COMMISSION STAFF WORKING PAPER IMPACT ASSESSMENT
Date: 2011-11-21
Institutions: European Commission
Subjects: free movement of goods, harmonisation of standards, market supervision, marketing, product safety, single market

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} 

 
 
 
 
  
 
TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

Procedural issues and consultation of interested parties .............................................. 3 

Identification ................................................................................................................ 3 

Organisation and timing............................................................................................... 3 

Consultation and expertise ........................................................................................... 3 

Scrutiny by the Commission Impact Assessment Board ............................................. 4 

Context ......................................................................................................................... 4 

The New Legislative Framework................................................................................. 4 

Political background..................................................................................................... 7 

Implementation of NLF................................................................................................ 7 

Specificities of this impact assessment and its link to the impact assessment on the 
New Legislative Framework ........................................................................................ 9 

2.5. 

Description of directives and sectors ........................................................................... 9 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

4. 

4.1. 

4.2. 

4.3. 

5. 

5.1. 

5.2. 

5.3. 

6. 

6.1. 

6.2. 

6.3. 

Problem description ................................................................................................... 14 

Products which do not comply with the requirements ............................................... 16 

Low quality of services delivered by certain Notified Bodies................................... 23 

Complexity of the regulatory environment ................................................................ 27 

EU right to act ............................................................................................................ 30 

Objectives................................................................................................................... 31 

General policy objectives........................................................................................... 31 

Specific and operational policy objectives................................................................. 31 

Consistency with other policies and objectives ......................................................... 32 

Options ....................................................................................................................... 32 

No policy change........................................................................................................ 32 

Alignment with the NLF Decision via non legislative measures............................... 32 

Alignment with the NLF Decision via legislative measures...................................... 32 

Impacts ....................................................................................................................... 34 

Overview of potential impacts and methodology for their assessment...................... 34 

Option 1: No policy change ....................................................................................... 35 

Option 2: Alignment via non-legislative measures.................................................... 38 

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6.4. 

Option 3: Alignment via legislative measures ........................................................... 41 

7. 

8. 

9. 

Comparison of options ............................................................................................... 51 

Monitoring and evaluation ......................................................................................... 55 

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 ..................................................................................................... 71 

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 participated 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 

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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  group  met  four  times,  on  1  December  2009,  7 
April 2010, 2 February 2011 and 1 March 2011 and representatives 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  been  consulted  through  the  Senior  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  consultation  was  carried  out  which  was 
published  on  the  Your  Voice  in  Europe  website.  It  consisted  of  four  targeted 
questionnaires for economic operators, authorities, notified bodies and users and we 
received  300  replies.6  In  view  of  the  high  number  of  SME  active  in  the  sectors 

1 

2 

3 

4 

5 
6 

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 
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  Directive  in  7  Member  States:  Belgium,  Finland, 
Germany, Italy, Portugal, Spain and the United Kingdom. 
Study  on  the  Technical  Assessment  of  Means  of  Preventing  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 Statham; Crown copyright (2007). The study aim was the 
examination whether the solutions available, other than free space or refuges, to prevent the crushing 
risk can provide an equivalent level of safety. 
See  “Market  description,  competitiveness  analysis  in  the  field  of  products  and  protective  systems 
intended 
on 
explosive 
http://ec.europa.eu/enterprise/sectors/mechanical/files/atex/atexcomp_finalreport_en.pdf 
A glossary and a list of acronyms can be found in Annex 1. 
A  summary  of 
goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm 

is  available  at  http://ec.europa.eu/enterprise/policies/single-market-

atmospheres” 

the  results 

potentially 

available 

(1999); 

use 

for 

in 

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3 

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concerned,  a  specific  SME  consultation  was  carried  out  in  addition  to  the  general 
consultation.  603  SME  were  consulted  through  the  Enterprise  Europe  Network  in 
May/June  2010.  More  information  on  stakeholders  who  participated  in  the 
consultation  can  be  found  in  the  annex  (see  section  11.2  in  Annex  3).  Several 
bilateral  meetings  also  took  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  alignment  of  legislation.  Certain  concerns 
were  expressed  on  very  specific  aspects,  mainly  relating  to  translation  obligations 
and  certain  aspects  of  traceability  requirements.  While  a  number  of  these  concerns 
can  be  addressed  by  appropriate  guidance,  some  could  not  be  taken  into  account 
because  these  measures  are  indispensable  to  increasing  the  efficiency  of  market 
surveillance.  They  do  not  entail  unreasonable  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 European Commission assessed a draft version 
of  the  present  impact  assessment  and  issued  its  opinion  on  12/04/2011.  The  Board 
made several recommendations and, in the light of these, the final impact assessment 
report: 

Clarifies  the  considerations  on  the  basis  of  which  the  ten  directives  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. 

CONTEXT 

2.1. 

The New Legislative Framework 

This  initiative  is  a  further  step  in  the  implementation  of  the  “goods  package” 
adopted in August 2008. The goods package is a set of horizontal measures aimed at 
improving  the  functioning  of  the  internal  market  for  goods.  It  consists  of  three 
instruments:  

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– 

– 

Regulation  764/20087,  which  is  intended  to  improve  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,  electrical  products,  lifts,  etc.  This  legislation 
has a twofold objective: On the one hand it ensures that products available in Europe 
meet  a  high  level  of  protection  of  public  interests  like  health  and  safety,  consumer 
protection  or  environmental  protection.  On  the  other  hand  it  ensures  the  free 
movement  of  products  by  replacing  national  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  stocktaking  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 significant  number of non-compliant products  that 
reach  the  market,  the  unsatisfactory  performance  of  certain  notified  bodies11,  and 
inconsistencies  throughout  the  legislation  making  its  application  unnecessarily 
complicated for manufacturers 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  common  framework  for  the  marketing  of 

7 

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10 

11 

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  certain  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 
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 
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 
The  evolution  of  the  EU’s  policy  on  technical  harmonisation  is  outlined  in  detail  in  the  impact 
assessment 
2007(173) 
the  New 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf  
Laboratories  and  certification  or  inspection  bodies  delivering  certificates  which  are  notified  to  the 
Commission by Member States. 

accompanied 

Framework. 

Legislative 

SEC 

that 

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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 legislation that lays down 
requirements  for  the  marketing  of  products.  It  contains  the  provisions  which  are 
commonly used in EU product legislation (e.g. definitions, 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  importers,  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 comply with the legal requirements, the NLF 
Decision  contains  the  corresponding  obligations  imposed  on  economic  operators 
such  as manufacturers,  importers  and distributors, as well as the bodies testing and 
certifying products. These obligations provide the means for authorities 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, individuals 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 process, Council, Parliament and Commission 
have  committed  themselves  to  use  its  provisions  as  much  as  possible  in  future 
legislation  on  products  in  order  to  further  the  utmost  coherence  of  the  regulatory 
framework14. To give practical effect to the NLF Decision’s provisions, they need to 
be integrated into the existing product legislation.  

12 

13 

14 

SEC 

2007(173) 

See 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf 
Accreditation  is  a  tool  for  the  control  of  the  competence  of  laboratories  and  certification/inspection 
bodies delivering certificates in the EU 
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  products  ("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".  

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2.2. 

Political background 

In  the  wake  of  large-scale  product  recalls,  product  safety  has  gained  a  lot  of 
political attention lately. In the summer of 2007, when 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 Europe (market surveillance to effectively 
deal  with  dangerous  products),  they  also  put  into  question  the  credibility  of  EU 
legislation and its capacity to adequately protect 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  economic  operators.  The 
negotiations on the goods package were finalised in record time. 

In response to these concerns, the Commission immediately presented a proposal for 
a  revised  Directive  on  the  Safety  of  Toys  in  2008.  It  fully  took  on  board  the  new 
framework set by the NLF Decision and became the first directive to be aligned to 
the NLF.15  

Improving  the  safety  of  products,  in  particular  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  enhanced  provisions  of  the  NLF 
Decision.  The  Decision  itself  provides  that  its  provisions  are  to  be  used  when 
legislation is drafted or revised. An internal survey showed that for a majority of the 
existing  directives  there  was  a  need  to  address  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  problems  observed  at  horizontal  cross-sector 
level. Hence a full revision of these directives had been planned within a time-frame 
of 5 years. Examples are the 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  directives  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 the adoption of the NLF.  

While no full revisions were thus planned for these directives - neither within the 5 
year  framework  nor  beyond  that  period  -  it  was  nevertheless  considered  that  the 

15 
16 

EN 

See http://ec.europa.eu/enterprise/sectors/toys/documents/directives/index_en.htm 
See for example the own initiative Report on the revision of the General Product Safety Directive and 
market 
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-
//EP//NONSGML+REPORT+A7-2011-0033+0+DOC+PDF+V0//EN&language=EN 

(2010/2085(INI)) 

surveillance 

7 

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cross-cutting  horizontal  problems  of  non-compliance  and  incoherence  need  to  be 
addressed and that these sectors should also fully benefit from the improvements of 
the NLF. Given the strong link between the NLF Regulation and the NLF Decision, 
and the objective of ensuring more consistency throughout the regulatory framework 
for products, it appeared desirable to also align these directives to the NLF Decision 
within  the  same  timeframe.  In  order  to  stress  the  fact  that  this  exercise  exclusively 
concerns the horizontal elements of these directives which will be aligned to the NLF 
Decision  -  as  the  follow-up  to  the  commitments  undertaken  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) 

(2) 

(3) 

(4) 

(5) 

(6) 

Low Voltage Directive: Directive 2006/95/EEC on the harmonisation of the 
laws  of  Member  States  relating  to  electrical  equipment  designed  for  use 
within certain voltage limits  

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 

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  intended  for  use  in  potentially  explosive 
atmospheres 

Lifts Directive: European Parliament and Council Directive 95/16/EC on the 
approximation of the laws of the Member States relating to lifts 

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  

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 Council on measuring instruments  

(8) 

(9) 

Non-automatic  Weighing  Instruments  Directive:  Council  Directive 
2009/23/EEC on the harmonisation of the laws of the Member States relating 
to non-automatic weighing instruments  

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  

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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 aforementioned 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 directives. The objective of the 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  solutions  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  problems  already  analysed  in  the  impact 
assessment  for  the  NLF  with  a  more  sector-specific  focus.  In  view  of  the  political 
commitment  laid  down  in  Article  2  of  the  NLF  Decision18  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 the 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  why  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 content will be made to the Directives. This 
means that reflections on purely sector-specific aspects like the products covered by 
the  directives,  the  adequacy  of  the  essential  health  and  safety  requirements  or  the 
choice of the applicable conformity assessment 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  guarantee  the  accuracy  of  measurements 
performed  by  measuring  instruments.  In  addition,  all  the  directives  simultaneously 
ensure the free movement of the products they cover throughout the EU.  

17 

18 

See 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf 
See footnote 14 

SEC 

2007(173) 

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   EN 

 
                                                 
The directives are all so-called New Approach 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  those  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 clause, whereby Member States must inform 
the  Commission  of  any  restrictive  measure  that  they  take  against  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  sectors  and  products  covered  by  the  directive 
(scope,  sector-specific  definitions,  essential  requirements,  choice  of  applicable 
conformity  assessment  procedures  and  specificities  of  procedure).  Others  are 
common to all directives (horizontal) and are basically the same (general definitions, 
manufacturers’ obligations, basic conformity assessment procedures, requirement for 
notified  bodies,  CE  marking,  safeguard  clause).  However,  certain  –  unnecessary  – 
discrepancies  have  gradually  made  their  way  into  the  directives.  See  chapter  3.3.

19 

20 

21 

EN 

assessment 

The  legislative  technique  of  the  New  Approach  is  explained  in  detail  in  sections  1.2  and  1.3  of  the 
impact 
NLF. 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf 
The  terminology  varies  from  directive  to  directive,  some  use  “essential  safety  requirements”,  others 
“essential requirements” and the Low Voltage Directive uses the term “safety objectives”. 
Notified bodies are conformity assessment bodies testing, inspecting and certifying a product. They are 
notified to the Commission by the Member States in which they are established. 

the 

on 

10 

   EN 

 
                                                 
2.5.2.  Key data of sectors concerned 

Table 1: Key data of sectors concerned 

Products 

Electro-technical 
sector 
(Low 
Voltage  Directive 
(LVD) and electro 
magnetic 
compatibility 
directive (EMC)) 

equipment, 
generators 

Electric  welding  and 
soldering 
tools,  electric  domestic  appliances, 
computers  and  other  information 
electric 
processing 
motors, 
and 
transformers. 
electricity 
distribution  and  control  apparatus, 
insulated  wire  and  cable  (LVD 
only), 
equipment  and 
electric  lamps  (LVD  only),  other 
electrical 
electronic 
equipment, 
tubes  and  other 
valves  and 
electronic  components  (LVD  only), 
television  and  radio  receivers, 
sound  or  video  recording  or  video 
reproducing 
or 
recording 
apparatus and associated goods. 

lighting 

Size of the 
industry 
(market 
output) 

€ 235.59 
billion 
(equipment 
covered by 
LVD) 

€ 200.12 
billion 
(equipment 
covered by 
EMC) 

Trade balance  
(share of imports) 

Industry structure, SME 
presence 

Number 
of NB in 
the EU22 

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) 

Negative trade balance:  

LVD:  €  103.93  billion  of 
imports  and  €  83.09  billion  of 
exports. 
internal 
The 
consumption  is  estimated  at  € 
256.42 billion. 

EMC:  €  100.78  billion  of 
imports  and  €  76.07  billion  of 
exports. 
internal 
The 
consumption  is  estimated  at  € 
224.83 billion 

come 

imports 

Most 
from 
a 
followed 
China, 
considerable  distance  by  the 
USA, Japan and South Korea. 

at 

ATEX 

and 
Mechanical, 
telecommunication 
equipment, 
protective  systems and  devices,  to 

electrical 

€ 2.2 billion 

Positive trade balance: Imports 
amount 
to  €  400  million. 
Internal consumption estimated 

22 

NANDO database on 3 January 2011 http://ec.europa.eu/enterprise/newapproach/nando/ 

ATEX 

is 
The 
characterised by a large number 
of  SME  and  micro  enterprises, 

sector 

55 

EN 

11 

EN 

 
  
 
 
                                                 
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 
the 
shares 
Netherlands,  Norway,  Poland, 
Spain,  Sweden  as  well  as  in 
Switzerland. 

in  Denmark, 

be  used  in  potentially  explosive 
atmospheres 
underground 
(in 
mines,  petrochemical  plants,  oil 
refineries, filling stations and other 
places  where  flammable  gases  may 
be  present,  and also  premises  like 
flour  mills 
agricultural 
and 
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 
similar  equipment;  vent 
other 
panels; 
sparks 
enclosures; 
arrestors;  temperature  protective 
devices; etc. 

Pressure 
Equipment 
simple 
vessels) 

(incl 
pressure 

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 

NAWI 

Non-automatic 
instruments, 

i.e. 

weighing 
measuring 

€ 2.5 billion 

Not available 

23 

This figure includes recognised third party organisations and user inspectorates. 

Small 
employees) 

companies 

50 
clearly  dominate 

(< 

23723 

95 
(simple 
pressure 
vessels) 

270 

EN 

12 

EN 

 
  
 
                                                 
Measuring 
Instruments 

Lifts 

Civil Explosives  

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-  

€ 3.25 billion 

Around  20-25%  of  measuring 
instruments  in  the  EU27  are 
imported 

Water  meters, 
gas  meters, 
electricity  meters,  heat  meters, 
meters for liquids other than water, 
taximeters, 
weighing  machines, 
material  measures 
to  measure 
dimensional  measuring 
length, 
gas 
instruments 
analysers. 

exhaust 

and 

€ 3.17 billion 

Lifts permanently serving buildings 
and  constructions  intended  for  the 
transport  of  persons,  persons  and 
goods  or  goods  alone  if  the  car  is 
accessible 
safety 
as  well 
components for use in such lifts 

as 

Very  positive  trade  balance:  € 
36 million of imports and € 693 
million of exports. 

Internal  consumption:  €  2.51 
billion 

are 

around 

There 
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. 

by 

The  structure  of  the  industry  is 
four 
characterised 
lifts  companies 
multinational 
small  companies 
and  many 
and 
designing 
specialised. 
and 
lifts 
installing 
producing safety components for 
this lifts 

new 

or 

police, 

Explosive  substances  and  articles 
which  are  not  used  by  the  armed 
forces 
but 
the 
commercially.  The  main  end-users 
of  civil  explosives  are  the  mining 
industry,  the  quarrying  industry, 
and 
the  construction  and  civil 
engineering industry (primarily for 
land  clearance  and 
demolition, 
tunnelling) 

play 

€ 1.35 billion.  Trade  with  third  countries  is 
limited. 
a 
Imports 
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 
500 
approximately 
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 
employing 
hand,  are  SME 
around  5  000  people.  Thus,  a 

140 

192 

13 

EN 

13 

EN 

 
  
in the oil drilling industry. 

Pyrotechnic 
articles 

Fireworks,  theatrical  pyrotechnic 
articles,  pyrotechnic  articles  for 
technical  purposes  and  automotive 
(automotive 
pyrotechnic  articles 
i.e.  most 
systems, 
restraint 
importantly  gas  generators  used  in 
airbags and seatbelt tensioners). 

€  1.4  billion 
(fireworks) 

95%  of  all  consumer  fireworks 
are manufactured overseas. 

€  2.8  billion 
(automotive) 

total  of  9  000  people  are 
employed  by  the  civil  explosives 
industry. 

industry:  mainly 
Fireworks 
SME;  altogether  employing  in 
total  an  estimated  15  000  to  20 
000 people. 

10 

Automotive pyrotechnic articles: 
big 
international  automotive 
supplier  companies,  around  40 
000 employees. 

3. 

PROBLEM DESCRIPTION 

The  consultations  have  identified  three  main  problems  with  regard  to  the  functioning  of  the  current  legislation:  (1)  non-compliance  of 
significant  number  of  products  that  reach  the  market,  (2)  unsatisfactory  performance  of  certain  Notified  bodies  and  (3)  complexity  of  the 
current legislation. Those have been analysed in a more horizontal context in the impact assessment for the New Legislative Framework. The 
problem tree below illustrates the drivers and the consequences of the abovementioned problems, which are discussed in more detail further in 
this chapter.  

EN 

14 

EN 

 
  
 
EN 

15 

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 manufactured in such a way that they do not 
pose  a  risk  to  the  health  and  safety  of  consumers  or  other  users,  that  they  produce 
accurate  measuring  results  (measuring  instruments)  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 well as products imported into the EU. 

Nevertheless  not  all  products  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 health and safety requirements. Examples 
of  non-compliance  with  formal  requirements  are  missing  documents,  missing  or 
wrongly  affixed  markings  or  missing  labelling  as  well  as  non-compliance  with 
procedural  requirements  (e.g.  application  of  wrong  conformity  assessment 
procedure)  while  the  product  itself  nevertheless  complies  with  the  requirements 
relating to its design and production. Substantial non-compliance means that there is 
a deficiency in the design or construction 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 risks relating to substantial non-compliance 
vary in accordance with the nature of the product.  

Defective electronic products can present a risk of electric shock or burns. Defective 
fireworks, e.g. fireworks which ignite prematurely, 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 potentially explosive atmospheres or pressure 
can  have  even  catastrophic  effects.  Consequences  of  this  kind  of  explosion  include 
severe or deadly injuries to persons, serious damage to installations 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  associated  with  the 
products  covered  by  the  directives  are  provided  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  general  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 the malfunctioning of a product or to misuse 
by the user. There is no Europe-wide database on accidents involving products and 
knowledge depends on national statistics, information collected from hospitals etc; 

Apart from posing risks to users, non-compliance (both formal and substantial) has 
important  economic  consequences:  It  leads  to  unfair  competition.  Operators  not 
adhering  to  the  rules  can  make  significant  savings  on  compliance  costs  by,  for 

EN 

16 

   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  competition  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 situation. 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 

20%

18%

16%

14%

12%

10%

8%

6%

4%

2%

0%

 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

% Respondents
considering that their
sector is affected by non
compliance (90)     

% of total number of
respondents (98)     

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  heterogeneous  sectors  like  electrical  equipment, 
pressure  equipment  or  measuring  instruments.  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 the actual share of non-compliant products on 
the market per sector.  

24 

25 

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  efficient  enforcement  mechanisms  some  manufacturers 
might be tempted to "take the easy way" and to market non-compliant products.” 
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 investigations. This explains why in certain sectors 
there is more information available than in others. 

EN 

17 

   EN 

 
 
                                                 
The problem of non-compliance is generally perceived in all sectors concerned. 92% 
of economic operators reacting to the public consultation consider that their sector is 
affected by non compliance. General findings across all sectors are that many non-
compliant  products  are  imported26  and  that  many  non-compliant  products  are 
counterfeit. 

