Proposal for a Council Decision on the conclusion of an Agreement between the European Community and the United States of America on the Mutual Recognition of Certificates of Conformity for Marine Equipment
Date: 2003-04-22
Institutions: European Commission
Subjects: United States, approval, liberalisation of trade, maritime safety, maritime transport, quality label, ratification of an agreement, safety standard

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 22.4.2003
COM(2003) 195 final

2003/0078 (ACC)
2003/0079 (ACC)

Proposal for a

COUNCIL DECISION

on the signature on behalf of the Community of an Agreement between the European
Community and the United States of America on the Mutual Recognition of Certificates
of Conformity for Marine Equipment

Proposal for a

COUNCIL DECISION

on the conclusion of an Agreement between the European Community and the United
States of America on the Mutual Recognition of Certificates of Conformity for Marine
Equipment

(presented by the Commission)

EXPLANATORY MEMORANDUM

I.

SUMMARY

The European Community (EC) and the United States of America (US) have negotiated and
initialled  an  agreement  on  mutual  recognition  of  certificates  of  conformity  for  marine
equipment, which should now be approved. The negotiations have been done according to the
negotiation  mandate  given  by  the  Council  under  the  Action  Plan  for  the  Transatlantic
Economic Partnership (TEP). The legal basis for the Agreement is Article 133 and 300 of the
Treaty.

This  Agreement  has  as  its  main  objective  the  facilitation  of  EU-US  trade  in  marine
equipment. This is achieved by ensuring the recognition of certificates of conformity based on
the  equivalence  between  the  Parties’  respective  regulations  and  conformity  assessment
requirements  for  a  specific  product.  A  Party  will  thus  recognise  certificates  of  conformity
issued by the Conformity Assessment Bodies of the other Party on the basis of the technical
regulations of that Party. This means a manufacturer can reach multiple markets on the basis
of compliance with one set of regulatory requirements instead of multiple ones as  would be
the  case  without  an  Agreement.  This  can  directly  lead  to  a  reduction  of  costs  for
manufacturers in terms of testing and certification. Indirectly it will also reduce costs that are
related  to  the  uncertainty  and  burden  of  contacting  a  conformity  assessment  body  in  the
importing country, as well as the time delays this leads to in terms of getting a product on the
market.

Basing the Agreement  on  equivalence  of  EU  and  US  technical  regulations  is  possible  since
both  Parties  have  based  their  respective  legislation  (in  the  EU  it  is  Directive  96/98/EC  on
marine equipment) on the Conventions of the International Maritime Organisation (IMO) and
the  relevant  international  standards.  The  Agreement  also  aims  at  promoting  regulatory  co-
operation and efficiency.

The  Commission  and  the  US  have  carried  out  several  detailed  analyses  of  their  respective
technical regulations  in  view of determining equivalence  where possible.  The  determination
of  equivalence  has  been  done  on  the  basis  the  EU  and  US  implementation  of  the  relevant
International  Instruments  of  the  International  Maritime  Organisation  (IMO).  The  products
included in Annex  II of the Agreement contain the initial results of the analysis and will be
expanded  as  equivalence  is  determined  for  further  products.  The  Agreement  provides  for
mechanisms  related  to  both  maintaining  and  suspending  equivalence  while  respecting  the
regulatory autonomy of the Parties.

In  its  assessment  of  the  Agreement,  the  Commission  draws  the  overall  conclusion  that  the
Agreement can offer substantial benefits to economic operators in terms of facilitating trade
by  reducing  costs  and  burdens  related  to  conformity  assessment,  can  increase  transparency
and predictability in relation to regulations, will promote regulatory co-operation and will not
compromise the regulatory objectives of the marine equipment directive, i.e. to enhance safety
at sea and improve the prevention of marine pollution.

2

II.

THE AGREEMENT

II.1

Basis for the Agreement

The Council endorsed the Action Plan for the TEP on 9 November 1998 and authorised the
Commission to enter into negotiations with the US in view of concluding bilateral agreements
in the field of, inter alia, technical barriers to trade. After consultation of the 133 Committee,
and  in  accordance  with  the  negotiation  authorisation,  the  Commission  commenced
negotiations  with  the  US  on  a  mutual  recognition  agreement  for  marine  equipment  in
September 1999. The Agreement was initialled on 21 March 2003.

The  Community  legal  basis  for  concluding  the  Agreement  is  Article  133  and  300  of  the
Treaty.

II.2

Objective of the Agreement

The objective of the Agreement is the facilitation of EU-US trade in marine equipment. This
is  done  by  giving  EU  manufacturers  the  possibility  of  approving  their  products  for  the  US
market with a Conformity  Assessment  Body  (CAB) located  in the  EU and  according  to  the
technical  regulations  of  Directive  96/98/EC  on  marine  equipment1.  US  manufacturers  will,
conversely,  be  able  to  approve  their  products  for  the  EU  market  in  the  US  on  the  basis  of
compliance  to  applicable  US  laws  and  regulations.  This  would  reduce  the  costs  related  to
testing  and  certification,  which  only  has  to  be  done  once  for  several  markets,  and  to  the
uncertainty,  time  and  administrative  burden  of  contacting  approval  bodies  in  the  importing
country.

The Agreement has also the aim of promoting regulatory co-operation and efficiency, but at
the same time respecting the regulatory autonomy of the Parties. This is necessary in order to
ensure the functioning of the Agreement and in particular that equivalence can be maintained
while ensuring a high level of health, safety and environmental protection.

II.3

Text of the Agreement

The  Agreement  is  composed  of  a  main  text,  consisting  of  twenty-one  articles  in  seven
chapters,  and  three  annexes.  An  article-by-article  explanation  and  evaluation  of  the
Agreement text follows hereunder. A more in-depth discussion on equivalence and the scope
of the Agreement follows in the next chapter.

Preamble:  This  sets  out  the  basic  objectives  and  principles  of  the  Agreement  which  is  the
facilitation of trade in marine equipment between the Parties.

Chapter 1 Definitions and Purpose

Article 1 Definitions: Sets out the definition of key terms that are necessary to ensure a clear
understanding of the Agreement and also refers to ISO/IEC Guide 2 for definitions of general
terms related to standards and conformity assessment.

Article  2  Purpose  of  the  Agreement:  This  Article  sets  out  the  general  objective  of  the
Agreement  -  facilitating  trade  in  marine  equipment  through  the  mutual  recognition  of

1 

OJ L 46, 17.2.97, p.25.

3

                                                
certificates  of  conformity  and  putting  into  place  the  necessary  regulatory  co-operation  to
ensure the well functioning of the Agreement.

Chapter 2 Mutual Recognition

Article  3  Basic  Obligations:  This  Article,  together  with  Articles  4,  6  and  10,  is  a  key
provision of the Agreement since it sets out the mutual recognition obligations and to which
products it applies to. Each Party is obliged to accept the certificates of conformity that have
been issued by a Conformity Assessment Body of the other Party in accordance with the legal
requirements  of  that  Party.  This  obligation  applies  only  to  the  products  that  are  listed  in
Annex II of the Agreement.

Article  4  Equivalence  of  Technical  Regulations:  This  lays  down  the  basis  for  the  mutual
recognition obligation, specified in Article 3, i.e. that equivalence between the respective EC
and US technical requirements (e.g. performance requirements, testing standards, conformity
assessment  requirements)  has  been  determined  for  a  specific  product.  The  basis  for
determining  equivalence  are  the  rules  of  the  IMO  related  to  marine  equipment  and  the
transposition of these rules into the respective technical regulations of the Parties.

Article  5  Marking:  Lays  down  that  the  Parties  maintain  their  respective  requirements  for
marking, numbering and identification of products. In general, it could have been conceived
that, since equivalence exists between the technical requirements for a product, the respective
marking required in EU and US regulations would also be mutually recognised. However, it
was considered better to maintain the respective marking requirements since there was a risk
of  causing  confusion  in  particular  for  enforcement  authorities  as  to  what  requirements  a
product complied to as denoted by its marking. The Article allows for the attribution of each
other’s marks and identification numbers.

Article 6 Conformity Assessment Bodies: This Article provides that the EU and US recognise,
as  Conformity  Assessment  Bodies  (CAB),  each  other’s  bodies  that  have  been  recognised
under  their  respective  regulations.  In  this  respect,  the  US  Coast  Guard  (USCG)  will  be  the
only US Conformity Assessment Body since it is only the USCG that can issue certificates of
conformity according to US law. The USCG will be carrying out this function together with
the independent laboratories it has recognised under its regulations. From the EU perspective,
all  notified  bodies  that  operate  under  the  marine  equipment  directive  are  both  eligible  and
recognised under the Agreement.

Chapter 3 Joint Committee

Article  7  Joint  Committee:  This  establishes  the  Joint  Committee  that  will  administer  the
Agreement. The Joint Committee can take decisions to amend the Annexes of the Agreement,
but will also serve as a forum for discussing technical issues and providing clarifications and
guidance needed to ensure a proper functioning of the Agreement. The Article also allows for
the establishment of Joint Working Groups which could provide, as necessary, expert advice
to the Joint Committee on specific issues.

Chapter 4 Regulatory Co-operation

Article 8: Preservation of Regulatory Authority: Here it is made clear that the Parties do not
relinquish  their  regulatory  authority  or  autonomy  with  regard  to  the  safety  at  sea  or  the
prevention of marine pollution.

4

Article  9  Exchange  of  Information  and  Contact  Points:  This  provides  for  the  Parties  to
establish the necessary contact points and means for exchange of information. It also provides
that the Parties are to publish on the World Wide Web the products that have been approved
under their respective regulations.

Article  10:  Regulatory  Changes:  This  is  an  essential  Article  of  the  Agreement.  Since
equivalence is determined on the basis of EU and US regulations that are in effect at a certain
point  in  time,  equivalence  needs  to  be  re-examined  when  these  regulations  are  amended  or
new ones are introduced that could affect equivalence.  In  this  respect  the  Article  states  that
the  Parties  shall  base  their  regulations  on  the  international  instruments  of  the  IMO.  The
Article sets out an obligation for the Parties to notify each other when regulatory changes take
place and calls on them to consult each other. This article lays down that the Joint Committee
is to consider whether equivalence is maintained when regulatory changes do take place and,
in  this  respect,  spells  out  what  the  outcome  of  the  considerations  will  lead  to:  1)  that
equivalence is maintained and the product is retained in Annex II of the Agreement; or 2) if
equivalence is not maintained, the product is removes from Annex II of the Agreement; or 3)
if agreement cannot be reached on whether equivalence is maintained or not, the possibility to
suspend mutual recognition for that product.

Article 11 Regulatory Co-operation: This Article sets out that the Parties are to co-operate in
the  relevant  international  organisations  with  a  view  to  establishing  international  rules  for
marine  equipment.  It  also  allows  for  bilateral  EU-US  regulatory  co-operation,  including,
when  necessary,  examining  their  respective  technical  regulations  in  view  of  establishing
equivalence for products that were not included within the scope of the Agreement upon its
entry  into  force  or  for  which  equivalence  has  been  discontinued  or  suspended.  The  Article
also  allows  the  Joint  Committee  to  take  decision  to  include  products  in  Annex  II  once
equivalence of the relevant technical regulations has been determined.

Article 12 Co-operation on Conformity Assessment: In view of maintaining confidence in the
Conformity Assessment Bodies and the conformity assessment procedures of the Parties, this
Article calls on the relevant authorities of the Parties to consult with each other and undertake
other actions as necessary. The Article also calls on the Parties to encourage their Conformity
Assessment Bodies to take part in co-operation and co-ordination activities.

Chapter 5 Surveillance and Safeguard Measures

Article 13 Surveillance of Conformity Assessment Bodies: This Article sets out that the Parties
shall  continuously  monitor,  through  inspections  and  audits,  the  competence  of  their
Conformity  Assessment  Bodies.  The  Article  allows  a  Party  to  contest,  based  on  objective
reasons, the technical competence of a Conformity Assessment Body of the other Party.

