report parliamentary committee draft, 7 November 2025
On the 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
Document CJ58-PR-775772 · (COM(2025)0501 – C100092/2025 – 2025/0130(COD))
Committee on Economic and Monetary Affairs Committee on the Environment, Climate and Food Safety Committee on Civil Liberties, Justice and Home Affairs · Rapporteur: Mariateresa Vivaldini, Niels Flemming Hansen, Lukas Mandl
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Draft european parliament legislative resolution 215 paragraphs
(COM(2025)0501 – C100092/2025 – 2025/0130(COD))
(Ordinary legislative procedure: first reading)
The European Parliament,
–having regard to the Commission proposal to Parliament and the Council (COM(2025)0501),
–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 (C100092/2025),
–having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
–having regard to the opinion of the European Economic and Social Committee of 18 September 2025,
–having regard to Rule 60 of its Rules of Procedure,
–having regard to the joint deliberations of the Committee on Economic and Monetary Affairs, the Committee on the Environment, Climate and Food Safety and the Committee on Civil Liberties, Justice and Home Affairs under Rule 59 of the Rules of Procedure,
–having regard to the opinions of the Committee on International Trade and the Committee on the Internal Market and Consumer Protection,
–having regard to the report of the Committee on Economic and Monetary Affairs, the Committee on the Environment, Climate and Food Safety and the Committee on Civil Liberties, Justice and Home Affairs (A[100000/2025]),
1.Adopts its position at first reading hereinafter set out;
Read the rest (203 paragraphs)
2.Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;
3.Instructs its President to forward its position to the Council, the Commission and the national parliaments.
Amendment 1
Proposal for a regulation
Recital 7
| 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. 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 supporting SMEs as the backbone of the European economy. Accordingly, the creation of the SMC category should not affect or reduce the scope of specific provisions tailored to SMEs, nor the budgetary allocations made available to them under the Multiannual Financial Framework. Given that the majority of SMEs are micro-enterprises, whose characteristics and resources differ substantially from those of SMCs, Union law should continue to apply the ‘think small first’ principle in order to ensure proportionality and adequate protection for the smallest companies. |
Or. en
Justification
Clarifies that introducing the SMC category strengthens access to finance for growing firms while safeguarding SME-specific support and proportionality. Ensures no diversion of SME-dedicated funds and upholds the “think small first” principle.
Amendment 2
Proposal for a regulation
Recital 7 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (7a) The establishment of a distinct category of SMCs aims to improve their access to financing and capital markets, in particular for enterprises that have grown beyond SME status but still face comparable barriers. This new category should not affect the scope or funding of Union measures dedicated to SMEs, nor alter the application of the “think small first” principle, which remains essential to ensuring that micro and small enterprises continue to benefit from proportionate obligations and targeted support within the Union’s legal framework. |
Or. en
Justification
Adds a complementary recital highlighting that the SMC category serves competitiveness and capital-market access without undermining SME policy priorities or budgetary safeguards.
Amendment 3
Proposal for a regulation
Recital 8
| 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. To take account of the specific situation of micro, small and medium-sized enterprises and SMCs, the obligation to maintain records of processing activities should be simplified so that that derogation applies to all enterprises and organisations with fewer than 1500 employees, provided that their processing activities are not likely to result in a high risk to the data subjects’ rights and freedoms. To avoid potential confusion, it should also be clarified that public authorities and bodies, regarded as organisations within the meaning of this amending Regulation, are not addressed by the objectives of the proposal and therefore are not meant to benefit from that derogation. |
Or. en
Justification
Clarifies the scope of application of this proposal to take into account the specificities of micro, small and medium-sized, as well as small midcap enterprises when keeping records of processing activities.
Amendment 4
Proposal for a regulation
Recital 9
| 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 enterprises and organisations with fewer than 1500 employees to allow also them to profit from that derogation and by providing that the derogation applies unless it is assessed that a given processing activity 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. It should also be clarified that enterprises and organisations with fewer than 1500 employees carrying out high-risk processing of personal data are only required to maintain a record of those specific processing activities which are likely to result in a ‘high-risk’ to data subjects’ rights and freedoms within the meaning of Article 35 of Regulation (EU) 2016/679. |
Or. en
Justification
Clarifies the fact that enterprises and organisations which carry out multiple data processing activities, some of which may be low-risk or are otherwise assessed not to pose a high risk, are only required to maintain records of those specific processing activities that are actually high-risk. This is to bring clarity as to the application of the record-keeping obligation and to avoid unnecessary burden.
