Table of contents

1.Introduction

1.1.    Purpose and scope of the evaluation    

2.What was the expected outcome of the intervention?

2.1.    Description of the intervention and its objectives    

2.1.1.    How the intervention fitted in the wider policy framework?    

2.1.2.    Problems and needs that the intervention aimed to address    

2.1.3.    General and specific objectives of the intervention    

2.1.4.    The intervention logic    

2.2.    Points of comparison    

2.2.1.    Reinforcement of the New Approach    

2.2.2.    Supporting the consistency and coherence of EU harmonisation legislation    

2.2.3.    Strengthening the quality of conformity assessment services through improved accreditation of notified bodies    

2.2.4.    Ensuring a clear meaning and credibility of CE marking    

3.How has the situation evolved over the evaluation period?

3.1.    Current state of play    

3.1.1.    The NLF and the reinforcement of the New Approach    

3.1.2.    Supporting the consistency and coherence of EU harmonisation legislation    

3.1.3.    Strengthening the quality of conformity assessment services through improved accreditation of notified bodies    

3.1.4.    Ensuring a clear meaning and enhanced credibility of CE marking    

4.Evaluation findings (analytical part)

4.1.    To what extent was the intervention successful and why?    

4.1.1.    Effectiveness    

4.1.2.    Efficiency    

4.1.3.    Coherence    

4.2.    How did the EU intervention make a difference?    

4.3.    Is the intervention still relevant?    

5.What are the conclusions and lessons learned?

5.1.    Conclusions    

5.2.    Lessons learned    

Annex I: Procedural Information

Annex II. Methodology and Analytical models used

Annex III. Evaluation matrix and, where relevant, Details on answers to the evaluation questions (by criterion)

Annex IV. Overview of benefits and costs

Annex V. Stakeholders consultation - Synopsis report

Annex VI. Conformity assessment – State of Play

Annex VII. Main costs and benefits identified by evaluations of certain NLF-aligned EU product legislation

Annex VIII. Case Studies

Annex IX. RAPEX – SAFETY GATE DATABASE – analysis of the Safety Gate Data

Annex X. Mapping of NLF-aligned legislation

Annex XI. Substantial modification – an overview of the divers definitions of modification of products following their placing on the market

Glossary

Purpose and scope of the evaluation

1 2 The New Legislative Framework (hereafter NLF) for EU product legislation consists of and aiming to improve the Internal Market for goods and boost the quality of conformity assessment of products. Hence, the internal market legal basis is used for both the Decision and the Regulation (Article 95 ECT, which corresponds to Article 114 TFEU, Approximation of laws). Besides Article 95 ECT, the legal basis of the Regulation is also Article 133 ECT (corresponds to Article 207 TFEU under the title Common Commercial Policy). 

3 4 Decision No 768/2008/EC contains a template for future Union product legislation. This Decision lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for legislation revisions or recasts. Currently, there are 23 pieces of legislation and one delegated act aligned to the NLF.

5 Regulation (EC) No 765/2008 established an overall framework of rules and principles related to accreditation, market surveillance, conformity assessment and the CE marking. The market surveillance provisions of this Regulation were replaced by Regulation 2019/1020, which started to apply on 16 July 2021. 

The key concepts used for the evaluation of the NLF are the following:

·New Approach: The New Approach is a legislative technique used to ensure the free movement of industrial products. This technique is inspired by the Cassis de Dijon 6 judgment of the Court of Justice and its key element is the reduced content of legislation to cover only the essential protection requirements which the Court had indicated were the only valid reasons for a national authority to block a product from another Member State. The asset of the New Approach is its flexibility. Keeping the directives and regulations free from detailed specifications has facilitated a flexible legal framework, which is technology-neutral and serves as a catalyst for innovation and growth. It has allowed keeping legislation slim, without frequent adaptations to technical progress, which is an important factor in a business environment characterised by fast developing technologies,

·Notified bodies: Conformity assessment is a responsibility of the manufacturer. However, depending on the risks of the products, the relevant legislation may require that a third party is involved in the conformity assessment procedure. The conformity assessment bodies involved in a third-party conformity assessment procedure based on the EU product legislation need to be designated for such conformity assessment activities. These bodies must be chosen, i.e. designated by the authorities of the Member States on the basis of certain minimum criteria (competence, impartiality, integrity, etc.), which are set out in the NLF. They are then “notified” to the Commission, after which they may carry out conformity assessment activities according to the procedures set out in the EU product legislation.

·Accreditation: The notified conformity assessment bodies may also be accredited. Accreditation is an authoritative statement of the technical competence of bodies whose task is to ensure conformity with the applicable requirements. To avoid that different approaches and differing systems are used throughout the EU for the accreditation of conformity assessment bodies, the NLF developed a comprehensive framework for accreditation and laid down at EU level the principles for its operation and organisation.

·CE marking: The New Approach introduced a common marking of conformity, which had become its most visible and well known element. The CE marking is in effect a declaration by the manufacturer that the product conforms to all the essential requirements of the relevant legislation and that it has been subject to the applicable conformity assessment procedures. Since products bearing the CE marking should be in compliance with the applicable directives and regulations and hence benefit from free circulation, the CE marking operates as a “passport” to the whole EU market.

Since the adoption of the NLF, industry and products have transformed radically, in particular due to the digital and the circular economy aspects. It needs to be reassessed whether the NLF continues to be fit for purpose in the current economic reality and the conformity assessment procedures still ensure that products placed on the Union market are safe and compliant with the applicable legislation. In addition, it is necessary to assess whether the NLF is also sufficiently able to cope with an increasing demand for integration of environmental aspects into product legislation.

The main purpose of this evaluation is 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.

In particular, the assessment focuses on whether:

a)the NLF is fit to address the way products may be changing during their lifetime to both support the take-up of smart connected or remanufactured products and to ensure safety;

b)the conformity assessment procedures remain fit for purpose and ensure the safety and compliance with the applicable requirements of the products placed on the Union market;

c)the rules for notified bodies are robust enough to ensure the competence of those bodies;

d)the accreditation system functions well and ensures that the competence of the notified bodies intervening in the conformity assessment procedures is sufficiently guaranteed;

e)affixing the CE marking and other product information physically to the product itself continues to be appropriate; and

f)the lack of a crisis instrument for urgency situations renders the NLF less effective or efficient.

Although the focus of the evaluation is retrospective, a forward-looking dimension is unmissable to assess the relevance of the NLF and its fitness for purpose. The evaluation takes into account the ongoing regulatory developments serving the digital transition. Legislative proposals that are relevant for the evaluation include the Proposal of the AI Act 7 , the Proposal of the Machinery Regulation 8 , the Proposal for the regulation on batteries and waste batteries and Proposal for a Regulation establishing a framework for setting eco-design requirements for sustainable products . Regarding the green transition and the circular economy, this evaluation takes into consideration also the Circular Economy Action Plan 9  and the regulatory pressure it created to integrate environmental aspects into product legislation. The evaluation also takes into account the Proposal of the General Product Safety Regulation (GPSR) 10 , which sets up a new horizontal framework for product safety of consumer non-food products in the EU. This evaluation is prepared with a view to provide a solid basis for a possible future impact assessment. 

Consequently this evaluation includes an evidence-based assessment of the extent to which the NLF might be able to accommodate the following developments in product markets and in manufacturing processes:

·Ability of products to change after they have been placed on the market, for instance due to software, firmware or hardware updates and upgrades, or through the continuous learning capabilities of machine learning systems.

·Increasing digitalisation and complexity of products, internet connectivity of certain products raises considerations regarding cybersecurity and product safety.

·Changes in manufacturing value chains and emergence of alternative means of production (e.g. 3-D printing) resulting in the blurring of delineations between economic operators, as well as between products and services.

·Circular economy developments, including increasing focus on placing on the market of products following their repair, refurbishment, and remanufacturing.

Scope of the evaluation

11 12 The material scope of this evaluation does not include the provisions of Regulation (EC) No 765/2008 relating to market surveillance, which were already subject to an evaluation and review and have since been replaced by Regulation 2019/1020.  

This evaluation conducts an evidence-based review of the performance of the NLF in the following key areas:

·Alignment of Union harmonisation legislation to the NLF’s common principles and reference provisions.

·Conformity assessment rules and procedures.

·Framework and rules for the accreditation and notification of conformity assessment bodies.

·CE marking and administrative requirements.

The material scope of the evaluation is extended to the specific pieces of EU product legislation that had been aligned with the NLF, in order to demonstrate the performance and impact of the NLF through the main evaluation criteria.

The evaluation does cover 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. However, it does not address the EU standardisation system beyond those aspects. The Evaluation of the standardisation system should be a stand-alone process.

The recently adopted Standardisation Strategy  announces a launch of a separate evaluation of Regulation (EU) 1025/2012 to assess whether it is still fit for purpose.

13 This evaluation builds upon and complements an earlier evaluation for the internal market legislation on Industrial products. The scope of this earlier evaluation was overarching and broad in nature, covering many New Approach directives, but only a few pieces of product legislation had been aligned to the NLF.

14 15 16 The temporal scope of the evaluation covers the period from 2014 to 2020. As already mentioned, Decision No 768/2008/EC only contains reference provisions to be integrated into the different pieces of product legislation. The Package of ten Directives to be aligned with the reference provisions and approaches outlined in the NLF was adopted in 2013-2014. Regarding the geographical scope, the evaluation covers EU Member States as well as the three additional State Parties to the EEA-EFTA Agreement (Iceland, Lichtenstein, Norway). It corresponds to the geographical scope of the NLF, considering that both the Decision and the Regulation are incorporated into the EEA Agreement.

Methodological approach

This Staff Working Document builds on the Study that was carried out for the European Commission – DG GROW by the Centre for Strategy & Evaluation Services ( CSES ), supported by the Centre for Industrial Studies ( CSIL ) 17 .

The Study has been conducted using a number of different research tools that have allowed for a verification and cross-checking of the evidence in accordance with triangulation principles.

It was challenging but necessary to methodologically design the evaluation in such a way that the effects of the horizontal NLF framework can be clearly distinguished from the effects of the product-specific legislation.

The assessment of the performance of the NLF is indeed almost inseparable from the performance of the specific pieces of EU product legislation, which sets limitation to the assessment of costs and benefits attributable to the NLF and especially to their quantification. Nonetheless, the case studies and all the evidence collected is carefully selecting the information relevant for the performance of the NLF.

The methods used include: an extensive desk research; consultations (both targeted and public consultations); direct interactions with stakeholders (via interviews and a validation stakeholder workshop); case studies.

A detailed description of the methodology and main sources of information for this evaluation are provided in Annex II.

2.1.    Description of the intervention and its objectives

2.1.1.    How the intervention fitted in the wider policy framework?

In 1985 the Commission proposed the so called New Approach. Instead of setting out detailed technical requirements in product legislation according to the Old Approach, the New Approach directives limit themselves to defining essential requirements in relation to issues such as health, safety, consumer protection and the protection of the environment.

On the basis of the feedback received from the stakeholders in a public consultation on the functioning of the New Approach, in March 2003, the Commission adopted a Communication entitled “ Enhancing the implementation of the New Approach directives 18 ”, setting out the main elements for the review:

1.Lack of confidence in notified bodies and in the whole notification process;

2.Weaknesses in market surveillance and efficient and consistent enforcement of the directives;

3.Inconsistencies between different directives;

4.Misunderstanding of the value and role of CE marking.

Following this, the Impact Assessment of 2007 accompanying the NLF Regulation and the Decision was prepared in 2007. 19  

The broader EU policy and legal context in which the NLF was developed is also important to mention. Besides the EU Industrial Policy-related interventions and goals, such as having an efficient and effectively functioning internal market in which European manufacturers, and in particular SMEs, can thrive, the Better Regulation agenda was also important. There was a need to strengthen regulatory coherence across the EU harmonisation legislation, but also to reduce the burden of red tape to promote efficiency savings for industry.

2.1.2.    Problems and needs that the intervention aimed to address

In the Impact Assessment of 2007 , there were six key needs and problems facing the EU that the NLF sought to address. These are detailed below.

·Recognition that the New Approach to harmonisation legislation needed to be updated. Although it supported the implementation of individual pieces of harmonisation legislation, the New Approach required a modernisation to become a more common approach across the EU product legislation, to strengthen coherence and consistency among the different pieces of product legislation.

·Need to ensure the free movement of goods within the Single Market in the most efficient and effective way. Setting general principles and a horizontal framework was seen as a means of removing the remaining obstacles to the free movement of goods.

·Need to surmount inconsistencies among the different pieces of legislation developed over a 30-year period. This necessitated the introduction of a horizontal regulatory framework to provide as much commonality across the legal framework as possible, whilst allowing flexibility for some divergence where necessary for specific sectors.

·Need to enhance cooperation and a more uniform approach to monitoring compliance with Union harmonisation legislation through more effective and better coordinated market surveillance and enforcement activities. This is mentioned as it constitutes part of the overall picture. However, as already explained, market surveillance is outside the scope of this evaluation.

·Conformity assessment practices in 2008 were perceived unsatisfactory, with insufficient attention across the EU to ensuring the high quality of conformity assessment services at national level. Therefore, strengthening the quality of accreditation procedures for conformity assessment bodies (including notified bodies) was an imperative.

·Need to enhance the credibility of CE marking. Whilst the CE marking was widely recognised internationally contributing to the development of the single market, industry stakeholders perceived that the CE marking was being undermined by low levels of compliance with the applicable EU legislation that allows the manufacturer to affix the CE marking, especially among some manufacturers in third countries. 20  

2.1.3.    General and specific objectives of the intervention

The general objectives set out in the Impact Assessment of 2007 of the NLF are to ensure a high level of protection of public interests and the free movement of goods throughout the EU within a flexible and innovation-friendly legal framework,

The specific objectives that are covered by the scope of this evaluation foreseen to achieve these general objectives of the NLF are the following:

1)To reinforce the implementation of the New Approach, such as setting technology-neutral essential requirements and leaving detailed technical aspects of implementation to the development of non-mandatory harmonised standards.

The NLF was expected to fill in the gaps and simplify implementation to reinforce its capacity to ensure a high level of protection and the free movement of goods throughout the EU within a flexible and innovation-friendly legal framework.

2)To strengthen the consistency and coherence of Union harmonisation legislation

The NLF was expected to provide economic operators with a clear and consistent legal framework to ensure better overall coherence of EU legislation and to simplify its implementation. This objective was to be achieved thanks to the regulatory toolbox established by the NLF to revise existing and to develop new Union product legislation.

3)To strengthen the quality of conformity assessment services through the improved accreditation of notified bodies and improve the monitoring of notified bodies by national authorities

The rules of the NLF relating to the operation of notified bodies and accreditation were expected to ensure equal conditions for conformity assessment bodies and avoid unfair competition which undermines the quality of conformity assessment.

4)To strengthen the efficiency and effectiveness of the enforcement of EU legislation to reduce the incidence of non-compliant products on the market

This objective relates to the NLF’s role in improving market surveillance in different ways. Whilst outside the scope of this evaluation, this is a crucial element of the NLF.

5)Clear meaning and enhanced credibility for CE marking.

The NLF was expected to reinforce the importance and enhance the clarity of the CE marking through setting out general principles and reference provisions to be integrated in new and revised EU product legislation.

2.1.4.    The intervention logic 

The NLF’s intervention logic aims to examine the inter-relationships between the different components relating to the NLF:

1)The needs and problems;

2)The general and specific objectives that it seeks to achieve;

3)The inputs (e.g. human and financial resources) required in order to achieve these objectives, the activities and implementation processes and the expected effects. The intended causal chains, seen from a theoretical perspective, have been integrated into the mapping. These are shown in terms of the linkages between the general and specific objectives of the NLF, and the outputs (shorter-term outcomes), results (intermediate outcomes) and impacts (longer-term outcomes) that are expected to be achieved through the NLF.

The following figure provides a visual overview of the intervention logic:

Figure 1 Intervention logic

2.2.    Points of comparison

In this section we will look back to the situation in the area of EU product legislation before the intervention – the adoption of the NLF.

The separate points of comparison in this section are structured around the specific objectives against which the intervention is assessed, while the description of the pre-intervention state-of-play relies on the findings of the Impact Assessment of 2007 . 

2.2.1.    Reinforcement of the New Approach 

The Impact Assessment of 2007 report explained that the harmonisation legislation and the New Approach could still be improved.

The New Approach directives are based on technological neutrality. They contain only the essential requirements the product has to fulfil, while products manufactured according to harmonised standards are deemed to be compliant with those essential requirements. Technical specifications, in the form of standards 21 allow products to meet the essential requirements needed and are considered as an ‘easy’ way to meet compliance with the legislation (presumption of conformity). The use of standards guarantees the required level of safety of products, but the use of harmonised standards is voluntary and a manufacturer may use any other technical solution which demonstrates that his product meets the essential requirements.

If a product is not manufactured along the harmonised standards, the manufacturer has to demonstrate the compliance of the product with the legal essential requirements. This New Approach and technical harmonisation have successfully contributed to eliminating some barriers to trade, but there were still weaknesses in the legislative framework, which prevented consumers and enterprises from fully exploiting the benefits of the Internal Market.

The then existing rules were often criticised as burdensome or for being uncertain or inconsistent. Also, within the 25 New Approach directives confusion has arisen due to inconsistencies in the requirements for the various elements making it increasingly difficult for all market players and national authorities to comply.

This has resulted in a lack of credibility and confidence in the system.

2.2.2.    Supporting the consistency and coherence of EU harmonisation legislation

According to the Impact Assessment of 2007 , inconsistencies and legal uncertainty in the pre-NLF regulatory framework were significant. 22

This represented a problem especially in case of products that had to comply with different pieces of EU product legislation 23 . 

Another problem in this context was the discrepancy of conformity assessment procedures. The individual directives have not always stuck to the text of the decision, which was confusing to manufacturer of a products covered by several different pieces of product legislation. 24  

Differences also existed regarding the information which had to be contained in the declaration of conformity. This led to different interpretations in the Member States which jeopardised the free movement of goods in the Community.

2.2.3.    Strengthening the quality of conformity assessment services through improved accreditation of notified bodies

Product legislation sometimes requires that a product is tested, inspected or certified by an independent third party, a “notified body”, before it is placed on the market. Notified bodies hence played an important role already within the New Approach system to guarantee the safety of products on the market. Their competence and capacity to carry out their tasks correctly has always been crucial. The Impact Assessment of 2007 , however, identified a lack of confidence in notified bodies and in the whole notification system. The main issues were the following:

·Uneven level of conformity assessment services provided by notified bodies

The interpretation of safety and procedural requirements often varied significantly from body to body. 25  Problems experienced with notified bodies were also relevant in an environmental context. 26  

·Lack of transparency and different approaches in the competence assessment and monitoring of notified bodies

Industry, public authorities and notified bodies themselves doubted that all notified bodies actually possessed the required competence to carry out the tasks for which they are notified. 27 60% of participants in the public consultation supporting the IA 2007 considered that notified bodies were not sufficiently monitored.

·Unnecessary burdensome requirements in the notification procedure

The notification procedure was significantly simplified and accelerated due to the introduction of "NANDO-Input" 28 , a web-based application designed for the direct notification of conformity assessment bodies, which has been operational since April 2006.

However, the pre-NLF legal framework obliged the Commission to publish a list of notified bodies in the Official Journal of the European Communities for information purposes before encoding them in the NANDO database. The lists were typically published once per year, whereby there was sometimes a significant time period between the notification of a body and the publication of a new list.

·Lack of an EU framework for accreditation and the legal status of the European Cooperation for Accreditation (EA)

Different approaches and differing systems for accreditation existed throughout the EU causing an uneven level of rigour throughout Member States 29 30 .

Member States co-ordinated their accreditation activities through the framework created by a pan-European organisation known as EA 31 . However, the position and influence of EA was limited by its legal status and its recognition by public authorities varied from Member State to Member State, due to the lack of common legal basis and of regulation on accreditation at EU level and a harmonised accreditation policy.

2.2.4.    Ensuring a clear meaning and credibility of CE marking 

By affixing the CE marking to the product the manufacturer declares that the product is in conformity with all applicable directives providing for the CE Marking. A product bearing CE marking, benefits from the free movement of goods inside the Union. However, pre-NLF legal texts did not give a definition or explained the meaning of the CE marking.

The CE marking was well known in the marketplace but its meaning was often unclear. 32  

CE marking represented the whole system of product conformity under the New Approach, and therefore weaknesses in the functioning of the system undermined the confidence in the CE marking. Lack of confidence in the CE marking had negative repercussions on industry. Manufacturers needed to have enhanced recourse to additional marking/testing to ensure the confidence of the market place in their products.

This section will outline the evolution of the EU product legislation following the adoption of the NLF. The state of play is presented focusing on outputs, results and impacts. To ensure a logical flow that is easy to follow, the presentation of the developments is structured around the specific objectives of this evaluation, similarly to the points of comparison in the previous section (see subtitles 2.2.1. – 2.2.4.).

