COMMISSION STAFF WORKING PAPER Accompanying document to10 PROPOSALS TO ALIGN PRODUCT HARMONISATION DIRECTIVES TO DECISION No 768/2008/ECEXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
Date: 2011-11-21
Institutions: European Commission
Subjects: free movement of goods, harmonisation of standards, market supervision, marketing, product safety, single market

EUROPEAN COMMISSION 

21.11.2011 
SEC(2011) 1375 final 

NEW LEGISLATIVE FRAMEWORK (NLF) ALIGNMENT PACKAGE 
(Implementation of Goods Package) 

COMMISSION STAFF WORKING PAPER 

Accompanying document to 

10 PROPOSALS TO ALIGN PRODUCT HARMONISATION DIRECTIVES TO 
DECISION No 768/2008/EC 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 

{COM(2011) 763 final} 
{SEC(2011) 1376 final} 

 
 
 
 
  
 
 
 
1. 

PROBLEM DEFINITION 

General problems with product harmonisation directives … 

Over a period of more than 30 years the EU has set up requirements in its “technical 
harmonisation”  directives  for  a  vast  range  of  products  such  as  machinery, 
automobiles, toys, electrical  products, lifts, etc. This legislation has two objectives: 
On  the  one  hand  it  ensures  that  products  available  in  Europe  safeguard  public 
interests like health and safety, consumer protection or environmental protection at a 
high level. On the other hand it ensures the free movement of products by replacing 
national  rules  with  a  single  harmonised  set  of  conditions  for  the  marketing  of  the 
products concerned that apply in all EU Member States1.  

A  stocktaking  exercise  on  experience  gained  with  existing  legislation  in  the 
harmonised  area,  and  in  particular  with  the  New  Approach  was  launched  in  2004. 
The  overall  conclusion  of  this  stocktaking  was  that  the  legislation  has  largely 
succeeded in liberalising trade in goods and in setting robust requirements ensuring 
the safety of products. However, it also revealed a number of shortcomings, namely a 
significant  number  of  non-compliant  products  still  reaching  the  market,  the 
unsatisfactory  performance  of  certain  notified  bodies2,  and 
inconsistencies 
throughout  the  legislation  making  its  application  unnecessarily  complicated  for 
manufacturers and authorities.  

… and general solution identified 

To  remedy  these  shortcomings,  the  “New  Legislative  Framework”  (NLF)  was 
adopted as part of the goods package. It consists of two complementary instruments: 

•  Regulation  (EC)  No  765/2008  on  accreditation  and  market  surveillance  (NLF 

Regulation)3  

•  Decision No 768/2008/EC establishing a common framework for the marketing of 

products (NLF Decision)4.  

Both  instruments  strengthen  and  complete  the  existing  rules  and  improve  the  way 
they are applied and enforced in practice by business and authorities.  

1 

2 

3 

4 

that 

Legislative 

accompanied 

The  evolution  of  the  EU’s  policy  on  technical  harmonisation  is  outlined  in  detail  in  the  impact 
assessment 
SEC(2007) 173, 
the  New 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf  
Laboratories  and  certification  or  inspection  bodies  delivering  certificates  which  are  notified  to  the 
Commission by Member States. 
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the  requirements  for  accreditation  and  market  surveillance  relating  to  the  marketing  of  products  and 
repealing Regulation (EEC) No 339/93, OJ L218 of 13.08.2008. 
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common 
framework  for  the  marketing  of  products,  and  repealing  Council  Decision  93/465/EEC,  OJ  L218  of 
13.08.2008. 

Framework. 

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1 

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The  Regulation  introduced  rules  on  accreditation  and  requirements  for  the 
organisation  and  performance  of market surveillance and controls of products from 
third countries. The Regulation became applicable on 1 January 2010. 

