COMMISSION STAFF WORKING DOCUMENT on small mid-cap companies Accompanying the documents Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2014/65/EU and (EU) 2022/2557 as regards the extension of certain mitigating measures available for small and medium sized enterprises to small mid-cap enterprises and further simplifying measures Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (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
Date: 2025-05-21
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: administrative formalities, competition law, data-processing law, environmental law, financial control, financial legislation, financial market, market access, single market, size of business

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 21.5.2025  SWD(2025) 501 final  COMMISSION STAFF WORKING DOCUMENT on small mid-cap companies Accompanying the documents    Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2014/65/EU and (EU) 2022/2557 as regards the extension of certain mitigating measures available for small and medium sized enterprises to small mid-cap enterprises and further simplifying measures   Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (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 {COM(2025) 501 final} - {COM(2025) 502 final}  
 
 
TABLE OF CONTENTS 

1 

Introduction ............................................................................................................... 3 

1.1 

1.2 

Policy context ..................................................................................................... 3 

Consultation with stakeholders .............................................................................. 6 

2  Main issues at stake and the ways to address them ......................................................... 7 

2.1  Main issues at stake ............................................................................................. 7 

2.2  Ways to address the main issues .......................................................................... 12 

2.2.1 

General Data Protection Regulation (GDPR) - Regulation (EU) 2016/679 ........ 14 

Basic anti-dumping and anti-subsidy regulations – Regulation (EU) 2016/1036 

2.2.2 
and Regulation (EU) 2016/1037 ................................................................................. 16 

2.2.3  Markets in financial instruments – Directive (EU) 2014/65 and Regulation (EU) 
2017/1129 (the ‘Prospectus Regulation’) ..................................................................... 16 

2.2.4 

2.2.5 

Batteries Regulation - Regulation (EU) 2023/1542 ......................................... 18 

Critical entities resilience - Directive (EU) 2022/2557 .................................... 19 

3  Conclusions – global impact of the proposal ................................................................ 21 

Page 1 of 21 

 
 
 
 
 
 
 
Acronym 

Meaning or definition 

Glossary of acronyms 

CS3D 
/CSDDD 

Corporate Sustainability Due Diligence Directive (Directive (EU) 2024/1760) 

CSRD 

Corporate Sustainability Reporting Directive (Directive (EU) 2022/2464) 

ECB 

EIB 

EU 

GBER 

GDPR 

JRC 

SMC 

SME 

SWD 

European Central Bank 

European Investment Bank 

European Union 

General Block Exemption Regulation (Regulation (EU) No 651/2014) 

General Data Protection Regulation (Regulation (EU) 2016/679) 

Joint Research Centre 

Small mid-cap company 

Small or medium-sized enterprise 

Staff working document 

Taxonomy 

Taxonomy Regulation (Regulation (EU) 2020/852) 

TFEU 

Treaty on the Functioning of the European Union 

Page 2 of 21 

 
 
 
 
 
 
 
1 

INTRODUCTION 

1.1  Policy context 

European  businesses  create  employment,  innovation  and  prosperity.  Competitiveness  and 
productivity are essential conditions for businesses to flourish; they have been at the heart of EU 
policy for decades1. To set the EU economy on a sustainable growth path, the EU and its Member 
States need to make structural improvements to the business environment, including through well-
focused investment and regulatory measures. 

President von der Leyen has set out a plan for Europe’s sustainable prosperity and competitiveness 
in  the  political  guidelines  for  the  European  Commission's  2024-2029  term2.  Making  business 
easier and deepening the Single Market are among the plan’s key priorities. 

The  Commission’s  better  regulation  agenda 3  also  supports  the  competitiveness  of  European 
enterprises  by  aiming  to  ensure  that  EU  laws  deliver  on  their  objectives  without  imposing  an 
unnecessary  burden.  In  2023,  the  Commission  identified  the  need  to  rationalise  and  simplify 
reporting  requirements  for  enterprises  and  administrations4 by  25%,  without  undermining  the 
policy objectives of the relevant  legislation. This  commitment was subsequently  increased  to  a 
25% reduction of all administrative costs and a 35% reduction for SMEs5. 

Mario Draghi in his report on ‘The future of European competitiveness’6, argues that EU regulation 
imposes a proportionally higher burden on SMEs and small mid-cap enterprises (SMCs)7 than on 
larger enterprises. The report suggests that the Commission should extend the existing mitigation 
measures currently available to SMEs to small mid-caps to extend proportionality in EU law to 

1 Long-term competitiveness of the EU: looking beyond 2030, COM/2023/168 final, https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:52023DC0168. 
2 https://commission.europa.eu/document/download/e6cd4328-673c-4e7a-8683-
f63ffb2cf648_en?filename=Political%20Guidelines%202024-2029_EN.pdf 
3  Better  regulation:  Joining  forces  to  make  better  laws,  COM(2021)  219  final,  available  at:  https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=COM:2021:219:FIN. 
4 Long-term  competitiveness  of  the  EU:  looking  beyond  2030,  COM(2023)  168  final,  available  at:  https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023DC0168. 
5 Mission letter to Stéphane Séjourné, Executive Vice-President-designate for Prosperity and Industrial Strategy, 
available at: https://commission.europa.eu/document/download/6ef52679-19b9-4a8d-b7b2-
cb99eb384eca_en?filename=Mission%20letter%20-%20S%C3%89JOURN%C3%89.pdf. See also Communication 
on implementation and simplification, https://commission.europa.eu/document/download/8556fc33-48a3-4a96-
94e8-8ecacef1ea18_en?filename=250201_Simplification_Communication_en.pdf  
6M. Draghi, The future of European competitiveness, 2024, available at: 
https://commission.europa.eu/topics/strengthening-european-competitiveness/eu-competitiveness-looking-
ahead_en#paragraph_47059, p. 65. 
7 Companies that have outgrown the SME definition. 

Page 3 of 21 

 
 
 
 
small mid-caps. The Draghi report also observes that EU lacks a commonly agreed definition of 
small mid-caps and readily available statistical data. 

According to Enrico Letta’s ‘Much more than a market’ report, distinguishing between mid-caps 
and large corporations in EU regulations will enable more suitable rules,  fostering their growth 
and equitable participation in the Single Market, especially during crises8. Mid-cap enterprises can 
therefore contribute to building the Single Market and making it work better. 

