Legal provisions of COM(2025)501 - Amendment of 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

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dossier COM(2025)501 - Amendment of Regulations (EU) 2016/679, (EU) 2016/1036, (EU) 2016/1037, (EU) 2017/1129, (EU) 2023/1542 and (EU) 2024/573 as ...
document COM(2025)501 EN
date May 21, 2025

Contents

Article 1 - Amendments to Regulation (EU) 2016/679  

Regulation (EU) 2016/679 is amended as follows: 

(1) in Article 4, the following points (27) and (28) are added: 

‘(27) ‘micro, small, and medium-sized enterprises’ means enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC*; 

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

________ 

* Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).  

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

(2) in Article 30, paragraph 5 is replaced by the following: 

’5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 750 persons unless the processing it carries out is likely to result in a high risk to the rights and freedoms of data subjects, within the meaning of Article 35.’; 

(3) in Article 40, paragraph 1 is replaced by the following: 

‘1. The Member States, the supervisory authorities, the Board and the Commission shall encourage the drawing up of codes of conduct intended to contribute to the proper application of this Regulation, taking account of the specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises and of small mid-cap enterprises.’; 

(4) in Article 42, paragraph 1 is replaced by the following: 

‘1. The Member States, the supervisory authorities, the Board and the Commission shall encourage, in particular at Union level, the establishment of data protection certification mechanisms and of data protection seals and marks, for the purpose of demonstrating compliance with this Regulation of processing operations by controllers and processors. The specific needs of micro, small and medium-sized enterprises and of small mid-cap enterprises shall be taken into account.’

Article 2 - Amendments to Regulation (EU) 2016/1036

Regulation (EU) No 2016/1036 is amended as follows:

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

‘The Commission shall facilitate access to the trade defence instrument for diverse and fragmented industry sectors, largely composed of small and medium-sized enterprises (‘SMEs’)* or small mid-cap enterprises (‘SMCs’)**, through a dedicated Helpdesk, for example by awareness raising, by providing general information and explanations on procedures and on how to submit a complaint, by releasing standard questionnaires in all official languages of the Union and by replying to general, non-case-specific queries.’

________ 

* Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

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

(2) in Article 6, paragraph 9, is replaced by the following: 

‘9. For proceedings initiated pursuant to Article 5(9), an investigation shall, whenever possible, be concluded within one year. In any event, such investigations shall in all cases be concluded within 14 months of initiation, in accordance with the findings made pursuant to Article 8 for undertakings or the findings made pursuant to Article 9 for definitive action. Investigation periods shall, whenever possible, especially in the case of diverse and fragmented sectors largely composed of SMEs or SMCs, coincide with the financial year.’.

Article 3 -    Amendments to Regulation (EU) 2016/1037

Regulation (EU) No 2016/1037 is amended as follows:

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

‘.The Commission shall facilitate access to the trade defence instrument for diverse and fragmented industry sectors, largely composed of small and medium-sized enterprises (SMEs)(*) or small mid-caps enterprises (SMCs)(**), through a dedicated Helpdesk, for example by awareness raising, by providing general information and explanations on procedures and on how to submit a complaint, by releasing standard questionnaires in all official languages of the Union and by replying to general, non-case-specific queries.’

________

* Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

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

(2) in Article 11, paragraph 9 is replaced by the following: 

‘9. For proceedings initiated pursuant to Article 10(11), an investigation shall, whenever possible, be concluded within one year. In any event, such investigations shall in all cases be concluded within 13 months of their initiation, in accordance with the findings made pursuant to Article 13 for undertakings or the findings made pursuant to Article 15 for definitive action. Investigation periods shall, whenever possible, especially in the case of diverse and fragmented sectors largely composed of SMEs or SMCs, coincide with the financial year.’.

Article 4 - Amendments to Regulation (EU) 2017/1129

Regulation (EU) 2017/1129 is amended as follows: 

(1) Article 1 is amended as follows:

(a)in paragraph 4, the following point (dc) is inserted:

‘(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;’;

____________

(*)  Directive (EU) 2025/1 of the European Parliament and of the Council of 27 November 2024 establishing a framework for the recovery and resolution of insurance and reinsurance undertakings and amending Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 and Regulations (EU) No 1094/2010, (EU) No 648/2012, (EU) No 806/2014 and (EU) 2017/1129 ( OJ L, 2025/1, 8.1.2025, ELI: http://data.europa.eu/eli/dir/2025/1/oj ).

(b)in paragraph 5, point (c) is replaced by the following:

(2) ‘(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;’;

(3) Article 2 is amended as follows:

(a)the following points (dc) and (dd) are inserted:

(4) ‘(dc) ‘relevant third-country authority’ means a relevant third-country authority as defined in Article 2(1), point (90), of Directive 2014/59/EU or a relevant third-country authority as defined in Article 2, point (74), of Directive (EU) 2025/1;

(5) (dd) ‘third-country resolution proceedings’ means third-country resolution proceedings as defined in Article 2(1), point (88), of Directive 2014/59/EU or third-country resolution proceedings as defined in Article 2, point (72), of Directive (EU) 2025/1;’;

(a)in Article 2, the following point (fa) is inserted:

“(fa) ‘small mid-cap enterprises’ or ‘SMCs’ means any of the following: 

(i)companies which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 750, a total balance sheet not exceeding EUR 129 000 000 and an annual net turnover not exceeding EUR 150 000 000;

(ii)small mid-cap enterprises as defined in Article 4(1), point (13a), of Directive 2014/65/EU;”;

(6) in Article 15a, paragraph 1 is replaced by the following: 

‘1. Without prejudice to Article 1(4) and Article 3(2) and (2a), the following persons may draw up an EU Growth issuance prospectus in the case of an offer of securities to the public, provided that they have no securities admitted to trading on a regulated market:  

(a)    SMEs; 

(b)    SMCs; 

(c)    issuers, other than SMEs and SMCs, whose securities are, or are to be admitted to trading on an SME growth market; 

(d)    offerors of securities that have been issued by issuers referred to in points (a), (b), and (c).’.

Article 5 - Amendments to Regulation (EU) 2023/1542 

Regulation (EU) 2023/1542 is amended as follows: 

(1) in Article 47, the first paragraph is replaced by the following: 

‘This Chapter does not apply to economic operators that had a net turnover of less than EUR 150 million in the financial year preceding the last financial year, and that are not part of a group, consisting of parent and subsidiary undertakings, which, on a consolidated basis, exceeds the limit of EUR 150 million.’;

(2) in Article 52(3), the first sentence is replaced by the following:

‘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.’.

Article 6 - Amendment to Regulation (EU) 2024/573 

Regulation (EU) 2024/573 is amended as follows:

in Article 20(4), point (a) is replaced by the following:

‘(a) the following imports and exports, except in the case of temporary storage as defined in Article 5, point (17), of Regulation (EU) No 952/2013:

(i) the import or export of fluorinated greenhouse gases;

(ii) the placing on the market of products and equipment containing fluorinated greenhouse gases that requires reporting under Article 26;

(iii) the export of products and equipment as referred to in Article 22(3) containing or whose functioning relies upon, fluorinated greenhouse gases with a GWP of 1000 or more as from the prohibition date stated in Annex IV;’.

Article 7 - Entry into force and application 

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union 

Article 4, points (2)(b) and (3), shall apply as of 5 March 2026. 

This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.