EUROPEAN COMMISSION 
Brussels, 21.11.2011 
SEC(2011) 1376 final 
  
NEW LEGISLATIVE FRAMEWORK (NLF) ALIGNMENT PACKAGE 
(Implementation of Goods Package) 
COMMISSION STAFF WORKING PAPER 
IMPACT ASSESSMENT 
Accompanying document to the 
10 PROPOSALS TO ALIGN PRODUCT HARMONISATION DIRECTIVES TO 
DECISION No 768/2008/EC 
Disclaimer: This report commits only the Commission's services involved in its 
preparation and does not prejudge the final form of any decision to be taken by the 
Commission. 
{COM(2011) 763 final} 
{SEC(2011) 1375 final}  
 
EN 1   EN TABLE OF CONTENTS 
1. Procedural issues and consulta tion of interested parties.............................................. 3 
1.1. Identification ............................................................................................................ .... 3 
1.2. Organisation and timing............................................................................................... 3 1.3. Consultation and expertise ........................................................................................... 3 1.4. Scrutiny by the Commission Impact Assessment Board ............................................. 4 2. Context ..................................................................................................................... .... 4 
2.1. The New Legislative Framework................................................................................. 4 2.2. Political background..................................................................................................... 7  
2.3. Implementation of NLF................................................................................................ 7 2.4. Specificities of this impact assessment a nd its link to the impact assessment on the 
New Legislative Framework........................................................................................ 9 
2.5. Description of directives and sectors ........................................................................... 9 3. Problem description ................................................................................................... 14 3.1. Products which do not comply with the requirements............................................... 16 3.2. Low quality of services delivered by certain Notified Bodies................................... 23 3.3. Complexity of the regulatory environment................................................................ 27 3.4. EU right to act ........................................................................................................... . 30 
4. Objectives.................................................................................................................. . 31 
4.1. General policy objectives........................................................................................... 31 4.2. Specific and operational policy objectives................................................................. 31 4.3. Consistency with other policies and objectives ......................................................... 32 5. Options ..................................................................................................................... .. 32 
5.1. No policy change........................................................................................................ 32  
5.2. Alignment with the NLF Decision via non legislative measures............................... 32 5.3. Alignment with the NLF Decision via legislative measures...................................... 32 6. Impacts ..................................................................................................................... .. 34 
6.1. Overview of potential impacts a nd methodology for their assessment...................... 34 
6.2. Option 1: No policy change ....................................................................................... 35 6.3. Option 2: Alignment via non-legislative measures.................................................... 38 
 
EN 2   EN 6.4. Option 3: Alignment via legislative measures ........................................................... 41 
7. Comparison of options ............................................................................................... 51 8. Monitoring and evaluation ......................................................................................... 55 9. ANNEX 1: Glossary and List of acronyms................................................................ 57 10. ANNEX 2: Detailed Sector Description .................................................................... 59 10.1. Civil Explosives ......................................................................................................... 59 
10.2. Pyrotechnic Articles................................................................................................... 61  
10.3. Pressure Equipment.................................................................................................... 64 10.4. The Low Voltage Directive........................................................................................ 66 10.5. The Electromagnetic Compatibility Directive ........................................................... 67 10.6. The ATEX Directive.................................................................................................. 69 10.7. The Lifts Directive ..................................................................................................... 7 1 
10.8. Measuring Instruments............................................................................................... 72 11. ANNEX 3: Overview of stakeholders consulted ....................................................... 75 11.1. Discussions in sector specific working groups .......................................................... 75 11.2. Overview of stakeholders having particip ated in the public and SME consultations 76 
12. ANNEX 4: Detailed analysis of information collected.............................................. 78 
12.1. Non-compliance with product requirements.............................................................. 78 
12.2. Performance of Notified Bodies................................................................................. 98 12.3. Inconsistency of terminology................................................................................... 114 12.4. Comparison of effectiveness of options 2 and 3 ...................................................... 115 13. ANNEX 5: SME test................................................................................................ 119 
 
EN 3   EN 1. PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  
1.1. Identification  
Lead DG: DG ENTR 
Agenda Planning/WP Reference: 2010/ENTR/002 
1.2. Organisation and timing 
Work on the present Impact Assessment started in spring 2009. DG ENV, EMPL, 
EUROSTAT, INFSO, MARKT, LS, SANCO,  TAXUD, TREN, TRADE and the SG 
were invited to join the IASG. The gr oup met four times, on 1 December 2009, 7 
April 2010, 2 February 2011 and 1 March 2011  and representati ves of DG SANCO, 
DG ENTR and the LS participated in these meetings.  
1.3. Consultation and expertise 
External expertise was used to obtain some  basic data on the measuring instruments 
sector.1 Furthermore, findings from studies concerning lifts (20042 and 20073), and 
equipment used in potentially explosive atmospheres (ATEX)4 have been used to 
underpin this report5.  
National authorities have b een consulted through the Se nior Officials Group for 
Standardisation and Conformity Assessment Policy and the sector specific working 
groups established under the ten directives concerned (see section 11.1 in Annex 3). 
Some bilateral meetings with national experts took place. 
From June to October 2010 a public c onsultation was carried out which was 
published on the Your Voice in Europe we bsite. It consisted of four targeted 
questionnaires for economic operators, author ities, notified bodies and users and we 
received 300 replies.6 In view of the high number  of SME active in the sectors 
                                                 
1 Interim Evaluation of the Measuring Instruments Directive , Final report by CSES Centre for Strategies 
and Evaluation Services (UK), July 2010: http://ec.europa.eu/enterprise/sectors/legal-metrology-and-
prepack/public-consultation/public-consultation-files/evaluation_report_by_cses_en.pdf  
2 Evaluation of the Application of the Lift Directive (95/16/EC) . Final Report to the European 
Commission (DG ENTR) submitted by: The European Evaluation Consortium,The Evaluation 
Partnership Limited (UK); Economisti Associati (Italy); Particip GmbH (Germany);navreme knowledge development (Austria); Authorised Representative The Evaluation Partnership Limited, 21 June 2004. 
The study examined the functioning of the Lifts Di rective in 7 Member Stat es: Belgium, Finland, 
Germany, Italy, Portugal, Sp ain and the United Kingdom. 
3 Study on the Technical Assessment of Means of Preventi ng the Crushing Risk on Lifts subject to 
Directive 95/16/EC , Report Number ME/07/07, Science Group: Hazard Reduction Group Health and 
Safety Laboratory; Project Leader: Jonathan Statha m; Crown copyright (2007). The study aim was the 
examination whether the solutions available, other th an free space or refuges, to prevent the crushing 
risk can provide an equivalent level of safety. 
4 See “Market description, competitiveness analysis in the field of products and protective systems 
intended for use in potentially explosive atmospheres” (1999); available on 
http://ec.europa.eu/enterprise /sectors/mechanical/files/atex /atexcomp_finalreport_en.pdf  
5 A glossary and a list of acronyms can be found in Annex 1. 
6 A summary of the results is available at http://ec.europa.eu/enterpri se/policies/single-market-
goods/regulatory-policies-common-rules-for-pr oducts/new-legislative-framework/index_en.htm  
 
EN 4   EN concerned, a specific SME consultation was carried out in addition to the general 
consultation. 603 SME were consulted thr ough the Enterprise Europe Network in 
May/June 2010. More information on stak eholders who part icipated in the 
consultation can be found in the annex (see section 11.2 in Annex 3). Several 
bilateral meetings also t ook place with industry associations from the electro-
technical sector, the measuring instruments sector, the pressure equipment sector and 
the lifts sector. The Commission’s minimum consultation standards were fully met.  
In general all stakeholders expressed wide -spread support for the initiative. There is 
unanimity on the need to improve market surveillance and the system for assessing and monitoring Notified Bodies. Authorities fully support the exercise because it will 
strengthen the existing system and improve  cooperation at EU level. Industry also 
expects a simplification effect from the al ignment of legislation. Certain concerns 
were expressed on very specific aspects, mainly relating to translation obligations and certain aspects of traceability requireme nts. While a number of these concerns 
can be addressed by appropr iate guidance, some could not be taken into account 
because these measures are indispensable to increasing the efficiency of market 
surveillance. They do not entail unreasona ble costs for industry and the benefits 
resulting from improved market surveillance should outweigh the costs. More details 
of stakeholders’ views can be found in section 11. 
1.4. Scrutiny by the Commission Impact Assessment Board 
The Impact Assessment Board of the Eur opean Commission assessed a draft version 
of the present impact assessment and issued its opinion on 12/04/2011. The Board 
made several recommendations a nd, in the light of these, the final impact assessment 
report: 
Clarifies the considerations on the basis of which the ten dire ctives have been 
selected to be part of this initative; 
Describes in more detail the measures intended to address all the aspects raised in the 
problem description;  
Presents in a clearer manner a comparison of the costs and benefits of this initiative; 
Clarifies the monitoring and evaluation arrangements for this initative. 
2. C
ONTEXT  
2.1. The New Legislative Framework 
This initiative is a further step in the implementation of the “goods package”  
adopted in August 2008. The good s package is a set of horizontal measures aimed at 
improving the functioning of the internal market for goods. It consists of three instruments:  
 
EN 5   EN – Regulation 764/20087, which is intended to impr ove the free movement of 
goods in the “ non-harmonised area ” (free movement is ensured by Articles 
34, 35 and 36 of the TFEU) by reinforcing the application of the principle of 
the mutual recognition.  
– Regulation 765/20088 and Decision 768/20089, which together form the “New 
Legislative Framework” , and which have the aim of improving the free 
movement of goods in the “ harmonised area ” (free movement is ensured by 
EU harmonisation legislation on the marketing of products). 
In the harmonised area the goods package was preceded by a stocktaking exercise on 
the experience gained with the existing legislation in that area, and in particular with 
the New Approach. Over a period of more than 30 years the EU has set up 
requirements in its “technical harmonisation” directives for a vast  range of products 
such as machinery, automobiles, toys, electr ical products, lifts, etc. This legislation 
has a twofold objective: On th e one hand it ensures that pr oducts availabl e in Europe 
meet a high level of protection of public in terests like health and safety, consumer 
protection or environmental protection. On the other hand it ensures the free 
movement of products by replacing nationa l rules with a single harmonised set of 
conditions for the marketing of the products concerned that apply in all EU Member 
States.10  
The overall conclusion of the stocktaki ng was that the legislation has largely 
succeeded in liberalising trade in goods and in setting robust requirements ensuring 
the safety of products. However, it also unveiled a number of shortcomings observed 
across various sectors, namely a significan t number of non-compliant products that 
reach the market, the unsatisfactory pe rformance of certain notified bodies11, and 
inconsistencies throughout the legislati on making its application unnecessarily 
complicated for manufacture rs and authorities.  
To remedy these shortcomings the “ New Legislative Framework” (NLF) was 
adopted as part of the goods package. It consists of two complementary instruments, 
Regulation 765/2008  on accreditation and market surveillance (NLF Regulation)  
and Decision 768/2008 establishing a commo n framework for the marketing of 
                                                 
7 Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying 
down procedures relating to the application of certa in national technical rules to products lawfully 
marketed in another Member State and repealing Decision No 3052/95/EC, OJ L218 of 13.08.2008. For 
more information see http://ec.europa.eu/enterprise/policies/single-market-goods/free-movement-non-
harmonised-sectors/mutual-recognition/index_en.htm  
8 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the requirements for accreditation and market surveillance relating to the marketing of products and 
repealing Regulation (EEC) No 339/93, OJ L218 of 13.08.2008 
9 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common 
framework for the marketing of products, and repealing Council Decision 93/465/EEC, OJ L218 of 
13.08.2008 
10 The evolution of the EU’s policy on technical harmonisation is outlined in detail in the impact 
assessment that accompanied the New Le gislative Framework. SEC 2007(173) 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf   
11 Laboratories and certification or inspection bodies  delivering certificates wh ich are notified to the 
Commission by Member States. 
 
EN 6   EN products (NLF Decision). The NLF was accompanied by an impact assessment12. Its 
objective is to strengthen and complete the existing rules and to improve the way in 
which the requirements are actually applied and enforced in practice by business and 
authorities.  
The NLF  Regulation  has introduced rules on accreditation13 and requirements for 
the organisation and performance of market surveillance  and controls of products 
from third countries. The Regulation became applicable on 1 January 2010 . 
The NLF  Decision  sets out a common framework  for EU legislati on that lays down 
requirements for the marketing of products. It contains the provisions which are 
commonly used  in EU product legislation (e.g. de finitions, obligations of economic 
operators, notified bodies, safeguard mechanisms, etc). These common provisions have been reinforced to ensure that the directives work more effectively in practice. New elements, such as obligations on im porters, have been introduced, which are 
crucial for improving the safety of products on the market.  
The NLF Decision complements the NLF Regulation . While the latter basically 
contains the obligations on Member States  and their authorities to ensure that 
products on their market are safe and comp ly with the legal requirements, the NLF 
Decision contains the corre sponding obligations imposed on economic operators 
such as manufacturers, importers and dist ributors, as well as the bodies testing and 
certifying products. These obligations provide the means for authoriti es to effectively 
carry out their obligations under the Regulation. Hence, the two instruments are 
inextricably linked  and can only fully deliver their results in interplay with each 
other.  
However, unlike the NLF Regulation, the NLF Decision does not  have immediate 
legal effects on economic operators, individual s or Member States. It is conceived as 
a “toolbox”  for future legislation . By adopting the NLF Decision the three EU 
institutions involved in the legislative pr ocess, Council, Parlia ment and Commission 
have committed themselves to use its prov isions as much as possible in future 
legislation on products in order to furthe r the utmost coherence of the regulatory 
framework
14. To give practical effect to the NL F Decision’s provision s, they need to 
be integrated into the existing product legislation.  
                                                 
12 See SEC 2007(173) 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf  
13 Accreditation is a tool for the control of the co mpetence of laboratories a nd certification/inspection 
bodies delivering certificates in the EU 
14 Article 2 of Decision 768/2008 reads: " Subject matter and scope : This Decision sets out the common 
framework of general principles and reference provisions for the drawing up of Community legislation 
harmonising the conditions for the marketing of pr oducts ("Community harmonisation legislation"). 
Community harmonisation legislation shall have recourse to the general principles set out in this 
Decision and to the relevant reference provisions of Annexes I, II and III. However, Community legislation may depart from those general principles and reference provisions if that is appropriate on 
account of the specificities of the sector concerned, especially  if comprehensive legal systems are 
already in place".  
 
EN 7   EN 2.2. Political background 
In the wake of larg e-scale product recalls, product safety  has gained a lot of 
political attention  lately. In the summer of 2007, wh en the NLF was actually under 
negotiation between Parliament and Council, a major recall of toys pushed the item 
up the political agenda. The events not only  exposed deficiencies in the way that 
market surveillance currently operates in Eu rope (market surveillance to effectively 
deal with dangerous products), they also put into question the credibility of EU 
legislation and its capacity to adequately pr otect the health  and safety of consumers. 
This added considerable momentum to the NLF negotiation process. There was 
consensus amongst all actors on the need to improve the situation on market 
surveillance and to strengthen the obligations on econo mic operators. The 
negotiations on the goods package were finalised in record time. 
In response to these concer ns, the Commission immediatel y presented a proposal for 
a revised Directive on the Safety of T oys in 2008. It fully took on board the new 
framework set by the NLF Decision and becam e the first directive to be aligned to 
the NLF.15  
Improving the safety of products, in partic ular as regards imported products, still 
remains an important issue for the European Parliament16 and there are high 
expectations to upgrade the remaining product safety legislation to the new standards 
set by the NLF Decision .  
2.3. Implementation of NLF 
Right after the adoption of the NLF in summer 2008 the Commission examined ways 
to bring the existing legislation  into line with the enhan ced provisions of the NLF 
Decision. The Decision itself provides that its provisions  are to be used when 
legislation is drafted or revi sed. An internal survey showed  that for a majority of the 
existing directives there was a need to a ddress technical, sector-specific elements 
(e.g. need to clarify or expand the scope, need to update safety requirements to 
technical progress) in addition to the pr oblems observed at horiz ontal cross-sector 
level. Hence a full revision of these directives had been  planned within a time-frame 
of 5 years. Examples are th e Recreational Craft Directive, the Directive on Personal 
Protective Equipment or the R&TTE Directive. In line with Article 2 of the NLF Decision such a revision will also include an alignment to the NLF.  
For a number of other directiv es no particular problems with their sector-specific 
elements were identified which would have required a full revision of these directives including the sector -specific elements. The only deficiencies perceived in 
these sectors were those of  a horizontal nature identified in the 2004 stocktaking 
exercise which led to th e adoption of the NLF.  
While no full revisions were t hus planned for these directiv es - neither within the 5 
year framework nor beyond that  period - it was neverthe less considered that the 
                                                
 
15 See http://ec.europa.eu/enterprise/sectors /toys/documents/directives/index_en.htm  
16 See for example the own initiative Report on the revision of the General Product Safety Directive and 
market surveillance (2010/2085(INI)) http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-
//EP//NONSGML+REPORT+A7-2011-0033+0+DOC+PDF+V0//EN&language=EN  
 
EN 8   EN cross-cutting horizontal problems of non-co mpliance and incoherence need to be 
addressed and that these sect ors should also fully benefit from the improvements of 
the NLF. Given the strong link between th e NLF Regulation and the NLF Decision, 
and the objective of ensuring more consis tency throughout the regulatory framework 
for products, it appeared desirable to also a lign these directives to the NLF Decision 
within the same timeframe. In order to stre ss the fact that this exercise exclusively 
concerns the horizontal elements of these di rectives which will be aligned to the NLF 
Decision - as the fo llow-up to the commitments undert aken in the context of the 
goods package - and to achieve a result which is as coherent as possible, it has been 
decided to deal with these directives in a package. 
The ten directives concerned are the following:  
(1) Low Voltage Directive:  Directive 2006/95/EEC on the harmonisation of the 
laws of Member States relating to electrical equipmen t designed for use 
within certain voltage limits  
(2) Electromagnetic Compatibility Directive:  Directive 2004/108/EC on the 
approximation of the laws of the Member  States relating to electromagnetic 
compatibility and repealing Directive 89/336/EEC 
(3) ATEX Directive:  Directive 94/9/EC of the European Parliament and the 
Council on the approximation of the laws of the Member States concerning equipment and protective systems inte nded for use in potentially explosive 
atmospheres 
(4) Lifts Directive : European Parliament and Counc il Directive 95/16/EC on the 
approximation of the laws of the Member States relating to lifts 
(5) Pressure Equipment Directive:  Directive 97/23/EC of the European 
Parliament and of the Council on the approximation of the laws of the 
Member States concerning pressure equipment  
(6) Simple Pressure Vessels Directive : Council Directive 2009/105/EC on the 
harmonisation of the laws of the Member States relating to simple pressure vessels 
(7) Measuring Instruments Directive:  Directive 2004/22/EC of the European 
Parliament and of the Counc il on measuring instruments  
(8) Non-automatic Weighing Instruments Directive:  Council Directive 
2009/23/EEC on the harmonisation of the la ws of the Member States relating 
to non-automatic weighing instruments  
(9) Civil Explosives Directive:  Council Directive 93/15/EEC on the 
harmonisation of the provisions relating to the placing on the market and 
supervision of explosives for civil use  
(10) Pyrotechnic Articles Directive:  Directive 2007/23/EC on the placing on the 
market of pyrotechnic articles  
 
EN 9   EN 2.4. Specificities of this impact assessment and its link to the impact assessment on 
the New Legislative Framework  
Against this background the objective of this impact assessment is to examine 
whether an alignment of the aforementione d directives to the new framework set by 
the NLF Decision would be beneficial for the sectors concerned and preferable to 
waiting for a full review of these directiv es. The objective of th e horizontal review, 
which resulted in the adoption of the NLF, was to address problems perceived 
globally throughout the various sectors - including those of the ten directives 
discussed in this document - and to provide solutions that can work across all sectors. 
In that context a number of possible soluti ons and their impacts have already been 
analysed17. To avoid unnecessary duplications, this report will draw to a large extent 
on the impact assessment carried out on the revision of the horizontal framework. This impact assessment will revisit the pr oblems already analysed in the impact 
assessment for the NLF with a more sector-s pecific focus. In vi ew of the political 
commitment laid down in Article 2 of the NLF Decision
18 to use the solutions 
offered by the Decision as consistently as possible, the number of options will be limited to different ways to give effect to the NLF Decision. Consequently the 
analysis of the impacts will also focus on th e impacts resulting from the measures set 
out by the NLF Decision and examine whether they are suitable solutions for the sectors concerned, and have a positive impact. 
This specific context also explains w hy the analysis will exclusively focus on 
horizontal elements of the directives  and their possible alignment to the NLF 
Decision. No other changes in terms of cont ent will be made to the Directives. This 
means that reflections on purely sector-sp ecific aspects like th e products covered by 
the directives, the adequacy of the essent ial health and safety requirements or the 
choice of the applicable conformity asse ssment procedures will be left aside.  
2.5. Description of directives and sectors 
This section provides a summary of the ten directives and the key data characterising 
the sectors concerned by this initiative. A more detailed description is contained in 
sections 10.1 to 10.8 in Annex 2. 
2.5.1.  Objective and content of the directives 
Most of the directives aim to ensure a high level of safety of the products they cover. 
The directive on electromagnetic compatibility protects against electromagnetic disturbance and the metrology directives gu arantee the accuracy  of measurements 
performed by measuring instruments. In ad dition, all the direct ives simultaneously 
ensure the free movement of the prod ucts they cover th roughout the EU.  
                                                
 
17 See SEC 2007(173) 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf  
18 See footnote 14 
 
EN 10   EN The directives are all so-called New Appro ach directives, using the same legislative 
technique19 to achieve their policy objectives. They contain essential (health and 
safety) requirements20 which the products must meet in order to be placed on the EU 
market. They also set out the procedures  that manufacturers must carry out to 
demonstrate that their products fulfil t hose requirements (conformity assessment 
procedures). Eight of the ten directives require the intervention of an independent 
third party, the notified body21 in that procedure. As a visible sign that the products 
comply with the essential requirements, the CE marking must be affixed to them. The directives also contain a safeguard cl ause, whereby Member States must inform 
the Commission of any restrictive measure that they take ag ainst non-compliant 
products which present a risk. The Commission then has to deliver an opinion as to 
whether the measure is justified. 
Some provisions are specific to the sect ors and products covered by the directive 
(scope, sector-specific definitions, essential requirements, choice of applicable conformity assessment procedures and sp ecificities of pro cedure). Others are 
common to all directives (horizontal) and ar e basically the same (general definitions, 
manufacturers’ obligations, basic conformity assessment procedures, requirement for 
notified bodies, CE marking, safeguard clau se). However, certain – unnecessary – 
discrepancies have gradually made their way into the directives. See chapter 3.3.
                                                
 
19 The legislative technique of the New Approach is explained in detail in sections 1.2 and 1.3 of the 
impact assessment on the NLF. 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf  
20 The terminology varies from direc tive to directive, some use “essential safety requirements”, others 
“essential requirements” and the Low Voltage Di rective uses the term “safety objectives”. 
21 Notified bodies are conformity assessment bodies testing, inspecting and certifying a product. They are 
notified to the Commission by the Member St ates in which they are established. 
 
EN 11   EN 2.5.2.  Key data of sectors concerned 
Table 1: Key data of sectors concerned 
 Products Size of the 
industry 
(market 
output) Trade balance  
(share of imports) Industry structure, SME 
presence Number 
of NB in 
the EU22 
Electro-technical 
sector (Low 
Voltage Directive (LVD) and electro magnetic compatibility 
directive (EMC)) Electric welding and soldering 
tools, electric domestic appliances, 
computers and other information 
processing equipment, electric 
motors, generators and 
transformers. electricity 
distribution and control apparatus, 
insulated wire and cable (LVD 
only), lighting equipment and 
electric lamps (LVD only), other 
electrical equipment, electronic 
valves and tubes and other 
electronic components (LVD only), 
television and radio receivers, 
sound or video recording or video 
recording or reproducing 
apparatus and associated goods. € 235.59 
billion 
(equipment 
covered by 
LVD) 
€ 200.12 
billion 
(equipment 
covered by 
EMC) Negative trade balance:  
LVD: € 103.93 billion of 
imports and € 83.09 billion of 
exports. The internal 
consumption is estimated at € 
256.42 billion. 
EMC: € 100.78 billion of 
imports and € 76.07 billion of 
exports. The internal 
consumption is estimated at € 
224.83 billion 
Most imports come from 
China, followed at a 
considerable distance by the 
USA, Japan and South Korea. The structure of the industry is 
characterised by a few large 
corporations producing a wide 
range of electrical equipment, 
and many small companies 
specialised in niche markets. 
 148 
(LVD) 
131 
(EMC) 
ATEX Mechanical, electrical and 
telecommunication equipment, 
protective systems and devices, to € 2.2 billion Positive trade balance: Imports 
amount to € 400 million. 
Internal consumption estimated The ATEX sector is 
characterised by a large number 
of SME and micro enterprises, 55 
                                                 
22 NANDO database on 3 January 2011 http://ec.europa.eu/enterprise/newapproach/nando/  
 
EN 12   EN be used in potentially explosive 
atmospheres (in underground 
mines, petrochemical plants, oil 
refineries, filling stations and other 
places where flammable gases may 
be present, and also premises like 
flour mills and agricultural 
warehouses where airborne dust 
can present an hazard): mechanical 
gears, brakes and seals; gas and 
steam turbines; electrical motors, 
pumps, fans; electrical tools and 
instrumentation; fork lift trucks; 
filter units and vented silo bins; 
switches, control and detection 
systems and components; torches; 
plugs and sockets outlets; heating 
cables; computers, phones and 
other similar equipment; vent 
panels; enclosures; sparks 
arrestors; temperature protective 
devices; etc. at € 1.9 billion, 86% of internal 
production. 
 around 90%, mainly based in 
France, Germany, Italy and the 
United Kingdom, but also with 
significant presences and market 
shares in Denmark, the 
Netherlands, Norway, Poland, 
Spain, Sweden as well as in 
Switzerland. 
Pressure 
Equipment (incl 
simple pressure vessels) Pressure vessels, piping, boilers, 
steam generator, safety accessories 
and pressure accessories, etc… No data 
available (see 
Annex 10.2) Manufacturing of pressure 
equipment is gradually shifting 
to low cost countries. A substantial number of SME is 
involved in production 23723 
95 
(simple 
pressure 
vessels) 
NAWI Non-automatic weighing 
instruments, i.e. measuring € 2.5 billion Not available Small companies (< 50 
employees) clearly dominate 270 
                                                 
23 This figure includes recognised third party organisations and user inspectorates. 
 
EN 13   EN instruments serving to determine 
the mass of a body and requiring 
the intervention of an operator 
during weighing with 60%. 35% are medium 
sized enterprises with 50-250 
employees and 4% are large 
companies with more than 250 
employees-  
Measuring 
Instruments Water meters, gas meters, 
electricity meters, heat meters, 
meters for liquids other than water, 
weighing machines, taximeters, 
material measures to measure 
length, dimensional measuring 
instruments and exhaust gas 
analysers. € 3.25 billion Around 20-25% of measuring 
instruments in the EU27 are 
imported There are around 900 
manufacturers active in the 10 
sectors covered by the MID not 
including the large number of 
SMEs operating as distributors, 
importers or providers of repair 
services. 140 
Lifts Lifts permanently serving buildings 
and constructions intended for the 
transport of persons, persons and 
goods or goods alone if the car is 
accessible as well as safety 
components for use in such lifts € 3.17 billion Very positive trade balance: € 
36 million of imports and € 693 
million of exports. 
Internal consumption: € 2.51 
billion The structure of the industry is 
characterised by four 
multinational lifts companies 
and many small companies 
specialised. designing and 
installing new lifts and 
producing safety components for 
this lifts 192 
Civil Explosives  Explosive substances and articles 
which are not used by the armed 
forces or the police, but 
commercially. The main end-users 
of civil explosives are the mining 
industry, the quarrying industry, 
and the construction and civil 
engineering industry (primarily for 
demolition, land clearance and 
tunnelling) € 1.35 billion. Trade with third countries is 
limited. Imports play a 
significant role only in niche 
markets like explosives used for 
offshore drilling operations. 
Important trading partners are 
Norway, Switzerland and the 
USA. Importers in the EU are 
generally large companies with 
specific demands, for example 20 manufacturers of explosives 
and approximately 500 
distributors are active in the EU. 
At manufacturers’ level, there 
are no SME: Around 4 000 
people are directly employed by 
these companies. Nearly all of 
the distributors, on the other 
hand, are SME employing 
around 5 000 people. Thus, a 13 
 
EN 14   EN in the oil drilling industry. total of 9 000 people are 
employed by the civil explosives 
industry. 
Pyrotechnic 
articles Fireworks, theatrical pyrotechnic 
articles, pyrotechnic articles for 
technical purposes and automotive 
pyrotechnic articles (automotive 
restraint systems, i.e. most 
importantly gas generators used in 
airbags and seatbelt tensioners). € 1.4 billion 
(fireworks) 
€ 2.8 billion 
(automotive) 95% of all consumer fireworks 
are manufactured overseas. Fireworks industry: mainly 
SME; altogether employing in 
total an estimated 15 000 to 20 
000 people. 
Automotive pyrotechnic articles: 
big international automotive 
supplier companies, around 40 
000 employees. 10 
3. PROBLEM DESCRIPTION   
The consultations have identified three main problems with rega rd to the functioning of the cu rrent legislation: (1) non-compli ance of 
significant number of products that reach the market, (2) unsatis factory performance of certain Notified bodies and (3) complex ity of the 
current legislation. Those have been analysed in a more horizont al context in the impact assessment for the New Legislative Fra mework. The 
problem tree below illustrates the drivers and the consequences of the abovementioned problems, which are discussed in more det ail further in 
this chapter.  
 
EN 15   EN 
 
 
EN 16   EN 3.1. Products which do not comply with the requirements 
3.1.1.  The problem that requires action and its underlying drivers 
The directives concerned by this initiative have set up strict requirements which 
ensure that products are designed and manuf actured in such a way that they do not 
pose a risk to the health and safety of c onsumers or other users, that they produce 
accurate measuring results (measuring inst ruments) or that they do not cause 
electromagnetic disturbances (electromagnetic compatibility directive). These requirements apply to all products placed  on the EU market, i.e. to products 
manufactured inside the EU as we ll as products imported into the EU. 
Nevertheless not all produc ts on the market comply with these requirements. Non-
compliance can take different forms ranging from simple formal non-compliance to substantial non-compliance with essential he alth and safety requirements. Examples 
of non-compliance with formal requireme nts are missing documents, missing or 
wrongly affixed markings or missing labe lling as well as non-compliance with 
procedural requirements (e.g. applicatio n of wrong conformity assessment 
procedure) while the product itself neve rtheless complies with the requirements 
relating to its design and pr oduction. Substantial non-complia nce means that there is 
a deficiency in the design or constructi on of the product itself.  The product does not 
attain the performance level laid down in the relevant essential requirement.  
If the product fails to meet an essential health and safety requirement it can be 
potentially dangerous for its users. The ri sks relating to substantial non-compliance 
vary in accordance with th e nature of the product.  
Defective electronic products can present a ri sk of electric shock or burns. Defective 
fireworks, e.g. fireworks which ignite premat urely, can lead to ear damage caused by 
excessive sound levels, severe burns and eye injuries, and in some cases even death. 
Non-compliance of equipment used in poten tially explosive atmos pheres or pressure 
can have even catastrophic effects. Conse quences of this kind of explosion include 
severe or deadly injuries to persons, seri ous damage to instal lations and surrounding 
civil and industrial infrastructures. Non compliance of measuring instruments can 
lead to wrong measuring results which can cause economic damage for end-users 
(e.g. electricity or water meters). Further details on the risks a ssociated with the 
products covered by the directives are pr ovided in Annex 2 (see detailed sector 
descriptions in section 10). 
According to available data the number of  accidents is however relatively low in 
relation to the number of products on the market. On a genera l note it has to be 
mentioned that it is often difficult to determine on the basis of the information available whether accidents are due to th e malfunctioning of a product or to misuse 
by the user. There is no Europe-wide data base on accidents involving products and 
knowledge depends on national statistics, info rmation collected from hospitals etc; 
Apart from posing risks to users, non-comp liance (both formal and substantial) has 
important economic consequences: It lead s to unfair competition. Operators not 
adhering to the rules can make signifi cant savings on compliance costs by, for 
 
EN 17   EN example, avoiding costly conformity assessment procedures. They can consequently 
offer their products at lower prices than  their competitors who respect the law.24 In 
sectors where there is tough compe tition from imported low-price products, 
European industry is disadvantaged. The situation “punishes” the law-abiding 
manufacturer, as compliance becomes a “competitive disadvantage”. 87% of economic operators responding to the public consultation consider that they suffer 
from unfair competition due to this situa tion. Economic operators have also provided 
estimates of the size of their losses in terms of their annual turnover, reproduced 
below: 
Figure 1: Perceived losses in % of annual turnover 
0%2%4%6%8%10%12%14%16%18%20%
% Respondents
considering that their
sector is affected by non
compliance (90)     % of total number of
respondents (98)      0 - 5% of the turnover
 6 - 10% of the turnover
 11 - 15% of the turnover
 16 - 20% of the turnover
 21 - 30% of the turnover
Greater than 30% of the turnover
Unable to provide indicative
estimates
 
Since much non-compliance often passes unnoticed, the share of non-compliant 
products on the market cannot be  quantified. It is also impossible to provide a solid 
estimate, in particular as regards heteroge neous sectors like el ectrical equipment, 
pressure equipment or measuring instrument s. Data availability also varies from 
sector to sector.25 The figures reported hereafter illustrate the problem, but they do 
not allow conclusions to be drawn on th e actual share of non-compliant products on 
the market per sector.  
                                                 
24 Quote from reply obtained in the 2006 public consultation on the NLF: “Expert estimations say that 
fulfilling the safety and administrative provisions required by our regulations can add up to a fifth of 
total manufacturing costs. In the absence of effi cient enforcement mechan isms some manufacturers 
might be tempted to "take the easy way" and to market non-compliant products.” 
25 Data availability depends to an important extent on the level of activity of market surveillance 
authorities. Market surveillance is carried out on a risk based approach and hence focuses on sensitive 
product categories (e.g. consumer products). In some sectors industry associations are very active in 
that area and sometimes even carry out their own inve stigations. This explains why in certain sectors 
there is more information available than in others. 
 