3.1.    Current state of play

3.1.1.    The NLF and the reinforcement of the New Approach

Thanks to the NLF, the New Approach gained ground in NLF-aligned EU product legislation, which ensured the uniform application and reinforcement of the New Approach. The reference provisions, often called as a regulatory toolbox, set out in Decision No 768/2008/EC ensured the availability of common definitions for the sectoral product legislation.

The NLF-aligned legislation is therefore reflecting the same structure and content of the common regulatory toolbox and its reference provisions. The regulatory toolbox, a model for revised and new product legislation, became available to facilitate the revision of existing and drawing up of new Union harmonisation legislation 33 .

The reinforcement of the New Approach via the NLF also comprises the emphasis of technological neutrality of product legislation and the presumption of product compliance with the essential requirements set out in the legislation and expressed in technical terms in the harmonised standards.

The Study of the CSES showed that this feature of the NLF is highly appreciated.

However, when harmonised standards are not available, the manufacturer may only rely on third-party assessment to prove that the product meets the essential requirements laid down in the legislation (See Chapter 4.1.1.).

3.1.2.    Supporting the consistency and coherence of EU harmonisation legislation

Definitions and common reference provisions are integrated in all NLF-aligned legislation. The aligned legislation may depart, totally or partially, from the common principles and reference provisions laid down in Decision No 768/2008/EC on account of the specificities of the sector concerned. However, any such departure should be justified. 34  

Following the adoption of the NLF, the gradual alignment of EU product legislation started and still continues. For example, although the Machinery Directive has not yet been aligned to the NLF, the recent Proposal of the Machinery Regulation does envisage alignment.

The number of the product legislation aligned with the common framework of the NLF from 2008 is 23 and on delegated act and they are presented in the table below:

Table 1 Aligned EU legislation and non-legislative acts of general application

In general, the alignment of product legislation to the NLF has resulted in limited differences across the 23 pieces of NLF-aligned legislation and one delegated act, which have been partly removed through further horizontal harmonisation brought by Regulation (EU) 1025/2012 and Regulation (EU) 2019/1020. This perspective is clearly illustrated by the responses to the targeted consultation.

The legislative mapping included in the Study of CSES compares the legal text of the 23 NLF-aligned legislation with the NLF reference provisions. This exercise demonstrates that there are only minor differences across the entire body of the NLF-aligned legislation (please see Annex X – Mapping of the NLF aligned legislation).    

Union harmonisation legislation imposes an obligation on the manufacturer to draw up and sign an EU Declaration of Conformity before placing a product on the market. The model for this declaration is contained in Annex III of Decision No 768/2008/EC. The NLF-aligned product legislation either refers to that model declaration or the model is directly annexed to the sectoral Union harmonisation legislation at stake. 35  

The integration of common reference provisions resulted in better alignment of the requirements for economic operators and of the approach to marketing products on the internal market. In addition, the Study of CSES shows that in the past ten years regulations are representing a growing trend comparing to directives as harmonisation instruments. Considering that regulations are directly applicable and do not need transposal to the national systems of the Member States, this choice of instrument is also preferred by the industry because it allows less scope for ambiguity and divergence in interpretations and implementation. 36

3.1.3.    Strengthening the quality of conformity assessment services through improved accreditation of notified bodies 37

To ensure a uniformly high level performance of notified bodies and their fair competition throughout the Union, the legislation that follows the NLF set out obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services 38 . To guarantee a consistent level of quality in the performance of conformity assessment, the legislation that follows the NLF set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of bodies. The system of notified conformity assessment bodies set out in Decision No 768/2008/EC is complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Although not mandatory for all notified bodies, accreditation is the most preferred means of verifying the competence of conformity assessment bodies. It provides an authoritative statement of the competence, professional integrity and impartiality of the bodies to be notified to the Commission and the other Member States.

The NLF strengthened the supervisory role of notifying authorities. When it ascertains that a notified body no longer meets the requirements set out in the relevant directive or regulation or is failing to fulfil its obligation, the notifying authority may restrict, suspend or withdraw the notification 39 .

The notification system also became simpler. The notified bodies encoded in the NANDO database do not need to be published previously in the Official Journal of the EU.

The adoption and practical implementation of the EU legal framework for accreditation is a very important achievement under the objective of strengthening the conformity assessment system in Europe.

The NLF created the European system for accreditation of conformity assessment bodies. Regulation (EC) No 765/2008 recognised the EA as a single organisation at European level and introduced a mandatory membership of the national accreditation bodies in the EA. The EA is responsible for the peer evaluation for its members (national accreditation bodies).

The conformity assessment system detailed in the NLF 40 underpins the entire internal market, as it represents the means by which economic operators demonstrate the compliance and conformity of their products with the essential requirements laid down in specific product legislations.

3.1.4.    Ensuring a clear meaning and enhanced credibility of CE marking

One of the key needs of the internal market at the time when the NLF was developed was to clarify and enhance the meaning of the CE marking.

The CE marking indicates that a product is declared by the manufacturer as in conformity with Union harmonisation legislation. CE marking is the visible consequence of a whole process comprising conformity assessment in a broad sense.

Member States are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. This also applies to products made in third countries which are sold in the EU.

Regulation (EC) No 765/2008 lays down the definition, the format and the general principles governing the CE marking, while Decision No 768/2008/EC provides for the reference provisions to be integrated into product legislation on the general principles of CE marking (Article R11) and the rules and conditions for affixing the CE marking (Article R12).

The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate 41 . 

Several pieces of Union harmonisation legislation foresee additional markings that are complementary and non-overlapping to the CE marking 42 .

4.1.    To what extent was the intervention successful and why? 

This chapter will outline the success of the NLF in terms of its effectiveness (fulfilling expectations and meeting the objectives), efficiency (in terms of the proportionality of its cost and benefits) and coherence (internal and external).

The evaluation matrix in Annex 2 of the underlying Study , which is also included in Annex 3 of this SWD, lists the data and information sources and evidence base, as well as the assessment methods of the general and specific objectives of the NLF. The methods used for assessing the specific objectives are desk research including legal mapping, targeted survey and the interview program. RAPEX-Safety Gate and NANDO were also used as a source of information when relevant.

In general, according to the majority of stakeholders, the NLF has provided a satisfactory benchmark for sectoral legislation that has been revised or modified since 2008, particularly considering the omnibus alignment of ten sectoral directives adopted in 2014 (see in Chapter 1.1., footnote 14 and 15).

Respondents to the consultations were likely to consider the NLF to have been effective in achieving its general objectives: The reinforcing of the free movement of products within the single market and ensuring a high level of protection of public interests. Based on the triangulation of the results of the consultations and interviews, stakeholders consider that it also succeeded in achieving of its specific objectives, which are the reinforcing of the technology neutral approach, better coherence, strengthened conformity assessment and enforced visibility and clarity of the CE marking system.

4.1.1.    Effectiveness

a)Reinforcement of the New Approach

The NLF ensured the reinforcement of the New Approach thanks to the creation of the regulatory toolbox and common definitions. All the NLF-aligned legal instruments are using the same definitions such as ‘manufacturer’ or ‘placing on the market’. This aspect of the effectiveness of the NLF is highly appreciated particularly when products are covered by more than one product legislation. The evidence used for the assessment was based on desk research including the legal mapping 43 and confirmed in the targeted surveys, interviews and validation workshop.

The NLF also managed to reinforce the technology-neutral approach to setting essential requirements for the EU product legislation.

The results of desk research are complemented here by the results of the targeted survey, interview program and stakeholders’ workshop. The majority of stakeholders throughout all stakeholders groups in the targeted consultations (84.1%, 174/207) considered the use of harmonised standards to have been effective as a voluntary mechanism for achieving of conformity with the essential requirements. They consider that as a technologically neutral regulatory framework based upon essential requirements, the NLF is perfectly suited to cope with the higher speed of technical innovation and customization coming with digitization, avoiding the stiffness and inflexibility of technical provisions fixed in laws.

Stakeholders in the interviews and targeted consultations often stress, however, that the effectiveness of the NLF might be jeopardized by reasons that despite not stemming from the NLF, may have a serious impact on its implementation. If harmonised standards are not available the moment when the new EU product legislation starts to apply (see title 3.1.1. above), manufacturers do not have recourse to harmonised standards and cannot rely on the presumption of conformity with the essential requirements. National competent authorities pointed out that the success of the NLF depends heavily on having a quick and effective standardisation process. If the citation of harmonised standards is too slow (or, effectively, non-existent), this renders market surveillance more difficult, to the detriment of the level-playing field for companies.

On one hand, the demonstration of conformity in the absence of harmonised standards represents a more serious financial burden 44 for manufacturers, because they may only rely on third-party assessment instead of harmonised standards to prove that the product meets the essential requirements laid down in the legislation. They would need to have recourse to documenting compliance with different generations of standards, which leads to additional costs.

On the other hand, the delay in adopting new standards is hindering innovation 45 , because the manufacturers that are departing from the standards to introduce innovative solutions are not able to rely on the presumption of conformity with the essential requirements. In that case, the presumption of conformity with the standards might become a double-edged sword: If the harmonised EU standards lag behind the newest international standards representing the state of the art, the NLF is not able to perform as expected. The presumption of conformity with a legal provision conferred by conformity to a harmonised standard would not seem to support innovation.

Specific product legislation should, wherever possible, avoid going into technical details. It should limit itself to the expression of essential requirements. However, where health and safety, the protection of consumers or of the environment, other aspects of public interest, or clarity and practicability so require, detailed technical specifications may be set out in the legislation concerned.  46 Nonetheless, industry stakeholders are highlighting that there is a trend in the new legislative proposals of EU product legislation to incorporate more granular technical requirements. Better implementation of the NLF, without technical details included in the product legislation whenever it is not absolutely necessary would help ensure the technological neutrality of the framework. According to these stakeholders, the impact of this tendency is reduced flexibility of the NLF-aligned legislation and of the framework to deal with changes in the market, an erosion of the principle of technological neutrality, resulting in negative impacts on innovation and competitiveness.

The performance of the NLF regarding its general objective to ensure the safety of products through the EU has been demonstrated in the Study of the CSES relying on the RAPEX-Safety Gate database (Annex IX). Nonetheless, the attribution of the results of this analysis is significantly impacted by the different market trends and changes for different products (including the increase of e-commerce from third countries) and also by the different practices of the national market surveillance authorities. These factors strongly influence both the number of unsafe products identified and reported via Safety Gate, and their proportion by product category from one Member State to another.

Based on the triangulation of the evidence collected in this evaluation we conclude that the NLF shows a high level of effectiveness in ensuring the reinforcement of the New Approach, relying on the technological neutrality of legislation containing only essential product requirements. Nonetheless, the full achievement of this approach requires consistency of the legislator not to include more detailed requirements into EU product legislations than necessary. It also requires the prompt delivery of harmonised standards, which is outside of the scope of the NLF.

b)Supporting the consistency and coherence of EU harmonisation legislation

The mapping of NLF-aligned legislation in Annex X corroborates the results of the surveys that the NLF showed a high level of effectiveness in regard of the alignment of EU product legislation 47 . The majority of respondents perceive that the NLF has been effective in facilitating the consistency and coherence of different EU harmonisation legislation.

44.8% of stakeholders (94 respondents) consider that, overall, the NLF has been effective to a great extent in facilitating the consistency and coherence of different EU harmonisation legislation for products, while 32.9%, (69 respondents) consider it to have been effective to a moderate extent.

However, views varied considerably by stakeholder type. Among the larger groups of stakeholders (types with over ten responses), national accreditation bodies were most likely to consider that the NLF has been effective in facilitating the consistency and coherence of different EU harmonisation legislation for products ‘to a great extent’: 80% held this view (16 responses). National notifying authorities were least likely to share this view (26.3%, five responses), just behind notified bodies / conformity assessment bodies (27.9%, 17 responses) and MSAs (28.6%, six responses). The reason for the differences in views of accreditation bodies on the one hand and notifying authorities on the other hand may lie in the different level of harmonisation of accredited and non-accredited notified bodies. The accreditation framework established by the NLF relies on accreditation standards and peer evaluation conducted by the EA. In some Member States only accredited conformity assessment bodies may become notified bodies, while in others accreditation is not mandatory for the notification. Desk research and the interviews conducted by the contractor showed 48 that the common reference provisions in the aligned sectoral legislation led to reduced divergences among those legislations. Businesses are able to find the same types of provisions in the different pieces of product legislation: definitions; the obligations of economic operators (manufacturers, authorised representatives, importers, distributors); conformity of the product; EU declaration of conformity; general principles and rules on CE marking; notification and rules on notified bodies and safeguard procedures. The obligations of the economic operators are clear and repetitive from legislation to legislation, therefore the efforts of familiarisation with the harmonisation legislation are less burdensome. Furthermore, Annex II of Decision No 768/2008/EC contains the different types of conformity assessment modules (from self-assessment to various types and rigour of third-party assessments) among which the legislators of the sectoral legislation may choose, depending on the risk related to specific products.

The 2014 Evaluation of the Internal Market Legislation for Industrial Products already concluded that the NLF provided a clearer definition of the obligations for different economic operators and supported administrative simplification across many areas of the legal framework 49 (e.g. through the common suite of conformity assessment modules and the declaration of conformity template). The evaluation results were reported in the context of the Commission Communication ‘ A vision for the internal market for industrial products ’.

The better alignment was further improved by the Guide to the implementation of directives 50 based on the New Approach and Global Approach, published in 2000, which was updated in 2016. The Blue Guide explains the provisions of the Decision and the Regulation to ensure their consistent interpretation throughout the body of the EU product legislation. The latest revision of the Blue Guide  was adopted on 13 June 2022. Nevertheless, certain divergent requirements have been identified in the Study 51  during the desk research and interviews between NLF-aligned legislation and the NLF reference provisions, as well as between different pieces of Union harmonisation legislation. In this respect, the targeted consultation was seeking for an answer from economic operators and industry associations to what extent they had experienced problems because of divergent requirements between EU product legislation in the following areas: administrative obligations; sectoral-specific requirements; conformity assessment modules and procedures; definitions of economic operators; and safeguard clauses.

Across all areas combined, most respondents have experienced problems 52 from a small to a great extent because of divergent requirements between one or more pieces of EU product legislation. Economic operators and industry associations identified administrative obligations (e.g. mandatory registration / labelling / declarations) as the aspect most likely to be problematic to a great extent. Conformity assessment modules and procedures were most likely to cause problems to them ‘to a moderate’ extent.

Although, from the perspective of each individual piece of legislation, the differences with the NLF reference provisions are minor, industry stakeholders and conformity assessment stakeholders in particular have commented in the interviews and targeted consultations on the cumulative impact of numerous smaller differences. These stakeholders highlight that, when a product is subject to multiple Union harmonisation legislations, any increase in the complexity of conformity assessment, due to an accumulation of minor differences in rules, also increases the costs of compliance.

The mapping of the NLF aligned legislation in Annex X lists the 23 pieces of NLF-aligned legislation, pointing to the provisions departing from the NLF.

In terms of definitions set out in the NLF, the majority of stakeholders perceive that these definitions are clear and have brought greater coherence to the application of legislation and its interpretation when enforced by Member State authorities.

Desk research showed that some EU legislations contain definitions to impose obligations on specific economic operators in the supply chain, whose role is not defined in the NLF, when it is necessary to ensure the safety of certain products 53 . Nonetheless, industry reports about difficulties experienced due to inconsistencies caused by unnecessary divergences of legislation from NLF principles. To avoid unnecessary divergences, some stakeholders stress that proposals for EU product legislation should be scrutinized from the perspective of alignment with the NLF principles, whereby, as suggested at the stakeholders’ workshop, any divergences should be justified and explained in the recitals of the legislation as they may cause unnecessary financial burden and generate legal uncertainty.

Based on the triangulation of the evidence collected in this evaluation, we conclude that the NLF has been effective in facilitating the consistency and coherence of different EU harmonisation legislations. Among the important achievements are reduced divergences, in large extent thanks to the clear and repetitive obligations of economic operators. Nonetheless, the cumulative impact of minor smaller divergences may increase the costs of compliance.

c)Strengthening the quality of conformity assessment services through improved accreditation of notified bodies

The NLF set clear and robust rules for notified conformity assessment bodies. Overall, most stakeholders across all groups have stated that the NLF approach ensures the safety and compliance of products placed on the single market. The desk research showed that NLF has positively impacted the implementation of the conformity assessment system and the process for notification of conformity assessment bodies. Industry noted during the interviews 54  that the continuity in conformity assessment procedures between the New Approach and the NLF is positive. This stems not only from the adoption and implementation of the rules for the accreditation of conformity assessment bodies stipulated in Regulation (EC) No 765/2008, but also from the reference provisions for specific product legislation on conformity assessment, including the suite of conformity assessment modules, and the notification procedure for conformity assessment bodies.

The frequency with which industry stakeholders use the services of NBs/CABs (whether required or not) was examined through the targeted consultation. 36 out of 82 industry respondents (individual economic operators or industry associations) reported that they or their member organisations use NBs / CABs ‘Always’ (12 responses) or ‘Often’ (24 responses). Only 3 respondents out of 82 reported that they ‘Never’ use the services of NBs / CABs.

Among the NLF’s most beneficial aspects, stakeholders frequently mentioned during the interviews the harmonised conformity assessment and accreditation system, which enables the free movement of goods within the EU. Others suggested that the NLF’s main advantage is that it determines the requirements for bodies assessing the conformity of products, which increases trust in their competence and the quality of their work. In relation to conformity assessment, industry representatives clearly stated that they perceive module ‘A’ (internal production control, without a mandatory involvement of a third party), in combination with effective market surveillance, to provide a good and fair level playing field for manufacturers.

In terms of the NLF’s effectiveness at providing rules for notified bodies, stakeholders’ views varied. 54,8% (74/130) of the respondents in the targeted consultations agreed, to a great extent, and 26,9% (35/130) to a moderate extent that the NLF provides an adequate set of requirements to ensure the independence of notified bodies.

When it comes to the question of personnel and real activity that the NB has to perform by itself without outsourcing, only 22% (34/135 responses) agreed in the targeted consultations to a great extent that the NLF is sufficiently clear on that issue. 22.2% (30/135) considered this sufficiently clear to a moderate extent; 27.4% (37/135) to a small extent; 5.9% not at all, while 17.7% did not know.

Some stakeholders participating in the interview program were wondering if there is a limitation regarding the tasks of notified bodies that must be performed by an employee of the notified body. More precisely, whether the certification decision should be taken by a person who is employed in the notified body. Such requirement is set in Section 3.2.7 of Annex VII of the Medical Device Regulation (EU 2017/745): “The personnel with overall responsibility for final reviews and decision-making on certification shall be employed by the notified body itself and shall not be external experts or be subcontracted.”

Desk research and interviews showed that some Member States established the same requirement for their notified bodies in all areas and not only under the Regulation on medical devices, while in the others the decision-making can also be subcontracted. It is reported to be a common practice in global organization groups that the decision-maker is a contracted staff in a third country and therefore the whole certification activity of the notified body takes place in a third country.

The Blue Guide explains that a notified body must have appropriate personnel and equipment and be able to carry out all necessary tests and evaluations according to the requirements of the modules itself. It is not possible to subcontract a task for which the notified body has no competence itself. The notified body cannot under any circumstances subcontract all of its activities, as that would make the notification meaningless.

Assessing whether the rules for notified bodies are robust enough to ensure their competence, 78.5% of stakeholders (106/135 respondents) in the targeted consultations considered that, at least to a moderate extent, the overall requirements set by the NLF are robust enough to ensure the competence of notified bodies, including 46.7% (63/135 respondents) who considered this to be the case to a great extent.

Nonetheless, when it comes to subcontracting of substantial technical tasks of notified bodies, certain difficulties have been identified based on desk research. The Evaluation of the Internal Market Legislation for Industrial Products 55  also noted that ensuring the quality of services when the subcontractor is located outside the EU is already a challenge and existing subcontracting practices make this even more problematic, particularly in relation to products where third-party certification is mandatory.

The stakeholders addressed problems related to the subcontracting of the activities to foreign subsidiaries, such as the difficulties to monitor subsidiaries of notified bodies in another EU or non-EU country. The Commission service dealing with marine equipment observed that in this sector there is a tendency for non-EU owned conformity assessment bodies to set up subsidiaries in the EU which are then formally notified as notified bodies. In some cases, these have been found to be mere letterbox companies, with no permanent full-time staff in the notifying Member State. There is an example for both, accredited and non-accredited notified bodies owned by a third-country company, without any staff or employing one person in the Member State. For the actual work, these companies are fully dependent on the services subcontracted from their non-EU based mother companies. This results in a situation where, for example, a manufacturer established in a third country can obtain access to the EU market by relying entirely on a third country conformity assessment infrastructure, raising questions about the EU’s autonomy in this area.

Most of these problems are due to insufficient monitoring activities of the subcontracted tasks and subcontractors if these activities are outsourced outside the European Union. The notifying authority/accreditation body has to assess the extent to which the notified body wants to rely on subcontractors and the authority may withdraw and limit the scope of the notification.

