COMMISSION STAFF WORKING DOCUMENT EVALUATION of the New Legislative Framework
Date: 2022-11-16
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, free movement of goods, harmonisation of standards, industrial product, market supervision, marketing standard, product safety, single market

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 16.11.2022  SWD(2022) 364 final/2  CORRIGENDUM This document corrects SWD(2022) 364 final of 11.11.2022. The double numbering of the chapters has been corrected. The text shall read as follows. COMMISSION STAFF WORKING DOCUMENT  EVALUATION  of the New Legislative Framework {SWD(2022) 365 final}  
 
 
Table of contents 

1. 

INTRODUCTION ................................................................................................. 5 

1.1. 

Purpose and scope of the evaluation ....................................................................... 5 

2.  WHAT  WAS  THE  EXPECTED  OUTCOME  OF  THE 

INTERVENTION? ................................................................................................ 9 

2.1.  Description of the intervention and its objectives .................................................. 9 

2.1.1.  How the intervention fitted in the wider policy framework? .................................. 9 

2.1.2.  Problems and needs that the intervention aimed to address ................................ 10 

2.1.3.  General and specific objectives of the intervention .............................................. 11 

2.1.4.  The intervention logic ........................................................................................... 11 

2.2. 

Points of comparison ............................................................................................ 12 

2.2.1.  Reinforcement of the New Approach .................................................................... 12 

2.2.2.  Supporting the consistency and coherence of EU harmonisation legislation ...... 13 

2.2.3.  Strengthening the quality of conformity assessment services through improved 

accreditation of notified bodies ............................................................................ 13 

2.2.4.  Ensuring a clear meaning and credibility of CE marking .................................... 15 

3. 

HOW  HAS  THE  SITUATION  EVOLVED  OVER  THE 
EVALUATION PERIOD? .................................................................................. 15 

3.1.  Current state of play.............................................................................................. 15 

3.1.1.  The NLF and the reinforcement of the New Approach ......................................... 15 

3.1.2.  Supporting the consistency and coherence of EU harmonisation legislation ...... 16 

3.1.3.  Strengthening the quality of conformity assessment services through improved 

accreditation of notified bodies ............................................................................ 18 

3.1.4.  Ensuring a clear meaning and enhanced credibility of CE marking ................... 19 

4. 

EVALUATION FINDINGS (ANALYTICAL PART) ..................................... 20 

4.1. 

To what extent was the intervention successful and why? ................................... 20 

4.1.1.  Effectiveness ......................................................................................................... 20 

4.1.2.  Efficiency .............................................................................................................. 30 

4.1.3.  Coherence ............................................................................................................. 37 

4.2.  How did the EU intervention make a difference? ................................................ 41 

4.3. 

Is the intervention still relevant?........................................................................... 43 

5.  WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? .............. 57 

5.1.  Conclusions .......................................................................................................... 57 

5.2. 

Lessons learned ..................................................................................................... 60 

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ANNEX I:   PROCEDURAL INFORMATION ........................................................... 55 

ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED .................. 62 

ANNEX  III.  EVALUATION  MATRIX  AND,  WHERE  RELEVANT, 
DETAILS  ON  ANSWERS  TO  THE  EVALUATION  QUESTIONS  (BY 
CRITERION) ................................................................................................................... 69 

ANNEX IV. OVERVIEW OF BENEFITS AND COSTS ............................................ 86 

ANNEX V. STAKEHOLDERS CONSULTATION - SYNOPSIS REPORT ............ 92 

ANNEX VI. CONFORMITY ASSESSMENT – STATE OF PLAY ........................ 102 

ANNEX  VII.  MAIN  COSTS  AND  BENEFITS  IDENTIFIED  BY 
EVALUATIONS  OF  CERTAIN  NLF-ALIGNED  EU  PRODUCT 
LEGISLATION ............................................................................................................. 111 

ANNEX VIII. CASE STUDIES.................................................................................... 115 

ANNEX IX. RAPEX – SAFETY GATE DATABASE – ANALYSIS OF THE 
SAFETY GATE DATA ................................................................................................. 131 

ANNEX X. MAPPING OF NLF-ALIGNED LEGISLATION ................................. 138 

ANNEX  XI.  SUBSTANTIAL  MODIFICATION  –  AN  OVERVIEW  OF 
THE  DIVERS  DEFINITIONS  OF  MODIFICATION  OF  PRODUCTS 
FOLLOWING THEIR PLACING ON THE MARKET ........................................... 147 

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Term or acronym 

Meaning or definition 

Glossary 

AI 

CAB 

CEN 

Cenelec 

CBA 

CPR 

DoC 

DoP 

DSM 

EA 

EC 

ECT 

EMCD 

EO 

ESO 

ETSI 

F4F 

GDPR 

GPSD 

GPSR 

IA 

IoT  

ICSMS 

IVDR 

LVD 

MD 

Artificial intelligence 

Conformity Assessment Body 

European Committee on Standardization 

European Committee on Electrotechnical 
Standardization 

Cost-Benefit Analysis 

Construction Products Regulation (EU) No. 305/2011 

Declaration of Conformity 

Declaration of Performance 

Digital Single Market 

European Cooperation for Accreditation 

European Commission 

Treaty establishing the European Community (Nice 
consolidated version) 

Electromagnetic Compatibility Directive 2014/30/EU 

Economic operators 

European standardisation organisation (CEN, Cenelec, 
ETSI) 

European Telecommunication Standards Institute 

Fit for Future Platform 

General Data Protection Regulation (EU) 2016/679 

General Product Safety Directive 

Proposal for a General Product Safety Regulation 

Impact Assessment 

Internet of Things. IoT system architecture is generally 
divided into three layers: the perception layer, the 
network layer and service layer (or application layer) 

Information and Communication System for Market 
Surveillance 

In Vitro Diagnostic Medical Devices Regulation (EU) 
2017/746 

Low Voltage Directive 2014/35/EU 

Machinery Directive 2006/42/EC 

3 

 
 
MDR 

MS 

MSA 

NA 

NAB 

NANDO 

NB 

NLF 

ODM 

OEM 

OPC 

PO 

RAPEX 

RED 

SBS 

SCM 

TFEU 

TSD 

WTP 

Medical Devices Regulation (EU) 2017/745 

Member State 

Market Surveillance Authority 

Notifying Authority 

National Accreditation Body 

New Approach Notified and Designated Organisations 
Information System 

Notified Body 

New Legislative Framework 

Original Design Manufacturer 

Original Equipment Manufacturer 

Open Public Consultation 

Policy option(s) 

Rapid Exchange of Information System 

Radio Equipment Directive 2014/53/EU 

Eurostat’s Structural Business Statistics (SBS), which 
shed light on relevant classes of connected Radio 
Equipment and Wearables.  

Standard Cost Model 

Treaty on the Functioning of the European Union 

Toys Safety Directive 

Willingness to Pay – the maximum amount that 
consumers are willing to pay for internet- connected 
radio equipment e.g. for products with, and without 
security features. 

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1. 

INTRODUCTION 

Purpose and scope of the evaluation 

The  New  Legislative  Framework  (hereafter  NLF)  for  EU  product  legislation  consists  of  Decision 
No  768/2008/EC1  and  Regulation  (EC)  No  765/20082  aiming  to  improve  the  Internal  Market  for 
goods and boost the quality of conformity assessment of products. Hence, the internal market legal 
basis  is  used  for  both  the  Decision  and  the  Regulation  (Article  95  ECT,  which  corresponds  to 
Article  114  TFEU,  Approximation  of  laws).  Besides  Article  95  ECT,  the  legal  basis  of  the 
Regulation  is  also  Article  133  ECT  (corresponds  to  Article  207  TFEU  under  the  title  Common 
Commercial Policy).  

Decision No 768/2008/EC contains a template for future Union product legislation. This Decision 
lays down common principles and reference provisions intended to apply across sectoral legislation 
in  order  to  provide  a  coherent  basis  for  legislation  revisions  or  recasts3. Currently,  there  are  23 
pieces of legislation and one delegated act aligned to the NLF.4 

Regulation (EC) No 765/2008 established an overall framework of rules and principles  related to 
accreditation,  market  surveillance,  conformity  assessment  and  the CE  marking.  The  market 
surveillance provisions of this Regulation were replaced by Regulation 2019/10205, which started to 
apply on 16 July 2021.  

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

  New  Approach:  The  New  Approach  is  a  legislative  technique  used  to  ensure  the  free 
movement  of  industrial  products.  This  technique  is  inspired  by  the  Cassis  de  Dijon6 
judgment of the Court of Justice and its key element is the reduced content of legislation to 
cover  only  the  essential  protection  requirements  which  the  Court  had  indicated  were  the 
only valid reasons  for a national  authority to  block a product  from  another Member State. 
The asset of the New Approach is its flexibility. Keeping the directives and regulations free 
from detailed specifications has facilitated a flexible legal framework, which is technology-
neutral and serves as a catalyst for innovation and growth. It has allowed keeping legislation 
slim,  without  frequent  adaptations  to  technical  progress,  which  is  an  important  factor  in  a 
business environment characterised by fast developing technologies,  

  Notified bodies: Conformity assessment is a responsibility of the manufacturer. However, 
depending on the risks of the products, the relevant legislation may require that a third party 
is  involved  in  the  conformity  assessment  procedure.  The  conformity  assessment  bodies 
involved  in  a  third-party  conformity  assessment  procedure  based  on  the  EU  product 

1 Decision No 768/2008/EC the European Parliament and the Council of 9 July 2008 on a common framework for the 
marketing of products, and repealing Council Decision 93/465/EEC, OJ L 218, 13.8.2008, p. 82–128 
2  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 L 218, 13.8.2008, p. 30–47. 
3 Recital (2) of Decision 768/2008/EC. 
4  List  of  the  23  NLF-aligned  directives,  regulations  and  delegated  act(s):  https://ec.europa.eu/growth/single-
market/goods/new-legislative-framework_en 
5 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June  2019 on market surveillance 
and  compliance  of  products  and  amending  Directive  2004/42/EC  and  Regulations  (EC)  No  765/2008  and  (EU)  No 
305/2011, started to apply on 16 July 2021. 
6  Judgment  of  20  February  1979,  Rewe-Zentral  AG  v  Bundesmonopolverwaltung  für  Branntwein,  C-120/78 
EU:C:1979:42 

5 

 
 
                                                 
 
legislation  need  to  be  designated  for  such  conformity  assessment  activities.  These  bodies 
must  be  chosen,  i.e.  designated  by  the  authorities  of  the  Member  States  on  the  basis  of 
certain minimum criteria (competence, impartiality, integrity, etc.), which are set out in the 
NLF.  They  are  then  “notified”  to  the  Commission,  after  which  they  may  carry  out 
conformity  assessment  activities  according  to  the  procedures  set  out  in  the  EU  product 
legislation. 

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

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

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

The  main  purpose  of  this  evaluation  is  to  bring  forward  an  informed  analysis  of  the  current 
performance of the NLF, assessing the effectiveness, efficiency and its relevance in particular given 
the  technological  development,  the  coherence  with  similar  initiatives  and  the  overall  EU  added 
value of certain aspects of the NLF.  

In particular, the assessment focuses on whether:  

a) 

b) 

c) 
d) 

e) 

f) 

the NLF is fit to address the way products may be changing during their lifetime to both 
support the take-up of smart connected or remanufactured products and to ensure safety;  
the conformity assessment procedures remain fit for purpose and ensure the safety and 
compliance  with  the  applicable  requirements  of  the  products  placed  on  the  Union 
market;  
the rules for notified bodies are robust enough to ensure the competence of those bodies;  
the accreditation system functions well and ensures that the competence of the notified 
bodies intervening in the conformity assessment procedures is sufficiently guaranteed;  
affixing the CE marking and other product  information  physically  to  the product  itself 
continues to be appropriate; and  
the  lack  of  a  crisis  instrument  for  urgency  situations  renders  the  NLF  less  effective  or 
efficient. 

Although the focus of the evaluation is retrospective, a forward-looking dimension is unmissable 
to assess the relevance of the NLF and its fitness for purpose. The evaluation takes into account the 

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ongoing  regulatory  developments  serving  the  digital  transition.  Legislative  proposals  that  are 
relevant  for  the  evaluation  include  the  Proposal  of  the  AI  Act7,  the  Proposal  of  the  Machinery 
Regulation8,  the  Proposal  for  the  regulation  on  batteries  and  waste  batteries  and  Proposal  for  a 
Regulation  establishing  a framework for setting eco-design requirements for sustainable products. 
Regarding the green transition and the circular economy, this evaluation takes into consideration 
also  the  Circular  Economy  Action  Plan9  and  the  regulatory  pressure  it  created  to  integrate 
environmental aspects into product legislation. The evaluation also takes into account the Proposal 
of the General Product Safety Regulation (GPSR)10, which sets up a new horizontal framework for 
product safety of consumer non-food products in the EU. This evaluation is prepared with a view to 
provide a solid basis for a possible future impact assessment.  

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

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

 

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

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

  Circular economy developments, including increasing focus on placing on the market of 

products following their repair, refurbishment, and remanufacturing. 

Scope of the evaluation 

The  material  scope  of  this  evaluation  does  not  include  the  provisions  of  Regulation  (EC)  No 
765/2008 relating to market surveillance, which were already subject to an evaluation and review11 
and have since been replaced by Regulation 2019/1020.12   

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

7  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  Laying  Down  Harmonised  Rules  on 
Artificial Intelligence (Artificial Intelligence Act) and Amending Certain Union Legislative Acts. 
8 Proposal for a Regulation of the European Parliament and of the Council on machinery products. 
9 Communication from the commission to the European Parliament, the Council, the European and Social Committee 
and the Committee of the Regions COM/2020/98/final- A new Circular Economic Action Plan for a cleaner and more 
competitive Europe 
10  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  general  product  safety,  amending 
Regulation  (EU)  No  1025/2012  of  the  European  Parliament  and  of  the  Council,  and  repealing  Council  Directive 
87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council. 
11  The  market  surveillance  provisions  of  Regulation  (EC)  No  765/2008  were  already  subject  to  a  REFIT  evaluation 
(SWD(2017) 469 final). Since then, a new Regulation (EU) 2019/1020 has been adopted and replaced those provisions 
as of April 2021. 
12 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance 
and  compliance  of  products  and  amending  Directive  2004/42/EC  and  Regulations  (EC)  No  765/2008  and  (EU)  No 
305/2011 

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  Alignment  of  Union  harmonisation  legislation  to  the  NLF’s  common  principles  and 

reference provisions. 

  Conformity assessment rules and procedures. 

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

  CE marking and administrative requirements. 

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

The  evaluation  does  cover  the  aspects  of  harmonised  standards  relevant  to  the  NLF,  such  as 
having  technologically  neutral  essential  requirements  and  relying  on  harmonised  standards  for 
presumption  of  conformity.  However,  it  does  not  address  the  EU  standardisation  system 
beyond  those  aspects.  The  Evaluation  of  the  standardisation  system  should  be  a  stand-alone 
process. 

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

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

The temporal scope of the evaluation covers the period from 2014 to 2020. As already mentioned, 
Decision  No  768/2008/EC  only  contains  reference  provisions  to  be  integrated  into  the  different 
pieces  of  product  legislation.  The  Package  of  ten  Directives14  to  be  aligned  with  the  reference 
provisions  and  approaches  outlined  in  the  NLF  was  adopted  in  2013-2014.15  Regarding  the 
geographical scope, the evaluation covers EU Member States as well as the three additional State 
Parties  to  the  EEA-EFTA  Agreement  (Iceland,  Lichtenstein,  Norway).  It  corresponds  to  the 
geographical  scope  of  the  NLF,  considering  that  both  the  Decision  and  the  Regulation  are 
incorporated into the EEA Agreement.16 

13 This evaluation will build upon, and complement the SWD/2014/023 Evaluation of the Internal Market Legislation 
for Industrial Products, and on COM/2014/025 A vision for the internal market for industrial products. 
14 Alignment of ten technical harmonisation directives to Decision No 768/2008/EC. 
15 Although the Toys Safety Directive revised by Directive 2009/48/EC of 18 June 2009 was the first product legislation 
fully  aligned  with  the  Decision,  the  Alignment  Package  of  ten  technical  harmonisation  directives  with  the  NLF  was 
adopted in 2013 – 2014. This was the first set of aligned legislation, able to manifest the effectiveness and consistency 
brought  by  the  NLF  into  the  EU  product  legislation  (1.  Pyrotechnic  Articles  Directive  (2013/29/EU)  -  OJ,  L  178, 
28.06.2013.;  2.  Recreational  craft  and  personal  watercraft  Directive  ((2013/53/EU)  -  OJ,  L  354,  28.12.2013.;  3.  Low 
Voltage  Directive  (2014/35/EU);  4.  Electromagnetic  Compatibility  Directive  (2014/30/EU);  5.  ATEX  Directive 
(2014/34/EU);  6.  Lifts  Directive  (2014/33/EU);  7.  Simple  Pressure  Vessels  Directive  (2014/29/EU);  8.  Measuring 
Instruments  Directive  (2014/35/EU);  9.  Non-automatic  Weighing  Instruments  Directive  (2014/31/EU);  10.  Civil 
Explosives Directive (2014/28/EU), these directives are published in OJ, L 096, 29.03.2014. 
16 Decisions of the Joint Committee No 126/2012 of 13 July 2012 amending Annex II (Technical regulations, standards, 
testing and certification) to the EEA Agreement. 

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Methodological approach 

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

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

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

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

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

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

2.  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? 

2.1.  Description of the intervention and its objectives 

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

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

On  the  basis  of  the  feedback  received  from  the  stakeholders  in  a  public  consultation  on  the 
functioning  of  the  New  Approach,  in  March  2003,  the  Commission  adopted  a  Communication 
entitled  “Enhancing  the  implementation  of  the  New  Approach  directives18”,  setting  out  the  main 
elements for the review:  

1.  Lack of confidence in notified bodies and in the whole notification process; 
2.  Weaknesses  in  market  surveillance  and  efficient  and  consistent  enforcement  of  the 

directives; 

3.  Inconsistencies between different directives; 
4.  Misunderstanding of the value and role of CE marking. 

17 Supporting Study for the evaluation of certain aspects of the New Legislative Framework (Decision No 768/2008/EC 
and Regulation (EC) No 765/2008), Final Report, Centre for Strategy & Evaluation Services (CSES) and CSIL, May 
2022 
18 Communication from the Commission to the Council and the European Parliament COM(2003) 240 final 

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Following  this,  the  Impact  Assessment  of  2007  accompanying  the  NLF  Regulation  and  the 
Decision was prepared in 2007.19  

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

2.1.2.  Problems and needs that the intervention aimed to address 

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

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

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

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

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

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

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

19 Impact assessment {COM(2007) 37 final SEC(2007) 173}accompanying the proposal for a Regulation setting out the 
requirements  for  accreditation  and  market  surveillance  relating  to  the  marketing  of  products  and  a  Decision  on  a 
common framework for the marketing of products (i.e. the NLF) 
20  See  for  instance  the  upcoming  Evaluation  of  the  Electromagnetic  Compatibility  Directive,  supporting  the  Study 
published in 2021; Evaluation of the Low Voltage Directive, 2019. 

10 

 
 
                                                 
 
2.1.3.  General and specific objectives of the intervention 

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

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

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

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

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

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

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

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

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

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

5)  Clear meaning and enhanced credibility for CE marking.  

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

2.1.4.  The intervention logic  

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

1)  The needs and problems; 

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

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

11 

 
 
outcomes) and impacts (longer-term outcomes) that are expected to be achieved through 
the NLF. 

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

2.2.  Points of comparison 

Figure 1 Intervention logic 

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

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

2.2.1.  Reinforcement of the New Approach  

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

The  New  Approach  directives  are  based  on  technological  neutrality.  They  contain  only  the 
essential  requirements  the  product  has  to  fulfil,  while  products  manufactured  according  to 
harmonised  standards  are  deemed  to  be  compliant  with  those  essential  requirements.  Technical 
specifications, in the form of standards21 allow products to meet the essential requirements needed 
and  are  considered  as  an  ‘easy’  way  to  meet  compliance  with  the  legislation  (presumption  of 
conformity). The use of standards guarantees the required level of safety of products, but the use of 
harmonised standards is voluntary and a manufacturer may use any other technical solution which 
demonstrates that his product meets the essential requirements.  

21  Harmonised  standards  are  developed  by  the  recognised  European  Standardisation  Organisations  (ESOs)  CEN, 
CENELEC and ETSI in line with specific mandates from the Commission.  

12 

Inputs-Human and financial resources allocated (Commission and Member State national authorities/ MSAs, economic operators)GeneralObjectivesResultsImpactsOutputsMember States§Transpose recast Directives aligned with NLF §Implement common surveillance and enforcement arrangements §Refrain from setting technicalbarriers to trade§Foster cooperation among MSAs§Cooperation and peer-assess accreditations within EA§Set penalties for non-complianceEU level§Common reference provisions§Suite of conformity assessment modules§Framework for accreditation of notified bodies§Regulatory alignment  of individual legislation§Development of Harmonised Standards§Monitoring of implementation of NLF§Evaluations of individual product and sectoral legislation falling under the NLFIndustry, economic operators, Conformity assessment bodies, Standardisation bodies §Involvement as direct end-user of NLF (e.g.through compliance by economic operators of requirements in individual NLF-aligned legislation§Provide conformity assessment services§Contribute to development of Harmonised Standards1.Provides a high level of protection of public interests (e.g.health and safety, consumer and environmental  protection) 2. Foster free movement of products within the single market3. Establish a common harmonisation frameworkEU policy & legal contextBetter Regulation agenda (administrative simplification)EU legal basis for NLF:Art. 95 / 133 TEC (& Art. 114 TFEU)Secondary legal base:§Regulation (EC) No 765/2008 §Decision No 768/2008/EC §Regulation (EU) 2019/1020§Partially Regulation (EU) 1025/2012EU legal basis for sectoral and product legislation:-Article 114 TFEU-Partially Article 192(1) –environment1. Reinforce the New Approach (technology-neutral essential requirements)2. Support the consistency and coherence of EU harmonisation legislation3. Strengthen the quality of conformity assessment services through improved accreditationof notified bodies4. Strengthen the enforcement of EU legislation to reduce non-compliant products on EU market5. Ensure a clear meaning and enhanced credibility of CE markingSpecificObjectivesInputsImplementation mechanisms, tools & processes 
 
 
                                                 
 
If  a  product  is  not  manufactured  along  the  harmonised  standards,  the  manufacturer  has  to 
demonstrate  the  compliance  of  the  product  with  the  legal  essential  requirements.  This  New 
Approach and technical harmonisation have successfully contributed to eliminating some barriers to 
trade, but there were still weaknesses in the legislative framework, which prevented consumers and 
enterprises from fully exploiting the benefits of the Internal Market.  

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

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

2.2.2.  Supporting the consistency and coherence of EU harmonisation legislation 

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

This  represented  a  problem  especially  in  case  of  products  that  had  to  comply  with  different 
pieces of EU product legislation23.  

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

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

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

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

22 Problems were often experienced with simple expressions used in the legislation, such as “manufacturer” or “placing 
on the market”22. Numerous pieces of legislation used these terms without defining them, others contained definitions, 
but  these  definitions  differed  from  one  legal  instrument  to  the  other.  The  existing  definitions  and  concepts  did  not 
always  took  account  of  the  developments.  Sometimes  definitions  were  not  sufficiently  precise  and  left  room  for 
diverging interpretations. 
23  For  example,  electrical  products,  which  are  (and  were  then  as  well)  often  covered  by  the  Low  Voltage  Directive, 
Directive  on  electromagnetic  compatibility,  environmental  requirements  set  out  in  the  “ROHS”23  and  “WEEE”23 
directives and, in addition, energy labelling provisions may have also applied to the product.  
24For  example,  outdoor  machinery  was covered by  four different directives: the  machinery directive, the directive on 
electromagnetic compatibility, the directive on emission from non-road machinery and the directive on noise emissions 
from outdoor equipment.  

13 

 
 
 
 
                                                 
 
  Uneven level of conformity assessment services provided by notified bodies 

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

  Lack  of  transparency  and  different  approaches  in  the  competence  assessment  and 

monitoring of notified bodies 

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

  Unnecessary burdensome requirements in the notification procedure 

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

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

  Lack  of  an  EU  framework  for  accreditation  and  the  legal  status  of  the  European 

Cooperation for Accreditation (EA) 

Different approaches and differing systems for accreditation existed throughout the EU causing an 
uneven level of rigour throughout Member States2930.  

Member States co-ordinated their accreditation activities through the framework created by a pan-
European organisation known as EA31. However, the position and influence of EA was limited by 
its legal status and its recognition by public authorities varied from Member State to Member State, 

25 This resulted in forum shopping for conformity assessment bodies based, for instance, on low prices or less rigorous 
services.  
26 A few directives had already addressed environmental aspects and foreseen the intervention of notified bodies in the 
conformity assessment process. Consequently, the  downgrading of quality in the  service delivered by  notified bodies 
could have seriously hampered the effective functioning of this control mechanism and result in products on the market 
which are harmful to the environment. 
27Evaluation of the application of the Lifts Directive, Final Report for DG Enterprise, 2004; Report on the functioning 
of  the  medical  devices  directive  20002;  Impact  assessment  on  the  proposal  for  a  Directive  on  common  rules  and 
standards  for  ship  inspection  and  survey  organisations  and  for  the  relevant  activities  of  maritime  administrations 
http://ec.europa.eu/governance/impact/docs/ia_2005/sec_2005_1498_fr.pdf, 
28NANDO = New Approach Notified and Designated Organisations 
29Accreditation of testing and certification bodies, KAN report 30e, June 2003. 
30 Most Member States used accreditation for evaluating the competence of a notified body and considered it as a useful 
qualification element for granting notification. However, since accreditation has been regulated at national level, due to 
different  designation,  accreditation  and  monitoring  policies,  notified  bodies  were  operating  under  uneven  conditions 
inside the EU.  
31EA is a non-profit association established in November 1997 and registered as an association under Dutch law in June 
2000. EA results from the merger of EAC, European Accreditation of Certification, and EAL, European co-operation 
for Accreditation of Laboratories. 

14 

 
 
                                                 
 
due  to  the  lack  of  common  legal  basis  and  of  regulation  on  accreditation  at  EU  level  and  a 
harmonised accreditation policy. 

2.2.4.  Ensuring a clear meaning and credibility of CE marking  

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

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

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

3.  HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? 

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

3.1.  Current state of play 

3.1.1.  The NLF and the reinforcement of the New Approach 

Specific objective: Reinforcement of the New Approach 

Output (immediate short-term outcomes): Number of NLF-aligned legislation 

Results (intermediate outcomes, linked to the achievement of specific objectives) 

  Availability of the regulatory toolbox to facilitate the revision of existing and drawing up of 

new Union harmonisation legislation; 

  Availability of common definitions for sectoral product legislation; 
  A  framework  that  allows  for  technological  evolution  with  technology  neutral  legislation 

setting only essential requirements. 

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

32 Studies have demonstrated that consumers in particular had a poor understanding of the role of CE marking. It was 
often perceived as an indication of origin or as a proof that CE marked products have been tested and approved by some 
kind of authority. For more information see: CE - A study of consumers’ and retailers’ knowledge of the CE mark, The 
Swedish Research institute of Trade, 2004 

15 

 
 
                                                 
 
The NLF-aligned legislation is therefore reflecting the same structure and content of the common 
regulatory  toolbox  and  its  reference  provisions.  The  regulatory  toolbox,  a  model  for  revised  and 
new  product  legislation,  became  available  to  facilitate  the  revision  of  existing  and  drawing  up  of 
new Union harmonisation legislation33.  

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

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

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

3.1.2.  Supporting the consistency and coherence of EU harmonisation legislation 

Specific objective: Supporting the consistency and coherence of EU harmonisation legislation 

Output (immediate short-term outcomes): Integration of the common reference provisions into 
the aligned product legislation 

Results (intermediate outcomes, linked to the achievement of specific objectives) 

  Better  alignment  of  the  requirements  for  economic  operators  and  of  the  approach  to 

marketing products on the internal market; 

  Reduced divergences and clearer administrative requirements; reduced costs of compliance 
(i.e. costs of familiarisation with Union harmonisation legislation and costs of conformity 
assessment procedures). 

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

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

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

33 Chapter R1 of Annex I of Decision No 768/2008/EC provides a common structure for the presentation of definitions 
within  Union  harmonisation  legislation,  as  well  as  17  common  definitions,  covering  key  product  legislation-related 
terms. More specifically, these definitions cover: 
Relevant  stakeholders,  including  ‘national  accreditation  body’,  ‘conformity  assessment  body’,  and  ‘economic 
operators’,  as  well  four  different  types  of  economic  operators  (the  manufacturer,  the  authorised  representative,  the 
importer, the distributor); and  
Other key terms related to products, such as ‘making available on the market’, ‘placing on the market’, or conformity 
assessment procedures, such as ‘CE marking’ and ‘accreditation’. 
This catalogue of definitions is supplemented by Article 2 of Regulation (EC) No 765/2008, which includes additionally 
the definitions of accreditation, national accreditation bod and peer evaluation. 
34 Recital 6 of Decision No 768/2008/EC. 

16 

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

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

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

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

35  The  standard  EN  ISO/IEC  17050-1  has  been  drawn  up  with  the  objective  of  providing  the  general  criteria  for  the 
declaration  of  conformity,  and  it  can  also  be  used  as  a  guidance  document  provided  it  is  in  line  with  the  applicable 
Union  harmonisation  legislation.  Where  several  pieces  of  Union  harmonisation  legislation  apply  to  a  product,  the 
manufacturer  or  the  authorised  representative  has  to  provide  a  single  declaration  of  conformity  in  respect  of  all  such 
Union  acts.  The  model  of  the  EU  declaration  of  conformity  is  used  in  all  NLF-aligned  legislation,  except  the 

17 

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

3.1.3.  Strengthening the quality of conformity assessment services through improved 
accreditation of notified bodies37 

Specific objective: Strengthening the quality of conformity assessment services through 
improved accreditation of notified bodies 

Output (immediate short-term outcomes): Common conformity assessment system and 
accreditation framework 

Results (intermediate outcomes, linked to the achievement of specific objectives) 

  Clearer and more robust rules on the conformity assessment system; 
  Higher quality and more consistent third-party conformity assessment services. 

To  ensure  a  uniformly  high  level  performance  of  notified  bodies  and  their  fair  competition 
throughout  the  Union,  the  legislation  that  follows  the  NLF  set  out  obligatory  requirements  for 
conformity  assessment  bodies  wishing  to  be  notified  in  order  to  provide  conformity  assessment 
services38. To guarantee a consistent level of quality in the performance of conformity assessment, 
the  legislation  that  follows  the  NLF  set  requirements  for  notifying  authorities  and  other  bodies 
involved  in  the  assessment,  notification  and  monitoring  of  bodies.  The  system  of  notified 
conformity  assessment  bodies  set  out  in  Decision  No  768/2008/EC  is  complemented  by  the 
accreditation system provided for in Regulation (EC) No 765/2008. Although not mandatory for all 
notified  bodies,  accreditation  is  the  most  preferred  means  of  verifying  the  competence  of 
conformity  assessment  bodies.  It  provides  an  authoritative  statement  of  the  competence, 
professional integrity and impartiality of the bodies to be notified to the Commission and the other 
Member States. 

The  NLF  strengthened  the  supervisory  role  of  notifying  authorities.  When  it  ascertains  that  a 
notified body no longer meets the requirements set out in the relevant directive or regulation or is 

Construction  Product  Regulation  and  the  Transportable  pressure  equipment  directive,  which  do  not  provide  for  the 
obligation  of  the  manufacturer  to  draw  up  such  declaration.  Some  of  the  NLF  legislations  that  are  covering  products 
with  a  higher  safety  risk  and  more  complex  conformity  assessment  depart  slightly  from  the  model,  requesting  more 
safety related  and details on the notified bodies taking part in the different modules of the conformity assessment (Lift 
Directive, Pressure Equipment Directive,  Recreational craft and personal  watercraft Directive,  Cableway Installations 
Regulation,  Medical  Devices  Regulation,  In  vitro  diagnostics  Medical  Devices  Regulation).  The  Lifts  Directive  also 
requires  different  forms  for  manufacturers  of  safety  components  for  lifts  (Annex  II.A)  and  installers  of  lifts 
(Annex II.B). 
36  The  Study  of  the  CSES  enumerates  several  pieces  of  EU  harmonisation  legislation  that  were  converted  from 
directives  to  regulations  following  their  revision,  such  as  the  Construction  Products  Regulation,  the  Regulations  on 
Medical Devices and on In Vitro Diagnostic Medical Devices, the Gas Appliances Regulation. In addition, the Proposal 
for the Machinery Regulation, published in April 2021, aims to replace the Machinery Directive and continue this trend 
37  More  details  on  the  System  of  notified  conformity  assessment  bodies  in  included  in  Annex  VI  –  Conformity 
assessment – State of Play. 
38 Recitals 37-39 of Decision No 768/2008/EC 

18 

 
 
                                                                                                                                                                  
 
failing  to  fulfil  its  obligation,  the  notifying  authority  may  restrict,  suspend  or  withdraw  the 
notification39.  

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

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

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

The conformity assessment system detailed in the NLF40 underpins the entire internal market, as it 
represents the means by which economic operators demonstrate the compliance and conformity of 
their products with the essential requirements laid down in specific product legislations.  

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

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

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

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

Regulation  (EC)  No  765/2008  lays  down  the  definition,  the  format  and  the  general  principles 
governing the CE marking, while Decision No 768/2008/EC provides for the reference provisions 
to be integrated into product legislation on the general principles of CE marking (Article R11) and 
the rules and conditions for affixing the CE marking (Article R12).  
The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate41.  

39  Based  on  the  NANDO  database,  the  evaluation  established  the  following:  Besides  the  expired  and  withdrawn 
notification,  from  2013  the  category  of  suspended  notification  has  been  introduced.  While  expired  and  non-extended 
notifications  are  not  necessarily  attributable  to  any  monitoring  activities  of  the  notifying  authorities,  suspended  and 
withdrawn  notifications  are  clearly  related  to  the  controls  conducted  by  the  notifying  authorities.  The  number  of 
suspended and withdrawn notifications suddenly raised from 2013. While this number is between 2 and 4 per year in 
2010-2012, it is 72 in 2013, 64 in 2014, 72 in 2015, 160 in 2016, 40 in 2017, 28 in 2018, 40 in 2019 and 37 in 2020. 
Therefore,  we  can  conclude  that  due  to  the  requirements  set  by  the  NLF,  the  notifying  authorities  strengthened  the 
supervision of the notified bodies. 
40 Annex II of Decision 768/2008/EC sets out in details 8 different overarching modules from module A, which does 
not include a third-party assessment, to module H, which is based on a full quality assurance.  
41 The CE marking may not, in principle, be affixed until the conformity assessment procedure has been completed to 
ensure  that  the  product  complies  with  all  the  provisions  of  the  relevant  Union  harmonisation  acts.  The  CE  marking 
replaces all mandatory conformity markings having the same meaning, which existed before harmonisation took place. 
Such national conformity markings are incompatible with the CE marking and would constitute an infringement of  the 
applicable European legislation in question.  

19 

 
 
                                                 
 
Several  pieces  of  Union  harmonisation 
complementary and non-overlapping to the CE marking42. 

legislation  foresee  additional  markings 

that  are 

4.  EVALUATION FINDINGS (ANALYTICAL PART) 

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

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

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

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

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

4.1.1.  Effectiveness 

a)  Reinforcement of the New Approach 

The NLF ensured the reinforcement of the New Approach thanks to the creation of the regulatory 
toolbox  and  common  definitions.  All  the  NLF-aligned  legal  instruments  are  using  the  same 
definitions such as ‘manufacturer’ or ‘placing on the market’. This aspect of the effectiveness of the 
NLF  is  highly  appreciated  particularly  when  products  are  covered  by  more  than  one  product 
legislation.  The  evidence  used  for  the  assessment  was  based  on  desk  research  including  the  legal 
mapping43 and confirmed in the targeted surveys, interviews and validation workshop. 

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

The results of desk research are complemented here by the results of the targeted survey, interview 
program  and  stakeholders’  workshop.  The  majority  of  stakeholders  throughout  all  stakeholders 
groups in the targeted consultations (84.1%, 174/207) considered the use of harmonised standards 

42 For example, the EU energy label for energy-related products; the specific marking of explosion protection required 
for  equipment  and  protective  systems  intended  for  use  in  potentially  explosive  atmospheres;  the  supplementary 
metrology marking required for measuring instruments and non-automatic weighing instruments. 
43 More information is available in the Study: Section 4.1.2. Achievement of the NLF’s general objectives and Annex 7 
Mapping of NLF-aligned legislation. 

20 

 
 
                                                 
 
to have been effective as a voluntary mechanism for achieving of conformity with the essential 
requirements.  They  consider  that  as  a  technologically  neutral  regulatory  framework  based  upon 
essential  requirements,  the  NLF  is  perfectly  suited  to  cope  with  the  higher  speed  of  technical 
innovation  and  customization  coming  with  digitization,  avoiding  the  stiffness  and  inflexibility  of 
technical provisions fixed in laws.  

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

On one hand, the demonstration of conformity in the absence of harmonised standards represents a 
more  serious  financial  burden44  for  manufacturers,  because  they  may  only  rely  on  third-party 
assessment  instead  of  harmonised  standards  to  prove  that  the  product  meets  the  essential 
requirements  laid  down  in  the  legislation.  They  would  need  to  have  recourse  to  documenting 
compliance with different generations of standards, which leads to additional costs.  

