REPORT 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)[...]

Text proposed by the Commission

Amendment

(2) The Commission's better regulation agenda4also supports the competitiveness of Union enterprises by aiming to ensurethat Union laws deliver on theirobjectives 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 agenda4also supports the competitiveness of Union enterprises by ensuringthat Union legislation achieves itsobjectives without imposing unnecessary costs, while making a concrete and positive contribution to consumers' lives and the internal market, thereby helping the Union address current and future challenges. In 2023, the Commission identified the need to rationalise and simplify reporting requirements for bothenterprises and publicadministrations5and committed to reduce administrative burdens by 25% and 35% for SMEs.

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4Better 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

4Better 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

5Long-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

5Long-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

(3) On 12 September 2023, the Commission published the SME Relief Package6, announcing its goal to help small and medium sized enterprises ('SMEs') compete and grow, by being attentive to the needs of enterprises that outgrow the thresholds of the SME definition7, and those in the broader range of small mid-cap enterprises. Action 18 of this relief package announced that the Commission would 'develop a harmonised definition for small mid-cap enterprises, build a dataset based on such definition and assess possible measures to support these enterprises in their growth (including potential application in adapted form of certain measures favouring SMEs)'.

(3) On 12 September 2023, the Commission published the SME Relief Package6, announcing its goal to help micro,small and medium sized enterprises ('SMEs') compete and grow, by being attentive to the needs of enterprises that outgrow the thresholds of the SME definition7, and those in the broader range of small mid-cap enterprises. Action 18 of this relief package announced that the Commission would 'develop a harmonised definition for small mid-cap enterprises, build a dataset based on such definition and assess possible measures to support these enterprises in their growth (including potential application in adapted form of certain measures favouring SMEs)'. It is necessary that such measures do not confer disproportionate advantages on small mid-cap enterprises over SMEs, particularly over micro and small enterprises. The Commission, Member States and competent authorities should ensure that any support for small mid-cap enterprises is designed in a manner that upholds the principles of fair competition, non-discrimination, high levels of consumer protection as well as the integrity of the internal market.

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6SME Relief Package (europa.eu). See also annex 3A to this report SME relief package policy tracker.

6SME Relief Package (europa.eu). See also annex 3A to this report SME relief package policy tracker.

7SMEs are defined as enterprises with under 250 employees, combined with an annual turnover up to 50 million euro or a balance sheet total up to 43 million - Recommendation 2003/361/EC - https://single-market-economy.ec.europa.eu/smes/sme-definition_en

7SMEs are defined as enterprises with under 250 employees, combined with an annual turnover up to 50 million euro or a balance sheet total up to 43 million - Recommendation 2003/361/EC - https://single-market-economy.ec.europa.eu/smes/sme-definition_en

Text proposed by the Commission

Amendment

(4) Enterprises outgrowingthe 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) 99% of all Union companies are SMEs, the vast majority of which are micro and small enterprises. Those that outgrowthe SME definition - the 'small mid-cap enterprises' ('SMCs') - alsoplay a vital role in the Union's economy. 8They 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. Both categories of businesses, while important and needing similar support in some respects, have different needs and requirements linked to their size and growth. Support for those categories should therefore be tailored accordingly, with particular attention paid to the specific and continuous challenges faced by SMEs.

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8Study 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

8Study 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

9https://www.esri.ie/system/files/publications/BKMNEXT429.pdf

9https://www.esri.ie/system/files/publications/BKMNEXT429.pdf

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 Union and tomake 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 in a balanced and proportionate manner, while ensuring that the Union's overarching rules on investor protection are maintained. Reducing administrative and reporting obligations is essential in order to strengthen the competitiveness of Union enterprises, in particular where such reductions have the greatest positive impact on innovation and digital transformation and would not lower the level of ambition of the relevant existing acts. Measures providing non-financial support, including measures that reduce administrative burden such as those concerning streamlined compliance and technical assistance as well as those that strengthen access to talent and skills, should be prioritised for SMEs and SMCs, in particular where they contribute to key innovation policy objectives.

Text proposed by the Commission

Amendment

(5a) The current challenges faced by small companies in trying to scale their businesses within the Union are significant. Those challenges risk undermining the efficacy and success of the internal market and should be addressed as a priority if the Union is to truly be a place that supports enterprise, entrepreneurship, and a competitive market economy. The Union should address the challenges currently faced by small companies in trying to scale up and should support competitiveness and compliance with Union rules through a predictable regulatory framework and compliance support.

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 definition of SMCs should serve to facilitate better access to capital markets for companies that have grown beyond SME status and should not dilute the Union's commitment to supporting SMEs as the backbone of the Union economy. Accordingly, the definition of SMCs should be clear and should not adversely affect or reduce the scope of specific measures tailored to SMEs, 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, 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.

Text proposed by the Commission

Amendment

(7a) In the context of future revisions of Union legislation, and in order to ensure a coherent and evidence-based approach to SMEs and SMCs, it is necessary to carefully assess whether, and under which conditions, additional measures could be extended to SMCs, including measures to reduce disproportionate administrative and financial obligations, while properly assessing their potential impact.

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 itapplies to all enterprises and organisations with fewer than 750employees, 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 thefree 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 activitiesshould be simplified so that the derogationapplies to all micro, small, and medium-sized enterprises and SMCsand organisations not exceeding 1000employees, provided that their processing activities are not likely to result in a high risk to the data subjects' rights and freedoms. Furthermore, it should be clarified that public authorities and bodies, regarded as organisations for the purposes of Regulation (EU) 2016/679, are not concerned by the objectives of this amending Regulation and therefore should not benefit from the derogation.

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 750employees to allow also them to profit from that derogation and by providing that the derogation applies unless theprocessing 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 micro, small, and medium-sized enterprises, SMCsand organisations not exceeding 1000employees to allow also them to profit from that derogation and by providing that the derogation applies unless it is assessed that a givenprocessing activityis 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 up-to-daterecords of its processing activities. Furthermore, it should be clarified that micro, small, and medium-sized enterprises, SMCs and organisations not exceeding 1000 employees carrying out high-risk processing of personal data are only required to maintain a record of those specific processing activities that 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.

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 by micro, small, and medium-sized enterprises, SMCs or organisations not exceeding 1000 employeeswhich 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 be likely to result in a high risk to data subjects, andshould not as such require that records of processing activitiesbe maintained, unless it is assessed that the processing is likely to result in a high risk.