It is important to highlight that if the notifying authority /accreditation body is not capable of ensuring effective monitoring of the competence of the body responsible for the tasks subcontracted by the notified body, it should not allow the subcontracting. Nonetheless, in 2020 the Commission received information from national market surveillance authorities and industry associations questioning the practices of an accredited notified body, with respect to the certification of FFP masks. Although the notified body cannot outsource all its activities and restrict them to purely administrative function, in that specific case the activities of the notified body were minimalized and the extent of outsourcing seemed to approach the entire activity of the notified body. The high number of RAPEX-Safety Gate notifications also indicated that the subcontracted tasks were threatening to undermine the quality of such services and raising the question of unfair competition and a level playing field. Following the correspondence between the Commission and the accreditation body, the notification of the notified body was not extended after its expiry.

The notified body cannot in any circumstances subcontract all of its activities and restrict its engagement to only administrative tasks. Better implementation of the existing rules on subcontracting by the notifying authorities/accreditation bodies could most probably improve the current situation and eliminate those subcontractors that cannot be effectively monitored and the so called ‘letter-box’ notified bodies fully dependent on the services subcontracted to their non-EU based mother companies. Nonetheless, stakeholders seem to agree that the NLF does not provide enough clarity on the mandatory staff, on the extent of the mandatory real activity of the notified body and possible limitations of the tasks to be subcontracted.

In terms of the effectiveness of the accreditation framework, the overall feedback from all stakeholders consulted, including prominent industry associations, suggests that the accreditation system functions well and ensures that the competence of the accredited notified bodies intervening in the conformity assessment procedures is sufficiently guaranteed.

Figure 2 Targeted consultations: Effectiveness of the accreditation framework set-up by the NLF (Question 27, N=130)

In support of that feedback, the most frequent arguments are that the NLF has improved both, the mutual confidence in test reports and certificates of conformity for cross-border trade and reducing the process associated with notification and designation. Industry stakeholders further highlighted that this reduction of differences in the activities carried out by notified bodies has increased fair competition between businesses.

As already explained in chapter 3.1.3., accreditation 56 is the preferred means of verifying the competence of conformity assessment bodies, but it is not mandatory. Therefore not all notified conformity assessment bodies are also accredited conformity assessment bodies. Even if conformity assessment bodies can be notified as accredited or non-accredited notified bodies, based on the data available in the NANDO database, we can see that the number of accredited notified bodies significantly outweigh those that are not accredited: 82% (2125) of all notified bodies (2589 in June 2022) are accredited, while only 18% (464) are not accredited.  

43.8% (53 of 130) of the respondents in the targeted consultation agreed that the NLF does not ensure that the procedures for monitoring non-accredited notified bodies are sufficiently reliable and appropriate for the purposes of notification. In contrast, only 15.4% (20/130) of respondents, 9 of which were national notifying or competent authorities, considered these procedures to be reliable and appropriate. 57

Furthermore, 46.9% (61 of 130) of the respondents in the targeted consultations noted that the existence of non-accredited notified bodies does not remain appropriate; 27.6% (36 respondents) stated that the existence of non-accredited notified bodies was ‘not at all’ appropriate. 58

Some stakeholders see mandatory accreditation 59 as the only way to ensure the appropriate and equal high level of competence of notified bodies, while others point to the significant amount of time and costs needed for accreditation comparing to its benefits. The Evaluation of the Internal Market Legislation for Industrial Products pointed out 60 that despite mixed views on the accreditation procedure and its effectiveness, there appears to be significant support towards mandatory accreditation across the EU. As presented on pg. 47 of the underlying Study and in Case Study No. 2 in Annex VIII of this SWD, consumer associations and industry associations interviewed have suggested that accreditation should become mandatory to create a true level playing field for notified bodies, based on competence. Nonetheless, there are a range of challenges related with mandatory accreditation that stakeholders have highlighted. According to notified bodies, mandatory accreditation is not considered the optimal solution, but could help ensure the best possible alignment in the notification processes and competencies of the assessing body (accreditation body) to be somewhat aligned through peer assessment and with that, ensure a level playing field in terms of requirements put on the Notified Bodies. 

Notified bodies in charge of the Lifts Directive pointed out that in countries where the national accreditation body related to the technical directive and the notifying authority are the same body, the difference between relying on a notified body having accreditation compared to a non-accredited notified body is not significant as the technical expertise is similar. Therefore, it is difficult to say whether mandatory accreditation would make much difference. For example, in Germany, there is a national accreditation body for each NLF-aligned directive or regulation and there is also a notifying authority. If a notified body chooses one of the German inspection bodies, with or without accreditation, the same inspectors perform the audit, but the day rates charged are different.

Several categories of stakeholders consider the definition of accreditation too vague. Certification bodies expressed the view that although the accreditation system is harmonised across all EU Member States, the definition of accreditation refers to unspecific “harmonised standards and where applicable additional requirements”, leaving room for varying interpretations 61 .

This situation may distort the EU level playing field between conformity assessment bodies with consequences for economic operators.

The Commission considers that the definition of accreditation in Regulation (EC) No 765/2008 referring in general to ‘harmonised standards and, where applicable, any additional requirements’ that the conformity assessment body should meet to obtain an attestation by a national accreditation body allows flexibility, instead of being vague. The EA is a body recognised under Regulation (EC) No 765/2008 and the mandatory membership of national accreditation bodies in the EA is also ensured by Regulation (EC) No 765/2008. The EU is financing the activities of the EA in connection with the application of Regulation (EC) No 765/2008, such as the coordination of accreditation activities and the processing of technical work linked to the operation of the peer evaluation system (Article 32 of Regulation (EC) No 765/2008). Consequently, the better implementation of the accreditation rules achieving more harmonised practices in the area of accreditation of conformity assessment bodies is rather seen via the coordination and accentuation of this aspect in the peer evaluation activities of the EA than through a possible amendments of the NLF, enumerating the relevant harmonised standards in the NLF.

Based on the triangulation of the evidence collected in this evaluation, we conclude that the rules of the NLF on notified conformity assessment bodies are clear and sufficiently robust to ensure safety and compliance of products, as well as the competence of notified bodies. Nonetheless, the NLF-rules show a lack of clarity when it comes to outsourcing of the services of notified bodies to third-country conformity assessment bodies. Considering, however, that in such cases ensuring the quality of the services is challenging due to difficulties in monitoring, the NLF foresees the possibility for the notifying authority not to allow subcontracting by the notified conformity assessment body if there are no means to ensure an adequate monitoring. The evaluation shows that the NLF does not provide for sufficiently reliable procedures of monitoring of non-accredited conformity assessment bodies. Concerning the effectiveness of the accreditation framework, the general conclusion is that it functions well and ensures the competence of the accredited notified bodies.

d)Ensuring a clear meaning and enhanced credibility of CE-marking

The issue of the performance of the NLF provisions related to the CE marking was most recently examined in the 2014 Evaluation of the Internal Market Legislation for Industrial Products . As summarised in the 2017 report on the implementation of Regulation (EC) No 765/2008 62 , the assessment “show[ed] an overall satisfaction with the CE marking, which is considered appropriate and effective. The assessment also showed that there is no need for any fundamental change in CE marking, although there is a need for greater consistency and to avoid having different requirements for different pieces of legislation and address the issue of products with multiple parts” 63 .

Most stakeholders consulted for this evaluation maintain that the CE marking holds significant value and works well. Overall, the provisions on CE marking are clear, enhance its clarity and credibility, increase industry attention on CE marking requirements, strengthen the visibility of CE marking, and iron out minor inconsistencies between different pieces of legislation. Stakeholders consider that it is a trustworthy indicator that a product will function safely and as intended.

For instance, 64.1% of respondents to the targeted consultation (100 of 156 respondents) perceive the NLF to have been either somewhat effective (34.6%, 54 respondents) or very effective (29.5%, 46 respondents) in strengthening the visibility and use of the CE marking system. In particular, stakeholders have highlighted the CE marking’s strong global reputation and the global benefit of having a common approach.

However, in this context, a few challenges have been highlighted by stakeholders. Consumer associations, for instance, still share concerns with regard to understanding the purpose of the CE marking among consumers. They stated that consumers may perceive it to be a quality or certification marking, rather than a compliance marking. Furthermore, industry stakeholders have highlighted challenges stemming from global trends related to product markings.

Based on the triangulation of the evidence collected in this evaluation we conclude that the NLF strengthened the visibility and clarity of CE marking, nonetheless, consumer associations consider that there is still room for raising awareness of consumers on the meaning of CE marking.

To conclude, the NLF has been effective in achieving its all four specific objectives. Thanks to the regulatory toolbox set out in the NLF, the provisions are repetitive in every single piece of NLF-aligned legislation, whereby divergences are reduced in the EU product legislation. Technological neutrality supports innovations and should be preserved in the future as well, by avoiding to include more detailed product requirement in the legislation than necessary. The effectiveness of the NLF may depend on factors outside of its scope, such as the prompt delivery of standards.

4.1.2.    Efficiency

a)Reinforcement of the New Approach

Two third of the surveyed economic operators and industry associations agreed that the NLF increased the overall efficiency of Union product legislation through simplification and burden reduction.

According to the stakeholders, the positive effects of the NLF, considering both monetary and non-monetary benefits, strongly outweigh the costs. The NLF comprises very few direct costs, as most costs associated with the framework of EU product legislation stem directly from compliance with individual pieces of NLF-aligned legislation. However, a wide range of cost savings and other benefits have been highlighted by stakeholders. For economic operators, these benefits included reduced costs in familiarisation with legislative requirements by economic operators due to the implementation of common provisions; greater regulatory certainty; greater harmonisation of obligations; reduced market barriers; and, as a result, enhanced industrial competitiveness. A further strategic benefit was the enhanced global recognition of the CE marking stemming from its prominence within the NLF.

In terms of specific benefits of the NLF, two-third of the economic operators and industry associations agreed that the NLF has reduced the costs of familiarisation with different EU product legislation, while a great majority reported that the NLF has reduced divergence 64 between different pieces of EU product legislation, leading to cost savings in the conformity assessment procedure. For example, Case Study No. 4 in Annex 4 of the Study , which is also included in Annex VIII demonstrates that none of the costs identified for economic operators can be entirely and directly attributed to the NLF. According to the Study of CSES, the benefits of the NLF are rather strategic 65 , such as fostering the free movement of goods in the internal market and increase in industrial competitiveness.

It should also be noted that the coherence and consistency of the NLF aligned legislation, the conformity assessment and CE marking are also the elements of the New Approach, which were supposed to be improved through the NLF. Consequently, the efficiency and performance of the NLF related to the other three specific objectives at the same time corroborate the efficiency of the NLF in reinforcing the New Approach.

Based on the triangulation of the evidence collected in this evaluation we conclude that the NLF is efficient in achieving the objective of enforcing the New Approach. The NLF has reduced divergences among the different pieces of legislations and therefore also the costs of familiarisation with EU product legislations.

b)Supporting the consistency and coherence of EU harmonisation legislation

In terms of efficiency of the NLF in supporting the consistency and coherence of EU product legislation, based on the surveys, respondents highlight that the enhanced regulatory certainty is a positive result of the NLF’s functioning. Reduced uncertainty over applicable rules, thanks to the common approach brought about by the NLF, is a direct benefit attributed to the NLF. If assessed against a counterfactual scenario characterised by regulatory fragmentation (by piece of legislation and/or by country), this benefit’s relevance is further underscored.

According to the results of the public consultation, 83% of the respondents (78) stated that the NLF has had a positive or very positive impact in terms of regulatory certainty and ease of compliance with EU product legislation. This positive opinion is in line with the wide consensus observed on this point during the interview programme.

Due to its very nature, a quantification or monetisation of this benefit cannot be achieved. At the same time, in light of the increase in NLF-aligned pieces of legislation, the conclusion can be drawn that over the 2014-2020 period the extent of this benefit has grown, compared to the pre-2014 baseline scenario.

Based on the triangulation of the evidence collected for this evaluation, we conclude that the NLF is efficient in supporting the consistency and coherence of EU harmonisation legislation. Although it is not possible to quantify the benefits over the costs of the NLF under this objective, stakeholders agree that the NLF brought regulatory certainty into the EU legislative framework for products and has facilitated compliance.

c)Strengthening the quality of conformity assessment services through improved accreditation of notified bodies

The efficiency of the conformity assessment procedure based on the same principle in the NLF-aligned product legislation and structured by modules is appreciated by the stakeholders. They report that the costs linked to the familiarisation with the procedures and preparation of the conformity assessment are also reduced.

In the targeted consultations 85.5% (47 of 55 responses) of economic operators and industry associations agreed that the NLF has reduced the costs of familiarisation with different EU product legislation to a great or moderate extent.

The opinions of stakeholders strongly support the argument that the NLF has brought about savings in terms of facilitated familiarisation and administrative simplification. Due to the growing number of pieces of legislation that have been aligned to the NLF over the 2014-2020 timeframe considered in this study, it can also be safely concluded that this cost saving has increased over time, compared to the pre-2014 scenario.

Case Study No 3. in Annex IV of the Study , which is included in Annex VIII of the SWD on the assessment of the NLF-related costs and benefits under an NLF-aligned legislation (the EMCD ) explains that in a hypothetical scenario without the NLF, the EMCD would probably still contain a conformity assessment procedure, with less similarities with the conformity assessment provided in other product legislation. The costs of familiarisation with the procedures would likely be higher in the absence of the NLF model of conformity assessment procedures, due to lack of harmonisation. Generally, the cost of complying with the EMCD corresponds to 5-15% of total costs of production 66 . Administrative and reporting costs therefore represent only a minority share of the total production costs borne by manufacturers. The self-certification approach made possible by the EMCD, in particular, contributes to keeping costs relatively low and grants a certain level of flexibility to economic operators. Some benefits, such as increased market efficiency and improved industrial competitiveness can be attributed to some extent to the NLF.

The Study of CSES shows that cost savings generally do not primarily concern the main bulk of conformity assessment costs (i.e. tests and the involvement of notified bodies), but focus on the costs related to technical documentation. Although the details included in the documentation depend on the nature of the product, the general requirements referring to the contents of the technical documentation that are relevant for proving the conformity of the product with the applicable harmonisation legislation are set out in the rules which follow Annex II of Decision No 768/2008/EC. In the case of the EMCD , the Directive’s evaluation reported costs of technical documentation as part of the conformity assessment procedure being in a range between 1,000 and 10,000 euro per product. In terms of staff resources required in relation to the documentation, most stakeholders providing an estimate indicated a cost between 4 and 10 man-days.

The most important costs reported in the targeted consultation by economic operators and industry associations were related to the involvement of notified bodies (rated by 60.7% – 34 of 56 responses – as high or very high) and the performing of laboratory tests (rated by 53.6% – 30 responses – as high or very high). Overall costs of conformity assessment procedures were deemed high or very high by a minority of respondents (35.7% – 20 responses). 67 Most of the costs deriving from the conformity assessment procedure for the products covered by an NLF-aligned product legislation may only be partially attributed to the NLF (see Case Study No. 4 in Annex 4 of the Study , which is also included in Annex VIII of this SWD on the assessment of the NLF-related costs and benefits under an NLF-aligned legislation (the TSD ).

The cost of testing is high in itself: Under the EMCD, for instance, the daily fees of third-party laboratories in the EU is reported to be in the range 800-1,500 Euro. 68 The Evaluation of the Toys Safety Directive also states that testing of toys entails considerable laboratory costs. This includes the operation and maintenance of the laboratory and its equipment as well as costs for hiring the appropriate staff. Tests need normally sophisticated, specialised equipment and machines and, in the case of chemical tests, a permanent input of chemicals, some of which can be very expensive 69 .

However, based on the interviews conducted for the Study of CSES, the view of individual companies and business associations concerning conformity assessment procedures is in general positive, as the framework of the modules for assessing compliance, as well as the individual modules, are considered to function well and are not considered excessively costly. Moreover, since the principles of conformity assessment have not changed significantly with the introduction of the NLF in 2008, no additional costs are identified compared to the previous conditions. In any case, the specificities of the conformity assessment procedures for different products (even if they use the models provided by the NLF) are included in NLF-aligned sectoral legislation.

Annex VII of the SWD contains an elaboration prepared by the contractor 70 of the main costs and benefits identified by the evaluations of certain NLF-aligned EU product legislation, (i.e. Evaluation of the CPR in 2019, Evaluation of the LVD in 2019, Evaluation of the TSD in 2020, Evaluation Restriction of Hazardous Substances in Electrical and Electronic Equipment Directive in 2021, Evaluation of the EMCD in 2021).

Regarding the efficiency of the NLF in relation to the accreditation framework it introduced, the resources spent by conformity assessment bodies on the accreditation framework, including examination fees and maintenance fees, represent inputs to the NLF’s functioning and an important novel element of the 2008 NLF legal texts. As such, they are attributed to the NLF.

To obtain an accreditation, conformity assessment bodies face a range of costs, which include: the examination fee to an accreditation body; annual fee to an accreditation body (continuous monitoring costs, or maintenance fee); cost of developing and maintaining a quality management system; insurance (in most cases) 71 72 .

National accreditation bodies, national competent authorities, national notifying authorities, and notified bodies were also asked to assess the burden they experienced resulting from the introduction of the accreditation framework. 42.3% of respondents (47 responses) reported the burden to be high or very high, while a further 27% (30 responses) considered it to be moderate.

However, there was some variation between stakeholder types: notified bodies were most likely to report that the burden was high or very high (53.8%, 21 responses), while responses from the other groups were more mixed.

Asked to identify and explain the main kinds of costs and burdens related to the introduction of the accreditation framework for conformity assessment bodies, three notified bodies / conformity assessment bodies commented in more detail. One said that the cost depends on the scope of accreditation and level of assurance addressed. It could range between €50k and €500k in capital expenses (CAPEX) and around €500k in operating expenses (OPEX). Another respondent referred to the costs of the audit of the accreditation body and the considerable time and overall operating costs of the auditee during the accreditation process. The respondent estimated this cost to be around €72k for an accreditation period of five years.

A third respondent reported that it is difficult to estimate the change in costs related to the introduction of the accreditation framework for conformity assessment bodies as accreditation and (some sort of) notification already existed prior to 2008. Costs occur for both becoming accredited and for maintaining the accreditation.

The general estimation is what a NAB representative consulted for the Study of CSES stated, that the cost of accreditation does not represent an excessive burden, as the most important cost to receive the accreditation is the cost to have the necessary equipment and to ensure a good level of competences and supervision of the technical experts. As such, in his opinion, the cost of accreditation should not be seen as a burden.

However, notified bodies engaged in smaller sectors who participated at the validation workshop see the cost for accreditation as a rather challenging problem. In case accreditation is made mandatory, this would create significant problems in terms of affordability. To solve the problem of different level of competence of notified bodies, they suggest a peer-assessment system for notified bodies, similar to the one in accreditation.

Most respondents were positive about the benefits that have been achieved as a result of the NLF. Regarding cost savings due to facilitated familiarisation with different EU legislation (e.g., due to common definitions, reduced market fragmentation etc.), 47% of the stakeholders agreed that strong benefits had been achieved (45 responses), while a further 30% thought there were at least some benefits (28 responses). Respondents were only slightly less positive regarding cost savings in the process of demonstration of conformity across different EU product legislation: 41% agreed that strong benefits had been achieved (39 responses), while a further 28% thought there were some benefits (27 responses).

Looking to efficiency in terms of possible simplification, in the targeted consultations 74.5% of the respondents thought that the efficiency of the conformity assessment procedure would improve to a great extent (35 responses) due to digitalisation of the declaration of conformity / technical product information / technical file, without hindering market surveillance activities, while a further 12.8% (six responses) thought it would improve to a moderate extent.

Another possibility for simplification would be seen in the broader application of the remote assessment techniques by the notified conformity assessment bodies, where it is appropriate (for more details, see Remote conformity assessment).

Based on the triangulation of the evidence collected for this evaluation, we conclude that easier familiarisation with the procedures and preparation of the conformity assessment, as well as the administrative simplification brought by the NLF led to cost savings. The modules provided in the NLF for assessing compliance are efficient, and since they have not changed significantly with the introduction of the NLF in 2008, there are no additional costs identified comparing to the pre-NLF period. The accreditation framework is considered efficient in the context of balance between costs and benefits. Except in the smaller sectors, the general opinion is that the costs of accreditation do not represent an excessive burden for the conformity assessment bodies. Digitalisation and remote assessments are identified as the way forward for a possible simplification.

d)Ensuring a clear meaning and enhanced credibility of CE-marking

In terms of the efficiency of the CE marking, economic operators and industry associations were asked in the targeted consultations to assess the scale of the burden deriving from the NLF’s communication obligations. The burden of printing out product information to accompany the product (e.g. safety documentation, instruction manuals, guidance on reasonably foreseeable use etc.) was most likely to be rated high or very high (83%, 39 responses). Affixing the CE marking visibly and indelibly on the product, as well as other traceability information such as the postal address of the manufacturer/importer was deemed the least burdensome: only 36.2% (17 responses) rated it as high or very high. Nonetheless, industry stakeholders highlighted that the need to indelibly mark products costs to manufacturers and limits the flexibility of economic operators to respond to market developments globally, as certain ‘marked’ stock can only be sold in the specific regions or countries they are marked for.

