EUROPEAN COMMISSION Brussels, 16.11.2020 SWD(2020) 266 final COMMISSION STAFF WORKING DOCUMENT



EVALUATION

OF THE OUTDOOR NOISE DIRECTIVE 2000/14/EC Accompanying the document Report from the Commission to the European Parliament and the Council on the implementation and administration of Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors {COM(2020) 715 final} - {SWD(2020) 267 final}



Table of contents 1.Introduction 2.Background to the intervention 2.1.Description of the Outdoor Noise Directive and its objectives 2.2.Baseline and points of comparison 3.Implementation / state of Play 3.1.Legal provisions, interactions and contributions 3.2.Studies and follow-up activities 4.Method 4.1.Short description of methodology 4.2.Sources of information/Literature 4.3.Limitations and robustness of findings 5.Analysis and answers to the evaluation questions 5.1.Effectiveness of the Directive 5.2.Efficiency of the Directive 5.3.Relevance of the Directive 5.4.Coherence and complementarity of the Directive 5.5.EU added value of the Directive

6.Conclusions Annex 1: Procedural information Annex 2: Synopsis report of the stakeholders’ consultations Annex 3: Methods and analytical models for data collection Annex 4: Legislative acts within the EU environmental noise framework Annex 5: Standards referred to in the OND Annex 6: “NOISE Application” database – Statistics Glossary Term or acronym Meaning or definition AdCo Administrative Co-operation CATI Computer-Assisted Telephone Interviewing CEN European Committee for Standardization CU Custom Union DG ENV Directorate-General for Environment DG GROW Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs DoC (EC) Declaration of conformity EC European Commission EEA European Economic Area EFTA European Free Trade Association EN European standard END Environmental Noise Directive 2002/49/EC EU European Union ISO International Organisation for Standardization MD Machinery Directive 2006/42/EC MRA Mutual Recognition Agreement MS Member State MSA Market Surveillance Authority NA / NLF New Approach / New Legislative Framework NACE Statistical classification of economic activities in the European Union NANDO New Approach Notified and Designated Organisations information system NB Notified body NOMAD Noise Machinery Directive project / task force NRMMR Non-Road Mobile Machinery Regulation (EU) 2016/1628 OND Outdoor Noise Directive 2000/14/EC OPC Open public consultation RAPEX Rapid alert system for dangerous non-food products RfUs Recommendation for Use sheet TFEU Treaty on the Functioning of the European Union WG Working Group 1.Introduction Purpose and scope of the evaluation The purpose of this evaluation is to analyse the performance of the Outdoor Noise Directive 2000/14/EC during its almost 20 years of its application. The results of the evaluation are intended to be used in view of a possible enactment of the empowerments for delegated acts foreseen in the Directive or the need for a revision of the sectorial legislation on noise emission by outdoor equipment, within the application of the EU strategy to reduce noise at source. The geographical coverage of the evaluation refers to the 28 Member States of the European Union (including for the period of reference the UK), the EEA countries – Iceland, Liechtenstein and Norway – as well as Switzerland and Turkey. It covers the period from the implementation of the Directive in 2002 – in particular after the last assessment of the Directive, carried out through the “NOMEVAL” study in 2007 –, to 2018 (when the “Supporting study for an evaluation and impact assessment of Directive 2000/14/EC on noise emission by outdoor equipment” was completed and released), seeking to understand trends over this period wherever possible. The evaluation covers the functioning of the Directive, including the processes involved in the transposition, implementation and enforcement. The evaluation assesses the performance of the Directive according to five criteria: effectiveness, efficiency, relevance, coherence and EU added value for outdoor equipment in the scope as referred to in Article 2, listed in Articles 12 and 13 and defined in Annex I to the Directive, and taking into consideration the responses and feedback received from sectoral stakeholders and interested parties, in particular from economic operators (manufacturers of outdoor equipment, importers, distributors and others), users (workers and consumers) and citizens exposed to noise emission.



2.Background to the intervention 2.1.Description of the Outdoor Noise Directive and its objectives Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the law of the Member States relating to the noise emissions in the environment by equipment for use outdoors (in short, the “Outdoor Noise Directive”, OND) is applicable since 3 January 2002. It is part of the EU strategy to reduce noise at source: the Fifth Environmental Action Programme and the Green Paper on Future Noise Policy identified noise in the environment as one of the main local and more pressing environmental problems in Europe especially in urban areas, and the source of an increasing number of public complaints. In line with this strategy, the Directive sets a framework to control noise emission by equipment for use outdoors. The OND refers to Article 95 of the EC Treaty (now replaced by Article 114 of the TFEU) that enables the EU to adopt measures to harmonise the legislation of the Member States in order to ensure the establishment and functioning of the internal market. Such measures must take as a base a high level of protection of the health and safety of people and of the environment.

Concerning the policy context, the OND is a piece of a wider environmental noise legislative framework, which includes Directive 2003/10/EC on health and safety requirements of workers exposed to noise, the Environmental Noise Directive 2002/49/EC (END), the Machinery Directive 2006/42/EC (MD) and the Non-Road Mobile Machinery Regulation (EU) 2016/1628 (NRMM). Annex 4 provides for additional information on these legislative acts and their relationship with the OND. The Outdoor Noise Directive 2000/14/EC, based partially on the principles of the “New Approach” policy, was developed with the specific objective of ensuring harmonisation of rules and procedures across the European Union with respect to noise emissions by outdoor equipment, to avoid fragmentation on the EU internal market and to simplify the existing EU legislation by merging seven specific product directives and two directives on test procedures (see Section 2.2.). It provides for detailed noise measurement methods and test codes (also by referring to European and international standards, including the “basic noise emission standards”, their “general supplements” and the operating parameters and conditions to be used); harmonised noise limits for a definite list of outdoor equipment; conformity assessment procedures, with or without intervention of a third party (the “notified bodies”); and marking requirements (CE marking of conformity and the specific noise marking, with the indication of the guaranteed sound power level). This is addressed to enable the free movement of outdoor equipment within the EU internal market, whilst reducing permissible noise levels for such equipment in order to protect the health and well-being of citizens and the environment. In parallel, the Directive has also the objective of providing information to the public on the noise emitted by such equipment, thereby promoting less noisy equipment and improving customer choice. A representation of the intervention logic of the Outdoor Noise Directive 2000/14/EC is provided in Figure 1 (next page). It shows the logical sequence and causal relationships between the different internal and external aspects to be considered, including the strategic and specific objectives; the EU inputs; and the expected outputs, outcomes and results. The OND covers 57 types of equipment used outdoors defined in its Annex I, out of which it establishes noise limits for 22 types (Article 12), while another 35 types are subject to noise marking only (Article 13). Such a classification of equipment with different grades of requirements is based on the existence of sufficient knowledge concerning the state of the art, appropriate definition and noise measurement and test methods, and of correlation between test methods and noise limits, for the products in the scope at the time when the Directive was drafted. Outdoor equipment in the scope of OND can be grouped into eight clusters:

I. Cleaning equipment

II. Construction equipment

III. Gardening equipment

IV. Loading and lifting equipment

V. Power generators and cooling equipment

VI. Pumping and suction equipment

VII. Snowmobiles and snow groomers

VIII. Waste collection, processing and recycling Together, these types of equipment represent more than 26,000 different models. Around 10,000 models are subject to both noise limits and marking, while nearly 16,000 are subject to noise marking only. The Directive covers equipment used by both professional and private users, workers and consumers. In the cleaning, construction, loading and lifting equipment, power generators and cooling equipment, and waste collection, processing and recycling categories, the majority of equipment is used by professional users. In gardening and pumping and suction equipment categories all types are used by both professional and private users. Typically, larger and more expensive equipment is used by professionals. Figure 1: Intervention logic of the Outdoor Noise Directive 2000/14/EC Source: “Supporting study” and further elaboration 2.2.Baseline and points of comparison The baseline scenario which can be taken into account in the evaluation is referred to the situation before Directive 2000/14/EC on noise emission by outdoor equipment was drafted, adopted and implemented. At that moment, as mentioned in Section 2.1., in the sector there were nine specific European Community directives (seven on products and two on test procedures), issued between 1979 and 1986. They established requirements on noise emission limits (in terms of permissible sound power levels), noise test codes, marking and conformity assessment procedures, for some types of outdoor equipment (construction machinery and lawnmowers) separately: -Council Directive 79/113/EEC of 19 December 1978 on the approximation of the laws of the Member States relating to the determination of the noise emission of construction plant and equipment (OJ L 33, 8.2.1979, p. 15); -Council Directive 84/532/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to common provisions for construction plant and equipment (OJ L 300, 19.11.1984, p. 111); -Council Directive 84/533/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of compressors (OJ L 300, 19.11.1984, p. 123); -Council Directive 84/534/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of tower cranes (OJ L 300, 19.11.1984, p. 130); -Council Directive 84/535/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of welding generators (OJ L 300, 19.11.1984, p. 142);