Text proposed by the Commission

Amendment

(10a) At the same time, the obligation to keep records of processing activities should always apply to activities for which the controller or processor is required to designate a data protection officer pursuant to Article 37(1), points (b) and (c), of Regulation (EU) 2016/679. Those core activities consist of processing operations which, by virtue of their nature, their scope and/or their purpose, require regular and systematic monitoring of data subjects on a large scale, or where the core activities of the controller or the processor consist of processing on a large scale of special categories of data pursuant to Article 9 and personal data relating to criminal convictions and offences referred to in Article 10 of Regulation (EU) 2016/679. Those cases bear particular importance where personal data processing presents structural or recurring risks and should therefore require that records of related processing activities are always maintained. Nevertheless, in the private sector, the core activities of a controller or processor relate to their primary activities and do not relate to the processing of personal data as ancillary activities. For example, where the processing of special categories of personal data pursuant to Article 9(2), point (b), of Regulation (EU) 2016/679 would constitute an ancillary activity, no records for that particular processing activity would be required to be maintained.

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:

(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:

- 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 colegislatoras expressed in recital (13) of the preamble to Regulation (EU) 2016/679. For SMCs, referenceshould 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-legislatoras expressed in recital (13) of the preamble to Regulation (EU) 2016/679. However,for SMCs, a horizontal definitionshould be laid down in this amending Regulation.

- 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 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

- 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

(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.

Text proposed by the Commission

Amendment

(13) Regulations (EU) 2016/1036 and (EU) 2016/1037 are part of the Union's trade defence system. They allow the Union to investigate and address dumping and subsidisation by third countries and restore a level playing field in the Union market. If an investigation confirms the existence of such practices and resulting injury to the Union industry, the Commission imposes an anti-dumping or countervailing duty, provided such imposition is not against the Union interest. Anti-dumping and antisubsidy investigations require active involvement from enterprises. Investigations are normally initiated on the basis of a formal complaint from the affected Union industry that must contain evidence of the unfair practice and of the injury it has caused. Investigations require active involvement of, and data from, producers, importers and users of the product in the Union. Mainly because of their fragmentation and lack of resources, it is often very difficult for SMEs to understand trade defence and cooperate in trade defence proceedings. This is why Regulations (EU) 2016/1036 and (EU) 2016/1037 include provisions to overcome the barriers that stop smaller enterprises from accessing and using trade defence, namely through a dedicated helpdesk, and by, whenever possible, aligning investigation periods with the financial year. It is considered appropriate to ensure that SMCs also benefit from those provisions.

(13) Regulations (EU) 2016/1036 and (EU) 2016/1037 are part of the Union's trade defence system. Effective implementation of trade defence measures is vital for maintaining the competitiveness of key Union industrial ecosystems and securing quality jobs. Those Regulations allow the Union to investigate and address dumping and subsidisation by third countries and restore a level playing field in the Union market. If an investigation confirms the existence of such practices and resulting injury to the Union industry, the Commission imposes an anti-dumping or countervailing duty, provided such imposition is not against the Union interest. Anti-dumping and antisubsidy investigations require active involvement from enterprises. Investigations are normally initiated on the basis of a formal complaint from the affected Union industry that must contain evidence of the unfair practice and of the injury it has caused. Investigations require active involvement of, and data from, producers, importers and users of the product in the Union. Mainly because of their fragmentation and lack of resources, it is often very difficult for SMEs to understand trade defence and cooperate in trade defence proceedings. This is why Regulations (EU) 2016/1036 and (EU) 2016/1037 include provisions to overcome the barriers that stop smaller enterprises from accessing and using trade defence, namely through a dedicated helpdesk, and by, whenever possible, aligning investigation periods with the financial year. It is considered appropriate to ensure that SMCs also benefit from those provisions.It is essential to ensure that the quality of the services provided by the dedicated helpdesk remains unaffected and that the services are delivered in a timely manner. The Commission should dedicate sufficient resources to actively monitor and effectively investigate unfair competition practices and swiftly adopt measures to counter dumping and illegal subsidies. It is important to shorten the average length of investigation procedures to mitigate the impact of unfair practices on SMEs and SMCs. A regular evaluation of the capacities of the helpdesk, including the need for more financial, technical and human resources, should therefore form an integral part of the annual report to the European Parliament and to the Council.

Text proposed by the Commission

Amendment

(13a) To embody the European principle of debureaucratisation and administrative efficiency for SMEs and SMCs, the Commission should facilitate access to the trade defence instrument for sectors that are largely composed of SMEs or SMCs through a dedicated helpdesk, not only by awareness raising and by providing general information and explanations on procedures but also by exploring and promoting avenues for financial and legal technical assistance from Member States in complex trade defence cases and by further promoting a fully digitalised and paperless process for the submission of non-confidential documentation. The Commission should also develop and establish a streamlined, simplified complaint format and process, tailored specifically for SMEs and SMCs to expedite the lodging of complaints by those entities.

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 forSMCs and potentially make them more attractive to investors, it is appropriate to also enable SMCsto draw up an EU Growth issuance prospectus for theiroffers of securities to the public, including when such offers are accompanied withan 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. To further supportSMCs and other enterprises that should be included within the scope of this amending Regulation and improve their access to capital markets, it is appropriate to allow those SMCs and other enterprisesto draw up an EU Growth issuance prospectus for publicoffers of securities, including when such offers are accompanied byan admission to trading on a multilateral trading facility. Furthermore, to facilitate access to finance for those SMEs, SMCs and other enterprises, simplified measures should be applied in respect of documentation and procedures so as to ease access to finance for such undertakings, including adjusted reporting requirements and technical support. Any simplification of prospectus and disclosure requirements should enhance access to capital markets, while ensuring that investors receive key information needed for informed decision making. Simplification should therefore be implemented in a way that balances reduced administrative requirements for enterprises with the need to preserve financial market integrity, investor protection and confidence in Union capital markets.

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 Council15and Directive (EU) 2025/1 of the European Parliament and of the Council16and 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 Council15and Directive (EU) 2025/1 of the European Parliament and of the Council16and 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.

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15Directive 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).

15Directive 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).

16Directive (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).

16Directive (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).

Text proposed by the Commission

Amendment

(17) The provision in Regulation (EU) 2017/1129 concerning the EU Growth issuance prospectus will apply as of 5 March 2026, as the Commission is required to developdelegated acts to specify the reduced content and the standardised format and sequence of that prospectus. It is therefore appropriate to defer the application of the amendments to Regulation (EU) 2017/1129 concerning the EU Growth issuance prospectus set out in this Regulation to 5 March 2026.

(17) The provision in Regulation (EU) 2017/1129 concerning the EU Growth issuance prospectus will apply as of 5 March 2026, as the Commission is required to adoptdelegated acts to specify the reduced content and the standardised format and sequence of that prospectus. It is therefore appropriate to defer the application of the amendments to Regulation (EU) 2017/1129 concerning the EU Growth issuance prospectus set out in this Regulation to 5 March 2026.

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 150million.

(18) Regulation (EU) 2023/1542 establishes rules concerning batteries and waste batteries. Pursuant to Article 48(5), (6) and (7) of that Regulation, the Commission is to provide guidance by July 2026 to facilitate compliance, and Member States and the Commission are able to 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. That exemption is essential in order to ensure the operational viability of the industrial supply chain in the Union and to avoid prohibitive costs for manufacturers. 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 200million.

