State of play, main conclusions, outlook

The evaluation of the new legislative framework was published on 11 November 2022. The NLF for EU product legislation consists of Decision No 768/2008/EC¹  and Regulation (EC) No 765/2008² aiming to improve the Internal Market for goods and boost the quality of conformity assessment of products. Since the provisions of Regulation (EC) No 765/2008 relating to market surveillance were already subject to an evaluation and review and have since been amended by Regulation (EU) 2019/1020³, the NLF evaluation did not include them.

The main purpose of this evaluation was to bring forward an informed analysis of the current performance of the NLF, assessing the effectiveness, efficiency and its relevance in particular given the technological development, the coherence with similar initiatives and the overall EU added value of certain aspects of the NLF.

The weaknesses of the NLF identified in the evaluation are mainly related to the relevance of certain elements of the framework. To be able to respond to the current and upcoming needs of product legislation and preserve its relevance, it might be useful to explore if the NLF should provide a general framework for dealing with the challenges of digitalisation and complex value chains, facilitating remanufacturing and high-quality recycling of products and introducing a digital product passport and digital CE marking.

Estimated savings and benefits

Some of the costs and benefits cannot be directly attributed to the NLF as a framework. Two case studies conducted by the contractor and presented in the SWD on recently evaluated directives, the Electromagnetic Compatibility Directive and the Toy Safety Directive, investigate the issue of attributing effects to the NLF or to the sector-specific legislation. They show also that drawing a line between NLF-related impacts and impacts that should be attributed only to the individual legislation is not straightforward.

Fit for Future Platform

The Fit for Future Platform adopted its opinion on the new legislative framework for products on 12 November 2021. The opinion includes nine suggestions of a wide range measures, as follows:

Suggestion 1: Maintain the European system for harmonized standards

Suggestion 2: Explain regulatory choices

Suggestion 3: Don’t fix what isn’t broken

Suggestion 4: Updating NLF to the current and future business environment

Suggestion 5: Evaluation of Member state’s Notified Bodies

Suggestion 6: Supplementary market surveillance activities focused on compliance processes in companies

Suggestion 7: Digital information and documentation

Suggestion 8: Fit for crisis situations

Suggestion 9: One catalogue of obligations for economic operators

The Commission considered these suggestions in its work, in particular in the evaluation of the framework and also beyond:

To respond to the suggestions of the opinion, based on this evaluation, a possible future revision of the NLF may consider introducing the possibility of the digital CE marking and the digital product passport. The digital product passport could include an electronic declaration of conformity and the description of the conformity assessment procedure.

Regarding the harmonised standards, the evaluation covers the aspects of harmonised standards relevant to the NLF, such as having technologically neutral essential requirements and relying on harmonised standards for presumption of conformity. The evaluation of the standardisation system should be a stand-alone process. It will take into account the evaluation of the NLF, which is already an extensive evaluation in itself covering a significant part of EU harmonised products. The recently adopted Standardisation Strategy provides for a separate evaluation of Regulation (EU) 1025/2012 to assess whether it is still fit for purpose.

Regarding regulatory choices, the NLF was adopted in 2008 to improve the internal market and ensure a high level of protection of public interests (e.g. safety, protection of environment, protection of public health). However, industry, and society at large are fundamentally different today compared to the situation in 2008. As a result, the more recent proposals for product legislation have departed to some degree from the reference provisions of the NLF in that they try to tackle the legal consequences of modifications to products after they have been put into service (the proposal for a Regulation on a regulatory framework for Artificial Intelligence (COM(2021) 206 final) and the proposal for a Regulation on Machinery (COM(2021)202)).

One of the main focuses of the evaluation of the NLF is therefore the relevance of NLF and whether it is fit enough to keep up with the ongoing digital and green transition.

Regarding the focus on improving uniform implementation and enforcement of the harmonised product rules and ensure a high level of protection of public interests, as the Platform suggested, such aspects would also be duly considered in any possible revision of the NLF.

In line with the Platform’s suggestion to updating the framework to the current and future business environment, the evaluation of the NLF indeed assesses the relevance of the NLF, including its definitions. The evaluation takes into consideration that the NLF is based on assessing the safety and compliance of products at the time they are placed on the market and does not address changes that may occur to products after they are put into service. Today, within the circular economy objectives, the Commission encourages that products are reused, refurbished or even remanufactured rather than discarded after being in use for certain time. This is one of the important perspectives of this evaluation.

Avoiding creating burdens and achieving increased efficiency while preserving the policy objectives are core principles that are considered when revising legislation. Findings of the evaluation on these aspects would inform any future potential revision of the NLF.