On 12 September 2023, the Commission published the SME Relief Package9, announcing its goal 
to help small and medium-sized enterprises compete and grow, for example, by being attentive to 
the  needs  of  enterprises  that  outgrow  the  thresholds  of  the  SME  definition10 and  those  in  the 
broader range of small mid-cap enterprises (SMCs). Action 18 of this relief package announced 
that the Commission would ‘develop a harmonised definition for small mid-cap companies, build 
a dataset based on such definition and assess possible measures to support these companies in their 
growth (including potential application in adapted form of certain measures favouring SMEs)’. 

A  study  to  ‘Map,  measure  and  portray  the  EU  mid-cap  landscape’ 11  showed  that  mid-cap 
enterprises that have outgrown the SME definition play a vital role in the EU economy, providing 
13% of overall employment. They are prominently present in industrial ecosystems that are key to 
the  EU’s  competitiveness  and  technological  sovereignty,  such  as  electronics,  aerospace  and 
defence, energy, energy-intensive industries and health. Around 20% of all mid-cap enterprises 
were SMEs  three years  earlier. Compared to SMEs,  they tend to  demonstrate a higher pace of 
growth, level of innovation and digitisation, although they face certain similar challenges such as 
administrative  burden  and  share  the  need  for  more  proportionality  in  new  legislation  and  for 
targeted  support.  These  challenges  must  be  addressed  in  a  consistent  manner  to  help  SMEs 
transition smoothly into small mid-cap enterprises. 

8 E.  Letta,  Much more  than  a market, 2024,  available  at:  https://www.consilium.europa.eu/media/ny3j24sm/much-
more-than-a-market-report-by-enrico-letta.pdf, p. 107. 
9 SME Relief Package, COM/2023/535 final, available at: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=COM:2023:535:FIN;. 
10 SMEs are currently defined as companies 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. 
11 B. Dachs, I. Siedschlag, W. Yan, M. Yoveska, F. Boeira, S. Ivory, Study to map, measure and portray the EU 
mid-cap landscape, European Union, 2022, available at: https://op.europa.eu/en/publication-detail/-
/publication/ad5fdad5-6a33-11ed-b14f-01aa75ed71a1/language-en/format-PDF/source-277396461. 

Page 4 of 21 

 
 
 
 
A report by the European Investment Bank12 also found that mid-caps – defined in that report as 
firms with 250 to 3 000 employees – contribute significantly to employment and value creation in 
the  European  economy.  They  are  vital  components  of  key  industrial  ecosystems,  including 
electronics,  health,  energy,  renewables,  and  aerospace  and  defence,  underpinning  Europe’s 
competitiveness.  Mid-caps  are  more  likely  to  invest  than  SMEs  and  large  firms  and  their 
investment volumes are also larger. Around 87% of them invested in training and skills between 
2018 and 2023, and 65% of small mid-caps are likely to do so. The report calls for a standardised 
definition and better understanding of mid-caps’ specific needs to unlock their full potential. 

A definition for small mid-cap enterprises is already in use under the General Block Exemption 
Regulation13 and the Guidelines on State aid to promote risk finance investments14. In the Annual 
Single  Market  and  Competitiveness  Report15,  adopted  on  14 February  2024,  the  Commission 
committed to monitoring – based on this definition16 – outcomes for both SMEs and small mid-
caps under relevant financial programmes and deepening its understanding of barriers impeding 
the growth and transition of medium-sized enterprises into SMCs. 

This Omnibus proposal follows in the context of a series of Omnibus simplification packages. The 
first  of  these  was  adopted  on  26 February  2025  and  concerned  the  Corporate  Sustainability 
Reporting Directive (CSRD), the Corporate Sustainability Due Diligence Directive (CSDDD), the 
Carbon Adjustment Mechanism (CBAM), and the InvestEU Regulation. It was accompanied by a 
draft Taxonomy Delegated Act for public consultation. 

The savings from that Omnibus package amounted to EUR 6.3 billion for all enterprises, and the 
potential savings for SMCs from these acts are significant. This proposal comes on top of these 
packages  and  allows  for  further  simplification  specifically  aimed  at  small  mid-caps,  enabling 
enterprises to scale up. 

12 L. Maurin, J. Delanote, H. Tran, G. Riekeles, P. Lausberg,, Hidden Champions, missed opportunities, EIB, 2024, 
https://www.eib.org/en/publications/20230277-hidden-champions-missed-opportunities-mid-caps-
available 
crucial-role-in-europe-s-economic-transition. 
13 Regulation (EU) No 651/2014 declaring certain categories of aid compatible with the internal market in 

at: 

application of Articles 107 and 108 of the Treaty, available at: https://eur-lex.europa.eu/EN/legal-
content/summary/general-block-exemption-regulation.html. 

14 Guidelines on State aid to promote risk finance investments, OJ C 508 of 16.12.2021, p.1. 
15 The  2024  Annual  Single  Market  and  Competitiveness  Report,  COM(2024)  77  final,  available  at:  https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52024DC0077. 
16 ‘Small mid-cap’ means an undertaking that is not an SME and whose number of employees does not exceed 499, 
calculated under Articles 3 to 6 of Annex I to the General Block Exemption Regulation, and the annual turnover of 
which does not exceed EUR 100 million or the annual balance sheet of which does not exceed EUR 86 million. For 
the application of this definition, several entities will be considered as one undertaking if any of the conditions listed 
in Article 3(3) of Annex I to the General Block Exemption Regulation is fulfilled. 

Page 5 of 21 

 
 
 
 
1.2  Consultation with stakeholders 

The idea of formalising a definition for small mid-cap enterprises, as a first step towards policy 
support that would focus on enterprises that manage to scale up out of the SME population, has 
received  growing  attention.  Calls  have  multiplied  at  all  levels,  from  business  organisations 
(Mouvement  des  Entreprises  de  taille  intermédiaire  -  METI,  France;  Bundesverband  der 
Deutschen  Industrie  e.  V.  –  BDI;  European  Family  Businesses)  and  Member  States  (Franco-
German paper on Better Regulation and Modern Administration in Europe in October 2023)17 to 
think tanks (European Policy Centre) and financial institutions (EIB), and from Enrico Letta in his 
‘Much more than a market’ report. 