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 avilabletheir due diligence policy only onlyevery threeyears 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 availabletheir due diligence policy only every fiveyears instead of annually or more often if a significant change occurs. 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 the submission of a single consolidated report. Doing so would avoid the duplication of reporting requirements and further reduce unnecessary administrative burden. The Commission should be able to issue guidance on how such joint reporting could be carried out. In addition to the guidance, the Commission should, where appropriate, present a legislative proposal to enable the use of a single consolidated report across the Union. This burden reduction should apply to all economic operators, including SMCs.

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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 ).

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 requirementsapply 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 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 requirementsapply and to exports for which an export limitation exists, by strictly applying the principle of proportionality. 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.

__________________

__________________

17Regulation (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)

17Regulation (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

(20a) While the simplification of the registration requirement laid down in Article 20(4), point (a), of Regulation (EU) 2024/573 aims to ensure traceability and facilitate enforcement and is not expected to impact the ability to enforce that Regulation, the risk of illegal trade in fluorinated greenhouse gases remains a significant challenge. 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 and regularly monitor the trade in fluorinated greenhouse gases and the potential risks of illegal trade, and, if necessary, make use of the empowerment established in Article 24 of that Regulation, to strengthen enforcement and improve cooperation between customs and market surveillance authorities to ensure that simplification does not compromise environmental or market-surveillance objectives.

Text proposed by the Commission

Amendment

(21a) The Commission should, by five years from the date of entry into force of this Regulation and every five years thereafter, carry out a review and present a report to the European Parliament and the Council on the implementation of the provisions of the regulations amended by this Regulation, including the impact on the reduction of administrative burden and on competitiveness, on the development and growth of micro, small and medium-sized enterprises, on social and environmental aspects and on consumer protection within the Union. The report should in particular focus on any need to review the thresholds defining SMCs in light of economic and market developments.

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 which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, or an annual balance sheet total not exceeding EUR 43 million;

_____________________

* 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).

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 21.5.2025on the definition of small mid-cap enterprises - C(2025) 3500 final**;

(28) 'small mid-cap enterprises' means enterprises that are not micro, small, and medium-sized enterprises and that:

(i) employ fewer than 1000 employees;

(ii) and have an annual turnover not exceeding EUR 200 million or;

(iii) have an annual balance sheet total not exceeding EUR 172 million; those numbers and amounts being calculated in accordance with points (1) and (3)-(6)of the Annex to Commission Recommendation 2025/1099on the definition of small mid-cap enterprises.

_____________________

** Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final.' ;

Text proposed by the Commission

Amendment

5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisationemploying fewer than 750persons unless theprocessing it carries outis 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, to small mid-cap enterprises or to organisationsemploying fewer than 1000persons unless and to the extent that a specificprocessing activity they carry out:

(i) 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 the cases referred to in paragraph 3 of that Article; or

(ii) constitutes a core activity within the meaning of Article 37(1), point (b) or (c). In such a case, the obligations referred to in paragraphs 1 and 2 of this Article shall only apply to that specific processing activity.

Text proposed by the Commission

Amendment

(2a) in Article 30, the following paragraph is added:

'5a. Notwithstanding paragraph 5, the obligations referred to in paragraphs 1 and 2 shall apply to public authorities and bodies.';

Present text

Amendment

(1a) in Article 5(1a), the second subparagraph is replaced by the following:

The SMEHelpdesk shall make available standard forms for statistics to be submitted for standing purposes and questionnaires.

'The Helpdesk shall make available standard forms for statistics to be submitted for standing purposes and questionnaires.';

Present text

Amendment

(2a) in Article 23(1), the second subparagraph is replaced by the following:

That report shall include information about the application of provisional and definitive measures, the termination of investigations without measures, undertakings, reinvestigations, reviews, significant distortions and verification visits, and the activities of the various bodies responsible for monitoring the implementation of this Regulation and fulfilment of the obligations arising therefrom. The report shall also cover the use of trade defence instruments by third countries targeting the Union and appeals against the measures imposed. It shall include the activities of the Hearing Officer of the Commission's Directorate General for Trade and those of the SMEHelpdesk in relation to the application of this Regulation.

'That report shall include information about the application of provisional and definitive measures, the termination of investigations without measures, undertakings, reinvestigations, reviews, significant distortions and verification visits, and the activities of the various bodies responsible for monitoring the implementation of this Regulation and fulfilment of the obligations arising therefrom. The report shall also cover the use of trade defence instruments by third countries targeting the Union and appeals against the measures imposed. It shall include the activities of the Hearing Officer of the Commission's Directorate General for Trade and those of the Helpdesk in relation to the application of this Regulationincluding the evaluation of the capacities of the Helpdesk to provide efficient services to SMEs and SMCs.';

Present text

Amendment

(1a) in Article 10(1a), the second subparagraph is replaced by the following:

The SMEHelpdesk shall make available standard forms for statistics to be submitted for standing purposes and questionnaires.

'The Helpdesk shall make available standard forms for statistics to be submitted for standing purposes and questionnaires.';

Present text

Amendment

(2a) in Article 32a(1), the second subparagraph is replaced by the following:

That report shall include information about the application of provisional and definitive measures, the termination of investigations without measures, undertakings, reinvestigations, reviews, significant distortions and verification visits, and the activities of the various bodies responsible for monitoring the implementation of this Regulation and fulfilment of the obligations arising therefrom. The report shall also cover the use of trade defence instruments by third countries targeting the Union and appeals against the measures imposed. It shall include the activities of the Hearing Officer of the Commission's Directorate General for Trade and those of the SMEHelpdesk in relation to the application of this Regulation.

'That report shall include information about the application of provisional and definitive measures, the termination of investigations without measures, undertakings, reinvestigations, reviews, significant distortions and verification visits, and the activities of the various bodies responsible for monitoring the implementation of this Regulation and fulfilment of the obligations arising therefrom. The report shall also cover the use of trade defence instruments by third countries targeting the Union and appeals against the measures imposed. It shall include the activities of the Hearing Officer of the Commission's Directorate General for Trade and those of the Helpdesk in relation to the application of this Regulation,including the evaluation of the capacities of the Helpdesk to provide efficient services to SMEs and SMCs.';

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;

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;

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' means enterprises that are not micro, small, and medium-sized enterprises, that employ fewer than 1000 employees, and have an annual turnover not exceedingEUR 200 million or an annualbalance sheettotal not exceeding EUR 172 million; those numbers and amounts being calculated in accordance with points (1) and (3)-(6) of the Annex to Commission Recommendation 2025/1099 on the definition of small mid-cap enterprises;

(i) companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number ofemployees during the financial year of less than 750, a total balance sheet not exceedingEUR 129 000 000 andan annual netturnover 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

(3a) in Article 48(2), the following point is added:

'(ha) an analysis of the impact and appropriateness of the definition of SMCs and the extension of the use of the EU Growth issuance prospectus by that 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 burden for listed firms;';

Text proposed by the Commission

Amendment

1. This Chapter does not apply to economic operators that had a net turnover of less than EUR 150million 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 150million.;

1. This Chapter does not apply to economic operators that had a net turnover of less than EUR 200million 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 turnoveron a consolidated basis, equals orexceeds the limit of EUR 200million in the financial year preceding the last financial year.