Related to the evaluation of member states notified bodies, conformity assessment procedures need to ensure that products are compliant in a changing environment. The objectives of promoting the circular economy and ensuring product safety must be equally addressed in the conformity assessment procedure. The NLF evaluation assesses if those procedures are efficient and effective to ensure the safety of products, as well as whether or not they remain relevant. Furthermore, the evaluation also considers the rules and requirements for notified bodies to find out if they are robust enough to ensure the competence of those bodies performing third-party conformity assessment for the purpose of EU legislation, as per Platform’s suggestion.

Regarding the suggestion for the Commission to take notice in the evaluation of the development in several Member States, who are successfully supplementing the traditional market surveillance – focused on products – with market surveillance activities focused on businesses’ knowledge and ability to ensure safety and, in particular, on the quality assurance process set up internally by economic operators to ensure product safety, Regulation (EC) No 765/2008 relating to market surveillance has been recently amended by Regulation (EU) 2019/1020 following an evaluation (SWD (2017) 469). Most of the Regulation’s provisions started to apply 16 July 2021.

The Commission also issued its Guidance on Article 9 of Regulation (EU) 2019/1020 on joint activities to promote compliance. Market surveillance authorities might carry out “joint activities” under Article 9 of Regulation (EU) 2019/1020 on market surveillance and compliance of products with other authorities or organisations representing economic operators or end users, with a view to promoting compliance, identifying non-compliance, raising awareness and providing guidance on Union harmonisation legislation and with respect to specific categories of products, including those that are offered for sale online. If a market surveillance authority decides to carry out such a “joint activity”, it must fulfil the obligations that are laid down in Article 9.

The NLF evaluation also takes into account that products are increasingly digital and continuously modified after they have been put into service. The NLF requires a CE marking that is visibly and indelibly affixed on the product, without the possibility of a digital CE marking. Additionally, certain paper-based documents are to be produced by the manufacturer and in some cases accompany the product. The evaluation looks into whether the NLF should still keep these requirements.

On the digital information and documentation, the evaluation takes into consideration under the relevance aspects the increasing digitalisation and complexity of products, illustrated by the development of the Internet of Things (IoT). Among other issues, the integration of internet connectivity into many products raises considerations regarding how far the horizontal legal framework needs to be updated to integrate cybersecurity, and the linkages between product safety and security.

Regarding the Platform’s suggestion to the Commission to consider an instrument for emergency situations, indeed, the COVID-19 crisis has put to test the resilience of Union product legislation based on the NLF and whether it can cope with an urgency situation. This evaluation assesses whether or not the lack of a crisis instrument renders the NLF less effective or efficient. Furthermore, the Commission Working Programme 2022 – Making Europe stronger together separately from this evaluation of the NLF, includes an initiative for a Single Market Emergency Instrument, which will consist of concrete elements in the short and medium term to respond to supply chain disruptions and possible future shortages.

Finally, regarding the suggestion to the Commission to consider whether it would be feasible to provide an overview of all obligations for economic operators in one place in the NLF Framework Decision it should be noted that the Commission’s proposal for the General Product Safety Regulation (GPSR) takes into account the well-established product safety framework provided for by EU harmonisation legislation. Several obligations set out in the GPSR proposal related to economic operators and market surveillance will not apply therefore to harmonised products. The specific safety requirements provided for in the GPSR proposal will not apply insofar as the risks or categories of risks covered by Union harmonisation legislation are concerned. As concerns market surveillance, the GPSR proposal market surveillance rules align with the provisions of the Market Surveillance Regulation (EU) 2019/1020. The proposal stipulates that relevant articles of Regulation 2019/1020 apply to products covered by the GPSR. Regulation (EU) 2019/1020, which replaced the market surveillance part of Regulation (EU) 765/2008 introduced new definitions, such as ‘fulfilment service provider’, ‘information society service provider’, ‘distance sales’ and ‘online interface’, to capture the new roles associated with the emergence of online marketplaces. Stakeholders who participated to the consolations on the evaluation of the NLF welcome this recent revision and consider that these definitions could serve as a blueprint for refining the conformity assessment procedures applicable to these new types of economic operators in the distribution chain and contribute to the overall coherence of the NLF model.

¹ Decision No 768/2008/EC the European Parliament and the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC, OJ L 218, 13.8.2008, p. 82–128

² Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, OJ L 218, 13.8.2008, p. 30–47.

³ The market surveillance provisions of Regulation (EC) No 765/2008 were already subject to a REFIT evaluation (SWD(2017) 469 final). Since then, a new Regulation (EU) 2019/1020 has been adopted and will replace those provisions as of April 2021.