Text · Amendment list
Amending Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (EU) 2023/1542 and (EU) 2024/573 as regards the extension of certain mitigating measures available for small and medium sized enterprises to small mid-cap enterprises and further simplification measures
Full title
Amending Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (EU) 2023/1542 and (EU) 2024/573 as regards the extension of certain mitigating measures available for small and medium sized enterprises to small mid-cap enterprises and further simplification measures
Document CJ58-AM-781364 · COM(2025)0501 – 2025/0130(COD)
- Kind
- Amendment list CJ58-AM-781364
- Date
- 12 December 2025
- Committee
- Committee on Economic and Monetary Affairs Committee on the Environment, Climate and Food Safety Committee on Civil Liberties, Justice and Home Affairs
- Dossier
- 2025-0130
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- Official page PDF Word
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- COM(2025)0501 – 2025/0130(COD)
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| Draft legislative resolution | Amendment |
| – having regard to Article 294(2) and Article 16, Article 114, Article 192(1) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C10-0092/2025), | – having regard to Article 294(2), Article 114, Article 192(1) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C10-0092/2025), |
| Text proposed by the Commission | Amendment |
|---|---|
| Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (EU) 2023/1542 and (EU) 2024/573 as regards the extension of certain mitigating measures available for small and medium sized enterprises to small mid-cap enterprises and further simplification measures | Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129 as regards the extension of certain mitigating measures available for small and medium sized enterprises to small mid-cap enterprises and further simplification measures |
| Text proposed by the Commission | Amendment |
|---|---|
| Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16, Article 114, Article 192 (1) and Article 207 (2) thereof, | Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114, Article 192 (1) and Article 207 (2) thereof, |
| Text proposed by the Commission | Amendment |
|---|---|
| (1) In the political guidelines for the European Commission’s 2024-2029 term3 , President von der Leyen set out a plan for the Union’s sustainable prosperity and competitiveness. Making business easier and deepening the Single Market are among the plan’s key priorities. | (1) In the political guidelines for the European Commission’s 2024-2029 term3 , President von der Leyen set out a plan for the Union’s sustainable prosperity and competitiveness. Making business easier, deepening the Single Market and staying in the course of the goals set out in the European Green Deal, focusing on the implementation of the existing legal framework for 2030, are among the plan’s key priorities. |
| 3 https://commission.europa.eu/document/download/e6cd4328-673c-4e7a-8683-f63ffb2cf648_en?filename=Political%20Guidelines%202024-2029_EN.pdf |
| Text proposed by the Commission | Amendment |
|---|---|
| (2) The Commission’s better regulation agenda4 also supports the competitiveness of Union enterprises by aiming to ensure that Union laws deliver on their objectives at a minimum cost. In 2023, the Commission identified the need to rationalise and simplify reporting requirements for enterprises and administrations5 and committed to reduce administrative burdens by 25%. | (2) The Commission’s better regulation agenda4 also supports the competitiveness of Union enterprises by aiming to ensure that Union laws deliver on their objectives at a minimum cost. In 2023, the Commission identified the need to rationalise and simplify reporting requirements for enterprises and administrations5 and committed to reduce administrative burdens by 25%. As recently stressed by the Ombudswoman1a, the Commission’s better regulation agenda foresees transparent, evidence-based and inclusive preparation of legislative proposals, including of ‘urgent’ ones, as well as documented consistency checks of its proposals with the EU’s climate goals. |
| 1a Recommendation on the European Commission’s compliance with ‘Better Regulation’ rules and other procedural requirements in preparing legislative proposals that it considered to be urgent (983/2025/MAS - the “Omnibus” case, 2031/2024/VB - the “migration” case, and 1379/2024/MIK - the “CAP” case) | |
| 4 Better regulation: Joining forces to make better laws, COM(2021) 219 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2021:219:FIN | 4 Better regulation: Joining forces to make better laws, COM(2021) 219 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2021:219:FIN |
| 5 Long-term competitiveness of the EU: looking beyond 2030, COM(2023) 168 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023DC0168 | 5 Long-term competitiveness of the EU: looking beyond 2030, COM(2023) 168 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023DC0168 |
| Text proposed by the Commission | Amendment |
|---|---|
| (2) The Commission’s better regulation agenda4also supports the competitiveness of Union enterprises by aiming to ensure that Union laws deliver on their objectives at a minimum cost. In 2023, the Commission identified the need to rationalise and simplify reporting requirements for enterprises and administrations5and committed to reduce administrative burdens by 25%. | (2) The Commission’s better regulation agenda4 also supports the competitiveness of Union enterprises by aiming to ensure that Union laws deliver on their objectives at a minimum cost. In 2023, the Commission identified the need to rationalise and simplify reporting requirements for enterprises and administrations5 and committed to reduce administrative burdens by 25%, a measure that is an essential step towards halting loss of competitiveness vis-à-vis third markets and preventing industrial relocation outside the Union. |
| 4 Better regulation: Joining forces to make better laws, COM(2021) 219 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2021:219:FIN | 4 Better regulation: Joining forces to make better laws, COM(2021) 219 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2021:219:FIN. |
| 5 Long-term competitiveness of the EU: looking beyond 2030, COM(2023) 168 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023DC0168 | 5 Long-term competitiveness of the EU: looking beyond 2030, COM(2023) 168 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023DC0168. |
| Text proposed by the Commission | Amendment |
|---|---|
| (4) Enterprises outgrowing the SME definition – the ‘small mid-cap enterprises’ (‘SMCs’) – play a vital role in the Union’s economy8 . They are prominently present in industrial ecosystems that are key to the competitiveness of the Union and its technological sovereignty, in fields including electronics, aerospace and defence, energy, energy-intensive industries and health. Around 20% of all small mid-cap enterprises were SMEs three years earlier9 . | (4) Enterprises outgrowing the SME definition – the ‘small mid-cap enterprises’ (‘SMCs’) – play a vital role in the Union’s economy8. They are prominently present in industrial ecosystems that are key to the competitiveness of the Union and its technological sovereignty, in fields including electronics, aerospace and defence, energy, energy-intensive industries and health. Around 20% of all small mid-cap enterprises were SMEs three years earlier9. Despite their importance for the Member States' economy and sovereignty, the administrative burden imposed upon them is the third biggest challenge for mid-caps in the EU, hampering their potential growth and their ability to thrive in the current globalised economy.9a |
| 8 Study to map, measure and portray the EU mid-cap landscape - https://op.europa.eu/en/publication-detail/-/publication/ad5fdad5-6a33-11ed-b14f-01aa75ed71a1/language-en/format-PDF/source-277396461 | 8 Study to map, measure and portray the EU mid-cap landscape - https://op.europa.eu/en/publication-detail/-/publication/ad5fdad5-6a33-11ed-b14f-01aa75ed71a1/language-en/format-PDF/source-277396461 |
| 9 https://www.esri.ie/system/files/publications/BKMNEXT429.pdf | 9 https://www.esri.ie/system/files/publications/BKMNEXT429.pdf |
| 9a Study to map, measure and portray the EU mid-cap landscape - https://op.europa.eu/en/publication-detail/-/publication/ad5fdad5-6a33-11ed-b14f-01aa75ed71a1/language-en/format-PDF/source-277396461 |
| Text proposed by the Commission | Amendment |
|---|---|
| (5) Compared to SMEs, SMCs tend to demonstrate a higher pace of growth, and level of innovation and digitisation. Nevertheless, where administrative burden is concerned, they face similar challenges as SMEs, leading to a need for proportionality in legislation and for targeted support. To enable the smooth transition of SMEs into SMCs, it is important to address in a coherent manner the cliff-effect that may arise once they outgrow the segment of SMEs and are faced with rules that apply to large enterprises. To make business easier for SMCs and reduce their administrative burden, a number of existing acts which provide for specific mitigating rules for SMEs should be adapted to extend the scope of those provisions and include SMCs. | (5) Compared to SMEs, SMCs tend to demonstrate a higher pace of growth, and level of innovation and digitisation. Nevertheless, where administrative burden is concerned, they face similar challenges as SMEs, leading to a need for proportionality in legislation and for targeted support. To enable the smooth transition of SMEs into SMCs, it is important to address in a coherent manner the cliff-effect that may arise once they outgrow the segment of SMEs and are faced with rules that apply to large enterprises. When an impact assessment, conducted in a transparent, evidence-based and inclusive way, concludes that the extension of mitigating rules from SMEs to larger companies would be the only or best solution to reduce administrative burden while maintaining the level of ambition of the relevant existing acts, such existing acts could be amended to extend the scope of those mitigating provisions in a balanced and proportionate manner. However, targeted support to companies that have outgrown the SME definition for the implementation of existing rules should be given precedence over de-regulation. |
| Text proposed by the Commission | Amendment |
|---|---|
| (5) Compared to SMEs, SMCs tend to demonstrate a higher pace of growth, and level of innovation and digitisation. Nevertheless, where administrative burden is concerned, they face similar challenges as SMEs, leading to a need for proportionality in legislation and for targeted support. To enable the smooth transition of SMEs into SMCs, it is important to address in a coherent manner the cliff-effect that may arise once they outgrow the segment of SMEs and are faced with rules that apply to large enterprises. To make business easier for SMCs and reduce their administrative burden, a number of existing acts which provide for specific mitigating rules for SMEs should be adapted to extend the scope of those provisions and include SMCs. | (5) Compared to SMEs, SMCs tend to demonstrate a higher pace of growth, and level of innovation and digitisation. Nevertheless, where administrative burden is concerned, they face similar challenges as SMEs, leading to a need for proportionality in legislation and for targeted support. To enable the smooth transition of SMEs into SMCs, it is important to address in a coherent manner the cliff-effect that may arise once they outgrow the segment of SMEs and are faced with rules that apply to large enterprises. To enhance the conditions for economic growth in the EU, six existing acts should be amended to make business easier for SMCs and reduce their administrative burden. Specifically, mitigating rules for SMEs in these acts should be adapted to extend the scope of those provisions and include SMCs, while ensuring that the Union’s overarching rules on investor protection are maintained. |
| Text proposed by the Commission | Amendment |
|---|---|
| (5) Compared to SMEs, SMCs tend to demonstrate a higher pace of growth, and level of innovation and digitisation. Nevertheless, where administrative burden is concerned, they face similar challenges as SMEs, leading to a need for proportionality in legislation and for targeted support. To enable the smooth transition of SMEs into SMCs, it is important to address in a coherent manner the cliff-effect that may arise once they outgrow the segment of SMEs and are faced with rules that apply to large enterprises. To make business easier for SMCs and reduce their administrative burden, a number of existing acts which provide for specific mitigating rules for SMEs should be adapted to extend the scope of those provisions and include SMCs. | (5) Compared to SMEs, SMCs tend to demonstrate a higher pace of growth, and level of innovation and digitisation. Nevertheless, where administrative burden is concerned, they face similar challenges as SMEs, leading to a need for proportionality in legislation and for targeted support. To enable the smooth transition of SMEs into SMCs, it is important to address in a coherent manner the cliff-effect that may arise once they outgrow the segment of SMEs and are faced with rules that apply to large enterprises. To make business easier for SMCs and reduce their administrative burden, a number of existing acts which provide for specific mitigating rules for SMEs should be adapted to extend the scope of those provisions and include SMCs, provided this does not dilute resources or prerogatives reserved for SMEs, such as financial support measures or access to funds, including the initiatives under the next Multiannual Financial Framework. Reducing administrative and reporting obligations is essential to strengthen the competitiveness of Union enterprises, in particular where such reductions have the greatest positive impact on innovation and digital transformation. Measures that deliver nonfinancial relief to small and medium-sized enterprises and to small mid-cap enterprises should therefore be prioritised, especially in areas of key importance for innovation policy. |
