From paper to pixels: The digital makeover of EU product legislation

The European Commission unveiled in May the fourth Omnibus package (“Omnibus IV”), part of its broader Single Market Strategy to modernise and simplify EU product legislation in line with the digital age. Omnibus IV aims to reduce regulatory burdens on businesses, improve legal clarity, and accelerate the digital transition across the EU.

For companies placing products on the EU market, Omnibus IV introduces significant changes — notably the removal of paper-based compliance requirements, the launch of the Digital Product Passport (“DPP”), and the establishment of common specifications as a new conformity assessment tool. In this article, we briefly explore these key developments and their practical implications for businesses operating in the EU.

Background: why Omnibus IV?

EU product legislation currently consists of numerous sector-specific rules governing product safety, labelling, conformity assessment, and environmental requirements. However, overlapping and outdated rules have created complexity and unnecessary costs, particularly for small and mid-sized companies.

Omnibus IV aims to address these challenges by:

• Simplifying regulatory frameworks.
• Reducing paperwork and administrative burdens.
• Facilitating access to the Single Market.
• Driving the digital transformation of product compliance processes.

Introducing “Small Mid-Caps” and postponing Battery Due Diligence

One notable feature of Omnibus IV is the introduction of a new business category, “small mid-caps” (“SMCs”). Defined as companies with fewer than 750 employees and either up to €150 million turnover or €129 million in total assets, SMCs will gain access to regulatory benefits and reduced regulatory burdens previously available only to small and medium-sized enterprises (SMEs).

These benefits include:

• Derogations under the EU General Data Protection Regulation (“GDPR”), Batteries Regulation, and F-gas Regulation;
• Reduced record-keeping obligations; and
• Simplified rules for capital market access, such as eased prospectus requirements for stock listings.

Another significant aspect of Omnibus IV is the proposal to delay the due diligence obligations of economic operators under the Batteries Regulation from 18 August 2025 to 18 August 2027. Under the Batteries Regulation, economic operators are required to implement due diligence policies that address the social and environmental risks (e.g., environment, climate, human health, human rights, labour rights and community life) linked to the sourcing, processing and trading of raw and secondary raw materials (cobalt, natural graphite, lithium and nickel).

The proposal seeks to give businesses more time to prepare by delaying the commencement of the due diligence obligations by two years. It also aims to give the Commission additional time to publish guidelines on the due diligence obligations, originally set for 18 February 2025 but now delayed to 26 July 2026, a year before the requirements are to take effect. 

Digitalisation, Product Legislation and Common Specifications: key changes for product compliance

At the heart of Omnibus IV lies two linked legislative proposals designed to overhaul product compliance through digitalisation and the harmonisation of conformity demonstration – a proposed Directive (COM/2025/503) and a proposed Regulation (COM/2025/504) on digitalisation and alignment of common specifications:

1. “Digital by Default” principle

The Commission proposes that all product compliance documentation — including declarations of conformity and instructions for use — shift to a “digital by default” regime. Under this approach:

• Paper documentation would no longer be strictly mandatory for businesses when placing products on the EU market (except for essential safety information, which would still need to be provided in paper format so as not to compromise the safety of users).
• Companies would be able to provide product information, instructions for use and compliance documents, such as declarations of conformity, electronically, for example via secure online platforms (though they would still need to provide such information in paper format if so requested by consumers). The products would need to be accompanied by the internet address or machine-readable code (QR codes) through which the electronic documentation could be accessed
• Businesses would be required to establish a “digital contact”, an up-to-date and accessible online communication channel through which they could be reached or engaged (without the need to register or to download an application). Exchanges between economic operators and national authorities would also take place electronically.

2. The Digital Product Passport (DPP)

A flagship component of the digital strategy, the DPP, acts as a comprehensive “digital container” of essential product data — from origin and material composition to compliance status and environmental footprint. Introduced by the Ecodesign for Sustainable Products Regulation (“ESPR”) to store information about sustainability, environmental impact and regulatory compliance, it has evolved beyond its initial scope into a general container of digitalised product information.

3. Common specifications: an alternative conformity assessment tool

Currently, businesses typically demonstrate product conformity through harmonised standards, which are developed by standardisation bodies and referenced in EU legislation. Where such standards do not exist, economic operators often have to resort to complex and costly third-party conformity assessments.

Omnibus IV introduces common specifications as a legally binding fallback option, adopted directly by the Commission to fill gaps where harmonised standards are unavailable. The new common specifications will provide an alternative, uniform framework for demonstrating conformity across relevant product legislation and reduce costs and delays associated with conformity assessments.