EN 18   EN The problem of non-compliance is generally perceived in all se ctors concerned. 92% 
of economic operators reacting to the public consultation consider that their sector is affected by non compliance. General findi ngs across all sector s are that many non-
compliant products are imported
26 and that many non-co mpliant products are 
counterfeit. 
Most data on non-compliance is available in th e electro-technical sect or. It is also the 
sector in which stakeholders and in partic ular industry associations have been most 
active in pointing to the problem.27 The LVD market surveillance authorities have 
undertaken three cross border act ions, on portable household lights28, cord extension 
sets29 and Christmas lighting30. Only 5% of the household lights tested showed no 
shortcomings (either administrative or technical). Whilst not causing immediate 
danger to consumers, the shortcomings we re considered serious  enough to require 
remedies. Only one in six cord extension sets fully complied with the requirements. 
58% of the cord extension sets tested were considered sufficiently unsafe by the authorities to justify a sales ban. Similar findings were obtained in three market 
surveillance campaigns carried out by th e EMC Administrative Cooperation group 
(ADCO) recently, which focused on Energy Saving Lamps
31, Power Tools32 and 
Consumer Entertainment Electronic Products33. The results of these campaigns 
showed that the level of technical n on-compliance was 23% for the Energy Saving 
Lamps, 20% for the Power Tools and 50% for the Consumer Entertainment Electronic Products. Further general conclusions drawn from the campaigns were 
that the share of non-complia nt imported products was ge nerally higher than the 
share of non-compliant products origina ting from EU countries, and that for a 
considerable part of non-compliant products  the origin could not be determined. 
In other sectors, in particular for produc ts for professional use, information on cases 
of non-compliance is based on feedback from  stakeholders and au thorities, reports 
from ADCO groups and notified body groups.
34 It appears that the problem is less 
felt in specialised sectors like ATEX or ci vil explosives sector, although a few cases 
of non-compliance have been reported. 
                                                 
26 This is also confirmed by th e number of RAPEX notifications. 73% of all notifications in 2009 
concerned imported products, as opposed to 20% of products originating from EU Member States. See 
“Keeping European Consumers Safe”,  2009 Annual Report on the operation of RAPEX, p.21 available 
at http://ec.europa.eu/consumers/safety/rapex/docs/2009_rapex_report_en.pdf. 
27 See e.g. ORGALIME position paper Call for an ef fective pan-European market surveillance system 
http://www.orgalime.org/Pdf/PP_Orgalime-ANE C_on%20market%20surveillance_apr09.pdf  
28 See 
http://europa.eu/rapid/pressReleasesAction.do?ref erence=IP/08/615&format=HTML&aged=0&languag
e=EN  
29 See http://ec.europa.eu/enterprise /sectors/electrical/files/lvd-adco/20 080903_lvd_adco_-_final_report_-
_extension_leads_-_2007_project_en.pdf 
30 See http://ec.europa.eu/enterpri se/sectors/electrical/files/lv/report_luminaires_en.pdf  
31 See Report on campaign concerning Energy Saving Lamps available at 
http://ec.europa.eu/enterprise /sectors/electrical/files/emc/ ms-campaign-first_en.pdf 
32 See Report on campaign concerning power tools 
http://ec.europa.eu/enterprise /sectors/electrical/files/emc/ ms-campaign-second_en.pdf 
33 Report on campaign concerning Consumer Entertainment Products available at 
http://ec.europa.eu/enterpri se/sectors/electrical/files/emc/ms-campaign-third_en.pdf  
34 Products for professional users (ATEX products, civil explosives and the majority of pressure 
equipment) as well as measuring instruments and lifts have only started being recorded in RAPEX since 
1 January 2010. 
 
EN 19   EN Table 2: Percentage of respondents to the public consulta tion considering th at their sector is affected by 
non-compliance 
  Electro-
technical ATEX Civil 
explosives Pyrotechnic 
articles Lifts Measuring 
instruments Pressure 
equipment Total
 
Economic 
Operators 96% 75% - 0% 
(100% don’t 
know)  88% 94% 83% 92% 
Authorities 86% 64% 0% 
(50% don’t 
know or 
No) 78% 55% 52% 80% 66% 
Notified B 94% 44% 25% 50% 
(50% don’t 
know)  44% 
(55% 
No) 31% 
(40% don’t 
know)  65% 60% 
Users 100%  25%  
(75% 
don’t 
know)  - 0%  
(50% don’t 
know or No) 100%  67% 82% 64% 
SMEs 53% 44% 12,5%  0% 
(50% don’t 
know or No)  35% 
(40% 
No) 41% 49% 48% 
A major reason for the considerable number of non compliant products on the market 
is that market surveillance does not operate  effectively in the European Union. There 
is a widely shared percepti on amongst stakeholders that market surveillance is not 
sufficiently active and rigorous . This view corresponds to the findings of the studies 
concerning the measuring instruments directive and the lifts directive: 
“For measuring instruments under Directiv e 2004/22/EC, the poor quality of market 
surveillance is one of the im portant concerns of industry and it is an area where most 
authorities recognise that thei r effort until recently has be en partial. Most authorities 
concentrate on checking whether the CE+M mark is properly affixed and that the 
necessary paperwork is conducted while in some countries even these typical tests 
are not properly conducted on a periodical ba sis. Only in few c ountries have there 
been actual tests of the conformity of th e products placed in the market usually on 
the basis of annual surveillance program mes focusing on specific categories of 
measuring instruments. The absence of pr oper surveillance appears to be the main 
reason for almost all occasions of unfair competition reported.” 35  
The study “Evaluation of the Applicati on of the Lift Directive (95/16/EC)”36 
concluded that market surveillance in the lifts sector was often limited to reactive 
                                                 
35 See CSES evaluation, p. 47 http://ec.europa.eu/enterprise/sectors /legal-metrology-and-prepack/public-
consultation/public-consultation-files/evaluation_report_by_cses_en.pdf  
36 See footnote 2. 
 
EN 20   EN surveillance, and many stakeholders were uninformed and even unaware of market 
surveillance activities in their countri es. It was recommended that market 
surveillance be improved.  
The organisational and structural reasons for the deficiencies in market surveillance 
were highlighted in section 2.2.1 of th e impact assessment on the NLF. The 
ineffectiveness of market surveillance is however also rooted in certain practical 
obstacles.  
One major difficulty for the au thorities is the la ck of traceability of non-compliant 
products and the operators who have supplie d them, in particular when the products 
originate in third countries.  When authorities have doubts about the conformity of a 
product they need specific information allowi ng them to evaluate its compliance with 
the legislation. This information is usually  in the hands of the manufacturer. While 
most of the directives require that th e name of the manufacturer appear on the 
product, it often proves difficult to identify and contact manufacturers based in third 
countries (delays in time, no contact deta ils, no voluntary cooperation, competence 
of authorities limited to the EU, etc)37 In many instances the origin of the product 
cannot be identified at all. For these reasons , the authorities need to be able to get 
back to the person who placed the product on the EU market, i.e. the importer. 
However there is currently no obligation to identify the importer on a product. There is also no requirement which would al low the authorities to track a product 
throughout the distribution chain, identify the actors involved and stop further 
supplies of potentially dangerous products.
38 Only for civil explosives has a 
particular traceability regime been set up by Commission Directive 2008/4339, 
ensuring the traceability of ev ery individual product. It will become applicable on 5 
April 2012. 
A further reason for the presence of non-co mpliant products on th e market is that 
operators further down the supply and di stribution chain, namely importers and 
distributors are not carrying out the necessa ry checks to ensure that they are not 
supplying non-compliant products. They rely on the fact that it is the task of the 
manufacturer to ensure the compliance of  the product and do not check whether the 
latter has actually carried out this task prope rly. Some of them are also not aware of 
the applicable legislation and, as regards im porters, fail to verify whether a product is 
actually intended to be sold on the EU  market. The directives only contain 
obligations for the manufacturers but do not  address the other economic operators. 40 
                                                 
37 A foreign manufacturer has the possibility to establish an authorised representative in the EU who inter 
alia acts as the contact point with EU authorities. Th is is however not obligatory. In practice mainly big 
companies with well known brand names have appointed an authorised representative. 
38 The problem of traceability and the high share of imported products was one of the main conclusions 
drawn from the market surveillance campaign s carried out by the LVD and EMC ADCOs. See 
footnotes 28 and 30.  
39 See http://ec.europa.eu/enterprise/sect ors/chemicals/documents/specific-
chemicals/explosives/index_en.htm  
40 The pyrotechnic articles directive is an exception, as it contains certain obligations for importers and 
distributors. . As regards consumer products the General Product Safety Directive has imposed a number of general obligations which also apply to consumer products covered by the directives in 
question. Furthermore the Blue Guide contains a section that gives some general guidance to importers 
and distributors which can be seen  as best practice recommendations. 
 
EN 21   EN The absence of specific obligations for importers and distributors hampers the 
efficiency of market surveillance actions, in particular as regards imported products. 
The competence of market surveillance authorit ies is limited to the territories of the 
EU Member States. If a manu facturer established outside  the EU does not cooperate 
with the European authorities by e.g. providing the necessary documentation or taking corrective action, the authorities have no legal means to enforce these measures upon the foreign manufacturer dire ctly. In such a case they can only take 
effective action against the non-compliant products by addressing the importer or the 
distributor of these products. 
Apart from that the absence of EU wide ob ligations for importers and distributors has 
led to Member States imposing differing ob ligations on importers and distributors in 
their national laws. This contributes to mark et surveillance authorities in different 
Member States having different approach es to cases of non-compliance.Measures 
taken against the product concerned (withdraw al, marketing ban, etc..) have different 
levels of severity, and different measures in relation to demonstrating compliance are 
requested from importers and distributors. One example is the approach towards product information (declaration of conformity, safety info rmation, user instructions, 
etc). First, not all of these documents are required by all directives and second, it is 
not always specified in the legislation which language ha s to be used. There have 
been a number of cases where national market surveillance authorities have 
requested translations into their na tional language. Economic operators and 
authorities reacting to the public consultation have  confirmed the existence of 
different practices (see section 12.1.1 in Annex 4). Sometimes non-compliant 
products are withdrawn in one Member State but still circ ulate in the territory of 
another Member State. In principle the safe guard clause procedures provided for in 
all directives should avoid such differences in treatm ent. These procedures do 
however not work effectively
41.  
To some extent the problem of non-complia nce is also due to the fact that some 
notified bodies do not carry out proper conformity assessment. This is outlined in more detail as a separate problem in section 3.2.
42 
3.1.2.  Who is affected and to what extent 
Final users of the products: consumers, workers and professional users 
– Risk of accidents and injury from pro ducts not meeting safety requirements 
– Economic damage from non-performing products and the need to replace 
defective goods 
                                                 
41 For more details see section 2.24 of  the impact assessment on the NLF. 
42 For the sake of completeness it is also mentioned th at certain weaknesses in the standardisation process 
sometimes lead to insufficient standards and consequently to non-compliant products As the 
standardisation system is currently undergoing a review which inter alia takes account of these weaknesses the issue is not further examined in this context. See 
http://ec.europa.eu/enterprise/policies/euro pean-standards/standardisation-policy/policy-
review/index_en.htm  
 
EN 22   EN Manufacturers, importers and distributors who abide to the law 
– Losses in turnover and market share due to unfair competition from competitors 
not complying with the rules 
– Different approaches by market surveillance authorities  
National market surveillance authorities 
– Inefficiencies, ineffective testing and i nvestigation costs if  operator cannot be 
found  
SME 
The results of the SME consultation show th at non-compliance is also a problem for 
SME, although the number of SME considering themselves affected is lower than the 
number of respondents to the public consulta tion considering themselves affected by 
the problem. 54% of SME indicated that they suffer from unfair competition due to non-compliance (compared to 87% of econo mic operators reacting to the public 
consultation).  
With regard to the economic damage suffered from this unfair competition, most 
SME (22%) could not give an estimate. 11% considered that their losses range 
between 6 to 10% of their annual turnover, 10% put their losses between 0 to 5% of 
their turnover as regards the product cat egory most concerned by non compliance. 
3.1.3.  Predicted evolution of the problem 
The NLF Regulation, which became applic able on 1 January 2010, should lead to a 
certain improvement of the current situat ion. It strengthened the obligations of 
Member States on market surveillance and provides for reinforced cooperation and information exchange on non compliant products. It also requires controls of imported products. Market surveillance shou ld hence become more effective and 
more visible and deter those operators w ho have been encouraged by a perceived 
absence of market surveillan ce activities to cheat the system. However, even under 
the best functioning market surveillance system, authorities can only control a 
relatively limited amount of products on th e market. Certain operators will still try 
their luck, given the economic savings they can achieve.  
Regarding the lack of traceability, the situ ation will improve in the civil explosive 
sector due to introduction of the trac eability regime of Commission Directive 
2008/43
43. In the other sectors the situation will remain the same. The NLF 
Regulation will also not improve the situation or the issue of unclear, missing or differing obligations for importers and dist ributors. Furthermore, although the NLF 
Regulation obliges market surveillance authorities to take restrictive action against non-compliant products and to inform the ma rket surveillance authorities of other 
Member States about this action, it does not oblige them to take a uniform approach 
towards non-compliant products found.  
                                                
 
43 See http://ec.europa.eu/enterprise/sect ors/chemicals/documents/specific-
chemicals/explosives/index_en.htm  
 
EN 23   EN Currently the Commission is carrying out  an information campaign on the CE 
marking which is specifically  targeted at professionals.44 It aims to improve the 
knowledge of importers and dist ributors in particular about  the system behind the CE 
marking and their respectiv e obligations. The campaign might lead to increased 
awareness among a certain number of economi c operators who will subsequently pay 
more attention to checking the conformity  of products which they are supplying. 
However it must be taken into the c onsideration that the campaign will most 
probably not reach all importers and distributors. Moreover, the campaign will not change the behaviour of economic operators  who are consciously disregarding the 
rules behind the CE marking. 
While the NLF Regulation and the CE mark ing campaign might lead to a certain 
improvement of the current situation, at the same time certain trends suggest a 
worsening of the problem. The continuous delocalisation of production towards third 
countries which is currently observed in ma ny of the sectors concerned will make the 
tasks of market surveillance authorities mo re complex and difficult. This is also 
underpinned by the fact that the share of  RAPEX notifications concerning imported 
products has been consis tently growing since 2004.
45 The problems that market 
surveillance authorities are encountering with imported non-co mpliant products will 
therefore be likely to increase. Consequently  they will need to rely increasingly on 
the information provided by importers and dist ributors. The lack of traceability in the 
supply and distribution chain will then  become an even bigger problem. One 
exception is the civil explosives sector, wher e the new traceability regime applicable 
from April 2012 should lead to a significan t improvement of the current situation. 
3.2. Low quality of services delivered  by certain Notified Bodies 
3.2.1.  The problem that requires action 
Eight of the ten directives  concerned require the cert ification of products by 
“notified bodies”46 before they can be placed on the market.47 Notified bodies hence 
play an important role in guaranteeing the safety of products on the market. 
Therefore, they must have the necessary competence and capacity to carry out their 
tasks correctly. Most notif ied bodies work in a thor ough and responsible manner. 
However there have been problems with the quality of services delivered by some of them.
48 In the lifts sector for example, five complaints were introduced against 
notified bodies between 2009 and 2010. Some  cases of incorrect issuing of 
certificates (e.g. for Category 3 equipment), l eading to some market distortions, have 
                                                 
44 For more information see http://ec.europa.eu/enterprise/po licies/single-market-goods/cemarking/  
45 See Annual reports on the operation of RAPEX, available at 
http://ec.europa.eu/consumers/safety/rapex/stats_reports_en.htm#annual .  
46 These bodies are conformity assessment bodies, which test, inspect and certify products. They are 
called “notified bodies”, because they are notif ied by the Member States to the Commission. 
47 In the electro-technical sector the role of notified bodies is differe nt. Under the Low Voltage Directive 
notified bodies are not involved in the conformity assessment, but only get involved if there is a 
challenge to the conformity of products. Under EMC Directive recourse to notified bodies in the 
conformity assessment procedure is voluntary and the purpose of the Body is to help the manufacturer 
by reviewing the technical documentation for apparatus.  
48 68% of the notified bodies reacting to the public co nsultation confirmed that th ey are aware of problems 
with the quality of services provided in their sect or. This assessment was shared by a high number of 
economic operators using notified bodies (84%) and by the majority of public authorities (53%). 
 
EN 24   EN been recorded by some Member States  and the ATEX Notif ied Bodies Group 
(ExNBG). The ADCO group on pressure equi pment has also raised a number of 
concerns relating to the work  of certain notified bodies, in particular as regards 
activities carried out by subs idiaries or subcontractors based in third countries. 
68% of notified bodies replying to the pub lic consultation stat ed that there are 
problems with the quality of services of notified bodies. This view was shared by 
84% of economic operators which use the services of notified bodies and 53% of 
public authorities. 
There are basically two reasons behind the poor quality of work delivered by certain 
notified bodies: Some do not have th e necessary competence to carry out 
assessments properly. This problem has in pa rticular been observe d with subsidiaries 
or subcontractors of European notified bodi es located outside the EU. Others are 
laxer in their assessment or in the application of procedures which allows them to issue their certificates at significantly lo wer rates. For example, the elimination or 
reduction of on site controls or relaxed re quirements as to the frequency of periodic 
audits/inspections can reduce the costs of assessments quite considerably.
49  
The study on the measuring instruments direct ive also identified concerns about the 
operation of notified bodies in the asse ssment of conformity and the overall 
certification procedure.  On the one hand, important parts of the industry and the 
national authorities claim that notified bodi es tend to use guidance documents as if 
they are regulations providing the only possible means of establishing conformity. 
Industry representatives referred to occas ions when alternative approaches were 
rejected or considered unfavourably. This is seen as having a negative effect on the 
development of technological innovation a lthough only a few specific examples were 
provided. On the other hand, notified bodies appear rather inc onsistent in their 
operation with important variations in their capacity to carry out the necessary tests, 
especially those in the new Member States. Th ey are also inconsistent in terms of the 
content of certificates issued and the use of evaluation certificates.50 
Improper conformity assessment not only creates a risk of unsafe products reaching 
the market, but also distorts competi tion within the manufacturing industry and 
among notified bodies. Less rigorous assessm ent of product conformity means that 
the manufacturer can make savings on comp liance and certification costs. Notified 
bodies performing diligent assessments fre quently lose projects or clients to 
competitors taking less stringent approaches and/or offering their services at lower prices due to unfair practices.  
3.2.2.  Underlying drivers 
The competence and performance of notified bo dies is assessed by the Member State 
which notified them. The approach, rigour  and regularity of such assessments 
however differs from one Member State to  another. The directives set out basic 
criteria which bodies must meet in order to  be notified (e.g. impartiality, technical 
know-how, objectivity etc). Some Member States apply these criteria more 
                                                
 
49 For a more detailed analysis of this problem see Chapter 2.1.1 of the impact assessment on the NLF 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf  page 13 
50 CSES evaluation , p48 
 
EN 25   EN stringently than others whic h results in an uneven play ing field for notified bodies. 
Some base their assessments on the relevant standards51 in that area, while others do 
not. Some Member States organise de signation, assessment and monitoring of 
notified bodies directly through their publ ic administration, others use national 
accreditation52. Chapter 2.1.2 of the NLF impact assessment provides details of the 
divergent approaches of Member States.53 
Notified bodies responding to the public consultation confirmed that there are 
marked differences in the assessmen t and monitoring of notified bodies. 
Figure 2: Differences in the assessment and monitoring of notified bodies 
0%10%20%30%40%50%60%70%
% Total number of respondents (76)     NA in different EU countries do
not impose the same
requirements on NB
NA in different EU countries do
not have the same capacity
(resources and/or skills) to verify that NB requirements are
fulfilled before notification
NA in different EU countries donot put the same efforts in
monitoring performance of NBafter notification
Other (please specify)
 
Due to these differences, the way in which the competence of notified bodies has 
been assessed and how they are monitored is  not transparent. The lifts sector is a 
good example of deficiencies in this contex t. In certain Member  States a strikingly 
high number of notified bodies54 does not correspond to the reality of the market in 
                                                 
51 The application of the standards is voluntary. Where they are us ed, they give a presumption of 
conformity with the requirements laid down in the dir ectives. It has to be noted here that only the more 
recent directives like the measuring instruments directive or the direc tive on pyrotechnic articles contain 
a set of requirements for notified bodies which correspo nds to the state of the art.  In the older directives 
the requirements are often rudimentary. The standards therefore go beyond what is strictly required by 
the directives. 
52 Accreditation is a formal system which provides an independent and authoritative attestation of the 
competence, impartiality and integrity of conformity assessment bodies, thereby supporting the value 
and credibility of the work done and certificates issued. 
53 SEC 2007(173) 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf  page 15 
54 The number of notified bodies and their orig in are available in the NANDO database : 
http://ec.europa.eu/enterprise/newapproach/nando/in dex.cfm?fuseaction=directive.notifiedbody&dir_id
=16&type_dir=NO%20CPD&pro_id=99999&prc_id=99999&ann_id=99999&prc_anx=99999  
 
EN 26   EN conformity assessment services in that sector. It can be assumed that many of these 
bodies do not actually perf orm any conformity assessme nt activity under the lifts 
directive and therefore do not have th e necessary competence to be notified.55 
The situation is particularly problematic with regard to subsidiaries or subcontractors 
located outside the EU which carry out conf ormity assessment activities on behalf of 
a European notified body, as it is totally unc lear how the competence of such bodies 
has been assessed.56  
Apart from divergences in the assessmen t and monitoring of notified bodies, the 
different quality of conformity assessments is also due to insufficient coordination. 
In principle notified bodies should coordi nate their work in the Notified Bodies 
groups set up under the directives. However not all notified bodies follow the work 
of these groups and implement their decisi ons. In the pressure equipment sector for 
instance, only 50 out of the 237 notified bodies participate in the regular meetings of 
the Conformity Assessment Bodies Forum PED/SPVD.57 Some notified bodies never 
participate and do not have any national re presentation. It is questionable whether 
and how these notified bodies keep up to date with the PED Guidance documents 
and the the Conformity Assessment Bodies Forum Recommendations.  
3.2.3.  Who is affected and to what extent 
Consumers or professional users of products :  
– Conformity assessment that is improperly carried out entails the risk that unsafe 
products get to the market. See also chapter 3.1. 
Manufacturing industry :  
– Distortion of competition in the manu facturing industry. Less rigorous 
implementation of the procedures means that certificates can be issued at 
significantly lower rates. Less rigorous assessment of conformity with the legal requirements also allows manufacturers to make savings on compliance costs. 
Notified bodies : 
– Notified bodies performing properly rigorous conform ity assessment services 
suffer from unfair competition. 
– Different treatment due to different a ssessment and monitoring practices applied 
by Member States. 
SME 
                                                
 
55 The issue was also raised in the 2004 study on the application of the lifts directive. It was furthermore 
subject of discussions in the li fts committee and in the Notified Bodies Group for lifts (NB-L). 
56 This problem has been intensely discussed in the pressure equipment ADCO group and was also raised 
in other Working groups or Notified Bodies groups, e.g. in the ATEX sector. 
57 Some Member States make notification conditional on participation in the meetings. For those Member 
States there is a good representation with national mirror groups. 
 
EN 27   EN According to the SME consultation 36% of  SME using Notified Body services are 
aware of problems in that area while 44% are not. The most frequently indicated 
problems were mistakes in assessment, lack  of competence, conflict of interests and 
poor quality of subcontractors. 
3.2.4.  Predicted evolution of the problem 
A certain improvement of the situation can be expected from the NLF Regulation. It 
has introduced EU wide rules on the opera tion of accreditation and a peer evaluation 
system that should lead to an even quality of accreditation activities. It does not render accreditation obligatory; however it obliges Member States which do not use 
accreditation to demonstrate the competen ce of a body to provide the necessary 
evidence that the body has been assessed in an equivalent manner.  
The NLF Regulation should lead to harmoni sation of accreditation practices. Bodies 
which are accredited should he nce have undergone a more or  less similarly rigorous 
assessment of their competence. Conse quently a certain improvement may be 
expected in relation to accredited notified bodies. Regarding notified bodies which are assessed according to different regimes, the problem will largely persist. 
3.3. Complexity of the regulatory environment 
3.3.1.  The problem that requires action and its underlying drivers 
The third problem to be tackled is the complexity and inconsistency of the existing 
regulatory environment for products. Today, products are often regulated by several 
legal instruments with diffe rent objectives (protectio n of health and safety, 
environmental protection, energy efficiency, etc)
58 Manufacturers must comply with 
all of their requirements. Multiple di rectives may apply simultaneously: For 
example, many measuring instruments must also comply with the Electromagnetic 
Compatibility directive. Certain pyrotechnic articles must also comply with the Low 
Voltage Directive or the Electromagnetic Compatibility Directive. Another example concerns lifts which must also to comply with requirements of the Machinery Directive. 
Inconsistencies among the directives create additional costs for enterprises, partly 
due to increased effort spent analysing comp lex legislation, be this  additional staff or 
working hours or the cost of external legal consultants. More important, however, are 
costs resulting from different procedures or different formal requirements, e.g. 
concerning the content of the Declaration of  conformity. They must all be complied 
with and thus lead to additional compliance and conformity assessment costs. 
The ten directives concerned by this initiative are based on the principles of the 
“New Approach” and use common elements like CE marking, conformity assessment procedures, notified bodies, cert ain definitions or safeguard clauses. 
However, the drafting of these common prin ciples varies - sometimes significantly - 
from one directive to another.  
                                                
 
58 Concrete examples have been presented in the impact assessment for the NLF in chapter 2.4.1 
 
EN 28   EN The directives have evolved over time a nd gradually certain inconsistencies have 
crept in. They do not use the same terminology for concepts common to all of them. Procedures for demonstrating conformity al so differ from one directive to another. 
Sometimes definitions or legal provisions  are not sufficiently precise and allow 
divergent interpretations, leading to incomp atibility, legal uncerta inty and confusion.  
Good examples of such inconsistencies are the terms “placing on the market” and 
“manufacturer” which are freque ntly used in all the direc tives concerned. Most of the 
directives do not define these terms. Where they do, the definitions vary, as can be seen in the table below: 
Table 3: Examples of inconsistencies in definitions 
•  “Placing on the market” “Manufacturer” 
Measuring 
instruments ‘Placing on the market’ means 
making available for the first time in 
the Community an instrument 
intended for an end user, whether 
for reward or free of charge ‘Manufacturer’ means a natural 
or legal person responsible for the 
conformity of the measuring 
instrument with this Directive 
with a view to either placing it on 
the market under his own name 
and/or putting it into use for his 
own purposes 
Lifts Placing on the market of the lift shall 
occur when the installer first makes 
the lift available to the user The ‘manufacturer of the safety 
components’ shall mean the 
natural or legal person who takes 
responsibility for the design and 
manufacture of the safety 
components and who affixes the 
CE marking and draws up the 
EC declaration of conformity 
Pyrotechnic articles ‘Placing on the market’ means the 
first making available on the 
Community market of an individual 
product, with a view to its 
distribution and/or use, whether for 
payment or free of charge. 
Fireworks built by a manufacturer 
for his own use and which have been 
approved by a Member State for use 
on its territory are not to be 
considered as having been placed on 
the market. ‘Manufacturer’ means a natural 
or legal person who designs 
and/or manufactures a 
pyrotechnic article, or who causes 
such an article to be designed and 
manufactured, with a view to 
placing it on the market under his 
own name or trademark. 
Civil explosives 'Placing on the market' shall mean 
any first disposal against payment or 
free of charge of explosives covered 
by this Directive with a view to their 
distribution and/or use on the No definition 
 
EN 29   EN Community market 
Inconsistencies are not limited to the use of  certain terms - they also concern entire 
provisions e.g. on the safeguard clause pr ocedure. In the measuring instruments 
directive, the procedure can only be launched if non-comp liance is of a systematic 
nature59, i.e. when it affects a whole series  of products. Under the low voltage 
directive60 and the directive on pyrotechnic articles61 the Commission only issues an 
opinion on the legitimacy of a national m easure when other Member States have 
raised objections against that measure. He nce, different procedural steps must be 
followed, making it more difficult for national authorities to apply them. 
Inconsistencies also affect conformity  assessment procedures. In principle, 
conformity assessment in the directives is based on the set of standardised conformity assessment procedures (“modules”) in Decision 93/465/EC
62. However 
the directives have slightly modified th ese standard procedures. To some extent, 
sector-specific aspects (e.g. te st methods) have been added to tailor the procedure to 
the sector. However, unnecessary differen ces in wording have given rise to 
interpretation questions. 
3.3.2.  Who is affected, how and to what extent? 
• Industry, business – manufacturers, importers and distributors 
– Difficulties in interpreting a nd correctly applying the legislation, additional effort 
in terms of time or additional costs for legal advice 
• National authorities implementing  and enforcing the legislation 
– Difficulties in interpretation, extra work 
• Notified bodies and other co nformity assessment bodies  
– Difficulties in interpretation, in particul ar as regards conformity assessment, 
additional procedural requirements 
SME 
The results of the SME consultation show that  differences in the legislation are also a 
problem for SME: 67% of respondents must apply some of the directives concerned 
by this initiative simultaneously. For 40% this means that they have to apply different conformity assessment procedures and 18% said that this causes significant 
additional burdens for them. 13% consider the extra-burden insi gnificant. Compared 
to the results of the public consultati on (21% significant bur den, 43% some extra 
                                                
 
59 See Article 19 of the Measuring instruments directive http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2004L0022:20091201:en:PDF  
60 See Article 9 of the Low Voltage Directive. http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:374:0010:0019:en:PDF  
61 See Article 16 of the Directive o Pyrotechnic Articles http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:154:0001:0021:en:PDF  
62 Decision 93/465 was the predecessor of Decision  768/2008 and contained a number of elements 
common to the New Approach. See section 1.2 of the impact assessment on the NLF. 
 