Most data on non-compliance is available in the electro-technical sector. It is also the 
sector in which stakeholders and in particular industry associations have been most 
active  in  pointing  to  the  problem.27  The  LVD  market  surveillance  authorities  have 
undertaken three cross border actions, 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  were  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  the  EMC  Administrative  Cooperation  group 
(ADCO)  recently,  which  focused  on  Energy  Saving  Lamps31,  Power  Tools32  and 
Consumer  Entertainment  Electronic  Products33.  The  results  of  these  campaigns 
showed that the level  of technical non-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-compliant  imported  products  was  generally  higher  than  the 
share  of  non-compliant  products  originating  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 products for professional use, information on cases 
of  non-compliance  is  based  on  feedback  from  stakeholders  and  authorities,  reports 
from  ADCO  groups  and  notified  body  groups.34  It  appears  that  the  problem  is  less 
felt in specialised sectors like ATEX or civil explosives sector, although a few cases 
of non-compliance have been reported. 

26 

27 

28 

29 

30 
31 

32 

33 

34 

This  is  also  confirmed  by  the  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. 
See  e.g.  ORGALIME  position  paper  Call  for  an  effective  pan-European  market  surveillance  system 
http://www.orgalime.org/Pdf/PP_Orgalime-ANEC_on%20market%20surveillance_apr09.pdf 
See 
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/08/615&format=HTML&aged=0&languag
e=EN 
See  http://ec.europa.eu/enterprise/sectors/electrical/files/lvd-adco/20080903_lvd_adco_-_final_report_-
_extension_leads_-_2007_project_en.pdf 
See http://ec.europa.eu/enterprise/sectors/electrical/files/lv/report_luminaires_en.pdf 
See 
Lamps 
http://ec.europa.eu/enterprise/sectors/electrical/files/emc/ms-campaign-first_en.pdf 
See 
http://ec.europa.eu/enterprise/sectors/electrical/files/emc/ms-campaign-second_en.pdf 
Report 
Products 
concerning  Consumer 
http://ec.europa.eu/enterprise/sectors/electrical/files/emc/ms-campaign-third_en.pdf 
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. 

Entertainment 

concerning 

concerning 

campaign 

campaign 

campaign 

available 

available 

Energy 

Saving 

Report 

Report 

power 

tools 

on 

on 

on 

at 

at 

EN 

18 

   EN 

 
                                                 
Table 2: Percentage of respondents to the public consultation considering that their sector is affected by 
non-compliance 

Economic 
Operators 

Electro-
technical 

ATEX 

Civil 
explosives 

Pyrotechnic 
articles 

Lifts  Measuring 
instruments 

Pressure 
equipment 

Total

96% 

75% 

- 

0% 

88% 

94% 

83% 

92% 

(100% don’t 
know) 

Authorities 

86% 

64% 

0% 

78% 

55% 

52% 

80% 

66% 

(50% don’t 
know or 
No) 

Notified B 

94% 

44% 

25% 

50% 

44% 

31% 

65% 

60% 

Users 

100% 

25%  

- 

0%  

100% 

67% 

82% 

64% 

(50% don’t 
know) 

(55% 
No) 

(40% don’t 
know) 

(75% 
don’t 
know) 

(50% don’t 
know or No) 

SMEs 

53% 

44% 

12,5% 

0% 

35% 

41% 

49% 

48% 

(50% don’t 
know or No) 

(40% 
No) 

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  perception  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 Directive 2004/22/EC, the poor quality of market 
surveillance is one of the important concerns of industry and it is an area where most 
authorities recognise that their effort until recently has been 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  basis.  Only  in  few  countries  have  there 
been actual tests of the conformity  of the  products  placed  in  the  market  usually  on 
the  basis  of  annual  surveillance  programmes  focusing  on  specific  categories  of 
measuring  instruments.  The  absence  of  proper  surveillance  appears  to  be  the  main 
reason for almost all occasions of unfair competition reported.” 35  

The  study  “Evaluation  of  the  Application  of  the  Lift  Directive  (95/16/EC)”36 
concluded  that  market  surveillance  in  the  lifts  sector  was  often  limited  to  reactive 

35 

36 

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 
See footnote 2. 

EN 

19 

   EN 

 
  
 
                                                 
surveillance,  and  many  stakeholders  were  uninformed  and  even  unaware  of  market 
surveillance  activities  in  their  countries.  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  the  impact  assessment  on  the  NLF.  The 
ineffectiveness  of  market  surveillance  is  however  also  rooted  in  certain  practical 
obstacles.  

One  major  difficulty  for  the  authorities  is  the  lack  of  traceability  of  non-compliant 
products and the operators who have supplied them, in particular when the products 
originate in third countries. When authorities have doubts about the conformity of a 
product they need specific information allowing 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  the  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  details,  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  allow  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 every individual product. It will become applicable on 5 
April 2012. 

A  further  reason  for  the  presence  of  non-compliant  products  on  the  market  is  that 
operators  further  down  the  supply  and  distribution  chain,  namely  importers  and 
distributors  are  not  carrying  out  the  necessary  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 properly. Some of them are also not aware of 
the applicable legislation and, as regards importers, 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 

38 

39 

40 

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. This is however not obligatory. In practice mainly big 
companies with well known brand names have appointed an authorised representative. 
The problem of traceability and the high share of imported products was one of the main conclusions 
drawn  from  the  market  surveillance  campaigns  carried  out  by  the  LVD  and  EMC  ADCOs.  See 
footnotes 28 and 30.  
See 
chemicals/explosives/index_en.htm 
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. 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-

EN 

20 

   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 authorities is limited to the territories of the 
EU Member States. If a manufacturer 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 directly. 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 obligations for importers and distributors has 
led to Member States imposing differing obligations on importers and distributors in 
their  national  laws.  This  contributes  to  market  surveillance  authorities  in  different 
Member  States  having  different  approaches  to  cases  of  non-compliance.Measures 
taken against the product concerned (withdrawal, 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 information, 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  has  to  be  used.  There  have 
been  a  number  of  cases  where  national  market  surveillance  authorities  have 
requested  translations  into  their  national  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  circulate  in  the  territory  of 
another Member State. In principle the safeguard clause procedures provided for in 
all  directives  should  avoid  such  differences  in  treatment.  These  procedures  do 
however not work effectively41.  

To  some  extent  the  problem  of  non-compliance  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 products not meeting safety requirements 

–  Economic  damage  from  non-performing  products  and  the  need  to  replace 

defective goods 

41 
42 

EN 

For more details see section 2.24 of the impact assessment on the NLF. 
For the sake of completeness it is also mentioned that 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 
See 
further 
weaknesses 
http://ec.europa.eu/enterprise/policies/european-standards/standardisation-policy/policy-
review/index_en.htm 

examined 

context. 

issue 

this 

not 

the 

in 

is 

21 

   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  investigation  costs  if  operator  cannot  be 

found 

SME 

The results of the SME consultation show that 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 consultation considering themselves affected by 
the problem. 54% of SME indicated that they suffer from unfair competition due to 
non-compliance  (compared  to  87%  of  economic  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 category most concerned by non compliance. 

3.1.3.  Predicted evolution of the problem 

The NLF Regulation, which became applicable on 1 January 2010, should lead to a 
certain  improvement  of  the  current  situation.  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  should  hence  become  more  effective  and 
more  visible  and  deter  those  operators  who  have  been  encouraged  by  a  perceived 
absence of market surveillance 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  the  market.  Certain  operators  will  still  try 
their luck, given the economic savings they can achieve.  

Regarding  the  lack  of  traceability,  the  situation  will  improve  in  the  civil  explosive 
sector  due  to  introduction  of  the  traceability  regime  of  Commission  Directive 
2008/4343.  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  distributors.  Furthermore,  although  the  NLF 
Regulation  obliges  market  surveillance  authorities  to  take  restrictive  action  against 
non-compliant  products  and  to  inform  the  market  surveillance  authorities  of  other 
Member States about this action, it does not oblige them to take a uniform approach 
towards non-compliant products found.  

See 
chemicals/explosives/index_en.htm 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-

22 

   EN 

43 

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 distributors in particular about the system behind the CE 
marking  and  their  respective  obligations.  The  campaign  might  lead  to  increased 
awareness among a certain number of economic operators who will subsequently pay 
more  attention  to  checking  the  conformity  of  products  which  they  are  supplying. 
However  it  must  be  taken  into  the  consideration  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  marking  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 many of the sectors concerned will make the 
tasks  of  market  surveillance  authorities  more  complex  and  difficult.  This  is  also 
underpinned by the fact that the share of RAPEX notifications concerning imported 
products  has  been  consistently  growing  since  2004.45  The  problems  that  market 
surveillance authorities are encountering with imported non-compliant products will 
therefore  be  likely  to  increase.  Consequently  they  will  need  to  rely  increasingly  on 
the information provided by importers and distributors. The lack of traceability in the 
supply  and  distribution  chain  will  then  become  an  even  bigger  problem.  One 
exception is the civil explosives sector, where the new traceability regime applicable 
from April 2012 should lead to a significant 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  certification  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  notified  bodies  work  in  a  thorough  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), leading to some market distortions, have 

44 
45 

46 

47 

48 

of 

the 

reports 

Annual 

RAPEX, 

operation 

For more information see http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/ 
available 
on 
See 
http://ec.europa.eu/consumers/safety/rapex/stats_reports_en.htm#annual.  
These  bodies  are  conformity  assessment  bodies,  which  test,  inspect  and  certify  products.  They  are 
called “notified bodies”, because they are notified by the Member States to the Commission. 
In the electro-technical sector the role of notified bodies is different. 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.  
68% of the notified bodies reacting to the public consultation confirmed that they are aware of problems 
with the quality of services provided in their sector. This assessment was shared by a high number of 
economic operators using notified bodies (84%) and by the majority of public authorities (53%). 

at 

EN 

23 

   EN 

 
                                                 
been  recorded  by  some  Member  States  and  the  ATEX  Notified  Bodies  Group 
(ExNBG).  The  ADCO  group  on  pressure  equipment  has  also  raised  a  number  of 
concerns  relating  to  the  work  of  certain  notified  bodies,  in  particular  as  regards 
activities carried out by subsidiaries or subcontractors based in third countries. 

68%  of  notified  bodies  replying  to  the  public  consultation  stated  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  the  necessary  competence  to  carry  out 
assessments properly. This problem has in particular been observed with subsidiaries 
or  subcontractors  of  European  notified  bodies  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  lower  rates.  For  example,  the  elimination  or 
reduction of on site controls or relaxed requirements as to the frequency of periodic 
audits/inspections can reduce the costs of assessments quite considerably.49  

The study on the measuring instruments directive also identified concerns about the 
operation  of  notified  bodies  in  the  assessment  of  conformity  and  the  overall 
certification  procedure.  On  the  one  hand,  important  parts  of  the  industry  and  the 
national authorities claim that notified bodies tend to use guidance documents as if 
they  are  regulations  providing  the  only  possible  means  of  establishing  conformity. 
Industry  representatives  referred  to  occasions  when  alternative  approaches  were 
rejected or considered unfavourably. This is seen as having a negative effect on the 
development of technological innovation although only a few specific examples were 
provided.  On  the  other  hand,  notified  bodies  appear  rather  inconsistent  in  their 
operation with important variations in their capacity to carry out the necessary tests, 
especially those in the new Member States. They 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  competition  within  the  manufacturing  industry  and 
among  notified  bodies.  Less  rigorous  assessment  of  product  conformity  means  that 
the  manufacturer  can  make  savings  on  compliance  and  certification  costs.  Notified 
bodies  performing  diligent  assessments  frequently  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 bodies 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 

50 

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 
CSES evaluation, p48 

EN 

24 

   EN 

 
                                                 
stringently than others which results in an uneven playing field  for notified bodies. 
Some base their assessments on the relevant standards51 in that area, while others do 
not.  Some  Member  States  organise  designation,  assessment  and  monitoring  of 
notified  bodies  directly  through  their  public  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 assessment and monitoring of notified bodies. 

Figure 2: Differences in the assessment and monitoring of notified bodies 

70%

60%

50%

40%

30%

20%

10%

0%

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 do
not put the same efforts in
monitoring performance of NB
after notification

Other (please specify)

% Total number of respondents (76)     

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  context. In certain Member  States  a  strikingly 
high number of notified bodies54 does not correspond to the reality of the market in 

51 

52 

53 

54 

The  application  of  the  standards  is  voluntary.  Where  they  are  used,  they  give  a  presumption  of 
conformity with the requirements laid down in the directives. It has to be noted here that only the more 
recent directives like the measuring instruments directive or the directive on pyrotechnic articles contain 
a set of requirements for notified bodies which corresponds 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. 
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. 
SEC 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf page 15 
The  number  of  notified  bodies  and 
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id
=16&type_dir=NO%20CPD&pro_id=99999&prc_id=99999&ann_id=99999&prc_anx=99999 

their  origin  are  available 

the  NANDO  database : 

2007(173) 

in 

EN 

25 

   EN 

 
 
                                                 
conformity assessment services in that sector. It can be assumed that many of these 
bodies  do  not  actually  perform  any  conformity  assessment  activity  under  the  lifts 
directive and therefore do not have the necessary competence to be notified.55 

The situation is particularly problematic with regard to subsidiaries or subcontractors 
located outside the EU which carry out conformity assessment activities on behalf of 
a European notified body, as it is totally unclear how the competence of such bodies 
has been assessed.56  

Apart  from  divergences  in  the  assessment  and  monitoring  of  notified  bodies,  the 
different  quality  of  conformity  assessments  is  also  due  to  insufficient  coordination. 
In  principle  notified  bodies  should  coordinate  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 decisions. 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  representation.  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 

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. 

the  manufacturing 

in 

Notified bodies: 

–  Notified  bodies  performing  properly  rigorous  conformity  assessment  services 

suffer from unfair competition. 

–  Different treatment due to different assessment and monitoring practices applied 

by Member States. 

SME 

55 

56 

57 

The issue was also raised in the 2004 study on the application of the lifts directive. It was furthermore 
subject of discussions in the lifts committee and in the Notified Bodies Group for lifts (NB-L). 
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. 
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 

26 

   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 operation 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  competence  of  a  body  to  provide  the  necessary 
evidence that the body has been assessed in an equivalent manner.  

The NLF Regulation should lead to harmonisation of accreditation practices. Bodies 
which are accredited should hence have undergone a more or less similarly rigorous 
assessment  of  their  competence.  Consequently  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  different  objectives  (protection  of  health  and  safety, 
environmental protection, energy efficiency, etc)58 Manufacturers must comply with 
all  of  their  requirements.  Multiple  directives  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 complex 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,  certain  definitions  or  safeguard  clauses. 
However, the drafting of these common principles 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 

27 

   EN 

 
                                                 
The  directives  have  evolved  over  time  and  gradually  certain  inconsistencies  have 
crept in. They do not use the same terminology for concepts common to all of them. 
Procedures  for  demonstrating  conformity  also  differ  from  one  directive  to  another. 
Sometimes  definitions  or  legal  provisions  are  not  sufficiently  precise  and  allow 
divergent interpretations, leading to incompatibility, legal uncertainty and confusion.  

Good  examples  of  such  inconsistencies  are  the  terms  “placing  on  the  market”  and 
“manufacturer” which are frequently used in all the directives 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 

Lifts 

Placing on the market of the lift shall 
occur when the installer first makes 
the lift available to the user 

Pyrotechnic 
articles 

Civil 
explosives 

‘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. 

'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 

‘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 

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 

‘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. 

No definition 

EN 

28 

   EN 

 
Community market 

Inconsistencies are not limited to the use of certain terms - they also concern entire 
provisions  e.g.  on  the  safeguard  clause  procedure.  In  the  measuring  instruments 
directive,  the  procedure  can  only  be  launched  if  non-compliance  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  measure  when  other  Member  States  have 
raised  objections  against  that  measure.  Hence,  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/EC62.  However 
the  directives  have  slightly  modified  these  standard  procedures.  To  some  extent, 
sector-specific aspects (e.g. test methods) have been added to tailor the procedure to 
the  sector.  However,  unnecessary  differences  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 and 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 conformity assessment bodies 

–  Difficulties  in  interpretation,  in  particular  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 insignificant. Compared 
to  the  results  of  the  public  consultation  (21%  significant  burden,  43%  some  extra 

59 

60 

61 

62 

EN 

9 

of 

19 

the 

Article 

Article 

Measuring 

See 
directive 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2004L0022:20091201:en:PDF 
See 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:374:0010:0019:en:PDF 
See 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:154:0001:0021:en:PDF 
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. 

Pyrotechnic 

instruments 

Directive. 

http://eur-

http://eur-

http://eur-

Directive 

Articles 

Voltage 

Article 

Low 

the 

the 

16 

of 

of 

o 

29 

   EN 

 
                                                 
burden)  the  figures  are  lower.  This  could  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  growing  rather  than  decreasing  to  reflect  new 
societal  concerns  (environmental  aspects,  energy  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  the  proper  functioning  of  the  internal  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  directives  concerned.  This  legislation  does 
however  not  address  the  identified  problems  effectively  or,  as  regards  the 
inconsistency  problem,  is  even  at  the  source  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  address  the  problems, 
this risks creating obstacles to the free movement of goods ensured by the directives 
concerned. Hence it is more appropriate to take action at EU level. 

As regards the problem of inconsistencies throughout the directives, this is a problem 
which can only be solved by the EU legislator. 

EN 

30 

   EN 

 
4. 

OBJECTIVES 

4.1. 

General policy objectives 

This initiative has 3 main objectives: The first is to ensure that products on the EU 
market are safe and fulfil all the requirements 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 
of 
level 
of 
protection 
public 
interests, 
particular 
public  health 
and  safety  and 
consumer 
protection 

in 

Reduce  the  number  of  non-
compliant 
in 
particular unsafe products 

products, 

Improve  market  surveillance 
mechanisms and tools 

Ensure  the  reliability  and  high 
quality 
conformity 
assessment activities carried out 
by notified bodies  

of 

Ensure traceability of products 

controls 

on  product 
Ensure 
conformity  throughout  the  whole 
supply and distribution chain 

surveillance 
Provide  market 
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  

the 

Ensure 
proper 
functioning  of 
the 
internal 
market  in  the 
sectors 
concerned 

Ensure equal treatment of non-
compliant  products  throughout 
the  EU  market  and  equal 
treatment 
economic 
of 
operators  in  the  enforcement 
process 

equal 

Ensure 
conditions 
regarding  the  assessment  and 
monitoring of notified bodies  

Provide  market 
surveillance 
effective 
authorities  with  an 
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  

the 

Simplify 
regulatory 
environment 

consistency 

Ensure 
of 
conformity  assessment  services 
carried out by notified bodies  

Ensure  coordinated  approach  of 
notified  bodies 
to  conformity 
assessment 

Facilitate 
implementation  

interpretation  and 

Clarify 
terms 
unclear 
provisions in the directives 

and 

Ensure  more  consistency  of 
terminology  and  procedural 
requirements 
the 
directives 

throughout 

Eliminate  unnecessary  differences 
in terminology 

EN 

31 

   EN 

 
4.3. 

Consistency with other policies and objectives 

This initiative is in line with the Commission’s policy on the Single Market (Single 
Market Act)63 and Better Regulation policy. 

5. 

OPTIONS 

Due  to  the  specific  context  of  this  initiative,  explained  in  section  2,  this  impact 
assessment  explores  a  limited  set  of  options.  The  impact  assessment  for  the  NLF 
identified and analysed a number of policy options 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  policy  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 situation unchanged. The horizontal elements of the 
directives would not be amended. Alignment 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 for any of the directive concerned).  

5.2. 

Alignment with the NLF Decision via non legislative measures 

Option 2 consists of a set of non-regulatory 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  agreements  which  economic  operators,  national 
authorities and notified bodies agree to apply. The measures could also be presented 
as  “best  practice”  in  guidance  documents.  This  could  for  example  be  done  by 
developing  current  general  guidance  sections  in  the  Blue  Guide  on  economic 
operators or on notified bodies. The parties concerned would be encouraged to apply 
them. The measures in the NLF Decision are explained in detail under option 3. 

In practice, this option would be a “voluntary" alignment to the NLF Decision.  

5.3. 

Alignment with the NLF Decision via legislative measures 

Under  Option  3  the  directives  concerned  take  on  board  the  solutions  set  out  in  the 
NLF  Decision  to  address  problems  relating  to  non-compliance,  quality  of  notified 
bodies  and  inconsistency  in  the  legal  framework.  The  measures  in  the  Decision 
designed to resolve these problems are as follows:64 

Measures intended to address the 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 
64 

See http://ec.europa.eu/internal_market/strategy/index_en.htm 
The description provides a complete list of all the measures foreseen in the Decision. 