Very few stakeholders attempted to quantify the costs related to their NLF information obligations. Most answered that it was not possible for them to estimate these costs. In relation to CE marking, a few respondents put the cost at “mere cents”. Others said that it would depend on the product, where it is marketed and under which circumstances.

Translating a manual into an EU language was said, by one stakeholder, to cost approximately €10,000 per language, while printing the manual was estimated at around €10 per copy. Administrative costs were said by another stakeholder to range between €5,000 and €20,000 per product.

The Study of CSES stresses that since no significant changes concerning CE marking were introduced with the 2008 NLF, the incremental costs compared to the previous conditions are nil. This is acknowledged in previous evaluations, too. For instance, the evaluation of the NLF-aligned Lifts Directive does not consider the cost of CE marking as relevant in its analysis, as similar requirements were already present in the previous Directive 73 .

As part of the stakeholder consultations, one of the key impacts widely agreed upon by interviewees was the enhanced global relevance of EU regulations, which in turn supports the standing of the EU in global commerce, thanks to the ability of EU legislation to elevate its model worldwide and shape international practices (named the ‘Brussels effect’). The NLF, in several interviewees’ opinion, clearly contributed to this benefit. A related element, in this regard, is the enhancement of Europe’s industrial competitiveness, in terms of comparative competitiveness between European manufacturers and third country counterparts.

According to evaluations of some NLF-aligned pieces of legislation, such as the Lifts Directive evaluation, the CE marking is increasingly perceived as a standard of quality by industry beyond EU borders: buyers in Asia and the US are reported to prefer products with a CE marking; also, the harmonised regulatory framework has reportedly helped companies implement a stronger internationalisation strategy in third countries. The EMCD evaluation reached similar conclusions.

Based on the triangulation of all data collected during the survey, we may conclude that the benefits of the CE marking clearly outweigh its costs.

In this respect, stakeholders from all groups agree that digitalisation offers a potential solution for simplification of administrative obligation related to product information requirements and CE marking.

This view is strongly supported by a study conducted for study conducted for DigitalEurope and the Mobile & Wireless Forum 74 , which examined the costs and benefits associated with digitalising certain compliance information in the consumer electronics sector. Quantitative estimates on e-labelling were provided on three segments of the European consumer electronics market: telephony, computing, and TV, radio and multimedia 75 . According to the study, under the current system the total annual costs of indicating compliance in these three fields are about 800 million Euros 76 . These costs are deemed to be high or very high by about half of the companies consulted as part of the study. Against this background, the study proposes an e-labelling scheme designed as an optional approach to a physical label and consisting of a label displayed electronically for devices with built-in screen, a QR code for equipment without screen, and a temporary label (e.g. film label) to allow consumers and market surveillance authorities to see product regulatory markings at the time of purchase or check without switching on the device. The study estimates that the e-labelling scheme would reduce costs of indicating compliance by around 15% (120 million Euros per year), due to lower costs associated with updating compliance information of products already on the market, lower costs linked to differences in national compliance procedures, as well as lower administrative costs linked to addressing requests from national market surveillance authorities.

After extrapolating the cost savings figure to other sectors under NLF scope, the cumulative cost saving related to the e-labelling scheme can be estimated to be at least 490 million Euro per year 77 .

The possible simplifications of the CE marking and other obligations by digital means is discussed below in more details under the assessment of the relevance of the NLF.

Based on the triangulation of the evidence collected for this evaluation, we conclude that the NLF has been efficient in ensuring the clear meaning and enhanced credibility of the CE marking. CE marking does not represent a serious burden for manufacturers, while often perceived as a standard of quality even outside of the EU. Digitalisation of CE marking and other product information obligations is nonetheless seen as a possible simplification. Having regard to the increasing number of intangible products such as software, this seems to be inevitable in the near future.

To conclude, the NLF has been efficient in achieving its all four specific objectives. Most of the benefits of the NLF are strategic, such as increasing Europe’s industrial competitiveness and the global relevance of EU regulation, fostering the free movement of goods in the internal market and increasing industrial competitiveness. Reduced divergences, facilitated familiarisation with the rules, ease of compliance regulatory certainty are benefits that are stressed by all stakeholders. Although their quantification is not possible, these benefits are vital for the everyday smooth functioning of the internal market and its reliability.

Some of the costs and benefits cannot be directly attributed to the NLF as a framework. Two case studies in Annex VIII of the SWD conducted by the contractor on recently evaluated directives, the EMCD and the Toy Safety Directive (TSD), 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.

For example, we are not able to conclude that costs related to the conformity assessment under the Electromagnetic Compatibility Directive 2014/30/EU (EMCD) (such as the costs of preparing technical documentation, performing laboratory tests and potentially using a notified body) are directly attributable to the NLF to a large extent because these costs stem from the integration of NLF rules into the EMCD. The EMCD would probably also contain some kind of conformity assessment even without the NLF. However, that procedure would probably have fewer similarities with the conformity assessments provided in other product legislation. Therefore, familiarisation costs and administrative burden would likely be higher in the absence of the NLF model of conformity assessment procedures, particularly in case of products covered by the EMCD and some other product legislation, which could also envisage a completely different conformity assessment procedure in the absence of the NLF legal framework and its toolbox.

4.1.3.    Coherence

The assessment of the coherence of the NLF as a framework reinforcing the New Approach with other relevant legislations will focus on both, the internal and external coherence of the NLF.

The internal aspect considers the coherence between Decision No 768/2008/EC and Regulation (EC) No 765/2008. This aspect also takes into account the extent to which the NLF’s provisions are clear to EU policymakers, national authorities and economic operators involved in its implementation, and whether the NLF’s scope is considered to be appropriate.

The external aspect focuses on the extent to which there are any gaps, loopholes, inconsistencies, or duplications in relation to the NLF and its interaction with the different pieces of product legislation.

As mentioned earlier, 23 different directives and regulations and a delegated act have been aligned with the NLF. Considering that strengthening the consistency and coherence of Union harmonisation legislation is one of the specific objectives of the NLF, the effectiveness and efficiency of the NLF in ensuring coherence with the NLF-aligned product legislation is analysed under the subtitles devoted to the effectiveness and efficiency of the NLF.

In the assessment of external consistency of the NLF with other pieces of EU legislation, we consider the coherence of the following as well:

­Horizontal legislation – The coherence with Directive 2001/95/EC on general product safety (GPSD) 78 and Directive on product liability 85/374/EEC 79 ;

­Other relevant legislation and legislative proposals, although the future-proofing coherence of the NLF is elaborated under the assessment of the relevance of the NLF;

­NLF aligned product legislations with the non-NLF aligned legislation;

­NLF and its alignment role for international trade agreements of the EU.

In terms of internal coherence, as the Study of CSES explains, there is a plenty of risk for inconsistencies and overlaps between the NLF legal texts, as many of the same issues are discussed in both pieces of legislation. For instance, while the general principles of the CE marking are stipulated in Regulation (EC) No 765/2008, the reference provisions to be included into the specific pieces of product legislation are contained in Annex I to Decision No 768/2008/EC (Articles R11-R12). Similarly, the rules on accreditation are set out in Chapter II of Regulation (EC) No 765/2008, while the reference provisions are contained in Annex I to Decision No 768/2008/EC (Articles R21-R23).

Nonetheless, stakeholders did not raise any issues regarding the internal coherence and consistency of the NLF. In both, targeted and public consultations the number of stakeholders considering that there were inconsistencies, overlaps or gaps between the different provisions of the NLF (i.e. between and within Decision No 768/2008/EC and Regulation (EC) No 765/2008) was very low: 1 answer out of 125 in the public consultations and 5 answers out of 122 in the targeted consultations 80 . Regulation (EU) 2019/1020, which replaced the market surveillance part of Regulation (EC) No 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 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.

Regarding the clarity of certain obligations set out in the NLF, 18,5% of stakeholders out of 200 (without important differences throughout the stakeholders group) found unclear the obligations and administrative requirements for economic operators placing products on the market following their substantial modifications. A more detailed assessment of this aspect is included in Chapter 4.3 under the evaluation of the relevance of the NLF.

Figure 3 Targeted consultations: Extent to which elements of the NLF remain clear and appropriate (Question 52, N=200)

Similarly to the feedback from stakeholders on internal coherence, a significant number of respondents did not know whether the NLF is coherent with other EU legislation that may apply simultaneously or in complementarity with NLF-aligned legislation (external coherence). Among those respondents expressing an opinion, the majority believe that the NLF is partially (rather than fully) coherent with horizontal policy and legislation, environmental legislation and other types of relevant legislation.

Figure 4 Targeted consultations: Extent to which the NLF is coherent with other EU legislation that may apply simultaneously or in complementarity with NLF-aligned legislation (Question 61, N=192)

The horizontal coherence of the NLF

Directive 2001/95/EC on general product safety (GPSD) 81 is intended to ensure product safety throughout the EU for all non-food consumer products to the extent that they are not covered by sector-specific EU harmonisation legislation. The GPSD also complements the provisions of sector legislation in some aspects. On 30 June 2021, the Commission adopted the Proposal for a new general product safety regulation , to replace the GPSD. Some elements of the Proposal are analysed as part of the section devoted to the relevance of the NLF, in Annex XI.

Directive on product liability 85/374/EEC 82 establishes a system of strict liability, i.e. liability without fault, for producers when a defective product causes physical or material damage to an injured person. The Directive is an important element of the EU product safety legislation framework. It underpins product safety legislation by giving producers incentives to comply with it, as well as legal certainty. This Directive is currently under revision .

Most stakeholders (110 out of 192, i.e. 57,2%) in the targeted consultation are of the view that horizontal policy and legislation, as the General Product Safety Directive and the Product Liability Directive are coherent with the NLF, while the remaining 42,7% do not know (please see the table above demonstrating the results of the targeted survey).

Coherence of other relevant legislations and legislative proposals with the NLF

There are examples in the body of EU legislation where terms defined in the NLF are redefined or have a slightly different meaning. One of such examples is the definition of ‘placing on the market’. According to Decision No 768/2008/EC, Annex I, Article R1(2) the ‘placing on the market’ is defined as the first making available of a product on the Union market. 83   Directive (EU) 2019/904 on single-use plastics , based on Article 192(1) TFEU, nonetheless defines the placing on the market in its Article 3(6) as the first making available of a product on the market of a Member State. The restriction in the definition set out in  Directive (EU) 2019/904 on single-use plastics  may require further clarification for economic operators who are familiar with the definition of placing products on the market as set out in the NLF.

Some industry associations expressed their concern at the interplay and the lack of coherence among some EU legislations that are currently being revised, reviewed, or newly proposed and the NLF. When it comes to proposals on general product safety, AI, and cybersecurity, respondents stressed the importance of consistency. The NLF should be the “leading legislation” for horizontal definitions. 

To further respond to the need for future-proofing coherence of the NLF as regards upcoming legislation that will address the use of products after their placing on the market and first use, some stakeholders suggest introducing additional definitions for ‘maintenance’, ‘repairer’, ‘disassembler’, ‘recycler’, ‘service provider’, ‘refurbisher’ and ‘remanufacturer’. Some of these questions are discussed in more details below, under the relevance criteria.

Coherence of the NLF-aligned product legislation with the non-NLF aligned legislation

23 pieces of EU product legislation and a delegated act have been aligned with the NLF, nonetheless there is a lack of coherence between the NLF and other types of legislation in some cases. This increases compliance and enforcement costs for economic operators, notified bodies and market surveillance authorities. In addition, differences in the combined implementation of EU legislation between Member States could prevent the full potential of a well-functioning internal market from being achieved. Case study No.1 in Annex 4 of the Study , which is also included in Annex VIII demonstrates the problem in more details.

NLF and its alignment role for international trade agreements of the EU

The European Commission represents the European Union for the purposes of administering the notification, recognition, challenge, suspension and withdrawal of conformity assessment bodies under the international agreements concerning the recognition of conformity assessment results. The Commission service responsible for negotiating international trade agreements highlighted that the process of notification, recognition, challenge, suspension and withdrawal of conformity assessment bodies under the international agreements concerning the recognition of conformity assessment results is administratively extremely burdensome.

The NLF toolbox shows a high level of effectiveness as a model for EU product legislation with respect to notification and withdrawal of conformity assessment bodies, while the Commission is lacking a similar set of rules when implementing bilateral mutual recognition agreements on conformity assessment. The lack of a modern set of rules to be employed when implementing international trade agreements concerning the recognition of conformity assessment results often leads to incoherence in the implementation.

Based on the triangulation of the evidence collected for this evaluation, we conclude that the NLF has been an effective tool to achieve both, internal and external coherence. Lack of clarity appears related to those obligations set out in the NLF that are impacted by the expansion of the circular economy (e.g. placing products on the market following their substantial modification). The importance of the NLF in creating coherence in the EU product framework is unarguable. An inconsistent use of NLF definitions in a legislation by determining them differently from the meaning used in the NLF leads to confusion among economic operators and authorities who are familiar with the NLF and therefore to additional costs.

4.2.    How did the EU intervention make a difference?

This chapter will focus on the results of the NLF and assess if they are beyond of what would have been achieved by the Member States acting alone and considering the extent to which the effects (i.e. outputs, results, impacts) achieved through the NLF could have been achieved using alternative means.

The vast majority of stakeholders considered that the common legal framework provided by the NLF delivered high added value compared to what could have been achieved through the development of product legislation in its absence.

Regarding the overall EU added value of the NLF, stakeholders interviewed across all groups were overwhelmingly positive about its role in avoiding regulatory divergence from emerging in EU product legislation, particularly during the first 10 years of its implementation. Stakeholders perceive the NLF to have had a positive impact across all its key objectives. More specifically, the NLF has added value through:

·General principles and common reference provisions for drawing up EU legislation in the form of a regulatory toolbox designed for EU regulators;

·Implementation of the conformity assessment system, the accreditation framework for CABs and the rules on notification of CABs;

·Reinforcing the principles initially embedded in the New Approach, such as setting non-technical essential requirements, whilst leaving the detailed specifications to harmonised standards;

·Strengthening the visibility of CE marking, thereby heightening its role and importance, 84 although the core CE marking requirements already existed under the New Approach as these were gradually introduced in product specific legislation starting with the Low Voltage Directive  in 1973 85 .

Collectively, through these different aspects, the NLF has contributed positively to supporting the free movement of products within the internal market and providing a high level of protection of public interests, especially in respect of product health and safety, for both workers and consumers.

Stakeholders considered that repealing the NLF (and having different obligations in different pieces of legislation) would generate diverging interpretations, overlaps and contradictions. Also, a system with detailed technical specifications (as per the Old Approach) would decrease the flexibility that the current NLF system provides. Stakeholders further highlighted that a more divergent set of sectoral requirements would be expected to bring with it an increased burden both for economic operators and authorities.

Some stakeholders expressed their concerns that the NLF’s added value could be watered down unless awareness is strengthened within the Commission itself regarding the regulatory toolbox and the NLF’s general principles. To avoid that, a range of stakeholder groups (including consumer organisations and certification bodies) believe that the NLF needs to be updated in order to better contribute towards achieving the objectives of the circular economy and close up to the digitalized environment.

Regarding the counterfactual assessment 86 , the question of what would have happened in the absence of the NLF has been analysed. There are different dimensions to this. Firstly, there is the question of what would have happened regarding the evolution of individual pieces of EU product legislation without the NLF. As shown in the legal mapping to assess the “before” and “after” situation in respect of NLF-aligned legislation, there would have remained divergence in the administrative requirements for economic operators, with more anomalies and inconsistences in the legislation, many of which were relatively minor, but which nonetheless undermined the overall coherence of the body of EU legislation applicable to products that manufacturers and other economic operators follow.

However, a more significant added value in the views of many industry associations and individual manufacturers was that the NLF prevented regulators from introducing divergent requirements across sectoral legislation that went against the NLF’s core principles. This was seen as being the case at least in the 10-year period from 2008. This has also considerably reduced national “red tape” measures.

A major EU industry association commented that if the NLF were to be repealed, this would be a disaster for industry as the NLF has helped to provide stability and predictability in the regulatory regime. This finding is validated by the targeted consultation results. Almost half of the stakeholders (49.6%, 59 responses) considered that the common legal framework provided by the NLF delivered high added value compared to what could have been achieved through the development of product legislation in its absence. A further 29.4% (35 responses) considered that the framework had delivered some added value.

Based on the triangulation of the evidence collected for this evaluation, we conclude that the common EU product framework created by the NLF brought a high level of EU added value compared to what the Member States could have achieved without the NLF. Repealing the NLF would generate diverging interpretations, overlaps and contradictions.

4.3.    Is the intervention still relevant?

Under this title we analyse if the objectives of the NLF still reflect current and future needs (continuing relevance), mainly in the light of digitalization and the circular economy objectives.

Considering the question of whether the NLF remains relevant, the findings point to the following main conclusion:

The NLF legal framework, as set out in Regulation (EC) No 765/2008 and Decision No 768/2008/EC, was relevant in addressing the problems identified in the 2007 impact assessment, prior to the adoption of the NLF. Although significant progress has been made towards addressing these needs, stakeholders clearly feel that these needs and the overarching framework implemented by the NLF remain relevant moving forward.

However, key developments in product markets have emerged since 2008 that have resulted in new needs and problems to be addressed by the EU legal framework for products. These developments, which primarily stem from the digital and circular economies, directly impact the provisions of the NLF, but also the wider EU legal framework for products.

Figure 5 Targeted consultations: Extent to which the needs and problems that the NLF was originally designed to address remain relevant (Question 51, N=129)

The relevance of the definitions set out in the NLF

The analysis provided by the Study of the CSES explains the reasons why the definitions of the NLF might sometimes be lacking relevance today. It explains that the set of definitions of the NLF reflects the legislator’s main concern, stemming from the 1970s, to improve the free circulation of goods within the single market. Given this focus on the internal market in 2008, the NLF did not take much consideration of the emerging globalisation of trade, which has had a considerable impact on: i) documenting and assessing compliance for economic operators and conformity assessment bodies; and ii) enforcing legislation on products imported from outside the EU.

For instance, the definition of the “importer” referred more to an intra-EU cross-border importer than to an international trader importing products from all over the world, therefore the NLF requires that the importer is established in the EU. However, nowadays, as reported to the Commission by Toys Industries of Europe , the EU-establishment criteria might lead to a less favourable treatment of EU-established importers comparing to e.g. online marketplaces sending products to the EU. In cases of online sales from third countries, there is no economic operator established in the EU (which could qualify as an importer), therefore in such cases there is no economic operator with the responsibility of an importer.

Another definition that may need rethinking is the definition of accredited NBs. According to Regulation (EC) No 765/2008, conformity assessment bodies can be accredited. The Regulation does not mention the possibility of accreditation of natural persons. Nonetheless, Regulation 1221/2009 87 (EMAS) defines as environmental verifier “any natural or legal person, or any association or group of such persons, which has obtained a licence to carry out verification and validation…..” while it also sets out (Article 2(30)) that “accreditation body means a national accreditation body appointed pursuant to Article 4 of Regulation (EC) No 765/2008 which is responsible for the accreditation and supervision of environmental verifiers”.

Furthermore, during the past years, there has been a gradual shift in the legislator’s priorities in designing NLF-aligned sectoral legislation, from ensuring the free movement of goods to reinforcing the level of confidence in the market in relation to core EU policy objectives applying not only to the products themselves but also to the way they are used.

Since the entry into force of the NLF in 2008, manufacturers have significantly changed their business models by making their products available on the market increasingly as a part of a customer-oriented solution. This involves numerous services, such as installation and putting into service 88 , regular monitoring and maintenance, software and performance updates, training, repair and refurbishing, and even take back and recycling. Such changes have brought them into competition with third-party servicing companies that were already involved to various extents in similar activities, such as machine, equipment and tool rental companies. Therefore, the dividing line between goods and services and the responsibility of different economic operators became blurred.

Interviewed stakeholders recognised the increasing blurring between products and services through the phenomenon known as servitisation. “As the complexity and variety of business activities grow and digitalisation spreads, the boundaries between services and manufacturing become increasingly elusive”. 89 However, the NLF does not define new aspects in the value chain, such as the increased role of services within products (either bundled or add-on services), and what this means from a regulatory perspective in terms of ensuring product safety at the point in time of placing on the market but especially post market placement, as services are typically provided once the product is in operation.

While historically the NLF was essentially focused on the free circulation of goods and compliance with a high level of safety, it has gradually expanded to cover compliance with environmental protection rules and other core EU interests. This requires consideration of the whole life cycle of a product, in addition to its ‘placing on the market’. The same logic applies to the consideration of safety and privacy aspects related to the marketing of digital solutions and systems involving products.