On  the  other  hand,  the  delay  in  adopting  new  standards  is  hindering  innovation45,  because  the 
manufacturers that are departing from the standards to introduce innovative solutions are not able to 
rely on the presumption of conformity with the essential requirements. In that case, the presumption 
of  conformity  with  the  standards  might  become  a  double-edged  sword:  If  the  harmonised  EU 
standards lag behind the newest international standards representing the state of the art, the NLF is 
not able to perform as expected. The presumption of conformity with a legal provision conferred by 
conformity to a harmonised standard would not seem to support innovation. 

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

44 An example: A large European association active in the digital sectors cited the example of the entry into force of the 
Radio Equipment Directive. All manufacturers of radio equipment hast to undergo a third-party conformity assessment, 
if the harmonised standards are not used. However, approximately a third of the updated RED standards were not cited 
in the OJEU when the Directive started to apply. The huge amount of certification request was on one hand challenging 
to handle for the notified bodies, while on the other hand added costs and delays for placing products on the market. 
45 A renowned pump manufacturer stressed when the market is moving faster than the development of standards that are 
used  as  a  reference  by  the  notified  bodies  to  perform  their  service,  the  innovative  products  cannot  benefit  from  the 
presumption  of  conformity  with  the  applicable  product  legislation.  This  viewpoint  was  confirmed  by  a  renowned 
manufacturer of garden machinery  who had a deceptive experience in resorting voluntarily to a NB to have a second 
opinion  on  innovative  ideas.  Therefore,  the  industry  often  perceives  that  standards,  technical  specifications  or 
procedures do not match market needs, and could ultimately constitute a barrier to trade or to innovation. 
46 Recital 8 of Decision No 768/2008/EC 

21 

 
 
                                                 
 
principle  of 
competitiveness.  

technological  neutrality,  resulting 

in  negative 

impacts  on 

innovation  and 

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

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

b)  Supporting the consistency and coherence of EU harmonisation legislation  

The mapping of NLF-aligned legislation in Annex X corroborates the results of the surveys that the 
NLF showed a high level of effectiveness in regard of the alignment of EU product legislation47. 
The majority of respondents perceive that the NLF has been effective in facilitating the consistency 
and coherence of different EU harmonisation legislation. 

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

However, views varied considerably by stakeholder type. Among the larger groups of stakeholders 
(types with over ten responses), national accreditation bodies were most likely to consider that the 
NLF has been effective in facilitating the consistency and coherence of different EU harmonisation 
legislation for products  ‘to  a great  extent’: 80% held  this view (16 responses). National  notifying 
authorities were least likely to share this view (26.3%, five responses), just behind notified bodies / 
conformity assessment bodies (27.9%, 17 responses) and MSAs (28.6%, six responses). The reason 
for the differences in views of accreditation bodies on the one hand and notifying authorities on the 
other hand may lie in the different level of harmonisation of accredited and non-accredited notified 
bodies. The accreditation framework established by the NLF relies on accreditation standards and 
peer  evaluation  conducted  by  the  EA.  In  some  Member  States  only  accredited  conformity 
assessment bodies may become notified bodies, while in others accreditation is not mandatory for 
the  notification.  Desk  research  and  the  interviews  conducted  by  the  contractor  showed48  that  the 
common reference provisions in the aligned sectoral legislation led to reduced divergences among 
those legislations. Businesses are able to find the same types of provisions in the different pieces of 
product  legislation:  definitions;  the  obligations  of  economic  operators  (manufacturers,  authorised 
representatives, importers, distributors);  conformity of the product; EU declaration of  conformity; 
general principles and rules on CE marking; notification and rules on notified bodies and safeguard 

47 More information is available in the Study: Section 4.1.1.1. Level of alignment of product harmonisation legislation 
with the NLF. 
48 More information is available in the Study: Section 4 To what extent was the NLF successful and why?.  

22 

 
 
                                                 
 
procedures. The obligations of the economic operators are clear and repetitive from legislation to 
legislation,  therefore  the  efforts  of  familiarisation  with  the  harmonisation  legislation  are  less 
burdensome.  Furthermore,  Annex  II  of  Decision  No  768/2008/EC  contains  the  different  types  of 
conformity  assessment  modules  (from  self-assessment  to  various  types  and  rigour  of  third-party 
assessments) among which the legislators of the sectoral legislation may choose, depending on the 
risk related to specific products.  

The 2014  Evaluation  of the  Internal  Market  Legislation for  Industrial  Products already concluded 
that the NLF provided a clearer definition of the obligations for different economic operators and 
supported administrative simplification across many areas of the legal framework49 (e.g. through the 
common suite of conformity assessment modules and the declaration of conformity template). The 
evaluation results were reported in the context of the Commission Communication ‘A vision for the 
internal market for industrial products’. 
The better alignment was further improved by the Guide to the implementation of directives50 based 
on the New Approach and Global Approach, published in 2000, which was updated in 2016. The 
Blue  Guide  explains  the  provisions  of  the  Decision  and  the  Regulation  to  ensure  their  consistent 
interpretation  throughout  the  body  of  the  EU  product  legislation.  The  latest  revision  of  the  Blue 
Guide  was  adopted  on  13  June  2022.  Nevertheless,  certain  divergent  requirements  have  been 
identified in the Study51 during the desk research and interviews between NLF-aligned legislation 
and  the  NLF  reference  provisions,  as  well  as  between  different  pieces  of  Union  harmonisation 
legislation.  In  this  respect,  the  targeted  consultation  was  seeking  for  an  answer  from  economic 
operators  and  industry  associations  to  what  extent  they  had  experienced  problems  because  of 
divergent  requirements  between  EU  product  legislation  in  the  following  areas:  administrative 
obligations;  sectoral-specific  requirements;  conformity  assessment  modules  and  procedures; 
definitions of economic operators; and safeguard clauses. 

Across all areas combined, most respondents have experienced problems52 from a small to a great 
extent  because  of  divergent  requirements  between  one  or  more  pieces  of  EU  product  legislation. 
Economic operators and industry associations identified administrative obligations (e.g. mandatory 
registration / labelling / declarations) as the aspect most likely to be problematic to a great extent. 
Conformity assessment modules and procedures were most likely to cause problems to them ‘to a 
moderate’ extent. 

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

49  More  information  is  available  in  the  2014  Evaluation  of  the  Internal  Market  Legislation  for  Industrial  Products: 
Section 2.3.1 Regulatory simplifications and clarification measures. 
50  European  Commission,  Directorate-General  for  Enterprise  and  Industry, Guide  to  the  implementation  of  directives 
based on the new approach and the global approach, Publications Office, 2000 
51 More information is available in the Study: Section 4.1.1.1 Level of alignment of product harmonization legislation 
with the NLF. 
52 More information is available in the Study: Section 4 To what extent was the NLF successful and why?, Figure 4-3: 
Problems  experienced  because  of  divergent  requirements  between  one  or  more  pieces  of  EU  product  legislation 
(Question 16, N=50)  

23 

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

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

Desk  research  showed  that  some  EU  legislations  contain  definitions  to  impose  obligations  on 
specific economic operators in the supply chain, whose role is not defined in the NLF, when it is 
necessary to ensure the safety of certain products53. Nonetheless, industry reports about difficulties 
experienced  due  to  inconsistencies  caused  by  unnecessary  divergences  of  legislation  from  NLF 
principles.  To  avoid  unnecessary  divergences,  some  stakeholders  stress  that  proposals  for  EU 
product legislation should be scrutinized from the perspective of alignment with the NLF principles, 
whereby,  as  suggested  at  the  stakeholders’  workshop,  any  divergences  should  be  justified  and 
explained  in  the  recitals  of  the  legislation  as  they  may  cause  unnecessary  financial  burden  and 
generate legal uncertainty.  

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

c)  Strengthening the quality of conformity assessment services through improved 

accreditation of notified bodies 

The  NLF  set  clear  and  robust  rules  for  notified  conformity  assessment  bodies.  Overall,  most 
stakeholders across all groups have stated that the NLF approach ensures the safety and compliance 
of  products  placed  on  the  single  market.  The  desk  research  showed  that  NLF  has  positively 
impacted the implementation of the conformity assessment system and the process for notification 
of  conformity  assessment  bodies.  Industry  noted  during  the  interviews54  that  the  continuity  in 
conformity assessment procedures between the New Approach and the NLF is positive. This stems 
not  only  from  the  adoption  and  implementation  of  the  rules  for  the  accreditation  of  conformity 
assessment  bodies  stipulated  in  Regulation  (EC)  No  765/2008,  but  also  from  the  reference 
provisions  for  specific  product  legislation  on  conformity  assessment,  including  the  suite  of 
conformity assessment modules, and the notification procedure for conformity assessment bodies. 

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

Among  the  NLF’s  most  beneficial  aspects,  stakeholders  frequently  mentioned  during  the 
interviews the harmonised conformity assessment and accreditation system, which enables the free 
movement  of  goods  within  the  EU.  Others  suggested  that  the  NLF’s  main  advantage  is  that  it 

53 For example, Article 2(6) of the Directive 2014/33/EU on lifts defines the installer as economic operator, to impose 
responsibilities on the person who makes a product operational and ready to use. Hence, the installer is a person who 
assumes  responsibilities  which  in  the  context  of  other  Union  harmonisation  legislation  are  typically  assigned  to  the 
manufacturer. 
54 More information is available in the Study: 4.1.1.2. Conformity assessment of the accreditation framework. 

24 

 
 
                                                 
 
determines  the  requirements for bodies assessing the conformity of products, which increases 
trust  in  their  competence  and  the  quality  of  their  work.  In  relation  to  conformity  assessment, 
industry representatives  clearly stated that they perceive  module ‘A’  (internal  production control, 
without  a  mandatory  involvement  of  a  third  party),  in  combination  with  effective  market 
surveillance, to provide a good and fair level playing field for manufacturers. 

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

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

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

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

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

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

Nonetheless, when it comes to subcontracting of substantial technical tasks of notified bodies, 
certain  difficulties  have  been  identified  based  on  desk  research.  The  Evaluation  of  the  Internal 
Market  Legislation for  Industrial Products55 also noted that  ensuring the quality of services when 
the  subcontractor  is  located  outside  the  EU  is  already  a  challenge  and  existing  subcontracting 
practices  make  this  even  more  problematic,  particularly  in  relation  to  products  where  third-party 
certification is mandatory. 

55  More  information  is  available  in  the  Evaluation  of  the  Internal  Market  Legislation  for  Industrial  Products:  4.3.2 
Regulation of Notified Bodies 

25 

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

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

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

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

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

26 

 
 
To what extent does the accreditation framework for notified 
bodies provided for by the NLF:

Ensure a level playing field among notified bodies

44

47

19

9

11

Guarantee a high a high level of competence of notified
bodies also in case of sub-contracting

52

41

21

4

12

Guarantee a high level of competence of notified bodies

Ensure compliance with legal requirements

62

67

37

16

5

10

42

9

2

10

To a great extent

To a moderate extent

0%

20%
To a small extent

40%

60%

Not at all

80%
Don’t know

100%

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

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

As  already  explained  in  chapter  3.1.3.,  accreditation56  is  the  preferred  means  of  verifying  the 
competence of conformity  assessment bodies, but  it  is  not  mandatory.  Therefore not  all notified 
conformity assessment bodies are also accredited conformity assessment bodies. Even if conformity 
assessment bodies can be notified as accredited or non-accredited notified bodies, based on the data 
available  in  the  NANDO  database,  we  can  see  that  the  number  of  accredited  notified  bodies 
significantly outweigh those that are not accredited: 82% (2125) of all notified bodies (2589 in June 
2022) are accredited, while only 18% (464) are not accredited.   

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

56 More details on the accreditation process and the challenges identified in the European system for accreditation are 
included in Case Stydy No. 2 in Annex VIII.  
57  Results  of  Question  30  (N=130):  While  accredited  notified  bodies  are  monitored  by  the  accreditation  body,  the 
monitoring of non-accredited notified bodies is ensured by national notifying authorities using alternative means. Does 
the  NLF  ensure  that  these  alternative  procedures  for  monitoring  the  non-accredited  notified  bodies  are  sufficiently 
reliable  and  appropriate  for  the  purposes  of  notification?  This  question  was  asked  to:  economic  operators,  industry 
associations, national accreditation bodies, national competent authorities and national notifying authorities. 

27 

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

Some stakeholders  see  mandatory accreditation59 as  the only way to  ensure the appropriate and 
equal high level of competence of notified bodies, while others point to the significant amount of 
time  and  costs  needed  for  accreditation  comparing  to  its  benefits.  The  Evaluation  of  the  Internal 
Market  Legislation  for  Industrial  Products  pointed  out60  that  despite  mixed  views  on  the 
accreditation  procedure  and  its  effectiveness,  there  appears  to  be  significant  support  towards 
mandatory accreditation across the EU. As presented on pg. 47 of the underlying Study and in Case 
Study  No.  2  in  Annex  VIII  of  this  SWD,  consumer  associations  and  industry  associations 
interviewed  have  suggested  that  accreditation  should  become  mandatory  to  create  a  true  level 
playing field for notified bodies, based on competence. Nonetheless, there are a range of challenges 
related  with  mandatory  accreditation  that  stakeholders  have  highlighted.  According  to  notified 
bodies,  mandatory  accreditation  is  not  considered  the  optimal  solution,  but  could  help  ensure  the 
best  possible  alignment  in  the  notification  processes  and  competencies  of  the  assessing  body 
(accreditation body) to be somewhat aligned through peer assessment and with that, ensure a level 
playing field in terms of requirements put on the Notified Bodies.  

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

Several categories of stakeholders consider the definition of accreditation too vague. Certification 
bodies  expressed  the  view  that  although  the  accreditation  system  is  harmonised  across  all  EU 
Member States, the definition of accreditation refers to unspecific “harmonised standards and where 
applicable additional requirements”, leaving room for varying interpretations61. 

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

The  Commission  considers  that  the  definition  of  accreditation  in  Regulation  (EC)  No  765/2008 
referring in general to ‘harmonised standards and, where applicable, any additional requirements’ 
that the conformity assessment body should meet to obtain an attestation by a national accreditation 
body allows flexibility, instead of being vague. The EA is a body recognised under Regulation (EC) 
No  765/2008  and  the  mandatory  membership  of  national  accreditation  bodies  in  the  EA  is  also 

58  Results  of  Question  28  (N=130):  To  what  extent  does  the  existence  of  non-accredited  notified  bodies  remain 
appropriate to ensure the competence required by the NLF? This question was asked to: economic operators, industry 
associations, national accreditation bodies, national competent authorities, and national notifying authorities. 
59 Stakeholder views on the question of whether accreditation should become mandatory are presented and discussed in 
Case Study No. 2 in Annex VIII. 
60  More  information  is  available  in  the  Evaluation  of  the  Internal  Market  Legislation  for  Industrial  Products:  4.4.2 
Compulsory accreditation 
61  More  details  on  the  views  of  stakeholders  about  the  definition  of  accreditation  is  included  in  Case  Study  No.  2. 
Annex VIII. 

28 

 
 
                                                 
 
ensured  by  Regulation  (EC)  No  765/2008.  The  EU  is financing  the  activities  of  the  EA  in 
connection  with  the  application  of  Regulation  (EC)  No  765/2008,  such  as  the  coordination  of 
accreditation  activities  and  the  processing  of  technical  work  linked  to  the  operation  of  the  peer 
evaluation  system  (Article  32  of  Regulation  (EC)  No  765/2008).  Consequently,  the  better 
implementation  of  the  accreditation  rules  achieving  more  harmonised  practices  in  the  area  of 
accreditation of conformity assessment bodies is rather seen via the coordination and accentuation 
of this aspect in the peer evaluation activities of the EA than through a possible amendments of the 
NLF, enumerating the relevant harmonised standards in the NLF. 

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

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

The issue of the performance of the NLF provisions related to the CE marking was most recently 
examined  in  the  2014  Evaluation  of  the  Internal  Market  Legislation  for  Industrial  Products.  As 
summarised  in  the  2017  report  on  the  implementation  of  Regulation  (EC)  No  765/200862,  the 
assessment “show[ed] an overall satisfaction with the CE marking, which is considered appropriate 
and effective. The assessment also showed that there is no need for any fundamental change in CE 
marking, although there is a need for greater consistency and to avoid having different requirements 
for different pieces of legislation and address the issue of products with multiple parts”63. 

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

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

62 More information is available in the 2017 Report on the implementation of Regulation (EC) No 765/2008: Section 3 
CE marking 
63 Report on the implementation of 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, COM(2017) 789 final. 

29 

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

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

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

4.1.2.  Efficiency 

a)  Reinforcement of the New Approach 

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

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

In  terms  of  specific  benefits  of  the  NLF,  two-third  of  the  economic  operators  and  industry 
associations  agreed  that  the  NLF  has  reduced  the  costs  of  familiarisation  with  different  EU 
product  legislation,  while  a  great  majority  reported  that  the  NLF  has  reduced  divergence64 
between  different  pieces  of  EU  product  legislation,  leading  to  cost  savings  in  the  conformity 
assessment  procedure.  For  example,  Case  Study  No.  4  in  Annex  4  of  the  Study,  which  is  also 
included in Annex VIII demonstrates that none of the costs identified for economic operators can be 
entirely and directly attributed to the NLF. According to the Study of CSES, the benefits of the NLF 

64  The  scope  of  the  evaluation  from  2014,  ‘A  vision  for  the  internal  market  for  industrial  products’,  COM(2014)  25 
final, was overarching and broad in nature, covering many New Approach directives. Among the key findings were that 
the NLF “provides a clearer definition of the obligations for different economic operators” and supported administrative 
simplification  across  many  areas  of  the  legal  framework  (e.g.  through  the  common  suite  of  conformity  assessment 
modules and the DoC template). The evaluation results were reported in the context of the Commission Communication 
‘A vision for the internal market for industrial products’. 

30 

 
 
                                                 
 
are  rather  strategic65,  such  as  fostering  the  free  movement  of  goods  in  the  internal  market  and 
increase in industrial competitiveness.  

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

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

b)  Supporting the consistency and coherence of EU harmonisation legislation  

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

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

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

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

c)  Strengthening the quality of conformity assessment services through improved 

accreditation of notified bodies 

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

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

65 More information is available in the Study: 4.2.4.1 Benefits of the NLF: Results (linked to specific objectives)  

31 

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

Case Study No 3. in Annex IV of the Study, which is included in Annex VIII of the SWD on the 
assessment  of  the  NLF-related  costs  and  benefits  under  an  NLF-aligned  legislation  (the  EMCD) 
explains that in a hypothetical scenario without the NLF, the EMCD would probably still contain a 
conformity assessment procedure, with less similarities with the conformity assessment provided in 
other product legislation. The costs of familiarisation with the procedures would likely be higher in 
the absence of the NLF model of conformity assessment procedures, due to lack of harmonisation. 
Generally,  the  cost  of  complying  with  the  EMCD  corresponds  to  5-15%  of  total  costs  of 
production66.  Administrative  and  reporting  costs  therefore  represent  only  a  minority  share  of  the 
total production costs borne by manufacturers. The self-certification approach made possible by the 
EMCD,  in  particular,  contributes  to  keeping  costs  relatively  low  and  grants  a  certain  level  of 
flexibility to economic operators. Some benefits, such as increased market efficiency and improved 
industrial competitiveness can be attributed to some extent to the NLF. 
The  Study  of  CSES  shows  that  cost  savings  generally  do  not  primarily  concern  the  main  bulk  of 
conformity  assessment  costs  (i.e.  tests  and  the  involvement  of  notified  bodies),  but  focus  on  the 
costs  related  to  technical  documentation.  Although  the  details  included  in  the  documentation 
depend  on  the  nature  of  the  product,  the  general  requirements  referring  to  the  contents  of  the 
technical  documentation  that  are  relevant  for  proving  the  conformity  of  the  product  with  the 
applicable harmonisation legislation are set out in the rules which follow Annex II of Decision No 
768/2008/EC.  In  the  case  of  the  EMCD,  the  Directive’s  evaluation  reported  costs  of  technical 
documentation as part of the conformity assessment procedure being in a range between 1,000 and 
10,000 euro per product. In terms of staff resources required in relation to the documentation, most 
stakeholders providing an estimate indicated a cost between 4 and 10 man-days. 

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

66  For  manufacturers:  Costs  during  product  development  (engineering  costs;  purchasing  standards;  pre-testing); 
Conformity assessment costs (preparing technical documentation; laboratory tests; involvement of notified body); Costs 
during  production  process  (e.g.  EMC-relevant  measures);  Familiarisation  with  legislative  requirements.  For  public 
authorities: Enforcement costs. 
67  These  considerations  are  also  supported  by  past  evaluations  of  NLF-aligned  pieces  of  legislation.  As  noted  in  the 
2020  evaluation  of  the  Toy  Safety  Directive  (TSD),  an  EC-type  examination  carried  out  by  a  notified  body  is  more 
expensive  than  laboratory  testing,  as  at  least  the  costs  for  the  review  of  the  technical  documentation  are  additional 
(typically around 500 Euro). Moreover, if test methods or protocols have to be developed (e.g. in light of innovations), 
costs  increase  further.  In  the  case  of  the  Electromagnetic  Compatibility  Directive  (EMCD),  according  to  its  2021 
evaluation, the overall cost of a notified body’s involvement ranges between 3,000 and 20,000 Euro. 

32 

 
 
                                                 
 
The  cost  of  testing  is  high  in  itself:  Under  the  EMCD,  for  instance,  the  daily  fees  of  third-party 
laboratories in the EU is reported to be in the range 800-1,500 Euro.68 The Evaluation of the Toys 
Safety Directive also states that testing of toys entails considerable laboratory costs. This includes 
the  operation  and  maintenance  of  the  laboratory  and  its  equipment  as  well  as  costs  for  hiring  the 
appropriate  staff.  Tests  need  normally  sophisticated,  specialised  equipment  and  machines  and,  in 
the case of chemical tests, a permanent input of chemicals, some of which can be very expensive69.  

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

Annex VII of the SWD contains an elaboration prepared by the contractor70 of the main costs and 
benefits  identified  by  the  evaluations  of  certain  NLF-aligned  EU  product  legislation,  (i.e. 
Evaluation  of  the  CPR  in  2019,  Evaluation  of  the  LVD  in  2019,  Evaluation  of  the  TSD  in  2020, 
Evaluation Restriction of Hazardous Substances in Electrical and Electronic Equipment Directive in 
2021, Evaluation of the EMCD in 2021).  

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

To obtain an accreditation, conformity assessment bodies face a range of costs, which include: the 
examination  fee  to  an  accreditation  body;  annual  fee  to  an  accreditation  body  (continuous 
monitoring  costs,  or  maintenance  fee);  cost  of  developing  and  maintaining  a  quality 
management system; insurance (in most cases)7172. 

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

68 The EMCD evaluation also highlighted the considerable flexibility provided to economic operators in terms of how to 
comply  with  the  essential  requirements,  in  particular  having  a  choice  of  conformity  assessment  procedure,  which  is 
widely  seen  as  reducing  undue  burden  and  appreciated  by  industry.  In  the  TSD  evaluation,  the  cost  of  testing  was 
estimated  to  represent  16%  of  the  total  man-hours  required  for  manufacturers  to  comply  with  the  Directive’s 
requirements when developing a toy (7% testing the quality and compliance of raw materials for the toy; 9% testing the 
toy  itself).  Generating  the  conformity  assessment  represented  6%;  obtaining  an  EC-type  examination  certificate  5%; 
generating the EC declaration of conformity 5%; and generating the technical documentation 12%.  
69 Evaluation of the Toys Safety Directive, pg. 61. 
70 More information available in the Study: Section 4. To what extent was the NLF successful and why? 
71  The  origin  of  this  clause  is  Decision  No  768/2008/EC,  Article  R17,  clause  9,  which  states  that  “Conformity 
assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national 
law, or the Member State itself is directly responsible for the conformity assessment.” In the different Member States, 
and across different pieces of NLF-aligned legislation, this provision has been implemented and transposed differently.  
72 More details on the cost of accreditation are available in Case Study No. 2. Of Annex VIII. 

33 

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

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

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

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

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

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

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

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

Based  on  the  triangulation  of  the  evidence  collected  for  this  evaluation,  we  conclude  that  easier 
familiarisation  with  the  procedures  and  preparation  of  the  conformity  assessment,  as  well  as  the 
administrative simplification brought by  the NLF led to cost savings. The modules provided in 
the  NLF  for  assessing  compliance  are  efficient,  and  since  they  have  not  changed  significantly 
with the introduction of the NLF in 2008, there are no additional costs identified comparing to the 

34 

 
 
pre-NLF period.  The accreditation framework  is  considered efficient  in  the context  of balance 
between  costs  and  benefits.  Except  in  the  smaller  sectors,  the  general  opinion  is  that  the  costs  of 
accreditation  do  not  represent  an  excessive  burden  for  the  conformity  assessment  bodies. 
Digitalisation  and  remote  assessments  are  identified  as  the  way  forward  for  a  possible 
simplification. 

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

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

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

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

The  Study  of  CSES  stresses  that  since  no  significant  changes  concerning  CE  marking  were 
introduced with the 2008 NLF, the incremental costs compared to the previous conditions are nil. 
This is acknowledged in previous evaluations, too. For instance, the evaluation of the NLF-aligned 
Lifts  Directive  does  not  consider  the  cost  of  CE  marking  as  relevant  in  its  analysis,  as  similar 
requirements were already present in the previous Directive73.  

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

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

73 At the same time, the evaluation states that this element is not burdensome for lift installers. 

35 

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

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

This view is strongly supported by a study conducted for study conducted for DigitalEurope and the 
Mobile  &  Wireless  Forum74,  which  examined  the  costs  and  benefits  associated  with  digitalising 
certain  compliance  information  in  the  consumer  electronics  sector.  Quantitative  estimates  on  e-
labelling were provided on three segments of the European consumer electronics market: telephony, 
computing, and TV, radio and multimedia75. According to the study, under the current system the 
total annual costs of indicating compliance in these three fields are about 800 million Euros76. These 
costs are deemed to  be high or very high by  about  half of the companies consulted as part of the 
study. Against this background, the study proposes an e-labelling scheme designed as an optional 
approach to a physical label and consisting of a label displayed electronically for devices with built-
in screen, a QR code for equipment without screen, and a temporary label (e.g. film label) to allow 
consumers  and  market  surveillance  authorities  to  see  product  regulatory  markings  at  the  time  of 
purchase or check without switching on the device. The study estimates that the e-labelling scheme 
would reduce costs of indicating compliance by around 15% (120 million Euros per  year), due to 
lower  costs  associated  with  updating  compliance  information  of  products  already  on  the  market, 
lower costs linked to differences in national compliance procedures, as well as lower administrative 
costs linked to addressing requests from national market surveillance authorities. 

After  extrapolating  the  cost  savings  figure  to  other  sectors  under  NLF  scope,  the  cumulative  cost 
saving  related  to  the  e-labelling  scheme  can  be  estimated  to  be  at  least  490  million  Euro  per 
year77. 

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

Based on the triangulation of the evidence collected for this evaluation, we conclude that the NLF 
has been efficient in ensuring the clear meaning and enhanced credibility of the CE marking. 

74 Research into e-labelling schemes outside the EU - DIGITALEUROPE 
75  Selected  NACE  coverage:  NACE  26.20  Manufacture  of  computers  and  peripheral  equipment;  NACE  26.30 
Manufacture of communication equipment; NACE 26.40 Manufacture of consumer electronics. 
76  Calculated  as  0.4%  of  the  turnover  of  the  industry  under  scope.  In  turn,  the  share  of  0.4%  is  the  result  of  a 
multiplication of the total cost of compliance (2% of annual turnover, based on previous literature) by the share of the 
total cost compliance related only to the cost of indicating compliance with  EU harmonisation legislation (20%, based 
on stakeholder consultation).  
77  Although  no  precise  correspondence  between  NACE  codes  and  NLF  scope  can  be  established,  a  list  of  17  NACE 
codes  were  first  selected  to  approximate  the  sectors  under  NLF  scope.  These  are:  26.10,  26.20,  26.30,  26.40,  26.50, 
26.60, 26.70, 26.80, 27.10, 27.20, 27.30, 27.40, 27.50, 27.90, 32.40, 32.50, and 32.90. For each of them, 2019 turnover 
data were then extracted from Eurostat SBS. In cases where 2019 data were not available, turnover data from previous 
years were used for the approximation. In the case of NACE code 32.40 (Manufacture of games and toys), for which no 
turnover data were available on Eurostat, data from the recent Commission evaluation of the Directive were used. The 
cumulated annual turnover of the 17 NACE codes selected is equal to 816.28 billion Euro. This annual turnover  was 
then multiplied by 0.4% (i.e. the cost of indicating compliance with EU harmonisation legislation, according to the 2018 
study  on  behalf  of  DigitalEurope  and  the  Mobile  &  Wireless  Forum)  to  estimate  the  annual  cost  of  indicating 
compliance,  corresponding  to  3.27  billion  Euro.  Adopting  the  same  share  of  cost  reduction  due  to  the  proposed  e-
labelling scheme as indicated in the 2018 study, i.e. 15%, the cumulative cost saving can be estimated at 489.77 million 
Euro  per  year.  It  should  be  noted  that  this  figure  likely  represents  an  underestimation,  due  to  the  exclusion  from  the 
NACE sectors considered of some further product types under NLF-aligned legislation, e.g. construction products. 

36 

 
 
                                                 
 
CE  marking  does  not  represent  a  serious  burden  for  manufacturers,  while  often  perceived  as  a 
standard  of  quality  even  outside  of  the  EU.  Digitalisation  of  CE  marking  and  other  product 
information  obligations  is  nonetheless  seen  as  a  possible  simplification.  Having  regard  to  the 
increasing number of intangible products such as software,  this seems to  be inevitable in the near 
future. 

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

Some of the costs and benefits cannot be directly attributed to the NLF as a framework. Two case 
studies in Annex VIII of the SWD conducted by the contractor on recently evaluated directives, the 
EMCD and the Toy Safety Directive (TSD), investigate the issue of attributing effects to the NLF 
or  to  the  sector-specific  legislation.  They  show  also  that  drawing  a  line  between  NLF-related 
impacts  and  impacts  that  should  be  attributed  only  to  the  individual  legislation  is  not 
straightforward. 

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

4.1.3.  Coherence 

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

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

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

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

37 

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

   Horizontal  legislation  –  The  coherence  with  Directive  2001/95/EC  on  general  product  safety 
(GPSD)78 and Directive on product liability 85/374/EEC79; 

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

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

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

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

Nonetheless, stakeholders did not raise any issues regarding the internal coherence and consistency 
of the NLF. In both, targeted and public consultations the number of stakeholders considering that 
there  were  inconsistencies,  overlaps  or  gaps  between  the  different  provisions  of  the  NLF  (i.e. 
between and within Decision No 768/2008/EC and Regulation (EC) No 765/2008) was very low: 1 
answer  out  of  125  in  the  public  consultations  and  5  answers  out  of  122  in  the  targeted 
consultations80.  Regulation  (EU)  2019/1020,  which  replaced  the  market  surveillance  part  of 
Regulation  (EC)  No  765/2008  introduced  new  definitions,  such  as  ‘fulfilment  service  provider’, 
‘information  society  service  provider’,  ‘distance  sales’  and  ‘online  interface’,  to  capture  the  new 
roles  associated  with  the  emergence  of  online  marketplaces.  Stakeholders  welcome  this  recent 
revision and consider that  these definitions could  serve as  a blueprint for refining the conformity 
assessment  procedures  applicable  to  these  new  types  of  economic  operators  in  the  distribution 
chain and contribute to the overall coherence of the NLF model. 

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

78 OJEC L 11 of 15.01.2002. 
79  Council  Directive  85/374/EEC  of  25  July  1985  on  the  approximation  of  the  laws,  regulations  and  administrative 
provisions of the Member States concerning liability for defective products L 210 of 07/08/1985. 
80  Among  the  few  stakeholders  who  identified  inconsistencies,  one  national  accreditation  body  said  that  the 
inconsistencies  are  not  so  much  in  the  legal  framework,  but  in  the  expectation  laid  down  in  the  Blue  Guide.  For 
instance, the requirement related to the conformity assessment bodies and their personnel and facilities in the Member 
States.  
An  industry  association  agreed  that  there  are  no  striking  inconsistencies  within  the  original  NLF.  However,  the 
adjustments  made  by  Regulation  (EU)  2019/1020  on  market  surveillance  (which  amended  Regulation  (EC)  No 
765/2008) introduced new concepts beyond the existing NLF (e.g. Articles 4, 5, 6 in relation to placing a product on the 
market). 

38 

 
 
 
                                                 
 
To what extent do the following elements of the NLF 
remain clear and appropriate?

The obligations and administrative requirements
for economic operators (re)placing products on the
market that involve substantial modifications

The definitions of different economic operators,
considering new models of production and value
chain complexity

43

103

37

17

67

103

9

21

The notions of ‘making available on the market’ 
and ‘placing on the market’

92

78

16

14

Fully clear

Partially clear and appropriate

Not clear at all

Don’t know

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

To what extent is the NLF coherent with other EU legislation 
that may apply simultaneously or in complementarity with 
NLF-aligned legislation? Consider the following options: 

Environment legislation (e.g. RoHS Directive, WEEE
Directive etc.)

Other types of relevant legislation (e.g. GDPR, Services
Directive, Occupational Health & Safety Framework
Directive etc.)

30

29

84

81

78

82

Horizontal policy and legislation (e.g. General Product
Safety Directive, Product Liability Directive etc.)

49

84

59

0%

20%

40%

60%

80%

100%

Fully coherent

Partially coherent

Don’t know

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

39 

 
 
 
 
 
 
The horizontal coherence of the NLF 
Directive  2001/95/EC  on  general  product  safety  (GPSD)81  is  intended  to  ensure  product  safety 
throughout  the  EU  for  all  non-food  consumer  products  to  the  extent that  they  are  not  covered  by 
sector-specific EU harmonisation legislation. The GPSD also complements the provisions of sector 
legislation  in  some  aspects.  On  30  June  2021,  the  Commission  adopted  the  Proposal  for  a  new 
general product safety regulation, to replace the GPSD. Some elements of the Proposal are analysed 
as part of the section devoted to the relevance of the NLF, in Annex XI. 
Directive  on  product  liability  85/374/EEC82  establishes  a  system  of  strict  liability,  i.e.  liability 
without  fault,  for  producers  when  a  defective  product  causes  physical  or  material  damage  to  an 
injured  person.  The  Directive  is  an  important  element  of  the  EU  product  safety  legislation 
framework. It underpins product safety legislation by giving producers incentives to comply with it, 
as well as legal certainty. This Directive is currently under revision. 

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

Coherence of other relevant legislations and legislative proposals with the NLF 

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

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

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

81 OJEC L 11 of 15.01.2002. 
82  Council  Directive  85/374/EEC  of  25  July  1985  on  the  approximation  of  the  laws,  regulations  and  administrative 
provisions of the Member States concerning liability for defective products L 210 of 07/08/1985. 
83  Blue  Guide,  Title  2.3.  Placing  on  the  market:  When  made  available  on  the  Union  market,  products  must  be  in 
compliance  with  the  Union  harmonisation  legislation  applicable  at  the  time  of  placing  on  the  market.  Compliant 
products  once  they  have  been  placed  on  the  market  may  subsequently  be  made  available  along  the  delivery  chain 
without  additional  considerations,  even  in  case  of  revisions  to  the  applicable  legislation  or  the  relevant  harmonised 
standards, unless otherwise specified in the legislation. 

40 

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

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

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

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

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

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

4.2.  How did the EU intervention make a difference? 

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

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

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

 

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

41 

 
 
 

 

 

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

Reinforcing the principles initially embedded in  the New Approach, such as setting non-
technical  essential  requirements,  whilst  leaving  the  detailed  specifications  to  harmonised 
standards; 
Strengthening the visibility of CE marking, thereby heightening its role and importance,84 
although  the  core  CE  marking  requirements  already  existed  under  the  New  Approach  as 
these  were  gradually  introduced  in  product  specific  legislation  starting  with  the  Low 
Voltage Directive in 197385. 

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

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

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

Regarding  the  counterfactual  assessment86,  the  question  of  what  would  have  happened  in  the 
absence of the NLF has been analysed. There are different dimensions to this. Firstly, there is the 
question of what would have happened regarding the evolution of individual pieces of EU product 
legislation  without  the  NLF.  As  shown  in  the  legal  mapping  to  assess  the  “before”  and  “after” 
situation  in  respect  of  NLF-aligned  legislation,  there  would  have  remained  divergence  in  the 
administrative requirements for economic operators, with more anomalies and inconsistences in the 
legislation,  many  of  which  were  relatively  minor,  but  which  nonetheless  undermined  the  overall 
coherence  of  the  body  of  EU  legislation  applicable  to  products  that  manufacturers  and  other 
economic operators follow. 

However, a more significant added value in the views of many industry associations and individual 
manufacturers was that the NLF prevented regulators from introducing divergent requirements 

84Council  Directive  93/68/EEC  of  22  July  1993  amending  Directives  87/404/EEC  (simple  pressure  vessels), 
88/378/EEC  (safety  of  toys),  89/106/EEC  (construction  products),  89/336/EEC  (electromagnetic  compatibility), 
89/392/EEC  (machinery),  89/686/EEC  (personal  protective  equipment),  90/384/EEC  (non-automatic  weighing 
instruments),  90/385/EEC  (active  implantable  medicinal  devices),  90/396/EEC  (appliances  burning  gaseous  fuels), 
91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous 
fuels)  and  73/23/EEC  (electrical  equipment  designed  for  use  within  certain  voltage 
limits):  https://eur-
lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A31993L0068 
85  Council  Directive  73/23/EEC  of  19  February  1973  on  the  harmonization  of  the  laws  of  Member  States  relating  to 
electrical 
https://eur-lex.europa.eu/legal-
equipment  designed 
content/EN/TXT/?uri=celex%3A31973L0023 
86 For more details please see Section 5 of the Study. 

for  use  within 

voltage 

certain 

limits: 

42 

 
 
                                                 
 
across sectoral legislation that went against the NLF’s core principles. This was seen as being 
the case at least in the 10-year period from 2008. This has also considerably reduced national “red 
tape” measures. 

