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 Term or acronym Meaning or definition AI Artificial intelligence CAB Conformity Assessment Body CEN European Committee on Standardization Cenelec European Committee on Electrotechnical Standardization CBA Cost-Benefit Analysis CPR Construction Products Regulation (EU) No. 305/2011 DoC Declaration of Conformity DoP Declaration of Performance DSM Digital Single Market EA European Cooperation for Accreditation EC European Commission ECT Treaty establishing the European Community (Nice consolidated version) EMCD Electromagnetic Compatibility Directive 2014/30/EU EO Economic operators ESO European standardisation organisation (CEN, Cenelec, ETSI) ETSI European Telecommunication Standards Institute F4F Fit for Future Platform GDPR General Data Protection Regulation (EU) 2016/679 GPSD General Product Safety Directive GPSR Proposal for a General Product Safety Regulation IA Impact Assessment IoT Internet of Things. IoT system architecture is generally divided into three layers: the perception layer, the network layer and service layer (or application layer) ICSMS Information and Communication System for Market Surveillance IVDR In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 LVD Low Voltage Directive 2014/35/EU MD Machinery Directive 2006/42/EC MDR Medical Devices Regulation (EU) 2017/745 MS Member State MSA Market Surveillance Authority NA Notifying Authority NAB National Accreditation Body NANDO New Approach Notified and Designated Organisations Information System NB Notified Body NLF New Legislative Framework ODM Original Design Manufacturer OEM Original Equipment Manufacturer OPC Open Public Consultation PO Policy option(s) RAPEX Rapid Exchange of Information System RED Radio Equipment Directive 2014/53/EU SBS Eurostat’s Structural Business Statistics (SBS), which shed light on relevant classes of connected Radio Equipment and Wearables. SCM Standard Cost Model TFEU Treaty on the Functioning of the European Union TSD Toys Safety Directive WTP Willingness to Pay – the maximum amount that consumers are willing to pay for internet- connected radio equipment e.g. for products with, and without security features. 1. Introduction Purpose and scope of the evaluation 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). 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. 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 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 , the Proposal of the Machinery Regulation , 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 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), 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 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. 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. 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 ). 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. 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? 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 ”, 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. 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. 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: 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 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. This represented a problem especially in case of products that had to comply with different pieces of EU product legislation. 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. 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. Problems experienced with notified bodies were also relevant in an environmental context. ·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. 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", 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.

Member States co-ordinated their accreditation activities through the framework created by a pan-European organisation known as EA. 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. 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. 3. How has the situation evolved over the evaluation period? 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 Specific objective: Reinforcement of the New Approach Output (immediate short-term outcomes): Number of NLF-aligned legislation Results (intermediate outcomes, linked to the achievement of specific objectives) ØAvailability of the regulatory toolbox to facilitate the revision of existing and drawing up of new Union harmonisation legislation; ØAvailability of common definitions for sectoral product legislation; ØA framework that allows for technological evolution with technology neutral legislation setting only essential requirements. 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. 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 Specific objective: Supporting the consistency and coherence of EU harmonisation legislation Output (immediate short-term outcomes): Integration of the common reference provisions into the aligned product legislation Results (intermediate outcomes, linked to the achievement of specific objectives) ØBetter alignment of the requirements for economic operators and of the approach to marketing products on the internal market; ØReduced divergences and clearer administrative requirements; reduced costs of compliance (i.e. costs of familiarisation with Union harmonisation legislation and costs of conformity assessment procedures). 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. 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:

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. 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. 3.1.3. Strengthening the quality of conformity assessment services through improved accreditation of notified bodies Specific objective: Strengthening the quality of conformity assessment services through improved accreditation of notified bodies Output (immediate short-term outcomes): Common conformity assessment system and accreditation framework Results (intermediate outcomes, linked to the achievement of specific objectives) ØClearer and more robust rules on the conformity assessment system; ØHigher quality and more consistent third-party conformity assessment services. 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. 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. 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 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. Several pieces of Union harmonisation legislation foresee additional markings that are complementary and non-overlapping to the CE marking. 4. Evaluation findings (analytical part) 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 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 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, 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. 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. 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 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 (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 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 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 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. 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 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 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. 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 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. 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. Some stakeholders see mandatory accreditation 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 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. 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, 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”. 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 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, 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. 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). 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. 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. 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 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). 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. 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 , 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. According to the study, under the current system the total annual costs of indicating compliance in these three fields are about 800 million Euros. 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. 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) and Directive on product liability 85/374/EEC ; ­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 Decisio