Article 14 Market Surveillance: This Article spells out that the Agreement in  no way limits
the  Regulatory  Authorities  of  the  Parties  to  take  enforcement  actions  (e.g.  prohibiting
placement  on  the  market  or  product  recalls)  against  products  that  pose  a  danger  to  health,
safety or the environment or otherwise do not comply with applicable regulations. The Parties
will inform each other of such measures.

Article 15 Suspending Mutual Recognition: Lays down the procedures to be followed if one
or both Parties considers that equivalence of the technical regulations for the products listed in
Annex II has not or cannot be maintained. If equivalence is not maintained then the product is
removed  from  Annex  II  and  the  mutual  recognition  obligations  for  that  product  are

5

suspended. The Parties undertake to co-operate in view of establishing equivalence  again to
the extent possible.

Article 16 Alert System: The Parties will set up a two-way alert system to inform each other of
products that have been found not to comply with applicable to technical  regulations or can
pose an imminent danger to health, safety or the environment.

Chapter 6 Additional Provisions

Article  17  Confidentiality:  This  contains  standard  clauses  and  relates  to  protecting  the
confidentiality of information exchanged between the Parties or their Conformity Assessment
Bodies.

Article 18 Fees: This Article ensures that fees are non-discriminatory and are not imposed for
conformity assessment services already rendered by the other Party.

Article 19 Territorial Application: This is a standard Article. However, it should be noted that
the special nature of the maritime sector has been taken into account with a reference to that
the Agreement is applicable to ships in international voyage that are entitled to fly the flag of
one the Parties or one of the Parties’ Member States.

Article 20 Agreements with other Countries: The first paragraph of this Article provides that
mutual  recognition  agreements  between  Parties  to  this  Agreement  and  other  countries  shall
have  no  force  in  regard  to  the  other  Party  to  the  Agreement.  According  to  the  second
paragraph the  EC  and  the  US  undertake  to  examine  the  possibility  of  establishing  a  mutual
recognition agreement on a multilateral basis.

Chapter 7 Final Provisions

Article 21 Entry into force, amendments and termination: These are standard provisions.

Article  22  Final  Provisions:  These  are  standard  institutional  and  legal  provisions.  It  can  be
noted  that  paragraph  2  calls  on  the  Parties  to  assess  the  functioning  of  the  Agreement  on  a
regular basis and the first time no later than 2 years after its entry into force.

Annexes

Annex  I  Legislation,  Regulations  and  Administrative  Provisions:  Refers  to  the  basic
legislative,  regulatory  and  administrative  provisions  of  the  Parties  related  to  marine
equipment.

Annex II Product Coverage for Mutual Recognition: This Annex indicates specifically which
products are  within the  scope of the  Agreement. Only those products listed in  Annex  II  are
subject to the mutual recognition obligations described in Article 3. This Annex will develop
as  the  programs  and  regulations  of  the  Parties  evolve.  The  products  that  are  listed  in  this
proposal represent an initial list of products for which equivalence could be determined at this
point in time.

Annex III Regulatory Authorities: Lists the Regulatory Authorities of the Parties.

6

III

DETERMINATION OF EQUIVALENCE AND PRODUCT COVERAGE

III.1

Basis for determining equivalence

As has been pointed out above, a key feature of the Agreement is that the mutual recognition
obligation is based on that the respective EU and US technical regulations related to a specific
product being equivalent. It is only once equivalence has been determined and is maintained
that a product can be listed in Annex II of the Agreement and kept there. The reason this can
be  done  is  that  both  the  EU  and  the  US  have  to  a  very  large  degree  based  their  respective
technical  regulations  related  to  marine  equipment  on  the  international  conventions  on
maritime safety and marine pollution prevention established within the IMO, in particular the
SOLAS  (Safety  of  Life  at  Sea)  and  MARPOL  (Prevention  of  Pollution  from  Ships)
Conventions,  together  with  the  relevant  test  methods  (e.g.  those  of  the  International
Telecommunications  Union  (ITU),  the  International  Organisation  for  Standardisation  (ISO)
and  the  International  Electrotechnical  Commission  (IEC))  referred  to  in  IMO  Resolutions,
Circulars, Codes etc.

In the EU marine equipment is regulated by Council directive 96/98/EC on marine equipment
as  amended,  hereafter  called  the  Marine  Equipment  Directive  (MED).  From  the  EU
perspective, the potential product coverage of the Agreement is determined by Annex A.1 of
the MED.  In the  US the majority of marine equipment  is  regulated  by  the  US  Coast  Guard
(USCG)  in  the  US  Code  of  Federal  Register  (CFR)  46  CFR  Parts  159  to  165,  while  radio
communication  equipment  and  navigation  equipment  using  radio  is  within  the  regulatory
remit of the US Federal Communications Commission (FCC) in 47 CFR Parts 2 and 80.

Article 4, paragraph 2, of the Agreement states that

“Determination of  equivalence of  technical  regulations  of  the  Parties  shall  be
based on their implementation of the relevant International Instruments in their
respective legislation, regulations and administrative provisions, except where
a Party regards the Instrument would be an ineffective or inappropriate means
of fulfilment of its regulatory objectives. In the latter case, equivalency shall be
determined on a mutually acceptable bases.”

In other words, the criteria for determining equivalence is the “degree” of implementation by
the  EU  and  US  of  the  IMO  requirements  into  their  respective  technical  regulations  for  a
specific  product.  The  general  rule  is  thus  that  the  EU  and  US  will  base  their  technical
regulations  on  the  instruments  of  the  IMO  (also  articulated  in  Article  10(1)  of  the
Agreement). On an exceptional basis, and as allowed by the WTO Agreement on Technical
Barriers to Trade, the  Parties  may  choose  not  to  use  the  IMO  rules  when  these  are  deemed
inappropriate  or  ineffective  in  terms  of  the  regulatory  objectives  pursued.  In  such  cases  the
criteria  for  determining  equivalence  must  be  agreed  between  the  Parties.  It  should  also  be
underlined  that  in  determining  equivalence  all  regulatory  requirements  related  to  a  specific
product  must  be  examined  and  found  equivalent  -  product  requirements,  testing  and
performance standards and conformity assessment procedures.

According to the definition of ‘equivalence of technical regulations’ in Article 1(1)(e) of the
Agreement,  EU  and  US  technical  regulations  do  not  have  to  be  identical,  but  must  be
sufficiently  comparable  to  ensure  that  the  objectives  of  their  respective  regulations  are
fulfilled. In other words, if the EU prescribes a standard in order to achieve a given level of
safety  or  environmental  protection,  the  US  standard  must  be  capable  of  ensuring  the  same
level of safety and protection.

7

III.2

Determining product coverage

On the basis of the above, a number of detailed studies and analysis have been carried out to
examine  equivalence  between  EU  and  US  technical  regulations  for  marine  equipment.  The
USCG  carried  out  an  analysis  with  regard  to  the  products  it  regulates.  This  analysis  was
verified  by  the  Commission  who  contracted,  after  an  open  public  tendering  procedure,  an
expert  consultant  to  carry  out  the  work.  The  Commission  also  contracted  (as  well  after  an
open  call  for  tenders)  an  analysis  related  to  marine  radio  communication  and  navigation
equipment. All these studies have been made publicly available.

The  analysis  and  examinations  made  by  the  Commission  and  the  US  have  led  to  the
conclusion  that  the  products  listed  in  Annex  II  of  the  present  proposal  is  an  initial  list  of
products for which there is equivalence. This list constitutes 43 product items, of which 11 are
life saving appliances, 12 fire protection equipment and 20 navigation equipment. It should be
pointed out that the final analysis has been made on the basis of the third amendment to the
MED.  Although  the  amending  directive  has  not  yet  been  formally  adopted,  its  technical
contents  is  known.  In  this  respect,  the  MRA  would  have  to  enter  into  force  in  conjunction
with the entry into force of the amending directive.

For the remaining products covered by the MED, it is considered that either equivalence can
be determined after further technical examinations and this can be done with a relatively short
timeframe  after  the  entry  into  force  of  the  Agreement  (1-2  years), or equivalence  cannot be
determined within a foreseeable timeframe. There are approximately 50 equipment items that
are candidates for future inclusion in Annex II of the Agreement, of which 24 are life saving
appliances,  5  pollution  prevention  equipment,  10  fire  protection  equipment,  9  navigation
equipment and 1 radio communication equipment. It is in particular within the area of radio
communication equipment equivalence cannot be established. This is mainly due  to  that the
US conformity assessment procedures for these products are at the moment not deemed to be
equivalent to those prescribed by the MED and that the relevant US technical regulations are
not always in line with the applicable ITU recommendations.

III.3 Maintaining equivalence and change in product coverage

The technical regulations of the Parties will evolve over time, in particular in response to new
or amended IMO rules. When a technical regulation of a Party changes and this could affect
equivalence, one needs to examine whether equivalence is maintained in terms of the new or
amended regulations of one or both Parties. As described above, Article 10 of the Agreement
sets out a mechanism of how changes to the technical regulations of the Parties is to be dealt
with  in  terms  of  the  Agreement.  It  should  be  underlined  that  nothing  in  the  Agreement
prejudices or  limits  the  regulatory  authority  of  the  EU  or  the  US  in  terms  of  pursuing  their
respective regulatory objectives and setting the level of protection they  consider  appropriate
(see Article 8 of the Agreement).

Key  elements  in  maintaining  equivalence  are,  notification  and  exchange  of  information  on
regulatory development and offering the opportunity to consult on such developments, within
the limits set by each Party’s legislative procedures, and, of particular importance, regulatory
co-operation  and  a  shared  commitment  to  the  work  of  the  IMO.  As  the  general  rule,  co-
operation on setting rules for marine equipment is to be done in IMO as well as in ITU, ISO
and  IEC.  However,  the  Agreement  also  offers  the  possibility  of  bilateral  EU-US  regulatory
co-operation and this will be necessary in view of not only maintaining equivalence, but can
also contribute  to improving the quality of  regulations  through  the  exchange  of  experiences
and best practices.

8

One important element in the bilateral co-operation, which will heavily rely on the work at the
international level, is setting out and carrying out a work plan for determining equivalence for
those products that have not been listed in Annex II of the Agreement. Once such work has
been  finalised  and  both  Parties  are  satisfied  that  equivalence  of  their  respective  technical
regulations for a specific product has been determined, that product can be listed in Annex II
by a decision of the Joint Committee (Article 11(4) of the Agreement).

It  goes  without  saying  that  if  equivalence  cannot  be  maintained  or  found  due  to  objective
reasons,  the  product  will  be  removed  from  or  not  listed  in  Annex  II.  For  products  that  are
removed from Annex II, the mutual recognition obligations of Article 3 of the Agreement will
cease to apply, but the Parties shall continue to recognise previously issued certificates, unless
reasons  due  to  the  protection  of  health,  safety  or  the  environment  warrants  otherwise.  This
may cause difficulties for economic operators, which may have to revert to seeking approvals
with  the  importing  Party.  However,  it  should  be  made  clear  that  the  Agreement  cannot
prejudice or put into question the integrity of the regulatory objectives of the Parties.

IV.

ASSESSMENT OF THE AGREEMENT

IV.1

General observations

In general, mutual recognition agreements have two objectives: facilitating trade by reducing
costs related to conformity assessment and promoting regulatory co-operation and efficiency.
The  Commission  considers  that  the  Agreement  presented  for  approval  can  fulfil  those
objectives for the reasons outlined below.

The Agreement is in a sense innovative since it is the first international agreement related to
goods  the  Community  would  enter  into  that  is  based  on  equivalence  with  the  regulatory
requirements of another country.

In  general  terms  the  Agreement  has  the  potential  to  offer  substantial  benefits  to  EU
manufacturers and importers. An EU manufacturer, for a product covered by the Agreement,
will be able to have direct access to the US market, in terms of regulatory requirements, on
the  basis  of  its  compliance  to  EU  requirements  in  the  form  of  the  MED.  This  means  the
manufacturer  can  reach  multiple  markets  on  the  basis  of  compliance  with  one  set  of
regulatory  requirements  and  one  approval  instead  of  multiple  ones  as  would  be  the  case
without  an  Agreement.  This  can  directly  lead  to  a  reduction  of  costs  for  manufacturers  in
terms  of  testing  and  certification.  Indirectly  it  will  also  reduce  costs  that  are  related  to  the
uncertainty and burden of contacting a conformity assessment body in the importing country,
as well as the time delays this leads to in terms of getting a product on the market.