Many stakeholders across all groups recognise the need for clarification of the roles and responsibilities of stakeholder categories that were not recognised in the NLF, but are playing increasingly important roles in the market. These include stakeholders, such as software and application developers, and online marketplaces.

Consequently, it seems that there is a potential need for updating and adding new definitions within the context of the NLF as a result of market trends and emerging Union legislative proposals.

Substantial modification of a product

The NLF is based on assessing the safety and compliance of products at the time they are placed on the market. It does not address changes that may occur to products after they are put into service. Today, it is encouraged that products are reused, refurbished or even remanufactured rather than discarded after being in use for certain time. Consequently, the NLF may not cover all the questions related to the safety of products under the new circumstances. It has therefore been argued that a more ‘dynamic notion’ of a product compliance is needed to reflect the changing reality in terms of how products evolve post-market placement, for example due to software updates and upgrades.

The conformity assessment procedures are correspondingly ensuring compliance when the product is placed on the market, but not necessarily in the changing environment. The objectives of promoting the circular economy and ensuring product safety should be equally addressed in the conformity assessment procedure.

Re-manufacturing may be seen as a driver of the circular economy, and is supported by key EU initiatives and strategies, such as the ‘European Innovation Partnership on Raw Materials’ (EIP-RM) which contributes to the objectives of the Innovation Union and Resource Efficient Europe initiatives and provides opportunities for the creation of highly skilled jobs and economic growth. 90  The main environmental argument for remanufacturing is that it results in dramatically less energy and material use than production of new products from virgin materials. 91

Remanufacturing involves practices in a wide range of industrial sectors, but is best suited for industries that are capital-intensive and produce products that have a long product life-cycle 92 . Industries which have been shown to be particularly suited to re-manufacturing include: aerospace, automotive, electrical and electronic equipment, furniture, heavy duty and off-road equipment, machinery, marine, medical devices and rail, among others. Although about 90% of remanufacturing activity is in the business-to-business sphere 93 , it is increasingly being applied to consumer products.

However, despite remanufacturing becoming a growing industry and a linchpin of the circular economy, the rules in terms of guaranteeing the safety and compliance of goods that are remanufactured are perceived to be unclear.

Most stakeholders consider the absence of the concept of a ‘substantial modification’ in the NLF a prominent legal gap, as the increased complexity of value chains is also inherent to circular economy business models. The NLF does not determine when a product to be considered modified to the extent where it becomes a new product and therefore should be subject to conformity assessment procedures prior to being placed on the market again. Since the NLF pre-dates the significant increase in refurbishing and remanufacturing, it does not include any definitions of economic operators involved in such modifications either, such as repairers, refurbishers or remanufacturers with their role in the value chain or stipulate any obligations.

The reference provision in Article R6 of Annex I of Decision No 768/2008/EC sets out the cases in which obligations of manufacturers apply to importers and distributors. According to this provision an importer or distributor should be considered a manufacturer subject to the obligations of the manufacturer, where they modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected.

Chapter 2.1. of the Blue Guide contains the following explanation on when a modified product should be considered as a new one and the responsibility of the person who carries out such modification: ‘A product which has been subject to important changes or overhauls aiming to modify its original performance, purpose or type may be considered as a new product. The person who carries out the changes becomes then the manufacturer with the corresponding obligations.’ The Blue Guide also explains that a product, which has been subject to important changes or overhaul after it has been put into service must be considered as a new product if: i) its original performance, purpose or type is modified, without this being foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased in relation to the relevant Union harmonisation legislation; and iii) the product is made available (or put into service if the applicable legislation also covers putting into service within its scope). This has to be assessed on a case-by-case basis and, in particular, in view of the objective of the legislation and the type of products covered by the legislation in question.

As is the case for physical repairs or modifications, a product should be considered as substantially modified by a software change where: i) the software update modifies the original intended functions, type or performance of the product and this was not foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased because of the software update; and iii) the product is made available (or put into service where this is covered by the specific Union harmonisation legislation).

Some stakeholders (a trade association) believe that the clarification provided in the Blue Guide is sufficient for manufacturers and authorities to understand their responsibilities and cope with their respective duties while preserving flexibility in doing so, depending on the level of risks involved. Others, however, oppose the non-binding status of the Blue Guide and the related risk of misinterpretation.

Stakeholder feedback on the NLF’s ability to accommodate the circular economy was gathered through the interview programme.

Some stakeholders interviewed from the refurbishing and remanufacturing sectors perceived that the NLF is outdated and not in line with current market practices and realities. However, there were differences of opinions regarding the best way forward in dealing with this question.

Some stakeholders were in favour of building on wider initiatives instead of changing the NLF, such as:

·The revisions of the Blue Guide: The Blue Guide provides a definition of a substantial modification, and explains the role of refurbishers, remanufacturers and repairers as new economic operators within value chains.

·The development of harmonised standards that provide specific definitions and concepts relevant to the circular economy. Examples of relevant harmonised standards mentioned were: TR 45550 94 – definitions relevant to the circular economy and EN 45559 on material efficiency 95 .

The lack of a common definition and the concept of ‘substantial modification’ may result in incoherence among the legislations trying to cope with the increased complexity of value chains and accommodate the circular economy business models. Some of the revised NLF-legislations and recent legislative proposals contain different definitions as to what constitutes a substantial modification or fully refurbishment. In any instance, all industry stakeholders consulted agreed on the need for the EU legislator to harmonise all the proposed definitions of substantial modification, to ensure a common understanding between all parties. Where needed, stakeholders considered that sector-specific, complementary provisions could be necessary to facilitate its application and ensure legal certainty for economic operators.

The examples in Annex XI demonstrate that there is a diversity in terminology to describe the modifications of products following their placing on the market in such a way that compliance with the applicable requirements is affected (e.g. refurbishment, remanufacturing, repurposing, substantial modifications).

96 97 98 It is important to keep in mind that the new legislative initiatives aim to modernise the EU’s legislative framework, as an integral part of the . They build on commitments and reports adopted by the European Commission, including the and the .

In the context of the UN Sustainable Development Goals (SDGs), the NLF is supposed to address responsible consumption and production. More specifically, it should contribute 1) to substantially reduce waste generation through prevention, reduction, recycling and reuse, by 2030 (target No. 12.5) and 2) to encourage companies, especially large and transnational companies, to adopt sustainable practices and to integrate sustainability information into their reporting cycle (target No.12.6).

Based on the triangulation of the responses in the survey it seems that the NLF is able to respond to the current and upcoming needs of product legislation and preserve its relevance if it is able to provide a general framework for dealing with the challenges of the complex value chains. The NLF needs to accommodate the principles set out in the New Circular Economy Action Plan and therefore enable and foster remanufacturing and high-quality recycling of products. The NLF will be able to retain its effectiveness and efficiency as an important general framework for product legislation if it manages to keep up with the objectives of the circular economy. The NLF has been identified as a decisive cohesion tool in EU product legislation. Thanks to it, the highest possible level of coherence has been achieved in the EU’s product legislation. Although Decision No 768/2008/EC only provides for a template specific legislation, it tremendously facilitates the drafting of EU product legislation and ensures the uniformity of the body of EU product legislation. If it does not contain framework provisions that are expected to be integrated in a modern EU legislative framework, the drafters of new legislative initiatives will necessarily look for inspiration anyplace else. Without the necessary updates of this general framework, the NLF may lose its actuality and become obsolete.

General relevance of the NLF in the light of digitalisation

Besides the CE marking that must be affixed on the product visibly, legibly and indelibly, the NLF requires that traceability information is indicated on the product or, where that is not possible, on its packaging or in a document accompanying the product.

The NLF also provides that the manufacturer has to draw up and upon a request of the market surveillance authorities provide the technical documentation and EU declaration of conformity 99 . Manufacturers also have to ensure that the product is accompanied by instructions and safety information, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Relatively few stakeholders (between 15.2% and 20.2%, depending on the trend in question, out of 198 responses) took the view that the NLF is able to accommodate key trends related to digitalisation and the integration of new technologies in products ‘to a great extent’, although even fewer (between 3.5% and 7.1%) consider that this was ‘not at all’ the case. Stakeholders were most likely to consider that the NLF is able to accommodate the key trends identified to a small or moderate extent, or to answer that they don’t know.

A series of questions were posed to the stakeholders related to the appropriateness of the CE marking, which must be visibly and indelibly affixed to the product and other product information and documentation that must be provided in a hard copy.

As indicated above in Chapter 4.1.4 devoted to the assessment of the efficiency of the CE marking and other product information obligation, industry estimates the affixing of the CE marking visibly and indelibly on the product as well as other traceability information such as the postal address of the manufacturer/importer less burdensome (36.2%, i.e. 17 responses) than printing out product information to accompany the product (83%, 39 responses).

Economic operators, industry associations, consumer associations, MSAs and national competent authorities were asked in the targeted consultations whether they consider that the NLF’s general information obligations addressed to consumers remain necessary and appropriate. Respondents were far more likely to agree that affixing the CE marking visibly and indelibly on the product, as well as other traceability information was, to a great extent, necessary and appropriate, compared to printing out information to accompany the product.

Industry respondents were in favour of moving towards digital-only CE marking, product compliance and user information as soon as possible. This was seen as potentially reducing costs, but only if hard copy versions were no longer required. However, none of the national competent authorities shared this view.

Figure 6 Public consultations - Impact on consumers of providing product information in a digital form (disaggregated by stakeholder type, N=102)

Respondents that viewed digitalisation positively argued that it should always be possible to provide and access information, regarding whether a product carries the CE mark, and in relation to its declaration of conformity or the technical file, in digital format rather than on paper.

Triangulating these findings with the views of interviewed stakeholders, a general consensus emerged across all stakeholder groups regarding the potential benefits of digitalising the obligations that require information to be printed.

Most stakeholders believe that digitalisation could facilitate and speed up compliance by simplifying the way in which manufacturers meet information obligations. Digitalisation would serve two objectives: simplification and environmental protection.

Based on the public consultations, 45,5% of the stakeholders would appreciate a digital CE marking, 63,2% would appraise positively the digital traceability information (e.g. postal address of the manufacturer/importer), while 72% took the view that providing safety documentation and instruction materials in a digital form would be beneficial.

The primary challenge for the digitalisation of these obligations is the potential impact on users that are less digitally adept. Economic operators, industry associations, consumer associations, MSAs and national competent authorities were asked in the targeted consultations about the extent to which the digitalisation of CE marking / traceability / product information would jeopardise the right of consumers to be duly informed. There was some divergence in the responses of the different stakeholder types. Industry associations (71%, 22 responses) and economic operators (43.8%, seven responses) were most likely to answer that digitalisation would ‘not at all’ jeopardise the consumer’s right to be informed. However, none of the national competent authorities shared this view. While some acknowledged that they preferred ‘a digital way forward’, it was also accepted that not all consumers are digitally adept. Stakeholders explain that providing information in a digital format of documents such as the EU declaration of conformity or the instruction accompanying the product, could be an ‘either/or’ option, and not an additional requirement. The development of common standards and specification for the content and format of the required product information would further facilitate the fulfilment of administrative obligations.

The Proposal of the machinery regulation foresees that manufacturers provide digital instructions and the declaration of conformity. Nevertheless, a paper format is mandatory upon request. (Essential health and safety requirements, 1.7.4). This Proposal explains that one of the problems identified were the monetary and environmental costs due to extensive paper-based documentation. On allowing digital formats for documentation, almost all the stakeholder groups representing the industry indicated that are in favour. Most Member States and consumers organisations are in favour of ensuring also paper format.

Using a digital product passport that would include an electronic declaration of conformity and the description of the conformity assessment procedure is often seen as possible simplification and means of lifting administrative burden of the economic operators. A digital passport could also facilitate market surveillance, reduce the costs and improve the effectiveness of the enforcement.

Some recent legislative proposals such as the Proposal for the regulation on batteries and waste batteries and the Proposal for a Regulation establishing a framework for setting eco-design requirements for sustainable products  provide for a digital product passport.

The Proposal for the regulation on batteries and waste batteries provides for an electronic record for industrial batteries and electric-vehicle batteries and a Battery Passport, for each individual battery placed on the market. The Battery Passport would be unique for each battery, to be identified through a unique identifier. The battery passport would be linked to the information about the basic characteristics of each battery type and model stored in the data sources of the system established by the Proposal and should be accessible online.

The Proposal for a Regulation establishing a framework for setting eco-design requirements for sustainable products  would apply to any physical goods placed on the market or put into service 100 , including components and intermediate products. The proposal foresees a digital product passport to electronically register, process and share product-related information amongst supply chain businesses, authorities and consumers. Recital (26) of the Proposal explains that the product passport should not replace but complement non-digital forms of transmitting information, such as information in the product manual or on a label. In addition, it should be possible for the product passport to be used for information on other sustainability aspects applicable to the relevant product group pursuant to other Union legislation.

The Proposal for a Regulation laying down harmonised conditions for the marketing of construction products, amending Regulation (EU) 2019/1020 and repealing Regulation (EU) 305/2011 in its Article 78 foresees an EU construction products database or system. This system or database would build on the digital product passport established by the Proposal for a Regulation establishing a framework for setting eco-design requirements for sustainable products .

Establishing the model for the product passport by the NLF in the future could be beneficial to retain its aligning function and ensure coherence among the different pieces of product legislations. The new legislative initiatives will most probably tend to keep up with the digitalisation, while the existing legislation will also be revised to meet the modern market trends. Without a general model offered by the NLF, product legislations will most probably create their own models of product passport. 

None of the product legislations and legislative initiatives have departed from the NLF when it comes to CE marking, even if, for example, the Medical Devices Regulation , In vitro diagnostics Medical Devices Regulation  foresee that software, as a standalone product can be a medical device/in vitro diagnostic medical device (Article 2(1) of both Regulations). If such product is a downloadable software and being sold without any data carrier, affixing the CE marking to an intangible product can be hardly imagined.

Similarly, the Proposal of the  AI Act  in Article 3(1) defines that the ‘artificial intelligence system’ (AI system) is a software, but the CE marking provisions of the AI Act refer to the relevant provisions of the NLF. 

A possible future impact assessment on the NLF should consider introducing the possibility of the digital CE marking to ensure the use of CE marking in the digital environment.

Relevance of the conformity assessment procedure

68,9% of stakeholders (73 respondents) in the targeted consultations considered that, at least to a moderate extent, the NLF requirements for notified bodies remain appropriate, including 34% (36 respondents) who considered this to be the case to a great extent.

Figure 7 Targeted consultations: Extent to which the NLF requirements for notified bodies remain appropriate (Question 25, N=106)

These overarching findings are validated by the targeted consultation results. 2/3 of the stakeholders (74/96 respondents) perceive that the suite of conformity assessment modules remains fit for purpose to at least a moderate extent to ensure that products placed on the Union market comply with relevant EU legislation.

Industry associations evaluate very positively the conformity assessment modules set out in Decision No 768/2008/EC and that the modules, although containing more or less phases depending on their complexity, are based on the same steps.

The majority of industry stakeholders believe that the use of module A (internal production control, without a mandatory involvement of a third party) should remain a cornerstone in the new product legislation and revised regulations. Industry stakeholders point out that several of the current legislative proposals tend to require third party conformity assessment for products over self-assessment, disregarding the risk-based approach for selecting conformity assessment modules mentioned above. Module A is linked to faster time-to-market, which is an important element for the competitiveness of European manufacturers.

Economic operators, industry associations, and national competent authorities were also asked in the targeted consultations and interviews to consider the extent to which the current conformity assessment modules are adapted to the latest manufacturing practices and were presented with three scenarios. Only a minority agreed that the modules were adapted to the latest practices to a great extent. Stakeholders were most likely to say that the modules are ‘not at all’ adapted to the latest practices in a scenario in which ‘if the product is modified following its placing on the market, it will remain safe and compliant during its lifetime’. As mentioned earlier, the focus of the NLF is the moment when the product is placed on the market and therefore the conformity assessment is also focusing on that moment, whereby the modifications done to the product following its placement on the market are not covered by the existing modules.

Under the NLF, manufacturers are required to undertake a risk assessment as part of the conformity assessment, prior to placing a product on the market. In addition, risks should be adequately considered in the technical documentation (i.e. in the technical file to support the DoC).

However, there remain outstanding questions as to whether the NLF addresses specific risks relating to the integration of new technologies into products, as there are no specific rules or guidance on these aspects. This gap already appears to have led to recent legislative proposals moving beyond the common provisions of the NLF and introducing additional regulatory requirements. For instance, in the Proposal of the machinery regulation , as well as the Proposal of the AI Act , manufacturers that are integrating AI technologies and systems into machinery would be required to perform a risk assessment of potential risks associated with the AI that may emerge post-market placement (given the autonomous learning capabilities of AI) before they place a product on the market.

The aim of these regulatory developments is to tackle market challenges that did not exist when the NLF was adopted and improve the robustness of risk assessment if increased risks are identified linked to particular new technologies. The Commission has indeed identified a need to introduce regulatory measures to address the specific risks and challenges posed by AI systems due to their specific characteristics. At the same time, most industry associations and large manufacturers interviewed expressed concerns about the concept of introducing risk assessment requirements linked to the use of specific new technologies, especially AI. The main concern is that this diverges from the technology-neutrality principle of the NLF (and earlier the New Approach), which states that “specific product legislation should, wherever possible, avoid going into technical detail but should limit itself to the expression of essential requirements” 101 .

Certification stakeholders noted that, in the context of the changes brought by the digital and green transitions and more specifically the trend that products are modified, refurbished and being placed on the market as new products, there may be room for an additional conformity assessment module. Such an additional module could focus on validation and verification of a product’s compliance of its entire lifecycle.

Directive 2013/53/EC on recreational craft and personal watercraft provides for a separate conformity assessment for products subject to substantial modification. This conformity assessment procedure is focused on the post-construction assessment of a product (Annex V, module PLC). The modified product must bear a plate with the words ‘post-construction assessment’. A future possible impact assessment may explore whether including a similar additional module to the NLF would render it more responsive to the modern supply chains and needs of the circular economy.

By triangulation of all the data collected, we may conclude that the existing conformity assessment and the menu of the modules contained in Decision No 768/2008/EC is still relevant. Nonetheless, the possible future impact assessment on the NLF may reconsider an update in terms of a new module, specifically serving the objectives of circular economy, foreseen for products subject to substantial modification.

Remote conformity assessment

As documented in an EA communication, published on 23rd March 2020, the outbreak of the COVID-19 pandemic 102 and the related travel restrictions implemented by governments across the EU, conformity assessment and national accreditation bodies were forced, in the first instance, to “cancel or postpone most of their in situ activities such as on-site assessments, audits, witnessing visits and inspections” 103 .

This situation forced all notified bodies to overcome any reluctance and implement remote assessment activities. As a peer evaluator at EA noted, the workforces at CABs and NABs across the EU, as well as EA peer evaluators, were required to adapt extremely quickly to ensure the competence and consistency of conformity assessment, accreditation and peer evaluation services was maintained when being conducted remotely. 104

Views on the success of this shift to remote activities were sought through interviews with relevant stakeholders and an open-ended question in the targeted consultation. In this respect, the interviewed notified bodies and NABs considered the experience to have been generally successful. In the first instance, a respondent to the targeted consultation praised the speed with which EA responded to the emerging COVID situation in March 2020.

However, stakeholders highlighted a few caveats and disadvantages to remote assessments:

·Remote assessments will never fully replace face to face activities, particularly in certain areas where face to face conversations are perceived to be essential, such as audits.

·In relation to remote peer evaluations, an EA evaluator highlighted that contact and interaction between the personnel involved in the peer evaluation process can be more difficult, as can the process for defining and agreeing on non-conformities. 105

With this in mind, the evolving situation of one NAB characterises the overall positive views across these stakeholder groups. The NAB noted that, in contrast to its pre-COVID scepticism about the appropriateness of remote assessments, it is now actively exploring ways in which remote methods can improve the accreditation process, highlighting ideas such as the use of smart glasses with an embedded camera and microphone for use in witnessing visits. However, as this is a recently emerging reality, the discussion on the merits and consensus on when remote conformity assessment services can be implemented and their appropriateness across different sectors is ongoing.

It was also suggested that the development of a normative harmonised procedure for conducting remote audits within the EN ISO/IEC 17000 series could be beneficial.

The remote conformity assessment procedure is not foreseen by the NLF. Nonetheless, the COVID-19 pandemic made us realise that even if it cannot replace the in situ procedure, it can often complement it. A possible future impact assessment may explore if the possibility to undertake remote conformity assessments should be included into the text of the NLF.

Relevance of the NLF in an emergency situation

Asked about the extent to which, during the pandemic, it took products that were instrumental in the fight against COVID-19 too long to be placed on the market, almost half of stakeholders (49.8%, 58 responses) in the targeted consultation agreed that it took too long (whether to a small, moderate, or great extent). However, 43.6% of the stakeholders (51/117) responded that they don’t know. Only 6.8% of stakeholders (eight responses) answered ‘not at all’ i.e., that it had not taken too long for products such as PPE and medical devices to be placed on the market during the pandemic.