-Council Directive 84/536/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of power generators (OJ L 300, 19.11.1984, p. 149); -Council Directive 84/537/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of powered hand-held concrete-breakers and picks (OJ L 300, 19.11.1984, p. 156); -Council Directive 84/538/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of lawnmowers (OJ L 300, 19.11.1984, p. 171); -Council Directive 86/662/EEC of 22 December 1986 on the limitation of noise emitted by hydraulic excavators, rope-operated excavators, dozers, loaders and excavator-loaders (OJ L 384, 31.12.1986, p. 1). The noise emission limits established by this set of legislation have been evolving towards a progressive reduction and can be considered as points of comparison with respect to those introduced by Directive 2000/14/EC for outdoor equipment in Article 12: see Section 5.1. on the effectiveness of the OND and the related Table 1. No specific benchmark study is available to analyse the situation before the adoption of Directive 2000/14/EC. This is an objective constraint in the reconstruction of the baseline scenario, also for the limited quality of available and collected data (see Section 4.2.). Thus, there are no specific or quantified estimates available about the effective performances of equipment on the market before the OND, in particular on equipment that was later included in Article 13. Nevertheless, based on feedback from sectoral stakeholders, users and consumers, it was recognised that the existence of several different European and national legislative acts concerning noise emission by equipment for use outdoors caused a fragmentation of the market and an insufficient answer to the related risks for the health and well-being of citizens, as well as for the environment. As explained in the Commission Proposal for a Directive on noise emission of equipment used outdoors and then in the recitals of the Directive itself as adopted on 8 May 2000, the rationale behind the legislative intervention was the need to simplify the referred legislation and to create a common framework for the reduction of such noise emissions. For outdoor equipment, the Directive 2000/14/EC introduced the requirement of noise marking for 57 types of equipment used outdoors, and additionally, set noise limits for 22 of these which had available statistical data to set the noise limits. These limits were set to eliminate the noisiest equipment in the market allowing only equipment that was 3dB (estimate between 30% and 50% on logarithmic base) quieter than the average on the market at the time of the adoption of the Directive.



3.Implementation / state of Play 3.1.Legal provisions, interactions and contributions In order to achieve its objectives, the Outdoor Noise Directive 2000/14/EC harmonised certain aspects of Member States’ laws, regulations and administrative provisions relating to noise emissions by outdoor equipment. Thus, the provisions of the OND, after the adoption on 8 May 2000, must be transposed and implemented by Member States: the necessary national legal provisions were due on 3 July 2001, and to be applied from 3 January 2002. Afterwards, the noise emission limits as laid down in the Directive continued to be progressively reduced. For permissible sound power levels for equipment subject to noise limits, Article 12 defines “Stage I” limits applicable as from 3 January 2002, followed by “Stage II” limits applicable as from 3 January 2006; later on, the OND was amended by Directive 2005/88/EC, to modify the table in Article 12 to take into account the effective technical feasibility of noise limits for some equipment, and to give more time to fulfil the provisions under Articles 16 (“Collection of noise data”) and 20 (“Reports”). The implementation of the OND requires a wide set of interactions and contributions by the different key actors, within their roles and responsibilities: ·Manufacturers design and produce quieter outdoor equipment in line with the requirements of the Directive, carrying out the relevant conformity assessment procedure, according to the requirement for each type of equipment. On that basis, they draw up and sign the EC declaration of conformity and affix the required markings (CE marking and the specific noise marking) to place equipment on the EU market. ·Notified bodies assess the conformity of equipment subject to noise limits, through the relevant conformity assessment procedures, ensuring a first and reliable third-party level of control for those products. ·Member States and their market surveillance authorities ensure that products on the market are in conformity with the applicable rules, and take appropriate action when necessary. ·Customers/users should be able to make an informed purchasing decision, towards less noisy products and therefore stimulating manufacturers to compete also on this specific product feature. For that, the Commission services collect, process and make public the relevant data through the “NOISE Application” database from the EC declarations of conformity transmitted by the manufacturers. ·Finally, on the basis of sound data from the operation of the whole system, the Commission provides reports and, on the base of these, legislation can be opportunely revised and updated. The listed interactions and contributions are made possible through the appropriate instruments provided by the Directive to effectively implement it since its adoption and applicability. In the following paragraphs, such instruments are briefly presented. More in detail, the related qualitative and quantitative evidences on their implementation and the operational state of play, collected through the studies carried out, are presented in Section 5 through the analysis and answers to the evaluation questions.

a)Standards in support of the Directive The OND defines, in Annex III, the technical standards to be used by manufacturers to determine the guaranteed sound power levels of outdoor equipment in specific conditions, as noise measurement methods and test codes, in order to obtain coherent and comparable measures of noise emissions. Such standards are developed by the European Committee for Standardization (CEN) (European standards, mostly of them referred to the Machinery Directive 2006/42/EC too) and by the International Organization for Standardization (ISO) (international standards): see Annex 5 for the complete list of standards referred to in the OND and their current status. The use of the referred standards as noise measurement methods and test codes has been widely and soundly implemented by manufacturers and notified bodies. Some of these standards have been already replaced by new versions to reflect the evolution of the state of the art. These updates, however, are not reflected in the text of the Directive. Hence, there is a common request from stakeholders to update the legal references of standards in the OND accordingly. b)Conformity assessment procedures and notified bodies The Directive prescribes, in Article 14 and Annexes V, VI, VII and VIII, different conformity assessment procedures for outdoor equipment subject to noise limits, and for those subject to noise marking only. In the first case, the intervention of a third party (“notified bodies”) is required; in the second case, an internal procedure (“self-assessment”) is allowed. Conformity assessment bodies, or “notified bodies” (NBs), are appointed by the relevant authorities of the Member States and notified to the Commission, as well as to the other Member States. The NANDO (New Approach Notified and Designated Organisations) information system lists all active notified bodies for the OND in the EU Member States, EEA-EFTA countries and others. To date, around 50 notified bodies from 20 countries are available in NANDO for the OND: this has ensured an adequate coverage. c)Collection of noise data: the “NOISE Application” database In order to assess the “state of the art” of equipment subject to the OND and to provide information to consumers and users while promoting their choices for “quieter equipment”, the manufacturer or his authorised representative is required to send copies of the EC declarations of conformity to both the Commission and the Member State where he resides or where he places such equipment on the market or puts it into service, according to Article 16 of the Directive. Then, the Commission has to collect and publish such data. Such information can be transmitted by different means, also via an on-line database called “NOISE Application”. At this point in time, the database contains about 31,000 copies and notifications of EC declarations of conformity for equipment in the scope of the OND (more than 12,000 under Article 12 and almost 19,000 under Article 13) placed on the EU market, from around 350 EU and non-EU manufacturers and 70 authorised representatives. The tool allows to produce a public output, making available the key data (in particular the guaranteed sound level and the measured sound power level) extracted from the EC declarations of conformity for the different types and models of equipment covered by Article 12 (subject to noise limits) and by Article 13 (subject to noise marking only). See Annex 6 for the statistics of the database and Annex 7 for the analysis of entries of the database for some equipment. d)Market surveillance Member States provide the Commission with specific market surveillance reports on the most typical irregularities found in inspections, concerning in particular the guaranteed sound power level, the EC declaration of conformity, definitions of equipment, etc. A supporting tool for market surveillance is the “Information and Communication System on Market Surveillance (ICSMS)” database. It is currently used to exchange information between the relevant Member States authorities about market surveillance activities they carry out and the related outcomes. No cases of non-compliance of equipment, according to the procedures laid down in Article 9 of the OND, have been reported by the Member States. e)Working parties under the Directive The “Noise Committee”, established by Article 18 of the Directive, is chaired by the Commission and composed of representatives of EU Member States, with EEA-EFTA-MRA-CU countries as observers, to assist and provide advice to the Commission in specific tasks related to the implementation and practical application of the legislation. Within the Noise Committee, the “Outdoor Noise Working Group” includes also representatives from EU-wide stakeholders and interested parties, as manufacturers’ organisations, trade unions, consumers and users’ associations, as well as from the European coordination of notified bodies and the relevant standardisation experts. The common approaches and agreements reached in the OND Committee and Working Group are reflected in the “Guidelines for the application of Directive 2000/14/EC”, drafted and made available by the Commission as guidance on the practical implementation of the Directive. A specific Interest Group “Noise Emissions” is established in the CIRCABC system, for information, communication and exchange of documents. The Outdoor Noise Administrative Cooperation (AdCo) Group is integrated by representatives of the national market surveillance authorities in the field, with the participation of the Commission as observer. A specific Interest Group “Noise emissions - AdCo” is established in CIRCABC, to support the activities of the group. The Outdoor Noise Notified Bodies Group has been established in order to ensure that harmonized practices for conformity assessment of equipment subject to noise limits are applied by all the notified bodies concerned by Directive 2000/14/EC. The work group produces the “Recommendation for Use (RfU) sheets” to be applied by the notified bodies in their activities; when endorsed by the OND Working Group, the RfUs are made available on the Commission’s sectoral website as general guidance. A specific Interest Group “Noise Emission NB” is established on CIRCABC. 3.2.Studies and follow-up activities The Commission has undertaken several studies to assess the implementation of the Directive, to collect as much as possible updated information on the performance of equipment in the scope, and to explore the a possible enactment of the empowerments for delegated acts foreseen in the Directive or the need for a revision of the different aspects of the legislation, as well as to comply with the reporting obligations established in Article 20 of the OND: ·the “Study on the experience in the implementation and administration of Directive 2000/14/EC relating to the noise emission in the environment by equipment for use outdoors” (the “NOMEVAL” study) in 2007; ·the “Impact assessment on possible policy options for reviewing the Outdoor Equipment Noise Directive” (the “ARCADIS” study) in 2009;

·the “Study on the merger of the Directive on noise from outdoor equipment, 2000/14/EC, with the Machinery Directive, 2006/42/EC” (the “CEPS” study) in 2013; ·the “Study on the suitability of the current scope and limit values of Directive 2000/14/EC relating to the noise emission in the environment by equipment for use outdoors” (the “ODELIA” study) in 2015-2016; ·the “Supporting study for an evaluation and impact assessment of Directive 2000/14/EC on noise emission by outdoor equipment”, structured in an “Evaluation Report” and an “Impact Assessment Report” (the “VVA” study), in 2017-2018. The referred set of studies and their results found that the Directive overall complied with the main objectives of the intervention, by improving the situation in terms of harmonisation of legislation, free circulation of products in the internal market, and reduction of noise emission by outdoor equipment. This represented significant progress in terms of health and well-being of citizens and protection of the environment. Based on such studies, especially on the most recent ones, the evaluation showed that the Directive has been fully and consistently transposed and implemented across the EU Member States and the other countries where it is applicable. After a short description in Section 4 of the methodology used to carry out the evaluation, Section 5 presents the analysis and answers to the evaluation questions, in terms of effectiveness, efficiency, relevance, coherence, complementarity and EU added value of the Directive, as well as the costs and benefits identified in the evaluation.