EN 30   EN burden) the figures are lower. This c ould be because SME often operate in 
specialised areas and on components and might be less affected than bigger 
manufacturers assembling complex products. 
3.3.3.  Predicted evolution of the problem 
Given that legislation on products is grow ing rather than decr easing to reflect new 
societal concerns (environmental aspects, en ergy efficiency aspects) it is expected 
that the situation will either remain the same or (more probably) worsen.  
3.4. EU right to act 
This initiative concerns th e proper functioning of the in ternal market in goods. EU 
action in this area is based on Article 114 of  the TFEU. The aspects addressed in this 
context are already regulated by the ten di rectives concerned. This legislation does 
however not address the identified pr oblems effectively or, as regards the 
inconsistency problem, is even at the s ource of the problem. National divergent 
national approaches to deal with the problems have led to  a different treatment of 
economic operators. If actions are taken at  national level to a ddress the problems, 
this risks creating obstacles to the free movement of goods ensured by the directives 
concerned. Hence it is more appropri ate to take action at EU level. 
As regards the problem of inconsistencies th roughout the directives, this is a problem 
which can only be solved by the EU legislator. 
 
EN 31   EN 4. OBJECTIVES  
4.1. General policy objectives 
This initiative has 3 main objectives: The fi rst is to ensure that products on the EU 
market are safe and fulfil all the requiremen ts guaranteeing a high level of protection. 
The second is to improve the functioning of the internal market. Thirdly, the initiative aims to simplify the regulatory environment for products.  
4.2. Specific and operational policy objectives 
GENERAL  
SPECIFIC  OPERATIONAL 
Ensure a high 
level of 
protection of public interests, in particular public health 
and safety and 
consumer protection
 Reduce the number of non-
compliant products, in 
particular unsafe products 
Improve market surveillance 
mechanisms and tools 
Ensure the reliability and high 
quality of conformity 
assessment activities carried out 
by notified bodies  Ensure traceability of products 
Ensure controls on product 
conformity throughout the whole 
supply and distribution chain 
Provide market surveillance 
authorities with an effective 
cooperation mechanism to ensure 
a common approach to non 
compliant products 
Specify common criteria for the 
assessment, monitoring and 
control of NB to be applied 
equally throughout the EU  
Ensure the proper 
functioning of 
the internal market in the sectors concerned
 Ensure equal treatment of non-
compliant products throughout 
the EU market and equal 
treatment of economic 
operators in the enforcement 
process 
Ensure equal conditions 
regarding the assessment and 
monitoring of notified bodies  
Ensure consistency of 
conformity assessment services 
carried out by notified bodies  Provide market surveillance 
authorities with an effective 
cooperation mechanism to ensure 
a common approach to non 
compliant products 
Specify common criteria for the 
assessment, monitoring and 
control of NBs to be applied 
equally throughout the EU  
Ensure coordinated approach of 
notified bodies to conformity 
assessment 
Simplify the 
regulatory 
environment  Facilitate interpretation and 
implementation  
Ensure more consistency of 
terminology and procedural 
requirements throughout the 
directives Clarify unclear terms and 
provisions in the directives 
Eliminate unnecessary differences 
in terminology 
 
EN 32   EN 4.3. Consistency with other policies and objectives 
This initiative is in line with the Comm ission’s policy on the Single Market (Single 
Market Act)63 and Better Regulation policy. 
5. OPTIONS  
Due to the specific context of this initiativ e, explained in section 2, this impact 
assessment explores a limited set of op tions. The impact assessment for the NLF 
identified and analysed a number of policy op tions to address the problems set out in 
chapter 3 across various sectors. As a result of this analysis, the NLF Decision was adopted, providing a set of pol icy measures considered to be the most adequate 
cross-sector solutions. Since the objective of  this impact assessment is to ascertain 
whether the directives concerned should make use of these measures, the options examine whether to align them with  the NLF Decision and, if so, how. 
5.1. No policy change 
Option 1 is to leave the existing situati on unchanged. The horizontal elements of the 
directives would not be amended. Alignmen t with the new framework would only be 
contemplated when there was also a need to update sector-specific aspects of the 
directives (which is not envisaged fo r any of the directive concerned).  
5.2. Alignment with the NLF Decision  via non legislative measures 
Option 2 consists of a set of non-regulator y instruments that encourage the voluntary 
application of all or part of the measures in the NLF Decision. Those measures could 
become the content of voluntary agreemen ts which economic operators, national 
authorities and notified bodies agree to appl y. The measures coul d also be presented 
as “best practice” in guidance document s. This could for example be done by 
developing current genera l guidance sections in th e Blue Guide on economic 
operators or on notified bodies . The parties concerned woul d be encouraged to apply 
them. The measures in the NLF Decisi on are explained in detail under option 3. 
In practice, this option would be a “vol untary" alignment to the NLF Decision.  
5.3. Alignment with the NLF Decisi on via legislative measures 
Under Option 3 the directives concerned take on board th e solutions set out in the 
NLF Decision to address problems relating to non-compliance, qua lity of notified 
bodies and inconsistency in the legal fr amework. The measures in the Decision 
designed to resolve these problems are as follows:
64 
Measures intended to address th e problem of non-compliance: 
• Introduction of obligations for importers and distributors:  Both must check 
that products bear the CE marking, are accompanied by the required documents 
                                                 
63 See http://ec.europa.eu/internal_market/strategy/index_en.htm  
64 The description provides a complete list of all the measures foreseen in the Decision. 
 
EN 33   EN and carry the name of the manufactur er and the importer (if relevant). Importers  
must furthermore check that the manuf acturer outside the EU has applied the 
correct conformity assessment procedure and establish a link to the manufacturer 
that allows the technical documentation to be obtained when it is requested by authorities. They must carry out samp le tests on products which they have 
supplied, when this is appropriate in the light of the risks presented by a product to the health and safety of consumers. If necessary, they must also keep a register 
of complaints, non-conforming products and product recalls and keep distributors 
informed about such monitoring (Article s R4 and R5 in Annex 1 of the NLF 
Decision). 
• Additional manufacturer obligations : In addition to the obligations that the 
current legislation already imposes on manufacturers , they must provide 
instructions and safety information in a language easily understood by consumers and end-users. Furthermore, they are subj ect to the same obligations on sample 
testing and product monitoring as importers (Article R3 in Annex 1 of the NLF Decision). 
• Introduction of traceability requirements: New obligations are introduced for all 
economic operators to ensure traceability  of products throughout the whole 
distribution chain. Manufacturers and impor ters must put their name and address 
on the product or, where this is not  possible, on the packaging or an 
accompanying document. Furthermore every economic operator must be able to 
inform the authorities from whom he purchased a product and to whom he 
supplied it. This obligation does not include  sales to end-users (Article R7 in 
Annex 1 of the NLF Decision). 
• Reorganisation of safeguard clause procedure (market surveillance) : The 
safeguard clause procedure has been reorganised and streamlined. The new 
procedure ensures that the relevant enfo rcement authorities are informed about 
dangerous products and that similar action is taken against that product in all 
Member States (Articles R31-33 in  Annex 1 of the NLF Decision). 
Measures intended to ensure  the quality of the work performed by notified bodies:  
• Reinforcement of the notification requirements  for notified bodies: To be 
authorised to carry out conformity a ssessment activities under the directives, 
notified bodies must satisfy certain requirements. These requirements have been 
reinforced and clarified. A ll notified bodies must follow the work of notified body 
coordination groups and apply guidance developed by them. They must have 
procedures in place which take due account of the size of the enterprise and the degree of the complexity of the prodcut assessed. Subcontractor s and subsidiaries, 
which carry out parts of the conformity assessment, must also fulfil the 
notification criteria (Article R17 to R20 in Annex 1 of the NLF Decision).  
• Revised notification process : Member States notifying a body must include 
information on the evaluation of compet ence of that body. Other Member States 
may object to the notification within a certain period. Where competence is 
demonstrated by an accreditation certificat e, a facilitated procedure applies. 
Where Member States have not used  accreditation to evaluate the body’s 
 
EN 34   EN competence, documentary evidence must be provided and the objection period is 
longer (2 months) (Articles R22 and R 23 in Annex 1 of the NLF Decision).  
• Requirements for notifying authorities  (i.e. the national aut horities in charge of 
the assessment, notification and mon itoring of notified bodies): Specific 
requirements and obligations for notifyi ng authorities are introduced (Articles 
R14, R15 in Annex 1 of the NLF Decisi on), according to which they must be 
organised and operated so as to safeguard objectivity, impartiality and competence in carrying out their activity. Notifying authorities must de-notify bodies which no longer meet the notificati on requirements or fail to fulfil their 
obligations (Article R25 in Annex 1 of the NLF Decision). 
• Information and other obligations for notified bodies: Notified bodies must 
inform notifying authorities about refu sals, restrictions, suspensions and 
withdrawals of certificates and other no tified bodies about negative conformity 
assessment results They must perform co nformity assessment in a proportionate 
manner taking due account of the size of an enterprise, the structure of the sector, 
the complexity of the product technology, et c. (Article R28 in Annex 1 of the 
NLF Decision).  
Measures intended to ensure more  consistency among the directives 
• Alignment of  commonly used definitions  and terminology: Definitions of 
common terms like “manufacturer”, “importe r”, “placing on the market” set out in 
Article R2 of the NLF D ecision are introduced into the directives concerned. 
Existing conflicting definitions are removed. 
• Alignment of the texts and certain elements of the conformity assessment 
procedures : The existing text of the modules in the directives is aligned with the 
standard modules set out in Annex II to the NLF Decision. 
6. I
MPACTS  
6.1. Overview of potential impacts and methodology for their assessment 
The following impacts have been considered: 
Economic impacts: functioning of the intern al market, competitiv eness of EU-firms, 
operating costs and admini strative burdens, public authorities, consumers, 
households and other users, third co untries and intern ational relations. 
Social impacts: public health and safety ; impact on employment and labour markets 
excluded as no serious impacts expected, although indirect effects on employment 
can follow from the impact on competitiveness. 
Environmental impacts: restriction of environmental unfriendly goods and 
prevention of fire, explosions and acci dents leading to e nvironmental risks. 
Furthermore, the report will assess impacts in terms of simplification of the 
regulatory environment.  
 
EN 35   EN The assessment of impacts relies to a great  extent on the resu lts of stakeholder 
consultations. This is because, as explaine d in the option section, the NLF Decision 
already commits the Commission to aligni ng harmonisation legislation with the 
principles contained in the annexes to th e NLF Decision itself unless departure is 
appropriate on account of sector specifici ties. Therefore, it was of the utmost 
importance to verify whether any such sp ecificity emerged during the stakeholder 
consultations and whether this would lead to different impacts than those assessed prior to the adoption of the NLF.  
For this reason, a very detail ed consultation was carried out by drawing stakeholders' 
attention specifically to all measures cont ained in the NLF Decision (see section 5.3 
above) and asking them to provide their views on the impacts expected in each 
sector. 
Finally, since the content of options 2 and 3 is identical, the views of stakeholders as 
regards the appropriateness of introducing th e specific measures are also identical, 
except for the difference in the enfor ceability of the measures under the two 
respective options.  
6.2. Option 1: No policy change 
In the assessment of the impacts of the no policy change option, the following 
development should be taken into account: 
– The progressive implementation of the NLF Regulation will certainly play a 
positive role in relation to the proble m of non-compliance by strengthening the 
powers of market surveillance authorities.  It will also address the problem of 
underperformance of NB as the new system of accreditation functions by 
reference to binding rules and helps stre ngthen mutual conf idence between MS 
– However in the context of increasing globa lisation and, in partic ular, as part of 
manufacturing activities in the relevant sectors shifts out of the EU, market 
surveillance and traceability of non-complia nt products will become increasingly 
more difficult in practice. 
– The ongoing information campaign on the EU rules underpinni ng the CE marking 
will increase stakeholders’ awareness of their existing obligations under EU product legislation and fo ster their application. 
6.2.1.  Internal market  
Current rules on the harmoni sation of product requirement s do not address all EO 
involved in the product supply chain. This cau ses an enforcement gap at the level of 
EU law and creates scope for differences between national laws as to obligations 
imposed on EO. It also introduces distortions  in the treatment of different categories 
of operators (e.g. importers of products fr om third countries vs manufacturers based 
in the EU) in the internal market. The ‘no policy change’ option will not remedy the 
legislative gaps at EU level as regard s the obligations of EO and so current 
divergences between national legislation as to the trea tment of different EO will 
remain. 
 
EN 36   EN As regards conformity assessment services, the implementation of the NLF 
Regulation will also improve the uniformity  of accreditation activities across MS and 
so have a positive impact on the internal market; however, it will not guarantee a uniform approach in the assessment of non accredited NB. 
6.2.2.  Competitiveness of EU-firms  
EO in the single market consider themselves affected by unfair competition from 
non-compliant products
65.Under the no policy change op tion, a considerable boost to 
the competitiveness of compliant firms (regardless of their origin) will be provided by the implementation of the NLF Regulation. Th is is because the la tter sets out clear 
obligations for MS to perform market su rveillance activities and strengthens the 
powers of market surveillance authorities. The implementatio n of these aspects of the 
NLF Regulation will then lead to an in crease in the number of physical and 
documentary checks of products made availabl e in the internal market and therefore 
make it more likely that non-compliant  products are taken off the market. 
Furthermore, increasing reliance on the new EU system of accreditation based on 
binding rules will help eliminate from the market unqualified or unscrupulous NB that do not assess the conformity of products accordi ng to the required procedures.  
On the other hand, despite this intensificati on of enforcement efforts, as globalisation 
leads to manufacturing activ ities in many of these s ectors (e.g. electrical and 
electronic goods, pressure equipment, pyrot echnic articles) moving far away from 
the geographical markets where products ar e ultimately sold, market surveillance 
will be increasingly hampered by the lack of general traceability obligations and 
insufficient clarity as to th e responsibilities of importers and distributors (except for 
the civil explosives sector
66). 
All in all, while more market surveillan ce on the basis of the NLF Regulation will 
certainly help to reduce the number of non-compliant products and have a positive 
impact on all stakeholders affected, this does not appear sufficient to address all 
drivers of the non-compliance problem.  
The possible benefit for firms producing comp liant products could be quantified as a 
portion of the losses generated by unfair comp etition. According to participants to 
the consultation, this would ra nge from a few percentage po ints up to more than 30% 
of annual turnover (see Figure 1: Perceived lo sses in % of annual turnover in section 
3.1.1).  
6.2.3.  Operating costs and administrative burden 
This option will not have any impact on operating costs and administrative burdens 
of EO.  
                                                 
65 During the public consultation, almost 95% of EO said to be affected by the unfair competition of non-
compliant products. They also mentioned that the competitive disadvantage suffered was of such an importance to affect their sales or market shares. EO provides estimates of % of turnover and market 
shares lost over last 5 years.  
66 See section 3.1.3. 
 
EN 37   EN 6.2.4.  Public authorities 
Thanks to the implementation of the NLF Regulation, under this option public 
authorities will benefit from a stronger regul atory framework for market surveillance 
that will progressively increase the eff ectiveness of national activities. This is 
because authorities will be able to rely on stronger cooperation across borders (e.g. by receiving information on investigations  carried out in a nother MS and by 
requesting assistance from other MS authorit ies) and with custom authorities. The 
NLF Regulation also contains  obligations to carry out an appropriate level of 
controls. Furthermore, the NLF Regulation ha s also significantly facilitated the task 
of public authorities related to the no tification and monitoring of conformity 
assessment bodies using accreditation. For a detailed assessment, reference is made 
to the overall costs a nd benefits of the NLF
67. 
6.2.5.  Consumers, households and other users 
Consumers and users in general suffer damage by unreliable and poor quality 
products. Indeed, the large majority of user s (61%) having participated in the public 
consultation acknowledge that non-compliance is damaging them to some extent and 
estimate the seriousness of the damage as either significant (a third of them) or 
moderate (two thirds); onl y 3% consider that non-comp liance does not negatively 
affect users.  
Economic damage may cover the cost of re placing parts of faulty products, the cost 
of replacing the whole product and possible damage to other properties caused by the 
non-compliant good. Damage to health can also occur. This damage cannot be quantified in general terms because of the wi de range of possible scenarios arising in 
each sector. However, specific examples of damage given in the consultation (mainly 
relating to professional goods) concerning el ectrical and electronic goods, pressure 
equipment, measuring instruments, lifts  and equipment for use in potentially 
explosive atmospheres are illustra ted in Annex 4 (see section 12.1.2.6). 
Under this option consumers and users in  general will benefit from the likely 
increase in the size and deterrent effect of market surveillance resulting from the implementation of the NLF Regulation. The benefits for users can be assumed to be equivalent to the expected reduction in  the damage stemming from non-compliant 
and faulty products. 
6.2.6.  Third countries and international relations  
This option does not affect specifically tr ade between the EU and third countries.  
6.2.7.  Public health and safety 
The implementation of the NLF Regulation s hould lead to a reduction in the number 
of non-compliant products made available on the EU market and, in particular, 
products potentially dangerous  to the health and safety  of consumers (e.g. unsafe 
lifts, domestic appliances causing a risk of el ectrical shocks and burns), citizens in 
                                                
 
67 See SEC 2007(173) 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf  
 
EN 38   EN general (e.g. defec tive outdoor piping equipment l eaking toxic or inflammable 
substances) and workers (e.g. pressure  equipment causing accidents in the 
workplace, work equipment causing sparks in potentially explosive atmospheres). 
This impact is not always relevant to  the measuring instruments sector whose 
legislation overall focuses on public interest  other than health and safety protection, 
although specific categories of measuring in struments relate also to public health. 
6.2.8.  Environmental impacts  
One of the 10 directives considered in this  report, the pyrotechni c articles directive, 
includes among its objectives not only the prot ection of human health but also that of 
the environment, and contains a list of forb idden substances in the relevant standards 
(e.g. persistent organic pollutants). Moreover,  the substances used  in explosives and 
pyrotechnic articles also fall under Regulation 1907/2006 on the Registration, 
Evaluation, Authorisation a nd Restriction of Chemicals (REACH). Since the NLF 
Regulation stengthens market surveillance it  also helps in restricting the circulation 
of environmentally unfrie ndly pyrotechnic articles. 
The other directives at stake do not specifi cally contain requirements that are meant 
to ensure the protection of  environment. However, it can be assumed that the 
reduction of non-compliance for certain categories of products (namely civil 
explosives, equipment for use in potentially explosive atmospheres and big pressure equipment) will help in preventing the occurrence of fire, explosions, accidents and accidental emissions that could al so create environmental risk. 
6.2.9.  Simplification of the regulatory environment  
This option will have no impact on the simp lification of the regulatory environment. 
6.3. Option 2: Alignment via non-legislative measures 
6.3.1.  Internal Market  
The non-legislative measures opti on may, by providing guidance on the 
responsibilities of the differe nt categories of operators, c ontribute to some extent to 
creating a more level playing field am ong EO in the EU. Similarly, voluntary 
commitments by NB and notifying authorities to follow best practice in the area of 
conformity assessment activities may help  establish common benchmarks across the 
EU also for non-accredited NB. Indeed, stak eholders have confirmed this view (see 
section 6.4.1).  
Nevertheless, as this option does not allow authorities to take legal action against non 
responsible EO or NB, additional positive impacts on the internal market with 
respect to the no policy change option will entirely depend on the good will of 
stakeholders. In this respect, it is importa nt to note that exis ting guidance contained 
in the so-called "Blue Guide"
68, which has been a reference guide for the 
implementation of directives for more than ten years, al ready points to the 
                                                 
68 Guide  to the implementation of directives based on the New Approach and the Global Approach , 
European Commission, September 1999. available at http://ec.europa.eu/enterprise/policies/single-
market-goods/documents/blue-guide/index_en.htm  
 
EN 39   EN responsibilities of EO that are then clarified by the NLF Decision. However, as the 
Blue Guide is not enforceable, this has no t been sufficient to address the issues 
identified. Furthermore, the NB require ments provided by the NLF Decision are 
already known to industry because they  reflect existing (non-binding) ISO 
standards69.  
6.3.2.  Competitiveness of EU-firms 
By proposing best practices that go beyond curre nt legal provisions applicable to EO 
and NB and improve current market surv eillance procedures, this option may to 
some extent help prevent non-compliance, as also confirmed by stakeholders' (see 
section 6.4.2). However, the positive impact of  non-legislative measures in terms of 
reducing the number of non-compliant produc ts and defending the competiveness of 
compliant firms will entirely depend on the voluntary commitment of industry 
stakeholders. For instance, if  EO do not voluntarily mark th eir names and contacts on 
products or do not provide upon request information on the origin of the goods traded, market surveillance au thorities will be unable to trace dangerous products and 
stop their supply to the market. Furthermor e, the competitiveness of compliant firms 
may be damaged if they incur additional costs to align their conduct with best 
practices while non-com pliant firms don't.  
6.3.3.  Operating costs and administrative burdens  
For those EO and NB that choose to act acco rding to the best practice established via 
guidance, the option of non-legislative measures will have the same impact on operating costs and/or administrative burden as the alignment option (for details see 
section 6.4.3). These costs are overall consider ed by stakeholders to be moderate. On 
the other hand, it will have no impact on the costs of EO and NB that do not voluntarily align with  best practice.  
6.3.4.  Public authorities 
The voluntary commitment of EO to act res ponsibly at all levels of the supply chain 
(including imports and distribution) and to ensure traceability should somewhat 
facilitate the task of market surveill ance authorities. Similarly NB voluntary 
commitment to follow stricter requiremen ts and to provide information on their 
conformity assessment activities would be ex pected to help notif ying authorities to 
monitor the quality  of NB. Stakeholders have confir med this view (s ee section 6.4.4). 
In both cases, however, the pos itive impact on public auth orities will simply not 
materialise if the authorities cannot consis tently rely on the c ooperation of EO and 
NB. This is why the additional positive imp act of this option by comparison with the 
no policy change option is expe cted to be rather limited. No specific additional costs 
or administrative burden have been identified for authorities. 
                                                
 
69 The relevant standards are 1) EN 45011:1998, General requirements for bodies operating product 
certification systems; 2)-EN ISO/IEC 17020:2004, General criteria for the operation of various types of 
bodies performing inspection; 3) EN ISO/IEC 17021:2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems; 4) EN ISO/IEC 17024:2003 
Conformity assessment – General re quirements for bodies operating ce rtification of persons; 5) EN 
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories. 
 
EN 40   EN 6.3.5.  Consumers, households and other users 
By proposing best practices that go beyond curre nt legal provisions applicable to EO 
and NB and improve current market surv eillance procedures, this option may to 
some extent help prevent material damage to consumers and users in general. However this will entirely depend on the vol untary commitment of stakeholders in 
each sector. As EO and NB will only bear, if any, additional moderate compliance costs, option 2 is not expected to give rise  to price increases for consumers/users.  
6.3.6.  Third countries and international relations 
Better information on products originating fr om third countries will be possible only 
by relying on importers' voluntary commitme nt to act responsibly and ensure 
traceability. This will not constitute any new technical trade barrier. Responsible 
manufacturers and other trading parties located in third countries will not be 
adversely affected by these provisions. To th e extent that importers act according to 
the guidance provided, there will be a po sitive impact in terms of increased 
transparency in the operations of EU, distri butors at lower levels of the supply chain 
(downstream) which overall may even facilita te international trade. However the real 
impacts will entirely depend on the goodwill of stakeholders. 
Non-legislative measures concerning NB  and notification activities will have no 
impact on international relations as the recognition of third country conformity 
assessment bodies will still depend on mutual recognition agreements. 
6.3.7.  Public health and safety 
The commitment of EO and NB to act accord ing to proposed best practice, which go 
beyond the current provisions of the NLF Re gulation, might in principle lead to a 
greater reduction of non-compliant products that may endanger the health and safety 
of consumers and workers in the EU (see stakeholders' view on the potential impact 
of the proposed measures in section 6.4.7). Ho wever, since this option does not allow 
authorities to enforce those practices, a stronger positive impact than under the no 
policy change scenario cannot be guaranteed. 
6.3.8.  Environmental impacts  
The commitment of EO and NB to act acco rding to proposed best practice, which 
goes beyond the current provisi ons of the NLF Regulation, mi ght in principle lead to 
a greater reduction of environmentally unf riendly pyrotechnic ar ticles or other 
products that might create environmental risks in case of fire, explosions and 
accidents. However, since this option does not allow authorities to enforce those 
practices, a stronger positive impact than under the no-policy change scenario cannot 
be guaranteed. 
6.3.9.  Simplification of the regulatory environment 
This option will have no impact on the simp lification of the regulatory environment. 
The problem of complexity and inconsistencies throughout the directives cannot be 
satisfactorily addressed by this option. Guidance documents can clarify unclear 
provisions but where the problems are rooted  in differences in the legal provisions, 
guidance documents cannot prevail over these provisions. 
 
EN 41   EN 6.4. Option 3: Alignment via legislative measures 
6.4.1.  Internal Market 
Pursuant to alignment, the relevant produc t directives will incl ude clear obligations 
applying to all EO throughout the EU and market surveill ance procedures that will 
eliminate the current differences in national legislation and create a more level playing field among EO. Furthermore, th e alignment of market surveillance 
(safeguard clause) procedures  will ultimately lead to the adoption of equivalent 
measures across the EU in relati on to products presenting a risk.  
The results of the public consultation largely support the conclusion that the 
specification of EO obligations will have a positive impact on the internal market for all sectors. This view is shared by three quarters (65 to 77%) of EO and NB and two 
thirds (60 to 72%) of authorities that part icipated in the cons ultation. Furthermore, 
the majority of those who identified a positive impact evaluate the impact of the alignment of obligations and market surveillance procedures as significant. The detailed analysis of the results of the c onsultations is presente d in the annex (see 
section 12.1.2.1 in Annex 4). 
Pursuant to alignment, the relevant product directives will include stricter 
requirements that will constitute a comm on benchmark for the assessment of NB 
throughout the EU regardless of the country  in which they are active and of the 
specific NB providing the serv ice. Moreover, according to the revised notification 
process, the notifying authority in a given MS will be able  to scrutinise and object to 
notifications put forward by another MS. Therefore NB w ill be subject to more 
transparent and more coherent assessment and this will strengthen the conditions for 
a level playing field. 
The results of the public cons ultation largely suppor t the conclusion that changes to 
NB requirements and notification process wi ll have a positive impact on the internal 
market for all sectors. This view is shared by two thirds of EO, of NB and authorities 
that participated in the consultation. Furthermore, the majority of those who 
identified a positive impact evaluate the benefit of the reinforcement of the notification requirements as si gnificant, while they evalua te the impact of revised 
procedures and information obligations as more moderate. More details on the 
findings can be found in Annex 4 (see section 12.2.1.1). 
6.4.2.  Competitiveness of EU-firms 
By imposing clear obligations on EO a nd market surveillance procedures the 
alignment is expected to help reducing the number of non-compliant products. In 
particular, the introduction of traceability re quirements for all operators will help the 
competent authorities to trace the non-co mpliant product and stop its circulation. 
Furthermore, the introduction of clear obl igations for importe rs and distributors 
regarding product compliance will allow action at all levels of the supply chain. This 
action will then help defend the competiv eness of compliant firms (regardless of 
their nationality) from unfair competition. 
 
EN 42   EN This conclusion is strongly supported by stak eholders of all sect ors as about three 
quarters (73 to 76%) of EO and SME70 participating in th e public consultation 
believed this policy action would help defe nd the competiveness of EU business vis-
à-vis unfair competition from non-compliant products. Furthermore, the majority of those who identified a positive impact evaluated the benefit of the clarifications of EO obligations and market surveillance procedures as significant. More details on the findings can be found in the annex (see section 12.1.2.2 in Annex 4).  
The alignment will also introduce stricter  requirements on NB and notification 
authorities and changes in the notification process that will allow the exclusion from 
the single market of those conformity assessment bodies that do not possess the necessary competence or whose evaluations are affected by a conflict of interests. 
The exclusion of the latter will both help reduce the scope for unfair competition amongst NB and help defend the competiven ess of firms that have their products 
properly assessed.  
This conclusion is strongly supported by stak eholders as 60-62% of EO participating 
in the public consultation believed this  policy action woul d help defend the 
competiveness of EU business vis-à-vis unfair competition from non-compliant 
products. Furthermore, the majority of  those who identified a positive impact 
evaluated the benefit of the reinforcement of notification requirements as significant, while they evaluated the benefit of revised procedures and information obligations as 
more moderate. More details on the findings  can be found in the annex (see section 
12.2.1.2 in Annex 4). 
6.4.3.  Operating costs and administrative burden  
6.4.3.1.  Costs and administrative burden for EO 
The specification of obligati ons for manufacturers, impor ters and distributors and 
new market surveillance procedures in the re levant sector directives is not expected 
to increase the overall costs of economic opera tors. Most of the EO obligations in the 
NLF Decision codify what is normal practic e for a responsible/compliant firm. It is 
no coincidence that some of the principl es underlying those provisions are already 
presented in the "Blue Guide"
71.  
This is particularly relevant for obligati ons on importers and di stributors and for the 
cooperation between EO and market surveill ance authorities. Therefore, while the 
alignment of sector directives will make these obligations formally enforceable, in 
principle it will not lead to additional adjustments for those operators that have been 
acting responsibly. On the other hand, the fact  that EO which have not hitherto taken 
their responsibilities seriously will need to incur the necessary compliance costs, should be seen as a benefit (posi tive impact) of this policy action.  
As regards traceability obligations for EO , some impact on operating costs and/or 
administrative burden is possible as manuf acturers and importers must indicate on 
products their names, addresses and batc hes or serial numbers. However, the 
traceability obligations will be an admini strative burden only if EO do not already 
                                                
 
70 The percentage is slightly lower (62 to 68%) for post-marketing obligations. 
71 See footnote 68 above.  
 
EN 43   EN have a system in place as part of quality management controls or pursuant to legal 
obligations already in force. For instan ce, manufacturers are already obliged to 
indicate their names on products on the basis of current directives, while batches or 
serial numbers are normally used by EO for internal management reasons. Furthermore, the NLF Decision leaves EO fr ee as to the choice of specific technical 
solution. 
The views expressed by those who participat ed in the consultati on (55% of general 
EO and 30-33% of SME) overall point to some, moderate impact on costs due to 
obligations for importers/distributors and traceability obligations.
72 Only 1-5% of EO 
and 12-15% of SME exp ect significant increases in costs.  
As to post-marketing obligations on manuf acturers, their possibl e impact on cost will 
be negligible as they involve few add itional elements that relate to existing 
responsibilities. These obligations merely require the establishment – if not already 
put in place by the operator - of basic proce dures for the quality control of marketed 
products (e.g. keep a register of complain ts and defective produc ts). 42% of general 
EO participating in the public consulta tion and 23% of SME attribute no or no 
significant cost increases to these el ements. However 30% of SME expect a 
moderate increase in costs a nd 18% a significant increase. 
The possibility of cost reductions due to these provisions should also be mentioned, 
since by clearly identifying the responsibilities of EO at different levels of the value 
chain, the provisions may help responsible  operators to save costs previously 
incurred in insuring agains t unfair practices of supplie rs or other traders, or 
additional testing of procured  products. A small percenta ge of respondents (1-5% of 
EO and 4-6% of SME) also acknowledged that the alignment would lead to a 
reduction of costs (e.g. costs to gather information on the reli ability of products 
supplied to them by importers or distributors;  costs of insurance to  cover risks due to 
non-compliant products)73. 
Specific concerns voiced by the electrical  and electronic goods industry and by the 
NAWI sector of relate to the costs of  translating technical documentation and 
preparing the declaration of conformity. It  is then important to clarify that the 
alignment does not introduce an obligati on to translate technical documentation74. As 
regards the declaration of conformity, this is normally a document of less than one 
page for which a template in all official languages is already provi ded in the Official 
                                                 
72 SME appeared less concerned than general EO about these obligations as the possibility of cost 
increases is supported only by a relative majority of SME, while a third of them believe that these 
obligations will not imply new costs or burden. 
73 A further reason for cost reductions should be mentioned for SME in the area of conformity assessment 
procedures. This is because the alignment of NB requ irements will also allow NB to take into account 
the size of economic operators when performing conformity assessment (see Article R17 (6) (c ) of the NLF Decision). 
74 The relevant parts of technical documentation may need – but not systematically – to be made available 
to market surveillance authorities in their nationa l language. Initially however the authority may be 
provided with only a summary of it. More detailed information will be requested in cases of serious 
doubt about the conformity of the products. Furtherm ore, if technical documentation is available in a 
language that the authority can understand, the latter will avoid asking for translations. See  Guide  to the 
implementation of directives based on the New Approach and the Global Approach , European 
Commission, September 1999, section 8.2, pages 49-50. 
 