EN 

32 

   EN 

 
                                                 
and carry the name of the manufacturer and the importer (if relevant). Importers 
must  furthermore  check  that  the  manufacturer  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  sample  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  (Articles  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  subject  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 importers 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  enforcement  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  assessment  activities  under  the  directives, 
notified  bodies  must  satisfy  certain  requirements.  These  requirements  have  been 
reinforced and clarified. All 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. Subcontractors 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 competence of that body. Other Member States 
may  object  to  the  notification  within  a  certain  period.  Where  competence  is 
demonstrated  by  an  accreditation  certificate,  a  facilitated  procedure  applies. 
Where  Member  States  have  not  used  accreditation  to  evaluate  the  body’s 

EN 

33 

   EN 

 
competence, documentary evidence must be provided and the objection period is 
longer (2 months) (Articles R22 and R23 in Annex 1 of the NLF Decision).  

•  Requirements for notifying authorities (i.e. the national authorities in charge of 
the  assessment,  notification  and  monitoring  of  notified  bodies):  Specific 
requirements  and  obligations  for  notifying  authorities  are  introduced  (Articles 
R14,  R15  in  Annex  1  of  the  NLF  Decision),  according  to  which  they  must  be 
organised  and  operated  so  as 
impartiality  and 
competence  in  carrying  out  their  activity.  Notifying  authorities  must  de-notify 
bodies  which  no  longer  meet  the  notification  requirements  or  fail  to  fulfil  their 
obligations (Article R25 in Annex 1 of the NLF Decision). 

to  safeguard  objectivity, 

•  Information  and  other  obligations  for  notified  bodies:  Notified  bodies  must 
inform  notifying  authorities  about  refusals,  restrictions,  suspensions  and 
withdrawals  of  certificates  and  other  notified  bodies  about  negative  conformity 
assessment  results  They  must  perform  conformity  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,  etc.  (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”, “importer”, “placing on the market” set out in 
Article  R2  of  the  NLF  Decision  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. 

IMPACTS 

6.1. 

Overview of potential impacts and methodology for their assessment 

The following impacts have been considered: 

Economic impacts: functioning of the internal market, competitiveness of EU-firms, 
operating  costs  and  administrative  burdens,  public  authorities,  consumers, 
households and other users, third countries and international 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 
prevention of fire, explosions and accidents leading to environmental risks. 

impacts:  restriction  of  environmental  unfriendly  goods  and 

Furthermore,  the  report  will  assess  impacts  in  terms  of  simplification  of  the 
regulatory environment.  

EN 

34 

   EN 

 
The  assessment  of  impacts  relies  to  a  great  extent  on  the  results  of  stakeholder 
consultations. This is because, as explained in the option section, the NLF Decision 
already  commits  the  Commission  to  aligning  harmonisation  legislation  with  the 
principles  contained  in  the  annexes  to  the  NLF  Decision  itself  unless  departure  is 
appropriate  on  account  of  sector  specificities.  Therefore,  it  was  of  the  utmost 
importance  to  verify  whether  any  such  specificity  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 detailed consultation was carried out by drawing stakeholders' 
attention specifically to all measures contained 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  the  specific  measures  are  also  identical, 
except  for  the  difference  in  the  enforceability  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  problem  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 strengthen mutual confidence between MS 

–  However  in  the  context  of  increasing  globalisation  and,  in  particular,  as  part  of 
manufacturing  activities  in  the  relevant  sectors  shifts  out  of  the  EU,  market 
surveillance and traceability of non-compliant products will become increasingly 
more difficult in practice. 

–  The ongoing information campaign on the EU rules underpinning the CE marking 
will  increase  stakeholders’  awareness  of  their  existing  obligations  under  EU 
product legislation and foster their application. 

6.2.1. 

Internal market  

Current  rules  on  the  harmonisation  of  product  requirements  do  not  address  all  EO 
involved in the product supply chain. This causes 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 from 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  regards  the  obligations  of  EO  and  so  current 
divergences  between  national  legislation  as  to  the  treatment  of  different  EO  will 
remain. 

EN 

35 

   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 products65.Under the no policy change option, a considerable boost to 
the competitiveness of compliant firms (regardless of their origin) will be provided 
by the implementation of the NLF Regulation. This is because the latter sets out clear 
obligations  for  MS  to  perform  market  surveillance  activities  and  strengthens  the 
powers of market surveillance authorities. The implementation of these aspects of the 
NLF  Regulation  will  then  lead  to  an  increase  in  the  number  of  physical  and 
documentary checks of products made available 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 according to the required procedures.  

On the other hand, despite this intensification of enforcement efforts, as globalisation 
leads  to  manufacturing  activities  in  many  of  these  sectors  (e.g.  electrical  and 
electronic  goods,  pressure  equipment,  pyrotechnic  articles)  moving  far  away  from 
the  geographical  markets  where  products  are  ultimately  sold,  market  surveillance 
will  be  increasingly  hampered  by  the  lack  of  general  traceability  obligations  and 
insufficient clarity as to the responsibilities of importers and distributors (except for 
the civil explosives sector66). 

All  in  all,  while  more  market  surveillance  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 compliant products could be quantified as a 
portion  of  the  losses  generated  by  unfair  competition.  According  to  participants  to 
the consultation, this would range from a few percentage points up to more than 30% 
of annual turnover (see Figure 1: Perceived losses 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 

66 

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.  
See section 3.1.3. 

EN 

36 

   EN 

 
                                                 
6.2.4.  Public authorities 

Thanks  to  the  implementation  of  the  NLF  Regulation,  under  this  option  public 
authorities will benefit from a stronger regulatory framework for market surveillance 
that  will  progressively  increase  the  effectiveness  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  another  MS  and  by 
requesting  assistance  from  other  MS  authorities)  and  with  custom  authorities.  The 
NLF  Regulation  also  contains  obligations  to  carry  out  an  appropriate  level  of 
controls. Furthermore, the NLF Regulation has also significantly facilitated the task 
of  public  authorities  related  to  the  notification  and  monitoring  of  conformity 
assessment bodies using accreditation. For a detailed assessment, reference is made 
to the overall costs and benefits of the NLF67. 

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 users (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);  only  3%  consider  that  non-compliance  does  not  negatively 
affect users.  

Economic damage may cover the cost of replacing 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 wide range of possible scenarios arising in 
each sector. However, specific examples of damage given in the consultation (mainly 
relating  to  professional  goods)  concerning  electrical  and  electronic  goods,  pressure 
equipment,  measuring  instruments,  lifts  and  equipment  for  use  in  potentially 
explosive atmospheres are illustrated 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 trade between the EU and third countries.  

6.2.7.  Public health and safety 

The implementation of the NLF Regulation should 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  electrical  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 

37 

   EN 

 
                                                 
general  (e.g.  defective  outdoor  piping  equipment  leaking  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 instruments relate also to public health. 

6.2.8.  Environmental impacts  

One of the 10 directives considered in this report, the pyrotechnic articles directive, 
includes among its objectives not only the protection of human health but also that of 
the environment, and contains a list of forbidden 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  and  Restriction  of  Chemicals  (REACH).  Since  the  NLF 
Regulation stengthens market surveillance it also helps in restricting the circulation 
of environmentally unfriendly pyrotechnic articles. 

The other directives at stake do not specifically 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 also create environmental risk. 

6.2.9. 

Simplification of the regulatory environment  

This option will have no impact on the simplification of the regulatory environment. 

6.3. 

Option 2: Alignment via non-legislative measures 

6.3.1. 

Internal Market  

The  non-legislative  measures  option  may,  by  providing  guidance  on 
the 
responsibilities of the different categories of operators, contribute to some extent to 
creating  a  more  level  playing  field  among  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, stakeholders 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 important to note that existing 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,  already  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 

38 

   EN 

 
                                                 
responsibilities of EO that are then clarified by the NLF Decision. However, as the 
Blue  Guide  is  not  enforceable,  this  has  not  been  sufficient  to  address  the  issues 
identified.  Furthermore,  the  NB  requirements  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 current legal provisions applicable to EO 
and  NB  and  improve  current  market  surveillance  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 products 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 their names and contacts on 
products  or  do  not  provide  upon  request  information  on  the  origin  of  the  goods 
traded, market surveillance authorities will be unable to trace dangerous products and 
stop their supply to the market. Furthermore, the competitiveness of compliant firms 
may  be  damaged  if  they  incur  additional  costs  to  align  their  conduct  with  best 
practices while non-compliant firms don't.  

6.3.3.  Operating costs and administrative burdens  

For those EO and NB that choose to act according 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 considered 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 responsibly at all levels of the supply chain 
(including  imports  and  distribution)  and  to  ensure  traceability  should  somewhat 
facilitate  the  task  of  market  surveillance  authorities.  Similarly  NB  voluntary 
commitment  to  follow  stricter  requirements  and  to  provide  information  on  their 
conformity  assessment  activities  would  be  expected  to  help  notifying  authorities  to 
monitor the quality of NB. Stakeholders have confirmed this view (see section 6.4.4). 
In  both  cases,  however,  the  positive  impact  on  public  authorities  will  simply  not 
materialise  if  the  authorities  cannot  consistently  rely  on  the  cooperation  of  EO  and 
NB. This is why the additional positive impact of this option by comparison with the 
no policy change option is expected 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  requirements  for  bodies  operating  certification  of  persons;  5)  EN 
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories. 

EN 

39 

   EN 

 
                                                 
6.3.5.  Consumers, households and other users 

By proposing best practices that go beyond current legal provisions applicable to EO 
and  NB  and  improve  current  market  surveillance  procedures,  this  option  may  to 
some  extent  help  prevent  material  damage  to  consumers  and  users  in  general. 
However  this  will  entirely  depend  on  the  voluntary  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 from third countries will be possible only 
by  relying  on  importers'  voluntary  commitment  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 the extent that importers act according to 
the  guidance  provided,  there  will  be  a  positive  impact  in  terms  of  increased 
transparency in the operations of EU, distributors at lower levels of the supply chain 
(downstream) which overall may even facilitate 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 according to proposed best practice, which go 
beyond  the  current  provisions  of  the  NLF  Regulation,  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). 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. 

6.3.8.  Environmental impacts  

The  commitment  of  EO  and  NB  to  act  according  to  proposed  best  practice,  which 
goes beyond the current provisions of the NLF Regulation, might in principle lead to 
a  greater  reduction  of  environmentally  unfriendly  pyrotechnic  articles  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 simplification 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 

40 

   EN 

 
6.4. 

Option 3: Alignment via legislative measures 

6.4.1. 

Internal Market 

Pursuant to alignment, the relevant product directives will include clear obligations 
applying to all EO throughout the EU  and market surveillance procedures that will 
eliminate  the  current  differences  in  national  legislation  and  create  a  more  level 
playing  field  among  EO.  Furthermore,  the  alignment  of  market  surveillance 
(safeguard  clause)  procedures  will  ultimately  lead  to  the  adoption  of  equivalent 
measures across the EU in relation 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  participated  in  the  consultation.  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  consultations  is  presented  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  common  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  service.  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  will  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 consultation largely support the conclusion that changes to 
NB requirements and notification process will 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  significant,  while  they  evaluate  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  and  market  surveillance  procedures  the 
alignment  is  expected  to  help  reducing  the  number  of  non-compliant  products.  In 
particular, the introduction of traceability requirements for all operators will help the 
competent  authorities  to  trace  the  non-compliant  product  and  stop  its  circulation. 
Furthermore,  the  introduction  of  clear  obligations  for  importers  and  distributors 
regarding product compliance will allow action at all levels of the supply chain. This 
action  will  then  help  defend  the  competiveness  of  compliant  firms  (regardless  of 
their nationality) from unfair competition. 

EN 

41 

   EN 

 
This  conclusion  is  strongly  supported  by  stakeholders  of  all  sectors  as  about  three 
quarters  (73  to  76%)  of  EO  and  SME70  participating  in  the  public  consultation 
believed this policy action would 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  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  competiveness  of  firms  that  have  their  products 
properly assessed.  

This conclusion is strongly supported by stakeholders as 60-62% of EO participating 
in  the  public  consultation  believed  this  policy  action  would  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  obligations  for  manufacturers,  importers  and  distributors  and 
new market surveillance procedures in the relevant sector directives is not expected 
to increase the overall costs of economic operators. Most of the EO obligations in the 
NLF Decision codify what is normal practice for a responsible/compliant firm. It is 
no  coincidence  that  some  of  the  principles  underlying  those  provisions  are  already 
presented in the "Blue Guide"71.  

This is particularly relevant for obligations on importers and distributors and for the 
cooperation  between  EO  and  market  surveillance  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 (positive impact) of this policy action.  

As  regards  traceability  obligations  for  EO,  some  impact  on  operating  costs  and/or 
administrative  burden  is  possible  as  manufacturers  and  importers  must  indicate  on 
products  their  names,  addresses  and  batches  or  serial  numbers.  However,  the 
traceability  obligations  will  be  an  administrative  burden  only  if  EO  do  not  already 

70 
71 

The percentage is slightly lower (62 to 68%) for post-marketing obligations. 
See footnote 68 above.  

EN 

42 

   EN 

 
                                                 
have a system  in place as part  of  quality management  controls  or pursuant  to legal 
obligations  already  in  force.  For  instance,  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 free as to the choice of specific technical 
solution. 

The views expressed by those who participated in the consultation (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 expect significant increases in costs.  

As to post-marketing obligations on manufacturers, their possible impact on cost will 
be  negligible  as  they  involve  few  additional  elements  that  relate  to  existing 
responsibilities. These obligations merely require the establishment – if not already 
put in place by the operator - of basic procedures for the quality control of marketed 
products (e.g. keep a register of complaints and defective products). 42% of general 
EO  participating  in  the  public  consultation  and  23%  of  SME  attribute  no  or  no 
significant  cost  increases  to  these  elements.  However  30%  of  SME  expect  a 
moderate increase in costs and 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  against  unfair  practices  of  suppliers  or  other  traders,  or 
additional testing of procured products. A small percentage 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  reliability  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 obligation 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 provided in the Official 

72 

73 

74 

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. 
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 requirements 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). 
The relevant parts of technical documentation may need – but not systematically – to be made available 
to  market  surveillance  authorities  in  their  national  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.  Furthermore, 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 

43 

   EN 

 
                                                 
Journal of the EU, accessible via the website of the Commission75. Information to be 
included  relates  mainly  to  names,  addresses  and  numerical  references  (product 
identification number, relevant directives and standards, etc.).  

Only  a  minority  of  respondents  (17%  of  general  EO  and  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-compliance  in  the  relevant  sector.  In  this  respect,  it 
should be noted that 38% of EO76 participating in the consultation considered those 
cost  increases  quite  reasonable  in  relation  to  the  objective  of  reducing  non-
compliance, while only 14% of respondents considered the increase unreasonable.  

The detailed results of the consultation and the comparisons of perceived costs and 
benefits  for  both  EO  in  general  and  SME  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  burden  on  NB  that  act  in  accordance  with 
recognised  professional  standards.  Indeed,  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  Accreditation  (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  conformity  assessment  bodies  for  some  time. 
Therefore, while the alignment of sector directives as regards those requirements will 
make them formally enforceable, it will not involve additional effort on the part of 
those conformity assessment bodies which were already complying with the spirit of 
the  legislation.  A  moderate  (temporary)  increase  in  administrative  burden  of  NB  is 
expected  since  they  will  need  to  request  new  notification  and  produce  updated 
evidence to show compliance with the requirements (e.g. accreditation and/or other 

75 

76 

77 
78 

http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-
products/new-legislative-framework/index_en.htm 
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. 
See footnote 69 above. 
EA-2/17- EA Guidance on the horizontal requirements for the accreditation of conformity assessment 
bodies for notification purposes, http://www.european-accreditation.org. 

EN 

44 

   EN 

 
                                                 
certificates  showing  professional  qualifications);  however,  any  re-notification  of  a 
properly assessed and monitored body should be a mere formality. 

On the other hand, the costs of compliance efforts by those NB that, by thriving on 
enforcement  difficulties  did  not  previously  meet  the  substantive  requirements  for 
conformity assessment, should be considered benefits (positive impact) of this policy 
action.  

The Commission thought that the revision of the notification process would provide 
an incentive to NB to move towards accreditation 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  accreditation  certificate  will  benefit  from  a 
facilitated  notification  procedure  (shorter  objection  period).  However,  detailed 
analysis  of  the  scope  of  accreditation  actually  shows  that  the  large  majority  of  NB 
has already chosen to be accredited regardless of the alignment. Currently, except for 
the Measuring Instruments Directive79, 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  induced  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  accreditation  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? 
No 
Yes 

Pyrotechnic 

% 
Civil Explosives 
% 

EMC 

LVD 

ATEX 

MID 

NAWI 

SPVD 

% 

% 

% 

% 

% 

% 

10

13

131

148

55

140

270

95

7
70%
9
69%
95
73%
119
80%
40
73%
32
23%
230
85%
90
95%

3 
30% 
4 
31% 
36 
27% 
29 
20% 
15 
27% 
108 
77% 
40 
15% 
5 
5% 

79 

The lower rate of accreditation of NB under the Measuring Instrument Directive appear to be explained 
by  the  fact  that  a  number  of  them  are  actually  public  authorities  who  did  not  consider  necessary  to 
require an accreditation certificate to demonstrate the fulfilment of legal requirements. 

EN 

45 

   EN 

 
 
 
  
  
  
  
  
  
  
  
                                                 
PED80 

Lifts 

% 

% 

237

192

179
76%
121
63%

58 
24% 
71 
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 information 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 negative conformity assessment results to be 
addressed  the  other  NB81).  Furthermore,  NB  are  free  to  choose  the  format  of  the 
transmission of information.  

In  conclusion,  overall  this  policy  option  will  not  have  a  big  impact  on 
costs/administrative  burden  for  NB.  The  impact  of  certain  modifications  to  the 
notification  process  needs  to  be  taken  into  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.  Furthermore,  the  costs  will  be  more  than 
outweighed  by  the  benefits  of  the  alignment,  notably  the  legal  basis  necessary  to 
enforce  the  NB  requirements  and  to  exclude  underperforming  NB  from  the  single 
market. 

The results of the public consultation overall support this assessment, as 34-46% of 
respondents  considered  there  would  be  no  or  no  significant  increase  in  operating 
costs and/or administrative burden linked to this policy action or that the latter would 
generate  savings,  32-37%  of  them  expected  a  moderate  increase  and  only  14-24% 
expected  a  significant  increase  in  operating  costs  and/or  administrative  burden. 
Information obligations represent the category raising the least concern.  

Furthermore, as regards the specific reasons for cost increases, while the majority of 
respondents  did  not  provide  any 
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  pointed  to  an  increase  in  costs  for  the 
employment or contracting of qualified personnel. However this would only increase 
existing costs of NB, if they do not already employ qualified personnel. 

indication,  30% 

Finally 37% of NB participating in the consultation considered that the possible cost 
increase  is  reasonable  in  relation  to  the  objective  of  enhancing  the  quality  of  the 
conformity assessment services provided. Only 16% of NB considered the increase 
unreasonable, while the remaining stakeholders did not express a view.  

80 

81 

These  figures  include  also  conformity  assessment  bodies  that  are  specific  to  the  Pressure  Equipment 
Directive (i.e. Recognised Third Parties Organisations and User Inspectorates). 
This latter exchange can take place in the context of notified bodies groups (see Article R30 of the NLF 
Decision). 

EN 

46 

   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  substantially  increase  the  effectiveness  of  public 
authorities'  enforcement  activities,  while  they  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 documentation and information from importers and 
distributors and to trace non-compliant products, including those imported from third 
countries.  The  EO  obligations  will  not  lead  to  additional  costs  or  administrative 
burden for authorities. They may even reduce authorities' investigation costs (e.g. the 
traceability  obligation  will  facilitate  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 products presenting a risk. These are, however, 
not new tasks for market surveillance authorities but part of their daily work under 
the  current  situation.  While  the  NLF  Regulation  establishes  specific  tools  for  the 
exchange of information among national authorities, the procedure laid down in the 
NLF Decision specifies when the relevant information should be exchanged in order 
to be useful for cross-border authorities82. : this will allow surveillance authorities to 
work more efficiently, as efforts already undertaken by the authorities in one MS will 
not  need  to  be  duplicated.  Furthermore  it  will  allow  authorities  to  take  coordinated 
action in cases of non-compliant products marketed in more than one MS. The NLF 
Decision  also  clarifies  and  streamlines  the  procedure  according  to  which  in  certain 
cases  the  Commission  is  called  on  to  express  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  the  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 users). As regards the extent to which the alignment may 
improve  the  current  situation,  the  majority  of  EO  who  identified  a  positive 
improvement  evaluated  the  contribution  made  by  traceability  obligations  as 
significant,  while  they  evaluated  the  contribution  made  by  the  other  measures  as 
more  moderate;  the  views  of  authorities  are  more  or  less  equally  shared  between 
significant and moderate impact; 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  should  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  inaction  of  the  economic  operator  and  the  adoption  of 
compulsory restrictive measures by the authority. 

