COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
Date: 2012-12-17
Institutions: European Commission
Subjects: EC conformity marking, international standard, maritime safety, market supervision, marketing standard, quality standard, technical standard, vehicle parts, vessel

EUROPEAN 
COMMISSION 

Brussels, 17.12.2012  
SWD(2012) 437 final 

COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 

Accompanying the document 

revision of Council Directive 96/98/EC of 20 December 1996 on marine equipment 

{COM(2012) 772 final} 
{SWD(2012) 438 final} 

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COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 

Accompanying the document 

revision of Council Directive 96/98/EC of 20 December 1996 on marine equipment 

Lead DG: DG MOVE 

Executive summary 

1. 

PROBLEM DEFINITION 

Experience  with  the  working  of  the  Marine  Equipment  Directive  (hereinafter  referred  to  as 
"MED") highlighted certain implementation and enforcement weaknesses, mostly as regards: 
the  quality  and  control  of  the  work  of  the  notified  bodies  (organisations  carrying  out 
conformity  assessment  procedures  on  the  Member  States'  behalf);  the  obligations  of  the 
economic  operators;  the  effectiveness  of  market  surveillance  activities;  the  safeguard 
mechanisms  (which  ensure  that  Member  States  take  measures  against  non-compliant 
equipment,  and  that  these  measures  are  controlled  in  order  to  ensure  that  they  do  not 
constitute disguised obstacles to the free movement). 

Given  that  the  legislative  technique  used  in  MED  to  achieve  its  policy  objectives  is  largely 
based on the principles defined in the New Approach1 for the area of free movement of goods, 
the  implementation  and  enforcement  issues  identified  above  are  shared  with  all  New 
Approach Directives. 

To  correct  the  malfunctions  of  the  system,  the  New  Approach  was  subject  to  a  revision  in 
2008  which  led  to  the  New  Legislative  Framework  (hereinafter  the  "NLF")  for  the 
marketing of products.2 

Therefore, the problems identified for the MED can be addressed by aligning the MED on the 
NLF  as  foreseen  by  the  co-legislators.  However,  in  light  of  the  specificities  of  the  marine 
equipment, a key issue is whether MED-specific solutions are also needed in some areas. The 
impact assessment provides a detailed mapping of the NLF against MED specificities. Among 
these: 

• 

• 

1 

2 

Marine equipment must comply with the construction and performance requirements, 
and be tested in accordance with the testing standards, laid down by the IMO;  

Marine equipment must be approved by the flag State; 

For  a  description  of  the  New  Approach  and  its  associated  problems,  see  the  Commission's  Impact 
assessment on 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, SEC 2007(173). 
Annex 7 of the present impact assessment contains a description of the elements of the NLF. 

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• 

• 

• 

Marine  equipment  is  not  necessarily  marketed  in  EU  territory,  but  it  is  rather 
installed  directly  on  board  EU  ships  wherever  these  are  built  or  repaired,  or  take 
supplies; 

Marine equipment includes many items which fall under the scope of other Internal 
Market  directives,  however  the  requirements  of  these  are  different  from  or 
incompatible with those of the IMO. 

In  addition,  the  transposition  process  of  IMO  rules  into  national  law  creates  legal 
uncertainty  and  imposes  excessive  burden  upon  the  industry  and  national 
administrations because of a long and complex legislative technique – making it very 
difficult to keep up with the production of technical requirements by the International 
Maritime Organisation. 

For these reasons, the MED does not ensure the complete application and implementation of 
IMO and other standards by Member States, leading to safety risks and inefficient functioning 
of the Internal Market for marine equipment. 

Stakeholders  affected  include  European  marine  equipment  manufacturers,  among  which  a 
large  number  of  SMEs,  shipyards,  ship  passengers  and  crews,  as  well  as  public 
administrations and governments. 

2. 

ANALYSIS OF SUBSIDIARITY AND PROPORTIONALITY 

Direct application of the IMO regulatory framework by the Member States in the absence of 
Community  harmonisation  would  lead  to  barriers  to  the  free  movement  of  goods,  mostly 
stemming  from  a)  the  broad  discretion  left  by  the  IMO  instruments  to  the  flag  state,  b)  the 
production  of  additional  national  requirements  and  c)  the  divergences  in  the  certification 
methods.  At  the  same  time,  the  resulting  divergences  in  national  regulations  would  lead  to 
uneven degrees of safety and environmental protection. 

Harmonisation  by  the EU resolves  these problems,  as it  results  in  a clearly  identified set of 
requirements and uniform certification procedures capable of ensuring a high level of safety 
and of environmental protection. Moreover, unlike the international system, the EU offers the 
advantage  of  a  judicial  enforcement  system  –  without  which  the  effectiveness  of  those 
requirements and procedures would be seriously undermined. 

