatory authorities. Homeophatic use A revised Consolidated List of Stocks for which Homeopathic Use is Justified was adopted for subsequent publication on the HMPWG website. Quality The Chairperson of the Quality Sub-Working Group (Qs-WG) summarised the activities undertaken since the last HMPWG meeting, including the group’s intention to develop new Q&A documents. https://www.ema.europa.eu/en/documents/other/working-arrangement-collaboration-exchange-information-therapeutic-products-medicinal-products-between-dg-sante-ema-new-zealand-ministry-health_en.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/06_2026_Public_Report_41st_HMPWG_Meeting_Cyprus_final.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/HU_rev_consolidated_list_de_1-6_February_2026.pdf AESGP OTC News | July 2026 5 | 14 The draft document Points to Consider on Pyrrolizidine Alkaloids in Homeopathic Medicinal Products was adopted for publication for public consultation on HMA website. Post-meeting note: AESGP submitted its feedback to this public consultation on 8 JUN 2026. Legislation Amendment of the regulations concerning homeopathic medicinal products An update on the New Pharmaceutical Legislation (NPL) was presented. Changes concerning homeopathic medicinal products were reported via detailed comparison to current valid legislation. SoHO Regulation Following a presentation concerning Regulation (EU) 2024/1938 (“SOHO Regulation”), its concrete impact on the regulation of homeopathic medicinal products was discussed among HMPWG members. In order to support a consistent regulatory interpretation and ensure alignment with the SoHO framework for homeopathic medicinal products, HMPWG plans to collect available information on the registration status of relevant products in member states. Status module 1.2 Homeopathic Application form This issue had been discussed, and it was agreed the need to have further clarifications in order to consider the applicability at European level. National Information Following comments received from HMPWG members on the proposed first draft concerning a Q&A on Bach Flower Remedies and Cell Mineral Products, a consolidated update will be elaborated for final agreement among HMPWG members. https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/202602_Draft_Points_to_consider_on__PA_26022026.pdf AESGP OTC News | July 2026 6 | 14 Environment ECGT Directive - EU Commission publication - Common Understanding on old stock situations There have been recent developments in the implementation of the Empowering Consumers for the Green Transition (ECGT) (Directive (EU) 2024/825), particularly the new EU Commission publication of the Common Understanding on ‘old stock’ situations which was agreed by the national authorities of the Consumer Protection Cooperation (CPC) network. • The link of the Common Understanding is available here: Common understanding on old stock situations under Directive (EU) 2024/825 on Empowering Consumers for the Green Transition | European Commission. Key takeaways • This document aims to support a coherent enforcement approach across the EU for products, packaging, and related communications that were manufactured, ordered, distributed, or placed on the market before the ECGT becomes applicable on 27 September 2026. • It acknowledges that some businesses may face transitional challenges where products or packaging bearing environmental claims or sustainability labels remain in the market after the application date due to factors such as packaging cycles, pre-existing production orders, supply chain constraints, stock volumes, or long product shelf-lives. • While the document is not legally binding and does not change companies’ legal obligations under the ECGT or the Unfair Commercial Practices Directive (UPCD), it provides insights into the enforcement approach that national authorities are expected to consider: o Traders are expected to continue working towards compliance without delay. o National authorities may take a phased and proportionate enforcement approach where specific transitional challenges can be demonstrated. o Practical constraints like stock volume, packaging cycles, prior orders, supply chain dependencies, and product shelf-life may be considered on a case-by-case basis. o Businesses are expected to undertake reasonable compliance efforts, including updating online claims, adapting future packaging, and maintaining evidence for their compliance activities. o Authorities may refrain from requiring disproportionate measures, including the destruction or recall of products, where this would result in excessive costs or unnecessary environmental harm. o In justified cases, national authorities may favour a compliance-oriented approach before considering sanctions. BACKGROUND • The ECGT introduces new requirements and prohibitions on environmental claims, sustainability labels, and business-to-consumer communications through amendments to the UPCD. • Member States were required to transpose the Directive by 27 March 2026; however, transposition has not been completed in a harmonised way across the EU and therefore the European Commission has initiated infringement proceedings against many Member States for failing to communicate national measures by the deadline. • Despite the delays, the Directive will apply from 27 September 2026, and companies should continue their compliance preparations accordingly. https://commission.europa.eu/document/264d8c70-2f9a-4955-8e7b-154d55a9b684_en https://commission.europa.eu/document/264d8c70-2f9a-4955-8e7b-154d55a9b684_en https://commission.europa.eu/document/264d8c70-2f9a-4955-8e7b-154d55a9b684_en AESGP OTC News | July 2026 7 | 14 EFSA EREN Food Supplement Project Report published EFSA’s supporting publication on “The European Food Supplement Project – Identification of emerging risks associated with food supplements, other than vitamins and minerals” has now been published. The project looked at possible emerging risks linked to food supplements other than vitamins and minerals, with a view to supporting prioritisation of substances that may be considered under Article 8 of Regulation (EC) No 1925/2006. The report highlights two main strands of work. The vigilance work package identified six ingredients as possible sources of emerging risks: Bifidobacterium, Coleus (Plectranthus barbatus), Guggul (Commiphora mukul), Toothed clubmoss (Huperzia serrata), Black radish (Raphanus sativus L.) and Ginseng (Panax ginseng). The plant work package examined 52 substances predicted to be toxic and their occurrence in food supplements on the EU market. Three substances were identified as being particularly widespread: furfural, emodin and chrysophanol. These substances were associated with a broad range of botanicals commonly found in food supplements, including acerola (Malpighia glabra), passionflower (Passiflora spp.), guarana (Paullinia cupana), grapefruit (Citrus paradisi), lemon (Citrus limon), rhubarb (Rheum spp.), buckthorn (Frangula spp.), Japanese knotweed (Fallopia japonica) and various Rumex species. The report also notes that, due to limitations in product labelling, EFSA assumed that all plant parts may contain the substances of concern, highlighting the need for further analytical and exposure data. As a next step, EFSA has launched a tender to identify a contractor for further work on these substances in food supplements sold across the EU, with EUR 200,000 made available for this activity. This follow-up will be important to better understand actual market presence and exposure, and to inform any further discussion on possible risk management or Article 8 prioritisation. Food https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2026.EN-10226 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2026.EN-10226 AESGP OTC News | July 2026 8 | 14 Post Market Surveillance and Vigilance Medical Devices WG Publication update of MIR 7.3.1. XSD files The Commission was recently notified that there was an inconsistency between the business rules of the MIR 7.3.1. PDF and of the XSD files as regards the field 4.3.3.d. for the report types “Combined” and “Final reportable”. After examination by COM, it was concluded that the above mentioned XSD files should be updated for field 4.3.3.d. These very limited modifications of these XSD files have not impact on the PDF and XML files and therefore the MIR 7.3.1. PDF publication date remains unchanged. The revised XSD files have been published on EUROPA at the following link. MDCG Standards WG OJEU Publication of MDR Harmonised Standards - Corrigendum to Commission Implementing Decision (EU) 2026/1231 The Corrigendum to Commission Implementing Decision (EU) 2026/1231 has been published in the OJEU. It includes the correct application date for EN ISO 15223-1:2021/A1:2025 (introduction of the new ‘EU REP’ symbol), namely 7 JUN 2031. Medical Devices https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202690511 AESGP OTC News | July 2026 9 | 14 Expansion of the list of well-established technologies Delegated acts published in the OJEU The two Commission delegated regulations amending MDR on Well-Established Technologies (WET) have been published in the Official Journal of the European Union today. • 2026/1359 Commission Delegated Regulation (EU) 2026/1359 of 20 March 2026 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device • 2026/1451 Commission Delegated Regulation (EU) 2026/1451 of 20 March 2026 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of implantable devices and class III devices exempted from the obligation to perform clinical investigations These regulations are binding in its entirety and directly applicable in all Member States. MDR/IVDR Implementation Overview on Applications for Designation as a NB - Update 01 July 2026 The overview on the applications for designation as a notified body under the MDR and IVDR has been updated by the Commission. The updated overview is accessible here. The presentation indicates that the MDCG recommendations equal the number of designated notified bodies. Notified Bodies Survey on Certifications & Applications - Data dated 28 February 2026 The Commission has published on its website the “Notified Bodies Survey on certifications and applications (MDR/IVDR)” based on data collected from notified bodies until 28 February 2026. The survey – accessible here – is based on data from 53 notified bodies designated under the MDR/IVDR. Please note that this data does not seem to be reflected yet in the dashboard of the corresponding study on the monitoring of availability of medical devices on the EU market. According to the data, there are 32.898 MDR applications (a decrease of 0.6%, explained by a change in methodology by some NBs, to October 2025 data) and 18.010 MDR certificates issued (an increase of 2.9% compared to October 2025 data). As usual, the survey also provides an overview of certifications and applications by annex and by type (QMS vs Product). Of further relevance, 9.724 applications have been lodged for changes received for already MDR issued certificates – this figure is included in the total number of applications (see slide 25). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 https://health.ec.europa.eu/document/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en AESGP OTC News | July 2026 10 | 14 Furthermore, the survey indicates that 1175 applications under Rule 14 MDR have been filed and 387 certificates have been issued thereof. The survey also indicates that now 162 applications under Rule 21, first indent, have been filed, with no certificates that has been issued thereof (see slide 26). Regarding timelines, for 62% of the NBs, it takes 13-18 months to issue a new QMS certificate under the MDR. For 51% of the NBs, it takes 13-18 months to issue a certificate (QMS+Product) under the MDR and 31% of the NBs need 19-24 months to issue a certificate (QMS+Product) under the MDR. Updated list of notified bodies’ standard fees The list of notified bodies’ standard fees has been updated and published on Commission website. Publication of the European Parliament Draft Report The European Parliament has published its Draft Report on the Commission’s proposal to simplify the MDR/IVDR. The report is available below: • Draft EP Report (PDF version) • Draft EP Report (Word version) AESGP and members have advocated close to MEPs for proportionate amendments to the Commission’s proposal and we are glad to see that many of these have been reflected in the European Parliament’s Draft report. Overall, the targeted amendments introduced in the Draft Report are expected to further enhance predictability, transparency, and legal certainty of the regulatory framework for medical devices. Team NB Proposal for risk adaptive surveillance system (MDR) Team-NB has released a position paper which details their views and proposed amendments on how to adapt the surveillance system considering the Commission proposal to remove the maximum validity of certificates. Study on Availability of MDs 3rd EO Survey - Survey Results The survey results of the third economic operator survey with data status 31 October 2025 within the study “Supporting the Monitoring of Availability of Medical Devices on the EU Market” have been published on the Commission website. The results of this third survey – accessible here – are based on 213 responses from manufacturers of MDs and IVDs and authorised representatives. The dataset provides information, amongst others, concerning: • Written agreements with Notified Bodies • Refusal of applications by Notified Bodies • MDR Implementation (applications, certificates, re-certification, and time periods) https://health.ec.europa.eu/document/download/ff5716d5-fe77-4f45-b883-fcf3da4acd15_en?filename=md_nbs_fees_en.pdf https://health.ec.europa.eu/latest-updates/updated-list-notified-bodies-standard-fees-2026-07-13_en https://www.europarl.europa.eu/doceo/document/SANT-PR-787987_EN.pdf https://www.europarl.europa.eu/doceo/document/SANT-PR-787987_EN.docx https://www.team-nb.org/wp-content/uploads/2026/07/Team-NB-PositionPaper-MDR-Update-Risk_adaptive-surveillance-V1-20260630.pdf https://health.ec.europa.eu/document/download/61b46045-744a-41a7-bbcc-1af40fb92632_en?filename=md_availability_study_presentation_2025_en.pdf AESGP OTC News | July 2026 11 | 14 • Estimates on the completed transition • Discontinuation of medical devices • Manufacturer preparedness Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 Update The Commission has published an update of the planned meeting dates of the MDCG and subgroups for 2026. The update concerns the addition of a market surveillance meeting in November and of a Nomenclature WG meeting (date still needs to be determined). https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf AESGP OTC News | July 2026 12 | 14 COMBINE programme launches phase 2 of the pilot coordinated assessment procedure for combined studies The European Commission and EU Member States are launching the second phase of the COMBINE coordinated assessment pilot. Phase 1 offered the first experience of coordinated assessment for combined studies through the Clinical Trials Information System (CTIS). Phase 2, which is expected to remain open for at least one year, expands the scope of studies eligible to participate and introduces a more agile, rolling process with monthly slots for the submission of expressions of interest. The launch of phase 2 marks a major step towards more streamlined, efficient, and coordinated regulatory pathways across combined medicine-device therapies . By simplifying processes and enabling joint assessment, the pilot aims to support innovation while maintaining robust regulatory oversight across the EU. What’s New in phase 2 • Eligibility for multinational investigational medicinal product (IMP) clinical trials combined with: o Performance studies of IVDs or companion diagnostics requiring authorisation o Clinical investigations of medical devices requiring authorisation • Combined studies with Advanced Therapy Medicinal Products (ATMPs) possible • Options for single or separate sponsors • Procedure for substantial modifications in combined studies authorised in the pilot to be launched later in phase 2 • Exploration of single protocols and joint documents When to express interest for phase 2 Sponsors must submit their expressions of interest by the 23rd of the month preceding the month in which they intend to submit their application. The first monthly application window will open in SEP 2026. To apply to the September round, sponsors must submit their expressions of interest by 23 AUG 2026. For more information and to apply for the pilot COMBINE coordinated assessment procedure, visit the European Commission's website. Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi - Summary conclusions An implementation dialogue on the European Health Data Space Regulation (EHDS Regulation) was held in Brussels on 10 June 2026 with the participation of industry, researchers, healthcare providers and patient organisations. The dialogue pursued two principal objectives. • First, it aimed to take stock of the stakeholders’ state of preparations for the EHDS, including by gathering evidence on measures already being taken to ensure compliance with the Regulation and on the main challenges expected. Cross-Sectorial News https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme_en https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme/combine-project-1-pilot-all-one-coordinated-assessment_en AESGP OTC News | July 2026 13 | 14 • Second, it sought to collect views on possible measures to facilitate and simplify the forthcoming implementation of the EHDS Regulation and to foster innovation, including through actions beyond the scope of the EHDS that could contribute to enhanced efficiency and competitiveness in the digital health sector. Industry representatives reported having started their preparations for the implementation of the EHDS while underlining the importance of the timely adoption of the relevant implementing acts. In addition, they stressed the need to build on existing standards. Many participants asked for harmonised implementation of the EHDS across the EU as much as possible and for further clarification of certain notions and concepts. They also asked for clarification of the interplay with other Union rules. To access the full summary, please check here. DG HERA RAMP UP - Pilot go-live The Commission’s DG HERA has now launched the pilot phase of RAMP UP (Rapid Agile Manufacturing Partnerships for Union Protection), a voluntary preparedness network aimed at strengthening Europe’s ability to rapidly scale up the production and supply of medical countermeasures (MCMs) during health emergencies. The initial launch of RAMP UP is positioned as a pilot phase, focusing on engaging and onboarding stakeholders whose portfolios include medicinal products relevant for medical countermeasure preparedness. While the application process remains open to all eligible members, the first phase will focus on pharmaceutical companies with portfolios covering pharmacological classes identified for the purpose of this initial RAMP UP pilot phase. This will allow DG HERA and participating partners to test and refine the practical arrangements of the initiative, including data requirements, templates and data- sharing processes, while ensuring that these are proportionate and fit for purpose. Applicants whose portfolios include medicinal products falling within the list of pharmacological classes for RAMP UP pilot phase are invited to apply. Why join RAMP UP? By joining the RAMP UP network, your organization can: • Establish a dedicated channel of communication with DG HERA on manufacturing, supply chain, and crisis readiness. • Increase visibility and be included in the RAMP UP registry to help identify key capabilities and potential supply chain bottlenecks. • Shape the initiative by helping develop practical data-sharing templates, formats, and procedures from the ground up. • Network and collaborate via the HERA Stakeholders Hub to explore cooperation opportunities across the MCM ecosystem. Note: RAMP UP is a preparedness partnership designed to improve mutual coordination before a crisis occurs; it does not guarantee future contracts or provide privileged procurement status. Who is eligible? Legal entities with a proven role in ensuring access to crisis-relevant MCMs in the EU/EEA, including: • Marketing authorization holders and manufacturers of medicines • Manufacturers of medical devices, PPE, and IVDs • CDMOs and CMOs • Suppliers of APIs, raw materials, intermediates, and fill-finish services • Innovators of advanced manufacturing technologies How to apply 1. Register your organization on the HERA Stakeholders Hub. 2. Complete the RAMP UP application form, including the eligibility verification. 