The  Decision  contains  model  text  that  is  meant  to  reinforce  various  provisions 
commonly  used  in  EU  product  legislation  (for  example  concerning  definitions, 
obligations  of  economic  operators,  notified  bodies,  safeguard  mechanisms,  etc)  so 
that the legislation works more effectively in practice. It also introduces new aspects, 
such  as  obligations  of  importers,  which  are  crucial  to  improving  the  safety  of 
products on the market.  

However, unlike the Regulation, the Decision does not have immediate legal effects 
on economic operators, individuals or Member States. It is conceived as a “toolbox” 
for future legislation. By adopting the Decision, the Parliament, the Council and the 
Commission have committed themselves to using its provisions as much as possible 
in  future  product  legislation  in  order  to  maximise  the  coherence  of  the  regulatory 
framework5. To give practical effect to the provisions of the Decision, they need to 
be integrated into existing and new product legislation.  

A specific set of harmonisation directives 

Against  this  background,  the  Commission  has  identified  a  specific  set  of  product 
harmonisation directives for which alignment with the NLF Decision could be dealt 
with as a 'package' (i.e. as opposed to individual alignments carried out at the same 
time as broader revisions6). The ten directives concerned are the following:  

–  Civil  Explosives  Directive:  Directive  93/15/EEC  on  the  harmonisation  of  the 
provisions relating to the placing on the market and supervision of explosives for 
civil use  

–  ATEX  Directive:  Directive  94/9/EC  on  the  approximation  of  the  laws  of  the 
Member States concerning equipment and protective systems intended for use in 
potentially explosive atmospheres 

–  Lifts Directive: Directive 95/16/EC of 29 June 1995 on the approximation of the 

laws of the Member States relating to lifts 

–  Pressure Equipment Directive (PED): Directive 97/23/EC on the approximation 

of the laws of the Member States concerning pressure equipment  

5 

6 

Article  2  (Subject  matter  and  scope)  of  Decision  No  768/2008/EC  reads:  "This  Decision  sets  out  the 
common framework of general principles and reference provisions for the drawing up of Community 
legislation  harmonising  the  conditions  for  the  marketing  of  products  (Community  harmonisation 
legislation. Community harmonisation legislation shall have recourse to the general principles set out in 
this  Decision  and  to  the  relevant  reference  provisions  of  Annexes I,  II  and III.  However,  Community 
legislation may depart from those general principles and reference provisions if that is appropriate on 
account  of  the  specificities  of  the  sector  concerned,  especially  if  comprehensive  legal  systems  are 
already in place." 
Examples  of  individual  alignments  that  are  being  carried  out  together  with  the  revision  of  sector-
specific  elements  (e.g.  product  requirements  or  testing  methods)  are  the  Recreational  Craft  Directive, 
the Directive on Personal Protective Equipment or the R&TTE Directive. 

EN 

2 

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–  Measuring  Instruments  Directive  (MID):  Directive  2004/22/EC  on  measuring 

instruments  

–  Electromagnetic  Compatibility  Directive  (EMC):  Directive  2004/108/EC  on 
the  approximation  of  the  laws  of  the  Member  States  relating  to  electromagnetic 
compatibility and repealing Directive 89/336/EEC 

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

–  Pyrotechnic  Articles  Directive:  Directive  2007/23/EC  on  the  placing  on  the 

market of pyrotechnic articles  

–  Non-automatic  Weighing 

Instruments  Directive 

(NAWI):  Directive 

2009/23/EC on non-automatic weighing instruments 

–  Simple  Pressure  Vessels  Directive  (SPVD):  Directive  2009/105/EC  relating  to 

simple pressure vessels 

The  directives  concerned  by  this  initiative  set  out  requirements  which  ensure  that 
products are designed and manufactured in such a way that they do not pose a risk to 
the  health  and  safety  of  consumers  or  other  users,  that  they  produce  accurate 
measuring results (measuring instruments) or that they do not cause electromagnetic 
disturbances (electromagnetic compatibility directive).  