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

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

4.3. 

Is the intervention still relevant? 

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

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

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

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

43 

 
 
To what extent do the needs and problems that the NLF 
was originally designed to address remain relevant?

Improve the quality and consistency of conformity
assessment services provided by notified bodies

Strengthen the visibility and use of the CE marking
system

Address inconsistencies between different pieces
of product / sectoral legislation

Ensure free movement of goods within the single
market

48

53

53

41

30

23

5

12

27

6

13

43

16

6

11

68

25

16

9

11

To a great extent

To a moderate extent

To a small extent

Not at all

Don’t know

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

The relevance of the definitions set out in the NLF 

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

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

Another  definition  that  may  need  rethinking  is  the  definition  of  accredited  NBs.  According  to 
Regulation  (EC)  No  765/2008,  conformity  assessment  bodies  can  be  accredited.  The  Regulation 
does  not  mention  the  possibility  of  accreditation  of  natural  persons.  Nonetheless,  Regulation 
1221/200987  (EMAS)  defines  as  environmental  verifier  “any  natural  or  legal  person,  or  any 
association  or  group  of  such  persons,  which  has  obtained  a  licence  to  carry  out  verification  and 
validation…..”  while  it  also  sets  out  (Article  2(30))  that  “accreditation  body  means  a  national 

87 Article 2 (20) (b) of Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 
2009  on  the  voluntary  participation  by  organisations  in  a  Community  eco-management  and  audit  scheme  (EMAS), 
repealing Regulation (EC) No 761/2001 and Commission Decisions 2001/681/EC and 2006/193/EC 

44 

 
 
 
 
                                                 
 
accreditation  body  appointed  pursuant  to  Article  4  of  Regulation  (EC)  No  765/2008  which  is 
responsible for the accreditation and supervision of environmental verifiers”.  

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

Since  the  entry  into  force  of  the  NLF  in  2008,  manufacturers  have  significantly  changed  their 
business  models  by  making  their  products  available  on  the  market  increasingly  as  a  part  of  a 
customer-oriented solution.  This  involves numerous services, such  as installation  and putting into 
service88, regular monitoring and maintenance, software and performance updates, training, repair 
and  refurbishing,  and  even  take  back  and  recycling.  Such  changes  have  brought  them  into 
competition  with  third-party servicing companies that were already involved to  various extents in 
similar  activities,  such  as  machine,  equipment  and  tool  rental  companies.  Therefore,  the  dividing 
line  between  goods  and  services  and  the  responsibility  of  different  economic  operators  became 
blurred.  

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

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

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

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

Substantial modification of a product 

The NLF is based on assessing the safety and compliance of products at the time they are placed on 
the market. It does not address changes that may occur to products after they are put into service. 

88 Currently the concept of “putting into service” is introduced in several pieces of Union harmonisation legislation. It 
also  may differ according to  specific Union harmonisation legislation,  such as the legislation on  medical devices.  As 
regards lifts and equivalent products, the putting into service should be considered to take place at the moment when the 
first use within the Union is possible. 
89 Hojnik, J. (2016) The servitisation of industry: EU law implications and challenges. 

45 

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

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

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

Remanufacturing  involves  practices  in  a  wide  range  of  industrial  sectors,  but  is  best  suited  for 
industries  that  are  capital-intensive  and  produce  products  that  have  a  long  product  life-cycle92. 
Industries which have been shown to be particularly suited to re-manufacturing include: aerospace, 
automotive,  electrical  and  electronic  equipment,  furniture,  heavy  duty  and  off-road  equipment, 
machinery,  marine,  medical  devices  and  rail,  among  others.  Although  about  90%  of 
remanufacturing activity is  in  the business-to-business  sphere93, it is  increasingly being  applied to 
consumer products. 

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

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

The reference provision in Article R6 of Annex I of Decision No 768/2008/EC sets out the cases in 
which obligations of manufacturers apply to importers and distributors. According to this provision 
an  importer  or  distributor  should  be  considered  a  manufacturer  subject  to  the  obligations  of  the 

90 European Commission. (2020). Innovation Union. 
91 Re-defining Value – The Manufacturing Revolution | Resource Panel 

92  The  circular  economy  dimension  within  European  manufacturing  has  grown  significantly  in  the  past  decade.  The 
European Remanufacturing Council has estimated the market to be worth approximately €30 billion annually in Europe. 
This was viewed as being relatively small as only about 2% of products that can be remanufactured are presently being 
remanufactured. This is likely to grow both as a result of the trend towards circular business models in some industries, 
but also as a result of the Sustainable Products Initiative92 (SPI) extending the requirements in the  current Ecodesign 
Directive92 to include not only energy efficiency, but also materials efficiency.   
93 Remanufacturing Market Study 

46 

 
 
                                                 
 
manufacturer,  where  they  modify  a  product  already  placed  on  the  market  in  such  a  way  that 
compliance with the applicable requirements may be affected.  

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

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

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

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

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

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

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

  The  development  of  harmonised  standards  that  provide  specific  definitions  and  concepts 
relevant to the circular economy. Examples of relevant harmonised standards mentioned were: 
TR  4555094  –  definitions  relevant  to  the  circular  economy  and  EN  45559  on  material 
efficiency95. 

The  lack  of  a  common  definition  and  the  concept  of  ‘substantial  modification’  may  result  in 
incoherence  among  the  legislations  trying  to  cope  with  the  increased  complexity  of  value  chains 

94 CLC/TR 45550, Definitions related to material efficiency 
95 EN 45559:2019 - Methods for providing information relating to material efficiency aspects of energy-related products 

47 

 
 
                                                 
 
and accommodate the circular economy business models. Some of the revised NLF-legislations and 
recent  legislative  proposals  contain  different  definitions  as  to  what  constitutes  a  substantial 
modification or fully refurbishment. In any instance, all industry stakeholders consulted agreed 
on  the  need  for  the  EU  legislator  to  harmonise  all  the  proposed  definitions  of  substantial 
modification, to ensure a common understanding between all parties. Where needed, stakeholders 
considered  that  sector-specific,  complementary  provisions  could  be  necessary  to  facilitate  its 
application and ensure legal certainty for economic operators. 

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

It is important to keep in mind that the new legislative initiatives aim to modernise the EU’s 
legislative framework, as an integral part of the EU’s Green Deal96. They build on commitments 
and  reports  adopted  by  the  European  Commission,  including  the  New  Circular  Economy  Action 
Plan97 and the New Industrial Strategy for Europe98. 

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

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

General relevance of the NLF in the light of digitalisation  

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

96 Communication from the Commission to the European Parliament, the European Council, the Council, the European 
Economic and Social Committee and the Committee of the Regions, The European Green Deal (COM (2019) 640 final) 
97 A new Circular Economy Action Plan For a cleaner and more competitive Europe, COM/2020/98 final 
98 Updating the  2020 New Industrial Strategy: Building a  stronger Single Market for Europe’s recovery, COM(2021) 
350 final 

48 

 
 
                                                 
 
The  NLF  also  provides  that  the  manufacturer  has  to  draw  up  and  upon  a  request  of  the  market 
surveillance authorities provide the technical documentation and EU declaration of conformity99. 
Manufacturers  also  have  to  ensure  that  the  product  is  accompanied  by  instructions  and  safety 
information, in a language which can be easily understood by consumers and other end-users, as 
determined by the Member State concerned. 

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

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

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

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

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

99  Blue  Guide,  Title  3.1.  Manufacturer:  Upon  a  reasoned  request,  the  manufacturer  has  to  provide  the  competent 
national authority with all the information and documentation necessary to demonstrate the conformity of a product, in 
a  language  which  can  be  easily  understood  by  that  authority.  This  would  include,  for  example,  the  declaration  of 
conformity, the  relevant part of the technical  documentation, or certificates issued by Notified Bodies.  If agreed with 
market surveillance authorities, this information may be transmitted electronically.  

49 

 
 
                                                 
 
To what extent would providing product information in a 
digital form positively or negatively impact consumers?

Citizen (EU or non-EU)

12
40%

10
33%

3
10%

4
13%

1
3%

Industry association

Economic operator

22
59%

11
61%

11
30%

5
28%

3
8%

1
3%

2
11%

Market surveillance authority (MSA)

Notified body / conformity assessment body

3
30%

2
29%

1
10%

1
14%

2
20%

1
14%

1
10%

1
10%

2
20%

3
43%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Very positive

Positive

Neutral

Negative

Very negative

Don’t know

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

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

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

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

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

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

50 

 
 
 
 
instruction  accompanying  the  product,  could  be  an  ‘either/or’  option,  and  not  an  additional 
requirement. The development of common standards and specification for the content and format of 
the  required  product  information  would  further  facilitate  the  fulfilment  of  administrative 
obligations. 

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

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

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

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

The  Proposal  for  a  Regulation  establishing  a  framework  for  setting  eco-design  requirements  for 
sustainable products would apply to any physical goods placed on the market or put into service100, 
including components and intermediate products. The proposal  foresees a digital product passport 
to  electronically  register,  process  and  share  product-related  information  amongst  supply  chain 
businesses,  authorities  and  consumers.  Recital  (26)  of  the  Proposal  explains  that  the  product 
passport should not replace but complement non-digital forms of transmitting information, such as 
information in the product manual or on a label. In addition, it should be possible  for the product 
passport to be used for information on other sustainability aspects applicable to the relevant product 
group pursuant to other Union legislation. 

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

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

100  Except  food,  feed,  medicinal  and  veterinary  medicinal  products,  living  plants/animals/microorganism,  products  of 
human origin, products of plants and animals relating directly to their future reproduction (Article 1(2) of the Proposal). 

51 

 
 
                                                 
 
model offered by the NLF, product legislations will most probably create their own models of 
product passport.  

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

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

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

Relevance of the conformity assessment procedure 

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

To what extent do the NLF requirements for notified bodies remain 
appropriate?

36

37

14

4

15

0%

20%

40%

60%

80%

100%

To a great extent

To a moderate extent

To a small extent

Not at all

Don’t know

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

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

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

The majority of industry stakeholders believe that the use of module A (internal production control, 
without a mandatory involvement of a third party) should remain a cornerstone in the new product 
legislation  and  revised  regulations.  Industry  stakeholders  point  out  that  several  of  the  current 
legislative  proposals  tend  to  require  third  party  conformity  assessment  for  products  over  self-
assessment, disregarding the risk-based approach for selecting conformity assessment modules 

52 

 
 
 
 
mentioned above. Module A is linked to faster time-to-market,  which is  an important element  for 
the competitiveness of European manufacturers. 

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

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

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

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

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

Directive  2013/53/EC  on  recreational  craft  and  personal  watercraft  provides  for  a  separate 
conformity assessment for products subject to substantial modification. This conformity assessment 
procedure is focused on the post-construction assessment of a product (Annex V, module PLC). The 
modified product must bear a plate with the words ‘post-construction assessment’. A future possible 

101 Recital 8, Decision No 768/2008/EC on a common framework for the marketing of products, and repealing Council 
Decision 93/465/EEC. 

53 

 
 
                                                 
 
impact  assessment  may  explore  whether  including  a  similar  additional  module  to  the  NLF  would 
render it more responsive to the modern supply chains and needs of the circular economy. 

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

Remote conformity assessment 

As  documented  in  an  EA  communication,  published  on  23rd  March  2020,  the  outbreak  of  the 
COVID-19 pandemic102 and the related travel restrictions implemented by governments across the 
EU, conformity  assessment  and national  accreditation bodies were  forced, in  the first  instance, to 
“cancel  or postpone most  of their  in  situ activities  such as on-site assessments, audits, witnessing 
visits and inspections”103.  

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

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

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

  Remote assessments will never fully replace face to face activities, particularly in certain areas 

where face to face conversations are perceived to be essential, such as audits. 

 

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

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

102 From more details please see the Study, Section 4.2.5.2. Remote assessment of conformity assessment, accreditation 
and peer evaluation. 
103 https://european-accreditation.org/ea-communication-to-the-impact-of-the-covid-19-outbreak/ 
104 https://european-accreditation.org/remote-peer-evaluation-feedback-from-mija-renko-sa-slovenia/ 
105 https://european-accreditation.org/remote-peer-evaluation-feedback-from-mija-renko-sa-slovenia/ 

54 

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

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

Relevance of the NLF in an emergency situation 

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

During the COVID-19 pandemic, to what extent did it take products that 
were instrumental in the fight against COVID-19 (e.g. PPE and medical 
devices) too long to be placed on the market?

16

22

20

8

51

To a great extent
To a moderate extent
To a small extent
Not at all
Don’t know

0%

20%

40%

60%

80%

100%

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

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

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

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

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

Nonetheless,  the  Commission  Working  Programme  2022  –  Making  Europe  stronger  together, 
separately  from  this  evaluation of the NLF, includes an initiative for  a Single Market  Emergency 

55 

 
 
 
 
Instrument106. Therefore, the Proposal for a Regulation on establishing the Single Market emergency 
instrument was adopted on 19 September 2022.  

During the COVID-19 pandemic, to what extent did it take products that 
were instrumental in the fight against COVID-19 (e.g. PPE and medical 
devices) too long to be placed on the market?

Notified body / conformity assessment
body

2

14

6

2

15

Economic operator

1

2

4

2

5

National notifying authority

1

1

1

9

National competent authority

2

1

4

1

6

Market surveillance authority (MSA)

2

1

1

1

6

To a great extent

To a moderate extent

To a small extent

Not at all

Don’t know

National accreditation body

3

2

2

Industry association

5

1

2

2

4

6

0%

20%

40%

60%

80%

100%

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

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

106 Single market – new EU instrument to guarantee functioning of single market during emergencies (europa.eu). The 
public consultations for the Call for evidence for an impact assessment were open between 13 April and 11 May 2022: 
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13181-Single-market-new-EU-instrument-to-
guarantee-functioning-of-single-market-during-emergencies_en  

56 

 
 
 
 
                                                 
 
5.  WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? 

5.1.  Conclusions 

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

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

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

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

Reinforcing the New Approach  

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

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

Nonetheless,  the  success  of  the  NLF  depends  heavily  on  having  a  quick  and  effective 
standardisation process. The absence or delay in the adoption of harmonised standards leads to the 

57 

 
 
increase of the costs of conformity assessment and may have a negative impact on innovations:  If 
the harmonised EU standards lag behind the newest international standards representing the state of 
the art, the NLF is not able to perform as expected.  

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

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

Supporting the consistency and coherence of EU harmonisation legislation 

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

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

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

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

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

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

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

58 

 
 
Strengthening the conformity assessment system  

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

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

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

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

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

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

Enhancing the clarity and credibility of the CE marking  

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

59 

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

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

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

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

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

5.2.  Lessons learned 

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

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

To respond to the suggestions of the Opinion, based on this evaluation, a possible future revision of 
the  NLF  may  want  to  consider  introducing  the  possibility  of  the  digital  CE  marking  and  the 
digital  product  passport.  The  digital  product  passport  could  include  an  electronic  declaration  of 
conformity  and  the  description  of  the  conformity  assessment  procedure.  The  digitalisation  of 
product  information  and  CE  marking  could  make  more  effective  the  work  of  market  surveillance 
authorities  and  customs107.  With  regards  to  customs  enforcement,  digitalisation  is  an  essential 
aspect  not  only  in  the  framework  of  the  digital  product  passport  but  also  for  the  possible  future 
revision of the NLF on these issues, and in the context of the Union Customs Code (UCC) revision 
and  the  reform  of  the  customs  governance  which  are  ongoing.  A  coordination  between  market 

107 The Wise Persons Group reporting to Commissioner Gentiloni has identified that  from  customs  union perspective 
there  is  a  need  for  digitalization  of  certificates  of  conformity  (see  p.  23  at  TAX-20-002-Future  customs-
REPORT_BIS_v5 (WEB).pdf (europa.eu). 

60 

 
 
                                                 
 
surveillance authorities and customs is therefore necessary to allow proper enforcement at the EU 
external  borders.  Instructions  that  must  accompany  the  product  could  also  be  alternatively 
provided in  a digital  format, but  provided in a hard-copy upon request,  while  safety information 
should always accompany the product in a paper-based format (with the exception of intangible 
products,  such  as  a  software),  to  ensure  that  all  consumers  have  the  opportunity  to  read  them 
immediately upon unpacking the product. The future possible impact assessment could assess how 
digitalisation can serve simplification and the red tape reduction, without presenting an additional 
obligation.  

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

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

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

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

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

61 

 
 
ANNEX I:   PROCEDURAL INFORMATION 

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

DG for Internal Market, Industry, Entrepreneurship and SMEs 

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

Organisation and timing. 

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

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

Fit for Future Platform 

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

Suggestions of the FFF Opinion 

Follow-up  

into 

take 

should 

system 

is  currently 

the  European 

Maintain 
for 
harmonized  standards:  The  evaluation  of  the 
NLF  should  consider  the  functioning  of  the 
European  system  for  harmonized  standards, 
which 
facing  a  number  of 
challenges. There is  an  urgent  need to  identify 
joint solutions to bring the system back on track 
and  ensure  that  it  is  fit  for  the  future.  The 
Commission 
account 
stakeholders’ concerns on this issue and ensure 
that the evaluation of the NLF is coordinated 
and  takes  account  of  coherence  aspects,  in 
view of existing and upcoming initiatives on 
such 
harmonized 
the 
standards, 
as 
standardisation 
Commission’s  upcoming 
strategy, which is expected in 2021. 
Explain  regulatory  choices:  The  NLF  evaluation 
should  consider  and  draw  lessons  relevant  to 
confirm and strengthen the mandate of the NLF 
as a key legal framework for Union harmonised 
legislation  for  products.  This  would  mean  that 
when the Commission makes a legislative proposal 
to  ensure  the  safety  of  products,  the  Commission 
should always consider using the NLF, and weigh it 
against the benefits of other alternative approaches. 
The  Commission  should  be  committed  to  explain 
their regulatory choices. 

and 

The  evaluation  will  cover 
the  aspects  of 
harmonised  standards  relevant  to  the  NLF,  such 
as  having 
technologically  neutral  essential 
relying  on  harmonised 
requirements 
standards  for  presumption  of  conformity.  The 
evaluation  of  the  standardisation  system  should 
be a stand-alone process. It will take into account 
the  evaluation  of  the  NLF,  which  is  already  an 
extensive  evaluation 
itself  covering  a 
in 
significant part of EU harmonised products. 
The  recently  adopted  Standardisation  Strategy 
provides  for  a  separate  evaluation  of  Regulation 
(EU) 1025/2012 to assess whether it is still fit for 
purpose. 

The NLF was adopted in 2008 to improve the internal 
market and ensure a high level of protection of public 
interests  (e.g.  safety,  protection  of  environment, 
protection  of  public  health).  However,  industry,  and 
society  at  large  are  fundamentally  different  today 
compared  to  the  situation  in  2008.  As  a  result,  the 
more  recent  proposals  for  product  legislation  have 
departed to some degree from the reference provisions 
of  the  NLF  in  that  they  try  to  tackle  the  legal 
consequences  of  modifications  to  products  after  they 
have  been  put  into  service  (the  proposal  for  a 
Regulation  on  a  regulatory  framework  for  Artificial 
Intelligence (COM(2021) 206 final) and the proposal 

55 

 
 
 
 
for a Regulation on Machinery (COM(2021)202)) 
One of the main focuses of the evaluation of the NLF 
is therefore the relevance of NLF and whether it is fit 
enough to keep up with the ongoing digital and green 
transition.  

Although  the  evaluation  of  the  NLF  has  a 
forward-looking  dimension,  which  is  unmissable 
to  assess  the  relevance  of  the  NLF,  its  focus  is 
retrospective.  
The evaluation findings include the effectiveness 
and efficiency of the uniform implementation and 
enforcement  of  harmonized  product  rules  and 
ensuring  a  high  level  of  protection  of  public 
interests.  These  aspects  would  also  be  duly 
considered in any possible revision of the NLF.  

Don’t fix what isn’t broken: The basic principles 
in  the  NLF  should  only  be  changed  if  necessary. 
The NLF evaluation and potential update should be 
done  with  respect  for  the  principle  of  better 
regulation. Based on analysis, any amendments of 
the NLF should maintain the focus on improving 
uniform implementation and enforcement of the 
harmonised  product  rules  and  ensure  a  high 
level  of  protection  of  public  interests,  such  as 
health and safety in general, health and safety in the 
workplace, 
the 
protection of the environment and public security. 

the  protection  of  consumers, 

and 

the  Commission 

security  without 

Updating  NLF  to  the  current  and  future 
business  environment:  We  encourage  the 
Commission  to  evaluate  and  update  the 
definitions  in  the  NLF  to  ensure  a  clear  and 
proportionate distribution of obligations, which 
corresponds  to  the  role  of  each  operator  in  the 
supply  and  distribution  process,  including  in 
the  digital  and  circular  economy.[…]  The 
Platform  encourages 
to 
consider  how  it  can  be  ensured  that  e.g. 
remanufactured,  upcycled  or  updated  products 
meet  the  relevant  product  requirements  for 
imposing 
safety 
and 
burdens 
disproportionate 
sustainable business models. It is important that 
the  NLF  makes  it  easy  and  attractive  for 
innovative  businesses,  especially  SMEs,  to 
place  safe,  secure  and  sustainable  products  on 
the internal market. It is important that the NLF 
does not create a burden for new and innovative 
business  models.  This  could  for  instance  be 
achieved  by  only  making  repairers  responsible 
for  the  part  of  the  product  they  have  repaired, 
rather than for the full product for the rest of its 
lifetime.  This  approach  is  already  applied  in 
some  Member  States,  and  the  experiences 
should be taken into consideration.   

new 

on 

Evaluation  of  Member  state’s  Notified  Bodies: 
As multiple approaches to assess the competence of 
Notified Bodies exist across EU member states, the 
NLF  must  facilitate  knowledge  sharing  among  the 
EU’s 
supervising 
authorities  so  that  an  approach  to  assess  the 
competence of Notified Bodies can be reached. This 
would  enhance  the  foundation  upon  which  the 

accreditation 

bodies 

and 

In  line  with  the  Platform’s  suggestion,  the 
evaluation  of  the  NLF  indeed  assesses  the 
relevance  of  the  NLF,  including  its  definitions. 
The  evaluation  takes  into  consideration  that  the 
NLF  is  based  on  assessing  the  safety  and 
compliance  of  products  at  the  time  they  are 
placed  on  the  market  and  does  not  address 
changes that may occur to products after they are 
put  into  service.  Today,  within  the  circular 
economy objectives, the Commission encourages 
that  products  are  reused,  refurbished  or  even 
remanufactured  rather  than  discarded  after  being 
in  use  for  certain  time.  This  is  one  of  the 
important perspectives of this evaluation. 
Avoiding 
creating  burdens  and  achieving 
increased  efficiency  while  preserving  the  policy 
objectives are core principles that are considered 
the 
when 
evaluation  on  these  aspects  would  inform  any 
future potential revision of the NLF. 

legislation.  Findings  of 

revising 

Conformity assessment procedures need to ensure 
in  a  changing 
that  products  are  compliant 
environment.  The  objectives  of  promoting  the 
circular  economy  and  ensuring  product  safety 
must  be  equally  addressed  in  the  conformity 
assessment  procedure.  The  NLF  evaluation 
assesses  indeed  if  those  procedures  are  efficient 
and effective to ensure the safety of products, as 

56 

 
 
to 

those  contained 

is  built.  An  evaluation  of 

notification 
the 
requirements that Notified Bodies have to fulfil, in 
addition 
in  harmonised 
standards, is necessary to provide evidence whether 
they  are still  fit  or they  need  to  be  further  detailed 
and/or  supplemented.   This  would  guarantee  the 
trust in and validity of the Notified Bodies, as well 
as their markings throughout the EU. Therefore, it 
is  proposed  that  the  NLF  evaluation  examines 
the  current  requirements  for  Notified  Bodies  in 
order  to  confirm  that  they  reflect  the  current 
market and society needs. 

well as whether or not they remain relevant. 
Furthermore,  the  evaluation  also  considers  the  rules 
and requirements for notified bodies to find out if they 
are robust enough  to  ensure  the  competence  of those 
bodies  performing  third-party  conformity  assessment 
for  the  purpose  of  EU  legislation,  as  per  Platform’s 
suggestion. 

(EU)  2019/1020 

Regulation  (EC) No 765/2008  relating to  market 
surveillance  has  been  recently  amended  by 
Regulation 
following  an 
evaluation (SWD (2017) 469), which was carried 
out in the REFIT programme context. Most of the 
Regulation’s  provisions  started  to  apply  16  July 
2021.  
The  Commission issued its  Guidance  on  Article  9  of 
Regulation  (EU)  2019/1020  on  joint  activities  to 
promote  compliance.  Market  surveillance  authorities 
might  carry  out  “joint  activities”  under  Article  9  of 
Regulation  (EU)  2019/1020  on  market  surveillance 
and  compliance  of  products  with  other  authorities  or 
organisations representing economic operators or end 
users,  with  a  view 
to  promoting  compliance, 
identifying  non-compliance,  raising  awareness  and 
harmonisation 
providing 
legislation  and  with  respect  to  specific  categories  of 
products,  including  those  that  are  offered  for  sale 
online.  If  a  market  surveillance  authority  decides  to 
carry  out  such  a  “joint  activity”,  it  must  fulfil  the 
obligations that are laid down in Article 9.  

on  Union 

guidance 

market 

internal  processes 

the  authorities  have 

Supplementary 
surveillance 
activities focused on compliance processes in 
companies:  With  an  ever-expanding  market 
and  further  increasing  complexity  of  products, 
that  have  a 
market  surveillance  activities 
broader  and  systemic  focus  can  assist  in 
ensuring  the  safety  of  products  at  an  early 
stage,  rather  than  simply  “catching”  them  at 
arrival. One way to work towards this goal is to 
supplement  traditional  controls  of  products 
with  a  review  of 
in 
companies and provide guidance for improving 
compliance  in  connection  with  inspections, 
where 
the  resources 
available  to  do  so.  Therefore,  it  is  suggested 
that  the  Commission  takes  notice  in  the 
evaluation  of  the  development  in  several 
Member  States,  who  are 
successfully 
supplementing 
traditional  market 
surveillance  –  focused  on  products  –  with 
market  surveillance  activities  focused  on 
businesses’  knowledge  and  ability  to  ensure 
safety  and,  in  particular,  on  the  quality 
assurance  process  set  up 
internally  by 
economic operators to ensure product safety. 
It  is  a  prerequisite  for  these  practices  that  the 
NLF  does  not  preclude  these  activities  and 
clearly  describes  quality  assurance  processes 
and  procedures  as  well  as  autonomous  control 
procedures and self-evaluation. 

the 

product 

Digital  information  and  documentation:  We 
recommend  that  the  Commission  evaluates 
carefully and draws lessons relevant to explore 
and 
whether 
documentation  could  be  given  digitally  as  a 
default  (digital-by-default),  except  when  the 
for 
product 
consumers.  This  information  should  always  be 
physically  available  on 
the  product.  We 
recommend  that  the  Commission  identifies 

is  mandatory 

information 

information 

The  NLF  evaluation  takes  into  account  that  products 
are  increasingly  digital  and  continuously  modified 
after  they  have  been  put  into  service.  The  NLF 
requires  a  CE  marking  that  is  visibly  and  indelibly 
affixed  on  the  product,  without  the  possibility  of  a 
digital CE marking. Additionally, certain paper-based 
documents  are  to  be  produced  by  the  manufacturer 
and  in  some  cases  accompany  the  product.  The 
evaluation  looks  into  whether  the  NLF  should  still 
keep these requirements. 

57 

 
 
 
 
where and when it could be encouraged that 
information  provided  on  the  product  could 
also  be  provided  digitally.  Digitizing 
documentation  and  other 
information  may 
improve the efficiency of enforcement and thus 
safety.  The  Commission  should  in  this  context 
take  other  ongoing  initiatives  on  digitalisation 
of  labels,  information  and  documentation  into 
consideration  and  ensure  coherence,  e.g.  with 
the  upcoming  product  passport.  A  situation 
with many different digital labels (for example 
QR-codes) on a product should be avoided.  

includes  whether  NLF 

Fit  for  crisis  situations:  We  support  that  the 
evaluation  also 
is 
adequate to perform urgently during crisis, such 
as during the COVID-19 crises. In this regard it 
might  be  relevant  to  consider  an  instrument 
for  emergency  situations,  while  considering 
potential  overlaps  with  existing  instruments. 
However,  the  Commission  must  also  consider 
whether 
and 
enforcement of existing instruments could have 
an impact as well.  

implementation 

better 

a 

One  catalogue  of  obligations  for  economic 
operators:  New obligations of economic operators 
have  been  included  in  Regulation  2019/1020  on 
Market  Surveillance  (chapter  II),  and  further 
obligations  have  been  proposed  in  the  General 
Product  Safety  Regulation.  We  would  like  this 
evaluation  to  consider  whether  it  would  be 
feasible to provide an overview of all obligations 
for  economic  operators in  one  place in the  NLF 
Framework Decision. 

of 

the 

products, 

The evaluation under the relevance aspects takes into 
increasing  digitalisation  and 
consideration 
complexity 
the 
illustrated 
development  of  the  Internet  of  Things  (IoT).  Among 
other  issues,  the  integration  of  internet  connectivity 
into  many  products  raises  considerations  regarding 
how  far  the  horizontal  legal  framework  needs  to  be 
updated  to  integrate  cybersecurity,  and  the  linkages 
between product safety and security. 

by 

The COVID-19 crisis has put to test the resilience of 
Union  product  legislation  based  on  the  NLF  and 
whether  it  can  cope  with  an  urgency  situation.  This 
evaluation assesses whether or not the lack of a crisis 
instrument renders the NLF less effective or efficient.  
Furthermore,  the  Commission  Working  Programme 
2022  –  Making  Europe  stronger  together  separately 
from this evaluation of the NLF, includes an initiative 
for  a  Single  Market  Emergency  Instrument,  which 
will  consist  of  concrete  elements  in  the  short  and 
medium  term  to  respond  to  supply  chain  disruptions 
and possible future shortages.  

The  Commission’s  proposal  for  the  General  Product 
Safety  Regulation  takes 
into  account  the  well-
established product safety framework provided for by 
EU  harmonisation  legislation.  Several  obligations  set 
out  in  the  GPSR  proposal  related  to  economic 
operators  and  market  surveillance  will  not  apply 
therefore to harmonised products. The specific safety 
requirements provided for in the GPSR proposal will 
not  apply  insofar  as  the  risks  or  categories  of  risks 
covered  by  Union  harmonisation 
legislation  are 
concerned.  As  concerns  market  surveillance,  the 
GPSR  proposal  market  surveillance  rules  align  with 
the provisions  of  the Market  Surveillance  Regulation 
(EU) 2019/1020. The proposal stipulates that relevant 
articles  of  Regulation  2019/1020  apply  to  products 
covered by the GPSR.      
Regulation  (EU)  2019/1020,  which  replaced  the 
market surveillance part of Regulation (EU) 765/2008 
introduced new definitions, such as ‘fulfilment service 
provider’,  ‘information  society  service  provider’, 
‘distance  sales’  and  ‘online  interface’,  to  capture  the 
new  roles  associated  with  the  emergence  of  online 
marketplaces.  Stakeholders  who  participated  to  the 
consolations  on  the  evaluation  of  the  NLF  welcome 
this recent revision and consider that these definitions 
could serve as a blueprint for refining the conformity 
assessment  procedures  applicable  to  these  new  types 
of  economic  operators  in  the  distribution  chain  and 
contribute to the overall coherence of the NLF model. 

58 

 
 
Consultation of the Regulatory Scrutiny Board (RSB):  

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

                     RSB recommendations 

                       Revisions introduced 

(B) Main considerations 

The  Board  notes  the  additional  information 
provided  in  advance  and  commitment  to 
make changes to the report. 

Reference  to  the  evaluation  matrix  is  added 
in  section  4.1.  For  more  details  on  changes 
please see C1) below. 

The  Board  gives  a  positive  opinion.  The 
Board  also  considers  that  the  report  should 
further improve with respect to the following 
aspects: 

(1)  The  report  does  not  make  the  evidence 
base sufficiently clear.  

(2) The presentation of evaluation findings is 
not well structured.  

The  presentation  of  evaluation  findings  is 
restructured. Please see C2) below. 

(3)  The  robustness  of  the  conclusions  is  not 
sufficiently analysed and presented. 

Please see C3) below. 

(C) Further considerations and recommendations 

Regular  references 
the  evidence  and 
to 
methods  of  evaluation  are  added  in  section 
4.1.1.. References to the underlying Study are 
also added throughout the SWD. 

References  to  the  earlier  evaluation  for  the 
Internal  Market  Legislation  on  Industrial 
Product are added in section 4.1.1.c)  . 

Reference  to  the  Evaluation  of  the  Toys 
Safety Directive is added in section 4.1.2. c). 

specific 

including 

(1) The report should be clear on the use and 
soundness  of  the  evidence  base.  It  should 
refer  more  regularly  and  precisely  to  the 
evidence, 
indicators 
outlined,  that  has  been  used  to  support  the 
findings including making specific references 
to the relevant parts of the underlying study. 
It should refer to the earlier evaluation for the 
Internal  Market  Legislation  on  Industrial 
the  earlier  sector  specific 
Products  and 
evaluations,  where 
report 
relevant.  The 
should  provide  more  details  on  the  various 
methods  used  for  collecting  and  analysing 
the  evidence.  It  should  also  provide  more 
details  on  the  evidence  used  for  the  cost-
it  has  been 
benefit  analysis  and  how 
conducted. 

(2) The evaluation  finding section should be  Sections  4.1.1.-  4.1.3.  are  restructured  as 

59 

 
 
 
 
 
 
suggested. 

reorganised  to  make  the  analysis  of  the 
evaluation  criteria,  effectiveness,  efficiency 
and coherence clearer. Currently this section 
is  structured  along  the  specific  objectives  of 
the  original  impact  assessment.  It  should  be 
restructured  by  reorganising  it  according  to 
the respective evaluation criteria.  

should  be 

clear  whether 

(3)  Taking  into  account  the  availability  and 
soundness  of  the  evidence  (see  above),  the 
report should be clearer about the robustness 
of the conclusions. Against this background, 
a  critical  reflection  on  the  quality  of  the 
conclusions  needs  to  be  incorporated.  The 
report 
the 
conclusions are largely based on stakeholder 
views  or  on  evidence  triangulated  from 
various  sources  by  different  methods.  The 
report should clarify whether data limitations 
or potential issues with the robustness of the 
analysis  have  an  impact  on  the  conclusions 
and the lessons drawn from the evaluation. In 
this  regard,  also  the  limitations  identified 
during  the  analysis  related  to  the  possible 
level of quantification, including of the costs 
and  benefits,  need  to  be  clearly  set  out.  The 
report  should  explain  why  no  other  data 
could be collected to  assess the performance 
of  the  NLF  and  in  what  respect  this  may 
affect the conclusions reached. 

the 

have 

(desk 

certain 

research, 

for  drawing 

We included short, more detailed conclusions 
at the end of every section and subsection in 
section  4.1.  This  ensures  a  more  detailed 
overview  of  the  arguments  and  limitations 
taken  account 
final 
conclusions.  The  conclusions  are  based  on 
the triangulation of all the evidence collected 
by  the  methods  listed  in  Section  1.1.  of  the 
SWD 
legal  mapping, 
interviews  and  consultations,  stakeholders’ 
workshop,  case  studies),  since  all  of  them 
separately 
limitations.  
Nonetheless,  in  the  absence  of  explicit  data 
eligible for quantification, for certain aspects 
of  the  efficiency  of  the  NLF  the  interviews 
with  the  stakeholders,  targeted  consultations 
and  the  workshop  were  crucial  methods  for 
collecting  evidence.  For  example,  reduced 
divergences,  facilitated  familiarisation  with 
the  rules,  ease  of  compliance  regulatory 
certainty  are  benefits  that  are  stressed  by  all 
stakeholders. Although their quantification is 
not  possible,  these  benefits  are  vital  for  the 
everyday  smooth  functioning  of  the  internal 
market  and  its  reliability.  We  also  explained 
in  more  details  that  some  of  the  costs  and 
benefits  cannot  be  directly  attributed  to  the 
NLF as a framework.  

evaluations, 

nonetheless, 

The Study takes account of the earlier sector 
specific 
their 
relevance  in  the  context  of  this  evaluation  is 
limited. The fact that these assessments rather 
evaluate  the  performance  of  the  specific 
pieces  of  EU  product  legislations,  from  the 
perspective of their specific policy objectives 
and without focussing on the performance of 
the NLF to the sector specific objectives sets 
limitations  to  the  suitability  of  conclusions 
drawn in the sector specific evaluations. The 
assessment 
and 
efficiency  is  in  most  cases  not  explicitly 

effectiveness 

the 

of 

60 

 
 
 
attributable to the NLF. The estimation of the 
NLF-related costs and benefits and especially 
their  quantification  are 
therefore  often 
limited.  
Although  we  often  relied  on  the  feedback 
from the stakeholders in our conclusions, we 
do  not  believe  that  this  should  weaken  the 
trustworthiness  of 
this  assessment.  The 
stakeholders’  consultations are  considered as 
a  credible  and  sufficiently  deep  base  of 
evidence,  given the diversity of participating 
stakeholders and high interest of stakeholders 
to take part in the surveys and workshop.  