3. Onboarding: Once DG HERA reviews and confirms your eligibility, you will receive further details during an ad-hoc onboarding meeting. https://health.ec.europa.eu/events/implementation-dialogue-european-health-data-space-regulation-commissioner-oliver-varhelyi-2026-06-10_en https://health-preparedness-industry-hub.ec.europa.eu/ramp-up https://health-preparedness-industry-hub.ec.europa.eu/ramp-up https://health-preparedness-industry-hub.ec.europa.eu/system/files/2026-07/pharmacological-classes-for-ramp-up-pilot.pdf https://health-preparedness-industry-hub.ec.europa.eu/system/files/2026-07/pharmacological-classes-for-ramp-up-pilot.pdf https://health-preparedness-industry-hub.ec.europa.eu/home https://health-preparedness-industry-hub.ec.europa.eu/system/files/2026-06/2026-06-09-eligibility-criteria-final.pdf AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu
27.08.2026 Datei PD
386. Ausgabe der "AESGP Euro OTC News"
27.08.2026 Beitrag PD
AESGP_Euro_OTC_News_Issue_385.pdf
AESGP Issue 385 | June 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • CMDh April minutes & May meeting report ___________________________________________________________________ 2 • 124th HMA meeting - 27-28 MAY 2026 - meeting report _________________________________________________________ 3 • EMA Management Board - JUN 2026 - Meeting highlights + Publication of EMA 2025 Annual Report _____________________ 4 • Preliminary Ruling - Case C-604/24 - Restriction of Online Sale of NPMs – Judgment _________________________________ 5 Herbal medicines ____________________________________________________________________________________________ 6 • EMA HMPC Meeting Report - 4-6 MAY 2026 _________________________________________________________________ 6 • HMPC RP on data recommendations for (T)HMPs used in paediatric patients published with overview of comments _________ 7 FOOD ___________________________________________________________________________________ 9 Law -13 May 2026 ____________________________________________________________________________________________ 9 • Summary report _______________________________________________________________________________________ 9 MEDICAL DEVICES _______________________________________________________________________ 11 MDCG Eudamed WG_________________________________________________________________________________________ 11 • Production release 2.27.0 deployed _______________________________________________________________________ 11 • Mandatory Use of First EUDAMED Modules from 28 May 2026 __________________________________________________ 11 • MDCG EUDAMED WG Meeting on 2 June 2026 _____________________________________________________________ 12 • MDCG Endorsement of Position Paper on SS(C)P Management in EUDAMED _____________________________________ 12 MDCG Standards WG ________________________________________________________________________________________ 12 • New references harmonised standards MDR/IVDR - Publication in the OJEU & Appendix 'EU REP' _____________________ 12 MDCG Nomenclature WG _____________________________________________________________________________________ 13 • EMDN Annual Update __________________________________________________________________________________ 13 MDR/IVDR Simplification Proposal _____________________________________________________________________________ 13 • Commission presentation to Council on EMA support, borderline & classification ____________________________________ 13 MDR/IVDR Implementation ____________________________________________________________________________________ 14 • Notified Bodies Survey on Certifications & Applications - Data dated 31 December 2025 ______________________________ 14 • Annex VII NB Requirements: AESGP statement and summary of timelines for NBs __________________________________ 14 Team NB Publications _______________________________________________________________________________________ 15 • Sector Survey 2025 ____________________________________________________________________________________ 15 • MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document _____ 16 • IVDR Application and appropriate surveillance Transfer agreement _______________________________________________ 16 • Micro and Small Enterprise Considerations _________________________________________________________________ 16 Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 _______________________________ 17 • Update _____________________________________________________________________________________________ 17 ESIP, AIM, TEAM-NB, CPME, TÜV Verband, IG-NB unified for a better WET approach ___________________________________ 17 CROSS-SECTORIAL NEWS _________________________________________________________________ 18 AI - Omnibus VII legislative package - Provisional agreement reached by the Council presidency and European Parliament negotiators _____________________________________________________________________________________________ 18 New Council of Europe Recommendation sets standards for remote and online medicine provision ______________________ 19 PPWR - EC guidance - 10 JUN 2026 ____________________________________________________________________________ 20 AESGP OTC News | June 2026 2 | 21 Regulatory News CMDh April minutes & May meeting report The minutes of the CMDh meeting held on 21-22 APR 2026 have been published. Among the items reported, the following may be noted: Working Party on Variations Regulation The WP Chair reported from the April 2026 meeting. The EMA presented a draft procedure for the preparation of the report laid down in Article 4 of the Variations Regulation, for adoption of the procedure at the May CMDh plenary meeting. Regarding the ROG proposal to delete the requirement for cover letters for Type IA variations, the WP Chair reported on the agreed changes to the CESP delivery file and eAF. The WP Chair presented updates to several CMDh guidance documents in relation to the deletion of the cover letter for Type IA variations. The publication of the updated documents is foreseen once the CESP delivery file is updated. The WP discussed several proposals to improve the process for requesting worksharing Reference Authorities (RA). It was proposed to clarify in the BPG that MSs acting as RMS or holding national MAs are expected to accept the RA role. MAHs should be reminded to give a list of proposed RAs in the order of priority and not only propose one MS. In addition, it was suggested that MAHs include a justification for the proposed RAs and the order of priority. The WP also discussed the regulatory consequences for products with already approved changes included in a worksharing procedure that is subsequently refused. It was agreed that this situation applies only to worksharing and not to super-grouping. In case of refusal of the worksharing, products retain their former status, and approved changes are not automatically reversed; however, the MAHs should consider the outcome of the worksharing procedure. In relation to the actions included in the new CMDh MAWP to 2028, the WP discussed the proposal from industry to set up a dedicated mailbox for questions about variations. It has been agreed that questions regarding variations should be addressed to the RMS/relevant NCA and answered by them by referring to the relevant guidance. Questions not covered by the guidance may be forwarded by the RMS/relevant NCA to and discussed by the VRWP, which will consider whether to develop new Q&As or update existing ones. Following the February WP meeting, the WP Chair confirmed that an amendment to the eAF has been implemented to add a type IAIN variation E.z to the RMS list. This change will allow the use of the eAF/PLM Portal for national transfers of MAs in specific MSs, where national legislation foresees the use of this procedure. Generally, the E.z code is currently not applicable for other type IA/IAIN notifications. In case any questions arise, it will be considered to prepare a Q&A. The WP discussed whether the approach agreed in February for annual updates (Type IA) including changes for which the variation codes are missing in the eAF, could be applied to Type IB and Type II procedures. It was clarified that this approach cannot be extrapolated to IB/II procedures, as these can be updated during validation or clock-stop. Missing Type IA codes or other changes cannot be added Medicines https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_04_CMDh_Minutes.pdf AESGP OTC News | June 2026 3 | 21 to an ongoing procedure once started but may be submitted in parallel or NCAs may request submission of single Type IA notifications. The WP discussed whether applicants may submit a variation of a higher classification than foreseen in the classification guideline. It was agreed that applicants may request a higher variation type under the same change code if justified, while retaining the correct classification category rather than using a z- category. The responsibility for selecting and justifying the variation type remains with the applicant. Finally, the WP discussed the lack of consistency in how applicants present changes when submitting multiple variations. It was suggested to develop a standardised annex template to improve clarity and consistency. A draft will be prepared for the next meeting. New Pharmaceutical Legislation (NPL) The EC gave a presentation on the simplification of