Isabel Benjumea Benjumea, Markus Ferber, Lídia Pereira, Antonio López-Istúriz White, Regina Doherty, Christophe Gomart, Paulius Saudargas, Angelika Winzig, Dirk Gotink, Fernando Navarrete Rojas, Kinga Kollár
| Text proposed by the Commission | Amendment |
|---|---|
| (5 a) Whereas the proposals set out in this Omnibus should be accompanied by a set of complementary legislative measures aimed at supporting SMEs and small mid-caps, not only through regulatory simplification but also through the reduction of administrative burdens, the use of fiscal incentives, the strengthening of access to talent and skills, as well as the promotion and adoption of innovative technologies, in order to ensure that the regulatory framework effectively contributes to their competitiveness, growth and access to finance; |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) Regulations (EU) 2016/67910 , (EU) 2016/103611 , (EU) 2016/103712 , (EU) 2017/112913 and (EU) 2023/154214 of the European Parliament and of the Council contain a number of provisions that aim at providing support, simplification or mitigating measures to SMEs. More specifically, those provisions are aimed at alleviating administrative burdens, reducing or eliminating market entry barriers, facilitating compliance, considering the specific situation of SMEs when implementing their obligations and when assessing the economic and social impacts of those obligations, providing dedicated guidance, support and assistance to SMEs. | (6) Regulations (EU) 2016/103611 , (EU) 2016/103712 , (EU) 2017/112913 and (EU) 2023/154214 of the European Parliament and of the Council contain a number of provisions that aim at providing support, simplification or mitigating measures to SMEs. More specifically, those provisions are aimed at alleviating administrative burdens, reducing or eliminating market entry barriers, facilitating compliance, considering the specific situation of SMEs when implementing their obligations and when assessing the economic and social impacts of those obligations, providing dedicated guidance, support and assistance to SMEs. |
| 10 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj) | |
| 11 Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 21, ELI: http://data.europa.eu/eli/reg/2016/1036/oj) | 11 Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 21, ELI: http://data.europa.eu/eli/reg/2016/1036/oj) |
| 12 Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 55, ELI: http://data.europa.eu/eli/reg/2016/1037/oj) | 12 Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 55, ELI: http://data.europa.eu/eli/reg/2016/1037/oj) |
| 13 Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12, ELI: http://data.europa.eu/eli/reg/2017/1129/oj) | 13 Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12, ELI: http://data.europa.eu/eli/reg/2017/1129/oj) |
| 14 Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1, ELI: http://data.europa.eu/eli/reg/2023/1542/oj). | 14 Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1, ELI: http://data.europa.eu/eli/reg/2023/1542/oj). |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) Regulations (EU) 2016/67910 , (EU) 2016/103611 , (EU) 2016/103712 , (EU) 2017/112913 and (EU) 2023/154214 of the European Parliament and of the Council contain a number of provisions that aim at providing support, simplification or mitigating measures to SMEs. More specifically, those provisions are aimed at alleviating administrative burdens, reducing or eliminating market entry barriers, facilitating compliance, considering the specific situation of SMEs when implementing their obligations and when assessing the economic and social impacts of those obligations, providing dedicated guidance, support and assistance to SMEs. | (6) Regulations (EU) 2016/67910, (EU) 2016/103611, (EU) 2016/103712 and (EU) 2017/112913 of the European Parliament and of the Council contain a number of provisions that aim at providing support, simplification or mitigating measures to SMEs. More specifically, those provisions are aimed at alleviating administrative burdens, reducing or eliminating market entry barriers, facilitating compliance, considering the specific situation of SMEs when implementing their obligations and when assessing the economic and social impacts of those obligations, providing dedicated guidance, support and assistance to SMEs. |
| 10 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj) | 10 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj) |
| 11 Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 21, ELI: http://data.europa.eu/eli/reg/2016/1036/oj) | 11 Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 21, ELI: http://data.europa.eu/eli/reg/2016/1036/oj) |
| 12 Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 55, ELI: http://data.europa.eu/eli/reg/2016/1037/oj) | 12 Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 55, ELI: http://data.europa.eu/eli/reg/2016/1037/oj) |
| 13 Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12, ELI: http://data.europa.eu/eli/reg/2017/1129/oj) | 13 Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12, ELI: http://data.europa.eu/eli/reg/2017/1129/oj) |
| 14 Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1, ELI: http://data.europa.eu/eli/reg/2023/1542/oj). |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) Regulations (EU) 2016/67910 , (EU) 2016/103611 , (EU) 2016/103712 , (EU) 2017/112913 and (EU) 2023/154214 of the European Parliament and of the Council contain a number of provisions that aim at providing support, simplification or mitigating measures to SMEs. More specifically, those provisions are aimed at alleviating administrative burdens, reducing or eliminating market entry barriers, facilitating compliance, considering the specific situation of SMEs when implementing their obligations and when assessing the economic and social impacts of those obligations, providing dedicated guidance, support and assistance to SMEs. | (6) Regulations (EU) 2016/67910 , (EU) 2016/103611 , (EU) 2016/103712 , (EU) 2017/112913 and (EU) 2023/154214 of the European Parliament and of the Council contain a number of provisions that aim at providing support, simplification or mitigating measures to SMEs. More specifically, those provisions are aimed at alleviating administrative burdens, reducing or eliminating market entry barriers, facilitating compliance, considering the specific situation of SMEs when implementing their obligations and when assessing the economic and social impacts of those obligations, providing dedicated guidance, support and assistance to SMEs. This proposal represents only a first step to alleviate the regulatory burden of SMCs. |
| 10 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj) | 10 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj) |
| 11 Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 21, ELI: http://data.europa.eu/eli/reg/2016/1036/oj) | 11 Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 21, ELI: http://data.europa.eu/eli/reg/2016/1036/oj) |
| 12 Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 55, ELI: http://data.europa.eu/eli/reg/2016/1037/oj) | 12 Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 55, ELI: http://data.europa.eu/eli/reg/2016/1037/oj) |
| 13 Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12, ELI: http://data.europa.eu/eli/reg/2017/1129/oj) | 13 Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12, ELI: http://data.europa.eu/eli/reg/2017/1129/oj) |
| 14 Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1, ELI: http://data.europa.eu/eli/reg/2023/1542/oj). | 14 Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1, ELI: http://data.europa.eu/eli/reg/2023/1542/oj). |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. While the definition of SMCs should in principle correspond to the definition in Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final and cover enterprises that are up to three times the size of SMEs, it should, where appropriate, build on the definitions of SMEs that are already provided in the acts that are being amended, which were considered fitting by the legislators. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. While the definition of SMCs should in principle correspond to the definition in Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final and cover enterprises that are up to three times the size of SMEs, it should, where appropriate, build on the definitions of SMEs that are already provided in the acts that are being amended, which were considered fitting by the legislators. | (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. While the definition of SMCs should in principle correspond to the definition in Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final and cover enterprises that are up to three times the size of SMEs, it should, where appropriate, build on the definitions of SMEs that are already provided in the acts that are being amended, which were considered fitting by the legislators. | (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. This definition, however, remains without prejudice to the definition and corresponding thresholds deemed appropriate in the State aid context. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. While the definition of SMCs should in principle correspond to the definition in Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final and cover enterprises that are up to three times the size of SMEs, it should, where appropriate, build on the definitions of SMEs that are already provided in the acts that are being amended, which were considered fitting by the legislators. | (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. While the definition of SMCs should in principle correspond to the definition in Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final and cover enterprises that are up to three times the size of SMEs, it should, where appropriate, build on the definitions of SMEs that are already provided in the acts that are being amended, which were considered fitting by the legislators. The introduction of a distinct category of SMCs should serve to facilitate better access to capital markets for companies that have grown beyond SME status, without diluting the Union’s commitment to SME growth as the backbone of the European economy. Accordingly, the scope of provisions specifically tailored to SMEs apart from other categories should be clearly defined, including in relation to the budgetary allocations made available to them under the Multiannual Financial Framework. Given that the majority of SMEs are micro-enterprises, the characteristics and resources of which differ substantially from those of small mid-caps, Union law should continue to apply the “think small first” principle in order to ensure proportionality and appropriate conditions for the smallest companies to scale, while not discouraging growth beyond the SME category due to the anticipation of higher compliance costs. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. While the definition of SMCs should in principle correspond to the definition in Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final and cover enterprises that are up to three times the size of SMEs, it should, where appropriate, build on the definitions of SMEs that are already provided in the acts that are being amended, which were considered fitting by the legislators. | (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. While the definition of SMCs should in principle correspond to the definition in Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final and cover enterprises that are up to three times the size of SMEs, it should, where appropriate, build on the definitions of SMEs that are already provided in the acts that are being amended, which were considered fitting by the legislators. The definition of SMCs should remain without prejudice to the thresholds deemed appropriate in the State aid context. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. While the definition of SMCs should in principle correspond to the definition in Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final and cover enterprises that are up to three times the size of SMEs, it should, where appropriate, build on the definitions of SMEs that are already provided in the acts that are being amended, which were considered fitting by the legislators. | (7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts that should apply where relevant in amended acts . While the definition of SMCs should in principle correspond to the definition in Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final and cover enterprises that are up to three times the size of SMEs, it should, where appropriate, build on the definitions of SMEs that are already provided in the acts that are being amended, which were considered fitting by the legislators. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7 a) The introduction of a distinct category of SMCs should serve to facilitate better the access to capital markets for companies that have grown beyond the SME status. This should be done without diluting the long-term Union’s commitment to supporting SMEs as the backbone of the European economy. Consequently, the creation of the SMC category should categorically not impact or reduce the scope of specific provisions tailored to SMEs. Specifically, the budgetary allocations made available to SMEs shall not be extended to EU funding under the Multiannual Financial Framework. Given that most SMEs are micro-enterprises, the characteristics and resources of which differ substantially from those of small mid-caps, Union law should continue to apply and prioritise the “think small first” principle in order to ensure proportionality and adequate protection for the smallest companies. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7 a) In order to ensure a coherent and evidence-based approach to the future extension of SME preferential measures to small mid-cap enterprises, it is necessary to establish a complete overview of all existing derogations, simplifications, exemptions and other preferential treatments granted to small and medium-sized enterprises across Union legislation. Such an inventory will serve as the factual basis for assessing, in subsequent legislative initiatives, whether and under which conditions those measures could be appropriately extended to small mid-cap enterprises. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7 b) The changes being applied in this Regulation should apply only and exclusively to the listed acts and do not alter other EU legislation dedicated to SMEs or other type of enterprises. In the context of future revisions of EU legislation, careful case-by-case assessment, including the potential impact on people, the environment, and other enterprises, is necessary to determine whether the introduction of new separate regimes for SMCs is appropriate and desirable. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7 b) By 31 December 2030, and every three years thereafter, the Commission shall submit to the European Parliament and to the Council a report evaluating the impact of the amendments introduced by this Regulation, including the effects on SMEs. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) Regulation (EU) 2016/679 provides for the protection of natural persons with regard to the processing of personal data and free movement of such data. The obligation to maintain records of processing should be simplified so that it applies to all enterprises and organisations with fewer than 750 employees, provided that their processing activities are not likely to result in a high risk to the data subjects’ rights and freedoms. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) Regulation (EU) 2016/679 provides for the protection of natural persons with regard to the processing of personal data and free movement of such data. The obligation to maintain records of processing should be simplified so that it applies to all enterprises and organisations with fewer than 750 employees, provided that their processing activities are not likely to result in a high risk to the data subjects’ rights and freedoms. | (8) Regulation (EU) 2016/679 provides for the protection of natural persons with regard to the processing of personal data and free movement of such data. The obligation to maintain records of processing should be simplified so that it does not apply to all enterprises and organisations with fewer than 500 employees. Enterprises or organisations with less than 500 employees should however be obliged to keep records when their processing activities are likely to result in a high risk to the data subjects’ rights and freedoms, the core activities of the controller or the processor consist of processing of personal data on a large scale, or the controller is required to appoint a data protection officer pursuant to Article 37(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) Regulation (EU) 2016/679 provides for the protection of natural persons with regard to the processing of personal data and free movement of such data. The obligation to maintain records of processing should be simplified so that it applies to all enterprises and organisations with fewer than 750 employees, provided that their processing activities are not likely to result in a high risk to the data subjects’ rights and freedoms. | (8) Regulation (EU) 2016/679 provides for the protection of natural persons with regard to the processing of personal data and free movement of such data. The obligation to maintain records of processing should be simplified so that it applies to all enterprises and organisations that can be considered either micro, small, and medium-sized or small mid-cap enterprises, provided that their processing activities are not likely to result in a risk to the rights and freedoms of data subjects, the processing is not occasional, or the processing includes special categories of data as referred to in Article 9(1) or personal data relating to criminal convictions and offences referred to in Article 10. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) Regulation (EU) 2016/679 provides for the protection of natural persons with regard to the processing of personal data and free movement of such data. The obligation to maintain records of processing should be simplified so that it applies to all enterprises and organisations with fewer than 750 employees, provided that their processing activities are not likely to result in a high risk to the data subjects’ rights and freedoms. | (8) Regulation (EU) 2016/679 provides for the protection of natural persons with regard to the processing of personal data and free movement of such data. The obligation to maintain records of processing should be simplified so that it applies proportionally. Therefore, the derogation should apply to all enterprises and organisations that meet at least two of the following three criteria: an average number of employees during the financial year of less than 750, an annual net turnover not exceeding EUR 150 000 000 and/or a total balance sheet not exceeding EUR 129 000 000, provided that their processing activities are not likely to result in a risk to the data subjects’ rights and freedoms. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8 a) In order to ensure that simplification measures remain compatible with the fundamental principles of Regulation (EU) 2016/679, exemptions from record-keeping obligations should not result in a reduction of accountability where processing presents structural or recurring risks. Experience has shown that thresholds based solely on the size of an undertaking may not accurately reflect the scale, nature or sensitivity of the processing of personal data, and may inadvertently weaken protection in contexts where sensitive data or non-occasional processing activities are involved. In line with Recital 13 of Regulation (EU) 2016/679, any derogation from documentation duties should therefore exclude controllers or processors whose core business consists of large-scale or systematic processing of personal data, as well as processing operations involving special categories of data or personal data relating to criminal convictions and offences. This approach preserves simplification for genuinely low-risk operators without undermining the level of protection guaranteed under Union law. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8 a) To avoid legal uncertainty, reduce administrative burden, and simplify compliance with Article 30 of Regulation (EU) 2016/679, the Commission, in cooperation with the European Data Protection Board (EDPB), should provide a free-of-charge and easy-to-use ‘Online Compliance Tool’. To facilitate compliance, this tool should assist micro, small, and medium-sized enterprises (SMEs) and small mid-cap enterprises (SMCs) in assessing whether the derogation provided in Article 30(5) apply to their specific processing activities and, where record-keeping is required, assist in the efficient creation and maintenance of those records. |
| Text proposed by the Commission | Amendment |
|---|---|
| (9) In order to reflect the above, it is necessary to amend Article 30(5) of Regulation (EU) 2016/679, by extending the scope of the derogation from the record-keeping obligation to SMCs and organisations with fewer than 750 employees to allow also them to profit from that derogation and by providing that the derogation applies unless the processing is likely to result in a ‘high risk’ to data subjects’ rights and freedoms, within the meaning of Article 35 of Regulation (EU) 2016/679. In particular the processing of personal data referred to in paragraph 3 of that provision should be considered as requiring the data controller or the processor to maintain records of its processing activities. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (9) In order to reflect the above, it is necessary to amend Article 30(5) of Regulation (EU) 2016/679, by extending the scope of the derogation from the record-keeping obligation to SMCs and organisations with fewer than 750 employees to allow also them to profit from that derogation and by providing that the derogation applies unless the processing is likely to result in a ‘high risk’ to data subjects’ rights and freedoms, within the meaning of Article 35 of Regulation (EU) 2016/679. In particular the processing of personal data referred to in paragraph 3 of that provision should be considered as requiring the data controller or the processor to maintain records of its processing activities. | (9) In order to reflect the above, it is necessary to amend Article 30(5) of Regulation (EU) 2016/679, by extending the scope of the derogation from the record-keeping obligation to small mid-cap enterprises and organisations to allow also them to benefit from that derogation and by providing that the derogation applies unless the processing, upon assessment, is likely to result in a risk to the rights and freedoms of data subjects. For example, when the processing involves personal data referred to in paragraph 3 of Article 35 of Regulation (EU) 2016/679, it should be considered as requiring the data controller or the processor to maintain up-to-date records of its processing activities. To assist such enterprises and organization to comply with these obligations set in Article 30, it is also necessary to amend that Article by adding new paragraph mandating the Commission to adopt an implementing act to establish an easy-to-use online tool. |
| Text proposed by the Commission | Amendment |
|---|---|
| (9) In order to reflect the above, it is necessary to amend Article 30(5) of Regulation (EU) 2016/679, by extending the scope of the derogation from the record-keeping obligation to SMCs and organisations with fewer than 750 employees to allow also them to profit from that derogation and by providing that the derogation applies unless the processing is likely to result in a ‘high risk’ to data subjects’ rights and freedoms, within the meaning of Article 35 of Regulation (EU) 2016/679. In particular the processing of personal data referred to in paragraph 3 of that provision should be considered as requiring the data controller or the processor to maintain records of its processing activities. | (9) In order to reflect the above, it is necessary to amend Article 30(5) of Regulation (EU) 2016/679, by extending the scope of the derogation from the record-keeping obligation to SMCs and organisations with fewer than 500 employees to allow also them to profit from that derogation and by providing that the derogation applies unless the processing is likely to result in a ‘high risk’ to data subjects’ rights and freedoms, within the meaning of Article 35 of Regulation (EU) 2016/679, the core activities of the controller or the processor consist of processing of personal data on a large scale, or the controller is required to appoint a data protection officer pursuant to Article 37(1). In particular the processing of personal data referred to in paragraph 3 of that provision should be considered as requiring the data controller or the processor to maintain records of its processing activities. |
| Text proposed by the Commission | Amendment |
|---|---|