4.Method 4.1.Short description of methodology This Staff working document relies on the findings of the “Supporting study for an evaluation and impact assessment of Directive 2000/14/EC on noise emission by outdoor equipment” as the most recent study to be taken into consideration for this evaluation. This study has built its results on the previous assessments, verifying some of their assumptions with the stakeholders and via a public consultation. All these assessments were carried out on the basis of Article 20 of the OND. The findings of the referred supporting study have been further assessed for the equipment in scope via desk research based on the EC declarations of conformity coming from the “NOISE Application” database. This work proved to be extremely challenging due to the limitations of the data extracted from the NOISE database. The database reports only the declaration of the equipment type but does not provide for the number of equipment placed on the EU market for each type. Hence it is not possible to carry out a balanced assessment of the equipment per type (for further explanations, please refer to Annex 7). Previous assessment and studies of the Directive which focused on a specific aspect were also taken into account for this purpose. 4.2.Sources of information/Literature Within the “Supporting study for an evaluation and impact assessment of Directive 2000/14/EC on noise emission by outdoor equipment”, the evaluation part was developed on the basis of a methodology for the data collection organised around four main tasks to ensure the most appropriate sources of information: a)Review of the literature: by using several search tools, the most relevant scientific articles and policy papers on technical, environmental, health, economic and social aspects related to outdoor equipment noise were identified, selected and analysed, in order to include the main outcomes into the report. b)Interviews and surveys: targeted consultations have been conducted with several EU and national stakeholders and interested parties directly affected by the Directive at EU and national level. This included a balanced geographic representation of market surveillance authorities, standardisers, notified bodies, associations of manufacturers, rental and distribution companies, users, consumers, environmental protection etc. c)Case study: carried out in the Netherlands about two relief schemes that have been active since 2001, as fiscal incentives that offer entrepreneurs the opportunity to make investments in environmentally friendly techniques in a fiscally attractive way. d)Open public consultation: running between January and April 2018, it collected 232 contributions from all interested parties (stakeholders, organisations and citizens, in general) who are affected by the Directive, its current functioning or any potential future modifications. More detailed information on the above mentioned activities is provided in Annex 2 “Synopsis report of the stakeholders’ consultations” and in Annex 3 “Methods and analytical models for data collection”. The studies carried out in the past (see Section 2.2.) also used a similar methodology to collect and analyse data and contributions from the different sectoral actors. In this sense, the latest study is in full continuity with them, providing a quite coherent basis for the evaluation of the OND as outlined in this document.

4.3.Limitations and robustness of findings As in the previous studies, there were a number of limitations with the data that were available or could be collected during the “Supporting study”, and used as a basis for the evaluation. a)Noise emission data: as mentioned in Section 2.2. about the baseline, at the time the OND came into force, little information was available on noise emissions of the covered equipment and the state of the art of it. The noise limits aimed at eliminating the noisiest equipment on the market (estimated at about 30% of the equipment in scope according to the information available before the adoption and the implementation of the Directive). For equipment without noise limits, an average reduction of 1 dB due to technical progress and some market demand is estimated since the OND came into force, according to the most recent studies carried out. For some equipment with higher demand for quieter products, more progress has been made than others, with an average estimated reduction of 2-3 dB, although it may not apply to the whole fleet (see Section 5.1. on the effectiveness of the Directive). b)Number of companies and equipment fleet data: estimating the number of EU manufacturing companies in the market is particularly complex. No official data are available and NACE codes used by Eurostat statistics are too broad to provide a precise picture. Similarly, equipment fleet data could not be assessed using available statistics as the available code systems cover broad categories which, in several cases, do not match with specific equipment. A combination of desk research, data from the “NOISE Application” database and expert opinion was used to produce an estimate which was then validated by sector organisations. c)Data on non-compliant equipment on the market: no data was found on the existence of non-compliant equipment on the market. Also, stakeholder views on the matter are patchy and mostly rely on anecdotal knowledge. Studies that assessed the compliance with other Directives and related requirements were used to provide an indication of the extent and potential impacts of the issue. d)Consumers’ participation: participation of consumers in the activities carried out within the “Supporting study” has been low. In general terms, few consumer associations are actively engaged in this specific topic which indicates that other issues are higher on their agenda. This is a finding per se, although it made it difficult to capture the views of consumers on the issue of outdoor noise. On the other hand, more than 100 citizens participated in the open public consultation, mostly persons exposed to noise by outdoor equipment. Despite these limitations, the reliability and robustness of the data gathered within the framework of the “Supporting study” can be overall considered as satisfactory, taking into account the objective situation of the specific sector of outdoor equipment in the scope of the OND, as well as the quality of the methodology developed by the consultants, with the support and participation of the Commission services and of the Inter-Service Steering Group closely monitoring the study. The study managed to collect and analyse the available information with a sufficient level of coverage and of precision, therefore the final results and conclusions are sufficiently reliable to use as a basis for the present document on the evaluation of Directive 2000/14/EC.



5.Analysis and answers to the evaluation questions The evaluation assesses the effectiveness, efficiency, relevance, coherence and EU added value of the Outdoor Noise Directive 2000/14/EC. To this end, a set of questions was defined for each evaluation criterion, to guide the data collection and analysis. The following sections are based on the information collected through the different sources for the referred “Supporting study”: literature reviews, interviews, surveys and the open public consultation. 5.1.Effectiveness of the Directive Did Member States implement the Directive in a coherent and effective way, ensuring common standards across the EU? As mentioned in Section 3, the evaluation showed that the Directive has been fully and consistently implemented across the Member States, with no significant issues detected in the national implementing processes through the relevant mechanisms of the OND itself. No infringement cases have been raised, and none of the stakeholders consulted in the “Supporting study” reported any concerns about a lack of implementation; stakeholder consultation and desk research also did not highlight the existence of national rules that could represent a challenge in this sense. About 67% of respondents to the open public consultation who expressed an opinion on this subject agreed that the transposition of the OND into national legislation was adequate and timely; among them, the same opinion was expressed by about the 70% of representatives of private enterprises and trade, business or professional associations. The majority of stakeholders recognise that the Directive has prevented the potential proliferation of different national standards and regulations, therefore allowing companies to sell their products across Europe. This was also confirmed by the results of the open public consultation, where about 80% of respondents indicated that the OND has ensured harmonisation of rules and procedures across the EU for the covered outdoor equipment. This rate is even higher, at about 94%, among professional respondents. Notified bodies responsible for carrying out conformity assessment procedures exist in the majority of the Member States, especially in those countries where there is a sufficient number of companies producing equipment covered by the OND. This is an objectively positive element, but, even if it is not an obligation for Member States to appoint notified bodies, the lack of such bodies in several Member States represents a challenge for manufacturers who need to seek the required expertise in other countries, which could imply additional costs. Were noise levels of outdoor equipment under Article 12 (subject to noise limits) reduced thanks to the Directive? Were noise levels of outdoor equipment under Article 13 (subject to noise marking only) also reduced thanks to the Directive? The OND came into force in a period when noise emissions and noise pollution by outdoor equipment were only starting to appear on national agendas and it had the effect of raising awareness of this issue. Over the years there have been more initiatives at national and local levels targeting noise emissions, indicating a renewed interest in this issue. According to the data available from different sources (in particular, the Commission’s “NOISE Application” database – see Annex 7 with the analysis of some entries) – and the studies carried out during the operation of the Directive – see Section 3.2.), noise emission levels of outdoor equipment have dropped over the last 20 years. As detected already in the “NOMEVAL” evaluation study (2007) and confirmed by subsequent studies, in particular the “ODELIA” study (2016), several types of equipment in the scope of the OND made significant progress in terms of reduction of noise emissions, especially when there is a market request for operation in sensitive areas (urban environment) or at night, or occupational or public procurement noise requirement. This is the case for example of compressors, excavators and loaders, all of them subject to both noise limits and marking (Article 12) and produced and placed on the market in large numbers, with significant evolution in technological solutions to increase their performances. At the same time, the majority of the consulted stakeholders recognised the positive role and effect of the OND on noise performance of outdoor equipment in the scope, attributing the reduction of noise levels to the Directive, especially in relation to noise emitted by equipment subject to the noise limits of Article 12. This is indicated by almost 75% of the respondents to the open public consultation, and among them, around 90% of professional respondents and representatives of private enterprises and trade, business or professional associations. Reliable information on noise emission levels before the OND was introduced is not available for the equipment covered, in particular for equipment subject to noise marking only. Nevertheless, the noise limits established by pre-OND legislation for a set of equipment allows a comparison with the noise limits established in the OND in its two stages of implementation (including indicative figures for stage II): Table 1 shows the evolution of noise limits expressed as permissible sound power levels (in dB/1 pW) for some outdoor equipment covered by Article 12 of the Directive.