The EU does not harmonise itself the detailed technical specifications applicable, which are 
decided at the IMO level with full contribution of the Member States. It merely identifies in a 
clear way what specifications and technical standards of the IMO should be applied. 

3. 

OBJECTIVES OF THE EU INITIATIVE 

3.1. 

General objectives 

Pursuant to Articles 90 and 91 TFEU, the Common Transport Policy (CTP) should contribute 
to  the  broader  objectives  of  the  Treaties.  Within  the  framework  of  CTP  and  taking  into 
account the specificities of marine equipment, the general objective of the proposed initiative 
is twofold: 

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• 

• 

to  enhance  the  implementation  and  enforcement  mechanisms  of  the  MED,  thereby 
guaranteeing  the  proper  functioning  of  the  internal  market  for  marine  equipment 
while ensuring a high level of safety at sea and prevention of marine pollution;  

to  simplify  the  regulatory  environment  while  guaranteeing  that  IMO  requirements 
are  applied  and  implemented  in  a  harmonised  way  across  the  EU,  thereby 
contributing to ensuring that the conditions necessary for the competitiveness of the 
Union's industry exist pursuant to Article 173 TFEU. 

3.2. 

Specific objectives 

Based on the problem and related root causes set out in section 2 above, the twofold general 
objective can be translated into more specific objectives: 

• 

• 

to find an optimal way to align MED on the New Legislative Framework (as required 
under  Article  2  of  Decision  768/2008/EC  (the  NLF  Decision)  while  taking  due 
account of the specificities of marine equipment in the field of market surveillance, 
conformity assessment of products and obligations of actors in the distribution chain.  

to  shorten,  simplify  and  clarify  the  transposition  of  amendments  to  IMO  standards 
into the European and national legal frameworks. 

4. 

POLICY OPTIONS 

The Commission has identified four policy options – besides the baseline scenario. All policy 
options have been designed to be able to address both specific objectives defined in section 3. 
The Commission performed a preliminary assessment of the 4 possible policy options on the 
basis  of  their  effectiveness  in  addressing  current  problem  drivers  and  of  their  efficiency.  In 
parallel,  the  coherence  of  the  possible  policy  options  with  the  principles  of  subsidiarity  and 
proportionality has been assessed. As a result of this pre-screening, 2 policy options, besides 
the baseline scenario, have been retained for in-depth assessment. 
Policy  Option  2  would  foresee  a  maximum  alignment  of  the  MED  on  the  NLF,  where 
departure  from  the  latter's  provisions  would  be  kept  to  those  issues  where  it  is  considered 
indispensable in any case – namely specific marking. 
Policy  Option  3  would  take  the  form  of  a  conditional  alignment  of  the  MED  on  the  NLF, 
where additional MED-specific solutions would be introduced to optimise the effectiveness of 
the  instrument,  namely  in  the  areas  of  IMO  requirements  and  standards,  obligations  of 
economic  operators,  use  of  conformity  assessment  modules,  product  traceability  and 
safeguard  clause.  These  areas  would  largely  be  the  same  where  the  MED  currently  departs 
from the New Approach. 

Table 1: Description of retained Policy Options 

Policy Option 2  

Policy Option 3 

maximal alignment to NLF 

conditional alignment to NLF 

• 

Specific  Objective  1:  to  find  an  optimal  way  to  align  MED  on  the  NLF  while  taking  into 
account the specificities of marine equipment 

Market surveillance 

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Common EU framework  Word by word transposition of 

NLF provisions into MED 

More effective post-
market control 
mechanism 

Word by word transposition of 
NLF provisions into MED 

• 

• 

Safeguard clause 
procedure 

Word by word transposition of 
NLF provisions into MED 

• 

Conformity assessment 
of products 

Essential requirements  Word by word transposition of 

• 

NLF provisions into MED - 
current annexes to MED to be 
abandoned; compliance with 
IMO requirements3 turned into 
"essential requirement". 