As has been mentioned above and will be further expanded upon below, the Agreement will
not  affect  the  level  of  health,  safety  and  environmental  protection  set  respectively  by  the
Parties. Although the Parties have a shared commitment to the work of the IMO and to base
their  respective  regulations  for  marine  equipment  on  the  relevant  International  Instruments,
the  Agreement  does  not  prejudice  or  compromise  the  regulatory  autonomy  or  enforcement
rights of the Parties.

IV.2

EC-US trade in marine equipment

The volume and value of trade in marine equipment between the EC and US has been difficult
to assess due to the lack of official statistics. Table 1 below gives an indication of the trade in
certain products..

9

Table 1: EC-US trade in certain marine equipment year 2000 (thousands of EUR)

Product and NC code

Import to EU

Export from EU

Radar apparatus (NC 85261090)

Signalling apparatus (NC 85318030)

Radio navigational aid apparatus (NC 8569190)

Radio  telegraphic  or  radio  telephonic  transmission
apparatus (NC 85251050)

Direction  finding  compasses,  including  parts  and
accessories (NC 90141090 and 90149090)

22 687

8 7814

150 391

10 247

115 987

46 218

16 809

36 208

3 873

97 025

Navigational instruments and apparatus (NC 90142090
and 901480)

251 361

202 668

Life jackets and life belts (NC 630720)

Vessels, incl. lifeboats (NC 89060091 and 89060099)

Inflatable rafts (NC 890710)

Signalling flares (NC 360490)

Source: Eurostat, COMEXT database

11 996

10 591

3 121

1 251

1 357

2 486

3 849

5 590

In  assessing  the  potential  impact  of  the  MRA,  an  alternative  approach  to  examining  trade
figures  could  be  to  look  at  the  size  of  the  respective  markets  for  marine  equipment.  An
indication of the size of the respective EU and US markets for marine equipment can be found
by  looking  at  the  number  of  ships  registered  in  the  EU  Member  States  and  the  US.  This  is
illustrated in Table 3 below, which gives both the number of ships and the total gross tonnage
(GT)  of  the  EC  and  US  registered  fleets.  In  this  respect,  it  should  be  kept  in  mind  that  the
Agreement  only  applies  to  ships  of  the  Parties  that  are  to  carry  equipment  that  must  be
approved according to the IMO Conventions and that is in international voyage. Data on the
number of ships that carry safety certificates according to the IMO Conventions has not been
readily  available.  However,  it  is  estimated  that  the  very  large  majority  (over  90%)  of
merchant ships carry a safety certificate. It should also be kept in mind that the figures below
can  include  ships,  for  example  those  used  for  fishing  or  on  inland  waterways,  which  are
covered by other Community directives.

It is primarily the number of ships that are of interest in assessing the market size for marine
equipment  since,  for  cargo  ships  in  particular,  the  cost  of  equipping  a  ship  with  the  IMO
Convention  required  equipment  does  not  vary  much  with  the  size  of  the  ship.  The  greatest
variation is between cargo and passenger ships, where passenger ships will necessarily bear a
higher  cost  in  relation  to  e.g.  life  saving  appliances  and  fire  protection  equipment.  Table  2
shows that the EC fleet is, in terms of numbers, double the size of the US and in particular the
EC registered passenger ship fleet is considerably larger than that of the US.

10

Table 2: EC and US merchant fleets

EC

EC % of world

US

US % of world

Total number of ships

Number of cargo ships

Number of other ships

Of which passenger ships

10 973

5 018

5 955

744

Total gross tonnage of ships

62 572 051

Gross tonnage cargo ships

58 931 568

Gross tonnage other ships

Of which passenger ships

3 640 483

2 129 766

12,5%

10,8%

14,4%

24,6%

11,2%

11,1%

12,4%

22,8%

Source: Lloyd’s Register of Shipping, World Fleet Statistics 2000

5 792

429

5363

33

11 110 901

9 283 757

1 827 144

107 612

6,6%

1,0%

13,0%

1,0%

2,0%

1,8%

6,2%

1,2%

The figures in Table 2 give the number of existing ships which have already been fitted with
the required marine equipment. It would therefore be useful to also look at  the evolution of
the number of ships under completion as this would give an indication of the potential market
for marine  equipment.  These  figures are  given  in  Table 3 and  illustrated in Figure  1. These
figures clearly show that EU ship building, in terms of number of ships, is at least twice the
size of the US.

Table 3: EU and US ships under completion 1996-2000 (number and gross tonnage)

1996

1997

1998

1999

2000

Nr.

GT

Nr.

GT

Nr.

GT

Nr.

GT

Nr.

GT

EU

US

315

3 915 963

325

4 142 821

384

4 900 834

321

3 657 185

323

5 962 587

149

106 321

112

86 059

98

196 707

145

228 596

115

68 456

Source: Lloyd’s Register of Shipping, World Fleet Statistics 2000

11

Figue 1: Number (Nr.) and gross tonnage (GT) of EU and US 
registered mechant ships under completion

e
g
a
n
n
o
t

s
s
o
r
G

7000000

6000000

5000000

4000000

3000000

2000000

1000000

0

450

400

350

300

250

200

150

100

50

0

s
p
i
h
s

f
o

r
e
b
m
u
N

1996

1997

1998

1999

2000

EU GT

US GT

EU Nr.

US Nr.

Source: Lloyd’s Register of Shipping, World Fleet Statistics 2000

IV.3

Conformity assessment costs related to marine equipment

It has  been  difficult  to  quantify  the  costs  related  to  the  type  approval  of  marine  equipment.
The main reason for this is that the different marine equipment items within the scope of the
MED cover a wide range of very differing technologies (cf. lifejackets and radar equipment),
which will necessarily lead to varying approval costs. There are also a number of other costs,
e.g.  time  to  market,  administrative  burdens,  uncertainty,  which  the  MRA  would  have  an
impact  on,  but  are  very  difficult  to  quantify.  Industry  sources  have  however  given  certain
indications of the costs involved. These are given below for purely illustrative purposes  and
must  be  considered  as  “anecdotal”  figures  since  they  are  not  supported  by  verifiable
quantitative data.

-

-

-

In  general  terms  it  is  estimated  that  the  cost  of  equipping  a  ship  with  the  IMO
convention required marine equipment varies, depending on its type and size, between
10-25 % of its building cost.

For  a  large  passenger  ship  (cruise  ship)  that  costs  EUR  350  million  to  build,  it  is
estimated that EUR 115 million (30%) relates to materials, equipment and approvals
from  classification  societies  required  by  IMO  rules.  Of  the  EUR  115  million,
approximately  EUR  90  million  relate  to  different  materials  (related  mainly  to  fire
protection)  and  EUR  17  million  to  life  saving,  navigation  and  radio  equipment.  An
interesting aspect that has been indicated was that a saving, in terms of costs related to
the approval by the classification society, of up to EUR 25 million could be achieved
by  using  materials  and  equipment  that  had  already  been  approved.  For  cargo  ships
(container vessels), irrespective of size, it is estimated that it costs EUR 1 million to
equip it with equipment required by IMO rules.

Costs related to obtaining  USCG  approval for  components for life-saving  appliances
are estimated to a minimum of EUR  50 000  and  can take up to 2  years. Certain  life

12

 
 
 
saving appliances, such as marine evacuation systems and davit launched high speed
craft, must be  tested  under realistic circumstances,  which  can  entail  approval  related
costs of over EUR 1 million.

-

With  regard  to  marine  radio  and  navigation  equipment  the  general  situation  is  that
approval related costs are high, while the size of the market is limited. For example,
for  Inmarsat  B  SES,  the  approval  cost  are  estimated  to  EUR  150  000  for  a  yearly
world-wide  market  of  500  items  representing  a  value  of  approximately  EUR  13,5
million. A complete radar series carries approval costs of an estimated EUR 150 000
for a yearly world-wide market of EUR 175 million.

IV.4

Overall assessment

In  making  an  overall  assessment  of  the  MRA  the  following  main  factors  need  to  be
considered:

-

-

-

The  cost/benefit  of  the  MRA,  for  example  in  terms  of  its  impact  on  trade,  market
access, reduction of costs etc. for EU manufacturers.

The possible impact on EU regulatory objectives.

The impact on other interested parties.

With  regard  to  the  cost/benefit,  the  information  above,  does  not  offer,  in  economic  terms
supported by quantitative data, a clear cut picture of the impact of the MRA on, for example,
trade and cost reduction for manufacturers. However, the available information does give an
indication that the costs related to equipping a ship with the IMO Convention required marine
equipment  are  not  negligible  and  the  direct  costs  related  to  conformity  assessment  are
considerable for many types of marine equipment. To this must be added indirect costs related
to,  for  example,  time  to  market,  uncertainty  and  administrative  burdens,  which  the  MRA
should also reduce but are difficult to quantify. The data in Tables 2 and 3 above show that
the EU merchant fleet is much larger than that of the US, both in terms of existing ships and
those  under  completion.  This  could  be  seen  as  an  imbalance  to  the  disadvantage  of  EU
manufacturers  of  marine  equipment.  However,  this  needs  to  be  seen  in  the  overall  market
access  situation.  Furthermore,  the  Agreement  can  offer  both  EU  and  US  manufacturers  the
possibility of being more competitive on each other markets. This should not only be to the
advantage of EU marine equipment manufacturers,  but also EU  shipbuilders who should  be
able to reduce their costs (see above) and thus become more competitive on the world market.

In  this  context,  it  must  be  underlined  that  the  MRA  in  itself  will  not  guarantee  benefits  to
economic operators. It offers possibilities for facilitating market access and reduction of costs,
but  it  is  up  to  the  economic  operators  and  in  particular  manufacturers  to  exploit  the
possibilities offered. It should also be pointed out that the use of the Agreement by business is
voluntary.  The  relevant  European  industry  federation  have  all  given  their  support  for  the
MRA. The Commission therefore assesses that the Agreement, can offer substantial benefits
to manufacturers, in particular since it is based on equivalence between EU and US regulatory
requirements - a manufacturer can reach several markets on the basis of one approval and one
technical regulation.

With regard to the possible impact on EU regulatory objectives, the Agreement, in its Article
8, makes it very clear that the regulatory autonomy or authority of the Parties is not limited in
any way. The Parties are free to pursue their respective regulatory objectives and set the level

13

of protection they consider appropriate. The Agreement is based on equivalence between EU
and US technical regulations and it is from this the benefits to economic operators can accrue.
If equivalence is not maintained, e.g. due to regulatory changes, these benefits could be lost.
This could be perceived as acting as a deterrent for a Party to set a level of protection that is
higher  then  the  other  Party,  thus  not  allowing  for  equivalence  to  be  maintained.  The
Commission  assesses  that  this  is  very  unlikely  to  happen  for  the  following  reasons:  1)  as
stated  above,  the  Parties  maintain  their  regulatory  autonomy;  2)  both  the  EU  and  US  are
strongly  committed  to  basing  their  technical  regulations  on  the  rules  of  the  IMO;  3)
equivalence will be maintained on the basis of the amended regulations of one or both Parties,
thus the Agreement is affected, or not, on the basis these amendments and not the other way
around; 4) the MRA rests on a solid basis of regulatory co-operation.

As has been the experience with other MRAs concluded by the Community, co-operation has
not  only  led  to  greater  transparency  in  applicable  regulations,  but  also  an  exchange  of
knowledge  and  experience  between  regulators  which  hopefully  can  lead  to  better  use  of
regulatory resources and improved quality of regulations.

Furthermore,  the  Agreement  does  not  prejudice  or  compromise  the  enforcement  of  the
Parties’  respective  technical  regulations  on  their  territories.  The  two-way  alert  system
foreseen by Article 16 of the Agreement could even help in increasing the efficiency of, for
example, market surveillance activities, since more information on defective products would
be made available to enforcement authorities.