Text proposed by the Commission

Amendment

3. The economic operator referred to in Article 48(1) shall, bythe latest one year after the date specified in Article 48(1)and at least every threeyears thereafter, review and make publicly available, including on the internet, a report on its battery due diligence policy..

3. The economic operator referred to in Article 48(1) shall, atthe latest one year after the date specified in thatArticle and at least every fiveyears thereafter, or more often if a significant change occurs,review, updateand make publicly available, including on the internet, a report on its battery due diligence policy.

Text proposed by the Commission

Amendment

(2a) the following paragraph is inserted:

'3a. To ensure coherence with other Union due diligence frameworks, such as the Corporate Sustainability Due Diligence Directive, economic operators may comply with their reporting obligations through the submission of a single consolidated report covering the requirements of all relevant Union instruments. The Commission shall, where appropriate, present a legislative proposal to enable the use of a single consolidated report across the Union due diligence frameworks, with a view to avoiding duplicate reporting and reducing administrative burden';

Text proposed by the Commission

Amendment

(ii) the placing on the market of products and equipment containingfluorinated greenhouse gases that requires reporting underArticle 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 otherfluorinated greenhouse gases that requires reporting pursuant toArticle 26 during the calendar year, contained in products and equipment;

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);

Present text

Amendment

(1a) in Article 22(1), the first subparagraph is replaced 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).';

Text proposed by the Commission

Amendment

Article 6a

Review

The Commission shall, by ... [five years from the date of entry into force of this amending Regulation], and at least every five years thereafter, review the thresholds applicable to SMCs in light of economic and market developments. As part of that review, the Commission shall compile an overview of existing definitions of small mid-cap and mid-cap enterprises in Union legislative acts, with the aim of creating one fully harmonised definition for maximum legal clarity. The review shall be accompanied by a report assessing the implementation of this Regulation, including its potential impact on economic, social and environmental aspects.

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

EDPS/EDPB

2. Representatives of public authorities of third countries, including their diplomatic missions and embassies

Text proposed by the Commission

Amendment

(13) Regulations (EU) 2016/1036 and (EU) 2016/1037 are part of the Union's trade defence system. They allow the Union to investigate and address dumping and subsidisation by third countries and restore a level playing field in the Union market. If an investigation confirms the existence of such practices and resulting injury to the Union industry, the Commission imposes an anti-dumping or countervailing duty, provided such imposition is not against the Union interest. Anti-dumping and antisubsidy investigations require active involvement from enterprises. Investigations are normally initiated on the basis of a formal complaint from the affected Union industry that must contain evidence of the unfair practice and of the injury it has caused. Investigations require active involvement of, and data from, producers, importers and users of the product in the Union. Mainly because of their fragmentation and lack of resources, it is often very difficult for SMEs to understand trade defence and cooperate in trade defence proceedings. This is why Regulations (EU) 2016/1036 and (EU) 2016/1037 include provisions to overcome the barriers that stop smaller enterprises from accessing and using trade defence, namely through a dedicated helpdesk, and by, whenever possible, aligning investigation periods with the financial year. It is considered appropriate to ensure that SMCs also benefit from those provisions.

(13) Regulations (EU) 2016/1036 and (EU) 2016/1037 are part of the Union's trade defence system. Effective implementation of trade defence measures is vital for maintaining the competitiveness of key Union industrial ecosystems and securing quality jobs. Those Regulations allow the Union to investigate and address dumping and subsidisation by third countries and restore a level playing field in the Union market. If an investigation confirms the existence of such practices and resulting injury to the Union industry, the Commission imposes an anti-dumping or countervailing duty, provided such imposition is not against the Union interest. Anti-dumping and antisubsidy investigations require active involvement from enterprises. Investigations are normally initiated on the basis of a formal complaint from the affected Union industry that must contain evidence of the unfair practice and of the injury it has caused. Investigations require active involvement of, and data from, producers, importers and users of the product in the Union. Mainly because of their fragmentation and lack of resources, it is often very difficult for SMEs to understand trade defence and cooperate in trade defence proceedings. This is why Regulations (EU) 2016/1036 and (EU) 2016/1037 include provisions to overcome the barriers that stop smaller enterprises from accessing and using trade defence, namely through a dedicated helpdesk, and by, whenever possible, aligning investigation periods with the financial year. It is considered appropriate to ensure that SMCs also benefit from those provisions.It is essential to ensure that the quality of the services provided by the dedicated helpdesk remains unaffected and that the services are delivered in a timely manner. The Commission should dedicate sufficient resources to actively monitor and effectively investigate unfair competition practices and swiftly adopt measures to counter dumping and illegal subsidies. It is important to shorten the average length of investigation procedures to mitigate the impact of unfair practices on SMEs and SMCs. A regular evaluation of the capacities of the helpdesk, including the need for more financial, technical and human resources, should therefore form an integral part of the annual report to the European Parliament and to the Council.

Text proposed by the Commission

Amendment

(13a) To embody the European principle of debureaucratisation and administrative efficiency for SMEs and SMCs the Commission should facilitate access to the trade defence instrument for sectors, largely composed of SMEs or SMCs, through a dedicated helpdesk, not only by awareness raising and by providing general information and explanations on procedures but also by exploring and promoting avenues for financial and legal technical assistance from Member States in complex trade defence cases and by further promoting a fully digitalised and paperless process for the submission of non-confidential documentation. The Commission should also develop and establish a streamlined, simplified complaint format and process, tailored specifically for SMEs and SMCs to expedite the lodging of complaints by those entities.

Text proposed by the Commission

Amendment

Regulation (EU) No2016/1036 is amended as follows:

Regulation (EU) 2016/1036 is amended as follows:

Present text

Amendment

(1a) in Article 5 (1a), the second subparagraph is replaced by the following:

The SMEHelpdesk shall make available standard forms for statistics to be submitted for standing purposes and questionnaires.

The Helpdesk shall make available standard forms for statistics to be submitted for standing purposes and questionnaires.

Present text

Amendment

(2a) in Article 23 (1), the second subparagraph is replaced by the following:

That report shall include information about the application of provisional and definitive measures, the termination of investigations without measures, undertakings, reinvestigations, reviews, significant distortions and verification visits, and the activities of the various bodies responsible for monitoring the implementation of this Regulation and fulfilment of the obligations arising therefrom. The report shall also cover the use of trade defence instruments by third countries targeting the Union and appeals against the measures imposed. It shall include the activities of the Hearing Officer of the Commission's Directorate General for Trade and those of the SMEHelpdesk in relation to the application of this Regulation.