Notification of 
conformity assessment 
bodies 

Word by word transposition of 
NLF provisions into MED 

Conformity assessment 
procedures 

Word by word transposition of 
NLF provisions into MED 

CE marking 

No alignment, CE marking 
replaced by a wheelmark 

Toolbox of measures for 
use in legislation 

• 

• 

• 

Obligations of actors in 
the distribution chain 

Word by word transposition of 
NLF provisions into MED 

• 

Same as PO2 

Same as PO 2 + Introduction of the 
possibility to use electronic tags to 
to  market 
tools 
give  better 
surveillance 
for  detecting  non-
conforming equipment. 

adapting 

Same  as  PO  2  +  Additional 
the 
provisions 
administration  of 
the  safeguard 
clause,  making  it  possible  for  the 
Commission  to  decide  to  limit  its 
assessment  to  the  respect  of  due 
procedure  by  the  Member  State 
concerned. 

technical 

Mandatory 
norms 
including  mandatory  and  non-
mandatory  IMO  requirements  as 
well  as  European  and  international 
testing  standards  developed  by 
European 
international 
standardisation  organisations  on 
the basis of the IMO requirements. 

and 

Same as PO2 

of 

use 

Selective 
conformity 
assessment  modules,  whereby 
notably  modules  A 
and  C 
(corresponding to the possibility of 
conformity  assessment  of  products 
by  in-house  Notified  Bodies)  are 
not retained. 

alignment,  CE  marking 

No 
replaced by a wheelmark 

Adaption of obligations of actors in 
the distribution chain, reflecting the 
irrelevance of concentrating on  the 
small  share  of  marine  equipment 
which  is  actually  placed  on  the 
market within the EU territory. 

3 

Consequently, non-mandatory requirements, recommendations and guidelines would not be covered by 
this essential requirement. 

• 

Manufacturers: same as in PO2 

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• 

and 

and 

Importers 
identification 
cooperation 
surveillance 
(information, 
removal of risks, etc.) 

with 

distributors: 
registration; 
market 
authorities 
documentation, 

Harmonised definitions 
and procedures (save the 
CE marking) 

Word by word transposition of 
NLF provisions into MED 

• 

Same as in PO2. 

• 

Specific Objective 2: to simplify, clarify and shorten the transposition of amendments to IMO 
standards into the European and national legal frameworks 

-/- 

• 

No transposition into EU legal 
order; IMO requirements in the 
form of essential requirements 
directly applicable in Member 
States. International and 
European standards are optional 
and give presumption of 
conformity. 

Transposition of IMO requirements 
through implementing or delegated 
Regulations,  which  do  not  require 
national 
transposition 
into 
standards 
legislations.  Testing 
(whether  developed  by  IMO  or  by 
standardisation 
are 
mandatory. 

bodies) 

5. 

ASSESSMENT OF IMPACTS 

The  following  table  presents  an  aggregated  qualitative  assessment  of  of  the  expected 
economic, social and environmental impacts. 

Table 2: Qualitative assessment of the expected impacts of PO2 and PO3  

Policy Option 2 

Policy Option 3 

Economic impacts 

Internal market 

Common EU framework 

More effective post-market control 
mechanism 

Safeguard clause procedure 

Conformity assessment of products 

Obligations for actors in the 
distribution chain 

Harmonised definitions 

Uniform interpretation and 
implementation of IMO 
requirements 

Operating costs and 
administrative burden 

++ 

++ 

++ 

++ 

- 

= 

-- 

++ 

+++ 

+++ 

+++ 

++ 

= 

= 

Economic operators 

++ 

+++ 

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Notified bodies 

SMEs 

Competitiveness of economic 
operators 

Enforcement system 

Traceability of products 

Obligations of actors in the 
distribution chain 

Conformity assessment 

Public authorities 

Users and passengers 

Third countries and international 
relations 

Social impacts 

Safety 

Environmental pollution 

Marine pollution 

Simplification of the regulatory 
environment 

= 

+ 

++ 

+ 

- 

++ 

= 

= 

= 

++ 

++ 

+ 

= 

++ 

+++ 

++ 

= 

+++ 

++ 

= 

= 

+++ 

+++ 

+++ 

Legend: 

= 
+ to +++ 
- to - - - 

baseline or equivalent to the baseline 
low to high improvement compared to the baseline 
low to high worsening compared to the baseline 

When compared with the baseline, both policy options have turned out to bring about positive 
impacts in most cases, particularly as regards the effectiveness of the control and enforcement 
mechanisms (notified bodies, market surveillance, safeguard clause). As a result of this, both 
policy options would on the whole result on more safety and better protection of the marine 
environment. The current system to transpose the IMO requirements into national legal orders 
would in both cases benefit from faster and more efficient mechanisms, centralised in the case 
of PO3 and left entirely to the Member States in the case of PO2. 

