COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Directive of the European Parliament and of the Council on marine equipment and repealing Directive 96/98/EC
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) 438 final 

COMMISSION STAFF WORKING DOCUMENT 

IMPACT ASSESSMENT 

Accompanying the document 

Proposal for a  

Directive of the European Parliament and of the Council on marine equipment and 
repealing Directive 96/98/EC 

{COM(2012) 772 final} 
{SWD(2012) 437 final} 

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COMMISSION STAFF WORKING DOCUMENT 

IMPACT ASSESSMENT 

Accompanying the document 

Proposal for a  

Directive of the European Parliament and of the Council on marine equipment and 
repealing Directive 96/98/EC 

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Contents 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

2. 

2.1. 

Procedural issues and consultation of interested parties .............................................. 2 

Organisation and timing............................................................................................... 2 

External expertise......................................................................................................... 2 

Consultation of stakeholders ........................................................................................ 2 

The key aspect of data availability............................................................................... 4 

Results of the consultation of the Impact Assessment Board ...................................... 6 

Context ......................................................................................................................... 6 

Current EU legal framework for placing marine equipment on board ships - the MED
...................................................................................................................................... 6 

2.2. 

Evolution of the EU reference legislation governing the free movement of goods..... 7 

3. 

Problem definition ........................................................................................................ 8 

3.1. 

Description of the problem........................................................................................... 8 

3.1.1.  The MED suffers from weak implementation and enforcement mechanisms ............. 8 

3.1.2.  The process of transposition of IMO rules into national law creates legal uncertainty 
and imposes excessive burden upon the industry and national administrations ........ 14 

3.1.3.  Conclusion.................................................................................................................. 17 

3.2. 

3.3. 

3.4. 

Stakeholders affected ................................................................................................. 17 

Baseline scenario........................................................................................................ 18 

Does the EU have the right to act?............................................................................. 19 

3.4.1.  Legal basis.................................................................................................................. 19 

3.4.2.  Subsidiarity ................................................................................................................ 20 

3.4.3.  Proportionality............................................................................................................ 20 

4. 

Objectives................................................................................................................... 21 

4.1. 

Policy Objectives ....................................................................................................... 21 

4.1.1.  General objectives...................................................................................................... 21 

4.1.2.  Specific objectives ..................................................................................................... 21 

4.2. 

Coherence with horizontal policies............................................................................ 22 

4.2.1.  New Legislative Framework ...................................................................................... 22 

4.2.2.  Better regulation strategy ........................................................................................... 23 

5. 

Policy options............................................................................................................. 23 

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5.1. 

5.2. 

6. 

6.1. 

6.2. 

Pre-screening of policy options.................................................................................. 24 

Description of retained Policy Options ...................................................................... 26 

Analysis of Impacts.................................................................................................... 28 

Preliminary remarks ................................................................................................... 28 

Economic impacts ...................................................................................................... 28 

6.2.1.  On the functioning of the Internal Market for marine equipment.............................. 28 

6.2.2.  On operating costs and administrative burden ........................................................... 31 

6.2.3. 

Impact on SMEs......................................................................................................... 33 

6.2.4.  On the competitiveness of economic operators ......................................................... 34 

6.2.5. 

Impact on public authorities....................................................................................... 35 

6.2.6. 

Impact on users and passengers ................................................................................. 36 

6.2.7.  Third countries and international relations ................................................................ 36 

6.3. 

6.4. 

6.5. 

7. 

7.1. 

7.2. 

7.3. 

7.4. 

8. 

Environmental and Social impacts – public health and safety................................... 37 

Simplification of the regulatory environment ............................................................ 37 

Conclusion.................................................................................................................. 38 

Comparison of options ............................................................................................... 39 

Effectiveness in relation to specific objectives .......................................................... 40 

Efficiency ................................................................................................................... 40 

Coherence with the overarching EU objectives, strategies and priorities.................. 40 

Conclusion.................................................................................................................. 41 

Monitoring and evaluation ......................................................................................... 41 

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1. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  

Identification  

Lead DG: DG MOVE 

Subject: Impact Assessment (IA) accompanying the revision  of Council  Directive 96/98/EC 

of 20 December 1996 on marine equipment1 (hereinafter MED). 

Agenda Planning/WP reference: 2008/TREN/004 - simplification 

1.1. 

Organisation and timing  

Work on the present Impact assessment started back in 2008, following the reform of the EU 
reference  legislation  governing  the  free  movement  of  goods2.  While  a  general  alignment  of 
the  internal  market  legislation  with  the  new  legislative  framework  took  place  in  2011,  the 
specificities of the marine equipment sector made it advisable to carry out a separate exercise 
that could take those into account.  

An  Impact  Assessment  Steering  Group  (IASG)  was  established  in  September  2008  for  the 
preparation  of  this  IA  to  which  all  Commission  departments  concerned  were  invited.  The 
following departments took part in the group's meetings: ENTR, ENV, TRADE and SG. The 
IASG  met  on  27  October  2008,  19  February  2009,  31  March  2009,  8  July  2009,  23  March 
2012 and for the last time on 12 July 2012.  

1.2. 

External expertise  

In  September  2008,  DG  TREN  called  upon  the  European  Maritime  Safety  Agency 
(hereinafter "EMSA") to provide technical assistance in the preparation of this IA. Additional 
research has been carried out by the Agency based on the IAB opinion of 11 September 2009. 

1.3. 

Consultation of stakeholders 

Since the coming into force of the MED in 19973, the Commission and EMSA have organised 
regular meetings with the relevant stakeholders (principally the Member States and Notified 
bodies) in order to provide training and guidance as well as sharing best practices relating to 
the implementation of MED.  

In  addition  the  following  steps  have  been  taken  specifically  for  the  improvement  of  the 
Directive in question: 

1  
2  

3 

Council Directive 96/98/EC of 20 December 1996 on marine equipment (OJ L 46, 17.2.1997, p. 25–56) 
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; 
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,  
Regulation  (EC)  No  764/2008  of  the  European  Parliament  and  of  the  Council  of  9  July  2008  laying 
down  procedures  relating  to  the  application  of  certain  national  technical  rules  to  products  lawfully 
marketed in another Member State and repealing Decision No 3052/95/EC. 
The deadline for transposition was fixed at 1 January 1999. 

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Questionnaire sent to the Member States by EMSA in September 2008, asking for data and 
figures on the most significant points concerning the implementation of the Directive. 4 

Questionnaire sent to the Member States, Industry and the MarED5 Group of notified 
bodies - in early October 2008, in preparation of the stakeholder meeting. The questionnaire 
contained a preliminary analysis and questions concerning the scope of the Directive, Notified 
bodies, Market Surveillance, Safeguard Clause and Intellectual Property Rights. 

Formal stakeholder consultation by the Commission6 - On 27 November 2008 at a meeting 
held in Brussels. The Commission also received written contributions from six Member States 
and three industry representatives following the stakeholder consultation.7 

In April 2012,  all stakeholders were contacted again by the Commission to see whether the 
organisations wanted to endorse their 2008 positions or not, or provide fresher views on the 
possible amendments of the directive or new data.8 The answers received largely confirmed 
the  problems  already  examined  in  2009,  and  provided  clearer  examples  of  the  issues 
associated with the rigidity of the existing mechanism for the alignment of the Directive with 
the IMO changing standards.9 

Throughout the preparation of this impact assessment, continuous consultation has been held 
with  the  marine  equipment  sector  through  their  representatives  in  Brussels  (the  European 
Marine  Equipment  Council).10  Bilateral  contacts  have  also  been  held  with  two  sub-sectoral 
associations who approached the Commission on specific issues. 

Consultation  of  the  stakeholders  has  shown  that  a)  the  Directive  is  necessary  in  order  to 
provide a legal framework capable of ensuring both an appropriate level of safety and the free 
movement of marine equipment within the Community; and b) the Directive is nevertheless in 
need  of  an  in-depth  revision.  Criticism  from  the  stakeholders  on  the  current  working  of  the 
MED focused around four main areas: 

(1) 

(2) 

4  
5  

6  

7  

8  

9  

10  

The Directive mechanisms do not work well because they do not tie in well with the 
particular circumstances of the marine equipment sector.  

There is limited supervision of the implementation of the Directive by Member States 
due to resource scarcity/available expertise.  

The results of this survey are attached in Annex 1. 
MarED – co-ordination group for the Notified bodies assigned by the Member States to carry out the 
conformity  assessment  procedures  referred to  in the  MED.  The  MarED Website  contains  information 
about the MarED Group, Notified bodies and the Directive. 
The group of stakeholders invited to comment was formed by the Member States, Iceland and Norway 
(flag States administrations), MarED Group on notified bodies and the equipment manufacturers. 
The  minutes  of  the  stakeholders'  meeting  of  November  2008,  are  attached  in  Annex  2  and  will  be 
available for consultation on the maritime safety webpage of DG MOVE . 
Observations  were  submitted  by  five  Member  States  and  three  industrial  associations  as  well  as  the 
notified bodies. 
The  replies  received  in  the  second  consultation  are  summarised  in  Annex  3  and  will  be  available  for 
consultation on the maritime safety webpage of DG MOVE. 
Consultation  with  EMEC  was  considered  indispensable  given  the  importance  of  SMEs  in  the  sector, 
which due to their size and scarce resources, would find it difficult to make their position known to the 
Commission. Indeed, in this way it has been possible to question individual companies through EMEC 
and obtain inputs which are representative also of the SMEs points of view. 

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(3) 

Complexity,  time  delays  and  unclear  roles  cause  uncertainty  for  the  Member  States, 
Notified bodies and equipment manufacturers. 

(4)  Wherever the Directive deviates from standard international and/or IMO practice, this 
translates  into  operational  difficulties  for  the  operators,  e.g.  when  the  respectively 
applicable requirements differ or when transition arrangements do not coincide.  

In  general,  while  meaningful  qualitative  input  was  received  from  the  stakeholders,  this  was 
not accompanied by quantitative information from either the industry or the Member States.  

All  in  all,  stakeholders  (including  SMEs)  have  been  fully  able  to  contribute  to  the  current 
proposal for the review of the MED. Their views have been assessed and appropriately taken 
into consideration. 

The  standards  set  in  the  "General  principles  and  minimum  standards  for  consultation  of 
interested parties by the Commission" have been met. 

1.4. 

The key aspect of data availability11 

There  is  not  one  sector-based  (NACE12)  classification  covering  the  sector  of  marine 
equipment.  This  means  that  in  many  cases  no  uniform  data  is  collected  centrally,  hence 
making this sector much harder to monitor than ship construction. 

Furthermore,  different  definitions  are  used  in  different  data  sources  making  it  difficult  to 
arrive at “hard” estimations. Marine equipment manufacturers are often also suppliers of other 
industries (e.g. automotive, aviation, etc.) or are still integrated into the shipyards like in Italy. 
This should be taken into account when interpreting the data presented in the present IA.  

It is worth mentioning that, according to a study undertaken by the Commission13, no studies 
have been done at European level to look at employment in this sector, whereas only a few 
such studies have been carried out at the national level. For most countries, it is not possible 
to obtain figures relating to employment in the sector. 

Lastly,  the  surveillance  and  control  activities  of  the  Member  States  face  considerable 
difficulties  given  the  specific  features  of  the  sector14  and  have  not  therefore  produced 
comparable  quantitative  information.  This  makes  it  very  difficult  to  gauge  precisely  the 
effectiveness of enforcement 

The second stakeholder consultation, while confirming the qualitative perceptions made in the 
past,  has  not  yielded  any  significant  quantitative,  up-to-date  input.  In  light  of  this,  the 
present IA and its conclusions are based on the best available sector-related data, even 
though being occasionally incomplete. Similarly, as a result of the known lack of data, it has 
been  considered  it  would  not  be  possible  to  carry  out  a  meaningful,  separate  ex-post 
evaluation exercise to supplement stakeholders' input without incurring further serious delays.  

11 

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Industry 

This  part  is  largely  based  on  the  findings  of  the  Study  on  the  Competitiveness  of  the  European 
Shipbuilding 
-  
http://ec.europa.eu/enterprise/sectors/maritime/files/fn97616_ecorys_final_report_on_shipbuilding_co
mpetitiveness_en.pdf. 
Statistical Classification of Economic Activities in the European Union. 
See "competitiveness" study, op.cit. 
See Annex 4. 

Commission 

prepared 

2009, 

the 

for 

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1.5. 

Results of the consultation of the Impact Assessment Board  

A  first  draft  report  for  this  IA  was  submitted  to  the  Impact  Assessment  Board  (IAB)  on  16 
July 2009. The IAB asked for a resubmission of the IA report in its opinion of 11 September 
2009. The IAB's recommendations led to significant shortening and complete restructuring of 
the initial draft, as well as to the improvements in a number of key aspects. 

A  revised  version  of  the  IA  report  has  been  resubmitted  to  the  IAB  on  20  July  2012.  The 
revised  document  takes  into  account  the  recommendations  of  the  IAB  in  the  following 
manner: 

•  The  report  has  been  brought  in  line  with  the  standard  structure  of  Commission  Impact 
Assessments,  including  a  clearer  description  of  the  different  steps,  a  refined  but  shorter 
problem  description  pointing  at  the  importance  of  the  different  issues  and  a  market 
description.  

•  The  sections  on  policy  options,  impacts,  comparison  of  options  and  monitoring  and 
evaluation  have  been  strengthened.  Objectives  have  been  regrouped  and  simplified  and 
policy options have individually been mapped to objectives identified. 

•  The report now places greater emphasis on safety considerations in the analysis of options. 

The IAB sent its second opinion on 28 August 2012, with a number of recommendations for 
inclusion in the final version of this impact assessment. As a result of these recommendations, 
the  baseline  scenario  has  been  strengthened,  more  explicit  references  to  input  from 
stakeholders  have  been  included  and  the  assessment  of  policy  options  in  regard  of 
simplification and reduction of administrative burden has become more detailed (with specific 
reference  to  quantitative  estimations),  while  the  monitoring  aspects  have  been  given  more 
attention in order to resolve the problems associated with data availability in view of a future 
ex-post evaluation. 

2. 

CONTEXT 

A detailed description of the market for marine equipment is provided in Annex 
4. 

2.1. 

Current EU legal framework for placing marine equipment on board ships - the 
MED 

Shipping accidents are a matter of serious concerns to the EU, in particular those that cause 
loss  of  human  life  and  pollution  of  seas  and  coastlines.  It  is  vital  to  ensure  that  safety 
requirements and standards of marine equipment keep up with the latest trends, especially as 
new  technologies,  materials  and  manufacturing  processes  are  constantly  being  developed 
while lessons keep being learnt from experience. 

In  order  to  ensure  high  safety  levels  in  the  performance  of  the  equipment  carried  on  board 
ships,  international  conventions  adopted  under  the  auspices  of  the  International  Maritime 
Organization (IMO) require marine equipment to conform to certain safety regulations. These 

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are  mostly  enshrined  in  the  main  maritime  conventions  themselves15  together  with  their 
protocols and amendments, as well as in a number of other IMO instruments. 

In  this  context,  the  MED  has  laid  down  common  standards  which  provide  a  harmonised 
interpretation and implementation of the above mentioned IMO rules for the performance of 
marine  equipment  to  be  placed  on  board  ships  flying  the  flag  of  the  EU  Member  States. 
Through  this  framework,  the  objective  of  this  Directive  is  to  contribute  to  safety  at  sea,  to 
prevent  marine  pollution  and  to  ensure  the  free  movement  of  marine  equipment  within  the 
EU. 

The legislative technique used in MED to achieve its policy objectives is largely based on the 
principles  defined  in  the  New  Approach  for  the  area  of  free  movement  of  goods.16 
Nevertheless, the MED has implemented a number of specific solutions which deviate from 
mainstream New Approach legislation due to the specificities of the marine equipment sector: 

•  marine equipment has to fulfil IMO international standards. Flag states are expressly 
required  to  issue  a  certificate  of  approval  by  the  IMO  conventions  described  above. 
The Directive has the specific objective to ensure compliance with this obligation as 
well as mutual recognition of these certificates between Member States. 

-  marine equipment encompasses some categories of equipment, which are also within 
the  scope  of  Directives  other  than  the  MED  (e.g.  fire  extinguishers,  electronic 
material,  protective  equipment,  pyrotechnics),  the  requirements  of  which  may  differ 
from, or even be incompatible with, those of the IMO. 

This  is  described  in  more  detail  in  Annex  5,  which  provides  a  description  of  the  New 
Approach and a comparison between this and the MED. 

2.2. 

Evolution of the EU reference legislation governing the free movement of goods  

Experience  over  the  years  with  the  implementation  of  EU  legislation  in  the  area  of  free 
movement  of  goods  has  highlighted  certain  weaknesses  and  shown  that  the  effectiveness  of 
the  system  can  still  be  improved.  In  2008,  the  New  Approach17  was  subject  to  a  revision 
which led to the New Legislative Framework (hereinafter the "NLF") for the marketing of 
products.18 

The  IA  accompanying  the  revision  of  the  New  Approach  identified  and  fully  analysed  the 
problem areas which are common to New Approach directives, namely lack of confidence in 
notified  bodies  and  in  the  whole  notification  process  in  general;  weaknesses  in  market 
surveillance  and  efficient  and  consistent  enforcement  of  the  directives,  inconsistencies  and 
legal uncertainty in the current regulatory framework and misunderstanding of the value and 
role of CE marking. This IA has also identified and analysed a number of policy options to 

15 
16  

17 

18  

See Annex 13 
The  New  Approach  revolutionised  the  way  legislation  is  written  by  moving  away  from  complex  and 
detailed  prescriptive  technical  requirements  and,  instead,  fixing  only  the  essential  public  interest 
requirements  to  which  products  must  comply  to  protect  the  public  goals  of  health  and  safety.  Other 
innovative  features  of  this  legislative  technique  include  the  setting  up  of  appropriate  conformity 
assessment procedures and the introduction of CE marking.  
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 contains a description of the elements of the NLF. 

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address  the  above  problems  across  various  sectors.  Decision  768/2008/EC,  which  was 
adopted  as  a  result  of  this  analysis,  provides  a  set  of  policy  measures  considered  being  the 
most  adequate  cross-sectorally,  and  which  cover  four  main  pillars:  market  surveillance, 
conformity assessment of products, CE marking and a set of measures for use of legislation. 

The NLF leaves little flexibility to the co-legislators on the choice of tools for eliminating the 
malfunctions  and  inefficiencies  of  legislation  based  on  the  New  Approach.  Article  2  of 
Decision 768/2008/EC clearly says that Community legislation in the area of free movement 
of goods "shall have recourse to the general principles set out in [the said] Decision and to 
the  relevant  reference  provisions  of  Annexes  I,  II  and  III  [to  that  Decision]"  while 
"[departing] from those general principles and reference provisions if that is appropriate on 
account of the specificities of the [marine equipment] sector[…]"19 

Pursuant to this substantive reform, the Commission proposed the alignment of 10 technical 
harmonisation directives in 2011. As mentioned above, due to its important specificities, the 
MED was not included in this mainstream alignment, but remained a separate exercise. 

3. 

PROBLEM DEFINITION 

3.1. 

Description of the problem 

As  indicated  above,  criticism  expressed  by  stakeholders  in  the  public  consultation  on  the 
current working of the MED focused on two main areas: 

3.1.1.  The MED suffers from weak implementation and enforcement mechanisms 

The stakeholders' consultation conducted in the context of the revision of MED has confirmed 
that  the  marine  equipment  sector  shares  the  same  problem  areas  with  other  New  Approach 
directives: unequal implementation in the Member States, ineffective market surveillance and 
misuse of safeguard clause. As a consequence, as suggested by stakeholders, the current legal 
framework  defined  by  MED  does  not  sufficiently  ensure  the  complete  application  and 
implementation of IMO standards in the EU, possibly leading to safety risks and inefficient 
functioning of the Internal Market for marine equipment20. Annex 6 explains in greater detail 
how  the  problem  areas  common  to  New  Approach  directives  materialise  in  the  marine 
equipment sector. 

The identified malfunctions of the MED system, which are shared with other New Approach 
Directives,  stem  from  the  fact  that  the  MED  has  not  yet  incorporated  the  corresponding 
regulatory  remedies  provided  by  the  NLF.  This  concerns  four  main  pillars:  market 

19  
20 

See also recital 7 of Decision768/2008/EC. 
Indeed, during the stakeholder consultation held in 2009, industry representatives highlighted the need 
for more effective action against non-compliant products and called for specific measures against IPR 
violation and counterfeit. Similarly, Member States complained about the difficulties faced by market 
surveillance  authorities  and  the  lack  of  transparency  between  administrations  themselves,  calling  for 
specific action in the field. As regards notified bodies, Member States administrations highlighted the 
need for better audit and monitoring and pointed at the lack of maritime expertise among accreditation 
bodies,  calling  for  a  set  of  clear  requirements  to  be  included    in  the  Directive  –  a  point  with  which 
industry representatives concurred, while highlighting the need to avert unfair competition and control 
underperforming bodies. The second consultation carried out in 2012 confirmed that the views of both 
industry and Member States as regards these problems remained unchanged; with stakeholders insisting 
on  different  aspects  needing  improvement  in  all  three  fronts  (notified  bodies,  market  surveillance, 
safeguard clause). 

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surveillance,  conformity  assessment  of  products,  CE  marking  and  a  set  of  other  standard 
measures to be used in future internal market legislation. 

However, in view of the explicit provision contained in Article 2 of Decision 768/2008/EC, 
addressing the malfunctions of the New Approach directives means mandatory alignment of 
MED  on  the  provisions  of  the  NLF,  and  notably  on  Decision  768/2008/EC  and  Regulation 
765/2008/EC.  Against  this  background,  and  taking  into  the  specificities  of  the  marine 
equipment, the problem discussed in this IA is not if MED should be aligned with the NLF, 
but how to align. In this respect,  

• 

• 

The  main  objective  of  the  NLF  is  to  contribute  to  the  design,  implementation  and 
improvement of a flexible regulatory framework providing access to the single market 
while  protecting  essential  public  requirements.  It  follows  that  trade-offs  can  be 
expected between the goal of ensuring cross-sectoral legislative coherence through the 
alignment to NLF on the one hand, and the goal of optimising the functioning of the 
internal market for marine equipment, on the other hand. 

The wording of Article 2 of Decision 768/2008 leaves no doubt that departure from 
the  NLF  needs  to  be  justified  on  precise  grounds  of  specificities  of  the  sector 
concerned. In the case of marine equipment, the specific features of the product indeed 
have a strong influence on the capacity of the legislation to reap the full benefits of EU 
harmonisation legislation and therefore it may be reasonable to consider MED-specific 
solutions in specific areas. This aspect has been confirmed by the public consultation. 

The  table  below  identifies  and  discusses  which  provisions  of  the  NLF  may  see  their 
effectiveness  affected  by  the  specificities  of  the  MED  in  a  way  that  the  full  benefits  of 
harmonisation legislation would not be attained by its direct application. 