Amendment 5
Proposal for a regulation
Recital 10
| 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, for example the processing of special categories of personal data by such enterprises or organisations 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, would not always likely result in a high risk to data subjects, and should not as such require that records of processing activities be maintained, unless it is assessed that the processing is likely to result in a high risk. |
Or. en
Justification
Clarifies that processing of certain special categories of personal data may not always result in a high-risk to the data subject, as currently assumed in the obligation to keep records under Article 30 of the GDPR. While in practice most cases of processing of special categories of personal data will presumably result in a high risk, it needs to be based on an individual assessment
Amendment 6
Proposal for a regulation
Recital 10 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) To reduce the risks arising from data processing, controllers and processors should be encouraged to implement appropriate technical and organisational measures such as pseudonymisation, access controls, encryption, and other relevant privacy-enhancing technologies. In particular, the effective use of pseudonymisation can substantially mitigate risks to the rights and freedoms of data subjects by separating identifying information from other data elements, thereby limiting or 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 P1a, European Data Protection Supervisor v Single Resolution Board, pseudonymised data would not be considered as personal data for recipients who lack the means to re-identify individuals. | |
| 1a Judgment of the Court of Justice of 4 September 2025, European Data Protection Supervisor v Single Resolution Board, C-413/23 P, ECLI:EU:C:2025:645. |
Or. en
Justification
While the distinction between high-risk and low-risk processing of personal data is an area that would benefit from further clarification, enterprises and organisations are in any case already now encouraged to implement measures that mitigate risk. Privacy-enhancing technologies, and specifically pseudonymisation, is a tangible example of such a risk-mitigation measure. The recent judgment by the Court of Justice of the European Union in Case C-413/23 P brought forward an important clarification as to how pseudonymised data may or may not be regarded as personal data, determining the applicability of the GDPR
Amendment 7
Proposal for a regulation
Recital 11 – indent 1
| 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. However, for SMCs, an overarching horizontal definition should be laid down in this amending Regulation, acknowledging point 2 of Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final, without being limited by its scope. |
Or. en
Justification
Acknowledges the Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C (2025) 3500 final, but clarifying that its scope of application is too narrow.
Amendment 8
Proposal for a regulation
Recital 11 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (11a) In order to fulfil the Commission’s new plan for Europe’s sustainable prosperity and competitiveness, outlined in its political guidelines for the 2024-2029 term, enterprises and organisations of all sizes would benefit from further simplification, clarification and harmonised application of Regulation (EU) 2016/679 across the Union. Further policy action could be taken with the aim of ensuring greater distinction between high and low-risk processing, including the consideration whether processing of personal data constitutes a core business activity of the enterprise, clarification of lawfulness of processing as regards, in particular, the legitimate interests pursued by the controller or by a third party as referred to in Article 6(1), point (f) of Regulation (EU) 2016/679, or further delineation of pseudonymised and anonymised data determining applicability of Regulation (EU) 2016/679. |
Or. en
Justification
Within the context of the objective of this proposal to achieve competitiveness and innovation for enterprises and organisations, it is relevant to mention additional areas where further clarification, simplification and harmonisation would achieve that goal.