However,  PO2  has  two  important  drawbacks.  In  the  first  place,  replacing  the  current 
Directive's  annexes  by  a  generic  requirement  of  compliance  with  the  relevant  international 
technical  requirements  and  testing  standards  would  in  the  long  term  negatively  affect  the 
smooth  functioning  of  the  internal  market,  as  differences  between  Member  States  would 
inevitably  build  over  time;  this  would  also  affect  safety,  as  not  all  Member  States  would 
implement  the  latest  requirements  punctually,  while  the  many  valuable  non-mandatory 
instruments produced by the IMO would be completely left aside. Secondly, an alignment of 
the  obligations  of  economic  operators  on  the  NLF  would  result  in  an  additional, 
disproportionate  burden  mainly  for  importers  and  distributors:  these  actors,  who  are  only 
relevant  for  the  small  fraction  of  equipment  which  is  imported  into  EU  territory,  would 

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nevertheless have to put in place an administrative structure which does not exist today and 
the benefits of which would not accrue to a majority of the products covered by the Directive 
–  which  are  directly  installed  on  board  EU  ships  in  ship  building  and  repair  yards,  mostly 
outside the EU territory. 

In  contrast,  PO3,  thanks  to  its  MED-specific  solutions  which  are  selectively  adapted  to  the 
particular features of the marine equipment sector, proves more advantageous in several areas: 

• 

• 

• 

• 

• 

The  use  of  implementing  or  delegated  regulations  instead  of  the  current  Directive 
annexes provides a mechanism which is as fast as the solution envisaged under PO2, 
but without the above mentioned drawbacks for the Internal Market as the applicable 
requirements  would  remain  fully  harmonised  at  all  times;  moreover  this  system 
provides  greater  legal  certainty  for  the  operators  and  is  cheaper  for  public 
administrations;  

Conformity checking improves thanks to the clear identification of testing standards, 
while the implementation of IMO non-mandatory instruments gives PO3 a clear edge 
in terms of safety; 

The  possibility  to  use  electronic  tags  improves  the  effectiveness  of  market 
surveillance and helps protect the manufacturers' IPR at a negligible cost; 

Better adapted obligations for economic operators removes unnecessary burdens; 

A  simpler,  faster  safeguard  clause  mechanism  removes  unnecessary  economic  and 
reputational costs for compliant manufacturers. 

6. 

COMPARISON OF OPTIONS 

In  terms  of  effectiveness,  the  specific  measures  contained  in  PO3  allow  the  MED  to  better 
serve the general objective of guaranteeing the proper functioning of the internal market for 
marine  equipment  while  ensuring  a  high  level  of  safety  at  sea  and  prevention  of  marine 
pollution, by better adapting to the particular features of the sector. This is mainly the case of 
the strengthened enforcement and control mechanisms (better market surveillance, simplified 
safeguard clause) and a system that ensures that all relevant IMO requirements (mandatory or 
not)  as  well  as  international  and  European  standards  are  implemented  within  the  EU  in  a 
harmonised  way.  In  addition,  PO3  eliminates  the  most  burdensome  and  confusing  need  to 
transpose  amendments  into  the  27  legal  systems  of  the  Member  States,  while  PO2  leaves  it 
untouched. For this reason, PO3 should be preferred over PO2. 

As  regards  efficiency,  PO3  offers  solutions  at  less  costs  and  administrative  burden  for  the 
different stakeholders than in PO2, along with a stronger beneficial effect on competitiveness 
(particularly as regards SME's). PO3 therefore emerges as the most efficient course of action.  

As  regards  coherence  with  the  overarching  EU  objectives,  strategies  and  priorities,  whereas 
both  policy  options  would  bring  about  improvements  in  terms  of  maritime  safety  and 
protection of the marine environment, and simplified legal framework, the best results should 
be expected from PO3, while PO2 might not be able to deliver in terms of smooth functioning 
of the internal market. 

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Table 3: Comparison of Policy Options 

Effectiveness 

Efficiency 

Coherence 

Baseline 

Policy Option 2 

Policy Option3 

no 

low 

high 

no 

low 

high 

no 

medium 

high 

In light of the above, PO3 overall rates better than PO2 and is therefore the preferred option. 

7. 

MONITORING AND EVALUATION 

Once aligned with the new regulatory framework for the marketing of products, the MED will 
fully benefit from the latter's monitoring and evaluation mechanism. Specific measures have 
been envisaged in addition to the alignment in order to verify the effectiveness of the action 
and gather feedback from the stakeholders such as:  

•  As  a  result  of  the  reform  more  informative  data  will  be  obtained  from  the  market 
surveillance activities as well as from port state control. EMSA will continue to refine the 
production of statistics on the implementation of the directive and to organise workshops 
for technical discussion and training activities with the Member States..  

•  Contacts  with  the  industry  will  continue  including  workshops  on  the  implementation  of 

the amended MED.  

•  Enhancing the activities of the MARED Group of notified bodies.  

•  Finally, an ex-post evaluation will be organised within [5 years] of the entry into force of 

the new system. 

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