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Table 1: Influence of marine equipment specificities on the effectiveness of NLF main provisions 

Content of NLF provisions 

Possible influence of marine equipment specificities 

Market surveillance 

Common EU framework  Regulation  (EC)  765/2008  improves  market  surveillance  through  explicit 
requirements  for  Member  States  to  carry  out  and  organise  market  surveillance 
activities  in  respect  of  the  principle  of  subsidiarity.  Market  surveillance  is 
organised and performed at two main stages: 

-  national  surveillance  authorities  monitor  that  products  placed  on  their 
market comply with the provisions of Community harmonisation legislation 
transposed into the national legislation; structured controls are carried out at 
the EU borders;  

-  national surveillance authorities take action, when necessary, either to bring 
non-compliant  products  into  compliance,  to  remove  unsafe  products  from 
the market and /or to ban them, or in justified cases to destroy them. 

Regulation (EC) 765/2008 defines market surveillance measures to be carried out 
by  the  surveillance  authorities.  These  include:  to  organise  random  and  spot 
checks; to require all necessary documentation from the manufacturer in order to 
be able to evaluate product conformity; when justified, to enter the manufacturer's 
premises and take samples for testing, and in extreme cases to destroy products. 
Market surveillance is put in the hands of a single national authority and subject 
to structured planning and implementation. 

More effective post-market 
control mechanism 

No  significant  influence.  However,  in  the  particular 
context  of  the  marine  equipment  sector,  the  quality  of 
surveillance authorities' work becomes a matter of critical 
importance. Surveillance authorities must in any case have 
a  good  mix  of  maritime  expertise  and  expertise  in  the 
technical fields covered by the Directive. 

The  relevant  market  for  the  legislator  is  not  the  marine 
equipment  sold  in  the  EU  territory,  but  rather  the  marine 
equipment due to be installed on board ships flying the flag 
of an EU Member State. Equipment due to be installed on 
board non-EU ships falls outside the scope and objectives 
of the MED (and hence outside the scope of this IA) even 
if  sold  within  EU  territory.  Conversely,  equipment  to  be 
placed on board EU ships may or may not physically enter 
the EU territory. As a result,  

- 

controls  at  the  borders  and  within  EU  territory 
become less relevant and; 

-  market surveillance becomes more difficult than in 

the case of other products.  

Moreover,  in  the  marine  equipment  sector,  national 
authorities (suffering a chronic dearth of resources) need to 

EN 

10 

EN 

 
  
 
 
Safeguard clause procedure  The  safeguard  clause  procedure has been  reorganised  and  streamlined. The new 
procedure  ensures  that  the  relevant  enforcement  authorities  are  informed  about 
dangerous  products  and  that  similar  action  is  taken  against  that  product  in  all 
Member  States.  The  Commission  ensures  that  these  measures  do  not  constitute 
disguised obstacles to the free movement of products. 

The great diversity of the equipment covered by the MED 
calls for equally diverse technical expertise, which may be 
beyond the Commission's or even EMSA's resources. This 
may  cause  delays  and  difficulties  in  the  assessment  of 
safeguard clauses. 

make  expertise  available  in  a  very  diverse  range  of 
technical  fields  (as  the  MED  covers  a  vast  range  of 
equipment e.g. from upholstery to radars) and gain access 
to very specialised test labs. 

Conformity assessment of 
products 

Common EU framework  The NLF clarifies and develops the rights and obligations of notified bodies, and 
strengthens  the  control  mechanisms  in  the  hands  of  the  Member  States  and  the 
Commission. 

Essential requirements  The  NLF  recommends  specific  product  legislation  to  avoid,  wherever  possible, 
going  into  technical  detail  and  to  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. 

No  significant  influence.  However,  in  the  particular 
context  of  the  MED,  as  described  above,  the  quality  of 
notified  bodies'  work  becomes  a  matter  of  critical 
importance. Notified bodies must in any case have a good 
mix  of  maritime  expertise  and  expertise  in  the  technical 
fields covered by the Directive. 

the  IMO,  and 

Marine  equipment  has  to  meet  the  requirements  of  the 
international  conventions,  the  relevant  resolutions  and 
the  associated  relevant 
circulars  of 
international  testing  standards.  These  instruments  contain 
detailed technical requirements against which the flag State 
must approve any equipment placed on board ships flying 
the latter's flag.  

However,  the  said  international  instruments  leave  very 
considerable  latitude  for  flag  States  in  the  interpretation 
the  relevant  requirements.  Some 
and  application  of 
requirements which are important for safety do not muster 
sufficient  consensus  to  be  made  mandatory  and  thus  are 
approved  as  recommendations  or  guidelines  only.  In  the 
absence  of  a  harmonising  instrument,  this  might  lead  to 
very  significant  differences  between  Member  States  and 
potentially affect both safety and the smooth functioning of 

EN 

11 

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Notification of conformity 
assessment bodies 

The Decision (EC) 768/2008 foresees stronger clearer rules on the requirements 
for  the  notification  of  conformity  assessment  bodies  (testing,  certification  and 
inspection laboratories) including the increased use of accreditation; a system to 
ensure 
that 
that  assessment  bodies  provide 
manufacturers, consumers and public authorities need. 

the  high  quality  services 

the internal market. 

No influence 

Conformity assessment 
procedures 

Decision (EC) 768/2008 provides a simple, coherent and complete menu to select 
the  most  appropriate  module(s)/procedure(s)  for  the  specific  area  of  activity.  A 
conformity assessment procedure covers both design and production phases. The 
assessment of the conformity of the product in question may be carried out either 
by  the  manufacturer  himself  or  by  a  (manufacturer's  in-house  or  external) 
conformity assessment body, depending on the provisions of the modules selected 
by the relevant sectoral legislative instrument. 

IMO  requirements  are  based  on  certification  by  or  on 
behalf of the flag State. Modules not compatible with this 
premise  must  be  excluded.  Furthermore,  the  particular 
circumstances  of  marine  equipment  make  the  sector 
vulnerable  to  notified  bodies'  conflicts  of  interest,  thus 
making  it  advisable  not  to  allow  for  in-house  notified 
bodies. 

CE marking 

The Decision (EC) 768/2008 confirms the fundamental requirement to use the CE 
marking and clarifies its meaning. In addition the CE marking21 is to be protected 
as a trade mark, which will give authorities and competitors additional means to 
take legal action against abuse. 

The  overlap  with  other 
internal  market  Directives 
applicable  to  marine  equipment  requires  a  mechanism  to 
identify  the  products  specifically  built  for  their  use  on 
board  EU  ships  and  conforming 
the  specific 
requirements of the IMO.  

to 

Set of measures for use in 
legislation 

Common EU legal framework 

Obligations of actors in the 
distribution chain 

The  Regulation 
manufacturers, importers, distributors. 

(EC)  765/2008  establishes  common  obligations 

for 

Importers and distributors must check that products bear the CE marking, are 
accompanied by the required documents and carry the name of the manufacturer 
and  the  importer  (if  relevant).  Importers  must  furthermore  check  that  the 
manufacturer  outside  the  EU  has  applied  the  correct  conformity  assessment 
procedure  and  establish  a  link  to  the  manufacturer  that  allows  the  technical 
documentation to be obtained when it is requested by authorities. They must carry 
out sample tests on products which they have supplied, when this is appropriate in 

The share of marine equipment which is actually placed on 
the  market  is  small,  with  most  of  them  being  fixed  on 
board  ships  in  the  shipyards.  Equipment  imported  for 
installation  on  board  non-EU  ships  is  not  relevant  for  the 
Directive.  

21 

EN 

The  CE  marking  is  an  indication  that  the  products  comply  with  the  essential  requirements  of  the  applicable  directives  and  that  the  products  have  been  subject  to  a 
conformity assessment procedure provided for in the directives. 

12 

EN 

 
  
 
 
 
                                                 
the light of the risks presented by a product to the health and safety of consumers. 
If  necessary,  they  must  also  keep  a  register  of  complaints,  non-conforming 
products  and  product  recalls  and  keep  distributors  informed  about  such 
monitoring. 

In  addition  to  the  obligations  that  the  current  legislation  already  imposes  on 
manufacturers,  they  must  provide  instructions  and  safety  information  in  a 
language  easily  understood  by  consumers  and  end-users.  Furthermore,  they  are 
subject  to  the  same  obligations  on  sample  testing  and  product  monitoring  as 
importers. 

New obligations are introduced for all economic operators to ensure traceability 
of products throughout the whole distribution chain. Manufacturers and importers 
must put their name and address on the product or, where this is not possible, on 
the  packaging  or  an  accompanying  document.  Furthermore  every  economic 
operator  must  be  able  to  inform  the  authorities  from  whom  he  purchased  a 
product and to whom he supplied it. This obligation does not include sales to end-
users. 

Harmonised definitions and 
procedures (save the CE 
marking) 

The Regulation (EC) 765/2008 establishes harmonised definitions and procedures 
among the NLF directives. 

No influence 

EN 

13 

EN 

 
  
The  table  above  shows  that,  for  some  key  components  of  the  application  and  enforcement 
mechanisms  of  MED,  the  specificities  of  the  marine  equipment  either  have  an  influence  on 
the  effectiveness  of  the  solutions  provided  by  the  NLF  or  are  simply  not  compatible  with 
them, thus making it necessary to deviate from these solutions.  

3.1.2.  The process of transposition of IMO rules into national law creates legal uncertainty 
and imposes excessive burden upon the industry and national administrations 

In the course of the stakeholders' consultation, both industry representatives and the Member 
States complained about the difficulty to establish, on the basis of the Annexes to MED and of 
the  amending  legislative  acts  (Commission  Directives),  which  requirements  apply  to 
particular pieces of marine equipment at a given time. The main elements of criticism were 
that: 

•  The date of entry into force of the requirement and the date of validity of certificates 

is not specified; 

•  The information on the most updated version of the annexes to MED is not available 

in an easily readable form online; 

•  Manufacturers are not notified in time of upcoming changes in standards; 

•  The  automatic  update  clause  is  too  rigid,  especially  as  regards  testing  standards, 
leading to massive and unnecessary re-certification of stocks even if construction and 
performance requirements remain unchanged; 

•  The directive's Annex is at present not suited to meet the needs of both industry and 
national authorities. The current update mechanism does not allow the Commission 
to  e.g.  address  equipment  components  if  and  when  necessary,  include  production 
standards, introduce elements of flexibility for Member States' implementation, etc.  

The  resulting  legal  uncertainty22  is  compounded  by  the  fact  that  safety  requirements  and 
standards of marine equipment as laid down in the Directive annexes do not necessarily keep 
up  with  the  latest  trends.  Therefore,  equally  important  are  the  inherent  safety  risks  in  the 
application  of  obsolete  requirements  to  marine  equipment,  as  the  update  of  the  latter  is  in 
most cases due to safety risks newly identified or the approval of more effective technologies 
to address known risks. Furthermore the risk of detention of ships by foreign port authorities 
for non-compliance with applicable IMO standards increases significantly.  Finally, it must be 
taken  into  account  that  many  items  of  marine  equipment  are  installed  into  larger  integrated 
systems  (e.g.  engines,  navigational  systems,  etc.)  which  may  have  been  designed  for 
components meeting the newest standards and which therefore could suffer from installation 
problems or low performance.  

The  resulting  confusion  for  manufacturers,  customers  and  national  authorities  can  lead  to 
unwanted mistakes and failures to conform to the requirements in force23. Moreover, this may 
render the management of stocks (at least part of which are kept overseas) extremely difficult 

22 

23  

Problems  with  legal  certainty  were  highlighted  by  industry  and  administrations,  especially  as  regards 
the administration of the Annex, both in 2009 and 2012. Indeed, the problems suffered by the MED in 
this respect were a central theme in the answers received in the second consultation, held in 2012. 
In extreme cases, EU ships, national authorities, notified bodies and other operators may be forced not 
to apply the Directive correctly in order to avoid  all these problems 

EN 

14 

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and indeed more costly, as well as lead to re-certification gluts due to limited capacity on the 
side of the labs and notified bodies. 24 

The Commission has estimated (see Annex 12) that the current system may result in a burden 
of up to €6-7 million a year for the marine e quipment industry only, of which approximately 
2/3 may correspond to lost return on investment and stock management, while up to 1/3 could 
directly derive from double certification. 

This situation stems from two main causes: 

The legislative technique chosen to keep up pace with the development of IMO requirements 
is complex 

As  indicated  above,  marine  equipment  has  to  meet  the  requirements  of  the  international 
conventions, the relevant resolutions and circulars of the IMO, and the relevant international 
testing  standards.  The  MED  therefore  deviates  from  the  principle  of  essential  requirements 
defined  in  the  New  Approach  so  that  IMO  standards  are  applied  and  implemented  in  a 
harmonised way across Europe. 

Currently,  Annex  A.1  to  the  MED  contains  the  list  of  the  specific  construction  and 
performance requirements to be met, as well as the mandatory testing standards to be used, in 
the  conformity  assessment  of  marine  equipment  due  to  be  placed  on  board  EU  ships.  This 
Annex is periodically updated in order to keep up with the legislative production of the IMO 
and, as appropriate, of the  international and European standardization bodies25.  The  updates 
take the form of Commission Directives adopted in accordance with the regulatory procedure 
with scrutiny. The updates are then transposed into national legislation of each Member State 
within a period of twelve months. 26 

As  an  additional  means  to  keep  pace  with  the  constant  development  of  requirements  and 
standards  by  IMO  and  the  international/European  standardisation  bodies,  the  Directive 
includes a so-called "automatic update" mechanism. According to this, the performance and 
testing standards listed in Annex A.1 apply in any case in their up-to-date version – regardless 
of their explicit update in the Annex. However, in practice, this mechanism has proven quite 
ineffective for the following reasons: 

- 

- 

- 

24  

25 

26 

not all standards are simply amended but sometimes outright replaced; 

new items need to be incorporated into the Annexes; 

not all new amendments to the relevant instruments have a clearly identifiable date of 
entry into force; lastly, because even if this date exists, the amendments may contain 
"grandfathering  clauses"  not  necessarily  aligned  with  the  principles  of  the  directive 

This  is  a  point  which  has  been  made  by  both  the  industry  and  the  Member  States,  especially  in  the 
course of the second consultation. 
The  International  Organization  for  Standardization  (ISO), 
the  International  Electrotechnical 
Commission (IEC), the European Committee for Standardization (CEN), the European Committee for 
Electro-technical  Standardization  (CENELEC),  and  the  European  Telecommunication  Standards 
Institute (ETSI) 
This  was  the  case  for  the  four  most  recent  amendments  of  Directive  96/98/EC.  Although  in  the  first 
three amendments the transposition period was fixed at six months, this has proven insufficient for the 
Member States and it is now an established practice to have a twelve months' transposition period for 
each update. 

EN 

15 

   EN 

 
                                                 
and thus rendering very confusing the regime to be applied to the existing stocks. The 
net  result  of  this  is  a  significant  degree  of  legal  uncertainty  and  uneven  practices 
among Member States, such that the automatic update mechanism cannot be relied on 
to replace a frequent, actual update of the annexes. 

In summary, these two mechanisms work in such a way that: 

1.  Where a new standard replaces, amends or supplements an existing standard which is 
listed in Annex A.1 to the Directive, it will apply automatically on the date of its entry 
into  force  even  without  explicit  change  in  the  Directive's  Annex.  The  immediate 
consequence of this is that what is listed in Annex A.1 may not coincide with what is 
actually applicable. 

2.  When a new standard does not fulfil the conditions under point 1, or does not have a 
date of entry into force, it will not apply until explicitly included in the Directive at the 
next periodic update of Annex A.1. The immediate consequence of this is that a new 
standard  may  not  be  applicable  in  the  EU  even  if  it  is  already  applicable 
internationally. 

The transposition process of IMO requirements into national law is lengthy 

IMO normally leaves a reasonable time between the adoption of safety requirements and their 
entry  into  force,  ranging  in  most  cases  between  twelve  and  twenty-four  months.  To  be 
effective,  the  EU  transposition  system  should  be  capable  of  bringing  the  new  requirements 
into national legislation within that time window. However, in practice, this is not the case. 
Experience has shown that the time lag between the update of instruments and international 
standards by IMO and the transposition of those into national law may easily reach 30 months 
per update (including update by the Commission and transposition by national authorities). 

Box 2 illustrates the problems related to the currently process of transposing IMO rules into 
European and national legislation in the extreme case of the 4th amendment of the MED. 

Box 2: Case study on the fourth amendment of Annex A  

Work on the 4th amendment started at the beginning of 2005, that is, barely two years after the 3rd amendment27. 
At  a  moment  of  a  particularly  intensive  activity  of  the  IMO  in  the  production  of  technical  specifications  for 
marine equipment, it soon became apparent that:  

–  Where new requirements had been adopted by the Organization, it was sometimes particularly difficult for the 
specialists to identify in a clear-cut manner their exact scope and the exact sequence of the application of new 
and old requirements depending on the type of ship and date of construction or putting into service. This was for 
instance  the  case  of  the  items  concerned  under  the  IMO  high-speed  craft  code,  and  extended  to  a  significant 
portion of Annex A.1. 

–  The laborious and time-consuming process of identifying the correct requirements combined with the length 
of the formalised procedures involved made the process of adoption extremely time consuming, to the point that 
IMO  requirements  changed  again  while  the  technical  discussion  still  went  on.  As  a  result,  a  number  of  items 
needed to be examined anew before their incorporation in the revised Annex. 

–  The adoption of the 4th amendment in these difficult circumstances required, in addition to countless rounds 
of  online  technical  discussion  coordinated  by  EMSA,  examination  of  the  dossier  at  three  formal  committee 
meetings and two specific committee expert meetings. 

27 

Adopted in September 2002 

EN 

16 

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Eventually, adoption was only possible by leaving the update of a number of items for the following amendment, 
at  the  inevitable  cost  of  making  part  of  the  4th  amendment  obsolete  already  on  the  very  day  of  its  adoption. 
Similarly, even if the transposition time was cut to the bare minimum, for some other items the requirements in 
the revised Annex would become obsolete even before their transposition into national law. The cascade effects 
of the difficulties experienced in the 4th amendment are highlighted by the fact that a total 16 items added anew 
in the 4th amendment to Annex A.1 were subsequently modified in the 5th amendment, adopted less than a year 
afterwards. This was clearly very disturbing for both the industry and national administrations. 

For economic operators, the delay between the entry into force of international requirements 
and the time when it can legally be placed on the market may also have implications in terms 
of  cost  at  different  levels.  In  the  first  place,  it  delays  the  return  on  the  investment  for  the 
company that has developed the new marine equipment. In addition, a too lengthy process for 
approval  of  new  marine  equipment  undermines  the  rate  of  innovation  in  the  sector.  As  a 
result,  long  transposition  delays  have  a  negative  effect  on  the  overall  profitability  of  the 
sector, especially as it is composed mainly by small and medium enterprises. 

Moreover,  the  lengthy  process  of  periodic  update  of  the  Directive's  Annex  adds  to  the 
confusion.  In  effect,  due  to  the  time  lag  between  the  entry  into  force  of  international 
requirements  and  their  enforcement  within  the  EU,  the  industry  is  left  in  a  situation  of 
significant  uncertainty  as  to  the  substantial  and  testing  requirements  actually  applicable  - 
especially in the case where there is significant departure from the practice in third countries.  

3.1.3.  Conclusion 

Experience  with  the  working  of  the  MED  highlighted  certain  implementation  and 
enforcement  weaknesses  common  to  New  Approach  Directives  that  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.  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. 

3.2. 

Stakeholders affected 

The  global  competitive  advantage  of  European  marine  equipment  manufacturers  relies 
greatly on innovation, having regard to the relatively low labour costs and other advantages 
that  often  benefit  their  competitors  in  the  emerging  countries.28  The  weakness  of  market 
therefore  affect  European  manufacturers 
surveillance  and 
disproportionately.  

the  safeguard  procedures 

The  current  transposition  procedure,  which  often  leads  to  the  temporary  coexistence  of 
conflicting  rules  at  EU  and  global  levels,  is  also  source  of  administrative  burden  and  costs 
related to the manufacturing of products according to two or more standards. The inefficiency 
of  certification  by  notified  bodies  is  finally  source  of  costs,  delays,  and  can  distort 

28 

Shipbuilding IPR Study, op. cit. 

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17 

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competition  between  manufacturers.  Given  the  strong  links  between  the  marine  equipment 
sector and the shipyards, the latter are equally affected. 

It must be borne in mind that SMEs, which are a majority among the EU marine equipment 
industry,  are  particularly  vulnerable  to  the  current  problems  as  they  have  to  face  fierce 
competition  in  distant  markets  in  a  strongly  regulated  environment  –  where  changes  in 
regulation are very frequent. The industry has to adapt to the decisions made by a plethora of 
regulators (IMO, EU, national authorities), having little if any information on those decisions 
which  in  practice  turn  out  to  be  uncoordinated  both  in  timing  and  in  content.  Changes  may 
have noticeable impacts on research and development investments, production planning or the 
management of stocks. These impacts may become important for SMEs, which find it harder 
to gain access to capital markets in order to adapt and stay competitive. The costs associated 
with  the  late  implementation  of  IMO  requirements  in  the  EU  (reduced  return  on  R&D 
investment, costs of double certification) represent a heavier burden for SMEs (given e.g. that 
the cost of one type approval does not depend on the volume of production).  

Ship passengers and crews are affected by the safety problems such as the presence on ships 
of counterfeit products of unknown performance (resulting from the ineffectiveness of market 
surveillance),  possible  use  in  the  same  mechanical  unit  of  parts  conforming  with  different 
standards (when new standards are not transposed in time), and the use of products certified 
by potentially incorrectly performing notified bodies. In case these problems lead to a major 
maritime accident, its consequences (eg. oil spill) could be felt by the inhabitants of coastal 
regions. 

Finally, the ineffectiveness of the transposition system is source of administrative costs for the 
public administration and governments. 

3.3. 

Baseline scenario 

It  is  expected  that  the  marine  equipment  sector  will  be  affected  by  two  trends  in  the 
foreseeable future. On the one hand, shipyards will gradually become final assembly facilities 
only, while most value added activity will continue migrating to the marine equipment sector. 
In this rising market, the share of Europe will however be declining (according to available 
sources, it would have already fallen to 31% in 2010 from 36% in 2005). Part of the reason is 
that many European players delocalise production to Asia where most of their customers – the 
shipyards – are located. As an effect, the problems related to market surveillance will become 
more acute in the future as an even larger fraction of the equipment will be manufactured and 
fitted on board European ships outside the physical borders of the EU. 

The possible future enlargement of the EU to maritime countries such as Croatia and Turkey 
would significantly increase the fleet covered by MED rules and slightly increase the share of 
the EU in the global marine equipment market. At the same time, the increase in the number 
of EU Member States will further complicate the process of transposing IMO rules into EU 
and national legislation, exacerbating current problems. 