EN 44   EN Journal of the EU, accessible via the website of the Commission75. Information to be 
included relates mainly to names, addr esses and numerical references (product 
identification number, relevant dire ctives and standards, etc.).  
Only a minority of respondent s (17% of general EO a nd 22% of SME) provided 
indicative estimates of the magnitude of cost  increases expected as a result of all 
these provisions. The large majority of  general EO (65%) and 40% of SME 
estimated the increase in cost at up to 5% of current operating costs, while a further 
30% of SME provided estimates between 6% and 10%. 
On the basis of this information, it is concluded that the burden of the measures 
proposed through the alignment will not be disproportionate either on general EO or 
on SME. 
Furthermore, possible cost increases due to  the alignment should be compared with 
the benefits of reducing non-co mpliance in the rele vant sector. In this respect, it 
should be noted that 38% of EO76 participating in the cons ultation considered those 
cost increases quite reasonable in rela tion to the objective  of reducing non-
compliance, while only 14% of respondents considered the increase unreasonable.  
The detailed results of the consultation a nd the comparisons of perceived costs and 
benefits for both EO in general and SM E can be found in Annex 4 (see sections 
12.1.2.3 and 12.1.2.4). 
6.4.3.2.  Costs and administrative burdens for NB 
The strengthening of NB requirements is not expected to lead to any additional 
operating costs and/or administrative burde n on NB that act in accordance with 
recognised professional standards. Indee d, while the alignment will strengthen the 
wording of current directives, in practice the relevant benchmark for the assessment 
of conformity assessment bodies (both in  the context of accreditation and the 
assessment carried out by notifying authorities)  has been the relevant series within 
the EN 45000 and EN ISO/IEC17000 standards77. The latter, as attested by the 
European co-operation for Accreditati on (EA), which pools together all EU 
accreditation bodies, already reflect the requirements included in the NLF 
Decision78. Indeed those standards have been the relevant benchmark for assessing 
the competence and independence of confor mity assessment bodies for some time. 
Therefore, while the alignment of sector dir ectives as regards those requirements will 
make them formally enforceable, it will not involve additional effort on the part of 
those conformity assessment bodies which we re already complying with the spirit of 
the legislation. A moderate (temporary) incr ease in administrative burden of NB is 
expected since they will need to reque st new notification and produce updated 
evidence to show compliance with the re quirements (e.g. accredi tation and/or other 
                                                 
75 http://ec.europa.eu/enterprise/policies/single-m arket-goods/regulatory-po licies-common-rules-for-
products/new-legislative-framework/index_en.htm 
76 This question was not asked to SME to whom it was addressed a simplified questionnaire. SME 
however have clearly signalled that they expect benefits from the alignment. 
77 See footnote 69 above. 
78 EA-2/17- EA Guidance on  the horizontal requirements for the accreditation of conformity assessment 
bodies for notification purposes, http://www.eur opean-accreditation.org. 
 
EN 45   EN certificates showing professional qualifica tions); however, any re-notification of a 
properly assessed and monitored bod y should be a mere formality. 
On the other hand, the costs of compliance efforts by those NB th at, by thriving on 
enforcement difficulties did not previously meet the substantive requirements for conformity assessment, should be considered benefits (pos itive impact) of this policy 
action.  
The Commission thought that the revision of  the notification process would provide 
an incentive to NB to move towards accred itation and would thus lead to additional 
costs for them. The incentive was thought to  derive from the fact that, although 
accreditation would not be made mandatory by alignment with the NLF Decision, notifications accompanied by an accredita tion certificate will benefit from a 
facilitated notification procedure (shorte r objection period). However, detailed 
analysis of the scope of accreditation actual ly shows that the large majority of NB 
has already chosen to be accredited regard less of the alignment. Currently, except for 
the Measuring Instruments Directive
79, the percentage of NB which are not formally 
accredited is relatively limited, ranging from 5 to 37% (see the table below). Thus, overall any move towards accreditation i nduced by alignment would – even in the 
most extreme scenario – involve no more  than a third of NB in each sector. 
Furthermore, as regards the cost of accreditation, the EA  stresses that conformity 
assessment bodies apply for accreditation the scope of which is considerably wider than that required for the NB activity. It follows that these cost are spread on a basis 
that is much wider and normally have a limited impact on the costs of specific 
services. Indicative estimates of accred itation fees are provided in Table 35: 
Accreditation fees charged by one European NAB in 2010 (EUR). 
Table 4: Share of accredited/not accredited EU NB per sector  
Directive Total EU NB  EU NB accredited? 
  Yes No 
Pyrotechnic 10 7 3 
%   70% 30% 
Civil Explosives 13 9 4 
%   69% 31% 
EMC 131 95 36 
%   73% 27% 
LVD 148 119 29 
%   80% 20% 
ATEX 55 40 15 
%   73% 27% 
MID 140 32 108 
%   23% 77% 
NAWI 270 230 40 
%   85% 15% 
SPVD 95 90 5 
%   95% 5% 
                                                 
79 The lower rate of accreditation of NB under the Meas uring Instrument Directive appear to be explained 
by the fact that a number of them are actually pub lic authorities who did not consider necessary to 
require an accreditation certificate to demons trate the fulfilment of legal requirements. 
 
EN 46   EN PED80 237 179 58 
%   76% 24% 
Lifts 192 121 71 
%   63% 37% 
Source: Commission estimates on the basis of information in the Nando (New Approach Notified and 
Designated Organisations) Information System (3 January 2011) 
The introduction of information obligations is  expected to lead to an additional – but 
overall negligible- administrative burden (i.e. basically the costs of transmitting the 
required information). This informa tion will only be provided on an ad hoc  basis as 
required by the nature of the information itself (i.e. information on refusals, restrictions, suspensions and withdrawals of certificates to be addressed to the 
notifying authority, and information on negativ e conformity assessment results to be 
addressed the other NB
81). Furthermore, NB are free to choose the format of the 
transmission of information.  
In conclusion, overall this policy op tion will not have a big impact on 
costs/administrative burden for NB. The im pact of certain modifications to the 
notification process needs to be taken in to account as it may push NB to incur 
accreditation costs. However possible cost increases in relation to the directive 
concerned should be regarded as limited. Fu rthermore, the costs will be more than 
outweighed by the benefits of the alignmen t, notably the legal basis necessary to 
enforce the NB requirements and to excl ude underperforming NB from the single 
market. 
The results of the public consultation overa ll support this assessment, as 34-46% of 
respondents considered there would be no or no significant in crease in operating 
costs and/or administrative burden linked to th is policy action or that the latter would 
generate savings, 32-37% of them expect ed a moderate incr ease and only 14-24% 
expected a significant increase in operati ng costs and/or administrative burden. 
Information obligations represent the category raising the least concern.  
Furthermore, as regards the sp ecific reasons for cost increases, while the majority of 
respondents did not provide any indi cation, 30% indicated accreditation 
(nevertheless, the public consultation did not allow meaningful estimates of cost 
increases expected due to accreditation to be  collected since only a few stakeholders 
provided figures). One or two respondents poi nted to an increase in costs for the 
employment or contracting of qualified pers onnel. However this would only increase 
existing costs of NB, if they do not  already employ qualified personnel. 
Finally 37% of NB participating in the cons ultation considered that the possible cost 
increase is reasonable in relation to the objective of enhancing the quality of the 
conformity assessment services provided. On ly 16% of NB considered the increase 
unreasonable, while the remaining stak eholders did not express a view.  
                                                 
80 These figures include also conformity assessment bodies that are specific to the Pressure Equipment 
Directive (i.e. Recognised Third Parties Organisations and Us er Inspectorates). 
81 This latter exchange can take place in the context of notified bodies groups (s ee Article R30 of the NLF 
Decision). 
 
EN 47   EN The detailed results of the consultation can be found in the annex (see section 
12.2.1.3 in Annex 4).  
6.4.4.  Public authorities  
The measures concerning clear obligations for all EO and clearer market surveillance 
procedures are expected to substantia lly increase the eff ectiveness of public 
authorities' enforcement activities, while th ey are not expected in general to have 
budgetary consequences.  
In particular the additional obligations for EO will make it easier for market 
surveillance authorities to obtain documenta tion and information from importers and 
distributors and to trace non- compliant products, includi ng those imported from third 
countries. The EO obligations will not l ead to additional costs or administrative 
burden for authorities. They may even reduc e authorities' inves tigation costs (e.g. the 
traceability obligation will f acilitate the identification of EO having marketed non-
compliant products). 
As regards the common safeguard procedure,  if compared to the current legal texts 
the new procedure contains a much more detailed description of the steps that the authorities have to take to deal with pr oducts presenting a risk. These are, however, 
not new tasks for market surveillance author ities but part of their daily work under 
the current situation. While the NLF Regul ation establishes specific tools for the 
exchange of information among national auth orities, the procedure laid down in the 
NLF Decision specifies when the relevant in formation should be exchanged in order 
to be useful for cross-border authorities
82. : this will allow survei llance authorities to 
work more efficiently, as efforts already unde rtaken by the authori ties in one MS will 
not need to be duplicat ed. Furthermore it will allow au thorities to take coordinated 
action in cases of non-compliant products marketed in more than one MS. The NLF 
Decision also clarifies and streamlines th e procedure according to which in certain 
cases the Commission is called on to expr ess its view on the measures adopted by 
MS so that ultimately a uniform approach has to be followed by all national authorities. 
The appropriateness of the alignment in this regard is acknowledged by the majority 
of stakeholders that participated in th e public consultations (i.e. between 67% and 
71% of EO, between 66% and 83% of NB, between 57% and 71% of authorities and 
between 73% and 80% of user s). As regards the extent to which the alignment may 
improve the current situation, the majo rity of EO who id entified a positive 
improvement evaluated the contribution made by traceability obligations as 
significant, while they evaluated the cont ribution made by the other measures as 
more moderate; the views of authorities are more or less equally shared between 
significant and moderate impac t; in general the majority of NB and users considered 
the impact significant. For more details see section 12.1.2.4 in Annex 4. 
                                                
 
82 For instance a first exchange of information shou ld take place after the authorities have checked the 
product, have found it not compliant and have asked the relevant economic operator to take action to 
bring the product into conformity and to restrict the marketing of the product. A second exchange of 
information, if necessary, will take place after inac tion of the economic operator and the adoption of 
compulsory restrictive measures by the authority. 
 
EN 48   EN The reinforced notificati on requirements for conformity assessment bodies, the 
revised notification procedur es, and the information oblig ations on NB are expected 
to increase the effectiveness of the contro ls carried out by notif ying authorities. In 
particular, the alignment of sector dire ctives with the NLF Decision will provide 
national authorities with the legal basis necessary to enforce the NB requirements 
and to exclude underperforming conform ity assessment bodies from the single 
market.  
The appropriateness of the alignment in this regard is acknowledged by the majority 
of stakeholders who participated in the public and SME consultations (i.e. between 
62% and 83% of EO, between 60% and 84% of NB83, between 65% and 72% of 
authorities, between 46% and 51% of SME). As regards the extent to which the 
alignment may improve the current situation, the majority of EO, SME and authorities who identified a positive impr ovement evaluated the contribution made 
by the reinforcement of the notification re quirements as significant, while they 
evaluated the contribu tion made by revised procedures and information obligations 
as more moderate. The NB considered th e improvement moderate for each of the 
three measures. For more details  see section 12.2.1.4 in Annex 4. 
On the other hand, laying down formally the criteria for NB will trigger a need for 
public authorities to re-notify existing NB . However, re-notification work will be 
more or less a formality for NB that ar e already accredited or whose requirements 
have in any case already been assessed by the notifying authority against the relevant 
EN 45000 and EN ISO/IEC17000 standards. Furthermore, bearing in mind the total number of NB per sector, the maximum av erage number of re-notifications to be 
handled by a single authority appears limited. Indeed the analysis of the Commission 
shows (see Table 42: Number of NB per Member States an d per relevant directive in 
the annex) that for the large majority of MS and directives the estimated number of 
re-notifications necessary is very small and often negligible. Germany, Italy, Poland 
and UK may be faced with bi gger - but overall very reasonable - numbers (e.g. from 
35 to 50) in a couple of sectors. Only It aly and the UK may be faced in one sector 
(non-automatic weighting instruments) with  a sizeable number of re-notifications 
(respectively 106 and 142). These estimates are based on the current number of NB. 
However it is reasonable to assume that  some of them will not apply for re-
notification, which should further reduce authorities' workload.  
In any case, in order to a ddress the matter, the Commissi on services will introduce a 
specific transitional provision which allows for the application of the notification procedure before the general date of appli cability of the directives. This will allow 
MS the time necessary to ensure that re -notification tasks ar e accomplished by the 
time the directives become applicable. 
As regards the revision of the notificatio n process, the alignment will introduce the 
possibility for other MS and the Comm ission to object to a notification. For 
notifications based on accreditation the period for raising such objections is two weeks, whereas for notifications not base d on accreditation the period is two months. 
The impact of the objection procedure shoul d be assessed bearing in mind the overall 
                                                
 
83 It is worth noting that 32% of NB disagrees on th e effectiveness of the introduction of information 
obligations. 
 
EN 49   EN regulatory framework for notification84. The objection procedure is expected to be 
used mainly for notifications of non- accredited conformity bodies, which are 
nowadays less common than notificati ons underpinned by accreditation. The 
objection procedure may give rise to some  administrative burden for an authority 
whose notification is ch allenged. However this is only like ly to occur if the authority 
has not carried out an accurate assessmen t of the NB. Therefore, objections should 
rather be seen as a sign that the new notification procedure meets the goal of 
ensuring that conformity  assessment bodies are notified only following a 
comprehensive assessment.  
The information obligations imposed on the notified bodies will not increase costs 
for public authorities and s hould rather diminish the costs of monitoring NB.  
The alignment with the NLF Decision w ill introduce requirements for notifying 
authorities that will clarify their responsib ilities (assessing, notifying and monitoring 
of notified bodies) and the possibility to dele gate certain tasks, in particular to 
accreditation bodies. A further set of criteria seeks to guarantee im partiality and to 
avoid conflicts of interests. For the majority of notifying authorities, complying with 
these criteria and obligations should in  principle involve ne ither organisational 
changes nor additional tasks. In the meas uring instrument sector, where national 
authorities carry out the f unction of notified bodies as  well as the function of 
notifying authorities the new requireme nts might trigger a need for some 
organisational rearrangements that should not, however, be a source of major 
concern for MS. 
This assessment also reflects the view e xpressed by the authorities participating in 
the public consultation. About a third (31-37%) indicated th at there would be no or 
no significant increase in costs and/or admini strative burden or considered that would 
be a reduction in costs, a nother third (25-36%) consider ed that there would be a 
moderate increase, and virtually none (0-2%)  pointed to a significant increase. It is 
also important to note that 32-38% of res pondents either did not answer the question 
or declared they were unable to evaluate impacts. The detailed results of the consultation can be found in the annex (see section 12.2.1.5 in Annex 4).  
6.4.5.  Consumers, households and other users 
Under the alignment option, consumers and users in general will benefit from the 
likely increase in the size and deterrent effect of market surveillance resulting not only from the implementation of the NLF Re gulation, but also from the extension of 
traceability obligations and from more sy stematic coordination at EU level.  
Due to the overall limited impact of alignment on costs, the new obligations on EO 
and NB are not expected to gi ve rise to price increases for consumers/users. If, for 
                                                
 
84 It has always been the responsibility of Member States to appropriately assess and monitor the bodies 
they are notifying. However, until the entry into fo rce of Regulation 765/2008 the notification process 
did not have the tools to check how this obligation has been complied with. In this connection, the Regulation, on the one hand, reinforces the regulatory framework for accreditation and, on the other 
hand, establishes in Article 5(2) that when accredita tion is not used notifying authorities have to provide 
evidence that the body has been adequately assessed. 
 
EN 50   EN specific products, moderate price increases o ccur, it is expected that the latter would 
be largely offset by the benefit of greater confidence in product quality. 
6.4.6.  Third countries and international relations  
The obligations of EO as such do not consti tute new technical trade barriers. Instead, 
they guarantee the free movement of safe goods, regardless of origin. According to 
the NLF Decision, importers of products from third countries are obl iged to be better 
informed about their products and sources , which is a minimum and proportionate 
requirement. The import of products from unknown sources is expected to become 
more difficult, precisely because this is lik ely to lead to non-compliance. Responsible 
importers who establish clear commercial re lations with their trading parties and 
responsible manufacturers loca ted in third countries will no t be negatively affected 
by these provisions. Increased transparency  may encourage distributors to buy 
imported products and may facilit ate international trade.  
The alignment of provisions concerning NB and notifications activities will have no 
impact on international relations as the recognition of third country conformity 
assessment bodies will still depend on mutual recognition agreements and no 
additional restrictions are introduced. In th e lift sector, where a third country has 
repeatedly complained about the poor quality of NB located in certain MS and of the 
bodies located in its own territory to whic h activities were subcontracted, it is felt 
that the new requirements will have a positive impact on international cooperation. 
6.4.7.  Public health and safety 
The alignment of provisions concerning EO  obligations and market surveillance 
procedures is expected to help in reduci ng the number of non-compliant products on 
the market and thus the number of products potentially dangerous to the health and safety of consumers and workers.  
The assessment is largely supported by the re sults of the public consultation as 58-
78% of EO, 72-78% of NB, 58-62% of au thorities and about 72-79% of users 
participating in the consultation (exc luding the measuring instrument sector
85) agreed 
that clarification of EO ob ligations and market surveilla nce procedures would help 
protect public health and safe ty. In general the majority of those EO and authorities 
who acknowledged a positive impact considered  it moderate, while in general the 
majority of those NB and users who ac knowledged a positive impact considered it 
significant. The detailed results of the cons ultation are illustrated in the annex (see 
section 12.1.2.7 in Annex 4). 
The alignment of provisions concerning NB requirements and notifications activities 
is also expected to have a positive, a lthough indirect, effect on the protection of 
public health and safety. The assessment is  supported by the re sults of the public 
consultation as 50-72% of EO, 73-85%  of NB and 68-77% of authorities 
                                                 
85 In the case of measuring instruments the relevant di rectives pursue mainly public interests other than 
health and safety protection and for this reasons th e question asked during the consultation did ot apply 
to this sector. Having said that, specific categories of measuring instruments may also relate to health 
and safety aspects (e.g. determination of mass in the practice of medicine and pharmacy). 
 
EN 51   EN participating in the consultation (exc luding the measuring instrument sector86) agreed 
that changes to the NB requirements and no tifications activities would help protect 
public health and safety. In general the majority of those who acknowledged a positive impact consider it moderate, a lthough a good share of respondents qualified 
the impact as significant. The detailed result s of the consultation are illustrated in the 
annex (see section 12.2.1.6 in Annex 4). 
6.4.8.  Environmental impacts  
The alignment of provisions concerning EO  obligations and market surveillance 
procedures is expected to lead to a great er reduction of envi ronmentally unfriendly 
pyrotechnic articles or other products that  may create environmental risks than under 
the no-policy change scenario. 
6.4.9.  Simplification of the regulatory environment 
This option will fully address the problem of current inconsistencies in overlapping 
legislation as consistent terminology will be inserted in the definitions provisions and 
in the different modules for conformity assessment procedures contained in all these directives. 
7. C
OMPARISON OF OPTIONS  
The first table below provides an overview of the impacts assessed for each option. 
Costs and benefits are identified by using respectively the "-" and "+" symbols. The 
magnitude of each impact is assessed according to the following indications: 
• (+++): significant positive impact 
• (++): moderate positive impact 
• (+): minor positive impact 
• (0): no impact/baseline 
• (-): minor negative impact/ small increase in costs  
• (--): moderate negative impact/increase in costs 
• (---): significant negative impact/increase in costs 
The comparisons show that the option of non-legislative measures  is considered far 
less effective than the alignment by legi slative measures option and barely more 
effective than the no policy change option. Th is is because, as regards the problem of 
non-compliance, non legislative measures w ould not improve the current situation 
where responsible EO already fulfil a number of obligations that are part of existing 
guidance provided to industry, while unscrupulous  ones exploit the fact that this best 
practice is not legally bi nding. Furthermore, as regards the inappropriate 
                                                 
86 See previous footnote. 
 
EN 52   EN performance of NB, it is doubt ful that the option of non-le gislative measures would 
make it possible to exclude from the sing le market those conformity assessment 
bodies that do not possess the necessary competence or whose evaluations are 
affected by conflicts of interests. This is because informal guidance will be taken into 
account by conformity assessment bodies and notifying authorities that are willing to 
provide good quality services  but appears insufficient to  motivate less responsible 
bodies. Furthermore, notifying authorities w ould normally need a formal legal basis 
to refuse or withdraw a notification. Fina lly, option 2 will not be effective to address 
divergences in terminology used by ex isting direc tives, which presuppose a 
modification of the legal provisions.  
This view is strongly  supported by the resu lts of the public cons ultation as the large 
majority of all stakeholders (EO, NB, aut horities, users) that participated in the 
consultation considered the option of a lignment by non legislative measures as 
ineffective overall, in relation to the objectives of reducing the number of non-
compliant products, ensuring strict and uni form control of NB across the EU and 
achieving consistency of directives. Stake holders, on the other hand, very largely 
agreed on the effectiveness of the alignment by legislative measures. Additional 
details on the view expressed by the diffe rent categories of stakeholders on the 
relative effectiveness of option 2 and 3 ar e provided in the annex (see section 12.4 in 
Annex 4). 
 
EN 53   EN Table 5: Overview of the impacts attributed to the listed options  
 ECONOMIC IMPACTS SOCIAL 
IMPACTS ENVIRONMENTAL 
IMPACTS OTHER 
IMPACTS 
 Internal 
market Competitiveness Costs and 
admin. 
Burdens for 
EO or NB Public authorities 
 Third 
countries 
relations Consumers 
and users Public health Restriction of 
polluting goods/ 
Likelyhood of 
environm. Risks Simplification  
    Benefits Costs      
Option 1 : No- 
change 
(Benefits and 
costs mainly 
due to application of 
Regulation 
765/2008) (0) (0) (0) (0) (0) (0) (0) (0) (0)  (0) 
Option 2 : 
Alignment via 
non-legislative measures (+) (─ )/(+) (─/ ─ ─) if 
follow 
guidance  (0) (0) (0) (+) (+) (+)  (0) 
Option 3 : 
Alignment via 
legislative 
measures (+++) (++)/(+++) (─ / ─ ─) (++)/(+++) (0/ ─) (0/ +) (+++) (++)/(+++) (++)  (++)/(+++)  
 
EN 54   EN The second table compares the policy options according to the criteria of 
effectiveness (i.e. to what extent they fulf il the specific objectives), efficiency (i.e. at 
which costs they do so) and cohere nce with other EU policies.  
Table 6: Comparison of the listed options  
 Effectiveness Efficiency  Coherence 
Option 1: No- 
change Neutral  
[It addresses to some 
extent the objectives of 
reducing the number of 
non-compliant products 
and scope for unfair 
competition. 
It addresses the objective 
of increasing reliability of 
NB, but only when 
accredited.  
It does not meet the 
objectives of equal 
treatment of EO and of 
consistency of legislation / 
simplification of product 
regulatory framework] Neutral   
[No additional resources 
needed, however objectives 
only partially met.]  Neutral   
[Incoherent with other 
NLF instrument and policy 
commitment underpinning 
NLF Decision] 
Option 2: Non-
legislative 
measures Low: does not provide 
tangible improvement with 
respect to Option 1 due to 
poor enforceability. It will 
increase the compliance 
gap between responsible 
and unscrupulous EO/NB. 
It does not address 
simplification. Low: less efficient than 
Option 1, same 
effectiveness vs higher 
costs for responsible 
stakeholders Neutral   
[Incoherent with other 
NLF instrument and policy 
commitment underpinning 
NLF Decision] 
Option 3: 
Alignment High : addresses all 
objectives. More effective 
than option 1 and option 2 
in relation to the objectives 
of reducing the number of 
non-compliant products 
and scope for unfair 
competition. Effective as to 
simplification.  High : important benefits 
for all stakeholders vs 
small or moderate 
additional costs Coherent  with other NLF 
instrument and policy 
commitment underpinning 
NLF Decision  
In terms of efficiency, the non-legislativ e measure represents the option with the 
lowest score since, on the one hand it doe s not guarantee additi onal benefits with 
respect to the no policy cha nge scenario, despite the a dditional compliance costs to 
be borne by those EO and NB who voluntarily  align with the propos ed best practices. 
As a matter of fact, this option woul d increase the compliance gap between 
responsible and unscrupulous EO/NB.  
 
EN 55   EN As regards coherence, the alignment option a ppears to be the only option that is truly 
coherent with the NLF Regulation, to whic h it represents the natural complement, 
and with the commitment of  the EU institutions to progressively aligning product 
legislation with the ‘model’ legisl ation introduced by the NLF Decision87. 
In the light of these cr iteria, option 3 stands out  as the preferred option. 
8. MONITORING AND EVALUATION  
8.1. Timing aspects 
The adoption of the proposal for the alignm ent of the ten directives with the NLF by 
the Commission is planned for summer 2011. After the adoption by the European 
Parliament and the Council, there will be a two-year transposition period. Hence the new legislation might possibly take effect in the second half of 2014. 
8.2. Evaluation arrangements 
No additional evaluation arrangements will be introduced. Specific reporting 
obligations are already envisaged for the lifts directive and the measuring 
instruments directive. The ev aluation of the effectiveness of the legislation will be 
based on the feedback received through th e various cooperation mechanisms already 
established under the directives  themselves to facilitate their implementation (expert 
groups, administrative cooperation groups (ADCOs), notified body groups). These 
groups meet regularly to discuss particular  aspects relating to  the functioning and 
enforcement (ADCOs) of the directives. Additional feedback will be obtained from the new or expanded cooperation and information exchange mechanisms provided for by NLF Regulation. 
In 2018 the Commission will produce a comp rehensive report on the functioning of 
market surveillance.
88 Which will also allow conclu sions to be drawn for the 
evaluation of this initiative.  
8.3. Monitoring  
8.3.1.  Reduction of non-compliant products 
The monitoring of the reduction of non-comp liance will be possible on the basis of a 
number of enforcement indicators (e.g. nu mber of products checked, number of non-
compliant products among those checked, type of non-compliance found, number of 
non-compliant products whose manufacturer/ importer was identified, number of 
products refused at the border). These enforcement indicators will be based on information provided via: 
– the RAPEX system that since 1 Januar y 2010 covers all products falling under 
the scope of the 10 directives. RAPEX is  the EU rapid alert system for all 
dangerous consumer and non-consumer  harmonised products. The system 
                                                
 
87 See footnote 14. 
88 See Article 40 of Regulation (EC) No 765/2008. 
 
EN 56   EN allows for the rapid exchange of information between MS and the Commission 
of measures taken to prev ent or restrict the marke ting of those products. Both 
measures ordered by national authorit ies and measures taken voluntarily by 
producers and distributors are covered by RAPEX; 
– a general database estab lished under Article 23 of the NLF Regulation for the 
exchange of information among MS on market surveillanc e activities and non-
compliant products 
– the data provided by customs author ities that on the basis of the NLF 
Regulation have a duty to cooperate w ith market surveillance authorities; 
– the National Market Surveillance Progr ammes established by MS on the basis 
of the NLF regulation and their report on the state of the implementation of 
activities programmed; 
– the safeguard clause notification pro cedures established under the relevant 
sector directives according to which MS  notify restrictive measures adopted 
against non-compliant products. 
If the obligations set up by the NLF work we ll, initially an increase in the number of 
products checked and in non-compliant produc ts found can be expected. In the long 
run however the number of non-complia nt products found would go down. The 
increased traceability will be measured by looking at the share of products checked 
for which it has been possible to identif y the main economic operators involved in 
the value chain, namely the manuf acturer and/or the importer. 
8.3.2.  Improving the quality of services  delivered by notified bodies 
The monitoring of the quality of notified bodi es will be based on indicators relating 
to notification practices of Member Stat es (number of notifications, information 
provided on assessment of the body notified , frequency of reassessment, objections, 
de-notification requests, etc..) as well as  on indicators rela ting to conformity 
assessment practices  
These indicators will be base d on information obtained via  
– the NANDO database 
– feedback from Notified Body Groups 
The first results should already become vi sible on the re-notif ication of existing 
notified bodies. Tighter notification require ments and the revised notification process 
should lead to a reduction of the current  number of notified bodies operating under 
the directives. Indicators pointing to more  coherent assessment practices will be an 
increase in notifications based on accreditati on and the need to have recourse to the 
objection procedure. A more coordinated approach towards conformity assessment 
should be reflected in  the increased partic ipation of notified bodi es in coordination 
activities. This will in particular be  monitored by the notified body groups.  
 
