EU: Public consultation on updating the New Legislative Framework and EU product rules

 

The European Commission has opened a public consultation on revising the New Legislative Framework (NLF) and, more broadly, EU product regulations.

Building on the evaluation of the NLF—which highlighted the need for increased digitalisation and various other enhancements—this initiative aims to update the EU’s product-related legal framework, including changes to the rules governing notified conformity assessment bodies.

According to the Commission, modernising the NLF is vital for embedding digital solutions within EU legislation (for example, through the introduction of the Digital Product Passport), supporting the EU’s circular-economy ambitions, and more effectively addressing shortcomings in the practices of notified bodies.

The NLF is composed of two legal instruments: Decision No. 768/2008/EC and Regulation (EC) No. 765/2008, which together serve as core mechanisms for harmonising product legislation across the EU. Decision No. 768/2008/EC sets out a common framework for placing products on the market, containing reference provisions that can be integrated into sector-specific harmonisation rules. Regulation (EC) No. 765/2008, by contrast, establishes requirements for accreditation and the CE marking of products.

The consultation examines a potential revision of the NLF to ensure its long-term suitability and consistency with the goals of digitalisation and the circular economy. The NLF evaluation conducted in 2022 highlighted several deficiencies that have arisen over the past 17 years. These include unnecessarily complex product documentation, uncertainty surrounding refurbished and substantially modified products, inconsistent or occasionally misleading practices among notified bodies, a lack of clarity in conformity assessment modules, and discrepancies in the implementation of trade agreements. Such issues may undermine public-interest objectives—such as consumer safety, public health, environmental protection and the proper functioning of the Single Market.

The consultation addresses, among others, the following themes:

a) Digital product compliance information

The 2022 evaluation of the NLF found that 83% of economic operators consider providing printed materials—such as compliance documentation, safety information and user instructions—to be burdensome. The evaluation suggested that digitalising declarations of conformity and conformity assessment procedures could streamline processes and decrease administrative burdens for businesses.The Commission is therefore asking how instructions for use (other than those directly linked to safety) should be made available to end users. Digital access must be possible without requiring personal data, without needing to download operator-specific apps, and without mandatory registration solely for accessing instructions or safety information. The options include:

• Providing them digitally and on paper together with the product
  • Providing them digitally with the product, with paper copies available upon request at purchase or within six months thereafter
  • Providing them only in digital form
  • Providing them only in printed form

The same options apply for safety-related information (e.g. safety warnings or instructions essential for product safety).
Another question relates to the type of data carrier best suited for accessing digitalised product information, possibly contained within the Digital Product Passport (DPP). Options include:

• QR codes
  • Other barcode formats
  • Contactless technologies such as NFC (Near Field Communication) or RFID (Radio Frequency Identification) tags, which use radio signals to enable wireless data exchange between a tag and a reader, widely used for payments, access control, product tracking and smart packaging.

The Commission also raises the issue of surveillance authorities’ rights. Certain products may remain available to consumers even after market surveillance authorities have identified them as non-compliant or unsafe, and such information may not be accessible to end users. In this context, the Commission asks whether surveillance authorities should have the ability to upload comments or notes regarding the measures taken into the digital compliance tool, so that consumers are immediately informed when scanning the data carrier leading, for instance, to the DPP.

b) Digital product compliance information and e-commerce

As part of revising the NLF, the Commission is contemplating a broader use of digital compliance tools, such as the DPP, thereby creating a general principle for the digital provision of compliance information to be further refined within sector-specific product rules.

At present, many unsafe or non-compliant products enter the Single Market via online sales or distance-selling channels, with a significant share originating from third countries.

The Commission has identified the DPP as a key facilitator for better monitoring e-commerce in its recently published EU Toolbox for Safe and Sustainable E-Commerce, which aims to address the widespread availability of non-compliant goods sold online.

Therefore, the consultation asks to what degree one agrees that market surveillance and customs authorities should have access to digital product compliance information—such as that provided by the DPP—for products offered online, enabling them to conduct compliance checks (e.g. verifying that the product underwent the required third-party conformity assessment).

c) Digital product compliance information and the CE mark

The CE mark represents a manufacturer’s self-declaration that a product complies with applicable EU rules relating to safety, health and other essential requirements or characteristics. It is mandatory for various product categories sold in the European Economic Area. While the 2022 evaluation of the NLF confirmed that the CE mark is highly valuable and generally functions well, it also found certain challenges. Consumer organisations continue to worry that the public mistakenly views the CE marking as a quality or certification symbol rather than a declaration of compliance.

The Commission is therefore considering adjustments to how the CE mark is used as a self-declaration of conformity and seeks opinions on whether the CE mark should be displayed only in digital form—for example by incorporating it into the DPP.

d) Strengthening circularity within the NLF

The 2022 NLF evaluation signals a potential need to introduce, update or clarify several definitions within the NLF and to refine the allocation of responsibilities related to different types of product modifications.

Market surveillance authorities frequently encounter challenges in differentiating between substantially modified (i.e. new), reused or refurbished products, partly due to the absence of definitions for key concepts such as refurbisher, refurbishment, repairer, reuse or repair within the NLF.

Under the Ecodesign for Sustainable Products Regulation (ESPR), ‘refurbishment’ is defined as actions taken to prepare, clean, test, service and, where necessary, repair a product or discarded product to restore performance or functionality within the scope intended at the design stage when originally placed on the market. ‘Repair’, in contrast, refers to actions taken to restore a defective product or waste item so that it fulfils its intended purpose. ‘Remanufacturing’ is defined as a process that produces a new product from waste, products or components by making at least one change that substantially affects the product’s safety, performance, purpose or type.

Although some sector-specific legal acts aligned with the NLF contain definitions of these concepts, the NLF itself does not yet provide a comprehensive set of definitions that captures the range of modifications a product may undergo after being placed on the market. For example, the Machinery Regulation defines ‘substantial modification’ as a physical or digital modification carried out after the product is placed on the market or put into service that was not planned by the manufacturer and may affect compliance with essential health and safety requirements. Refurbishment, by contrast, does not alter a product’s risks or performance.

The Construction Products Regulation defines a ‘used product’ re-introduced to the market and a ‘remanufactured product’, which has undergone a transformative process beyond basic checking, cleaning or repair. The Medical Devices Regulation describes ‘reprocessing’ as a procedure carried out on a used device to make it safe again for reuse, including cleaning, disinfection, sterilisation, testing and restoring its technical and functional safety.

Given the increasing policy emphasis on circular-economy objectives and the lack of a clear overarching legal structure, market surveillance authorities may struggle to assess the compliance of modified products, and economic operators may lack certainty regarding their obligations. This raises the question of whether the NLF should expand its scope to cover any modifications made to products once they have been placed on the market, particularly in light of circularity considerations.

To find out more about product compliance in the EU and the CE conformity assessment, do not hesitate to contact the Product Compliance Institute.