| (9) In order to reflect the above, it is necessary to amend Article 30(5) of Regulation (EU) 2016/679, by extending the scope of the derogation from the record-keeping obligation to SMCs and organisations with fewer than 750 employees to allow also them to profit from that derogation and by providing that the derogation applies unless the processing is likely to result in a ‘high risk’ to data subjects’ rights and freedoms, within the meaning of Article 35 of Regulation (EU) 2016/679. In particular the processing of personal data referred to in paragraph 3 of that provision should be considered as requiring the data controller or the processor to maintain records of its processing activities. | (9) In order to reflect the above, it is necessary to amend Article 30(5) of Regulation (EU) 2016/679, by extending the scope of the derogation from the record-keeping obligation to SMCs to allow also them to profit from that derogation and by providing that the derogation applies unless the processing is likely to result in a ‘high risk’ to data subjects’ rights and freedoms, within the meaning of Article 35 of Regulation (EU) 2016/679. In particular the processing of personal data referred to in paragraph 3 of that provision should be considered as requiring the data controller or the processor to maintain records of its processing activities. |
| Text proposed by the Commission | Amendment |
|---|---|
| (9) In order to reflect the above, it is necessary to amend Article 30(5) of Regulation (EU) 2016/679, by extending the scope of the derogation from the record-keeping obligation to SMCs and organisations with fewer than 750 employees to allow also them to profit from that derogation and by providing that the derogation applies unless the processing is likely to result in a ‘high risk’ to data subjects’ rights and freedoms, within the meaning of Article 35 of Regulation (EU) 2016/679. In particular the processing of personal data referred to in paragraph 3 of that provision should be considered as requiring the data controller or the processor to maintain records of its processing activities. | (9) In order to reflect the above, it is necessary to amend Article 30(5) of Regulation (EU) 2016/679, by extending the scope of the derogation from the record-keeping obligation to SMCs and organisations to allow also them to profit from that derogation and by providing that the derogation applies unless the processing is likely to result in a risk to data subjects’ rights and freedoms, within the meaning of Article 35 of Regulation (EU) 2016/679. In particular the processing of personal data referred to in paragraph 3 of that provision should be considered as requiring the data controller or the processor to maintain records of its processing activities. |
| Text proposed by the Commission | Amendment |
|---|---|
| (9 a) Where undertakings rely on an exemption from the obligation to maintain records of processing activities, transparency and accountability require that they document the assessment underpinning that decision. At present, such assessments are often made without any written record, preventing supervisory authorities from verifying whether the conclusion that a processing operation is unlikely to result in a high risk is reasonable or consistent with the criteria laid down in Regulation (EU) 2016/679. To avoid the creation of an unreviewable self-assessment regime, controllers should therefore be required to record the reasons and criteria supporting their risk determination and to make this documentation available to supervisory authorities upon request. This ensures that the exemption remains limited to occasional and low-risk operations and that the rights and freedoms of data subjects continue to receive effective protection. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) In this context, the processing of special categories of personal data which is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law, as referred to in Article 9(2), point (b), of Regulation (EU) 2016/679, should not as such require that records of processing be maintained. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) In this context, the processing of special categories of personal data which is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law, as referred to in Article 9(2), point (b), of Regulation (EU) 2016/679, should not as such require that records of processing be maintained. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) In this context, the processing of special categories of personal data which is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law, as referred to in Article 9(2), point (b), of Regulation (EU) 2016/679, should not as such require that records of processing be maintained. | (10) In this context, the processing of special categories of personal data, as referred to in Article 9 or Article 10 of Regulation (EU) 2016/679, should as such require that records of processing be maintained. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) In this context, the processing of special categories of personal data which is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law, as referred to in Article 9(2), point (b), of Regulation (EU) 2016/679, should not as such require that records of processing be maintained. | (10) In this context, the processing of special categories of personal data which is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law, as referred to in Article 9(2), point (b), of Regulation (EU) 2016/679, should in all cases be regarded as processing involving a risk to data subjects and should therefore always require that records of processing activities be maintained, irrespective of the number of employees or the number of affected data subjects. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) In this context, the processing of special categories of personal data which is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law, as referred to in Article 9(2), point (b), of Regulation (EU) 2016/679, should not as such require that records of processing be maintained. | (10) In this context, where the processing of special categories of personal data is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject, records of processing should be maintained, while ensuring that the administrative burden of documenting these activities is minimized. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10 a) To reduce the risks arising from data processing, controllers and processors should implement appropriate technical and organisational measures such as pseudonymisation, access controls, encryption, and other relevant privacy-enhancing technologies. In particular, the effective use of anonymisation or pseudonymisation can mitigate risks to the rights and freedoms of data subjects by separating identifying information from other data elements, thereby limiting or in exceptional cases completely preventing re-identification. As confirmed by the Court of Justice of the European Union in its judgment of 4 September 2025 in Case C-413/23 P, European Data Protection Supervisor v Single Resolution Board and previous case-law cited therein, whether pseudonymised data constitutes personal data for a given recipient must be assessed on the basis of objective criteria, including whether that recipient or any subsequent recipient has means reasonably likely to be used to re-identify individuals; on that objective assessment, pseudonymised data can in exceptional cases be regarded as non-personal data if all recipients lack such means. |
As confirmed by the Court of Justice of the European Union in its judgment of 4 September 2025 in Case C‑413/23 P, European Data Protection Supervisor v Single Resolution Board and previous case-law cited therein, whether pseudonymised data constitutes personal data for a given recipient must be assessed on the basis of objective criteria, including whether that recipient or any subsequent recipient has means reasonably likely to be used to re‑identify individuals; on that objective assessment, pseudonymised data can in exceptional cases not be regarded as personal data if all recipients lack such means.
| Text proposed by the Commission | Amendment |
|---|---|
| (10 b) In assessing whether processing operations carried out by a controller are likely to result in a risk to the rights and freedoms of natural persons, the number of employees or the annual turnover of the controller should not, in itself, be regarded as a determining criterion. Such organisational or economic indicators do not reliably reflect the nature, scope, context, or purposes of the processing, nor the likelihood or severity of potential risks to data subjects. This assessment should therefore be based on the characteristics of the processing activities and the risks they pose and should be clearly distinguished from the exemption provided in Article 30(5) of Regulation (EU) 2016/679 regarding the obligation to maintain records of processing activities, which applies on the basis of organisational thresholds. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10 c) The derogation from the obligation to maintain records of processing activities should apply only where the scale of processing remains limited so as not to impede effective risk assessment and accountability. To ensure legal certainty for controllers an objective, relevant threshold should be established. Limiting the derogation in this manner, and in light of the general burden of proof in Article 5(2) of Regulation (EU) 2016/679, this should preserve the ability of supervisory authorities to oversee significant processing operations and of the data subject to be able to proof violations in practice, while ensuring that small-scale or lower-risk processing continues to benefit from proportionate administrative relief. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10 d) To determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used, such as singling out, either by the controller or by another person to identify the natural person directly or indirectly. This Regulation should therefore follow an objective assessment to determine if any data constitutes personal data, to ensure a high level of protection and a consistent application of the law throughout a chain of controllers. Only if personal data is anonymised to an extent where the controller and all subsequent recipients cannot reasonably re-identify a data subject, such data should be considered non-personal data. |
| Text proposed by the Commission | Amendment |
|---|---|
| (11) Furthermore, in order to extend to SMCs, the provisions that are available for micro, small and medium-sized enterprises under Regulation (EU) 2016/679, the following articles should also be amended: | deleted |
| — Article 4, which contains the definitions applicable for the purpose of Regulation (EU) 2016/679. For reasons of clarity, definitions should be added for micro, small and medium-sized enterprises, and for small mid-cap enterprises. For small and medium-sized enterprises, it is appropriate to follow the choice of the co-legislator as expressed in recital (13) of the preamble to Regulation (EU) 2016/679. For SMCs, reference should be made to point 2 of Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final. | |
| — Article 40, which provides that Member States, the supervisory authorities, the Board and the Commission are to encourage associations and other bodies representing categories of controllers or processors to draw up codes of conduct, and that the specific needs of micro, small and medium-sized enterprises are to be taken into account when doing so. This requirement should be extended to include the specific needs of SMCs. | |
| — Article 42, which provides that when Member States, the supervisory authorities, the Board and the Commission are to encourage, in particular at Union level, the establishment of data protection certification mechanisms and of data protection seals and marks by certification bodies referred to in Article 43 of that Regulation or by competent supervisory authorities, the specific needs of micro, small and medium-sized enterprises are to be taken into account. This requirement should also be extended to include the specific needs of SMCs. |
| Text proposed by the Commission | Amendment |
|---|---|
| – Article 4, which contains the definitions applicable for the purpose of Regulation (EU) 2016/679. For reasons of clarity, definitions should be added for micro, small and medium-sized enterprises, and for small mid-cap enterprises. For small and medium-sized enterprises, it is appropriate to follow the choice of the co-legislator as expressed in recital (13) of the preamble to Regulation (EU) 2016/679. For SMCs, reference should be made to point 2 of Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final. | – Article 4, which contains the definitions applicable for the purpose of Regulation (EU) 2016/679. For reasons of clarity, definitions should be added for micro, small and medium-sized enterprises, and for small mid-cap enterprises. For small and medium-sized enterprises, it is appropriate to follow the choice of the co-legislator as expressed in recital (13) of the preamble to Regulation (EU) 2016/679. |
| Text proposed by the Commission | Amendment |
|---|---|