The lack of data makes it impossible to measure the magnitude of these problems and hence 
to complete this assessment with the analysis of a set of meaningful quantitative indicators.29  

29  

It is expected that, in the future, this problem will be resolved. In effect, the Commission has recently 
commissioned a study on the competitiveness of the sector, which is expected to provide an in-depth 
analysis of the market and examine  the foreseeable evolution of the marine equipment industry.  

EN 

18 

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A  mechanism  for  a  more  efficient  yearly  update  of  MED  Annex  A  has  been  initiated  by 
EMSA  at  the  request  of  the  Commission  as  from  2008.  This  mechanism  is  based  on  a 
continuous  monitoring  of  the  essential  requirements  and  testing  standards  for  marine 
equipment  and  a  Web  based  tool  developed  in  order  to  facilitate  the  EU  Member  State 
contributions. Unfortunately, whatever the efficiency of these improvements is, it appears that 
the delay involved  by the “amendment” procedure is still too important, as the time needed 
for  a  new  IMO  requirement  to  become  effective  within  the  national  legal  orders  of  the 
Member  States  continues  to  exceed  significantly  the  window  left  by  the  IMO  for  its 
worldwide implementation. Annex 12 shows that the total costs incurred by the industry due 
to  the  delays  in  the  transposition  of  IMO  requirements  into  the  MED  can  be  estimated  at 
approximately 6 to 7 million € per year of dela y; in the baseline scenario, these costs should 
be expected to grow concomitant with the expectedly growing production of safety standards 
by the IMO, given the Organisation's ambitious work programme.  

The  EU  procedure  for  the  transposition  of  IMO  rules  will  be  affected  by  the  changes 
introduced  by  the  Treaty  on  the  Functioning  of  the  EU  (TFEU).  Currently,  as  stipulated  by 
Articles 17 and 18.3 of MED, the annexes to the Directive are amended in accordance with a 
Regulatory  Committee  Procedure  with  Scrutiny.  This  will  need  adaption  to  the  new  Treaty 
provisions.  Whether  their  fate  is  to  become  implementing  acts  (with  an  associated 
examination committee procedure) or, more plausibly, delegated acts30, this should not bring 
about any significant reduction in the length of the procedures relative to the current state of 
affairs.  Indeed,  technical  consultation  with  the  Member  States,  be  it  at  an  expert  or  at  a 
committee level, would continue to be necessary – as would transposition of each new Annex 
into the Member States' national legal orders. 

In  conclusion,  the  analysis  of  the  baseline  scenario  seems  to  indicate  that  the  problems 
concerning MED will grow in the future, making it even more urgent to review sub-optimal 
rules. 

3.4. 

Does the EU have the right to act? 

3.4.1.  Legal basis 

The EU transport policy, including maritime safety policy, has a well-established Treaty base 
in  Article  100  of  the  TFEU  (ex  Article  80)  upon  which  Directive  96/98/EC  is  based.  This 
proposal  modifies  existing  EU  legislation  principally  to  reflect  the  reform  of  the  New 
Approach on which MED is partly based. The review uses the reference provisions provided 
in  the  Annexes  to  Decision  768/2008/EC,  in  line  with  Article  2  of  the  said  Decision  which 
stipulates  that  "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."  In  some  points,  the  proposal  departs  from  the  provisions  of  the  Decision,  which  is 
justified in light of the rest of Article 2 of the Decision "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".31 

30  

31 

The Commission has committed to replace, by 2014, all PRAC provisions by a reference to Delegated 
Acts in line with the Article 290 TFEU. 
Point  (5)  of  the  recital  to  Decision  768/2008/EC  actually  mentions  marine  equipment  as  one  of  the 
sectors for which specific adaptations of the common principles and reference provisions are needed. 

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3.4.2. 

Subsidiarity 

As  the  Commission  already  identified  in  its  1995  proposals,  direct  application  of  the  IMO 
regulatory framework by the Member States in the absence of Community harmonisation had 
led to significant 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  had  led  to  uneven  degrees  of  safety  and 
environmental protection. 

At  the  time  it  was  established  that  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 2004 and 2007 enlargements have considerably increased the size of the Single Market 
and  nearly  doubled  the  number  of  Member  States,  making  harmonisation  even  more 
necessary  that  before.  At  the  same  time,  the  expected  steady  increase  in  maritime  transport 
volumes,  and  the  enlargement  of  the  EU  to  Member  States  having  large  fleets  –  notably 
Cyprus  and  Malta  –  has  increased  the  importance  of  fixing  and  enforcing  a  common  high 
level of safety and environment protection. 

3.4.3.  Proportionality 

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. 

It is legitimate to enquire whether harmonisation could be achieved with soft law or mutual 
recognition.  The  Agreement  between  the  European  Community  and  the  United  States  of 
America on the mutual recognition of Certificates of Conformity of marine equipment32 can 
serve as an example of the limited effectiveness of such an approach. The agreement is based 
on the verification of the equivalence of the respectively applicable standards and the mutual 
recognition  of  certifications  bodies  and  procedures.  Given  that  both  parties  implement  the 
IMO  standards,  a  significant  degree  of  convergence  might  have  been  expected.  However,  it 
appears  that  so  far  agreement  has  been  reached,  in  this  agreement,  on  the  recognition  of 
roughly 1/3 of the marine equipment listed in Annex A.1 to MED; for the rest, European and 
American  rules  have  been  deemed  too  divergent  to  make  mutual  recognition  possible.  This 
confirms the above mentioned Commission's findings of 1995, and clearly shows that in order 
to  ensure  the  smooth  functioning  of  the  Internal  Market  and  the  full  recognition  of  marine 
equipment between Member States, only a mandatory legislative approach can be effective – 
which is why only legislative options are analysed in what follows. 

4. 

OBJECTIVES 

This section defines the general and specific policy objectives of the proposed initiative and 
verifies their consistency with other EU horizontal objectives. 

32 

OJ L 150/46, 30.04.2004. 

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4.1. 

Policy Objectives 

4.1.1.  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: 

• 

• 

to  enhance  the  implementation  and  enforcement  mechanisms  of  the  MED,  thereby 
guaranteeing  the  proper  functioning  of  the  internal  market  for  marine  equipment33 
while ensuring a high level of safety at sea and prevention of marine pollution34;  

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. 

4.1.2. 

Specific objectives 

Based on the problem and related root causes set out in section 2 above, the twofold general 
objective can be translated into 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  market  surveillance,  conformity 
assessment of products and obligations for actors in the distribution chain;  

• 

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

The above specific objectives are sufficiently precise and inevitably contain the specific areas 
where  measures  are  necessary.  Therefore,  it  does  not  appear  necessary  to  break  them  down 
into operational objectives. 

33  

34  

Art. 26 par. 1 TFEU on ensuring the functioning of the internal market as further explained in Art. 28 
and 29 TFEU on the free movement of goods. 
Art. 91 par. 1(c) TFEU on improving transport safety read in conjunction with Art. 100§2 TFEU, and 
Art. 11 TFEU on integrating environmental requirements into the definition and implementation of the 
Union's policies and activities. 

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Table 2: Mapping problem, drivers and objectives 

Problems 

General objectives 

The  MED  suffers  from  weak 
implementation  and 
enforcement  mechanisms,  leading  to  safety  risks  and 
inefficient  functioning  of  Single  Market  for  marine 
equipment.  

The  transposition  process  of  IMO  rules  into  national  law 
imposes  excessive  burden  upon  the  industry  and  national 
administrations and legal uncertainty about what standard 
is applicable. 

enhance 

implementation 

To 
and 
enforcement  mechanisms  of  MED,  thereby 
guaranteeing  an  efficient  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 
a 
harmonised way across the EU. 

implemented 

applied 

and 

in 

Drivers 

Specific objectives 

D1  The  MED  has  not  been  aligned,  in  a  way  that  is 
compatible  with  the  specific  features  of  the  sector, 
with the tools provided for by the NLF as regards: 

SO1 

to  define  an  optimal  way  to  align  MED  on 
the NLF in the field of:  

-  market surveillance; 

-  market surveillance; 

- 

- 

- 

CE marking; 

conformity assessment of products; 

tools  for  use  of  legislation  (obligations  for 
actors in the distribution chain, harmonised 
definitions, etc) . 

- 

- 

- 

CE marking; 

conformity assessment of products; 

for  use  of 

for  actors 
chain, 

legislation 
in 
the 
harmonised 

tools 
(obligations 
distribution 
definitions). 

D2  The 

legislative 

transposing 
technique 
international  safety  standards  for  marine  equipment 
into national law is complex and lengthy. 

for 

SO2 

simplify,  clarify  and 

to 
the 
transposition process of IMO standards into 
the European and national legal frameworks  

shorten 

4.2. 

Coherence with horizontal policies  

4.2.1.  New Legislative Framework 

The objective of the proposed initiative clearly contributes to the objectives laid down in the 
New  Legislative  Framework  which  is  the  tool  for  harmonising  across  all  sectors  European 
legislation  concerning  the  certification  of  products  in  the  internal  market  and,  hence,  to 
facilitate the free movement of goods.  

4.2.2.  Better regulation strategy 

The objective of the proposed initiative is fully in line with the Better Regulation Strategy35, 
the  Smart  Regulation  Communication36  and  the  efforts  to  reduce  administrative  burden 
illustrated  by  the  activities  of  the  High  Level  Group  of  Independent  Stakeholders  on 
Administrative Burdens (the so-called "Stoiber Group").37 

35 
36 
37 

See: http://ec.europa.eu/governance/better_regulation/index_en.htm.  
See COM/2010/0543 final. 
See:http://ec.europa.eu/enterprise/policies/smart-regulation/administrative-burdens/high-level-
group/index_en.htm.  

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5. 

POLICY OPTIONS 

In light of the above and on the basis of the stakeholders' consultation, the Commission has 
identified  four  policy  options  –  besides  the  baseline  scenario  –  that  combine  specific  EU 
actions across the two areas for action described in section 2 above. All policy options have 
been designed to be able to address both specific objectives defined in section 4. 

Policy  Option  1  would  foresee  the  discontinuation  of  EU  action.  Under  this  option,  the  EU 
would  abandon  the  specific  regulation  of  the  Internal  Market  for  marine  equipment  which 
would  then  be  governed  by  the  general  principles  of  the  Treaty,  including  the  principle  of 
mutual recognition, and, where applicable, relevant horizontal legislation such as Regulation 
(EC) No 764/2008 - also part of the NLF. The latter regulation establishes procedures aimed 
at framing how authorities in the Member States monitor compliance with national technical 
rules on goods not covered by the harmonised Community rules. 

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. 

Policy Option 4 would represent a minimum alignment of the MED on the NLF, while still 
being inspired by the latter. It would build upon Policy Option 3 by adding the possibility of 
creating  a  MED-specific  EU  authority  for  market  surveillance  and  one  for  notified  bodies 
which  would  replace  the  national  systems.  This  set  of  MED-specific  measures  could  be 
considered  in  theory  in  order  to  channel  maritime  expertise  into  the  Directive's  control 
mechanisms in the two areas mentioned. In other words, these two additional measures would 
seek,  compared  to  Policy  Option  3,  to  combine  the  beneficial  effects  of  pooling  resources 
with  the  need  to  ensure  familiarity  with  the  maritime  and  shipbuilding/ship  repair  markets, 
their operation and their regulation at an international level. Policy Option 4 would therefore 
abandon  the  choice  made  in  the  NLF  to  maintain  these  two  key  functions  in  the  hands  of 
national authorities, pooling resources cross-sectorally at national level in the first place and 
ensuring mutual support, cross-fertilisation and coordination of national authorities at an EU 
level by means of EU-wide cooperative structures or the Commission itself. 

5.1. 

Pre-screening of policy options 

The Commission performed a preliminary screening of the above 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.  This  pre-screening  enabled  the  Commission  to  exclude  PO  1  and  PO  4 
from in-depth assessment for the following reasons. 

Policy Option 1 – Discontinuation of EU action 

Under  this  option,  Member  States  would  apply  IMO  mandatory  requirements  for  marine 
equipment  based  on  their  own  individual  assessment  of  the  international  conventions  and 

EN 

23 

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depending  on  what  specific  conventions  and  instruments  they  are  a  party  to.  Each  Member 
State would decide on the procedures leading to the delivery of a type-approval certificate to 
each item of equipment. Finally, Member State administrations would deliver the certificates 
either  directly  or  through  classification  societies  or  other  types  of  bodies/laboratories  for 
testing and certification. 

Abrogation of the MED would mean that the rigidities introduced by the current formulation 
of the MED would be removed. Furthermore, marine equipment would benefit from a more 
developed  legal  framework  for  non-harmonised  products,  where  objections  based  on  the 
quality  of  accredited  certification  bodies  would  no  longer  be  possible  and  a  structured 
procedure  would  protect  manufacturers  in  the  case  of  technical  decisions  made  in  another 
Member State38. 

However  these  advantages  are  clearly  outweighed  by  the  problems  that  abrogation  would 
bring about. In the absence of an enforceable, harmonised system, the risk of competition at 
the expense of safety is particularly acute in the specific circumstances of the maritime sector, 
and  the  safety  benefits  brought  about  by  this  Directive  would  run  a  serious  risk  of  being 
reversed.  Manufacturers  would  be  obliged  to  produce  several  versions  of  their  product  for 
Member  States  applying  the  international  Conventions  differently  or  at  different  times. 
Divergence in the interpretation and application of international conventions would not only 
have an impact on safety, but also on the good functioning of the Internal Market: even in the 
absence  of  objections  as  to  the  quality  of  notified  bodies,  problems  would  arise  from 
diverging application of the compulsory testing standards - with the result that Member States 
would become reluctant to mutually accepting their respective conformity certificates without 
additional  national  controls.  Control  over  certifying  bodies  and  market  surveillance  would 
either remain as is or would be further relaxed. Free movement of goods would inevitably be 
affected – as had been the case in the past. In the long term the situation within the EU could 
become somewhat comparable to the current state of affairs in the trade with the USA under 
the  mutual  recognition  agreement  in  force,  and  thus  only  one  fraction  of  the  products 
currently covered by the MED would truly benefit from mutual recognition and move without 
problems between Member States. 

For  these  reasons,  the  discontinuation  of  EU  action  has  not  been  retained  for  in-depth 
assessment. 

Policy Option 4 - minimum alignment of the MED on the NLF 

Preliminary analysis of this option by the Commission soon made it apparent that: 

• 

• 

38  
39  

While unification of market surveillance is clearly not seen by the Member States as 
a need39, one stakeholder only has suggested a centralised approach for the licensing 
and control of notified bodies. 

Compatibility with existing national structures and coherence with the parallel, cross-
sectoral coordination would become difficult;  

See in particular Articles 5 to 8 in Regulation 764/2008 
Indeed, in the second consultation one national administration claimed for the clear identification of an 
"expert  body  or  organization  in  charge  of  coordination  of  the  EU  market  surveillance,  which  would 
also  provide  support  to  Member  States  in  establishing  the  surveillance  system,  and  define  for  every 
product the method of conformity assessment". 

EN 

24 

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• 

• 

Cooperation with third countries would be rendered more difficult by the existence 
of parallel, MED-specific structures; 

The  volume  and  diversity  of  products  covered  by  market  surveillance  and  the 
number  of  notified  bodies  under  the  MED  would  put  such  a  task  beyond  reach,  in 
terms of resources, of the Commission or EMSA. 

In addition: 

For market surveillance: 

• 

• 

The  vast  range  of  products  covered  by  the  MED  makes  cross-sectoral  expertise  as 
indispensable  for  market  surveillance  as  is  maritime  expertise  itself.  Indeed,  the 
MED covers items as diverse as protective equipment, electronics, pressure vessels, 
pyrotechnics, etc. 

Moreover, as mentioned above, marine equipment manufacturers usually serve more 
than  one  market  and  do  not  necessarily  direct  their  production  to  ships  only;  thus 
extracting  the  marine  equipment  sector  from  a  cross-sectoral  market  surveillance 
structure would automatically affect the both systems' effectiveness.  

For notified bodies 

• 

Similarly, while notified bodies need to have specific maritime expertise in order to 
be  able  to  certify  marine  equipment,  their  activities  are  seldom  limited  to  the 
maritime domain and the reasons of potential shortcomings need not be linked to one 
particular area of activity; 

In  light  of  the  above,  the  Commission  has  considered  that  these  policy  measures  were  both 
ineffective  and  disproportionate  relative  to  the  simpler  method  of  incorporating  the  marine 
equipment sector and its associated expertise into the general framework created by the NLF 
in the two areas under consideration, thus reaping the benefits of both resource pooling and 
cross-sectoral cooperation.  Moreover,  these policy measures  would become  very difficult to 
justify under the prism of subsidiarity, as a priori they can be expected to bring no net added 
EU value to the Member States' action. 

The above confirms that the reasons which led the Commission's choice for the NLF's general 
case, clearly justified in the original impact assessment40, remain valid for the specific case of 
the MED. 

For these reasons, Policy Option 4 has not been retained for in-depth assessment. 

5.2. 

Description of retained Policy Options 

In light of the above, the Commission has identified two policy options - besides the baseline 
scenario - that constitute viable policy alternatives for achieving the objectives. 

The table below summarises in detail the content of the envisaged possible policy options and 
highlights their main differences. 

40  

See Annex 8 

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25 

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Table 3: 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 

Market surveillance 

Common EU framework  Word by word transposition of 

Same as PO2 

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 

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

surveillance 

Same  as  PO  2  +  Additional  provisions 
adapting  the  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. 

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 requirements41 turned into 
"essential requirement". 

technical 
and 

norms 
non-mandatory 

including 
Mandatory 
mandatory 
IMO 
requirements  as  well  as  European  and 
international  testing  standards  developed  by 
European  and  international  standardisation 
organisations  on 
the  IMO 
requirements. 

the  basis  of 

Notification of 
conformity assessment 
bodies 

Word by word transposition of 
NLF provisions into MED 

Same as PO2 

Conformity assessment 
procedures 

Word by word transposition of 
NLF provisions into MED 

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

possibility 

the 

to 

CE marking 

No alignment, CE marking 
replaced by a wheelmark 

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 

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 

41  

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

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market within the EU territory. 

Manufacturers: same as in PO2 

Importers  and  distributors:  identification  and 
cooperation  with  market 
registration; 
(information, 
surveillance 
documentation, removal of risks, etc.) 

authorities 

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 
into 
standards 
national 
(whether  developed  by 
IMO  or  by 
standardisation bodies) are mandatory. 

legislations.  Testing 

transposition 

6. 

ANALYSIS OF IMPACTS 

6.1. 

Preliminary remarks 

The  two  policy  options  considered  in  this  IA  report  constitute  alternative  ways  of  aligning 
MED on the NLF. 

As said above, the impacts of the alignment of sectoral legislation on the NLF have already 
been  assessed  in  two  IA  reports,  namely  the  one  accompanying  the  Communication  on 
alignment  of  ten  technical  harmonisation  directives  to  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 products42, and obviously the one accompanying the Proposals for the revision 
of the New Approach43. 

For this reason, the assessment of impacts of the policy options will rely to a certain extent on 
these analyses. Most of the impacts identified in the above-mentioned documents are indeed 
very  relevant  for  PO  2  given  that  the  latter,  except  for  the  CE  marking,  foresees  maximum 
alignment to the NLF. Part of the impacts of the NLF is also pertinent for PO3 which foresees 
a conditional alignment to the NLF. Besides, the assessment also builds upon the results of the 
stakeholders' consultation. 

In  light  of  the  scarce  availability  of  quantitative  data  explained  above,  a  qualitative 
assessment is predominant. 

42 
43 

SEC(2011)763 
SEC(2007)173. 

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6.2. 

Economic impacts 

6.2.1.  On the functioning of the Internal Market for marine equipment 

Common EU framework 

Both  policy  options  would  import  the  relevant  NLF  provisions  word  by  word.  The  MED 
would  thus  benefit  from  the  significant  evolution  which  the  NLF  represents  relative  to  the 
baseline, with clear, structured and effective obligations for market surveillance authorities. 

Market surveillance and safeguard clause 

In  PO2  and  PO3,  the  alignment  of  market  surveillance  to  a  common  EU  framework  should 
ensure a more uniform and sufficiently rigorous level of market surveillance across Member 
States  compared  to  the  baseline.  This  common  EU  framework  should  contribute  also  to  a 
better protection of both consumers and professionals from unsafe products. 

However, in addition to the more effective post-market control mechanism contained in PO2, 
PO3  also  foresees  the  possibility  to  use  electronic  tags.  These  will  facilitate  detection  of 
counterfeit  and  control  of  equipment  already  placed  on  board  by  both  flag  and  port  States. 
Given that marine equipment may or may not physically enter the EU territory before being 
placed on board EU ships, this additional measure gives PO3 a slight edge over PO2 in terms 
of effectiveness of market surveillance. 44 

Furthermore, the alignment of the MED's safeguard clause mechanism with the NLF in PO2 
will  ultimately  lead  to  the  adoption  of  equivalent  measures  across  the  EU  in  relation  to 
products presenting a risk. However, in PO2, the variety of marine equipment and hence the 
diversity of technical expertise required is likely to render more difficult and time-consuming 
the assessment by the Commission of whether or not a national measure restricting the  free 
movement of a product is justified. This drawback of PO2 is overcome in PO3 by allowing 
the  Commission  to  limit  its  intervention  to  examining  the  respect  of  due  procedure  by  the 
Member States – and thus examine the substance of the case only when justified. 

Conformity assessment of products 

PO2 and PO3 will include stricter requirements that will constitute a common benchmark for 
the assessment  of  NB throughout the EU regardless of the country in which they are active 
and of the specific NB providing the service. Moreover, according to the revised notification 
process,  the  notifying  authority  in  a  given  MS  will  be  able  to  scrutinise  and  object  to 
notifications  put  forward  by  another  MS.  Therefore  NB  will  be  subject  to  more  transparent 
and more coherent assessment and this will strengthen the conditions for a level playing field. 
Compared  to  the  baseline,  PO2  and  PO3  will  enhance  equally  the  quality  of  (and  hence 
confidence in) the conformity assessment of products. 

44 

Logically,  the  effectiveness  of  electronic  tags  as  a  tool  to  render  market  surveillance  more  efficient 
largely  depends  on  the  penetration  of  this  measure.  While  it  is  not  excluded  to  make  the  use  of 
electronic tags mandatory for all or part of the equipment falling under the scope of the MED, it is not 
the  purpose  of  this  IA  to  examine  the  optimal  intensity  of  this  particular  measure  and  the  most 
conservative  approach,  i.e.  optional  use,  has  been  taken  as  the  working  hypothesis.  In  any  case  (see 
Annex  14)  it  is  clear  that  RFID  technology  presents  enormous  advantages  for  the  manufacturers  at  a 
very low cost, and it is therefore reasonable to expect that the use of electronic tags will spread very 
quickly as soon as it is made possible, even if not mandatory. 