Type of equipment Net installed power (P) [kW] Electric power (Pel) [kW] Mass of appliance (m) [kg] Cutting width (L) [cm] Directive Permissible sound power level [dB/1 pW] Pre-Directive Pre-Directive Pre-Directive Implementation of Directive Implementation of Directive 1986-1989 1989-1996 1997-2001 2002-2006 (stage I) 2006- (stage II) Compressors (P ≥ 350) (Q: air flow) Q ≤ 5 m3/min 84/533/EEC 2000/14/EC 101 100 100 97+2lgP 95+2lgP 5 < Q ≤ 10 m3/min 102 10 < Q ≤ 30 m3/min 104 102 102 Q > 30 m3/min 106 104 104 Concrete-breakers and picks, hand-held m < 20 84/537/EEC 2000/14/EC 110 108 108 107 105 20 ≤ m ≤ 35 113 111 111 94+11lgm 92+11lgm m > 35 116 114 114 96+11lgm 94+11lgm Excavators, hydraulic/rope-operated (P < 500) P ≤ 70 86/662/EEC 89/514/EEC 94/27/EC 2000/14/EC 106 96 83+11lgP 80+11lgP 70 < P ≤ 160 108 160 < P ≤ 350 112 P > 350 118 Excavators-loaders (P < 500) P ≤ 70 86/662/EEC 89/514/EEC 95/27/EC 2000/14/EC 106 104 85+11lgP 82+11lgP 70 < P ≤ 160 108 160 < P ≤ 350 113 P > 350 118 Lawnmowers L ≤ 50 84/538/EEC 2000/14/EC 96 96 96 96 94 50 < L ≤ 120 100 100 100 100 98 L > 120 105 105 105 105 103 Loaders, tracked (P < 500) P ≤ 70 86/662/EEC 89/514/EEC 95/27/EC 2000/14/EC 106 106 87+11lgP 84+11lgP 70 < P ≤ 160 108 160 < P ≤ 350 113 P > 350 118 Loaders, wheeled (P < 500) P ≤ 70 86/662/EEC 89/514/EEC 95/27/EC 2000/14/EC 106 104 85+11lgP 82+11lgP 70 < P ≤ 160 108 160 < P ≤ 350 113 P > 350 118 Power generators (Pel < 400) Pel ≤ 2 84/536/EEC 2000/14/EC 104 102 102 97+lgPel 95+lgPel 2 < Pel ≤ 8 100 100 98+lgPel 96+lgPel 8 < Pel ≤ 240 103 97+lgPel 95+lgPel Pel > 240 105 Tower cranes 84/534/EEC 2000/14/EC 102 100 98+lgP 96+lgP The Outdoor Noise Directive 2000/14/EC led to enhanced noise control and reduction for the different types of equipment in scope, especially for those in Article 12 which have to comply with the noise limits established in the legislation. On the contrary, there are not enough data to quantify to what extent this is the case also for equipment in Article 13 subject to noise marking only. However, the most recent studies carried out, in particular the CATI interviews performed within the “Supporting study”, suggested that noise marking, with the declaration of the guaranteed sound power level, contributed to some extent to promote purchasing of less noisy equipment by public authorities for being the noise level a more relevant feature for this type of consumers. The limit reduction for several types of equipment already in previous Directives, introduced by the OND, was effectively around 1-3 dB, except for lawnmowers, for which reductions were 0 dB. In the last amendment to the OND (Directive 2005/88/EC), subsequent reductions were made in noise limits, between 2-3 dB. A representation of the typical evolution of average noise emission of equipment following introduction of noise marking, first stage and subsequent stage noise limits, is shown in Figure 2. Sources: “NOMEVAL” and “ODELIA” studies For equipment not covered by any previous legislation, it is more difficult to provide an indication of how noise emissions have changed. New equipment introduced into the OND with noise limits was mainly construction equipment, mobile cranes, and lawn-edge trimmers. For some of this equipment, while pre-OND data is not available, new lower limits were established in the 2005 amendment. On the basis of the indications of the above mentioned studies and the output of the “NOISE Application” database, a noise reduction of at least 3 dB is estimated for equipment subject to noise limits (Article 12) not covered by previous legislation. On the other hand, for equipment subject to noise marking only (Article 13), it is not easy to establish whether this provision helped to reduce noise levels of the equipment covered, due to a lack of relevant and comparable data. Using data from the “NOISE Application” database, the average declared values for the period 2000-2007 were compared with those for the period 2007-2015. This exercise was conducted tentatively on three types of equipment covered by Article 13. It found that the values increased for both chainsaws (by 1 dB) and leaf blowers (by 3 dB), while they decreased for shredders (by 1 dB). These results may be due to different factors. For example, an increase in power of this equipment may have led to an increase in noise emissions. However, also the sample selection and the number of declarations received in specific years may affect the result. The general opinion expressed by stakeholders is that the inclusion of equipment under Article 13 was not sufficient to encourage manufacturers to develop less noisy products to the extent of those under Article 12. At the same time, the results of the open public consultation evidenced a lack of awareness and knowledge among consumers about the meaning of the noise marking and how to correctly interpret it. Such a situation did not allow these provisions of the OND to achieve its intended objective. Some examples of the average trends towards a progressive reduction of noise emission limits for outdoor equipment covered by the Directive are analysed in Annex 7, on the basis of the data available in the “NOISE Application” database, from the EC declarations of conformity of equipment placed on the EU market. Were noise levels of outdoor equipment reduced by the extent to have an impact on the health and well-being of citizens? The OND played an important role in protecting the health and well-being of citizens and the environment by reducing permissible noise levels of outdoor equipment. As mentioned above, noise emission levels of outdoor equipment have dropped over the last years, as evidenced in particular from the data extracted by the “NOISE Application” database from the EC declaration of conformity of equipment placed on the market; the majority of the respondents to the open public consultation supported this view. However, whether noise levels have reduced to the extent to be safe for the health and well-being of citizens, is difficult to evaluate. Several studies assessed the impact of noise emissions on health, and when exposure to noise is inevitable, it can have detrimental effects on human health, amenity, productivity and natural environment, in particular for a longer duration. Learning and memory start to be affected at 50 dB, sleep at 42 dB (self-reported) or 32 dB (detected in polysomnography). Blood pressure increases at 50 dB. Noise can already be disturbing or annoying at 42 dB, affecting wellbeing. Talking in a noisy environment stresses vocal cords and causes hoarseness. Several evidence suggests that at an equivalent continuous sound level (LAeq) of 24 h of less than 70 dB does not lead to any permanent hearing loss. However, the LAeq value of more than 80 dB(A) is the limit above which preventive noise reduction measures should be taken in the workplace. Hearing damage may occur when exposed to LAeq noise levels between 90 and 130 dB (A), or at lower levels but with prolonged exposure. In addition to hearing loss, it can generate extensive collateral damages, such as stress, increased heart rate, blood pressure, respiratory rate, vascular tone, gastric secretion, sweating, muscle tone, and pupil size. Therefore, while sounds higher than 90 dB sound pressure level are considered dangerous to hearing and general health, already noise above 50 dB sound pressure level can have impacts on the wellbeing of people exposed (e.g. sleep disturbance), and over the longer term potentially lead to more serious health effects. Lower noises from machines used for a shorter period of time (e.g. gardening equipment) can still have an impact on wellbeing, annoyance and stress effects. The OND establishes sound power limits and the resulting sound pressure level depends on the distance. Also, the equivalent sound level LAeq over a longer period may be lower if operating conditions are considered. The sound pressure to which a bystander or observer could be exposed is calculated as follows depending on the distance from the noise source: -sound power level minus 26 dB for 7.5 m distance -sound power level minus 37 dB for 25 m distance