'That report shall include information about the application of provisional and definitive measures, the termination of investigations without measures, undertakings, reinvestigations, reviews, significant distortions and verification visits, and the activities of the various bodies responsible for monitoring the implementation of this Regulation and fulfilment of the obligations arising therefrom. The report shall also cover the use of trade defence instruments by third countries targeting the Union and appeals against the measures imposed. It shall include the activities of the Hearing Officer of the Commission's Directorate General for Trade and those of the Helpdesk in relation to the application of this Regulationincluding the evaluation of the capacities of the Helpdesk to provide efficient services to SMEs and SMCs.

Text proposed by the Commission

Amendment

Regulation (EU) No2016/1037 is amended as follows:

Regulation (EU) 2016/1037 is amended as follows:

Present text

Amendment

(1a) in Article 10(1a), the second subparagraph is replaced by the following:

The SMEHelpdesk shall make available standard forms for statistics to be submitted for standing purposes and questionnaires.

The Helpdesk shall make available standard forms for statistics to be submitted for standing purposes and questionnaires.'

Present text

Amendment

(2a) in Article 32a (1), the second subparagraph is replaced by the following:

That report shall include information about the application of provisional and definitive measures, the termination of investigations without measures, undertakings, reinvestigations, reviews, significant distortions and verification visits, and the activities of the various bodies responsible for monitoring the implementation of this Regulation and fulfilment of the obligations arising therefrom. The report shall also cover the use of trade defence instruments by third countries targeting the Union and appeals against the measures imposed. It shall include the activities of the Hearing Officer of the Commission's Directorate General for Trade and those of the SMEHelpdesk in relation to the application of this Regulation.

'That report shall include information about the application of provisional and definitive measures, the termination of investigations without measures, undertakings, reinvestigations, reviews, significant distortions and verification visits, and the activities of the various bodies responsible for monitoring the implementation of this Regulation and fulfilment of the obligations arising therefrom. The report shall also cover the use of trade defence instruments by third countries targeting the Union and appeals against the measures imposed. It shall include the activities of the Hearing Officer of the Commission's Directorate General for Trade and those of the Helpdesk in relation to the application of this Regulation,including the evaluation of the capacities of the Helpdesk to provide efficient services to SMEs and SMCs.

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

References

COM(2025)0501 - C10-0092/2025 - 2025/0130(COD)

Committee(s) responsible

Date announced in plenary

ECON

10.7.2025

ENVI

10.7.2025

LIBE

10.7.2025

Opinion by

Date announced in plenary

INTA

10.7.2025

Rapporteur for the opinion

Date appointed

Bernd Lange

15.7.2025

Rule 59 - Joint committee procedure

Date announced in plenary

10.7.2025

Discussed in committee

4.11.2025

Date adopted

2.12.2025

Result of final vote

+:

-:

0:

30

2

4

Members present for the final vote

Christophe Bay, Anna Bryłka, Daniel Caspary, Benoit Cassart, Andi Cristea, Markéta Gregorová, Bart Groothuis, Enikő Győri, Svenja Hahn, Karin Karlsbro, Martine Kemp, Rudi Kennes, Sebastian Kruis, Bernd Lange, Ilia Lazarov, Miriam Lexmann, Thierry Mariani, Gabriel Mato, Javier Moreno Sánchez, Daniele Polato, Francesco Torselli, Inese Vaidere, Catarina Vieira, Iuliu Winkler, Bogdan Andrzej Zdrojewski, Juan Ignacio Zoido Álvarez

Substitutes present for the final vote

Mika Aaltola, Nicolas Bay, Saskia Bricmont, Danilo Della Valle, Tomasz Froelich, Jean-Marc Germain, Hana Jalloul Muro, Branislav Ondruš

Members under Rule 216(7) present for the final vote

Laurent Castillo, Günther Sidl

30

+

ECR

Nicolas Bay, Daniele Polato, Francesco Torselli

NI

Branislav Ondruš

PPE

Mika Aaltola, Daniel Caspary, Laurent Castillo, Martine Kemp, Ilia Lazarov, Miriam Lexmann, Gabriel Mato, Inese Vaidere, Iuliu Winkler, Bogdan Andrzej Zdrojewski, Juan Ignacio Zoido Álvarez

PfE

Christophe Bay, Anna Bryłka, Enikő Győri, Sebastian Kruis, Thierry Mariani

Renew

Benoit Cassart, Bart Groothuis, Svenja Hahn, Karin Karlsbro

S&D

Andi Cristea, Jean-Marc Germain, Hana Jalloul Muro, Bernd Lange, Javier Moreno Sánchez, Günther Sidl

2

-

The Left

Danilo Della Valle, Rudi Kennes

4

0

ESN

Tomasz Froelich

Verts/ALE

Saskia Bricmont, Markéta Gregorová, Catarina Vieira

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 theirobjectives 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 agenda4also supports the competitiveness of Union enterprises by ensuring that Union legislation achieves itsobjectives without imposing unnecessary costs, while making a concrete and positive contribution to the market and consumers' lives, helping the Union address current and future challenges. In 2023, the Commission identified the need to rationalise and simplify reporting requirements for bothenterprises and publicadministrations5and committed to reduce administrative burdens by 25% and 35% for SMEs.

__________________

__________________

4Better 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

4Better 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

5Long-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

5Long-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

(2a) SMEs are the backbone of the Union economy. The support for SMEs should remain a key policy priority, especially in times of economic uncertainty, increased costs, and competitiveness challenges. The efforts to promote business growth and scaling, particularly for SMCs, should not constitute a challenge to the support and resources allocated for SMEs, including financial support, simplified legal arrangements, special recognition in legislation and public policy, and unnecessary administrative burden reduction.

Text proposed by the Commission

Amendment

(3) On 12 September 2023, the Commission published the SME Relief Package6, announcing its goal to help small and medium sized enterprises ('SMEs') compete and grow, by being attentive to the needs of enterprises that outgrow the thresholds of the SME definition7, and those in the broader range of small mid-cap enterprises. Action 18 of this relief package announced that the Commission would 'develop a harmonised definition for small mid-cap enterprises, build a dataset based on such definition and assess possible measures to support these enterprises in their growth (including potential application in adapted form of certain measures favouring SMEs)'.