61 

 
ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED 

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

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

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

  Key research questions and issues for exploration;  

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

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

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

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

Online survey questionnaires  

  The targeted consultation was supposed to be open for 8 weeks, however they were open 

for ten more days due to multiple requests from stakeholders.  

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

  The  Commission  promoted  the  evaluation  among  SMEs  and invited  them  for  contribution 

via the Enterprise Europe Network. 

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

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

62 

 
Validation workshop with the stakeholders. CSES organized a workshop with the stakeholders to 
ensure the cross-checking of the evidence and information collected in the interviews and targeted 
consultations.  46  external  stakeholders  participated  in  the  workshop,  covering  all  key  stakeholder 
groups. 
The public consultation questionnaire was open for 12 weeks, from 13th December 2021 until 7th 
March 2022. The total number of responses is 125. 

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

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

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

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

General literature on the NLF: 

  Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards, 

OJ C 136, 4.6.1985, p. 1–9. 

  2008-08-13  -  Decision  No  768-2008-EC  on  a  Common  Framework  for  the  marketing  of 

products (More) 

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

  2017-12-19  -  EC  report  on  the  implementation  of  Regulation  (EC)  No  765-2008  - 

COM/2017/0789 final (More) 

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

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

  2017-06-20  -  Ex-post  evaluation  of  the  application  of  the  market  surveillance  provisions  of 

Regulation (EC) No 765/2008 (More) 

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

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

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

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

(Download) 

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

  2017-04  -  Study  on  introducing  an  electronic  tag  to  supplement  or  replace  the  wheel  mark  in 

63 

 
marine equipment (More) 

  2018-04-19  -  EC  Implementing  Regulation  (EU)  2018-608  laying  down  technical  criteria  for 

electronic tags for marine equipment (More) 

  2017-02-16 - ECJ Case C-219-15 Elisabeth Schmitt vs TÜV Rheinland LGA Products GmbH 

(More) 

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

  2020-11 – European Parliament – IMCO Study on Legal obstacles in Member States to Single 

Market rules (more) 

  2018-11  –  Glinski  &  Rott  -  Role  and  Liability  of  Certification  Organisations  in 

Transnational Value Chains (More) 

  2018-07-12 – EC/EASME Study on the potential of servitisation and other forms of product-

service provision for EU small and medium-sized enterprises (More) 

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

  2014-10-30 – ECSIP Study for DG GROW on the relation between industry and services in 

terms of productivity and value creation – Final report (More) 

Special reports of the European Court of Auditors: 

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

  2016- – ECA Special Report - Has the Commission ensured  effective implementation of the 

Services Directive? (More) 

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

  2020 – ECA Special report on EU added value (various consideration on a functional single 

market) (More) 

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

  2020 – ECA Risks, challenges and opportunities in the EU’s economic policy response to the 

COVID-19 crisis (More) 

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

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

  2021 – 04 – new horizontal regulatory framework on AI  

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

(More) 

  2020-08-31  -  VVA  -  Impact  assessment  study  on  the  revision  of  Directive  2006-42-EC  on 

machinery - Final Report - ET0319199ENN (More) 

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

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

initiatives (More) 

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

64 

 
  2019-09-26 - High-level expert group on Artificial Intelligence POLICY AND INVESTMENT 

RECOMMENDATIONS FOR TRUSTWORTHY AI (More) 

  2019-11-06 – Guide to the application of the Directive 2006-42-EC on machinery – Edition 

2.2 (More) 

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

intelligence (More) 

NLF and the circular economy: 

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

  2020-12-10  -  Study  on  the  Competitiveness  of  the  European  Companies  and  Resource 

Efficiency (More) 

  2020-03-11  –  Communication  on  A  new  Circular  Economy  Action  Plan  for  a  cleaner  and 

more competitive Europe - COM(2020) 98 final (More) 

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

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

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

report) 

Regulatory framework regarding civil product liability: 

  2018-05-07 – EC report on the Application of the Directive on liability for defective products 

(85/374/EEC) (More) 

  2018-01  –  VVA  -  Evaluation  of  Directive  85-374-EEC  on  product  liability  -  Final  report  - 

ET0118507ENN.en (More) 

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

  2020-12  -  Cybersecurity  –  new  EU  strategy  (More).  The  strategy  was  published  on  16 
https://eur-lex.europa.eu/legal-
- 

December 
content/EN/TXT/?uri=CELEX%3A52020JC0018&qid=16116700818942020-12-02 
Industrial products - evaluation of the new legislative framework (More) 

2020 

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

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

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

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

  2020-06-30  -  Digital  Services  Act  –  deepening  the  internal  market  and  clarifying 

responsibilities for digital services (More) 

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

  2020-06-08  -  Energy  efficiency  in  buildings  –  consultation  on  ‘renovation  wave’  initiative 

(More) 

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

  2020-01-20 - Circular economy – new action plan to increase recycling and reuse of products 

65 

 
in the EU (More) 

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

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

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

  2018-06-04 - Towards an EU Product Policy Framework contributing to the Circular Economy 

(More) 

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

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

Evaluations and impact assessments of individual pieces of product legislation: 

  Evaluation  of  the  Electromagnetic  Compatibility  Directive  2014/30/EU  (still  in  progress,  but 

nearing completion). 

 

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

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

 

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

  Commission  Staff  Working  Document  -  Evaluation  of  the  Machinery  Directive  (SWD(2018) 

161 final). 

 

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

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

  Evaluation roadmap and impact assessment of the GPSD. 

Position papers: 

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

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

comments. 

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

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

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

  Eurosmart.  (2019).  The  Revision  of  the  Machinery  Directive,  Answer  to  the  European 

Commission Public Consultation. 

  Digital  Europe.  (2019).  A  strong  and  united  Europe  that  reflects  European  values  and  thrives 

globally in an open economy. 

Impact of new technologies (including AI) and digitalisation: 

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

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

trustworthy AI. 

66 

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

age. 

  Check Point. (2020). Cybersecurity Report. 

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

Good AI Society. 

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

  CSES (2020). Study on the Competitiveness of the EU Engineering Industries and the Impact of 

Digitalisation (EASME Executive Agency/ DG GROW, 2020). 

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

Parliament). 

  DG  CONNECT.  (2020).  Artificial  Intelligence.  from  https://ec.europa.eu/digital-single-

market/en/news/eu-member-states-sign-cooperate-artificial-intelligence. 

  DigitalEurope.  (2018).  Recommendations  on  AI  Policy  Towards  a  sustainable  &  innovation 

friendly approach Brussels. 

  DigitalEurope. (2019). DIGITALEUROPE recommendations on standardisation in the field of 

Artificial Intelligence. 

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

  European Commission.  (2016). Communication on Digitising European  Industry:  Reaping  the 

full benefits of a Digital Single Market, Brussels, 19.4.2016, COM(2016) 18 final. 

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

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

  European  Commission.  (2018).  Communication  Coordinated  Plan  on  Artificial  Intelligence, 

Brussels, 7.12.2018, COM(2018) 795 final. 

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

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

  European Commission. (2019). Communication on Building Trust in Human-Centric Artificial 

Intelligence, Brussels, 8.4.2019, COM(2019) 168 final. 

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

2024. 

  European  Commission.  (2020).  Communication  on  A  European  strategy  for  data,  Brussels, 

19.2.2020, COM(2020) 66 final. 

  European Commission. (2020). White Paper On Artificial Intelligence – A European approach 

to excellence and trust, Brussels, 19.2.2020, COM(2020) 65 final. 

  European  Court  of  Auditors.  (2019).  Briefing  paper:  challenges  to  effective  cybersecurity 

policy, March 2019. 

67 

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

  European  Group  on  Ethics  in  Science  and  New  Technologies.  (2018).  Statement  on  Artificial 

Intelligence, Robotics and ‘Autonomous’ Systems, Brussels, 9 March 2018. 

  Expert  Group  on  Liability  and  New  Technologies  New  Technologies  Formation.  (2019). 

Liability for Artificial Intelligence and other Emerging Digital Technologies. 

  European  Parliament.  (2019).  A  comprehensive  European  industrial  policy  on  artificial 

intelligence and robotics. 

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

  European  Parliament.  (2019).  Resolution  on  automated  decision-making  processes:  ensuring 

consumer protection and free movement of goods and services (2019/2915(RSP)). 

  European  Parliament.  (2020).  Resolution  of  20  October  2020  with  recommendations  to  the 

Commission on a civil liability regime for artificial intelligence (2020/2014(INL)). 

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

 

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

  Kreutzer,  R.  and  Sirrenberg,  M.  (2019).  Understanding  Artificial  Intelligence:  Fundamentals, 

Use Cases and Methods. 

  McKinsey  Analytics.  (2018).  Notes  from  the  AI  frontier:  AI  adoption  advances,  but 

foundational barriers remain. 

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

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

Work. 

  NESTA. (2020). AI Governance Database. 

  OECD. 

(2019).  Recommendation 

of 

the  Council 

on  Artificial 

Intelligence, 

OECD/LEGAL/0449, Adopted on 22/05/2019. 

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

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

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

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

2020. 

  REFIT  Platform.  (2017).  Opinion  on  Intention,  Digitalisation  and  Technology  Neutrality, 

Adopted 23/11/2017. 

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

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

68 

 
 
ANNEX III. EVALUATION MATRIX AND, WHERE RELEVANT, DETAILS ON ANSWERS TO THE EVALUATION QUESTIONS (BY CRITERION) 

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

Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

Effectiveness: How effective has the NLF been in achieving its general and specific objectives? 

 To what extent have the general 

 Degree of progress in 

 Perceptions on perceived obstacles 

 Desk research  

 Qualitative assessment 

and specific objectives of the NLF 
been achieved? 

achievement of the global and 
specific objectives of the NLF: 

 

Sub-question: 

1. Are there any objectives that have 
not yet been achieved and what are 
the explanatory factors? 

 Existence of objectives that 
have not been achieved and 
reasons why 

 

 Existence 

of 

obstacles 

to 

achieving the objectives 

 Perceptions as to which objectives have been achieved, 

 Survey (targeted) 

not yet achieved and any explanatory factors 

  Perceptions on factors that influenced achievement of 

objectives  

  Type of relevant technological developments and type 

of relevant environmental developments 

 Survey (public) 

 Interview programme  

of ‘effectiveness’ 
criterion  

 Case studies  

 Contextual multi-

stakeholder analysis of 
perceptions 

 Descriptive statistics 

analysis 

General objectives:  

Qualitative indicators 

 Desk research  

 Qualitative assessment 

 How  effectively  has 

towards 

the  NLF 
contributed 
the 
achievement  of  providing  a  high 
level  of  protection  of  public 
interests, such as health and safety 
in general, health and safety at the 
protection  of 
workplace, 
the 
the 
consumers,  protection  of 
environment 
security 
(Regulation (EC) No 765/2008)? 

and 

towards 

 How  effectively  has 

the  NLF 
contributed 
the 
achievement  of  ensuring  that  the 
free movement of products is not 
restricted thereby  guaranteeing  an 
internal 
efficient  and  effective 

  Effective protection of public 
interest (health and safety, 
including at the workplace, 
consumer and environmental 
protection) 

  Extent to which public interests have been protected. 

 Survey (targeted) 

  Extent to which products are circulating freely on the 

 Survey (public) 

internal market. 

 Interview programme 

of ‘effectiveness’ 
criterion  

 Case studies 

  Level of confidence in products 

in the European market  

Quantitative indicators 

  Improvements 

in 
the 

the 
effectiveness  of 
internal 
market  for  goods  through  the 
removal 
outstanding 
barriers; 

of 

  Number and % of Union harmonisation legislation 
(directives, regulations) aligned with the NLF 

  Number of CABs accredited to perform services under 

different pieces of legislation (using NLF as the 
common framework)  

  Union harmonisation 

legislation more consistent and 

 Context indicator – evolution in market size and 

structure across product legislation aligned with the 

69 

 
 
 
 
 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

market  for  economic  operators? 
(Regulation (EC) 765/2008) 

 How  effectively  has 

towards 

the  NLF 
contributed 
the 
achievement  of  establishing  a 
common  framework  of  general 
principles and reference provisions 
for  drawing  up  EU 
legislation 
harmonising  conditions  for  the 
marketing  of  products  (Decision 
No 768/2008/EC)? 

easier to implement; 

NLF. 

  Existence of the free movement 
of products without restrictions 
contributing to an effective 
internal market for economic 
operators? 

  Extent to which the EU product 
legislation is well-aligned to 
the NLF 

Specific objectives: 

 Extent to which specific 

Qualitative indicators 

 Desk research  

 Qualitative assessment 

  How  effective  has  the  NLF  been 
in  terms  of  providing  a  coherent 
basis  for  revision  or  recasts  of 
specific  product  legislation  that 
avoids  going  into  technical detail 
but  limit  itself  to  the  expression 
of essential requirements? 

terms 

  How  effective  has  the  NLF  been 
harmonising 
of 
in 
administrative 
common 
economic 
for 
requirements 
a 
operators 
Declaration 
Conformity, 
of 
technical  file,  affixing  of  the  CE 
marking)? 

(e.g.  producing 

  How  effective  has  the  NLF  been 
in  terms  of  fostering  an  efficient 
and  effective  internal  market  for 
economic operators by expressing 
requirements  without 
essential 
going  into  technical  details  while 
having  recourse  to  harmonised 
expressing 
for 
standards 

product legislation has been 
revised in line with NLF 
provisions  

 Extent to which the NLF has 
led to harmonising common 
administrative requirements  

 Extent to which rules for 
accreditation of CABs are 
clear and transparent 

 Degree to which quality and 

trust in conformity assessment 
processes has been improved 

 Extent to which CE marking 

has been clarified and 
increased in credibility 

 Clearer administrative 

requirements and information 
obligations for economic 
operators; 

 More harmonised approach to 
marketing products on the 

  More harmonised approach to marketing products on 

 Survey (targeted) 

of ‘effectiveness’ 
criterion  

 Interview programme  

 Case studies 

the European internal market;  

  More harmonised administrative requirements for 

economic operators; 

  Clearer administrative requirements and information 

obligations for economic operators 

Quantitative indicators 

  Number and % of specific product legislation revised 

in line with NLF provisions  

  Availability and number of harmonised standards 

  Number of notified bodies accredited to perform 

services under each piece of legislation aligned with 
the NLF 

70 

 
 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

technical specifications? 

European internal market; and 

terms  of 

  How  effective  has  the  NLF  been 
in 
improving  your 
confidence  in  products  placed  on 
the  market  thanks  to  the  system 
of  presumption  of  conformity 
through  the  use  of  harmonised 
standards? 

 Increased quality of the 
conformity assessment 
services 

terms  of 

improving 

  How  effective  has  the  NLF  been 
the 
in 
transparency,  quality  of  third-
party conformity assessment by 
setting clear and transparent rules 
for 
of 
conformity  assessment  bodies 
(Regulation (EC) No 765/2008)? 

accreditation 

the 

  How  effective  has  the  NLF  been 
strengthening 
of 
value 

within 

in 
terms 
traceability 
chains? 

  How  far  has 

effective 
in 
administrative simplification? 

the  NLF  been 
fostering 

  How far is the role of harmonised 
standards 
in 
accommodating  state-of-the-art 
effectively? 

for  purpose 

fit 

  How 

has 

the 
effective 
development 
accreditation 
of 
procedures  for  notified  bodies 
conformity 
and 
in 
been 
assessment 
strengthening 
the  quality  of 
conformity assessment services? 

third-country 
bodies 

71 

 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

 Has the NLF had unintended 

positive or negative consequences 
or collateral effects? 

 List  and  nature  of  unintended 
collateral 
and 

or 
positive 

both 

consequence 
effects, 
negative 

 Extent 

to 

which 

these 
consequences  or 
unintended 
collateral 
have 
contributed,  or  acted  as  a 
barrier,  to  the  achievement  of 
the objectives of the NLF 

effects 

 To what extent does the NLF 

ensure the safety and compliance 
of products during its lifetime? 

 List  and  nature  of  challenges 
to  modification  of 

related 
products during their lifetime 

 List  and  nature  of  challenges 
and 

related 
remanufacturing of products 

reuse 

to 

 Level  of  product  safety  and 
the 
compliance 
lifetime  of  products,  including 
variation by product type 

throughout 

 Level  of  variation  of  intended 
across 

product 
different product categories 

lifetimes 

 Number  and  type  of  positive  unintended  consequences 

or collateral effects 

 Number and type of negative unintended consequences 

or collateral effects 

 Survey (targeted) and 
with 
interviews 
economic  operators 
and 
industry 
associations 

 Case studies 

 Contextual 

multi-
stakeholder analysis of 
perceptions 

 Perceptions  of  the  scale  of  any  positive  or  negative 

unintended consequences or collateral effects 

  Desk research  

 Perceptions  on  their  impact  on  the  achievement  of  the 

objectives of the NLF 

 Number and type of products becoming unsafe or non-

compliant during their lifetime 

 Intended  product  lifetimes  across  different  product 

categories 

 Survey (targeted) and 
interviews 
with 
economic  operators 
and 
industry 
associations 

 Case studies  

 Contextual 

multi-
stakeholder analysis of 
perceptions 

 Number  and  type  of  products  being  modified  during 

their lifetime (e.g. software updates, AI & ML) 

 Prevalence of re-use, remanufactured products 

 Perceptions  on  the  safety  and  compliance  of  modified 

and reused / remanufactured products 

 Roles  and  types  of  economic  operators  involved  in 

remanufacturing and product modifications 

 RAPEX-SAFETY 

GATE 

 Desk research 

 To what extent has the NLF 
ensured robust conformity 
assessment procedures and made 
sure that Notified Bodies are 
accessible to economic operators 
when needed? 

 Extent to which rules for 

 Number of CABs/NBs notified for each piece of 

 Survey (targeted) and 

 Case studies 

accreditation of CABs and NBs 
are clear and transparent 

 Quality and trust in conformity 
assessment process have been 
improved, including issues of 
accessibility 

 CABs / NBs can be used by 

economic operators, across all 

harmonisation legislation  

 Number of CABs/NBs formally accredited for each 

piece of harmonisation legislation  

 Perceptions on the impacts of the NLF on CAB 

accreditation 

 Perceptions on the impacts of the NLF on the 

conformity assessment procedures, including issues of 

interviews with 
economic operators 
and industry 
associations 

 Desk research 

  Contextual multi-

stakeholder analysis of 
perceptions 

72 

 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

product legislation 

accessibility 

 % of economic operators using CABs / NBs, per 

product legislation 

 Does the accreditation guarantee 
the competence of conformity 
assessment bodies in the EU? 

 Rules for accreditation of CABs 

and NBs are clear and 
transparent 

 Quality and trust in conformity 
assessment process have been 
improved, including issues of 
accessibility 

 Number of CABs approved by regulation and directive 
across Union harmonisation legislation aligned with the 
NLF and perceptions on the impacts of the NLF on 
CAB accreditation 

 Perceptions on the impacts of the NLF on the 

conformity assessment procedures, including issues of 
accessibility 

 Survey (targeted) and 

 Descriptive statistics 

interviews with 
economic operators 
and industry 
associations 

 Desk research 

   

analysis 

 Case studies  

 Contextual multi-

stakeholder analysis of 
perceptions 

 CABs / NBs are used by 

 % of economic operators using CABs / NBs, per 

economic operators, across all 
product legislation 

product legislation 

Efficiency: To what extent were the effects achieved at a reasonable cost? 

 How far has the NLF increased the 

efficiency of EU product 
legislation overall? 

 EU product legislation has been 
successfully aligned with the 
NLF 

 Market surveillance rules have 
been improved, for products 
that could damage the 
environment or human health.108 

 Greater reliability in the quality 
of the conformity assessment 
services provided by notified 
bodies 

 Rules on requirements for the 

 Perception of stakeholders and of market surveillance 

 Survey (targeted) and 

 Qualitative assessment 

authorities. 

 Number of non-compliant products withdrawn from the 
market, by reason for non-compliance e.g. related to CE 
marking, declaration of conformity, technical 
documentation 

 Number of complaints regarding non-compliance of 

products with EU legislation (users) 

 Number of complaints regarding non-compliance of 

interviews with 
economic operators 
and industry 
associations 

 RAPEX-SAFETY 

GATE 

 EU - European Injury 
Data Base (IDB)  

of ‘efficiency’ 
criterion  

 Descriptive statistics 

analysis  

 Case studies  

 Contextual multi-

stakeholder analysis of 
perceptions  

products with EU legislation (by economic operators) 

 Desk research  

 Number of complaints regarding problems with 

 Eurostat data on 

cross- border trade in 

108 The study will not reinvent the wheel and make use of existing data e.g. REFIT evaluation (SWD(2017) 469 final) (c.f. first page of the ToR) 

73 

 
                                                 
 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

notification of conformity 
assessment bodies have been 
made clearer 

 The meaning and use of CE 
marking added value vs cost 

 Cross-border trade of products 
in the Internal Market has been 
enhanced?  

 Toolbox measures are being 

used to inform the development 
of future legislation. 

 Cost of NLF implementation in 
terms of human and financial 
resources 

accreditation rules 

goods  

 Number of complaints regarding problems with 

 Imports data  

requirements for the notification of conformity of 
assessment 

 Reported court cases, litigation or accidents, by Member 

State 

 Volume of cross-border trade in goods in the internal 

market over time, with focus on SMEs 

 Number of reported deaths and injuries involving 
certain regulated categories of products (electrical 
goods, home and leisure goods, machines used at work 
etc.) 

 Cross-comparison 

with EU27 
population growth 

 Growth in volume 

and scope of 
legislation fully or 
partially aligned with 
the NLF 

 Number of 

harmonised standards 
developed under 
NLF-type legislation 

 Data on deaths and 
injuries at work, 
home and during 
leisure activities 

 Preparing the documentation and information requested 

 Desk research  

by MSAs in NLF legislation 

 Benefits Costs Ratio and Net Present Value for 

 Regulatory costs and benefits 

economic operators  

for economic operators 

 Regulatory and administrative 
costs and benefits for notified 
bodies and market surveillance 
authorities  

 Actions required for inspections 

and their costs for national 
authorities and economic 
operators 

 Benefits Costs Ratio and Net Present Value for all 

stakeholders  

 Average time and cost for manufacturers to ensure 

conformity of equipment 

 % of the market/product segments broadly using 
harmonised standards vs. non harmonised/ other 
standards 

74 

 Triangulation with the 
number of reported 
accidents or injuries 
for certain NLF 
regulated products. 

 Sectoral CBA and 
Societal CBA 

 Survey (targeted) and 

interviews with 
economic operators 
and industry 
associations 

 Budget spent on 

market surveillance 
vs. size of the 
population 

 Survey of European/ 

national 
standardisation 

  To what extent has the NLF led to 
administrative simplifications 
and a reduction in costs and 
burdens? 

Sub-questions: 

1.  What  are  the  main  human 
resources 
financial 
the 
to 

implement 

and 
required 
NLF? 

2.  What  have  been  the  main 
types of administrative costs 
the  NLF’s 
associated  with 

 
 
Questions 

Judgement criteria 

Indicators 

from 

implementation 
an 
industry  perspective?  How 
does  this  compare  with  the 
situation  before 
the  NLF 
existed? 

3.  What  difference  have 

the 
common  provisions  in  the 
NLF  (especially  in  Decision 
No  768/2008/EC)  made 
in 
terms  of  cost  savings  (e.g. 
more 
through 
consistent 
coherent 
legislation)? 

having 
and 

 Amount of cost savings through 

common provisions 

 Costs to follow/participate in 
the standardisation process 

 Costs to use harmonised 

standards in product design 
(average in key categories of 
products: e.g. electrical, radio, 
mechanical, etc…) 

Data and information 
sources / evidence 
base 

bodies 

Assessment methods 

4.  How  far  has  the  putting  in 
place  of  the  NLF  stimulated 
innovation  and  risk-taking 
by industry? 

5.  What  are  the  overall  benefits 
of  the  NLF?  What  are  the 
specific  benefits  for  industry, 
NGOs?  To  what  extent  can 
these be quantified? 

6. 

Is the overall cost-benefit ratio 
favourable seen from i) an 
economic operator and 
industry ii) a national 
competent authority and MSA 
perspective? 

7.  How far has the NLF reduced 

compliance costs by 
eliminating inconsistencies in 
admin requirements? 

 How far do current conformity 

 Proportionate cost of 

 Average time and cost for producers to ensure 

assessment procedures and the role 

conformity assessments 

conformity of equipment 

 Survey and 

interviews with 

 Descriptive statistics 

analysis  

75 

 
Questions 

Judgement criteria 

Indicators 

of NBs guarantee product 
compliance, without creating any 
disproportionate costs? 

 Extent of product compliance 

 Number of products being rejected by notified bodies 

 Availability of relevant and 
updated information on 
applicable legislation, 
procedures and standards 

due to failing conformity assessments 

 Number of non-compliant products withdrawn from the 
market that claim to have been certified by a notified 
body 

 % of fraudulent use of a NB’s mark or certificate for 
certain product categories (domestic or imported) 

 Availability of accredited NBs 

Assessment methods 

 Case studies  

 Contextual multi-

stakeholder analysis of 
perceptions 

Data and information 
sources / evidence 
base 

economic operators 
and industry 
associations 

 Desk research 

RAPEX-SAFETY 
GATE reports 

 ICSMS database 

 Survey of Notified 
Bodies (e.g., incl. 
product blacklists on 
their own web sites 

 Survey (targeted) and 

 Descriptive statistics 

 To what degree do existing 
horizontal requirements e.g. 
affixing CE marking or other 
information required by the NLF 
remain necessary and does not 
create unnecessary burdens? 

 CE marking or other 

information required by the 
NLF is being applied correctly. 

 Strengthened awareness of the 
rules concerning the affixing of 
CE marking and other product 
information to the product itself 
(e.g., among manufacturers, 
end-users) 

 How far does the voluntary 

participation of notified bodies in 
the new accreditation framework 
introduced through the NLF ensure 
1) the quality of their services and 
2) ensure their professional 
competence? 

 How does the quality of conformity 

assessment services compare 
between notified bodies that are 
accredited and those that are not? 

 Extent to which there has been a 
discernible improvement in the 
quality of conformity 
assessment services. 

 Reduction of the need for 

central and local government to 
employ specialist assessment 
personnel.  

 Competence of NBs approved 
by accreditation organisations 

 Number of non-compliant products withdrawn from the 
market, by reason for non-compliance e.g., related to 
CE marking, declaration of conformity, technical 
documentation. 

 % of formal non-compliance vs. substantial non-

interviews with 
economic operators 
and industry 
associations 

compliance as case study of certain product categories 

 Desk research  

  ICSMS and other 

MSA data wherever 
available 

analysis  

 Case studies  

 Contextual multi-

stakeholder analysis of 
perceptions 

 % of NBs that are accredited / total. 

 Survey and 

 Descriptive statistics 

 Average time and cost needed to ensure the 

accreditation of NBs 

 Number of NBs failing their regular verification 

 Qualitative - assessment of the quality of conformity 
assessment services (i) accredited NBs and ii) non- 
accredited NBs 

 Average time and cost needed to monitor and control 

the accreditation of NBs, including for those that mostly 

interviews with 
economic operators 
and industry 
associations 

 Desk research  

 

analysis  

 Case studies  

 Contextual multi-

stakeholder analysis of 
perceptions 

76 

 
 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

operate from outside of the EU 

 To what extent has the NLF led to 
enhanced MS cooperation, market 
surveillance and border controls? 

 Strong cooperation between 
MSAs and border controls 

 Type and level of sanctions at MS level  

 National market 

 Descriptive statistics 

 Perception of stakeholders of market surveillance and 
border controls to protect consumers and ensure non-
compliant products are removed from the market 

surveillance reports 

 Contextual multi-

 Evaluation reports of 
sectoral legislation 

stakeholder analysis of 
perceptions 

 Primary research 

Future-oriented questions: 

 Additional administrative 

 Perceived room for additional administrative 

 Desk research 

 Case studies 

simplification  

 More simplified common 
horizontal requirements 

simplification 

 
 Perceived need for additional simplification of common 

horizontal requirements 

 More digitisation of the affixing 

 % of tracked products with digitised CE marking 

of the CE marking 

 Perceived clarity and effectiveness of product 

 Improved communication of 

information communication 

product information 

Survey (public and 
target) and interviews 
with economic 
operators and industry 
associations 

 Contextual multi-

stakeholder analysis of 
perceptions 

  How  far  would  it  be  possible  to 
further  simplify  administrative 
requirements 
the 
horizontal framework of the NLF 
in respect of the preparation of i) 
a DoC and ii) technical files? 

through 

  To  what  extent  could  the  NLF’s 
common 
horizontal 
requirements  be  simplified  or 
improved  in  other  specific  areas, 
e.g. modernisation of the rules on 
packaging? 

  Which  challenges 

can 

through 

technologies 

linked  with 
be 
new 
other 
addressed 
legislation? 
the  Product 
(e.g. 
Liability  Directive?  the  Services 
Directive?  an  ad  hoc  horizontal 
legislation?) 

  To 

what 

extent 

could 
digitalisation  of  the  affixing  of 
the  CE  marking  play  a  role  in 
traceability  of 
enhancing 
responsible 
products 
the 
(including 
economic  operator 

the 
to 

77 

 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

regulatory  compliance  aspects) 
along industry value chains? How 
far  could  it  lead  to  efficiency 
savings?  Would  this  also  have 
benefits for MSAs or industry? 

  How  far  could  the  efficiency  of 
the  communication  of  product 
information 
to  end-users  be 
improved  (e.g.  through  use  of  e-
documentation)?  Would  this  also 
have benefits for MSAs? 

  Are  there  any  ways  in  which  the 
NLF  could  be  updated  and/  or 
improved in a way that could help 
to  strengthen  its  efficiency  and 
yes,  what 
effectiveness? 
If 
specific  changes  need 
to  be 
made? 

 To what extent are the NLF’s 
objectives still appropriate? 

Relevance and fitness for purpose: To what extent do the objectives of the NLF still correspond to the needs? 

 Identified needs and objectives 

 Degree of alignment between the objectives of the NLF 

 Desk research 

 Qualitative assessment 

are aligned 

and identified needs, by stakeholder group 

 The role of economic 

operators vs risk assessment 
and responsibility 

 Understanding and credibility 

of CE marking 

 Conformity assessment and 

accreditation of CABs 

 Understanding and credibility 

of CE marking 

 Regulatory fitness 

 Sector-specific cases and practices that are not fully 

covered by the features in the NLF 

 Current and emerging problems regarding health, safety 
and other public interest related to marketing of non-
food products 

 Stakeholders’ perception on the need to update the NLF 
in light of emerging issues in the internal market and 
public interest 

 Primary research 

from all stakeholder 
consultation methods 
(public consultation, 
online survey, 
interview 
programme) 

of ‘Relevance’ 
criterion 

 Descriptive statistics 

analysis 

 Case studies 

 Contextual multi-

stakeholder analysis of 
perceptions 

78 

 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

 The current temporal scope 

limit of “placing on the market” 
or “putting into service” 
continues to be appropriate 

 Product harmonisation 

legislation has been brought in 
line with the NLF 

 To what extent has the NLF 
allowed for technological, 
scientific, environmental and social 
developments? 

Sub-questions: 

 Is the NLF fit for purpose in 
addressing the potential for 
substantial modifications to be 
made to products after the placing 
on the market (e.g. through 
software and firmware updates, the 
integration of third-party apps?) 

 Are the provisions of the NLF clear 
enough in respect of the roles and 
responsibilities of the different 
economic operators? 

 How far does the ‘Blue Guide’ 
provide sufficient support to 
manufacturers in understanding the 
requirements of Union 
harmonisation legislation at a more 
horizontal level?  

 Conformity assessment 

 Type of technological developments that may impact 

 Desk research 

 Qualitative assessment 

the NLF features 

 Type of obstacles to technological, scientific, 

environmental and social developments resulting from 
the NLF features 

 Type of challenges related to substantial modifications 

made to products after placing on the market 

 Primary research 

from online survey 
and interview 
programme 

of ‘Relevance’ 
criterion  

 Case studies 

 Contextual multi-

stakeholder analysis of 
perceptions 

procedures and CE marking 
facilitate technological, 
scientific, environmental and 
social developments 

 Obstacles to technological, 

scientific, environmental and 
social developments resulting 
from the NLF 

 Coverage of and challenges 

related to substantial 
modifications made to products 
after the placing on the market 

 Roles and responsibilities of the 
different economic operators are 
clearer 

 Quality of non-binding application guidelines of NLF-

aligned legislation 

 Survey (targeted) 
with economic 
operators and 
industry associations 

 Interviews with 

economic operators, 
industry associations 
and MSAs 

 Descriptive statistics 

analysis 

 Case studies 

 Contextual multi-

stakeholder analysis of 
perceptions 

 How far are the NLF provisions 

 The features of the NLF are 

 

Perception of stakeholders as to 

 Desk research 

 Descriptive statistics 

79 

 
 
Questions 

Judgement criteria 

Indicators 

still relevant in terms of new modes 
of production (i.e. remanufacturing 
and reuse, 3D printing)? 

considered appropriate to apply 
to e.g.: 

whether the NLF is fit for 
purpose in accommodating: 

o evolutive products during 

 New modes of production (i.e. remanufacturing and 

their lifetime 

reuse, 3D printing)? 

Sub-question: 

 The  NLF  (and  aligned  individual 
pieces  of  product  legislation)  is 
designed  to  be  technology-neutral. 
How far are the NLF features fit for 
in  accommodating  new 
purpose 
technologies  in  products  and  the 
changeable  nature  of  products  post 
market-placement? 

o products resulting from 

distributed design software 

 Changes to the concept of placing a product on the 
European market (e.g. due to software updates and 
upgrades, AI and machine learning) 

 

 Number/type of safety or security issues. 

 Number and type of manufacturing practices that may 

impact the NLF features. 

Data and information 
sources / evidence 
base 

Assessment methods 

 Survey (targeted) and 

analysis 

interviews with 
economic operators 
and industry 
associations 

 Case studies 

 Contextual multi-

stakeholder analysis of 
perceptions 

to 

reflect 

 To  what  extent  does  the  NLF  need 
to  be  updated 
the 
increased  complexity  of  supply 
chains  (e.g.  the  close  interactions 
between  manufacturers, 
service 
providers  and  software  and  apps 
product 
developers 
both 
development 
post-market 
placement)? 

and 

in 

 To what extent is the current suite 
of conformity assessment modules 
well-adapted to the latest 
manufacturing and distribution 
practices? (e.g. division of roles 
across different economic operators 
in value chain in the design phase 
and in manufacturing)? 

Sub-question: 

 Should 

there 

be 

a 

specific 

 Coverage of, and challenges 

 Number and type of manufacturing and business/ 

 Desk research 

 Descriptive statistics 

related to new types of business 
models (e.g. distributed 
servitisation) and new types of 
economic operators (e.g. digital 
platforms, fulfilment centres) 

 Impact on product safety by 

products already on the market 
undergoing substantial 
modifications  

distribution practices that may impact the NLF features. 

 Survey and 

interviews with 
economic operators 
and industry 
associations 

analysis  

 Case studies  

 Contextual multi-

stakeholder analysis of 
perceptions 

80 

 
 
 
 
 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

in 

regime 

regulatory 
terms  of 
obligations  of  economic  operators 
and administrative requirements for 
(re)placing  products  on  the  market 
that  do  not  involve  substantial 
modifications to products that have 
already been placed on the market? 
If yes, in which way?  

to 

 To  what  extent  does 

relevant 

the  NLF 
continue 
to 
be 
addressing  [MSA;  industry;  NGO] 
needs  (e.g.  for  regulatory  certainty 
and  predictability,  for  common, 
consistent  and  coherent  rules  on 
placing  products  on  the  European 
market)  and  consumer  needs  (e.g. 
considering  new 
tech,  circular 
economy)? 

 How far does the lack of a specific 
crisis instrument make the NLF less 
effective or efficient? 

Sub-questions: 

 How  far  has  the  NLF  helped  or 
hindered  in  mitigating  the  adverse 
economic effects of the COVID-19 
pandemic? 

they 

 Are  there  legal  gaps  in  the  NLF 
that need to be addressed? How far 
could 
be 
individual 
through 
addressed 
pieces  of  product  legislation,  or 
through  new  horizontal 
legal 
frameworks  (e.g.  on  AI,  possibly 

alternatively 

 Balance between economic 

 Number and type of mandatory administrative steps 

 Survey (targeted) and 

 Descriptive statistics 

operators taking responsibility 
and mandatory pre-marketing 
controls (third-party) 

 Availability of alternative CA or 
fast-track approval procedures  

 Existence of legal gaps within 

the NLF 

before placing a product on the market under the NLF 

 Levels of awareness among new market entrants about 

the requirements in the legislation on PPE 

 Speed of development of harmonised standards and 

availability for use after citation in the OJEU 

analysis  

 Case studies 

  Contextual multi-

stakeholder analysis of 
perceptions 

interviews with 
economic operators 
and industry 
associations, 
especially in the 
medical device and 
personal protective 
equipment sectors 

 Survey of European/ 

national 
standardisation 
bodies 

81 

 
 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

on cybersecurity)? 

Coherence: To what extent are there issues of coherence with other interventions and wider EU policy or legislation? 

 Are there any inconsistencies, 
overlaps or gaps within the 
different provisions of Decision No 
768/2008/EC and Regulation (EC) 
No 765/2008)?  

 To what extent is the NLF still 

consistent with Union harmonised 
legislation applicable to products? 