Amendment 9
Proposal for a regulation
Recital 12
| Text proposed by the Commission | Amendment |
|---|---|
| (12) The European Data Protection Supervisor and the European Data Protection Board were consulted, in accordance with Article 42(1) and (2) of Regulation (EC) 2018/1725, and they delivered a joint opinion on [XXX, date]. | (12) The European Data Protection Supervisor and the European Data Protection Board were consulted, in accordance with Article 42(1) and (2) of Regulation (EC) 2018/1725, and they delivered a joint opinion on 8 July 2025. |
Or. en
Amendment 10
Proposal for a regulation
Recital 16
| Text proposed by the Commission | Amendment |
|---|---|
| (16) SMEs and SMCs are particularly dependent on services provided by credit institutions and insurers, often relying on only one or few principal providers of these services. Resolution regimes ensure uninterrupted access to deposits and critical functions where a financial institution fails. Where resolution authorities use their power to convert liabilities of a financial institution to resolve it in a timely manner and ensure the continuity of critical functions, prior preparation and publication of a prospectus is not feasible due to the short timeframe imposed in the context of a resolution. It is therefore important to introduce an exemption from the obligation to publish a prospectus that applies to an offer to the public of both securities resulting from a conversion due to the exercise of powers under Directive 2014/59/EU of the European Parliament and of the Council15 and Directive (EU) 2025/1 of the European Parliament and of the Council16 and securities resulting from a conversion due to the exercise of a comparable power in third-country resolution proceedings that implements the Financial Stability Board’s ‘Key Attributes of Effective Resolution Regimes for Financial Institutions’, published in October 2011. Equally, the existing exemption for the admission to trading on a regulated market of securities resulting from a conversion due to the exercise of powers under Directive 2014/59/EU and Directive (EU) 2025/1 from the obligation to publish a prospectus should be extended to securities resulting from a conversion due to the exercise of a comparable power in third-country resolution proceedings that implements those internationally agreed standards. | (16) SMEs and SMCs are particularly dependent on services provided by credit institutions and insurers, often relying on only one or few principal providers of these services. Resolution regimes ensure uninterrupted access to deposits and critical functions where a financial institution fails. Where resolution authorities use their power to convert liabilities of a financial institution to resolve it in a timely manner and ensure the continuity of critical functions, prior preparation and publication of a prospectus is not feasible due to the short timeframe imposed in the context of a resolution. It is therefore important to introduce an exemption from the obligation to publish a prospectus that applies to an offer to the public of both securities resulting from a conversion due to the exercise of powers under Directive 2014/59/EU of the European Parliament and of the Council15 and Directive (EU) 2025/1 of the European Parliament and of the Council16 and securities resulting from a conversion due to the exercise of a comparable power in third-country resolution proceedings that implements the Financial Stability Board’s ‘Key Attributes of Effective Resolution Regimes for Financial Institutions’, published in October 2011. Equally, the existing exemption for the admission to trading on a regulated market of securities resulting from a conversion due to the exercise of powers under Directive 2014/59/EU and Directive (EU) 2025/1 from the obligation to publish a prospectus should be extended to securities resulting from a conversion due to the exercise of a comparable power in third-country resolution proceedings that implements those internationally agreed standards, clarifying that such an exemption, as well as the new exemption related to the public offer, could only be applied in the context of a resolution action or in the context of the exercise of the write down or conversion powers. |
| 15 Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190). | 15 Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190). |
| 16 Directive (EU) 2025/1 of the European Parliament and of the Council of 27 November 2024 establishing a framework for the recovery and resolution of insurance and reinsurance undertakings and amending Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 and Regulations (EU) No 1094/2010, (EU) No 648/2012, (EU) No 806/2014 and (EU) 2017/1129 (OJ L, 2025/1, 8.1.2025, ELI: http://data.europa.eu/eli/dir/2025/1/oj). | 16 Directive (EU) 2025/1 of the European Parliament and of the Council of 27 November 2024 establishing a framework for the recovery and resolution of insurance and reinsurance undertakings and amending Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 and Regulations (EU) No 1094/2010, (EU) No 648/2012, (EU) No 806/2014 and (EU) 2017/1129 (OJ L, 2025/1, 8.1.2025, ELI: http://data.europa.eu/eli/dir/2025/1/oj). |
Or. en
Justification
The addition aims to clarify the scope of the exemption, specifying that it applies exclusively to offers of financial instruments made in the context of a resolution action or in the exercise of write-down or conversion powers by the resolution authority. The amendment prevents an overly broad interpretation of the provision that could lead to applying the exemption also to offers or exchanges of financial instruments not linked to an actual resolution measure. In this way, the rule ensures that the prospectus exemption operates only where the conversion or exchange takes place as part of resolution actions necessary to preserve financial stability, and not in ordinary market contexts.