The Commission has engaged with and listened to the business community to identify how such a 
small mid-cap company definition could be used for cross-cutting policy purposes and to identify 
fields for proportionate regulatory, funding or policy measures. 

Position  papers  sent  by  stakeholders  give  a  number  of  recommendations  for  this,  such  as 
‘considering the specific characteristics of mid-caps in the better regulation context’, or ‘ensuring 
that EU regulation is more sensitive to business size’. These papers further indicate that, while 
SMEs are often targeted with support or spared the burden of regulation, mid-caps are treated as 
similar to very large firms, which stakeholders do not see as an optimal policy choice. 

The  Commission  also  consulted  representatives  of  European  industry  on  specific  ideas  for 
providing  tailored  support  to  small  mid-cap  companies,  both  in  bilateral  meetings  and  in  a 
‘roundtable on simplification’ on the necessary policy support for small mid-cap enterprises held 
on 6 February 2025. The results of all these discussions have contributed to the list of proposals 
put forward in this document. 

The Commission validates the registrations in the F-gas Portal and has through this process been 
in  direct  contact  with  the  stakeholders  that  were  impacted  by  the  extended  registration 
requirements in the F-gas Regulation that entered into force in 2024. Moreover, one Member State 
contacted the Commission to request that the rules be simplified. 

17 Reducing  bureaucracy  in  these  unprecedented  times  –  French-German  Paper  on  Better  Regulation  and  Modern 
Administration  in  Europe,  Bundesministerium  für  Wirtschaft  und  Klimaschutz,  Bundesministerium  der  Justiz, 
Ministère  de 
industrielle  et  numérique,  available  at: 
https://www.bmwk.de/Redaktion/EN/Downloads/B/french-german-paper-on-better-regulation-and-modern-
administration-in-europe.pdf?__blob=publicationFile&v=8. 

l’Économie  des  Finances  et  de 

la  Souveraineté 

Page 6 of 21 

 
 
 
 
2  MAIN ISSUES AT STAKE AND THE WAYS TO ADDRESS THEM 

2.1  Main issues at stake 

Mid-caps play a key role in industrial ecosystems that are essential to the competitiveness of the 
European Union18 and in several Member States mid-cap enterprises provide a significant number 
of jobs19. 

A mid-cap study20, based on the Orbis database21, provided estimates for the number of enterprises 
under different definitions (by Member State and industry) and extrapolations of the sample given 
the varying availability of data across the Member States. 

Based on these estimations, in absolute terms, there are around 31 000 mid-cap firms with 250 – 
499 staff and another 18 000 mid-caps with 500-1 499 staff in the EU22. Mid-cap firms can be 
found in all EU Member States. There are also around 3 600 very large mid-cap firms (1 500-2 999 
employees) in the EU. Due to inherent limitations in the available data23, these estimates may not 
fully reflect the total number of mid-cap enterprises in the EU. 

The above figures are generally confirmed by more recent analyses. Eurostat recently collected 
2023 data on companies with 250-499 employees on a voluntary basis from Member States. While 
only eight Member States participated in the data collection24, the average share of small mid-caps 

at: 

available 

18 Electronics, Aerospace & Defence, Energy, Energy-intensive Industries and Health; B. Dachs, I. Siedschlag, W. 
Yan, M. Yoveska, F. Boeira, S. Ivory, Study to map, measure and portray the EU mid-cap landscape, European Union, 
https://op.europa.eu/en/publication-detail/-/publication/ad5fdad5-6a33-11ed-b14f-
2022, 
01aa75ed71a1/language-en/format-PDF/source-277396461. 
19 Mid-caps  employ  around  20%  of  all  employees  in  the  business  sector  of  the  Nordic  countries,  in  Luxembourg, 
Germany and Austria; B. Dachs, I. Siedschlag, W. Yan, M. Yoveska, F. Boeira, S. Ivory, Study to map, measure and 
portray the EU mid-cap landscape, European Union, 2022, available at:  https://op.europa.eu/en/publication-detail/-
/publication/ad5fdad5-6a33-11ed-b14f-01aa75ed71a1/language-en/format-PDF/source-277396461. 
20 B. Dachs, I. Siedschlag, W. Yan, M. Yoveska, F. Boeira, S. Ivory, Study to map, measure and portray the EU mid-
cap landscape, European Union, 2022, available at: https://op.europa.eu/en/publication-detail/-/publication/ad5fdad5-
6a33-11ed-b14f-01aa75ed71a1/language-en/format-PDF/source-277396461. 
21 Sample base of companies with employment data for 2019 and still active in April 2022. 
22 For the estimation here, relying only on staff headcount. 
23 ESTAT divides businesses into categories based on staff headcount classified in four groups: 0-9, 10-49, and 50-
249 and 250 and more employees. The size-class with 250 staff or more, does not offer further breakdowns based 
on headcount and all companies are considered as one group. The available data does not make it possible to calculate 
how many companies would match a particular segment of a size-class. Private databases, e.g. Orbis, allow for more 
granulated subdivisions. An additional limitation is the fact that the staff headcount is the only criterion, and there 
is no one-on-one relationship with the turnover of the company, or the ownership (all elements that are considered 
in the SME definition). As a result, a company is put into a segment solely based on the headcount. Orbis considers 
a company’s ownership to a limited extent. 

24 The  Member  States  that  submitted  data  were  Bulgaria,  Germany,  Croatia,  Italy,  Latvia,  Lithuania,  Malta,  and 
Finland. 

Page 7 of 21 

 
 
 
 
in  the  total  number  of  enterprises  in  this  sample  was  0.12% 25 ,  representing  around  31 200 
enterprises when extrapolated to the EU’s enterprise population of approximately 26 million as 
given  by  the  Annual  Report  on  European  SMEs26.  A  recent  JRC  analysis27,  based  on  both  the 
above-mentioned Eurostat data and an Orbis analysis, also arrives at similar numbers.  

The share of mid-caps varies significantly between countries (ranging from a share of 0.42% of all 
enterprises  to  barely  0.06%,  source:  JRC)  and  industrial  ecosystems.  According  to  the  JRC 
analysis, the industrial ecosystems with the highest share of mid-caps are electronics and energy – 
renewables, whereas those with the lowest shares are cultural & creative industries, construction 
and tourism. 