(3) On 12 September 2023, the Commission published the SME Relief Package6, announcing its goal to help micro,small and medium sized enterprises ('SMEs') compete and grow, by being attentive to the needs of enterprises that outgrow the thresholds of the SME definition7, and those in the broader range of small mid-cap enterprises. Action 18 of this relief package announced that the Commission would 'develop a harmonised definition for small mid-cap enterprises, build a dataset based on such definition and assess possible measures to support these enterprises in their growth (including potential application in adapted form of certain measures favouring SMEs)'. Such measures must not confer disproportionate advantages to small mid-cap entreprises over SMEs, particularly micro and small enterprises. The Commission, Member States and competent authorities should ensure that any support for small mid-caps is designed in a manner that upholds the principles of fair competition, non-discrimination, a high level of consumer protection as well as the integrity of the Internal Market.

__________________

__________________

6SME Relief Package (europa.eu). See also annex 3A to this report SME relief package policy tracker.

6SME Relief Package (europa.eu). See also annex 3A to this report SME relief package policy tracker.

7SMEs are defined as enterprises with under 250 employees, combined with an annual turnover up to 50 million euro or a balance sheet total up to 43 million - Recommendation 2003/361/EC - https://single-market-economy.ec.europa.eu/smes/sme-definition_en

7SMEs are defined as enterprises with under 250 employees, combined with an annual turnover up to 50 million euro or a balance sheet total up to 43 million - Recommendation 2003/361/EC - https://single-market-economy.ec.europa.eu/smes/sme-definition_en

Text proposed by the Commission

Amendment

(3a) Mitigating and simplification measures proposed for micro, small and medium-sized enterprises under the Regulations covered by this Omnibus Regulation should be extended, where appropriate, to small mid-cap enterprises and other enterprises that should be included within the scope of this amending act, provided that any such extensions are applied in a proportionate and balanced manner and do not weaken key regulatory obligations.

Text proposed by the Commission

Amendment

(4) Enterprises outgrowingthe 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) 99% of all EU companies are small and medium-sizedenterprises (SMEs), the vast majority of which are micro and small enterprises. Those that outgrowthe SME definition - the 'small mid-cap enterprises' ('SMCs') - alsoplay 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. Both categories of businesses, while important and needing similar support in some aspects, have different needs and requirements linked to their size and growth. This support should therefore be tailored accordingly, with particular attention to the specific and continuous challenges faced by SMEs.

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8Study 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

8Study 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

9https://www.esri.ie/system/files/publications/BKMNEXT429.pdf

9https://www.esri.ie/system/files/publications/BKMNEXT429.pdf

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. In order to achieve the overarching objective of facilitating the growth and scaling of businesses, reducing the impact of the regulatory cliff-edge when transitioning from an SME to an SMC and strengthen the support for Union businesses, and the internal market generally, with a particular focus on SMCs, a number of existing acts should be adjusted. In particular,to make business easier for SMCs and other entreprises that should be included within the scope of this amending actand 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 and those other entreprises, while still supporting SMEs and maintaining the existing approach, as well as ensuring that the Union's overarching goals are preserved.

Text proposed by the Commission

Amendment

(5a) The current challenges faced by small Union companies in trying to scale their businesses within the Union are significant. These challenges present a direct threat to the efficacy and success of the Internal Market, which should be addressed as a priority if the Union is to truly be a place that supports enterprise, entrepreneurship, and a competitive market economy.

Text proposed by the Commission

Amendment

(7) To ensure consistency and legal certainty, a definition of SMCs should be introduced in those acts. Whilethe 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 finaland cover enterprises that are up to three times the size of SMEs, it should, whereappropriate, build on the definitions of SMEsthat are already provided in the actsthat 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. The definition of SMCs should in principle correspond to the definition in Commission Recommendation 2025/1099 of 21 May 2025and cover enterprises that are up to three times the size of SMEs. While this definition may be useful in the context of some policy areas, for the purpose of this simplification exercise it isappropriate to extend certain mitigating measures also to enterprisesthat are not SMEs, SMCs and that employ fewer than 1000 persons, and that either have an annual turnover not exceeding EUR 200 000 000 or an annual balance sheet total not exceeding EUR 172 000 000. That scope covers enterprisesthat are up to four times the size of SMEs, without extending to large mid-caps or large enterprises, thereby ensuring achievement of the objectives referred to in recital 5 in a proportionate way.

Text proposed by the Commission

Amendment

(7a) The economic health of businesses in the Union, as well as compliance with Union's rules, depends on the predictability of obligations and the provision of adequate support for their implementation.

Text proposed by the Commission

Amendment

(7b) The Commission should, by three years from the entry into force of this Regulation and every five years thereafter, carry out an evaluation and present a report to the European Parliament and the Council on the implementation of the provisions of the Regulations amended by this Regulation, including the impact on administrative burden-reduction and competitiveness, on the development and growth of micro, small and medium-sized enterprises, and on consumer protection within the Union. The report should particularly focus on the possible need to review the thresholds defining SMCs, in light of economic and market developments. The report should be accompanied, if appropriate, by a legislative proposal.

Text proposed by the Commission

Amendment

(7c) The creation of a new category of enterprises must not come at the expense of support for SMEs, which constitute the backbone of the European economy and provide the majority of jobs across the Union. Exemptions or derogations proposed under this and future legislation for SMEs, SMCs and other enterprises that should be included within the scope of this amending act, for example in digital and sustainability legislation, should not create regulatory gaps or potential loopholes and should therefore be carefully assessed and accompanied by targeted guidance and support to ensure consistency, legal certainty, and the continued achievement of Union objectives.

Text proposed by the Commission

Amendment

(7d) Thresholds defining enterprise categories should be based on objective, verifiable, and up-to-date data, underpinned by a clear policy rationale, and subject to regular review.

Text proposed by the Commission

Amendment

(7e) Even if the changes provided for in this Regulation are tailored to the specific legal acts in question, it is important that when drafting future legislative proposals, the Commission considers ensuring coherence and harmonisation in the Internal Market by using the same definitions and proportionality principles for small mid-cap enterprises as established in this Regulation, unless specific circumstances justify divergence.

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 itapplies to all enterprises and organisations with fewer than 750employees, 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 andthe obligation to maintain records of processing activitiesshould be simplified so that the derogationapplies to all enterprises and organisations with fewer than 1000employees, provided that their processing activities are not likely to result in a high risk to the data subjects' rights and freedoms.

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 SMCsand organisations with fewer than 750employees to allow alsothem to profitfrom 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 itsprocessing 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 enterprisesand organisations with fewer than 1000employees to allow them to also benefitfrom that derogation and by providing that the derogation applies unless the processing, upon assessment by the data controller and data processor and, where applicable, the controller's or the processor's representative,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 thoseprocessing activities. Furthermore, it should be clarified that enterprises and organisations with fewer than 1000 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.