| – Article 4, which contains the definitions applicable for the purpose of Regulation (EU) 2016/679. For reasons of clarity, definitions should be added for micro, small and medium-sized enterprises, and for small mid-cap enterprises. For small and medium-sized enterprises, it is appropriate to follow the choice of the co-legislator as expressed in recital (13) of the preamble to Regulation (EU) 2016/679. For SMCs, reference should be made to point 2 of Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final. | – Article 4, which contains the definitions applicable for the purpose of Regulation (EU) 2016/679. For reasons of clarity, definitions should be added for micro, small and medium-sized enterprises, and for small mid-cap enterprises. For small and medium-sized enterprises, it is appropriate to follow the choice of the co-legislator as expressed in recital (13) of the preamble to Regulation (EU) 2016/679. For small mid-cap enterprises, it is appropriate to follow reference in point 2 of Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final. |
| Text proposed by the Commission | Amendment |
|---|---|
| (14) Regulation (EU) 2017/1129 sets out requirements for drawing up of a prospectus in cases where securities are offered to the public or admitted to trading on a regulated market. That Regulation, as amended by Regulation (EU) 2024/2809, provides for a streamlined EU Growth issuance prospectus that has lighter requirements, compared to a standard prospectus, to make the listing process less burdensome and less costly for certain types of enterprises and in certain cases. The main categories of beneficiaries of such streamlined prospectus are enterprises with a growth potential, notably SMEs and other enterprises whose securities are admitted or are to be admitted to trading on an SME growth market. In order to reduce the burden for SMCs and potentially make them more attractive to investors, it is appropriate to also enable SMCs to draw up an EU Growth issuance prospectus for their offers of securities to the public, including when such offers are accompanied with an admission to trading on a multilateral trading facility. | (14) Regulation (EU) 2017/1129 sets out requirements for drawing up of a prospectus in cases where securities are offered to the public or admitted to trading on a regulated market. That Regulation, as amended by Regulation (EU) 2024/2809, provides for a streamlined EU Growth issuance prospectus that has lighter requirements, compared to a standard prospectus, to make the listing process less burdensome and less costly for certain types of enterprises and in certain cases. The main categories of beneficiaries of such streamlined prospectus are enterprises with a growth potential, notably SMEs and other enterprises whose securities are admitted or are to be admitted to trading on an SME growth market, as well as issuers where the offer of securities to the public is of a total consideration in the Union that does not exceed EUR 50 000 000 calculated over a period of 12 months, and provided that such issuers have no securities traded on an MTF, and have an average number of employees during the previous financial year of up to 499. To reduce the burden for SMCs and potentially make them more attractive to investors, it is appropriate to also enable SMCs to draw up an EU Growth issuance prospectus for their offers of securities to the public, including when such offers are accompanied with an admission to trading on a multilateral trading facility. |
| Text proposed by the Commission | Amendment |
|---|---|
| (15) In order to clarify the treatment of SMCs in Regulation (EU) 2017/1129, it is necessary to introduce in its Article 2 a definition of SMC, distinct from the definition of an SME. Small mid-cap enterprises for the purpose of that Regulation should be defined either as enterprises that meet at least two out of the three criteria based on the average number of employees, a total balance sheet and an annual net turnover, or as enterprises that meet the definition of small mid-cap enterprises set out under Directive 2014/65/EU. | deleted |
While exemptions and regulatory relief for small and new enterprises may be justified, creating new enterprise categories and adding complexity should generally be avoided, as regulatory exceptions can distort market incentives and weaken market integrity and transparency. Moreover, the dominant concern for SMEs across the EU regarding factors that limit their access to finance is interest rates and the high cost of financing. It seems unlikely that such concerns would be adequately addressed by establishing new enterprise categories.
| Text proposed by the Commission | Amendment |
|---|---|
| (15) In order to clarify the treatment of SMCs in Regulation (EU) 2017/1129, it is necessary to introduce in its Article 2 a definition of SMC, distinct from the definition of an SME. Small mid-cap enterprises for the purpose of that Regulation should be defined either as enterprises that meet at least two out of the three criteria based on the average number of employees, a total balance sheet and an annual net turnover, or as enterprises that meet the definition of small mid-cap enterprises set out under Directive 2014/65/EU. | (15) In order to clarify the treatment of SMCs in Regulation (EU) 2017/1129, it is necessary to introduce in its Article 2 a definition of SMC, distinct from the definition of an SME. Small mid-cap enterprises for the purpose of that Regulation should be defined as enterprises that meet the definition of small mid-cap enterprises set out under Directive 2014/65/EU. |
| Text proposed by the Commission | Amendment |
|---|---|
| (18) Regulation (EU) 2023/1542 establishes rules concerning batteries and waste batteries. Article 47 of that Regulation exempts SMEs from certain obligations regarding battery due diligence policies. The scope of that provision should be extended to SMCs, so that they are also exempted from those obligations. To ensure consistency, it is appropriate to refer to SMCs in the same way bearing in mind that they are entities up to three times the size of SMEs, i.e. with a net turnover which should thus be less than EUR 150 million. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (18) Regulation (EU) 2023/1542 establishes rules concerning batteries and waste batteries. Article 47 of that Regulation exempts SMEs from certain obligations regarding battery due diligence policies. The scope of that provision should be extended to SMCs, so that they are also exempted from those obligations. To ensure consistency, it is appropriate to refer to SMCs in the same way bearing in mind that they are entities up to three times the size of SMEs, i.e. with a net turnover which should thus be less than EUR 150 million. | (18) Regulation (EU) 2023/1542 establishes rules concerning batteries and waste batteries. Chapter VII of that Regulation lays down obligations of economic operators as regards battery due diligence policies. Those obligations are key to ensuring a sustainable and ethical electrification of Europe’s economy, and to guaranteeing public support for Europe’s decarbonisation agenda. The application of those obligations, agreed upon in 2023, has been postponed to August 2027, giving four years to economic operators to prepare for the implementation. Following Articles 48(5), (6) and (7) of that Regulation, the Commission will provide guidance by July 2026 to facilitate compliance, and Member States and the Commission may provide information and support to economic operators, by setting up dedicated websites, platforms or portals, and through other actions and measures. Article 47 of that Regulation exempts SMEs from certain obligations regarding battery due diligence policies. The scope of that provision should be extended to larger companies to the extent this does not reduce the effectiveness and credibility of due diligence obligations, ensuring that companies with substantial market and supply chain impacts remain in the scope. To ensure consistency, it is appropriate to refer to SMCs in the same way bearing in mind that they are entities up to three times the size of SMEs, i.e. with a net global turnover which should thus be less than EUR 100 million. |
| Text proposed by the Commission | Amendment |
|---|---|
| (18) Regulation (EU) 2023/1542 establishes rules concerning batteries and waste batteries. Article 47 of that Regulation exempts SMEs from certain obligations regarding battery due diligence policies. The scope of that provision should be extended to SMCs, so that they are also exempted from those obligations. To ensure consistency, it is appropriate to refer to SMCs in the same way bearing in mind that they are entities up to three times the size of SMEs, i.e. with a net turnover which should thus be less than EUR 150 million. | (18) Regulation (EU) 2023/1542 establishes rules concerning batteries and waste batteries. Article 47 of that Regulation exempts SMEs from certain obligations regarding battery due diligence policies. The scope of that provision should be extended to SMCs, so that they are also exempted from those obligations. This exemption is an essential step towards ensuring the operational viability of the industrial supply chain in the Union and to prevent unaffordable costs for manufacturers. To ensure consistency, it is appropriate to refer to SMCs in the same way bearing in mind that they are entities up to three times the size of SMEs, i.e. with a net turnover which should thus be less than EUR 150 million. |
| Text proposed by the Commission | Amendment |
|---|---|
| (19) Pursuant to Article 52 of Regulation (EU) 2023/1542, economic operators referred to in Article 48(1) of that Regulation are required - on an annual basis – to review and make publicly available, including on the internet, a report on their battery due diligence policy. With a view to reducing the administrative burden on economic operators, operators should be required to review and make publicly avilable their due diligence policy only only every three years instead of annually. This burden reduction should apply to all economic operators, including SMCs. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (19) Pursuant to Article 52 of Regulation (EU) 2023/1542, economic operators referred to in Article 48(1) of that Regulation are required - on an annual basis – to review and make publicly available, including on the internet, a report on their battery due diligence policy. With a view to reducing the administrative burden on economic operators, operators should be required to review and make publicly avilable their due diligence policy only only every three years instead of annually. This burden reduction should apply to all economic operators, including SMCs. | (19) Pursuant to Article 52 of Regulation (EU) 2023/1542, economic operators referred to in Article 48(1) of that Regulation are required - on an annual basis – to review and make publicly available, including on the internet, a report on their battery due diligence policy. With a view to reducing the administrative burden on economic operators while maintaining transparency in this fast-evolving and high-impact sector, operators should be required to review and make publicly available their due diligence policy only every two years instead of annually, or more often, if a significant change occurs. This burden reduction should apply to all economic operators, including SMCs. Operators can join their reports due under this Regulation with reports due under other relevant legislation, and the Commission may issue guidance on how such joint reporting could be carried out. |
| Text proposed by the Commission | Amendment |
|---|---|
| (19) Pursuant to Article 52 of Regulation (EU) 2023/1542, economic operators referred to in Article 48(1) of that Regulation are required - on an annual basis – to review and make publicly available, including on the internet, a report on their battery due diligence policy. With a view to reducing the administrative burden on economic operators, operators should be required to review and make publicly avilable their due diligence policy only only every three years instead of annually. This burden reduction should apply to all economic operators, including SMCs. | (19) Pursuant to Article 52 of Regulation (EU) 2023/1542, economic operators referred to in Article 48(1) of that Regulation are required - on an annual basis – to review and make publicly available, including on the internet, a report on their battery due diligence policy. With a view to reducing the administrative burden on economic operators, operators should be required to review and make publicly avilable their due diligence policy only only every two years instead of annually. This burden reduction should apply to all economic operators, including SMCs. |
| Text proposed by the Commission | Amendment |
|---|---|
| (20) The requirement in Article 20(4), point (a) of Regulation (EU) 2024/573 of the European Parliament and of the Council17 to register in the F-gas Portal prior to carrying out any imports and exports of products and equipment containing fluorinated greenhouses gases, is intended to facilitate enforcement. However, the burden resulting from that requirement may be disproportionate compared to its benefit, in particular for SMEs and SMCs. Therefore, the registration requirement should be limited to imports for which reporting requirments apply and to exports for which an export limitation exists. To the extent that this Regulation amends Regulation (EU) 2024/573 the appropriate legal basis, in so far as those amendments are concerned, is Article 192(1) TFEU. | deleted |