DCP/MRP in the NPL. The final text is expected to be made available to NCAs shortly, and MSs were invited to carefully review the translations. Meetings attended by the CMDh chair 16th ISG Meeting The Commission presented an overview of the NPL, with adoption expected in Q4 2026, and most provisions applying from Q4 2028. The EMA presentation addressed NPL governance, the implementation planning, and a request for industry to provide input on implementation priorities. Industry representatives shared updates on PMS development and data quality. ROG plenary meeting with industry representatives Discussions focused on the impact of the NPL on industry and the EMRN Strategic Portfolio (IT projects and systems) and data interoperability. The ROG also provided an update on ongoing optimisation activities related to PMS data and Type IA variations. Electronic Application Form The EMA presented a summary of proposed changes to the Human Marketing Authorisation Application form (MAA eAF) to align where possible with the PMS IDMP format to improve the quality of product data and to address structural limitations in the current form. It was noted that currently the use of OMS is not proposed to be mandatory for CROs. The CMDh proposed that mandatory use of OMS could also be considered for CROs. It was noted that, once the proposed changes are agreed and implemented, the user guide of the eAF would also need to be updated. The EMA will keep the CMDh informed. Additionally, please be informed that the report from the CMDh meeting held on 19-20 MAY has been published. Among the items reported, the following may be noted: Template for the non-clinical and clinical assessment of a generic application in MRP/DCP The CMDh agreed an update of the template for the non-clinical and clinical assessment of a generic application in MRP/DCP. The wording in relation to the environmental risk assessment has been aligned with the wording used in other templates. The updated template can be found here. 124th HMA meeting - 27-28 MAY 2026 - meeting report The meeting report of the 124th Heads of Medicines Agencies (HMA) meeting, held on 27-28 May 2026, has now been published. Below is a brief overview of relevant items from the meeting. HMA MG Report The HMA Management Group provided updates on strategic and operational priorities across the EMRN, including work from HMA groups, Joint Actions, clinical trials developments, and potential implications of the proposed PFAS restriction. Updates were also given on preparations for the next EMANS and on international cooperation activities. EMA Update https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_May_2026.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_202_2005_Rev7_2026_05_clean_-_NonClinical_Clinical_AR_forGenerics_MRP_DCP.docx https://www.hma.eu/fileadmin/dateien/HMA_joint/03-Stakeholders_Info/2026-05-HMA-II-Paphos-Stakeholders-Information.pdf AESGP OTC News | June 2026 4 | 21 EMA presented updates on crisis preparedness and scientific readiness, including responses related to viral outbreaks and the Middle East context. Additional topics included NPL, international cooperation through ICMRA and with China, vaccine confidence initiatives, collaboration with ECHA, and upcoming network activities. Commission Update The EC provided updates on public health preparedness (hantavirus, Ebola), implementation of the Clinical Trials Regulation via the CTA framework, NPL, the Biotech Act, and the Substances of Human Origin (SoHO) legislation. Cooperation of National Agencies/EMA in the Proposed MDR/IVDR Revision HMA discussed the importance of close cooperation between NCAs and the EMA in the context of the proposed MDR/IVDR revision. The discussion highlighted the need for coordinated regulatory approaches, efficient use of expertise across the network, and strengthened collaboration to support innovation, patient safety, and effective implementation of the revised legislative framework. CAMD Update CAMD updated HMA on discussions regarding the future governance and structure of the European medical devices network. Feedback from CAMD members showed support for strengthening cooperation between medicines and medical devices regulatory systems, while maintaining a dedicated medical devices network in the short term. Opportunities for closer collaboration were identified in training, clinical trials, innovation, enforcement and shared regulatory infrastructures, with a longer-term vision of greater integration across the two sectors. Trio-Theme Megatrends – HMA Concept Paper to Inform the Next EMANS HMA endorsed a Trio Presidency concept paper on megatrends affecting the EMRN, including technological innovation, digital transformation, demographic change, and evolving health needs. The paper provides a strategic basis for the next EMANS (from 2028) and was finalised after consultation with NCAs. Joint Session with EMACOLEX EMACOLEX updated HMA on legal and regulatory developments relevant to the network, supporting coordination, knowledge exchange, and regulatory preparedness. The Subgroup on Horizontal Scanning presented its work on monitoring external policy developments affecting medicines and medical devices, enabling early identification and proactive regulatory response. Upcoming Irish Presidency HMA was introduced to the upcoming Irish Presidency priorities and planned activities, with a focus on continued collaboration across the regulatory network and invitations to upcoming meetings and exchanges among MSs. EMA Management Board - JUN 2026 - Meeting highlights + Publication of EMA 2025 Annual Report The highlights of the EMA Management Board JUN 2026 meeting, have been published. Among the items reported, the following may be noted: Positive assessment of EMA’s activities in 2025 – Annual Report The Board positively assessed the Executive Director’s 2025 annual activity report, which describes the implementation of the Agency’s work programme and the management and control systems in place. The Board noted the work on marketing authorisations via the centralised procedure, both in human and veterinary medicines. EMA delivered 104 positive recommendations for new medicines for human use, including 38 containing a new active substance, many of them addressing unmet medical needs. The Agency issued 30 recommendations for new veterinary medicines – the highest number of recommendations for a second consecutive year. Of these, 13 had a new active substance. https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2026-meeting AESGP OTC News | June 2026 5 | 21 The Board also acknowledged activities carried out to accelerate and optimise assessment processes, as well as the Agency’s continued role in addressing challenges related to the availability of medicines and security of supply. The annual activity report will be published on the EMA website shortly. This complements EMA’s 2025 annual report (see here the digital version and here the PDF) that was published on 11 JUN. Preparations for implementation of the new EU pharmaceutical legislation Preparations for implementing the new EU pharmaceutical legislation (NPL) have progressed. The Board received a comprehensive overview of the activities under the NPL EMA Management Board governance structure. Planning is advancing across the delivery streams, aligned with the European Commission’s work on the delegated and implementing acts. The NPL Oversight Group has also endorsed a network collaboration model to ensure broad expert involvement from across the European medicines regulatory network in the preparations from the outset. Update from Network Data Steering Group EMA, in collaboration with the national medicines agencies, is further developing the product management service (PMS) to support regulatory activities across the EU with structured and standardised medicinal product master data for all human medicines authorised in the EU. These data are routinely used by regulators and industry, e.g. pharmacovigilance and shortages activities, and other targeted regulatory procedures. The Agency is now looking at enabling wider use beyond medicines development and regulation by the public. From 12 JUN 2026, PMS will make additional data publicly accessible through the release of a ‘beta’ version of an Application Programming Interface (API) for public use. PMS data are already available via a web interface, but the API will enable external access in a structured, machine- readable format. This is an important step towards greater transparency, improved accessibility and broader use of trusted EU medicinal product information. With the beta release, EMA and stakeholders can gain experience, test use cases, and further refine the service. Release of a final API version is planned for early 2027. Preliminary Ruling - Case C-604/24 - Restriction of Online Sale of NPMs – Judgment The Court of Justice of the European Union (CJEU) delivered its judgment in the Court proceedings C-604/24 concerning the request for a preliminary ruling by the Greek Council of State to provide clarity as regards the Member States’ discretion to restrict online sales of non-prescription medicines under Article 85c of Directive 2001/83/EC. Dispute in the main proceedings The applicant is a Greek company operating both a physical pharmacy and an online sales channel. In April 2022, Greece adopted a Ministerial Decision, which narrowed the previously unrestricted authorisation to sell all non-prescription medicines (NMPs) online to a single subcategory: over-the- counter (OTC) medicinal products classifiable as such under their marketing authorisation and available for sale outside pharmacies, without the presence of a pharmacist or an auxiliary pharmacist being required. The measure amounted in practice to a ban of online sales of NMPs because no product had been classified in the OTC subcategory on the Greek market. The questions referred by the Greek Council of State asked in essence whether Article 85c(1) and (2) of Directive 2001/83 must be interpreted as precluding national legislation which, on grounds of public health