The economic sectors to which the directives apply are electric and electronic goods 
(LVD  and/or  EMC),  equipment  for  use  in  potentially  explosive  atmospheres 
(ATEX),  pressure  equipment  (SPVD  or  PED),  measuring  instruments  (MID  or 
NAWI), civil explosives, lifts and pyrotechnic articles. 

General problems also affect this specific set of directives  

This impact assessment examines to what extent the general problems identified with 
product  harmonisation  legislation  also  affect  these  10  directives  and  whether  their 
alignment  with  the  new  framework  established  by  the  NLF  Decision  would  be 
beneficial for the sectors concerned.  

The  problem  of  non-compliance  with  the  requirements  of  directives  is  generally 
perceived  throughout  all  sectors  concerned,  whereas  certain  sectors  (and  product 
categories)  are  more  affected  than  others.  Overall  92%  of  economic  operators 
answering  the  public  consultation  consider  that  their  sector  is  affected  by  non 
compliance.  

Non-compliance can be potentially harmful for product users, although the risks vary 
according  to  the  nature  of  the  product.  For  instance  defective  electronic  products 
falling  under  the  scope  of  the  LVD  can  present  a  risk  of  electric  shock  or  burns. 
Electrical  equipment  that  does  not  comply  with  the  essential  requirements  of  the 
EMC could produce electromagnetic disturbances that affect the correct functioning 
of other apparatus (TVs, radio and telecommunications networks) and may not work 
as  intended.  The  explosion  of  industrial  pressure  equipment  such  as  a  boiler  or  a 
reactor vessel in a chemical plant is likely to lead to serious injuries and may cause 

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significant  damage  to  surrounding  infrastructures.  Non  compliance  of  measuring 
instruments  can  lead  to  wrong  measuring  results  linked  with  economic  damage  for 
end-users. 

In addition, non-compliance hampers the competitiveness of compliant  firms. Non-
compliant economic operators can gain significant cost advantages (e.g. by avoiding 
costly conformity assessment procedures) by comparison with those who follow the 
rules7. In sectors where there is tough competition from imported low-price products, 
European  industry  is  disadvantaged.  87%  of  economic  operators  responding  to  the 
public  consultation  consider  that  they  suffer  from  unfair  competition  due  to  this 
situation.  

A  major  reason  for  non  compliance  is  that  market  surveillance  does  not  operate 
effectively  in  the  EU.  This  perception  is  widely  shared  amongst  stakeholders.  A 
specific difficulty for the authorities is the traceability of non-compliant products and 
the  operators  who  supplied  them,  in  particular  when  the  products  originate  in  third 
countries.  

A  further  reason  is  that  existing  obligations  in  product  directives  focus  on 
manufacturers, while importers and distributors do not carry out the necessary checks 
to ensure that they are not supplying non-compliant products. They rely on the fact 
that it is the task of the manufacturer to ensure the compliance of the product and do 
not  check  whether  the  manufacturer  has  actually  carried  out  this  task  properly.  To 
remedy  this,  Member  States  have  introduced  obligations  on  importers  and 
distributors in their national laws, which however differ from country to country and 
lead to different approaches when dealing with non-compliant products. 

Eight  of  the  ten  directives  concerned  require  the  certification  of  products  by 
“notified bodies”8 before they can be placed on the market9. Notified bodies hence 
play  an  important  role  in  ensuring  the  safety  and  compliance  of  products  on  the 
market. However there have been problems with the quality of services delivered by 
some  of  them.  This  assessment  was  shared  by  68%  of  notified  bodies,  84%  of 
economic  operators  using  notified  bodies  and  53%  of  public  authorities  that 
participated in the public consultation. 

One reason is that certain notified bodies lack the necessary competence to carry out 
conformity  assessments  properly.  Another  reason  is  that,  in  order  to  issue  their 
certificates at significantly lower rates, certain bodies do not put the required level of 
effort  into  their  assessment  or  into  the  application  of  procedures.  For  example,  the 
elimination  or  reduction  of  on  site  controls  or  relaxed  requirements  regarding  the 
frequency  of  periodic  audits/inspections  can  reduce  the  costs  of  assessments  quite 
considerably. 

