The European Commission continues on its stride to simplify the single market with a new package of measures aimed at cutting €400 million in annual administrative costs for businesses, marking the latest step in a broader campaign to reduce regulatory burdens across the EU. This initiative builds on earlier simplification efforts that already targeted €8 billion in savings. The latest proposals are particularly geared toward SMEs and introduce a new category of companies, referred to as small mid-caps (SMCs) that have between 250 and 749 employees—to ease compliance and free up resources for growth and investment. INSME welcomes this route toward smarter, more proportionate regulation—an essential step to drive innovation, investment, and sustainable growth throughout the Union.
The Commission also proposes simplifying GDPR record-keeping obligations for SMEs and SMCs. Companies with fewer than 750 employees will only need to maintain data processing records when activities are deemed high-risk. This risk-based approach allows businesses to focus efforts where data protection matters most without compromising individuals’ rights.
Digitization is another key focus. The new rules aim to eliminate outdated paper-based requirements in EU product legislation. Companies will be able to submit declarations of conformity and usage instructions digitally, streamlining both business processes and regulatory oversight.
In areas where EU-wide harmonized standards are unavailable, the Commission will provide clearer guidance through common specifications. This will help businesses, especially SMEs, to demonstrate compliance with EU rules more easily, enhancing legal certainty and reducing costs. This comes within the comprehensive strategy titled “Choose Europe”, aiming at making Europe attractive for talent, startups and scaleups.
Commission Executive Vice President for Prosperity and Industrial Strategy Stéphane Séjourné presented the Single Market Strategy, adopted by the College of Commissioners the previous day. The strategy, which aims to tackle the so-called “Terrible Ten”, the most significant obstacles in ten areas that prevent EU businesses from expanding into other member states, stresses the need for greater ambition in services, simplification and digitization, particularly for SMEs, and calls for greater political involvement through the appointment of an internal market “Sherpa” for each member state.
This package is the fourth in a series of Simplification Omnibus initiatives rolled out under the current Commission mandate. Previous packages have already delivered significant administrative relief in areas such as sustainability reporting, EU investments, and agricultural policy. The ultimate goal is to create a regulatory environment that fosters innovation, drives sustainable growth, and supports the EU’s economic resilience in a rapidly changing world.
Read more at: https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1277
Source: INSME Secretariat