protection, prohibits the online sale of non-prescription medicinal products, with the exception of a subcategory thereof. Court Ruling In its ruling, the Court clarifies that the wording Article 85c(1) of Directive 2001/83 establishes an obligation on part of Member States to offer the online sale of all NPMs. Consequently, the Court finds that the Greek legislation under consideration prohibiting the online sale non-prescription medicinal products, with the exception of a subcategory, fails to fulfil the obligation arising from https://www.ema.europa.eu/assets/en/annual-report/2025/index.html https://www.ema.europa.eu/en/documents/annual-report/2025-annual-report-european-medicines-agency_en.pdf https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:62024CJ0604 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:62024CJ0604 AESGP OTC News | June 2026 6 | 21 Article 85c(1) of Directive 2001/83. The only limitation in Article 85c(1) concerns prescription medicinal products. In addition, the Court specifies that national legislation prohibiting the online sale non-prescription medicinal products, with the exception of a subcategory, cannot be justified under Article 85c(2) as a "condition". Such legislation only partially authorises the offer for online sale of non-prescription medicinal products. The conditions referred to in Article 85c(2) of Directive 2001/83 cannot have the effect of rendering meaningless the obligation on Member States, under Article 85c(1), to ensure that medicinal products, at least all non-prescription medicinal products, are offered for online sale. The Court concludes therefore that Member States cannot rely on Article 85c(2) of Directive 2001/83 in order to impose conditions justified on grounds of public health protection as concerns the online sale of non-prescription medicinal products, where such conditions have the effect of depriving the obligation set out in Article 85c(1) of its effectiveness. At the same time, the Court provides guidance as to what “conditions” under Article 85c(2) may be permissible to regulate the online sale of NPMs. Such conditions must be justified on grounds of public health protection aimed at reducing the risks associated with the online sale of medicinal products and could consist, for example, of putting in place effective mechanisms to monitor the consumption of medicinal products, such as establishing order limits per consumer or the creation of an online system for identification and registration of consumer health data in order to combat overmedication. Nevertheless, in that context the Court stresses that those conditions must not call into question the possibility of offering NPMS for online sale by restricting access. Based on the foregoing, the Court stipulates that Article 85c(1) and (2) of Directive 2001/83/EC precludes national legislation that, on grounds of public health protection, prohibits the online sale of non-prescription medicinal products, with the exception of a subcategory thereof. Herbal medicines EMA HMPC Meeting Report - 4-6 MAY 2026 The report on European Union herbal monographs, guidelines, and other activities from the EMA Committee on Herbal Medicinal Products (HMPC) meeting, held on 4-6 May 2026 has been published. Among the reported items, the following may be noted: Revised European Union herbal monograph – final The HMPC adopted after systematic review, revision and public consultation the following revised monograph: • Revised EU herbal monograph on on Fragariae folium The final revised monograph together with supporting documents will be published on the European Medicines Agency's website. European Union herbal monographs’ review The HMPC adopted after systematic review and revision the following revised monograph (draft) for 3 month public consultation until 31 August 2026: • Draft revised EU herbal monograph on Lecithinum ex soya The review reports will be published as addenda to the existing assessment reports on the European Medicines Agency's website. Guidance documents The HMPC adopted the following reflection paper: https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-4-6-may-2026_en.pdf https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-4-6-may-2026_en.pdf https://www.ema.europa.eu/en/search?f%5B0%5D=ema_search_categories%3A85&f%5B1%5D=ema_search_content_type%3Aema_herbal&landing_from=73303 https://www.ema.europa.eu/en/search?f%5B0%5D=ema_search_categories%3A85&f%5B1%5D=ema_search_content_type%3Aema_herbal&landing_from=73303 AESGP OTC News | June 2026 7 | 21 • Reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in paediatric patients (EMA/HMPC/71333/2023). The reflection paper will be published on the European Medicines Agency's website here. HMPC RP on data recommendations for (T)HMPs used in paediatric patients published with overview of comments The reflection paper on data recommendations for HMPs used in paediatric patients has been published by the EMA, together with the overview of comments received. At a glance, the RP has been minimally changed. The overview of comments responded to the general comments, pointing out the rather strict approach taken by the guideline in comparison with ICH E11, as follows: WEU and PK-PD It is agreed that WEU herbal medicinal products are not excluded from the scope of the ICH E11A extrapolation guideline and that the principles described in this guideline are applicable to WEU HMPs, despite the fact that WEU HMPs usually do not provide comprehensive pharmacokinetic and pharmacodynamic data. This is also acknowledged in the ICH guideline which states that when there is lack of correlation between systemic drug exposures/biomarker and therapeutic response, dose response relationships can rely on a clinical endpoint. The respective parts of the reflection paper have been therefore updated accordingly. [...] Extrapolation concerns safety and efficacy It must be underlined that in line with the ICH E11A guideline, extrapolation concerns both efficacy and safety. Therefore, it is not agreed that the main focus of extrapolation exercise in WEU HMPs should be on safety only. At the same time, in line with the ICH E11A guideline, the use of paediatric extrapolation ensures that the paediatric population only participates in clinical trials when necessary for further scientific understanding of the paediatric use of a medicinal product. First, available published data should be reviewed to confirm the acceptability of WEU status and to identify possible gaps in evidence. If any gaps in evidence are identified, an assessment in line with the ICH E11A guideline should take a place to understand whether it is acceptable to fill these gaps with extrapolation. Only if this is not possible, generation of additional paediatric data should be required. These principles are also described in the ICH E11A guideline; therefore, no additional changes are proposed to the reflection paper. It is agreed that HMPs tend to have good safety profiles with wider safety margins, although this is not always the case. This is also acknowledged in the ICH E11A guideline which states that if the safety margin is wide, it may be acceptable to target higher exposures than in adults. As the applicability of this guideline was acknowledged, no additional changes are proposed to the reflection paper. It is agreed that evidence from similar/same-class products could be included among alternative supportive data sources. This approach is also supported by the ICH E11A guideline. At the same time, the differences between products need to be reviewed critically in line with the guideline. As the applicability of this guideline was acknowledged, no additional changes are proposed to the reflection paper. Conditional approval and absence of unmet medical needs The proposed approach of conditional approval of adjacent paediatric age groups where generation of data in the adjacent paediatric age group would take place only after granting of conditional approval for the respective age group is not supported. This is because according to the current requirements for conditional marketing authorisation, the product has to fulfil an unmet medical need. However, HMPs are generally not used in indications where significant unmet medical need exists. Second, to grant a conditional marketing authorisation, the benefit-risk balance in the respective age group needs to be positive while according to this proposal, no data would be available in the respective age group for benefit-risk assessment. This way of extrapolation is also not in line with the requirements set by ICH https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishment https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-recommendations-herbal-medicinal-products-traditional-herbal-medicinal-products-used-paediatric-patients_en.pdf https://www.ema.europa.eu/en/documents/comments/overview-comments-draft-reflection-paper-data-recommendations-herbal-medicinal-products-traditional-herbal-medicinal-products-used-children-adolescents_en.pdf AESGP OTC News | June 2026 8 | 21 E11A guideline. Third and most importantly, according to the current legal requirements, such a conditional approval does not exist in monograph development. Traditional use As for TU herbal medicinal products, proof of TU requires the gathering of all available evidence for the specific herbal substance/ preparation and based on this evidence of use, the indication is granted. Such an approach ensures that plausibility of TU and safety is established by proven long-term use without any unacceptable reported issues while no actual hard clinical data are available. This means that extrapolation of TU, to age groups which are not explicitly mentioned in TU evidence, is not generally acceptable. AESGP OTC News | June 2026 9 | 21 Law -13 May 2026 Summary report The summary report of the Standing Committee on Plants, Animals, Food and Feed – Section General Food meeting of 13 May 2026 has been published and can be accessed here. The following topics of relevance have been discussed: ▪ Results of Priority Control Area on