EN 

47 

   EN 

 
                                                 
The  reinforced  notification  requirements  for  conformity  assessment  bodies,  the 
revised notification procedures, and the information obligations on NB are expected 
to  increase  the  effectiveness  of  the  controls  carried  out  by  notifying  authorities.  In 
particular,  the  alignment  of  sector  directives  with  the  NLF  Decision  will  provide 
national  authorities  with  the  legal  basis  necessary  to  enforce  the  NB  requirements 
and  to  exclude  underperforming  conformity  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  improvement  evaluated  the  contribution  made 
by  the  reinforcement  of  the  notification  requirements  as  significant,  while  they 
evaluated  the  contribution  made  by  revised  procedures  and  information  obligations 
as  more  moderate.  The  NB  considered  the  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  are  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  average  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 and 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 bigger - but overall very reasonable - numbers (e.g. from 
35 to 50) in a couple of sectors. Only Italy 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 address the matter, the Commission services will introduce a 
specific  transitional  provision  which  allows  for  the  application  of  the  notification 
procedure  before  the  general  date  of  applicability  of  the  directives.  This  will  allow 
MS  the  time  necessary  to  ensure  that  re-notification  tasks  are  accomplished  by  the 
time the directives become applicable. 

As regards the revision of the notification process, the alignment will introduce the 
possibility  for  other  MS  and  the  Commission  to  object  to  a  notification.  For 
notifications  based  on  accreditation  the  period  for  raising  such  objections  is  two 
weeks, whereas for notifications not based on accreditation the period is two months. 
The impact of the objection procedure should be assessed bearing in mind the overall 

83 

It  is  worth  noting  that  32%  of  NB  disagrees  on  the  effectiveness  of  the  introduction  of  information 
obligations. 

EN 

48 

   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  notifications  underpinned  by  accreditation.  The 
objection  procedure  may  give  rise  to  some  administrative  burden  for  an  authority 
whose notification is challenged. However this is only likely to occur if the authority 
has not carried  out an accurate assessment 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 should rather diminish the costs of monitoring NB.  

The  alignment  with  the  NLF  Decision  will  introduce  requirements  for  notifying 
authorities that will clarify their responsibilities (assessing, notifying and monitoring 
of  notified  bodies)  and  the  possibility  to  delegate  certain  tasks,  in  particular  to 
accreditation  bodies.  A  further  set  of  criteria  seeks  to  guarantee  impartiality  and  to 
avoid conflicts of interests. For the majority of notifying authorities, complying with 
these  criteria  and  obligations  should  in  principle  involve  neither  organisational 
changes  nor  additional  tasks.  In  the  measuring  instrument  sector,  where  national 
authorities  carry  out  the  function  of  notified  bodies  as  well  as  the  function  of 
notifying  authorities  the  new  requirements  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  expressed  by  the  authorities  participating  in 
the public consultation. About a third (31-37%) indicated that there would be no or 
no significant increase in costs and/or administrative burden or considered that would 
be  a  reduction  in  costs,  another  third  (25-36%)  considered  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 respondents 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 Regulation, but also from the extension of 
traceability obligations and from more systematic 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 give 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 force 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 accreditation is not used notifying authorities have to provide 
evidence that the body has been adequately assessed. 

EN 

49 

   EN 

 
                                                 
specific products, moderate price increases occur, 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 constitute 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 obliged 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 likely to lead to non-compliance. Responsible 
importers  who  establish  clear  commercial  relations  with  their  trading  parties  and 
responsible  manufacturers  located  in  third  countries  will  not  be  negatively  affected 
by  these  provisions.  Increased  transparency  may  encourage  distributors  to  buy 
imported products and may facilitate 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  the  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  which  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 reducing 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 results of the public consultation as 58-
78%  of  EO,  72-78%  of  NB,  58-62%  of  authorities  and  about  72-79%  of  users 
participating in the consultation (excluding the measuring instrument sector85) agreed 
that  clarification  of  EO  obligations  and  market  surveillance  procedures  would  help 
protect public health and safety. 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  acknowledged  a  positive  impact  considered  it 
significant.  The  detailed  results  of  the  consultation  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,  although  indirect,  effect  on  the  protection  of 
public  health  and  safety.  The  assessment  is  supported  by  the  results  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 directives  pursue  mainly  public  interests  other  than 
health and safety protection and for this reasons the 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 

50 

   EN 

 
                                                 
participating in the consultation (excluding the measuring instrument sector86) agreed 
that  changes  to  the  NB  requirements  and  notifications  activities would help  protect 
public  health  and  safety.  In  general  the  majority  of  those  who  acknowledged  a 
positive impact consider it moderate, although a good share of respondents qualified 
the impact as significant. The detailed results 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  greater  reduction  of  environmentally  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. 

COMPARISON 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  legislative  measures  option  and  barely  more 
effective than the no policy change option. This is because, as regards the problem of 
non-compliance,  non  legislative  measures  would  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 
inappropriate 
legally  binding.  Furthermore,  as  regards 
practice 

is  not 

the 

86 

See previous footnote. 

EN 

51 

   EN 

 
                                                 
performance of NB, it is doubtful that the option of non-legislative measures would 
make  it  possible  to  exclude  from  the  single  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 would normally need a formal legal basis 
to refuse or withdraw a notification. Finally, option 2 will not be effective to address 
divergences  in  terminology  used  by  existing  directives,  which  presuppose  a 
modification of the legal provisions.  

This view is strongly supported by the results of the public consultation as the large 
majority  of  all  stakeholders  (EO,  NB,  authorities,  users)  that  participated  in  the 
consultation  considered  the  option  of  alignment  by  non  legislative  measures  as 
ineffective  overall,  in  relation  to  the  objectives  of  reducing  the  number  of  non-
compliant  products,  ensuring  strict  and  uniform  control  of  NB  across  the  EU  and 
achieving  consistency  of  directives.  Stakeholders,  on  the  other  hand,  very  largely 
agreed  on  the  effectiveness  of  the  alignment  by  legislative  measures.  Additional 
details  on  the  view  expressed  by  the  different  categories  of  stakeholders  on  the 
relative effectiveness of option 2 and 3 are provided in the annex (see section 12.4 in 
Annex 4). 

EN 

52 

   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 

Simplification 

Restriction of 
polluting goods/ 
Likelyhood of 
environm. Risks 

(0) 

(0) 

(0) 

(0) 

(0) 

(0) 

(0) 

(0) 

(0)  

(0) 

Benefits 

Costs 

(+) 

(─ )/(+) 

(─/ ─ ─) if 
follow 
guidance  

(0) 

(0) 

(0) 

(+) 

(+) 

(+)  

(0) 

(+++) 

(++)/(+++) 

(─ / ─ ─) 

(++)/(+++) 

(0/ ─) 

(0/ +) 

(+++) 

(++)/(+++) 

(++)  

(++)/(+++) 

Option 1: No- 
change 
(Benefits and 
costs mainly 
due to 
application of 
Regulation 
765/2008) 

2: 
Option 
Alignment  via 
non-legislative 
measures 

Option 3: 
Alignment via 
legislative 
measures 

EN 

53 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
The  second  table  compares  the  policy  options  according  to  the  criteria  of 
effectiveness (i.e. to what extent they fulfil the specific objectives), efficiency (i.e. at 
which costs they do so) and coherence with other EU policies.  

Table 6: Comparison of the listed options 

Effectiveness 

Efficiency  

Coherence 

Option  1:  No- 
change 

Neutral 

Neutral  

Neutral  

to 

[It  addresses 
some 
extent  the  objectives  of 
reducing  the  number  of 
products 
non-compliant 
and 
for  unfair 
scope 
competition. 

It  addresses  the  objective 
of  increasing  reliability  of 
NB, 
only  when 
but 
accredited.  

of 

the 
It  does  not  meet 
objectives 
equal 
treatment  of  EO  and  of 
consistency  of  legislation  / 
simplification  of  product 
regulatory framework] 

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 
address 
not 
does 
simplification. 

addresses 

all 
High: 
objectives.  More  effective 
than option 1 and option 2 
in relation to the objectives 
of  reducing  the  number  of 
products 
non-compliant 
and 
for  unfair 
competition. Effective as to 
simplification.  

scope 

Option  2:  Non-
legislative 
measures 

Option 
Alignment 

3: 

[No  additional  resources 
needed, however objectives 
only partially met.]  

[Incoherent  with 
other 
NLF instrument and policy 
commitment  underpinning 
NLF Decision] 

1, 

less  efficient  than 
same 
vs  higher 
responsible 

Low: 
Option 
effectiveness 
costs 
for 
stakeholders 

Neutral  

[Incoherent  with 
other 
NLF instrument and policy 
commitment  underpinning 
NLF Decision] 

important  benefits 
stakeholders  vs 
moderate 
or 

High: 
for  all 
small 
additional costs 

Coherent  with  other  NLF 
instrument 
policy 
commitment  underpinning 
NLF Decision  

and 

In  terms  of  efficiency,  the  non-legislative  measure  represents  the  option  with  the 
lowest  score  since,  on  the  one  hand  it  does  not  guarantee  additional  benefits  with 
respect to the no policy change scenario, despite the additional compliance costs to 
be borne by those EO and NB who voluntarily align with the proposed best practices. 
As  a  matter  of  fact,  this  option  would  increase  the  compliance  gap  between 
responsible and unscrupulous EO/NB.  

EN 

54 

   EN 

 
 
As regards coherence, the alignment option appears to be the only option that is truly 
coherent  with  the  NLF  Regulation,  to  which  it  represents  the  natural  complement, 
and  with  the  commitment  of  the  EU  institutions  to  progressively  aligning  product 
legislation with the ‘model’ legislation introduced by the NLF Decision87. 

In the light of these criteria, option 3 stands out as the preferred option. 

8. 

MONITORING AND EVALUATION 

8.1. 

Timing aspects 

The adoption of the proposal for the alignment 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  evaluation  of  the  effectiveness  of  the  legislation  will  be 
based on the feedback received through the 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 comprehensive report on the functioning of 
market  surveillance.88  Which  will  also  allow  conclusions  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-compliance will be possible on the basis of a 
number of enforcement indicators (e.g. number 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 January 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 
88 

See footnote 14. 
See Article 40 of Regulation (EC) No 765/2008. 

EN 

55 

   EN 

 
                                                 
allows for the rapid exchange of information between MS and the Commission 
of measures taken to prevent or restrict the marketing of those products. Both 
measures  ordered  by  national  authorities  and  measures  taken  voluntarily  by 
producers and distributors are covered by RAPEX; 

a general database established under Article 23 of the NLF Regulation for the 
exchange of information among MS on market surveillance activities and non-
compliant products 

the  data  provided  by  customs  authorities  that  on  the  basis  of  the  NLF 
Regulation have a duty to cooperate with market surveillance authorities; 

the National Market Surveillance Programmes 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  procedures  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 well, initially an increase in the number of 
products checked and in non-compliant products found can be expected. In the long 
run  however  the  number  of  non-compliant  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  identify  the  main  economic  operators  involved  in 
the value chain, namely the manufacturer and/or the importer. 

8.3.2. 

Improving the quality of services delivered by notified bodies 

The monitoring of the quality of notified bodies will be based on indicators relating 
to  notification  practices  of  Member  States  (number  of  notifications,  information 
provided on assessment of the body notified , frequency of reassessment, objections, 
de-notification  requests,  etc..)  as  well  as  on  indicators  relating  to  conformity 
assessment practices  

These indicators will be based on information obtained via  

– 

– 

the NANDO database 

feedback from Notified Body Groups 

The  first  results  should  already  become  visible  on  the  re-notification  of  existing 
notified bodies. Tighter notification requirements 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 accreditation and the need to have recourse to the 
objection  procedure.  A  more  coordinated  approach  towards  conformity  assessment 
should  be  reflected  in  the  increased  participation  of  notified  bodies  in  coordination 
activities. This will in particular be monitored by the notified body groups.  

EN 

56 

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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 European 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  organisation  representing  the 
interests of several economic operators. 

Civil Explosives  Civil 

Explosives 

CO 

EA 

EMC 

EO 

Directive 

Consumer 
organisation 

European 
operation 
Accreditation 

Co-
for 

Electromagnetic 
Compatibility 
Directive 

Economic 
Operator(s) 

Lifts 

Lifts 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 

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  

Directive  2004/108/EC  on  the  approximation  of  the 
laws of the Member States relating to electromagnetic 
compatibility and repealing Directive 89/336/EEC 

Typical  economic  operators  are  manufacturers, 
importers  and  distributors.  Some  directives  envisage 
additional categories of EO (e.g. lift installers). 

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 

MID 

Low 
Directive 

Voltage 

Directive  2006/95/EEC  on  the  harmonisation  of  the 
laws of Member States relating to electrical equipment 
designed for use within certain voltage limits 

Measuring 
Instruments 
Directive 

Directive 2004/22/EC of the European Parliament and 
of the Council on measuring instruments 

MS 

Member State(s)  

Member State(s) of the EU 

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NAWI 

Non-automatic 
Weighing 
Instruments 
Directive 

NANDO 

New  Approach  Notified 
and 
Designated 
Organisations  

NB 

Notified Body(ies) 

NLF 

New 
Framework 

Legislative 

NLF Decision 

Decision 768/2008 

NLF Regulation   Regulation 

PED 

765/2008 

Pressure 
Equipment 
Directive 

Council  Directive  2009/23/EEC  on  the  harmonisation 
of  the  laws  of  the  Member  States  relating  to  non-
automatic weighing instruments 

Information  System  containing  information  on  all 
conformity  assessment  bodies  notified  under  New 
Approach  Directives  by  MS,  EFTA  countries  (EEA 
members) and  other  countries  with  which  the  EC  has 
concluded  Mutual  Recognition  Agreements  (MRAs) 
and  Protocols 
the  Europe  Agreements  on 
Conformity  Assessment  and  Acceptance  of  Industrial 
Products (PECAs) 

to 

Body notified by a Member State to the Commission as 
entitled  to  carry  out  conformity  assessment  (e.g. 
calibration,  testing,  certification  and  inspection)  of 
products  covered  by  a  given  product  harmonisation 
directive. 

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. 

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 

Pyrotechnic 

Pyrotechnic 
Articles Directive 

Directive  2007/23/EC  on  the  placing  on  the  market  of 
pyrotechnic articles 

RTPO 

SME 

SPVD 

Recognised  Third 
Party Organisation 

Conformity  assessment  body  under  Article  13  of  the 
PED for a limited list of services 

Small  and  medium 
enterprise 

Expression used in the documents to identify the small 
and  medium  enterprises  having  participated  in  the 
consultation  run  through  the  Enterprise  Europe 
Network. 

Simple 
Vessels Directive 

Pressure 

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 

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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  adopted  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 improving security in the industry by setting 
out how the movement of explosives between Member States should be supervised. 
It  therefore  contains  strict  rules  on  the  registration  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 industry (primarily for demolition, land clearance 
and tunnelling).  

The conformity assessment procedures provided for in the directive make mandatory 
use of the services of notified bodies. 13 bodies are currently notified under the Civil 
Explosives Directive.  

10.1.2.  The civil explosives sector 

The  civil  explosives  sector  in  Western  Europe  (mainly  the  old  EU  15)  has  a 
consumption  in  excess  of  250  000  metric  tons  per  year,  while  in  Eastern  Europe 
(mainly  the  new  Member  States),  the  figure  is  around  350  000  metric  tons. 
Altogether,  as  shown  in  table  7  and  8  below,  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

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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 
propellent powders) 

explosives 

(excluding 

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  sector  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 total consumption in 
2003. However, in the EU, the mining and quarrying industries typically 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 sector, are an important source of demand in the EU and 
constitute a significant market.  

In  addition,  the  sector  covered  by  the  Civil  Explosives  Directive  also  comprises 
initiating  systems,  which  include  detonators.  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 individually, but mostly as part of larger 
service  packages,  which  can  include  such  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 sector, including blasting and drilling devices, 
amounts  to  EUR  1.1  billion.  Adding  the  value  of  EUR  250  million  generated  by 
distributors  in  the  sector,  the  total  market  size  of  the  EU  civil  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 countries is expected.  

As far as businesses in the civil explosives sector are concerned, 20 manufacturers of 
explosives,  as  well  as  approximately  500  dealers  and  distributors  are  active  in  the 
EU. At the manufacturers’ level, there are 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.  Nearly  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 explosives industry in the EU. 

All  businesses  operating  in  the  civil  explosives  sector  face  a  highly  competitive 
environment.  Most  of  them  have  overcapacity  and  consumption  is  not  growing, 
forcing manufacturers to rationalize and concentrate their operations. As a result, the 
trend  in  the  industry  is  towards  consolidation.  Larger  competitors  buy  up  smaller 
ones  to  expand  their  businesses  across  national  borders.  Consequently,  a  small 

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number  of  international  groups  have  emerged.  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  respective  national  markets,  intra-community 
trade  is  increasing.  Trade  between  EU  Member  States  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 more 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 sector, since explosives 
are  bulk  products  with  strict  safety  and  security  requirements  causing  high 
transportation costs. This makes the proximity of production units to the sites of use 
a  crucial  factor  for  success  and  is  another  reason  for  the  increased  consolidation 
activity in the sector. Concerning exports, 100 000 tons of explosives and 30 million 
units of detonators corresponding to 16% of sales of EU companies are generated in 
the  global  market.  Imports,  on  the  other  hand,  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 in the oil drilling industry. 

Accidents with civil explosives can have severe consequences including casualties or 
serious  injuries  and  may  cause  significant  economic  damage  to  surrounding 
infrastructures. They are rather 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  adopted  in  2007.  It  is  thus  a  very  new 
directive,  which  has  to  be  applied  by  Member  States  from  July  2010  for  consumer 
fireworks and from July 2013 for all other pyrotechnic articles. The directive’s main 
objectives  are  to  protect  human  health  and  safety  and  to  create  a  single  market  for 
pyrotechnic articles in the EU. 

The directive regulates the placing on the market of pyrotechnic articles. As such, it 
mainly  applies  to  fireworks,  theatrical  pyrotechnic  articles  and  pyrotechnic  articles 
for technical purposes in vehicles (automotive restraint systems, i.e. most importantly 
gas generators used in airbags and seatbelt tensioners). Some pyrotechnic articles are 
excluded from the scope of the directive, such as ammunition, and products used in 
marine equipment, in the aerospace industry and by the armed forces, the police or 
fire departments. 

Conformity assessment procedures in the directive make the involvement of notified 
bodies  obligatory.  Until  now,  10  bodies  have  been  notified  under  the  Directive  A 
particular challenge for notified bodies dealing with consumer fireworks arises from 
the  fact  that  more  than  95%  are  manufactured  overseas,  notably  in  China,  which 
makes it more difficult to apply quality assurance modules that necessitate an audit 

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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 Articles Directive, correspond in principle 
to two sectors: fireworks and automotive occupant restraint systems. 

The total EU market for fireworks is estimated by industry at around EUR 1.4 billion 
per year. This is equally distributed between sales to consumers (categories 1, 2 and 
3 of the directive) and sales to professionals only (category 4 of the directive).  

Automotive  occupant  restraint  systems  mainly  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 market 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  the  number  of  cars  sold.  The  difficult 
economic situation in 2009, especially for the car industry, must thus be taken into 
account  when  considering  the  market  size  of  automotive  pyrotechnic  articles. 
Depending on future recovery, this could grow significantly. 

Concerning  the  structure  of  businesses  operating  in  the  pyrotechnics  sector,  the 
fireworks  and  automotive  sectors  must  again  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 companies operate in more than just the 
fireworks  area  and  additionally  employ  seasonal  workers  for  the  peak  season  from 
late  November  onwards,  this  number  is  very  hard  to  judge.  In  general,  most 
businesses  in  the  pyrotechnics  sector  are  engaged  in  the  purchase,  distribution, 
storage or professional display of fireworks. There are roughly 500 importers in the 
EU,  serving  an  estimated  number  of  200  000  distributors  (including  large  chain 
stores  etc.).  The  manufacture  of  fireworks  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 and focuses on fireworks for professional 
use  (category  4).  As  shown  in  table  1  below,  other  manufacturing  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  companies  generate  about  two  thirds  of 
pyrotechnic  articles  sales  in  the  EU.  Three  international  groups  active  in  the 
automobile occupant restraint sector account for about 75% of the global market.  

Differences between the fireworks and the automotive pyrotechnics sectors are also 
evident with regard to trade patterns. Whereas, 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. 

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Table 9: EU 27 Trade in fireworks (Source: EUROSTAT, Comext) 

EU 27 Trade in fireworks (in 100kg) 

Period Total imports 

Imports from China 

in 100kg  % of total 

Total exports 

2004 

1,094,751 

1,059,577 

96.79% 

2005 

1,049,011 

837,278 

79.82% 

2006 

1,113,285 

1,062,821 

95.47% 

2007 

1,182,618 

1,143,455 

96.69% 

2008 

1,103,475 

1,088,056 

98.60% 

9,182 

17,077 

13,138 

16,202 

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 airbags (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 ignite 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 often 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  injuries.  It  is  estimated  that  misuse  is 
responsible for most of these injuries although high product failure rates (sometimes 
more than 50 per cent) are reported by notified 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:  KfV;  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/” 

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10.3. 