It should be noted that the Transatlantic Consumer Dialogue (TACD)2 has been quite critical
of  MRAs  in  general  and  the  concept  of  equivalence  of  technical  regulations.  The  main
objections raised by the TACD relates to that MRAs, as well as equivalence, could lead to: 1)
transfer of regulatory authority to foreign entities who may operate under different conflict of
interest,  transparency  and  liability  rules;  2)  privatisation  of  public  functions;  3)  loss  of
domestic  regulatory  control;  4)  reduced  levels  of  public  participation  in  the  regulatory
decision making process; 5) increased opportunities for regulatory evasion by industry; and 6)
reduction  in  levels  of  health,  safety  and  environmental  protection.  For  the  reasons  already
mentioned above, the Commission cannot share the conclusions drawn by the TACD.

Concerning the possible impact on EU regulatory objective, the Commission therefore assess
that the Agreement will not compromise the regulatory objectives of the MED, i.e. to enhance
safety at sea and improve the prevention of marine pollution. The Agreement will not have a
negative impact on the health and safety of crew, passengers or other persons or the marine
environment.

In  relation  to  the  possible  impact  on  other  interested  parties,  it  is  mainly  conformity
assessment  bodies  and  ship  builders  that  could  be  affected.  According  to  the  Impact
Assessment Form attached to this proposal, the MRA would offer EU conformity assessment
bodies (the notified bodies under the marine  equipment  directive)  the possibility of  offering
additional services to existing and new clients. However, the MRA could also mean that they
could loose some business since US exporters no longer have to use their services in order to
demonstrate  compliance  with  directive  96/98/EC.  As  mentioned  above,  EU  ship  builders

2 

The Transatlantic Consumer Dialogue is a forum of EU and US consumer organisations which develops
and  agrees  joint  consumer  policy  recommendations  to  the  US  government  and  European  Union  to
promote the consumer interest in EU and US policy making.

14

                                                
should  face  reduced  cost  for  marine  equipment  due  to,  inter  alia,  reduced  conformity
assessment costs and an increased competition between EU manufacturers and US exporters.

The  Commission  draws  the  overall  conclusion  that  the  Agreement  can  offer  substantial
benefits  to  economic  operators  in  terms  of  facilitating  trade  by  reducing  costs  and  burdens
related  to  conformity  assessment,  can  increase  transparency  and  predictability  in  relation  to
regulations,  will  promote  regulatory  co-operation  and  will  not  compromise  the  regulatory
objectives  of  the  MED,  i.e.  to  enhance  safety  at  sea  and  improve  the  prevention  of  marine
pollution.

V.

RELATIONS  TO  THE  EFTA  STATES,  MEMBERS  OF  THE  EUROPEAN  ECONOMIC
AREA

In  accordance  with  the  general  information  and  consultation  procedures  set  out  in  the  EEA
Agreement  and  its  Protocol  12,  the  Commission  has  kept  the  EFTA/EEA  States  regularly
informed about developments in the negotiations and has informed them of the final results of
the negotiations.

VI.

THE DRAFT COUNCIL DECISIONS

A proposal for two Council Decisions on the signature and the conclusion of the Agreement is
attached.

The legal basis for both decisions is Articles 133 and 300 of the Treaty.

The Decision concerning the conclusion of the Agreement must also establish the appropriate
Community  procedure  to  enable  the  Commission,  assisted  by  the  special  Committee  to  be
designated  by  the  Council,  to  represent  the  Community  in  the  Joint  Committee  and  in  any
Joint Working Groups that might be established.

VII.

CONCLUSIONS

For  the  reasons  outlined  in  this  explanatory  memorandum,  the  Commission  proposes  to  the
Council to adopt the two attached decisions.

15

2003/0078 (ACC)

Proposal for a

COUNCIL DECISION

on the signature on behalf of the Community of an Agreement between the European
Community and the United States of America on the Mutual Recognition of Certificates
of Conformity for Marine Equipment

THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Article 133, in conjunction with the first sentence of the first subparagraph of Article 300(2)
thereof,

Having regard to the proposal from the Commission,

Whereas:

(1) 

(2) 

The Commission has negotiated an Agreement between the European Community and
the United States of America on the Mutual Recognition of Certificates of Conformity
for Marine Equipment,

Subject  to  its  conclusion  at  a  later  date,  the  Agreement,  initialled  in  Brussels  on  21
March 2003, should be signed.

HAS DECIDED AS FOLLOWS:

Sole Article

The President of the Council is hereby authorised to designate the person empowered to sign,
on  behalf  of  the  Community,  the  Agreement  between  the  European  Community  and  the
United States of America on the Mutual Recognition of Certificates of Conformity for Marine
Equipment, subject to its conclusion at a later date.

Done in Brussels,

For the Council
The President

16

2003/0079 (ACC)

Proposal for a

COUNCIL DECISION

on the conclusion of an Agreement between the European Community and the United
States of America on the Mutual Recognition of Certificates of Conformity for Marine
Equipment

THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Article 133  in  conjunction  with  Article  300,  paragraph  2,  first  subparagraph,  first  sentence,
paragraph 3, fist subparagraph, first sentence, and paragraph 4 thereof,

Having regard to the proposal from the Commission3,

Whereas:

(1) 

The Agreement between the European Community and the United States of America
on the mutual recognition of certificates of conformity for marine equipment has been
signed, on behalf of the Community, on […], subject to its conclusion at a later date,

(2) 

The Agreement should be approved,

(3) 

The  appropriate  internal  procedures  should  be  established  to  ensure  the  good
functioning of the Agreement; it is therefore necessary to delegate to the Commission
the power to take certain decision for its implementation.

HAS DECIDED AS FOLLOWS:

Article 1

The Agreement between the European Community and the United States of America on the
mutual recognition of certificates of conformity for marine equipment is hereby approved on
behalf of the Community.

The text of the Agreement is attached to this Decision.

Article 2

The  President  of  the  Council  is  hereby  authorised  to  designate  the  person  empowered  to
transmit,  on  behalf  of  the  Community,  the  note  provided  for  in  Article  21(1)  of  the
Agreement.

3

OJ C , , p. .

17

                                                
Article 3

1.

2.

3.

The Commission, assisted by the special committee appointed by the Council, shall
represent  the  Community  in  the  Joint  Committee  provided  for  in  Article  7  of  the
Agreement and in any Working Group that may be established according to Article
7(4)  of  the  Agreement.  The  Commission  shall  proceed,  after  consultation  with  the
above-mentioned  special  committee,  to  the  notifications,  exchanges  of  information
and requests for information specified in the Agreement.

The  position  of  the  Community  with  regard  to  decisions  to  be  taken  by  the  Joint
Committee  shall  be  determined  by  the  Commission,  following  consultation  of  the
special committee..

A decision relating to terminating the Agreement according to Article 21(3) shall be
taken  by  the  Council,  acting  by  qualified  majority  on  a  proposal  from  the
Commission.

Done at Brussels,

For the Council
The President

18

ANNEX

Agreement

between the European Community and the United States of America on the
mutual recognition of certificates of conformity for marine equipment

Preamble

The  EUROPEAN  COMMUNITY,  and  the  UNITED  STATES  OF  AMERICA,
hereinafter referred to as "the Parties",

CONSIDERING  the  traditional  links  of  friendship  that  exist  between  the  United
States of America (U.S.) and the European Community (EC);

DESIRING  to  facilitate  bilateral  trade  in  marine  equipment  and  to  increase  the
effectiveness of each Party’s regulatory actions;

RECOGNISING  the  opportunities  offered  to  regulators  by  the  elimination  of
unnecessary duplication of their activities;

NOTING  the  shared  commitment  of  the  Parties  to  the  work  of  the  International
Maritime Organization (IMO);

CONSIDERING  that  the  aim  of  the  Parties  is  enhancing  safety  at  sea  and  the
prevention of marine pollution;

RECOGNISING, on the one hand, that mutual recognition agreements can positively
contribute to greater international harmonization of standards;

BEARING IN MIND, on the other hand, that the determination of equivalence must
ensure that the fulfilment of the regulatory objectives of the Parties is fully respected
and shall not lead to a lowering of their respective levels of safety and protection;

RECOGNISING  that  mutual  recognition  of  certificates  of  conformity  based  on  the
equivalence of EC and U.S. marine equipment regulations is an important means  of
enhancing market access between the Parties;

RECOGNISING  that  agreements  providing  for  mutual  recognition  are  of  particular
interest to small and medium-sized businesses in the U.S. and the EC;

RECOGNISING  that  any  mutual  recognition  also  requires  confidence  in  the
continued reliability of the other Party’s conformity assessments;

19

BEARING  IN  MIND  that  the  Agreement  on  Technical  Barriers  to  Trade,  an
agreement  annexed  to  the  Agreement  Establishing  the  World  Trade  Organization
(WTO),  encourages  WTO  Members  to  enter  into  negotiations  for  the  conclusion  of
agreements  for  the  mutual  recognition  of  results  of  each  other’s  conformity
assessment  procedures,  as  well  as  to  give  positive  consideration  to  accepting  as
equivalent  technical  regulation  of  other  Members,  provided  they  are  satisfied  that
these regulations adequately fulfil the objectives of their own regulations;

HAVE AGREED AS FOLLOWS:

20

1. 

(a)

(b)

(c)

(d)

(e)

(f)

2. 

Chapter 1 Definitions And Purpose

Article 1

Definitions

The following terms and definitions shall apply to this Agreement:

‘Regulatory  Authority’  means  a  government  agency  or  entity  that  has  the
authority  to  issue  regulations  regarding  issues  related  to  safety  at  sea  and
prevention of marine pollution, that exercises a legal right to control the use
or sale of marine equipment within a Party’s jurisdiction, and that may take
enforcement  action  to  ensure  that  products  marketed  within  its  jurisdiction
comply  with  applicable 
legal  requirements.  The  Parties’  respective
Regulatory Authorities are identified in Annex III.

‘Conformity  Assessment  Body’  means  a  legal  entity,  whether  a  Regulatory
Authority  or  a  other  body,  public  or  private,  that  has  the  authority  to  issue
Certificates  of  Conformity  under  a  Party’s  domestic  laws  and  regulations.
the  Parties  respective  Conformity
For  purposes  of 
Assessment Bodies are those referred to in Article 6.

this  agreement, 

‘Technical  regulations’  comprise  the  mandatory  product  requirements,
testing  and  performance  standards  and  conformity  assessment  procedures
laid down in the  legislative,  regulatory  and administrative provisions  of  the
Parties related to marine equipment, as well as any applicable guidelines for
their application.

‘Certificate  of  Conformity’  means  the  document  or  documents  issued  by  a
Conformity Assessment Body of a Party certifying that a product fulfils the
relevant legislative, regulatory and administrative requirements of that Party.
In  the  U.S.,  this  is  the  Certificate  of  Type  Approval  issued  by  the  United
States  Coast  Guard.  In  the  EC,  they  are  the  certificates,  approvals  and
declarations foreseen by Directive 96/98/EC.

‘Equivalence of technical regulations’ means that the technical regulations of
the Parties related to a specific product are sufficiently comparable to ensure
that  the  objectives  of  each  Parties’  respective  regulations  are  fulfilled.
Equivalence  of  technical  regulations  does  not  require  that  the  respective
technical regulations are identical.

‘International  Instrument’  means  the  relevant  international  conventions,
resolutions,  codes  and  circulars  of  the  International  Maritime  Organization
(IMO), and the relevant testing standards.

Other terms concerning conformity assessment used in this Agreement shall
have  the  meaning  given  elsewhere  in  this  Agreement  or  in  the  definitions
contained  in  Guide  2  (1996  edition)  of  the  International  Organization  for
Standardization  (ISO)  and  the  International  Electrotechnical  Commission
(IEC).  In  the  event  of  an  inconsistency  between  ISO/IEC  Guide  2  and
definitions in this Agreement, the definitions in this Agreement shall prevail.

21

Article 2

Purpose of the Agreement

1.