Amendment 11
Proposal for a regulation
Recital 18
| 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. 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 450 million. |
Or. en
Justification
The adjustment of the SMC turnover ceiling to EUR 450 million seeks to mirror the proportional relationship between the SME and mid-cap definitions, while reflecting evidence from the Commission study showing wide heterogeneity across national and sectoral benchmarks. In France, entreprises de taille intermédiaire (ETI) extend up to EUR 1.5 billion in turnover; Germany’s Mittelstand definition used by KfW applies thresholds of EUR 500 million. Within that spectrum, 450 million EUR offers a balanced midpoint consistent with the scale of European mid-caps observed in manufacturing, energy, health, and technology sectors. The study underlines that mid-caps form a heterogeneous population, with differences in productivity, capital intensity and financing structure. A ceiling at 450 million EUR therefore functions as an operational guideline ensuring consistency across Union programmes without precluding future adjustments should empirical evidence or market conditions evolve.
Amendment 12
Proposal for a regulation
Recital 19
| 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 available their due diligence policy only every five years instead of annually. In addition, in order to ensure coherence with other Union due diligence frameworks, such as Directive (EU) 2024/1760 of the European Parliament and of the Council1a, economic operators should be allowed to fulfil their reporting obligations through a single consolidated report. This would avoid the duplication of reporting requirements and further reduce unnecessary administrative burden. This burden reduction should apply to all economic operators, including SMCs. |
| 1a Directive (EU) 2024/1760 of the European Parliament and of the Council of 13 June 2024 on corporate sustainability due diligence and amending Directive (EU) 2019/1937 and Regulation (EU) 2023/2859 (OJ L, 2024/1760, 5.7.2024, ELI: http://data.europa.eu/eli/dir/2024/1760/oj ). |
Or. en
Justification
Introduces the option of a single consolidated due-diligence report across EU frameworks (e.g. CSDDD and Batteries Regulation) to streamline reporting, reduce duplication, and cut red tape for businesses.
Amendment 13
Proposal for a regulation
Recital 20 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (20a) While the registration requirement laid down in Article 20(4), point (a), of Regulation (EU) 2024/573 aims to ensure traceability and facilitate enforcement, the risk of illegal trade in fluorinated greenhouse gases remains a significant challenge to the effective implementation of that Regulation. To safeguard the integrity of the Union’s phase-down mechanism, the Commission should, in close cooperation with national customs authorities and industry representatives, assess, within two years of the entry into force of this amending Regulation, whether the amendments introduced have led to a rise in illegal imports or other circumvention practices. Based on that assessment, the Commission should, where appropriate, propose measures to reinforce enforcement, improve cooperation between customs and the F-gas portal, and ensure that simplification does not compromise environmental or market-surveillance objectives. |
Or. en
Amendment 14
Proposal for a regulation
Recital 21 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (21a) The Commission should, at least every 5 years after the entry into force of this amending Regulation, review the thresholds defining SMCs in consultation with the European Parliament, along with the review of the thresholds for SMEs, in light of economic and market developments. |
Or. en
Amendment 15
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EU) 2016/679
Article 4 – point 28
| Text proposed by the Commission | Amendment |
|---|---|
| (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**.; | (28) ‘small mid-cap enterprises’ means enterprises that fulfil at least one of the following criteria: |
| (i) employing fewer than 1500 persons; | |
| (ii) have an annual turnover not exceeding EUR 450 million; | |
| (iii) an annual balance sheet total not exceeding EUR 387 million. | |
| ** Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final.’ ; |
Or. en
Justification
As mentioned above in the Amendment on Recital 11, indent 1, the definition provided in point 2 of the Annex to the Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final is not adequately representing the needs of the enterprises in the European Union and fostering competitiveness. The proposed adjustment reinforces legal clarity and coherence by establishing a transparent and practical set of criteria for identifying small mid-cap enterprises. Extending the simplified record-keeping threshold to enterprises with up to 1,500 employees aligns with existing practices across the EU and its Member States for defining mid-cap companies, as outlined in the Commission’s 2025 study Mapping, Measuring and Portraying the EU Mid-Cap Landscape. Similar limits are already applied in EU policies such as the Risk-Finance Guidelines and the InvestEU programme. The increase of the SMC turnover cap to EUR 450 million preserves the proportional balance between SME and mid-cap definitions and reflects evidence from the Commission study highlighting significant variation across countries and sectors. The annual balance sheet total is a proportional adjustment to the employee and turnover thresholds.