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However,  compared  to  PO2,  PO3  operates  a  choice  in  the  available  conformity  assessment 
procedures by excluding the possibility for manufacturers to assess themselves the conformity 
of their products - hence avoiding possible conflicts of interest and, again, providing a more 
level  playing  field.  While  it  is  true  that  for  very  specialised  products  it  is  the  manufacturer 
itself who can provide the best expertise and testing facilities, on the whole this is a healthy 
measure  given  that  (see  below)  the  entire  process  of  conformity  assessment,  production 
control,  delivery  and  installation  on  board  may  happen  at  very  distant  locations  and  under 
significant pressure from the shipyards; moreover, self-certification would hardly tie in with 
the IMO requirement for the flag State to approve the equipment placed on board. 

Obligations of actors' in the distribution chain 

In PO2, the MED will include clear obligations applying to all actors throughout the EU that 
are likely to eliminate the current differences in national legislation and to create a more even 
level playing field among actors. However, the additional obligations placed on actors in the 
distribution  chain  (obligations  on  importers  and  distributors  concerning  post-marketing 
controls  and  conditions  of  transport  as  well  as  those  which  mirror  the  obligations  of  the 
manufacturer) can be seen as disproportionate in PO2 compared to the baseline, in light of the 
relatively  small  share  of  products  actually  placed  on  the  market.  The  reason  for  this  is 
twofold:  

- 

In  the  first  place,  when  placed  on  board  and  subsequently  throughout  its  lifetime 
marine equipment is subject to control by the public authorities, be it the flag State45 
or, while in service, also the port States.   

-  Secondly, and more importantly, for a majority of products the figures of the importer 
and the distributor, as well as their respective associated obligations are meaningless: 
the items are sold directly to the ships or to the building/repair yards who will install 
them on board – in most cases outside the EU territory. Only a fraction of the products 
(namely  those  imported  and  distributed  into  EU  territory  by  commercial  operators 
other  than  shipyards)  would  actually  benefit  from  the  above  mentioned  obligations. 
These  measures  would  therefore  generate  an  important,  unjustified  asymmetry 
between products (or even between different batches of the same product, depending 
on where they are placed on board) and place an uneven burden on operators, while in 
practice having insignificant effect.  

PO 3 would limit the obligations incumbent on the operators to a level which would be more 
commensurate with the specificities of the marine equipment sector, concentrating on: a) the 
obligations of the  manufacturers, as it is  the manufacturer who is ultimately responsible for 
the safety of the product; and b) those obligations incumbent on the other operators (importers 
and distributors) which are specifically conceived to facilitate the task of market surveillance 
authorities – i.e. identification, access to information and documents and removal of risks. 

Harmonised definitions 

Both PO2 and PO3 would import the definitions contained in the NLF, which is not expected 
to have any influence on the functioning of the internal market.  

Uniform  interpretation  and  implementation  of  IMO  requirements  and  testing  standards 
developed by standardisation bodies 

45  

Or by classification societies acting on the flag State's behalf 

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PO  2  proposes  to  turn  compliance  with  IMO  requirements  into  an  essential  requirement. 
Compared to the baseline scenario, only mandatory IMO requirements would be covered by 
this  provision.  This  would  be  a  generic  provision:  there  would  be  no  list  of  specific 
requirements  applicable  to  each  item  of  equipment.  Furthermore,  non-mandatory  IMO 
requirements  as  well  as  non-mandatory  testing  standards  developed  by  European  and 
international standardisation organisations would not be covered by the essential requirement; 
similar  to  the  NLF,  compliance  with  European  standards,  and  in  this  case  also  international 
standards, would simply provide a presumption of conformity. 

Careful  formulation  of  this  framework  (together  with  a  number  of  accompanying  measures 
such as lists of IMO requirements and international/European standards being published and 
kept up-to-date by EMSA) could greatly reduce, but never completely remove Member States' 
discretion  both  in  the  determination  of  the  specific  requirements  and  in  the  conduct  of  the 
assessment process; as a result, divergences between Member States in the application of the 
MED  should  be  expected  to  appear  sooner  or  later,  which  in  turn  would  render  mutual 
recognition more difficult. 

The  distortions  to  the  Internal  Market  caused  by  this  measure  would  be  partly  –  but  not 
entirely  –  mitigated  by  the  alignment  on  the  NLF,  which  will  raise  the  overall  trust  in  the 
quality of the work of NB. Conversely, market surveillance would become more difficult in 
the  face  of  divergences  in  the  basic  requirements.  The  final  outcome,  in  terms  of  the 
functioning  of  the  Internal  Market,  would  be  probably  worse  in  PO2  than  in  the  current 
situation. 

Under PO 3, the MED would make technical norms mandatory, including IMO requirements 
as well as technical standards - as it is currently the case. The technical norms will then be 
transposed into national law through implementing or delegated Regulations. The legislative 
framework will thus be completely harmonised, as is also the case today. This new technique 
will allow timely transposition of the applicable requirements and standards into the national 
legal  orders,  thereby  ensuring  consistency  between  the  MED  system  and  the  IMO  practice. 
Therefore, any  incentives  for operators to deviate from the harmonised framework46 will be 
removed.  The  final  conclusion  is  that  PO3  should  be  expected  to  slightly  improve  the 
functioning of the internal market relative to the baseline. 

6.2.2.  On operating costs and administrative burden47 

For economic operators 

Under  PO2,  the  additional  obligations  for  the  operators  (especially  distributors  and 
importers)48    would  translate  into  an  important  additional  administrative  burden  and  hence 
costs for the said operators, which would be disproportionate (especially for the large number 
of SMEs in the sector) in light of the expected low benefits in terms of compliance rates. As 
has  been  explained  this  is  due  to  the  fact  that,  in  the  marine  equipment  sector,  most  of  the 
products are never placed on the market and economic operators have so far had little reason 
or incentive for putting in place costly follow-up strategies for their products. 49 This aspect is 

46  
47  
48  
49  

See section 3.1.2 
See annex 9 for a detailed assessment 
See section 5.2 
Contrary to the conclusions drawn the IA report on the Communication on alignment of ten technical 
harmonisation directives [See SEC(2011) 763] in which the Commission concluded that the additional 

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30 

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a  considerable  drawback  of  PO  2  compared  to  the  baseline.  Better  adapted  obligations  on 
economic operators in PO3 would increase operating costs for economic operators compared 
to the baseline, but in a much lesser extent than in PO2 and, more importantly, this additional 
burden would be commensurate with the associated safety benefits. 

Thus e.g. the traceability obligations of the NLF, which would be transposed into the MED 
in both Policy Options, would require manufacturers and importers to indicate on the products 
their names, addresses and batches or serial numbers. This would inquire some costs, which 
shouldn't however be too high. Anyway, manufacturers are already obliged by legislation in 
place to indicate their names on the products, while batches and serial numbers are normally 
used for internal management reasons. 

PO3 also includes a specific measure to facilitate market surveillance, namely the introduction 
of  electronic  tags.  As  discussed  in  Annex  14,  the  costs  of  electronic  tags  (the  use  of  which 
only  needs  to  be  made  possible  but  not  necessarily  compulsory  for  the  manufacturers)  is 
marginal50, while the associated benefits are very considerable both in terms of safety and in 
terms of IPR protection. 

The undeniable simplification of conformity assessment requirements in both Policy Options 
would  reduce  the  costs  of  conformity  certification  for  marine  equipment  manufacturers. 
However,  in  the  case  of  PO2  where  the  applicable  requirements  are  not  harmonised, 
divergences among Member States  could lead to uncertainty and re-assessment requirements, 
and  the  risk  that  in  some  cases  several  versions  of  the  same  product  may  have  to  be 
manufactured cannot be excluded; this means that the final costs for the manufacturers could 
be actually higher than today. For ship operators, the lack of recognition of certificates issued 
by  other  Member  States,  together  with  difficulties  in  the  identification  of  the  applicable 
requirements  by  Port  State  Control  officers,  could  lead  –  in  extreme  situations  –  to  the 
detention of ships, causing very high costs. 

In comparison with the baseline, PO 3 foresees the abandoning of the conformity assessment 
module H (full quality assessment), which is in theory extremely expensive for manufacturers 
in the case of marine equipment. But even under the existing MED, this module – although 
allowed – was never used. The gains of the measure in terms of operating costs are close to 
zero. 

Both Policy Options contain measures shortening the time needed for the implementation of 
IMO requirements within the European legal framework. In PO 2, this objective is achieved 
by eliminating the need to transpose IMO standards into the MED, while the Member States 
still  have  to  transpose  these  into  their  national  legal  orders.  In  PO3,  the  same  objective  is 
achieved  by  eliminating  the  need  to  transpose  the  IMO  standards  into  national  legislation. 
Each of the solutions should reduce the time necessary for the changes to become applicable 
in Europe to the limits imposed by IMO. This will put an end to a certain extent to the current 
situation which, according to the Commission estimates, may result in administrative burden 
of up to €6-7 million a year for the marine equipment industry only. 

In the absence of transposition of IMO requirements into the EU legal order in PO2, a certain 
number of differences in the implementation of IMO requirements by the Member States, be 
in in terms of content or in terms of timing, will inevitably remain despite the fact that PO2 

obligations would not increase in a significant way the overall costs of economic operators, since the 
new provisions merely codify what is already normal practice for a responsible firm. 
Between €0,1 and €0,3 per unit 

50  

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31 

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also  foresees  the  creation  of  a  website  clarifying  the  rules  in  place  at  each  given  moment. 
Therefore,  PO2  will  probably  not  be  able  to  completely  remove  the  administrative  burden 
generated by these differences, especially in terms of double certification, as described above. 

Under PO3 standards would remain codified in the EU legislation rather than being separately 
transposed  into  the  27  legal  systems  of  the  Member  States  as  it  would  be  the  case  in  PO2. 
This will allow PO3 to be considerably more effective than PO2 and bring about considerable 
improvement  relative  to  the  current  situation,  as  the  burden  for  national  administrations  as 
regards the administration of the Directive's Annex would be reduced to a minimum. 

For notified bodies 

The  strengthening  of  NB  control  and  requirements  foreseen  in  both  Policy  Options  is  not 
expected to lead to any additional operating costs and/or administrative burden on those NB 
which  already  act  in  accordance  with  high  professional  standards.  Indeed,  the  relevant 
benchmark  for  the  assessment  of  conformity  assessment  bodies  has  already  been  codified 
within  EN  and  ISO  standards.51  The  costs  would  be  much  more  significant  for  those  NB 
which  currently  perform  poorly,  but  their  efforts  to  comply  with  higher  quality  standards 
should be actually considered as benefits of both policy options. Following the alignment on 
the  NLF,  MED  would  also  provide  the  national  authorities  with  a    stronger  legal  basis  to 
exclude underperforming conformity assessment bodies from the single market. 

The introduction of information obligations in both Policy Options is expected to lead to an 
additional  –  but  overall  negligible-  administrative  burden  (i.e.  basically  the  costs  of 
transmitting the required information). This information will only be provided on an ad hoc 
basis  as  required  by  the  nature  of  the  information  itself  (i.e.  information  on  refusals, 
restrictions,  suspensions  and  withdrawals  of  certificates  to  be  addressed  to  the  notifying 
authority,  and  information  on  negative  conformity  assessment  results  to  be  addressed  the 
other NB). Furthermore, NBs are free to choose the format of the transmission of information. 

Compared  to  the  baseline,  PO  2  proposes  to  remove  the  restrictions  in  the  choice  of 
conformity assessment modules. Currently, a number of so-called modules (notably modules 
A and C) which foresee self- certification by the manufacturer, are not allowed in the marine 
equipment sector; neither is the use of in-house notified bodies. The major advantage of self-
certification  or  using  in-house  NB  is  the  high  level  of  expertise  available  inside  the 
manufacturing  companies,  which  in  some  cases  is  lacking  in  many  of  the  independent  NB. 
Moreover,  potential  synergies  within  the  companies  could  lead  to  cost  savings  compared  to 
the  baseline.  However,  self-certification  would  probably  give  raise  to  problems  for  ships  in 
third countries, as these might not accept it as a valid method to comply with the flag State 
approval requirement in the international conventions. In the case of in-house notified bodies, 
safety would also probably be affected given their high exposure to conflict of interests in the 
particular circumstances of the sector. PO3 would remove both possibilities, thus representing 
higher costs for the manufacturers but also reducing the risks for the fleet.  

6.2.3. 

Impact on SMEs52 

Among  the  measures  foreseen,  none  are  specifically  addressed  to  SMEs,  or  have  a  specific 
impact on them. However, in the same way as SMEs are particularly vulnerable to the MED 

51 
52  

See SEC(2001)763, footnote 69 for the complete list of the relevant standards. 
See  strengthened  SME  test  in  Annex  10,  which  includes  the  explanation  of  why  micro-enterprises 
should not be excluded from the scope of the proposed initiative. 

EN 

32 

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system's  weaknesses53,  one  should  expect  the  benefits  and  drawbacks  of  both  options  to  be 
particularly felt by SMEs. The introduction under PO3 of the possibility to use electronic tags, 
an effective and very economical way to improve the effectiveness of market surveillance, is 
expected to help reduce counterfeit – a problem which is very acutely felt by SMEs. 

SMEs, which are less equipped to face unfair competition from non-compliant products, will 
particularly benefit from improvements in market surveillance under both PO2 and PO3.  

Under  PO2,  the  burden  of  the  extended  obligations  foreseen  for  importers  and  distributors 
should  also  be  felt  mainly  by  SMEs;  while  under  PO3,  the  removal  of  obligations  whose 
benefits  are  considered  less  significant  will  work  particularly  in  favour  of  SMEs  without 
detriment to safety. 

The improvement of the safeguard procedure in both PO2 and PO3 will reduce the exposure 
of SMEs to the costs associated with lengthy procedures where they are currently placed in a 
particularly  weak  position.  This  effect  will  be  more  acute  in  the  case  of  PO3,  especially  as 
regards  potential  reputational  damage,  as  the  specific  measures  foreseen  constitute  a  strong 
incentive for a fairer procedure already at national level. 

SMEs should particularly benefit of the simplification foreseen under PO2 by the recourse to 
IMO requirements in the form of essential requirements only – accompanied by informative 
instruments  as  to  the  applicable  standards.  However,  this  would  come  at  the  cost  of  greater 
uncertainty  in  the  absence  of  clear-cut  lists  of  requirements  enshrined  in  an  enforceable 
instrument,  a  problem  resolved  under  PO3  with  the  adoption  of  delegated/implementing 
regulations.  Again,  these  effects  –  both  favourable  and  adverse  –  would  be  magnified  for 
SMEs,  which  have  more  difficulty  in  gaining  access  to  information  on  requirements  and 
standards. 

Under both PO2 and PO3, SMEs would greatly benefit from a system which would drastically 
reduce  the  time  needed  for  IMO  requirements  to  become  applicable  in  the  EU  and  thus  a) 
improve  return  on  R&D  investments  and  b)  reduce  the  costs  associated  with  multiple 
certifications. 

6.2.4.  On the competitiveness of economic operators 

Competitiveness of economic operators analysed below refers to the ability of firms to sustain 
and gain in market share through their cost and pricing policy, innovative use of production 
factors and novelties in product characteristics.54 55 

Enforcement system 

Under  PO2  and  PO3,  the  more  effective  enforcement  of  MED  through  better  market 
surveillance  and  better  supervised  NB  activity  resulting  in  higher  quality  of  compliance 
controls will help defend the competitiveness of compliant firms against unfair competition. 
This aspect concerns in the first place notified bodies: it will become more difficult and risky 
for lenient or sub-standard NBs to certify products which in reality do not meet the stringent 
standards required by the law. In the second place, non-conforming equipment (or equipment 

53  
54  

55  

See section 2.3 
"Operational guidance for assessing impacts on sectoral competitiveness within the Commission Impact 
Assessment system" SEC(2012)91. 
A study of the impact on the sector's competitiveness under the prism of the main areas identified in the 
"LeaderShip 2015" initiative is provided in Annex 11 

EN 

33 

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in breach of intellectual property rights) will be more easily detected if placed on the market 
or  installed  on  board  EU  ships  –  from  which  it  will  be  removed.  Since  European 
manufacturers  have  a  comparative  advantage  in  high  value  added,  innovative  and  reliable 
products56, more effective enforcement of MED should be particularly beneficial for them. 

Traceability of products 

In  addition,  compared  to  the  baseline,  the  introduction  of  requirements  on  traceability  and 
cooperation  with  surveillance  authorities  for  all  economic  operators  in  both  policy  options 
will  help  the  former  to  trace  non-compliant  products  and  stop  their  circulation.  57  58  PO3 
incorporates the possibility of using an additional tool for market surveillance authorities, i.e. 
the  electronic  tag,  to  trace  in  a  more  efficient  way  non-compliant  products.  Thanks  to  this 
additional element in PO3, the level of protection of Intellectual Property Rights is likely to 
increase,  protecting  better  marine  equipment'  manufacturers  and  stimulating  thereby  also 
research and innovation. 

Obligations of actors in the distribution chain 

Furthermore, the introduction of clear obligations for importers and distributors regarding the 
compliance  of  marketed  products  (more  effective  post-market  control)  in  PO2  will  allow 
action at all levels of the supply chain. This action will then help defend the competitiveness 
of  compliant  firms  from  unfair  competition.  However,  these  additional  obligations  in  PO2 
will  only  increase  the  rate  of  compliance  for  products  placed  on  the  market;  they  will  not 
affect  the  vast  majority  of  marine  equipment,  which  is  placed  on  board  ships  without  ever 
being marketed in the European Union, while probably coming at a net cost for the operators 
concerned  as  has  been  described  above.59  Compared  to  PO2,  better  adapted  obligations  in 
PO3 will reduce the burden on operators without  significantly affecting  the effectiveness of 
the system.  

Conformity assessment 

For  both  options,  a  strengthened,  more  effective  framework  for  conformity  assessment  will 
greatly  increase  the  pressure  on  any  unscrupulous  manufacturers  who  could  be  tempted  to 
turn the weaknesses of the current system into a competitive strategy and place substandard 
products in the market. Conversely, compliant, quality-conscious manufacturers and notified 
bodies  will  see  their  position  strengthened.  Since  the  competitive  advantage  of  European 
manufacturers  resides  notably  in  the  high  quality  of  their  products,  they  could  be 
proportionately  more  affected  than  their  global  competitors.  This  effect  should  be  clearly 
more noticeable in PO3 than in PO2, given that under the latter marine equipment would not 
need to comply with non-mandatory IMO requirements and international/European technical 
standards.  

6.2.5. 

Impact on public authorities60 

Compared  to  the  baseline,  the  measures  concerning  clear  obligations  for  all  economic 
operators and clearer market surveillance procedures in both Policy Options are expected to 

56 
57 
58 
59 
60  

See section 2.1.1 above. 
See SEC(2007) 173. 
See SEC(2011) 763. 
See section 2.2.1.2 above, indent "Market surveillance". 
See Annex 9 for detailed assessment 

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34 

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substantially  increase  the  effectiveness  of  public  authorities'  enforcement  activities,  while 
they are not expected in general to have negative budgetary consequences. 

The  new  traceability  obligations  on  operators  will  make  it  easier  for  market  surveillance 
authorities to obtain documentation and information from manufacturers and importers and to 
identify non-compliant products, including from third countries. This may actually reduce the 
investigation  costs  of 
the  authorities,  while  better  cooperation  between  national 
administrations within a European market surveillance framework, will increase the efficiency 
and  reduce  the  costs  of  market  surveillance  bodies.  This  impact  is  even  more  important  in 
Policy  Option  3  which  incorporates  the  possibility  to  use  electronic  tags61 in  order to better 
trace non-compliant products.  

In  addition,  the  new  safeguard  procedure  in  the  NLF  contains  a  much  more  detailed 
description of the steps that the authorities have to take to deal with products presenting a risk. 
Most notably, it specifies when the relevant information should be exchanged in order to be 
useful  for  cross-border  authorities:  this  will  allow  surveillance  authorities  to  work  more 
efficiently, as efforts already undertaken in one Member State will not have to be duplicated. 
Compared  to  PO2,  PO3  would  include  a  mechanism  to  simplify  the  safeguard  procedure 
before the Commission, with a consequential positive impact for this and the administration(s) 
concerned. 

In PO2, by turning into an essential requirement the compliance to IMO requirements, there is 
no  longer  need  to  transpose  the  latter  into  EU  legal  order.  As  described  above,  national 
administrations  will  no  longer  be  required  to  contribute  to  the  preparation  of  the  periodic 
updates of the directive's Annex, but will still need to identify the relevant IMO requirements 
and  transpose  them  into  their  national  legal  orders.  Conversely,  the  legislative  technique 
proposed in PO3 that would ensure transposition of IMO requirements through implementing 
or  delegated  Regulations  does  not  require  any  longer  transposition  into  national  law  – 
although  national  administrations  would  still  participate 
the 
implementing  or  delegated  acts.  All  in  all,  PO2  should  not  have  any  noticeable  impact  on 
national  administrations  or  slightly  increase  their  costs,  while  PO3  should  bring  about  net 
savings. Costs for the Commission would be lower as well for both Policy Options compared 
to the baseline, with PO3 being more costly because transposition into EU legal order would 
still be necessary under this Policy Option. 

the  preparation  of 

in 

6.2.6. 

Impact on users and passengers 

Users  and  passengers  in  general  will  benefit  from  greater  levels  of  safety  as  described  in 
section 6.3 below. This impact is likely to be more important in PO3 than in PO2 compared to 
the baseline because of the higher potential of PO3 in terms of traceability of non-compliant 
products. 

Due  to  the  overall  limited  impact  of  alignment  on  costs,  the  new  obligations  on  economic 
operators and NB are not expected to give rise to price increases for users/passengers. If, for 
specific  products,  moderate  price  increases  occur,  it  is  expected  that  the  latter  would  be 
largely offset by the benefit of greater confidence in product quality. 

61  

See Annex 14 

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35 

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6.2.7.  Third countries and international relations 

Neither PO2 nor PO3 contain trade-related measures, the matter falling completely out of the 
scope of the MED.  

6.3. 

Environmental and Social impacts 

The  expected  improvement  of  market  surveillance  together  with  an  enhanced  system  for 
conformity assessment in both policy options is expected to strengthen the implementation of 
IMO standards across the EU. This is likely to help in reducing the number of non-compliant 
products on the market and thus the number of products potentially dangerous to the safety of 
passengers/ users and the environment. 

More precisely, changes brought to the system of certification and to the enforcement of MED 
can  therefore  be  expected  to  have  a  concomitant,  indirect,  but  clearly  positive  impact  on 
health,  on  safety  and  on  the  protection  of  the  marine  and  coastal  environment.  This  impact 
should result in a perceptible improvement relative to the current situation for both PO2 and 
PO3. 

In addition, the shortening of the procedure for transposing IMO requirements (be it in PO2 or 
PO3) will accelerate the application in the EU of the latest safety norms, with a likely positive 
impact  on  the  level  of  safety  and  on  the  protection  of  the  marine  and  coastal  environment 
compared to the baseline scenario. 

