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Recital 6

Digital Omnibus on AI

(6) Most Union companies are small and medium-sized enterprises, the majority of which are micro and small enterprises. Enterprises outgrowing the micro, small and medium-sized enterprises (SMEs) definition, namely the ‘small mid-cap enterprises’ (SMCs), play a vital role in the Union’s economy. Compared to SMEs, SMCs tend to demonstrate a faster pace of growth, and a higher level of innovation and digitisation. Nevertheless, they face challenges similar to SMEs in relation to administrative burden, leading to a need for proportionality in the implementation of Regulation (EU) 2024/1689 and for targeted support. To enable the smooth transition of enterprises from SMEs to SMCs, it is important to address in a coherent manner the effect that Regulation may have on their activity once those enterprises become SMCs and are faced with rules that apply to large enterprises. Regulation (EU) 2024/1689 provides for several measures for small-scale operators, which should be extended to SMCs where appropriate while safeguarding the overarching objectives and level of protection afforded under Regulation (EU) 2024/1689. In order to clarify the treatment of SMEs and SMCs in Regulation (EU) 2024/1689, it is necessary to introduce definitions for SMEs and SMCs, which should correspond to the definition set out in the Annex to Commission Recommendation 2003/361/EC (6) and Annex to Commission Recommendation (EU) 2025/1099 (7), respectively.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.