 How far is the NLF coherent with 
other types of new legislation (e.g. 
the non-mandatory Cybersecurity 
Act) and in terms of the application 
of Directive 2001/95/EC to 
harmonised products not already 
covered by sectoral legislation? 

Sub-questions: 

 Are there any missing definitions? 

 How  far  are  the  definitions  in  the 
NLF  appropriate?  Does  this  take 
into  adequate  consideration 
the 
evolution of business models where 
products  are  placed  on  the  market 

 Extent to which discrepancies 

 Number of discrepancies, gaps or inconsistencies 

 Desk research 

 SCM analysis 

and inconsistencies have 
emerged within the different 
provisions of Decision No 
768/2008/EC and Regulation 
(EC) No 765/2008)? 

 Elimination of inconsistencies, 
overlaps and gaps in Union 
harmonisation legislation 
compared with previous 
situation 

 Extent to which the NLF has 
brought coherence across the 
current pieces of EU product 
legislation 

 Consistency of NLF with 

future/other EU legislation 
addressing other aspects of the 
product than its placing on the 
market. 

between Decision No 768/2008/EC and Regulation 
(EC) No 765/2008) 

 Survey and 

interviews with 
economic operators 
and industry 
associations 

 Content/categorical 
analysis based on 
survey and interview 
data 

 Contextual multi-

stakeholder analysis of 
how the discrepancies 
influence market 
behaviour 

 Number of discrepancies with the NLF by product 

 Desk research 

 SCM analysis 

legislation 

 Types of inconsistencies between NLF and different 

legal provisions in EU legislation (e.g. GPSD, 
occupational health and safety legislation, 
cybersecurity, etc…) 

 Perceived clarity by stakeholders of definitions within 

 Survey (targeted) and 

interviews with 
economic operators 
and industry 
associations 

 Content/categorical 
analysis based on 
survey and interview 
data 

 Contextual multi-

stakeholder analysis of 
how the discrepancies 
influence market 
behaviour 

 Clarity of definitions within the 

the NLF 

NLF 

 Perceived regulatory certainty by economic operators  

 Degree of regulatory certainty 

for economic operators 

82 

 
 
 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

the 
as  part  of  services,  and 
the  complexity  of 
evolution 
value  chains  prior  to  putting  those 
serviced products onto the market? 

in 

 Are  the  common  obligations  and 
administrative  requirements  set 
out  in  individual  pieces  of  sectoral 
legislation 
(NLF-aligned) 
sufficiently  clear  to  provide  for 
economic operators with regulatory 
certainty? 

 To  what  extent 

is 

the  NLF 
sufficiently  clear  in  terms  of  how 
risks  relating  to  the  integration  of 
into  products 
new  technologies 
should  be  assessed,  managed  and 
mitigated  by  manufacturers  and 
other  EO  in  the  value  chain?  Does 
the  new  AI  proposal  provide 
regulatory clarity for the NLF? 

 Are  there  any  comments  on  the 
interaction between the NLF  and 
other  EU  legislation,  in  particular 
individual  pieces  of  product  safety 
and sectoral legislation? Horizontal 
the 
legislation, 
Product 
Liability  Directive, 
the  General 
Product  Safety  Directive  (GPSD)? 
Other  types  of  relevant  legislation 
and  policies  e.g. 
the  Services 
Directive,  Occupational  Health  & 
Safety Directives? 

e.g. 

EU added value: To what extent does the NLF add value compared to what could be achieved at the national level? 

 What is the NLF’s added value 

 Stakeholder perceptions on 

 Estimated costs saved by complying with a harmonised 

 Survey (targeted) of 

 Qualitative assessment 

83 

 
Questions 

Judgement criteria 

Indicators 

regime over several national regimes. 

 Estimated benefit of the harmonisation in case of 

national divergent regulations for the same product 

 Number and cost of eliminated inspections (as 

conducted in other MS) 

 Estimated reputational benefits 

compared to what could have been 
achieved at merely national level? 

counterfactual considerations 
relating to added value.  

 Assessment of the extent of 
European value added for 
manufacturers following 
regulatory requirements at EU 
rather than national level. 

 Assessment of the extent of 
European value added for 
consumers. 

a 

 How  far  has  the  NLF  framework 
added  value  through  the  provision 
legal 
common  EU 
of 
framework  to  ensure  a  high  level 
of  protection  of  public  interests, 
such  as  health  and  safety 
in 
general,  health  and  safety  at  the 
protection  of 
the 
workplace, 
consumers,  protection  of 
the 
environment and security? 

 How  far  has  the  NLF  framework 
added  value  to  establish  general 
principles and reference provisions 
for drawing up EU legislation for 
regulators? 

Data and information 
sources / evidence 
base 

economic operators 
and industry 
associations 

Assessment methods 

of EU value added  

 Quantitative 

assessment of 
estimated cost savings 

 What  are  the  main  differences 
between  the  situation  before  the 
NLF was adopted and the recasting 
of 
and 
Regulations  thus  far  aligned  with 
the NLF? 

23  Directives 

the 

 Do the needs and challenges 

 Extent to which identified needs 

 Proxy indicators - % non-compliance of particular 

 Survey (targeted) and 

 Descriptive statistics 

addressed by the NLF continue to 
require (harmonisation) action at 
EU level?  

and objectives are aligned. 

products  

 Extent to which the features of 

 

the NLF are considered 
appropriate 

(identified in joint market surveillance campaigns under 
particular  directives  and  regulations  e.g.  through  the 
ADCOs)  

 Whether provisions are needed 
to ensure the product remains 
compliant during its lifetime. 

 Number of enforcement measures taken against non-

compliant products by MSAs 

 Degree of alignment between the NLF objectives, the 

interviews with 
economic operators 
and industry 
associations 

analysis  

 Case studies  

 Contextual multi-

stakeholder analysis of 
perceptions 

84 

 
 
Questions 

Judgement criteria 

Indicators 

Data and information 
sources / evidence 
base 

Assessment methods 

essential requirements and identified needs 

 What would be the most likely 
consequences of repealing the 
NLF? 

 Extent to which stakeholders 
and national administrations 
would be affected by a repeal of 
the NLF 

 Budget allocated to market surveillance (including costs 

 Survey (targeted) and 

 Contextual multi-

of the enforcement activities) 

 Difference in the enforcement costs by MS  

 Trends of internal market trade and exports  

interviews with 
economic operators 
and industry 
associations 

stakeholder analysis of 
perceptions 

85 

 
 
ANNEX IV. OVERVIEW OF BENEFITS AND COSTS 

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

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

Overview of costs and benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

[Other] 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Enforcement costs 

Resources spent 
by bodies at 
European level 
to ensure NLF 
implementation 

Resources spent 
by national 
authorities to 
ensure NLF 
implementation 

Resources spent 
by economic 
operators during 
conformity 
assessment 
procedures 

Resources spent 
by economic 
operators for 
development of 
standards 

Recurrent 

N/A 

N/A 

N/A 

N/A 

0 

Resources spent by 
the Commission’s 
relevant units in 
relation to NLF 
implementation are 
considered to be 
business-as-usual 
costs. 

270,000-
360,000 Euro 

Incremental cost of EA 

Recurrent 

N/A 

N/A 

N/A 

N/A 

Recurrent 

N/A 

N/A 

Recurrent 

N/A 

N/A 

0 

0 

Since the principles of 
conformity assessment 
have not changed with 
the 2008 introduction of 
the NLF, no additional 
costs are identified 
compared to the previous 
conditions. 

The cost of the 
development of 
standards within the 
ESOs was approximately 
3,000 million Euro in 
2009. The approximate 

86 

Not 
quantifiable 

Resources spent by 
notifying authorities 
in relation to NLF 
implementation. 

Not 
quantifiable 

Resources spent by 
accreditation bodies in 
relation to NLF 
implementation (importantly, 
this cost is however borne 
largely by conformity 
assessment bodies through 
the purchase of accreditation 
services). 

N/A 

N/A 

N/A 

N/A 

0 

The approximate 
cost of creating one 
standard was 
estimated at 
approximately 1 
million Euro. This 

N/A 

N/A 

 
 
Overview of costs and benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

[Other] 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

cost of creating one 
standard was estimated 
at approximately 1 
million Euro. This cost is 
financed primarily by 
industry (93-95%). Since 
no changes related to 
standards were 
introduced with the 2008 
NLF, no additional costs 
are identified compared 
to the previous 
conditions. 

Since no changes related 
to CE marking were 
introduced with the 2008 
NLF, no additional costs 
are identified compared 
to the previous 
conditions. 

cost is financed by 
national 
governments for 
around 3-5% and the 
Commission/EFTA 
for around 2%. 
Since no changes 
related to standards 
were introduced 
with the 2008 NLF, 
no additional costs 
are identified 
compared to the 
previous conditions. 

N/A 

N/A 

N/A 

N/A 

Cost of CE 
marking 

Recurrent 

N/A 

N/A 

0 

Costs related to 
the accreditation 
framework: 
examination fee 
to an 
accreditation 
body 

One-off 
(every time an 
accreditation 
expires) 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

Costs related to 
the accreditation 
framework: 
annual fee to 
accreditation 
body 

Recurrent 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

87 

4,000-20,000 
Euro per 
accreditation 

(cumulative 
cost borne by 
CABs on the 
European 
scale in 
relation to 
accreditation 
in the order of 
magnitude of 
hundreds 
million Euro) 

Different 
practices by 
country (see 
comment). 

In addition to country-
specific differences in fees, 
variations in costs borne by 
conformity assessment 
bodies also depend on the 
extent of the scope being 
sought, the number of 
locations, the experience and 
involvement of the 
conformity assessment body, 
the maturity of the quality 
management system and its 
processes, the availability of 
staff resources. 

Concerning this cost, 
differences between 
accreditation bodies 
emerged. Among those 
bodies who foresee a 
maintenance fee, there are 

 
 
(continuous 
monitoring costs, 
maintenance fee) 

Costs related to 
the accreditation 
framework: cost 
of developing a 
quality 
management 
system 

Costs related to 
the accreditation 
framework: 
insurance fee 

Reduced costs in 
familiarisation 
with legislation 
thanks to the 
introduction of 
common 
definitions 

Cost savings in 
conformity 
assessment 
activities 

Enhanced legal 
certainty 

Overview of costs and benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

[Other] 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Recurrent 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

0 

the Italian body (maintenance 
fee calculated as a share of 
turnover) and the Latvian 
body (annual fee of 425 
Euro). In Slovenia, a 
maintenance fee is charged at 
each surveillance visit (either 
on 12 or 15 months). 

Established CABs typically 
already have a quality 
management system with 
established procedures in 
place, and already had a 
quality manager dealing with 
it. Considering this cost as 
being 100% borne even in 
the absence of the 2008 NLF, 
no additional costs can be 
identified compared to the 
previous scenario. 

Recurrent 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

Not 
quantifiable 

Sector-specific and country-
specific variations. 

Recurrent 

N/A 

N/A 

Not 
quantifiable 

Direct benefits 

Savings thanks to 
absence of divergent 
requirements (e.g. 
common suite 
conformity assessment 
modules) 

Not 
quantifiable 

N/A 

N/A 

N/A 

Recurrent 

N/A 

Recurrent 

N/A 

N/A 

N/A 

Not 
quantifiable 

Savings thanks to greater 
coherence between 
directives 

Not 
quantifiable 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

88 

 
 
 
Overview of costs and benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

[Other] 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Indirect benefits 

Increased safety, 
health, and 
reduced 
environmental 
damages 

Recurrent 

Not 
quantifiable 

Benefits deriving 
from the reduction 
of differences in the 
activities carried out 
by the notified 
bodies (thanks to the 
NLF). 

Single market 
benefits 

Recurrent 

N/A 

N/A 

Enhanced global 
relevance of EU 
regulations 

Recurrent 

Not 
quantifiable 

Benefit deriving 
from the ability of 
EU legislation to 
elevate its model 
worldwide and 
shape international 
practices (so-called 
‘Brussels effect’). 
This in turn supports 
the global standing 
of the EU in global 
commerce. 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

Order of 
magnitude: 
tens of 
billions of 
Euro. 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

Enhancement of 
Europe’s 
industrial 
competitiveness 

Recurrent 

N/A 

N/A 

Not 
quantifiable 

Comparative 
competitiveness between 
European manufacturers 
and third country 
counterparts. 

N/A 

N/A 

N/A 

N/A 

89 

 
 
 
 
 
 
Overview of simplification and burden reduction in the NLF 

Simplification and burden reduction (savings already achieved) 

Citizens / Consumers 

Businesses 

Administrations 

[Other] 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Indirect compliance cost savings 

Recurrent 

N/A 

N/A 

Not quantifiable 

Savings thanks to absence of 
divergent requirements (e.g. 
common suite conformity 
assessment modules) 

Not quantifiable 

N/A 

N/A 

N/A 

Recurrent 

N/A 

N/A 

Not quantifiable 

Savings thanks to greater 
coherence between directives 

N/A 

N/A 

N/A 

N/A 

Reduced costs in 
familiarisation 
with legislation 
thanks to the 
introduction of 
common 
definitions 

Cost savings in 
conformity 
assessment 
activities 

Potential simplification and burden reduction (savings) 

Further potential simplification and savings that could be achieved with a view to make the initiative more effective and efficient without prejudice to its policy objectives. 

Citizens/Consumers 

Businesses 

Administrations 

[Other] 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Possibility to increase efficiency through the introduction of an e-labelling scheme 

Recurrent 

N/A 

N/A 

490 million 
Euro per 
year 

A general consensus was found among 
interviewees on the possibility to 
increase efficiency through the 
introduction of an e-labelling. 

N/A 

N/A 

N/A 

Recurrent 

Recurrent 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

Possibility of accreditation with accreditation body of a different MS 

Not 
quantifiable 

Opening the chance of being 
accredited to the accreditation 
body of a different Member 
State could increase efficiency 
(e.g. since a national body can 
be slower and more costly than 
other ones) 

Remote assessment 

90 

 
 
 
 
Further potential simplification and savings that could be achieved with a view to make the initiative more effective and efficient without prejudice to its policy objectives. 

Citizens/Consumers 

Businesses 

Administrations 

[Other] 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Quantitative 

Comment 

Potential simplification and burden reduction (savings) 

Recurrent 

N/A 

N/A 

Not 
quantifiable 

Not 
quantifiable 

Strong indications that CABs could 
achieve cost savings and other positive 
impacts through the use of remote 
assessment techniques. 

Potential additional costs related to 
developing / familiarisation with new 
standards on remote techniques. 

Strong indications that NABs 
could achieve cost savings and 
positive environmental and 
efficiency impacts through the 
use of remote assessment 
techniques. However, given the 
nature of NABs, the cost 
savings should be passed on to 
CABs. 

Potential additional costs 
related to developing / 
familiarisation with new 
guidance / standards on remote 
techniques. 

Not 
quantifiable 

Strong indications that EA could 
achieve cost savings and other 
positive impacts through the use 
of remote techniques in the peer 
evaluation process. However, 
there will be additional costs 
(borne by EA and ESOs) 
associated with developing 
guidance and standards related 
to remote assessment 
techniques. 

91 

 
 
 
ANNEX V. STAKEHOLDERS CONSULTATION - SYNOPSIS REPORT  

Objectives of the consultation 

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

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

Consultation methods and tools 

The  main  consultation  activities  contained  an  interview  programme,  a  targeted  online 
consultation survey and a public online consultation survey. A total of 92 stakeholders were 
interviewed;  the  targeted  consultation  received  a  total  of  361  responses  with  190  complete 
responses; and the public consultation received 125 responses, with 95 complete responses. 
Furthermore,  a  stakeholder  validation  workshop  was  held  on  9th  March  2022,  where  the 
Commission presented the background and context  to the evaluation  of the NLF, clarifying 
the scope and the objectives of both  the NLF and the evaluation.  The evaluation  team  then 
presented  an  overview  of  the  study’s  methodological  approach,  the  conceptual  challenges 
related to the evaluation and the findings and conclusions from the research. 

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

Results of the consultation activities 

Interviews 

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

In  total,  117  stakeholders  were  contacted  and  interviews  were  conducted  with  92 
stakeholders.  These  engagements  span  the  following  key  stakeholder  groups:  economic 
operators;  industry  associations;  conformity  assessment  stakeholders  (including  notified 
bodies); consumer associations; EU and national authorities; standardisation bodies; and legal 

92 

 
 
 
 
experts.  The  below  table  provides  the  full  breakdown  of  interview  status  per  stakeholder 
group. 

Targeted consultation 

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

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

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

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

technology-neutral  approach 

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

93 

 
 
framework and the efficacy of its implementation, as well as ensuring the safety of products 
within the single market.  

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

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

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

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

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

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

94 

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

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

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

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

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

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

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

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

95 

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

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

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

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

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

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

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

Stakeholders were consistent in their answers regarding the extent to which the NLF is able 
to accommodate important trends related to the circular economy examined: between 41.4% 
and 45.5% (82 and 90 responses) agreed to at least a moderate extent that the NLF was able 
to accommodate the key trends in question. On the other hand, between 27.3% and 41.4% (54 
and 82 responses) thought this was only the case to a small extent or not at all. Only 21.5% of 
stakeholders (43 responses) perceive that the requirements for economic operators related to 
(re)placing substantially modified products on the market remain fully clear, while 33.5% (67 
responses)  perceive  that  the  definitions  of  different  economic  operators,  in  light  of  new 
models  of  production  and  increasing  value  chain  complexity,  remain  fully  clear.  Finally, 

96 

 
regarding  the  impact  of  the  COVID-19  pandemic,  asked  about  the  extent  to  which  it  took 
products that were instrumental in the fight against COVID-19 too long to be placed on the 
market,  almost  half  of  stakeholders  (49.7%,  89  responses)  agreed  that  it  took  too  long 
(whether  to  a  small,  moderate,  or  great  extent).  However,  most  stakeholders  (43.6%,  78 
responses)  responded  that  they  don’t  know.  Only  6.7%  of  stakeholders  (12  responses) 
answered ‘not at all’ i.e., that it had not taken too long for products such as PPE and medical 
devices to be placed on the market during the pandemic. 

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

Public consultation 

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

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

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

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

97 

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

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

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

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

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

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

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

98 

 
sure  about  providing  the  CE  marking  in  a  digital  form:  44%  thought  this  would  have  a 
positive  or  very  positive  impact  on  consumers  (54  responses),  while  24%  thought  it  would 
have a negative or very negative impact (30 responses). 

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

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

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

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

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

Stakeholder validation workshop 

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

99 

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

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

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

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

Feedback to stakeholders 

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

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

100 

 
barriers; and, as a result, enhanced industrial competitiveness. A further strategic benefit was 
the enhanced global recognition of the CE marking stemming from its prominence within the 
NLF. 

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

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

101 

 
ANNEX VI. CONFORMITY ASSESSMENT – STATE OF PLAY  

The system of notified conformity assessment bodies 

Notifying authorities. The model provision R14 of the Annex of Decision No 768/2008/EC 
sets out that Member States should designate a notifying authority responsible for setting up 
and carrying out the necessary procedures for the assessment and notification of conformity 
assessment bodies and the monitoring of notified bodies. 
Across the body of NLF-aligned legislation, 160 notifying authorities are in operation,109 with 
139 based across the EU-27, 12 in the EEA-EFTA countries110 and nine spanning seven third 
countries111.  These  notifying  authorities  may  have  responsibility  for  one  or  multiple  NLF-
aligned legislation.  

In  terms  of  territorial  coverage  in  the  Member  States,  25  Member  States  have  established 
notifying authorities for each of the NLF-aligned legislation (at least 17 out of 21) for which 
notification  of  CABs  is  relevant.112113  In  some  instances,  Member  States  have  multiple 
notifying authorities with responsibility for one NLF-aligned legislation.114  

Only  two  directives  have  notifying  authorities  in  all  27  Member  States:  the  Toys  Safety 
Directive and the Construction Products Regulation115.  

Notified  conformity  assessment  bodies.  Chapter  R4  of  the  Annex  of  Decision  No 
768/2008/EC details extensive reference provisions related to the notification of conformity 
assessment  bodies,  including,  amongst  other  provisions,  the  procedure  for  notification,  and 
the  requirements  relating  to,  and  obligations  on,  both  notifying  authorities  and  notified 
bodies. 
There are 1649 notified bodies across the 21 NLF legislation.116  

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

109  NB:  Analysis  conducted  on  data  extracted  from  the  European  Commission’s  online  NANDO  database  in 
November  2021.  Since,  a  small  number  of  changes  to  the  roles  of  national  notifying  authorities  have  been 
implemented; for instance, in Germany, the authority responsible for Directives 2014/31/EU and 2014/32/EU is 
now the Bundesministerium für Wirtschaft und Klimaschutz (BMWK); it was formerly the Bundesministerium 
für Wirtschaft und Energie (BMWi). 
110 Comprising 5 notifying authorities in Iceland, 1 in Liechtenstein, and 6 in Norway. 
111 Comprising 1 in Australia, 2 in Canada, 1 in Switzerland, 1 in Japan, 1 in New Zealand, 1 in Turkey and 2 in 
the US. 
112 The RoHS Directive 2011/65/EU and the  Low Voltage Directive 2014/35/EU only use module A (internal 
product control) and therefore do not require the notification of conformity assessment bodies. 
113  The  exceptions  are  Cyprus,  which  covers  13  of  the  21  relevant  NLF-aligned  laws,  and  Malta,  which  only 
covers eight. 
114  For  example,  in  Poland,  both  the  Ministry  of  Economic,  Development,  Labour  and  Technology  and  the 
Ministry of Infrastructure have responsibility for the Transportable Pressure Equipment Directive. 
115 Most NLF-aligned legislation are covered in most Member States (between 24-27 countries); the remaining 
legislation  is  the  Marine  Equipment  Directive  (23  Member  States),  the  Radio  Equipment  Directive  (22),  the 
Civil Explosives Directive (21) and the Cableway Installations Regulation (18). 
116 The vast majority (1,489) of CABs are notified by Member State authorities: these NBs account for 90.7% of 
the total notifications (2,198 of 2,424).  
The remaining NBs have been notified by EEA-EFTA countries (29) or third countries which may notify their 
conformity  assessment  bodies  based  on  Mutual  Recognition  Agreements  with  the  EU116  (131).  These  NBs 
account for 1.7% (40) and 7.7% (186) of the total notifications, respectively.  

102 

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

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

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

Statistics from NANDO  

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

117 Beyond these, the highest number of notifications for a single legislation is 175 (8% – Transportable Pressure 
Equipment Directive). The legislation with the fewest notifications at the time of analysis are the EU Fertilising 
Products Regulation (3 notification) and the In vitro Diagnostic Medical Devices Regulation (6 notifications). 
118 https://ec.europa.eu/growth/tools-databases/nando/ 

103 

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

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

Legislation 

Name of legislation  

In force 

NLF-aligned 

2014/34/EU 

ATEX Directive  

Regulation (EU) 2016/424 

Cableway Installations Regulation 

2014/28/EU 

Civil Explosives Directive 

Regulation (EU) 305/2011 

Construction Products Regulation 

2014/30/EU 

Electromagnetic Compatibility Directive  

Regulation (EU) 2019/1009 

Fertilising Products Regulation 

Regulation (EU) 2016/426 

Gas Appliances Regulation  

Regulation (EU) 2017/746 

In Vitro Diagnostic Medical Devices Regulation  

2014/33/EU 

2014/90/EU 

2014/32/EU 

Lifts Directive 

Marine Equipment Directive  

Measuring Instruments Directive 

Regulation (EU) 2017/745 

Medical Devices Regulation 

2014/31/EU 

Non-automatic Weighing Instrument Directive 

Regulation (EU) 2016/425 

Personal Protective Equipment Regulation 

2014/68/EU 

2013/29/EU 

2014/53/EU 

2013/53/EU 

2014/29/EU 

2009/48/EC 

2010/35/EU 

Pressure Equipment Directive  

Pyrotechnic Articles Directive  

Radio Equipment Directive  

Recreation Craft and Personal Watercraft Directive  

Simple Pressure Vessels Directive  

Toy Safety Directive  

Transportable Pressure Equipment Directive  

Regulation (EU) 2019/945 

Unmanned Aircraft Systems Regulation 

104 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

 
 
Legislation 

Name of legislation  

In force 

Regulation (EC) 552/2004 

Air Interoperability Regulation 

92/42/EEC  

Boiler Efficiency Directive  

Not NLF-aligned 

Decision 2009/750/EC 

European Electronic Toll Service Decision 

2006/42/EC 

2000/14/EC 

2016/797 

90/385/EEC 

94/9/EC 

2000/9/EC 

93/15/EEC 

89/106/EEC 

89/336/EEC 

2004/108/EC 

2009/142/EC 

98/79/EC 

95/16/EC 

Machinery Directive  

Outdoor Noise Directive 

Rail Interoperability Directive 

Old Active Implantable Medical Devices Directive  

Old ATEX Directive 

Old Cableway Installations Directive  

Old Civil Explosives Directive 

Old Construction Products Directive  

Old Electromagnetic Compatibility Directive_1989 

Old Electromagnetic Compatibility Directive_2004 

Old Gas Appliances Directive 

Old In Vitro Diagnostic Medical Devices Directive  

Old Lifts Directive  

2006/95/EC 

Old Low Voltage Directive 

98/37/EC 

96/98/EC 

2004/22/EC 

93/42/EEC 

Old Machinery Directive 

Old Marine Equipment Directive  

Old Measuring Instruments Directive  

Old Medical Devices Directive  

2009/23/EC (ex-90/384/EEC)  Old Non-automatic Weighing Instruments Directive  

89/686/EEC 

97/23/EC 

2007/23/EC 

99/5/EC 

2008/57/EC 

94/25/EC 

2009/105/EC 

98/13/EEC 

Old Personal Protective Equipment Directive 

Old Pressure Equipment Directive  

Old Pyrotechnic Articles Directive  

Old Radio Equipment Directive  

Old Rail Interoperability Directive 

Old Recreational Craft Directive  

Old Simple Pressure Vessels Directive  

Old Telecommunications Terminal Equipment Directive  

105 

Yes 

Yes 

No 

Yes 

Yes 

Yes 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

 
Legislation 

88/378/EEC 

2001/16/EC 

96/48/EC 

99/36/EC 

ATEX Directive  

Old ATEX Directive 

Name of legislation  

Old Toy Safety Directive  

In force 

No 

Old Trans-European Conventional Rail Interoperability Directive  No 

Old Trans-European High-Speed Rail Interoperability Directive  No 

Old Transportable Pressure Equipment Directive 

No 

Table 2 Pieces of legislation covered by NANDO 

2008  2009  2010  2011  2012  2013  2014  2015  2016  2017  2018  2019  2020  2021 

0 

0 

0 

0 

0 

0 

0 

0 

0 

57 

63 

68 

71 

75 

0 

0 

0 

0 

0 

81 

89 

92 

95 

96 

3 

0 

0 

0 

3 

0 

0 

8 

3 

0 

0 

3 

0 

0 

3 

0 

0 

37 

47 

45 

0 

0 

0 

2 

0 

4 

Cableway Installations Regulation 

0 

0 

0 

0 

0 

0 

0 

0 

0 

53 

53 

54 

54 

56 

59 

61 

64 

66 

0 

0 

0 

1 

0 

0 

0 

17 

18 

19 

Old Cableway Installations Directive  

23 

23 

24 

23 

24 

23 

24 

24 

23 

24 

23 

0 

0 

0 

Civil Explosives Directive 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Old Civil Explosives Directive 

13 

13 

13 

12 

12 

12 

13 

13 

12 

8 

0 

11 

10 

10 

10 

0 

0 

0 

0 

Construction Products Regulation119 

0 

0 

0 

0 

0 

0  459  587  620  632  648  653  653  669 

Old Construction Products Directive120  

554  612  651  669  697  732 

Electromagnetic Compatibility Directive  

Old Electromagnetic Compatibility Directive_1989 

0 

3 

0 

3 

0 

3 

0 

3 

0 

3 

0 

3 

0 

0 

3 

0 

0 

3 

0 

1 

3 

Old Electromagnetic Compatibility Directive_2004 

119  160  163  165  170  153  153  145  143 

Fertilising Products Regulation121 

Gas Appliances Regulation  

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Old Gas Appliances Directive 

46 

46 

45 

47 

48 

49 

47 

49 

50 

50 

55 

In Vitro Diagnostic Medical Devices Regulation  

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Old In Vitro Diagnostic Medical Devices Directive  

21 

19 

19 

20 

21 

22 

22 

21 

20 

18 

17 

18 

18 

18 

Lifts Directive 

Old Lifts Directive  

0 

0 

0 

0 

0 

0 

1 

1 

14  224  235  231  229  234 

234  251  256  253  241  230  238  239  235 

0 

0 

0 

0 

0 

Marine Equipment Directive  

0 

0 

0 

0 

0 

0 

0 

0 

0 

22 

37 

37 

40 

44 

Old Marine Equipment Directive  

30 

30 

30 

30 

29 

30 

31 

33 

34 

1 

1 

1 

1 

1 

Measuring Instruments Directive 

0 

0 

0 

0 

0 

0 

0 

0 

1 

86 

97 

98 

96 

93 

Old Measuring Instruments Directive  

53 

76 

92 

94  103  104  104  104  104 

Medical Devices Regulation 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

8 

0 

17 

Old Active Implantable Medical Devices Directive  

19 

19 

19 

18 

18 

19 

17 

16 

15 

13 

12 

11 

11 

10 

Old Medical Devices Directive  

69 

68 

68 

69 

75 

75 

70 

66 

58 

53 

52 

54 

54 

53 

Non-automatic Weighing Instrument Directive 

0 

0 

0 

0 

0 

0 

0 

0 

1 

65 

71 

71 

71 

74 

Old Non-automatic Weighing Instruments Directive  

205  204  206  182  186  188  188  184  175 

1 

1 

1 

1 

1 

119  Data  include  also  Technical  Assessment  Bodies  under  the  current  Construction  Products  Regulation.  See 
legislation-specific section for further details. 
120 Data include also  Approved Bodies under the  old Construction Products Directive. See legislation-specific 
section for further details. 
121 Three NBs under the Fertilising Products Regulation started their activities in late 2021. As the figures for 
each year relate to the 1st of January, these three NBs are not considered in the table. 

106 

 
 
  
                                                 
 
2008  2009  2010  2011  2012  2013  2014  2015  2016  2017  2018  2019  2020  2021 

Personal Protective Equipment Regulation 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

36 

89  101  106 

Old Personal Protective Equipment Directive 

98  102  105  104  104  105  109  106  106  104  104 

92 

1 

1 

Pressure Equipment Directive122  

0 

0 

0 

0 

0 

0 

0 

0 

7  266  298  321  336  336 

Old Pressure Equipment Directive123  

249  254  263  259  254  255  261  270  280 

4 

4 

4 

4 

4 

Pyrotechnic Articles Directive  

Old Pyrotechnic Articles Directive  

Radio Equipment Directive 

0 

0 

1 

0 

1 

1 

0 

3 

1 

0 

0 

0 

0 

0 

11 

13 

13 

14 

13 

12 

10 

13 

13 

17 

17 

1 

1 

1 

1 

1 

0 

1 

0 

0 

0 

0 

0 

41 

54 

66 

68 

71 

Old Radio Equipment Directive 

49 

52 

52 

50 

50 

50 

51 

55 

55 

58 

Old Telecommunications Terminal Equipment Directive  

Recreation Craft and Personal Watercraft Directive  

1 

0 

1 

0 

1 

0 

1 

0 

1 

0 

1 

0 

1 

0 

1 

0 

1 

3 

1 

1 

1 

1 

1 

1 

1 

1 

1 

21 

26 

28 

32 

31 

Old Recreational Craft Directive  

29 

30 

28 

31 

29 

31 

34 

35 

35 

27 

6 

5 

5 

1 

Simple Pressure Vessels Directive  

0 

0 

0 

0 

0 

0 

0 

0 

3 

56 

69 

72 

72 

73 

Old Simple Pressure Vessels Directive124  

94  100  103  104  102  103  100  102 

98 

8 

7 

6 

5 

4 

Toy Safety Directive  

Old Toy Safety Directive  

0 

0 

0 

1 

37 

45 

46 

46 

43 

42 

42 

40 

41 

42 

59 

59 

60 

57 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

Transportable Pressure Equipment Directive  

0 

0 

0 

0 

79 

96  107  122  126  131  138  145  144  144 

Old Transportable Pressure Equipment Directive125 

147  151  152  144 

0 

0 

0 

0 

0 

Old Low Voltage Directive126 

139  139  146  143  144  145  143  143  141 

0 

1 

0 

1 

0 

1 

0 

1 

0 

1 

Table 3 Evolution of number of notified bodies over time, by piece of legislation (2008-2020) 

Source: CSES report based on NANDO database. 

Notification procedure. The approach/procedure of the notified bodies is  not  based on the 
same  set  of  rules  everywhere.  Some  industry  stakeholders  report  that  national  level 
notification procedures for the notification of NBs diverge across the Member States.  

Many stakeholders that responded to the questions of the targeted consultation have stressed 
the weakness of the NLF in ensuring the harmonisation of notification requirements among 
the Member States. This is  conducive to  reliability  and  appropriateness  issues (see  Chapter 
4.1.3.).  

Subcontracting  of  substantial  technical  tasks.  The  Blue  Guide  provides  a  number  of 
clarifications  on  the  scope  and  conditions  of  such  contracts  in  its  Section  5.2.5.  A  notified 
body can subcontract strictly limited technical tasks (such as tests and examinations), as long 
as these can be defined as substantial and coherent parts of the technical operation. A notified 
body can only subcontract a task for which it has the competence itself, if the subcontractor 
also  has  and  maintains  that  necessary  competence.  The  notified  body  must  be  able  to 
demonstrate  the  compliance  of  its  subcontractors  with  the  requirements  laid  down  in  the 
relevant Union harmonisation legislation. A subcontracting notified body remains responsible 

122 Data include also User inspectorates as well as Recognised third-party organisations (as recognised in current 
PED). See legislation-specific section for further details. 
123 Data include also Article 14 user inspectorates as well as Third-party organisations. See legislation-specific 
section for further details. 
124 Data include also Third-party organisations. See legislation-specific section for further details. 
125  Data  include  also  Approved  Bodies  under  Article  9  of  the  old  TPED.  See  legislation-specific  section  for 
further details. 
126 In the received database, no NB is related to the Low Voltage Directive currently in force. 

107 

 
  
 
                                                 
 
for all the activities covered by the notification. Subcontracting does not entail the delegation 
of powers or responsibilities.  

The notified body must inform the notifying authority of its intention to subcontract certain 
work.  The  extent  to  which  the  notified  body  intends  to  rely  on  subcontractors  must  be 
appropriately assessed by the notifying authority. The notifying authority may decide that it 
cannot  take  the  overall  responsibility  for  such  an  arrangement,  and  withdraw  or  limit  the 
scope  of  the  notification.  The  notified  body  must  keep  a  register  of  all  its  subcontracting 
activities, and update it systematically. The notifying  authority must be capable of ensuring 
effective monitoring of the competence of the body subcontracted by the notified body.  

If accreditation is the chosen path for notification, it must cover the subsidiary companies of 
notified bodies to which they have recourse. If notification is not based on accreditation, the 
contents  of  the  information  to  be  provided  to  the  notifying  authority  should  be  further 
specified by aligning it to the relevant practices in accreditation. 

During the interviews conducted by CSES, conformity assessment bodies confirmed that the 
subcontracting  of  conformity  assessment  activities  is  a  well-established  and  necessary 
instrument.  

The conformity assessment bodies explained that outsourcing by an accredited CAB to non-
accredited CABs is not possible. Besides, the CAB must verify that the test reports on which 
they  rely  are  trustworthy.  For  instance,  the  standard  EN  ISO/IEC  17065:2012  Conformity 
assessment - Requirements for bodies certifying products, processes and services allows EU 
CABs to rely on test reports from labs established in the USA, China and Australia; however, 
in the standard EN ISO/IEC 17025:2017 General requirements for the competence of testing 
and calibration laboratories, systematic outsourcing is not allowed. 

The European system for accreditation of conformity assessment bodies 

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

The  NLF  created  the  European  system  for  accreditation  of  conformity  assessment  bodies. 
Regulation  (EC)  No  765/2008  recognised  the  European  Cooperation  for  Accreditation 
(EA) as a single organisation at European level and introduced a mandatory membership of 
the national accreditation bodies in the EA. The EA is responsible for the peer evaluation for 
its  members  (national  accreditation  bodies).  The  Commission  may  request  the  EA  to 
contribute to the development and implementation of the accreditation in the EU and to lay 
down  evaluation  criteria  and  procedures  for  peer  evaluation  and  to  develop  sectoral 
accreditation  schemes,  including  the  development  of  sectoral  accreditation  schemes.  In  this 
context,  the  General  Guidelines  for  Cooperation  between  the  European  cooperation  for 
Accreditation and the European Commission, the European Free Trade Association and the 
Competent  National  Authorities  was  signed  on  1  April  2009.127  This  agreement  aimed  to 
strengthen  cooperation  on  accreditation  and  “stabilise  the  position  of  accreditation  [and] 
accreditation  bodies  in  EU  and  EFTA  Member  States”128.  Since  its  inception,  EA  has  also 

127 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52009XC0521%2804%29 
128  European  Accreditation  (EA).  (2019).  EA  MLA  Report  2019.  Building  on  this  agreement,  EA  and  the 
Commission  signed  the  first  Framework  Partnership  Agreement  (FPA)  covering  the  four-year  period  2010-
2013. The second FPA ran from 2014-2017 and the third and current iteration of the FPA was signed in 2018 
for the period 2019-2022. 