Despite  the  small  share  in  numbers,  mid-caps  account  for  a  sizeable  share  of  employment  and 
turnover in the EU economy. The shares vary depending on the study; the 2021 mid-cap study28 
found  that  mid-caps  with  250-499  employees  provide  6%  of  all  employment,  while  the  JRC 
analysis found this share to be around 9%. Their share of turnover represents 13% of all business 
turnover29. 

All these figures mainly look at companies with 250 to 499 employees. In the current economic 
context, to better accompany scaling up of enterprises and to cover a larger number of companies, 
the new definition will, however, cover enterprises that are three times the size of SMEs: 

Based on the available figures for the 250-499 and the 500-1,499 brackets (where the 2021 mid-
cap study estimates around 31,000 and 18,000 companies, respectively), it can be estimated that 
around 35-40% of companies in the 500-1499 bracket have 500-749 employees. This would lead 
to an estimate of around 38,000 SMCs defined as 250-749 employees. 

Applying  the  same  method  of  estimation  to  different  industrial  ecosystems,  in  terms  of  total 
numbers, the highest numbers of small mid-caps can be found in construction, retail and mobility 
– transport – automotive. These figures, however, reflect the large sizes of these ecosystems in 

25  Eurostat,  Enterprises  by  extended  size  classes  (including  small  mid-caps)  and  NACE  Rev.  2  activity, 
https://ec.europa.eu/eurostat/databrowser/view/sbs_ovw_smc/default/table?lang=en&category=bsd.sbs.sbs_ovw. 
26 https://single-market-economy.ec.europa.eu/smes/sme-strategy-and-sme-friendly-business-conditions/sme-
performance-review_en.. 
27 European  Commission:  Joint  Research  Centre,  Lagüera  Gonzalez,  J.,  Di  Bella,  L.,  Katsinis,  A.A.  and  Schulze 
Brock, P., A comprehensive analysis of mid-cap enterprises in the EU business economy, Publications Office of the 
European Union, Luxembourg, 2025, https://data.europa.eu/doi/10.2760/9616331, JRC141271. 
28 B. Dachs, I. Siedschlag, W. Yan, M. Yoveska, F. Boeira, S. Ivory, Study to map, measure and portray the EU mid-
cap landscape, European Union, 2022, available at: https://op.europa.eu/en/publication-detail/-/publication/ad5fdad5-
6a33-11ed-b14f-01aa75ed71a1/language-en/format-PDF/source-277396461. 
29 European  Commission:  Joint  Research  Centre,  Lagüera  Gonzalez,  J.,  Di  Bella,  L.,  Katsinis,  A.A.  and  Schulze 
Brock, P., A comprehensive analysis of mid-cap enterprises in the EU business economy, Publications Office of the 
European Union, Luxembourg, 2025, https://data.europa.eu/doi/10.2760/9616331, JRC141271. 

Page 8 of 21 

 
 
 
 
general, while percentage shares give a better picture of the importance of small mid-caps to each 
industrial ecosystem. 

   250-499 

500-749 

Small mid-caps 
(250-749)30 

Retail 
Construction 
Mobility  Transport Automotive 
Tourism 
Agri food 
Digital 
Energy Intensive Industries 
Proximity Social Economy & Civil Security 
Aerospace and Defence 
Cultural & Creative Industries 
Health 
Energy Renewables 
Electronics 
Textile 

4124 
3779 
2860 
2206 
2084 
1898 
1644 
1307 
1216 
821 
648 
626 
571 
509 

850 
732 
556 
410 
364 
379 
377 
276 
262 
134 
167 
111 
118 
69 

4974 
4511 
3416 
2616 
2447 
2277 
2022 
1584 
1478 
955 
815 
737 
689 
578 

In terms of percentage shares, the highest shares of small mid-caps with 250-749 employees are 
found in electronics, energy renewables and aerospace and defence31.  

The SMC definition should allow for targeted policy support, especially in relevant sectors. This 
is why the bracket 250-749 seems appropriate to reach a sufficiently large number of companies 
and alleviate the challenges they face. 

Although  small  mid-caps  usually  grow  faster,  are  more  innovative  and  deal  better  with 
digitalisation than SMEs, they still face certain challenges32. Different factors may adversely affect 
the speed of their growth. 

30 Due to data limitations and missing data for certain NACE codes, the numbers by ecosystems do not fully add up 
to the 38 000 SMCs identified above. 
31 Small  mid-caps  represent  0.61%  of  all  companies  in  electronics,  0.58%  in  Energy  Renewables  and  0.47%  in 
Aerospace and Defence; European Commission: Joint Research Centre, Lagüera Gonzalez, J., Di Bella, L., Katsinis, 
A.A.  and  Schulze  Brock,  P.,  A  comprehensive  analysis  of  mid-cap  enterprises  in  the  EU  business  economy, 
Publications  Office  of  the  European  Union,  Luxembourg,  2025,  https://data.europa.eu/doi/10.2760/9616331, 
JRC141271. 
32 SME Relief Package, COM(2023) 535 final, available at: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=COM%3A2023%3A535%3AFIN. 

Page 9 of 21 

 
 
 
 
 
 
Figure 1: Main challenges for mid-caps in the European Union33 

The  main  difficulties  for  small  mid-cap  enterprises  concern  finding  employees,  dealing  with 
supply  chain  disruptions,  and  complying  with  regulation  and  administrative  requirements,  as 
outlined in the interviews carried out for the 2022 mid-cap study34. Rising energy prices and other 
production inputs have been another major challenge for mid-caps in recent months.  

The  Commission  proposal  also  includes  an  amendment  of  Regulation  (EU)  2024/573  on 
fluorinated greenhouse gases (F-gas Regulation). The F-gas Regulation that entered into force in 
2024  expands  a  registration  requirement  in  the  F-gas  Portal  to  all  imports  of  products  and 
equipment, including those not subject to reporting requirements, and includes a new registration 
obligation for exports of products and equipment containing F-gases, including for products and 

33 B. Dachs, I. Siedschlag, W. Yan, M. Yoveska, F. Boeira, S. Ivory, Study to map, measure and portray the EU mid-
cap landscape, European Union, 2022, available at: https://op.europa.eu/en/publication-detail/-/publication/ad5fdad5-
6a33-11ed-b14f-01aa75ed71a1/language-en/format-PDF/source-277396461. 
34 B. Dachs, I. Siedschlag, W. Yan, M. Yoveska, F. Boeira, S. Ivory, Study to map, measure and portray the EU mid-
cap landscape, European Union, 2022, available at: https://op.europa.eu/en/publication-detail/-/publication/ad5fdad5-
6a33-11ed-b14f-01aa75ed71a1/language-en/format-PDF/source-277396461. 