E-commerce Imports Action: Food Supplements. DG SANTE and DG TAXUD jointly presented the results of the Priority Control Area (PCA) on e-commerce imports of food supplements, integrating findings from food safety authorities (via the Alert and Cooperation Network) and customs controls. The PCA was carried out with a view to strengthening customs controls on food supplements sold online to EU consumers, with a particular focus on low-value consignments (under EUR 150) from major e-commerce platforms. It targeted food supplements containing ingredients unauthorised or prohibited in the EU, grouped into four categories: sexual enhancement; sports performance and bodybuilding; weight loss; and mental distress, pain relief and disease management. Under the PCA, customs authorities suspended suspect products and referred them to food safety authorities, which then decided on release, further examination or refusal of entry to the EU market. Member States requested that the presentation (or report) prepared by DG TAXUD be made available. However, the European Commission clarified that, as the work is still ongoing, these documents are to be treated as confidential and cannot be disclosed at this stage. ▪ Exchange of views and possible opinion of the Committee on a draft Commission Regulation (EU) amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice. The Commission presented to the Committee a draft Commission Regulation, aimed at prohibiting the use of monacolins from red yeast rice in food. This follows a period of Union scrutiny, during which interested parties may submit scientific evidence to demonstrate the safety of the substance in accordance with the procedure laid down in Article 8(4) of Regulation (EC) No 1925/2006. The Commission explained that the draft Regulation was based on the scientific opinion of the European Food Safety Authority (EFSA), adopted on 29 January 2025, which concluded that the safety of the substance could not be established based on the data submitted by interested parties. Furthermore, EFSA reiterated the concerns raised in its opinion of 3 August 2018 on the safety of monacolins in red yeast rice that exposure to monacolins from red yeast rice at intake levels as low as 3 mg/day could lead to severe adverse effects on the musculoskeletal system, including rhabdomyolysis, and on the liver. During the exchange of views, two Member States took the view that the 12-month transition period, as provided for in the draft Regulation for products lawfully placed on the market before the entry into force of the measure, should be extended until existing stocks are exhausted. One Member State noted that Food https://food.ec.europa.eu/document/download/54af8d7d-2d0d-4758-94d0-45412aa2df98_en?filename=reg-com_gfl_20260513_sum.pdf AESGP OTC News | June 2026 10 | 21 studies aimed at demonstrating the safety of monacolins from red yeast rice were being carried out by industry stakeholders. Another Member State considered that the use of monacolins from red yeast rice should be allowed in food, subject to certain conditions of use. The Commission explained that the industry had been given sufficient time to prepare for the possible risk-management actions, given that EFSA’s conclusions on monacolins from red yest rice had been known since 29 January 2025. It further explained that a 12-month transition period would ensure a smooth transition while considering the EFSA’s conclusions in its opinions of 3 August 2018 and 29 January 2025 regarding the severe adverse health effects. Therefore, any further delay in the entry into application of the measure would not be justified. AESGP OTC News | June 2026 11 | 21 MDCG Eudamed WG Production release 2.27.0 deployed The EUDAMED Production release 2.27.0 has been successfully deployed. This release will be the one for mandatory use, which will start on 28 May 2026. The main key additions are: • The Clinical Evaluation Consultation Procedure (CECP) feature in the Notified Bodies & Certificates module • The Mechanism for Scrutiny (MfS) feature in the Notified Bodies & Certificates module • The Market Surveillance module (mainly intended for the EC and CAs – and NBs/DAs in certain circumstances) Production Access: • EUDAMED restricted • EUDAMED public Documentation: See the details in the Release Notes and the updated documentation in the EUDAMED Information Centre. Mandatory Use of First EUDAMED Modules from 28 May 2026 As of 28 May 2026, the first four EUDAMED modules have become mandatory for use: • Actors • UDI/Devices • Notified Bodies & Certificates • Market Surveillance The mandatory use of these modules marks an important milestone in the implementation of the European medical devices regulatory framework and is expected to further support transparency, traceability, and regulatory cooperation across the EU medical devices sector. EUDAMED will be used by manufacturers, authorised representatives, importers, notified bodies, and competent authorities to ensure regulatory compliance, as it serves as the backbone of the MDR. Citizens, Medical Devices https://webgate.ec.europa.eu/eudamed/ https://ec.europa.eu/tools/eudamed/ https://webgate.ec.europa.eu/eudamed-help/en/files/EUDAMED%20-%20release%20notes.pdf https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html AESGP OTC News | June 2026 12 | 21 patients, healthcare professionals, and all key actors in the sector will now have access to a wealth of essential information on devices placed on the EU market. MDCG EUDAMED WG Meeting on 2 June 2026 AESGP participated to the MDCG EUDAMED Working Group on 2 June 2026. The European Commission presented the state of play and upcoming developments of EUDAMED, reporting a significant increase in registrations following the mandatory use of the first four modules, with more than 2.3 million devices now registered. Despite a sharp rise in support requests, system performance remains stable. Development priorities include the finalisation of the Summary of Safety and Clinical Performance (SSCP) management functionality, enhancements to the Vigilance module, and continued work on M&A and UDI-related functionalities. A key topic was the transfer of responsibility for SSCP management in EUDAMED from notified bodies to manufacturers. The new functionality is expected to be available in the Playground environment in the second half of July and in production in October 2026. Until then, notified bodies will continue uploading master SSCPs, while manufacturers will remain responsible for translations. Industry representatives also highlighted the need for transition periods, improved support mechanisms, greater flexibility in the UDI module, and enhanced training and access arrangements for the Vigilance module. The next EUDAMED Working Group meeting is scheduled for 21 October 2026. MDCG Endorsement of Position Paper on SS(C)P Management in EUDAMED At the EUDAMED Working Group meeting which took place on 2 June 2026, one of the points for discussion was the Position Paper on management of SS(C)P in EUDAMED. During the WG discussion, representatives from industry associations raised a point regarding the timeline for uploading SS(C)Ps for devices placed on the market before the mandatory use of the UDI/Devices module. For devices placed on the market before mandatory use, since manufacturers will only be able to provide SS(C)Ps from October 2026 onwards, the original transitional period of 6 months for devices registration is de facto reduced substantially for the SS(C)P. Moreover, many devices may already be registered, but their corresponding certificates/SS(C)Ps might not yet be uploaded by notified bodies, which have a longer transition period (until 27 May 2027). This could create delays and operational bottlenecks, as the manufacturers will have to retrospectively upload those SS(C)Ps by 27 November 2026, deadline according to the transition period for device registration. To address these issues, the Commission amended the Position Paper previously shared with MDCG for endorsement, to allow manufacturers to upload SS(C)Ps for these devices until 27 February 2027 (unless a certificate update occurs after the mandatory use date). The Position Paper was endorsed by the MDCG on 19 June 2026. The MDCG-endorsed Position Paper is currently in the process of being published on the European Commission’s MDCG Guidance webpage. MDCG Standards WG New references harmonised standards MDR/IVDR - Publication in the OJEU & Appendix 'EU REP' https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en AESGP OTC News | June 2026 13 | 21 Publications in the Official Journal of the European Union (OJEU) of new references of harmonised standards in support of the Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) took place on 17 JUN 2026: • For the MDR: Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, symbols to be used with information to be supplied by the manufacturer, medical electrical equipment, transfusion equipment for medical use, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics and sharps injury protection (OJ L, 2026/1231, 17.6.2026, https://eur-lex.europa.eu/eli/dec_impl/2026/1231/oj ). To correct the data of application of Commission Implementing Decision (EU) 2026/1231, a Corrigendum was published on 22 JUN 2026 – reaching 65 references overall • For the IVDR: Commission Implementing Decision (EU) 2026/1313 of 15 June 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer (OJ L, 2026/1313, 17.6.2026, https://eur- lex.europa.eu/eli/dec_impl/2026/1313/oj ) – keeping 23 references overall These publications include also the reference of EN ISO 15223-1:2021/A1:2025, amending the harmonised standard on “Symbols to be used with information to be supplied by the manufacturer”, to introduce the new symbol ‘EU REP’ for authorised representatives, with a transition period of 60 months (5 years) ending on 17 JUN 2031. A supporting guidance document, as Appendix “Transition to the ‘EU REP’ symbol in EN ISO 15223-1” to the main guidance document MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices, has been published as