Pressure Equipment 

10.3.1.  The Simple Pressure Vessels 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 the 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  vessels  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 which is not intended to be 
fired” (Art. 1(2)). The types of vessels covered include air receivers and vessels used 
in braking systems of trucks and railway vehicles. 

Simple  pressure  vessels  are  classified  depending  on  their  total  energetic  content, 
which is determined by the pressure and the 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  equipment  and  assemblies  with  a  maximum 
allowable  pressure  greater  than  0,5  bar,  as  designed  and  specified  by  the 
manufacturer.  The  products  covered  by  the  directive  can  roughly  be  grouped  into 
vessels  (e.g.  vessels  for  liquefied  gas  storage,  chemical  reactors  and  distillation 
columns,  industrial  compressed  air  receivers,  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  functional  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  directive  (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  mandatory,  most  procedures  require  the 
involvement  of  a  notified  body.  Currently,  166  European  NBs  operate  under  the 
PED. In addition, there are 53 Recognised Third Party Organisations (RTPO) and 20 

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User  Inspectorates  (UI)  with  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  equipment  is  used  as  components  of  a  larger 
whole  (e.g.  pressure  vessels  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, there are also some consumer products (e.g. 
pressure cookers, domestic air conditioning systems, fire extinguishers, high pressure 
cleaning  systems,  etc.),  adding  to  the  overall  diversity.  As  a  result,  the  market 
characteristics of pressure equipment covered 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 impossible to obtain. Information sources are 
restricted,  as  there  is  no  single  EU  professional  association  representing  the  whole 
pressure equipment sector. Official statistical 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. 

trends  can  be  discerned.  Most 

A  complete  picture  of  the  sector  in  quantitative  terms  cannot  therefore  be  given. 
the 
However,  some  general 
manufacturing of pressure equipment is gradually shifting to low cost countries. This 
certainly applies to mainstream pressure equipment, but also (and increasingly) more 
complex  products.  While  these  are  for  the  most  part  still  designed  in  Europe,  low 
cost  countries  are  catching  up  quickly  with  regard  to  know-how  and  worker 
qualifications. More competition is expected, especially from Asian countries, on the 
worldwide market in all product groups. 

importantly, 

Production  of,  and  trade  in,  fire  extinguishers  is  a  good  illustration  of  this  trend. 
Within two years, China developed into the leading export country to the EU. Nearly 
half (11 million units) of all fire extinguishers imported into the EU 27 in 2005 (22 
million units) originated in China.  

Failure of pressure equipment can have catastrophic 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 

91 

For this example, a distinction between boilers for 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  situation  for  each  of  these  products  would  be  very 
different and what is valid for one category might not be valid at all for another. 
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 machinery 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”). 

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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  electrical  equipment  within  certain voltage  limits  provides  a 
high level of protection for European citizens. It covers a broad variety of electrical 
and electronic products, as well as equipment and systems.  

According  to  the  Statistical  Classification  of  Economic  Activities  in  the  European 
Community (NACE) the products covered by the Directive are: 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, lighting equipment and 
electric  lamps,  other  electrical  equipment,  electronic  valves  and  tubes  and  other 
electronic  components,  television  and  radio  receivers,  sound  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  atmosphere  (which  is  covered  by  the  ATEX 
directive,  also  included  in  this  alignment  exercise),  electrical  equipment  for 
radiology  and  medical  purposes,  electrical  parts  for  goods  and  passenger  lifts, 
electricity  meters,  plugs  and  socket  outlets  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 electrical 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  subject  to  the  Directive  on  Electromagnetic 
compatibility  (EMC  Directive).  Although  recognising  the  need  for  and  benefits  of 
harmonisation, industry believes that the cumulative effect of legislation originating 
from various policy areas and levels can pose problems, particularly for SMEs.  

The total output of the electrical, electronic 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 these products in Europe with €103,929 million 
is  due  to  the  sustained  increase  in 
of  imports  and  €83,091  million  of  exports.  This 
ICT imports from south-east Asian countries in the last four years. Most imports of 

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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  characterised  by  a  few  large  corporations 
producing  a  wide  range  of  electrical  equipment,  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 shock 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 
in  200992 
safety  of  consumers.  138  RAPEX  notifications  were  registered 
corresponding  to  8%  of  the  total  number  of  RAPEX  notifications.  Given  that  most 
notifications  are  not  linked  to  accidents,  the  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 installations. The main objective of the EMC is to 
guarantee the free movement of apparatus and create an acceptable electromagnetic 
environment in the Community. To achieve this, the EMC requires a harmonised and 
acceptable level of protection, leading to full EU harmonisation. 

The main objectives of the EMC are: 

(1)  To  ensure  that  electromagnetic  disturbance  produced  by  equipment  does  not 
affect  the  correct  functioning  of  other  apparatus  and  radio  and  telecommunications 
networks, related equipment and electricity distribution networks. 

(2)  To  ensure  that  equipment  has  an  adequate  level  of  intrinsic  immunity  to 
electromagnetic disturbances to enable them to operate as intended. 

The  involvement  of  the  Notified  Body  is  rather  limited.  It  is  voluntary  and  the 
purpose  of  the  body  is  to  help  the  manufacturer  by  reviewing  the  technical 
documentation for apparatus drawn up by the manufacturer.  

According  to  the  Statistical  Classification  of  Economic  Activities  in  the  European 
Community  (NACE)  the  group  of  products  that  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 

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are: electric welding and soldering tools, electric domestic appliances, computers and 
information  processing  equipment,  electric  motors,  generators  and 
other 
transformers,  electricity  distribution  and  control  apparatus,  other  electrical 
equipment,  television  and  radio  receivers,  sound  or  video  recording  or  video 
recording or reproducing apparatus and associated goods. 

the 

scope  of 

the  Directive: 

Equipment  outside 
radio  equipment  and 
telecommunication terminal equipment, aeronautical products, radio equipment used 
by  radio  amateurs  as  defined  in  the  International  Telecommunications  Union 
Regulations,  motor  vehicles,  medical  devices, measuring instruments, and any kind 
of  inherently  benign  equipment,  this  is  to  say  equipment  whose  inherent  physical 
characteristics  are  such  that  it  is  incapable  of  generating  or  contributing  to 
and 
electromagnetic 
telecommunications equipment and other equipment to operate as intended, and that 
it  will  operate  without  unacceptable  degradation 
the 
electromagnetic disturbance normally present in its intended environment. 

emissions  which 

the  presence  of 

allowing 

exceed 

radio 

level 

in 

a 

10.5.2.  Facts and figures 

This Directive is based on manufacturer self-declaration of conformity and is much 
appreciated by industry. Most electrical equipment is also subjected to the LVD. 

The total output of the electrical, electronic 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  characterised  by  a  few  large  corporations 
producing  a  wide  range  of  electrical  equipment,  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 telecommunications networks. 
If it does not have the required level of electromagnetic immunity it will not operate 
as intended in the electromagnetic environment for which it is intended.  

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10.6.  The ATEX Directive 

10.6.1.  Definitions and scope 

The ATEX Directive 94/9/EC (in force since 1 July 2003) regulates Equipment and 
Protective systems intended for use in Potentially Explosive Atmospheres.  

A  potentially  explosive  atmosphere  is  composed  by  air  mixtures  of  gases,  vapors, 
mists or dusts, which can ignite under certain operating conditions. 

ATEX provides the technical requirements to be applied and the relevant conformity 
assessment procedures before placing this equipment on the European market. These 
requirements are given technical expression by “Harmonized Standards”, developed 
by the European Standardization Organizations. 

Member  States  and  others  who  apply  the  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  intended  for  use  in  potentially  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 explosive atmosphere may be present. 

Products affected by this Directive are some of the mechanical and electrical sectors 
specially  manufactured  to  be  used  in  potentially  explosive  atmospheres  such  as: 
pumps  and  compressors,  bearings,  gears  and  driving  elements,  lifting  and  handling 
equipment, non-domestic cooling and ventilation equipment, machinery for mining, 
quarrying  and  construction,  electric  motors,  generators  and  transformers,  electric 
distributing  and  control  apparatus,  lighting  equipment  and  electric  lamps  and 
industrial process control 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-consumer goods but with specific industrial 
products in a relatively restricted 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 specialise in ATEX equipment in Europe. ATEX 
equipment  of  different  kinds  and  categories  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  market  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 countries outside the EEA as well as to the United 

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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”  manufacturers,  operating  in 
niche markets with few competitors. 

There  are  around  100  importers,  mainly  international/multinational  companies.  The 
ATEX  sector  is  characterized  by  a  large  number  of  SME’s  and  micro  enterprises, 
around 90%, mainly based in France, Germany, Italy and the United Kingdom, but 
also  with  a  significant  presence  and  market  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 factories 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  owned  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  entry  into  force  on  1st  July  2003),  the  market  did  not  record 
relevant  changes,  given  that  a  large  number  of  products  already  fall  under  “Old 
Approach”  legislation.  During  the  second  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  sectors,  the  market  evolved  towards  a  re-
organisation  and  increasing  effectiveness:  the  number  of  producers  continues  to 
decrease,  via  a  series  of  mergers  or  acquisitions,  with  both  European  and  non-
European  entities,  in  order  to  enable  greater  economies  of  scale  and  cost-sharing 
relating  to  the  development  of  new  products  and  innovative  solutions,  in  particular 
for intrinsic safety. 

At present, there are 55 ATEX Notified Bodies in the European Union.  

Non-compliance  of  equipment  used  in  potentially  explosive  atmospheres  can  have 
catastrophic  effects.  In  fact,  risks  derive  from  equipment  capable  of  causing  an 
explosion through its own potential sources of ignition, for example electric sparks, 
electrostatic  discharges  or  hot  surfaces.  Consequences  of  this  kind  of  explosion 
include  severe  or  deadly  injuries  to  persons,  serious  damage  to  installations  and 
surrounding civil and industrial infrastructures. Recent accidents in the EU related to 
the sector (e.g. in chemical plants, coal mines or agricultural premises), do not seem 
to be caused by non-compliant or unsafe equipment 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 operation 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 

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10.7.  The Lifts Directive 

10.7.1.  Definition and scope 

Lifts provide an essential means of comfortable 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  integration  of  people  with 
special needs. 

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 establishes European 
legal requirements for the design, installation 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  requirements.  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 market and ensuring a high level of safety 
for lift users and maintenance staff. 

While  harmonized  European  legislation  governing  the  design,  manufacturer  and 
installation  of 
installers  and  components 
manufacturers, it also has important implications for owners and users of lifts 

is  mainly  addressed 

lifts 

lift 

to 

The Directive covers new lifts permanently installed in buildings and constructions 
for  carrying  passengers  or  passengers  and  loads.  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 operated 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 total), 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). However, Europe also leads the way in lift 
technology development. Furthermore, European 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 

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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.  Manufacturers  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  (incl.  Switzerland  and  Norway)  reached  4.7 
million units.  

Production progressed over recent years before 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  refuge  when  the  lift  car  is  in  one  of  its 
extreme positions can create a risk of crushing. 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 all these being regulated by the provisions 
of the Lifts Directive.  

10.8.  Measuring Instruments 

10.8.1.  The Non-Automatic Weighing Instruments Directive 2009/23/EC 

NAWI  was  adopted  in  1990  and  is  thus  one  of  the  oldest  directives  based  on  the 
1985  New  Approach.  It  was  recently  codified  in  a  new  single  legal  document 
2009/23/EC  integrating  all  amendments  to  the  original  directive,  without  however 
substantially changing its technical content. 

NAWI  applies  to  all  non-automatic  weighing  instruments,  i.e.  to  measuring 
instruments serving to determine the mass of a body and requiring the intervention of 
an  operator  during  weighing.  Such  instruments  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 parties) against incorrect results 
of weighing operations. 

As  regards  conformity  assessment,  NAWI  provides  for  a  choice  between  two 
different procedures. However, both procedures envisage the involvement 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. 

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10.8.2.  The Measuring Instruments Directive 2004/22/EC 

MID  was  adopted  in  2004,  repealing  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 the free movement of measuring instruments 
and  in  particular  to  avoid  barriers  to  trade  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,  taximeters,  material  measures  to  measure 
length, dimensional measuring instruments and 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,  different  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  measuring  instruments  sector  is  the  weighing 
industry. In 2008, production of weighing instruments covered by NAWI amounted 
to €2.5 billion. 

Only  a  limited  number  of  companies  manufacture weighing instruments in  the EU, 
such  as  balances  and  scales,  from  beginning  to  end.  The  majority  of  companies 
assemble components from different manufacturers. 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  employees  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 companies  (of less than 50 
employees) make up 60%. Altogether, 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 MID not including the large number of SME 
operating  as  distributors,  importers  or  providers  of  repair  services.  The  number  of 
employees in the sector is around 175,000- 205,000.  

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Table 11: – Total size of market covered by the MID 

Market size – 
number of items sold 
annually (000s) 

MI-001: Water Meters 
MI-002:  Gas  Meters  & 
Conversion Devices 
MI-003:  Active  Electricity 
Energy Meters 
MI-004: Heat Meters 
MI-005:  Measuring  Systems 
than 
for  Liquids  other 
Water 
MI-006: 
Weighing Instr. 
MI-007: Taximeters 
MI-008: Material Measures94 
MI-009:Dimensional 
Measuring Instr. 
MI-010: 
Analysers 
Total 

Automatic 

Exhaust 

Gas 

18,000 

6,900 

14,000 

800 

31.2 

21 

50 
300,000 

300-400 

25-35 

345,000 

Market size- 
value of items 
sold annually  
(million €s)  
450 

410 

610 

290 

240 

550 

25-40 
440-490 

70-80 

130 

3,250 

Share in 
total Mis 
market 

13.8% 

12.6% 

18.8% 

8.9% 

Employees 
occupied in 
sector  
(1000s) 
25 

30 

32 

18 

7.4% 

14-16 

16.9% 

1% 
14.3% 

2.3% 

4.0% 

100% 

25 

1 
34 

7 

17.5 

190 

Around 20-25% of measuring instruments in the EU27 are imported while 25-30% 
of  measuring  instruments  produced  in  the  EU27  are  exported  to  third  countries. 
There is however considerable variation among the different categories of measuring 
instruments. Trade levels in both directions are particularly high (over 50% of total) 
for  the  less  technology-intensive  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 exported 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 gravimetric filling instruments) and in the 
Gas Meters category (44%) where EU firms are world leaders. 

94 

Data refer to all material measures of length in the market. Not only MID certified.  

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11. 

ANNEX 3: OVERVIEW OF STAKEHOLDERS CONSULTED 

11.1.  Discussions in sector specific working groups 

Discussions with stakeholders took place under the sector specific working groups established 
under the different directives concerned: 

•  Electrical  and  electronic  goods:  the  LVD  Working  Party  established  under  Directive 
2006/95/EEC discussed the alignment to the 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  established  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  October  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  Measuring  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  February  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  NLF  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.  

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11.2.  Overview  of  stakeholders  having  participated  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 category 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  

  EO 

  NB 

  AUT 

  Users 

332 

63 

78 

67 

44 (14 BO) 

8 (2 BO) 

6 

35 (8 BO) 

16 

28 

5 

9 

11 

1 (CO) 

23 

15 

11 

13 

21 

6 

8  

0 

4 

6 

0 

24  

1  

2 

9 

2 

25 

4 

9 

11 

8 

The  views  expressed  are  overall  considered  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: replies are considered representative 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 Commission via other channels. 

–  Lifts: even if only a small part of the lift industry 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 representing respectively the interest of SME and 
big EO. 

–  Pressure  equipment:  only  a  small  group  of  EO  (and  no  BO)  participated  in  the  public 
consultation. This is not surprising as directives on pressure equipment cover a wide range 
of  products  and  EO  whose  interests  can  hardly  be  represented  by  one  main  industry 
association.  However  a  respectable  number  of  SME,  NB  and  to  some  extent  authorities 
participated in the consultation and this strengthens 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 geographical coverage. Furthermore, participants in 
the  consultation  include  the  main  EU-wide  industry  association  with  which  the 
Commission has also discussed 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  participation  of  SME  and 

EN 

76 

   EN 

 
  
  
 
 
 
 
 
 
 
authorities  is  not  negligible).  In  order  to  cross  check  the  representativeness  of  the  views 
expressed,  the  Commission  has  had  bilateral  contact  with  some  European  industry 
associations.  

–  Equipment for use in potentially explosive atmospheres: there is a small response. This is 
because EO dealing with equipment for use in potentially explosive atmospheres deal more 
generally with mechanical, electrical and also telecom equipment which is then “adapted” 
for  specific  use  in  potentially  explosive  atmospheres  (e.g.  underground  mines,  chemical 
plants,  mills)..  In  practice  respondents  may  have  preferred  to  identify  themselves  with 
other  sectors  (notably  electrical  and  electronic  goods).  This  is  confirmed  by  the  replies 
provided  in  section  D  of  the  questionnaire  where  many  respondents  indicated  that  they 
apply ATEX together with another of the directives 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 

77 

   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  stakeholders,  SME  consultation,  analysis  based  on  the 
Commission database of NB and figures provided by EA). 

In what follows, the expressions “Action 1”, “Action 2” and “Action 3” refer to the content of 
the policy measures which are respectively intended to address 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 authorities (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 

MSA in different EU countries do not impose the 
same obligations on distributors 

MSA in different EU countries do not impose the 
same 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) 

The same product may be withdrawn from 
market or otherwise restricted in an EU country 
and supplied freely in another 

When a safeguard clause procedure is 
launched, not all EU countries follow 
Commission opinion 

Other 

46 

49 

56 

42 

36 

10 

9 

59,74% 

46,94% 

63,64% 

50,00% 

72,73% 

57,14% 

54,55% 

42,86% 

46,75% 

36,73% 

12,99% 

10,20% 

11,69% 

9,18% 

Table 14: Differences in approaches of national market surveillance authorities (AUT replies) 

Number of 
requested records 

% of total 
number records (101)

MSA in different EU countries do not impose the same 
obligations on importers 

MSA in different EU countries do not impose the same 
obligations on distributors 

MSA in different EU countries do not impose the same 

33 

30 

29 

32,7% 

29,7% 

28,7% 

EN 

78 

   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) 

The same product may be withdrawn from market or 
otherwise restricted in an EU country and supplied freely in 
another 

When a safeguard clause procedure is launched, not all EU 
countries follow Commission opinion 

Other 

12.1.2.  Assessment of impacts 

12.1.2.1. Internal Market 

41 

31 

4 

7 

40,6% 

30,7% 

4% 

6,9% 

•  Answer to EO consultation (questions B11.3 “Impact of the following elements of Action 
1 on well-functioning of the internal 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.  from  65%  to  76%  depending  on  the  element  of 
Action  1)  considers  that  this  policy  action  will  have  some  positive  impact  on  the  well-
functioning of the internal market. Furthermore, the majority of those having identified a 
positive impact evaluate the impact as significant. 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 

79 

   EN 

 
Table 15: Impact of Action 1 on the well-functioning of the internal market (EO replies) 

   Obligations for importers/distributors 

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   N/A 
   Traceability obligations  

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   N/A 
    Post marketing obligations on 

manufacturers 

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   N/A 
    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) 

9 

30 

40 

11 

8 

(9.2%) 

(9.2%) 

(10%) 

(30.6%) 

(30.6%) 

(33.3%) 

(40.8%) 

(40.8%) 

(44.4%) 

(11.2%) 

(11.2%) 

(12.2%) 

(8.2%) 

(8.2%) 

- 

Number of 
requested 
records 

Requested 
records 
(98) 

% of total 
number 
records 
(98) 

% of total 
number 
records 
(90) 

7 

38 

37 

8 

8 

(7.1%) 

(7.1%) 

(7.8%) 

(38.8%) 

(38.8%) 

(42.2%) 

(37.8%) 

(37.8%) 

(41.1%) 

(8.2%) 

(8.2%) 

(8.9%) 

(8.2%) 

(8.2%) 

- 

Number of 
requested 
records 

Requested 
records 
(98) 

% of total 
number 
records 
(98) 

% of total 
number 
records 
(90) 

19 

30 

34 

7 

8 

(19.4%) 

(19.4%) 

(21.1%) 

(30.6%) 

(30.6%) 

(33.3%) 

(34.7%) 

(34.7%) 

(37.8%) 

(7.1%) 

(7.1%) 

(7.8%) 

(8.2%) 

(8.2%) 

- 

Number of 
requested 
records 

Requested 
records 
(98)  

% of total 
number 
records 
(98)  

% of total 
number 
records 
(90)  

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   N/A 

6 

27 

47 

10 

8 

(6.1%) 

(6.1%) 

(6.7%) 

(27.6%) 

(27.6%) 

(30%) 

(48%) 

(48%) 

(52.2%) 

(10.2%) 

(10.2%) 

(11.1%) 

(8.2%) 

(8.2%) 

- 

EN 

80 

   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 majority 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  consultation  (i.e.  from  60%  to  72%  depending  on  the 
element of Action 1) consider that this policy action will have some positive impact on the 
well-functioning  of  the  internal  market.  As  regards  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 imports/distributors, traceability obligations and 
common safeguard procedures as significant, while as regards post-marketing obligations 
the percentage is a bit lower (about 40%). 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 (16.8%). 