With this in mind, several types of equipment covered by the OND are above 92 dB sound power level, ranging up to 120 dB for the noisiest. Considering the distance, an observer could be exposed to sound pressure levels ranging between 66 dB and 94 dB at 7.5 metres and 55 dB and 83 dB at 25 metres. Both ranges exceed the guard levels mentioned above indicating that the noise emissions of the equipment covered by the Directive still have the potential to have long-term negative effects on health. The key source of data with regards to the evolution of noise emission would be the “NOISE Application” database (see also Annexes 6 and 7). The “ODELIA” study analysed data contained in this and other databases: it identified types of outdoor equipment for which current noise limits are still adequate and suggested a revision for a number of them. While the recommendations contained in that study were based on several factors (e.g. the assumed exposure to certain noise emissions), it also took into account the technological development of the equipment covered. Out of the 22 types of equipment covered by Article 12, it was found possible to propose new limits for eight of them, indicating that, for these types of equipment, solutions for lower noise emissions are available. However, since emission levels of outdoor equipment have dropped over the last years also thanks to the Directive and its requirements on noise limits and marking, it can be concluded that citizens exposed to them are better off now than they would have been without the OND, even if they may still be exposed to harmful noise emissions. This is confirmed by the generally shared opinion of stakeholders against the repeal of the Directive, as detected in the different consultation activities carried out. Did the Directive raise awareness among consumers encouraging a “buy quiet” attitude? The OND provisions appear not to be sufficient to motivate consumers to buy equipment producing lower noise. The Directive establishes specific obligations on noise marking and communication of noise data, to inform consumers and raise awareness about noise emissions of outdoor equipment. The ultimate goal is to encourage them to prefer quieter machinery over noisier alternatives. There are different factors that impact consumer choice and hinder the OND in reaching its objective in this area: -first, non-professional purchasers and users of the equipment under the scope of the Directive lack knowledge and awareness about noise emissions. This is widely agreed by all stakeholders reached and documented in the literature. As a consequence, the average consumer does not have a clear understanding of the noise unit measure (dB) used for the noise marking established by the OND. Through the open public consultation, users of outdoor equipment (83%) considered the current noise marking moderately clear to not clear at all; -second, there seems to be a general expectation among consumers that the types of products covered by the OND are noisy and that similar products are equally noisy. Stakeholders consulted pointed out that the type of equipment covered by the OND is generally known to be noisy and consumers may pay less attention to this characteristic assuming that no perceivable differences exist between noise emissions of similar machinery; -third, the current marking requires a proactive attitude by the consumer to compare different products in order to identify the most noise efficient one. However, the preconception that similar equipment will be equally noisy and the lack of at least a basic understanding of what a 1 or 2 dB difference concretely means are not favourable conditions for this to happen. Although a majority of respondents to the open public consultation recognised that the OND had positive effects in improving the level of information provided to consumers and users (almost 55%, corresponding to 52% of professional users and more than 55% of representatives of private enterprises and of trade, business or professional associations), stakeholders also generally agree that the current noise marking is seen as not easy to read, understand and use for the average consumer. Rather than noise emissions, information collected from stakeholders indicates that general performance is the key criterion considered for outdoor equipment, followed by energy efficiency, safety and price. Moreover, users who responded to the OPC mentioned that while they tend to consider noise emission levels when buying or renting outdoor equipment, they prefer quieter equipment only if it offers similar features/performances to other noisier alternatives. Interestingly, the noise emission level seems to play a more important role than weight and aesthetics. Further, while price remains one of the key drivers of consumer choice, respondents to the OPC as individuals in their personal capacity indicated that, on average, they would be prepared to pay up to 12% more for quieter outdoor equipment. This is an interesting finding to be taken into account, even if the respondents may not be representative of the “average consumer” (due to possible selection bias), and the difference between “stated preferences” and “revealed preferences” in reality should be considered. Confirming that noise emission levels are still a low importance purchasing criterion, only a fifth of the rental organisations that replied to the CATI interviews within the “Supporting study” reported offering noise emissions among the research criteria on their website. Manufacturers and rental companies reported that demand for quieter equipment is greater among public purchasers (33%) than among private or professional users (22% and 20% respectively), as from the CATI interviews within the “Supporting study” (see Table 2). This appears to be particularly relevant for equipment used for cleaning and waste collection services (for which up to 91% of manufacturers recognised a moderate to large demand). This was further confirmed by the manufacturers that replied to the open public consultation. They indicated that while information about noise emission is provided to customers mostly in all sectors, this is usually required by customers only for cleaning and waste collection, processing and recycling equipment. Respondents indicated that stronger demand for silent products exists also for power generators and cooling equipment. Power generators are often used in specific contexts where excessive noise can be problematic. This is the case for example of movie sets where power generators are used while filming, hence the need for more silent equipment. Not at all / to a small extent To a moderate extent To a large / very large extent Total Total respondents For business 48% 30% 20% 100% 479 For consumers 42% 34% 22% 100% 226 For public authorities 34% 28% 33% 100% 183 Source: “Supporting study” - CATI interviews However, while noise emissions in general tend to be a secondary purchasing criterion, the type of customer affects the relative importance of the product features. For instance, occasional or leisure consumers tend to be more focused on the price, while professional users aim to buy high-performance equipment that allows them to complete the job in the shortest amount of time possible. Public authorities, local ones in particular, may on the contrary be more interested in low noise equipment for machines employed during night time or early in the morning (e.g. street cleaning machines). Have non-certified products reached the market? If so, were they identified, and their commercialisation blocked? How has the number of non-compliant equipment, or notifications of it, changed since 2007? Have Member States established appropriate authorities and measures to ensure conformity of relevant equipment? Effective and comprehensive market surveillance is one of the key issues of the enforcement of the EU legislative framework. Complying with the requirements of the OND poses a burden on manufacturers as resources need to be allocated to the reduction of noise emission, measurements and conformity assessment. While these costs may be deemed acceptable when applied to everyone and enforced equally, gaps in market surveillance would undermine the level playing field, putting compliant manufacturers at a competitive disadvantage compared with those who ignore the legislation. While market surveillance authorities are established in all Member States, only some of them are responsible for compliance with the OND: out of the about 800 MSAs established in the EU Member States, only 91 are responsible for compliance with the OND (against for example the 233 in charge of compliance with the Machinery Directive). This lower number of dedicated MSAs can be explained by several factors. Noise emission measurement is an extremely technical procedure, and specific training should be provided to responsible authorities. In this regard, it makes sense for some Member States to focus expertise in fewer authorities so that they use their resources more efficiently. However, all stakeholders consulted within the “Supporting study” agreed that the current resources (human and economic) allocated to national MSAs are not sufficient to allow for effective enforcement of the OND. In particular, it was highlighted that additional resources should be made available to provide adequate training to market surveillance officers.

MSA used the ICSMS platform to share information on their market surveillance activities, results and experiences. In the period 2016-2018, about 70 compliance reports were input into the system, focusing on certain types of equipment such as chainsaws, power generators, air compressors, pressure washers, tillers, high-pressure water jet machines, lawnmowers, hedge trimmers and brush cutters. About 60% of the equipment reviewed was found in compliance with the requirements of the Directive on the product and the documents. On the contrary, the main causes of non-conformity were due to rather formal issues, such as the absence or a non-compliant EC declaration of conformity, the absence of the noise marking on the product and incomplete or inaccurate information provided on the product. Although more than half of the consulted stakeholders consider that the OND had a positive effect on the prevention of non-compliant equipment on the market (about 56% of respondents to the open public consultation, with higher rates among individuals, when on the contrary, only 38% of representatives of private enterprises and of trade, business or professional associations agreed on that), there is a general recognition that non-conform equipment still reaches the market mostly undisturbed. However, no general statistics were identified to support this view. Stakeholders’ views on the share of non-compliant equipment on the market are quite scattered. As shown in Figure 3, less than half of respondents took a stand, and the opinions expressed are very diverse. Source: Open public consultation Weighting the answers from the open public consultation, according to the stakeholders consulted the gardening sector has the largest share of non-compliant equipment, followed by construction, power generators and cooling. While this data cannot be taken as a definitive indication of the share of non-compliant equipment currently on the market, it represents the stakeholders’ perception of the status quo. In particular, stakeholders are convinced that smaller, cheap equipment, mostly destined for private use and imported from non-European countries, tends to be more at risk of non-compliance than professional equipment. Market surveillance activity is mainly exercised ex-post on equipment already on the market. The most significant ex-ante control is, on the contrary, carried out by notified bodies, for equipment subject to noise limits. Although not imposed by any legislation, synergies between MSAs and NBs, as well as with the sectorial economic operators, could lead to better results in preventing non-compliant equipment from reaching the market. About half of the respondents to the survey to MSAs and NBs recognised that this type of collaboration is missing in their country, or not fully working. However, ensuring market safety and enforcing EU harmonisation legislation on health and safety of industrial and consumer product in the single internal market and at the external borders for imported products, is not limited to the respect of the obligations deriving from the OND, but it is a quite horizontal issue. In particular, problems with market surveillance and enforcement in the Member States mean that EU manufacturers may not enjoy a competitive edge in the EU market as a result of the implementation of the Directive: although official data are not available, consulted sectorial stakeholders mentioned that there is still a large number of non-compliant outdoor equipment imported from non-EU countries that are unfairly competing with their EU counterparts. On the basis of the general recognition that the whole market surveillance framework needs to be rethought and improved, the Commission drafted in December 2017 a proposal (within the “Goods package”) to address the significant number of non-compliant products on the EU market. At the end of the ordinary legislative procedure in the European Parliament and the Council, the Regulation (EU) 2019/1020 on market surveillance and compliance of products was adopted in June 2019, to become applicable from 16 July 2021. The provisions on “coordinated enforcement and international cooperation” – including in particular the “Union Product Compliance Network” – will be applicable already from 1 January 2021. By merging previous legislation, did the Directive simplify legislation improving stakeholders’ activities? As mentioned above (see Section 2.2.), the OND merged and replaced seven product Directives and two procedure Directives applied to specific types of equipment, at the same time extending the population of outdoor equipment subject to noise limits or noise marking. This simplification brought greater clarity to the legislative framework and improved the activity of the concerned economic operators and stakeholders, as indicated also by the results of the open public consultation: more than 90% of the respondents who expressed their opinion agreed that “the Directive has ensured harmonisation of rules and procedures across the EU for the covered outdoor equipment” and “by merging previous legislation, the Directive improved the effectiveness and internal coherence of EU legislation”. Among other aspects, it was noticed that the OND became a reference point for manufacturers, notified bodies and national authorities. All of them can, in fact, find all information required (types of equipment, markings, noise limits, conformity assessment procedures, noise measurement methods and test codes, etc.) in one single document, for the whole EU and according to the national transposition acts of the Member States. Even if the simplification of previous legislation was welcomed by stakeholders, they pointed out, through the consultation activities carried out within the “Supporting study”, that the classification and grouping of products that are currently applied might cause difficulties for manufacturers in understanding whether a product is actually covered by the Directive and increase the risk of arbitrary inclusion or exclusion of equipment from the scope of the OND. In fact, some categories may cover different types of equipment, spanning from small electric products to larger ones powered by combustion engines. An improvement on definitions of outdoor equipment in scope of the Directive was requested by several sectoral actors. Were noise limits set achievable? Are there specific types of equipment that represent a challenge in meeting the standards? By complying with them in a large majority, as shown by the market surveillance reports provided by the Member States (see Section 3.1.) and the information available in the ICSMS system, manufacturers have proven that the noise limits set by the Directive for specific outdoor equipment were indeed achievable, by using different available technologies (combustion engines, electrical power, batteries, etc.). Moreover, in the consultation activities carried out within the “Supporting study”, no stakeholder mentioned a specific type of equipment for which it was particularly difficult from a technical point of view to reach the required noise reduction by complying with the noise limits established for outdoor equipment listed in Article 12. However, when designing a product, manufacturers need to balance different technical features often in conflict between each other, taking into account not only the requirements on noise emission reduction laid down in the OND, but also the safety requirements from other EU legislation. In general, the choice of which features to privilege aims at developing products that will attract consumers, but at the same time legal obligations must be fulfilled. For instance, safety components or protections for a machine to comply with specific requirements of the Machinery Directive 2006/42/EC, can lead to more vibrations and consequently to higher noise emission levels; or, a more powerful tool will be less energy efficient, while less polluting equipment may need to use an engine requiring more ventilation through additional fans and more openings that would increase the noise produced by the machine, as in the case of equipment covered also by the Non-Road Mobile Machinery Regulation (EU) 2016/1628. If achieving the required noise reduction may not be technically difficult as such, when this objective is put into the context of a complex machine where different features (performance, energy efficiency, safety, weight, noise, cost, etc.) must be balanced, reaching the same result may represent a challenge, in particular in terms of R&D costs to achieve the necessary technical improvements. Are current conformity assessment procedures effective? Was the given choice a benefit allowing flexibility, or did it create confusion?