EN 57   EN  
9. ANNEX  1: GLOSSARY AND LIST OF ACRONYMS  
The following acronyms are used throughout the document: 
Acronym or 
abbreviations Meaning Additional details  
ATEX ATEX Directive Directive 94/9/EC of the Eu ropean Parliament and the 
Council on the approximation of the laws of the 
Member States concerning equipment and protective 
systems intended for use in potentially explosive 
atmospheres 
BO Business 
Organisation Expression used in the questionnaires for the public 
consultation to identify or ganisation representing the 
interests of several economic operators. 
Civil Explosives Civil Explosives 
Directive Council Directive 93/15/EEC on the harmonisation of 
the provisions relating to the placing on the market 
and supervision of explosives for civil use 
CO Consumer 
organisation  
EA European Co-
operation for 
Accreditation EA is the European network of nationally 
recognised accreditation bodies located in the 
European geographical area. The EA is the 
body recognised pursuant to Article 14(1) of 
the NLF Regulation  
EMC Electromagnetic 
Compatibility 
Directive Directive 2004/108/EC on th e approximation of the 
laws of the Member States relating to electromagnetic 
compatibility and repealin g Directive 89/336/EEC 
EO Economic 
Operator(s) Typical economic operators  are manufacturers, 
importers and distributors . Some directives envisage 
additional categories of EO (e.g. lift installers). 
Lifts Lifts Directive European Parliament and Council Directive 95/16/EC 
of 29 June 1995 on the approximation of the laws of 
the Member States relating to lifts 
LVD Low Voltage 
Directive Directive 2006/95/EEC on th e harmonisation of the 
laws of Member States relat ing to electrical equipment 
designed for use within certain voltage limits 
MID Measuring 
Instruments 
Directive Directive 2004/22/EC of th e European Parliament and 
of the Council on measuring instruments 
MS Member State(s)  Member State(s) of the EU 
 
EN 58   EN NAWI Non-automatic 
Weighing 
Instruments 
Directive Council Directive 2009/23/EEC on the harmonisation 
of the laws of the Memb er States relating to non-
automatic weighing instruments 
NANDO New Approach Notified 
and Designated 
Organisations  Information System containi ng information on all 
conformity assessment bo dies notified under New 
Approach Directives  by MS, EFTA countries (EEA 
members) and other countries with which the EC has 
concluded Mutual Recogn ition Agreements (MRAs) 
and Protocols to the Europe Agreements on 
Conformity Assess ment and Acceptance  of Industrial 
Products (PECAs) 
NB Notified Body(ies) Body notified by a Member State to the Commission as 
entitled to carry out conformity assessment (e.g. 
calibration, testing, certific ation and inspection) of 
products covered by a given product harmonisation 
directive. 
NLF New Legislative 
Framework Consisting of two complementary instruments: (i) 
Regulation 765/2008 on accreditation and market 
surveillance and (ii) Decision 768/2008 establishing a 
common framework for the marketing of products. 
NLF Decision Decision 768/2008  
NLF Regulation  Regulation 
765/2008  
PED Pressure 
Equipment 
Directive Directive 97/23/EC of the Eu ropean Parliament and of 
the Council on the approximat ion of the laws of the 
Member States concerning pressure equipment 
Pyrotechnic Pyrotechnic 
Articles Directive Directive 2007/23/EC on the pl acing on the market of 
pyrotechnic articles 
RTPO Recognised Third 
Party Organisation Conformity assessment body under Article 13 of the 
PED for a limited list of services 
SME Small and medium 
enterprise Expression used in the docu ments to identify the small 
and medium enterprises having participated in the 
consultation run through the Enterprise Europe 
Network. 
SPVD Simple Pressure 
Vessels Directive Council Directive 2009//105/EC on the harmonisation 
of the laws of the Member States relating to simple 
pressure vessels 
UI User Inspectorate Conformity assessment body under Article 14 of the 
PED for a limited list of services 
 
EN 59   EN  
10. ANNEX  2: DETAILED SECTOR DESCRIPTION  
10.1. Civil Explosives  
10.1.1.  The Civil Explosives  Directive 1993/15/EEC 
The Civil Explosives Directive was a dopted in 1993. Its main objective is the 
establishment of a single market for explosives, while maintaining a high level of safety protection. In addition, it aims at im proving security in the industry by setting 
out how the movement of explosives betw een Member States should be supervised. 
It therefore contains stri ct rules on the registrati on and documentation of the 
whereabouts of explosives.  
The directive applies to civil explosives, i.e. to explosive substances and articles 
which are not used by the armed forces or  the police, but commercially. The main 
end-users of civil explosives  are the mining industry, the quarrying industry, and the 
construction and civil engineering industr y (primarily for demolition, land clearance 
and tunnelling).  
The conformity assessment procedures provi ded for in the directive make mandatory 
use of the services of notified bodies. 13 bodi es are currently notified under the Civil 
Explosives Directive.  
10.1.2.  The civil explosives sector 
The civil explosives sector in Wester n Europe (mainly the old EU 15) has a 
consumption in excess of 250 000 metric t ons per year, while in Eastern Europe 
(mainly the new Member States), th e figure is around 350 000 metric tons. 
Altogether, as shown in table 7 and 8 be low, more than 550 000 metric tons of 
explosives at a value of around EUR 700 million are placed on the EU-27 market every year. 
Table 7: EU 27 Civil Explosives sold in 1000kg (Source: EUROSTAT, Prodcom) 
EU 27 Civil Explosives sold (in 1000kg) 
Type of Civil Explosives 2004 2005 2006 2007 2008 
Prepared explosives (excluding propellent powders) 486,649 435,930 485,656 485,961 549,546
Propellent powders 7,762 8,296 10,382 23,754 8,915
Safety fuses; detonating fuses 199 198 192 178 191
Total 494,610 444,425 496,230 509,892 558,652
 
EN 60   EN Table 8: EU 27 Civil Explosives sold in EUR (Source: EUROSTAT, Prodcom) 
EU 27 Civil Explosives sold (in EUR) 
Type of Civil Explosives 2004 2005 2006 2007 2008 
Prepared explosives (excluding 
propellent powders) 508,772,694 494,115,602 538,996,396 579,364,617 568,264,920
Propellent powders 78,525,105 81,861 ,678 90,777,257 97,336,385 101,994,321
Safety fuses; detonating fuses 38,600,347 37,869,040 37,880,126 36,592,109 35,054,003
Total 625,898,146 613,846,320 667,653,779 713,293,111 705,313,244
While quarrying is the most important se ctor of the Western European mining 
industry, representing 58% of the market in  2003, coal mining is the most important 
activity in Eastern Europe, accounting for an  estimated 53% of to tal consumption in 
2003. However, in the EU, the mining and quarrying industries ty pically make up a 
much lower share of overall explosives consumption than elsewhere in the world. That is, explosives used for civil engineering purposes, in particular for demolition works in the construction sect or, are an important source  of demand in the EU and 
constitute a significant market.  
In addition, the sector covered by the Ci vil Explosives Directive also comprises 
initiating systems, which include detonato rs. In the EU, around 68 million units of 
detonators at a value of approximately  EUR 70 million are produced annually for 
EU-consumption. Explosives are rarely sold i ndividually, but mostly as part of larger 
service packages, which can include su ch initiating systems (detonators and 
detonating cords), storage, drilling, filling and blasting advice and execution, as well 
as dragging and even crushing.  
The business volume of the explosives sect or, including blasting a nd drilling devices, 
amounts to EUR 1.1 billion. Adding the va lue of EUR 250 million generated by 
distributors in the sector, the total market  size of the EU civ il explosives industry 
amounts to EUR 1.35 billion. As demonstrated  in the first table above, the overall 
consumption of civil explosives in the EU is more or less stable. However, growing 
demand by developing count ries is expected.  
As far as businesses in the civil explosives  sector are concerned, 20 manufacturers of 
explosives, as well as approximately 500 d ealers and distributors are active in the 
EU. At the manufacturers’ level, there ar e no SMEs, as major investments are needed 
to fulfil safety and security conditions  for market entry. Around 4 000 people are 
directly employed by these companies. Near ly all of the distributors, on the other 
hand, are SMEs and altogether employ around 5 000 people. Thus, a total of 9 000 
people are employed by the civil ex plosives industry in the EU. 
All businesses operating in the civil explosives sector face a highly competitive 
environment. Most of them have over capacity and consump tion is not growing, 
forcing manufacturers to rationa lize and concentrate their op erations. As a result, the 
trend in the industry is towards consolid ation. Larger competitors buy up smaller 
ones to expand their businesses across na tional borders. Consequently, a small 
 
EN 61   EN number of international groups have em erged. Companies operating in more than 
one country is a feature which is expected to continue to develop. 
The industry’s trade patterns reflect these trends. While businesses still derive the 
majority of their income from their resp ective national market s, intra-community 
trade is increasing. Trad e between EU Member Stat es amounts to about 35 000 
metric tons per year, i.e. to around 6% of total EU explosives consumption. For 
safety and security reasons, most of this cross-border trade occurs between existing 
explosives manufacturers at intra-company level. With mo re and more manufacturers 
establishing subsidiaries in several Member States, intra-company trade across borders can be expected to intensify. 
Trade with third countries is limited in the civil explosives sect or, since explosives 
are bulk products with strict  safety and security re quirements causing high 
transportation costs. This makes the proxim ity of production units to the sites of use 
a crucial factor for success and is anot her reason for the incr eased consolidation 
activity in the sector. Concerning exports , 100 000 tons of explosives and 30 million 
units of detonators correspondi ng to 16% of sales of EU companies are generated in 
the global market. Imports, on the other ha nd, play a significant role only in niche 
markets like explosives used for offshore drilling operations. Important trading 
partners are Norway, Switzerland and the US A. Importers in the EU are generally 
large companies with specific demands, fo r example in the o il drilling industry. 
Accidents with civil explosives can have severe consequences including casualties or 
serious injuries and may cause signi ficant economic damage to surrounding 
infrastructures. They are rath er rare, given the tonnage of explosives used annually in 
the EU. 
10.2. Pyrotechnic Articles 
10.2.1.  The Pyrotechnic Articles Directive 2007/23/EC 
The Pyrotechnic Articles Directive was a dopted in 2007. It is thus a very new 
directive, which has to be applied by Me mber States from July 2010 for consumer 
fireworks and from July 2013 for all other py rotechnic articles. The directive’s main 
objectives are to protect human health and sa fety and to create a single market for 
pyrotechnic articles in the EU. 
The directive regulates the placing on the ma rket of pyrotechnic articles. As such, it 
mainly applies to fireworks, theatrical pyrotechnic articles a nd pyrotechnic articles 
for technical purposes in vehicles (automotiv e restraint systems, i.e. most importantly 
gas generators used in airbags and seatbelt tensioners). Some pyrot echnic articles are 
excluded from the scope of the directive, such as ammunition, a nd products used in 
marine equipment, in the aerospace industry and by the armed forces, the police or fire departments. 
Conformity assessment procedures in the di rective make the involvement of notified 
bodies obligatory. Until now, 10 bodies ha ve been notified under the Directive A 
particular challenge for notif ied bodies dealing with consum er fireworks arises from 
the fact that more than 95% are manufact ured overseas, notably in China, which 
makes it more difficult to apply quality assu rance modules that necessitate an audit 
 
EN 62   EN of the quality system put in place by the manufacturer, and raises questions about 
subcontracting to non-EU entities. 
10.2.2.  The pyrotechnics sector 
The products covered by the Pyrotechnics Ar ticles Directive, correspond in principle 
to two sectors: fireworks and auto motive occupant restraint systems. 
The total EU market for fireworks is es timated by industry at around EUR 1.4 billion 
per year. This is equally di stributed between sales to c onsumers (categories 1, 2 and 
3 of the directive) and sales to professiona ls only (category 4 of the directive).  
Automotive occupant restraint systems ma inly comprise airbags and seatbelt 
tensioners. In 2009, around 65 million airbag systems were produced in the EU market, representing a market value of around EUR 1.8 billion. As regards seatbelts, 
approximately 80 million units at a value of about EUR 1 billion were produced in the EU in 2009. This amounts to a total mark et size of roughly EUR 2.8 billion for 
automotive occupant restraint systems. 
The overall market size of the pyrotechnics sector covered by  the Directive is thus in 
the region of EUR 4.2 billion per year. While sales of fireworks are stagnant, sales of 
automotive pyrotechnic articles depend on th e number of cars sold. The difficult 
economic situation in 2009, especially for th e car industry, must thus be taken into 
account when considering the market si ze of automotive pyrotechnic articles. 
Depending on future recovery, th is could grow significantly. 
Concerning the structure of  businesses operat ing in the pyrotechnics sector, the 
fireworks and automotive sectors must ag ain be distinguished. The EU fireworks 
industry mainly consists of SMEs and altogether employs an estimated 15000 to 
20000 people in the EU. However, as most co mpanies operate in more than just the 
fireworks area and additionally employ seas onal workers for the peak season from 
late November onwards, this number is ve ry hard to judge. In general, most 
businesses in the pyrotechnics sector ar e engaged in the pur chase, distribution, 
storage or professional display of firework s. There are roughly 500 importers in the 
EU, serving an estimated number of 200 000 distributors (including large chain 
stores etc.). The manufacture of firework s in the EU has diminished significantly 
over the last decades and is very limited today. It mainly takes place in Germany, 
Italy, France, Spain, Portugal and the UK a nd focuses on fireworks for professional 
use (category 4). As shown in table 1 below, other manufact uring has primarily 
moved to China, where by far the most European imports come from today.  
The situation for automotive pyrotechnic articles is very different. The enterprises 
active in this sector in the EU are big international automotive supplier companies 
and have around 40 000 employees. These comp anies generate about two thirds of 
pyrotechnic articles sales in the EU. Th ree international groups active in the 
automobile occupant restraint sector acc ount for about 75% of the global market.  
Differences between the fireworks and the automotive pyrotechnics sectors are also 
evident with regard to trade patterns. Wher eas, as illustrated by the tables below, the 
EU is a net importer of fireworks, it is  a net exporter of automotive components 
containing pyrotechnic articles. 
 
EN 63   EN Table 9: EU 27 Trade in firewo rks (Source: EU ROSTAT, Comext) 
EU 27 Trade in fireworks (in 100kg)  
Imports from China 
Period Total imports 
in 100kg % of total Total exports 
2004 1,094,751 1,059,577 96.79% 9,182 
2005 1,049,011 837,278 79.82% 17,077 
2006 1,113,285 1,062,821 95.47% 13,138 
2007 1,182,618 1,143,455 96.69% 16,202 
2008 1,103,475 1,088,056 98.60% 18,093 
The available import and export figures for airbag systems are given in table 2 and 
demonstrate the EU’s export activity in this field. However, it must be noted that more airbag systems are exported as part of assembled motor vehicles.  
Table 10: EU 27 Trade in airb ags (Source: EUROSTAT, Comext) 
EU 27 Trade in airbags (in EUR)  
  2007 2008 
Import 202,567,266 208,777,513 
Export 229,243,222 320,151,508 
 
Defective fireworks, e.g. fireworks which i gnite prematurely, can lead to ear damage 
caused by excessive sound levels, severe burns  and eye injuries, and in some cases 
even death. As in other sectors, it is of ten difficult to determine if accidents caused 
by fireworks were caused by malfunction or  by misuse. According to a projection by 
the EU injury database89, there are about 27.000 injuries due to fireworks in the EU 
annually. This represents 0.07% of all inju ries. It is estimated that misuse is 
responsible for most of th ese injuries although high product failure rates (sometimes 
more than 50 per cent) are reported by no tified bodies when they  perform conformity 
assessment.  
                                                 
89 Kuratorium für Verkehrssicherheit KfV (Ed.) (2010) Data Report “Injuries with Fireworks in the EU”, 
EU Injury Data & Reporting Services. Vienna: Kf V; Source: EU Injury Database (IDB) of the 
European Commission, DG SANCO, and the network of national IDB data providers at 
https://webgate.ec.europa.eu/idb/ ” 
 
EN 64   EN 10.3. Pressure Equipment 
10.3.1.  The Simple Pressure Ve ssels Directive 2009/105/EC 
The SPVD was adopted in 1987 (87/404/EEC). As such, it is the oldest directive 
based on the 1985 New Approach. Its main objective is to guarantee the free movement of simple pressure vessels in th e internal market, while maintaining a high 
level of safety. The directive was recently codified, integrating the amendments to 
the original directive in a new single legal document 2009/ 105/EC without changing 
the technical content. 
The SPVD applies to simple pressure vesse ls manufactured in series. These are 
defined as “any welded vessel subjected to an internal gauge pressure greater than 
0,5 bar which is intended to contain air or nitrogen and wh ich is not intended to be 
fired” (Art. 1(2)). The types of vessels covered include ai r receivers and vessels used 
in braking systems of trucks and railway vehicles. 
Simple pressure vessels are classified de pending on their total energetic content, 
which is determined by the pressure and th e volume of the vessel. Depending on this 
category, different conformity assessment procedures apply, which mostly require 
the involvement of a notified body. 95 bodies  are currently notified under the SPVD. 
10.3.2.  The Pressure Equipment Directive 97/23/EC 
The PED was adopted in 1997. It primarily aims at ensuring the free placing on the 
market and putting into service of pressure equipment within the internal market, while maintaining a high level of safety. 
The PED covers stationary pressure e quipment and assemblies with a maximum 
allowable pressure greater than 0,5 ba r, as designed and specified by the 
manufacturer. The products covered by th e directive can roughly be grouped into 
vessels (e.g. vessels for liquefied gas st orage, chemical reactors and distillation 
columns, industrial compressed air receiver s, etc.), boilers (e .g. hot water boilers, 
steam generators, etc.), piping (i.e. systems of pipes used to convey fluids), pressure 
and safety accessories (e.g. valves, pressure  regulators, etc.) and assemblies, which 
integrate pressure equipment into a func tional whole (e.g. (petro)chemical process 
plants, air conditioning systems, etc.).  
Most products covered by the PED are used  in an industrial environment (process 
industries, energy production), but there are also some consumer products, such as pressure cookers and fire extinguishers. 
Significant subsets of products, covered by other (harmonised)  legislation, are 
excluded from the scope of the directiv e (e.g. automobile, machinery, medical 
devices, etc.). 
Regarding conformity assessment, the PED provides for a wide range of modules (or 
combinations thereof) depending on the product category. Even though the services 
of a notified body are not always manda tory, most procedures require the 
involvement of a notified body. Currentl y, 166 European NB s operate under the 
PED. In addition, there are 53 Recognised Third Party Organisations (RTPO) and 20 
 
EN 65   EN User Inspectorates (UI) w ith specific and limited responsibilities, defined in the 
directive. 
10.3.3.  The pressure equipment sector 
Describing the market characteristics of  the sector covered by the PED and the 
SPVD is difficult. The problem is that the pressure equipment sector as such does not 
exist on the market. Most pressure equipm ent is used as components of a larger 
whole (e.g. pressure vesse ls and piping in chemical  plants, components of 
machinery, etc.) and is thus very hard to trace in terms of market data. While most 
pressure equipment is used industrially, th ere are also some consumer products (e.g. 
pressure cookers, domestic air conditioning systems, fire extinguishers, high pressure 
cleaning systems, etc.), adding to the ove rall diversity. As a result, the market 
characteristics of pressure equipment c overed by the PED and the SPVD may vary 
substantially, even within just one  product category such as boilers.90  
Market data on these sectors is almost im possible to obtain. Information sources are 
restricted, as there is no single EU prof essional association representing the whole 
pressure equipment sector. Official statis tical classification systems only reference a 
limited number of relevant products.91 Several attempts undertaken in the past to 
quantify the market for pressure equipment in Europe have failed. 
A complete picture of the sector in qua ntitative terms cannot therefore be given. 
However, some general trends can be discerned. Most importantly, the 
manufacturing of pressure equipment is gra dually shifting to low cost countries. This 
certainly applies to mainstream pressure eq uipment, but also (a nd increasingly) more 
complex products. While these are for the mo st part still desi gned in Europe, low 
cost countries are catching up quickly w ith regard to know-how and worker 
qualifications. More competiti on is expected, especially from Asian countries, on the 
worldwide market in all product groups. 
Production of, and trade in, fi re extinguishers is a good ill ustration of this trend. 
Within two years, China developed into th e leading export country  to the EU. Nearly 
half (11 million units) of all fire extingui shers imported into the EU 27 in 2005 (22 
million units) originated in China.  
Failure of pressure equipment can have cat astrophic consequences. The explosion of 
a boiler or a reactor vessel in a chemical plant is likely to lead to casualties or serious injuries and may cause significant economic damage to surrounding infrastructures.  
                                                
 
90 For this example, a distinction between boilers fo r small applications (e.g. warm water production for 
domestic use), boilers for smaller and bigger industrial applications (e.g. hot water or steam 
production), and specifically designed boilers for the (petro-)chemical industry or for power generation would have to be made. Evidently, the market situ ation for each of these pr oducts would be very 
different and what is valid for one category might not be valid at all for another. 
91 Within Eurostat’s classifications, the classes of NACE (Rev. 2, currently used alongside the older 
version Rev. 1.1) 24 covering the “manufacture of basic metals” and NACE 25 on the “manufacture of 
fabricated metal products, except m achinery and equipment” are of particular importance. The two most 
relevant sub-classes are NACE 25.21 (“manufacture of tanks, reservoirs and containers of metal” – 
“manufacture of central heating radiators and boilers”) and NACE 25.3 (“manufacture of steam 
generators, except central heating hot water boilers”). 
 
EN 66   EN 10.4. The Low Voltage Directive 
10.4.1.  Definitions and scope 
For the purposes of the LVD, “electrical equipment” means any equipment designed 
for use with a voltage rating of between  50v and 1000v for alternating current and 
between 75v and 1500v for direct current, other than the equipment and phenomena 
listed in Annex II (see below).  
The LVD ensures that electri cal equipment within certain voltage limits provides a 
high level of protection for Eu ropean citizens. It covers a broad variety of electrical 
and electronic products, as well as equipment and systems.  
According to the Statistical Classificati on of Economic Activitie s in the European 
Community (NACE) the products  covered by the Directive are: electric welding and 
soldering tools, electric domestic app liances, computers and other information 
processing equipment, electric motors, ge nerators and transf ormers. Electricity 
distribution and control apparatus, insula ted wire and cable, lighting equipment and 
electric lamps, other electrical equipment, electronic valves and tubes and other electronic components, televisi on and radio receivers, s ound or video recording or 
video recording or reproducing apparatus and associated goods. 
Equipment listed in Annex II is outside the scope of the Directive: electrical 
equipment for use in an explosive atmos phere (which is covered by the ATEX 
directive, also included in this alignm ent exercise), electrical equipment for 
radiology and medical purposes, electrical  parts for goods and passenger lifts, 
electricity meters, plugs and socket out lets for domestic use, electric fence 
controllers, radio-electrical interference, specialized electrical equipment, for use on 
ships, aircraft or railways.  
10.4.2.  Facts and figures 
The EU is the most open market for elect rical equipment and appliances among large 
trade blocs and industrial countries. The EU legislation that most directly concerns 
electrical equipment of low voltage is  the LVD. The absence of third-party 
intervention in the conformity assessment procedures laid down by the LVD greatly reduces the burden on the manufacturer. This is a model of business friendly 
legislation for other trade blocs. The LVD has substantially contributed to the EU 
internal market for electrical and electronic products since 1973. 
Most electrical equipment is also subj ect to the Directive on Electromagnetic 
compatibility (EMC Directive). Although recognising the need for and benefits of harmonisation, industry believes that the cumulative effect of legislatio n originating 
from various policy areas and levels can pose problems, particularly for SMEs.  
The total output of the electrical, electr onic and telecom sector was €501,771 million 
in 2007 of which €235,585 million was attributable to products covered by the LVD. 
The balance of trade is negative for th ese products in Europe with €103,929 million 
of imports and €83,091 million of exports. This is due to the sustained increase in 
ICT imports from south-east Asian countries in  the last four years. Most imports of 
 
EN 67   EN these products come from China, followed at a considerable distance by the USA, 
Japan and South Korea. 
Internal consumption is estimated at € 256,423 million. The number of enterprises involved in the sector is 60,485 employing 1,645,495 
people. The structure of the industry is ch aracterised by a few large corporations 
producing a wide range of electrical e quipment, and many small companies 
specialised in niche markets. 
During the last decade, production, exports and the internal market have steadily 
grown. This trend was abruptly stopped by the economic crisis. 
Defective electronic products can present a risk of electric shoc k or burns. Electronic 
products are among the product categories most frequently notified through the 
Commission’s RAPEX system (Rapid Alert system for non-food consumer products), a system that contains products which pose a serious risk to the health and 
safety of consumers. 138 RAPEX notif ications were registered in 2009
92 
corresponding to 8% of the total number of RAPEX notifications. Given that most 
notifications are not linked to accidents, th e number is relatively low in view of a 
total of 2 million product types in a market of more than € 250 billion/year and 500 
million citizens.  
10.5. The Electromagnetic Compatibility Directive 
10.5.1.  Definitions and scope 
The EMC applies to a vast range of equipment encompassing electrical and 
electronic appliances, systems and installati ons. The main objective  of the EMC is to 
guarantee the free movement of apparatus and create an accepta ble electromagnetic 
environment in the Community. To achieve  this, the EMC requires a harmonised and 
acceptable level of protection, l eading to full EU harmonisation. 
The main objectives of the EMC are: (1) To ensure that electromagnetic di sturbance produced by equipment does not 
affect the correct functioning of other a pparatus and radio a nd telecommunications 
networks, related equipment and el ectricity distribution networks. 
(2) To ensure that equipment has an adequate level of intrinsic immunity to 
electromagnetic disturbances to en able them to operate as intended. 
The involvement of the Notified Body is ra ther limited. It is voluntary and the 
purpose of the body is to help the ma nufacturer by reviewing the technical 
documentation for apparatus drawn up by the manufacturer.  
According to the Statistical Classificati on of Economic Activitie s in the European 
Community (NACE) the group of products th at could be covered by the Directive 
                                                
 
92 See 2009 Annual Report on the operation of the Rapid Alert system for non-food consumer products. 
http://ec.europa.eu/consumers/safety/rapex/docs/2009_rapex_report_en.pdf  
 
EN 68   EN are: electric welding and soldering tools, electric domestic appliances, computers and 
other information processing equipmen t, electric motors, generators and 
transformers, electricity distribution a nd control apparatus, other electrical 
equipment, television and radio receivers , sound or video recording or video 
recording or reproducing apparatus and associated goods. 
Equipment outside the scope of th e Directive: radio equipment and 
telecommunication terminal equipment, aer onautical products, radio equipment used 
by radio amateurs as defined in the International Telecommunications Union 
Regulations, motor vehicles, medical device s, measuring instruments, and any kind 
of inherently benign equipment, this is to say equipment whose inherent physical 
characteristics are such that it is incap able of generating or contributing to 
electromagnetic emissions which exceed a level allowing radio and telecommunications equipment and other equi pment to operate as intended, and that 
it will operate without unacceptable degradation in the presence of the electromagnetic disturbance normally pr esent in its intended environment. 
10.5.2.  Facts and figures 
This Directive is based on ma nufacturer self-declaration of  conformity and is much 
appreciated by industry. Most electrical equi pment is also subjected to the LVD. 
The total output of the electrical, electr onic and telecom sector was €501,771 million 
in 2007 of which €200,117 million relates to the products covered by the Electromagnetic Compatibility Directive. 
The balance of trade is negative for these products with €100,775 million of imports 
and €76,066 million of exports. This is due to the sustained increase of ICT imports from south-east Asian countries in the last four years. Most imports of these products 
come from China, followed at a considerable distance by the USA, Japan and South Korea. 
Internal consumption is estimated at €224,826 million. The number of the enterprises involved  in the sector is 51,362 employing 1,209,533 
people. The structure of the industry is ch aracterised by a few large corporations 
producing a wide range of electrical e quipment, and many small companies 
specialised in niche markets. 
During the last decade, production, exports and the internal market have steadily 
grown. This trend was abruptly stopped by the economic crisis. 
Electrical equipment that does not comply with the essential requirements of the 
EMC directive could produce electromagnetic disturbances that affect the correct 
functioning of other apparatus like TVs or  radio and telecomm unications networks. 
If it does not have the requi red level of electro magnetic immunity it will not operate 
as intended in the electromagnetic environment for which it is intended.  
 
EN 69   EN 10.6. The ATEX Directive 
10.6.1.  Definitions and scope 
The ATEX Directive 94/9/EC (in force si nce 1 July 2003) regulates Equipment and 
Protective systems intended for use in Potentially Explosive Atmospheres.  
A potentially explosive atmosphere is com posed by air mixtures of gases, vapors, 
mists or dusts, which can ignite under certain operating conditions. 
ATEX provides the tech nical requirements to be applie d and the relevant conformity 
assessment procedures before placing this  equipment on the European market. These 
requirements are given technical expressi on by “Harmonized Standards”, developed 
by the European Standardization Organizations. 
Member States and others who apply th e requirements of ATEX are directly 
responsible for its implementation and enforcement, as well as, for example, the management of notified bodies. 
Equipment and protective systems inte nded for use in poten tially explosive 
atmospheres cover quite a large range of products, including equipment used on fixed offshore platforms and in petrochemical plants, mines, flour mills and other areas where a potentially explosiv e atmosphere may be present. 
Products affected by this Directive are some  of the mechanical and electrical sectors 
specially manufactured to be used in po tentially explosive atmospheres such as: 
pumps and compressors, bearings, gears a nd driving elements, lifting and handling 
equipment, non-domestic cooling and ventil ation equipment, machinery for mining, 
quarrying and construction, electric motors, generators and transformers, electric 
distributing and control apparatus, lig hting equipment and electric lamps and 
industrial process c ontrol equipment. 
10.6.2.  Facts and figures 
The group of products covered by ATEX cannot be considered an economic sector in 
the usual sense of the term. It includes both mechanical and electrical equipment, and 
even telecom equipment, including non-c onsumer goods but with  specific industrial 
products in a relatively restrict ed sector. The ATEX sector is a very specific market, 
primarily with products for oil, gas and petro-chemical plants.  
Only a small number of enterprises specia lise in ATEX equipment in Europe. ATEX 
equipment of different kinds and categorie s is used as part of a wider production 
process, as “ATEX-adaptation” of basic equipment. In this sense, it is quite difficult 
to evaluate the real turnover and mark et share of ATEX equipment for these 
enterprises. 
The production value of ATEX products is estimated at € 2.2 billion of which we 
export around 32%. Imports amount to €400  million. Consequently, our internal 
consumption is estimated at € 1.9 billion, 86% of our production. 
ATEX equipment manufactured in Europe is mainly aimed at the internal market, but 
is also exported to other European countri es outside the EEA as well as to the United 
 
EN 70   EN States of America and to Asian countries. The most important countries of origin of 
imports are the USA, China, Japan, South Korea and Canada. 
More than 750 companies produce ATEX products in Europe, employing around 
15,600 people. There are relatively few “real  ATEX” manufacturer s, operating in 
niche markets with few competitors. 
There are around 100 importers, mainly inte rnational/multinationa l companies. The 
ATEX sector is characterized by a large number of SME’s and micro enterprises, 
around 90%, mainly based in France, Germ any, Italy and the United Kingdom, but 
also with a significant presence and ma rket share in Denmark, the Netherlands, 
Norway, Poland, Spain, Sweden as well as in Switzerland. In many cases, the largest 
companies have local branches and/or fact ories in other European and non-European 
countries. 
On the European market there is also a significant presence and market share of 
ATEX equipment produced by companies with factories, production and/or 
distribution centres in Europe but owne d by non-European groups, or directly 
imported from non-European countries. 
As noted by market analysts, legislation on hazardous areas contributed to significant 
market growth. During the first period of the implementation of the ATEX Directive 
(from publication to en try into force on 1st July 2003), the market did not record 
relevant changes, given that a large num ber of products already fall under “Old 
Approach” legislation. During the sec ond period (from entry into force on 1st July 
2003 onwards), taking into consideration also the general growth of  production in the 
oil, gas, chemical and pharmaceutical sect ors, the market evolved towards a re-
organisation and increasing effectiveness:  the number of pr oducers continues to 
decrease, via a seri es of mergers or acquisitions , with both European and non-
European entities, in order to enable greater economies of s cale and cost-sharing 
relating to the development of new products  and innovative solutions, in particular 
for intrinsic safety. 
At present, there are 55 ATEX Notifie d Bodies in the European Union.  
Non-compliance of equipment used in pot entially explosive atmospheres can have 
catastrophic effects. In fact, risks deri ve from equipment capable of causing an 
explosion through its own potential sources of  ignition, for example electric sparks, 
electrostatic discharges or hot surfaces. C onsequences of this kind of explosion 
include severe or deadly injuries to persons, serious damage to installations and surrounding civil and industrial infrastructures. Recent accide nts in the EU related to 
the sector (e.g. in chemical plants, coal mi nes or agricultural pr emises), do not seem 
to be caused by non-compliant or unsafe e quipment as such, but rather by the use of 
equipment not suitable for specific hazard zones, failure to identify environments 
with potentially explosive atmospheres, failure to take specific safety measures, or even by the incorrect operati on and misuse of equipment.
93  
                                                 
93 In any case, investigation of accidents in these cases  is normally quite difficult and complex, due to the 
large number of factors and operational aspects to be taken into consideration, as well as their 
interconnections ("chain of events"). Main source of  reference for accidents: Marzio Marigo, "Rischio 
 
EN 71   EN 10.7. The Lifts Directive 
10.7.1.  Definition and scope 
Lifts provide an essential means of comfor table and safe access to modern buildings. 
The provision of lifts in new buildings has an  increasingly important role to play in 
an ageing society giving growing priority to the social integr ation of people with 
special needs. 
European Parliament and Council Di rective 95/16/EC of 29 June 1995 on the 
approximation of the laws of the Member States relating to lifts establishes European legal requirements for the design, installati on and placing on the market of new lifts. 
It also sets out the conformity assessment procedures to be followed by lift installers 
to ensure conformity with these requireme nts. The provisions of the Directive are 
implemented in the national law of each Member State of the European Union. 
The Directive has the twin aims of facilitating the free circulation of lifts and its 
safety components within the internal EU ma rket and ensuring a high level of safety 
for lift users and maintenance staff. 
While harmonized European legislati on governing the design, manufacturer and 
installation of lifts is mainly addre ssed to lift installers and components 
manufacturers, it also has important impli cations for owners and users of lifts 
The Directive covers new lifts permanently installed in buildings and constructions 
for carrying passengers or passengers and load s. It also applies to certain safety 
components for lifts listed in Annex IV to the Directive. 
In the European classification of activities , the scope of this Directive would be 
covered by heading 28221630 ‘Electrically opera ted lifts and skip hoists’ and in the 
Combined Nomenclature by heading 84281020. 
10.7.2.  Facts and figures 
Europe is by far the leading continent in terms of lifts installed, 56% of world lifts 
compared to 14% in North America and 30% in Asia Pacific, in 2009. 
Although Europe, with 150 000 new lifts/year (30% of world to tal), is still the leader, 
the manufacturing of new lifts is shifting to Asia (China  – 315,000 new lifts/year and 
North America – 35,000 new lifts/year). Howeve r, Europe also l eads the way in lift 
technology development. Furthermore, Europ ean standards for lifts are used widely 
around the world and more than 85% of lifts and escalators are based on those 
standards. 
In 2009, the production value of lifts in  Europe amounted to €3.167 billion.  
EU trade balance is positive with €36 m illion of imports and €693 million of exports. 
                                                                                                                                                        
 
atmosfere esplosive: classificazione, valutazione, prevenzione e protezione". IPSOA-Indicitalia, Milano 
2009. Pages 13-29 
 
EN 72   EN Consumption in the internal market was €2.51 billion. 
In Europe the main producing countries are Spain, Germany and France, showing a 
steady progression over recent years. 17,778 enterprises make lifting and handling 
equipment in Europe. Around 134,000 employees work in the sector.  
The main countries of origin of imports are China and Turkey. The European market is dominated by 4 big companies but there is also a significant 
number of SMEs. Manufact urers usually outsource the production of many 
components and buy from suppliers. 
“Machine-room less lifts ” are now the leading technology in Europe.  
In 2009, the number of lifts in Europe (i ncl. Switzerland and Norway) reached 4.7 
million units.  
Production progressed over recent years be fore the economic slowdown, increasing 
by 9% between 2006 and 2007 and by 5% between 2008 and 2007. 
A lift that lacks appropriate free spaces or re fuge when the lift car is in one of its 
extreme positions can create a risk of crus hing. Although lifts are used 1 billion times 
a day across Europe, only a small number of  persons killed using lifts has been 
recorded. The most frequent cause of accidents is the absence of a lift door, locking 
problems or bad stopping accuracy despite al l these being regulated by the provisions 
of the Lifts Directive.  
10.8. Measuring Instruments 
10.8.1.  The Non-Automatic Weighing Inst ruments Directive 2009/23/EC 
NAWI was adopted in 1990 and is thus one of the oldest dire ctives based on the 
1985 New Approach. It was recently codi fied in a new single legal document 
2009/23/EC integrating all amendments to th e original directive, without however 
substantially changing it s technical content. 
NAWI applies to all non-automatic weig hing instruments, i.e. to measuring 
instruments serving to determine the mass of a body and requiring the intervention of 
an operator during weighing. Such instrume nts are used for a broad variety of 
purposes, for instance the calculation of payments, the application of laws or 
regulations, for determining a price of  sale on the basis of mass, making up 
medicines on prescription in a pharmacy, etc. They are used in quite sensitive areas. Apart from ensuring their free movement, an  important objective of the directive is 
therefore the protection of the public (users and third partie s) against incorrect results 
of weighing operations. 
As regards conformity assessment, NAWI provides for a choice between two 
different procedures. However, both procedur es envisage the invol vement of notified 
bodies, making them an integral part of  NAWI conformity assessment. 270 bodies 
are currently notified under NAWI, many of which are local public  authorities like 
city councils. 
 