108 

 
                                                 
 
published  a  wide  range  of  mandatory,  guidance  and  informative  documents  to  support  its 
members.129 

EA  currently  has  49  NAB  members  covering  the  EU-27,  EEA-EFTA  countries  and  third 
countries. 

Based on the NLF, national accreditation bodies have been appointed in all Member States.  
Although  in  many  cases  these  bodies  were  already  operating  prior  to  the  NLF,  all  27  EU 
Member  States  and  Norway,  as  well  as  Switzerland,  Canada,  and  Turkey,  have  appointed 
NABs in line with Regulation (EC) No 765/2008. 

The European  accreditation  system ensures the  mutual  recognition  of test  reports issued by 
accredited notified bodies. According to Article 11 of Regulation (EC) No 765/2008, national 
authorities in the Member States should recognise the equivalence of the services delivered 
by the accreditation bodies in the different Member States. Therefore, the principle of mutual 
recognition  of  certificates  and  test  reports  issued  by  the  accredited  conformity  assessment 
bodies in the area of their competence is applicable throughout the EU. 

Accreditation  is  the  favoured  instrument  for  the  verification  of  competence  of  conformity 
assessment bodies, although not mandatory for the notification. Nevertheless, it provides an 
authoritative  statement  of  the  competence,  professional  integrity  and  impartiality  of  the 
bodies to be notified to the Commission and the other Member States. 

The harmonised standards of the EN ISO/IEC 17000 series that can be used to demonstrate 
the  competence  of  the  candidate  notified  body  may  vary  depending  on  the  specific 
conformity  assessment  tasks  (modules)  and  the  different  products  in  Union  harmonisation 
legislation.  First  of  all  national  accreditation  bodies  have  to  meet  the  requirements  of  the 
harmonised standard EN ISO/IEC 17011 “Conformity assessment – General requirements for 
accreditation bodies accrediting conformity assessment bodies”. To demonstrate that they are 
capable  and  competent  to  carry  out  accreditation  in  the  different  fields  of  conformity 
assessment  serviced  by  them,  the  following  standards  are,  for  example,  available:  EN 
ISO/IEC  17025  for  testing  and  calibration  laboratories;  EN  ISO/IEC  17020  for  inspection 
bodies or EN ISO/IEC 17065 for bodies certifying products, services and processes.  

In  order  to  ensure  harmonisation  of  the  assessment  of  competence  of  candidate  notified 
bodies, the European Cooperation for Accreditation (EA) has developed  a recommendation 
on standards for accreditation for each relevant Union harmonisation legislation and for each 
conformity assessment module130.  For a notification to be considered as accompanied by an 
accreditation  certificate,  the  accreditation  certificate  must  indicate  the  competence  of  the 
candidate notified body in relation to the specific Union harmonisation legislation for which 
notification is being sought.  

According  to  EA,  there  are  sufficient  common  criteria  for  the  notification  of  CABs  in 
Decision No 768/2008/EC.  

The conformity assessment procedures 

The conformity assessment system detailed in the NLF underpins the entire internal market, 
as  it  represents  the  means  by  which  economic  operators  demonstrate  the  compliance  and 

129  Recent  examples  from  2020  include:  the  guidance  document  on  Consultancy,  and  the  Independence  of 
CABs129;  the  document  listing  the  risks  of  accreditation  processes  and  operation  of  NABs129;  and  the 
document 
https://european-accreditation.org/wp-
content/uploads/2018/10/ea-2-17-m.pdf 
130 EA-2/17 - EA Document on Accreditation for Notification Purposes 

on  Accreditation 

for  Notification 

Purposes, 

109 

 
                                                 
 
conformity  of  their  products  with  the  essential  requirements  laid  down  in  specific  product 
legislation.  

Annex II of Decision 768/2008/EC sets out in details 8 different overarching modules from 
module A, which does not include a third-party assessment, to module H, which is based on a 
full quality assurance. All the modules are based on the same phases or steps, although the 
more complex modules contain more of those phases. These modules represent a menu, from 
which the legislator may choose the most appropriate for a specific legislation, depending on 
the risk related to the product within its scope. 

For example, under the Low Voltage Directive or Toys Safety Directive the involvement of 
notified bodies is not mandatory, since they foresee only module A. On the other hand, the 
involvement  of  notified  bodies  is  mandatory  for  example  under  the  Pressure  Equipment 
Directive for categories II, III and IV of pressure equipment. 

110 

 
 
 
 
ANNEX  VII.  MAIN  COSTS  AND  BENEFITS  IDENTIFIED  BY  EVALUATIONS  OF  CERTAIN  NLF-
ALIGNED EU PRODUCT LEGISLATION  

Legislation and 
evaluation 

Toy Safety 
Directive 

2009/48/EU 

2020 Evaluation 

Costs 

Benefits 

Directives 

For manufacturers: 

  One-off  costs  to  adapt  to  manufacturing, 
testing  and  documentation  requirements: 
2%  of  annual  turnover,  and  recovered 
over 3 years on average. 

  Recurring  costs  due 

to  new  safety 

requirements. 

  Time 

spent 

comply  with 

to 
requirements 

the 
Directive’s 
when 
developing  a  toy:  485  man-hours  on 
average  (corresponding  to  €10,900  per 
toy),  of  which  43%  for  testing  and 
documentation  (€4,700);  33%  for  safety 
aspects 
packaging 
(€3,600); 
(€1,400); 12% other. 

12% 

  Ensuring 
safety. 

  Ensuring  legal 
certainty. 

a 
playing 
the 
in 

  Ensuring 
level 
field 
internal 
market. 

Proportionality of 
costs and benefits 

  No 

quantification 
possible. 

  Stakeholders 
consider 
benefits 
outweigh costs. 

that 

  Preparing 

and 

updating 

technical 
documentation 
assessment, 
conformity  assessment  documents  and 
supply chain information). 

(safety 

  Purchasing standards. 

  Testing of raw materials. 

  Testing of toys. 

  Translation of product documentation. 

For importers: 

  Time  spent  to  comply  with  Directive’s 
requirements:  110  man-hours  per  toy 
type (€2,500). 

For distributors: 

  Time  spent  to  comply  with  Directive’s 
requirements: 86 man-hours per toy type 
(€1,953). 

For public authorities: 

  Enforcement costs. 

For manufacturers: 

  Compliance costs of the RoHS Directive 
for  businesses  include  collecting  and 
reviewing  information,  gathering  supply 
chain  information,  costs  related  to  a 
dedicated  IT  system 
to  manage  all 
required pieces of information, and costs 
related to the exemption system. 

  Technical  costs  include  complying  with 

111 

Restriction of 
Hazardous 
Substances in 
Electrical and 
Electronic 
Equipment 
Directive 

2011/65/EU 

to 

  Reduced 
exposure 
restricted 
substances, 
leading 
environmental 
and 
benefits. 

health 

to 

  Economic 

  Benefits  driven 
the 

health 

by 
environmental 
and 
benefits 
outweigh 
compliance 
and 
enforcement 

the 

 
 
 
Proportionality of 
costs and benefits 

costs. 

  Stakeholders 

also  generally 
agree  that  costs 
of the  Directive 
are justified. 

  Stakeholders 
consider 
benefits 
outweigh costs. 

that 

Legislation and 
evaluation 

2021 Evaluation 

Electromagnetic 
Compatibility 
Directive 

2014/30/EU 

2021 Evaluation 

Costs 

Benefits 

the 
of 

benefits: 
the 
levelling 
field 
playing 
for  businesses 
in  the  internal 
market 
regarding 
use 
hazardous 
substances, 
creating 
legal 
certainty,  and 
sometimes 
spurring 
innovation 
through 
substitutions. 

  The 

main 

indirect 
benefit  of  the 
is 
Directive 
that 
it 
influences 
creation 
similar 
legislation 
in 
many  countries 
outside the EU. 

of 

of 

  Technical 
benefits: 
reduced 
incidence 
electromagneti
c  disturbance 
leading  to  the 
incorrect 
functioning  of 
electrical 
equipment  and 
increased 
electromagneti
c immunity. 

  Strategic 
benefits: 
fostering of the 
free  movement 
of  products  in 
internal 
the 
and 
market 
increase 
in 
industrial 
competitivenes
s. 

the  hazardous  substance  restrictions  in 
their  product  (i.e.  product  development). 
The  highest  costs  are  related  to  the 
exemption 
product 
development. 

system 

and 

For public authorities: 

 

In Member States, resources  allocated to 
enforcement  and  implementation  range 
from  0.3  to  4.75  full-time  equivalent 
employees  (FTE)  per  country  and  per 
year.  Their  annual  budget  ranges  from 
€10,000 to over €400,000. 

Almost all costs  generated by the  EMCD are 
borne  by  manufacturers.  The  largest  type  of 
costs  are  the  costs  of  development  and  the 
costs  of  laboratory  tests  (part  of  conformity 
assessment  costs  to  produce  the  technical 
file).  However,  most  of  the  costs  borne  by 
manufacturers can be considered as business-
as-usual costs. 

the 

Generally,  the  cost  of  complying  with  the 
EMCD corresponds to 5-15% of total costs of 
production.  Administrative  and 
reporting 
costs therefore represent only a minority share 
of 
total  production  costs  borne  by 
manufacturers. The self-certification approach 
made  possible  by  the  EMCD,  in  particular, 
contributes  to  keeping  costs  relatively  low 
and  grants  a  certain  level  of  flexibility  to 
economic operators.  

For manufacturers: 

  Costs  during  product  development 
(engineering costs; purchasing standards; 
pre-testing).  

  Conformity  assessment  costs  (preparing 
technical documentation; laboratory tests; 
involvement of notified body). 

  Costs  during  production  process  (e.g. 

112 

 
 
 
Legislation and 
evaluation 

Costs 

Benefits 

Proportionality of 
costs and benefits 

EMC-relevant measures). 

  Familiarisation 

with 

legislative 

requirements. 

For public authorities: 

  Enforcement costs. 

Low Voltage 
Directive 

For  manufacturers, 
importers: 

distributors 

and 

2014/35/EU 

2019 Evaluation 

  Resources  to  deal  with  LVD  compliance 
(Internal  resources  for  regulatory  follow 
up  and  participation  in  standardisation 
activities; external legal advice). 

  Technical 

compliance 

during 
production  process  (internal  resources  to 
ensure compliant manufacturing. 

cost 

  Purchase of standards. 

compliance 

  Procedural 
cost  during 
conformity 
(internal 
resources  for  verification  of  compliance, 
drawing  of  DoC  and  other  documents, 
labelling; third party labs and certifiers). 

assessment 

  Administrative  cost  (internal  resources 
and 
of 

products 
for 
updates 
documentation 
archiving 
documentation; third party services). 

of 
and 

For national authorities: 

  Transposition costs. 

 

Implementation  costs  (e.g.  day-to-day 
operations  of  national  implementation 
bodies). 

  Enforcement costs (market surveillance). 

For taxpayers: 

  Taxes  for  public  health  and  social 

security. 

113 

For 
manufacturers, 
distributors 
importers: 

and 

  Stakeholders 
consider 
benefits 
outweigh costs. 

that 

  Access 

to 
markets  thanks 
to  harmonised 
and 
rules 
procedures. 

  Access 

to 

to 

innovation: 
voluntary  use 
standards 
of 
allows 
tap 
into  innovation 
opportunities 
the 
and 
scene 
for 
updated  safety 
requirements. 

set 

  Compliance 
savings. 

  Reputational 
benefits. 

For 
authorities: 

national 

  Regulatory 

cost savings. 

on 

  Savings 
market 
surveillance 
and 
coordination. 

in 

  Synergies 
topical 
expertise. 

For taxpayers: 

  Wider 

choice 
of  low  voltage 
products. 

 

Increased 
safety 
products 
throughout  the 

of 

 
 
Legislation and 
evaluation 

Costs 

Benefits 

EU. 

Proportionality of 
costs and benefits 

  Costs 

are 
commensurate 
benefits. 
to 
this 
However, 
is 
an 
assessment 
based 
on 
average  costs. 
The main factor 
influencing  the 
proportionality 
of  costs  is  the 
the 
of 
size 
company,  and 
largest 
the 
burdens 
(in 
terms) 
relative 
are  borne  by 
the 
smallest 
companies.  The 
burden  of  costs 
also depends on 
the 
of 
type 
product  and  the 
complexity  of 
requirements  of 
relevant 
the 
as 
standard, 
the 
well 
as 
of 
number 
different 
products 
company 
produces. 

each 

  Better 

access 
to  other  EU 
markets. 

  Common 
technical 
language 
and 
common rules. 

  Uniformity 

in 
information  for 
end users. 

 

Improvement 
in  production 
processes  due 
to 
CPR 
requirements. 

Regulations 

Construction 
Products 
Regulation 

305/2011 

2018 Evaluation 

For manufacturers: 

 

Increased  regulatory  and  administrative 
costs  (0.6-1.1%  of  the  sector’s  turnover, 
to  €2.62-3.4  billion), 
corresponding 
linked to the supply of the Declaration of 
Performance (DoP) and the CE marking. 
It  is  also  noted  that  the  information 
required in the DoP and the CE marking 
overlap, generating unnecessary burden. 

  Testing 

costs 

control 
mechanisms  would  also  have  incurred 
without the CPR. 

and  quality 

Efficiency  for  individual  manufacturers  (in 
terms of cost-effectiveness) depends to a large 
extent on the size of the company. For larger 
companies  and  those  that  have  a  history  of 
compliance  (e.g.  they  have  installed  Factory 
Production  Control 
systems),  costs  are 
relatively low. 

114 

 
 
 
 
ANNEX VIII. CASE STUDIES  

This Annex presents a selection of four case studies developed to support the evaluation of 
the NLF: 

  Case  study  1:  Coherence  of  non-aligned  EU  product  legislation  with  NLF-aligned 

legislation. 

  Case study 2: Accreditation process 

  Case study 3: Assessment of NLF-related costs and benefits under the Electromagnetic 

Compatibility Directive (EMCD). 

  Case  study  4:  Assessment  of  NLF-related  costs  and  benefits  under  the  Toy  Safety 

Directive (TSD). 

Case study 1: Coherence of non-aligned Union harmonisation legislation with NLF-
aligned legislation 

Case Study: Coherence of non-aligned Union legislation with NLF-aligned legislation 

Purpose:  This  short  case  study  aims  to  illustrate  the  complexity  for  manufacturers  to  comply  with 
Union legislation through examples of industrial products falling under both EU product legislation ( for 
placing product on the market and non-aligned legislation that covers other aspects such as the putting 
into service, installation or use of these products. 

Background and context: Legislation aligned with the NLF aims to harmonise the condition of placing 
products on the Union market. Union harmonisation legislation covers a wide range of products, hazards 
and impacts (e.g. energy consumption), which both overlap and complement each other. Due to product 
complexity,  several  pieces  of  EU  product  legislation  may  apply  to  the  same  product,  besides  other 
pieces  of Union  legislation  that  regulate other  energy,  chemical,  environmental,  recycling,  privacy,  or 
cybersecurity aspects. 

For  example,  as  illustrated  in  the  below  table,  a  manufacturer  of  household  appliances  should  pay 
attention to between 2 and 4 pieces of NLF-aligned legislation and 5 to 7 other pieces of EU legislation. 
These can require different conformity assessment procedures, some of them involving a notified body. 

EU legislation applicable to household appliances in 2021 

Type of products 

All household appliances 

EU product legislation-
NLF 
RoHS Directive 
(2011/65/EU) 

Other Union legislation 

All electrical appliances 

Consumer and industrial laundry 
washing or drying machines and 
dishwashers 
Kitchen robots 

Low Voltage Directive 
(LVD) 2014/35/EU 
Electromagnetic 
Compatibility (EMC) 
Directive 2014/30/EU 

Machinery Directive 
2006/42/EC 

115 

Directive 2009/125/EC on the Ecodesign 
of energy related products (with all 
product specific Regulations) 
Regulation (EC) No 1907/2006 (REACH) 

WEEE Directive 2012/19/EU 

Regulation (EC) No 1935/2004 on Food 

 
 
 
 
 
 
 
 
 
 
 
 
Type of products 

Appliances for cooking, heating, 
hot water production, 
refrigeration, lighting and 
washing 
All wireless appliances 

Refrigerating appliances 
Large household appliances 

EU product legislation-
NLF 

Regulation (EU) 
2016/426 on appliances 
burning gaseous fuels 

Radio Equipment 
directive RED 
(2014/53/EU) 

All Internet connected appliances 

Household appliance with 
medical applications 

Source: CSES Study and APPLiA  

Medical Devices 
Regulation (EU) 
2017/745 

Other Union legislation 

Contact Materials 

F-gas Regulation (EU) No 517/2014 
Energy Label Framework Regulation 
(2017/1369) with all product specific 
delegated Regulations (supplementing 
Directive 2010/30/EU) 
General Data Protection Regulation (EU) 
2016/679) 

Besides, additional national provisions may apply regarding the putting into service, installation or use 
of these products (in compliance with the Treaty, in particular Articles 34 and 36 TFEU), which renders 
even more complex the range of legal and administrative information obligations for manufacturers. The 
following paragraphs provide concrete examples of cases where overlaps, gaps and divergence between 
NLF-aligned legislation and other types of legal requirements impacts on economic operators. 

Stakeholder feedback on the Machinery Directive vs. other Union legislation 

A good illustration of divergence in the simultaneous application of the NLF and non-harmonised Union 
legislation occurs for products covered by Directive 2006/42/EC on Machinery (MD) which is almost –
but  not  fully–  aligned  with  the  NLF  yet,  although  a  new  Proposal  for  the  Machinery  Regulation  to 
replace the Directive has been put forward (cf. below figure). 

Figure 11 Divergence in the simultaneous application of NLF and non-harmonised Union legislation 

Machinery Directive vs. Outdoor Noise Directive (OND): The OND is not harmonised with the NLF. 
According  to  a  large  Italian  machinery  manufacturer,  this  results  in  duplication  of  work, 
inconsistencies,  differences  in  conformity  assessment  procedures,  legal  uncertainty  regarding 
terminology  and  definitions,  etc.  According  to  a  European  trade  association  of  garden  machinery, 

116 

 
 
 
 
 
 
 
 
 
there  is  a  mismatch  between  the  concept  of  risks  to  users  and  the  environment  in  the  simultaneous 
application  of  the  OND  and  the  MD;  for  instance,  a  circular  saw  is  not  regarded  as  a  high-risk 
machinery  and  conformity  with  the essential  requirements could  be self-declared  by  the  manufacturer 
(under  module  A),  while  the  measurement  of  the  noise  limits  for  all  types  of  machines  requires  the 
involvement  of  a  notified  body.  It  is  expected  that  new  legislation  under  development  will  take 
coherence as the guiding principle. 

Machinery Directive vs. Non-Road Mobile Machinery (NRMM): Mobile machinery is indispensable 
for  the  proper  functioning  of  the  agricultural,  construction,  municipal  equipment,  lifting/handling, 
gardening  and  forestry  sectors.  It  is  subject  to  the  Machinery  Directive  2006/42/EC,  but  also  to 
diverging national safety requirements for the design and manufacturing of such machinery in various 
Member  States.  These  requirements  are  particularly  demanding  in  the  main  manufacturing  Member 
States  of  mobile  machinery  (Germany,  Italy  and  France).  According  to  the  Industrial  Task  Force  on 
Non-Road Mobile Machinery (ITF NRMM)131, companies can spend between 25 % and 50 % of their 
staff time to produce and maintain the technical files for national homologation purposes, in addition to 
the costs of additional product markings required for this type of machinery. The assessment of vehicle 
performance and control, its dimensions and braking requirements, in particular, generate difficulties for 
the industry that are way beyond the administrative burden and costs required for compliance with the 
MD. The Commission has however commissioned various studies and a cost-benefit analysis to support 
a possible future impact assessment to examine ways forward to harmonise the NRMM132. 

Machinery  Directive  vs.  workers’  protection:  In  the  Guide  to  the  application  of  the  Machinery 
Directive (MD)133, it is explained that Directive 2009/104/EC on the use of work equipment by workers 
at work (UWEWW) can be considered as a measure complementary to the Machinery Directive: On the 
one  hand,  the  MD,  which  is  almost  aligned  with  the  NLF  but  not  fully  requires  the  manufacturer  to 
design  machinery  to  be  inherently  safe  for  their  placing  on  the  market,  on  the  other  hand,  non-
harmonised Directive 2009/104 requires the employer to ensure that the same machinery is safe during 
its  lifetime.  As  reported  in  the  Impact  Assessment  on  the  revision  of  Directive  2006/42/EC  on 
machinery (2020)134, “if a machine that is compliant is modified later (e.g. by software changes) to now 
work  within  different  boundaries,  then  a  new  risk  assessment  would  be  needed”.  However,  when  the 
machine is in use, maintained or possibly upgraded via software updates, there is no consensus to date, 
including  among  industry  stakeholders,  as  to  whether  it  is  the  responsibility  of  the  manufacturer  to 
conduct the risk assessment under the Machinery Directive or up to the employer-user to do it according 
to Directive 2009/104/EC. This legal uncertainty generates diverging interpretations and costs (See also 
Chapter 6.3.2 “Impact of the circular economy”). 

Other stakeholder feedback on NLF external coherence: 

NLF vs. environmental legislation: According to a large German trade association “the obligations for 
Economic operators under the Energy-related Products (ErP) Directive 2009/125/EC (Formerly EuP) 
are  not  fully  consistent  with  NLF.  The  definition  of  placing  on  the  market  in  REACH  is  also  not 
consistent with the NLF framework”. 

NLF vs. General Product Safety Directive: A consumer association backed by a Competent Authority 
in Ireland stress that the NLF is not applied coherently with the GPSD, because of diverging definitions 
“The proposal for a GPSR, which aligns with Regulation 1020/1019 is an improvement, but not for all 
aspects.” (See Chapter 5.3.2 on definitions for more details) 

Machinery Directive/ NLF vs. Cybersecurity legislation:  the Radio Equipment Directive Delegated 
Act on Article 3.3 (d, e and f), the AI Act, the Cybersecurity Act, the proposal for a NIS 2 Directive and 
the proposed GPSR provide diverging definitions of cybersecurity features which according to an Italian 
federation  of  mechanical  products  will  adversely  impact  the  coherence  of  the  NLF  regulatory 

131 https://www.cema-agri.org/index.php?option=com_content&view=article&id=710&catid=21&Itemid=212 
132 European Commission, (2019), Cost-benefit analysis study for impact assessment on road circulation of non-
road mobile machinery. 
133 Guide to application of the Machinery Directive 2006/42/EC, Edition 2.2 – 2019 (Update of 2nd Edition) 
134  European  Commission,  (2020),  Impact  Assessment  report  on  the  revision  of  Directive  2006/42/EC  on 
machinery (08/2020) 

117 

 
                                                 
 
framework and “cause unnecessary costs and burdens” to manufacturers. 

Radio  Equipment  Directive  (RED)  vs.  Automotive  directives  and  other  legislation:  According  to 
the German authority for radio equipment, there is a tendency to apply equal rules for the protection of 
the radio spectrum to all sectors; “whereas this might be acceptable for formal requirements, uniformity 
may  adversely  impact  the  technical  content  of  products  and  equipment  for  medical,  cybersecurity  or 
automotive  applications”.  For  instance,  in  the  latter  case,  this  could  cause  conflicts  of  assessments 
between notified bodies involved, whether notified under the RED or the non-NLF aligned Automotive 
Directives. 

LVD,  RED  and  Medical  Devices  Directives  vs.  electromagnetic  fields:  as  stressed  by  a  large 
manufacturer of medical devices, the protection of users from electromagnetic fields (EMF) is referred 
to  in  several  pieces  of  NLF-aligned  legislation,  especially  in  the  Low  Voltage  Directive,  the  Radio 
Equipment Directive and the Medical Devices Directives. Besides, either Directive 2013/35/EU on the 
minimum  health  and  safety  requirements  regarding  the  exposure  of  workers  to  the  risks  arising  from 
EMF or the Council recommendation on the limitation of exposure of the general public to EMF apply. 
The  alignment  with  the  NLF  was  suggested  alongside  EURATOM/EU  Basic  Safety  Standards  on 
Radiation protection. 

All  these  examples  show  how  whilst  core  pieces  of  EU  product  legislation  have  been  NLF-aligned, 
there is a lack of external coherence between the NLF and other types of legislation in some cases. This 
increases  compliance  and  enforcement  costs  for  economic  operators,  notified  bodies  and  market 
surveillance  authorities.  In  addition,  differences  in  the  combined  implementation  of  EU  legislation 
between Member States could prevent the full potential of a well-functioning internal market from being 
achieved. 

Case study 2: Accreditation process 

Case study: Accreditation process 

Purpose:  Illustrate  the  weaknesses  in  the  accreditation  framework  and  their  impacts 
through an examination of the accreditation process and its complexity. 

Background  and  context:  Regulation  (EC)  No  765/2008  established  a  European 
accreditation  system  and  ensured  the  mutual  recognition  of  test  reports  and  certificates 
issued by accredited notified bodies. In summary, the Regulation establishes inter alia: 

  Principles of the accreditation framework (Art. 4), including that Member States shall 
appoint  a  single  national  accreditation  body  (NAB)  and  the  principle  of  non-
competition (Art. 6). 

  Rules  for  the  operation  of  accreditation  activities  (Art.  5),  including  rules  on 
evaluating,  certifying,  and  monitoring  conformity  assessment  bodies  (CABs),  and  on 
cross-border accreditation (Art. 7). 

  Requirements for NABs (Art. 8), covering, amongst others, independence, impartiality, 
confidentiality,  and  the  identification  of  areas  of  competence,  as  well  as  the  need  for 
sufficient competent persons and internal controls. 

  Rules for the peer evaluation of NABs (Art. 10). 

The accreditation framework is a key part of the European conformity assessment system 
alongside  the  suite  of  conformity  assessment  modules,  the  rules  on  notification  of 
conformity assessment bodies relying on the system of harmonised standards cited in the 
Official Journal of the EU (OJEU).  

As stipulated in Article 11 of Regulation (EC) No 765/2008, NABs are presumed to fulfil 
the  relevant  requirements  summarised  above  if  they  have  undergone  peer  evaluation  and 
demonstrated  conformity  with  the  criteria  laid  down  in  the  relevant  harmonised  standard 

118 

 
 
 
 
published in the OJEU. In this respect, EN ISO/IEC 17011:2017 is the relevant harmonised 
standard against which national accreditation bodies are assessed. 

Similarly,  as  per  Article  R18  of  Annex  I  to  Decision  No  768/2008/EC,  NBs  can  use  the 
relevant harmonised standards referenced in the OJEU to obtain presumption of conformity 
with  the  requirements  for  NBs  provided  for  in  NLF-aligned  legislation  (based  on  Article 
R17). 

Accreditation cycle: In line with Regulation (EC) No 765/2008, EN ISO/IEC 17011:2017 
details  requirements for  the “accreditation process but  also  the structure  of the NAB, the 
impartiality and competence of a NAB, the management and internal controls, procedures, 
subcontracting,  appeals  and  complaints”135.  An  outline  of  the  overarching  accreditation 
cycle is illustrated in the below figure. The main steps of the process, described based on 
EN ISO/IEC 17011 and detail from the Italian accreditation body (Accredia), include: 

  Application  for  accreditation:  CABs  must  submit  an  application  for  accreditation 
that:  i)  clearly  specifies  the  activities  required  by  the  CAB;  and  ii)  provides  key  pre-
defined documentation, including a copy of management systems.  

  Resource  review  and  assessment  preparation:  The  NAB  will  conduct  an  initial 
review of the application to check for adequacy. In this context, the NAB will examine 
its own ability to carry out the assessment to a sufficient level of quality and in a timely 
manner,  considering  its  own  policies,  competence  and  availability  of  suitable 
personnel.  If  the  outcome  of  this  initial  review  is  positive,  a  cost  estimate  for  the 
accreditation services will be provided to the CAB.136 

Subsequently,  the  NAB  will  start  preparations  for  the  assessment  of  the  CAB.  This 
includes:  i)  the  appointment  of  an  assessment  team  comprising  a  lead  assessor, 
assessors and/or experts; ii) establishing procedure for sampling where the scope of the 
assessment covers multiple conformity assessment services. A preliminary visit to the 
CAB may also be conducted at this stage. 

 

Initial assessment: Within the context of the initial assessment, the NAB will conduct 
a thorough review and analysis of the documents provided with the aim of assessing the 
conformity  of  the  CABs  activities  against  the  applicable  requirements.  Upon 
completion  of  this  review,  an  on-site  assessment  is  performed,  aiming  to  determine 
whether  the  applicant’s  modalities  are  in  line  with  the  requirements,  technical 
regulations,  standards,  and  procedures  defined  by  the  CAB  in  its  formalised 
management system documentation. A report is written summarising the findings of the 
on-site assessment. If critical challenges or non-conformities have been identified, the 
NAB may conduct further assessments or stop the accreditation process. 

When accrediting CABs for certain conformity assessment activities (i.e. certification, 
inspection and verification), a witness visit takes place after a successful on-site visit. 
Witness  visits  take  place  at  a  public  or  private  client  of  the  CAB.  As  for  the  on-site 
visit,  a  follow-up  report  will  be  developed  and  further  actions  taken  based  on  the 
findings. 

On the basis of these initial activities, a first decision for accreditation will be taken by 

135  European  Commission,  (2022),  Guidance  Document:  The  Accreditation  and  Verification  Regulation  – 
Relation between the AVR and EN ISO/IEC 17011. 
136  Accredia,  (2022),  The  path  to  accreditation,  accessed  via  the  website  of  ACCREDIA  (the  Italian 
accreditation body) on 16 March 2022. 

119 

 
                                                 
 
the  NAB.  In  the  case  of  Accredia,  an  internal  Sector  Accreditation  Committee  with 
expertise and responsibility for the relevant conformity assessment sector will evaluate 
the  evidence  from  the  assessment  activities  and  take  a  decision.  If  positive,  an 
agreement between Accredia and the CAB is signed and the accreditation certificate is 
issued.  In  addition,  the  name  of  the  CAB  is  then  published  in  Accredia’s  online 
databanks. 

The key output of the initial assessment is an accredited CAB with a clear scope, and 
comprehensive records of the CAB and the accreditation assessment. 

In Italy, accreditation has a validity period of four years. However, setting the length of 
the  validity  period  is  the  responsibility  of  the  Member  States  and  therefore  differs 
across the EU. EA notes that the accreditation cycle can cover 2-5 years.137 

  Surveillance: Over the accreditation cycle, the NAB will undertake period surveillance 
assessments of the activities of accredited CABs. The purpose of these assessments is 
to  check  the  maintenance  of  compliance  requirements,  including  CAB  competence, 
independence,  impartiality,  and  conformity  with  standards.  Concerning  the  frequency 
of surveillance assessments, the Polish NAB noted that for a typical accreditation in the 
field  of  the  Construction  Products  Regulation,  three  surveillance  visits  would  be 
conducted over the four-year cycle. 

  Reassessment:  Before the expiration of each  accreditation cycle, the accredited CAB 
can initiate the accreditation renewal process, which will follow the same process as the 
initial  accreditation.  In  addition,  accredited  CABs  can  apply  for  an  extension  of 
accreditation  to  new  activities  and  locations  within  the  context  of  an  existing 
accreditation or the renewal process. 

However, there are a range of application challenges within this process that stem from the 
NLF legal texts and their implementation. These challenges are examined below. 

Figure 12 Illustration of a typical accreditation process 

Source: CSES, adapted from IAQG, (2015), Presentation on Oversight Assessment of Accreditation Bodies – Overview 
from ISO/IEC 17011. 

137 European Accreditation (EA), (2018), Accreditation: A tool to support regulators. 

120 

Accreditation ProcessResource Review and Assessment PreparationInitial AssessmentSurveillanceReassessmentDecision-MakingInputs:•CAB Client•CABManagementSystem•Application for accreditationOutputs:•Accredited CAB•ScopeofAccreditation•RecordsCore ProcessesSupport ProcessesManagement System –Development, Implementation & MaintenanceHuman Resource ManagementImpartiality Management 
 
                                                 
 
Analysis  and  stakeholder  feedback:  Although  the  approach  to  the  process  of  accreditation  is  well 
understood and established through Regulation (EC) No 768/2008 and EN ISO/IEC 17011, stakeholders 
have highlighted related challenges that can impact the effectiveness and efficiency of the accreditation 
framework and the wider conformity assessment system. 

The  first  challenge  relates  to  the  practice  of  accreditation  for  the  purposes  of  notification  and 
results from the interplay between the following elements: 

i) 

Definition of accreditation in Regulation (EC) No 765/2008, which includes a general reference 
to “harmonised standards and where applicable additional requirements”. 

In  Regulation (EC) No 765/2008 accreditation is defined as follows:  an attestation by a national 
accreditation  body  that  a  conformity  assessment  body  meets  the  requirements  set  by  harmonised 
standards and, where applicable, any additional requirements including those set out in relevant 
sectoral schemes, to carry out a specific conformity assessment activity”. 

The  definition  refers  to  harmonised  standards  without  specifying  them.  EA  has  issued  a  policy 
document  EA-2/17  M:  2020”  with  a  focus  on  accreditation  “as  a  tool  to  support  notification  of 
CABs in the framework of Union harmonisation legislation elaborated according to the provisions 
of Decision No 768/2008/EC”. However, certification bodies are of the opinion, that accreditation 
of CABs cannot be reduced to notification purposes only, as provided in the harmonised standard 
EN  ISO/IEC  17065:2012  on  “Conformity  assessment  —  Requirements  for  bodies  certifying 
products, processes and services”.  For example, the German Federal Maritime and Hydrographic 
Agency (BSH), as a notifying authority, provides the example of the Marine Equipment Directive 
(MED) 2014/90/EU. According to its ANNEX III, which prescribes the requirements for notified 
bodies,  the  condition to  comply  with  EN  ISO/IEC  17065:2012  is  one  of the  19 requirements for 
notified  bodies  defined  in  that  legislation.  Stakeholders  consider  that  this  can  lead  to  a  situation 
where member State have different interpretations of the different criteria for accreditation, as for 
example the objection period for notification138. 

Certification bodies have expressed concerns regarding varying interpretations of the definition of 
‘accreditation’ across the Member States. The definition states that conformity assessment should 
be  based  on  harmonised  standards  without  specifying  to  what  depth  the  applicable  harmonised 
standards should be developed. This leaves room for ambiguity and, as experience shows, varying 
interpretations  by  both  national  accreditation  bodies  and  notifying  authorities  that  set  different 
criteria and implementation procedures from one Member State to another.   

According  to  CABs,  this  situation  may  distort  the  EU  level  playing  field  between  conformity 
assessment  bodies  with  consequences  for  economic  operators.  More  specifically,  certifiers  and 
economic operators point at different levels of competence among notified bodies that allow rogue 
operators to ‘forum shop’ and have their products certified by less competent bodies. Most of the 
CABs are of the opinion that this situation can hamper the eventual level of safety of products on 
the market, especially for risks arising from connected or refurbished products, and thus contribute 
to reducing trust in certified products, which is damaging for the business of conformity assessment 
services. 

ii) 

Descriptions  of  conformity  assessment  activities  and  procedures  in  the  suite  of  conformity 
assessment  modules  and  aligned  EU  product  legislation,  which  often  use  general  instructions 
for notified bodies such as ‘carry out appropriate examinations and tests’ in accordance with the 
relevant harmonised standards for the product being examined. 

138 Sometimes authorities do not agree that another authority assessed the conformity assessment body against 
EN  17025  instead  of  EN  17065. They  consider  that  in  such  cases  the  notification  should  be  submitted  as  the 
COB has not been accredited and an objection period of 2 months instead of 2 weeks should apply. 

121 

 
                                                 
 
iii) 

Harmonised standards related to conformity assessment, which detail requirements for different 
types of conformity assessment bodies. As illustrated below, there are many different types of 
bodies, aligned to different activities, with specific harmonised standards. 

Figure 13 Types of bodies with specific harmonised standards 

Source: European Accreditation (EA), (2018), Accreditation: A tool to support regulators. 

While recognising that Regulation (EC) No 765/2008 is clear that NABs shall use harmonised standards 
in  assessments  for  accreditation,  EA  summarised  the  challenge  stemming  from  these  elements  as 
follows:  “the  conformity  assessment  activities  described  in  the  modules  defined  in  Decision  (EC) 
768/2008 or conformity assessment procedures defined in other EU product legislation are not described 
in  a way  which fits exactly  with  the description  in  the  [harmonised  standards]  (i.e. testing,  inspection 
and  certification),  and  each  module  does  not  identify  the  [harmonised  standards]  to  be  used  for  its 
conformity assessment activities”139. 

As  such,  individual  NABs  across  the  single  market  are  free  to  determine  the  harmonised  standard(s) 
against  which  CABs  will  be  assessed  for  accreditation  for  the  purposes  of  notification  under  specific 
pieces  of  EU  product  legislation.  Stakeholders  across  NABs  and  CABs  noted  that,  in  turn,  this  has 
resulted in divergent accreditation requirements for the purposes of notification across the EU. 

EA  has  taken  steps  to  address  this  challenge,  most  prominently  through  document  EA-2/17.  Through 
this  document,  EA  presented  a  thorough  mapping  of  the  requirements  across  pieces  of  EU  product 
legislation and the suite of conformity assessment modules with the different harmonised standards for 
conformity assessment. The main outputs were tables presenting: 

  Preferred alignment of harmonised standards per module and per legislation for aligned Directives 

and Regulations. 

  Preferred  harmonised  standards  for  non-aligned  Directives  and  Regulations  and  conformity 

assessment activities (e.g. under the PED, the CPR and the IVDMD). 