Page 10 of 21 

 
 
 
 
equipment for which no export restrictions exist. If a trader is not able to present a valid registration 
in the F-gas Portal, customs should block the goods. 

This Commission received many new registration requests from traders in products and equipment 
containing F-gases. They mostly concern relatively small enterprises that trade with used cars that 
have F-gases in the air-conditioning equipment and that were not covered by any obligations under 
the  previous  F-gas  Regulation.  To  register,  importers  and  exporters  must  submit  an  electronic 
application form to the Commission and provide the required information related to their business 
activities and their legal and financial identity. The Commission validates the registration in the 
F-gas Portal. It appears that this requirement is not fully proportionate. 

2.2  Ways to address the main issues 

The Draghi report calls for ensuring proportionality for mid-caps in EU law and extending some 
mitigation measures, which benefit SMEs, to mid-cap enterprises. The Letta report also advocates 
recognising mid-caps distinctly from large corporations in EU regulations. 

To  help  small  mid-caps  tap  their  growth  potential  and  scale  up  their  contribution  to  European 
competitiveness, welfare, and prosperity, the Commission is proposing to: 

1)  formalise the definition of a European small mid-cap company, by adopting a recommendation 

on an ‘EU definition of small mid-cap enterprises’, and 

2)  extend some mitigating measures currently available to small and medium-sized enterprises to 
this new category of small mid-caps by adopting an Omnibus proposal amending certain EU 
legislation.  This  SWD  provides  the  evidence  and  analysis  supporting  such  an  Omnibus 
proposal. 

Once the definition is adopted, this will allow SMCs’ needs to also be considered in pending and 
upcoming Commission proposals. 

1) Formalising the definition of a European small mid-cap company 

The General Block Exemption Regulation and the Guidelines on State aid to promote risk finance 
investments include already a definition of small mid-caps, covering enterprises up to a size that 
is  twice  that  covered  by  the  SME  definition  (up  to  499  staff,  combined  with  EUR 100  million 
turnover or EUR 86 million balance sheet total). As seen above, estimations point to some 31 000 
enterprises  in  this  size  category.  The  purpose  of  a  general  SMC  definition  is,  however,  not  to 
replicate  the  definition  used  in  State  aid  rules  per  se,  which  are  determined  for  the  purpose  of 
identified  market  failures  susceptible  to  be  addressed  through  targeted  public  financial  support 

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from national resources, but to allow for a basis for targeted policy support that can help companies 
to scale in relevant and important sectors. In the current economic context and with a view to the 
sectors  with  high  shares  of  companies  in  the  bracket  250-749  employees,  ,  the  definition  is 
therefore deemed most effective when covering enterprises that are three times the size of SMEs 
to better accompany scaling up of enterprises and to cover a larger number of companies. This is 
expected to yield significant benefits, as demonstrated by the amendments to the acts that are part 
of this package and will be complemented by future use cases. This remains, of course, without 
prejudice to the thresholds deemed appropriate in the State aid context. 

2)  Extending  certain  mitigating  measures  currently  available  to  SMEs  to  this  new  category  of 
small mid-caps 

Following the commitment made in the SME Relief Package35 to assess possible measures to help 
small mid-cap enterprises grow, the Commission has analysed the acquis with a particular focus 
on initiatives considered as burdensome and on including dedicated lighter regimes or mitigating 
measures for SMEs. Extensive consultations with industry and business stakeholders and actors 
(see also section 1.2 for details) have contributed to setting up the list of proposals for amendment. 
The screening has revealed a range of possibilities to ensure better proportionality for small mid-
cap enterprises. 

Initial amendments to the pieces of legislation presented below will be made through Omnibus 
proposals (one for Regulations and one for Directives). 

For  each  act,  an  attempt  is  made  to  estimate  potential  savings  despite  the  inherent  difficulties. 
General order-of-magnitude figures have been derived from both the information provided in the 
impact  assessment  reports  underlying  each  of  the  acts  concerned  and  other  available  relevant 
information  from  the  implementation  of  the  acts.  While  these  impact  assessments  reflect  the 
content  of  the  initial  Commission  proposal  rather  than  the  act  ultimately  adopted  by  the  co-
legislators, they can nonetheless provide an approximation of what costs small mid-caps currently 
incur  and  what  savings  extending  the  mitigating  measures  for  SMEs  to  SMCs  could  bring. 
However, none of the impact assessments specifically look at effects on small mid-caps, or at the 
number of small mid-caps affected, and data used to estimate costs for SMEs are also extrapolated 
for the purpose of this exercise. 

Wherever possible, the cost per company as currently incurred was estimated, based on the impact 
assessment report figures or ex post evaluations. In a second step, the number of small mid-caps 

35 SME Relief Package, COM(2023) 535 final, available at: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=COM%3A2023%3A535%3AFIN. 

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the particular requirement may apply to was estimated. Based on these, the total cost savings per 
measure was calculated. This approach is necessarily limited to the data available. 

2.2.1  General Data Protection Regulation (GDPR) - Regulation (EU) 2016/679 

The GDPR contains a derogation from the obligation to maintain records of processing activities 
for enterprises  and organisations employing  fewer than 250 persons. This  derogation applies if 
their processing is only occasional, not likely to cause risk to data subjects, and does not involve 
special categories of personal data or data on criminal offences. The Omnibus proposal proposes 
that this derogation be extended to SMCs and organisations with fewer than 750 employees and 
be simplified by limiting the obligation to maintain records only for ‘high risk’ processing under 
Article 35 GDPR. 

In addition to SMCs and organisations with fewer than 750 employees, the extended derogation 
would benefit those SMEs and organisations with less than 250 employees which are not, despite 
their size, covered by the current SME derogation and are therefore already maintaining records. 