Amendment 16
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EU) 2016/679
Article 30 – paragraph 5
| 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 1500 persons unless and to the extent that a specific processing activity 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, in particular with regard to cases referred to in paragraph 3 of that Article. In such a case, the obligations referred to in paragraphs 1 and 2 of this Article shall only apply to that specific processing activity.’; |
Or. en
Justification
This provision follows the logic of the Commission’s proposal in simplifying and clarifying the derogation from the record-keeping obligation. It also further clarifies that the obligation to keep records only applies to the specific data processing activities that pose a high risk to the data subjects. This will be relevant for enterprises and organisations which carry out multiple data processing activities, some of which may be low-risk or are otherwise assessed not to pose a high risk.
Amendment 17
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point a
Regulation (EU) 2017/1129
Article 1– paragraph 4 – point dc
| Text proposed by the Commission | Amendment |
|---|---|
| (dc) 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;’; | (dc) 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, provided that such an offer is carried out within a resolution action or within the exercise of the write down or conversion powers; |
Or. en
Justification
The addition aims to clarify the scope of the exemption, specifying that it applies exclusively to offers of financial instruments made in the context of a resolution action or in the exercise of write-down or conversion powers by the resolution authority.The amendment prevents an overly broad interpretation of the provision that could lead to applying the exemption also to offers or exchanges of financial instruments not linked to an actual resolution measure. In this way, the rule ensures that the prospectus exemption operates only where the conversion or exchange takes place as part of resolution actions necessary to preserve financial stability, and not in ordinary market contexts.
Amendment 18
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
Regulation (EU) 2017/1129
Article 1 – paragraph 5 – point c
| 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 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, provided that the admission to trading on a regulated market of such securities is carried out within a resolution action or within the exercise of the write down or conversion powers; |
Or. en
Justification
The addition aims to clarify the scope of the exemption, specifying that it applies exclusively to offers of financial instruments made in the context of a resolution action or in the exercise of write-down or conversion powers by the resolution authority.The amendment prevents an overly broad interpretation of the provision that could lead to applying the exemption also to offers or exchanges of financial instruments not linked to an actual resolution measure. In this way, the rule ensures that the prospectus exemption operates only where the conversion or exchange takes place as part of resolution actions necessary to preserve financial stability, and not in ordinary market contexts.
Amendment 19
Proposal for a regulation
Article 4 – paragraph 1 – point 3 – point b
Regulation (EU) 2017/1129
Article 2 – point fa – indent i
| 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 1 500, a total balance sheet not exceeding EUR 387 000 000 and an annual net turnover not exceeding EUR 450 000 000; |
Or. en
Amendment 20
Proposal for a regulation
Article 5 – paragraph 1 – point 1
Regulation (EU) 2023/1542
Article 47 – paragraph 1
| 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 .; |
Or. en
Justification
The adjustment of the SMC turnover ceiling to EUR 450 million seeks to mirror the proportional relationship between the SME and mid-cap definitions, while reflecting evidence from the Commission study showing wide heterogeneity across national and sectoral benchmarks. In France, entreprises de taille intermédiaire (ETI) extend up to EUR 1.5 billion in turnover; Germany’s Mittelstand definition used by KfW applies thresholds of EUR 500 million. Within that spectrum, 450 million EUR offers a balanced midpoint consistent with the scale of European mid-caps observed in manufacturing, energy, health, and technology sectors. The study underlines that mid-caps form a heterogeneous population, with differences in productivity, capital intensity and financing structure. A ceiling at 450 million EUR therefore functions as an operational guideline ensuring consistency across Union programmes without precluding future adjustments should empirical evidence or market conditions evolve.
Amendment 21
Proposal for a regulation
Article 5 – paragraph 1 – point 2
Regulation (EU) 2023/1542
Article 52 – paragraph 3
| 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 5 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. |
Or. en
Justification
The amendment introduces a five-year review cycle for due diligence reporting, combined with an obligation to update the report whenever a significant change occurs. This approach provides a balanced framework between regulatory certainty and flexibility, ensuring that reports remain accurate and relevant without imposing excessive administrative burden. It also offers clearer timing and a uniform standard across Member States, reducing the risk of divergent interpretations while maintaining transparency on companies’ due diligence policies.