| 17 Regulation (EU) 2024/573 of the European Parliament and of the Council of 7 February 2024 on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014 (OJ L 2024/573, 20.02.2024, ELI: http://data.europa.eu/eli/reg/2024/573/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (20) The requirement in Article 20(4), point (a) of Regulation (EU) 2024/573 of the European Parliament and of the Council17to register in the F-gas Portal prior to carrying out any imports and exports of products and equipment containing fluorinated greenhouses gases, is intended to facilitate enforcement. However, the burden resulting from that requirement may be disproportionate compared to its benefit, in particular for SMEs and SMCs. Therefore, the registration requirement should be limited to imports for which reporting requirments apply and to exports for which an export limitation exists. To the extent that this Regulation amends Regulation (EU) 2024/573 the appropriate legal basis, in so far as those amendments are concerned, is Article 192(1) TFEU. | (20) The requirement in Article 20(4), point (a) of Regulation (EU) 2024/573 of the European Parliament and of the Council17 to register in the F-gas Portal prior to carrying out any imports and exports of products and equipment containing fluorinated greenhouses gases, is intended to facilitate enforcement. However, the burden resulting from that requirement may be disproportionate compared to its benefit, in particular for SMEs and SMCs and could have repercussions for the operating costs of critical sectors. Therefore, the registration requirement should be limited to imports for which reporting requirements apply and to exports for which an export limitation exists, applying the principle of proportionality strictly. To the extent that this Regulation amends Regulation (EU) 2024/573 the appropriate legal basis, in so far as those amendments are concerned, is Article 192(1) TFEU. |
| 17 Regulation (EU) 2024/573 of the European Parliament and of the Council of 7 February 2024 on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014 (OJ L 2024/573, 20.02.2024, ELI: http://data.europa.eu/eli/reg/2024/573/oj) | 17 Regulation (EU) 2024/573 of the European Parliament and of the Council of 7 February 2024 on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014 (OJ L, 2024/573, 20.02.2024, ELI: http://data.europa.eu/eli/reg/2024/573/oj). |
| Text proposed by the Commission | Amendment |
|---|---|
| (20 a) The competitiveness of the small and medium-sized enterprises, including the small and mid-caps, is threatened by the excessive regulatory requirements, which impose disproportionate administrative and financial obligations on these enterprises. In order to boost innovation, ensure growth and the creation of new jobs, the Commission should provide a comprehensive and thorough evaluation of the currently applicable legislation in order to assess its financial and administrative impact of the small and medium-sized enterprises. On the basis of this evaluation, the Commission should propose legislative proposals in order to address these bottlenecks. |
| Text proposed by the Commission | Amendment |
|---|---|
| (20 a) Considering that this Regulation is expected to have significant economic, social or environmental impacts, and that no impact assessment was carried out prior to the adoption of this Regulation, it is essential to monitor and evaluate the implementation of this Regulation. In this regard, the Commission should submit a report one year after adoption of this Regulation, and every two years thereafter, on the implementation of this Regulation, specifically assessing its impact on the fundamental rights and benefits to the competitiveness of Union enterprises and organizations. |
| Text proposed by the Commission | Amendment |
|---|---|
| (20 a) While the simplification of the registration requirement laid down in Article 20(4), point (a), of Regulation (EU) 2024/573 is not expected to impact the ability to enforce that Regulation, the Commission may, on the basis of its regular monitoring of trade in fluorinated greenhouse gases and assessment of the potential risks of illegal trade, make use of the empowerment established in article 24 of that Regulation, to strengthen enforcement and improve cooperation between customs and market surveillance authorities. |
| Text proposed by the Commission | Amendment |
|---|---|
| (21) Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (EU) 2023/1542 and (EU) 2024/573 should therefore be amended accordingly, | (21) Regulations (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (EU) 2023/1542 and (EU) 2024/573 should therefore be amended accordingly, |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 1 | deleted |
| Amendments to Regulation (EU) 2016/679 | |
| Regulation (EU) 2016/679 is amended as follows: | |
| (1) in Article 4, the following points (27) and (28) are added: | |
| ‘(27) ‘micro, small, and medium-sized enterprises’ means enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC*; | |
| (28) | |
| ‘small mid-cap enterprises’ means enterprises as defined in point (2) of the Annex to Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final**.; | |
| * Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj). | |
| ** Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final.’ ; | |
| ‘5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 750 persons unless the processing it carries out is likely to result in a high risk to the rights and freedoms of data subjects, within the meaning of Article 35.; | |
| ‘1. The Member States, the supervisory authorities, the Board and the Commission shall encourage the drawing up of codes of conduct intended to contribute to the proper application of this Regulation, taking account of the specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises and of small mid-cap enterprises.; | |
| ‘1. The Member States, the supervisory authorities, the Board and the Commission shall encourage, in particular at Union level, the establishment of data protection certification mechanisms and of data protection seals and marks, for the purpose of demonstrating compliance with this Regulation of processing operations by controllers and processors. The specific needs of micro, small and medium-sized enterprises and of small mid-cap enterprises shall be taken into account. |
| Text proposed by the Commission | Amendment |
|---|---|
| (27) ‘micro, small, and medium-sized enterprises’ means enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC*; | (27) ‘micro, small, and medium-sized enterprises’ means enterprises according to its last annual or consolidated account, meets at least two of the following three criteria: (a) employ fewer than 250 persons (b) an annual turnover not exceeding EUR 50 000 000, (c) an annual balance sheet total not exceeding EUR 43 000 000; |
| Text proposed by the Commission | Amendment |
|---|---|
| ‘small mid-cap enterprises’ means enterprises as defined in point (2) of the Annex to Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final**.; | ‘small mid-cap enterprises’ means enterprises, which is not a micro, small or medium-sized enterprise and which, according to its last annual or consolidated accounts, meets at least two of the following three criteria: (a) an average number of employees during the financial year of less than 750; (b) an annual net turnover not exceeding EUR 150 000 000; (c) a total balance sheet not exceeding EUR 129 000 000; |
| Text proposed by the Commission | Amendment |
|---|---|
| ‘small mid-cap enterprises’ means enterprises as defined in point (2) of the Annex to Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final**.; | ‘small middle capitalisation company’ or ‘small mid-cap’ means an enterprise that is not a SME and whose number of employees does not exceed 499, calculated in accordance with Articles 3 to 6 of the Annex to Recommendation 2003/361/EC, the annual turnover of which does not exceed EUR 100 million or the annual balance sheet of which does not exceed EUR 86 million; |
Definition as proposed by the Commission in the European Defence Industry Programme, COM(2024)150 final, procedure 2024/0061(COD).
| Text proposed by the Commission | Amendment |
|---|---|
| ‘small mid-cap enterprises’ means enterprises as defined in point (2) of the Annex to Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final**.; | (28) ‘small mid-cap enterprises’ means enterprises that fulfil at least one of the following criteria: |
| (i) employing fewer than 1750 persons; | |
| (ii) have an annual turnover not exceeding EUR 500 million; | |
| (iii) an annual balance sheet total not exceeding EUR 500 million. |
| Text proposed by the Commission | Amendment |
|---|---|
| ‘small mid-cap enterprises’ means enterprises as defined in point (2) of the Annex to Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final**.; | ‘small mid-cap enterprises’ means enterprises that are not SMEs, that employ fewer than 500 persons, and that either have an annual turnover not exceeding EUR 100 000 000 or an annual balance sheet total not exceeding EUR 86 000 000; |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 750 persons unless the processing it carries out is likely to result in a high risk to the rights and freedoms of data subjects, within the meaning of Article 35.; | 5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 500 persons unless the processing it carries out is likely to result in a high risk to the rights and freedoms of data subjects, within the meaning of Article 35, the core activities of the controller or the processor consist of processing of personal data on a large scale, or the controller is required to appoint a data protection officer pursuant to Article 37(1). |
| Controllers to which the obligations referred to in paragraphs 1 and 2 of this Article do not apply shall document the assessment of whether a processing operation is likely to result in a high risk to the rights and freedoms of data subjects within the meaning of Article 35. Such documentation shall include the reasons for the assessment and the criteria applied. Supervisory authorities shall be entitled to get access to that documentation at any time. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 750 persons unless the processing it carries out is likely to result in a high risk to the rights and freedoms of data subjects, within the meaning of Article 35.; | 5. The obligations referred to in paragraphs 1 and 2 shall not apply to micro, small, and medium-sized enterprises and small mid-cap enterprise as defined in Article 4(27) and (28) respectively, unless the processing it carries out is likely to result in a risk to the rights and freedoms of data subjects, the processing is not occasional, or the processing includes special categories of data as referred to in Article 9(1) or personal data relating to criminal convictions and offences referred to in Article 10. This exemption shall not apply to controllers or processors whose core business consists of large-scale or systematic processing of personal data, or to controllers required to appoint a data protection officer pursuant to Article 37(1), regardless of whether they fall in the categories of Article 4(27) and (28). |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 750 persons unless the processing it carries out is likely to result in a high risk to the rights and freedoms of data subjects, within the meaning of Article 35.; | 5. The obligations referred to in paragraphs 1 and 2 shall not apply to a micro, small and medium-sized enterprise and small mid-cap enterprise or an organisation unless, upon assessment, the processing it carries out is likely to result in a risk to the rights and freedoms of data subjects, the processing is not occasional, or the processing includes special categories of data as referred to in Article 9(1), or personal data relating to criminal convictions and offences referred to in Article 10; The obligations referred to paragraphs 1 and 2 shall still apply to public bodies or authorities; |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 750 persons unless the processing it carries out is likely to result in a high risk to the rights and freedoms of data subjects, within the meaning of Article 35.; | 5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 500 persons unless the processing it carries out is likely to result in a high risk to the rights and freedoms of data subjects, within the meaning of Article 35; |
Raising the threshold would extend the SMC category to companies up to four times larger than SMEs, undermining the purpose of SME-specific support. This would distort competition by placing genuinely small companies in direct competition with significantly larger firms for regulatory advantages and funding, despite their very different financial and human resource capacities. Increasing the thresholds would instead facilitate the transition of SMCs into large companies, rather than helping SMEs scale up.