A  new  threshold  of  ‘high  risk’  processing  would  mean  that  any  enterprise  or  organisation  that 
employs less than 750 people is no longer obliged to create records of processing or update their 
existing records unless their processing activities are likely to present a ‘high risk’ to data subjects. 

According to Eurostat business demography statistics, the number of enterprises with 0 employees 
is around 62%. Based on this, it could be assumed that at least 38% of  SMEs have processing 
activities for which they have to keep records, as they have to process employees’ data regularly 
rather than occasionally, which means they are not covered by the derogation under Article 30(5) 
GDPR. 

Given that there are around 26 million SMEs, this would translate into around 10 million SMEs 
[38% out of 26 million =9.8 million] that are affected by the proposed amendment, provided that 
their processing is not likely to result in a ‘high risk’ to data subjects. 

Assuming  that  90%  of  those  SMEs,  i.e.  around  9  million  SMEs,  do  not  carry  out  ‘high  risk’ 
processing, which would exclude them from the scope of the proposed extended derogation, and 
that around half of those 9 million SMEs [=4.5 million SMEs] would each need to use around 0.5 
hours  every  year  to  comply  with  the  record-keeping  obligation,  mainly  to  update  their  already 
existing  records  when  their  processing  activities  change,  an  annual  saving  of  approximately 
EUR 66 million could be expected, based on the hourly rate from the ‘one in, one out’ calculator 
[= EUR 29.4 x 4.5 million SMEs x 0.5 hour = +/- EUR 66 million]. 

Given the very small population of SMCs compared to that of SMEs, those savings will not be of 
an  order  of  magnitude  that  significantly  impacts  the  rounded  global  figure  of  EUR 60 million 

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estimated for SMEs and SMCs together. Applying the same calculation as for all SMEs above 
would lead to a saving of around EUR 560 000 for small mid-caps [= EUR 29.4 x 38 000 SMCs x 
0.5 hour]. 

However, several caveats apply that could affect the expected saving. These include at least the 
following: 

A considerable number of the 26 million SMEs are likely to carry out processing activities other 
than the processing of employees’ data that could fall in the scope of the current record-keeping 
obligation. An example of this is processing on a regular basis of customer data. Also those SMEs 
would  thus  be  ‘affected’  and  they  could  profit  from  the  proposed  extended  derogation  if  their 
processing is not ‘high risk’. 

There is no factual data supporting the assumption that most SMEs would fall in the scope of the 
extended derogation and that half of them currently use half an hour for maintaining records of 
processing per year. The exact number of SMEs obliged to maintain/update their records depends 
on  whether  those  enterprises  introduce  new  processing  activities  requiring  record-keeping  or 
change their ongoing processing in a way that requires updating the information in their existing 
records. Furthermore, the number of hours used to comply with this obligation depends on factors 
such  as  the  expertise  within  the  organisation  and  the  availability  of  support  measures,  such  as 
simplified templates provided by data protection authorities or the industry. This is likely to vary 
from one SME to another and possibly from one Member State to another. 

In addition to possible savings for SMCs and organisations of the same size, the estimated saving 
does not include the saving for organisations with fewer than 250 employees, which are covered 
under certain conditions by the current derogation. Also some of those entities could be affected 
if their processing is not likely to result in a ‘high risk’. 

The estimated saving does not take into account the possibility that the costs of complying with 
the record-keeping  obligation may be balanced out  to  some extent by possible savings in  non-
compliance costs, such as the loss of reputation, administrative fines, or compensation for damage, 
because the record-keeping obligation supports the general compliance with the GDPR. 

2.2.2  Basic  anti-dumping  and  anti-subsidy  regulations  –  Regulation  (EU)  2016/1036  and 

Regulation (EU) 2016/1037 

These two regulations are part of the EU’s trade defence system, allowing the EU to investigate 
and address dumping and subsidisation by non-EU countries and restore a level playing field in 
the EU market. If an investigation confirms the existence of such practices harmful to EU industry, 
the Commission imposes an anti-dumping or countervailing duty, provided this is not against the 
EU interest. 

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Given  the  technical  nature  of  trade  defence,  and  the  fact  that  investigations  require  active 
involvement from companies in the EU, Regulations (EU) 2016/1036 and (EU) 2016/1037 include 
provisions to overcome the barriers that stop smaller companies from accessing and using trade 
defence.  A  dedicated  helpdesk  offers  general,  no-case-specific  information  on  trade  defence  to 
SMEs,  for  example  on  procedures  or  on  how  to  submit  complaints  to  initiate  cases.  Another 
provision provides that, in investigations where EU industry is fragmented and largely composed 
of  SMEs,  the  investigation  period  should,  whenever  possible,  coincide  with  the  companies’ 
financial  year,  which  facilitates  the  investigations  for  companies  as  much  of  the  data  required 
would be readily available from their financial statements. The Omnibus proposal proposes that 
these  provisions  be  extended  to  SMCs.  This  is  consistent  with  the  objective  of  helping  small 
enterprises understand and gain access to trade defence instruments. 

Since those provisions mainly focus on awareness raising and providing general information about 
trade  defence,  as  well  as  facilitating  companies’  involvement  in  investigations  by,  whenever 
possible,  aligning  the  periods  for  investigation  with  the  financial  year,  there  is  no  quantified 
estimate of how much SMCs may save. 

2.2.3  Markets  in  financial  instruments  –  Directive  (EU)  2014/65  and  Regulation  (EU) 

2017/1129 (the ‘Prospectus Regulation’) 

Regulation  (EU)  2017/1129,  as  amended  by  Regulation  (EU)  2024/2809,  introduced  the  EU 
growth issuance prospectus, a new short-form and standardised prospectus primarily focusing on 
SMEs and companies listed or to be listed on an SME growth market. While SMCs listed on an 
SME growth market can already benefit from the lighter EU growth issuance prospectus, its use 
could be further extended to all offers of securities to the public made by SMCs, irrespective of 
whether  those  offers  are  accompanied  by  a  listing  on  a  multilateral  trading  facility  or  an  SME 
growth market. This would reduce their regulatory compliance burden and potentially make them 
more  attractive  to  investors  (as  an  EU  growth  issuance  prospectus  is  shorter  than  a  standard 
prospectus and hence easier for investors to navigate). 