Amendment 22
Proposal for a regulation
Article 5 – paragraph 1 – point 2 a (new)
Regulation (EU) 2023/1542
Article 52 – paragraph 3 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) the following paragraph is inserted: | |
| ‘3a. To ensure coherence with other Union due diligence frameworks, such as Corporate Sustainability Due Diligence Directive, economic operators may comply with their reporting obligations through a single consolidated report covering the requirements of all relevant Union instruments. The Commission shall, within 24 months from the date of entry into force of this Regulation, assess the feasibility and, where appropriate, present a legislative proposal to enable the use of a single consolidated report across Union due diligence frameworks, with a view to avoiding duplicate reporting and reducing administrative burden.’; |
Or. en
Amendment 23
Proposal for a regulation
Article 6 – paragraph 1
Regulation (EU) 2024/573
Article 20 – paragraph 4 – point a – indent ii
| Text proposed by the Commission | Amendment |
|---|---|
| (ii) the placing on the market of products and equipment containing fluorinated greenhouse gases that requires reporting under Article 26; | (ii) the placing on the market of 10 tonnes of CO2 equivalent or more of hydrofluorocarbons or 100 tonnes of CO2 equivalent or more of other fluorinated greenhouse gases that requires during the calendar year, contained in products and equipment; |
Or. en
Justification
Clarifies reporting obligations for fluorinated gases in line with Council language, ensuring better legal precision and alignment with emission-equivalent thresholds.
Amendment 24
Proposal for a regulation
Article 6 – paragraph 1
Regulation (EU) 2024/573
Article 20 – paragraph 4 – point a – indent iii
| Text proposed by the Commission | Amendment |
|---|---|
| (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;. | (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 where the export is allowed pursuant to Article 22(3), second subparagraph, or Article 22(4); |
Or. en
Justification
Clarifies export provisions for fluorinated gases to ensure consistency with Articles 22(3) and 22(4), preventing legal ambiguity on allowed export cases.
Amendment 25
Proposal for a regulation
Article 6 – paragraph 1 – point 1 a (new)
Regulation (EU) 2024/573
Article 22 – paragraph 1 – subparagraph 1
| Present text | Amendment |
|---|---|
| (1a) in Article 22(1), the first subparagraph isreplaced by the following: | |
| 1. The import and export of fluorinated greenhouse gases, and products and equipment containing those gases or whose functioning relies upon those gases shall be subject to the presentation of a valid licence to customs authorities issued by the Commission pursuant to Article 20(4) and (5), except in the case of temporary storage. | ‘1. The import and export of fluorinated greenhouse gases, and products and equipment containing those gases or whose functioning relies upon those gases shall be subject to the presentation of a valid licence to customs authorities issued by the Commission pursuant to Article 20(4) and (5), where registration is required pursuant to Article 20(4), point (a).’ |
Or. en
Justification
Introduces clearer customs-licensing requirements for F-gases and related products to enhance enforcement and traceability, addressing stakeholder concerns on regulatory implementation.
Amendment 26
Proposal for a regulation
Article 6 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 6 a | |
| Review | |
| The Commission shall: | |
| (a) by … [5 years from the entry into force of this amending Regulation] and at least every 5 years thereafter, review the thresholds defining small mid-cap companies, in consultation with the European Parliament, in light of economic and market developments and alongside those applicable to SMEs and shall, where appropriate, adopt delegated acts to adjust those thresholds accordingly; | |
| (b) by … [3 years from the entry into force of this amending Regulation], and every 5 years thereafter, present to the European Parliament and to the Council a report assessing the implementation of this amending Regulation, including its impact on administrative burden reduction and competitiveness, which may be presented as part of the Commission’s broader reporting on SMEs and on the reduction of administrative burdens in the Union. |
Or. en
Justification
This amendment ensures regular review of both the SMC definition and the Regulation’s overall impact, while avoiding duplication of reporting obligations. Allowing the evaluation to be integrated into the Commission’s existing SME and burden-reduction reporting strengthens coherence and reduces administrative effort.
Amendment 27
Proposal for a regulation
Article 6 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 6b | |
| Future Legislation | |
| The Commission shall ensure that future horizontal Omnibus legislative proposals and other Union acts applying simplification measures for enterprises use the same definition and proportionality principles for small mid-cap companies as established in this amending Regulation. Any deviation from those definitions shall be duly justified and limited to cases where sector-specific circumstances demonstrably require divergence. |
Or. en
Justification
This provision strengthens legal coherence and predictability across future simplification packages by requiring the Commission to maintain a uniform definition of small mid-caps. Any departure must be explicitly justified to prevent fragmentation and ensure equal treatment of enterprises across Union legislation.