EN 73   EN 10.8.2.  The Measuring Instruments Directive 2004/22/EC 
MID was adopted in 2004, rep ealing a number of old directives on specific 
measuring instruments and bringing the whole field under the New Approach. The 
main objective of the MID is to ensure th e free movement of measuring instruments 
and in particular to avoid barriers to tr ade because of different provisions of legal 
metrological control in the Member States. In the context of such legal metrological 
control, public health and safety as well as  the protection of the environment and the 
consumer are also concerns of the MID. 
The MID covers 10 categories of devices and systems with a measuring function, 
namely water meters, gas meters, electricity meters, heat meters, meters for liquids other than water, weighing machines, taxi meters, material measures to measure 
length, dimensional measuring instruments a nd exhaust gas analysers. Each of these 
diverse categories is defined in more detail in the annexes to the directive, where the respective essential requirements as well as the conformity assessment procedures 
are specified. 
Overall, the MID provides for a very wide  range of conformity assessment modules. 
Depending on the category of product, differe nt combinations of modules may be 
used at the choice of the manufacturer. However, the involvement of a notified body 
is always obligatory. Currently, 140 bodies are notified under the MID. 
10.8.3.  The measuring instruments sector 
An important sub-sector of the measuri ng instruments sector is the weighing 
industry. In 2008, production of weighing in struments covered by NAWI amounted 
to €2.5 billion. 
Only a limited number of companies manuf acture weighing instruments in the EU, 
such as balances and scales, from begi nning to end. The majority of companies 
assemble components from different manufact urers. Regarding the size of companies 
in the EU weighing industry, the sector is  without a doubt carried by SME. In fact, 
bigger companies with more than 250 em ployees account for only 4% of the total 
number of businesses in the industry. While medium sized  enterprises (of less than 
250 but more than 50 employees ) represent 35%, small comp anies (of less than 50 
employees) make up 60%. Altoge ther, 25 000 people work in  the industry, more than 
half employed by SME. 
Apart from these companies, another 4000 to 5000 micro companies of only 1 to 3 
employees, i.e. a total of about 10000 people, are involved in the weighing industry. They mostly provide services, but occasionally  assemble scales in limited editions.  
Market for legal metrology instruments covered by the MID The MID applies to around 345 million units of measuring instruments sold annually 
in the EU with a total sales value of  around €3.25 billion. Ar ound 900 manufacturers 
operate in the 10 sectors covered by the MI D not including the large number of SME 
operating as distributors, impor ters or providers of repa ir services. The number of 
employees in the sector is around 175,000- 205,000.  
 
EN 74   EN Table 11: – Total size of market covered by the MID 
  Market size – 
number of items sold 
annually (000s) Market size- 
value of items 
sold annually  
(million €s)  Share in 
total Mis 
market Employees 
occupied in 
sector  
(1000s) 
MI-001 : Water Meters 18,000 450 13.8% 25 
MI-002: Gas Meters & 
Conversion Devices 6,900 410 12.6% 30 
MI-003: Active Electricity 
Energy Meters 14,000 610 18.8% 32 
MI-004: Heat Meters 800 290 8.9% 18 
MI-005: Measuring Systems 
for Liquids other than 
Water 31.2 240 7.4% 14-16 
MI-006: Automatic 
Weighing Instr. 21 550 16.9% 25 
MI-007: Taximeters 50 25-40 1% 1 
MI-008: Material Measures94 300,000 440-490 14.3% 34 
MI-009:Dimensional 
Measuring Instr. 300-400 70-80 2.3% 7 
MI-010: Exhaust Gas 
Analysers 25-35 130 4.0% 17.5 
Total 345,000 3,250 100% 190 
Around 20-25% of measuring instruments in  the EU27 are imported while 25-30% 
of measuring instruments produced in th e EU27 are exported to third countries. 
There is however considerable variation am ong the different cate gories of measuring 
instruments. Trade levels in both directions  are particularly high (over 50% of total) 
for the less technology-int ensive categories of material measures (MI-008) and 
dimensional measuring instruments (MI-009) but also for electricity meters (65%). 
At the same time, the share of production expo rted is particularly high in the case of 
more advanced technology instruments such  as Automatic Weighing Instruments (up 
to 42% for the sub-category of automatic gr avimetric filling instruments) and in the 
Gas Meters category (44%) where EU firms are world leaders. 
                                                 
94 Data refer to all material measures of le ngth in the market. Not only MID certified.  
 
EN 75   EN 11. ANNEX  3: OVERVIEW OF STAKEHOLDERS CONSULTED  
11.1. Discussions in sector specific working groups 
Discussions with stakeholders took place under th e sector specific working groups established 
under the different directives concerned: 
• Electrical and electronic goods : the LVD Working Party es tablished under Directive 
2006/95/EEC discussed the alignment to th e NLF Decision on 12 March 2009 (LVD WP 
14) and 27 May 2010 (LVD WP 15). Furthermore the EMC Working Party (Directive 
2004/108/EC ) discussed the issue on 30 June 2009 (EMC WP 15)and on 8 June 2010 (EMC WP 16). 
• Equipment intended for use in potentially explosive atmospheres
: Experts Working Group 
of the Standing Committee set-up according to  ATEX Directive 94/9/ EC debated on the 
alignment to the NLF Decision at its meetings on 23 January 2009, 22 June 2009, 16 December 2009, 7 July 2010 and 21 January 2011. 
• Pressure equipment
: the Working Group Pressure esta blished under the PED (Directive 
97/23/EC) and SPVD (Directive 2009//105/EC) debated on the alignment to the NLF Decision at its meetings on 16 Octobe r 2009, 31 March 2010 and 24 November 2010. 
Furthermore the Conformity Assessment Bodies Forum for PED/SPVD discussed the alignment on 17 and 18 November 2009, 2 and 3 March 2010, 1 and 2 June 2010. 
• Measuring instruments
: the Working Group on Measurin g Instruments established under 
the MID (Directive 2004/22/EC) and NAWI  (Directive 2009/23/EEC) discussed the 
alignment to the NLF Decision 6 July 2009, 4 November 2009, 12 March 2010, 2 July 
2010 and 12 November 2010. 
• Lifts : the Committee set up under Article 6(3) of the Directive 95/16/EC discussed the 
alignment to the NLF Decision on 10 Fe bruary 2009, 1-2 March 2010 and. 17 January 
2011. 
• Civil explosives: The Civil Explosives Working Group established under Directive 
93/15/EEC discussed the alignment to the NL F Decision at its meetings on 12 October 
2009 and 22 October 2010. 
• Pyrotechnic articles : The Pyrotechnics Working Group established under Directive 
2007/23/EC discussed the alignment of  on 27 March 2009 and 5 March 2010.  
 
EN 76   EN 11.2. Overview of stakeholders having pa rticipated in the public and SME 
consultations 
• The following table gives details of the number of stakeholders having participated in the 
SME and public consultations by cate gory of respondents and by sector. 
Table 12: Overview of stakeholders by  category of respondent and by sector 
  Electrical & 
Electronic goods Lifts Pressure 
equip Measuring 
Instr. Civil 
explosive. Pyrotechnic 
articles Equp. For use in 
explosive 
atmospheres 
         
  SME  332 63 78 67 8  24  25 
  EO 44 (14 BO) 8 (2 BO) 6 35 (8 BO) 0 1  4 
 NB 16 9 23 13 4 2 9 
  AUT 28 11 15 21 6 9 11 
  Users 5 1 (CO) 11 6 0 2 8 
The views expressed are overall c onsidered representative of the positions of the different 
stakeholder categories. Specific considerations  should be taken into  account regarding how 
representative the replies are by sector: 
– Electrical and Electronic goods: re plies are considered represen tative of industry’s position 
in view of the overall number of responses  (EO+SME). Furthermore, the main industry 
associations participated in the consultation and the views expressed are in line with those 
communicated to the Commi ssion via other channels. 
– Lifts: even if only a small part of the lift i ndustry EO participated in  the consultations, it 
appears that the data reflect the views of all parties in the lifts sector due to the 
participation of 2 business organizations repres enting respectively the interest of SME and 
big EO. 
– Pressure equipment: only a sm all group of EO (and no BO) pa rticipated in the public 
consultation. This is not surprising as directiv es on pressure equipment cover a wide range 
of products and EO whose interests can ha rdly be represented by one main industry 
association. However a respecta ble number of SME, NB and to some extent authorities 
participated in the consultation and this streng thens the sectoral data. Users’ replies focus 
on professional users rather than consumers. 
– Measuring instruments: there is overall a good response (EO+SME), although most of the 
35 EO replies come from a single MS. This is offset by the fact that answers from SME, 
NB and authorities have a much wider geographi cal coverage. Furthermor e, participants in 
the consultation include the main EU-wid e industry associatio n with which the 
Commission has also discusse d bilaterally various aspects of the alignment option. 
– Civil explosives and pyrotechnic articles: there is overall a small response from EO and 
NB (although, in view of the small size of these sectors, the partic ipation of SME and 
 
EN 77   EN authorities is not negligible). In order to cross check the representativeness of the views 
expressed, the Commission has had bilatera l contact with some European industry 
associations.  
– Equipment for use in potentially explosive atmo spheres: there is a small response. This is 
because EO dealing with equipment for use in  potentially explosive atmospheres deal more 
generally with mechanical, elec trical and also telecom equipm ent which is then “adapted” 
for specific use in potentially explosive atmo spheres (e.g. underground mines, chemical 
plants, mills).. In practice respondents may have preferred to identify themselves with other sectors (notably electrical and electr onic goods). This is confirmed by the replies 
provided in section D of th e questionnaire where many res pondents indicated that they 
apply ATEX together with another of the di rectives covered by the consultation. Thus, to 
some extent, the interests of stakeholders dealing with this special equipment can be 
considered better represented then at first appears. Furthermore, the views expressed 
during the public consultation are in line with information the Commission has received from working parties and regulator contacts with interested parties. 
 
EN 78   EN 12. ANNEX  4: DETAILED ANALYSIS OF INFORMATION COLLECTED  
This annex contains some detailed analysis of information collected via different information 
sources (public consultation of stakeholde rs, SME consultation, an alysis based on the 
Commission database of NB a nd figures provided by EA). 
In what follows, the expression s “Action 1”, “Action 2” and “Ac tion 3” refer to the content of 
the policy measures which are respectively intended to addr ess problems of non-compliance, 
to ensure the quality of the work performed by notified bodies and intended to ensure more 
consistency amongst the directives.  
12.1. Non-compliance with product requirements 
12.1.1.  Problem Description  
Table 13: Differences in approaches of national  market surveillance au thorities (EO replies) 
 Number of 
requested 
records % Requested 
records (77) % of total 
number records
(98) 
MSA in different EU countries do not impose the 
same obligations on importers 46 59,74% 46,94% 
MSA in different EU countries do not impose the 
same obligations on distributors 49 63,64% 50,00% 
MSA in different EU countries do not impose the 
same obligations on manufacturers 56 72,73% 57,14% 
MSA in EU countries act differently when they 
deal with products presenting a risk (i.e. when 
they verify if products comply with legal 
requirements and when they address any risk found) 42 54,55% 42,86% 
The same product may be withdrawn from 
market or otherwise restricted in an EU country 
and supplied freely in another 36 46,75% 36,73% 
When a safeguard clause procedure is 
launched, not all EU countries follow Commission opinion  10 12,99%  10,20%  
Other 9 11,69% 9,18% 
Table 14: Differences in approaches of national market surveillance auth orities (AUT replies) 
 Number of 
requested records % of total 
number records (101)
MSA in different EU countries do not impose the same 
obligations on importers 33 32,7% 
MSA in different EU countries do not impose the same 
obligations on distributors 30 29,7% 
MSA in different EU countries do not impose the same 29 28,7% 
 
EN 79   EN obligations on manufacturers 
MSA in EU countries act differently when they deal with 
products presenting a risk (i.e. when they verify if products 
comply with legal requirements and when they address any 
risk found) 41 40,6% 
The same product may be withdrawn from market or 
otherwise restricted in an EU co untry and supplied freely in 
another 31 30,7% 
When a safeguard clause procedure is launched, not all EU 
countries follow Commission opinion  4 4% 
Other 7 6,9% 
12.1.2.  Assessment of impacts 
12.1.2.1.  Internal Market 
• Answer to EO consultation  (questions B11.3 “Impact of the following elements of Action 
1 on well-functioning of the intern al market (i.e. creation of a level playing field within the 
EU where economic operators are subject to  the same rules and the same market 
surveillance procedure regardless  of the country they are active in”): The large majority of 
EO participating in the consultation (i.e. fr om 65% to 76% depending on the element of 
Action 1) considers that this policy acti on will have some positive impact on the well-
functioning of the intern al market. Furthermore, the majo rity of those having identified a 
positive impact evaluate the impact as signifi cant. The % of those believing that the policy 
action will have no, or no significant, impact remains below 10% except for post-marketing obligations on manufacturers (19%). 
 
EN 80   EN Table 15: Impact of Action 1 on the well-functioning of the internal market (EO replies) 
      
  Obligations for importers/distributors  Number of 
requested 
records Requested 
records 
(98) % of total 
number 
records 
(98) % of total 
number 
records 
(90) 
  No, or no significant improvement 9 (9.2%) (9.2%) (10%) 
  Moderate improvement 30 (30.6%) (30.6%) (33.3%) 
  Significant improvement 40 (40.8%) (40.8%) (44.4%) 
  Unable to evaluate impact 11 (11.2%) (11.2%) (12.2%) 
  N/A 8 (8.2%) (8.2%) - 
  Traceability obligations  Number of 
requested 
records Requested 
records 
(98) % of total 
number 
records 
(98) % of total 
number 
records 
(90) 
  No, or no significant improvement 7 (7.1%) (7.1%) (7.8%) 
  Moderate improvement 38 (38.8%) (38.8%) (42.2%) 
  Significant improvement 37 (37.8%) (37.8%) (41.1%) 
  Unable to evaluate impact 8 (8.2%) (8.2%) (8.9%) 
  N/A 8 (8.2%) (8.2%) - 
   Post marketing obligations on 
manufacturers Number of 
requested 
records Requested 
records 
(98) % of total 
number 
records 
(98) % of total 
number 
records 
(90) 
  No, or no significant improvem ent 19 (19.4%) ( 19.4%) (21.1%) 
  Moderate improvement 30 (30.6%) (30.6%) (33.3%) 
  Significant improvement 34 (34.7%) (34.7%) (37.8%) 
  Unable to evaluate impact 7 (7.1%) (7.1%) (7.8%) 
  N/A 8 (8.2%) (8.2%) - 
   Common safeguard (market surveillance) 
procedures across the EU to deal with 
products presenting a risk Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(90)  
  No, or no significant improvement 6 (6.1%) (6.1%) (6.7%) 
  Moderate improvement 27 (27.6%) (27.6%) (30%) 
  Significant improvement 47 (48%) (48%) (52.2%) 
  Unable to evaluate impact 10 (10.2%) (10.2%) (11.1%) 
  N/A 8 (8.2%) (8.2%) - 
 
EN 81   EN • Answer to NB consultation  (questions B11.3): As for EO , the large majority of NB 
participating in the consultation (i.e. from 71% to 77% depending on he element of Action 
1) considers that this policy action will have some positive impact on the well-functioning of the internal market. Furthermore, the major ity evaluate the impact as significant. The % 
of those believing that the policy action will have no, or no significant, impact remains below 10% for all elements of the policy action. 
• Answer to authorities consultation
 (questions B11.3: As for EO  and NB, the large majority 
of authorities participating in the consulta tion (i.e. from 60% to  72% depending on the 
element of Action 1) consider that this polic y action will have some positive impact on the 
well-functioning of the internal market. As re gards the scale of this positive impact, the 
answers are slightly more nuanced than for EO  and NB: half or more of these authorities 
still evaluate the impact of obligations on im ports/distributors, traceability obligations and 
common safeguard procedures as significant, while as regards post-marketing obligations 
the percentage is a bit lower (about 40%). Th e % of those believing that the policy action 
will have no, or no significant, impact re mains below 10% except for post-marketing 
obligations on manufacturers (16.8%). 
• Findings per sector : The fact that the majority of stakeh olders consider that this action will 
improve to some extent the functioning of the internal market is broadly confirmed when 
looking at replies provided by all respondents (E O, NB and competent authorities) for each 
sector.  
Table 16: Impact of Action 1 on the well-function ing of the internal mark et (EO replies per sector) 
    Electrical & 
Electronic 
goods (88) Lifts 
(28) Pressure 
equip 
(44) Measuring 
Instr. (69) Civil 
explosives 
(10) Pyrotech. 
Articles 
(12) Equip. for use 
in explosive 
atmospheres 
(24) 
  Obligations for 
importers/distributo
rs         
  No, or no significant 
improvement 10% 7% 0% 7% 20% 0% 21% 
  Moderate 
improvement 43% 21% 32% 23% 30% 33% 21% 
  Significant 
improvement 35% 29% 50% 54% 20% 25% 38% 
  Unable to evaluate 
impact 1% 21% 9% 7% 0% 17% 17% 
  N/A 10% 21% 9% 9% 30% 25% 4% 
           
           
  Traceability 
obligations         
  No, or no 
significant 
improvement 9% 4% 0% 4% 20% 0% 13% 
  Moderate 
improvement 43% 43% 43% 32% 20% 0% 38% 
 
 
EN 82   EN   Significant 
improvement 34% 36% 39% 48% 30% 50% 25% 
  Unable to evaluate 
impact 2% 4% 9% 7% 0% 25% 13% 
  N/A 11% 14% 9% 9% 30% 25% 13% 
           
           
   Post marketing 
obligations on 
manufacturers         
  No, or no 
significant 
improvement 26% 4% 5% 6% 50% 18% 25% 
  Moderate 
improvement 31% 54% 48% 35% 20% 18% 25% 
  Significant 
improvement 27% 25% 30% 41% 0% 27% 25% 
  Unable to evaluate 
impact 5% 4% 9% 9% 0% 18% 13% 
  N/A 11% 14% 9% 10% 30% 18% 13% 
           
           
   Common 
safeguard (market 
surveillance) 
procedures          
  No, or no 
significant improvement 13% 7% 0% 1% 20% 0% 8% 
  Moderate 
improvement 34% 14% 25% 23% 20% 8% 67% 
  Significant 
improvement 38% 50% 50% 49% 30% 50% 4% 
  Unable to evaluate 
impact 5% 7% 11% 13% 0% 17% 8% 
  N/A 11% 21% 14% 13% 30% 25% 13% 
 
EN 83   EN  
12.1.2.2.  Competitiveness of EU-firms 
• Answer to EO consultation  (questions B11.4: Impact of th e following elements of Action 1 
on the defence of the competitiveness of EU compliant firms against unfair competition of 
non-compliant firms): Three quarters of EO agr ee that action 1 will ha ve a positive impact 
on the defence of the competitiveness of EU compliant firms against unfair competition of non-compliant firms. The percentage is slightly lower (62.3% for post-marketing 
obligations on manufacturers. Furthermore, the majority of them evaluate the impact as 
significant. 
Table 17: Impact of Action 1 on the defe nce of competitiveness of EO (EO replies) 
   Number of 
requested recordsRequested 
records 
(88)  % of total 
number records
(98)  
  Obligations for importers/distributors     
  Moderate improvement 30 (30.6%) (34.1%) 
  Significant improvement 45 (45.9%) (51.1%) 
  Traceability obligations Number of 
requested recordsRequested 
records 
(88)  % of total 
number records
(98)  
  Moderate improvement 32 (32.7%) (36.4%) 
  Significant improvement 40 (40.8%) (45.5%) 
   Post marketing obligations on manufacturersNumber of 
requested recordsRequested 
records 
(88)  % of total 
number records
(98)  
  Moderate improvement 19 (19.4%) (21.8%) 
  Significant improvement 42 (42.9%) (48.3%) 
   Common safeguard (market surveillance) 
procedures across the EU to deal with products presenting a risk Number of 
requested recordsRequested 
records 
(88)
  % of total 
number records
(98)  
  Moderate improvement 26 (26.5%) (29.5%) 
  Significant improvement 46 (46.9%) (52.3%) 
 
• Answer to SME consultation  (question 9: Do you think that  the following elements of 
"Action 1" will give you any help in defe nding the competitiveness of your business 
against the unfair competition of non-compliant  products?): very positive. From 68 to 73% 
of SME believe that this policy action will help  them to defend the competitiveness of their 
business against unfair competition from non-compliant products. 
 
EN 84   EN Table 18: Impact of Action 1 on the defen ce of competitiveness of SME (SME replies) 
  Obligations for importers/distributors Number of 
requested recordsRequested 
records 
(597)  % of total 
number records
(597)  
  some help  157 (26.3%) (26.3%) 
  significant help  300 (50.3%) (50.3%) 
  Traceability obligations Number of 
requested recordsRequested 
records 
(597)  % of total 
number records
(597)  
  some help  152 (25.5%) (25.5%) 
  significant help  260 (43.6%) (43.6%) 
   Post marketing obligations on manufacturers Number of 
requested recordsRequested 
records 
(597)  % of total 
number records
(597)  
  some help  144 (24.1%) (24.1%) 
  significant help  264 (44.2%) (44.2%) 
   Common safeguard (market surveillance) 
procedures across the EU to deal with products presenting a risk Number of 
requested recordsRequested 
records 
(597)
  % of total 
number records
(597)  
  some help  119 (19.9%) (19.9%) 
  significant help  298 (49.9%) (49.9%) 
• Findings per sector  (based on SME answers) confirm the overall analysis, despite slightly 
different percentages for pyrotechnic articl es and equipment fo r use in potentially 
explosive atmospheres.  
Table 19: Impact of Action 1 on the defence of  competitiveness of SME (SME replies by sector) 
  Electrical & 
Electronic goods 
(336) Lifts 
(63) Pressure 
equip 
(78) Measuring 
Instr. (67)Civil 
explosive.
(8) Pyrotechnic 
articles (24) Equip. for use in 
explosive 
atmospheres (25) 
 Obligations for 
importers/distributors         
  some help  27.1% 34.9% 28.2% 22.1% 25% 20% 8% 
  significant help  51.8% 34.9% 57.7% 50% 37.5% 56% 48% 
 Traceability obligations        
  some help  25.9% 31.7% 17.9% 27.9% 50% 20% 16% 
  significant help  44.6% 36.5% 59% 41.2% 25% 28% 32% 
   Post marketing obligations 
on manufacturers         
  some help  25.6% 28.6% 23.1% 22.1% 25% 16% 8% 
  significant help  41.7% 47.6% 56.4% 48.5% 37.5% 32% 40% 
 
EN 85   EN    Common safeguard 
(market surveillance) procedures          
  some help  17.6% 19% 24.4% 22.1% 25% 40% 12% 
  significant help  52.1% 54% 56.4% 41.2% 25% 36% 36% 
 
12.1.2.3.  Operating costs and administrative burden 
• Answer to EO consultation  (question B11.5: Impact of each element of "Action 1' on 
operating costs and/or administrative burde n for economic operators; question B13.1 & 2 
& 3 "If you answered that one or more of th e elements of Action 1 may give rise to a 
significant increase in operating costs/admini strative burden, please  explain why" and 
"please provide an indicative estimate of the increase you exp ect" and " please explain how 
do you regard this increase in operating costs and/or administrative burden in relation to 
the objective of reducing non-compliance"). 
Overall findings: depending on the various el ements of Action 1 from 11 to 42% of 
respondents consider there will be no, or no significant, increas e in operating costs and/or 
administrative burden, from 32-55 % consider there will be a moderate increase, 1-5% 
consider that there will be a reduction, 16-26% e ither did not answer the question or declared 
themselves unable to evaluate the impact, while  only the remaining 5-9%  (virtually 5 to 9 
respondents out of 98 EO95) believed that action 1 would give ri se to a significant increase in 
operating costs and/or administrative burden.  
Table 20: Impact of Action 1 on operating costs and/ or administrative burden for EO (replies by general 
EO)  
   Obligations for importers/distributors Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(90)  
  Reduction of operating costs and/or administrative burden 1 (1%) (1%) (1.1%) 
  No, or no significant increase in 
operating costs and/or adm. burden 11 (11.2%) (11.2%) (12.2%) 
  Moderate increase in operating costs 
and/or adm. burden 54 (55.1%) (55.1%) (60%) 
  Significant increase in operating costs 
and/or adm. burden 6 (6.1%) (6.1%) (6.7%) 
  Unable to evaluate impact  18 (18.4%) (18.4%) (20%) 
  N/A 8 (8.2%) (8.2%) - 
 
  Traceability obligations  Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(89)  
  Reduction of operating costs and/or administrative burden 2 (2%) (2%) (2.2%) 
                                                 
95 8 of them in the electric and el ectronic good sectors and 1 for th e measuring instrument sectors. 
 
EN 86   EN  
  No, or no significant increase in 
operating costs and/or adm. burden 12 (12.2%) (12.2%) (13.5%) 
  Moderate increase in operating costs 
and/or adm. burden 53 (54.1%) (54.1%) (59.6%) 
  Significant increase in operating costs 
and/or adm. burden 9 (9.2%) (9.2%) (10.1%) 
  Unable to evaluate impact 13 (13.3%) (13.3%) (14.6%) 
  N/A 9 (9.2%) (9.2%) - 
 
   Post marketing obligations on 
manufacturers  Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(90)  
  Reduction of operating costs and/or administrative burden 4 (4.1%) (4.1%) (4.4%) 
  No, or no significant increase in 
operating costs and/or adm. burden 41 (41.8%) (41.8%) (45.6%) 
  Moderate increase in operating costs 
and/or adm. burden 31 (31.6%) (31.6%) (34.4%) 
  Significant increase in operating costs 
and/or adm. burden 6 (6.1%) (6.1%) (6.7%) 
  Unable to evaluate impact 8 (8.2%) (8.2%) (8.9%) 
  N/A 8 (8.2%) (8.2%) - 
 
  Common safeguard (market 
surveillance) procedures   Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(90)  
  Reduction of operating costs and/or 
administrative burden 5 (5.1%) (5.1%) (5.6%) 
  No, or no significant increase in 
operating costs and/or adm. burden 23 (23.5%) (23.5%) (25.6%) 
  Moderate increase in operating costs 
and/or adm. burden 41 (41.8%) (41.8%) (45.6%) 
  Significant increase in operating costs 
and/or adm. burden 5 (5.1%) (5.1%) (5.6%) 
  Unable to evaluate impact 16 (16.3%) (16.3%) (17.8%) 
  N/A 8 (8.2%) (8.2%) - 
The groups of obligations that will give ri se to some additional costs, according to 
the majority of respondents, are obligations  for importers/distributors and traceability 
obligations. However, among the same re spondents, an overwhelming majority 
believed that the cost increase would be moderate.  
Only a minority of respondents (17%) provi ded indicative estimates of the magnitude 
of cost increases expected: the large major ity (65%) estimated the increase in cost 
between 0.3% and 5% of current operating cost s; as to the rest, half of them (17%) 
provided an estimate of 10% and the other half provided estimates between 20 and 25%.  
Furthermore 38% of EO partic ipating in the consultation considered the possible cost 
increase quite reasonable in relation to  the objective of reducing non-compliance. 
 
EN 87   EN This figure should be compar ed to the 14% of respondent s considering the increase 
unreasonable.  
Table 21: Overview of EO replies to the question "Ple ase explain how do you regard this increase in 
operating costs and/or administrative burden in rel ation to the objective of  reducing non-compliance" 
    Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(56)  
  Very reasonable 7 (7.1%) (7.1%) (12.5%) 
  Quite reasonable 30 (30. 6%) (30.6%) (53.6%) 
  Quite unreasonable 9 (9.2%) (9.2%) (16.1%) 
  Not reasonable at all 5 (5.1%) (5.1%) (8.9%) 
  I don't know 5 (5.1%) (5.1%) (8.9%) 
  N/A 42 (42.9%) (42.9%) - 
Looking at the answers of the group of EO (19 respondents)  believing that at least 
one of the elements of action 1 would give rise to a significant increase in operating 
costs and/or administrative burden: 
- Two thirds (13 respondents, including 4 business organisations96) of economic 
operators expecting a significant increase in co sts are in the sector  of electrical and 
electronic products; 3 respondents, includi ng 1 small regional business organisation 
are in the measuring instruments sector. 
- The category of economic operators most  concerned appear to be manufacturers 
(10 respondents) 
- Traceability obligations are mentioned mo st often (9 times) as giving rise to 
significant cost increases; the other groups of  obligations were mentioned only 5 or 6 
times. 
- As regards the reasons for allegedly si gnificant cost increases, the reason most 
often mentioned (16 times) is the cost of paperwork (e.g. ch ecking documentation 
accompanying products, filing and storing information on products), 8 operators 
mentioned costs of testing and physic al inspection of products, 6 respondents 
considered that the specific reasons for co st increases would be the translation of 
technical documentation (including test repo rts) and declaration of conformity (DoC) 
in all EU languages. Furthermore 1 ma nufacturer and a business organisation 
explained that a major source of costs w ould be the logistics involved in adding 
importer contact details on products shipped fr om third countries a nd suggested as an 
alternative indicating on products details of  the EU authorised representative or the 
EU based manufacturer when available. However, the contact details of the EU 
authorised representative would not have the same value as those of the importer since the former is often only a legal cons ultant of the manufacturer and not involved 
in the commercialisation of the product; on the other hand when the EU based manufacturer is available then no imports into the EU take place and there are no 
importers that would be obliged  to make their contacts known. 
                                                
 
96 Two of which representing a specific product segm ent in one MS, one repres enting a specific product 
segment at European level and the last one representing EO located in a third country.. 
 