The  Markets  in  Financial  Instruments  Directive  (MiFID  II)  would  be  amended  to  ease  the 
authorisation of multilateral trading facilities as SME growth markets, by enabling them to list all 
small mid-caps and still be eligible for the SME growth market status. That means that all SMCs 
could  now  potentially  benefit  from  the  less  stringent  disclosures  requirements  under  the  EU 
Growth issuance prospectus regime. While it would be impossible to estimate the actual future 
number of SMCs that will list on SME growth markets (and not all SMCs may want to do so, 
opting for listing, for example, on a regulated market), it is possible to calculate the hypothetical 
maximum cost savings that could be achieved if it were assumed that: (i) all currently listed SMCs 
would list on SME growth markets, and: (ii) all of those SMCs would otherwise list on regulated 
markets, being subject to more stringent disclosure requirement (such as a full prospectus). 

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Under this assumption, the alleviation would apply to approx. 635 companies (or 14% of all listed 
companies, based on the annual average market capitalisation for 2022-2024, source: Orbis) that 
would  fall  under  the  definition  of  an  SMC  (companies  with  a  market  capitalisation  of  up  to 
EUR 1 billion). The impact assessment report accompanying the Listing Act proposal estimated 
that SMEs and other companies that are eligible to use the EU growth issuance prospectus36 could 
save up to 40% of their costs (EUR 20 000 out of EUR 50 000) for drawing up the EU growth 
prospectus  that  pre-dated  the  EU  growth  issuance  prospectus  (the  Listing  Act  considerably 
alleviated the requirements for the EU growth prospectus)37. Savings would be of an even greater 
magnitude (70%) for SMCs that are currently using a standard prospectus and that would now be 
able to benefit from an EU growth issuance prospectus (about EUR 35 000)38.  

Therefore,  if  it  were  assumed  that  drawing  up  an  alleviated  form  of  an  EU  growth  issuance 
prospectus instead of a full prospectus would generate a cost saving of approximately EUR 20 000 
per  company,  the  total  maximum  estimated  cost  savings  for  SMCs  would  amount  to 
EUR 12 700 000 (joined cost savings resulting from amendments to the MiFID II Directive and 
the Prospectus Regulation). This number is however likely to overestimate the actual number of 
‘new uses’ of the EU growth issuance prospectus by SMCs, as some SMCs that are listed on an 
SME  growth  market  (but  not  on  a  multilateral  trading  facility)  can  already  benefit  from  this 
alleviated form of prospectus and some may continue to draw up a full prospectus when they list 
on a regulated market. 

The  Prospectus  Regulation  would  be  further  amended  to  include  a  new  exemption  from  the 
obligation to publish a prospectus for offers of securities to the public where such offers result 
from  actions  taken  by  EU  resolution  authorities  under  the  EU  framework  for  the  resolution  of 
banks or insurers (Directives 2014/59/EU and (EU) 2025/1) or by third-country authorities under 
a comparable legal framework. Additionally, the existing resolution-specific exemption from the 
obligation to publish a prospectus for the admission of securities to trading on an EU regulated 
market would be extended to similar actions taken by third-country resolution authorities. These 
amendments introduce simplification and burden reduction for complying entities and they ensure 
that  resolution  authorities  can  implement  resolution  actions  within  a  timeframe  in  which  the 
preparation and publication of a prospectus would not be possible. SMCs will benefit from the 
improvements brought forward by these amendments in their capacity as clients and beneficiaries 
of the services provided by banks and insurers.  

36 At the time of the impact assessment report, this was still referred to as an ‘EU admission document’. 
37 See Table 4 and Table 12 of the impact assessment report. 
38 See Table 6 of the impact assessment report. 

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A key objective of resolution action is to preserve critical functions provided by banks and insurers 
to the real economy, such as lending, payment and cash services and insurance coverage where it 
is a precondition of economic activity. Resolution action ensures the smooth continuity of these 
functions  provided  to  SMCs,  without  interruption  or  impact  on  their  daily  activities.  This 
particularly benefits SMCs that obtain their services from only one bank and/or insurer instead of 
a diversified range of business partners. Additionally, SMCs benefit from the financial stability 
provided  by  resolution  action,  as  the  disorderly  failure  of  a  bank  or  an  insurer  can  disrupt  the 
normal function of the financial system and subsequently of the real economy.’ Despite a rather 
limited number of resolution cases in the EU, potentially all of the 26 million SMEs and 38,000 
SMCs in the EU could be at risk of falling short of credit facilities or access to cash if the timely 
resolution  of  a  bank  or  insurer  could  not  be  implemented  due  to  the  obligation  to  prepare  and 
publish a prospectus. 

2.2.4  Batteries Regulation - Regulation (EU) 2023/1542 

SMEs' exemption from the rules on due diligence rules and tracing back supply chains could be 
extended to SMCs. The exemption was based on the definition of the high-impact sectors in the 
Commission  proposal  for  a  Directive  on  Corporate  Sustainability  Due  Diligence,  but  the 
provisions on high-impact sectors were not included in the final Directive. 

The impact assessment report estimates EUR 40 000 - 500 000 per year for each company for due 
diligence requirements. It estimated around 50 companies are affected, but the scope substantially 
changed in co-decision and may now affect more than 250 companies. Only a small share of those 
are expected to have a turnover between EUR 40 and 150 million. Since much larger companies 
account for the vast majority of raw materials and volumes of batteries placed on the market, the 
impact of this exemption on the policy objectives is negligible. 

As the number of SMCs affected is estimated to be small, the total savings are likely  to be low 
considering the current market situation. 

2.2.5  F-gas Regulation – Regulation (EU) 2024/573 

The registration requirement should be better targeted to companies that perform activities that are 
covered  by  other  obligations  in  the  F-gas  Regulation  to  serve  the  purpose  of  facilitating  the 
enforcement.  It  is  therefore  proposed  to  limit  the  obligation  to  imports  subject  to  a  reporting 
obligation for companies to the Commission under the F-gas Regulation and to exports of products 
and  equipment  that  are  covered  by  limitations  on  the  global  warming  potential  of  the  F-gas 
contained.  