This measure aims to streamline market access and reduce legal uncertainty, particularly benefiting manufacturers of innovative or niche products without existing harmonised standards.

Next steps

The Omnibus IV proposals were unveiled on 21 May 2025 and will now undergo the EU ordinary legislative procedure. This involves negotiations and approval by the European Parliament and the Council of the European Union. It is expected that trilogue negotiations will start after the summer and latest by October. Given the complexity and broad impact of these proposals, the legislative process may take 12–24 months, potentially resulting in final adoption around late 2026 or early 2027.

What about the UK?

While the EU charges ahead with its ambitious digitalisation reforms, the UK government has indicated forthcoming legislation to modernise product labelling requirements, but no such measures are yet in force.

In January 2024, when the UK government announced the formal introduction of legislation to indefinitely recognise the CE marking for certain products placed in Great Britain (allowing businesses the flexibility of both CE and UKCA conformity assessments), the government also announced its intention to introduce an additional statutory instrument “later in 2024” providing permanent labelling flexibility.

The new legislation would allow the UKCA marking and importer details to be located on a sticky label or accompanying document (not necessarily directly on the product), and it would also introduce a voluntary digital labelling option, allowing companies to apply the UKCA marking, manufacturer details, and importer details digitally.

According to the government’s statement, details of which regulations would be affected by the new measures, as well as the precise implementation timeline, would be provided “in due course”, however, no such announcements have yet been made. As the government’s focus has been on finalising the Product Regulation and Metrology Act 2025 (which received Royal Assent on 21 July 2025), it remains to be seen whether further laws on this matter will be introduced now the Act is place (though the government has identified digital labelling as a key area for exercising its powers under the Act to implement secondary legislation).

What this means for companies placing products on the EU (and UK) markets

Transition to digital compliance documentation:

Manufacturers and importers will have the option to transition away from paper-based declarations, instructions (except safety-related information), and labelling for products placed on the EU market. This would reduce printing and distribution costs, speed up regulatory checks, and provide greater flexibility in updating product information, also facilitating consumer access to information (e.g. via QR codes), noting that accessibility requirements may also apply (for the most recent developments in the realm of digital accessibility, please see our article From Alignment to Autonomy: Digital Accessibility in the EU and the UK Post-Brexit). However, this will likely require investment in digital platforms, training staff, and establishing robust IT systems and secure processes for data storage and exchange. Businesses should review and audit current compliance workflows to identify areas where digitalisation can be implemented effectively.

Preparing for the Digital Product Passport:

DPP will enhance transparency and traceability along the supply chain, facilitate compliance verification by authorities and consumers as well as support circular economy objectives by enabling better product lifecycle management. Affected companies, starting with battery producers, should begin mapping product data flows and identifying information required under the DPP scheme. Early engagement will facilitate smooth compliance. Businesses should also carefully consider and invest in IT infrastructure that supports digital documentation management, secure data exchange, and DPP integration.

Leverage common specifications:

Companies facing challenges in conformity assessments due to lack of harmonised standards should monitor the development of common specifications. These will offer a practical, legally supported alternative, potentially lowering certification costs. Businesses may therefore wish to engage with industry groups to participate in the formulation of common specifications in due course, where possible.

Opportunities for small mid-caps:

Companies that meet the new “small mid-cap” criteria will be able to benefit from reduced administrative burdens and simplified capital market access, helping them scale more efficiently. Businesses should evaluate their eligibility for SMC benefits and adjust corporate governance and compliance policies accordingly.

Monitoring developments:

Companies must carefully monitor these developments, in particular those that operate across both the EU and UK. The UK’s approach reflects a more gradual move towards digital labelling, which will coexist with existing paper-based requirements until permanent reforms are enacted. Businesses should prepare for differing compliance regimes and potentially dual labelling strategies in the medium term.

Conclusion

Omnibus IV signals a fundamental shift in EU product legislation towards greater simplicity, digitalisation, and harmonisation. These reforms will streamline compliance and reduce burdens in the long term, and companies must proactively adapt to new digital requirements, keeping track of the evolving legislative landscape.

Our team of experienced product lawyers is closely monitoring these developments and stands ready to assist clients in navigating the evolving regulatory landscape, ensuring compliance and leveraging new opportunities for growth in the EU and in the UK. Please don’t hesitate to reach out if you have any questions!

Authored by Valerie Kenyon, Magdalena Bakowska, Eshana Subherwal, and Lorena Baltazar.