Conformity assessment procedures make reference to test codes and measurement methods to be used to perform the measurement, as defined in the OND also through European or international standards for each specific equipment. Test codes and measurement methods, and the related standards, have not been updated since entry into force of the Directive itself, therefore several of them are not in line with technological development and would need to be revised. This would require to amend the legal provisions of the Directive. More than a third of the manufacturers that responded to the open public consultation reported a low degree of satisfaction with this specific aspect of the conformity assessment, indicating that the procedures are poorly adapted to technical progress. The interrelation between the OND and other EU legislation, in particular the Machinery Directive, also causes issues of coherence and efficiency. Both require the measurement of noise emissions, but the former looks at the sound power and the latter at sound pressure, and they often require that the respective measurements should be done with different methods, even based in different versions of standards. Moreover, the lack of a clear and uniform procedure to determine the uncertainties related to measurements in the OND may cause inconsistency between guaranteed sound power levels depending on the subject performing the measurement and the method used. Uncertainty as such is always correlated to all measurement operations, and in the OND it is needed to establish the guaranteed sound power level, calculated as the sum of the measured sound power level and the uncertainty (as laid down in Article 3). The determination of the uncertainty is therefore fundamental to ensure that declared guaranteed sound power levels are legitimate, reliable and comparable. Nevertheless, the OND does not include a procedure to determine the uncertainty, which led to practical problems for manufacturers and notified bodies when transposing the measured sound power level of noise emission to the guaranteed sound power level to be declared in the noise marking. This gap is partly filled by an agreed method between notified bodies, and also by some indications included in the “Guidelines for the application of Directive 2000/14/EC”. The three procedures allowed by the OND for Article 12 equipment subject to noise limits and marking were developed in order to allow enough flexibility to manufacturers depending on the type of products and company organisation. So, companies that have the resources can develop an internal “Full quality assurance” (Annex VIII) system to determine in-house the measured sound power level, the uncertainties and the guaranteed value. Manufacturing companies producing unique or tailored equipment can employ the “Unit verification” (Annex VII) process, while in all other cases the procedure of “Internal control of production with assessment of technical documentation and periodical checking” (Annex VI) is used. In terms of these conformity assessment procedures with third-party intervention, no specific concerns were raised. However, it is not clear whether this contributed to ensuring that only compliant products are placed on the EU market. Stakeholders reported different opinions in this regard: on one side there are manufacturing companies mostly advocating a “self-assessment” system, as an extension of the applicability of the internal control of production procedure (Annex V) currently allowed by the OND for Article 13 equipment subject to noise marking only; on the other, consumer organisations, MSAs and also a few sector organisations consider the third-party conformity assessment as the first line of control to ensure the compliance of products reaching the market. Opinions expressed through the open public consultation also represent this diversity of views. An equal mix of different stakeholders (private individuals, sector organisations, public authorities, sector experts, etc.) support both positions which confirms the complexity of this dialogue (see Figure 4). Source: Open public consultation For adequate and effective conformity assessment procedures, it is necessary to ensure the uniform quality of the notified bodies. Several stakeholders reported that the assessments performed by NBs have not always the same level of quality and reliability across the entire EU. As mentioned above, noise emission measurement is an extremely technical procedure, and a number of factors can impact its results, from the skills and experience of the professionals working in the NB to the equipment available. Was there an increase in the international trade of outdoor equipment? Was competition from extra-EU manufacturing companies affected by the lower noise standards set by the Directive? A general agreement was found through the different consultation activities carried out in the “Supporting study” on the fact that the OND allowed for better trading across borders inside the EU; but quantitative data are scarce. Available intra-EU trade data for 2000-2007 showed that equipment covered by Articles 12 and 13 performed better than equipment that is not covered, with more constant increases over time. While this could be due to different factors, the fact that the OND prevented the emergence of different regulations at the national level may be one of them. The issue of extra-EU trade, on the contrary, is more complex. All stakeholders interviewed and desk research conducted highlighted that the EU is at the forefront in terms of regulation of the noise emissions of outdoor equipment, taking into account the information and resources available at international level, as from the World Health Organisation and countries like the United States of America, Canada, Japan and Australia. Therefore, on the one hand, European manufacturers have to comply with stricter regulations than non-EU producers; on the other hand, non-EU manufacturers will have to comply with the stricter EU limits if they wish to sell their products in the EU. As a consequence, European manufacturers should be able to propose to foreign markets more advanced products possibly more appealing to customers abroad; in contrast, non-European manufacturers have to catch up on R&D to design products in compliance with EU regulation, giving a competitive edge to EU producers. As a result, one would expect an increase of exports towards non-EU countries and a decrease in imports. This, however, does not seem to be the case. Available extra-EU trade data does not point in any of these directions, and both import from and export to non-EU countries increased over that period in line with the overall market trend. An assessment for a limited group of products is in Annex 8. Stakeholders interviewed for the “Supporting study” mentioned that when going abroad EU manufacturers have to deal with customers who (like their EU counterparts) are not particularly sensitive to reducing noise emissions, but they are more interested in equipment performance. This obliges some EU producers to adapt their products to these preferences by changing the design, increasing the power and even removing noise reduction elements to reduce weight and increase power. As a result, rather than favouring the competitiveness of EU producers, the stricter noise emissions thresholds set by the OND could undermine the competitiveness of EU companies selling abroad. Table 3 reports the views of rental and manufacturing companies that answered the CATI interviews within the “Supporting study”. According to the majority of the respondents, the OND did not have any impact on the respondents’ business either in their home country, in the EU market or outside the EU. Interestingly respondents consider that the OND made intra-EU trade slightly more difficult than extra-EU. This is probably due to the fact that while manufacturers have to meet the requirements set by the OND for the EU market, they do not have to do so for extra-EU exports. In this sense, the impact of the OND on extra-EU trade is less felt than the one on intra-EU trade. Much more difficult/ Somewhat difficult No impact Somewhat easier/ Much easier Don't know Total In the home country 24% 54% 14% 8% 538 In the rest of the EU 24% 51% 17% 8% 387 In other extra-EU countries 16% 53% 22% 9% 306 Source: “Supporting study” - CATI interviews