Text proposed by the Commission

Amendment

(11) Furthermore, in order to extend to SMCs, the provisions that are availablefor micro, small and medium-sized enterprises underRegulation (EU) 2016/679, the followingarticles should also be amended:

(11) Furthermore, definitions should be addedfor micro, small and medium-sized enterprises and for SMCs in Article 4 ofRegulation (EU) 2016/679. The requirements provided for inArticles 40 and 42 of that Regulation to take particularly into account the specific needs of micro, small and medium-sized enterprises as regards the drawing-up of codes of conduct and the establishment of data protection certification mechanisms and of data protection seals and marksshould be extended to include the specific needs of SMCs and other enterprises that should be included within the scope of this amending act. It is important that these codes of conduct take into account inter alia with the principles of administrative burden reduction and digitalisation while contributing to the proper compliance with this Regulation.

- 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

(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 forSMCs and potentially make them more attractive to investors, it is appropriate to also enable SMCsto draw up an EU Growth issuance prospectus for theiroffers of securities to the public, including when such offers are accompanied withan 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. To further supportSMCs and other enterprises that should be included within the scope of this amending act and improve their access to capital markets, it is appropriate to allow those SMCs and those other enterprisesto draw up an EU Growth issuance prospectus for publicoffers of securities , including when such offers are accompanied byan admission to trading on a multilateral trading facility. Furthermore, to facilitate access to finance for those SMEs, SMCs and those other enterprises, simplified measures shall be applied in respect of documentation and procedures so as to ease access to finance for such undertakings, including adjusted reporting requirements and technical support. Any simplification of prospectus and disclosure requirements should enhance access to capital markets, while ensuring that investors receive key information needed for informed decision making. Simplification should therefore be implemented in a way that balances reduced administrative requirements for enterprises with the need to preserve financial market integrity, investor protection, and confidence in Union capital markets.

Text proposed by the Commission

Amendment

(17) The provision in Regulation (EU) 2017/1129 concerning the EU Growth issuance prospectus will apply as of 5 March 2026, as the Commission is required to developdelegated acts to specify the reduced content and the standardised format and sequence of that prospectus. It is therefore appropriate to defer the application of the amendments to Regulation (EU) 2017/1129 concerning the EU Growth issuance prospectus set out in this Regulation to 5 March 2026.

(17) The provision in Regulation (EU) 2017/1129 concerning the EU Growth issuance prospectus will apply as of 5 March 2026, as the Commission is required to adoptdelegated acts to specify the reduced content and the standardised format and sequence of that prospectus. It is therefore appropriate to defer the application of the amendments to Regulation (EU) 2017/1129 concerning the EU Growth issuance prospectus set out in this Regulation to 5 March 2026.

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 and other enterprises that should be included within the scope of this amending act, so that they are also exempted from those obligations. To ensure consistency, it is appropriate to refer to SMCs in the same way whilst aligning with the Omnibus IV definition of SMCs referred to in recital 7, i.e. exempting SMCswith a net turnover which should thus be less than EUR 150 million and other enterprises that should be included within the scope of this amending act. While such an extension could provide proportional relief, care must be taken to ensure that transparency, consumer protection, sustainability objectives, and the integrity of the Union's regulatory framework are not undermined.

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 three years instead of annually. This burden reduction should apply to all economic operators, including SMCs. In between the three years, economic operators should be required to review, and make publicly available their due diligence policy without undue delay after a significant change occurs.

Text proposed by the Commission

Amendment

(28) 'small mid-cap enterprises' means enterprises as defined in point (2) of the Annex to Commission Recommendationof 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final**.;

(28) 'small mid-cap enterprises' means enterprises as defined in point (2) of the Annex to Commission Recommendation 2025/1099of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final**.;

_________________

___________________

** Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final.' ;

** Commission Recommendation of 21.5.2025 on the definition of small mid-cap enterprises - C(2025) 3500 final.' ;

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 750persons 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 1000persons 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.;

Text proposed by the Commission

Amendment

(2a) the following article is inserted:

Article 31a

Simplified tools

Supervisory authorities and, where relevant, the Commission, shall ensure that controllers and processors which qualify as micro, small or medium-sized enterprises, or as small mid-cap enterprises or enterprises employing fewer than 1000 persons, and either have an annual turnover not exceeding EUR 200 000 000 or an annual balance sheet total not exceeding EUR 172 000 000, have access to simplified tools harmonised at Union level and proportionate to their economic and operational circumstances. Those tools shall include, inter alia, standardised forms, templates for records of processing activities, models for risk assessments adapted to the specific characteristics of such enterprises, as well as other resources and practical guidance intended to facilitate the effective and consistent application of this Regulation.

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 andof 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 specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises,of small mid-cap enterprises, and of enterprises employing fewer than 1000 persons, and either have an annual turnover not exceeding EUR 200 000 000 or an annual balance sheet total not exceeding EUR 172 000 000.;

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 andof 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 of micro, small and medium-sized enterprises,of small mid-cap enterprises, and of enterprises employing fewer than 1000 persons, and either have an annual turnover not exceeding EUR 200 000 000 or an annual balance sheet total not exceeding EUR 172 000 000shall be taken into account.

Text proposed by the Commission

Amendment

(b a) companies referred to Article 2 point (fa) (i), 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 1000, a total balance sheet not exceeding EUR 172 000 000 and an annual net turnover not exceeding EUR 200 000 000;

Text proposed by the Commission

Amendment

This Chapter does not apply to economic operators that had a net turnover of less than EUR 150million 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 150million.;

This Chapter does not apply to economic operators that had a net turnover of less than EUR 200million 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 turnoverwhich group, on a consolidated basis, equals orexceeds the limit of EUR 200million in the financial year proceeding the last financial year.;

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 three years thereafter, and without undue delay after a significant change occurs,review and where necessary, updateand make publicly available, including on the internet, in a prominent, and easily accessible manner,a report on its battery due diligence policy..

Text proposed by the Commission

Amendment

Article 6a

Review

By ...[ three years from the entry into force of this Regulation] and every five years thereafter, the Commission shall carry out an evaluation and present a report to the European Parliament and the Council on the implementation of the provisions of the Regulations amended by this Regulation, including the impact on administrative burden-reduction and competitiveness, on the development and growth of micro, small and medium-sized enterprises, and on consumer protection within the Union. The report shall particularly focus on the possible need to review the thresholds defining SMCs, in light of economic and market developments. The report shall be accompanied, if appropriate, by a legislative proposal.