7 

8 

9 

Quote  from  questionnaire  reply:  “Expert  estimations  say  that  fulfilling  the  safety  and  administrative 
provisions required by our regulations can add up to a fifth of total manufacturing costs. In the absence 
of efficient enforcement mechanisms some manufacturers might be tempted to "take the easy way" and 
to market non-compliant products.” 
These  bodies  are  conformity  assessment  bodies,  which  test,  inspect  and  certify  products.  They  are 
called “notified bodies”, because they are notified by the Member States to the Commission. 
In the electro-technical sector the role of notified bodies is different. For instance under EMC Directive 
recourse to notified bodies in the conformity assessment procedure is voluntary.  

EN 

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The third problem to be tackled is the inconsistency gradually built up in the existing 
product  legislation  due  to  the  fact  that  the  directives  have  evolved  over  time.  For 
example  different  terminology is used for concepts that are common to  all of them 
(conformity  assessment  procedures,  definitions  or  safeguard  clauses).  Sometimes 
definitions or legal provisions leave room for divergent interpretations and this leads 
to legal uncertainty and confusion, in particular when two or more directives apply 
simultaneously. For example, a considerable number of measuring instruments also 
have to comply with the EMC. Certain pyrotechnic articles also have to comply with 
the LVD or EMC. 

2. 

ANALYSIS OF SUBSIDIARITY 

This  initiative  concerns  the  proper  functioning  of  the  internal  market  in  goods.  EU 
action in this area is based on Article 114 of the TFEU. The aspects addressed in this 
context  are  already  regulated  by  the  ten  directives  concerned,  although  they  do  not 
effectively address the weaknesses identified or, as regards inconsistency, may even 
be the source of the problem. Action taken at national level to address these problems 
has led to divergent national approaches in the treatment of economic operators and 
risks  creating  obstacles  to  the  free  movement  of  goods.  Hence  it  is  appropriate  to 
take action at EU level. 

3. 

OBJECTIVES 

This initiative has 3 main objectives. The first is to ensure that products on the EU 
market are safe and fulfil all the requirements ensuring a high level of protection of 
(health  and  safety,  electromagnetic  compatibility,  correct 
public 
measurements).  The  main  specific  goal  is  to  reduce  the  number  of  non-compliant 
products on the market by providing authorities with more effective tools to carry out 
market surveillance controls and to monitor the activities of notified bodies. 

interests 

The  second  objective  is  to  improve  the  functioning  of  the  internal  market,  by 
ensuring that non-compliant products and economic operators are equally treated and 
that notified bodies are equally assessed throughout the EU market. 

Finally, this initiative aims to simplify the regulatory environment for products. 

4. 

POLICY OPTIONS 

Due  to  the  specific  context  of  this  initiative  as  explained  in  section  1,  this  impact 
assessment explores a limited set of options. The objective is to ascertain whether the 
directives concerned should make  use of  the measures of the NLF Decision  and, if 
so, to assess whether alignment with the Decision should be carried out by legislative 
or non legislative means. The resulting options are: 

–  Option 1: No policy change. This option consists of not introducing any changes 

to the existing situation. 

–  Option  2:  Alignment  with  the  NLF  Decision  by  non  legislative  measures. 
Option  2  consists  of  a  set  of  non-regulatory  instruments  that  encourage  the 

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voluntary application of all or part of the solutions contained in the NLF Decision. 
The latter  could  also  be presented as “best practice” in guidance  documents and 
the parties concerned would be encouraged to apply them. In practice, this option 
would be a “voluntary” alignment with the NLF Decision. 

–  Option 3: Alignment with the NLF Decision by legislative measures. Option 3 
consists of the modification of the directives concerned that would then make use 
of the measures set out in the NLF Decision. 