| Text proposed by the Commission | Amendment |
|---|---|
| 5 a. The Commission shall adopt an implementing act to establish, in cooperation with the European Data Protection Board (EDPB), an official, free and interactive Online Compliance Tool. That tool shall guide an enterprise or an organization referred to in paragraph 5 to facilitate compliance with this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5 a. Controllers and processors relying on the exemption in the previous paragraph shall document their assessment of whether a processing operation is likely to result in a high risk to the rights and freedoms of data subjects within the meaning of Article 35. Such documentation shall include the reasons for the assessment and the criteria applied and shall be made available to the supervisory authority on request. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Member States, the supervisory authorities, the Board and the Commission shall encourage the drawing up of codes of conduct intended to contribute to the proper application of this Regulation, taking account of the specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises and of small mid-cap enterprises.; | 1. The Member States, the supervisory authorities, the Board and the Commission shall encourage the drawing up of codes of conduct intended to contribute to the proper application of this Regulation, taking account of the needs, protection and enforcement of data subjects’ fundamental rights, specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises and of small mid-cap enterprises.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Member States, the supervisory authorities, the Board and the Commission shall encourage, in particular at Union level, the establishment of data protection certification mechanisms and of data protection seals and marks, for the purpose of demonstrating compliance with this Regulation of processing operations by controllers and processors. The specific needs of micro, small and medium-sized enterprises and of small mid-cap enterprises shall be taken into account. | 1. The Member States, the supervisory authorities, the Board and the Commission shall encourage, in particular at Union level, the establishment of data protection certification mechanisms and of data protection seals and marks, for the purpose of demonstrating compliance with this Regulation of processing operations by controllers and processors. The specific needs, protection and enforcement of data subjects’ fundamental rights and needs of micro, small and medium-sized enterprises and of small mid-cap enterprises shall be taken into account. |
| Text proposed by the Commission | Amendment |
|---|---|
| an offer of securities resulting from the conversion or exchange of other securities, own funds or eligible liabilities by a resolution authority due to the exercise of a power referred to in Article 53(2), Article 59(2) or Article 63(1) of Directive 2014/59/EU or the exercise of a power referred to in Article 35(1), Article 39(2) or Article 42(1) of Directive (EU) 2025/1 of the European Parliament and of the Council (\*) or by a relevant third-country authority due to the exercise of a comparable power in third-country resolution proceedings;’; | an offer of securities resulting from the conversion or exchange of other securities, own funds or eligible liabilities by a resolution authority and carried out in the course of the exercise of a power referred to in Article 53(2), Article 59(2) or Article 63(1) of Directive 2014/59/EU or the exercise of a power referred to in Article 35(1), Article 39(2) or Article 42(1) of Directive (EU) 2025/1 of the European Parliament and of the Council (\*) or by a relevant third-country authority due to the exercise of a comparable power in third-country resolution proceedings;’; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) securities resulting from the conversion or exchange of other securities, own funds or eligible liabilities by a resolution authority due to the exercise of a power referred to in Article 53(2), Article 59(2) or Article 63(1) of Directive 2014/59/EU or the exercise of a power referred to in Article 35(1), Article 39(2) or Article 42(1) of Directive (EU) 2025/1 or by a relevant third-country authority due to the exercise of a comparable power in third-country resolution proceedings;; | (c) securities resulting from the conversion or exchange of other securities, own funds or eligible liabilities by a resolution authority and admitted to trading on a regulated market in the course of the exercise of a power referred to in Article 53(2), Article 59(2) or Article 63(1) of Directive 2014/59/EU or the exercise of a power referred to in Article 35(1), Article 39(2) or Article 42(1) of Directive (EU) 2025/1 or by a relevant third-country authority due to the exercise of a comparable power in third-country resolution proceedings; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) in Article 2, the following point (fa) is inserted: | deleted |
| ‘(fa) ‘small mid-cap enterprises’ or ‘SMCs’ means any of the following: | |
| (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 750, a total balance sheet not exceeding EUR 129 000 000 and an annual net turnover not exceeding EUR 150 000 000; | |
| (ii) small mid-cap enterprises as defined in Article 4(1), point (13a), of Directive 2014/65/EU;;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) in Article 2, the following point (fa) is inserted: | (b) the following point (fa) is inserted: |
| Text proposed by the Commission | Amendment |
|---|---|
| (fa) ‘small mid-cap enterprises’ or ‘SMCs’ means any of the following: | (fa) ‘small mid-cap enterprises’ or ‘SMCs’ means: |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 750, a total balance sheet not exceeding EUR 129 000 000 and an annual net turnover not exceeding EUR 150 000 000; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 750, a total balance sheet not exceeding EUR 129 000 000 and an annual net turnover not exceeding EUR 150 000 000; | (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 1 750, a total balance sheet not exceeding EUR 500 000 000 and an annual net turnover not exceeding EUR 500 000 000; |
| (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 750, a total balance sheet not exceeding EUR 129 000 000 and an annual net turnover not exceeding EUR 150 000 000; | (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 500, a total balance sheet not exceeding EUR 86 000 000 and an annual net turnover not exceeding EUR 100 000 000; |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 750, a total balance sheet not exceeding EUR 129 000 000 and an annual net turnover not exceeding EUR 150 000 000; | (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 750 or a total balance sheet not exceeding EUR 129 000 000 or an annual net turnover not exceeding EUR 150 000 000; |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 750, a total balance sheet not exceeding EUR 129 000 000 and an annual net turnover not exceeding EUR 150 000 000; | (i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 500, a total balance sheet not exceeding EUR 129 000 000 and an annual net turnover not exceeding EUR 150 000 000; |
| Text proposed by the Commission | Amendment |
|---|---|
| (3) in Article 15a, paragraph 1 is replaced by the following: | (3) in Article 15a, the following point (aa) is inserted : |
| aa. SMCs; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Without prejudice to Article 1(4) and Article 3(2) and (2a), the following persons may draw up an EU Growth issuance prospectus in the case of an offer of securities to the public, provided that they have no securities admitted to trading on a regulated market: | deleted |
| (a) SMEs; | |
| (b) SMCs; | |
| (c) issuers, other than SMEs and SMCs, whose securities are, or are to be admitted to trading on an SME growth market; | |
| (d) offerors of securities that have been issued by issuers referred to in points (a), (b), and (c).. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Without prejudice to Article 1(4) and Article 3(2) and (2a), the following persons may draw up an EU Growth issuance prospectus in the case of an offer of securities to the public, provided that they have no securities admitted to trading on a regulated market: | deleted |
| (a) SMEs; | |
| (b) SMCs; | |
| (c) issuers, other than SMEs and SMCs, whose securities are, or are to be admitted to trading on an SME growth market; | |
| (d) offerors of securities that have been issued by issuers referred to in points (a), (b), and (c).. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) issuers, other than SMEs and SMCs, whose securities are, or are to be admitted to trading on an SME growth market; | (c) issuers, other than SMEs and SMCs, for those securities that are to be admitted to trading on an SME growth market; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1 a. Member States may, in accordance with Directive 2014/65/EU, designate a specific segment of a multilateral trading facility as a “mid-cap growth market” for issuers that are small and medium-sized enterprises or small mid-cap enterprises, as defined in this Regulation. Admission of securities of such issuers to a mid-cap growth market shall be deemed, for the purposes of paragraph 1, equivalent to admission to an SME growth market. |
| Text proposed by the Commission | Amendment |
|---|---|
| (3 a) In Article 48, paragraph 2, the following point (hi) is added: | |
| (hi) an analysis of the impact and appropriateness of the SMCs definition and the extension of the use of the EU Growth issuance prospectus by this category, taking into account the size and growth trajectory of listed companies in the Union, and whether the definition strikes a proper balance between investor protection considerations and the reduction of administrative burdens for listed firms; |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 5 | deleted |
| Amendments to Regulation (EU) 2023/1542 | |
| Regulation (EU) 2023/1542 is amended as follows: | |
| (1) in Article 47, the first paragraph is replaced by the following: | |
| ‘This Chapter does not apply to economic operators that had a net turnover of less than EUR 150 million in the financial year preceding the last financial year, and that are not part of a group, consisting of parent and subsidiary undertakings, which, on a consolidated basis, exceeds the limit of EUR 150 million.; | |
| ‘The economic operator referred to in Article 48(1) shall, by the latest one year after the date specified in Article 48(1) and at least every three years thereafter, review and make publicly available, including on the internet, a report on its battery due diligence policy.. |
| Text proposed by the Commission | Amendment |
|---|---|
| This Chapter does not apply to economic operators that had a net turnover of less than EUR 150 million in the financial year preceding the last financial year, and that are not part of a group, consisting of parent and subsidiary undertakings, which, on a consolidated basis, exceeds the limit of EUR 150 million.; | This Chapter does not apply to economic operators that had a net turnover of less than EUR 450 million in the financial year preceding the last financial year, and that are not part of a group, consisting of parent and subsidiary undertakings, the net turnover of, which group on a consolidated basis, equals or exceeds the limit of EUR 450 million in the financial year preceding the last financial year .; |
| Text proposed by the Commission | Amendment |
|---|---|
| This Chapter does not apply to economic operators that had a net turnover of less than EUR 150 million in the financial year preceding the last financial year, and that are not part of a group, consisting of parent and subsidiary undertakings, which, on a consolidated basis, exceeds the limit of EUR 150 million.; | This Chapter does not apply to economic operators that had a net global turnover of less than EUR 100 million in the financial year preceding the last financial year, and that are not part of a group, consisting of parent and subsidiary undertakings, whose net global turnover, on a consolidated basis, equals or exceeds the limit of EUR 100 million in the financial year preceding the last financial year.; |
| Text proposed by the Commission | Amendment |
|---|---|
