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The Enterprise Europe Network informs:
11.09.2025
As part of the so-called Omnibus IV package, which we first reported on in February 2025, a draft directive (document COM (2025) 503) and a regulation (document COM (2025) 504) have now been published to amend numerous existing or transitional EU product regulations.
Digital contact addresses and operating instructions
In future, digital contact addresses will be mandatory on product labels . In addition, the draft stipulates that operating and user instructions may also be provided digitally - provided that they remain available online for at least ten years after the product was last placed on the market.
In the case of consumer products , safety-related information and any other product-specific information required by the respective directive/regulation should always be provided in paper form regardless of this. These requirements for digital operating instructions are already prescribed in a similar form in the Machinery Regulation (EU) 2023/1230, for example, which will apply from 20.01.2027.
Electronic evidence for market surveillance
In the event of a request for market surveillance by the authorities, the current drafts also stipulate that the manufacturer or their authorized representative must provide the corresponding verification documents electronically. In practice, such a provision should have little impact, as digital data exchange for such purposes is already common practice.
"Common specifications" as an alternative to standards
Another innovation allows the legislator to issue so-called "common specifications" as an alternative to harmonized standards, i.e. technical specifications that trigger a presumption of conformity with the essential requirements of the directives and regulations. However, this option should only be possible in cases where harmonized standards do not exist or prove to be insufficient to meet the essential requirements. This concept of "common specifications" is currently the subject of numerous position papers (e.g. by DIN e.V. or the Commission for Occupational Health and Safety and Standardization) and its future adoption and implementation is still subject to many unanswered questions
Bavarian SMEs that have questions about the planned changes or are looking for support with international requirements can contact the Enterprise Europe Network team at Bayern Innovativ at any time.
P.S.: Workshops on the topics of CE marking, product safety regulation, etc. can be found here.
Further information & sources:
- Omnibus IV
- EUR-Lex - COM(2025)503
- DIN position paper
- KAN position paper on the Common Specifications