The positive impact described above will be mitigated in PO2 by several elements. First, the 
unrestricted choice of conformity assessment modules in PO 2, including those which imply 
the  certification  of  products  by  in-house  NB,  can  have  a  negative  impact  on  the  quality  of 
assessment.  Second,  the  choice  of  turning  compliance  with  IMO  requirements  into  an 
essential requirement in PO2 implies that non-mandatory requirements, testing standards from 
standardisation  bodies,  recommendations  and  guidelines  would  not  be  covered  by  this 
essential  requirement  and  their  implementation  is  not  guaranteed.  This  is  likely  to  have  a 
negative impact on safety compared to the baseline. Similarly, given that IMO requirements 
will not be  transposed  into EU legal order in PO2, fully uniform application of  IMO safety 
standards for marine equipment within the EU will no longer be ensured in PO2. As a result, 
PO2 will not be able to achieve the same high standards for marine equipment as PO3, and 
thus the risks to health, safety and environment will be higher. 

In  the  case  of  PO3,  a  fast  and  uniform  EU  procedure  will  give  more  certainty  and  have  a 
positive  influence  on  manufacturers'  expectations,  thus  facilitating  the  availability  of  more 
advanced,  safer  products  in  the  market  and  further  reducing  the  risk  of  attracting  stocks  of 
obsolete  products  which  could  otherwise  still be  placed  on  board  ships  of  EU  flags  lagging 
behind.  Furthermore,  the  introduction  of  electronic  tags  to  replace  or  supplement  the 
wheelmark (PO 3) will increase the efficiency of market surveillance, therefore contributing 
to the detection and elimination of equipment (e.g. counterfeit) which is dangerous for health 
and safety. 

6.4. 

Simplification of the regulatory environment 

The use of the consistent and updated terminology provided for in the NLF will address the 
current  problems  of  inconsistencies  and  legal  uncertainty.  It  will  reduce  the  administrative 
costs and burden linked to the need to conform to incompatible pieces of legislation. 

EN 

36 

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As mentioned above, the choice made in PO3 not to include module H (full quality control) 
into the list of allowed conformity modules is aimed at eliminating from MED the reference 
to a provision which was anyway never used. 

The  changes  to  the  method  of  transposing  changes  to  IMO  requirements  are  the  main 
simplifying  element.  PO3,  which  eliminates  the  most  burdensome  procedure  of  transposing 
changes  to  MED  into  national  legislation,  seems  the  most  interesting.  PO2,  and  the 
elimination of the need to transpose rules into European legislation, has also its advantages, 
which  must  however  be  weighed  against  the  distortions  of  the  internal  market  it  brings  - 
noting that the need for MS to identify the applicable IMO requirements and transpose them 
into their national legal orders will remain. For the industry, both policy options would offer 
the opportunity to improve return on investment in the development of new products meeting 
the latest IMO requirements and, more markedly under PO3, a reduction in the current costs 
deriving  from  double  certification.  As  is  shown  in  annex  12,  the  respective  savings  for  the 
industry could potentially reach 4 to 7 M€ for PO2against 6  to 7 M€ for PO3. Although these 
are  relatively  moderate  figures  when  compared  to  the  sector's  overall  turnover,  it  must  be 
taken into account that the improvement would be particularly felt by SMEs which in extreme 
cases might at present be facing double certification costs reaching 1% of their turnover. 

6.5. 

Conclusion 

Both policy options propose the alignment of MED on the NLF. This will bring considerable 
positive impacts – compared to the baseline – which have been assessed in the IA on the NLF 
and  summarised  above.  The  difference  between  options  2  and  3  lies  with  the  specific 
provisions  concerning  marine  equipment.  The  following  table  provides  a  qualitative 
appreciation of the impacts of these measures in each of the policy options compared to the 
baseline. 

Table 4: 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 

EN 

++ 

++ 

++ 

++ 

- 

= 

-- 

37 

++ 

+++ 

+++ 

+++ 

++ 

= 

= 

   EN 

 
 
 
 
 
 
Operating costs and administrative 
burden 

Economic operators 

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 

7. 

COMPARISON OF OPTIONS 

The  analysis  above  has  shown  that  the  different  policy  options  have  clear  implications  in 
terms of the related socio-economic and environmental impacts. 

This section provides for an assessment of how the said policy options will contribute to the 
realization  of  the  policy  objectives,  as  set  in  Section  3,  in  light  of  the  following  evaluation 
criteria: 

• 

• 

• 

EN 

Their effectiveness in relation to the objective; 

Their efficiency in reaching the objectives; 

Their coherence with overarching EU objectives, strategies and priorities. 

38 

   EN 

 
 
 
 
 
 
 
 
 
 
 
7.1. 

Effectiveness in relation to specific objectives 

The  analysis  contained  in  the  preceding  sections  shows  that  both  options  represent  a  very 
substantial  alignment  of  the  MED  on  the  NLF.  PO2  would  result  in  a  virtually  complete 
alignment, while PO3 would slightly deviate from the mainstream NLF solutions. However, 
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,  without  differences 
between  Member  States  in  terms  of  timing,  content  or  practice.  By  comparison,  under  PO2 
such differences between Member States could appear and significantly develop over time, to 
the  point  that  the  situation  could  deteriorate  compared  to  the  baseline.  As  a  result,  the 
objective of optimal alignment is clearly better met by PO3.  

Both  policy  options  would  allow  shortening  the  transposition  process  to  a  period  of  time 
compatible with the deadlines given by the IMO. The difference between the options is that 
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. 

Table 5: Effectiveness of envisaged policy options in light of objectives 

Baseline 

Policy option 2 

Policy option 3 

To define an optimal way to 
align MED on the NLF 

To simplify, clarify and 
shorten the transposition 
process of IMO standards in 
national legal orders 

7.2. 

Efficiency 

0 

0 

Low 

Medium - IMO standards 
directly applicable, but 
not in a harmonised way 

High 

High 

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

7.3. 

Coherence with the overarching EU objectives, strategies and priorities 

As  highlighted  in  Table  4  above,  both  policy  options  would  on  the  whole  bring  about 
considerable  improvements  in  terms  of  maritime  safety  and  protection  of  the  marine 
environment.  Both  options  would  result  in  a  simplified  legal  framework,  favouring  the 
competitiveness of the EU marine equipment industry. However, it has been shown that the 
best results should be expected from PO3 in all fields, while PO2 might not be able to deliver 
in terms of smooth functioning of the internal market. 

EN 

39 

   EN 

 
 
7.4. 

Conclusion 

The  table  below  summarizes  the  results  of  the  comparison  of  policy  options  in  terms  of 
effectiveness, efficiency and coherence. 

Table 6: 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. 

8. 

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 mechanism62. There is indeed no need 
to develop independent mechanisms for the MED but it is necessary to envisage an active and 
substantial  contribution  from  the  marine  equipment  sector  to  the  monitoring  and  evaluation 
mechanisms. 

As  regards  the  specific  measures  envisaged  in  addition  to  the  alignment  the  following 
activities have been foreseen in order to verify their effectiveness and gather feedback from 
the stakeholders:  

•  As  a  result  of  the  reform  more  informative  data  will  be  obtained  from  the  market 
surveillance  activities  and  similarly  EMSA  will  continue  to  refine  the  production  of 
statistics on the implementation of the directive. The possibility to include this sector in the 
Commissions statistical work programme will be examined. 

•  Contacts with the industry will continue beyond the adoption of the amending instrument 
and  become  standard  practice;  this  will  include  workshops  with  the  industry  on  the 
implementation of the amended MED. One main aim of this cooperation will be to develop 
methodologies for the production of relevant data on the marine equipment market which 
can underpin future assessments. 

•  The  activities  of  the  MARED  Group  of  notified  bodies  are  an  important  forum  for 
discussion  between  the  Commission,  EMSA  the  industry  and  the  Member  States  on  the 
implementation of the directive, and provide most valuable feedback on operational issues.   

•  A  specific  agenda  item  on  MED  is  included  in  the  meetings  of  the  COSS  Committee 
several  times  per  year  which  allows  having  productive  exchanges  of  views  with  the 
Member States and examining ways to improve the functioning of this directive. 

62 

See in particular SEC(2011)1376 final, pages 55-56 

EN 

40 

   EN 

 
 
                                                 
•  In  addition  to  the  above  measures,  EMSA  will  continue  to  organise  workshops  for 
technical  discussion  and  training  activities  with  the  Member  States  in  order  to  refine 
Member States practise and obtain their feedback.  

•  Based on this, an ex-post evaluation will be organised within 5 years of the entry into 
force of the new system, with the objective to measure safety benefits, gauge with as much 
precision as possible the impact on the sector and its competitiveness, assess the costs and 
benefits  for  the  different  stakeholders,  identify  potential  malfunction  and  carry  out  a 
comparative analysis of the EU system against that of a selected group of third countries.  

– 

For  this  purpose,  a  system  of  indicators  will  be  developed  based  on  those 
already  foreseen  for  the  body  of  directives  already  aligned  with  the  NLF 
(including e.g. number of products checked, number of non-compliant products 
among  those  checked,  type  of  non-compliance  found,  number  of  non-
compliant products whose manufacturer was identified; or, as regards notified 
bodies,  number  of  notifications,  information  derived  from  notified  body 
assessments,  frequency  of  reassessment,  objections,  de-notifications,  etc.)63. 
Furthermore,  a  limited  number  of  additional  indicators  will  be  developed  in 
order  to  cater  for  MED  specificities.  Thus  e.g.  the  time  taken  for  IMO 
requirements to become effective in national legal orders will be systematically 
monitored;  the  possibility  to  refine  the  input  provided  by  Port  State  Control 
statistics  in  order  to  render  them  more  meaningful  for  the  assessment  of  the 
MED  implementation  will  also  be  examined,  e.g.  as  regards  the  use  of 
electronic tags.  

• 

Preparatory  arrangements,  particularly  as  regards  the  work  of  EMSA  and  the 
MARED  group,  as  well  as  contacts  with  the  industry  and  Member  States  will  start 
immediately so that a system capable of producing relevant information and data can 
be in place within one year of the entry into force of the new system.  

63 

Id. 

EN 

41 

   EN 

 
                                                 
ANNEX 1 

Results of the questionnaire sent to Member States 

EN 

42 

   EN 

 
 
 
 
 
 
 
EN 

43 

   EN 

 
 
 
 
 
 
 
EN 

44 

   EN 

 
 
 
 
 
 
 
 
EN 

45 

   EN 

 
 
 
 
 
 
 
 
EN 

46 

   EN 

 
 
 
 
 
 
 
 
EN 

47 

   EN 

 
 
 
 
 
 
 
 
EN 

48 

   EN 

 
 
 
 
 
 
 
 
EN 

49 

   EN 

 
 
 
 
 
 
 
 
EN 

50 

   EN 

 
 
 
 
 
 
 
 
EN 

51 

   EN 

 
 
 
 
 
 
 
 
EN 

52 

   EN 

 
 
 
 
 
 
 
 
EN 

53 

   EN 

 
 
 
 
 
 
 
ANNEX 2 

Minutes of the stakeholders' meeting on the revision of the Marine Equipment Directive 

EN 

54 

   EN 

 
 
 
EN 

55 

   EN 

 
 
EN 

56 

   EN 

 
 
EN 

57 

   EN 

 
 
EN 

58 

   EN 

 
 
 
 
 
 
ANNEX 3 

Respondents: 

Results of 2nd Stakeholder consultation 

•  5 EU/EEA MS Administrations: France, the Netherlands, UK, Norway and Croatia 

•  4  Industry  stakeholders:  MarED  Group  of  MED  NB,  EMEC,  CIRM  and  Holland 

Shipbuilding. 

In relation to: 

•  Technical Annexes  

•  Notified Bodies 

•  Market Surveillance 

•  Safeguard Clause  

• 

Intellectual Property Rights 

•  Other aspects. 

1. TECHNICAL ANNEXES 

MS provided the following comments: 

•  Provisions  for  allowing  MS  for  early  application  of  the  amendments  of  certain 
requirements provided by the international regulations e.g MSC 1319 lifeboat hooks. 

•  Provisions to take timely corrective action if a standard is no longer appropriate. The 
directive assumes that standards will keep in line with the IMO requirement, but this is 
not guaranteed. A standard is only published if there is consensus. 

•  Provisions  that  allow  mitigating  action  when  a  standard  affects  a  large  number  of 
product  changes  e.g.  IEC  60945.  A  change  that  required  retest  would  likely  create 
market difficulty. 

•  COM to foster changes to Directive 96/98/EC on equipment for which detailed testing 

standards already exist in international instruments. 

•  Column  5,  to  facilitate  control,  to  indicate  the  proposed  amendments  to  IMO 

instruments to verify that the requirements for equipment are met. 

EN 

59 

   EN 

 
 
 
 
• 

In column 6, to adapt the evaluation of the module for type conformity to the type of 
marine  equipment.  The  recast  of  the  directive  should  pay  particular  attention  to 
matching the modules of conformity assessment and the article to which reference is 
made  (column  2)  and  possibly  to  forecast  the  necessary  tailoring  to  the  functions  of 
the article. 

•  Beyond the existing procedures for prototypes (Module B quality assessment), to add 
a  column  7,  referring  to  production  standards  already  existing  in  international 
instruments,  to  make  them  mandatory  .  For  example,  for  life-saving  appliances,  the 
reference  to  Resolution  MSC81  (70)  part  2  of  the  IMO  could  be  cited,  or  the  item 
A.1/1.2, ISO 24408 as standard to follow up factory production . 

•  To add a clause stating that the standards laid down by Directive 96/98/EC (other than 
those  listed  in  the  IMO  instruments  that  apply  according  the  version  quoted  in  the 
IMO instrument), when modified, are not applicable immediately, so as to leave time 
to  adapt  to  industry  in  the  production  of  marine  equipment.  Indeed,  the  approach  of 
the current directive is that of "standard date", which implies an immediate adjustment 
of  the  equipment.  Such  a  clause  would  allow  time  to  adjust  to  industry  for  the 
establishment of standard and to modify the launch of a production. This rule applies 
only to standard added by the European Commission, other than the standards listed in 
the IMO instruments. 

•  To  add  provisions  to  clarify  in  Appendix  A  that,  for  vessels  under  construction, 
regulatory  requirements  are  those  in  effect  at  the  date  of  keel  laying  of  the  ship, 
provided that they have not entered into force for too long before the installation of the 
equipment. 

• 

In the interest of safety, IMO sometimes encourages contracting governments to apply 
certain  international  instruments  (ie  performance  standards  or  testing  standards)  as 
early  as  possible  in  advance  of  their  legal  entry  into  force.  However  due  to  the 
mechanism  of  the  present  directive,  MS  are  not  allowed  to  give  effect  to  such 
encouragement. Quite recently we have seen a dilemma with respect to the application 
of  the  new  LSA  Code  requirements  in  IMO  resolution  MSC.32(89),  encouraged  for 
early application trough MSC.1/Circ.1393.  

•  Since the Annex to the Directive is often amended (for instance three last amendments 
were  adopted  in  September  2009,  October  2010  and  September  2011)  it  is  very 
difficult to determine which equipment is allowed on the market. COM to add the 7th 
column  stating  date  of  entry  into  force  for  every  item  and  the  date  of  validity  of 
certificates. 

•  To  make  a  regularly  updated  Annex  A  available  on  the  web  or  to  give  the  legal 
relevance to the web data base created by the MarED group of the Notified Bodies. 

Industry provided the following comments 

•  Provisions  to  insert  marine  equipment  into  Annex  A.1  of  MED  should  clearly  be 
defined  and  consequently  all  marine  equipment  being  in  compliance  with  these 
requirements should be listed in Annex A.1, whether there are products available on 
the  market  or  not;  these  provisions  could  be:  carriage  requirements  based  on 
international  instruments,  requirement  of  type-approval  based  on  international 

EN 

60 

   EN 

 
instruments,  existing  IMO-Performance  Standards,  existing  and  applicable  testing 
standards. 

•  Clear  provisions  should  be  defined  to  shift  marine  equipment  from  Annex  A.1  of 

MED to Annex A.2. 

•  A change in a test standard will make the approval invalid from one day to the other 
(date of publishing the standard) and subsequently the equipment cannot be installed 
before a notified body has issued a new type approval.  It must be observed that these 
changes  concern  all  manufacturers,  resulting  in  a  general  problem  for  business. 
Grandfathering clauses of up to 2 years should be considered. 

•  The  right  sequence  in  the  process  to  come  to  the  wheel  mark  is  not  always  clear: 
preferred  sequences is as  follows: Type approval, Production Survey,  DOC, affixing 
Wheel mark. In case of an update of [testing standards in] the MED and its annexes, is 
it necessary to get a new type approval certificate for a product [even] in the case that 
there are no amendments to the [construction and performance] requirements of  that 
specific  product.  In  that  specific  case  an  issue  of  a  new  type  approval  certificate 
should not be necessary, or it should be automatically issued, and not be treated as a 
new type approval.  

•  To  keep  clarity  in  the  legal  process  and  updates  of  the  MED,  it  is  not  preferable  to 
give the MarED group a legal status. Issues brought up by the MarED group should be 
handled by the Committee. 

2. NOTIFIED BODIES 

MS provided the following comments 

•  Directive  in  its  Art  9  requires  MS  to  designate  organizations,  Notified  Bodies,  who 
will carry out type approval work on their behalf. It could be beneficial if the Directive 
includes provision on the steps which need to be taken when NB ceases its activities 
voluntarily and as a result of insolvency. 

•  Provisions  to  request  material  that  documents  the  results  of  tests  and  the  conformity 
assessment  procedures  required  by  article  5  of  directive  96/98  and  carried  out  by  a 
Notified Body not designated by the requesting EU MS Administration other than the 
appointing one. 

•  Article 12  cf. articles 5, 6 and 9  establishes  the  framework  for  some  kind  of  control 
that a piece of equipment actually conforms to the requirements contained in relevant 
international conventions and related standards. Although article 12 authorizes the flag 
state  to  request  inter  alia  the  manufacturer  to  provide  inspection/testing  reports  of 
equipment  installed  on  board,  some  administrations  would  prefer  that  every  MS 
subject to the authority of a relevant article of the reformed directive 96/98, legally can 
request any NB to disclose all documents relevant for the assessment for conformity 
required by article xx cf. article yy (numbers of revised articles 5 and 10 of directive 
96/98) of directive yyyy/nnnn (identification of revised 96/98). 

EN 

61 

   EN 

 
•  The  criteria  for  Notified  Bodies  and  the  system  of  their  accreditation  is  insufficient. 
Therefore it is suggested the introduction of the approach similar to the one used under 
Directive 2009/15/EC. 

Industry provided the following comments 

•  The reporting of data to the MarED-databse should be an obligation to all NBs. 

• 

It  should  be  clarified,  how  far  the  European  accreditation  scheme  should  have 
influence to the MED, e.g. whether there should be an obligation to all NBs to hold an 
accreditation for their work etc. 

•  Accreditation of test houses. Notified bodies do not always accept the accreditation of 
test houses. In these cases accreditation by the Notified Body is necessary or re-test at 
another, NoBo-accredited, test house . This will come with extra cost and time for the 
manufacturers.  It  should  be  more  clear  which  accreditation  of  test  houses  should  be 
accepted by Notified Bodies. 

• 

In case of showing to a notified body that the equipment fulfils the requirements, the 
equipment manufacturers are of the opinion that lab testing done at the manufacturers 
account,  should  only  be  verified  by  the  notified  body  and  not  be  checked  by  doing 
testing by an external lab (or at the NoBo lab) compulsorily. This only increases cost. 
If the NB can be satisfied that the tests are done well, this should be enough to fulfil 
the requirements. 

3. MARKET SURVEILLANCE 

MS provided the following comments 

•  With regard to the facilities already installed on board, the directive does not specify 
what  rule  should  apply  when  these  devices  are  subject  to  change  (change  of  parts, 
replacement part not identical ). It should be ensured that the European Commission 
maintains  its  position  on  changes  of  equipment  in  service.  The  position  of  the 
European  Commission  that  the  equipment  is  in  use,  once  installed,  are  the 
responsibility of the flag, but did not specify the nature of the modification. 

•  Better  cooperation  and  coordination  of  Member  States’  administrations  is  necessary, 
which  entails  establishment  of  mechanisms  and  sufficient  resources  providing  the 
basis for efficient surveillance. 

• 

Information  on  every  product  not  in  accordance  with  the  Directive  should  be  made 
available  on  the  Internet  and  measures  taken  against  the  ones  responsible  for  the 
distribution of such products. 

•  To appoint an expert body or organization in charge of coordination of the EU market 
surveillance, which would also provide support to Member States in establishing the 
surveillance  system,  and  define  for  every  product  the  method  of  conformity 
assessment. 

•  To  make  available  guidelines  or  recommendations  for  the  surveillance  of  equipment 
on  the  market,  i.e.  on-board  vessel  equipment,  or  setting  up  new  requirements  as  a 

EN 

62 

   EN 

 
proposal  of  on-board  vessel  equipment,  since  this  would  enable  a  more  harmonized 
approach to the surveillance. 

4. SAFEGUARD CLAUSE 

MS provided the following comments 

•  To  change  Article  13  paragraph  2  of  Directive  96/98/EC,  to  provide  a  maximum 
period  for  objection  to  the  Commission  following  a  safeguard  clause  of  a  Member 
State. Indeed, when a Member State ascertains that equipment referred to in Appendix 
A1  of  the  directive  is  likely  to  endanger  the  health  and  /  or  safety  of  the  crew,  and 
although this equipment is Wheel marked that Member State shall take all appropriate 
provisional  measures  to  remove  the  equipment  market  and  then  to  inform  the  other 
Member  States  and  the  European  Commission  to  conclude  on  the  validity  of 
provisional  measures  taken  by  the  Member  State.  The  period  within  which  the 
European Commission must make its decision should  be specified. 

5. INTELLECTUAL PROPERTY RIGHTS 

Industry provided the following comments 

IP  ownership information  when  applying 

•  Measures  should  be  in  place  to  identify  counterfeited  products.  For  instance,  the 
for 
manufacturers  should  provide 
certificates.   Such  information  should  be  recorded  in  a  systematic  manner  which  the 
notified  body  and  Class  can  use  later  to  double  check  the  authentication  of  the 
application.   Whenever  there  is  any  suspicious  application  (e.g.  exactly  the  same 
product  but  by  different  producers),  the  notified  body  should  contact  the  related 
producers for further proof.   In addition, if feasible, a database should be established 
by  a  competent  independent  body  for  notified  body  and  Class  to  check  the 
authentication of the information provided by the manufacturers. 

•  State of the art technology (e.g. RFID tags) should be used in marking and identifying 
MED  equipment.   Certificates  issued  by  notified  body  and  Class  should  be  printed 
with  security  measures  so  that  it  is  difficult  for  the  counterfeiting  manufacturers  to 
counterfeit the certificates. 