2.

3.

This Agreement establishes the conditions under which the importing Party’s
Regulatory  Authority  shall  accept  the  Certificates  of  Conformity  issued  by
the exporting Party’s Conformity Assessment Bodies in accordance with the
technical regulations of the exporting Party, hereinafter referred to as ‘mutual
recognition’.

This  Agreement  also  lays  down  a  framework  for  regulatory  co-operation
with the objective of maintaining and furthering mutual recognition between
the  EC  and  the  U.S.  of  their  respective  regulatory  requirements  for  marine
equipment;  of  encouraging  the  improvement  and  evolution  of  regulatory
requirements  for  the  purpose  of  enhancing  the  safety  at  sea  and  the
prevention of marine pollution; and ensuring a consistent application of this
Agreement.  This  co-operation  will  take  place  fully  respecting  the  Parties
regulatory  autonomy  and  their  evolving  policies  and  regulations  as  well  as
their  shared  commitment  to  the  evolution  of  the  relevant  International
Instruments.

This Agreement is intended to evolve as programs and policies of the Parties
evolve.  The  Parties  will  review  this  Agreement  periodically,  in  order  to
assess  progress  and  identify  potential  enhancements  to  this  Agreement  as
U.S. and EC policies evolve over time. Particular attention will also be given
to the evolution of the International Instruments.

22

Chapter 2 Mutual Recognition

Article 3

Basic Obligations

1.

2.

3.

1.

2.

With respect to each product listed in Annex II, the United States shall accept
as  complying  with  its  own  legislative,  regulatory  and  administrative
provisions  as  referred  to  in  Annex  I,  without  any  further  conformity
assessment,  Certificates  of  Conformity  issued  by  the  EC  Conformity
Assessment  Bodies  in  accordance  with  the  legislative,  regulatory  and
administrative provisions of the EC.

With  respect  to  each  product  listed  in  Annex  II,  the  European  Community
and its Member States shall accept as complying with their own legislative,
regulatory  and  administrative  provisions  as  referred  to  in  Annex  I,  without
any further conformity assessment, Certificates of Conformity issued by the
U.S.  Conformity  Assessment  Body  in  accordance  with  the  legislative,
regulatory and administrative provisions of the United States.

The  technical  regulations  applicable  in  the  U.S.  and  the  EC  to  each  such
product within the scope of this Agreement are specified in Annex II.

Article 4

Equivalence of Technical Regulations

The mutual recognition obligations referred to in Article 3 are based on the
determination by the Parties that the technical regulations applicable to each
product listed in Annex II are equivalent.

Determination of equivalence of technical regulations of the Parties shall be
based  on  their  implementation  of  the  relevant  International  Instruments  in
their respective legislation, regulations and administrative provisions, except
where a Party regards the Instrument would be an ineffective or inappropriate
means  of  fulfilment  of  its  regulatory  objectives.  In  the  latter  case,
equivalency shall be determined on a mutually acceptable basis.

Article 5

Marking

The  Parties  may  maintain  their  respective  requirements  with  regard  to  the  marking,
numbering and identification of products. With respect to the products listed in Annex
II,  the  EC  Conformity  Assessment  Bodies  shall  have  the  right  to  issue  the  marking
and numbering required by the U.S. legislation and regulations, as allocated to them
by the U.S. Coast Guard. The U.S. Conformity Assessment Body shall be  given the
identification  number  provided  for  in  Directive  96/98/EC,  as  allocated  to  it  by  the
European  Commission,  which  shall  be  affixed  next  to  the  marking  required  by  that
Directive.

23

1.

(a)

(b)

2.

(a)

(b)

3.

(a)

(b)

4.

5.

6.

Article 6

Conformity Assessment Bodies

For the purpose of issuing Certificates of Conformity in accordance with the
provisions of this Agreement, the following shall apply:

The U.S. recognises the Notified Bodies that have been designated by the EC
Member States under Directive 96/98/EC as Conformity Assessment Bodies;

The  EC  and  its  Member  States  recognise  the  United  States  Coast  Guard
together  with  the  laboratories  it  has  accepted  under  46  CFR  159.010,  as  a
Conformity Assessment Body.

Each  Party  recognises  that  the  Conformity  Assessment  Bodies  of  the  other
Party  are  authorised  to  perform  the  following  procedures  in  relation  to  the
legislative, regulatory and administrative provisions referred to in Annex I:

testing and issuing of test reports,

performing quality assurance functions or system certification.

The  Regulatory  Authorities  of  the  Parties  are  responsible  for  the  following
procedures,  but  may  delegate  some  or  all  of  these  functions  to  Conformity
Assessment Bodies:

reviewing equipment design and test results against identified standards,

issuing Certificates of Conformity.

Prior to the entry into force of this Agreement the Parties shall exchange their
respective  lists  of  Conformity  Assessment  Bodies.  The  Parties  shall  inform
each  other  promptly  of  any  changes  to  their  list  of  Conformity  Assessment
Bodies. The Parties shall maintain on the World Wide Web up-dated lists of
their Conformity Assessment Bodies.

Each Party shall require that its Conformity Assessment Bodies to record and
retain  details  of  their  investigations  of  the  competence  and  compliance  of
their  sub-contractors  and  maintain  a  register  of  all  sub-contracting.  These
details will be available to the other Party on request.

Each Party shall require that its Conformity Assessment Bodies, upon request
of  a  Regulatory  Authority  of  the  other  Party  listed  in  Annex  III,  make
available  to  the  Regulatory  Authorities,  copies  of  the  Certificates  of
Conformity and related technical documentation they have issued.

24

Chapter 3 Joint Committee

Article 7

Joint Committee

1.

2.

3.

(a)

(b)

(c)

(d)

(e)

(f)

4.

The Parties hereby establish a Joint Committee consisting of representatives
of  each  Party.  The  Joint  Committee  shall  be  responsible  for  the  effective
functioning of the Agreement.

Each Party shall have one vote in the Joint Committee. The Joint Committee
shall make its decisions by unanimity. The Joint Committee shall determine
its own rules of procedure.

The  Joint  Committee  may  consider  any  matter  relating  to  the  effective
functioning of this Agreement. The Joint Committee shall have the authority
to  take  decisions  in  the  cases  provided  for  in  this  Agreement.  The  Parties
shall  take  the  necessary  measures  to  implement  such  decisions  of  the  Joint
Committee. In particular, the Joint Committee shall be responsible for:

developing  and  maintaining  the  list  in  Annex  II  of  products  and  associated
legislative,  regulatory  and  administrative  provisions  that  the  Parties  have
determined to be equivalent;

discussing  issues  and  resolving  problems  that  may  arise  concerning  the
implementation  of  this  Agreement,  including  concerns  that  technical
regulations of the Parties applicable to a specific product in Annex II may no
longer be equivalent;

addressing  technical,  conformity  assessment  and  technology  issues  in  order
to ensure a consistent application of this Agreement, in particular in relation
to the relevant International Instruments;

amending the Annexes;

providing guidance and, if necessary, developing  guidelines to facilitate the
successful implementation and application of this Agreement;

establish  and  maintain  a  work  plan  for  aligning  and  harmonizing  the
technical requirements of the Parties;

The  Joint  Committee  may  establish  Joint  Working  Groups  comprised  of
appropriate  Regulatory  Authorities’  representatives  and  appropriate  experts
deemed  necessary,  in  order  to  address  and  advise  the  Joint  Committee  on
specific issues related to the functioning of this Agreement.

25

Chapter 4 Regulatory Co-operation

Article 8

Preservation of Regulatory Authority

Nothing  in  this  Agreement  shall  be  construed  to  limit  the  authority  of  a  Party  to
determine, through its legislative, regulatory and administrative measures, the level of
protection  it  considers  appropriate  for  enhancing  safety  at  sea  and  improving  the
prevention of marine pollution, or otherwise act with regard to risks within the scope
of this Agreement.

1.

2.

3.

4.

1.

2.

Article 9

Exchange of Information and Contact Points

The  Regulatory  Authorities  of  the  Parties  listed  in  Annex  III  will  establish
appropriate  means  of  exchanging  information  on  any  regulatory  problems
concerning products subject to this Agreement.

Each  Party  shall  designate  at  least  one  contact  point,  which  may  be  the
Regulatory  Authorities  listed  in  Annex  III,  to  provide  answers  to  all
reasonable inquiries from the other Party and other interested parties such as
manufacturers,  consumers,  trade  unions,  regarding  procedures,  regulations,
and other matters related to this Agreement. The Parties shall exchange, and
make publicly available, lists of contact points.

With  regard  to  the  exchange  of  information  and  notifications  under  this
Agreement  a  Party  shall  have  the  right  to  communicate  in  its  official
language or languages. If a Party deems that information it receives must be
translated  into  its  official  language  or  languages,  that  Party  shall  undertake
the necessary translation and bear the cost.

Each  Party  agrees  to  make  available  to  the  public  its  list  of  products    for
which it has issued Certificates of Conformity under its respective legislative,
regulatory and administrative provisions on the World Wide Web and update
it on a regular basis.

Article 10

Regulatory Changes

When a Party introduces new technical regulations related to this Agreement,
it shall do so on the basis of existing International Instruments, except when
a  Party  considers  the  Instrument  would  be  an  ineffective  or  inappropriate
means for fulfilment of its regulatory objectives.

Each  Party  shall  notify  the  other  Party  of  changes  to  technical  regulations
related to the subject matter  of  this Agreement  at least 90  days before  their
entry  into  force.  Where  considerations  of  safety,  health  or  environmental
protection require more urgent action, a Party shall notify the other Party as
soon as practicable.

26

3.

(a)

(b)

(c)

The  Parties  and  their  Regulatory  Authorities  shall  inform  and  consult  with
one another, as permitted by their respective laws and regulations, on:

proposals  to  amend  or  introduce  new  technical  regulations  as  laid  down  in
their respective legislative, regulatory and administrative provisions referred
in, or related to, provisions listed in Annexes I and II;

timely incorporation of amended or new international instruments  into their
respective legislation, regulations and administrative provisions; and

the  renewal  of  existing  and  valid  Certificates  of  Conformity    when  the
renewal  is  required  by  amended  or  new  legislative,  regulatory  and/or
administrative provisions.

The Parties will provide each other the opportunity to comment on such proposals.

4.

In  the  event  of  changes  to  the  legislation,  regulations,  and  administrative
provisions referred to in Annex I and II, the Joint Committee shall consider
whether  or  not  the  equivalence  of  the  technical  regulations  with  respect  to
products listed in Annex II has been maintained.

If it is agreed in the Joint Committee that equivalence is maintained, then the product
shall be retained in Annex II.

If  it  is  agreed  in  the  Joint  Committee  that  equivalence  cannot  be  maintained,
references  to  products  and  the  relevant  technical  regulations  for  which  equivalence
cannot  be  maintained  shall  be  removed  from  Annex  II.  The  Joint  Committee  shall
update  Annex  II  by  a  decision  to  reflect  the  changes.  Upon  the  discontinuance  of
mutual recognition, the Parties are no longer bound by the  obligations referred  to in
Article  3  of  this  Agreement  for  the  specific  product.  However,  the  importing  Party
shall continue to recognize previously-issued Certificates of Conformity for products
that have been placed on the market of that Party prior to the discontinuance of mutual
recognition,  unless  a  Regulatory  Authority  in  the  Party  decides  otherwise  based  on
health, safety or environmental considerations or failure to satisfy other requirements
within the scope of the Agreement.

If the Parties, within the Joint Committee, cannot agree on whether or not equivalence
of  their  technical  regulations  with  respect  to  a  product  listed  in  Annex  II  is
maintained,  then  mutual  recognition  with  respect  to  that  product  shall  be  suspended
according to the terms of Article 15.

5.

1.

The  Parties  shall  make  available  on  the  World  Wide  Web  an  up-to-date
version of Annex II.

Article 11

Regulatory Co-operation

The Parties  agree  to  co-operate  in  the  IMO  and  other  relevant  international
organisation  such  as  the  International  Organization  for  Standardization
the
(ISO), 
International Telecommunications Union (ITU),  with  a  view to  establishing

the  International  Electrotechnical  Commission  (IEC)  and 

27

2.