Question 57 was asked to: economic operators, industry associations, MSAs, national competent authorities, national accreditation bodies, national notifying authorities and notified bodies.

Figure 8 Targeted consultations: Extent to which it took products that were instrumental in the fight against COVID-19 too long to be placed on the market (Question 57, N=117)

There was some variation by stakeholder type: industry associations (31.3%, five responses) and national accreditation bodies (27.3%, three responses) were the most likely to agree to a great extent that it took too long for products to be placed on the market. Some stakeholders believe that the product conformity assessment system is too complex for crisis situations and that a special crisis-adapted procedure should be considered, perhaps centralised through an EU solidarity mechanism.

Others posited that the main problem in bringing products, such as PPE, to the market during the COVID crisis related primarily to supply and demand. It would have been more advantageous to address the shortage through increasing production capacity and conformity assessment capacity rather than by easing regulatory requirements. To reduce regulation would be to risk inadvertently allowing non-compliant and unsafe products to be marketed.

Another tool put forward by stakeholders to ensure an accelerated response to the market needs in case of emergency could be the more extended use of the remote conformity assessment, where it is appropriate.

Nonetheless, 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 106 . Therefore, the Proposal for a Regulation on establishing the Single Market emergency instrument was adopted on 19 September 2022.

Figure 9 Targeted consultations: Extent to which it took products that were instrumental in the fight against COVID-19 too long to be placed on the market: responses by stakeholder type (Question 57, N=117)

Based on the triangulation of the evidence collected for this evaluation, we conclude that the NLF by and large is still able to respond to current and emerging needs, nonetheless in the light of ongoing digitalisation and trends to better achieve the objectives of the circular economy, some of its provisions may soon lag behind the more modern solutions foreseen in newer proposals or legislations and therefore lose their future-proof coherence. Digitalisation of the CE marking would be highly appreciated in some sectors, while it seems to be less relevant for others. Regarding the product information obligations, digitalisation has already been foreseen in certain legislative proposals, therefore in case of a possible future revision of the NLF it will be necessary to rely on the digital solutions already foreseen by then in certain product legislations.

5.1.    Conclusions

The above assessment, based on the triangulation of different data sources and expertise, shows that the NLF has contributed strongly to the achievement of its general objectives: it has provided a high level of protection of public interests, fostering the free movement of products within the single market and establishing a common harmonisation framework.

The conclusions are based on the triangulation of all the evidence collected with the methods listed in Section 1.1. (desk research, legal mapping, interviews and consultations, stakeholders’ workshop, case studies), conducted by CSES. Nonetheless, in the absence of explicit data eligible for quantification, for certain aspects of the efficiency of the NLF, the interviews with the stakeholders, targeted consultations and the workshop were crucial for collecting evidence. Despite their usual limitations, the stakeholders’ consultations are considered to be a credible and sufficiently deep base of evidence, given the diversity of participating stakeholders and their high interest in participating in the surveys and workshop.

The alignment with the NLF’s reference legal provisions and use of the NLF’s common implementation mechanisms has been ensured across 16 directives,7 regulations and a delegated act to date. Therefore, this assessment takes account of the earlier sector-specific evaluations, nonetheless, their relevance in the context of this evaluation is often limited. The fact that these assessments rather evaluate the performance of the specific pieces of EU product legislations, from the perspective of their specific policy objectives and without focussing on the performance of the NLF sets limitations to the suitability of conclusions drawn in the sector specific evaluations. The assessment of the effectiveness and efficiency is in most cases not explicitly attributable to the NLF. The estimation of the NLF-related costs and benefits and especially their quantification are therefore often limited. The positive effects of the NLF, considering both monetary and non-monetary benefits, strongly outweigh the costs. The NLF comprises very few direct costs, as most costs associated with the framework of EU product legislation stem directly from compliance with individual pieces of NLF-aligned legislation. However, a wide range of cost savings and other benefits have been highlighted by stakeholders. For economic operators, these benefits included reduced costs in familiarisation with legislative requirements by economic operators due to the implementation of common provisions; greater regulatory certainty; greater harmonisation of obligations; reduced market barriers; and, as a result, enhanced industrial competitiveness. Nonetheless, the lack of quantification elements impedes us to draw more precise conclusions on the costs and benefits of the NLF.

Positive progress has also been made across the NLF’s specific objectives relevant to this evaluation as explained below, however, certain implementation challenges were highlighted in many cases.

Reinforcing the New Approach

The commitment to expressing essential requirements that avoid going into technical details has been clearly implemented across NLF-aligned legislation. The NLF managed to reinforce the technology-neutral approach throughout the EU product legislation.

Thanks to the technologically neutral regulatory framework based upon essential requirements, the NLF is perfectly suited to cope with the higher speed of technical innovation.

Nonetheless, the success of the NLF depends heavily on having a quick and effective standardisation process. The absence or delay in the adoption of harmonised standards leads to the increase of the costs of conformity assessment and may have a negative impact on innovations: If the harmonised EU standards lag behind the newest international standards representing the state of the art, the NLF is not able to perform as expected.

Industry stakeholders are highlighting that there is a trend in the new legislative proposals of EU product legislation to incorporate more granular technical requirements. The impact of this tendency, according to these stakeholders, is reduced flexibility of the legal framework to deal with changes in the market, an erosion of the principle of technological neutrality, resulting in negative impacts on innovation and competitiveness.

To retain the NLF’s technological neutrality, product legislation should limit itself to the expression of essential requirements. The drafters of new legislative initiatives should make sure not to include unnecessary technical details into the texts of future EU legislations to preserve the technological neutrality of the NLF-aligned legislations.

Supporting the consistency and coherence of EU harmonisation legislation

The process of aligning 23 pieces of EU legislation and a delegated act to the NLF has heavily strengthened the consistency and coherence of these acts. In support of these achievements, the internal coherence of the two NLF legal texts being examined was considered to be strong; no particular inconsistencies or overlaps have been identified.

In this respect, the coherence of the NLF with wider EU legislation was considered to be strong in its first decade, with only minor examples of divergence between the NLF / NLF-aligned legislation and non-NLF aligned legislation identified.

Mostly minor challenges and examples of divergence exist across the wide body of NLF-aligned legislation, but it remains important to consider the cumulative impact of these minor challenges and divergences.

Better implementation of the NLF in the revised or new product legislation could improve the coherence of the EU product legislation. To ensure consistency and avoid unnecessary divergences some stakeholders at the validation workshop suggested that justifications for deviations in NLF-aligned legislations should be included in the recitals of the product legislation, noting that such an exercise could also restrict the scale of deviations by ensuring that the legislator fully considers their necessity.

To further respond to the need of future-proofing coherence of the NLF as regards upcoming legislation developments to address the objective of the circular economy, some stakeholders and other experts in the field, including in the Commission services, suggest introducing additional definitions, such as ‘refurbisher’, ‘remanufacturer’, ‘substantial modification’.

It seems that there is a potential need for updating and adding new definitions within the context of the NLF as a result of market trends and emerging Union legislative proposals, which could be further explored in a possible future impact assessment.

The Commission service responsible for trade stressed that to ensure coherence and consistency in the implementation of international trade agreements concerning the recognition of conformity assessment results, a possible future impact assessment could explore whether a set of reference provisions (e.g. on conformity assessment and notification of conformity assessment bodies under the mutual recognition agreements) to be used for the purpose of implementation of international trade agreements concerning the recognition of conformity assessment results could also be included in the NLF.

Strengthening the conformity assessment system

The adoption and practical implementation of the legal framework for accreditation was a very important achievement under this objective, as no European framework for accreditation existed previously. Similarly, the suite of conformity assessment modules detailed in Annex II to Decision No 768/2008/EC and the requirements for notification of conformity assessment bodies were considered to be important outputs by all relevant stakeholders. Due to the requirements set by the NLF, the notifying authorities also strengthened the supervision of the notified bodies.

However, the analysis done in the framework of the CSES study concludes that more needs to be done to ensure uniformity in conformity assessment services across the EU, as a range of application challenges currently persist, including the non-mandatory nature of accreditation. Therefore, the majority of stakeholders agreed that the NLF does not ensure that the procedures for monitoring non-accredited notified bodies are sufficiently reliable and appropriate for the purposes of notification.

The monitoring of subcontracted tasks of conformity assessment bodies seems to pose challenges to notifying authorities/accreditation bodies when these tasks are performed in another Member State or in a third country. Notifying authorities/accreditation bodies could most probably improve the current situation and eliminate those subcontractors that cannot be effectively monitored and the so called ‘letter-box’ notified bodies fully dependent on the services subcontracted from their non-EU based mother companies through a more consistent implementation of the existing rules on subcontracting. Nonetheless, stakeholders seem to agree that the NLF does not provide enough clarity on the mandatory staff, on the extent of the activities that cannot be outsourced by the notified body and possible limitations of the tasks to be subcontracted.

A future possible impact assessment may want to explore if more precise rules should be introduced in this regard to ensure the continuous high quality of services and level-playing field for the NBs, including when outsourcing certain substantial technical tasks.

The CSES study notes that, in the context of the changes brought by the digital and green transitions and more specifically the trend that products are modified, refurbished and being placed on the market as new products, there may be room for an additional conformity assessment module. Such an additional module applicable exclusively for remanufactured products, although not provided in the NLF, is not new in EU product legislation since it is foreseen in Directive 2013/53/EC on recreational craft and personal watercraft. A possible new module in the NLF could focus on validation and verification of products that were subject to substantial modification following their placing on the market or putting into service or the product’s compliance for its entire lifecycle.

By triangulation of all the data collected, we may conclude that the existing conformity assessment and the menu of the modules contained in Decision No 768/2008/EC is still relevant. Nonetheless, the potential impact assessment on the NLF may reconsider an update in terms of a new module, specifically serving the objectives of the circular economy and add clarifications to rules on NBs.

Enhancing the clarity and credibility of the CE marking

Although the CE marking regime was well established prior to 2008, the NLF’s rules contributed to the clarification of the CE marking. They increased the industry attention on CE marking requirements, strengthened its visibility and ironed out minor inconsistencies between the different pieces of legislation.

Consumer associations still share concerns with regard to understanding the purpose of the CE marking among consumers. Balanced against this, industry respondents made clear that CE marking was well-recognised among consumers and seen as a de facto quality mark which can allow them to export to some third countries without further product testing. Nonetheless, the reservations coming from consumer associations show that there still might be room for awareness raising and clarifying the meaning of the CE marking.

Industry stakeholders highlighted that the need to indelibly mark products costs to manufacturers and limits the flexibility of economic operators to respond to market developments globally, as certain ‘marked’ stock can only be sold in the specific regions or countries they are marked for.

None of the product legislations and legislative initiatives have departed from the NLF when it comes to CE marking, even if some EU product legislation explicitly foresee software as a standalone product. If such product is a downloadable software and being sold without any data carrier, affixing the CE marking to an intangible product can be hardly imagined.

Concerning other obligations, such as printing out product information to accompany the product (e.g. instruction manuals, guidance on reasonably foreseeable use etc.), more stakeholders consider burdensome providing hard-copy instructions to accompany the product, than CE marking.

In this respect, it can be concluded that digitalisation offers a potential solution for simplification of administrative obligations related to product information requirements and CE marking and could also serve the environmental protection. In addition to this, we should note that digitalisation of the CE marking and other obligations might be more appropriate in some product sectors (e.g. medical devices) that in others, where the characteristics of the products and the type of consumers require the CE marking affixed to the products (e.g. toys).

5.2.    Lessons learned

More and more legislative proposals include provisions on certain aspects of digitalisation of the product information obligations, while the NLF does not provide for any digitalisation of product information obligations. A lack of a digital solutions could render the NLF less relevant in the future and hamper its future-proofing coherence.

The Opinion of the Fit for Future Platform (F4F) suggested that the Commission evaluates carefully and draws lessons relevant to explore whether product information and documentation could be given digitally as a default (digital-by-default), except when the product information is mandatory for consumers. The F4F recommended that the Commission identifies where and when it could be encouraged that information is provided digitally.  

To respond to the suggestions of the Opinion, based on this evaluation, a possible future revision of the NLF may want to 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. The digitalisation of product information and CE marking could make more effective the work of market surveillance authorities and customs 107 . With regards to customs enforcement, digitalisation is an essential aspect not only in the framework of the digital product passport but also for the possible future revision of the NLF on these issues, and in the context of the Union Customs Code (UCC) revision and the reform of the customs governance which are ongoing. A coordination between market surveillance authorities and customs is therefore necessary to allow proper enforcement at the EU external borders. Instructions that must accompany the product could also be alternatively provided in a digital format, but provided in a hard-copy upon request, while safety information should always accompany the product in a paper-based format (with the exception of intangible products, such as a software), to ensure that all consumers have the opportunity to read them immediately upon unpacking the product. The future possible impact assessment could assess how digitalisation can serve simplification and the red tape reduction, without presenting an additional obligation.

The lack of a general framework for a product passport may lead to a proliferation of versatile definitions (e.g. product passport, e-labelling) and different levels of digitalisation depending on the specific legislations. The absence of such a general framework may risk the proliferation of versatile sectoral initiatives, leading to the fragmentation of the market and therefore increased burden for businesses. The NLF should be able to keep its position as the future-proof framework and alignment tool for product legislation. Without the necessary instruments for the alignment, including definitions and blueprints, this role of the NLF might be endangered. Without a general framework for the digital solutions included in the NLF, the high level of coherence among product legislations could be jeopardized because the NLF does not contain a response to the current needs of the market.

Establishing the model for the product passport by the NLF in the future could be beneficial to retain its aligning function and ensure coherence among the different pieces of product legislations. The new legislative initiatives could tend to keep up with the digitalisation, while the existing legislation will also be revised to meet the modern market trends. Without a general model offered by the NLF, product legislations could create their own models of the digital product passport. 

Regarding the digital passport model and concept, the possible future impact assessment on the NLF may want to explore the possibilities of building on the currently proposed EU digital passport model foreseen in the  Proposal for a Regulation establishing a framework for setting eco-design requirements for sustainable products .

To be able to respond to the current and upcoming needs of product legislation and preserve its relevance, the NLF should provide a general framework for dealing with the challenges of the complex value chains, accommodating the principles set out in the New Circular Economy Action Plan and therefore facilitating remanufacturing and high-quality recycling of products. The NLF will be able to retain its effectiveness and efficiency as an important general framework for product legislation if it manages to keep up with the UN Sustainable Development Goals and the objectives of the circular economy and digitalisation.

The NLF has been identified as a decisive cohesion tool in EU product legislation. Thanks to it, the highest possible level of coherence has been achieved in the EU’s product legislation. Although Decision No 768/2008/EC only provides a template for specific legislation, it tremendously facilitates the drafting of EU product legislation and ensures the uniformity of the body of EU product legislation. If it does not contain framework provisions that are expected to be integrated in a modern EU legislative framework, the drafters of new legislative initiatives will necessarily look for inspiration anywhere else. Without the necessary updates of this general framework, the NLF may lose its actuality and become obsolete.

Lead DG, Decide reference and, if relevant, Work Programme reference.

DG for Internal Market, Industry, Entrepreneurship and SMEs

Agenda planning/ Work programme reference: PLAN/2020/9304

Organisation and timing.

Work started in November 2020, which the creation of the roadmap document. An Inter-Service Steering Group (ISSG) chaired by DG for Internal Market, Industry, Entrepreneurship and SMEs was established to this purpose. The ISSG met six (6) times (06/05/2021, 10/12/2021, 18/02/2022, 05/04/2022, 28/04/2022 and 27/06/2022).

Use of external expertise. Centre for Strategy & Evaluation Services ( CSES ), supported by the Centre for Industrial Studies ( CSIL ) produced a supporting study.

Fit for Future Platform

The following table summarises the Opinion of the Fit for Future Platform  and the Commission’s response as to how these issues are considered in its work.

Consultation of the Regulatory Scrutiny Board (RSB): 

The draft evaluation was submitted to the RSB on 11 May 2022. The Board dealt with this evaluation in a written procedure and issued a positive opinion on 10/06/2022. The table below explains how the draft SWD was revised in order to take into account the recommendations contained in the Board’s opinion:

The main sources of information used for this evaluation are the following:

Extensive desk research. It involved a review of a wide range of documents and a bibliography provided below in this Annex. The literature also included the previous evaluation for the Internal market legislation on Industrial products (SWD(2014)23), as well as the REFIT evaluation accompanying the Proposal for a Regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and annexes (SWD(2017)469).

Data collection and mapping. In particular, the following were developed:

§Key research questions and issues for exploration;

§Set of tailored interview questionnaires, targeted to the different stakeholder groups (economic operators, industry associations, consumer associations, national authorities, and market surveillance authorities (MSAs), and notified bodies);

§Stakeholder mapping - To support the stakeholder consultations, an extensive stakeholder mapping exercise was conducted. Stakeholders across all relevant categories were identified and collated in an excel database to support the interview programme.

§Legislative mapping framework - A framework to map legislation that has been NLF-aligned was developed to support the assessment of the NLF’s contribution to the alignment of product legislation. The legislative mapping compared the legal text of the 23 NLF-aligned legislation with the NLF reference provisions.

Interview programme. A pilot interview program testing the interview guides was launched by CSES before the exercise of the interviews. Thanks to the pilot interview program, the interview guides were refined an adjusted to better reflect the data relevant for the assessment. In total 110 interviews were conducted.

Online survey questionnaires

·The targeted consultation was supposed to be open for 8 weeks, however they were open for ten more days due to multiple requests from stakeholders.

·An additional reach-out to important stakeholders (notified bodies, notifying authorities, MSAs responsible for NLF-aligned legislation) were conducted to ensure a broad support of the consultation results. CSES circulated the survey directly to more than 2,500 relevant stakeholders by email.

·The Commission promoted the evaluation among SMEs and invited them for contribution via the Enterprise Europe Network .

·The targeted consultation received a total 190 complete responses, rising to 226 for certain questions. These responses cover all key stakeholder groups: economic operators (19); industry associations (32); MSAs (13); national accreditation bodies (19); national competent authorities (17); national notifying authorities (15); notified bodies (59); consumer associations (4); standardisation bodies (5) and others (7).

·The Commission conducted a survey among notified bodies to identify whether or not remote assessment techniques have been used, in the context of the COVID-19 pandemic and guidance provided by the European co-operation for Accreditation. Out of the 1536 NCABs reached, 142 responded to the survey (9%). Two thirds of the respondents (91 or 64%) have made use of remote assessment techniques, while one third (51 or 36%) have not.

Validation workshop with the stakeholders. CSES organized a workshop with the stakeholders to ensure the cross-checking of the evidence and information collected in the interviews and targeted consultations. 46 external stakeholders participated in the workshop, covering all key stakeholder groups.

The public consultation questionnaire was open for 12 weeks, from 13th December 2021 until 7th March 2022. The total number of responses is 125.

The data analysis methods included all the tools necessary to ensure counterfactual analysis, the triangulation of information and their well-structured presentation. The intervention logic analysis allowed us to carefully design outputs, results and impacts to ensure that the information and evidence collected during the evaluation is presented in a logical way.

The cost-benefit analysis is one of the challenges of this evaluation. The research covered both administrative and regulatory costs stemming from the NLF. The benefits were identified at minimum by estimating costs saved due to the NLF harmonisation, although other benefits were included wherever it was possible. The limitations of this analysis can be traced back to the often blurry separation of the effects and therefore costs and benefits that are directly attributable to the NLF from those that are related to specific product legislations is

Case studies. Case studies are related to specific product categories to provide practical examples of NLF-related issues. Case studies are used for the costs and benefits analysis, but also to demonstrate the fitness for purpose of the NLF.

Detailed analysis of each method is provided in the Study that was carried out for the European Commission – DG GROW by the Centre for Strategy & Evaluation Services ( CSES ), supported by the Centre for Industrial Studies ( CSIL ). 

General literature on the NLF:

·Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards , OJ C 136, 4.6.1985, p. 1–9.