Under  option  2  and  option  3  the  measures  provided  by  the  NLF  Decision  can  be 
summarised as follow:  

(1)  Measures intended to address the problem of non-compliance: 

• 

Obligations for importers and distributors to check that products bear the CE 
marking,  are  accompanied  by  the  required  documents  and  carry  traceability 
information. Additional obligations are imposed on importers. 

•  Manufacturer  obligations  to  provide  instructions  and  safety  information  in  a 
language  easily  understood  by  consumers  and  end-users,  to  carry  out  sample 
testing and product monitoring. 

• 

• 

requirements 

Traceability 
the  whole  distribution  chain: 
manufacturers and importers must put their name and address on the product; 
every economic operator must be able to inform the authorities from whom he 
purchased a product and to whom he supplied it.  

throughout 

Reorganisation of safeguard clause procedure (market surveillance) to clarify 
how  the  relevant  enforcement  authorities  are  informed  about  dangerous 
products  and  ensure  that  equivalent  action  is  taken  against  that  product  in  all 
Member States. 

(2)  Measures intended to ensure the quality of notified bodies' work:  

• 

• 

• 

• 

Reinforcement  of  the  notification  requirements  for  notified  bodies  (including 
subcontractors  and  subsidiaries)  such  as  impartiality  and  competence  in 
carrying  out  their  activity  and  application  of  guidance  developed  by 
coordination groups.  

Revised  notification  process:  Member  States  notifying  a  body  must  include 
information on the evaluation of the competence of that body. Other Member 
States can object to the notification within a certain period.  

Requirements for notifying authorities (i.e. the national authorities in charge of 
the  assessment,  notification  and  monitoring  of  notified  bodies)  such  as 
objectivity and impartiality in carrying out their activity. 

Information  obligations:  Notified  bodies  must  inform  notifying  authorities  of 
refusals, restrictions, suspensions and withdrawals of certificates.  

(3)  Measures intended to ensure more consistency among the directives: 

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• 

• 

Alignment of commonly used definitions and terminology. 

Alignment of the texts of the conformity assessment procedures.  

5. 

ASSESSMENT OF IMPACTS 

The impact assessment report examines the economic impacts of the options in terms 
of  internal  market,  competitiveness,  costs  and  administrative  burdens  for  economic 
operators  or  notified  bodies  and 
impacts  on  public  authorities  and 
the 
consumers/users.  The  report  also  looks  at  the  social  impact  on  public  health  and 
safety and on the simplification of the regulatory environment.  

Although  no  additional  policy  initiative  is  taken,  the  no  policy  change  option  is 
expected to have some positive impact in the  sectors  concerned  already,  due  to  the 
progressive implementation of the NLF Regulation, which strengthens the powers of 
market  surveillance  authorities.  This  plays  a  positive  role  in  relation  to  the  goal  of 
reducing  non-compliance  and  delivers  benefits  both 
to  compliant-firms 
(competitiveness) and users (economic and safety impact). The NLF Regulation also 
facilitates the task of public authorities in their activities relating to the notification 
and  monitoring  of  some  conformity  assessment  bodies  (i.e. 
those  using 
accreditation). However, the option has no real impact on the internal market or on 
the simplification of the regulatory environment.  

The option of alignment with the NLF Decision by non-legislative measures has the 
potential  for  positive  impacts  on  all  stakeholders.  For  instance,  clarifying  the 
responsibilities  of  importers  and  distributors  and  introducing  specific  traceability 
requirements  would  facilitate  the  equal  treatment  of  the  parties  involved  (positive 
impact  on  internal  market);  it  would  also  provide  authorities  with  more  effective 
tools  to  address  non-compliance  and  so  reduce  the  scope  for  unfair  competition 
(competitiveness) and risks taken by users (economic and safety impact). However, 
under option 2 the provisions of the NLF Decision would only be non binding 'best 
practice'  and  so  their  implementation  would  entirely  depend  on  the  voluntary 
commitment  of  the  different  stakeholders.  This  casts  serious  doubt  on  whether  the 
positive  impacts  identified  will  actually  materialise  and  provide  real  added  value 
with respect to the no- change option10. 