Explanatory statement 5 paragraphs
This report introduces a harmonised and operational definition of small mid-cap (SMC) enterprises across selected Union acts in order to enhance legal clarity, strengthen regulatory coherence and ensure proportionate simplification for companies that have outgrown the SME category but continue to face structural barriers similar to those affecting smaller enterprises. The definition proposed by the Parliament sets clear, measurable thresholds (fewer than 1 500 employees, annual turnover up to EUR 450 million or a balance sheet total up to EUR 387 million), which reflect the scale and economic profile of EU mid-caps while maintaining proportional alignment with existing SME parameters. The amendments ensure that extending targeted simplification to SMCs does not affect SME-specific support, dedicated funding or the application of the “think small first” principle.
The report extends selected regulatory reliefs already available to SMEs to eligible SMCs where justified, while preserving safeguards for micro and small enterprises and maintaining sector-specific risk controls. In data-protection rules (Regulation (EU) 2016/679), the text clarifies that the exemption from record-keeping obligations should apply to enterprises and organisations with fewer than 1 500 employees only for non-high-risk processing, and that documentation requirements should apply exclusively to high-risk processing activities, thereby reducing unnecessary administrative burden. It also recognises the role of robust technical safeguards, including pseudonymisation, for risk mitigation.
In Prospectus Regulation (EU) 2017/1129), the amendments are intended to enhance legal clarity specifying that prospectus exemptions relating to securities issued in resolution apply within the context of resolution actions, supporting a coherent and predictable regulatory framework. Thresholds linked to mid-cap status are updated consistently with the new SMC definition. In the Batteries Regulation (EU) 2023/1542), SME exemptions for battery due diligence obligations are extended to SMCs, reporting cycles are streamlined to a five-year review period (or upon significant change), and companies are allowed to fulfil obligations through a single consolidated report across EU due-diligence frameworks to reduce duplication. Under the F-gas Regulation (EU) 2024/573), reporting thresholds based on CO₂-equivalence are clarified for legal precision, customs licensing provisions are strengthened, and the Commission is tasked with reviewing within two years whether simplification affects enforcement or contributes to illegal trade or circumvention risks.
To ensure durability and legal coherence, the report introduces a five-year review cycle for the SMC definition, aligned with SME threshold reviews, and requires the Commission to apply the same SMC definition consistently in future Omnibus or simplification initiatives, with any deviation subject to justification based on objective sectoral needs. Evaluation of the Regulation’s impact on administrative burden and competitiveness is aligned with existing SME and better-regulation reporting, ensuring monitoring without creating parallel reporting obligations.
Taken together, the amendments establish a legally sound, proportionate and future-proof framework enabling small mid-caps to benefit from targeted simplification while protecting SME policy objectives, ensuring regulatory predictability, and preserving effective enforcement across Union law.
Annex: declaration of input 4 paragraphs
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteurs declare that they included in their report input on matters pertaining to the subject of the file that they received, in the preparation of the report, prior to the adoption thereof in committee, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:
| 1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register |
| ABI (Associazione Bancaria Italiana) |
| Association of German Banks |
| Confartigianato |
| Bitkom |
| Blockchain for Europe |
| Business Europe |
| Confederation of Danish Industry |
| Daikin Europe N.V |
| Danish Chamber of Commerce |
| Digital Europe |
| EBF (European Banking Federation) |
| EDRI |
| Eurochambres |
| EuroCommerce |
| Euronext |
| European Portable Battery Association (EPBA) |
| FEDMA |
| French Dairy Interbranch Organisation |
| GBIC (German Banking Industry Committee) |
| Orgalim |
| SME United |
| SMVdanmark |
| VDMA |
| Wirtschaftskammer Österreich |
| 2. Representatives of public authorities of third countries, including their diplomatic missions and embassies |
The list above is drawn up under the exclusive responsibility of the rapporteurs.
Where natural persons are identified in the list by their name, by their function or by both, the rapporteurs declare that they have submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.