·2008-08-13 - Decision No 768-2008-EC on a Common Framework for the marketing of products ( More )

·2008-08-13 - Regulation (EC) 765-2008 on accreditation and market surveillance ( More )

·2017-12-19 - EC report on the implementation of Regulation (EC) No 765-2008 - COM/2017/0789 final ( More )

·2017-12-19 – EC Staff WD - Impact Assessment of the Alignment Package ( More )

·2017-12-19 - EC Staff WD - Refit Evaluation of the Alignment Package ( More )

·2017-06-20 - Ex-post evaluation of the application of the market surveillance provisions of Regulation (EC) No 765/2008 ( More )

·2014-01-22 - COM(2014)25 a vision for the internal market for industrial products ( More )

·2014-03-12 – CSES Evaluation of the internal market legislation for industrial products - Final report. Lot VI, Interim, final and ex-post evaluations of policies, programmes and other activities ( More )

·2018-05-07 - SWD(2018)160-F1 - Evaluation of the Machinery Directive ( Download )

·2019-02-19 - COM(2019)87/F1 - EC report on the implementation of the Lifts Directive ( Download )

·2019-02-22 - EC Staff WD on the evaluation of the Lifts Directive ( More )

·2017-04 - Study on introducing an electronic tag to supplement or replace the wheel mark in marine equipment ( More )

·2018-04-19 - EC Implementing Regulation (EU) 2018-608 laying down technical criteria for electronic tags for marine equipment ( More )

·2017-02-16 - ECJ Case C-219-15 Elisabeth Schmitt vs TÜV Rheinland LGA Products GmbH ( More )

NLF and the Single Market; trends towards the servitisation of manufacturing:

·2020-11 – European Parliament – IMCO Study on Legal obstacles in Member States to Single Market rules ( more )

·2018-11 – Glinski & Rott - Role and Liability of Certification Organisations in Transnational Value Chains ( More )

·2018-07-12 – EC/EASME Study on the potential of servitisation and other forms of product-service provision for EU small and medium-sized enterprises ( More )

·2016-07-26 - The ‘Blue Guide’ on the implementation of EU products rules 2016 ( More )

·2014-10-30 – ECSIP Study for DG GROW on the relation between industry and services in terms of productivity and value creation – Final report ( More )

Special reports of the European Court of Auditors:

·2020-01 – ECA Special Report - EU action on Ecodesign and Energy Labelling: important contribution to greater energy efficiency reduced by significant delays and non-compliance ( More )

·2016- – ECA Special Report - Has the Commission ensured effective implementation of the Services Directive? ( More )

·2020 – ECA special report - Digitising European Industry: an ambitious initiative whose success depends on the continued commitment of the EU, governments and businesses ( More )

·2020 – ECA Special report on EU added value (various consideration on a functional single market) ( More )

·2019-03 – ECA Briefing paper on Challenges to effective EU cybersecurity policy ( More )

·2020 – ECA Risks, challenges and opportunities in the EU’s economic policy response to the COVID-19 crisis ( More )

·Guide to application of the Machinery Directive 2006/42/EC - Edition 2.2 ( More )

NLF and the regulatory framework regarding robotics and AI in the EU:

·2021 – 04 – new horizontal regulatory framework on AI

·2020-10-11 EPRS_ATA(2020)659282_EN An EU framework for artificial intelligence ( More )

·2020-08-31 - VVA - Impact assessment study on the revision of Directive 2006-42-EC on machinery - Final Report - ET0319199ENN ( More )

·2020-07-01 IPOL_STU(2020)621926_EN Artificial Intelligence and Civil Liability ( More )

·2020-03-01 EPRS_STU(2020)634452_EN The ethics of artificial intelligence- Issues and initiatives ( More )

·2020-06-01 IPOL_STU(2020)652713_EN - Opportunities of Artificial Intelligence ( More )

·2019-09-26 - High-level expert group on Artificial Intelligence POLICY AND INVESTMENT RECOMMENDATIONS FOR TRUSTWORTHY AI ( More )

·2019-11-06 – Guide to the application of the Directive 2006-42-EC on machinery – Edition 2.2 ( More )

·2019-06-01 EPRS_STU(2019)631752_EN Cost of non-Europe in robotics and artificial intelligence ( More )

NLF and the circular economy:

·Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning batteries and waste batteries, repealing Directive 2006/66/EC and amending Regulation (EU) No 2019/1020

·2020-12-10 - Study on the Competitiveness of the European Companies and Resource Efficiency ( More )

·2020-03-11 – Communication on A new Circular Economy Action Plan for a cleaner and more competitive Europe - COM(2020) 98 final ( More )

·2018-03-13 - EU competitiveness and the 2030 framework ( More )

·2016-11-08 - Final report - Regulatory barriers for the Circular Economy ( More )

·2016-08-03 - Identifying levers to unlock clean industry (More: Summary ;  Background report )

Regulatory framework regarding civil product liability:

·2018-05-07 – EC report on the Application of the Directive on liability for defective products (85/374/EEC) ( More )

·2018-01 – VVA - Evaluation of Directive 85-374-EEC on product liability - Final report - ET0118507ENN.en ( More )

Contributions to public consultations on issues related to the NLF review (EC Have Your Say web page)

·2020-12 - Cybersecurity – new EU strategy ( More ). The strategy was published on 16 December 2020 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020JC0018&qid=1611670081894 2020-12-02 - Industrial products - evaluation of the new legislative framework ( More )

·2020-11-26 - Health & Safety at Work – EU Strategic Framework (2021-2027) ( More )

·2020-09-01 - General Product Safety Directive – review ( More )

·2020-08-19 - Construction products – review of EU rules ( More )

·2020-07-17 - Union Customs Code – mid-term evaluation ( More )

·2020-06-30 - Digital Services Act – deepening the internal market and clarifying responsibilities for digital services ( More )

·2020-06-14 - Artificial intelligence – ethical and legal requirements ( More )

·2020-06-08 - Energy efficiency in buildings – consultation on ‘renovation wave’ initiative ( More )

·2020-02-21 - Electromagnetic compatibility - evaluation of the EU rules ( More )

·2020-01-20 - Circular economy – new action plan to increase recycling and reuse of products in the EU ( More )

·2019-08-30 - Revision of the Machinery Directive ( More )

·2019-03-04 - Upload of software on radio equipment ( More )

·2019-03-04 - Internet-connected radio equipment and wearable radio equipment ( More )

·2018-06-04 - Towards an EU Product Policy Framework contributing to the Circular Economy ( More )

·2017-11-27 - Evaluation of the Low Voltage Directive 2014/35/EU ( More )

·2017-11-17 – EC Public consultation on the rules on liability of the producer for damage caused by a defective product ( More ) + 2017-10-20 Product Liability Conference ( More )

Evaluations and impact assessments of individual pieces of product legislation:

·Evaluation of the Electromagnetic Compatibility Directive 2014/30/EU (still in progress, but nearing completion).

·Interim Evaluation of the Low Voltage Directive 2014/35/EU.

·The Evaluation of Directive 2006/42/EC on Machinery (September 2017).

·Impact assessment study on the revision of Directive 2006/42/EC on machinery (European Commission’s DG GROW, 2020).

·Commission Staff Working Document - Evaluation of the Machinery Directive (SWD(2018) 161 final).

·Impact Assessment on Increased Protection of Internet-Connected Radio Equipment and Wearable Radio Equipment (European Commission’s DG GROW, 2020).

·Commission Staff Working Document - Evaluation of the Lifts Directive 2014/33/EU

·Evaluation roadmap and impact assessment of the GPSD .

Position papers:

Position papers relating to the NLF and other product legislation where the NLF has been applied through the alignment process:

·BusinessEurope. (2020). The New Legislative Framework (NLF) evaluation: provisional comments.

·Orgalim. (2020). Orgalim comments on the 2020 draft ‘Blue Guide’.

·Bitkom. (2019). Requirements for coherent cybersecurity regulation.

·BIN-DIN-DKE (2021) EU-wide Cybersecurity Requirements.

·Eurosmart. (2019). The Revision of the Machinery Directive, Answer to the European Commission Public Consultation.

·Digital Europe. (2019). A strong and united Europe that reflects European values and thrives globally in an open economy.

Impact of new technologies (including AI) and digitalisation:

·AI High-Level Expert Group (HLEG). (2019). Ethics guidelines for a trustworthy AI.

·AI High-Level Expert Group (HLEG). (2019). Policy and investment recommendations for trustworthy AI.

·BEUC. (2020). Product Liability 2.0 – How to make EU rules fit for consumers in the digital age.

·Check Point. (2020). Cybersecurity Report.

·Cowls, J, and Floridi, L. (2018). Prolegomena to a White Paper on an Ethical Framework for a Good AI Society.

·CSES. (2020). Framing the Nature and Scale of Cyber Security Vulnerabilities within the Current consumer Internet of Things (IoT) Landscape , study for DCMS – included a case study on ICT-facilitated abuse.

·CSES (2020). Study on the Competitiveness of the EU Engineering Industries and the Impact of Digitalisation (EASME Executive Agency/ DG GROW, 2020).

·CSES (2020). Study on Opportunities of Artificial Intelligence (ITRE Committee, European Parliament).

·DG CONNECT. (2020). Artificial Intelligence. from https://ec.europa.eu/digital-single-market/en/news/eu-member-states-sign-cooperate-artificial-intelligence .

·DigitalEurope. (2018). Recommendations on AI Policy Towards a sustainable & innovation friendly approach Brussels.

·DigitalEurope. (2019). DIGITALEUROPE recommendations on standardisation in the field of Artificial Intelligence.

·Espinoza, J. (2020). Coronavirus prompts delays and overhaul of EU digital strategy.

·European Commission. (2016). Communication on Digitising European Industry: Reaping the full benefits of a Digital Single Market, Brussels, 19.4.2016, COM(2016) 18 final.

·European Commission. (2017). Communication on Mid-Term Review on the implementation of the Digital Single Market Strategy: A Connected Digital Single Market for All, COM(2017) 228 final.

·European Commission. (2018). Communication Artificial Intelligence for Europe.

·European Commission. (2018). Communication Coordinated Plan on Artificial Intelligence, Brussels, 7.12.2018, COM(2018) 795 final.

·European Commission. (2018). Evaluation of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products.

·European Commission. (2018). Staff Working Document on Liability for emerging digital technologies accompanying the Communication on Artificial intelligence for Europe, Brussels, 25.4.2018, SWD(2018) 137 final.

·European Commission. (2019). Communication on Building Trust in Human-Centric Artificial Intelligence, Brussels, 8.4.2019, COM(2019) 168 final.

·European Commission. (2019). Political guidelines for the next European Commission 2019-2024.

·European Commission. (2020). Communication on A European strategy for data, Brussels, 19.2.2020, COM(2020) 66 final.

·European Commission. (2020). White Paper On Artificial Intelligence – A European approach to excellence and trust, Brussels, 19.2.2020, COM(2020) 65 final.

· European Court of Auditors. (2019). Briefing paper: challenges to effective cybersecurity policy, March 2019 .

·European Economic and Social Committee. (2017). Opinions: Artificial Intelligence.

·European Group on Ethics in Science and New Technologies. (2018). Statement on Artificial Intelligence, Robotics and ‘Autonomous’ Systems, Brussels, 9 March 2018.

·Expert Group on Liability and New Technologies New Technologies Formation. (2019). Liability for Artificial Intelligence and other Emerging Digital Technologies.

·European Parliament. (2019). A comprehensive European industrial policy on artificial intelligence and robotics.

·European Parliament. (2019). Economic impacts of AI.

·European Parliament. (2019). Resolution on automated decision-making processes: ensuring consumer protection and free movement of goods and services (2019/2915(RSP)).

·European Parliament. (2020). Resolution of 20 October 2020 with recommendations to the Commission on a civil liability regime for artificial intelligence (2020/2014(INL)).

·EY et al. (2018) map enforcement costs, substantive compliance costs, administrative burden and indirect costs, as well as (on the benefit side) improved well-being, market efficiency and increased harmonisation.

·Joint Research Centre, European Commission. (2019). Legal and regulatory implications of Artificial Intelligence (AI): The case of autonomous vehicles, m-health and data mining.

·Kreutzer, R. and Sirrenberg, M. (2019). Understanding Artificial Intelligence: Fundamentals, Use Cases and Methods.

·McKinsey Analytics. (2018). Notes from the AI frontier: AI adoption advances, but foundational barriers remain.

·McKinsey. (2019). Driving impact at scale from automation and AI.

·Moore, P. (2019). Artificial Intelligence: Occupational Safety and Health and the Future of Work.

·NESTA. (2020). AI Governance Database.

·OECD. (2019). Recommendation of the Council on Artificial Intelligence, OECD/LEGAL/0449, Adopted on 22/05/2019.

·OECD. (2020). OECD.AI Policy Observatory: A platform to share and shape AI policies.

·Office of the Chancellor of Justice, Finland. (2019). Competitive Europe and the Regulation of Artificial Intelligence (AI) and Other Emerging Technologies? Principles of Better Regulation in the Context of AI and the Future of Better Regulation, 27.6.2019.

·Optimity Advisors. (2018). algo:aware, Raising awareness on algorithms, State-of-the-Art Report on algorithmic decision-making, commissioned by DG Connect, European Commission.

·Orgalim. (2020). Orgalim Manifesto: a European Agenda on Industrial AI, Brussels, 15 January 2020.

·REFIT Platform. (2017). Opinion on Intention, Digitalisation and Technology Neutrality, Adopted 23/11/2017.

·Saunders, K. (2018). How far AR and VR create effective supply chains.

·ShareWork. (2019). D8.3 Report on the standardisation landscape and applicable standards, Project: H2020-NMBP-FOF-2018 No 820807 on Safe and effective human-robot cooperation towards a better competitiveness on current automation lack manufacturing processes.

This below table presents the evaluation matrix for the study. For each key evaluation question, it presents sub-questions, judgement criteria, and indicators, as well as relevant data and information sources and assessment methods.

The following Tables offer an overview of costs and benefit identified, assessed compared to the situation that preceded the 2008 legislative package, and of the potential for burden reduction.

Overview of costs and benefits identified in the evaluation of the NLF

Overview of simplification and burden reduction in the NLF

Objectives of the consultation

The Commission wanted to assess the effectiveness, efficiency, relevance, coherence, and EU added-value of certain aspects of the NLF. Although the study scope is further detailed below, it is important to note that the study will exclude the provisions of Regulation (EC) No 765/2008 relating to market surveillance. The market surveillance provisions were subject to an ex-post evaluation study in 2017 and have since been amended by Regulation 2019/1020. However, the evaluation will include the provisions within Regulation (EC) No 765/2008 pertaining to conformity assessment, accreditation, and CE marking.

The focus of the evaluation was retrospective, providing an informed assessment of the NLF’s current performance and an evidence-based assessment of the above-mentioned evaluation criteria. However, there was also a forward-looking dimension to the evaluation, which formed an important part of the assessment of the NLF’s relevance.

Consultation methods and tools

The main consultation activities contained an interview programme, a targeted online consultation survey and a public online consultation survey. A total of 92 stakeholders were interviewed; the targeted consultation received a total of 361 responses with 190 complete responses; and the public consultation received 125 responses, with 95 complete responses.

Furthermore, a stakeholder validation workshop was held on 9th March 2022, where the Commission presented the background and context to the evaluation of the NLF, clarifying the scope and the objectives of both the NLF and the evaluation. The evaluation team then presented an overview of the study’s methodological approach, the conceptual challenges related to the evaluation and the findings and conclusions from the research.

The workshop participants were then separated into three break-out groups, where they had the opportunity to provide general feedback on the evaluation study’s findings and conclusions, as well as specific feedback on one of the following specific topics: i) Weaknesses in the accreditation and notification systems; ii) COVID-19 & the NLF; and iii) Ongoing fitness for purpose of the NLF.

Results of the consultation activities

Interviews

The piloting of the interview guides was initiated in July 2021. At first, a small number of key stakeholders was targeted, spanning the wide variety of stakeholder groups. The aim of the piloting exercise was to test and ensure the suitability of the interview guide. Through this exercise, it was identified that, for the most part, the questions posed in the different interview guides worked as intended. Following this exercise and the refinement of the interview guides, the full interview programme was initiated.

In total, 117 stakeholders were contacted and interviews were conducted with 92 stakeholders. These engagements span the following key stakeholder groups: economic operators; industry associations; conformity assessment stakeholders (including notified bodies); consumer associations; EU and national authorities; standardisation bodies; and legal experts. The below table provides the full breakdown of interview status per stakeholder group.

Targeted consultation

The targeted consultation was launched on 16th November 2021 and was originally intended to be open for 8 weeks, closing on 11th January 2022. However, following multiple requests for an extension from key stakeholders, the deadline was extended to 21st January 2022. To support the reach of the targeted consultation, an additional stakeholder mapping process was conducted to develop a comprehensive list of relevant national authorities. Through this process, contact details for all national accreditation bodies, national notifying authorities and MSAs responsible for each NLF-aligned legislation across all Member States were collected, as well as all notified bodies covering all NLF-aligned legislations. As many of the publicly available contact details, particularly for notifying authorities were generic, this stakeholder mapping was enhanced by liaising with the Commission to get explicit permission from specific contacts within national notifying authorities. In total, the survey was circulated directly to more than 2,500 relevant stakeholders by email.

The targeted consultation received a total 190 complete responses, rising to 226 for certain questions.

A total of 361 organisations covering all 27 EU Member States and seven non-EU countries took part in the consultation. The most common country of origin for respondents was Germany, which accounted for 14.4% of responses (52 respondents), followed by Belgium and Czechia, each accounting for 12.2% of responses (44 respondents). However, 29 of the Belgium-based respondents identified as EU-level and/or international organisations. Together, respondents from the EU made up just over 94% of the total (340 respondents). Among the non-EU countries (21 respondents), the most represented country was Switzerland (1.9%, seven respondents).

In terms of achieving its objectives, stakeholders responded positively across all key NLF objectives. Respondents were most likely to consider the NLF to have been either very or somewhat effective at reinforcing the free movement of products within the single market (80.5%, 182 respondents). Considering the other objectives, 75.7% (171 respondents) considered that the NLF was either very or somewhat effective in reinforcing a high level of protection of public interests; similarly, respondents perceived the NLF to have been effective in: strengthening the visibility and use of the CE marking system (70%, 158 respondents); and reinforcing the technology-neutral approach to setting essential requirements (66%, 149 respondents).

Among the NLF’s most beneficial aspects, stakeholders frequently mentioned the harmonised conformity assessment and accreditation system, which enables the free movement of goods within the EU. Others suggested that the NLF’s main advantage is that it determines the requirements for bodies assessing the conformity of products, which increases trust in their competence and the quality of their work. In relation to conformity assessment, industry representatives clearly stated that they perceive module ‘A’ (Internal Production Control involving a self-declaration of conformity), in combination with effective market surveillance, as providing a flexible and fair level playing field for manufacturers. The fact that the NLF provides a flexible suite of conformity assessment modules, sets out rules on accreditation for conformity assessment bodies, and makes provisions for effective market surveillance (including for strengthening cooperation and coordination between MSAs and customs authorities) was said to build stakeholder confidence in the overall regulatory framework and the efficacy of its implementation, as well as ensuring the safety of products within the single market.

Respondents praised the NLF for creating a situation in which actors in the supply chain are responsible for placing their product on the market, for risk assessment and must be aware of its properties. This was seen as leading to a well-defined supply chain with differentiated responsibilities, depending on the role of the specific economic operator (EO) concerned. Stakeholders pointed out that this was a paradigm shift, as manufacturers (or importers or distributors) assume full legal responsibility to ensure compliance for the product they are placing on the market according to the specified obligations for different types of EOs.

Nonetheless, the NLF was said to have been broadly effective in protecting the integrity of the single market and in supporting effective enforcement and surveillance. The overall NLF approach of setting high-level essential requirements but with technical details being set in harmonised standards to provide a presumption of conformity is also appreciated by stakeholders. The option for manufacturers of choosing Module A, which relies on internal production control was seen as allowing for greater flexibility, speed, and lower cost, and gives a predictable timeline to obtain market access for new products. However, the timeliness of the availability of published harmonised standards was a concern identified by industry stakeholders.

Industry associations and economic operators were convinced that the New Approach and the continuation of its principles through the implementation of the New Legislative Framework are the best tools to support the free movement of goods and the proper functioning of the Single Market for goods. The introduction of the NLF was also said to have been beneficial for SMEs in that it has reinforced access to the EU’s single market for smaller firms, in particular through the availability of harmonised standards and the ability to reduce costs by following Module A should SMEs so wish. Having a stronger Single Market was said to have further benefitted the global competitiveness of European industry and economic operators as it has improved the speed of adoption of state-of-the-art technologies, as compared to the old approach. Strengthened coherence across sectoral legislation was reported to have improved legal certainty, the ease of compliance, and led to higher compliance levels, resulting in an improved level-playing field for economic operators.

The NLF was considered fit for purpose to deal with upcoming challenges through technological developments. Reducing the technical details in the EU product legislation and placing the focus on essential health and safety requirements through a technology-neutral approach was seen by industry respondents to the consultation as allowing manufacturers space to innovate. Leaving the technical details to harmonised EU standards was said to allow the legislation to follow state of the art. Yet, delays in the process for developing harmonised standards and in their citation in the Official Journal were also identified as a problem.

Industry associations urged that any changes to the NLF should be made only in response to clear needs, within the existing framework. Some respondents maintained that, although the NLF has contributed to achieving all the strategic objectives, environmental protection was the area where progress had been the least obvious. Furthermore, according to some respondents, there remain a considerable number of unsafe products, as illustrated by reports on RAPEX/Safety Gate. Stakeholders argued that all EU harmonised product legislation should be founded on NLF-principles, including CPR, eco-design, and batteries.

In turn, 41.2% of respondents (93 responses) considered that there are negative impacts, challenges or unintended consequences resulting from the NLF.