EN 88   EN - Only 5 respondents were able to provide indicative estimates of the magnitude of 
the increase expected. The average estimate provided is 9%. 
- Slightly less than half of these responde nts (42%) considered the possible new costs 
reasonable with respect to the desired objec tive, most of the rest (47%) considered 
them unreasonable, while the remainder took no position on this issue. 
• Answer to SME consultation  (question 10: "What effects do  you think that the following 
elements of Action 1 will have on operating costs and/or administrative burden?"; question 
11.a) and b): If you answered that one or more of  the elements of Action 1 may give rise to 
a significant increase in operating costs and/ or administrative burde n, please explain why 
and please provide an indicative estimate of the increase you expect either as a percentage 
of current operating costs or in te rms additional time spent (hours/month) 
• Overall findings: depending on the various elements of Action 1, about 21-27% of 
respondents considered there would be no, or no significant, increase, 21-27% 
considered there would be a moderate incr ease, 4-6% considered that would be a 
reduction, 15% declared themselves una ble to evaluate impact, while the 
remaining 12-18% (from 72 to 106 respondent s) believed that action 1 would give 
rise to a significant increase in opera ting costs and/or admi nistrative burden.  
• None of the specific elements of Action 1 is expected to give rise to cost increases 
according to the majority or respondents.  
• Only a subgroup of respondent s (134, i.e. 22%) provide d indicative estimates of 
the magnitude of cost increases expected : 40% of them estimated the increase in 
cost between 1% and 5% of current operating costs; a further 30% provided 
estimates between 6% and 10%; a furthe r 18% provided estima tes up to 20%; the 
small remaining groups provided disparat e estimates ranging from 25% to 60%.  
Table 22: Impact of Action 1 on operating costs and/or administrative burden for SME (replies by SME)  
  Obligations for importers/distributors  Number of requested 
records  Requested 
records 
(597)  % of total 
number 
records 
(597)  
  reduction of operating costs and/or 
administrative burden 35 (5.9%) (5.9%) 
  no or no significant increase in operating costs 
and/or administrative burden  160 (26.8%) (26.8%) 
  moderate increase in operating costs and/or 
administrative burden  196 (32.8%) (32.8%) 
  significant increase in operating costs and/or 
adm. burden  73 (12.2%) (12.2%) 
  unable to evaluate impact  87 (14.6%) (14.6%) 
  Traceability obligations  Number of requested 
records  Requested 
records 
(597)  % of total 
number 
records 
(597)  
  reduction of operating costs and/or 
administrative burden 25 (4.2%) (4.2%) 
 
EN 89   EN   no or no significant increase in operating costs 
and/or administrative burden  162 (27.1%) (27.1%) 
  moderate increase in operating costs and/or 
administrative burden  182 (30.5%) (30.5%) 
  significant increase in operating costs and/or 
adm. burden  90 (15.1%) (15.1%) 
  unable to evaluate impact  86 (14.4%) (14.4%) 
   Post marketing obligations on manufacturers Number of requested 
records  Requested 
records 
(597)  % of total 
number 
records 
(597)  
  reduction of operating costs and/or 
administrative burden 25 (4.2%) (4.2%) 
  no or no significant increase in operating costs 
and/or administrative burden  140 (23.5%) (23.5%) 
  moderate increase in operating costs and/or 
administrative burden  177 (29.6%) (29.6%) 
  significant increase in operating costs and/or 
adm. burden  106 (17.8%) (17.8%) 
  unable to evaluate impact  93 (15.6%) (15.6%) 
  Common safeguard (market surveillance) 
procedures  Number of requested 
records  Requested 
records 
(597)  % of total 
number 
records 
(597)  
  reduction of operating costs and/or 
administrative burden 36 (6%) (6%) 
  no or no significant increase in operating costs 
and/or administrative burden  124 (20.8%) (20.8%) 
  moderate increase in operating costs and/or 
administrative burden  141 (23.6%) (23.6%) 
  significant increase in operating costs and/or 
adm. burden  72 (12.1%) (12.1%) 
  unable to evaluate impact  166 (27.8%) (27.8%) 
• Findings per sector: Looking at the answer s of the group of SME (175) believing 
that at least one of the elements of action 1 would give ri se to a significant 
increase in operating costs and/or ad ministrative burden: 57% of respondents 
belong to the electrical a nd electronic goods sector, a bout 12% respectively to 
those of measuring instruments and pressu re equipment, while 9% to pyrotechnic 
articles. It should be noted that these fi gures more or less mirror the proportion of 
overall respondents from those sectors. SM E in pyrotechnic articl es sector appear 
more concerned about cost increases, related obligations for importers and 
distributors and to traceability obligations.  
12.1.2.4.  Comparison between costs and benefits for EO and SME 
In order to facilitate comparis on between costs and benefits fo r EO and to better demonstrate 
that the burdens for SME would not be dispropo rtionate, the following tables show the views 
expressed by shareholders as regards the exte nt of the possible positive and negative impacts 
of the alignment. 
 
EN 90   EN Table 23: Comparisons of perceived costs and be nefits for general Economic Operators (EO) 
 Benefits (B) Costs (C) C/B Comparison  View of EO on 
overall C /B 
balance97 
 Defence of competitiveness 
(i.e. Reduction in losses due 
to unfair competition 
identified in Figure 1, p.19) Increase in 
operating costs 
and/or adm. burden   
Obligations 
on importers 
and 
distributors Significant improvement 
(46% EO ) 
Moderate improvement 
(31%) Significant increase 
(6% EO ) 
Moderate increase 
(55%) 1) More 
respondents 
pointing to benefits 
than respondents pointing to cost 
increase 
 2) Most frequent 
view: significant 
improvement vs moderate costs Reasonable (38%) 
Unreasonable 
(14%) 
Traceability Significant improvement 
(41% EO ) 
Moderate improvement 
(33%) Significant increase 
(10% EO ) 
Moderate increase 
(54%) Same as above  
Post-
marketing obligation on 
manufacturers Significant improvement 
(43% EO ) 
Moderate improvement 
(19%) Significant increase 
(6% EO ) 
Moderate increase 
(32%) Same as above  
Common 
safeguard (market 
surveillance) 
procedures Significant improvement 
(47% EO ) 
Moderate improvement 
(27%) Significant increase 
(5% EO ) 
Moderate increase 
(42%) Same as above  
 
                                                 
97 Answers to question: "Please explain how do you rega rd this increase in oper ating costs and/or adm. 
burden in relation to the objective of reduction non-compliance". The question was not asked to SME 
who received a shorter questionnaire. 
 
EN 91   EN Table 24: Comparisons of perceived costs and benefits for SME  
 Benefit (B) Costs (C) C/B Comparison  
 Defence of competitiveness 
(i.e. Reduction in losses due to unfair competition 
identified in Figure 1, p.19) Increase in 
operating costs and/or adm. burden  
Obligations 
on Importers and 
Distributors Significant help (50% SME) 
Some help (25%) Significant increase 
(12% EO ) 
Moderate increase 
(33%) 1) More 
respondents pointing to benefits 
than respondents 
pointing to cost increase 
 
2) Most frequent 
view: significant 
improvement vs 
moderate costs 
Traceability Significant help (44%) 
Some help (26%) Significant increase 
(15% EO ) 
Moderate increase 
(30%) Same as above. 
 
3) Less than the 
majority of SME 
identifies possible 
cost increase 
Post-marketing 
obligation on 
manufacturers Significant help (44%) 
Some help (24%)
 Significant increase 
(18% EO ) 
Moderate increase 
(30%) Same as above. 
 
Common 
safeguard 
(market 
surveillance) procedures Significant help (50%) 
Some help (20%) Significant increase 
(12% EO ) 
Moderate increase 
(24%) Same as above. 
 
 
The burden of the proposed measures will not be disproportionate either on EO in general or 
on SME. As regards the proportionality of the propos ed measures, it is perhaps also useful to 
recall that the new obligations normally build on principles already presented via guidance 
(good practices for responsible operators) or clarify/expand the content of existing 
obligations. Therefore compliance with the aligned rules is not expected to require economic 
operators (including SME) to set-up significant  new procedures. Furthermore, the alignment 
does not modify any of the currently applicable technical product requir ements. The fact that 
a remarkable share of SME does not expect cost  increases (and certainly  not significant ones) 
supports this conclusion. 
 
EN 92   EN Furthermore the new obligations  already incorporat e a strong element of  proportionality, as 
they have been designed to make economic oper ators at different levels of the value chain 
(e.g. an SME distri buting a product vs a big manufacturer) only accountable for aspects linked 
to their actual scope of action (e.g. a distributor  will basically only verify if the product bears 
the conformity marking and that it is a ccompanied by the required documentation and 
instructions, while the manufacturer will re main responsible for showing compliance). 
12.1.2.5.  Public authorities 
• Answer to EO consultation  (question B11.1: "Impact of th e following elements of Action 1 
on the level of non-compliance"): between 67% and 71% of EO partic ipating in the public 
consultation consider that this policy action w ill have a positive impact on the level of non-
compliance (proxy for increase in  effectiveness of enforcemen t activities). Between 9 and 
15% of respondents believed this would not be the case. The majority of EO having 
identified a positive improvement evalua ted the contribution given by traceability 
obligations as significant, while evaluating th e contribution given by the other elements as 
being more moderate.  
Table 25: Impact of Action 1 on leve l of non-compliance (replies by EO)  
   Obligations for importers/distributors Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(90)  
  No, or no significant improvem ent 15 (15.3%) ( 15.3%) (16.7%) 
  Moderate improvement 45 (45.9%) (45.9%) (50%) 
  Significant improvement 23 (23.5%) (23.5%) (25.6%) 
  Unable to evaluate impact 7 (7.1%) (7.1%) (7.8%) 
  N/A 8 (8.2%) (8.2%) - 
 
   Traceability obligations Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(91)  
  No, or no significant improvem ent 16 (16.3%) ( 16.3%) (17.6%) 
  Moderate improvement 27 (27.6%) (27.6%) (29.7%) 
  Significant improvement 39 (39.8%) (39.8%) (42.9%) 
  Unable to evaluate impact 9 (9.2%) (9.2%) (9.9%) 
  N/A 7 (7.1%) (7.1%) - 
 
   Post marketing obligations on 
manufacturers  Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(90)  
  No, or no significant improvem ent 14 (14.3%) ( 14.3%) (15.6%) 
  Moderate improvement 39 (39.8%) (39.8%) (43.3%) 
  Significant improvement 28 (28.6%) (28.6%) (31.1%) 
  Unable to evaluate impact 9 (9.2%) (9.2%) (10%) 
  N/A 8 (8.2%) (8.2%) - 
 
EN 93   EN  
   Common safeguard (market 
surveillance) procedures to deal with 
products presenting a risk across the 
EU Number of 
requested 
records Requested 
records 
(98)  % of total 
number 
records 
(98)  % of total 
number 
records 
(90)  
  No, or no significant improvement 9 (9.2%) (9.2%) (10%) 
  Moderate improvement 43 (43.9%) (43.9%) (47.8%) 
  Significant improvement 27 (27.6%) (27.6%) (30%) 
  Unable to evaluate impact 11 (11.2%) (11.2%) (12.2%) 
  N/A 8 (8.2%) (8.2%) - 
• Answer to NB consultation  (question B11.1: "Impact of th e following elements of Action 1 
on the level of non-compliance): between 66% a nd 83% of NB particip ating in the public 
consultation considered that this policy action would have a positive impact on the level of non-compliance (proxy for increase in effectiv eness of enforcement activities). Between 
6% and 13% of respondents beli eved this would not be the case (except for post-marketing 
obligations for which this percentage is 21%). As regards the extent to which the alignment 
may improve the current situation, the views of authorities having identified a positive 
impact were more or less equally shared  between significant and moderate impact.  
• Answer to authorities consultation
 (question B11.1: " Impact of  the following elements of 
Action 1 on the level of non-compliance) : between 57% and 71 % of authorities 
participating in the public consultation consid ered that this policy action would have a 
positive impact on the level of non-compliance (proxy for increase in effectiveness of enforcement activities) Between  6 and 14% of respondents belie ved this would not be the 
case. As regards the extent to which the alignment may improve current situation, the 
majority of NB having identified a positive impact considered the impact as significant (except for traceability obligations, the views of  these NB are almost equally distributed 
between 'moderate' and 'significant'). 
Table 26: Impact of Action 1 on level of  non-compliance (replies by authorities)  
   Obligations for importers/distributors Number of 
requested 
records Requested 
records 
(101)  % of total 
number 
records 
(101)  % of total 
number 
records 
(82)  
  No. or no significant improvement 12 11.9% 11.9% 14.6% 
  Moderate improvement 34 33.7% 33.7% 41.5% 
  Significant improvement 32 31.7% 31.7% 39.0% 
  Unable to evaluate impact 4 4.0% 4.0% 4.9% 
  N/A - - 18.8% - 
   Traceability obligations Number of 
requested 
records Requested 
records 
(101)  % of total 
number 
records 
(101)  % of total 
number 
records 
(82)  
  No. or no significant improvement 6 5.9% 5.9% 7.2% 
  Moderate improvement 36 35.6% 35.6% 43.4% 
 
EN 94   EN   Significant improvement 36 35.6% 35.6% 43.4% 
  Unable to evaluate impact 5 5.0% 5.0% 6.0% 
  N/A - - 17.8% - 
   Post marketing obligations on 
manufacturers  Number of 
requested 
records Requested 
records 
(101)  % of total 
number 
records 
(101)  % of total 
number 
records 
(82)  
  No. or no significant improvement 14 13.9% 13.9% 16.7% 
  Moderate improvement 41 40.6% 40.6% 48.8% 
  Significant improvement 17 16.8% 16.8% 20.2% 
  Unable to evaluate impact 12 11.9% 11.9% 14.3% 
  N/A - - 16.8% - 
   Common safeguard (market 
surveillance) procedures to deal with 
products presenting a risk across the EU
 Number of 
requested 
records Requested 
records 
(101)  % of total 
number 
records 
(101)  % of total 
number 
records 
(82)  
  No. or no significant improvement 10 9.9% 9.9% 12.8% 
  Moderate improvement 30 29.7% 29.7% 38.5% 
  Significant improvement 28 27.7% 27.7% 35.9% 
  Unable to evaluate impact 10 9.9% 9.9% 12.8% 
  N/A - - 22.8% - 
• Answer to user consultation  (question B11.1: " Impact of the following elements of Action 
1 on the level of non-compliance): 73% to 80 % of users participa ting in the public 
consultation consider that the different elemen ts of this policy action will have a positive 
impact on the level of non-compliance As rega rds the extent to which the alignment may 
improve current situation, the majority of  users having identified a positive impact 
considered the impact as significant, except for traceability obligations. 
12.1.2.6.  Consumers and households; professional users 
• Answer to users consultation: (question B 6 "Do you think that this sector is affected by 
non-compliance?"; question B5.1: "do you th ink that the problem of non-compliance 
affects negatively end-users in this sector ?"; question B11.1:"impact of Action 1 on the 
level of non-compliance") 
The large majority of users (64%) indicated th at they consider the relevant sectors to 
be affected by the problem of non-compliance;  only 12% considered that this was not 
the case. Furthermore, 60% considered that non-compliance is damaging users to some extent and estimated the seriousness of the damage as either significant (a third 
of them) or moderate (two thirds); only 3% considered that non-compliance was not 
negatively affecting users; the remaining users did not reply to this question.  
 
EN 95   EN Specific examples of damages provi ded by respondents (quotations):  
Electrical and el ectronic good sector : 3 to 5 % of the primary costs are necessary to 
balance non-compliance (professional user). 
Measuring instruments : if the product does not pass th e control prescribed, then the 
users cannot rely on the claimed qua lity and duration (professional user 
organisation). Estimates unknown, but it is qui te clear that non-compliance can allow 
fraudulent weightings, implying bad pri ces and economical damage for users 
(professional users). 
Lifts : lack of accessibility [e.g. for disabled and old people] and safety (consumer 
organisation). 
Pressure equipment :  
– Increased safety risk from catastrophic failu re if materials used are prone to brittle 
fracture. Reduced service life for equipm ent if materials used have reduced 
corrosion resistance. Production loss resulti ng from need to repair non-compliant 
equipment during service (profe ssional user organisation). 
– Non compliant products may lead to: i)  delayed putting in to operation ii) 
interrupted chemical produc tion (professional user).  
– Project delays; replacement costs and of ten interim temporary measures put in 
place to resume production; increased hydr ocarbon leaks leading to higher risks 
(professional user). Relationship with auth orities, final users must prove that 
products are in accordance with law and sta ndard regulations in Europe; potential 
injuries or fatalities when such produc ts are in production with toxic or 
inflammable liquid or gas (professional user). 
ATEX : more expensive spare parts. Manuf acturers only allow maintenance by the 
manufacturer’s personnel. Equipment that does not fall under the guidelines was sold 
at a higher price (more than 50%). Disc ussions with supplier over the conformity 
cost a lot of money (professional user). 
 
EN 96   EN 12.1.2.7.  Public health and safety 
• Replies provided by stakeholders of al l sectors, except measuring instruments  to question 
B11.2 "Impact of the following elements of Ac tion 1 on health and safety conditions for 
consumers and workers dealing with products in this sector [this ques tion does not apply to 
the measuring instruments sector]". 
Table 27: Impact of Action 1 on health and safety (replies by EO) 
   Obligations for importers/distributors  Number of 
requested 
records Requested 
records 
(36) % of total 
number 
records (98) 
  No, or no significant improvement 8 (22.2%) (8.2%) 
  Moderate improvement 19 (52.8%) (19.4%) 
  Significant improvement 2 (5.6%) (2%) 
  Unable to evaluate impact 7 (19.4%) (7.1%) 
  Traceability obligations   Number of 
requested 
records Requested 
records 
(36) % of total 
number 
records 
(98) 
   9 (25%) (9.2%) 
   19 (52.8%) (19.4%) 
  Significant improvement 5 (13.9%) (5.1%) 
  Unable to evaluate impact 3 (8.3%) (3.1%) 
   Post marketing obligations on manufacturers  Number of 
requested 
records Requested 
records 
(36) % of total 
number 
records 
(98) 
  No, or no significant impr ovement 13 (36.1%) (13.3%) 
  Moderate improvement 15 (41.7%) (15.3%) 
  Significant improvement 6 (16.7%) (6.1%) 
  Unable to evaluate impact 2 (5.6%) (2%) 
   Common safeguard (market surveillance) procedures 
to deal with products presenting a risk across the EU  Number of 
requested 
records Requested 
records 
(36) % of total 
number 
records 
(98) 
  No, or no significant improvement 6 (16.7%) (6.1%) 
  Moderate improvement 14 (38.9%) (14.3%) 
  Significant improvement  14 (38.9%) (14.3%) 
  Unable to evaluate impact 2 (5.6%) (2%) 
 
EN 97   EN Table 28: Impact of Action 1 on health and safety (replies by NB) 
   Obligations for importers/distributors  Number of 
requested 
records Requested 
records 
(60) % of total 
number 
records 
(76) 
  No, or no significant improvement 5 (8.3%) (6.6%) 
  Moderate improvement 21 (35%) (27.6%) 
  Significant improvement  25 (41.7%) (32.9%) 
  Unable to evaluate impact 5 (8.3%) (6.6%) 
  Traceability obligations   Number of 
requested 
records Requested 
records 
(60) % of total 
number 
records 
(76) 
  No, or no significant improvement 4 (6.7%) (5.3%) 
  Moderate improvement 24 (40%) (31.6%) 
  Significant improvement  23 (38.3%) (30.3%) 
  Unable to evaluate impact 5 (8.3%) (6.6%) 
   Post marketing obligations on manufacturers  Number of 
requested 
records Requested 
records 
(60) % of total 
number 
records 
(76) 
  No, or no significant impr ovement 8 (13.3%) (10.5%) 
  Moderate improvement 19 (31.7%) (25%) 
  Significant improvement 24 (40%) (31.6%) 
  Unable to evaluate impact 5 (8.3%) (6.6%) 
  Common safeguard (market surveillance) procedures 
to deal with products presenting a risk across the EU   Number of 
requested 
records Requested 
records 
(60) % of total 
number 
records 
(76) 
  No, or no significant improvement 2 (3.3%) (2.6%) 
  Moderate improvement 19 (31.7%) (25%) 
  Significant improvement 27 (45%) (35.5%) 
  Unable to evaluate impact 8 (13.3%) (10.5%) 
Table 29: Impact of Action 1 on health and safety (replies by authorities) 
   Obligations for importers/distributors  Number of 
requested 
records Requested 
records 
(66) % of total 
number 
records 
(101) 
  No, or no significant im provement 12 (18.2%) (11.9%) 
  Moderate improvement 17 (25.8%) (16.8%) 
 
EN 98   EN   Significant improvem ent 21 (31.8%) (20.8%) 
  Unable to evaluate impact 6 (9.1%) (5.9%) 
   Traceability obligations   Number of 
requested 
records Requested 
records 
(66) % of total 
number 
records 
(101) 
  No, or no significant im provement 12 (18.2%) (11.9%) 
  Moderate improvement 22 (33.3%) (21.8%) 
  Significant improvem ent 19 (28.8%) (18.8%) 
  Unable to evaluate impact 5 (7.6%) (5%)  
  Post marketing obligations on manufacturers   Number of 
requested 
records Requested 
records 
(66) % of total 
number 
records 
(101) 
  No, or no significant improvement 10 (15.2%) (9.9%) 
  Moderate improvement 24 (36.4%) (23.8%) 
  Significant improvem ent 17 (25.8%) (16.8%) 
  Unable to evaluate impact 6 (9.1%) (5.9%) 
 
   Common safeguard (market surveillance) procedures 
to deal with products presenting a risk across the  EU Number of 
requested 
records Requested 
records 
(66) % of total 
number 
records 
(101) 
  No, or no significant improvement 10 (15.2%) (9.9%) 
  Moderate improvement 24 (36.4%) (23.8%) 
  Significant improvem ent 16 (24.2%) (15.8%) 
  Unable to evaluate impact 6 (9.1%) (5.9%)      
12.2. Performance of Notified Bodies  
12.2.1.  Assessment of impacts 
12.2.1.1.  Internal Market 
Replies to public consultation, question C25.3: "Impact of the following elements of Action 2 
on well-functioning of the internal market (i.e. creation of a leve l playing field within the EU 
where economic operators are subject to conformity assessment carried out according to the same level of quality regardless of the country in which they are active and of the specific Notified Bodies provid ing the service)". 
• Answer to EO consultation:
 Two thirds (64%) of EO that ha ve recourse to the services of 
NB considered that action 2 would have a pos itive impact on internal market. Only 7-8% 
of respondents believed action 2 would have no  or no significant impact. The strongest 
positive impact was attributed to the reinfor cement of notification requirements for NB for 
which 41% of respondents expect ed a significant improvement. 
 
EN 99   EN Table 30: Impact of Action 2 on the well-functioning of the internal market 
   Reinforcement of notification requirements for NB   Number of requested 
records Requested records 
(8798)  
  No or no significant improvement 6 (6.9%) 
  Moderate improvement 20 (23%) 
  Significant improvement 36 (41.4%) 
  Unable to evaluate impact 5 (5.7%) 
   Revised procedures for notification  Number of requested 
records Requested records 
(87)  
  No or no significant improvement 6 (6.9%) 
  Moderate improvement 37 (42.5%) 
  Significant improvement 18 (20.7%) 
  Unable to evaluate impact 6 (6.9%) 
   Information obligations on NB  Number of requested 
records Requested records 
(87)  
  No or no significant improvement 7 (8%) 
  Moderate improvement 43 (49.4%) 
  Significant improvement 13 (14.9%) 
  Unable to evaluate impact 4 (4.6%) 
• Answer to NB consultation : from 65 to 78% of NB considered that these three elements of 
action 2 wouldl contribute to the creation of  a level playing field within the EU where 
economic operators are subject to conformity assessment carried out according to the same 
level of quality regardless of the country in which they are active and of the specific NB providing the service. Between 12 and 22% of  NB participating in the consultation 
believed this would not be the case. Among the respondents having identified a positive 
impact, the majority qualified th e extent of the positive impact as 'moderate' (as opposed to 
'significant'). 
• Answer to authorities' consultation
: from 59 to 66% of authorities believed in a positive 
impact on the internal market; from 9 to 16% did not. Among the respondents having 
identified a positive impact, the majority qualified the extent of the positive impact as 'significant' (as opposed to 'moderate'). 
12.2.1.2.  Competitiveness of EU-firms 
• Answer to EO consultation
 (Replies to question C25.4: "I mpact of the following elements 
of Action 2 on the defence of the competitiveness of EU compliant firms against unfair 
competition of non-compliant firms): 60-62% of  EO participating in the consultation 
believed this policy action would help defend the competiveness of EU business vis-à-vis 
unfair competition from non-compliant products; only 6-9% believed this would not be the 
case. The remainder did not take a position on this issue
                                                 
98 Only the replies of EO that declared to make use of NB's services have been taken into account. 
 
EN 100   EN Table 31: Impact of Action 2 on the defence of competitiveness 
   Reinforcement of notification requirements for NB  Number of 
requested 
records Requested records 
(87)  
  No or no significant improvement 6 (6.9%) 
  Moderate improvement 17 (19.5%) 
  Significant improvement 37 (42.5%) 
  Unable to evaluate impact 4 (4.6%) 
 N/A 23 (26%) 
  Revised procedures for notification   Number of 
requested 
records Requested records 
(87)  
  No or no significant improvement 5 (5.7%) 
  Moderate improvement 34 (39.1%) 
  Significant improvement 20 (23%) 
  Unable to evaluate impact 6 (6.9%) 
 N/A 22 (25%) 
   Information obligations on NB Number of 
requested 
records Requested records 
(87)  
  No or no significant improvement 8 (9.2%) 
  Moderate improvement 35 (40.2%) 
  Significant improvement 17 (19.5%) 
  Unable to evaluate impact 4 (4.6%) 
 N/A 23 (26%) 
• Answer to NB consultation  (replies to question C20): 64% of NB participating in the 
consultation believed that they were affected to some extent by unfair competition from 
other NB which did not assess correctly the conformity of products with legal 
requirements; 20% believed this was not the case; 16% did not express a view. 
12.2.1.3.  Operating costs and admi nistrative burden for NB 
• Answer to NB consultation  (replies to question C25.5 "Impact of the following elements of 
Action 2 on operating costs and/or administra tive burden for Notified Bodies" ; question 
C27.1 & 2 & 3 " If you an swered that one or mo re of the elements of Action 1 may give 
rise to a significant increase in operating co sts/administrative burde n, please explain why" 
& "please provide an indicative estimate of the increase you expect" & " please explain 
how do you regard this increase in operating co sts and/or administra tive burden in relation 
to the objective of ensuring the quality of services provided by notified bodies") 
 
EN 101   EN • Overall findings: depending on the various elements of Action 2 about 30-42% of 
respondents considered there w ould be no or no si gnificant increase in operating costs 
and/or administrative burden, 32-37% considered that there w ould be a moderate increase, 
1-4% considered that there w ould be a reduction, 5% either di d not answer the question or 
declared themselves unable to evaluate imp act, while only the remaining 14-24% (11 to 18 
respondents out of 76 NB) believed that action 2 w ould give rise to a significant increase in 
operating costs and/or administrative burden. 
Table 32: Impact of Action 2 on operating costs and/or administrative burden for NB  
  Reinforcement of notification 
requirements for NB  Number of 
requested 
records Requested 
records 
(76)  % of total 
number 
records (76)  % of total 
number 
records (72)  
  Reduction of operating costs and/or 
administrative burden 3 (3.9%) (3.9%) (4.2%) 
  No or no significant increase in 
operating costs and/or adm. burden 23 (30.3%) (30.3%) (31.9%) 
  Moderate increase in operating costs 
and/or adm. burden 28 (36.8%) (36.8%) (38.9%) 
  Significant increase in operating costs 
and/or adm. burden 18 (23.7%) (23.7%) (25%) 
  N/A 4 (5.3%) (5.3%) - 
 
  Revised procedures for notification  Number of 
requested records Requested 
records (76)  % of total 
number records 
(76)  % of total 
number records 
(72)  
  Reduction of operating costs and/or 
administrative burden 1 (1.3%) (1.3%) (1.4%) 
  No or no significant increase in 
operating costs and/or adm. burden 31 (40.8%) (40.8%) (43.1%) 
  Moderate increase in operating costs 
and/or adm. burden 24 (31.6%) (31.6%) (33.3%) 
  Significant increase in operating costs 
and/or adm. burden 16 (21.1%) (21.1%) (22.2%) 
  N/A 4 (5.3%) (5.3%) - 
 
   Information obligations on NB  Number of 
requested 
records Requested 
records 
(76)  % of total 
number 
records 
(76)  % of total 
number 
records 
(72)  
  Reduction of operating costs and/or 
administrative burden 3 (3.9%) (3.9%) (4.2%) 
  No or no significant increase in 
operating costs and/or adm. burden 32 (42.1%) (42.1%) (44.4%) 
  Moderate increase in operating costs 
and/or adm. burden 26 (34.2%) (34.2%) (36.1%) 
  Significant increase in operating costs 
and/or adm. burden 11 (14.5%) (14.5%) (15.3%) 
  N/A 4 (5.3%) (5.3%) - 
As regards the specific elements of Action 2, the reinforcement of notification requirements 
for NB and the revised procedure of notification appear to raise slightly more concerns than 
information obligations. Among those respondents  expecting cost increases, the majority 
believed that the increase would be moderate.  
 