•  Findings per sector: The fact that the majority of stakeholders 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 (EO, NB and competent authorities) for each 
sector.  

Table 16: Impact of Action 1 on the well-functioning of the internal market (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 

   Moderate 

improvement 

   Significant 

improvement 

   Unable to evaluate 

impact 

   N/A 

   Traceability 
obligations 
   No, or no 
significant 
improvement 

   Moderate 

improvement 

10% 

7% 

0% 

7% 

20% 

0% 

21% 

43% 

35% 

1% 

10% 

21% 

32% 

23% 

29% 

50% 

54% 

21% 

9% 

21% 

9% 

7% 

9% 

30% 

20% 

0% 

33% 

21% 

25% 

38% 

17% 

17% 

30% 

25% 

4% 

9% 

4% 

0% 

4% 

20% 

0% 

13% 

43% 

43% 

43% 

32% 

20% 

0% 

38% 

EN 

81 

   EN 

 
  
  
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
   Significant 

improvement 
   Unable to evaluate 

impact 

   N/A 

 Post marketing 
obligations on 
manufacturers 

   No, or no 
significant 
improvement 

   Moderate 

improvement 

   Significant 

improvement 
   Unable to evaluate 

impact 

   N/A 

 Common 
safeguard (market 
surveillance) 
procedures  

   No, or no 
significant 
improvement 

   Moderate 

improvement 

   Significant 

improvement 
   Unable to evaluate 

impact 

   N/A 

34% 

36% 

39% 

48% 

30% 

50% 

25% 

2% 

4% 

9% 

7% 

0% 

25% 

13% 

11% 

14% 

9% 

9% 

30% 

25% 

13% 

26% 

4% 

5% 

6% 

50% 

18% 

25% 

31% 

54% 

48% 

35% 

20% 

18% 

25% 

27% 

25% 

30% 

41% 

0% 

27% 

25% 

5% 

4% 

9% 

9% 

0% 

18% 

13% 

11% 

14% 

9% 

10% 

30% 

18% 

13% 

13% 

7% 

0% 

1% 

20% 

0% 

8% 

34% 

14% 

25% 

23% 

20% 

8% 

67% 

38% 

50% 

50% 

49% 

30% 

50% 

4% 

5% 

7% 

11% 

13% 

0% 

17% 

8% 

11% 

21% 

14% 

13% 

30% 

25% 

13% 

EN 

82 

   EN 

 
  
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
12.1.2.2. Competitiveness of EU-firms 

•  Answer to EO consultation (questions B11.4: Impact of the 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 agree that action 1 will have 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 defence of competitiveness of EO (EO replies) 

   Obligations for importers/distributors 

   Moderate improvement 

Significant improvement 

    Traceability obligations 

  Moderate improvement 

  Significant improvement 

 Post marketing obligations on manufacturers

  Moderate improvement 

  Significant improvement 

Number of 
requested records

Requested 
records 
(88)  

% of total 
number records
(98)  

30 

45 

(30.6%) 

(34.1%) 

(45.9%) 

(51.1%) 

Number of 
requested records

Requested 
records 
(88)  

% of total 
number records
(98)  

32 

40 

(32.7%) 

(36.4%) 

(40.8%) 

(45.5%) 

Number of 
requested records

Requested 
records 
(88)  

% of total 
number records
(98)  

19 

42 

(19.4%) 

(21.8%) 

(42.9%) 

(48.3%) 

 Common safeguard (market surveillance) 
procedures across the EU to deal with 
products presenting a risk 

Number of 
requested records

Requested 
records 
(88)  

% of total 
number records
(98)  

  Moderate improvement 

  Significant improvement 

26 

46 

(26.5%) 

(29.5%) 

(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  defending  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 

83 

   EN 

 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
Table 18: Impact of Action 1 on the defence of competitiveness of SME (SME replies) 

    Obligations for importers/distributors 

    some help  
    significant help  
    Traceability obligations 

    some help  
    significant help  
     Post marketing obligations on manufacturers 

    some help  
    significant help  
     Common safeguard (market surveillance) 
procedures across the EU to deal with 
products presenting a risk 

   some help  
   significant help  

Number of 
requested records

Requested 
records 
(597)  

% of total 
number records
(597)  

157 

300 

(26.3%) 

(26.3%) 

(50.3%) 

(50.3%) 

Number of 
requested records

Requested 
records 
(597)  

% of total 
number records
(597)  

152 

260 

(25.5%) 

(25.5%) 

(43.6%) 

(43.6%) 

Number of 
requested records

Requested 
records 
(597)  

% of total 
number records
(597)  

144 

264 

(24.1%) 

(24.1%) 

(44.2%) 

(44.2%) 

Number of 
requested records

Requested 
records 
(597)  

% of total 
number records
(597)  

119 

298 

(19.9%) 

(19.9%) 

(49.9%) 

(49.9%) 

•  Findings per sector (based on SME answers) confirm the overall analysis, despite slightly 
different  percentages  for  pyrotechnic  articles  and  equipment  for  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 

Lifts 

(63) 

(336) 

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  
  significant help  
  Traceability obligations 

  some help  
  significant help  
   Post marketing obligations 

on manufacturers 
  some help  
  significant help  

27.1% 

34.9% 28.2% 22.1% 25% 

20% 

51.8% 

34.9% 57.7% 50%  37.5% 56% 

25.9% 

31.7% 17.9% 27.9% 50% 

20% 

44.6% 

36.5% 59% 41.2% 25% 

28% 

25.6% 

28.6% 23.1% 22.1% 25% 

16% 

41.7% 

47.6% 56.4% 48.5% 37.5% 32% 

8% 

48% 

16% 

32% 

8% 

40% 

EN 

84 

   EN 

 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Common safeguard 
(market surveillance) 
procedures  
  some help  
  significant help  

17.6% 

19% 24.4% 22.1% 25% 

40% 

52.1% 

54% 56.4% 41.2% 25% 

36% 

12% 

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 burden for economic operators; question B13.1 & 2 
&  3  "If  you  answered  that  one  or  more  of  the  elements  of  Action  1  may  give  rise  to  a 
significant  increase  in  operating  costs/administrative  burden,  please  explain  why"  and 
"please provide an indicative estimate of the increase you expect" 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  elements  of  Action  1  from  11  to  42%  of 
respondents  consider  there  will  be  no,  or  no  significant,  increase  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% either 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 rise 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 

   Reduction of operating costs and/or 

administrative burden 

   No, or no significant increase in 

operating costs and/or adm. burden 
   Moderate increase in operating costs 

and/or adm. burden 

   Significant increase in operating costs 

and/or adm. burden 

   Unable to evaluate impact 
   N/A 

Traceability obligations  

   Reduction of operating costs and/or 

administrative burden 

Number of 
requested 
records 

Requested 
records 
(98)  

% of total 
number 
records 
(98)  

% of total 
number 
records 
(90)  

1 

11 

54 

6 

18 
8 

(1%) 

(1%) 

(1.1%) 

(11.2%) 

(11.2%) 

(12.2%) 

(55.1%) 

(55.1%) 

(60%) 

(6.1%) 

(6.1%) 

(6.7%) 

(18.4%) 
(8.2%) 

(18.4%) 
(8.2%) 

(20%) 
- 

Number of 
requested 
records 

Requested 
records 
(98)  

% of total 
number 
records 
(98)  

% of total 
number 
records 
(89)  

2 

(2%) 

(2%) 

(2.2%) 

95 

8 of them in the electric and electronic good sectors and 1 for the measuring instrument sectors. 

EN 

85 

   EN 

 
 
 
 
 
 
 
 
 
  
 
  
                                                 
   No, or no significant increase in 

operating costs and/or adm. burden 
   Moderate increase in operating costs 

and/or adm. burden 

   Significant increase in operating costs 

and/or adm. burden 

   Unable to evaluate impact 
   N/A 

 Post marketing obligations on 
manufacturers 

   Reduction of operating costs and/or 

administrative burden 

   No, or no significant increase in 

operating costs and/or adm. burden 
   Moderate increase in operating costs 

and/or adm. burden 

   Significant increase in operating costs 

and/or adm. burden 

   Unable to evaluate impact 
   N/A 

Common safeguard (market 
surveillance) procedures  

   Reduction of operating costs and/or 

administrative burden 

   No, or no significant increase in 

operating costs and/or adm. burden 
   Moderate increase in operating costs 

and/or adm. burden 

   Significant increase in operating costs 

and/or adm. burden 

   Unable to evaluate impact 
   N/A 

12 

53 

9 

13 
9 

(12.2%) 

(12.2%) 

(13.5%) 

(54.1%) 

(54.1%) 

(59.6%) 

(9.2%) 

(9.2%) 

(10.1%) 

(13.3%) 
(9.2%) 

(13.3%) 
(9.2%) 

(14.6%) 
- 

Number of 
requested 
records 

Requested 
records 
(98)  

% of total 
number 
records 
(98)  

% of total 
number 
records 
(90)  

4 

41 

31 

6 

8 
8 

(4.1%) 

(4.1%) 

(4.4%) 

(41.8%) 

(41.8%) 

(45.6%) 

(31.6%) 

(31.6%) 

(34.4%) 

(6.1%) 

(6.1%) 

(6.7%) 

(8.2%) 
(8.2%) 

(8.2%) 
(8.2%) 

(8.9%) 
- 

Number of 
requested 
records 

Requested 
records 
(98)  

% of total 
number 
records 
(98)  

% of total 
number 
records 
(90)  

5 

23 

41 

5 

16 
8 

(5.1%) 

(5.1%) 

(5.6%) 

(23.5%) 

(23.5%) 

(25.6%) 

(41.8%) 

(41.8%) 

(45.6%) 

(5.1%) 

(5.1%) 

(5.6%) 

(16.3%) 
(8.2%) 

(16.3%) 
(8.2%) 

(17.8%) 
- 

The  groups  of  obligations  that  will  give  rise  to  some  additional  costs,  according  to 
the majority of respondents, are obligations for importers/distributors and traceability 
obligations.  However,  among  the  same  respondents,  an  overwhelming  majority 
believed that the cost increase would be moderate.  

Only a minority of respondents (17%) provided indicative estimates of the magnitude 
of  cost  increases  expected:  the  large  majority  (65%)  estimated  the  increase  in  cost 
between 0.3% and 5% of current operating costs; 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 participating in the consultation considered the possible cost 
increase  quite  reasonable  in  relation  to  the  objective  of  reducing  non-compliance. 

EN 

86 

   EN 

 
 
 
  
 
  
This figure should be compared to the 14% of respondents considering the increase 
unreasonable.  

Table  21:  Overview  of  EO  replies  to  the  question  "Please  explain  how  do  you  regard  this  increase  in 
operating costs and/or administrative burden in relation to the objective of reducing non-compliance" 

   Very reasonable 
   Quite reasonable 
   Quite unreasonable 
   Not reasonable at all 
   I don't know 
   N/A 

Number of 
requested 
records 

Requested 
records 
(98)  

7 
30 
9 
5 
5 
42 

(7.1%) 
(30.6%) 
(9.2%) 
(5.1%) 
(5.1%) 
(42.9%) 

% of total 
number 
records 
(98)  

(7.1%) 
(30.6%) 
(9.2%) 
(5.1%) 
(5.1%) 
(42.9%) 

% of total 
number 
records 
(56)  

(12.5%) 
(53.6%) 
(16.1%) 
(8.9%) 
(8.9%) 
- 

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 costs are in the sector of electrical and 
electronic products; 3 respondents, including 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  most  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  significant  cost  increases,  the  reason  most 
often  mentioned  (16  times)  is  the  cost  of  paperwork  (e.g.  checking  documentation 
accompanying  products,  filing  and  storing  information  on  products),  8  operators 
mentioned  costs  of  testing  and  physical  inspection  of  products,  6  respondents 
considered  that  the  specific  reasons  for  cost  increases  would  be  the  translation  of 
technical documentation (including test reports) and declaration of conformity (DoC) 
in  all  EU  languages.  Furthermore  1  manufacturer  and  a  business  organisation 
explained  that  a  major  source  of  costs  would  be  the  logistics  involved  in  adding 
importer contact details on products shipped from third countries and 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 consultant 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 segment in one MS, one representing a specific product 
segment at European level and the last one representing EO located in a third country.. 

EN 

87 

   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 respondents (42%) considered the possible new costs 
reasonable  with  respect  to  the  desired  objective,  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 burden, please explain why 
and please provide an indicative estimate of the increase you expect either as a percentage 
of current operating costs or in terms 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 increase, 4-6% considered that would be a 
reduction,  15%  declared  themselves  unable  to  evaluate  impact,  while  the 
remaining 12-18% (from 72 to 106 respondents) believed that action 1 would give 
rise to a significant increase in operating costs and/or administrative 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 respondents (134, i.e. 22%) provided 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 further 18% provided estimates up to 20%; the 
small remaining groups provided disparate 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 
no or no significant increase in operating costs 
and/or administrative burden  
moderate increase in operating costs and/or 
administrative burden  
significant increase in operating costs and/or 
adm. burden  
unable to evaluate impact 

35 

160 

196 

73 

87 

(5.9%) 

(5.9%) 

(26.8%) 

(26.8%) 

(32.8%) 

(32.8%) 

(12.2%) 

(12.2%) 

(14.6%) 

(14.6%) 

Traceability obligations  

reduction of operating costs and/or 
administrative burden 

Number of requested 
records 

Requested 
records 
(597)  

25 

(4.2%) 

% of total 
number 
records 
(597)  
(4.2%) 

EN 

88 

   EN 

 
  
  
  
  
  
  
  
  
no or no significant increase in operating costs 
and/or administrative burden  
moderate increase in operating costs and/or 
administrative burden  
significant increase in operating costs and/or 
adm. burden  
unable to evaluate impact 

162 

182 

90 

86 

 Post marketing obligations on manufacturers 

Number of requested 
records 

reduction of operating costs and/or 
administrative burden 
no or no significant increase in operating costs 
and/or administrative burden  
moderate increase in operating costs and/or 
administrative burden  
significant increase in operating costs and/or 
adm. burden  
unable to evaluate impact 

25 

140 

177 

106 

93 

Common safeguard (market surveillance) 
procedures  

Number of requested 
records 

reduction of operating costs and/or 
administrative burden 
no or no significant increase in operating costs 
and/or administrative burden  
moderate increase in operating costs and/or 
administrative burden  
significant increase in operating costs and/or 
adm. burden  
unable to evaluate impact 

36 

124 

141 

72 

166 

(27.1%) 

(27.1%) 

(30.5%) 

(30.5%) 

(15.1%) 

(15.1%) 

(14.4%) 

(14.4%) 

Requested 
records 
(597)  

(4.2%) 

% of total 
number 
records 
(597)  
(4.2%) 

(23.5%) 

(23.5%) 

(29.6%) 

(29.6%) 

(17.8%) 

(17.8%) 

(15.6%) 

(15.6%) 

Requested 
records 
(597)  

(6%) 

% of total 
number 
records 
(597)  
(6%) 

(20.8%) 

(20.8%) 

(23.6%) 

(23.6%) 

(12.1%) 

(12.1%) 

(27.8%) 

(27.8%) 

•  Findings per sector: Looking at the answers of the group of SME (175) 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:  57%  of  respondents 
belong  to  the  electrical  and  electronic  goods  sector,  about  12%  respectively  to 
those of measuring instruments and pressure equipment, while 9% to pyrotechnic 
articles. It should be noted that these figures more or less mirror the proportion of 
overall respondents from those sectors. SME in pyrotechnic articles 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 comparison between costs and benefits for EO and to better demonstrate 
that the burdens for SME would not be disproportionate, the following tables show the views 
expressed by shareholders as regards the extent of the possible positive and negative impacts 
of the alignment. 

EN 

89 

   EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Table 23: Comparisons of perceived costs and benefits for general Economic Operators (EO) 

Benefits (B) 

Costs (C) 

C/B Comparison   View  of  EO  on 
/B 

overall  C 
balance97 

Defence  of  competitiveness 
(i.e. Reduction in losses due 
to 
competition 
identified in Figure 1, p.19) 

unfair 

in 
Increase 
operating 
costs 
and/or adm. burden 

importers 

Obligations 
on 
and 
distributors 

Significant 
(46% EO ) 

Moderate 
(31%) 

improvement 

Significant  increase 
(6% EO ) 

improvement 

Moderate 
(55%) 

increase 

More 

1) 
respondents 
pointing to benefits 
respondents 
than 
pointing 
to  cost 
increase 

Reasonable (38%) 

Unreasonable 
(14%) 

2)  Most  frequent 
significant 
view: 
vs 
improvement 
moderate costs 

Traceability 

Post-
marketing 
obligation  on 
manufacturers 

Common 
safeguard 
(market 
surveillance) 
procedures 

Significant 
(41% EO ) 

Moderate 
(33%) 

Significant 
(43% EO ) 

Moderate 
(19%) 

Significant 
(47% EO ) 

Moderate 
(27%) 

improvement 

Significant  increase 
(10% EO ) 

Same as above 

improvement 

Moderate 
(54%) 

increase 

improvement 

Significant  increase 
(6% EO ) 

Same as above 

improvement 

Moderate 
(32%) 

increase 

improvement 

Significant  increase 
(5% EO ) 

Same as above 

improvement 

Moderate 
(42%) 

increase 

97 

Answers  to  question:  "Please  explain how do  you  regard this  increase  in  operating  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 

90 

   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 
competition 
identified in Figure 1, p.19) 

unfair 

Increase 
in 
costs 
operating 
and/or adm. burden 

Obligations 
on  Importers 
and 
Distributors 

Significant help (50% SME) 

Some help (25%) 

Significant  increase 
(12% EO ) 

Moderate 
(33%) 

increase 

More 

1) 
respondents 
pointing to benefits 
respondents 
than 
to  cost 
pointing 
increase 

2)  Most  frequent 
significant 
view: 
improvement 
vs 
moderate costs 

Traceability 

Significant help (44%) 

Significant  increase 
(15% EO ) 

Same as above. 

Some help (26%) 

Moderate 
(30%) 

increase 

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 ) 

Same as above. 

Moderate 
(30%) 

increase 

Common 
safeguard 
(market 
surveillance) 
procedures 

Significant help (50%) 

Some help (20%) 

Significant  increase 
(12% EO ) 

Same as above. 

Moderate 
(24%) 

increase 

The burden of the proposed measures will not be disproportionate either on EO in general or 
on SME. As regards the proportionality of the proposed 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 requirements. The fact that 
a remarkable share of SME does not expect cost increases (and certainly not significant ones) 
supports this conclusion. 

EN 

91 

   EN 

 
 
 
 
 
 
 
 
 
 
Furthermore  the  new  obligations  already  incorporate  a  strong  element  of  proportionality,  as 
they  have  been  designed  to  make  economic  operators  at  different  levels  of  the  value  chain 
(e.g. an SME distributing 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  accompanied  by  the  required  documentation  and 
instructions, while the manufacturer will remain responsible for showing compliance). 

12.1.2.5. Public authorities 

•  Answer to EO consultation (question B11.1: "Impact of the following elements of Action 1 
on the level of non-compliance"): between 67% and 71% of EO participating in the public 
consultation consider that this policy action will have a positive impact on the level of non-
compliance (proxy for increase in effectiveness of enforcement activities). Between 9 and 
15%  of  respondents  believed  this  would  not  be  the  case.  The  majority  of  EO  having 
identified  a  positive  improvement  evaluated  the  contribution  given  by  traceability 
obligations as significant, while evaluating the contribution given by the other elements as 
being more moderate.  