1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register

Chambers Ireland

Cork Chamber of Commerce

SME United

2. Representatives of public authorities of third countries, including their diplomatic missions and embassies

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

References

COM(2025)0501 - C10-0092/2025 - 2025/0130(COD)

Committee(s) responsible

Date announced in plenary

ECON

10.7.2025

ENVI

10.7.2025

LIBE

10.7.2025

Opinion by

Date announced in plenary

IMCO

10.7.2025

Rapporteur for the opinion

Date appointed

Cynthia Ní Mhurchú

25.9.2025

Rule 59 - Joint committee procedure

Date announced in plenary

10.7.2025

Discussed in committee

25.9.2025

11.11.2025

Date adopted

27.1.2026

Result of final vote

+:

-:

0:

36

9

4

36

+

ECR

Stefano Cavedagna, Piotr Müller, Denis Nesci, Gheorghe Piperea, Reinis Pozņaks, Ivaylo Valchev

PPE

Peter Agius, Pablo Arias Echeverría, Henrik Dahl, Regina Doherty, Christian Doleschal, Kamila Gasiuk-Pihowicz, Arba Kokalari, Andreas Schwab, Tomislav Sokol, Dimitris Tsiodras, Inese Vaidere, Adina Vălean, Axel Voss, Tomáš Zdechovský

Renew

Jeannette Baljeu, Sandro Gozi, Svenja Hahn, Anna-Maja Henriksson, Nikola Minchev

S&D

Alex Agius Saliba, Biljana Borzan, Delara Burkhardt, Adnan Dibrani, Maria Grapini, Elisabeth Grossmann, Maria Guzenina, Pierre Jouvet, Pierfrancesco Maran, Idoia Mendia, Christel Schaldemose

9

-

ESN

Alexander Jungbluth, Milan Mazurek

NI

Kateřina Konečná

The Left

Leila Chaibi, Gaetano Pedulla'

Verts/ALE

Anna Cavazzini, Katrin Langensiepen, Reinier Van Lanschot, Kim Van Sparrentak

4

0

PfE

Jaroslav Bžoch, Elisabeth Dieringer, Jorge Martín Frías, Pál Szekeres

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

References

COM(2025)0501 - C10-0092/2025 - 2025/0130(COD)

Date submitted to Parliament

21.5.2025

Committee(s) responsible

Date announced in plenary

ECON

10.7.2025

ENVI

10.7.2025

LIBE

10.7.2025

Committees asked for opinions

Date announced in plenary

INTA

10.7.2025

ITRE

10.7.2025

IMCO

10.7.2025

Not delivering opinions

Date of decision

ITRE

16.7.2025

Rapporteurs

Date appointed

Mariateresa Vivaldini

23.9.2025

Niels Flemming Hansen

23.9.2025

Lukas Mandl

23.9.2025

Rule 59 - Joint committee procedure

Date announced in plenary

10.7.2025

Discussed in committee

4.12.2025

Date adopted

25.2.2026

Result of final vote

+:

-:

0:

158

9

10

Date tabled

3.3.2026

158

+

ECR

Stephen Nikola Bartulica, Nicolas Bay, Stefano Cavedagna, Alessandro Ciriani, Pietro Fiocchi, Paolo Inselvini, Assita Kanko, Denis Nesci, Jacek Ozdoba, Michele Picaro, Claudiu-Richard Târziu, Laurence Trochu, Sebastian Tynkkynen, Johan Van Overtveldt, Alexandr Vondra, Charlie Weimers, Jadwiga Wiśniewska

NI

Fabio De Masi, Fernand Kartheiser

PPE

Georgios Aftias, Pascal Arimont, Bartosz Arłukowicz, Isabel Benjumea Benjumea, Hildegard Bentele, Stefan Berger, Alexander Bernhuber, Ioan-Rareş Bogdan, Krzysztof Brejza, Caterina Chinnici, Henrik Dahl, Regina Doherty, Lena Düpont, Marco Falcone, Markus Ferber, Christophe Gomart, Dirk Gotink, Branko Grims, Michalis Hadjipantela, Niels Flemming Hansen, Esther Herranz García, Dariusz Joński, Radan Kanev, Martine Kemp, Stefan Köhler, Arba Kokalari, Jeroen Lenaers, Norbert Lins, Elżbieta Katarzyna Łukacijewska, Lukas Mandl, Verena Mertens, Nadine Morano, Dan-Ştefan Motreanu, Siegfried Mureşan, Luděk Niedermayer, Ana Miguel Pedro, Lídia Pereira, Sirpa Pietikäinen, Jessica Polfjärd, Manuela Ripa, Massimiliano Salini, Ralf Seekatz, Sander Smit, Susana Solís Pérez, Alice Teodorescu Måwe, Tomas Tobé, Flavio Tosi, Dimitris Tsiodras, Michał Wawrykiewicz, Isabel Wiseler-Lima, Javier Zarzalejos, Tomáš Zdechovský

PfE

Barbara Bonte, Paolo Borchia, Mireia Borrás Pabón, Jorge Buxadé Villalba, Ton Diepeveen, Csaba Dömötör, Marieke Ehlers, Viktória Ferenc, Ondřej Knotek, Jaroslav Knot, Tomáš Kubín, Fabrice Leggeri, Jana Nagyová, Pierre Pimpie, Jaroslava Pokorná Jermanová, Silvia Sardone, Antonín Staněk, Petra Steger, Tom Vandendriessche

Renew

Abir Al-Sahlani, Malik Azmani, Jeannette Baljeu, Stine Bosse, Gilles Boyer, Raquel García Hermida-Van Der Walle, Gerben-Jan Gerbrandy, Irena Joveva, Billy Kelleher, Fabienne Keller, Moritz Körner, Ľudovít Ódor, Jan-Christoph Oetjen, Christine Singer, Anouk Van Brug, Ana Vasconcelos, Emma Wiesner, Michal Wiezik, Sophie Wilmès

S&D

Sakis Arnaoutoglou, Thomas Bajada, Delara Burkhardt, Mohammed Chahim, Annalisa Corrado, Jonás Fernández, André Franqueira Rodrigues, Heléne Fritzon, Eero Heinäluoma, Evin Incir, Romana Jerković, Marina Kaljurand, Aurore Lalucq, Murielle Laurent, Juan Fernando López Aguilar, César Luena, Pierfrancesco Maran, Ana Catarina Mendes, Alessandra Moretti, Matjaž Nemec, Maria Noichl, Nikos Papandreou, Tsvetelina Penkova, Evelyn Regner, René Repasi, Chloé Ridel, Elena Sancho Murillo, Birgit Sippel, Krzysztof Śmiszek, Cecilia Strada, Marco Tarquinio, Marta Temido, Kristian Vigenin, Tiemo Wölken, Lara Wolters

Verts/ALE

Jaume Asens Llodrà, Damian Boeselager, Saskia Bricmont, Mélissa Camara, Bas Eickhout, Daniel Freund, Erik Marquardt, Tilly Metz, Rasmus Nordqvist, Jutta Paulus, Kira Marie Peter-Hansen, Majdouline Sbai, Kai Tegethoff, Marie Toussaint

9

-

The Left

Lynn Boylan, Per Clausen, Emma Fourreau, Martin Günther, Gaetano Pedulla', Ilaria Salis, Jussi Saramo, Isabel Serra Sánchez, Pasquale Tridico

10

0

ESN

Anja Arndt, Ivan David, Siegbert Frank Droese, Marc Jongen, Mary Khan, Volker Schnurrbusch, Milan Uhrík, Petar Volgin

Verts/ALE

Pär Holmgren, Alice Kuhnke