EN 102   EN Only some respondents (21%) provided indicativ e estimates of the magnitude of the cost 
increases expected. The average estimate pr ovided was 28%, which however should be 
interpreted with caution since it  does not seem to reflect the vi ew expressed by the majority of 
respondents and because the estimates provided for specific cost items are very disparate (see 
below for accreditation costs). 
As regards the specific reasons for cost incr eases, 57% of respondent s did not provide any 
indication, 30% of respondents indicated accreditation, other respondents cited:  
– Need for notification 
– Increased testing and documentation 
– Employment or contracting of qualified personnel 
– Possible additional equipment and personnel costs due to fewer tests performed at 
subcontractors 
– Administrative burden 
– Administrative and legal costs due to the fact that EO will complain more often 
From these responses it appears th at NB have attributed to this policy some effects that relate 
more generally to technical legislation alre ady in place that will not change with the 
alignment of these provisions with the NL F Decision. For instance alignment does not 
introduce the need for notification (which is an existing legal obligation), nor increased 
testing and documentation; the employment of qualified personnel will increase existing costs 
of NB only if they do not al ready employ qualified personnel; alignment does not prevent 
subcontracting (it only requires that NB take  responsibility for work carried out by 
subcontractors); lastly, alignm ent does not increase the likeli hood of complaints from EO. 
As regards accreditation costs, only 5 NB provide d estimates of the percentage increase in 
operating costs that ranged widely from 1% to  70%; while 5 more NB provided estimates of 
the additional time spent per month which was estimated at between 7% and 16%. 
Furthermore, 37% of NB participating in th e consultation considered the possible cost 
increase quite reasonable in relation to the obj ective of enhancing the quality of conformity 
assessment services provided, while only 16% of respondents considered the increase 
unreasonable. 
Table 33: Overview of NB replies to  question C27.3 "Ple ase explain how you regard this increase in 
operating costs and/or administrative burden in relation to the objective of ensuring  the quality of services 
provided by notified bodies in this sector"-  
    Number of 
requested records Requested 
records (76)  % of total 
number records 
(76)  % of total 
number records 
(48)  
  Very reasonable 3 (3.9%) (3.9%) (6.2%) 
  Quite reasonable 25 (32. 9%) (32.9%) (52.1%) 
  Quite unreasonable 8 (10. 5%) (10.5%) (16.7%) 
  Not reasonable at all 3 (3.9%) (3.9%) (6.2%) 
  I don't know 9 (11.8% ) (11.8%) (18.8%) 
  N/A 28 (36.8%) (36.8%) - 
 
EN 103   EN • Findings per sector : the analysis of sectoral data sugge sts that respondents from the Lift 
sector are most concerned about  cost increases due to revised requirements for NB and 
those from the measuring instruments are concerned both about NB requirements and 
revision of the notification pro cess. However due to the limited data in these sectors, these 
results should be treated with caution. 
Table 34: Overview of NB replies to  question C27.3 "Ple ase explain how you regard this increase in 
operating costs and/or administrative burden in relation to the objective of ensuring  the quality of services 
provided by notified bodies in this sector" per sector  
  Electrical & 
Electronical goods 
(16) Lifts (9) Pressur
e equip 
(23) Measurin
g Instr. 
(13) Civil 
explosive 
(4). Pyrotechnic 
articles (2) Equip. for use in 
explosive 
atmospheres (9) 
 Reinforcement of notification 
requirements for NB          
 Reduction of operating costs 
and/or administrative burden 0 0 4.3 7.7 0 0 11.1 
 No or no significant increase 
in operating costs and/or adm. 
burden 18.8 11.1 39.1 30.8 75 50 22.2 
 Moderate increase in 
operating costs and/or adm. 
burden 56.2 44.4 34.8 23.1 25 0 33.3 
 Significant increase in 
operating costs and/or adm. burden 18.8 33.3 17.4 30.8 0 50 33.3 
 N/A        
  Revised procedures for 
notification         
 Reduction of operating costs 
and/or administrative burden 0 0 0 0 0 0 11.1 
 No or no significant increase 
in operating costs and/or adm. 
burden 31.2 33.3 43.5 38.5 75 50 44.4 
 Moderate increase in 
operating costs and/or adm. 
burden 43.8 44.4 34.8 23.1 25 0 11.1 
 Significant increase in 
operating costs and/or adm. burden 18.8 11.1 17.4 30.8 0 50 33.3 
 N/A        
  Information obligations on NB         
 Reduction of operating costs 
and/or administrative burden 0 11.1 0 0 50 0 0 
 No or no significant increase 
in operating costs and/or adm. 
burden 18.8 33.3 43.5 61.5 25 50 66.7 
 Moderate increase in 
operating costs and/or adm. burden 56.2 33.3 34.8 23.1 25 0 22.2 
 Significant increase in 
operating costs and/or adm. 
burden 18.8 11.1 17.4 7.7 0 50 11.1 
 
EN 104   EN • Estimates of accreditation costs   
The cost basis for accreditation within the regu lated sector, for instance for a conformity 
assessment body (CAB) wishing to be accredited in  order to become a NB, is no different to 
that applied to those seeki ng accreditation in the voluntary sector. However, even for 
accreditation costs in the voluntary s ector, it is not possible to pr ovide a general estimate. This 
is because national accreditation bodies (NAB) have different fee stru ctures based on their 
individual circumstances and they charge fo r their work at different man-day rates. 
Furthermore, the economic situation varies from Member State to Member State, and this will 
impact on the cost of accreditation through factors such as overhead costs, salary levels, travel 
costs, etc., in each NAB. Whether or not NAB  receive government funding for accreditation 
activities also has a direct beari ng on the man-day rate that they use, and so on the overall cost 
of the accreditation.  
In the light of these constraints, the following table shows the analysis  of accreditation fees 
that have been charged to its customers (lab oratories, inspection bodies and certification 
bodies) by one specific European NAB in the last financial year. Although an accurate 
comparison with other NAB is not possible, it can be reasonably assumed that the fees charged by this specific NAB constitute at l east a rough estimate for average accreditation 
fees in the EU.  
The fees shown include all costs (e.g. assessment costs, annual fees, travel and subsistence of 
assessment staff, etc) and therefore represent the full cost to the accredited organisation for 
the full scope of their accredited activity. For general information, the data is based on over 2 000 among laboratories, inspectio n bodies, and certification bodies. 
Table 35: Accreditation fees charged by one European NAB in 2010 (EUR) 
 Analysis of Fees paid by all Laboratories          
Indicative range of fees : from 0 to 90 000    Fees % charged  
     More Less 
Mean Fees charged   7 213  28% 72% 
Median Fees Charged   4 863  50% 50% 
      
 Analysis of Fees paid by Inspection Bodies       
Indicative range of fees : from 0 to 52 000    Fees % charged 
    Fees More Less 
Mean Fees charged    5 286  30% 70% 
Median Fees Charged    3 839  50% 50% 
  
 Analysis of Fees paid by Certification Bodies        
Indicative range of fees : from 0 to 170 000      Fees  % charged  
       More Less 
Mean Fees charged      17 700  29% 71% 
Median Fees Charged      11 168  50% 50% 
Source: EA 
As different CAB may ask for substantially differe nt scopes of accreditation, the range of fees 
applied to a single CAB is very wide. A sm all CAB requesting accreditation for simple 
conformity assessment procedures for a limite d range of products will be charged much 
smaller fees than a big multi-site CAB re questing accreditation for complex conformity 
assessment procedures over a large range of products.  
However, even with those constraints, it is very us eful to see what is the mean of the fees that 
have been charged in each conformity assessment  sector, and what percen tage of the bodies in 
 
EN 105   EN each sector is actually charged below this  mean. In the most common situations the 
accreditation costs will have a limited impact  on each of the conformity assessment 
certificates granted by a CAB. Furthermore, as  regards the cost of accreditation, the EA 
stresses that conformity assessment bodies apply for accreditation the scope of which is 
considerably wider than that required for the NB  activity. It follows that these cost are spread 
on a basis that is much wider and this further reduces their impact on the costs of specific 
services. On the other hand, it also follows that  it is very difficult to identify precisely the 
share of accreditation costs possibly induced by the alignment of each directive to the NLF 
Decision. 
12.2.1.4.  Public authorities: benefits 
• Answer to EO consultation  (questions C25.1 "Impact on the level of services provided by 
NB"): between 62% and 83% of EO participati ng in the public consultation consider that 
this policy action will have a positive impact  on the level of quality of conformity 
assessment services provided by NB (proxy fo r increase in effectiveness of notifying 
activities). Between 5 and 8% of respondents believed this would not be the case. The 
strongest positive impact was attributed to reinforcement of the notification criteria. 
Table 36: Impact of Action 2 on the level of services provided by NB (replies by EO) 
 Reinforcement of notification 
requirements for NB  Number of requested records % Requested records(87) 
No or no significant improvement 6 7% 
Moderate improvement 24 28% 
Significant improvement 40 46% 
Unable to evaluate impact 7 8% 
      
 Revised procedures for notification  Number of requested records % Requested records(87) 
No or no significant improvement 4 5% 
Moderate improvement 44 51% 
Significant improvement 21 24% 
Unable to evaluate impact 7 8% 
      
 Information obligations on NB  Number of requested records % Requested records(87) 
No or no significant improvement 7 8% 
Moderate improvement 47 54% 
Significant improvement 14 16% 
Unable to evaluate impact 6 7% 
• Answer to NB consultation  (questions C25.1 "Impact on the level of services provided by 
NB"): between 60% and 84% of NB participati ng in the public consultation consider that 
this policy action will have a positive impact on the level of quality of NB services proxy 
for increase in effectiveness of notifying ac tivities). Between 9 a nd 14% of respondents 
believed this would not be the case (except for information obligations for which this percentage was 32%) 
 
EN 106   EN Table 37: Impact of Action 2 on the level of services provided by NB (replies by NB) 
 Reinforcement of notification 
requirements for NB  Number of 
requested records % Requested 
records(76)  % of 
total number records(72)  
No or no significant improvement 7 9% 10% 
Moderate improvement 36 47% 50% 
Significant improvement 28 37% 39% 
Unable to evaluate impact 1 1% 1% 
N/A - 5% - 
        
 Revised procedures for notification  Number of 
requested 
records % Requested 
records(76)  % of 
total number 
records(72)  
No or no significant improvement 11 14% 15% 
Moderate improvement 34 45% 47% 
Significant improvement 24 32% 33% 
Unable to evaluate impact 3 4% 4% 
N/A - 5% - 
        
 Information obligations on NB  Number of 
requested 
records % Requested 
records(76)  % of 
total number 
records(72)  
No or no significant improvement 24 32% 33% 
Moderate improvement 36 47% 50% 
Significant improvement 10 13% 14% 
Unable to evaluate impact 2 3% 3% 
N/A - 5% - 
• Authorities consultation  (questions C25.1 "Impact on the level of services provided by 
NBs"): between 65% and 72% of authorities participating in the public consultation 
considered that this policy action would have  a positive impact on the level of quality of 
NB services (proxy for increase in effectiv eness of notification ac tivities) Between 5 and 
15% of respondents believed this would not be  the case. The strongest positive impact was 
attributed to the reinforcemen t of notification criteria.  
Table 38: Impact of Action 2 on the level of services provided by NB (replies by authorities) 
 Reinforcement of notification 
requirements for NB  Number of 
requested records % Requested 
records(101)  % of total number 
records(87) 
No or no significant improvement 9 8.91% 10.34% 
Moderate improvement 31 30.69% 35.63% 
Significant improvement 42 41.58% 48.28% 
Unable to evaluate impact 5 4.95% 5.75% 
N/A 14 14% - 
        
 Revised procedures for notification  Number of 
requested records % Requested 
records(101)  % of total number 
records(86)  
No or no significant improvement 5 4.95% 5.81% 
Moderate improvement 39 38.61% 45.35% 
 
EN 107   EN Significant improvement 32 31.68% 37.21% 
Unable to evaluate impact 10 9.90% 11.63% 
N/A 15 15% - 
        
 Information obligations on NB  Number of 
requested records % Requested 
records(101)  % of total number 
records(87)  
No or no significant im provement 16 15.84% 18.39% 
Moderate improvement 37 36.63% 42.53% 
Significant improvement 29 28.71% 33.33% 
Unable to evaluate impact 5 4.95% 5.75% 
N/A 14 14% - 
• SME consultation  (relevant question: "15.) Do you th ink that the following elements of 
"Action 2" will help improving th e level of quality of services provided by Notified Bodies 
in this sector?" ): between 46% and 51% of  SME participating in the public consultation 
considered that this policy action would have  a positive impact on the level of quality of 
NB services (proxy for increase in effectiven ess of notification acti vities). Between 13 and 
14% of respondents believed this would not  be the case. Between 19 and 23% of 
respondents considered they were un able to evaluate this impact.  
Table 39: Impact of Action 2 on the level of services provided by NB (replies by SME) 
   Reinforcement of notification requirements for NB  Number of 
requested recordsRequested 
records 
(597)  % of total 
number 
records 
(597)  
  No or no significant impr ovement 81 (13.6%) (13.6%) 
  Moderate improvement 151 (25.3%) (25.3%) 
  Significant improvement 155 (26%) (26%) 
  Unable to evaluate impact 113 (18.9%) (18.9%) 
     
   Revised procedures for notification  Number of 
requested recordsRequested 
records 
(597)  % of total 
number 
records 
(597)  
  No or no significant impr ovement 78 (13.1%) (13.1%) 
  Moderate improvement 154 (25.8%) (25.8%) 
  Significant improvement  120 (20.1%) (20.1%) 
  Unable to evaluate impact 135 (22.6%) (22.6%) 
     
   Information obligations on NB  Number of 
requested recordsRequested 
records 
(597)  % of total 
number 
records 
(597)  
  No or no significant impr ovement 75 (12.6%) (12.6%) 
  Moderate improvement 133 (22.3%) (22.3%) 
 Significant improvement 161 (27%) (27%) 
 
EN 108   EN  Unable to evaluate impact 118 (19.8%) (19.8%) 
12.2.1.5.  Public authorities: costs and administrative burden 
• Answer to authorities consultation  (question C29: "Impact of the following elements of 
Action 2 on administrative bur dens and/or reorganisation co sts for authorities"; question 
C30.1 & 2 " If you answered that one or more of  the elements of Action 2 may give rise to 
a significant increase in costs/administrative burden, plea se explain why"; question C31.1 
& 2 " If you answered that one  or more of the elements of  Action 2 may give rise to a 
significant increase in costs/administrative bur den, please explain why" & "please provide 
an indicative estimate of the increase you e xpect"): depending on the various elements of 
Action 2 about 26-34% of res pondents considered there w ould be no or no significant 
increase in costs and/or administrative bur den, 25-36% considered that there would be a 
moderate increase, 3-5% considered that ther e would be a reduction, 32-38% either did not 
answer the question or declared themselves unable to evaluate impact, while almost none 
(0-2%) believed that action 2 would give ri se to a significant increase in costs and/or 
administrative burden.  
Table 40: Impact of Action 2 on operating costs and/or administrative burden for public authorities 
(replies by authorities)  
 Requirements for notifying authorities  Number of 
requested 
records % Requested 
records(101)  % of total number 
records(82)  
Reduction of costs / administrative burden 5 5% 6% 
No or no significant increase in costs / administrative burden 26 26% 32% 
Moderate increase in costs / 
administrative burden 36 36% 44% 
Significant increase in costs / 
administrative burden 2 2% 2% 
Unable to evaluate impact 13 13% 16% 
N/A - 19% - 
        
 Revised procedures for notification  Number of 
requested 
records % Requested 
records(101)  % of total number 
records(82)  
Reduction of costs / administrative burden 4 4% 5% 
No or no significant increase in costs / administrative burden 28 28% 34% 
Moderate increase in costs / 
administrative burden 35 35% 43% 
Significant increase in costs / 
administrative burden 0 0% 0% 
Unable to evaluate impact 15 15% 18% 
N/A - 19% - 
        
 Information obligation on NB  Number of 
requested 
records % Requested 
records(101)  % of total number 
records(82)  
Reduction of costs / administrative burden 3 3% 4% 
No or no significant increase in costs / administrative burden 34 34% 41% 
 
EN 109   EN Moderate increase in costs / 
administrative burden 25 25% 30% 
Significant increase in costs / 
administrative burden 1 1% 1% 
Unable to evaluate impact 19 19% 23% 
N/A - 19% - 
Only five respondents (5%) provided indicative es timates of the magnitude of cost increases 
expected. The average estimate provided was 20%, which however should be interpreted with caution since it does not seem to reflect the view expressed by the majority of respondents. 
As regards the specific reasons for cost increase, one respondent mentioned costs of 
translating documents for notifications and two mentioned the need for more detailed 
verification of documentation require d by this policy intervention.  
• Findings per sector: 
Table 41: Impact of Action 2 on operating costs an d administrative burden of authorities per sector 
(replies by authorities)  
  Electrical & 
Electronical goods 
(28) Lifts (11) Pressur
e equip 
(15) Measuring 
Instr. (21)Civil 
explosive 
(6). Pyrotechnic 
articles (9) Equip. for use in 
explosive atmospheres 
(11) 
  Requirements for notif ying
authorities         
 Reduction of costs /
administrative burden 3.6 0 13.3 9.5 0 0 0 
 No or no significant increase
in costs / administrativeburden 21.4 36.4 20 38.1 16.7 11.1 27.3 
 Moderate increase in costs /
administrative burden 28.6 36.4 53.3 9.5 66.7 55.6 45.5 
 Significant increase in costs /
administrative burden 3.699 0 0 4.81000 0 0 
 Unable to evaluate impact 14.3 18.2 6.7 14.3 16.7 11.1 9.1 
 N/A 28.5 9.0 6.7 23.8 0.0 22.2 18.1 
          
  Revised procedures for
notification         
 Reduction of costs /
administrative burden 3.6 0 6.7 9.5 0 0 0 
                                                 
99 Reply provided by one authority with the generic explanation that additional administrative burden will 
increase cost of personnel or reduce time for other tasks. 
100 Reply provided by one authority without specific explanations. 
 
EN 110   EN  No or no significant increase
in costs / administrative
burden 17.9 27.3 26.7 42.9 16.7 11.1 45.5 
 Moderate increase in costs /
administrative burden 32.1 45.5 53.3 4.8 66.7 55.6 27.3 
 Significant increase in costs /
administrative burden 0 0 0 0 0 0 0 
 Unable to evaluate impact 17.9 18.2 6.7 19 16.7 11.1 9.1 
 N/A 28.5 9.0 6.6 23.8 0.0 22.2 18.1 
          
  Information obligation on NB         
 Reduction of costs /
administrative burden 3.6 0 6.7 4.8 0 0 0 
 No or no significant increase
in costs / administrative
burden 28.6 45.5 20 47.6 16.7 11.1 54.5 
 Moderate increase in costs /
administrative burden 14.3 18.2 53.3 4.8 66.7 44.4 18.2 
 Significant increase in costs /
administrative burden 3.699 0 0 0 0 0 0 
 Unable to evaluate impact 21.4 27.3 13.3 19 16.7 22.2 9.1 
 N/A 28.5 9.0 6.7 23.8 0.0 22.3 18.2
         
• Estimate of number of re-notificatio ns needed per MS and per authority : 
The table below shows the distribution of NB pe r MS and per relevant directive. Normally 
MS appoint different notificati on authorities by areas of compet ence; furthermore, when a MS 
appoints a single notification auth ority for all directives, the la tter usually acts mainly as a 
contact point for the Commi ssion, but the notifications ar e underpinned by the work of 
sectoral authorities. Since ve ry often authorities are compet ent for groups of directives 
concerning similar products, some of the figures in  the table have been aggregated to reflect 
the workload of authorities responsib le for 2 or 3 related directives.  
The table shows that for the large majority of MS and directives the es timated number of re-
notifications necessary is very small and often negligible. Germany, Italy, Poland and UK can 
be faced with bigger - but overall very reasona ble - numbers (e.g. from 35 to 60) in two or 
three sectors among electrical and electron ic goods, pressure equipment, measuring 
instruments and lifts. Only Italy and UK may be faced in one sector (measuring instruments –
NAWI) with a sizeable number of re- notifications (respectively 106 and 142).  
 
EN 111   EN In particular, by looking at  specific directives: 
– For the directives on pyrotechnic articles, ci vil explosives and ATEX, the estimates of 
possible re-notifications  are (largely) below 12. 
– For the lifts directive figures are normally we ll below 21 and only Italy could be faced with 
almost 60 re-notifications. 
– For the two directives on elec trical and electronic goods jo intly (EMC and LVD), for the 
majority of MS the numbers of possible re- notifications are well below 16; only Germany 
France, Italy and UK could be faced with a high er number of re-notifications (between 33 
and 46).  
– For the two directives on measuring instru ments jointly (MID and NAWI) the number for 
the majority of MS is well below 25; Germ any and Poland could be faced with 2 re-
notifications and only Italy and UK could be  faced with more significant figures of 
respectively 106 and 142 re-notifications. 
– For the two directives on pressure equipment jointly (SVPD and PED) for the majority of 
MS the numbers are well below 25; Germ any, Italy and UK Poland could be faced 
respectively with 40, 48 a nd 35 re-notifications. 
 
EN 112   EN Table 42: Number of NB per Member States and per relevant directive 
Countries of NB                                                       
                               
  Total 
NB BE BG CZ DK DE EE IE EL ES FR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK 
Pyrotechnic 10 1  1  1    2 1      1  1    1  1     
                              
Civil Expl. 13 1 1 1  1    1 1      1    1  1  1 1 1 1 
                               
                               
EMC 131 8 2 6 1 18 1  1 9 20   1   1  6 2 17 2  1 4 3 2 26 
                               
LVD 148 6 3 8 2 20 1  3 7 13 6  1 2  1  5 5 25 7 1 3 7 1 1 20 
                               
EMC+LVD 14 5 14 3 38 2 0 4 16 33 6 0 2 2 0 2 0 11 7 42 9 1 4 11 4 3 46 
                               
Atex 55 4 1 1 2 12    1 2 9    1 1  1 1 6  1 1 2 1 1 7 
                               
MID 140 1  1 4 18 1 1  7 4 9  1 1  1  5 1 22 7 1 2 3 1 1 48 
                               
NAWI 270 1 2 1 5 14 2 2 1 17 2 97  3 2 1 1  1 1 10 7 2 1 1 1 1 94 
                               
MID+NAWI 2 2 2 9 32 3 3 1 24 6 106 0 4 3 1 2 0 6 2 32 14 3 3 4 2 2 142 
          
                               
SPVD 95 4 4 3 1 9 1 1 10 7 3 14  3 1 1 3  1 3 4 2 2 1 6 1 1 9 
                               
PED 237 8 6 7 7 31 2 1 14 18 8 34  5 1 1 4  10 8 8 6 3 2 9 12 6 26 
                               
SPVD+PED 12 10 10 8 40 3 2 24 25 11 48 0 8 2 2 7 0 11 11 12 8 5 3 15 13 7 35 
                               
Lifts 192 8 5 5 2 9 1 1 12 15 21 58 1 4 3 3 3  4 2 2 5 2 4 4 4 7 7 
                                                          
 
EN 113   EN 12.2.1.6.  Public health and safety 
• Answer to EO consultation  (questions C25.2 "Impact of th e following elements of Action 2 
on health and safety") 50-72% of EO partic ipating in the consultation (excluding the 
measuring instrument sector) believed this policy action would help protect public health 
and safety; 17-25% believed this would not be the case. As for information obligations on 
NB, the impact was less clear. The major ity of those who acknowledged a positive impact 
qualified it as moderate as far as notification procedures and information obligations were concerned. On the other hand, as regards NB  requirements the number of EO qualifying 
the impact as moderate was equal to the number of EO qualifying it as significant. 
Table 43: Impact of Action 2 on health and safety (replies by EO) 
   Reinforcement of notification requirements for NB  Number of requested 
records (36) Requested records 
(36)  
  No or no significant improvement 6 (16.7%)  
  Moderate improvement 13 (36.1%)  
  Significant improvement 13 (36.1%)  
  Unable to evaluate impact 4 (11.1%)  
  Revised procedures for notification   Number of requested 
records (36) Requested records 
(36) 
  No or no significant improvement 7 (19.4%)  
  Moderate improvement 13 (36.1%)  
  Significant improvement 12 (33.3%)  
  Unable to evaluate impact 4 (11.1%)  
   Information obligations on NB Number of requested 
records (36) Requested records 
(36) 
  No or no significant improvement 9 (25%)  
  Moderate improvement 13 (36.1%)  
  Significant improvement 5 (13.9%)  
  Unable to evaluate impact 9 (25%)  
• Answer to NB consultation  (question C25.2 "Impact of the following elements of Action 2 
on health and safety") 73-85% of NB partic ipating in the consultation (excluding the 
measuring instrument sector) believed this policy action would help protect public health 
and safety; 12-23% believed this would not be the case. The majority of those who 
acknowledged a positive impact  qualified it as moderate. 
Table 44: Impact of Action 2 on health and safety (replies by NB) 
   Reinforcement of notification requirements for NB  Number of requested 
records (60) Requested records 
(60) 
  No or no significant improvement 7 (11.7%) 
  Moderate improvement 33 (55%) 
  Significant improvement 18 (30%) 
  Unable to evaluate impact 2 (3.3%) 
  Revised procedures for notification   Number of requested 
records (60) Requested records 
(60) 
  No or no significant improvement 12 (20%) 
  Moderate improvement 27 (45%) 
 
EN 114   EN   Significant improvement 17 (28.3%) 
  Unable to evaluate impact 4 (6.7%) 
   Information obligations on NB Number of requested 
records (60) Requested records 
(60) 
  No or no significant improvement 14 (23.3%) 
  Moderate improvement 29 (48.3%) 
  Significant improvement 15 (25%) 
  Unable to evaluate impact 2 (3.3%) 
• Answer to authorities consultation  (question C25.2 "Impact of the following elements of 
Action 2 on health and safety") 68-77% of authorities participating in the consultation 
(excluding the measuring instrument sector) be lieved this policy acti on would help protect 
public health and safety; 12-21% believed this would not be the case. The majority of those 
who acknowledged a positive impact qualified it as significant for the NB requirements and as moderate for notification proc edures and information obligations. 
Table 45: Impact of Action 2 on health and safety (replies by authorities) 
   Reinforcement of notification requirements for NB  Number of requested 
records (66) Requested records 
(66) 
  No or no significant improvement 8 (12.1%) 
  Moderate improvement 25 (37.9%) 
  Significant improvement 26 (39.4%) 
  Unable to evaluate impact 7 (10.6%) 
  Revised procedures for notification   Number of requested 
records (66) Requested records 
(66) 
  No or no significant improvement 10 (15.2%) 
  Moderate improvement 31 (47%) 
  Significant improvement 15 (22.7%) 
  Unable to evaluate impact 10 (15.2%) 
   Information obligations on NB Number of requested 
records (66) Requested records 
(66) 
  No or no significant improvement 14 (21.2%) 
  Moderate improvement 30 (45.5%) 
  Significant improvement 15 (22.7%) 
  Unable to evaluate impact 7 (10.6%) 
12.3. Inconsistency of terminology  
• Answers to question D38: "Which effects do you expect from clarifying and harmonising 
generally used notions like “placing on th e market”, “manufacturer”, "importer", 
"distributor", etc.? (multiple choices possibl e)" and to question D34:  "If you are applying 
simultaneously two or more of the ten dire ctives concerned by th is consultation, which 
impacts do you expect from aligning the texts of the conformity assessment procedures to the texts of the corresponding conformity asse ssment procedures set out in Annex II of 
Decision 768/2008? (multiple choices possible)". 
 
EN 115   EN Table 46: Impacts of Action 3 (replies by EO, NB, authorities and users- mult iple choices possible) 
• (a) Alignment of terminology in definitions (e .g. “placing on the market”, “manufacturer”, 
"importer", "distributor", etc.) 
 EO NB Authorities   
No or no significant changes  7% 10% 1%  
It will make the relevant  directives clearer 57% 70% 81%  
It will avoid different interpretations by 
national authorities 80% 61% 79%  It will lead to difficulties since existing 
definitions by which I am concerned will be 
changed 3% 4% 2%  It will make the whole legal framework 
more confusing 5% 4% 1%  
It will make the whole legal framework clearer 54% 52% 82%  
It will allow more consistency throughout 
legislation 47% 65% 72%  
• (b) Alignment of terminology in texts on conformity assessment procedures 
  EO NB Authorities   
No or no significant changes 33% 13% 16%  
It will create difficulties as the conformity 
assessment procedures in the NLF 
Decision are not adequate fo r my sector 3% 7% 1%  
It will lead to more coherence with other 
legislation 21% 44% 78%  
It will or may reduce costs for EO 8% 27% 28%  
It will or may increase costs for EO 14% 10% 10%  
It will give rise to interpretation difficulties 
and differences in application by NB 
throughout the EU 4% 6% 3%  
It will lead to more coherent conformity 
assessment carried out by NB throughout 
sectors 56% 48% 73%  
12.4. Comparison of effectiveness of options 2 and 3 
(a) Effectiveness in relation to th e objective of reducing non-compliance 
The formal alignment and the non legislative measures options di ffer only in relation to the 
way the measures in the NLF Decision are im plemented. Therefore th e categories of impacts 
identified for the alignment option are in pr inciple also relevant to the non legislative 
measures option. However, whether the impact identified will materialise (at all or to a different degree) depends on the effectiveness of  either option in relation to the objective of 
reducing the non-compliance of products marketed in the EU. 
The option of non legislative measures is cons idered far less effective than the alignment 
option. This is because non legislative measures  would not modify the current situation where 
responsible EO already de facto  fulfil a number of obligations  that are part of existing 
guidance provided to industry, while unscrupulous EO explo it the fact that this best practice is 
not legally binding.  
 
EN 116   EN This view is strongly supporte d by the results of the public consultation as almost three 
quarters of all stakeholders (EO,  NB, authorities, users) having pa rticipated in it considered 
the option "Non legislative m easures" ineffective overall. 
The majority of all respondents (81%) considered the option of alignment of legal texts as 
quite (51%) or very (30%) effective, compar ed to the 17% of respondents recognising some 
degree of effectiveness (12% quite and 5% very  effective) in the op tion of non-legislative 
measures. 
Table 47: Comparison of effectiveness of the options 2 and 3 (replies by EO, NB, authorities and users) 
Alignment of legal texts (option 3)    
  EO NB Authorities Users Total % over 
Total 
Very effective 31 17 36 9 93 30%
Quite effective 46 52 43 15 156 51%
Quite ineffective 6 1 0 4 11 4%
Not effective at all 3 1 1 2 7 2%
I don't know 2 3 15 1 21 7%
N/A 10 2 6 2 20 6%
Total replies per type of respondents 98 76 101 33 308      
Non-legislative measures (option 2)   
  EO NB Authorities Users Total % over 
Total 
Very effective 3 4 6 2 15 5%
Quite effective 6 8 19 3 36 12%
Quite ineffective 26 32 47 16 121 39%
Not effective at all 48 26 10 6 90 29%
I don't know 3 4 4 3 14 5%
N/A 12 2 15 3 32 10%
Total replies per type of respondents 98 76 101 33 308   
(b) Effectiveness in relation to strict and uniform control of  NB across the EU 
The alignment and the 'non legislative measures ' options differ only in  relation to the way 
they are implemented. However, whether the impact identified will manifest  itself (at all or to 
a different degree) depends on the effectiveness of  either option in relation to the objective of 
strict and uniform contro l of NB across the EU. 
The Commission considers the op tion of non legislative measures  far less effective than the 
alignment option. This is because national authorit ies would have to base  their assessment of 
NB on non-binding requirements and it would be di fficult for them to ju stify in a tribunal a 
decision not to notify a conformity assessment body that does not fulfil those requirements. 
Furthermore, when requesting NB to provide  information on the validity of certificates 
provided by them or on negative conformity a ssessment results, national authorities would 
have to rely solely on NB willi ngness to cooperate with limited possibilities of enforcing their 
requests.  
This view is strongly supporte d by the results of the public consultation, as two thirds of 
stakeholders (EO, NB, authoriti es) having participated in the consultation considered the 
option "Non legislative measures "as ineffective overall. 
 
EN 117   EN The majority of all respondents (83%) considered the option of alignment of legal texts as 
quite (51%) or very (32%) e ffective, as compared to th e 21% of respondents recognising 
some degree of effectiveness (18% quite an d 3% very effective)  in the option of non-
legislative measures. 
Table 48: Comparison of effectiveness of options 2 and 3 (replies by EO, NB and authorities) 
Alignment of legal texts (option 3)  
  EO NB AuthoritiesTotal % over 
Total 
Very effective 31 19 37 87 32% 
Quite effective 41 50 48 139 51% 
Quite ineffective 2 4 1 7 3% 
Not effective at all 0 0 0 0 0% 
I don't know 4 0 4 8 3% 
N/A 20 3 11 34 12% 
Total replies per type of respondents 98 76 101 275     
Non-legislative measures(option 2)  
  EO NB AuthoritiesTotal % over 
Total 
Very effective 4 3 2 9 3% 
Quite effective 11 13 26 50 18% 
Quite ineffective 41 36 45 122 44% 
Not effective at all 18 21 12 51 19% 
I don't know 4 1 5 10 4% 
N/A 20 2 11 33 12% 
Total replies per type of respondents 98 76 101 275  
(c) Effectiveness in relation to the problem of inconsistencies in current legislation  
The Commission considers the op tion of non legislative measures  far less effective than the 
alignment option for the simple reason that without  formal alignment of the directives, current 
inconsistencies (identif ied in some definitions or in th e terminology used for conformity 
assessment procedures) will not be addressed.  
This view is strongly supporte d by the results of the public consultation, as two thirds of 
stakeholders (EO, NB, authoriti es) having participated in the consultation considered the 
option "Non legislative measures "as ineffective overall. 
The majority of all respondents (81%) considered the option of alignment of legal texts as 
quite (44%) or very (37%) e ffective, as compared to th e 27% of respondents recognising 
some degree of effectiveness (24% quite an d 3% very effective)  in the option of non-
legislative measures. 
Table 49: Comparison of effectiveness of options 2 and 3 (replies by EO, NB and authorities) 
Alignment of legal texts (option 3)  
  EO NB AuthoritiesTotal % over 
Total 
Very effective 47 15 54 116 44% 
Quite effective 29 33 35 97 37% 
Quite ineffective 2 2 0 4 2% 
Not effective at all 1 0 0 1 0% 
I don't know 8 2 1 11 4% 
 
EN 118   EN N/A 11 24 11 34 13% 
Total replies per type of respondents 98 76 101 263   
   
Non-legislative measures (option 2)  
  EO NB AuthoritiesTotal % over 
Total 
Very effective 3 0 6 9 3% 
Quite effective 30 14 20 64 24% 
Quite ineffective 40 24 51 115 44% 
Not effective at all 6 12 9 27 10% 
I don't know 8 2 4 14 5% 
N/A 11 24 11 33 13% 
Total replies per type of respondents 98 76 101 262   
 
EN 119   EN 13. ANNEX  5: SME  TEST  
(1) Consultation with SME 
representatives  SME were specifically consulted through the 
Enterprise Europe Network during the months of May and June 2010. A significant number of SME participated in the exercise. See section 1.3, as well as section 11.2 in Annex 3.  
(2) Preliminary assessment of 
businesses likely to be affected  According to the findings of the consultation, 
SME are among the economic operators affected by the problems identified, i.e. non-compliance, inappropriate quality of the services provided by 
certain NB and inconsistent terminology of existing directives. See sections 3.1.2, 3.2.2 and 3.3.2.  
(3) Measurement of the impact on SME  SME will be positively impacted by policies 
aiming at reducing the problems identified. In particular, this policy intervention will help defending the competiveness of compliant economic operators. The benefit of the selected option in this regards wi ll be the same for both 
SME and other economic operators.  
As regards negative impacts, both SME and 
other economic operators  believe that overall 
this policy action will not bring about significant 
costs increases.  
See sections, 6.4.2, 6.4.3.1, as  well as Table 19, 
Table 22 and section 12.1.2.4 in Annex 3. 
 
EN 120   EN (4) Assess alternative options and 
mitigating measures  At the end of the impact assessment, there was 
no indication that the selected option might result in a disproportionate burden for SME. Consequently, there is no element showing the need for SME specific measures in order to ensure compliance with  the proportionality 
principle.