3.

4.

1.

2.

and  improving  international  rules  for  enhancing  the  safety  at  sea  and  the
prevention of marine pollution.

The  Parties  will  consider  what  technical  work,  data  and  information
exchange,  scientific  and  technological  co-operation  or  other  co-operative
activities can be pursued between them with a view to improving the quality
and  level  of  their  technical  regulations  applicable  to  marine  equipment  and
making efficient use of resources for regulatory development.

For products that are not included in Annex II upon entry into force of this
Agreement  or  for  which  equivalence  of  technical  regulations  has  been
discontinued or suspended, the Parties undertake to examine their respective
technical  regulations  with  a  view  to  establishing,  to  the  extent  possible,
mutual recognition.  The Parties will  set  out  a  work  program  and  time-table
for  alignment  of  their  technical  regulations,  including  the  initiation  of
appropriate international standards work. The Parties shall endeavour to align
their  technical  regulations  to  the  extent  possible  on  the  basis  of  existing
International  Instruments  in  pursuit  of  the  objective  of  their  domestic
legislation  to  enhance  safety  at  sea  and  improve  the  prevention  of  marine
pollution.

When the Parties have determined that equivalence can be  established for  a
product and associated legislative,  regulatory and  administrative provisions,
the Joint Committee shall take a decision to amend Annex II accordingly.

Article 12

Co-operation on Conformity Assessment

The Parties and their authorities responsible for conformity assessment issues
shall  consult  as  necessary  to  ensure  the  maintenance  of  confidence  in
conformity assessment procedures and Conformity Assessment Bodies. This
can  take  the  form  of,  for  example,  comparison  of  methods  to  verify  and
monitor  the  technical  competence  and  ability  of  Conformity  Assessment
Bodies,  and,  with  the  consent  of  both  Parties,  joint  participation  in
audits/inspections  related  to  conformity  assessment  activities  or  other
assessment of Conformity Assessment Bodies.

The Parties shall encourage their Conformity Assessment Bodies to take part
in  co-ordination  and  co-operation  activities  organised  by  the  Parties  either
separately or jointly.

28

Chapter 5 Surveillance and Safeguard Measures

Article 13

Surveillance of Conformity Assessment Bodies

The Parties shall ensure that their Conformity Assessment Bodies are capable
and  remain  capable  of  properly  assessing  conformity  of  products  or
regulations  and
processes,  according 
administrative provisions. In this regard, the Parties shall maintain, or cause
to  maintain,  ongoing  surveillance,  as  applicable,  over  their  conformity
assessment bodies and/or recognised laboratories, by means of regular audit
or assessment.

the  applicable 

legislation, 

to 

In case a Party has objective reasons for contesting the technical competence
of a Conformity Assessment Body of the other Party, it shall inform the other
Party  thereof.  Such  contestation  shall  be  exercised  when  justified  in  an
objective  and  reasoned  manner.  The  other  Party  shall  in  a  timely  manner
present  information  in  order  to  refute  the  contestation  or  to  correct  the
deficiencies which form the basis of the contestation. If necessary the matter
shall be discussed in the Joint Committee. If agreement cannot be reached on
the competency of the Conformity Body, the contesting Party may refuse to
grant its marking and/or numbering to the contested Conformity Assessment
Body  and  refuse  to  recognise  the  Certificates  of  Conformity  issued  by  the
contested Conformity Assessment Body.

Article 14

Market Surveillance

Nothing  in  this  Agreement  shall  be  construed  to  limit  the  authority  of  a
Regulatory  Authority  to  take  all  appropriate  and  immediate  measures
whenever it ascertains that a product may:

although  correctly  installed,  maintained  and  used  for  its  intended  purpose,
compromise  the  health  and/or  safety  of  the  crew,  the  passengers  or,  where
applicable, other persons, or adversely affect the marine environment;

not  meet  the  legislative,  regulatory,  or  administrative  provisions  within  the
scope of the Agreement; or

1.

2.

1.

(a)

(b)

(c)

otherwise fail to satisfy a requirement within the scope of the Agreement.

Such  measures  may  include  withdrawing  the  products  from  the  market,  prohibiting
their  placement  on  the  market,  restricting  their  free  movement,  initiating  a  product
recall,  and  preventing  the  recurrence  of  such  problems,  including  through  a
prohibition on imports. If the Regulatory Authority takes such action, it shall inform
the other Party no later than fifteen days of taking such action, providing its reasons
for such action.

29

2.

3.

1.

2.

3.

Nothing in this Agreement shall prevent the Parties from removing products
from  the  market  that  do  not  in  fact  conform  to  a  Parties’  technical
regulations.

The  Parties  agree  that  any  applicable  border  inspections  and  checks  of
products which  have  been  certified,  labelled  or  marked  as  conforming  with
the importing  Party’s requirements specified  in Annex  I shall be  completed
as  expeditiously  as  possible.  With  regard  to  any  inspections  related  to
internal  movement  within  their  respective  territories,  the  Parties  agree  that
these  shall  be  completed  in  no  less  a  favourable  manner  than  for  like
domestic products.

Article 15

Suspending Mutual Recognition

In  case  a  Party  considers  that  equivalence  of  technical  regulations  with
respect to one or more products listed in Annex II is not being or cannot be
maintained,  it  shall  inform  the  other  Party  thereof  and  give  the  objective
reasons  for  this.  Any  contestation  of  equivalence  shall  be  discussed  in  the
Joint Committee. If no decision is reached by the Joint Committee within 60
days  of  the  referral  to  it  the  mutual  recognition  obligation  with  respect  to
such  products  shall  be  suspended  by  one  or  both  Parties.  The  suspension
shall  remain  in  effect  until  agreement  has  been  reached  by  the  Joint
Committee.

The  Joint  Committee  shall  update  Annex  II  by  a  decision  to  reflect  the
suspension  of  mutual  recognition  for  the  products  in  question.  The  Parties
agree  to  co-operate  according  to  the  terms  of  Article  11  in  view  of
establishing equivalence again, to the extent possible.

Upon suspension of mutual recognition of technical regulations referred to in
Annex  II  the  Parties  are  no  longer  bound  by  the  obligations  referred  to  in
Article 3 of this Agreement for the specific product. However, the importing
Party shall continue to recognize previously-issued certificates of conformity
for  products  that  have  been  placed  on  the  market  of  that  Party  prior  to  the
suspension of mutual recognition, unless a Regulatory Authority in the Party
decides otherwise based on health, safety or environmental considerations or
failure to satisfy other requirements within the scope of the Agreement.

Article 16

Alert System

The  Parties  will  put  into  place  a  two-way  alert  system  between  their  Regulatory
Authorities  in  order  to  inform  each  other  of  products  that  have  been  found  not  to
comply  with  applicable  technical  regulations  or  can  pose  an  imminent  danger  to
health, safety or the environment.

30

Chapter 6 Additional Provisions

Article 17

Confidentiality

1.

2.

3.

Each  Party  agrees  to  maintain,  to  the  extent  required  under  its  laws,  the
confidentiality of information exchanged under this Agreement. In particular,
neither  Party  shall  disclose  to  the  public,  nor  permit  a  Conformity
Assessment Body  to disclose,  information exchanged under  this  Agreement
that  constitutes 
financial
trade  secrets,  confidential  commercial  or 
information, or information that relates to an ongoing investigation.

A  Party  or  a  Conformity  Assessment  Body  may,  upon  exchanging
information with the other Party or with a  Conformity Assessment  Body of
the other Party, designate the portions of the information that it wishes to be
exempt from disclosure.

Each  Party  shall  take  all  precautions  reasonably  necessary  to  protect
information exchanged under this Agreement from unauthorised disclosure.

Article 18

Fees

Each  Party  shall  endeavour  to  ensure  that  fees  imposed  for  services  related  to  the
subject matter  of  this Agreement shall be commensurate with  the  services  provided.
Each Party shall ensure that, for conformity assessment procedures covered under this
Agreement,  it  shall  charge  no  fees  with  respect  to  conformity  assessment  services
provided by the other Party.

Article 19

Territorial Application

1.

2.

1.

This Agreement  shall apply, on  the  one  hand  to the  territories  in  which  the
Treaty  establishing  the  European  Community  is  applied,  and  under  the
conditions laid down in that Treaty and, on the other hand, to the territory of
the United States.

Without prejudice to paragraph 1, this Agreement applies to ships entitled to
fly the flag of either Party, or one of the Parties’ Member States, operating in
international voyages.

Article 20

Agreements with other Countries

Except  where  there  is  written  agreement  between  the  Parties,  obligations
contained in mutual recognition agreements concluded by either Party with a

31

party not a signatory to this Agreement (a third party) shall have no force and
effect with regard to the other Party in terms of acceptance of the results of
conformity assessment procedures in the third party.

2.

In  view  of  furthering  trade  facilitation  in  marine  equipment  with  other
countries,  the  EC  and  the  U.S.  undertake  to  examine  the  possibility  of
establishing  a  multilateral  agreement  on  the  subject  matter  covered  by  this
Agreement with other interested countries.

32

Chapter 7 Final Provisions

Article 21

Entry into force, amendments and termination

This  Agreement  shall  enter  into  force  on  the  first  day  of  the  second  month
following  the  date  on  which  the  Parties  have  exchanged  letters  confirming
the completion of their respective procedures for the entry into force of this
Agreement.

This Agreement may be amended as specified in Article 7 or by the Parties.

Either  Party  may  terminate  this  Agreement  by  giving  the  other  Party  six
months notice in writing.

Following termination of the Agreement, a Party shall continue to accept the
Certificates  of  Conformity  issued  by  Conformity  Assessment  Bodies  under
this  Agreement  prior  to  termination,  unless  a  Regulatory  Authority  in  the
Party  decides  otherwise  based  on  health,  safety  and  environmental
considerations or failure to satisfy other requirements within the scope of the
Agreement.

Article 22

Final Provisions

This  Agreement  shall  not  affect  the  rights  and  obligations  of  the  Parties
under any other international agreement.

The Parties will review the functioning of this Agreement on a regular basis,
the first time no later than two years after its entry into force.

This Agreement is drawn up in two originals in the Danish, Dutch, English,
Finnish,  French,  German,  Greek,  Italian,  Portuguese,  Spanish  and  Swedish
languages, each text being equally authentic. In the event of inconsistencies
of interpretation, the English text shall be determinative.

1.

2.

3.

4.

1.

2.

3.

Done at…….., this……..day of……

For the European Community

For the United States of America

33

Annex I

Legislation, Regulations and Administrative Provisions

– 

EC legislation, regulations and administrative provisions:

Council Directive 96/98/EC of 20 December 1996 on marine equipment, as amended.

The Parties recognise  that the “Guide  to  the  Implementation of  Directives  Based  on
the  New  Approach  and  Global  Approach”  provides  useful  guidelines  for  the
implementation  of  in  particular  conformity  assessment  procedures  falling  under  this
Directive.

– 

U.S. legislation, regulations and administrative provisions:

46 U.S.C. 3306

46 CFR Parts 159 to 165

34

Annex II

Product Coverage For Mutual Recognition

Life saving appliances

Product item identification

Lifebuoy self-activating smoke signals
(pyrotechnics)

Note: Expiration date not to exceed 48
months after month of manufacture.
Rocket parachute flares (pyrotechnics)

Note: Expiration date not to exceed 48
months after month of manufacture.
Hand flares (pyrotechnics)

Note: Expiration date not to exceed 48
months after month of manufacture.
Buoyant smoke signals (pyrotechnics)

Note: Expiration date not to exceed 48
months after month of manufacture.

Applicable international instruments for construction,
performance and testing requirements4

LSA Code, sections 1.2, and 2.1.3;
Recommendation on Testing, Part 1, paragraphs 4.1 to 4.5, and 4.8,
and Part 2, section 4;
IMO MSC Circ.980, section 3.3.