By better targeting the registration requirement for imports and exports of products and equipment 
containing  F-gases  to  trades  for  which  other  requirements  exist  in  the  F-gas  Regulation,  the 

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administrative costs on traders, in particular small enterprises, will decline without compromising 
the objectives of the Regulation. On the contrary it will allow Member States’ authorities, customs 
and the Commission to focus more on cases relevant for enforcement. 

The  registration  requirement  results  in  one-off  costs  and  costs  to  keep  information  and 
documentation up to date. In cases where the trader is not aware of the obligation to register, there 
are costs associated with  having  goods stopped at  the border until the company has obtained a 
valid  registration  by  the  Commission.  Based  on  experience,  this  concerns  typically  smaller 
enterprises that are not covered by the F-gas Regulation for other reasons and thus not familiar 
with the legislation.  

It  is  very  difficult  to  estimate  how  many  companies  would  be  impacted  in  the  future  by  the 
simplification. The impact assessment for the F-gas Regulation proposal in 2022 estimated that if 
all exporters had to be registered it would affect a high number of companies (approximately 2000) 
and it was not part of the preferred option. Based on recent experience it is clear that the original 
impact assessment underestimated the number. In the first months of 2025 there were more than 
2000 registration requests and modifications per month, many of which are linked to imports or 
exports of relatively few (used) cars. Currently, they are mostly in one Member State and it can be 
expected that a similar situation will gradually occur in other Member States too.  

Hence, assuming conservatively that 2000 new registrations per month will take place also in the 
remaining months of year 2025, there would be 24 000 new registrations in 2025. A conservative 
assumption is a decline  of this number to 12 000 in 2026, and to 1 200 registration requests in 
2027. If the proposed simplification would reduce these requests by 80%, it would result in 6 400 
fewer registrations in 202539, 9 600 in 2026 and 960 in 2027.  

Further, it is assumed that the time used by those companies is equivalent to 1.5 full working days 
per  registration/intervention  at  a  cost  of  EUR  352.8  per  registration 40 .  Consequently,  the 
simplification option is estimated to save 9 600 working days in 2025, 14 400 working days in 
2026 and 1 440 working days in 2027, generating estimated cost savings of EUR 3.4 million in 
2025, EUR 5.1 million in 2026 and EUR 508 000 in 2027. After that time, very few new initial 
registrations would be expected and costs would only remain for updating and completing existing 
registrations, so that cost savings from 2028 would be more limited.  

The amendment is not expected to have any environmental or social impacts. Moreover, the 
change is in line with the preferred option and with the intervention logic in the Impact 

39 Provided the amendment starts to apply from September 2025. 
40 Using the estimated hourly cost of EUR 29.4 from the Administrative Burden Calculator. 

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Assessment that accompanied the Commission proposal in 202241, since the preferred option did 
not include any extended obligation for importers and exporters of products and equipment, 
while taking into account the principle that it is useful to facilitate the enforcement of a new 
limitation that was introduced by the co-legislators on certain exported products and equipment. 

2.2.6  Critical entities resilience – Directive (EU) 2022/2557 

Each  Member  State  must  adopt  a  strategy  for  enhancing  the  resilience  of  critical  entities  by 
17 January 2026. In this strategy, Member States have to provide a description of measures already 
in  place  which  aim  to  facilitate  the  implementation  of  the  obligations  by  the  SMEs  that  are 
identified as critical entities. 

The Omnibus proposes that any facilitating measures that exist for SMEs and SMCs in the Member 
States should be described in the strategy. 

3  CONCLUSIONS – GLOBAL IMPACT OF THE PROPOSAL 

Amending  the  above-mentioned  acts  to  extend  SME  mitigating  measures  to  small  mid-caps  is 
likely to lead to savings not only for SMCs, but also for SMEs and the wider enterprise population. 

While some acts cover all or a large proportion of the enterprise population and are likely to apply 
to most small mid-caps (e.g. the GDPR), other acts only apply to a small sub-section of enterprises 
(e.g. the Prospectus  Act).  Section 2 of this document includes  estimations of  how many SMCs 
might be concerned by each act, to the extent possible. 

Using the figures from Section 2.2 on the potential savings for each act, as well as the number of 
potentially affected SMCs, EUR 20 000-35 000 per company incurred by 635 SMCs per year was 
estimated, stemming from  the Prospectus  Act. These figures would lead  to  a  yearly saving  for 
SMCs on the whole of EUR 12.7 million per year using the lower bound estimates, or EUR 22.2 
million using the upper bound estimates.  

In  addition,  some  simplifications  will  bring  savings  for  both  SMEs  and  SMCs  by  making 
compliance with certain obligations easier. This is notably the case for the GDPR and F-gases. On 
the GDPR, despite the lack of first-hand data, based on a number of assumptions and hypothesis, 
we can estimate that the proposed amendment could save SMEs and SMCs across the EU around 

41 SWD(2022) 96 final. 

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EUR 66 million per year. The F-gas amendment is further estimated to save companies EUR 5.1 
million decreasing over time to 0.51 million per year. 

Taking all these different impacts together, it is estimated that this Omnibus package will save EU 
enterprises between EUR 79.2-93.3 million per year. It has to be stressed that these figures are 
conservative and the true savings are likely to be much larger.  

It should be noted that some acts listed above are not included in this calculation due to insufficient 
data. This is the case for the Trade Defence regulations and the Batteries Regulation. However, 
the revised Regulations and the Critical Entities Resilience Directive will offer qualitative benefits 
for small mid-caps beyond the monetary impact. These largely concern clearer and simpler legal 
obligations and making additional guidance or support structures already available to SMEs also 
available to small mid-caps. 

The  savings  presented  here  can  be  achieved  with  no  negative  impact  on  the  associated  policy 
objectives. The proposed simplifications focus on simplifying existing rules or making it easier for 
enterprises to apply these rules, rather than removing obligations necessary to achieve the policy 
objectives. Importantly, the proposed amendments will not affect the obligations of enterprises to 
continue complying with each act. For instance, the amendment proposed to the GDPR derogation 
from  the  record-keeping  obligation  would  not  affect  the  enterprises  and  organisations’  duty  to 
comply  with  other  GDPR  obligations,  and  it  would  not  compromise  the  risk-based  approach 
underlying this act. Therefore, the proposed measures would still ensure a proportionate and fair 
balance between the achievement of policy objectives and the interests of smaller enterprises and 
organisations. 

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