•  To set up a positive  list  of tested equipment  following  market  surveillance,  a “black 
list”  should  also  be  published  to  reveal  counterfeiting  MED  equipment  (and  its 
manufacturers)  as  well  as  those  which  have  caused  safety  and  environmental 
problems. 

OTHER ASPECTS. 

MS provided the following comments 

•  Clarification  of  the  term  “placed  on  board”  and  “installed  on  board”  –  when   the 
equipment is required to have a valid type approval certificate: date when the keel was 
laid;   date  of  equipment  delivery  (equipment  is  sometimes  delivered  6  months  in 
advance of vessel survey or the ship programme may be delayed after the equipment is 
delivered); date of installation of equipment (the ships are built in blocks, thus e.g. a 

EN 

63 

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radar antenna may be installed on the mast but the mast may not be on the ship at the 
time of installation). 

• 

 Provision which MS can apply, when product listed under Annex A.1 is not available 
on the market. 

•  To  amending  Article  18  to  take  into  account  the  new  comitology  rules.  In  this  case, 
taking  into  account  that,  in  accordance  with  Article  2  of  Regulation  182/2011,  the 
examination  procedure  applies  to  the  adoption  of  acts  implementing  environmental, 
safety and security, or protection of health or safety of persons, animals or plants. 

Industry provided the following comments 

•  The  rights  and  obligation  of  all  parties  involved  should  be  clearly  defined,  e.g. 

manufacturer, notified body, COSS, market surveillance, etc. 

• 

In analogy to international instruments, e.g. SOLAS, MARPOL, COLREG etc.,  also 
MED  should  contain  regulations  regarding  the  possibility  to  grant  exemptions  from 
MED under very strict restrictions (to avoid a misuse of exemption possibilities), e.g. 
for the case, that marine equipment is listed in Annex A.1 of MED but no products are 
available on the market. 

•  The  obligation  to  report  withdrawn  applications  should  be  deleted,  because  a 
withdrawn application by the applicant has no influence to the market yet, and instead 
of  that  an  obligation  to  report  suspensions  of  certifications  and  withdrawal  of 
certifications should be inserted. 

•  EU  should  always  strive  to  a  world-wide  level  playing  field.  At  this  moment  the 
directive  is  only  EU  based.  Creating  a  level  playing  field  for  example  via  IMO  or 
treaties with countries would be of great benefit for the EU based companies. 

•  At  this  moment  the  definition  of  a  community  ship  still  gives  some  uncertainty. 
Especially  for  ships,  like  (auxiliary)  war  ships,  which  do  not  have  to  comply  with 
SOLAS  and  MARPOL  requirements.  It  is  not  always  clear  whether  these  ships  are 
community ships or not. 

EN 

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ANNEX 4:  

Marine equipment in a nutshell 

Marine equipment is the key supply industry of shipyards and of the whole maritime industry, 
including  off-shore  activities.  Whereas  several  product  and  service  categories  can  be 
distinguished  within  the  sector,  no  standard  categorization  of  marine  equipment  supplies 
exists. The term “marine equipment” is defined by the European Marine Equipment Council 
as all products and services supplied for the building, conversion, and maintenance of ships 
(seagoing and inland). 

 Main groups and categories of marine equipment 

Source:  ECORYS  et  al.,  Study  on  Competitiveness  of  the  European  Shipbuilding  Industry, 
op. cit. 

Only  some  thirty  years  ago  most  of  the  shipbuilding  work  was  carried  out  at  the  shipyards 
themselves. Since then however an increasing trend can be observed towards outsourcing and 
subcontracting of activities.  Nowadays it is assessed that 50-70% of the  value added comes 
from external subcontractors and suppliers (many of whom are regarded as marine equipment 
suppliers), whereas for more complex ships this can be as high as 70-80%.64 

Shipyards  are  therefore  major  partners  of  marine  equipment  manufacturers.  Thanks  to  the 
sector's  diversification  strategy,  when  a  reduction  in  ship  orders  occur,  marine  equipment 
manufacturers  can  partly  compensate  the  reduced  demand  from  this  side  with  services  and 
maintenance activities, as well as supplies to other industries. 

64  

See "competitiveness" study, Op. cit. 

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According to a study undertaken for the Commission, between 2000 and 2005 the total annual 
worldwide marine equipment market (turnover) was estimated at €60 billion. Of this, around 
€35 billion concerns naval marine (military) equi pment, while some €21 billion relate to the 
marine equipment in the commercial shipbuilding sector.65 Taking into account supplies to the 
oil and gas sector66, an additional turnover of some €50 bi llion per annum can be added. This 
would  bring  the  total  turnover  to  over  €100  bil lion.  Industry  sources  give  different  figures, 
calculating turnover at € 46 billion in 2008. 67 

Europe  has  a  relatively  strong  position  in  marine  equipment  worldwide  and  acts  as  a  net 
exporter. The European marine equipment industry is a high value added sector. The industry 
derives  its  competitiveness  from  innovative  and  reliable  high  quality  products.  However, 
many  production  facilities  in  Europe  are  in  fact  owned  by  Asian  concerns  nowadays.  The 
global market share of the marine equipment sector in Europe is higher than the share of ship 
construction, reflecting the strong export position of this sector (export share of 46%). Within 
Asia, the shipbuilding nations Japan and Korea have the strongest position. Over the period 
2000-2005 the Asian manufacturers (Japan and South Korea) accounted for some 50% of the 
marine equipment market as compared to 30-35% for the European Union.68 

Contrary  to  the  shipbuilding  industry,  the  marine  equipment  sector  is  highly  heterogeneous 
and consists of many small and medium-sized enterprises, which, according to a study carried 
out for the Commission in 200969, could account for up to 70% of the companies in the sector. 
There is no information available on SMEs' share in total sector turnover, but is assumingly 
more  than  50%.  Most  of  the  existing  innovations  in  the  sector  are  developed  by  enterprises 
ranging  from  50  to  200  jobs70.  In  total,  estimates  range  from  5,000  to  6,000  companies  in 
Europe  (key  European  countries  for  marine  equipment  production  are  Germany,  the  UK, 
Norway,  The  Netherlands,  Italy  and  France).71  Inevitably,  the  relatively  high  presence  of 
SMEs  in  the  industry  results  in  a  number  of  vulnerabilities  such  as  the  presence  of  weak 
financial structures or the insufficient co-operation with other enterprises and/or universities 
on Research Development and Innovation.72 

A  study  undertaken  by  the  Commission73  estimates  that  the  European  marine  equipment 
industry  employs  directly  more  than  287,000  people  whilst  indirect  employment  would 
amount to about 436,000 people. 

65 
66  
67  
68  
69  
70  
71  
72  
73  

See "competitiveness" study, Op. cit. note 64. 
As is done in certain definitions of the marine equipment industry 
This will be the reference figure taken for the purposes of this IA. 
See "competitiveness" study, Op. cit. note 64. 
Study on EU SMEs and subcontracting, October 2009 
Id. 
See "competitiveness" study, Op. cit. note 64. 
Study on EU SMEs and subcontracting, Op. cit. 
http://ec.europa.eu/maritimeaffairs/studies/employment/summary_report.pdf 

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ANNEX 5 

1. The New Approach 

The New Approach and the MED 

The Single Market for goods is one of the EU most important and continuing priorities which 
aims to create a user-friendly environment for businesses and consumers. Since the end of the 
60s, the EU has developped original and innovative instruments to remove the barriers to free 
circulation of goods. 

These  instruments  had  a  twofold  objective.  On  the  one  hand  they  ensure  that  products 
available in Europe meet a high level of protection of public interests like health and safety, 
consumer  protection  or  environmental  protection.  On  the  other  hand  they  ensure  the  free 
movement of products by replacing national rules with a single harmonised set of conditions 
for the marketing of the products concerned that apply in all EU Member States.74  

Among  these  innovative  instruments,  the  New  Approach  to  product  regulation  and  the 
Global Approach to conformity assessment occupy an important place. The common thread 
between  these  complementary  approaches  is  that  they  limit  public  intervention  to  what  is 
essential  and  leave  business  the  greatest  possible  choice  on  how  they  meet  their  public 
obligations. 

The New Approach dated from 7 May 1985 limited legislation to cover only essential health 
and safety requirements of products. This simplification was a step forward in the legislative 
provisions which allowed all the technical elements for product specification to be covered in 
harmonised  European  standards,  not  the  legislation  itself,  providing  thereby  a  flexible, 
technology neutral and non-prescriptive means of regulation. 

Box 7: Standard elements of New Approach directives75 

-  Harmonisation: limited to essential requirements that lay down the necessary elements for protecting 

the public interest. 

-  Mandatory essential requirements: Only products fulfilling the essential requirements may be placed 

on the market and put into service. 

-  Presumption  of  conformity:  Harmonised  standards,  the  reference  numbers  of  which  have  been 
published in the Official Journal and which have been transposed into national standards, are presumed 
to conform to the corresponding essential requirements. 

-  Conformity assessment procedure: Before placing a product on the EU market, manufacturers must 
subject the product to a conformity assessment procedure provided for in the applicable directive with 
the veiw to affixing CE marking. 

74 

75  

EN 

that 

accompanied 

The  evolution  of  the  EU’s  policy  on  technical  harmonisation  is  outlined  in  detail  in  the  impact 
assessment 
2007(173) 
the  New 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf  
See  in  this  respect  Guide  to  the  implementation  of  directives  based  on,  the  New  Approach  and  the 
Global 
(http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-
guide/guidepublic_en.pdf ). 

Framework. 

Legislative 

Approach 

SEC 

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-  Notified bodies: Third party conformity assessment is carried out by notified bodies, which have been 
designated by the Member States among bodies that fulfill the requirements laid dwon in the directive 
and that are established on their territory. 

-  CE marking: is an indication that the products comply with the essential requirements of the applicable 
directives and that the products have been subject to a conformity assessment procedure provided for in 
the directives. Products in compliance with all provisions of the applicable directives providing for the 
CE marking must bear this marking. 

-  Market  surveillance:  National  market  surveillance  shall  monitor  that  products  placed  on  the  market 

comply with the provisions of the national legislation transposing the New Approach directives. 

-  Safeguard  clause:  Member  States  are  obliged  to  prohibit  or  restrict  the  placing  on  the  markets  of 
products bearing the CE marking if the latter might compromise the safety and health of individuals or 
other public interests covered by the applicable directive. 

The Global Approach76 covers the various methods of examining a product to determine if it 
complies  with  the  essential  requirements  of  new  approach  directives,  including  any 
requirements relating to the design and manufacture of products.77 The main principle of the 
global  approach  is  that  the  manufacturer  issues  an  EU  declaration  of  conformity,  declaring 
that  the  product  satisfies  the  requirements  of  the  applicable  directives  or  conforms  with  an 
approved type. 

Box 8: Basic elements for Conformity assessment 

-  manufacturers’ internal design and production control activities; 

- 

- 

- 

third party type examination combined with manufacturers’ internal production control activities; 

third  party  type  or  design  examination  combined  with  third  party  approval  of  product  or  production 
quality assurance systems, or third party product verification; 

third party unit verification of design and production; or 

-  third party approval of full quality assurance systems. 

2. Comparing MED with the New Approach 

Some provisions of MED deviate however from the New Approach because of the particular 
features of marine equipment: 

•  First, marine equipment has to fulfil IMO international standards. Flag states are expressly 
required  to  issue  a  certificate  of  approval  by  the  IMO  conventions  described  above.  The 

76  

77  

The  Global  Approach  was  completed  by  Council  Decision  90/683/EEC,  which  was  replaced  and 
brought up to date by Decision 93/465/EEC. These decisions lay down general guidelines and detailed 
procedures for conformity assessment that are to be used in New Approach directives. 

It introduced a modular approach, which subdivided conformity assessment into a number of operations 
(modules).  These  modules  differ  according  to  the  stage  of  development  of  the  product  (for  example 
design, prototype, full production), the type of assessment involved (for example documentary checks, 
type  approval,  quality  assurance),  and  the  person  carrying  out  the  assessment  (the  manufacturer  or  a 
third party). 

EN 

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Directive  has  the  specific  objective  to  ensure  compliance  with  this  obligation  as  well  as 
mutual recognition of these certificates between Member States. 

•  Second,  marine  equipment  encompasses  some  categories  of  equipment,  which  are  also 
within  the  scope  of  Directives  other  than  the  MED  (e.g.  fire  extinguishers,  electronic 
material, protective equipment, pyrotechnics), the requirements of which may differ from, 
or even be incompatible with, those of the IMO.  

These  features  have  a  number  of  consequences  on  how  the  New  Approach  has  been 
implemented in the field of marine equipment: 

•  Whereas the legislation on marine equipment is restricted to the requirements necessary to 
protect the public goals of health and safety as defined by IMO, compliance with the latter 
is  not  formulated  as  an  'essential  requirement'  in  the  meaning  of  the  New  Approach. 
Instead, the MED includes a detailed list of the mandatory requirements contained in the 
international  conventions,  the  relevant  resolutions  and  circulars  of  the  International 
Maritime Organization (IMO), and the relevant international testing standards.  

•  As indicated above, these international requirements may either be substantially different, 
or go beyond those connected with the CE marking for similar products. For this reason, a 
specific MED marking (the wheelmark) has been put in place replacing the traditional CE 
marking for equipment falling under the scope of the MED. 

•  In order to comply with IMO requirements, conformity certificates for marine equipment 
must be issued by or on behalf of the flag State and not by the manufacturer of the product. 
This  means  that  those  conformity  assessment  modules  provided  under  the  Global 
Approach78,  which  imply  assessment by the  manufacturer of the product, cannot be used 
for marine equipment. 

78  

The Global Approach, which is one of the elements of the New Approach, provides various methods of 
examining  a  product  to  determine  if  it  complies  with  the  essential  requirements  of  new  approach 
directives. 

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ANNEX 6 

Problematic areas common to New Approach directives, with a specific attention on marine 
equipment 

The impact assessment accompanying the revision of the New Approach identified, described 
and fully analysed the problem areas which are common to New Approach directives79, later 
confirmed by the Commission when preparing the alignment of ten sectoral Directives with 
the NLF80. Among the four areas identified, three are of particular importance for the MED, 
namely: 

•  lack  of  confidence  in  notified  bodies  and  in  the  whole  notification  process  in 

general; 

•  inefficient  enforcement  tools  of  the  directive  (market  surveillance  and 

safeguard mechanism); 

•  inconsistencies and legal uncertainty in the current regulatory framework. 

The stakeholders' consultation conducted in the context of the revision of MED has confirmed 
that the marine equipment sector suffers from unequal implementation in the Member States, 
unequal market surveillance and misuse of safeguard clause. 

i.  Lack of confidence in notified bodies and in the whole notification process 

Notified  bodies  (hereafter  NB)  are  responsible  for  testing,  inspecting  and  certifying 
equipment before it can be placed on board a community ship. They are notified by Member 
States to the Commission. 

A number of problems in the functioning of the notified body system were highlighted in the 
NLF IA report for the ensemble of the internal market directives. Among these: 

-  Notified bodies provide their services as a commercial activity and are in competition 
with  each  other.  Feedback  from  the  industry  had  pointed  to  the  fact  that  this 
competition is not always fair: the most frequent reason for unfair competition is the 
less rigorous implementation of procedures which can reduce the costs of NB by 30-
75%.  In  this  situation,  "good"  and  law-abiding  NBs  loose  business,  and  the  general 
image and quality of the NB and their work are undermined. Manufacturers have an 
incentive to test their equipment with the less rigorous NB, and those who choose to 
do  so  gain  a  competitive  advantage  vis-à-vis  manufacturers  who  undertake  correct 
conformity assessment work.  

79 

80 

The NLF was accompanied by an impact assessment where these problems are presented and analysed 
in detail. See SEC 2007(173) 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf,  pages  12-
23 and 27-28. 
See 
(http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2011:1376:FIN:EN:PDF  ).  A  summary  graph  of 
these  problems,  with  their  causes  and  consequences,  is  provided  in  page  15.  Worth  noting  is  the 
recurrence of the same problems across sectors, as can be seen from the abundant supporting material 
cited both in this impact assessment and in SEC 2007(173), which includes answers to questionnaires, 
sectoral evaluation reports, RAPEX and market surveillance information as well as court cases. 

SEC(2011)1376 

16-30 

pages 

final, 

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-  The  final  consequence  is  an  increased  risk  of  non-compliant  products  reaching  the 

market (or being placed on board ships in the case of marine equipment).  

-  The  NLF  IA  report  identified  the  main  reason  in  the  lack  of  transparency  and  of 
harmonisation  in  the  competence  assessment  and  monitoring  of  NB,  meaning  in 
practice that NB are operating under uneven conditions inside the EU: accreditation is 
a precondition for notification in some Member States but not in others, monitoring is 
carried out more or less frequently (or not at all), etc…  

The  marine  equipment  sector  is  by  no  means  immune  to  these  problems.  On  the  contrary, 
these  are  compounded  by  the  very  specific  circumstances  of  the  shipbuilding  markets, 
concentrated in the Far East and characterised in recent years by the emergence of a plethora 
of shipyards with only elementary, still developing quality culture. Such a situation, from time 
to time encountered by the Commission's own inspectors, makes these shipyards vulnerable to 
pressure  to  reduce  costs  and  meet  their  building  schedule  at  the  expense  of  quality  –  while 
being  beyond  reach  of  the  traditional  market  surveillance  techniques.  It  is  true  that 
verification  sur  place  is  carried  out  by  flag  State  inspectors  or  classification  societies, 
however these cannot – and it is not their role – substitute for a properly functioning, high-
quality notified body system.  

Box 1 – Inconsistency among Notified Bodies (NB) 

The  industry  has  highlighted  that  "In  addition  to  the  issue  of  potential  conflicts  between  IMO  and 
MED    standards,  difficulties  in  complying  with  the  regulatory  framework  have  been  reported  as  a 
consequence of inconsistent interpretation by  (NB) surveyors". 

The  divergences  in  the  control  of  their  notified  bodies  by  national  administrations  are  somehow 
reflected, in the marine equipment sector, in the results of the questionnaire sent to the Member States 
in 2008: since the entry into force of MED in 1999 only 42% of the notified bodies would have been 
audited five times or more, as would be expected; on the contrary, 33% would have been audited only 
three or four times, 17% less than three times and 8% would never have been audited. 

ii.  Weakness and difficulties in the enforcement of the directives 

The two tools for the enforcement of New Approach Directives are market surveillance and 
the associated safeguard clause mechanism. 

Market surveillance 

A  good  level  of  market  surveillance  in  each  Member  State  is  essential  to  ensure  that  only 
compliant  products  circulate  on  the  market,  and  weaknesses  in  the  organisation  of  market 
surveillance  in  one  single  Member  State  can  seriously  undermine  the  efforts  taken  by  other 
Member States to keep non-compliant products from the market. Currently, the organisation 
of  market  surveillance  differs  strongly  from  one  Member  State  to  another.  In  the  marine 
equipment  sector,  39%  of  stakeholders  indicate  that  administrations  in  their  country  don't 
carry out any market surveillance. Only 10% report about administations performing regular 
market surveillance campaigns.  

As  was  highlighted  in  the  IA  on  the  NLF,  competence  of  market  surveillance  authorities  is 
limited to the national territory. Where action is needed beyond the border, authorities must 
rely  on  their  colleagues  in  the  other  Member  State.  However,  as  there  is  not  a  sufficiently 
broad legal basis, cross-border co-operation in the EU does not work efficiently – the IA on 

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the NLF indicates that only 34% of stakeholders report having ever taken any action due to 
information provided by another Member State. 

In the current situation, MED contains a generic clause allowing national administrations to 
carry out market surveillance, rather than laying down a specific obligation to do so. While in 
practice most national administrations do carry out market surveillance, this is affected by a 
dramatic dearth of resources. Moreover, market surveillance activity is limited to the marine 
equipment  placed  on  the  European  market,  which  constitutes  only  a  small  fraction  of  the 
overall equipment on board community ships.  Indeed most of the equipment is being placed 
on board wherever ships are built or repaired – most often outside the EU  – and may never 
physically  enter  the  EU  territory.  For  the  rest,  market  surveillance  must  largely  rely  on 
information drawn from port State control activities and from information received from the 
industry. 

For the above reasons, market surveillance is unlikely to play its role of providing the national 
authorities  with  sufficient  information  to  prevent  the  placing  of  non-compliant  products  on 
board  Community  ships.  The  results  of  the  stakeholders'  consultation    concerning  the 
violation of intellectual property rights (IPR) in the marine equipment sector seem to confirm 
this  assumption:  while  the  industry  complained  about  massive  counterfeit  and  violation  of 
Intellectual property rights (according to the industry’s own estimate , “almost any percentage 
from  100  down  to  not  less  than  80  percent  of  Korean  marine  equipment  [could  be] 
counterfeited  and  pirated",  and  other  sources  indicate  similar  problems  in  other  Asian 
countries  and  in  the  EU  itself  ),  in  contrast  78%  of  Member  State  administration    declared 
never having been confronted with issues concerning IPR. 

Safeguard clause mechanism  

Under article 13 of MED, a Member State, if it discovers a piece of marine equipment non-
compliant  with  the  Directive,  shall  take  interim  measures  to  restrict  it  being  placed  on  the 
market  or  being  used  on  board  a  ship  for  which  the  Member  State  issues  the  safety 
certificates. The Commission is then responsible for verifying if the measures are justified or 
not. 

Under this mechanism, Member States have no incentive to carry out an exhaustive procedure 
during market surveillance and all the way to the adoption of restrictive measures, since the 
final responsibility for the investigation lies with the Commission. Actually, Member States 
have a tendency to notify every restrictive measure at a very early stage, sometimes after only 
a superficial assessment as to whether the product really poses a risk to health and safety has 
been completed.  

At  the  same  time,  the  Commission  does  not  have  the  necessary  technical  competence  to 
evaluate  the  conformity  of  a  product.  The  need  for  the  Commission  to  rely  on  external 
expertise and the gathering of the information missing from the Member State's notification 
can  both  lead  to  considerable  delays  in  the  procedure.  These  can  be  extremely  costly  for 
compliant manufacturers, who must live for a long time under suspicion while the outcome of 
the  Commission  verification  remains  unknown.  The  case  study  in  Box  1  illustrates  the 
problems which arise from the inefficient safeguard clause mechanism. 

Box 2: Case study on Korean pressure-vacuum valves 

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In  February  2004,  the  Danish  authorities  notified  the  Commission  their  ban  on  a  brand  of  high 
velocity  pressure/vacuum  relief  valves  of  Korean  origin.  In  its  examination  of  the  case    the 
Commission found that:  

a) a production error had rendered part of the production faulty and not in accordance with the type; 
however, this was not apparent from the documents submitted by the notifying authority but had been 
found and reported by the manufacturer itself following the ban; 

b) for  the  rest of  the  production,  the  information provided  by  the notifying  Member  State  (and  also 
third  parties)  was  inconclusive  given  the  significant  uncertainties  surrounding  the  testing  which 
reportedly led to the ban.  