| This Chapter does not apply to economic operators that had a net turnover of less than EUR 150 million in the financial year preceding the last financial year, and that are not part of a group, consisting of parent and subsidiary undertakings, which, on a consolidated basis, exceeds the limit of EUR 150 million.; | This Chapter does not apply to economic operators that can be defined as small mid-cap enterprises in the sense of Commission Recommendation (EU) 2025/1099 of 21 May 2025 on the definition of small mid-cap enterprises. |
| Text proposed by the Commission | Amendment |
|---|---|
| The economic operator referred to in Article 48(1) shall, by the latest one year after the date specified in Article 48(1) and at least every three years thereafter, review and make publicly available, including on the internet, a report on its battery due diligence policy.. | The economic operator referred to in Article 48(1) shall, by the latest one year after the date specified in Article 48(1) and at least every five years thereafter, review and make publicly available, including on the internet, a report on its battery due diligence policy. |
| Text proposed by the Commission | Amendment |
|---|---|
| The economic operator referred to in Article 48(1) shall, by the latest one year after the date specified in Article 48(1) and at least every three years thereafter, review and make publicly available, including on the internet, a report on its battery due diligence policy.. | The economic operator referred to in Article 48(1) shall, at the latest one year after the date specified in that Article and at least every two years thereafter, or more often if a significant change occurs, review, update and make publicly available, including on the internet, a report on its battery due diligence policy. |
| Text proposed by the Commission | Amendment |
|---|---|
| The economic operator referred to in Article 48(1) shall, by the latest one year after the date specified in Article 48(1) and at least every three years thereafter, review and make publicly available, including on the internet, a report on its battery due diligence policy.. | The economic operator referred to in Article 48(1) shall, by the latest one year after the date specified in Article 48(1) and at least every two years thereafter, review and make publicly available, including on the internet, a report on its battery due diligence policy.. |
| Text proposed by the Commission | Amendment |
|---|---|
| The economic operator referred to in Article 48(1) shall, by the latest one year after the date specified in Article 48(1) and at least every three years thereafter, review and make publicly available, including on the internet, a report on its battery due diligence policy.. | The economic operator referred to in Article 48(1) shall, at the latest one year after the date specified in that Article and at least every three years thereafter, or whenever a significant change occurs, review, update and make publicly available, including on the internet, a report on its battery due diligence policy. |
| Text proposed by the Commission | Amendment |
|---|---|
| -1. A new Recital 145 is inserted: | |
| '(145) In order to ensure a regular review of the effectiveness, proportionality and necessity of the measures provided for in Regulation 2023/1542, their application should be limited in time. The provisions of this Regulation should therefore expire on a specified date, unless renewed or replaced by a new legal act. The Commission should be required to carry out an evaluation in good time before this deadline and to report to the European Parliament and the Council.' |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. In Article 96, the following paragraphs are added: | |
| (2a) The provisions of this Regulation shall expire on 31 June 2031, unless they are expressly extended or replaced by a new act before that date. | |
| (2b) The European Commission shall review the effectiveness, efficiency and necessity of the obligations laid down in this Regulation no later than three years before the expiry date referred to in paragraph 3. It shall submit a report on the outcome of this review to the European Parliament and the Council no later than two years before said expiry date. If the Commission considers it necessary to maintain or to adapt the provisions of the Regulation, it shall submit a legislative proposal to that effect in good time.’ |
The sunset clause ensures that the regulation is reviewed after a fixed period and extended only if it is proven necessary. This forces an active examination to be carried out of the impact and proportionality of the provisions. The automatic sunset clause prevents the regulation from expiring due to inactivity and strengthens legal certainty.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 6 | deleted |
| Amendment to Regulation (EU) 2024/573 | |
| Regulation (EU) 2024/573 is amended as follows: | |
| in Article 20(4), point (a) is replaced by the following: | |
| ‘(a) the following imports and exports, except in the case of temporary storage as defined in Article 5, point (17), of Regulation (EU) No 952/2013: | |
| (i) the import or export of fluorinated greenhouse gases; | |
| (ii) the placing on the market of products and equipment containing fluorinated greenhouse gases that requires reporting under Article 26; | |
| (iii) the export of products and equipment as referred to in Article 22(3) containing or whose functioning relies upon, fluorinated greenhouse gases with a GWP of 1000 or more as from the prohibition date stated in Annex IV;. |
| Text proposed by the Commission | Amendment |
|---|---|
| Regulation (EU) 2024/573 is amended as follows: | deleted |
| in Article 20(4), point (a) is replaced by the following: | |
| ‘(a) the following imports and exports, except in the case of temporary storage as defined in Article 5, point (17), of Regulation (EU) No 952/2013: | |
| (i) the import or export of fluorinated greenhouse gases; | |
| (ii) the placing on the market of products and equipment containing fluorinated greenhouse gases that requires reporting under Article 26; | |
| (iii) the export of products and equipment as referred to in Article 22(3) containing or whose functioning relies upon, fluorinated greenhouse gases with a GWP of 1000 or more as from the prohibition date stated in Annex IV;.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Article6a | |
| Report on preferential measures for micro, small and medium-sized enterprises and future extensions to small mid-cap enterprises | |
| 1. By [31 December 2026], the Commission shall submit to the European Parliament and to the Council a comprehensive report identifying and listing all provisions of Union law that grant derogations, simplified procedures, exemptions, reduced administrative or reporting obligations, financial or non-financial advantages, or any other preferential treatment specifically to micro, small and medium-sized enterprises. | |
| 2. The report shall, for each identified measure: | |
| (a) describe the objective and scope of the preferential treatment; | |
| (b) indicate the legal act and specific article concerned; | |
| (c) assess its relevance for innovation, growth and reduction of administrative burden; | |
| (d) evaluate, on a preliminary basis, the potential suitability of extending the measure, fully or in adapted form, to small mid-cap enterprises, taking into account the need to preserve specific support for micro, small and medium-sized enterprises and to avoid undue distortions of competition. | |
| 3. Where the preliminary assessment under paragraph 2, point (d), concludes that an extension to small mid-cap enterprises appears appropriate, the report shall identify the preferred legislative measure (including future Omnibus simplification packages) for proposing such extension. | |
| 4. The Commission shall make the report publicly available and it shall be accompanied, where appropriate, by legislative proposals to extend selected preferential measures for micro, small and medium-sized enterprises to small mid-cap enterprises. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article6a | |
| Review | |
| By 30 June 2026, the Commission shall evaluate this amending Regulation with a view to assessing and mapping out further measures necessary to decrease the administrative, regulatory and financial burden on small and medium-sized enterprises and small mid-cap enterprises. The evaluation shall, inter alia, assess: | |
| -the impact of the existing legislation on the functioning of small and medium-sized enterprises and small mid-cap enterprises and its proportionality and effectiveness to reach objectives of the legislation; | |
| - financial impact of the existing legislation on small and medium-sized enterprises and small mid-cap enterprises. | |
| The Commission shall present a report on the findings of that evaluation to the European Parliament and to the Council. Where appropriate, the report shall be accompanied by a legislative proposal. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article6a | |
| Monitoring and Evaluation | |
| The Commission shall by … [1 year from the entry into force of this amending Regulation], and every 2 years thereafter, submit a report assessing the implementation of this amending Regulation, including its impact on fundamental rights and the competitiveness of Union enterprises or organisations. The report shall include a detailed retrospective impact assessment regarding the costs and benefits of the amending Regulation. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article6b | |
| Report on the impact of measures extended to small mid-cap enterprises | |
| 1. By 31 December 2030, and every three years thereafter, the Commission shall submit to the European Parliament and to the Council a report evaluating the impact of the amendments introduced by this amending Regulation, in particular the effects of extending preferential measures for small and medium-sized enterprises to small mid-cap enterprises. | |
| 2. The report shall assess, at least, the following: | |
| (a) the actual reduction in administrative and compliance costs for small mid-cap enterprises; | |
| (b) the extent to which the extended measures have facilitated the growth and scaling up of former small and medium-sized enterprises into small mid-cap enterprises; | |
| (c) any effects on the competitive position or level of support received by micro, small and medium-sized enterprises that continue to fall under the definition of small and medium-sized enterprises; | |
| (d) the impact on innovation, digital transformation and investment in the sectors most concerned; | |
| (e) any unintended market distortions or effects on the internal market. | |
| 3. The Commission shall make the reports publicly available. Where the evaluation reveals that certain extensions have proven particularly effective or, conversely, have produced negative effects, the Commission shall, where appropriate, present legislative proposals to adjust, expand or repeal the measures concerned. |
Connections
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Sources & citation
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- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2025). “AMENDMENTS 28 - 136 - Draft report Amending Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (EU) 2023/1542 and (EU) 2024/573 as regards the extension of certain mitigating measures available for small and medium sized enterprises to small mid-cap enterprises and further simplification measures”. Text, 12 December 2025. docId CJ58-AM-781364. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/CJ58-AM-781364 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/CJ58-AM-781364 (CC BY 4.0).
BibTeX
@misc{epw-text-cj58-am-781364,
author = {{European Parliament}},
title = {{AMENDMENTS 28 - 136 - Draft report Amending Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (EU) 2023/1542 and (EU) 2024/573 as regards the extension of certain mitigating measures available for small and medium sized enterprises to small mid-cap enterprises and further simplification measures}},
year = {2025},
date = {2025-12-12},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/CJ58-AM-781364}},
url = {https://news.eu-parl.st-solutions.dev/texts/CJ58-AM-781364},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId CJ58-AM-781364. Data: EP Open Data API: document record (CC BY 4.0)}
}