Digital Transformation of EU Harmonisation legislation under the New Legislative Framework: digitalisation and common specifications

The proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) No 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 as regards digitalisation and common specifications, COM(2025) 504 final, aims to modernize and simplify the EU's New Legislative Framework (NLF) for products by incorporating the principle of "digital by default." The core objective is to reduce administrative burdens on economic operators, particularly SMEs, without compromising consumer safety or market surveillance effectiveness. The document seeks to achieve this by:

• Promoting Digital Documentation: It moves away from mandatory paper-based documentation, requiring the EU Declaration of Conformity and related materials to be provided in electronic form, accessible via an internet address or machine-readable code (e.g., QR code).
• Introducing "Digital Contact": Manufacturers would be required to provide a digital contact, like a web address or a pre-defined communication channel, on products and in documentation to facilitate rapid communication with market surveillance authorities.
• Allowing Digital Instructions: Manufacturers can provide instructions for use in digital formats, but crucial safety information must still be available in a physical form on the product or in paper. Consumers also retain the right to request a paper copy of the full instructions.
• Formalizing Common Specifications: It introduces a legal basis for "common specifications" as an alternative to harmonized standards in cases where standards are unavailable, insufficient, or require urgent action.
• Centralizing Data with DPP: The proposal requires the information from the EU Declaration of Conformity and instructions to be stored within a product's Digital Product Passport (DPP) when such a passport is mandatory under other EU legislation.

The proposal, if approved, will act as an "omnibus regulation," meaning it makes the same changes to multiple pieces of legislation to ensure consistency. It directly amends the following key NLF regulations, such as:

• Machinery Regulation (EU) 2023/1230
• Batteries Regulation (EU) 2023/1542
• Ecodesign for Sustainable Products Regulation (EU) 2024/1781
• Cableway Installations Regulation (EU) 2016/424
• Personal Protective Equipment Regulation (EU) 2016/425
• Appliances Burning Gaseous Fuels Regulation (EU) 2016/426

The changes across these regulations are largely identical: adding a definition of "digital contact," allowing electronic instructions (with safety exceptions), and requiring electronic documentation. This uniform approach avoids inconsistencies and reduces the burden on businesses that manufacture products falling under the scope of multiple regulations. The integration with the Digital Product Passport (DPP) also ensures that data is stored in a single, accessible location, which will be a key compliance requirement for many products moving forward.

The proposal may also affect the Regulation 765/2008 on Accreditation and the Regulation 2019/1020 on Market Surveillance: The proposed changes would directly affect their provisions in the following ways:

• New Definition: The most direct impact is the addition of a new definition for "common specification" to Article 2. This creates a formal, legal pathway for compliance that previously wasn't explicitly defined within this foundational regulation.
• Digitalization of Market Surveillance: The proposal shifts the entire process of information exchange between economic operators and competent national authorities to an electronic-only format. Instead of "paper or electronic," the new rule would be "electronic form" only. This streamlines market surveillance by providing authorities with a standardized digital channel for all necessary documentation and communication.

Keywords CE Marking, Digital Products Passport (DPP), Harmonised Standards, Regulation 765/2025, Regulation 2019/1020