The  Commission  therefore  supported  the  Danish  ban  for  the  part  of  the  production which  had  been 
proven faulty and invited the parties to carry out new testing for the rest of the production.  

The follow-up testing did not provide additional information in support of the original ban. The case 
was finally resolved by an agreement between the parties which included the voluntary replacement of 
the  valves  concerned  by  a  full  set  of  new  models,  fully  re-tested,  and  a  number  of  precautionary 
checks on the valves already installed on board Community ships.  

The proceedings lasted nearly 40 months in total and required a significant involvement of the 
manufacturers, the notified body, the notifying authorities and the authorities of the Member 
State  on  whose  behalf  the  MED  certificate  had  been  delivered,  as  well  as  EMSA  and  the 
Commission itself. 

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ANNEX 7 

The elements of the New Legislative Framework 

Two decades of operation of the New Approach revealed a number of areas where there still 
was  room  for  improvement.  Although  New  Approach  was  popular  and  supported  in  many 
sectors, it did not always guarantee a sufficient, perceptible level of confidence in the market 
place, whether for products manufactured in the EU or imported from third countries. This led 
to unequal implementation in the Member States, unequal market surveillance interventions, 
and  misuse  of  safeguard  mechanisms.  In  certain  sectors,  the  consumers  or  end  users  also 
lacked trust in the validity and added value of the CE marking on products. Thus economic 
operators sometimes felt that they could not benefit from a level playing field on the market 
while consumers did not always feel that they were effectively protected. 

With  the  aim  of  increasing  the  effectiveness  of  the  system,  its  transparency  as  well  as  its 
smoother  functioning  for  the  benefit  of  all  involved  (manufacturers,  conformity  assessment 
bodies,  authorities  and  consumers  and  users),  the  New  Approach  was  therefore  subject  to  a 
revision which in 2008 led to the New Legislative Framework (hereinafter the "NLF") for 
the marketing of products.81 Its objective is to strengthen and complete the existing rules and 
to improve the way in which the requirements are actually applied and enforced in practice by 
business and authorities. The NLF consists of three instruments: 

Regulation  764/200882  is  intended  to  improve  the  free  movement  of  goods  in  the  "non-
harmonised area" by reinforcing the application of the principle of the mutual recognition. 

Regulation  765/200883  introduces  better  rules  on  market  surveillance  to  protect  both 
consumers  and  professionals  from  unsafe  products,  including  imports  from  third  countries. 
This particularly applies to procedures for products which can be a hazard for, health or the 
environment  for  instance,  which  in  such  a  case  will  be  withdrawn  from  the  market.  It  also 
enhances  the  confidence  in  and  quality  of  conformity  assessments  of  products  through 
reinforced  and  clearer  rules  on  the  requirements  for  notification  of  conformity  assessment 
bodies  (testing,  certification  and  inspection  laboratories)  including  the  increased  use  of 
accreditation; a reinforced system to ensure that these bodies provide the high quality services 
that manufacturers, consumers and public authorities need. Finally, it improves the credibility 
and clarifies the meaning of CE marking. In addition the CE marking will be protected as a 
community  collective  trade  mark,  which  will  give  authorities  and  competitors  additional 
means to take legal action against manufacturers who abuse it;  

81 

82 

83 

See SEC 2007(173) 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf 
Regulation  (EC)  No  764/2008  of  the  European  Parliament  and  of  the  Council  of  9  July  2008  laying 
down  procedures  relating  to  the  application  of  certain  national  technical  rules  to  products  lawfully 
marketed in another Member State and repealing Decision No 3052/95/EC, OJ L218 of 13.08.2008. For 
more  information  see  http://ec.europa.eu/enterprise/policies/single-market-goods/free-movement-non-
harmonised-sectors/mutual-recognition/index_en.htm. This regulation  
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 

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Decision  768/200884  establishes  a  common  legal  framework  for  industrial  products  in  the 
form of a toolbox of measures for use in future legislation. This includes provisions to support 
market  surveillance  and  application  of  CE  marking,  amongst  other  things  and  it  sets  out 
simple common definitions (of terms which are sometimes used differently) and procedures 
which  will  allow  future  sectoral  legislation  to  become  more  consistent  and  easier  to 
implement. The provisions are split for legal reasons, but must be considered in parallel, as 
they are fully  complementary and together form the basis of consistent legal framework for 
the marketing of products. The provisions of the Decision will be fed into existing Directives 
as and when they are revised - in effect, it is a basis for future regulation. 

The  initiative  accompanied  by  this  IA  is  a  further  step  in  the  implementation  of  the 
goods package adopted on 9 July 2008 by the Council. 

84 

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 

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ANNEX 8  

Description of the elements of alignment on the New Legislative framework, as presented in 
the IA on NLF (SEC(2007) 173) 

1. Creating a network of notified bodies and a horizontal group of notified bodies  

To improve the co-ordination of conformity assessment activities in the different directives all 
notified bodies could be interlinked through a formal network. The presidents of the sectoral 
notified  body  groups  could  also  be  grouped  into  a  horizontal  co-ordination  group  under  the 
chairmanship  of  the  Commission,  to  address  horizontal  issues  to  ensure  coherence  and  a 
consistently  high  quality  of  conformity  assessment  activities  across  all  directives.49  The 
advantages of doing this are flexibility of approach, low cost and minimal resourcing needed 
for its implementation. There is, however, one important impediment to the effectiveness of 
this option. Participation in the notified body groups is, at present, not compulsory as a legal 
requirement, participation is purely voluntary. The idea would be to oblige participation of all 
notified  bodies  in  their  relative  sector  group  (even  in  a  ‘virtual’  way  using  web-based 
applications, to reduce costs for SMEs). For this reason, this option standing alone may not be 
sufficient to overcome the current problems.  

2.  Competence  assessment  and  monitoring  of  notified  bodies  performed  at  national  level 
based on a common EU legal framework and supported by a European infrastructure.  

This option would build upon the current system (decentralised competence assessment and 
monitoring carried out under the responsibility of each Member State) and complete it with a 
common legal  framework for  accreditation and a co-ordination infrastructure at Community 
level.  

Regulation  at  EU  level  will  bring  the  current  diverging  national  systems  closer  and  provide 
the necessary framework for a more coherent and uniform implementation of accreditation at 
national level and its use in support of notification. As the non-regulatory measures taken so 
far have been insufficient to overcome the national differences, it is indispensable to opt for 
the  regulatory  solution.  A  common  legal  framework  would  harmonise  the  general  rules  for 
accreditation,  such  as  the  principle  of  non-competition,  the  public  authority  nature  of 
accreditation, the rules on cross-frontier accreditation policy and oblige co-operation between 
the different Member States’ accreditation bodies.  

In  order  to  ensure  the  coherent  application  of  the  accreditation  framework,  this  option 
foresees  a  European  infrastructure  for  accreditation  that  would  steer  and  govern  its 
implementation.  This  role  could  be  taken  over  by  the  existing  European  Co-operation  for 
Accreditation  (EA).  […]  EA  operates  at  EU  level,  promotes  mutual  recognition  and 
acceptance  of  accreditation  certificates  thus  contributing  to the  free  movement  of  goods.  Its 
system of peer evaluation provides greater coherence between accreditation bodies’ practices 
and increases mutual confidence. The option would provide EA with public recognition and 
reinforce its structure and operation. As EA brings together representatives of national public 
authority  organisations,  it  would  therefore  be  in  a  position  to  guarantee  the  level  of 
independence and technical capabilities required.  

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3. Electronic notification procedure  

This option foresees the introduction of a legal basis for electronic notification on the website 
which  would  replace  the  obligation  to  publish  the  list  of  notified  bodies  in  the  Official 
Journal. The logical conclusion of this is, therefore, to abolish the publication in the Official 
Journal as a web based publication is quicker and more easily updateable.  

4.  Enhance  co-operation  of  market  surveillance  authorities  by  extending  the  existing  co-
operation mechanisms  

The  existing  co-operation  mechanisms  and  information  exchange  tools  could  be  extended 
without  any  need  to  change  the  existing  framework.  More  than  ten  sectoral  specific  ADCO 
groups  do  presently  exist,  covering  directives  such  as  toys,  personal  protective  equipment, 
machinery  and  construction  products,  etc.  These  groups  provide  a  mechanism  for  Member 
States’ market surveillance enforcement authorities to come together to exchange information 
regarding  surveillance  for  a  particular  sector.  This  concept  could  be  extended  to  cover  all 
directives and  their organisation and the working methods  could be improved to exploit the 
existing the opportunities more efficiently.  

The Commission could also establish an overarching horizontal group, complementary to the 
sector specific groups. Such a group could ensure that there is better coherence, co-ordination 
and co-operation across directives. However, to avoid duplication such a group should limit 
its operation to cover only horizontal aspects related to market surveillance, exchange of best 
practice from sector to sector and the identification of priority actions and specific fields for 
inter-sectoral co-operation. There could also be opportunities to share resources.  

The big advantage of these measures is that they can be implemented using the existing legal 
and  operational  framework,  with  limited  additional  resource  costs.  However,  the  success  of 
these  groups  depends  on  the  active  involvement  and  support  from  all  Member  States  based 
upon  what  is  currently  a  voluntary  system.  Participation  in  these  activities  does  require 
resource  allocation  from  member  States  which  does  incur  a  cost  for  them.  In  sectors  where 
there  is  currently  little  or  no  market  surveillance,  measures  such  as  ADCOs  will  not  be 
sufficient to overcome the general problem that the legislation is not enforced.  

5. More effective controls of the market place  

More effective post-market control mechanism:  

This  option  comprises  of  improving  the  organisation  of  market  surveillance  activities  at  the 
European level, to promote more coherency and efficiency of action. Reinforced co-operation 
and  co-ordination  mechanisms  would  be  introduced,  both  at  the  national  level  and  cross-
border,  in  order  for  market  surveillance  to  operate  effectively  throughout  the  whole 
Community.  

In this context, the centralisation of certain activities or the setting up of an Agency could a 
priori  be  seen  as  options,  given  that  there  are  already  examples  in  certain  sectors  (eg. 
European Agency for Aviation Safety (EASA), European Maritime Safety Agency (EMSA), 
European Railway Agency (ERA) and the Food Veterinary office (FVO)). Whilst, there may 
be a case for a central organisation of market surveillance activities at the EU level in certain 
sectors, this option is unfeasible and unrealistic in the true horizontal context, due to the vast 
range  of  products  to  be  covered  and  the  organisation  and  vast  expertise  that  would  be 
necessary.  

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Similarly  the  complete  harmonisation  of  market  surveillance  operation  and  requirements 
written into the legislation raises some questions  with  regard  to  subsidiarity,  proportionality 
and the effectiveness point of view. Whilst such harmonisation would, without doubt, have a 
positive  impact  in  aligning  the  level  and  rigour  of  market  surveillance  throughout  the 
Community51  it  would  also  lead  to  difficulties  in  maintaining  flexibility  for  sector  specific 
problems,  flexibility  to  cope  with  different  Member  States’  market  structures  and  could, 
therefore,  lead  either  to  overkill  of  requirements  or  to  gaps  in  the  system.  Furthermore, 
complete harmonisation would result in considerable costs for the adaptation of what are often 
well established and well functioning national structures and procedures.  

6. Common EU framework on market surveillance setting out minimum requirements  

This option consists of the creation of an EU legal framework which would set out minimum 
requirements  for  the  organisation  and  operation  of  the  national  market  surveillance  system, 
combined  with  co-ordination  mechanisms  (as  proposed  in  option  B1).  The  framework 
requires  the  establishment  of  an  effective  and  efficient  organisation  for  national  market 
surveillance,  including,  for  example,  sufficient  resources,  necessary  powers,  effective 
communication  between  authorities,  etc.  It  also  sets  out  certain  obligations  including  the 
withdrawal  of  non-compliant  products  from  the  market,  requirements  to  perform  checks  on 
products,  to  follow  up  complaints,  to  monitor  accidents,  to  co-operate  with  economic 
operators etc. 

Furthermore, it establishes an obligation to participate in horizontal EU co-operation activities 
and to provide mutual assistance, when necessary.  

This  option  would  also  create  a  legal  basis  for  enhancing  the  existing  co-operation  and  co-
ordination  mechanisms,  to  build  upon  and  improve  what  we  already  have  in  place.  This 
would, therefore, ensure exchange of information and best practices, common projects and the 
sharing  of  resources.  It  would  also  provide  for  a  single  electronic  information  exchange 
system by extending the use of the current RAPEX system53 to products for professional use.  

Under this option, the existing safeguard clause procedure would be rationalised. The idea is 
to split the safeguard procedure into an information exchange phase taking place at national 
level and a second phase taking place at Community level. In the first phase, Member States 
would  inform  each  other  of  national  measures  taken  to  restricting  the  free  movement  of  a 
product.  The  procedure  would  then  be  completed  unless  there  were  objections  from  other 
Member States. Only in the case of disagreement between Member States on the justification 
of the measure, would a decision be taken at the Community level.  

7. Reinforcing traceability and the introduction of specific obligations for importers  

This option would ensure that that market surveillance authorities can identify a responsible 
person in the EU and obtain the necessary information. The legislation would be amended to 
ensure traceability of a product and its supplier throughout the whole supply and distribution 
chain. The legislation would also specify the obligation of importers and distributors in more 
detail.  

Traceability could be ensured by:  

•  Introducing  a  general  obligation  to  appoint  an  authorised  representative  for  products 
imported from third countries;  

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• Establishment of a registration system for manufacturers and importers;  

• An obligation to identify the manufacturer and the importer of a product and an obligation 
on  them  to  identify  products  they  purchased  and  supplied  on  (except  supplies  to  final 
users/consumers).  

Specific obligations for importers and distributors could be introduced in the legal framework, 
clarifying  that  these  operators  must  check  whether  the  manufacturer  has  fulfilled  his 
obligations. These obligations would take account of the role of these operators and would be 
minimum obligations applying in addition to those arising from national law. 

8. Creation of a reference legal document  

A  better,  more  flexible  solution  is  to  establish  a  horizontal  reference  document  containing 
standard  terminology  and  procedures  o  which  the  individual  legal  instruments  could  be 
adapted  in  the  future.  Then,  as  sectoral  texts  are  revised  they  can  use  this  framework  to 
include the harmonised elements appropriate for their sector. 

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ANNEX 9 

PO 

Measure 

PO2, 
PO3 

PO2, 
PO3 

Harmonising  definitions  and  procedures 
with other sectoral Directives in order to 
improve coherence 

Harmonised  competence  assessment 
and monitoring of Notified Bodies across 
the EU in order to improve the quality of 
their work 

Detailed assessment of impacts on operating costs and administrative burden 

Operating costs and administrative 
burden 

Economic 
operators 

Notified 
bodies 

Public 
authorities 

Comments 

No 

No 

No 

Measure of a strict legislative nature 

No 

Negligible  Negligible 

Competence  assessment  is  an  existing  obligation:  benchmark 
for  conformity  assessment  bodies  will  not  change;  measure 
aimed  at  avoiding  circumvention  rather  than  creating  new 
obligations. Moderate but temporary effort for NBs to produce 
new evidence may be necessary or negligible additional burden 
of transmitting information which is already in NB hands85. For 
public  authorities, 
facilitate 
implementation  of  obligations  which  also  already  exist  and 
should, 
if  anything,  reduce  their  monitoring  costs.  Re-
notification  (if  necessary)  of  bodies  already  complying  with 
quality standards will be a mere formality.86 

the  new  measure  will 

85 See  SEC(2011)1376 final, pp. 44-47 
86 See  SEC(2011)1376 final, pp. 48-49 

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PO2, 
PO3 

cooperation  of  market 
Enhancing 
surveillance  authorities  and  setting  out 
minimum 
requirements  on  market 
surveillance  so  that  this  becomes  more 
effective and reaps the benefits of cross-
sectoral action 

No 

No 

integrated 

Negligible  Market  surveillance  structure  and  obligations  (cooperation, 
exchange  of  information,  etc.)  already  exist  under  Regulation 
765/2008.  The  MED  will  be 
these. 
Incorporation into single national structures should reduce the 
costs of administrations which now carry out sufficient market 
surveillance.  If incorporation of the MED into these structures 
resulted  in  a  net  increase  of  the  latter's  activities,  one  should 
increase  of  the  associated  costs  for 
expect  a  moderate 
administrations, which should however be partly offset by the 
economies of scale and the synergies of cross-sectoral control. 
The overall result is probably going to be a moderate increase 
in the costs for administrations. 

into 

PO2, 
PO3 

Reorganisation  of 
safeguard  clause 
procedure    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 

PO2, 
PO3 

Reinforcing  traceability  of  equipment  in 
order 
both  market 
facilitate 
surveillance and port State control 

to 

Negligible 

No 

No 

Occasional  effort  for  operators  facing  a  more  detailed 
procedure, however this contributes to ensuring fair treatment 
and avoid costs associated with incorrect technical assessment 
by surveillance authorities. For public authorities, the measure 
codifies what should already be good practice and application 
of basic legal principles. 87  

Negligible 

Negligible  No 

Information  already  with  notified  bodies  and  manufacturers, 
and facilitating task of public authorities.88 

87 See  SEC(2011)1376 final, p. 47 
88 See  SEC(2011)1376 final, pp. 44-49 

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PO2, 
PO3 

Using  a  "wheelmark" 
standard CE  

instead  of  the 

No 

PO2 

control  mechanism 

Requirements  on  more  effective  post-
and 
market 
obligations  by  the  economic  operators 
(especially  as 
regards  post-market 
control mechanism)  

Yes 

No 

No 

No 

No 

Wheelmark already in the MED 

from  general  alignment,  where 

Impact  differs 
it  was 
considered that these requirements merely codify what should 
be  good  practice  of  operators  working  in  accordance  with 
recognised  quality  standards89.    Given  that  other  internal 
market directives focus on products which are either produced 
in EU territory or imported into it, similar obligations foreseen 
for  manufacturers  and  importers  are  assumed  not  to  overlap. 
In the case of the MED, none of these assumptions should be 
expected  to  hold  given  that  a)  marine  equipment  is  in  most 
cases  directly  installed  on  board  at  ship  building  or  repair 
yards,  where  it  is  integrated  into  a  higher  system  (the  ship), 
itself certified by the flag State or a classification society on the 
latter's  behalf;  and  b)  only  a  fraction  of  the  equipment  to  be 
installed  on  board  EU  ships  is  actually  imported  into  EU 
territory. 
control 
requirements  for  economic  operators  would  imply  additional 
costs for these; these costs would be higher for the fraction of 
the  equipment  which  is  imported  into  EU  territory  as  a  result 
of  the  accumulation  of  obligations  for  manufacturers  and 
importers. However, for the reasons given further up under a) 
and b), the practical benefits should be expected to be few – if 
any at all.  

adopting  post-market 

In  practice, 

89 See  SEC(2011)1376 final, p. 42 

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PO2 

Full  alignment  of  the  texts  of  the 
conformity 
procedures. 
assessment 
Allowing  for  conformity  assessment  by 
in-house  bodies  (conformity  assessment 
modules  A  and  C),  which  are  not 
retained in the current MED 

Negligible 

No 

No 

Between  

No 

Negligible 

-4M€  

and  

-7M€ 

"essential 

assessment. 

PO2  Abandoning  the  annexes  to  MED  and 
turning respect of the IMO requirements 
into 
requirements" 
constituting the reference in the NLF for 
conformity 
Norms 
produced  by  the  standardisation  bodies 
would be dealt with in the same way as 
in  the  NLF,  thus  only  providing  a 
presumption  of  conformity.  Conformity 
assessment  is  made  against  mandatory 
technical  norms  created  by  European 
and 
standardisation 
organisations  and  reflecting  the  IMO 
requirements 

international 

Cost  of  certification  against  same  standards  and  type  of 
production with accredited labs does not change if an in-house 
NB  is  used.  In  this  case,  the  manufacturer  will  benefit  of 
economies  of  scale  and  better  expertise  –  although  these 
benefits  will  only  accrue  to  manufacturers  of  a  certain  size, 
capable  of  maintaining  a  structure  meeting  the  necessary 
standards, which are a minority in the market. 

See  Annex  12.  Costs  to  industry  generated  by  transposition 
delays would largely be removed, but double-certification costs 
would  not  completely  disappear  due  to  differences  between 
Member  States  in  the  content  and  timing  of  implementation 
and uncertainty on applicable requirements. 

For  Member  States,  transposition  into  national  orders  would 
still  be  necessary.  Technical  assessment  in  isolation  would 
probably  mean  marginally  higher  costs  for  the  national 
administrations. 

PO3 

Selective  use  of  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 

No 

No 

No 

Situation would not change relative to current MED practice. 

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PO3 

PO3 

Lightening of obligations of actors in the 
distribution  chain,  reflecting  the  small 
share  of  marine  equipment  which  is 
actually placed on the market 

No 

No 

No 

tags 

the  possibility 

to  use 
Introducing 
electronic 
supplement  or 
to 
accompany  the  wheelmark  gives  better 
tools 
for 
detecting non-conforming equipment 

to  market 

surveillance 

No 

No 

No 

Limiting  obligations  to  what  is  proportionate  for  the  sector 
renders valid the assumption that the measure merely codifies 
what  should  be  good  practice  and  therefore  it  should  not  be 
expected to generate any additional burden on stakeholders. 

Measure of a strictly technical nature; cost of RFID < €0.5 per 
unit  largely  compensated  by  the  benefits90.  Will  facilitate  task 
of surveillance and Port State Control authorities thus reducing 
their costs. 

PO3  Adapting  the  administration  of  the 
safeguard  clause,  making  it  possible  for 
the  Commission  to  decide  to  limit  its 
assessment  to  the  respect  of  due 
the  Member  State 
procedure  by 
concerned 

PO3 

Transposing  IMO  requirements  through 
implementing  or  delegated  Regulations, 
which  do  not  require  transposition  into 
national 
the 
Commission greater formal flexibility 

legislations  and  allow 

No 

No 

No 

Does  not  change  material  obligations  on  administrations  or 
stakeholders while making procedure more efficient. 

Between   

No 

No 

See Annex 12. 

-6M€  

and  

-7M€ 

For the Member States, the measure would imply an effective 
cost reduction given that, although technical consultation costs 
would  continue  to  be  incurred,  transposition  of  requirements 
into national legal orders would no longer be necessary.  