Stakeholders reporting negative impacts suggested that the implementation of the NLF has not always been as effective as it could be, depending on the understanding of economic operators and the practical application of the rules at national level. Economic operators, industry associations, and some national notifying authorities suggested that there are diverging requirements in NLF-aligned legislation when it comes to the type of accreditation granted to notified bodies, and depending on the Member States, since competences required for notification under a particular NLF-aligned directive or regulation can vary.

Furthermore, economic operators and industry associations were asked to indicate the scale of the costs stemming from the conformity assessment procedure established by the NLF, excluding the costs of compliance with individual sectoral / product legislation. The most important costs reported related to the involvement of notified bodies (rated by 60.7% - 34 responses - as high or very high) and performing laboratory tests (rated by 53.6% - 30 responses - as high or very high).

Looking to efficiency in terms of possible simplification, 79.2% of the respondents (54.2% to a great extent and 25% to some extent) considers that digitalisation of the declaration of conformity / technical product information / technical file would improve the efficiency of the conformity assessment procedure, without hindering market surveillance activities.

Economic operators, industry associations, and national competent authorities were asked whether the common requirements for economic operators in the NLF could be further simplified or improved. Two thirds (66.7%, 48 responses) agreed that they could. Areas identified for improvement by respondents included: documentation (and its digitisation), languages, circular economy requirements, harmonisation (greater consistency of definitions and terminology between different legal acts), material compliance, and transition periods.

National accreditation bodies, national competent authorities, national notifying authorities, and notified bodies / conformity assessment bodies were also asked to assess the burden they experienced resulting from the introduction of the accreditation framework. 42.3% of respondents (47 responses) reported the burden to be high or very high, while a further 27% (30 responses) considered it to be moderate.

Considering internal coherence, a majority of respondents (35.8%, 69 responses) reported that they did not know to what extent inconsistencies, overlaps or gaps exist between the different provisions of the NLF. 28% (54 responses) considered that such inconsistencies, overlaps, or gaps exist to a small extent, while 10.7% and 3.6% consider they exist to a moderate or great extent (20 and seven responses respectively).

Similarly, on external coherence, significant numbers of respondents did not know whether the NLF is coherent with other EU legislation that may apply simultaneously or in complementarity with NLF-aligned legislation. Among those respondents expressing an opinion, the majority believe the NLF is partially (rather than fully) coherent with horizontal policy and legislation, environmental legislation, and other types of relevant legislation.

81.5% of stakeholders (123 respondents) perceive that the suite of conformity assessment modules remains fit for purpose to at least a moderate extent to ensure that products placed on the Union market comply with relevant EU legislation, including 50.3% (76 respondents) who considered this to be the case to a great extent. When it comes to the question of personnel and real activity that the NB has to perform by itself without outsourcing, only 22% (34/135 responses) agreed in the targeted consultations to a great extent that the NLF is sufficiently clear on that issue.

Some industry associations expressed their concern at the interplay and the lack of coherence among some of the main pieces of EU legislation that are currently being revised, reviewed, or newly proposed and the NLF. When it comes to proposals on general product safety, AI, and cybersecurity, respondents stressed the importance of consistency. The NLF should be the “leading legislation” for horizontal definitions.

Over half of the stakeholders (57.9%, 110 responses) considered that the common legal framework provided by the NLF delivered high added value compared to what could have been achieved through the development of product legislation in its absence. A further 25.3% (48 responses) considered that the framework had delivered some added value.

Furthermore, 27.4% of stakeholders (52 responses) considered that the needs and challenges addressed by the NLF’s common legal framework still require (harmonisation) action at the EU level to a great extent, while a further 45.3% (86 responses) thought this was the case to a moderate extent. Only three respondents perceive that EU level action is no longer required.

Stakeholders found it difficult to imagine that a more robust or progressive framework could replace the NLF. It was said that other regions around the world, that deploy more “regressive” approaches (i.e. jurisdictions with greater reliance on third party certification, less sophisticated approaches to the presumption of conformity and self-declaration, and less mature standardisation frameworks), do not show greater levels of safety and compliance. At the same time, market access in such countries can be more difficult and expensive for economic operators and, ultimately, for end users. A national competent authority suggested that an important consequence of repealing the NLF would be damage to the confidence in the safety of products among consumers and other users, which has been built up for decades.

Regarding the relevance of the NLF, the proportion of stakeholders who judged that the needs and problems that the NLF was originally designed to address remain relevant, at least to a moderate extent, ranged between 68% (136 responses, in relation to the need to strengthen the visibility and use of the CE marking system) and 78% (156 responses, in relation to the need to address inconsistencies between different pieces of product / sectoral legislation). The need to ensure the free movement of goods within the single market was most often seen by stakeholders as remaining relevant to a great extent (57.5%, 115 responses).

2/3 of the stakeholders (74/96 respondents) perceive that the suite of conformity assessment modules remains fit for purpose to at least a moderate extent to ensure that products placed on the Union market comply with relevant EU legislation.

Significant numbers of stakeholders considered that the scale of the burden deriving from the NLF’s communication obligations were ‘not all appropriate’: 35.7% took this view regarding the obligation to print out technical product information and the technical file (30 responses) and 34.5% for printing out the EU declaration of conformity (29 responses). As mentioned above, digitalisation is seen as a possible simplification in this regard.

Stakeholders were consistent in their answers regarding the extent to which the NLF is able to accommodate important trends related to the circular economy examined: between 41.4% and 45.5% (82 and 90 responses) agreed to at least a moderate extent that the NLF was able to accommodate the key trends in question. On the other hand, between 27.3% and 41.4% (54 and 82 responses) thought this was only the case to a small extent or not at all. Only 21.5% of stakeholders (43 responses) perceive that the requirements for economic operators related to (re)placing substantially modified products on the market remain fully clear, while 33.5% (67 responses) perceive that the definitions of different economic operators, in light of new models of production and increasing value chain complexity, remain fully clear. Finally, regarding the impact of the COVID-19 pandemic, asked about the extent to which it took products that were instrumental in the fight against COVID-19 too long to be placed on the market, almost half of stakeholders (49.7%, 89 responses) agreed that it took too long (whether to a small, moderate, or great extent). However, most stakeholders (43.6%, 78 responses) responded that they don’t know. Only 6.7% of stakeholders (12 responses) answered ‘not at all’ i.e., that it had not taken too long for products such as PPE and medical devices to be placed on the market during the pandemic.

There was some variation by stakeholder type: national accreditation bodies (21.1%, four responses), industry associations and MSAs (each with 20%, seven and three responses respectively) were the most likely to agree to a great extent that it took too long for products to be placed on the market.

Public consultation

The public consultation questionnaire was finalised and sent for translation on 9th November 2021. It was launched on 13th December 2021 and ran until 7th March 2022. A total of 125 responses were received, with 95 complete responses covering all relevant stakeholder groups.

A total 125 respondents spread across 22 EU Member States and five non-EU countries took part in the consultation. The largest group were based in Belgium, representing 30% of all respondents (37 responses), over 75% of which were EU-level organisations or multi-national companies. The second largest group of respondents were based in Germany (26%, 32 responses), far ahead of the third largest group, Austria (6%, seven responses). 94% of all respondents were based in the EU (117 responses). Among the eight responses from third countries (6%), half were from the United Kingdom. The largest group of respondents by type were industry associations. This group represented 30% of all consultation responses (37 responses). The next largest groups were citizens (EU or non-EU) (24%, 30 responses) and economic operators (14%, 18 responses).

All respondents, except citizens, were asked for their views on the effectiveness of the NLF in its contributions to achieving the objectives of EU product legislation, through providing a common regulatory toolbox to be applied across all different product legislations, establishing a framework for the accreditation of notified bodies, and reinforcing the rules on CE marking. The majority agreed that the NLF has been very effective in reinforcing the free movement of products within the single market (55%, 52 responses) and in reinforcing a high level of protection of public interests (e.g., health and safety, consumer and environmental protection) (49%, 47 responses).

Respondents who took a positive view of its effectiveness said that the NLF enables the free movement of goods in the EU Internal Market and provides for a high level of protection of public interests. SMEs were said to benefit from effective market access. The NLF allows for recent technological developments to be quickly used and to implement the state-of-the art. Through the combination of manufacturer self-declaration (Module A) for conformity assessment, which provides for an acceptable time to market, combined with a strong market surveillance control system for possible intervention, the system provides for a level playing field. This makes a very effective regime in comparison to third countries, where certification is predominantly used, said some respondents. Moreover, the NLF provides an excellent a concept that allows for coherence across different pieces of sectoral legislation that apply to a specific product at the same time.

All respondents, except citizens, were asked for their views on the extent to which the NLF has performed well or faced challenges in relation to four important issues. Improving the regulatory alignment of EU product legislation was the issue for which most respondents considered the NLF has delivered a strong performance (47%, 45 responses); at the other end of the scale, only 34% (32 responses) considered the NLF to have delivered a strong performance in relation to introducing clear and transparent rules for the accreditation of conformity assessment bodies.

For three of the issues, the proportion of respondents who considered the NLF to be performing well though with some challenges was slightly smaller than the proportion who considered the NLF to be delivering a strong performance. The exception was the issue of introducing clear and transparent rules for the accreditation of conformity assessment bodies: here, the proportion of respondents who considered there were some challenges (38%, 36 responses) were in the majority. Strengthening the clarity and credibility of the CE marking system was the issue with the highest proportion of respondents indicating that strong challenges existed in relation to the NLF’s performance (15%, 14 responses).

Respondents were asked for their views on the extent to which the NLF had a positive or negative impact in specific areas. The responses showed significant variation: while 83% of respondents (78 responses) thought the NLF had a positive or very positive impact on compliance levels and product safety, and on regulatory certainty and ease of compliance with EU product legislation, only 48% took this view regarding the NLF’s impact on product innovation.

Most stakeholders agreed that the meaning of the CE marking is clear to a great extent (50%, 62 responses) or to a moderate extent (34%, 42 responses). Slightly fewer took the same view regarding the trustworthiness of the CE marking as an indicator that a product will function safely and as intended: 46% agreed this was the case to a great extent (57 responses) and 31% to a moderate extent (39 responses).

Economic operators and industry associations were asked to indicate the scale of the most important costs stemming from the conformity assessment procedure established by the NLF. Costs related to the involvement of notified bodies were most likely to be described as very high (47%, 26 responses). High or very high costs were also identified as pertaining to laboratory tests, with 77% of respondents reporting this to be high or very high (42 responses). 59% described the overall costs of the conformity assessment procedure as high or very high (32 responses).

Most respondents were positive about the benefits that have been achieved as a result of the NLF. Regarding cost savings due to facilitated familiarisation with different EU legislation (e.g., due to common definitions, reduced market fragmentation etc.), 47% agreed that strong benefits had been achieved (45 responses), while a further 30% thought there were at least some benefits (28 responses). Respondents were only slightly less positive regarding cost savings in the process of demonstration of conformity across different EU product legislation: 41% agreed that strong benefits had been achieved (39 responses), while a further 28% thought there were some benefits (27 responses).

Looking to efficiency in terms of possible simplification Regarding the provision of information in digital form, most stakeholders agreed that providing product information in a digital format (e.g. instruction manuals) would be positive (26%, 33 responses) or even very positive (46%, 57 responses) in its impact on consumers. Over half of stakeholders (63%, 79 responses) agreed that providing other traceability information (e.g., the postal address of the manufacturer/importer) digitally would be positive or very positive. Respondents were less sure about providing the CE marking in a digital form: 44% thought this would have a positive or very positive impact on consumers (54 responses), while 24% thought it would have a negative or very negative impact (30 responses).

Stakeholders were asked to consider to what extent the provisions of the NLF are coherent with one another, in particular whether Decision 768/2008/EC containing a model to be used in preparing and revising Union harmonisation legislation is coherent with Regulation 765/2008/EC applicable to accreditation and CE marking. Stakeholders were broadly positive about the coherence of the NLF’s provisions with one another. 36% agreed that the provisions were fully coherent (34 responses), while a further 26% consider that they are partially coherent (25 responses). 37% of stakeholders said that they did not know (35 responses).

Most stakeholders agreed that the NLF has delivered high added value compared to what could have been achieved through the development of product legislation without the NLF (60%, 56 responses). A further 23% consider the NLF to have delivered some added value (21 responses).

Reflecting their positive views of the NLF’s added value, many respondents reiterated their view that the NLF had proven its ability to add value in multiple aspects. The NLF is of great importance for the placing of products on the market and underpins the competitiveness of European industry. The added value of the NLF lies in its consistent application, said respondents. Businesses have built their entire compliance system around this regulatory framework. The very idea of significantly changing the structure of the NLF would have very negative consequences for businesses, weaken the internal market and the competitiveness of European industry, and have a negative impact on the European quality infrastructure.

Stakeholders agreed that the objectives of the EU legal framework for products remain relevant, although there was some variation between the objectives. While 77% of respondents agreed that improving the regulatory alignment of product legislation remains a relevant objective to a great extent (73 responses), only 57% took the same view regarding the continuing relevance of the objective to ensure clear and transparent rules for the accreditation of conformity assessment bodies (54 responses).

Stakeholders were asked for their views regarding the extent to which the NLF, through its technology-neutral approach, is able to accommodate important trends related to the digital and circular economy. The answers showed significant variation depending on the trend in question: while 33% of stakeholders (31 responses) consider the NLF is able to accommodate trends relating to cyber security and the increasing complexity and interconnectedness of products (e.g., the Internet of Things), only 12% (11 responses) agreed that this was the case in relation to the emergence of new types of economic operators due to new models of production and increasing value chain complexity. Increasing product refurbishment and remanufacturing was the trend that the highest proportion of stakeholders (18%, 17 responses) thought the NLF is not at all able to accommodate.

Stakeholder validation workshop

First and foremost, many participants across all stakeholder groups noted their general agreement with the conclusions presented by the contractor, highlighting the positive impact of the NLF overall, the strong performance of the suite of conformity assessment modules and the generally positive role played by the accreditation framework. However, participants noted the following challenges and areas for improvement across the NLF, such as divergence between NLF-aligned legislation and the conformity assessment system.

The more general challenge of updating the NLF and ensuring it remains fit for purpose divided stakeholders. Some participants referred to this as a “chicken and egg” situation whereby the NLF and its general principles remain broadly relevant and coherent in many areas, but the wide array of new legal developments in recent years means that the NLF needs to be reviewed and possibly modernised and updated. A key challenge in this regard relates to circular economy developments. New types of economic operators (such as repairers, refurbishers, and remanufacturers) have become more prominent in the market since the NLF’s adoption; currently, such economic operators are not defined in the NLF and their obligations with regard to conformity assessment and compliance are not clear.

Mixed views were presented regarding whether the NLF itself should be amended or whether some of these developments could be better addressed by building on existing work ongoing within the Commission and other stakeholder fora. For instance, work is being done to update the Blue Guide and to provide an appropriate place within it (instead of within the NLF) to support the implementation of the legal framework to accommodate the need for common definitions (such as “remanufacturing, refurbishing and reprocessing”). Furthermore, other stakeholders noted the positive experience with CE marking of software under the MDR. However, there was no consensus on which approach was most appropriate.

Work by the Commission to extend the ecodesign requirements through the Sustainable Products Initiative (SPI) to adopt more of a product lifecycle approach was also mentioned. It was questioned whether the NLF itself should be reformed or could simply build on and cross-reference to other legislative developments, including standardisation-related initiatives with horizontal relevance. The updating of the Blue Guide, for instance, expected to be published in May 2022 was mentioned as a suitable place to provide a broader set of common definitions.

Looking forward, there was no consensus amongst participants on how the weaknesses and challenges identified should be tackled, whether through a revision and updating of the NLF or by using the NLF as the basic building block and relying on other mechanisms. For instance, some participants pointed to the upcoming revision of the Blue Guide as a key opportunity to tackle many of these challenges without needing to make legislative changes. However, the Blue Guide is not legally binding and other participants stated that tackling many of these challenges would require a revision of the NLF. DG GROW confirmed that the revised Blue Guide does aim to tackle some of the definitional issues and questions relating to the circular economy (e.g. substantial modifications) and should be adopted by May 2022.

Feedback to stakeholders

The consultation processes revealed that the NLF has contributed strongly to the achievement of its general objectives; namely providing a high level of protection of public interests, fostering the free movement of products within the single market, and establishing a common harmonisation framework.

Concerning the efficiency of the NLF, the positive effects of the NLF, considering both monetary and non-monetary benefits, strongly outweigh the costs identified. The NLF comprises very few direct regulatory and administrative costs, as most costs associated with the framework of EU product legislation either stem directly from compliance with individual pieces of NLF-aligned legislation or did not change significantly with the introduction of the NLF. However, a wide range of cost savings and other benefits have been highlighted by stakeholders. For economic operators, these benefits included reduced costs in familiarisation with legislative requirements by economic operators due to the implementation of common provisions; greater regulatory certainty; greater harmonisation of obligations; reduced market barriers; and, as a result, enhanced industrial competitiveness. A further strategic benefit was the enhanced global recognition of the CE marking stemming from its prominence within the NLF.

The NLF legal framework, as set out in Regulation (EC) No 765/2008 and Decision No 768/2008/EC, was relevant in addressing the problems identified in the 2007 impact assessment, prior to the adoption of the NLF. In particular, the reference provisions and common implementation mechanisms have been appropriate to improve legislative harmonisation, maintain the technology-neutral approach to setting essential requirements, and improve the rules and systems for conformity assessment and CE marking. Although significant progress has been made towards addressing these needs, stakeholders clearly feel that these needs, the related objectives, and the overarching framework implemented by the NLF remain relevant moving forward.

Finally, there is a need to ensure that the NLF retains its core principles, as there is a broad consensus that these are appropriate in terms of their effectiveness, relevance and efficiency. However, given changes to the EU legal framework and trends in product markets towards digitalisation and the circular economy, there is a clear need for the NLF to be reviewed with active consideration given to its possible revision to ensure that it remains fit for purpose.

The system of notified conformity assessment bodies

Notifying authorities. The model provision R14 of the Annex of Decision No 768/2008/EC sets out that Member States should designate a notifying authority responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies.

Across the body of NLF-aligned legislation, 160 notifying authorities are in operation, 109  with 139 based across the EU-27, 12 in the EEA-EFTA countries 110 and nine spanning seven third countries 111 . These notifying authorities may have responsibility for one or multiple NLF-aligned legislation.

In terms of territorial coverage in the Member States, 25 Member States have established notifying authorities for each of the NLF-aligned legislation (at least 17 out of 21) for which notification of CABs is relevant. 112 113 In some instances, Member States have multiple notifying authorities with responsibility for one NLF-aligned legislation. 114  

Only two directives have notifying authorities in all 27 Member States: the Toys Safety Directive  and the Construction Products Regulation 115 .

Notified conformity assessment bodies. Chapter R4 of the Annex of Decision No 768/2008/EC details extensive reference provisions related to the notification of conformity assessment bodies, including, amongst other provisions, the procedure for notification, and the requirements relating to, and obligations on, both notifying authorities and notified bodies.

There are 1649 notified bodies across the 21 NLF legislation. 116  

The following map illustrates the prevalence of notified bodies by Member State. As can be seen, the number of notifications per Member State varies significantly from 2 in Malta or 9 in Luxembourg to 348 in Italy and 309 in Germany, with a median of 59 notifications.

Figure 10 Number of notifications of conformity assessment bodies per Member State

Considering notifications across the different NLF-aligned legislation by EU Member States, 54% of these notifications are related to three pieces of legislation: the Construction Products Regulation with 30.6% (673 notifications), the Pressure Equipment Directive with 12.5% (275 notifications, and the Lifts Directive with 10.8% (238 notifications) 117 .

Data from the Commission’s NANDO database has been extracted to investigate the evolution of the number of notified bodies under NLF-aligned pieces of legislation. Trends are not consistent across different directives and regulations. In some cases (Toy Safety Directive, Recreational Craft Directive, Lifts Directive, Electromagnetic Compatibility Directive and Simple Pressure Vessels Directive) a reduction in the number of notified bodies has been observed in the 2008-2020 period, broadly coinciding with the introduction of the new NLF-aligned directives. In other cases (Marine Equipment Directive, Pressure Equipment Directive), however, the number of notified bodies has increased.

Statistics from NANDO

EU Member States, EFTA countries (EEA members) and other countries with which the EU has concluded  Mutual Recognition Agreements  (MRAs) and Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs) designate Notified Bodies, established per individual piece of legislation. Notified Bodies can be searched on the website of the NANDO (New Approach to Notified and Designated Organisations) Information System  118 .

This Annex offers an overview of the evolution over time of Notified Bodies by piece of legislation and country. It is based on a database provided to the evaluation team in the form of an Excel spreadsheet by the European Commission (DG GROW). The evaluation team performed consistency checks and cleaned the data before performing elaborations and reporting the results.

In addition to NLF-aligned directives and regulations and their predecessors, the received database extracted from NANDO includes data on other legislation as well. The list of all 56 pieces of legislation covered by the received database is provided in the following table. In what follows, the analysis is however focused only on NLF-aligned directives and regulations and their predecessors.

Table 2 Pieces of legislation covered by NANDO