Under  the  option  of  alignment  with  the  NLF  Decision  by  legislative  measures  the 
provisions  of  the  NLF  Decision  would  be  part  of  applicable  sector  legislation.  The 
provisions  of  the  NLF  Decision  would  be  binding  obligations  enforceable  by 
Commission  and  by  national  authorities.  This  would  give  a  stronger  guarantee  that 
the positive impacts of the alignment would actually occur.  

This  analysis  of positive impacts is  largely supported by stakeholders. For instance 
73-76%  of  general  economic  operators  and  small  and  medium  enterprises 

10 

It  this  respect,  it  is  important  to  note  that  existing  guidance  contained  in  the  so-called  "Blue  Guide" 
(Guide  to  the  implementation  of  directives  based  on  the  New  Approach  and  the  Global  Approach, 
European  Commission,  September  1999),  already  points  to  the  responsibilities  of  the  economic 
operators  that  are  then  clarified  by  Decision  No  768/2008/EC.  However  as  the  Blue  Guide  is  not 
binding, it has not been sufficient to address the issues identified. 

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participating  in  the  public  consultation  believe  that  clarification  of  obligations 
relating  to  them  and  market  surveillance  procedures  will  help  defend  the 
competiveness of EU businesses. Similarly most stakeholders11 agree that this policy 
action will help protect public health and safety. 

Alignment by legislative measures is not expected to have a significant impact on the 
costs  of  firms  and  notified  bodies.  Most  obligations  of  economic  operators 
complement  existing  obligations  or  codify  what  would  be  normal  practice  for  a 
responsible/compliant  firm  according  to  the  spirit  of  existing  legislation.  Similarly, 
the  requirements  for  notified  bodies  are  fully  in  line  with  standards  defining  the 
relevant benchmark for the assessment of conformity assessment bodies12. Overall an 
impact  on  costs  is  possible,  in  relation  to  obligations  of  importers/distributors  and 
traceability, but is considered moderate. Indeed 55% of general economic operators 
and 30-33% of small and medium enterprises having participated in the consultations 
believe  that  the  alignment  of  these  obligations  will  bring  about  moderate  cost 
increases, while a further 12% and 27% respectively consider that there will be no or 
no significant cost increases. Due to the large variety of products concerned by this 
exercise, it is not possible to provide quantitative estimates.  

At the end of the impact assessment there was no indication that the selected option 
might result in a disproportionate burden for SME. 

Some implementation costs for public authorities have been identified, in particular 
as regards the need to re-notify conformity assessment bodies in accordance with the 
requirements  in  the  NLF  Decision.  However,  the  number  of  re-notifications  to  be 
handled  by  each  competent  authority  is  very  limited  (with  the  exception  of  the 
authorities dealing with non-automatic weighing instruments, in only 2 countries). In 
any case, the Commission will introduce a specific transitional provision that allows 
time for re-notifications before the general date of applicability of the directives. 

6. 

COMPARISON OF OPTIONS 

The no policy change option is only partly effective in relation to the objectives of 
this policy intervention. Furthermore, it is not coherent with the policy commitment 
underpinning the NLF Decision. 