EC technical regulations,
item number indicated in
Annex A.1 of directive
98/96/EC, as amended

A.1/1.3

LSA Code, sections 1.2, and 3.1;
Recommendation on Testing, Part 1, paragraphs 4.1 to 4.6, and Part 2,
section 4;
IMO MSC Circ.980, section 3.1.

LSA Code, sections 1.2, and 3.2;
Recommendation on Testing, Part 1, paragraphs 4.1 to 4.5, and 4.7,
and Part 2, section 4;
IMO MSC Circ.980, section 3.2.

LSA Code, sections 1.2, and 3.3;
Recommendation on Testing, Part 1, paragraphs 4.1 to 4.5, and 4.8;
and Part 2, section 4;
IMO MSC Circ.980, section 3.3.

A.1/1.8

A.1/1.9

A.1/1.10

U.S. technical regulations

Guidelines for Approval of
“SOLAS” Pyrotechnic Devices,
October 1998

Guidelines for Approval of
“SOLAS” Pyrotechnic Devices,
October 1998

Guidelines for Approval of
“SOLAS” Pyrotechnic Devices,
October 1998

Guidelines for Approval of
“SOLAS” Pyrotechnic Devices,
October 1998

4 

(IMO  Resolution  MSC.48(66)).
"LSA  Code" 
   "Recommendation  on  Testing"  refers  to  the  IMO  recommendation  on  Testing  of  Life-Saving  Appliances  adopted  on  6  November  1991  (IMO  Resolution  A.689(17))  as
amended on 11 December 1998 (IMO Resolution MSC.81(70).

Life-Saving  Appliance  Code 

International 

adopted 

refers 

1996 

June 

the 

on 

to 

4 

35

                                                
Product item identification

Applicable international instruments for construction,
performance and testing requirements4

Line-throwing appliances (pyrotechnics)

Note: Expiration date not to exceed 48
months after month of manufacture.
Rigid liferafts

Note: The emergency pack is not covered
by the Agreement

Automatically self-righting rigid liferafts

Note: The emergency pack is not covered
by the Agreement

Canopied reversible rigid liferafts

Note: The emergency pack is not covered
by the Agreement

Float-free arrangements for liferafts
(hydrostatic release units)

LSA Code, sections 1.2, and 7.1;
Recommendation on Testing, Part 1, section 9; and Part 2, section 4;
IMO MSC Circ.980, section 7.1.

LSA Code, sections 1.2, 4.1 and 4.3;
Recommendation on Testing, Part 1, paragraphs 5.1 to 5.16, and 5.20;
IMO MSC Circ.811;
IMO MSC Circ.980, section 4.2;
IMO MSC Circ.1006 or other appropriate standard for hull or fire-
retardant covering.
LSA Code, sections 1.2, 4.1 and 4.3;
Recommendation on Testing, Part 1, paragraphs 5.1 to 5.16, and 5.18
to 5.21;
IMO MSC Circ.809;
IMO MSC Circ.811;
IMO MSC Circ.980, section 4.2;
IMO MSC Circ.1006 or other appropriate standard for hull or fire-
retardant covering.
LSA Code, sections 1.2, 4.1 and 4.3;
Recommendation on Testing, Part 1, paragraphs 5.1 to 5.16, 5,18, and
5.21;
IMO MSC Circ.809;
IMO MSC Circ.811;
IMO MSC Circ.980, section 4.2;
IMO MSC Circ.1006 or other appropriate standard for hull or fire-
retardant covering.
LSA Code, sections 1.2 and 4.1.6.3;
Recommendation on Testing, Part 1, section 11;
IMO MSC Circ.980, section 4.3.1;

EC technical regulations,
item number indicated in
Annex A.1 of directive
98/96/EC, as amended

A.1/1.11

A.1/1.13

A.1/1.14

A.1/1.15

U.S. technical regulations

Guidelines for Approval of
“SOLAS” Pyrotechnic Devices,
October 1998

Rigid Liferaft – Coast Guard
(G-MSE-4) Review Checklist,
27 July 1998

Rigid Liferaft – Coast Guard
(G-MSE-4) Review Checklist,
27 July 1998

Rigid Liferaft – Coast Guard
(G-MSE-4) Review Checklist,
27 July 1998

A.1/1.16

46 CFR 160.062

36

Product item identification

Applicable international instruments for construction,
performance and testing requirements4

Release mechanism for

a.  Lifeboats and rescue boats and
b.  Liferafts

Launched by a fall or falls

LSA Code, sections 1.2 and 6.1.5;
Recommendation on Testing, Part 1, section 8.2;
and Part 2, paragraphs 6.2.1 through 6.2.4;
IMO MSC Circ.980, section 6.1.3.

EC technical regulations,
item number indicated in
Annex A.1 of directive
98/96/EC, as amended

A.1/1.26

U.S. technical regulations

(Nothing in addition to
international instruments)

Limited to Davit-launched liferaft
automatic release hook
Marine evacuation systems

LSA Code, sections 1.2 and 6.2;
Recommendation on Testing, Part 1, section 12,
IMO MSC Circ.980, section 6.2.

A.1/127

(Nothing in addition to
international instruments)

37

Fire protection
Product item identification

Primary Deck coverings

“A” and “B” Class division fire integrity,
including:

Bulkheads (without windows)

Decks

Fire doors (with windows no larger

than 645 cm2)

Ceilings and linings

Non-combustible materials

Fire doors

Limited to fire doors without windows or
with total window area no more than 645
cm2 in each door leaf.
Approval limited to maximum door size
tested.
Doors must be used with a fire tested
frame design.

Applicable international instruments for construction,
performance and testing requirements*

FTP Code Annex 1, Parts 2 & 6, Annex 2;
IMO Resolution A.687(17);
MSC/Circ. 916;
MSC/Circ. 1004.
SOLAS II-2/3.2; II-2/3.4;
FTP Code Annex 1, Part 3, and Annex 2;
IMO Resolution A.754 (18);
MSC/Circ.916;
MSC/Circ.1004;
MSC/Circ.1005.

EC technical regulations,
item number indicated in
Annex A.1 of directive
98/96/EC, as amended

A.1/3.1

U.S. technical regulations

(Nothing in addition to
international instruments)

A.1/3.11

(Nothing in addition to
international instruments)

SOLAS II-2/3.33;
FTP Code Annex 1, Part 1, and Annex 2.
SOLAS II-2/9.4.1.1.2, II-2/9.4.1.2.1, and II-2/9.4.2;
FTP Code Annex 1, Part 3;
IMO Resolution A.754 (18);
MSC/Circ. 916;
MSC/Circ. 1004.

A.1/3.13

A.1/3.16

(Nothing in addition to
international instruments)
(Nothing in addition to
international instruments)

38

Product item identification

Applicable international instruments for construction,
performance and testing requirements*

Fire door control systems

Surface materials and floor coverings with
low flame-spread characteristics

Limited to exposed surfaces of ceilings,
walls, and floors.  Does not apply to pipes,
pipe coverings, or cables.

Draperies, curtains and other suspended
textile materials and films

Upholstered furniture

Bedding components

Fire dampers

Penetrations through ‘A’ class divisions by
electric cables, pipes, trunks, ducts etc.

Penetrations through ‘B’ class divisions by
pipes other than steel or copper

SOLAS II-2/9.4.1.1.4;
1994 HSC Code 7.9.3.3;
2000 HSC Code 7.9.3.3;
FTP Code Annex 1, Part 4.
SOLAS II-2/3.29;
1994 HSC Code 7.4.3.4.1 and 7.4.3.6;
2000 HSC Code 7.4.3.4.1 and 7.4.3.6;
FTP Code, Annex 1, Parts 2  & 5, and Annex 2;
IMO Resolution A.653 (16);
ISO 1716 (1973);
MSC/Circ. 916, MSC/Circ. 1004 and MSC/Circ. 1008.
SOLAS II-2/3.40.3;
FTP Code Annex 1, Part 7.
FTP Code Annex 1, Part 8;
IMO Resolution A.652 (16).
FTP Code Annex 1, Part 9;
IMO Resolution A.688 (17).
SOLAS II-2/9.4.1.1.8, and II-2/9.7.3.1.2;
FTP Code Annex 1, Part 3;
IMO Resolution A.754 (18);
MSC/Circ. 916.
SOLAS II-2/9.3.1;
FTP Code Annex 1, Part 3;
IMO Resolution A.754 (18);
MSC/Circ. 916, and MSC/Circ. 1004.
SOLAS II-2/9.3.2.1;
FTP Code Annex 1, Part 3;
IMO Resolution A.754 (18);
MSC/Circ. 916, and MSC/Circ. 1004.

39

EC technical regulations,
item number indicated in
Annex A.1 of directive
98/96/EC, as amended

A.1/3.17

U.S. technical regulations

(Nothing in addition to
international instruments)

A.1/3.18

(Nothing in addition to
international instruments)

A.1/3.19

A.1/3.20

A.1/3.21

A.1/3.22

A.1/3.26

A.1/3.27

(Nothing in addition to
international instruments)

(Nothing in addition to
international instruments)
(Nothing in addition to
international instruments)
(Nothing in addition to
international instruments)

(Nothing in addition to
international instruments)

(Nothing in addition to
international instruments)

Navigation equipment
Product item identification

Magnetic compass

Transmitting magnetic heading device
(TMHD)

Gyrocompass

Echo-sounding equipment

Speed and distance measuring equipment
(SDME)

Rate of turn indicator

Loran-C equipment

Applicable international instruments for construction,
performance and testing requirements*

SOLAS V/19.2.1.1;
IMO Resolution A.382 (X),;
IMO Resolution A.694 (17);
ISO 449 (1997), ISO 694 (2000), ISO 1069 (1973), ISO 2269 (1992),
IEC 60945 (1996).
IMO Resolution MSC 86 (70) annex 2;
IMO Resolution A.694 (17);
ISO 11606 (2000), IEC 60945 (1996), IEC 61162.

IMO Resolution A.424 (XI);
IMO Resolution A.694 (17);
ISO 8728 (1997), IEC 60945 (1996), IEC 61162.

IMO Resolution A.224 (VII) as amended by
IMO Resolution MSC74 (69) Annex 4, IMO Resolution A.694 (17);
ISO 9875 (2000), IEC 60945 (1996), IEC 61162.

1994 HSC Code 13.3.2;
2000 HSC Code 13.3.2;
IMO Resolution A.824 (19) as amended
IMO Resolution MSC 96(72);
IMO Resolution A.694 (17);
IEC 60945 (1996), IEC 61023 (1999), IEC 61162.
IMO Resolution A.694 (17);
IMO Resolution A.526 (13);
IEC 60945 (1996), IEC 61162.
IMO Resolution A.694 (17);
IMO Resolution A.818 (19);
IEC 61075 (1991), IEC 60945 (1996), IEC 61162.

40

EC technical regulations,
item number indicated in
Annex A.1 of directive
98/96/EC, as amended

A.1/4.1

A.1/4.2

A.1/4.3

A.1/4.6

A.1/4.7

A.1/4.9

A.1/4.11

U.S. technical regulations

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.101.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.102.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.103.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.107.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.105.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.106.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.135.

Product item identification

Applicable international instruments for construction,
performance and testing requirements*

EC technical regulations,
item number indicated in
Annex A.1 of directive
98/96/EC, as amended

U.S. technical regulations

Chakya equipment

GPS equipment

GLONASS equipment

Heading control system HCS

Automatic radar plotting aid (ARPA)

(Radar equipment used with ARPA must
have separate EU and U.S. certifications.)
Automatic Tracking Aid (ATA)

(Radar equipment used with ATA must
have separate EU and U.S. certifications.)

Electronic Plotting Aid (EPA)

(Radar equipment used with EPA must
have separate EU and U.S. certifications.)
Integrated bridge system

IMO Resolution A.694 (17);
IMO Resolution A.818 (19);
IEC 61075 (1991), IEC 60945 (1996), IEC 61162.

IMO Resolution A.819 (19), IMO Resolution A.694 (17);
IEC 60945 (1996), IEC 61108-1 (1994), IEC 61162.