Similarly, only about 30% of the respondents to the open public consultation believe that the OND has had a positive impact on competition from manufacturing companies outside of the EU. This perception is even lower, about 25%, for representatives of private enterprises and of trade, business or professional associations. Is the “NOISE Application” database an effective tool? The “NOISE Application” database (as discussed in Section 3 – see also Annex 6 for the statistics of the database and Annex 7 for the analysis of entries of the database for some equipment) has the potential to be a useful tool, but it needs improvements. In 2007 and in 2016, two studies (“NOMEVAL” and “ODELIA”), conducted to determine the need to and feasibility of updating the noise limits, highlighted the limitations of the database: -incorrect equipment type was registered; -electrical and combustion engine powered equipment was often mixed; -technical parameters were often missing or clearly out of range, especially for Article 13 equipment; -data from important manufacturers were found missing; -no clear correlation of the evolution of the noise emission levels for different types of equipment during the years of operation of the Directive. In particular, the “ODELIA” study was able to rely only on 77% of total data available in the database while the publicly accessible research function of the database was taken offline in 2016 due to the low quality and reliability of the output data. Some of the issues reported were due to the data input method used over the first years of existence of the database. Manufacturers were sending paper documents to the European Commission that then had to be manually entered into the database. This two-step procedure led to mistakes and false data that undermined the reliability of the database. In recent years the tool was upgraded to be filled directly online. However, this tool is still considered outdated, the user interface not user-friendly, and the management of companies’ profiles and equipment registered not sufficiently easy and flexible. Manufacturers, for example, have problems in registering their “brand names” and the system to validate/accept the requests for authorised representatives is not working. The database should also ideally provide a clear picture of the market and the manufacturers, and other operators, active in the sectors covered by the OND. However, over the years there has not been strict control over the users registering in the database. Manufacturing companies could, for example, create multiple accounts or authorised representatives could register the same company creating a risk of double counting. Also, information on manufacturers that sent their EC declaration of conformity by e-mail or postal mail was not always recorded. On the other hand, the data exporting features of the database (the “public output”) appear to be limited and not sufficient to comply with the objective of providing comprehensive information on the status of the market for outdoor equipment. The database as it is will most likely stop working by 2020. In fact, the “NOISE Application” uses the Adobe ColdFusion web application development platform: this technology is outdated, and Adobe will stop its support in 2025. Also, the informatics services of the Commission, in the context of a wider efficiency assessment exercise, decided to stop their technical support by the end of 2020. This means that after that date the database will no longer be functional. Given the current shortcomings of the database and its limited access and functionalities, it is clear that, if the report, collection and publication obligations ex Article 16 are to be kept (and there are reasons to do so) a complete revision of the database is to be envisaged. All the stakeholders highlighted the need for refurbishment of the tool. In the absence of such action, manufacturers would prefer the obligation to be lifted. Are there unexpected or unwanted effects? Two main risks for unexpected or unwanted effects related to the operation of the Directive have been identified in the “Supporting study”: 1)Risk of undermining the level playing field in the sector The problems with market surveillance and enforcement highlighted above prevent the OND from reaching its full potential. Indeed, gaps in market surveillance mean that non-conform products on the market risk to undermine the competitiveness of compliant companies. This is especially the case because consumers often do not understand (or do not care much about) the value and importance of reduction of noise emissions and the information provided by the related product marking. As price remains one of the key purchasing criteria for the average consumer, the risk is that market demand for cheaper products may push the production or import of non-compliant products. As mentioned above, the work of notified bodies would also benefit from the greater consistency provided by the OND requirements. Nevertheless, it was reported by several stakeholders consulted within the “Supporting study” that conformity assessment procedures conducted by notified bodies are not always consistent across the EU: differences in the application of the test codes or in the determination of the uncertainty in relation to noise emissions measurements risk limiting the effect of the Directive.

2)Risk of hindering technological development As mentioned above, the widespread use of electric engines instead of combustion engines allows reducing sound power levels for some types of equipment. But, at the current state of the art, this type of technology cannot yet deliver the same level of operational performance as combustion engines (in terms of power, autonomy, portability) and for this reason, at the moment, electric equipment is more likely to be used by leisure or casual users than by professionals. However, while the OND establishes specific noise limits for combustion-engine driven equipment (as for builders’ hoists for the transport of goods, construction winches and lifts trucks), in other cases electric and combustion engines equipment are subject to the same noise limits. This may have hindered the development of products capable of offering better performances at a similar noise level of the combustion engine version of the same equipment, and, on the other hand, the current noise limits could be considered to be not strict enough to encourage the development of more performant electric equipment, taking into account the differences in sound power levels. Another way the OND could have hindered technological development is by diverting resources from R&D in other technology areas to noise reduction. As discussed above, manufacturers have to balance different features when developing a product. Having to comply with the OND obliges manufacturers to allocate part of the R&D budget to the reduction of noise emission possibly having to divert resources that could have been used to develop other technologies. This issue was however not specifically reported by manufacturers and, as mentioned, it is difficult to clearly identify the exact amount of investment made in R&D on noise control and reduction, as R&D is usually a holistic process. 5.2.Efficiency of the Directive Did the Directive reduce the administrative burden for stakeholders’ activities? The administrative burden of the OND is generally related to the compliance and conformity procedures. For manufacturers producing equipment not previously covered by equipment specific Directives, the OND introduced some new costs, in particular with respect to conformity assessment procedures. Regarding construction machinery, lawnmowers, tower cranes, welding generators, power generators and compressors, which were previously covered by the product and procedure Directives merged into the OND, the consulted stakeholders agreed that the merger brought greater clarity, and it provided a single reference point for both manufacturers and notified bodies. For notified bodies and market surveillance authorities, the change in administrative burden brought by the Directive was largely identified as non-existent or minimal (71% of notified bodies and 73% of market surveillance authorities consulted within the “Supporting study” suggested either a neutral impact or an increase of 0-25% of their administrative burden). However, the notified bodies observed that certain investments had to be made in order to perform the tasks required by the Directive, including investments in equipment, personnel training, yearly surveillance, and information and clarification acquisition and dispersal. It was noted that the costs of accreditation are a source of burden for notified bodies, especially where there are very few manufacturers for certain types of outdoor equipment subject to noise limits. However, only 3% of the notified bodies suggested that the Directive had strongly increased their administrative burden. Similarly, handling new products and setting up teams of noise specialists can add to the burden for MSAs, yet no respondents indicated a strong increase in administrative burden. These costs naturally depend on the extent to which market surveillance takes place. What administrative costs arise due to compliance and conformity assessment procedures? For equipment listed under Article 13 (subject to noise marking only), the OND allows for internal control (“self-assessment”), while for equipment listed under Article 12 (subject to noise limits), it allows for a choice between three types of conformity assessment procedure with third-party intervention of a notified body. To follow the compliance procedures, manufacturers must have sufficient personnel resources or the ability to hire an expert, as well as knowledge, time, and financial resources. Table 4 displays the costs of self-assessment (“Internal control of production, Annex V) by company size based on turnover, as estimated through the CATI interviews carried out within the “Supporting study”. The costs increase somewhat for the bigger companies. This can potentially be explained by larger and more complicated equipment produced by bigger companies, but due to the complexity of the range of products provided by the participating companies, this could not be conclusively confirmed. Company size (turnover) Time (in days) Cost Less than EUR 2 million 12 EUR 1,900 Between EUR 2 and 10 million 11 EUR 2,100 Between EUR 10 and 50 million 14 EUR 2,300 More than EUR 50 million 17 EUR 3,700 Average 13 EUR 2,350 Note: The costs increase for the bigger companies can potentially be explained by larger and more complicated equipment produced by bigger companies, but due to the complexity of the range of products provided by the participating companies, this could not be conclusively confirmed. Source: “Supporting study” - CATI interviews On the other hand, according to the CATI respondents, the conformity assessment procedure according to Annex VI (“Internal control of production plus assessment of technical documentation and periodical checking”) costs on average EUR 2,250, with an average turnaround of 7 days. It has to be noted that almost all respondents to this question were companies with a turnover below EUR 10 million. The average cost of assessment according to Annex VII (“Unit verification”) was reported to be EUR 6,550 (around EUR 4,650 for smaller companies), with the average turnaround of 7 days. For both Annex VI and Annex VII, the relatively low number of responses did not allow for a meaningful segmentation by size. However, also for Annex VII more than 70% of respondents had a turnover of EUR 10 million or less. Larger companies mostly rely on their internal quality assurance system developed in compliance with Annex VIII (“Full quality assurance”). As a consequence, this cost should be compared with the corresponding self-assessment cost figure reported by companies in the same category. Table 5 details the costs of conformity assessment according to Annex VIII per company turnover, including the cost of the system required. Again, the costs are higher for bigger companies.

Company size Time (in days) Audit procedure cost on the system QA System set-up cost Less than EUR 2 million 9 EUR 4,950 EUR 7,500 Between EUR 2 and 10 million 8 EUR 5,500 EUR 21,150 Between EUR 10 and 50 million 6 EUR 10,450 EUR 42,600 More than EUR 50 million 10 EUR 21,300 EUR 46,700 Average 8 EUR 8,350 EUR 30,800 Source: “Supporting study” - CATI interviews Given the high implementation costs and skills required to develop and use it, access to this kind of system also increases with the size of the company. As shown in Figure 5, the bigger the company, the more likely it is that it will have developed an internal quality insurance system. Source: “Supporting study” - CATI interviews It is assumed that the cost of performing a measurement using the internal quality assurance system is similar to the cost of self-assessment according to Annex V. Notified bodies also have to carry out yearly audits on the quality assurance systems. Assuming the cost of this audit requirement to be a quarter of the cost of the initial cost, it would range between EUR 1,000 and EUR 5,000 per year depending on the company size. All in all, over ten years it is estimated that audits on the quality assurance system cost to a company between EUR 15,000 and EUR 70,000 depending on its company size (EUR 30,000 on average). The notified bodies reported that the cost to the client for the conformity assessment procedure under each Annex is up to EUR 5,000 ex Annex VI, up to EUR 2,000 ex-Annex VII, and up to EUR 8,000 ex-Annex VIII. However, the response rate among notified bodies was low and does not allow for a reliable comparison of costs. In general, the average cost of a conformity assessment with third-party involvement has been determined by the evaluation of the internal market legislation for industrial products. Based on a survey of 128 notified bodies and a programme of 201 interviews, including industry associations and companies, it identified the cost to be in the range of EUR 30,000 to EUR 50,000 per company per annum, or EUR 3,000 to EUR 4,000 per product. On the basis of the estimated number of manufacturing companies producing each equipment covered by the OND, it was possible to estimate the annual compliance cost. It has to be noted that the estimates change on the basis of the assumed number of measurements per year per type of equipment. CATI results indicate that, on average, a manufacturing company conducts six measurements in a year per type of equipment. This could depend, for example, on the existence of different versions of the same equipment type. On average, a manufacturing company conducts six measurements in a year per type of equipment. Table 6 presents the cost range of compliance for equipment covered by Articles 12 and 13. As a result, the compliance cost with the Directive ranges from EUR 18 million to EUR 27 million. Lower end Higher end Article 12 EUR 8 million EUR 10 million Article 13 EUR 10 million EUR 17 million Total EUR 18 million EUR 27 million Source: “Supporting study” - CATI interviews In the open public consultation manufacturer respondents were asked to evaluate the conformity assessment procedures regarding implementation, administrative and information burdens. As presented in Figure 6, the majority considers the procedures to be fair/neutral. Source: Open public consultation The respondents were also asked to rate the efficiency of the conformity assessment procedures on a scale from 0 to 5 on selected aspects. As presented in Figure 7, for the procedure according to Annex V the majority of aspects are ranked at moderate efficiency (3 out of 5), however technical documentation is more commonly ranked considerably efficient (4 out of 5).