90 See Annex XIV 

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ANNEX 10  

SME test 

ASPECT 

COMMENTS 

(1) Consultation with SME 

representatives 

(2) Preliminary assessment of 

businesses likely to be affected 

indispensable  given 

Throughout the preparation of this impact assessment, 
continuous consultation has been held with the marine 
equipment  sector  through  their  representatives  in 
Brussels  (the  European  Marine  Equipment  Council). 
This  was  considered 
the 
importance of SMEs in the sector, which due to their 
size  and  scarce  resources,  would  find  it  difficult  to 
make their position known to the Commission. Indeed, 
in this way it has been possible to question individual 
companies through EMEC and obtain inputs which are 
representative  also  of  the  SMEs  points  of  view. 
Bilateral  contacts  have  also  been  held  with  two  sub-
sectoral associations who approached the Commission 
on specific issues. These contacts have indeed helped 
the Commission gain a clearer insight on the nature of 
the problems affecting the MED. 

turn  out 

they  have 

impacts  on 

SMEs,  which  are  a  majority  among  the  EU  marine 
equipment  industry,  are  particularly  vulnerable  to  the 
current  problems  as 
to  face  fierce 
competition in distant markets in a strongly regulated 
environment  –  where  changes  in  regulation  are  very 
frequent.  The  industry  has  to  adapt  to  the  decisions 
made  by  a  plethora  of  regulators  (IMO,  EU,  national 
authorities),  having  little  if  any  information  on  those 
to  be 
in  practice 
decisions  which 
uncoordinated both in timing and in content. Changes 
may  have  enormous 
research  and 
development  investments,  production  planning  or  the 
management  of  stocks.  These  impacts  may  become 
dramatic for SMEs, which find it harder to gain access 
to  adapt  and  stay 
to  capital  markets 
in  order 
late 
competitive.  The  costs  associated  with 
implementation  of  IMO  requirements  in  the  EU 
(reduced  return  on  R&D  investment,  costs  of  double 
certification)  represent  a  heavier  burden  for  SMEs 
(given e.g. that the cost of one type approval does not 
depend on the volume of production).  SMEs are also 
particularly  vulnerable  to  problems  like  the  violation 
of IPR and counterfeit (directly linked to the failure of 
the  market  surveillance  system)  to  the  point  that  in 
extreme  cases,  as  industry  sources  report,  "legitimate 

the 

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(3)  Measurement  of  the  impact  on 
SME  

(4) Assess alternative options and 

mitigating measures 

Application 

(5) 
undertakings 

to 

micro-

manufacturers (particularly SMEs) are often and “silently“ 
driven out of the market". 

Among  the  measures  foreseen,  none  are  specifically 
addressed to SMEs, or have a specific impact on them. 
the  benefits  and 
However,  one  should  expect 
drawbacks  of  both  options  to  be  particularly  felt  by 
SMEs  –    these  are  assessed  in  detail  in  sections  5.2 
and 5.3 

At  the  end  of  the  impact  assessment,  there  was  no 
indication  that  the  selected  option  might  result  in  a 
disproportionate  burden  for  SME  –  on  the  contrary, 
SME's  should  benefit  from  the  measures  foreseen. 
Consequently,  there  is  no  element  showing  theneed 
for  SME  specific  measures 
to  ensure 
compliance with the proportionality principle 

in  order 

The  MED  concerns  the  application  of  international 
safety requirements to marine equipment and therefore 
no  exceptions  can  be  made  based  on  the  size  of  the 
producers  or  the  ship  operators.  On  the  contrary, 
micro-undertakings  can  greatly  benefit 
from  a 
harmonised,  well  structured  environment  with  a  high 
degree of legal certainty. 

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ANNEX 11 

Impact on competitiveness 

The marine equipment sector remains a dynamic, innovative sector in the EU, with significant 
capacity  to  generate  high  value-added  employment.  Thus  the  potential  impact  of  the  policy 
options  envisaged  can  be  gauged  against  the  main  strategic  factors  which  should  allow  the 
sector to stay competitive. Thus, looking at the main areas identified in the "LeaderShip2015" 
initiative91: 

Impact of Policy Options on competitiveness 

AREA 

IMPACT OF REVISION 

Establishing a Level Playing 
Field in World Shipbuilding  

Neither PO2 or PO3 contain trade-related measures, the 
matter falling completely out of the scope of the MED.  

Improving Research, 
Development and Innovation 
Investment  

Developing Advanced Financing 
and Guarantee Schemes  

Promoting Safer and More 
Environment-Friendly Ships  

Neither  PO2  nor  PO3  contain  specific  RDI-related 
measures.  However,  both  aim  at  improving  return  on 
investment  by  reducing  delays  in  the  transposition  of 
international  requirements.  In  this  sense,  both  options 
should have a positive, if only marginal, impact.  

Neither  PO2  or  PO3  contain  finance-related  measures, 
the  matter  falling  completely  out  of  the  scope  of  the 
MED 

Both  PO2and  PO3  contribute  to  four  out  of  five 
recommendations made by the LeaderShip2015 advisory 
group, by: 

•  Facilitating  strict  implementation  of  EU  and 
international safety requirements, thus providing 
an "exportable" regulatory model.  

– 

– 

– 

A  more  transparent,  uniform,  efficient  and 

independent system of conformity assessment.  

Improvements 

in  quality  assessment  of 
notified  bodies  and  improvements  in  market 
surveillance,  thus  compensating  for  weaknesses 
in shipyard quality at world-wide level  

to 

the 

Contributing 

strengthening  of 
shipbuilding and repairing capabilities within the 
EU  by 
the  marine  equipment 
industry's  competiveness  and  capacity  to  offer 
state-of-the  art  technology  to  meet  new  safety 

improving 

91  
92  

“LeaderSHIP 2015”, Enterprise publications, October 2003 
A good example is provided by the process to adapt EU legislation to the amended limits for sulphur 
content in marine fuels (COM(2011)439 final) where the possibility of recourse to scrubber technology, 
developed by EU manufacturers, has been key in meeting the challenges. 

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A European Approach to Naval 
Shipbuilding Needs  

Protection of Intellectual 
Property Rights (IPR)  

Securing the Access to a Skilled 
Workforce  

Building a Sustainable Industry 
Structure  

and environmental protection challenges92 

Neither PO2 or PO3 contain any measures in this field, 
the  matter  falling  completely  out  of  the  scope  of  the 
MED 

Although this area falls outside of the scope of the MED 
and  is  addressed  by  a  specific  EU  strategy,  more 
effective market surveillance will no doubt contribute to 
improving the protection of IPR in the hands of the EU 
marine equipment industry. As discussed in section 5.3, 
however,  PO3,  with  the  recourse  to  electronic  tagging, 
should be better equipped for the task. 

Neither PO2 or PO3 contain any measures in this field, 
the  matter  falling  completely  out  of  the  scope  of  the 
MED 

Neither PO2 or PO3 contain any measures in this field, 
the  matter  falling  completely  out  of  the  scope  of  the 
MED 

In conclusion, the contribution of the MED and the review options envisaged under this IA to 
preserving employment in the marine equipment industry is in any case indirect, and probably 
also marginal, although most probably also positive. 

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 ANNEX 12  

Impact of delayed adoption of MED updates on the industry 

Continuation of the regulatory status quo is likely to generate additional costs to the industry 
deriving from the fact that, for a significant fraction of the products falling under the scope of 
the directive, it will have to produce against different standards for the EU market and for the 
international  market.  Discussion  with  industry  representatives  has  highlighted  that  this 
increases production and certification costs, obliges manufacturers to keep higher stocks and 
reduces return on the investment incurred for the development of new products. However, this 
effect  should  be  mitigated  by  the  fact  that  there  is  a  considerable  lack  of  uniformity  in  the 
application of the IMO requirements by third  states, which may oblige many manufacturers 
who are present in the world market to continue to produce anyway a high number of models.  

A rudimentary estimation of the related impact could be as follows:  

The EU marine equipment sector's rate of investment in R+D is particularly intensive and has 
been  estimated  at  around  8%  (with  larger  companies  spending  at  least  10%93)  of  its  annual 
turnover of €42 billion, of which 30% would re late to equipment certified under MED – that 
is, approximately € 1 billion  

 Working  on  the  hypothesis that efficient annual updates could stabilise at a rate of 20% of 
change  (items  changed  or  added  over  total  items  in  Annex  1),  and  using  a  return  on 
investment of  4%, two calculations are possible: 

–  based on an EU fleet of 22% of the total world fleet, the potential lost return on 
investment  would be: 1 billion x 0.20 x 0.22 x 0.04  = € 1.76 million per year of 
delay; 

–  based  on  the  actual  percentage  of  sales  in  the  EU  market,  which  is94 
approximately 54% of the total, the potential lost return on investment would be: 
1 billion x 0.20 x 0.54 x 0.04 = 4.3 million per year of delay.  

Thus  one  can  estimate  that  every  year  of  delay  in  the  entry  into  force  of  new  IMO 
requirements may be costing the industry in the region of €3 million plus administrative costs 
and  overheads.  Therefore  the  current  system  with  inherent  delays  may  be  generating 
maximum  costs  of  approximately  €4  million  to   €5  million  in  terms  of  lost  return  on 
investment for the industry for each annual update. 

Delay  in  the  transposition  of  IMO  requirements  also  generates  double-certification  costs 
which can be estimated as follows: 

–  During the last full yearly amendment periods (corresponding to the 4th, 5th and 6th 
amendments),  an  average  of  8,500  new  MED  certificates  have  been  issued  per 
year.  With  a  stable  innovation  rate  of  20%,  1,700  certificates  are  issued  against 
newly  adopted  requirements  (while  6,800  correspond  to  ordinary  periodic 
renewals). 

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94 

Source: EMEC, 2010 
Source: EMEC annual report 2009, p.7 

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–  Among  these  1,700  certificates,  approximately  13%  correspond  to  items  newly 
added to Annex  A.1 in each new annual update95. Thus an estimated 1,500 new 
certificates per year correspond to re-issuing of previous certificates following the 
update of existing requirements.  

–  Based on a standard 5-year period of validity for a MED certificate, 20% of these 
1,500 certificates, that is 300 certificates, will have to be renewed for each year of 
delay in the transposition of new IMO requirements before they can be replaced 
by  new  certificates  issued  against  the  new  requirements.  Based  on  an  estimated 
cost  of  6,000€  per  renewal 96,  the  total  costs  for  the  industry  in  terms  of  double-
certification may amount to approximately 2M€ for each annual update. 

Thus  the  total  costs  incurred  by  the  industry  due  to  the  delays  in  the  transposition  of 
IMO requirements into the MED can be estimated at approximately 6 to 7 million € per 
year. 

This is a relatively small cost compared to the sector's turnover. However, it must be borne in 
mind that these costs are not distributed evenly. The cost of delays may become particularly 
significant  for  SME's,  some  of  which  have  only  one  or  two  products  and  a  high  rate  of 
innovation. Sources from the industry indicated that duplication of certificates may represent 
up to 20% of the total certification costs linked to one single set of requirements97. This means 
that  in  extreme  cases  (low-value  product,  produced  in  reduced  volumes,  where  the  total 
certification  costs  may  near  5%  of  the  company's  turnover),  an  SME  could  face  double-
certification costs reaching 1% of its annual turnover. 

95  
96  
97  

Average of last three annual updates 
Source: EMEC – cost reported to be in a range of 6,000€ to 10,000€ per each new certificate 
Source: EMEC, 2010 

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ANNEX 13 

List of main international maritime conventions applying to marine equipment98 

• 

• 

• 

• 

• 

the 1966 International Convention on Load Lines (LL66), 

the 1972 Convention on the International Regulations for Preventing Collisions 
at Sea (Colreg), 

the  1973  International  Convention  for  the  Prevention  of  Pollution  from  Ships 
(Marpol) 

the 1974 International Convention for the Safety of Life at Sea (Solas), 

the 2004 International Convention for the Control and Management of Ships’ 
Ballast Water and Sediments (BWMC) 

98 

EN 

Convention 
(http://www.imo.org/Publications/Pages/Home.aspx )  

obtained 

from 

texts 

can 

be 

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the 

International  Maritime  Organisation 

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ANNEX 14 

Electronic tagging by means of RFID99 

BASIC PRESENTATION OF THE RADIO-FREQUENCY IDENTIFICATION (RFID) TECHNOLOGY 

For  the  purposes  of  this  document,  Radio  Frequency  Identification  (RFID)  is  the  use  of  an 
object (typically referred to as an RFID tag) applied to or incorporated into a product, for the 
purpose of identification and tracking using radio waves. Some tags can be read from several 
meters away and beyond the line of sight of the reader. 

Radio-frequency  identification  comprises  interrogators  (also  known  as  readers),  and  tags 
(also known as labels). 

A basic RFID system consists of three components:  

•  An antenna or coil  

(5) 

A transceiver (with decoder)  

•  A transponder (RF tag) electronically programmed with unique information  

Figure 5: electronic tag system 

•  The antenna emits radio signals to activate the tag and to read and write data to it.  

•  The  reader  emits  radio  waves  in  ranges  of  anywhere  from  one  inch  to  100  feet  or 
more, depending upon its power output and the radio frequency used. When an RFID 
tag passes through the electromagnetic zone, it detects the reader's activation signal.  

•  The reader decodes the data encoded in the tag's integrated circuit (silicon chip) and 

the data is passed to the host computer for processing. 

Most  RFID  tags  contain  at  least  two  parts.  One  is  an  integrated  circuit  for  storing  and 
processing  information,  modulating  and  demodulating  a  radio-frequency  (RF)  signal,  and 
other specialized functions. The second is an antenna for receiving and transmitting the signal. 

There are generally three types of RFID tags:  

•  active RFID tags, which contain a battery and can transmit signals autonomously, 

99 

Source: EMSA 

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•  passive RFID tags, which have no battery and require an external source to provoke 

signal transmission, and, 

•  battery assisted passive (BAP) which require an external source to wake up but have 

significant higher forward link capability providing great read range. 

The  Electronic  Product  Code  (EPC) Global  standard  defines  four  classes  of  tags  as  class  1, 
class 2, class 3 and class 4. Each successive class has higher functionality than the previous 
one and is also backward compatible. 100 

RFID has many applications, for example, it is used in enterprise supply chain management to 
improve the efficiency of inventory tracking and management. 

The first patent to be associated with the abbreviation RFID was granted in 1983 but today the 
technology is quite mature and RFIDs are easy to conceal or incorporate in a range of items. 
For  example,  in  2009  researchers  at  Bristol  University  successfully  glued  RFID  micro 
transponders  to  live  ants  in  order  to  study  their  behavior.  This  trend  towards  increasingly 
miniaturized RFIDs is likely to continue as technology advances. However, the ability to read 
at a distance is limited by the inverse-square law. 

The record for the smallest RFID chip is at 0.05mm x 0.05mm. The Mu chip tags are 64 times 
smaller  than  the  new  RFID  tags.  Manufacture  is  enabled  by  using  the  Silicon-on-Insulator 
(SOI) process. These "dust" sized chips can store 38-digit numbers using 128-bit Read Only 
Memory  (ROM).  A  major  challenge  is  the  attachment  of  the  antennas,  thus  limiting  read 
range to only millimeters. 

Potential alternatives to the radio frequencies (0.125–0.1342, 0.140–0.1485, 13.56, and 840–
960 MHz) used are seen in optical RFID (or OPID) at 333 THz (900 nm), 380 THz (788 nm), 
750  THz  (400  nm).  The  awkward  antennas  of  RFID  can  be  replaced  with  photovoltaic 
components and IR-LED on the ICs. 

CURRENT USE IN TRANSPORTATION AND LOGISTICS 

Logistics and transportation are major areas of implementation for RFID technology. RFID is 
currently used in a variety of applications such as the following: 

•  Yard management, shipping and freight and distribution centers are some areas where 
RFID tracking technology is used. Transportation companies around the world value 
RFID technology due to its impact on the business value and efficiency.  

•  The North American railroad industry operates an automatic equipment identification 
system based on RFID. Locomotives and rolling stock are equipped with two passive 
RFID tags (one mounted on each side of the equipment); the data encoded on each tag 
identifies the equipment owner, car number, type of equipment, number of axles, etc. 
The  equipment  owner  and  car  number  can  be  used  to  derive  further  data  about  the 
physical characteristics of the equipment from the Association of American Railroads' 
car  inventory  database  and  the  railroad's  own  database  indicating  the  lading,  origin, 
destination, etc. of the commodities being carried. 

100  

Apart  from  these  four  classes,  sometimes  class  5  is  also  referred  by  users  in  the  industry  which  are 
nothing but RFID readers 

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•  Aerospace applications that incorporate RFID technology are being incorporated into 
networks architecture. This technology serves to help facilitate more efficient logistics 
support for systems maintenance on-board commercial aircraft. 

•  Pieces of luggage passing through an airport are individually tagged with RFID tags as 
they  navigate  the  airport's  baggage  handling  system,  which  improves  efficiency  and 
reduces misplaced items.  

The  RFID  technology  has  also  already  been  implemented  in  the  maritime  transport  sector 
notably for container tracking. Systems based on RFID enable the identification of containers 
over long distances and in demanding environments such as a port area. RFID help in real-
time identification and tracking of containers, reaching new levels of traceability and control.  

For  example,  the  Port  of  Singapore  Authority  (PSA)  deployed  thousands  of  RFID 
transponders  into  its  container  yard  to  create  a  multi-dimensional  tracking  grid  as  early  as 
1993. The PSA tracks many thousands of multi-ton cargo containers daily, and also manages 
arrivals  and  departures  of  up  to  50  ships.  PSA  spent  close  to  $910  million  in  1993  on 
development  projects.    A  centralized  system  manages  the  placement  and  location  of 
containers. Nowadays, the PSA is ranked the number one port worldwide.  

In Europe, the Port of Rotterdam is one of the largest operators of container handling systems 
in Holland’s massive port of Rotterdam. Buried RFID transponders guide automated guided 
vehicles  (AGVs).  Deployment  of  this  system  began  in  1990  using  the  Texas  Instruments 
technology.     

POSSIBILITIES OFFERED BY RFID IN THE MED CONTEXT AND ADDED VALUE COMPARED TO 
THE PREVIOUS TECHNOLOGIES. 

1.  The  Radio  Frequency  Identification  (RFID)  added  value  compared  to  the 
previous technologies. 

Concretely, Radio frequency identification (RFID) is a generic term that is used to describe a 
system  that  transmits  the  identity  (in  the  form  of  a  unique  serial  number)  of  an  object 
wirelessly,  using  radio  waves.  It's  grouped  under  the  broad  category  of  automatic 
identification technologies. 

Unlike  ubiquitous  UPC  bar-code  technology,  RFID  technology  does  not  require  contact  or 
line of sight for communication. RFID data can be read through the human body, clothing and 
non-metallic materials. 

The  data  transmitted  by  the  tag  may  provide  identification  or  location  information,  or 
specifics about the product tagged, such as price, colour, date of purchase, etc. RFID quickly 
gained attention because of its ability to track moving objects. 

To retrieve the data stored on an RFID tag, a reader is necessary. A typical reader is a device 
that  has  one  or  more  antennas  that  emit  radio waves  and  receive  signals  back  from  the  tag. 
The reader then may pass the information in digital form to a computer system. It is possible 
that active or semi-passive RFID devices could be complemented with data storage capacity 
in order to include, for example, protected copies of the certificates. 

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2. RFID Wheelmark tag 

Currently the Wheelmark must be legible, visible and indelible throughout the anticipated life 
of the equipment. The mark of today is a printed label or plate. 

The Wheelmark indicates that a piece of equipment holds a Declaration of Conformity which 
is based on the certification issued by Notified Bodies (NB) acting on behalf of the Maritime 
Administrations.  Consequently  that  piece  of  equipment  is  entitled  to  free  movement  on  the 
Internal Market and to be used on board ships flying a Community flag. 

Currently the Wheelmark is a passive label. 

The  control  of  equipment  addresses  two  kinds  of  needs  which  are  connected  to  the 
implementation of the MED and the operation in real scenarios: 

•  Priority need: to ensure that products comply with the requirements” 
•  Added  value  need:  intended  to  the  efficient  use  of  resources  and  sources  of 

information. 

2.1 

Priority need 

MED  stakeholders  have  different  needs  concerning  access  to  information  related  to  the 
equipment during trading and operations. This information is linked to the relevant legal basis 
given in MED, namely, 

•  Article 7. Standard versions used for approval 
•  Article 9. Status of the notification and qualification of the certifying NB. 
•  Article 10. Certificates on board and limitation of use. 
•  Article 11. Wheelmark. Authenticity might be verified on the spot. 
•  Article 12. Market surveillance: Coordination and a feasible approach. 
•  Article  13.  Safeguard  actions:  For  comprehensive  identification  of  particular 

manufacturing facts and identification of the piece of equipment. 

•  Article 14. Temporary/innovative equipment limitations. 

2.2 

Added value: 

This chiefly concerns the daily use of equipment in operation and involves the availability of 
the following information: 

•  Declaration of conformity. 
•  NB Certificates and associated testing reports. 
•  Full  identification  of  the  equipment  available  to  crosscheck  with  information  of  the 

official list of approved equipment. 

•  Base of operation of the equipment and ownership. 
•  Control of the property rights and particular registration. 
•  Certainty of authenticity of the piece of marine equipment on board. 
•  Means to fight against fake equipment on board. 
• 

Installation manual on board. 

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• 
Instruction manual on board. 
•  Maintenance manual on board. 
•  Service manual on board. 
•  Troubleshooting manual on board. 
•  Replacement manual on board. 
•  Hazardous handling warnings. 
•  Anticipated plan of control points on the piece of equipment for facilitating authorities 
to perform efficient Market surveillance visits and campaigns. (Categories of control 
points may be preset up: deep, medium, documentary). 

•  Recommended points of control for Market Surveillance Authorities. 
•  Recommended points of verification for Classification Societies (and Flag States). 
• 
•  Allowed testing in operation. 
•  Forbidden testing in operation. 

Information for Port State Control authorities and recommended points of verification. 

CONCLUSIONS 

In  view  of  the  potential  benefits  of  current  technology  on  RFID,  MED  marking  might  be 
evolved to look the same but built to perform as a RFID tag. In that case RFID tags would 
offer the stakeholders a powerful resource of control and verification. Wheelmark performing 
as a RFID might be proposed to be used on a voluntary basis, however even in this case the 
concerns identified  among Member states and the  industry regarding counterfeit  products is 
likely to lead to a wide use. 

Embedded RFID would provide a simple and cost-effective solution to counterfeiting as well 
as  to  the  problems  associated  with  non-compliant  products.  RFID  allows  manufacturers  to 
embed  inconspicuous  tags  that  typically  cost  10-30  cents  each  directly  into  or  onto  their 
products  or  consumables.  Once  a  tag  is  added  to  a  product  or  consumable,  it  can  then  be 
encoded with a digital fingerprint using state-of-the-art cryptography that uniquely identifies 
the product or consumable.  

The  use  of  labels  containing  all  the  necessary  information  for  management  of  the  marine 
equipment  will  facilitate  rapid  access  to  the  necessary  documentation  for  every  MED 
stakeholder. Evidently the limited need to archive and maintain documentation control will be 
an additional asset.  

With the increase of verification and control possibilities, the fight against illegal equipment 
will  be  enhanced  as  per  the  use  of  RFID  tags  for  Wheelmark.  Future  consideration  could 
foresee the list of serial numbers within the current data base of approved marine equipment. 

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