An  extract  of  the  first  alignment  table,  for  Modules  A1,  A2,  B  and  C,  is  presented  below.  Although 
complexities still exist, as reflected by  the ‘Exceptions’ column and the different ‘Preferred Standard’ 
for different pieces of legislation under module C, a preferred approach for harmonised accreditation is 
clearly stated.  

139  European  Accreditation  (EA),  (2020),  EA  Document  on  Accreditation  for  Notification  Purposes,  EA-2/17 
M:2020. 

122 

 
 
                                                 
 
Source: EA, (2020), EA Document on Accreditation for Notification Purposes, EA-2/17 M: 2020. 

However,  NAB  and  CAB  stakeholders have  highlighted  that,  as  this is not  implemented in  a uniform 
manner and divergence in this respect still exists across the EU. 

Other challenges highlighted by NAB and CAB stakeholders include: 

  Although the Blue Guide contains clarifications on ‘multi-site accreditation’ and subcontracting, the 
relevant  harmonised  standards  for  conformity  assessment  activities  take  different  approaches  to 
outsourcing. For instance, EN ISO/IEC 17065 allows test reports from US, Chinese and Australian 
laboratories,  but  EN  ISO/IEC  17025  does  not  permit  systematic  outsourcing.  In  this  complex 
landscape, NABs are unable to directly assess any CAB subsidiaries or facilities when outside 
their country  of  operation,  making  it  difficult  to  ensure  the competence of  such  subsidiaries.  In 
this respect, some NABs have taken steps to address this challenge; in Spain, for instance, ENAC 
has  developed  and  implemented  their  own  requirements  to  ensure  all  the  necessary  skills  for 
conducting the relevant conformity assessment services are permanently available in Spain. 

  CABs  have  highlighted  the  introduction  of  additional  national  level  requirements  for 
accreditation beyond those detailed in the relevant Union harmonisation legislation or harmonised 
standards  for  conformity  assessment.  For  example,  it  was  highlighted  that  a  German  authority 
requires  notified  bodies  providing  conformity  assessment  services  in  the  field  of  protective 
equipment against non-ionizing radiation to have a laboratory with appropriate own competency or 
an exclusive contract with a competent laboratory. As a result, a German notified body was not able 
to provide such a service because they could not agree on exclusivity with a competent laboratory. 

These challenges, in combination, can lead to a range of negative impacts on individual businesses and 
on the functioning of the single market. More specifically, NAB and CAB stakeholders highlighted that 
the  lack  of  harmonised  requirements  and  practices  across  the  single  market  can  lead  to  certain  CABs 
achieving  accreditation  at  a  reduced  cost  on  the  basis  of  less  stringent  or  less  costly  accreditation 
processes in some countries compared with others.  

Furthermore, when permitted by certain countries, the challenge related to the use of subsidiaries –for 
instance, when taken to the extreme of establishing a mere letterbox company in the EU and conducting 
all  real  activity  outside  the  EU  –  raises  questions  related  to  the  EU’s  strategic  autonomy  regarding 
compliance  with  the  NLF.  This  can  also  exacerbate  the  challenge  of  unfair  competition  if  such 

123 

 
 
subsidiaries can deliver the same conformity assessment services at a much lower cost. 

In  combination,  these  competitiveness  impacts  can  undermine  the  trustworthiness  of  conformity 
assessment services and certificates, as well as trust in the compliance of products placed on the single 
market. 

Costs related to the accreditation of conformity assessment bodies 

Examination fee to an accreditation body: Examination fees vary significantly, depending 
on the number and types of legislation covered, the conformity assessment module(s) to be 
accredited  against,  the  staff  size140  and  number  of  locations  of  the  organisation  under 
assessment, and whether the examination has a quick positive outcome or requires multiple 
assessments because of initial failure to pass the examination. Country-specific differences 
emerge.141  While  daily  fees  are  made  publicly  available  by  accreditation  bodies,  duration 
and  frequency  are  generally  kept  confidential,  contributing  to  a  lack  of  harmonisation  in 
examination  practices  across  Europe.  In  addition  to  fees,  it  is  also  necessary  to  consider 
costs for travelling, for internal consultations as well as consultations with third parties, or 
for the involvement of other authorities, if necessary.  

Anecdotal evidence of examination costs is provided: 

  Evidence  from  Spain  suggests  that,  for  a  small  CAB  (with  a  staff  size  of  2-3 
employees)  covering  one  module,  the  assessment  will  require  around  4-5  days  of  work, 
with a cost of about 8,000 Euro. 

 
In the area of Personal  Protective Equipment (PPE), in  Italy, a notified body reported 
paying  for  an  in  site  and  on  file  examination  fee  of  around  4,000-5,000  Euro  for  each 
Directive / Regulation. 

  A Spanish certification body, mainly active in the area of RED and EMCD, reported a 
cost of around 7,000 Euro for a new scheme accreditation, including for CE marking. 

  A  German  CAB  estimated  a  typical  cost  of  15,000-20,000  Euro  per  accreditation 
corresponding  to  the  average  procedure  and  scope.  However,  cases  of  less  complex 
accreditations (10,000 Euro), as well as more elaborate ones (50,000-100,000 Euro) were 
also mentioned, illustrating the potential differences in scale across accreditation exercises. 

Annual  fee  to  an  accreditation  body  (continuous  monitoring  costs,  or  maintenance  fee): 
The differences in cost of accreditation bodies (borne by accredited bodies) depend (as for 
examination fees) on the number and type of legislations covered and are also linked with 
the different living standards and price levels of EU countries. Not all accreditation bodies 
foresee  an  annual  maintenance  fee.  Among  those  who  do,  there  are  the  Italian  body 
(maintenance fee calculated as a share of turnover) and the Latvian body (annual fee of 425 
Euro). In Slovenia, a maintenance fee is charged at each surveillance visit (either on 12 or 
15  months).  However,  the  Hungarian  NAB  is  an  example  of  an  accreditation  body  that 
does not foresee maintenance fees. 

Cost  of  developing  and  maintaining  a  quality  management  system:  Large  organisations 
typically already have a quality management system with established procedures in place, 
and already have a quality manager dealing with it, irrespective of the accreditation needs. 

140  For  example,  according  to  the  Lifts  Directive  evaluation,  the  average  cost  for  accreditation  increases  with 
size:  from  625  Euro  for  micro  notified  bodies  (1%  of  annual  turnover)  to  3,800  Euro  for  medium  and  large 
notified bodies (0.01% of annual turnover). 
141 For example, the fee per hour of an assessor at the German accreditation body is 120 Euro, while the hourly 
fee of an assessor at the Italian accreditation body’s Department of calibration Laboratories is 96.25 Euro. 

124 

 
                                                 
 
As such, this cost is not necessarily borne by newly accredited bodies. The development of 
operative  instructions  for  a  quality  management  system  is  estimated  to  require  at  least  3 
months. 

Insurance fee (in most cases): For instance, some of the Spanish requirements foresee that 
conformity assessment bodies shall have a civil liability insurance of 300,000 Euro (RED) / 
1,200,000 Euro (EMCD, CPR) or a bank guarantee for that amount. According to feedback 
from  a  Spanish  notified  body,  this  liability  is  very  specific  and  usually  not  covered  in 
general  insurance  contracts.  Therefore,  even  if  the  company  already  has  an  insurance 
contract,  certification  liability  must  be  additionally  subscribed.  No  figures  about  the 
insurance fees could however be provided. 

Should accreditation become mandatory and why? 

Stakeholder  views  on  the  question  of  whether  and  how  accreditation  should  become 
mandatory are presented and discussed in the following box. 

Certification stakeholders highlighted that the notification system is not harmonised at EU 
level, and as such does not impose accreditation as a prerequisite, leaving room for varying 
implementation procedures. 

Both  consumer  associations  and  industry  associations  interviewed  have  suggested  that 
accreditation  should  become  mandatory  to  create  a  true  level  playing  field  for  notified 
bodies, based on competence. The primary  goal  of mandatory  accreditation, according to 
these  stakeholders,  would  be  to  ensure  that  all  notified  bodies  are  certified  to  the  same 
minimum level of competence, thereby providing a consistent service of a known quality to 
economic  operators  across  the  EU.  One  NAB  respondent  noted  that  accreditation  is 
essential for this purpose. 

However,  there  are  a  range  of  challenges  related  with  mandatory  accreditation  that 
stakeholders have highlighted. Some notification authorities, for instance, noted that when 
an  organisation  which  is  not  notified  wishes  to  become  an  accredited  CAB,  it  can  be 
difficult  for  it  to  achieve  this  accreditation.  In  some  Member  States  only  notified 
conformity  assessment  bodies  may  apply  for  accreditation.  For  instance,  in  Slovenia,  the 
accreditation body does not accredit conformity assessment bodies without evaluating their 
product assessment process (as set out in relevant product legislation); however, the would-
be-notified-body is not able to make such a demonstration since it is not notified. In such 
case,  as  some  of  the  stakeholders  highlight,  notifying  the  conformity  assessment  bodies 
without accreditation makes sense, but only for a certain period of time. 

Another national notifying authority responsible for the Marine Equipment Directive noted 
that it notifies CABs without accreditation due to the significant amount of time it takes to 
complete  this  process  and  the  associated  costs.  This  authority  stated  that,  for  the  most 
recent instance of accreditation, the process took nearly five years. Compared with around 
6  months  for  the  quickest  notification  process,  this  represents  a  significant  additional 
burden for CABs. 

For notified bodies, it is less a problem  of diverging rules, than a problem  of absence of 
effectiveness  in  the  harmonised  application  and  uniform  enforcement  of  those  rules  by 
national notifying authorities and accreditation bodies. Notified bodies interviewed believe 
that one solution to this challenge could be peer assessment among notified bodies. Mixed 
Assessment Teams, including a Technical Assessor from  an active foreign notified body, 
accompanying  the  local  Member  State  assessing  /  authorising  body  could  help  align  and 
ensure  the  quality  of  the  approaches  across  the  EU,  as  well  as  support  the  effective 
exchange of information. 

125 

 
According  to  notified  bodies,  mandatory  accreditation  is  not  considered  the  optimal 
solution, but could help ensure the best possible alignment in the notification processes and 
competencies of the assessing body (accreditation body) to be somewhat aligned through 
peer assessment and with that, ensure a level playing field in terms of requirements put on 
the Notified Bodies. Some notifying authorities also have reservations about the need for 
mandatory accreditation for all CABs because of its cost, which many small entrants to the 
conformity assessment market cannot afford. 

EA,  however,  suggests  that  the  peer  evaluation  system  could  be  rejuvenated  either  by 
appointing  an  agency  within  the  Commission,  or  a  service  of  the  European  Commission 
that  would  perform  the  peer  evaluation  of  accreditation  bodies  in  an  independent  and 
objective way. It seems reasonable to the EA that each accreditation body could detach one 
staff for two years to contribute with expertise to such task. 

Case study 3: Assessment of NLF-related costs and benefits under certain NLF-aligned 
legislation (EMCD) 

Case study: Assessment of NLF-related costs and benefits under the EMCD 

Background and context: The European Commission has recently published an evaluation of the NLF-
aligned  Electromagnetic  Compatibility  Directive  No  2014/30/EU  (EMCD).142  In  this  case  study,  the 
costs and benefits generated by the EMCD are mapped and assessed. The assessment of the EMCD was 
mainly  based  on  a  critical  analysis  of  replies  to  online  stakeholder  consultations,  enriched  with 
anecdotal evidence and illustrative figures whenever available. 

The below tables list the costs and benefits identified in the EMCD evaluation (structured based on the 
categories  set  out  in  the  European  Commission’s  Better  Regulation  Toolbox,  which  distinguishes 
between direct costs, enforcement costs and indirect costs, and between direct and indirect benefits) and 
for each of them, offers considerations on whether it can be attributed to the NLF.  

Stakeholder  feedback  and  other  evidence:  The  results  of  the  EMCD  evaluation  (although  no 
monetisation  of  the  costs  and  benefits  was  acknowledged  to  be  possible)  suggest  that  the  benefits 
generated by the EMCD are considerably higher than its costs. 

Within  this  overarching  context,  EMC-relevant  costs  of  product  development  and  costs  related  to 
the  conformity  assessment  to  produce  the  technical  file  were  the  types  of  costs  most  frequently 
identified as costly by consulted stakeholders. Although significant, the other costs were less frequently 
deemed to be high, according to the results of the evaluation’s surveys. 

According to the EMCD evaluation, EMCD-compliance costs are in a range between 5 and 15% of the 
total cost of production. Moreover, the impact of the EMCD in percentage terms does not significantly 
change depending on how much the cost of production of the selected product amounts to in absolute 
terms. Despite this relatively high share, according to the evaluation analysis, the benefits generated by 
the Directive clearly outweigh its costs. 

Out  of  the  EMCD  costs,  as  noted  above,  those  that  were  identified  as  most  costly  were  i)  EMC-
relevant  costs  of  product  development  and  ii)  costs  related  to  the  conformity  assessment  to 
produce the technical file. In the first case, the cost can be attributed to the NLF only to a very limited 
extent.  For  instance,  one  contributing  aspect  is  that  although  the  framework  for  and  incentives  to  use 
harmonised standards to achieve a presumption of conformity are established in the NLF, the standards 
are highly specific to the area of EMC and are paid-for, rather than freely available (as is the case for the 
RED).  In  addition,  costs  such  as  EMC-related  engineering  costs  and  pre-testing  costs  are  exclusively 
business as usual costs that are not related to the NLF. See the below tables for more detail. 

In the second case (costs related to conformity assessment), the costs can be partially attributed to the 

142 CSES (2021). Study on the Evaluation of the Electromagnetic Compatibility Directive 2014/30/EU (EMCD). 

126 

 
 
                                                 
 
NLF,  as  they  stem  from  the  integration  of  NLF  rules  in  the  EMCD.  These  costs  include  preparing 
technical documentation, performing laboratory tests and potentially using a notified body. However, in 
a  hypothetical  scenario  without  the  NLF,  the  EMCD  would  probably  still  contain  a  conformity 
assessment procedure, with  less similarities with the conformity assessment provided in other product 
legislation. Moreover, costs of familiarisation with the procedures would likely be higher in the absence 
of the NLF model of conformity assessment procedures, due to lack of harmonisation: in fact, although 
conformity assessment costs are NLF-related, the NLF actually brings about cost savings compared to a 
scenario without NLF. 

Considering  conformity  assessment  costs,  and  the  other,  less  burdensome  costs,  the  share  of  NLF-
related costs generated by the EMCD can be estimated to be significantly lower than 5-15% of total 
cost of production, for products falling under the EMCD scope.  

Similarly,  many of the EMCD-specific benefits are primarily  the result of EMCD provisions, such as 
the technical benefits of reduced incidence of electromagnetic disturbance resulting from  the essential 
requirements.  However,  some  benefits,  such  as  increased  market  efficiency  and  improved  industrial 
competitiveness can be attributed to some extent to the NLF. 

Although the EMCD costs attributed to some extent to the NLF are more than its benefits, their scale, 
based on stakeholder feedback, is strongly pending towards benefits, which are more strategic and wide-
ranging than punctual costs generated upfront. 

Costs generated by the EMCD and relationship with NLF 

Type of cost  Name of cost 

Relationship with NLF 

Direct costs  Cost  of  product  development 
(EMC relevant): 

a) Cost of purchasing the relevant 

standard 

b) Cost  of  engineering  (i.e.  the 
addressing  EMC-

cost  of 
relevant aspects) 

c) Cost of pre-testing  

d) Cost of risk assessment 

Cost of conformity assessment  to 
produce the technical file: 

a) Documentation 

b) Cost 

of 

laboratory 
(internally / third party)  

tests 

c) Involvement of a notified body 

a)  The  cost  of  purchasing  standards  (which  varies 
depending  on  the  product,  ranging  from  1,000  to 
15,000  EUR)  can  be  only  partially  attributed  to 
the NLF. Under the  EMCD,  harmonised standards 
are  paid  for,  due  to  the  active  role  of  CEN-
CENELEC  and  industry,  whereas  under  the  RED, 
standards  are  developed  by  ETSI,  and  are  freely 
downloadable.  CENELEC  seeks  to  base  EMC 
standards  closely  on  the  international  standards  of 
CISPR and the IEC,  which can generate  some cost 
savings  in  having  EN  standards  as  closely  aligned 
with international EMC standards as possible. 

b)  EMC-related  engineering  costs  are  not  related  to 

the NLF (business-as-usual cost). 

c)  Pre-testing  costs  are  not  related  to  the  NLF 

(business-as-usual cost). 

d)  Risk  assessment  costs  can  be  partially  attributed 
to the NLF. However, the EMCD evaluation noted 
that  risk  assessments  on  EMC  are  conducted  very 
rarely, if ever 

a)  The  cost  of  preparing  the  technical  documentation 
as part of the conformity assessment procedure can 
be attributed to the NLF. 

b)  The  cost  of  performing  laboratory  tests  (either 
internally  or  through  a  third-party  laboratory)  as 
part of the conformity assessment procedure can be 
partially attributed to the NLF. 

c)  The cost of involving a notified body as part of the 
conformity assessment procedure (when applicable) 
can be attributed to the NLF. 

127 

 
 
Type of cost  Name of cost 

Relationship with NLF 

Compliance  costs  during 
production process: 

the 

a)  EMC-relevant measures are not related to the NLF 

(business-as-usual costs). 

a) EMC-relevant  measures  (e.g. 

b)  Can be attributed to the NLF. 

shielding) 

b) Including  information  to  the 

user 

c) Markings 

(traceability, 

identification, CE marking) 

c)  Can be attributed to the NLF. 

d)  Can be partially attributed to the NLF. 

d) Ensuring 

that 

the 
manufacturing  process  and  its 
monitoring  are  compliant  with 
the technical documentation 

Cost  of  familiarisation  with  the 
legal framework 

Can  be  partially  attributed  to  the  NLF.  Importantly, 
the NLF generates cost savings compared to a situation 
characterised by a lack of harmonisation. 

of 

Cost 
documentation for 10 years 

keeping 

technical 

Can be attributed to the NLF. 

Enforcement 
costs 

Cost of authorised representative  Can be attributed to the NLF. 

Enforcement costs: 

Can be partially attributed to the NLF. 

a)  Enforcement 

costs 

(for 

authorities) 

b)  Enforcement 

costs 

(for 

manufacturers) 

Source: CSES Study. 

Type 
benefit 

Direct 
benefits 

Benefits generated by the EMCD and relationship with the NLF 

of 

Name of benefit 

Relationship with NLF 

Technical benefits: 

Can be partially attributed to the NLF. 

a)  Reduction 

the 

of 
electromagnetic  disturbance 
incorrect 
of 
equipment 

functioning 

incidence 

leading 

of 
to 
electrical 

b)  Regulation 

good 
engineering practices for fixed installations  

application 

of 

of 

c) 

Improvement  of  harmonised  standards 
relating to EMC 

d) 

Increased electromagnetic immunity 

Indirect 
benefits 

Market efficiency 

Can be partially attributed to the NLF. 

Industrial  competitiveness 
countries) 

(EU  vs  Third 

Can be partially attributed to the NLF. 

Source: CSES Study. 

128 

 
 
 
 
Case study 4: Assessment of NLF-related costs and benefits under certain NLF-aligned 
legislation (Toy Safety Directive) 

Case study: Assessment of NLF-related costs and benefits under the TSD 

Background and context: The 2020 evaluation of the Toy Safety Directive (TSD)143 aimed to assess 
the performance of the Directive since its entry into force in relation to its two objectives of (1) ensuring 
a  high  level  of  safety  of  toys  with  a  view  to  ensuring  the  health  and  safety  of  children,  and  of  (2) 
guaranteeing the functioning of the internal market for toys. 

The below tables list the costs and benefits identified in the TSD evaluation and for each of them, offers 
considerations on whether it can be attributed to the NLF.  

Stakeholder feedback and other evidence: The evaluation quantified costs generated by the TSD to a 
certain extent, while benefits could not be quantified. Stakeholder response however pointed to benefits 
outweighing costs. 

According  to  the  evaluation,  complying  with  the  TSD  caused  one-off  costs  to  economic operators, in 
particular  manufacturers, due  to  the many  new  requirements. These one-off  costs  were  reported to  be 
between 1%  and 3%  of  turnover.  The  ongoing  costs for  producing  toys  were considered to  be higher 
than  under  the  previous  Directive,  due  to  the  higher  number  of  requirements  to  be  met.  In  monetary 
terms the median value of this one-off cost amounted to an average of € 17 million per large firm and € 
110,000  per  SME.  This  meant  an  average  of  €  150,000  per  toy  type  produced  by  a  large  firm  and  € 
12,000 per toy type produced by a SME. This one-off cost was on average recovered over 2 years and 
10 months (3 years in case of SMEs). Using Eurostat data on turnover and number of companies, the 
one-off  cost  for  the  whole  toy  manufacturing  industry  amounted  to  between  €  140  million  and  €  200 
million.  

On  the  other  hand,  costs  did  not  prevent  several  hundred  companies  from  entering  the  market, 
increasing the total number of companies by some 10% between 2013 and 2017 and the TSD did not 
hinder  the  cost  competitiveness  of  the  toy  industry.  Furthermore,  according  to  the  evaluation, 
manufacturers are only exceptionally required to request the intervention of a third party (notified body), 
namely when producing novel toys that have hazardous features not covered by the existing toy safety 
standards, the references of which have been published in the Official Journal. 

Costs generated by the TSD and relationship with NLF 

Name of cost 

Relationship with NLF 

Type of 
cost 

Direct costs  One-off  costs  for  adapting  to  the 

TSD 

Recurring  costs  for  manufacturers 
(production costs) 

spent  by  manufacturers, 
Time 
to 
distributors 
and 
importers 
comply  with 
the  Directive’s 
requirements  when  developing  a 
toy. 

One-off adaptation costs are not related to the NLF, as 
they stem from the increased number of detailed safety 
requirements for toys, in particular on chemicals. 

Recurring  production  costs  increase  are  not  related  to 
the  NLF,  as  they  stem  from  new  requirements  of  the 
TSD on chemicals, an increase in the cost of materials, 
fixed costs, salaries, energy and transport cost. 

Time  resources  spent  to  ensure  compliance  with  the 
TSD  can  be  partially  attributed  to  the  NLF  (e.g.  as 
regards testing and documentation and safety aspects). 

Preparing  and  updating  technical 
documentation  (safety  assessment, 
conformity  assessment  documents 

As  defined  in  the  evaluation,  the  cost  related  to 
technical documentation can be partially attributed to 
the NLF. 

143 European Commission, SWD(2020) 287 final. 

129 

 
 
                                                 
 
Type of 
cost 

Name of cost 

Relationship with NLF 

supply  chain 
of 

and 
translation 
documentation). 

information, 
product 

Other 
costs 
manufacturers:  

borne 

by 

a)  The  cost  of  standard  can  be  only  partially 

attributed to the NLF. 

a)  Purchasing standards. 

b)  Testing costs can be only  partially attributed to 

b)  Testing  of  raw  materials  and 

testing of toys. 

the NLF. 

Enforcement 
costs 

Enforcement  costs  borne  by  public 
authorities 

Can be partially attributed to the NLF. 

Source: CSES Study. 

Benefits generated by the TSD and relationship with the NLF 

Type of benefit  Name of benefit 

Relationship with NLF 

Direct benefits 

Safety 

Can be partially attributed to the NLF. 

Indirect benefits 

Reduced legal uncertainty 

Can be attributed to the NLF. 

Level  playing  field  in  the  internal 
market 

Can be partially attributed to the 
NLF. 

Source: CSES Study. 

130 

 
 
ANNEX  IX.  RAPEX  –  SAFETY  GATE  DATABASE  –  ANALYSIS  OF  THE  SAFETY  GATE 
DATA  

The  RAPEX-Safety  Gate  system,  is  the  EU’s  rapid  alert  system  for  sharing  information 
between  national  authorities  on  dangerous  non-food  products.  The  system  operates  as 
follows: 

  When  a  national  authority  in  an  EU  Member  State  or  EEA/EFTA  country  discovers  a 
dangerous product on the market, it submits an alert to Safety Gate. Each alert contains a 
wide  range  of  information,  including  the  type  of  product,  a  description  of  the  risk,  the 
country  of  origin  and  the  measures  ordered  by  the  authority  or  taken  by  the  economic 
operator. 

  All other authorities are required to follow up on each alert and share any information on 

the presence of the dangerous product on their own market. 

This Annex provides an overview of the key methodological considerations before presenting 
an analysis of the data contained in the Safety Gate alerts covering the period 2005-2021. 

Methodological considerations 

This  analysis  aims  to  support  the  evaluation  of  certain  aspects  of  the  NLF  by  providing 
contextual  descriptive  statistics  on  trends  related  to  the  detection  of  unsafe  products 
that are subject to NLF-aligned legislation across the internal market. 

The Safety Gate data was provided to the evaluation team in the form of an Excel spreadsheet 
by the European Commission (DG GROW). The evaluation  team  prepared and cleaned the 
data  before  conducting  an  exploratory  analysis  and  reporting  the  results.  A  key  activity 
undertaken  in  the  data  preparation  phase,  in  collaboration  with  DG  GROW,  was  the 
development of a mechanism for linking the Safety Gate data to the NLF. 

As Safety Gate contains a wide variety of different information (up to 28 data fields for more 
than 30,000 alerts across 17 years), it was important to consider the relevance and utility of 
the data to  the  evaluation and work to  maximise these elements  through  the analysis. Most 
prominently,  the  utility  of  the  analysis  relied  on  the  ability  to  link  Safety  Gate  alerts  to 
specific pieces of NLF-aligned legislation. The following two data points were useful in this 
regard, but came with challenges: 

i)  Product categories: Each year from 2005-2018, between 25 and 29 product categories 
were used in  Safety  Gate;  this figure increased in  2019 (31), 2020 (37)  and 2021 (41). 
Although  some  of  these  categories  have  strong  links  to  specific  pieces  of  NLF-aligned 
legislation  (e.g.  ‘Toys’  with  the  Toy  Safety  Directive  and  ‘Protective  equipment’  with 
the  PPE  Regulation),  many  are  not  closely  aligned  to  the  legislation  that  sets  the  rules 
and  requirements  that  ultimately  define  whether  a  product  is  safe.  For  instance, 
categories such as ‘Gadgets’ and ‘Hobby/sports equipment’ have no clear link to specific 
pieces of legislation.  

ii)  Risk  /  Risk  legal  provision:  In  many  cases,  reference  to  the  specific  piece  of  EU 
legislation  with  which  a  product  is  non-compliant  is  flagged  within  the  ‘Risk’  (from 
2005-2010)  and  ‘Risk  legal  provision’  (from  2011-2021)  data  fields.  However,  these 
fields  are  qualitative  in  nature,  as  they  also  contain  a  description  of  the  risk  identified. 
Given  the  lack  of  pre-determined  options,  it  is  therefore  not  clear  whether  the  relevant 
legislation has been flagged in all alerts. 

131 

 
 
On this basis, the evaluation team identified all instances where non-compliance with one or 
more  NLF-aligned  legislation  was  specifically  indicated  in  the  ‘Risk’  or  ‘Risk  legal 
provision’ data fields. A new column was created to record these links and a total of 10,788 
alerts (35% of all alerts) were positively identified as being linked to NLF-aligned legislation. 
Additional  complexity  is  added  by  the  fact  that  non-compliance  with  more  than  one 
legislation is referenced in some alerts. 

As for the evaluation, the primary scope of the analysis is the period 2014-2021. However, 
contextual data from 2005-2013 will also be included where useful, in particular to examine 
the  impact  of  NLF-related  legislative  changes  prior  to  2014.  Throughout  the  examined 
period, different pieces of legislation were aligned to the NLF at different times; this has been 
factored into the analysis. 

Beyond the above challenges, it is important to note the  impact of external factors on the 
Safety Gate data. Over the period under examination, for instance: 

  Product  markets  have  experienced  significant  changes,  including  the  growth  of  e-
commerce  and  the  increased  presence  of  products  from  third  countries  (and  China,  in 
particular) on the internal market. As will be seen, more than 16,000 products originating 
in  China  have  been  reported  through  Safety  Gate  in  the  period  2005-2021;  this  is  six 
times  more  than  the  second  most  common  country  of  origin,  which  is  the  combined 
‘Unknown’ category (2,757 alerts).  

  Roles,  responsibilities  and  practices  of  market  surveillance  authorities  (MSAs)  have 
changed  over  this  period,  and  differences  exist  in  the  practices  and  resources  of  MSAs 
across  EU  Member  States  and  EEA/EFTA  countries,  as  clearly  reported  in  the  impact 
assessment  study  of  the  proposed  Goods  Package  from  2013144.  These  factors  strongly 
influence  both  the  number  of  unsafe    products  identified  and  reported  via  Safety  Gate, 
and their proportion by product category from one Member State to another. 

These external factors, as well as others, significantly restrict the ability of the analysis to 
attribute or link any product safety trends identified to the NLF. As a result, this analysis 
will  focus  on  providing  contextual  descriptive  statistics,  highlighting  this  caveat  where 
relevant. 

Analysis of all NLF-related alerts 

In total,  30,532 product  alerts  have been reported via Safety Gate in  the period 2005-2021, 
with  16,765  alerts  in  the  period  2014-2021.  A  total  of  10,788  of  these  alerts  are  directly 
linked to NLF-aligned or their predecessor legislation; 6,183 in the period 2014-2021 (37% 
of alerts in this period). As illustrated in the below figure, both the annual number of alerts 
and the annual  number of NLF-related alerts have stayed relatively consistent  in  the period 
2014-2021.  The  number  of  unsafe    products  reported  via  Safety  Gate  has  increased 
significantly in the period 2005-2014, rising from 713 in 2005 to 2,268 in 2014; however, the 
number of NLF-related alerts did not change as significantly. 

144 SWD(2013) 33 final of 13.2.2013, Commission staff document on an impact assessment accompanying the 
document "Product Safety and Market Surveillance Package" 

132 

 
                                                 
 
2500

2000

1500

1000

500

0

Safety Gate alerts, 2005-2014

1969

2035

1929

1886 1916

2268

2046 2110 2196 2214 2129

1691

1554

1542

1376

958

713

352

383

572

606

506

578

421

530

657

763

633

647

765

769

826

959

821

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

All Alerts

NLF-related Alerts

Figure 14 Total number of Safety Gate alerts and NLF-related alerts, 2005-2021 

For each NLF-related alert, the reporting national authority and the product’s country of 
origin are also recorded. As illustrated in the below map, the countries that most commonly 
report products with clear reference to NLF-aligned legislation or its predecessor legislations 
in  the  period  2005-2021  are  Hungary  (1,392,  12.9%),  Spain  (1,262,  11.7%),  the  UK  (884, 
8.2%) and France (875, 8.1%). 

Considering  differences  between  the  2005-2013  and  2014-2021  periods,  changes  in  the 
reporting practices of certain countries are notable. For some countries, the number of alerts 
submitted has increased considerably over the time period; one reason for this could be the 
time taken for MSAs to adapt to the using RAPEX - Safety Gate. In the following countries, 
the  number  of  alerts  in  the  period  2014-2021  was  more  than  50%  higher  than  the  period 
2005-2013: Belgium, Denmark, Italy, Latvia, Luxembourg, Poland and Sweden. 

In  other  countries,  however,  the  number  of  alerts  submitted  has  decreased  over  this  time 
period.  In  Bulgaria,  Greece,  and  Portugal,  for  instance,  the  number  of  alerts  in  the  period 
2014-2021 was more than 130% lower than the period 2005-2013. Although in some cases 
this may reflect changes stemming from the NLF, these trends are more likely the result of a 
wide range of other external factors such as changes in MSA resourcing, changes in market 
surveillance priorities, and changes in import routes. 

133 

 
 
 
Figure 15 Number of NLF-related alerts submitted by country, 2005-2021 

The  below  table  illustrates  the  top  ten  countries  of  origin  for  alerts  specifically  related  to 
NLF-aligned  legislation.  China  is  by  far  the  most  common  country  of  origin  for  non-
compliant  products,  totalling  8,456  alerts  specifically  referencing  NLF-aligned  legislation 
over  2005-2021.  This  equates  to  78%  of  all  such  alerts.  Furthermore,  the  number  of  such 
alerts related to Chinese-origin products has increased over this period; from 2005-2013, an 
average  of  385  alerts  per  year  related  to  products  originating  from  China  compared  to  624 
alerts per year in the period 2014-2021. 

Products of ‘Unknown’ origin are the second most common (853 alerts over the period 2005-
2021), followed by prominent EU markets (Germany, Poland, Italy, Spain, the Netherlands) 
and  Asian  countries  with  strong  reputations  in  industrial  manufacturing  (Hong  Kong, 
Taiwan). However, the number of alerts from these countries are minimal compared to those 
coming from China. 

Together,  the  top  10  countries  of  origin  account  for  94%  of  all  alerts  that  specifically 
reference NLF-aligned or predecessor legislation. 

134 

© GeoNames, Microsoft, TomTomPowered by Bing35435476849311011312616617719722923524227536644151459668473987512621392Number of NLF-related alerts submitted per country, 2005-2021351392Number of alerts© GeoNames, Microsoft, TomTomPowered by Bing35435476849311011312616617719722923524227536644151459668473987512621392Number of NLF-related alerts submitted per country, 2005-2021351392Number of alerts© GeoNames, Microsoft, TomTomPowered by Bing35435476849311011312616617719722923524227536644151459668473987512621392Number of NLF-related alerts submitted per country, 2005-2021351392Number of alertsNumber of NLF-related alerts submitted by country, 2005-2021884121 
 
 
 
People's Republic of China 

Unknown 

Germany 

Poland 

Italy 

Hong Kong 

Taiwan 

Spain 

Turkey 

The Netherlands 

… 

2005-2013 

2014-2021 

Total 

3,466 

432 

97 

51 

54 

54 

64 

33 

32 

26 

4,990 

421 

102 

61 

52 

47 

28 

37 

35 

34 

8,456 

853 

199 

112 

106 

101 

92 

70 

67 

60 

Total (all NLF-related alerts) 

4,605 

6,183 

10,788 

Table 4 Top 10 countries of origin – NLF-related alerts, 2005-2021 

Safety Gate also records the risk type associated with each alert, spanning from asphyxiation 
to chemical risks to electromagnetic disturbance. The below table shows the scale of different 
risk types in NLF-related alerts. As can be seen the most common risk type are electric shock 
(3,753 alerts), choking (3,226), injuries (1,474) and fire (1,278). 

Risk type 

- 

Allergy 

Asphyxiation 

Burns 

Chemical 

Choking 

Cuts 

Damage to hearing 

Damage to sight 

Drowning 

Electric shock 

Electromagnetic disturbance 

Entrapment 

Environment 

Fire 

Health risk / other 

Injuries 

Microbiological 

135 

Total 

3 

0 

45 

890 

965 

3,226 

127 

364 

132 

33 

3,753 

8 

24 

194 

1,278 

329 

1,474 

125 

 
 
 
 
 
 
Strangulation 

Suffocation 

Total 

237 

335 

13,543 

Table 5 Number of NLF-related alerts, by risk type 

Disaggregated analysis by NLF-aligned legislation 

Of the 23 NLF-aligned  pieces of legislation, 16 are directly referenced in Safety Gate alerts. 
These  include  both  current  NLF-aligned  legislations  and  their  non-aligned  predecessors(for 
instance,  the  Radio  Equipment  Directive  and  the  Radio  Equipment  &  Telecommunications 
Terminal Equipment Directive are both referenced). 

The  below  table  lists  these  legislations,  alongside  the  total  number  of  Safety  Gate  alerts 
related  to  each  and  the  number  of  alerts  pre-and  post-alignment  with  the  NLF.  As  can  be 
seen,  the  most  commonly  referenced  legislations  are  the  Toy  Safety  Directive  and  its 
predecessor (total of 5,351 alerts over the period 2005-2021), the Low Voltage Directive and 
its  predecessor  (4,206  over  this  period)  and  the  legislations  on  PPE  (629  over  this  period). 
Other  regularly  referenced  legislations  include  the  Pyrotechnic  Articles  Directive  and  the 
RoHS Directive (both 196 alerts). The following sectoral trends are interesting to note: 

  Although the absolute number of post-alignment alerts related to the Toy Safety Directive 
is  much  greater  than  the  number  of  pre-alignment  alerts,  the  average  number  of  annual 
alerts  per  year  is  not  as  significant.  Post-NLF-alignment,  an  average  of  345  alerts  have 
been  submitted  per  year  compared  with  259  in  the  pre-alignment  period.  However,  the 
number of alerts per year has remained relatively constant since 2007. 

  The  average  number  of  alerts  per  year  under  the  Low  Voltage  Directive  (LVD)  is  very 
similar  for  the  pre-  and  post-alignment  periods;  243  across  11  pre-alignment  years  and 
256  across  six  post-alignment  years.  In  addition,  LVD  alerts  spanned  18  Safety  Gate 
categories,  the  widest  range  of  any  NLF-aligned  legislation.  These  categories  included 
‘Electrical appliances and equipment’, ‘Lighting equipment’ and ‘Lighting chains’. 

  For PPE, there is a clear escalation in 2020 (164 alerts) and 2021 (157) as a result of the 

COVID-19 pandemic, rising from an average of 22 over the preceding years. 

  RoHS-related  unsafe  products  experienced  large  increases  in  2019  (89  alerts)  and  2021 

(56). Together, these years comprise 74% of all RoHS-related alerts. 

However, as highlighted above, there are a range of caveats and external factors that could be 
impacting  these  data,  including  better  labelling  practices  for  the  risks  related  to  certain 
legislations. 