Table 25: Impact of Action 1 on level of non-compliance (replies by EO)  

    Obligations for importers/distributors 

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   N/A 

    Traceability obligations 

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   N/A 

    Post marketing obligations on 

manufacturers 

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   N/A 

% of total 
number 
records 
(98)  

(15.3%) 
(45.9%) 
(23.5%) 
(7.1%) 
(8.2%) 

% of total 
number 
records 
(98)  

(16.3%) 
(27.6%) 
(39.8%) 
(9.2%) 
(7.1%) 

% of total 
number 
records 
(98)  

(14.3%) 
(39.8%) 
(28.6%) 
(9.2%) 
(8.2%) 

% of total 
number 
records 
(90)  

(16.7%) 
(50%) 
(25.6%) 
(7.8%) 
- 

% of total 
number 
records 
(91)  

(17.6%) 
(29.7%) 
(42.9%) 
(9.9%) 
- 

% of total 
number 
records 
(90)  

(15.6%) 
(43.3%) 
(31.1%) 
(10%) 
- 

Number of 
requested 
records 

Requested 
records 
(98)  

15 
45 
23 
7 
8 

(15.3%) 
(45.9%) 
(23.5%) 
(7.1%) 
(8.2%) 

Number of 
requested 
records 

Requested 
records 
(98)  

16 
27 
39 
9 
7 

(16.3%) 
(27.6%) 
(39.8%) 
(9.2%) 
(7.1%) 

Number of 
requested 
records 

Requested 
records 
(98)  

(14.3%) 
(39.8%) 
(28.6%) 
(9.2%) 
(8.2%) 

14 
39 
28 
9 
8 

92 

EN 

   EN 

 
 
 
    Common safeguard (market 

surveillance) procedures to deal with 
products presenting a risk across the 
EU 

Number of 
requested 
records 

Requested 
records 
(98)  

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   N/A 

9 
43 
27 
11 
8 

(9.2%) 
(43.9%) 
(27.6%) 
(11.2%) 
(8.2%) 

% of total 
number 
records 
(98)  

(9.2%) 
(43.9%) 
(27.6%) 
(11.2%) 
(8.2%) 

% of total 
number 
records 
(90)  

(10%) 
(47.8%) 
(30%) 
(12.2%) 
- 

•  Answer to NB consultation (question B11.1: "Impact of the following elements of Action 1 
on the level of non-compliance): between 66% and 83% of NB participating in the public 
consultation considered 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 13% of respondents believed 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  considered  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 believed 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 

   No. or no significant improvement 

   Moderate improvement 

   Significant improvement 

   Unable to evaluate impact 

   N/A 

    Traceability obligations 

   No. or no significant improvement 

   Moderate improvement 

Number of 
requested 
records 

Requested 
records 
(101)  

% of total 
number 
records 
(101)  

% of total 
number 
records 
(82)  

12 

34 

32 

4 

- 

11.9% 

11.9% 

14.6% 

33.7% 

33.7% 

41.5% 

31.7% 

31.7% 

39.0% 

4.0% 

4.0% 

4.9% 

- 

18.8% 

- 

Number of 
requested 
records 

Requested 
records 
(101)  

% of total 
number 
records 
(101)  

% of total 
number 
records 
(82)  

5.9% 

5.9% 

7.2% 

35.6% 

35.6% 

43.4% 

6 

36 

93 

EN 

   EN 

 
 
   Significant improvement 

   Unable to evaluate impact 

   N/A 

    Post marketing obligations on 

manufacturers 

   No. or no significant improvement 

   Moderate improvement 

   Significant improvement 

   Unable to evaluate impact 

   N/A 

    Common safeguard (market 

surveillance) procedures to deal with 
products presenting a risk across the 
EU 

   No. or no significant improvement 

   Moderate improvement 

   Significant improvement 

   Unable to evaluate impact 

   N/A 

36 

5 

- 

35.6% 

35.6% 

43.4% 

5.0% 

5.0% 

6.0% 

- 

17.8% 

- 

Number of 
requested 
records 

Requested 
records 
(101)  

% of total 
number 
records 
(101)  

% of total 
number 
records 
(82)  

14 

41 

17 

12 

- 

13.9% 

13.9% 

16.7% 

40.6% 

40.6% 

48.8% 

16.8% 

16.8% 

20.2% 

11.9% 

11.9% 

14.3% 

- 

16.8% 

- 

Number of 
requested 
records 

Requested 
records 
(101)  

% of total 
number 
records 
(101)  

% of total 
number 
records 
(82)  

10 

30 

28 

10 

- 

9.9% 

9.9% 

12.8% 

29.7% 

29.7% 

38.5% 

27.7% 

27.7% 

35.9% 

9.9% 

9.9% 

12.8% 

- 

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  participating  in  the  public 
consultation consider that the different elements of this policy action will have a positive 
impact on the level of non-compliance As regards 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  think  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 that 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 

94 

   EN 

 
Specific examples of damages provided by respondents (quotations):  

Electrical and electronic 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 the control prescribed, then the 
users  cannot  rely  on 
the  claimed  quality  and  duration  (professional  user 
organisation). Estimates unknown, but it is quite clear that non-compliance can allow 
fraudulent  weightings,  implying  bad  prices  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 failure if materials used are prone to brittle 
fracture.  Reduced  service  life  for  equipment  if  materials  used  have  reduced 
corrosion resistance. Production loss resulting from need to repair non-compliant 
equipment during service (professional user organisation). 

–  Non  compliant  products  may  lead  to:  i)  delayed  putting  into  operation  ii) 

interrupted chemical production (professional user).  

–  Project  delays;  replacement  costs  and  often  interim  temporary  measures  put  in 
place  to  resume  production;  increased  hydrocarbon  leaks  leading  to  higher  risks 
(professional  user).  Relationship  with  authorities,  final  users  must  prove  that 
products are in accordance with law and standard regulations in Europe; potential 
injuries  or  fatalities  when  such  products  are  in  production  with  toxic  or 
inflammable liquid or gas (professional user). 

ATEX:  more  expensive  spare  parts.  Manufacturers  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%).  Discussions  with  supplier  over  the  conformity 
cost a lot of money (professional user). 

EN 

95 

   EN 

 
12.1.2.7. Public health and safety 

•  Replies provided by stakeholders of all sectors, except measuring instruments to question 
B11.2 "Impact of the following elements of Action 1 on health and safety conditions for 
consumers and workers dealing with products in this sector [this question 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 

No, or no significant improvement 

Moderate improvement 

Significant improvement 

Unable to evaluate impact 

   Traceability obligations  

Significant improvement 

Unable to evaluate impact 

 Post marketing obligations on manufacturers 

No, or no significant improvement 

Moderate improvement 

Significant improvement 

Unable to evaluate impact 

 Common safeguard (market surveillance) procedures 
to deal with products presenting a risk across the EU 

No, or no significant improvement 

Moderate improvement 

Significant improvement 

Unable to evaluate impact 

Number of 
requested 
records 

Requested 
records 
(36) 

% of total 
number 
records (98) 

8 

19 

2 

7 

(22.2%) 

(8.2%) 

(52.8%) 

(19.4%) 

(5.6%) 

(2%) 

(19.4%) 

(7.1%) 

Number of 
requested 
records 

Requested 
records 
(36) 

% of total 
number 
records 
(98) 

9 

19 

5 

3 

(25%) 

(9.2%) 

(52.8%) 

(19.4%) 

(13.9%) 

(5.1%) 

(8.3%) 

(3.1%) 

Number of 
requested 
records 

Requested 
records 
(36) 

% of total 
number 
records 
(98) 

13 

15 

6 

2 

(36.1%) 

(13.3%) 

(41.7%) 

(15.3%) 

(16.7%) 

(6.1%) 

(5.6%) 

(2%) 

Number of 
requested 
records 

Requested 
records 
(36) 

% of total 
number 
records 
(98) 

6 

14 

14 

2 

(16.7%) 

(6.1%) 

(38.9%) 

(14.3%) 

(38.9%) 

(14.3%) 

(5.6%) 

(2%) 

EN 

96 

   EN 

 
  
  
  
  
  
  
 
  
 
  
  
  
  
  
  
  
  
  
  
  
  
Table 28: Impact of Action 1 on health and safety (replies by NB) 

 Obligations for importers/distributors 

No, or no significant improvement 

Moderate improvement 

Significant improvement 

Unable to evaluate impact 

   Traceability obligations  

No, or no significant improvement 

Moderate improvement 

Significant improvement 

Unable to evaluate impact 

 Post marketing obligations on manufacturers 

No, or no significant improvement 

Moderate improvement 

Significant improvement 

Unable to evaluate impact 

   Common safeguard (market surveillance) procedures 
to deal with products presenting a risk across the EU  

No, or no significant improvement 

Moderate improvement 

Significant improvement 

Unable to evaluate impact 

Number of 
requested 
records 

Requested 
records 
(60) 

% of total 
number 
records 
(76) 

5 

21 

25 

5 

(8.3%) 

(6.6%) 

(35%) 

(27.6%) 

(41.7%) 

(32.9%) 

(8.3%) 

(6.6%) 

Number of 
requested 
records 

Requested 
records 
(60) 

% of total 
number 
records 
(76) 

4 

24 

23 

5 

(6.7%) 

(5.3%) 

(40%) 

(31.6%) 

(38.3%) 

(30.3%) 

(8.3%) 

(6.6%) 

Number of 
requested 
records 

Requested 
records 
(60) 

% of total 
number 
records 
(76) 

8 

19 

24 

5 

(13.3%) 

(10.5%) 

(31.7%) 

(25%) 

(40%) 

(31.6%) 

(8.3%) 

(6.6%) 

Number of 
requested 
records 

Requested 
records 
(60) 

% of total 
number 
records 
(76) 

2 

19 

27 

8 

(3.3%) 

(2.6%) 

(31.7%) 

(25%) 

(45%) 

(35.5%) 

(13.3%) 

(10.5%) 

Table 29: Impact of Action 1 on health and safety (replies by authorities) 

 Obligations for importers/distributors 

   No, or no significant improvement 
   Moderate improvement 

Number of 
requested 
records 

Requested 
records 
(66) 

12 
17 

(18.2%) 
(25.8%) 

% of total 
number 
records 
(101) 

(11.9%) 
(16.8%) 

EN 

97 

   EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
   Significant improvement 
   Unable to evaluate impact 

   Traceability obligations  

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 

   Post marketing obligations on manufacturers  

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 

 Common safeguard (market surveillance) procedures 
to deal with products presenting a risk across the EU 

   No, or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 

12.2. 

Performance of Notified Bodies  

12.2.1.  Assessment of impacts 

12.2.1.1. Internal Market 

21 
6 

(31.8%) 
(9.1%) 

(20.8%) 
(5.9%) 

Number of 
requested 
records 

Requested 
records 
(66) 

12 
22 
19 
5 

(18.2%) 
(33.3%) 
(28.8%) 
(7.6%) 

Number of 
requested 
records 

Requested 
records 
(66) 

10 
24 
17 
6 

(15.2%) 
(36.4%) 
(25.8%) 
(9.1%) 

Number of 
requested 
records 

Requested 
records 
(66) 

10 
24 
16 
6 

(15.2%) 
(36.4%) 
(24.2%) 
(9.1%) 

% of total 
number 
records 
(101) 

(11.9%) 
(21.8%) 
(18.8%) 
(5%) 

% of total 
number 
records 
(101) 

(9.9%) 
(23.8%) 
(16.8%) 
(5.9%) 

% of total 
number 
records 
(101) 

(9.9%) 
(23.8%) 
(15.8%) 
(5.9%) 

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 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 
Notified Bodies providing the service)". 

•  Answer to EO consultation: Two thirds (64%) of EO that have recourse to the services of 
NB considered that action 2 would have a positive 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 reinforcement of notification requirements for NB for 
which 41% of respondents expected a significant improvement. 

EN 

98 

   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 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
    Revised procedures for notification 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
    Information obligations on NB 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 

Requested records 
(8798)  

(6.9%) 
(23%) 
(41.4%) 
(5.7%) 

6 
20 
36 
5 

Number of requested 
records 

Requested records 
(87)  

6 
37 
18 
6 

(6.9%) 
(42.5%) 
(20.7%) 
(6.9%) 

Number of requested 
records 

Requested records 
(87)  

7 
43 
13 
4 

(8%) 
(49.4%) 
(14.9%) 
(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 the 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: "Impact 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 
issue
case. 

remainder 

position 

take 

The 

this 

not 

did 

on 

a 

98 

Only the replies of EO that declared to make use of NB's services have been taken into account. 

EN 

99 

   EN 

 
                                                 
Table 31: Impact of Action 2 on the defence of competitiveness 

    Reinforcement of notification requirements for NB 

   No or no significant improvement 

   Moderate improvement 

   Significant improvement 

   Unable to evaluate impact 

  N/A 

   Revised procedures for notification  

   No or no significant improvement 

   Moderate improvement 

   Significant improvement 

   Unable to evaluate impact 

  N/A 

    Information obligations on NB 

   No or no significant improvement 

   Moderate improvement 

   Significant improvement 

   Unable to evaluate impact 

  N/A 

Number of 
requested 
records 

Requested records 
(87)  

6 

17 

37 

4 

23 

(6.9%) 

(19.5%) 

(42.5%) 

(4.6%) 

(26%) 

Number of 
requested 
records 

Requested records 
(87)  

5 

34 

20 

6 

22 

(5.7%) 

(39.1%) 

(23%) 

(6.9%) 

(25%) 

Number of 
requested 
records 

Requested records 
(87)  

8 

35 

17 

4 

23 

(9.2%) 

(40.2%) 

(19.5%) 

(4.6%) 

(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 administrative 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 administrative  burden  for  Notified Bodies" ; question 
C27.1 & 2 & 3 " If you answered that one or more of the elements of Action 1 may give 
rise to a significant increase in operating costs/administrative burden, please explain why" 
&  "please  provide  an  indicative  estimate  of  the  increase  you  expect"  &  "  please  explain 
how do 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") 

EN 

100 

   EN 

 
•  Overall  findings:  depending  on  the  various  elements  of  Action  2  about  30-42%  of 
respondents  considered  there  would  be  no  or  no  significant  increase  in  operating  costs 
and/or administrative burden, 32-37% considered that there would be a moderate increase, 
1-4% considered that there would be a reduction, 5% either did not answer the question or 
declared themselves unable to evaluate impact, while only the remaining 14-24% (11 to 18 
respondents out of 76 NB) believed that action 2 would 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  

   Reduction of operating costs and/or 

administrative burden 

   No or no significant increase in 

operating costs and/or adm. burden 
   Moderate increase in operating costs 

and/or adm. burden 

   Significant increase in operating costs 

and/or adm. burden 

   N/A 

   Revised procedures for notification 

   Reduction of operating costs and/or 

administrative burden 

   No or no significant increase in 

operating costs and/or adm. burden 
   Moderate increase in operating costs 

and/or adm. burden 

   Significant increase in operating costs 

and/or adm. burden 

   N/A 

    Information obligations on NB 

Number of 
requested 
records 

Requested 
records 
(76)  

% of total 
number 
records 
(76)  

% of total 
number 
records 
(72)  

3 

23 

28 

18 

4 

(3.9%) 

(3.9%) 

(4.2%) 

(30.3%) 

(30.3%) 

(31.9%) 

(36.8%) 

(36.8%) 

(38.9%) 

(23.7%) 

(23.7%) 

(25%) 

(5.3%) 

(5.3%) 

- 

Number of 
requested 
records 

Requested 
records 
(76)  

% of total 
number 
records 
(76)  

% of total 
number 
records 
(72)  

1 

31 

24 

16 

4 

(1.3%) 

(1.3%) 

(1.4%) 

(40.8%) 

(40.8%) 

(43.1%) 

(31.6%) 

(31.6%) 

(33.3%) 

(21.1%) 

(21.1%) 

(22.2%) 

(5.3%) 

(5.3%) 

- 

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 

   No or no significant increase in 

operating costs and/or adm. burden 
   Moderate increase in operating costs 

and/or adm. burden 

   Significant increase in operating costs 

and/or adm. burden 

   N/A 

3 

32 

26 

11 

4 

(3.9%) 

(3.9%) 

(4.2%) 

(42.1%) 

(42.1%) 

(44.4%) 

(34.2%) 

(34.2%) 

(36.1%) 

(14.5%) 

(14.5%) 

(15.3%) 

(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 

101 

   EN 

 
 
 
Only  some  respondents  (21%)  provided  indicative  estimates  of  the  magnitude  of  the  cost 
increases  expected.  The  average  estimate  provided  was  28%,  which  however  should  be 
interpreted with caution since it does not seem to reflect the view 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  increases,  57%  of  respondents  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 that NB have attributed to this policy some effects that relate 
more  generally  to  technical  legislation  already  in  place  that  will  not  change  with  the 
alignment  of  these  provisions  with  the  NLF  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  already  employ  qualified  personnel;  alignment  does  not  prevent 
subcontracting  (it  only  requires  that  NB  take  responsibility  for  work  carried  out  by 
subcontractors); lastly, alignment does not increase the likelihood of complaints from EO. 

As  regards  accreditation  costs,  only  5  NB  provided  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  the  consultation  considered  the  possible  cost 
increase quite  reasonable in  relation to the  objective 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  "Please  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"- 

   Very reasonable 
   Quite reasonable 
   Quite unreasonable 
   Not reasonable at all 
   I don't know 
   N/A 

EN 

Number of 
requested 
records 

Requested 
records 
(76)  

% of total 
number 
records 
(76)  

% of total 
number 
records 
(48)  

(3.9%) 
(32.9%) 
(10.5%) 
(3.9%) 
(11.8%) 
(36.8%) 

(3.9%) 
(32.9%) 
(10.5%) 
(3.9%) 
(11.8%) 
(36.8%) 

(6.2%) 
(52.1%) 
(16.7%) 
(6.2%) 
(18.8%) 
- 

3 
25 
8 
3 
9 
28 

102 

   EN 

 
  
  
•  Findings  per  sector:  the  analysis  of  sectoral  data  suggests  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 process. 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  "Please  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 

No or no significant increase 
in operating costs and/or adm. 
burden 
Moderate increase in 
operating costs and/or adm. 
burden 
Significant increase in 
operating costs and/or adm. 
burden 
N/A 

 Revised procedures for 
notification 

Reduction of operating costs 
and/or administrative burden 

No or no significant increase 
in operating costs and/or adm. 
burden 
Moderate increase in 
operating costs and/or adm. 
burden 
Significant increase in 
operating costs and/or adm. 
burden 
N/A 

 Information obligations on NB 

Reduction of operating costs 
and/or administrative burden 

No or no significant increase 
in operating costs and/or adm. 
burden 
Moderate increase in 
operating costs and/or adm. 
burden 
Significant increase in 
operating costs and/or adm. 
burden 

0 

0 

4.3 

7.7 

0 

0 

18.8 

11.1  39.1

30.8 

75 

50 

11.1 

22.2 

56.2 

44.4  34.8

23.1 

25 

0 

33.3 

18.8 

33.3  17.4

30.8 

0 

50 

33.3 

0 

0 

0 

0 

0 

0 

31.2 

33.3  43.5

38.5 

75 

50 

11.1 

44.4 

43.8 

44.4  34.8

23.1 

25 

0 

11.1 

18.8 

11.1  17.4

30.8 

0 

50 

33.3 

0 

11.1 

0 

0 

50 

0 

0 

18.8 

33.3  43.5

61.5 

25 

50 

66.7 

56.2 

33.3  34.8

23.1 

25 

0 

22.2 

18.8 

11.1  17.4

7.7 

0 

50 

11.1 

EN 

103 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
•  Estimates of accreditation costs  

The  cost  basis  for  accreditation  within  the  regulated  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  seeking  accreditation  in  the  voluntary  sector.  However,  even  for 
accreditation costs in the voluntary sector, it is not possible to provide a general estimate. This 
is  because  national  accreditation  bodies  (NAB)  have  different  fee  structures  based  on  their 
individual  circumstances  and  they  charge  for  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 bearing 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  (laboratories,  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  least  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, inspection 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 

Mean Fees charged 
Median Fees Charged 

 Analysis of Fees paid by Inspection Bodies 
Indicative range of fees: from 0 to 52 000 

Mean Fees charged 
Median Fees Charged 

 Analysis of Fees paid by Certification Bodies 
Indicative range of fees: from 0 to 170 000 

Mean Fees charged 
Median Fees Charged 

Source: EA 

 Fees 

7 213  
4 863  

% charged  
Less 
72% 
50% 

More 
28% 
50% 

 Fees 
  Fees 

5 286  
3 839  

% charged 
Less 
70% 
50% 

More 
30% 
50% 

 Fees 

 % charged  
More 
   17 700   29% 
   11 168   50% 

Less 
71% 
50% 

As different CAB may ask for substantially different scopes of accreditation, the range of fees 
applied  to  a  single  CAB  is  very  wide.  A  small  CAB  requesting  accreditation  for  simple 
conformity  assessment  procedures  for  a  limited  range  of  products  will  be  charged  much 
smaller  fees  than  a  big  multi-site  CAB  requesting  accreditation  for  complex  conformity 
assessment procedures over a large range of products.  
However, even with those constraints, it is very useful to see what is the mean of the fees that 
have been charged in each conformity assessment sector, and what percentage of the bodies in 

EN 

104 

   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 participating 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  for  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 
No or no significant improvement 
Moderate improvement 
Significant improvement 
Unable to evaluate impact 

Number of requested records  % Requested records(87) 

6 
24 
40 
7 

7% 
28% 
46% 
8% 

 Revised procedures for notification 

Number of requested records  % Requested records(87) 

No or no significant improvement 
Moderate improvement 
Significant improvement 
Unable to evaluate impact 

4 
44 
21 
7 

5% 
51% 
24% 
8% 

 Information obligations on NB 

Number of requested records  % Requested records(87) 

No or no significant improvement 
Moderate improvement 
Significant improvement 
Unable to evaluate impact 

7 
47 
14 
6 

8% 
54% 
16% 
7% 

•  Answer to NB consultation (questions C25.1 "Impact on the level of services provided by 
NB"): between 60% and 84% of NB participating 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  activities).  Between  9  and  14%  of  respondents 
believed  this  would  not  be  the  case  (except  for  information  obligations  for  which  this 
percentage was 32%) 