well, as endorsed by the MDCG and updated with the publication references. For further information on harmonised standards for medical devices, the dedicated Commission’s webpage is available here. MDCG Nomenclature WG EMDN Annual Update The EMDN technical team is currently assessing stakeholder requests submitted under the annual EMDN update procedure and will soon provide a summary of the requests and their status. Due to the volume of submissions and ongoing evaluations, the July EMDN meeting may be postponed to November, with the latter expected to focus on validating the annual update. In the meantime, a first draft of the update proposal will be circulated for consultation by the end of July. Regarding translations, the English version has been completed and validated, while translations into the remaining EU languages are expected in September 2026. The current three-year translation project will support annual EMDN updates throughout its duration. MDR/IVDR Simplification Proposal Commission presentation to Council on EMA support, borderline & classification In the context of the ongoing negotiations on the Commission proposal to revise the MDR/IVDR, please find below the presentation delivered by the Commission to Member State representatives in the Council on the provisions related to EMA support to the regulatory system, as well as borderline and classification. https://eur-lex.europa.eu/eli/dec_impl/2026/1231/oj https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202690511 https://eur-lex.europa.eu/eli/dec_impl/2026/1313/oj https://eur-lex.europa.eu/eli/dec_impl/2026/1313/oj https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdf https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdf https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en AESGP OTC News | June 2026 14 | 21 The Commission presentation on cluster 2 - Support to the regulatory system provides further details on the Commission’s rationale for proposing stronger EMA support in the regulatory system and on the envisaged coordination processes for borderline and classification issues. MDR/IVDR Implementation Notified Bodies Survey on Certifications & Applications - Data dated 31 December 2025 The Commission has published on its website the “Notified Bodies Survey on certifications and applications (MDR/IVDR)” based on data collected from notified bodies until 31 December 2025. The survey – accessible here – is based on data from 53 notified bodies designated under the MDR/IVDR. Please note that this data does not seem to be reflected yet in the dashboard of the corresponding study on the monitoring of availability of medical devices on the EU market. According to the data, there are 31.101 MDR applications (the decrease in the number is due to a change in the methodology used by one NB to count applications) and 21.791 MDR certificates issued, with 944 MDR applications refused. As usual, the survey also provides an overview of certifications and applications by annex and by type (QMS vs Product). However, this time, the report does not include data on the number of applications under Rule 14 and Rule 21, first indent. This data will be made available in the dashboard. Regarding timelines, only 32% of NBs have a system for monitoring conformity assessment activities that can provide data on certification timelines. For certification costs, only 30% of NBs have such a system. Please be reminded that, under the new Commission Implementing Regulation (EU) 2026/977, NBs will be required to document and implement a system to monitor the duration and costs of conformity assessment activities. Annex VII NB Requirements: AESGP statement and summary of timelines for NBs On 8 May 2026, the AESGP Secretariat published a statement on its website welcoming the adoption of the Commission Implementing Regulation (EU) 2026/977, highlighting its potential to improve predictability and efficiency in relation to the quality management and processes in the context of conformity assessment activities. Additionally, please find below an overview table of the maximum timelines and allowed clock stops for notified bodies per conformity assessment activity under the new implementing regulation. Please note that the regulation has entered into force on 25 May 2026, with several provisions applying mostly from 25 February 2027. Activity Maximum time Starting on Allowed number of clock stops* Date of application Application review and contract signing 30 days The day the NB receives the complete application One Feb. 25, 2027 https://data.consilium.europa.eu/doc/document/WK-5589-2026-INIT/en/pdf https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj https://aesgp.eu/articles/aesgp-statement-on-commission-implementing-regulation-eu-2026-977-setting-maximum-timelines-for-conformity-assessment-activities-of-medical-devices https://aesgp.eu/articles/aesgp-statement-on-commission-implementing-regulation-eu-2026-977-setting-maximum-timelines-for-conformity-assessment-activities-of-medical-devices AESGP OTC News | June 2026 15 | 21 Quality management system auditing 120 days The day the NB initiates the audit programme’s first activity Four + two for each additional site Feb. 25, 2027 Product verification 90 days The day the NB initiates the assessment of the technical documentation Four Feb. 25, 2027 Decision and certification 20 days The day after the completion of the last review One Feb. 25, 2027 Substantial change – review of proposed planned change 30 days The day the NB receives the information on the planned change Five Feb. 25, 2027 Substantial change – additional conformity assessment activities 90 days The day the NB initiates the audit’s programme first activity or the assessment of technical documentation, whichever is the earlier Five Feb. 25, 2027 Substantial change – certificate issued 20 days The day following that of the notification of the approval of the planned change One Feb. 25, 2027 Re-certification – products 90 days The day the NB receives the complete documentation Three Nov. 25, 2027 Re-certification – QMS 90 days The day the NB receives the complete application Three Nov. 25, 2027 Recertification – certificate decision 20 days The day after the final review One Nov. 25, 2027 * Please note that interruption from EMA opinions do not count as a clock stop. Team NB Publications Sector Survey 2025 Team NB has published a press release outlining the data received from their members for the annual sector survey 2025, as well as a slide deck presenting the data. The survey provides information, amongst others, on the evolution of MDR/IVDR certificates issued, the withdrawal of certificates, the number of ISO 13485 certificates, and the transition process from the Directives to the Regulations. According to the slides, in 2025, there was a slowdown in the growth of certificate issuance, with an increase of two-thirds compared to the doubling observed in 2023 and 2024. Compared with the results of the “Study supporting the monitoring of availability of medical devices on the EU market”, with data up to December 2025: https://www.team-nb.org/wp-content/uploads/2026/05/Team-NB-MD-Sector-Survey-PressRelease-20260518.docx https://www.team-nb.org/wp-content/uploads/2026/05/Survey-2025.pdf AESGP OTC News | June 2026 16 | 21 • Team NB Team-NB certificates represent 81% of the total issued; and • applications received by Team-NB members represent 84% of the total applications. MDR Certification Process (including Pre- application, Application and Post Application phases) – Consensus document Team-NB has published a position paper on the MDR Certification process. The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). The document was developed by reviewing the application process and associated documents of individual Team-NB members and harmonising the processes where possible. This document is applicable to both legacy devices (pursuant to Article 120) transitioning to MDR, and devices that are new to the market and have not been certified under the Directives before. The document also briefly describes the certification activities that are undertaken after the application process is concluded. IVDR Application and appropriate surveillance Transfer agreement Team-NB members have adopted and published , a template Agreement form related to the transfer of IVDR formal application and of appropriate surveillance of legacy devices specifying the terms of the transfer in respect of legacy devices covered by Directives certificates. Micro and Small Enterprise Considerations Team NB has released a position paper commenting the changes brought by the ongoing revision of the European medical device regulatory framework (article 50 on access to notifies bodies and fees). As reminder, among the proposed measures is an expectation that notified bodies offer significantly reduced conformity assessment fees, up to a 50% discount for micro and small enterprises. The Team NB position paper highlight that the challenges faced by these organisations are structural and systemic in nature, extending far beyond notified body fees alone. Measures focused solely on fee reductions risk addressing symptoms rather than root causes, and may unintentionally undermine the capacity, independence, and sustainability of the conformity assessment system. According to them, the analysis presented in this paper demonstrates that the primary barriers encountered by micro and small manufacturers relate to limited regulatory experience, high costs associated with clinical evidence generation and external services, variability in the quality of regulatory advice, and inefficiencies arising from disproportionate or repetitive conformity assessment activities. They believe addressing these challenges requires a more balanced and ecosystem-wide approach. The most effective solutions lie in improving regulatory capability at source, increasing predictability of requirements, and ensuring that oversight activities are applied in a proportionate and risk-based manner. They propose the following measures : • Strengthening and formalising structured dialogue, including pre-submission interactions, to improve early alignment and reduce uncertainty; • Introducing greater flexibility in post-certification surveillance and sampling, enabling notified bodies to apply justified, risk-based approaches and avoid unnecessary duplication; • Establishing EU and Member State-funded programmes to support regulatory capability development and to offset the broader costs of clinical investigations, laboratory testing, and https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-MDR-Certification-Process-Consensus-Document-V2-20260604.pdf https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer-agreement-V1-20260610.pdf https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-Micro-Small-Entreprise-Initiatives-V1-20260616.pdf https://health.ec.europa.eu/document/download/7c4e871e-ebaf-46e0-ae76-93478e3d3fbc_en?filename=md_sector_proposed-amendments-mdr-articles.pdf AESGP OTC News | June 2026 17 | 21 associated services; • Improving transparency, consistency, and assurance in the use of regulatory consultants, including mechanisms for validation of regulatory approaches through structured dialogue; • Expanding the use of remote and hybrid audit models where appropriate, reducing operational burden on smaller organisations; • Advancing harmonisation of guidance, templates, and submission frameworks to improve clarity, consistency, and first-time quality of submissions. Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 Update The Commission has published an update of the planned meeting dates of the MDCG and subgroups for 2026. ESIP, AIM, TEAM-NB, CPME, TÜV Verband, IG-NB unified for a better WET approach The European Social Insurance Platform (ESIP), Team-NB, the Association of Mutual Benefit Societies (AIM), the Standing Committee of European Doctors (CPME), TÜV Verband and the Interest Group of Notified Bodies( IG-NB) have cosigned a joint statement which highlights shared concerns among healthcare insurers, medical doctors and notified bodies regarding the Commission’s Delegated Regulations on well-established technologies (WET) and calls for further refinement to ensure legal certainty and consistent application under MDR. The statement is accessible on Team-NB website. https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://www.team-nb.org/wp-content/uploads/2026/06/Joint-Stakeholder-Statement-MDR-WET.pdf https://www.team-nb.org/esip-team-nb-cpme-tuv-verband-ig-nb-unified-for-a-better-wet-approach/ AESGP OTC News | June 2026 18 | 21 AI - Omnibus VII legislative package - Provisional agreement reached by the Council presidency and European Parliament negotiators On 7 MAY, the Council presidency and European Parliament negotiators reached a provisional agreement on a proposal to streamline certain rules regarding artificial intelligence (AI), which has been published on the Council’s website. The proposal forms part of the so-called ‘Omnibus VII’ legislative package under the EU’s simplification agenda, comprising two proposed regulations intended to simplify the EU’s digital legislative framework and the implementation of harmonised rules on AI. What did the Commission originally proposed? 1. An adjustment of the timeline for the application of rules on high-risk AI systems by up to 16 months, so that the rules would start applying once the Commission confirms that the necessary standards and implementing tools are in place; 2. Targeted amendments to the AI Act to extend certain regulatory exemptions granted to SMEs to small mid-caps (SMCs), reduce requirements in a limited number of cases, extend the possibility to process sensitive personal data for bias detection and mitigation, reinforce the AI Office’s powers and reduce governance fragmentation. What are the main amendments introduced by the co-legislators at political agreement stage? Timelines for high-risk AI systems • The introduction of a fixed timeline for the delayed application of rules for high risk AI systems: ➢ 2 DEC 2027 (new application date) for stand alone high risk AI systems; and ➢ 2 AUG 2028 (new application date) for high risk AI systems embedded in products. Obligations and standard for the processing of personal data • An obligation for providers to register AI systems in the EU database for high-risk AI systems, where they consider their systems to be exempted from classification as high-risk. • The introduction of a standard of strict necessity for the processing of special categories of personal data for the purpose of ensuring bias detection and correction. Regulatory sandboxes and transparency • Postponement of the deadline for the establishment of AI regulatory sandboxes by competent authorities at national level until 2 AUG 2027. • A reduction of the grace period for providers to implement transparency solutions for artificially generated content from 6 months to 3 months, with the new deadline set on 2 DEC 2026. Governance and supervision Cross-Sectorial News https://www.consilium.europa.eu/en/press/press-releases/2026/05/07/artificial-intelligence-council-and-parliament-agree-to-simplify-and-streamline-rules/ AESGP OTC News | June 2026 19 | 21 • Clarification of the competences of the AI Office for the supervision of AI systems based on general-purpose AI models where the model and that system are developed by the same provider by listing exceptions where national authorities remain competent, including law enforcement, border management, judicial authorities and financial institutions. Interaction with sectoral legislation • The introduction of a mechanism allowing the resolution of situations, where sectoral legislation contains AI-specific requirements similar to those of the AI Act, by limiting the latter’s application in such cases through implementing acts. This is particularly relevant to the AI Act’s provisions on industrial AI and their interaction with sectoral legislation governing areas such as medical devices, toys, lifts, machinery, and watercraft. • An exemption of the machinery regulation from direct applicability of the AI act. • An empowerment for the Commission to adopt delegated acts under the machinery regulation which would add health and safety requirements in respect of AI systems that are classified as high-risk pursuant to the AI act, with a aim to effectively addresses any possible overlaps between the high-risk requirements from the AI act and those from sectoral legislation. • The addition of a new obligation for the Commission to provide guidance to assist economic operators of high-risk AI systems covered by sectoral harmonisation legislation in complying with the high-risk requirements of the AI act in a manner that minimises compliance burden. New prohibitions • The addition of a new provision to the AI Act prohibiting AI practices regarding the generation of non-consensual sexual and intimate content or child sexual abuse material (CSAM). Team-NB has released a statement regarding the provisional agreement reached by the Council Presidency and the European Parliament on the AI omnibus. BACKGROUND • In OCT 2024, the European Council called on all EU institutions, member states and stakeholders, as a matter of priority, to take work forward, notably in response to the challenges identified in the reports by Enrico Letta (‘Much more than a market’) and Mario Draghi (‘The future of European competitiveness’). • The Budapest declaration of 8 NOV 2024 subsequently called for ‘launching a simplification revolution’, by ensuring a clear, simple and smart regulatory framework for businesses and drastically reducing administrative, regulatory and reporting burdens, in particular for SMEs. • Since February 2025, as a follow-up to the call by EU Leaders at that and subsequent meetings, the Commission has put forward ten ‘Omnibus’ packages aiming to simplify existing legislation on sustainability, investment, agriculture, small mid-caps, digitalisation and common specifications, defence readiness, chemical products, digital issues including on AI, environment, the automotive sector and food and feed safety. New Council of Europe Recommendation sets standards for remote and online medicine provision The Council of Europe Committee of Ministers has adopted Recommendation CM/Rec(2026)7, setting out best practices for the remote and online provision of medicines. Co-ordinated by the European Directorate for the Quality of Medicines & HealthCare, the Recommendation responds to the expansion of digital healthcare which has highlighted both the benefits of remote access to medicines and the need for robust safeguards. As a Council of Europe Recommendation, the instrument is non-binding and now serves as a framework for Member States to consider and implement through national policies, legislation and regulatory practice. For more details, the following news are available here. https://www.team-nb.org/artificial-intelligence-council-parliament-agree-to-simplify-and-streamline-rules/ https://search.coe.int/cm#{%22CoEIdentifier%22:[%2209125948802b8d9e%22],%22sort%22:[%22CoEValidationDate%20Descending%22]} https://www.edqm.eu/en/-/new-council-of-europe-recommendation-sets-standards-for-remote-and-online-medicine-provision AESGP OTC News | June 2026 20 | 21 PPWR - EC guidance - 10 JUN 2026 The European Commission has published its final, non-binding guidance on the Packaging and Packaging Waste Regulation (PPWR) on 10 June 2026. This guidance document follows the draft guidance endorsed in March 2026 and comes just over two months ahead of the start of PPWR application on 12 August 2026. The link to the guidance document is available here: Commission Notice – Guidance document for Regulation (EU) 2025/40 on packaging and packaging waste https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202603084 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202603084 AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu
27.08.2026 Datei PD
385. Ausgabe der "AESGP Euro OTC News"
27.08.2026 Beitrag PD
384. Ausgabe der "AESGP Euro OTC News"
27.08.2026 Beitrag PD
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