NLF-aligned legislation 

Pre-alignment 

Post-alignment  Total 

Toy Safety Directive 2009/48/EU 

Low Voltage Directive 2014/35/EU 

Personal Protective Equipment Regulation (EU) 
2016/425 

Pyrotechnic Articles Directive 2013/29/EU 

Restriction of Hazardous Substances in Electrical and 
Electronic Equipment Directive 2011/65/EU 

1,552 

2,668 

262 

79 

3,799 

1,538 

367 

117 

196 

5,351 

4,206 

629 

196 

196 

136 

 
 
 
 
Gas Appliances Regulation (EU) 2016/426 

Construction Products Regulation (EU) No 305/2011 

Pressure Equipment Directive 2014/68/EU 

Radio Equipment Directive 2014/53/EU 

Recreational Craft and Personal Watercraft Directive 
2013/53/EU 

Electromagnetic Compatibility Directive 2014/30/EU 

Transportable Pressure Equipment Directive 2010/35/EU 

Medical Devices Regulation (EU) 2017/745 

ATEX Directive 2014/35/EU 

Marine Equipment Directive 2014/90/EU 

Lifts Directive 2014/33/EU 

Grand Total 

68 

22 

12 

20 

12 

10 

1 

1 

2 

9 

23 

25 

7 

8 

7 

2 

2 

1 

77 

45 

37 

27 

20 

10 

8 

3 

2 

2 

1 

10,810 

Table 6 Number of alerts per NLF-aligned legislation, pre- and post-NLF-alignment 

Considering  the  national  authorities  reporting  the  alerts,  a  few  findings  emerge  from  the 
data: 

  Despite  the  relatively  consistent  spread  of  toy  safety-related  submissions  across  30 
countries,  Spain  is  the  most  common  contributor  by  a  large  margin,  submitting  around 
16% of all toy safety alerts (839 alerts) over the 2005-2021 period. The contributions of 
France (489, 9%), Poland (463, 9%) and Hungary (413, 8%) are also notable. 

 

In the same manner, Hungary is by far the most active country considering alerts related 
to  the  Low  Voltage  Directive,  submitting  around  23%  (967  alerts).  Finland  (435,  10%) 
and Spain (361, 9%) are the next highest contributors. Alerts related to the Low Voltage 
Directive have been submitted across 29 countries. 

  Alerts  related  to  PPE  legislations  are  also  relatively  evenly  spread  across  30  countries. 
Germany  is  the  most  productive  country,  submitting  131  PPE-related  alerts  (21%), 
followed by Belgium (80, 13%). 

When  analysing  the  disaggregated  data  by  a  product’s  country  of  origin,  the  most  notable 
trends all relate to products originating in China. More specifically, Chinese-origin products 
are the target of the majority of NLF-related alerts across the Low Voltage Directive (3,210, 
76%),  the  Toy  Safety  Directive  (4,382,  82%),  PPE  legislations  (423,  67%),  and  the  RoHS 
Directive (165, 84%). 

The risk types that are prominent across NLF-relevant Safety Gate alerts are: 

  Alerts related to the Low Voltage Directive and its predecessor are strongly aligned to the 
risk type category of electrical shocks, which was reported in around 66% of such alerts 
(3,733).  In  addition,  fire-related  risks  were  highlighted  in  1,157  (21%)  alerts  that 
specifically referenced the LVD. 

  Half  of  the  alerts  that  reference  the  Toy  Safety  Directive  or  its  predecessor  (3,211) 
highlight choking as a risk type, while injuries (998, 16%) and chemical risks (829, 13%) 
are also key for this piece of legislation. 

 

In line with its purpose, RoHS-related alerts have a strong alignment with environmental 
risks. In fact, around 81% of all RoHS-related alerts (193) highlight environmental risks. 

137 

 
 
 
 
 
 
 
ANNEX X. MAPPING OF NLF-ALIGNED LEGISLATION 

The mapping of NLF-aligned legislation focuses  on: i) mapping the conformity assessment modules used within each directive and regulation; and ii) 
examining the extent to which substantive differences exist between the reference provisions detailed in Annex I to Decision No 768/2008/EC and the 
provisions stipulated in each of the NLF-aligned legislations. The first table below covers the first point above, as well as Chapters R1 and R2 of the 
reference provisions; namely the definitions and obligations for economic operators. 

The second table covers Chapters R3 and R4 of the reference provisions, which present  template legal  text  on issues related to the conformity of the 
product  (e.g.  presumption  of  conformity,  EC/EU  declaration  of  conformity,  CE  marking)  and  the  notification  of  conformity  assessment  bodies. 
Moreover,  in  the  examination  of  the  provisions  from  Chapter  R3,  divergence  from  the  declaration  of  conformity  template  (Annex  III  to  Decision  No 
768/2008/EC) and the CE marking provisions from Regulation (EC) No 765/2008 were also considered. 

Legislation 

Conformity assessment modules used 

Differences in the definitions used (Chapter 
R1, Decision No 768/2008/EC) 

Differences in the obligations of economic operators (Chapter R2, Decision 
No 768/2008/EC) 

Toy Safety Directive  

Article 19 & 20: Module A (if OJEU cited 
harmonised 
by 
standards 
manufacturer) 

applied 

No 

Module B + C (under four circumstances) 

No 

Transportable Pressure 
Equipment Directive  

Restriction of Hazardous 
Substances in Electrical 
and Electronic 
Equipment Directive  

Pyrotechnic Articles 
Directive  

Not explicitly stated in the Directive 

Minor differences: e.g. Economic Operators 

External link suggests a range of modules 
possible, including: A1, C1, F & G. 

To be validated with relevant Commission 
desk officer 

Article 7(b) - Module A 

No 

Minor  differences:  less  developed  in  the  Directive  than  in  the  NLF  re 
manufacturers (e.g. no mention of instructions and safety information).  

Additional mention of owners and operators. 

Reassessment of conformity linked to the Pi marking 

Minor differences: e.g. Art.7(f) refers only to a register etc. whereas Art.R2(4) 
includes  also  sample  testing  and  investigation;  and  Art.7  (c)  or  (h)  RoHS 
contain an additional sentence compared to Art.R2 (2) or (6). 

Article  17  -  either  module  B+C2/D/E  or 
module G or module H, depending on the 
type of product 

Minor differences: e.g. Economic Operators 

No 

Recreational Craft and 
Personal Watercraft 

Article  20-22  -  significant  variation  in 
required  modules  based  on  product  type 

No  difference  in  definitions  of  traditional  Major  in  relation  to  novel  Article  12  'obligations  of  private  importers',  e.g. 
stating  that  "If  the  required  technical  documentation  is  not  available  from  the 

138 

 
 
 
Legislation 

Conformity assessment modules used 

Differences in the definitions used (Chapter 
R1, Decision No 768/2008/EC) 

Differences in the obligations of economic operators (Chapter R2, Decision 
No 768/2008/EC) 

Directive  

and other aspects 

economic operators 

Article  23  –  Additional  novel  module  for 
post-construction 
(Module 
PCA) 

assessment 

Novel definition of “private importer” 

Civil Explosives 
Directive  

Article  20  -  Module  B  +  C2/D/E/F  or 
Module G 

Minor  differences:  e.g.  dealer  &  economic 
operators 

Simple Pressure Vessels 
Directive  

Article  13  -  Module  B  +  C1,  C2  or  C 
depending on the product 

No 

Electromagnetic 
Compatibility Directive  

Article  14  (for  apparatus)  -  Module  A  or 
Module B + C 

Minor  differences:  e.g.  "components"  or 
"mobile installations" considered as apparatus 

Non-automatic Weighing 
Instruments Directive  

Article  13  -  Module  B  +  D/F  (or  Module 
D1  or  F1  in  certain  circumstances)  or 
Module G 

No 

Minor  differences,  apart 
definitions: e.g. putting into use 

from  additional 

manufacturer,  the  private  importer  shall  have  it  drawn  up  using  appropriate 
expertise" (art. 12.2). 

Private Importer can carry responsibility for compliance (art. 12.1). 

Economic  operators  or  private  importers  are  required  to  affix  watercraft 
identification  (Annex  I.A.2.2.1)  and  watercraft  builder’s  plate  (Annex 
I.A.2.2.2). 

DoC  in  Directive  may  in  some  cases  include  additional  information  e.g. 
statement of the propulsion engine manufacturer and that of the person adapting 
an engine in accordance. 

No 

No 

Minor differences, no mention of the responsibility of manufacturers/importers 
to "carry out sample testing of marketed products, investigate, and, if necessary, 
keep a register of complaints, of non-conforming products and product recalls, 
and  shall  keep  distributors  informed  of  such  monitoring"  (Decision  No 
768/2008/EC R2 Art.4) 

No 

No 

Minor differences: e.g. "placing on the market" 
of lifts (see recital 4) or "installer" 

No  –  additional  role  of  installers  (in  practice,  ‘installer’  is  equivalent  to  a 
‘manufacturer’, however, the choice was  made to call a manufacturer of a lift 
an ‘installer’) 

Measuring Instruments  

Lifts Directive  

Article  17  –  manufacturers  can  use  any 
modules  detailed  in  Annex  II,  which 
presents Modules A, A2, B + C/C2/D/E/F, 
D1,  E1,  F1,  G,  H,  H1  (i.e.  all  except  A1 
and C1) 

Article  16  –  Annexes  detail  different 
modules for different products. i.e. Annex 
IV  (Module  B),  Annex  VI  (Module  E), 
Annex  VII  (Module  H),  Annex  VIII 
(Module  G),  Annex  IX  (Module  C2), 
Annex X (Module E), Annex XI (Module 
H1), Annex XII (Module D) 

ATEX Directive  

Article  13  -  for  certain  products,  Module 
B (detailed in Annex III) + D (Annex IV) / 

"intended  use"; 
Minor  differences:  e.g. 
Manufacturer  is  a  person  who  either  markets 

Minor differences: e.g. Art.6.1 – Obligation of manufacturer refers to products, 
which are supposed to be placed on the market or products which are supposed 

139 

 
Legislation 

Conformity assessment modules used 

Differences in the definitions used (Chapter 
R1, Decision No 768/2008/EC) 

Differences in the obligations of economic operators (Chapter R2, Decision 
No 768/2008/EC) 

Radio Equipment 
Directive   

F  (Annex  V);  for  other  products,  Module 
B  +  C1  (Annex  VI)  /  E  (Annex  VII);  for 
other  products,  Module  A  (Annex  VIII); 
for other products, Module G (Annex IX) 

Article  17  –  for  essential  requirements  in 
Article  3.1,  any  of  Module  A  (detailed  in 
Annex  II),  Module  B  +  C  (Annex  III)  or 
Module H (Annex IV). 

For  essential  requirements  in  Articles  3.2 
and  3.3,  Module  B  +  C  (Annex  III)  or 
Module H (Annex IV). 

the  designed  product  or  uses  it  for  own 
purposes. 

to be used for their own use; and Art. 6.2 Manufacturers of components shall 
accompany such component by “attestation of conformity” instead of EU DoC. 

as 
Minor 
definitions: e.g. "put into service" 

differences, 

such 

additional 

No 

Low Voltage Directive  

Referred to in Articles 6 and 15 – detail in 
Annex III, which presents Module A only 

No 

Pressure Equipment 
Directive  

Article  14  -  CA  procedure  determined  by 
equipment categories: 

Cat 1 - Module A 

Cat 2 - Modules A2, D1 or E1 

Cat 3 - Modules B + D/F/E/C2, or Module 
H 

Cat  4  -  Modules  B  +  D/F,  Module  G  or 
Module H1 

Minor  differences,  apart 
definitions:  e.g.  "European  approval 
material", "putting into service" 

from  additional 
for 

No 

No 

Marine Equipment 
Directive  

Article 15 - Module B + D/E/F, or Module 
G 

Minor differences: e.g. "notified body" 

Construction Products 
Regulation 

Declaration of performance demonstrating 
assessment  and  verification  of  constancy 
of  performance,  rather  than  conformity 
assessment (see Recital 29) 

No  

Minor.  Manufacturers  not  located  in  MS  need  to  appoint  an  authorised 
representative. An importer or distributor is considered a manufacturer for the 
purposes of this Directive 

No 

Cableway Installations 
Regulation 

Medical Devices 

Article 18 – Module B (detailed in Annex 
III)  +  D  (Annex  IV)  /  F  (Annex  V);  or 
Module  G  (Annex  VI);  or  Module  H1 
(Annex VII) 
Article 52 – as for the In Vitro Diagnostic 
Medical  Devices  Regulation.  CA 

Minor  differences:  e.g.  "manufacturer"  or 
"technical specification" 

Minor: time for importers to keep the EU declaration of conformity available is 
30 years after the subsystem/safety component has been placed on the market 

Minor 
representative", 

differences: 

e.g. 

"putting 

into 

140 

"authorised 
service", 

Major differences: 

 
Legislation 

Conformity assessment modules used 

Differences in the definitions used (Chapter 
R1, Decision No 768/2008/EC) 

Regulation 

procedures  set  out  in  Annexes  IX-XI; 
modules depend on device classification. 

"notified  body",  “post-market  surveillance”  or 
“sponsor”. 

In Vitro Diagnostic 
Medical Devices 
Regulation 

Article  48  –  as  for  Medical  Devices 
Regulation.  CA  procedures  set  out  in 
Annex  IX-XI;  modules  depend  on  device 
classification 

differences: 

"authorised 
Minor 
representative", 
service", 
"putting 
"notified  body",  "post-market  surveillance"  or 
"sponsor". 

into 

e.g. 

Differences in the obligations of economic operators (Chapter R2, Decision 
No 768/2008/EC) 
-  Manufacturers  not  located  in  the  EU  must  appoint  an  authorised 
representative. 
-  Manufacturers  shall  have  a  system  for  risk  management  as  described  in 
Section 3 of Annex I and a quality management system, registration of products 
on  the  UDI  system,  manufacturers  not  located  in  MS  need  to  appoint  an 
authorised representative. 
-  Additional  provisions  expand  on  the  obligations  of  manufacturers without 
contradicting the NLF provisions (e.g. Manufacturers shall [...] have measures 
in  place  to  provide  sufficient  financial  coverage  in  respect  of  their  potential 
liability under Directive 85/374/EEC), manufacturers need to have one person 
responsible for regulatory compliance (art 15) and register devices on the UDI 
system 
-  Authorised  representative  has  more  tasks/responsibilities,  e.g.  "the  right  to 
terminate the mandate if the manufacturer acts contrary to its obligations under 
this Regulation", "authorised representative shall be legally liable for defective 
devices on the same basis as, and jointly and severally with, the manufacturer" 
-  Importers  need  to  forward  complaints  to  manufacturer  and  authorised 
representative 
Major differences: 
-  Manufacturers  not  located  in  the  EU  must  appoint  an  authorised 
representative 
-  Manufacturers  shall  have  a  system  for  risk  management  as  described  in 
Section 3 of Annex I and a quality management system, registration of products 
on  the  UDI  system,  manufacturers  not  located  in  MS  need  to  appoint  an 
authorised representative 
-  Additional  provisions  expand  on  the  obligations  of  manufacturers  without 
contradicting the NLF provisions (e.g. Manufacturers shall [...] have measures 
in  place  to  provide  sufficient  financial  coverage  in  respect  of  their  potential 
liability under Directive 85/374/EEC), manufacturers need to have one person 
responsible for regulatory compliance (art 15) and register devices on the UDI 
system 
-  Authorised  representative  has  more  tasks/responsibilities,  e.g.  "the  right  to 
terminate the mandate if the manufacturer acts contrary to its obligations under 
this Regulation", "authorised representative shall be legally liable for defective 
devices on the same basis as, and jointly and severally with, the manufacturer" 

141 

 
Legislation 

Conformity assessment modules used 

Differences in the definitions used (Chapter 
R1, Decision No 768/2008/EC) 

Personal Protective 
Equipment Regulation 

Article  19  -  modules  vary  by  risk 
categories of product: 

No 

Cat 1 - Module A (Annex IV) 

Cat 2 - Module B (Annex V) + C (Annex 
VI) 

Cat 3 - Module B (Annex V) + C2 (Annex 
VII) / D (Annex VIII) 

Differences in the obligations of economic operators (Chapter R2, Decision 
No 768/2008/EC) 
-  Importers  need  to  forward  complaints  to  manufacturer  and  authorised 
representative 

Minor differences: 

- The manufacturer shall either provide the EU declaration of conformity with 
the  PPE  or  include  in  the  instructions  and  information  set  out  in  point  1.4  of 
Annex II the internet address at which the EU declaration of conformity can be 
accessed 

-  Importers  can  if  asked  provide  the  documentation  to  demonstrate  the 
conformity of PPE in paper or electronic form 

Gas Appliances 
Regulation 

Article 14 – For certain products, Module 
B  +  C2/D/E/F;  for  certain  products, 
Module G is also possible 

No 

No 

EU Fertilising Products 
Regulation 

Article  15  refers  to  Annex  IV,  which 
refers to CA procedures: 

Minor 
specification" 

differences: 

For  certain  products,  Module  A,  Module 
A1, Module B + C, Module D1 

e.g. 

"technical 

Minor differences: 

-  Manufacturers/importer  shall  keep  the  technical  documentation  and  the  EU 
declaration  of  conformity  for  5  years  after  the  EU  fertilising  product  covered 
has been placed on the market 

Legislation 

Differences in the reference provisions related to 
conformity of the product and the DoC (Chapter R3, 
Decision No 768/2008/EC) 

Differences in the provisions on CE 
marking (Regulation (EC) No 765/2008 & 
Chapter R3, Decision No 768/2008/EC) 

Differences in the provisions on notification of 
conformity assessment bodies (Chapter R4, Decision No 
768/2008/EC) 

Toy Safety Directive   

No 

Transportable Pressure 
Equipment Directive  

Minor  –  specific 
certificates  of  conformity; 
inspections, 
checks); no DoC 

intermediate 

requirements  on  conformity 
requirements 

(e.g. 
for  periodic 
inspections  and  exceptional 

Minor  differences  in  R11  and  R12  on  CE 
marking 

Minor  –  specific  Pi  marking  provisions; 
however,  similarities  to  Regulation  (EC)  No 
765/2008 

Restriction of Hazardous 
Substances in Electrical 

Minor differences (e.g. location of Art 16(1) text is different  No 

142 

Minor (e.g. no provisions on accredited in-house bodies) 

No  provisions  on  notification  (R14),  presumption  of 
conformity, 
and 
objection, 
subcontracting by notified bodies, accredited in-house bodies 

subsidiaries 

formal 

of 

Slight  differences  in  'Requirements  relating  to  notifying 
authorities' 

Significant  differences  in  'Requirements  relating  to  notified 
bodies' – specific rules under Directive 2008/68/EC 

Sector-specific details throughout related to inspections 

Minor differences: e.g. Art.9 RoHS compared to Article R4; 
and  Art.9(e)  refers  to  keeping  a  register  of  non-compliant 

 
 
Legislation 

Differences in the reference provisions related to 
conformity of the product and the DoC (Chapter R3, 
Decision No 768/2008/EC) 

Differences in the provisions on CE 
marking (Regulation (EC) No 765/2008 & 
Chapter R3, Decision No 768/2008/EC) 

Differences in the provisions on notification of 
conformity assessment bodies (Chapter R4, Decision No 
768/2008/EC) 

and Electronic Equipment 
Directive  

Pyrotechnic Articles 
Directive  

Recreational Craft and 
Personal Watercraft 
Directive   

from other legislations); no difference on DoC 

EEE and EEE recalls, not to sample testing or investigation. 

Minor (e.g. no provisions on formal objection to harmonised 
standard  as  regulated  by  Standardisation  Regulation);  also, 
DoC  includes  provisions  related  the  possibility  of  products 
being  subject  to  multiple  legislations,  and  requires  specific 
information on registration number) 

No 

Minor variation on 'notifying authorities' 

No provisions on formal objection to a harmonised standard 
or accredited in-house bodies 

Obligation  for  notified  bodies  to  maintain  a  register  of 
pyrotechnic  articles  that  have  been  subject  to  conformity 
assessment 

Additional  provisions  on 
notified bodies' 

'Appeal  against  decisions  of 

provisions 

Minor (e.g. no provisions on formal objection to harmonised 
regulated  by  Standardisation  Regulation; 
standard  as 
additional 
Post-Construction 
to 
related 
Assessment  –  Annex  V);  also, on  DoC  (e.g.  requirement  to 
provide the DoC with certain products; includes reference to 
private 
information 
requirements) 

additional 

importer; 

specific 

Minor (e.g. infringements covered under Art. 
53) 

No  provisions  on 
standard' for NBs or 'accredited in-house bodies' 

'Formal  objection  to  a  harmonised 

Minor (e.g. product specific requirements) 

Minor variation on 'notifying authorities' 

Civil Explosives Directive    Minor (e.g. no provisions on formal objection to harmonised 
standard  as  regulated  by  Standardisation  Regulation);  also, 
on DoC (e.g. provisions related to the possibility of products 
being subject to multiple legislations) 

Simple Pressure Vessels 
Directive  

Electromagnetic 
Compatibility Directive  

Minor (e.g. no provisions on formal objection to harmonised 
standard  as  regulated  by  Standardisation  Regulation);  also, 
on DoC (e.g. provisions related to the possibility of products 
being  subject 
legislations);  and  specific 
provisions  in  the  conformity  assessment  procedures  that  go 
beyond the NLF modules. 

to  multiple 

No 

Minor (e.g. no provisions on formal objection to harmonised 
standard, although referenced in Recitals); also, on DoC (e.g. 
provisions related to the possibility of products being subject 
to multiple legislations) 

No 

143 

No provisions on formal objection to a harmonised standard 
or accredited in-house bodies 

Different  provisions  on  challenging  the  competence  of 
notified bodies 

Provisions on 'Appeal against decisions of notified bodies' 

No  provisions  on 
standard' for NBs or 'accredited in-house bodies'. 

'Formal  objection  to  a  harmonised 

Different  provisions  on  challenging  the  competence  of 
notified bodies 

Provisions on 'Appeal against decisions of notified bodies' 

No provisions on formal objection to a harmonised standard 
or accredited in-house bodies 

Different provisions on challenging competence of NBs 

 
Legislation 

Differences in the reference provisions related to 
conformity of the product and the DoC (Chapter R3, 
Decision No 768/2008/EC) 

Differences in the provisions on CE 
marking (Regulation (EC) No 765/2008 & 
Chapter R3, Decision No 768/2008/EC) 

Differences in the provisions on notification of 
conformity assessment bodies (Chapter R4, Decision No 
768/2008/EC) 

Non-automatic Weighing 
Instruments Directive  

Minor (e.g. no provisions on formal objection to harmonised 
standard, although referenced in Recitals); also, on DoC (e.g. 
provisions related to the possibility of products being subject 
to multiple legislations) 

Measuring Instruments  

Minor 
(e.g.  use  of  normative  documents,  alongside 
harmonised  standards  for  presumption  of  conformity; 
specific  tests  noted  in  legal  provisions;  no  provisions  on 
formal  objection 
standard,  although 
to  harmonised 
referenced in Recitals); also, on DoC (e.g. provisions related 
to  the  possibility  of  products  being  subject  to  multiple 
legislations) 

Lifts Directive   

ATEX Directive  

to  harmonised 

Minor  on  legal  provisions  (e.g.  no  provisions  on  formal 
objection 
regulated  by 
Standardisation  Regulation);  also,  on  DoC  (e.g.  provisions 
related to the possibility of products being subject to multiple 
legislations) 

standard  as 

Extensive  differences  in  DoC  template  (e.g.  additional  info, 
different  structure,  separate  forms  for  lifts  and  safety 
components for lifts) 

Minor  (e.g.  promotion  of  national  standards  and  technical 
specifications  in  the  absence  of  harmonised  standards;  no 
provisions  on  formal  objection  to  harmonised  standard  as 
regulated by Standardisation Regulation); also, on DoC (e.g. 
provisions related to the possibility of products being subject 
to multiple legislations) 

Minor  (e.g.  related  to  additional,  product 
specific metrology marking) 

No provisions on formal objection to a harmonised standard 
or accredited in-house bodies 

Provisions on 'Appeal against decisions of notified bodies' 

Different provisions on challenging competence of NBs 

Provisions on 'Appeal against decisions of notified bodies' 

Minor  (e.g.  related  to  additional,  product 
specific metrology marking; requirements for 
NB  identification  number  to  be  indelible  or 
self-destructive if removed) 

No provisions on formal objection to a harmonised standard 

Additional sector-specific information within the notification 
procedure 

Minor (e.g. product specific provisions) 

Different provisions on challenging competence of NBs 

Provisions on 'Appeal against decisions of notified bodies' 

No provisions on formal objection to a harmonised standard 
for NBs or accredited in-house bodies 

Different provisions on challenging competence of NBs 

Provisions on 'Appeal against decisions of notified bodies' 

Minor  (e.g.  specific  additional  explosion 
protection and other information markings) 

No provisions on formal objection to a harmonised standard 
for NBs or accredited in-house bodies. 

Radio Equipment Directive    Minor (e.g. no provisions on formal objection to harmonised 
standard,  although  referenced  in  Recitals);  also,  on  DoC 
legal  provisions  (e.g. provisions related  to  the  possibility  of 
products being subject to multiple legislations; provisions for 
a simplified DoC) 

(e.g.  product 

Minor 
specific  general 
principle;  CE  marking  shall  be  affixed  to 
both the product and the packaging) 

On  DoC  Annex,  minor  divergences 
(e.g.  additional 
information  required  –  a  description  of  accessories  and 
components  which  allow  the  radio  equipment  to  operate  as 

No provisions on formal objection to a harmonised standard 
or accredited in-house bodies 

Different provisions on challenging competence of NBs 

Provisions on 'Appeal against decisions of notified bodies' 

Additional information obligations under Annexes III and IV 

144 

 
Legislation 

Differences in the reference provisions related to 
conformity of the product and the DoC (Chapter R3, 
Decision No 768/2008/EC) 

Differences in the provisions on CE 
marking (Regulation (EC) No 765/2008 & 
Chapter R3, Decision No 768/2008/EC) 

Differences in the provisions on notification of 
conformity assessment bodies (Chapter R4, Decision No 
768/2008/EC) 

Low Voltage Directive  

intended) 

Minor  (e.g.  additional  provisions  on  presumption  of 
conformity based on international and national standards; no 
provisions  on  formal  objection  to  harmonised  standard, 
although  referenced 
in  Recitals);  also,  on  DoC  (e.g. 
provisions related to the possibility of products being subject 
to multiple legislations) 

No 

Pressure Equipment 
Directive  

Minor (e.g. no provisions on formal objection to harmonised 
standard  as  regulated  by  Standardisation  Regulation);  also, 
on DoC (e.g. provisions related to the possibility of products 
being  subject 
legislations);  and  specific 
provisions  in  the  conformity  assessment  procedures  that  go 
beyond the NLF modules. 

to  multiple 

Minor  (e.g.  product  specific  provisions  on 
affixing CE marking) 

No  NB  and  thus  notifying  requirements  (clearly  stated  in 
Recitals) 

Sector  specific  requirements  on  user  inspectorates  and  lists 
user 
of 
inspectorates. 

organisations 

recognised 

third-party 

and 

No provisions on formal objection to a harmonised standard 
for NBs or accredited in-house bodies. 

Different provisions on challenging competence of NBs 

Provisions  on  'Appeal  against  decisions  of  notified  bodies 
etc.' 

Major  (e.g.  use  of  different  mark  –  ‘Wheel 
mark’,  rather  than  CE  marking,  although 
provisions are similar) 

Significantly  different  structure  (e.g.  notification  procedure, 
requirements for notifying authorities and notified bodies all 
included as separate Annexes) 

Marine Equipment 
Directive  

Major (e.g. Article 35 empowers the Commission to indicate 
by  means  of  Implementing  Acts  mandatory  standards,  no 
presumption  of  conformity,  no  provisions  on  formal 
objection  to  harmonised  standard);  also,  on  DoC  (e.g. 
product specific provisions). The reason for this is the need 
to apply the IMO instruments without providing the notified 
bodies with the possibility to deviate from them. 

Construction Products 
Regulation 

No  differences  related  to  R8  &  R9;  specific  requirements 
instead of DoC (e.g. Declaration of performance - Annex III; 
Assessment  and  Verification  of  constancy  of  performance  - 
Annex V) 

Cableway Installations 
Regulation 

Minor (e.g. no provisions on formal objection to harmonised 
standard);  also,  on  DoC  (e.g.  provisions  related  to  the 

No 

145 

(e.g. 

requirement 

Minor  differences 
to 
include  two  last  digits  of  the  year  in  which 
the  CE  marking  was  first  affixed  and  other 
the  CE 
information  alongside 
additional 
marking;  no  provisions  on  mechanisms  to 
ensure correct application) 

Specific monitoring timeline (2 years) 

Additional  requirements  for  notified  bodies  related  to  ISO 
standards 

No  provisions  on  presumption  of  conformity,  formal 
objection  to  a  harmonised  standard  or  accredited  in-house 
bodies 

Well  aligned;  with  sector-specific  wording 
constancy of performance) 

(e.g.  on 

No explicit provisions on formal objection and accredited in-
house bodies 

Specific  provisions  on  'Use  of  facilities  outside  the  testing 
laboratory of the notified body' 

No provisions on formal objection to a harmonised standard 
or accredited in-house bodies 

 
Legislation 

Differences in the reference provisions related to 
conformity of the product and the DoC (Chapter R3, 
Decision No 768/2008/EC) 

Differences in the provisions on CE 
marking (Regulation (EC) No 765/2008 & 
Chapter R3, Decision No 768/2008/EC) 

Differences in the provisions on notification of 
conformity assessment bodies (Chapter R4, Decision No 
768/2008/EC) 

Medical Devices 
Regulation 

In Vitro Diagnostic 
Medical Devices 
Regulation 

possibility of products being subject to multiple legislations) 

Minor (e.g. R8 provisions under heading 'use of harmonised 
standards; no provisions on formal objection); on DoC legal 
provisions  (e.g.  differences  in  the  text  and  structure; 
provisions related to the possibility of products being subject 
to multiple legislations; possibility of delegated acts) 

On DoC Annex  - major differences in structure and content 
(e.g.  requirements  for  product  specific  information,  such  as 
the Basic UDI-DI, risk class etc.) 

Minor (e.g. R8 provisions under heading 'use of harmonised 
standards; no provisions on formal objection); on DoC legal 
provisions  (e.g.  differences  in  the  text  and  structure; 
provisions related to the possibility of products being subject 
to multiple legislations; possibility for delegated acts) 

On DoC Annex  - major differences in structure and content 
(e.g.  requirements  for  product  specific  information,  such  as 
the Basic UDI-DI, risk class etc.) 

Minor  (e.g.  different  structure;  CE  marking 
/  packaging  and 
required  on  product 
instructions  for  use  and  sales  packaging;  no 
provisions 
correct 
application, but penalties for infringements in 
Art. 113) 

ensuring 

the 

on 

Minor  (e.g.  different  structure;  CE  marking 
/  packaging  and 
required  on  product 
instructions  for  use  and  sales  packaging;  no 
provisions 
correct 
application, but penalties for infringements in 
Art. 106) 

ensuring 

the 

on 

Personal Protective 
Equipment Regulation 

Minor (e.g. no provisions on formal objection to harmonised 
standard);  also,  on  DoC  (e.g.  provisions  related  to  the 
possibility of products being subject to multiple legislations) 

No 

On DoC Annex - minor (e.g. additional information required 
on which conformity assessment module used) 

Gas Appliances Regulation  Minor (e.g. no provisions on formal objection to harmonised 
standard  as  regulated  by  Standardisation  Regulation);  also, 
on DoC (e.g. provisions related to the possibility of products 
being subject to multiple legislations, specific provisions for 
fittings and requirement to provide DoC with fittings) 

EU Fertilising Products 
Regulation 

Minor (e.g. no provisions on formal objection to harmonised 
standard);  also,  on  DoC  (e.g.  provisions  related  to  the 
possibility of products being subject to multiple legislations) 

No 

146 

Different provisions on challenging competence of NBs 

Provisions on 'Appeal against decisions of notified bodies' 

Significant  differences  in  the  structure  and  approach  to 
stipulating  the  rules  for  notification,  notifying  authorities 
('authorities  responsible  for  notified  bodies')  and  notified 
bodies 

Significant  differences  in  the  structure  and  approach  to 
stipulating  the  rules  for  notification,  notifying  authorities 
('authorities  responsible  for  notified  bodies')  and  notified 
bodies 

No provisions on formal objection to a harmonised standard 
or accredited in-house bodies 

Different provisions on challenging competence of NBs 

Provisions on 'Appeal against decisions of notified bodies' 

Different provisions on challenging competence of NBs 

Provisions on 'Appeal against decisions of notified bodies' 

No provisions on formal objection to a harmonised standard 
or accredited in-house bodies 

Different provisions on challenging competence of NBs 

Provisions on 'Appeal against decisions of notified bodies' 

Minor (e.g. specific information to be placed 
alongside the CE marking) 

No provisions on formal objection to a harmonised standard 
for NBs or accredited in-house bodies 

 
 
ANNEX  XI.  SUBSTANTIAL  MODIFICATION  –  AN  OVERVIEW  OF  THE  DIVERS  DEFINITIONS  OF 
MODIFICATION OF PRODUCTS FOLLOWING THEIR PLACING ON THE MARKET 

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

Article 2(13), (14) and (15) of Directive 2009/125/EC for the setting of ecodesign requirements for 
energy-related products defines the ‘life cycle’145, ‘reuse’146 and ‘recycling’147. 

Article 2(1)(31) of Regulation (EU) 2017/745 on medical devices and Article 2(24) of Regulation  
(EU) 2017/746 on in vitro diagnostic medical devices define ‘fully refurbishing’ as the complete 
rebuilding  of  a  device  already  placed  on  the  market  or  put  into  service,  or  the  making  of  a  new 
device from used devices, to bring it into conformity with the respective Regulation, combined with 
the assignment of a new lifetime to the refurbished device. 

Article 3(1)(16) of the Proposal of the machinery regulation defines ‘substantial modifications’ as 
a modification of  a machinery  product,  by physical  or digital  means after that machinery product 
has been placed on the market or put into service, which is not foreseen by the manufacturer and as 
a  result  of  which  the  compliance  of  the  machinery  product  with  the  relevant  essential  health  and 
safety requirements may be affected. 

The Proposal for the regulation on batteries and waste batteries recognizes that at the end of the first 
life,  used  batteries  are  considered  waste  (except  for  reuse).  Repurposing148  is  considered  a  waste 
treatment operation. Repurposed (second life) batteries are considered as new products which have 
to  comply  with  the  product  requirements  when  they  are  placed  on  the  market.  The  Proposal  also 
defines the ‘reuse’149 and ‘lifetime’150 of batteries.  

According to  Article 3(23) of the  Proposal for a  Regulation  on artificial intelligence  ‘substantial 
modification’  is  a  change  to  the  AI  system  following  its  placing  on  the  market  or  putting  into 
service which affects the compliance of the AI system with the essential requirements set out in the 
Proposal  or  results  in  a  modification  to  the  intended  purpose  for  which  the  AI  system  has  been 
assessed. 

Article 12(2) of the Proposal for the general product safety regulation sets out that a modification 
should be deemed to be substantial where a) the modification changes the intended functions, type 
or performance of the product in a manner which was not foreseen in the initial risk assessment of 

145 Life cycle’ means the consecutive and interlinked stages of a product from raw material use to final disposal 
146 Reuse: means any operation by which a product or its components, having reached the end of their first use, are used 
for the same purpose for which they were conceived, including the continued use of a product which is returned to a 
collection point, distributor, recycler or manufacturer, as well as reuse of a product following refurbishment; 
147 Recycling:  means the reprocessing in a production process of waste materials for the original purpose or for other 
purposes but excluding energy recovery 
148 Article 2 of the Proposal defines ‘repurposing’ as any operation that results in parts or the complete battery being 
used for a different purpose or application than the one that the battery was originally designed for.  
149 Article 2(40) of the Proposal defines  ‘reuse’ as the complete  or partial direct re-use of  the battery for the original 
purpose the battery was designed for. 
150 Article 2(47) of the Proposal defines the ‘lifetime’ of the battery as the period of time that starts when the battery is 
placed on the market, and ends when the battery becomes waste. 

147 

 
 
 
                                                 
 
the product; b) the nature of the hazard has changed or the level of risk has increased because of the 
modification; c) the changes have not been made by the consumer for their own use. 

Article  2  of  the  Proposal  for  a  Regulation  establishing  a  framework  for  setting  eco-design 
requirements  for  sustainable  products  defines  the  terms  of  ‘life  cycle’151,  remanufacturing152 
‘refurbishment’153 and ‘repair’154 of the product.  

151  Article  2(12)  of  the  Proposal  defines  ‘life  cycle’  as  the  consecutive  and  interlinked  stages  of  a  product’s  life, 
consisting  of  raw  material  acquisition  or  generation  from  natural  resources,  pre-processing,  manufacturing,  storage, 
distribution, installation, use, maintenance, repair, upgrading, refurbishment and re-use, and end-of-life; 
152 Article 2(16) of the Proposal defines ‘remanufacturing’ as an industrial process in which a product is produced from 
objects that are waste, products or components and in which at least one change is made to the product that affects the 
safety, performance, purpose or type of the product typically placed on the market with a commercial guarantee; 
153 Article 2(18) of the Proposal defines ‘refurbishment’ as preparing or modifying an object that is waste or a product 
to  restore  its  performance  or  functionality  within  the  intended  use,  range  of  performance  and  maintenance  originally 
conceived at the design stage, or to meet applicable technical standards or regulatory requirements, with the result of 
making a fully functional product; 
154 Article 2(20) of the Proposal defines ‘repair’ as returning a defective product or waste to a condition where it fulfils 
its intended use;  

148