EN 

105 

   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 
Moderate improvement 
Significant improvement 
Unable to evaluate impact 
N/A 

7 
36 
28 
1 
- 

9% 
47% 
37% 
1% 
5% 

10% 
50% 
39% 
1% 
- 

 Revised procedures for notification 

Number of 
requested 
records 

% Requested 
records(76)  

% of 
total number 
records(72)  

No or no significant improvement 
Moderate improvement 
Significant improvement 
Unable to evaluate impact 
N/A 

11 
34 
24 
3 
- 

14% 
45% 
32% 
4% 
5% 

15% 
47% 
33% 
4% 
- 

 Information obligations on NB 

Number of 
requested 
records 

% Requested 
records(76)  

% of 
total number 
records(72)  

No or no significant improvement 
Moderate improvement 
Significant improvement 
Unable to evaluate impact 
N/A 

24 
36 
10 
2 
- 

32% 
47% 
13% 
3% 
5% 

33% 
50% 
14% 
3% 
- 

•  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 effectiveness of notification activities) Between 5 and 
15% of respondents believed this would not be the case. The strongest positive impact was 
attributed to the reinforcement 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 
Moderate improvement 
Significant improvement 
Unable to evaluate impact 
N/A 

9 
31 
42 
5 
14 

8.91% 
30.69% 
41.58% 
4.95% 

14% 

10.34% 
35.63% 
48.28% 
5.75% 
- 

 Revised procedures for notification 

Number of 
requested records 

% Requested 
records(101)  

% of total number 
records(86)  

No or no significant improvement 
Moderate improvement 

5 
39 

4.95% 
38.61% 

5.81% 
45.35% 

EN 

106 

   EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
Significant improvement 
Unable to evaluate impact 
N/A 

32 
10 
15 

31.68% 
9.90% 

15% 

37.21% 
11.63% 
- 

 Information obligations on NB 

Number of 
requested records 

% Requested 
records(101)  

% of total number 
records(87)  

No or no significant improvement 
Moderate improvement 
Significant improvement 
Unable to evaluate impact 
N/A 

16 
37 
29 
5 
14 

15.84% 
36.63% 
28.71% 
4.95% 

14% 

18.39% 
42.53% 
33.33% 
5.75% 
- 

•  SME  consultation  (relevant  question:  "15.)  Do  you  think  that  the  following  elements  of 
"Action 2" will help improving the 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 effectiveness of notification activities). Between 13 and 
14%  of  respondents  believed  this  would  not  be  the  case.  Between  19  and  23%  of 
respondents considered they were unable 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 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 

    Revised procedures for notification 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 

    Information obligations on NB 

   No or no significant improvement 
   Moderate improvement 
  Significant improvement 

Number of 
requested records

Requested 
records 
(597)  

81 

151 

155 

113 

(13.6%) 

(25.3%) 

(26%) 

(18.9%) 

Number of 
requested records

Requested 
records 
(597)  

78 

154 

120 

135 

Number of 
requested records

75 

133 

161 

(13.1%) 

(25.8%) 

(20.1%) 

(22.6%) 

Requested 
records 
(597)  

(12.6%) 

(22.3%) 

(27%) 

% of total 
number 
records 
(597)  

(13.6%) 

(25.3%) 

(26%) 

(18.9%) 

% of total 
number 
records 
(597)  

(13.1%) 

(25.8%) 

(20.1%) 

(22.6%) 

% of total 
number 
records 
(597)  

(12.6%) 

(22.3%) 

(27%) 

EN 

107 

   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  burdens  and/or  reorganisation  costs  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, please 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 burden, please explain why" & "please provide 
an indicative estimate of the increase you expect"): depending on the various elements of 
Action  2  about  26-34%  of  respondents  considered  there  would  be  no  or  no  significant 
increase  in  costs  and/or  administrative  burden,  25-36%  considered  that  there  would  be  a 
moderate increase, 3-5% considered that there 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  rise  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 
No or no significant increase in costs / 
administrative burden 
Moderate increase in costs / 
administrative burden 
Significant increase in costs / 
administrative burden 
Unable to evaluate impact 
N/A 

2 

26 

36 

13 
- 

5% 
26% 

36% 

2% 

13% 
19% 

6% 
32% 

44% 

2% 

16% 
- 

 Revised procedures for notification 

Number of 
requested 
records 

% Requested 
records(101)  

% of total number 
records(82)  

Reduction of costs / administrative burden  4 
No or no significant increase in costs / 
administrative burden 
Moderate increase in costs / 
administrative burden 
Significant increase in costs / 
administrative burden 
Unable to evaluate impact 
N/A 

0 

28 

35 

15 
- 

4% 
28% 

35% 

0% 

15% 
19% 

5% 
34% 

43% 

0% 

18% 
- 

 Information obligation on NB 

Number of 
requested 
records 

% Requested 
records(101)  

% of total number 
records(82)  

Reduction of costs / administrative burden  3 
No or no significant increase in costs / 
administrative burden 

34 

3% 
34% 

4% 
41% 

EN 

108 

   EN 

 
  
  
  
  
  
  
  
  
Moderate increase in costs / 
administrative burden 
Significant increase in costs / 
administrative burden 
Unable to evaluate impact 
N/A 

25 

1 

19 
- 

25% 

1% 

19% 
19% 

30% 

1% 

23% 
- 

Only five respondents (5%) provided indicative estimates 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 required by this policy intervention.  

•  Findings per sector: 

Table  41:  Impact  of  Action  2  on  operating  costs  and  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 
authorities 

for  notifying

 Reduction 
administrative burden 

of 

costs 

3.6 

0 

13.3

9.5 

0 

0 

0 

/

 No  or  no  significant  increase
/  administrative
in 
burden 

costs 

 Moderate  increase  in  costs  /
administrative burden 

 Significant  increase  in  costs  /
administrative burden 

 Unable to evaluate impact 

21.4 

36.4 

20 

38.1  16.7 

11.1 

27.3 

28.6 

36.4  53.3

9.5 

66.7 

55.6 

45.5 

3.699 

0 

0 

4.8100

0 

0 

0 

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 
notification 

procedures 

for

 Reduction 
administrative burden 

of 

costs 

3.6 

0 

6.7 

9.5 

0 

0 

0 

/

99 

100 

Reply provided by one authority with the generic explanation that additional administrative burden will 
increase cost of personnel or reduce time for other tasks. 
Reply provided by one authority without specific explanations. 

EN 

109 

   EN 

 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 No  or  no  significant  increase
/  administrative
in 
burden 

costs 

 Moderate  increase  in  costs  /
administrative burden 

 Significant  increase  in  costs  /
administrative burden 

 Unable to evaluate impact 

17.9 

27.3  26.7

42.9  16.7 

11.1 

45.5 

32.1 

45.5  53.3

4.8 

66.7 

55.6 

27.3 

0 

0 

0 

0 

0 

0 

0 

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 
administrative burden 

of 

costs 

3.6 

0 

6.7 

4.8 

0 

0 

0 

/

 No  or  no  significant  increase
in 
/  administrative
burden 

costs 

 Moderate  increase  in  costs  /
administrative burden 

 Significant  increase  in  costs  /
administrative burden 

 Unable to evaluate impact 

28.6 

45.5 

20 

47.6  16.7 

11.1 

54.5 

14.3 

18.2  53.3

4.8 

66.7 

44.4 

18.2 

3.699 

0 

0 

0 

0 

0 

0 

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-notifications needed per MS and per authority: 

The  table  below  shows  the  distribution  of  NB  per  MS  and  per  relevant  directive.  Normally 
MS appoint different notification authorities by areas of competence; furthermore, when a MS 
appoints  a  single  notification  authority  for  all  directives,  the  latter  usually  acts  mainly  as  a 
contact  point  for  the  Commission,  but  the  notifications  are  underpinned  by  the  work  of 
sectoral  authorities.  Since  very  often  authorities  are  competent  for  groups  of  directives 
concerning similar products, some of the figures in the table have been aggregated to reflect 
the workload of authorities responsible for 2 or 3 related directives.  

The table shows 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 can 
be faced with bigger - but overall very reasonable - numbers (e.g. from 35 to 60) in two or 
three  sectors  among  electrical  and  electronic  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 

110 

   EN 

 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
In particular, by looking at specific directives: 

–  For  the  directives  on  pyrotechnic  articles,  civil  explosives  and  ATEX,  the  estimates  of 

possible re-notifications are (largely) below 12. 

–  For the lifts directive figures are normally well below 21 and only Italy could be faced with 

almost 60 re-notifications. 

–  For the two directives on electrical and electronic goods jointly (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 higher number of re-notifications (between 33 
and 46).  

–  For the two directives on measuring instruments jointly (MID and NAWI) the number for 
the  majority  of  MS  is  well  below  25;  Germany  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;  Germany,  Italy  and  UK  Poland  could  be  faced 
respectively with 40, 48 and 35 re-notifications. 

EN 

111 

   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 

Civil Expl. 

EMC 

LVD 

10

13

131

148

1 

1 

8 

6 

1 

1 

6 

8 

1 

2 

3 

EMC+LVD 

14 

5  14 

Atex 

MID 

NAWI 

55

140

270

4 

1 

1 

1 

2 

1 

1 

1 

MID+NAWI 

2 

2 

2 

SPVD 

PED 

95

237

4 

8 

4 

6 

3 

7 

SPVD+PED 

12 

10  10 

Lifts 

192

8 

5 

5 

1  

1  

18

20

38

12  

18

14

32

9

31

40

9

1

2

3

2

4

5

9

1

7

8

2

EN 

1

2

3

1

2

3

1

2

3

1

1

2

1

2

1

9

7

1  

1  

20  

13

6  

1  

1  

1

3

2

0

4  16

33 

6

0

1  

1

7

1

17

2

4

2

9  

9  

97  

1  24

6 106 

0

10

7

14

18

3

8

14  

34  

24  25

11 

48 

12

15

21

58

0

1

112 

1  

1  

1  

1  

1  

1  

1  

1  

2  

1  

1 

1 

2 

1 

3 

4 

3 

5 

8 

4 

2

1  

2

3

1

1

2

3

0

1

1

1

1

1

2

3

6

5

2

0

11 

1  

1  

1  

2

0

3  

1

5

1

6

1

4  

10

2

5

7

1

1

1

2

3

8

17

25

42 

6  

22

10

2  

7

9

7

7

32  14 

4

8

2

6

8

5

1

1

1

1

2

3

2

3

5

2

7

0

11  11  12 

3  

4

2

2

1

4

7

11

2

3

1

4

1 

1 

1 

3 

1 

4 

1 

1 

1 

2 

1 

3 

1 

1 

1 

26 

20 

46 

7 

48 

94 

2 

2  142 

6

1 

9 12 

15 13 

4

4 

1 

6 

7 

7 

9 

26 

35 

7 

1

3

4

1

2

1

3

1

2

3

4

EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
12.2.1.6. Public health and safety 

•  Answer to EO consultation (questions C25.2 "Impact of the following elements of Action 2 
on  health  and  safety")  50-72%  of  EO  participating  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 majority 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 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   Revised procedures for notification  

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
    Information obligations on NB 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 

Number of requested 
records (36) 

Requested records 
(36)  

6 

13 

13 

4 

(16.7%) 

(36.1%) 

(36.1%) 

(11.1%) 

Number of requested 
records (36) 

Requested records 
(36) 

7 

13 

12 

4 

(19.4%) 

(36.1%) 

(33.3%) 

(11.1%) 

Number of requested 
records (36) 

Requested records 
(36) 

9 
13 
5 
9 

(25%) 
(36.1%) 
(13.9%) 
(25%) 

•  Answer to NB consultation (question C25.2 "Impact of the following elements of Action 2 
on  health  and  safety")  73-85%  of  NB  participating  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 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   Revised procedures for notification  

   No or no significant improvement 
   Moderate improvement 

Number of requested 
records (60) 

Requested records 
(60) 

7 
33 
18 
2 

(11.7%) 
(55%) 
(30%) 
(3.3%) 

Number of requested 
records (60) 

Requested records 
(60) 

12 
27 

(20%) 
(45%) 

EN 

113 

   EN 

 
   Significant improvement 
   Unable to evaluate impact 
    Information obligations on NB 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 

17 
4 

(28.3%) 
(6.7%) 

Number of requested 
records (60) 

Requested records 
(60) 

14 
29 
15 
2 

(23.3%) 
(48.3%) 
(25%) 
(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) believed this policy action 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 procedures and information obligations. 

Table 45: Impact of Action 2 on health and safety (replies by authorities) 

    Reinforcement of notification requirements for NB 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
   Revised procedures for notification  

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 
    Information obligations on NB 

   No or no significant improvement 
   Moderate improvement 
   Significant improvement 
   Unable to evaluate impact 

12.3. 

Inconsistency of terminology  

Number of requested 
records (66) 

Requested records 
(66) 

8 
25 
26 
7 

(12.1%) 
(37.9%) 
(39.4%) 
(10.6%) 

Number of requested 
records (66) 

Requested records 
(66) 

10 
31 
15 
10 

(15.2%) 
(47%) 
(22.7%) 
(15.2%) 

Number of requested 
records (66) 

Requested records 
(66) 

14 
30 
15 
7 

(21.2%) 
(45.5%) 
(22.7%) 
(10.6%) 

•  Answers to question D38: "Which effects do you expect from clarifying and harmonising 
generally  used  notions  like  “placing  on  the  market”,  “manufacturer”,  "importer", 
"distributor", etc.? (multiple choices possible)" and to question D34: "If you are applying 
simultaneously  two  or  more  of  the  ten  directives  concerned  by  this  consultation,  which 
impacts do you expect from aligning the texts of the conformity assessment procedures to 
the  texts  of  the  corresponding  conformity  assessment  procedures  set  out  in  Annex  II  of 
Decision 768/2008? (multiple choices possible)". 

EN 

114 

   EN 

 
Table 46: Impacts of Action 3 (replies by EO, NB, authorities and users- multiple choices possible) 

•  (a) Alignment of terminology in definitions (e.g. “placing on the market”, “manufacturer”, 

"importer", "distributor", etc.) 

No or no significant changes 
It will make the relevant directives clearer 
It will avoid different interpretations by 
national authorities 
It will lead to difficulties since existing 
definitions by which I am concerned will be 
changed 
It will make the whole legal framework 
more confusing 
It will make the whole legal framework 
clearer 
It will allow more consistency throughout 
legislation 

EO 

NB 

Authorities 

7%
57%

80%

3%

5%

54%

47%

10%
70%

61%

4%

4%

52%

65%

1% 
81% 

79% 

2% 

1% 

82% 

72% 

•  (b) Alignment of terminology in texts on conformity assessment procedures 

No or no significant changes 
It will create difficulties as the conformity 
assessment procedures in the NLF 
Decision are not adequate for my sector 
It will lead to more coherence with other 
legislation 
It will or may reduce costs for EO 
It will or may increase costs for EO 
It will give rise to interpretation difficulties 
and differences in application by NB 
throughout the EU 
It will lead to more coherent conformity 
assessment carried out by NB throughout 
sectors 

EO 

NB 

Authorities 

33%

13%

16% 

3%

21%
8%
14%

7%

44%
27%
10%

1% 

78% 
28% 
10% 

4%

6%

3% 

56%

48%

73% 

12.4.  Comparison of effectiveness of options 2 and 3 

(a) Effectiveness in relation to the objective of reducing non-compliance 

The formal alignment and the non legislative measures options differ only in relation to the 
way the measures in the NLF Decision are implemented. Therefore the categories of impacts 
identified  for  the  alignment  option  are  in  principle  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  considered  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 exploit the fact that this best practice is 
not legally binding.  

EN 

115 

   EN 

 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
This  view  is  strongly  supported  by  the  results  of  the  public  consultation  as  almost  three 
quarters  of  all  stakeholders  (EO,  NB,  authorities,  users)  having  participated  in  it  considered 
the option "Non legislative measures" ineffective overall. 

The  majority  of  all  respondents  (81%)  considered  the  option  of  alignment  of  legal  texts  as 
quite (51%) or very (30%) effective, compared to the 17% of respondents recognising some 
degree  of  effectiveness  (12%  quite  and  5%  very  effective)  in  the  option  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) 

Very effective 
Quite effective 
Quite ineffective 
Not effective at all 
I don't know 
N/A 
Total replies per type of respondents 

Non-legislative measures (option 2) 

Very effective 
Quite effective 
Quite ineffective 
Not effective at all 
I don't know 
N/A 
Total replies per type of respondents 

EO
31
46
6
3
2
10
98

EO
3
6
26
48
3
12
98

NB 

17
52
1
1
3
2
76

Authorities
36
43
0
1
15
6
101

Users 

9 
15 
4 
2 
1 
2 
33 

NB 

4
8
32
26
4
2
76

Authorities
6
19
47
10
4
15
101

Users 

2 
3 
16 
6 
3 
3 
33 

Total 

93 
156 
11 
7 
21 
20 

% over 
Total 

30%
51%
4%
2%
7%
6%

308   

Total 

15 
36 
121 
90 
14 
32 

% over 
Total 

5%
12%
39%
29%
5%
10%

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 control of NB across the EU. 

The Commission considers the option of non legislative measures far less effective than the 
alignment option. This is because national authorities would have to base their assessment of 
NB on non-binding requirements and it would be difficult for them to justify 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  assessment  results,  national  authorities  would 
have to rely solely on NB willingness to cooperate with limited possibilities of enforcing their 
requests.  

This  view  is  strongly  supported  by  the  results  of  the  public  consultation,  as  two  thirds  of 
stakeholders  (EO,  NB,  authorities)  having  participated  in  the  consultation  considered  the 
option "Non legislative measures "as ineffective overall. 

EN 

116 

   EN 

 
  
  
 
 
 
 
  
The  majority  of  all  respondents  (83%)  considered  the  option  of  alignment  of  legal  texts  as 
quite  (51%)  or  very  (32%)  effective,  as  compared  to  the  21%  of  respondents  recognising 
some  degree  of  effectiveness  (18%  quite  and  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) 

Very effective 
Quite effective 
Quite ineffective 
Not effective at all 
I don't know 
N/A 
Total replies per type of respondents 

Non-legislative measures(option 2) 

Very effective 
Quite effective 
Quite ineffective 
Not effective at all 
I don't know 
N/A 
Total replies per type of respondents 

EO 
31 
41 
2 
0 
4 
20 
98 

EO 
4 
11 
41 
18 
4 
20 
98 

NB 
19 
50 
4 
0 
0 
3 
76 

NB 
3 
13 
36 
21 
1 
2 
76 

Authorities
37 
48 
1 
0 
4 
11 
101 

Authorities
2 
26 
45 
12 
5 
11 
101 

Total 

87 
139 
7 
0 
8 
34 
275 

Total 

9 
50 
122 
51 
10 
33 
275 

% over 
Total 
32% 
51% 
3% 
0% 
3% 
12% 

% over 
Total 
3% 
18% 
44% 
19% 
4% 
12% 

(c) Effectiveness in relation to the problem of inconsistencies in current legislation  

The Commission considers the option of non legislative measures far less effective than the 
alignment option for the simple reason that without formal alignment of the directives, current 
inconsistencies  (identified  in  some  definitions  or  in  the  terminology  used  for  conformity 
assessment procedures) will not be addressed.  

This  view  is  strongly  supported  by  the  results  of  the  public  consultation,  as  two  thirds  of 
stakeholders  (EO,  NB,  authorities)  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%)  effective,  as  compared  to  the  27%  of  respondents  recognising 
some  degree  of  effectiveness  (24%  quite  and  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) 

Very effective 
Quite effective 
Quite ineffective 
Not effective at all 
I don't know 

EO 
47 
29 
2 
1 
8 

NB 
15 
33 
2 
0 
2 

Authorities
54 
35 
0 
0 
1 

Total 

116 
97 
4 
1 
11 

% over 
Total 
44% 
37% 
2% 
0% 
4% 

EN 

117 

   EN 

 
  
 
 
 
 
  
 
  
N/A 
Total replies per type of respondents 

11 
98 

Non-legislative measures (option 2) 

Very effective 
Quite effective 
Quite ineffective 
Not effective at all 
I don't know 
N/A 
Total replies per type of respondents 

EO 
3 
30 
40 
6 
8 
11 
98 

24 
76 

NB 
0 
14 
24 
12 
2 
24 
76 

11 
101 

Authorities
6 
20 
51 
9 
4 
11 
101 

34 
263 

Total 

9 
64 
115 
27 
14 
33 
262 

13% 

% over 
Total 
3% 
24% 
44% 
10% 
5% 
13% 

EN 

118 

   EN 

 
  
 
 
 
  
  
13. 

ANNEX 5: SME TEST 

(1) 
representatives 

Consultation 

with 

SME 

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.  

Preliminary 

(2) 
businesses likely to be affected 

assessment 

of 

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  will  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 

119 

   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. 

EN 

120 

   EN