The  option  of  aligning  by  non-legislative  measures  might  be  more  effective  than 
option  1  as,  in  principle,  it  addresses  all  the  objectives,  except  simplification. 
However,  it  does  not  guarantee  positive  impacts  due  to  its  poor  enforceability.  In 
terms  of  efficiency  the  non-legislative  measure  is  the  option  with  the  lowest  score 
since, on the one hand it does not guarantee significant benefits by comparison with 

11 

12 

58-78% of economic operators, 72-78% of notified bodies 58-62% of authorities and about 72-79% of 
users participating in the consultation (excluding the measuring instrument sector). 
These are 1) EN 45011:1998, General requirements for bodies operating product certification systems; 
2)  EN  ISO/IEC  17020:2004,  General  criteria  for  the  operation  of  various  types  of  bodies  performing 
inspection; 3) EN ISO/IEC 17021:2006, Conformity assessment – Requirements for bodies providing 
audit and certification of management systems; 4) EN ISO/IEC 17024:2003, Conformity assessment – 
General  requirements  for  bodies  operating  certification  of  persons;  5)  EN  ISO/IEC  17025:2005, 
Conformity  assessment  –  General  requirements  for  the  competence  of  testing  and  calibration 
laboratories. 

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the no policy change scenario, and on the other hand it brings about some (moderate) 
increase  in  compliance  costs  for  economic  operators  and  notified  bodies  that 
voluntarily commit to the best practice proposed.  

The  option  of  aligning  by  legislative  measures  addresses  all  the  objectives  and  is 
more  effective  than  both  option  1  and  option  2.  This  option  will  bring  about 
moderate costs that are more than offset by its positive impacts. This option is then 
considered  efficient.  Furthermore,  this  option  is  fully  consistent  with  the  policy 
commitment underpinning the NLF Decision. 

In the light of its effectiveness, efficiency and coherence, option 3 stands out as the 
preferred option. 

Table 1: Comparison of the listed options 

Effectiveness 

Efficiency  

Coherence 

Option  1:  No 
change 

Neutral 

Neutral  

Neutral  

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

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

to 

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

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

of 

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

Option  2:  Non-
legislative 
measures 

Low 

Low 

Neutral  

less efficient than Option 1, 
same 
vs 
higher costs for responsible 
stakeholders 

effectiveness 

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

does  not  provide  tangible 
improvement  with  respect 
to  Option  1  due  to  poor 
enforceability. 
It  will 
increase 
the  compliance 
gap  between  responsible 
and  unscrupulous  EO/NB. 
It 
address 
not 
does 
simplification. 

Option 
Alignment 

3: 

High 

addresses  all  objectives. 
More  effective  than  option 
1  and  option  2  in  relation 
of 
to 
reducing  the  number  of 

objectives 

the 

High 

Coherent 

important  benefits  for  all 
stakeholders  vs  small  or 
moderate additional costs 

with other NLF instrument 
and  policy  commitment 
underpinning 
NLF 
Decision  

EN 

9 

   EN 

 
 
scope 

products 
non-compliant 
for  unfair 
and 
competition. Effective as to 
simplification.  

7. 

MONITORING AND EVALUATION 

The evaluation of the effectiveness of the legislation will be based on the feedback 
received through the various cooperation mechanisms already established under the 
directives 
(experts  groups, 
facilitate 
administrative cooperation groups (ADCOs), notified body groups).  

implementation 

themselves 

their 

to 

In 2018 the Commission will produce a comprehensive report on the functioning of 
market  surveillance,13  which  will  also  allow  conclusions  to  be  drawn  for  the 
evaluation of this initiative. 

Indicators  allowing  to  monitor  the  reduction  of  non-compliant  products  on  the 
market  and  the  improvement  of  the  quality  of  conformity  assessment  services 
delivered by notified bodies will be based on information obtained via the RAPEX 
system,  the  market  surveillance  database  established  under  Article  23  of  the  NLF 
Regulation,  data  provided  by  authorities  responsible  for  the  controls  at  external 
borders, the National Market Surveillance Programmes established under Article 18 
of  the  NLF  Regulation,  the  market  surveillance  and  safeguard  clause  notification 
procedures established under every directive and the NANDO14 database. 

13 
14 

See Article 40 of Regulation (EC) No 765/2008. 
http://ec.europa.eu/enterprise/newapproach/nando/ 

EN 

10 

   EN