Source: Open public consultation As presented in Figure 8, opinions of manufacturers are somewhat more divided on the efficiency of the conformity assessment procedure according to Annex VI and Annex VII. Annex VI is more commonly assessed as either somewhat efficient (2 out of 5) or moderately efficient (3 out of 5), with 23% each, while Annex VII is more commonly assessed as either slightly efficient (1) or moderately efficient (3) with 25% each. Source: Open public consultation From their point of view, notified bodies and market surveillance authorities considered that providing the choice between different conformity assessment procedures is an adequate way to balance the need for noise limits and information to users with some degree of flexibility for industry, without creating confusion or unnecessary difficulty. The majority of the consulted stakeholders consider that the overall costs for manufacturers from following the requirements of the OND are proportionate to the benefits gained, as long as they are sufficiently and equally enforced. Nevertheless, as mentioned above, the gaps in market surveillance and enforcement undermine the level playing field on the single market, putting compliant manufacturers at a competitive disadvantage due to the investments they have made to comply. There is disagreement among different stakeholder groups whether the current third-party conformity assessment procedures should be replaced by internal / self-assessment. Manufacturer representatives consider the self-assessment a more efficient way of quality assurance with lower costs, while consumer organisations, notified bodies and market surveillance authorities consider that it would be less reliable than third-party assessment, leading to negative impacts for consumers and the environment. These stakeholders expressed the view that third-party conformity assessment acts as a “first line of control” to prevent that non-compliant products reach the market. In addition, according to the analysis of the results of the open public consultation, 49% of the respondents felt that self-assessment should be used in very limited cases only or be removed entirely. Therefore, the need to minimize costs needs to be carefully balanced against the reliability of the conformity assessment procedure and the information provided to users, as well as ensuring the level playing field on the single internal market, especially where market surveillance is still insufficient. Did the Directive introduce unnecessary burdens for manufacturers and other economic operators? While the focus of the OND is controlling the noise emissions of outdoor equipment in the environment, the limits and requirements mainly impact manufacturers and other economic operators. Therefore, the benefits and costs brought by the Directive fall largely on different stakeholder groups. The open public consultation respondents familiar with the Directive considered that some excessive administrative burden had been brought by the implementation of the Directive, particularly by the third-party conformity assessment procedures, and the reporting obligations on collection of noise data. The respondents considered that these requirements, particularly providing information for the “NOISE Application” database, do not generate any clear environmental or health benefits. Some of the consulted stakeholders did express the opinion that some increase in burden compared to the pre-OND era is acceptable, as no benefits will be achieved without some investment in compliance and conformity processes. The majority of stakeholders acknowledge that the OND has had a positive impact on the overall reduction of noise emission levels by outdoor equipment. Table 7 presents the view of the CATI respondents within the “Supporting study” on how the noise performance impacts the final price of the product as paid by the customer. Across all sectors, for more than half of the respondents, the noise performance has no impact on the final price. In these cases, the burden introduced by the Directive is not necessarily fully passed on to the consumer. However, it is also noticeable that in specific sectors the impact on price is more evident: this is the case for cleaning equipment, power generators and cooling equipment, and waste collection, processing and recycling equipment. Cleaning and waste collection, processing and recycling equipment are typically needed by public and local authorities to provide related services to their citizens. As mentioned, this type of customer is more interested in less noisy equipment in order to perform these activities during the night. Power generators are often used in specific contexts where excessive noise can be problematic: this is the case for example of movie sets where power generators are used while filming, hence the need for more silent equipment. In this case, being a valuable feature of the equipment, lower noise emission has a stronger impact on the final product price. No difference Increase of 5% 6% -10% 11% -25% 26% - 50% > 50% Cheaper for customers All sectors 57% 17% 14% 9% 1% 0% 1% Cleaning 44% 16% 20% 12% 4% 4% 0% Construction 59% 19% 15% 4% 1% 0% 1% Gardening 54% 14% 21% 7% 0% 4% 0% Loading and lifting 63% 14% 15% 5% 1% 0% 1% Power generators and cooling 35% 18% 20% 20% 3% 0% 3% Pumping and suction 59% 17% 8% 11% 3% 1% 1% Snowmobiles and snow groomers 33% 0% 67% 0% 0% 0% 0% Waste collection, processing and recycling 40% 23% 10% 27% 0% 0% 0% Source: “Supporting study” - CATI interviews Manufacturing companies responding to the OPC also gave the impact of noise performance to the final price of their equipment. For two-thirds of the respondents, the increase falls between 1 and 20 per cent. 55% of the manufacturers participating to the OPC reported that information on noise emission level is a criterion offered to and required by the customers, 44% reported that the information is offered but not required, and 6% that it is neither. Are there elements of the Directive that require more resources (manpower, time, etc.) in comparison with others?

R&D costs for technical compliance and third-party conformity assessments for outdoor equipment subject to noise limits are identified by the stakeholders as the most expensive and time-consuming elements of the Directive. Out of the 150 respondents to the OPC that are familiar with the OND, 65% considered that the Directive had a positive to strong positive effect on research, development and innovation on equipment; among them, 62% of professional users and 61% of representatives of private enterprises and trade, business or professional associations. It was, however, observed that noise limits need to be feasible and sufficiently ambitious to stimulate innovation and improve noise performance. The limited importance given by consumers at the moment of purchase to noise performance was considered an inhibiting factor on the manufacturers’ motivation to invest in noise reduction R&D. Indeed, the lack of a competitive advantage in relation to noise performance, in combination with the conflict between noise limits and other legal requirements (such as exhaust emissions or machinery safety), was seen as a negative factor for noise-specific R&D, and the consequent R&D expenses to be disproportionally high on compliant enterprises. According to the CATI interviews carried out within the “Supporting study”, it is estimated that about 5% of the turnover is spent on overall R&D with small differences across the different sectors. It is difficult for stakeholders to indicate the amount of R&D spent on noise reduction. R&D budgets are usually more holistic and include many other product features on top of noise emissions. As such, any data on this specific aspect needs to be considered with caution. Based on CATI responses, the “Supporting study” estimated that between 2.5% and 7% of total R&D expenditure is spent on noise reduction. Interestingly, manufacturers of cleaning equipment and of power generators and cooling tend to invest more than producers in other sectors, 7% and 5% on average respectively against 3.5% of average for the other sectors. The estimated expenditure on R&D on noise reduction ranges between EUR 40 million and EUR 120 million. Table 8 provides the average value per sector. It has, however, to be considered that this value is not constant over the years and it follows the production cycle. Also, some of the investment in R&D on noise reduction is not borne by companies but passed on to the consumers. This means that the cost is also spread among the final users of the equipment, especially in cleaning equipment, power generators and cooling equipment, and waste collection, processing and recycling equipment categories. For example, it is estimated that about 17 million units of gardening equipment have been sold in 2017. This would mean that, on average, EUR 0.50 have been passed on to each customer to cover R&D cost related to noise reduction. Estimated turnover R&D Expenditure R&D on noise reduction expenditure Cleaning equipment EUR 1 billion EUR 48 million EUR 4 million Construction machinery EUR 21 billion EUR 1 billion EUR 31 million Gardening equipment EUR 4 billion EUR 200 million EUR 8 million Loading and lifting equipment EUR 7 billion EUR 300 million EUR 10 million Power generators and cooling equipment EUR 3 billion EUR 130 million EUR 8 million Pumping and suction equipment EUR 1.5 billion EUR 70 million EUR 3 million Snowmobiles and snow groomers EUR 0.2 billion EUR 10 million EUR 0.3 million Waste collection, processing and recycling EUR 2.5 billion EUR 120 million EUR 3 million Total EUR 40 billion EUR 1.8 billion EUR 67 million Source: “Supporting study” - CATI interviews The third-party conformity assessment is also somewhat resource-consuming for notified bodies, who suggested that the effort to demonstrate compliance with the OND could be more significant than for those of other applicable EU legislation, in particular for the evaluation of measurement uncertainties for outdoor equipment in Article 12. Are SMEs disproportionately affected by the Directive’s requirements in comparison to larger enterprises? Fixed compliance costs can be expected to have a larger impact on SMEs, as du