IMO Resolution MSC 53 (66);
IMO Resolution A.694 (17);
IEC 61108-2 (1998), IEC 60945 (1996), IEC 61162.

SOLAS V/24.1;
IMO Resolution A.342 (IX);
as amended by  IMO Resolution MSC 64 (67) Annex 3;
IMO Resolution A.694 (17);
ISO 11674 (2000), IEC 60945 (1996), IEC 61162.
IMO Resolution A.823 (19);
 IMO Resolution A.694 (17);
IEC 60872-1 (1998), IEC 61162.

IMO Resolution MSC 64(67), Annex 4, Appendix 1;
IMO Resolution A.694 (17);
IEC 60872-2 (1999), IEC 60945 (1996), IEC 61162.

IMO Resolution MSC 64(67), Annex 4, Appendix 2;
IMO Resolution A.694 (17);
IEC 60872-3 (2000), IEC 60945 (1996), IEC 61162.

IMO Resolution MSC.64 (67) Annex 1;
IMO Resolution A.694 (17);
IEC  61209 (1999), IEC 60945 (1996), IEC 61162.

41

A.1/4.12

A.1/4.14

A.1/4.15

A.1/4.16

A.1/4.34

A.1/4.35

A.1/4.36

A.1/4.28

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.136.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.130.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.131.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.110.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.120.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.111.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.121.

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.140.

Product item identification

Applicable international instruments for construction,
performance and testing requirements*

EC technical regulations,
item number indicated in
Annex A.1 of directive
98/96/EC, as amended

U.S. technical regulations

Voyage data recorder

Gyro compass for high speed craft

Universal Automatic Identification System
equipment (AIS)

IMO Resolution A.861(20);
IMO Resolution A.694 (17);
IEC 61996 (2000), IEC 60945 (1996), IEC 61162.
IMO Resolution A.821 (19);
IMO Resolution A.694 (17);
ISO 16328 (2001), IEC 60945 (1996), IEC 61162.
IMO Resolution MSC.74 (69) Annex 3;
IMO Resolution A.694 (17);
ITU R. M. 1371-1 (10/00)
IEC 61993-2 (2002), IEC 60945 (1996),  IEC 61162

Track control system

Radar reflector

IMO Resolution MSC.74 (69) Annex 2;
IMO Resolution A.694 (17);
IEC 62065 (2002), IEC 60945 (1996), IEC 61162.
IMO Resolution A.384 (X);
IEC 60945 (1996), ISO 8729 (1997).

A.1/4.29

A.1/4.31

A.1/4.32

A.1/4.33

A.1/4.39

Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.150.
Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.203.
Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.155.
NOTE:  In addition, the radio
transmitter is required to be
authorized by the U.S. Federal
Communications Commission
Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.112.
Navigation and Vessel
Inspection Circular NVIC 8-01,
enclosure (4), 2/165.160.

42

Annex III

Regulatory Authorities

– 

European Community

Belgium

Denmark

Germany

Greece

Spain

France

Ireland

Ministère des Communications et de l'Infrastructure
Administration des Affaires maritimes et de la
Navigation
Rue d'Arlon 104
1040 Bruxelles

Ministerie voor Verkeer en Infrastructuur
Bestuur voor Maritime zaken en Scheepvaart
Aarlenstraat 104
1040 Brussel

Søfartsstyrelsen
Vermundsgade 38 C
2100 København Ø

Bundesministerium für Verkehr,
Bau- und Wohnungswesen (BMVBW)
Invalidenstraße 44
10115 Berlin

ΥΠΟΥΡΓΕΙΟ ΕΜΠΟΡΙΚΗΣ ΝΑΥΤΙΛΙΑΣ
Γρ.Λαµπράκη 150
185 18 Πειραιας Ελλάς

Ministry of Merchant Marine
150,Gr. Lampraki str.
185 18 Piraeus

Ministerio De Fomento
Dirección General de la Marina Mercante.
C/ Ruíz de Alarcón 1
ES-28071 Madrid

Le Ministère de l'Equipement, du Transport et du
Logement
Direction des affaires maritimes et des gens de mers
3, place de Fontenoy
F-75700 Paris

Maritime Safety Division
Department of the Marine and Natural Resources
Leeson Lane
Dublin 2

43

Italy

Luxembourg

The Netherlands

Austria

Portugal

Finland

Sweden

United Kingdom

Ministerio delle Infrastructure e dei Trasporti
Unita di Gestione del trasporto maritimo
Via dell'arte, 16
00144 - Roma

Commissariat aux Affaires Maritimes
26 place de la Gare
L-1616 Luxembourg

Ministerie van Verkeer en Waterstaat
Directoraat-Generaal Goederenvervoer (DGG)
Directie Transportveiligheid
Nieuwe Uitleg 1,
Postbus 20904
NL-2500 EX Den Haag

Bundesaministerium für Verkehr, Innovation und
Technologie
Oberste Schiffahrtsbehörde
Abteilung II/20
Radetzkystrasse 2
A-1030 Wien

Ministerio do Equipamento Social
Palacio Penafiel
rua S. Mamede ao Caldas 21
1149-050 Lisboa

Liikenne- ja viestintäministeriö /
kommunikationsministeriet
PO Box 235
FIN-00131 Helsinki

Sjöfartsverket
S-601 78 Norrköping

Maritime and Coastguard Agency
Spring Place
105 Commercial Road
Southampton SO15 1EG

Commission of the European
Communities

Directorate General for Energy and Transport
Maritime Safety Unit
200, rue de la Loi
B-1049 Brussels

44

– 

United States of America

United States Coast Guard
Office of Design and Engineering Standards (G-MSE)
2100 Second Street S.W.
Washington DC 20593

45

LEGISLATIVE FINANCIAL STATEMENT

Policy  area(s):  External  Trade  Relations,  including  access  to  markets  of  non-Community
countries

Activit(y/ies): Conformity assessment procedures and acceptance of industrial products

TITLE  OF  ACTION:  AGREEMENT  BETWEEN  THE  EUROPEAN  COMMUNITY  AND  THE  UNITED
STATES OF AMERICA ON THE MUTUAL RECOGNITION OF CERTIFICATES OF CONFORMITY FOR
MARINE EQUIPMENT

1.

BUDGET LINE(S) + HEADING(S)

B7-8500 and A-7010

OVERALL FIGURES

Total allocation for action (Part B): € 615950

Period of application:

2.

2.1.

2.2.

The proposed Agreement is foreseen to be of unlimited duration.

2.3.

Overall multiannual estimate of expenditure:

(a)

Schedule  of  commitment  appropriations/payment  appropriations 
intervention) (see point 6.1.1)

(financial

€

Year

2003
156700

Commitments

2004
106700

2005
95850

2006
95850

2007
95850

Total
550950

Payments

156700

106700

95850

95850

95850

550950

(b)

Technical and administrative assistance and support expenditure(see point 6.1.2)

Commitments

40000

10000

5000

5000

5000

65000

Payments

40000

10000

5000

5000

5000

65000

Subtotal a+b

Commitments

196700

116700

100850

100850

100850

615950

Payments

196700

116700

100850

100850

100850

615950

(c)

Overall  financial  impact  of  human  resources  and  other  administrative  expenditure
(see points 7.2 and 7.3)

46

167140

169950

167380

167380

164700

Commitments
/ payments

TOTAL
a+b+c

Commitments

363840

286650

268230

268230

265550

1452500

Payments

363840

286650

268230

268230

265550

1452500

2.4.

Compatibility with financial programming and financial perspective

Proposal is compatible with existing financial programming.

2.5.

Financial impact on revenue:5

The proposal does not involve any type of revenue.

3.

BUDGET CHARACTERISTICS

Type of expenditure

New

EFTA
contribution

Contributions
form applicant
countries

Heading in
financial
perspective

Non-comp

Diff

NO

NO

NO

No 4

4.

LEGAL BASIS

Article 133 and 300 of the Treaty

Action  Plan  for  the  Transatlantic  Economic  Partnership  as  endorsed  by  the  Council  on  9
November 1998 and the ensuing negotiation mandate.

Proposal  for  a  Council  Decision  on  the  conclusion  of  an  Agreement  between  the  European
Community  and  the  United  States  of  America  on  the  Mutual  Recognition  of  Certificates  of
Conformity for Marine Equipment.

5.

5.1.

DESCRIPTION AND GROUNDS

Need for Community intervention 6

5.1.1. Objectives pursued

General  objective:  DG  Trade  has  the  task  of  conducting  the  European  Union's  commercial
policy in accordance with the objectives set out in Article 131 of the Treaty: "to contribute, in
the common interest, to the harmonious development of world trade, the progressive abolition
of  restrictions  on  international  trade  and  the  lowering  of  customs  barriers".  The  common

5

6

For further information, see separate explanatory note.
For further information, see separate explanatory note.

47

                                                
commercial policy shall be based on uniform principles, particularly in regard to changes in
tariff  rates,  the  conclusion  of  tariff  and  trade  agreements,  the  achievement  of  uniformity  in
measures  of  liberalisation,  export  policy  and  measures  to  protect  trade  such  as  those  to  be
taken in the event of dumping or subsidies (Article 133(1) of the Treaty).

Specific  objectives:  The  Community’s  external  trade  policy  objectives  in  the  field  of
standards  and  conformity  assessment  can  be  summarised  as  follows  (see  Commission
Communication  on  the  Community  External  Trade  Policy  if  the  field  of  Standards  and
Conformity Assessment7). First, to reduce technical barriers to trade in external markets and
to prevent the emergence of new ones; and second, to encourage our trading partners to adopt
standards and regulatory approaches based on, or compatible with international or European
practice. These trade objectives have so far been pursued through a four-fold strategy. One of
them is the negotiation of Mutual Recognition Agreements (MRAs).

EU  manufacturers,  when  exporting  to  the  US,  must  have  their  products  approved  by  the
USCG, which adds costs and delays in order to gain access to the US market. The MRA on
marine equipment has thus the following two objectives: 1) the facilitation of EU-US trade in
marine equipment; and 2) promoting regulatory co-operation and efficiency. This is achieved
by  ensuring  the  recognition  of  certificates  of  conformity  issued  by  the  Conformity
Assessment Bodies of the Parties and setting up a framework for regulatory co-operation.

5.1.2. Measures taken in connection with ex ante evaluation

The  New  Transatlantic  Agenda  (NTA),  adopted  in  1995,  provides  a  framework  for  EU-US
partnership  and  co-operation  across  a  wide  range  of  activities  under  four  broad  chapters:
promoting peace and stability, democracy, and development around the world; responding to
global changes; contributing to the expansion of world trade and fostering closer ties; building
bridges across the Atlantic. The Transatlantic Economic Partnership (TEP), launched in 1998,
is an extension of the NTA and the TEP Action Plan calls for, in terms of bilateral EU-US co-
operations, the removal of remaining barriers to trade. This Action Plan was endorsed by the
Council on 9 November 1998 and at the same time the Council mandated the Commission to
negotiate mutual recognition agreements with the US.

In view of implementing the TEP Action Plan the EU and the US, in consultation with their
relevant stakeholders, identified a number potential projects, one them being a possible MRA
related  to  marine  equipment.  Based  on  an  initial  assessment  of  EU  and  US  technical
regulations made by the USCG (this report has been publicly available and will be put of DG
Trade’s web-site), it was deemed both beneficial and feasible to start negotiations on a MRA
based on equivalence of EU and US technical regulations related to marine equipment. After
consultation of the Council 133 Committee negotiations started in September 1999.

5.2.

Action envisaged and budget intervention arrangements

– 

The target population

The target population are the manufacturing, exporting and importing companies, conformity
assessment  bodies,  business  associations,  chambers  of  commerce  and  public  institutions  of
the European Union, as well as passengers, ship builders and owners, which will benefit, or
have an interest in the mutual recognition of certificates of conformity. For more details see
the Impact Assessment Form attached to this proposal.

7 

COM(96)564 final.

48

                                                
– 

The specific objectives set

Based  on  the  objectives  set  out  under  point  5.1.1,  the  MRA  has  the  following  specific
objectives:

– 

– 

– 

– 

– 

– 

– 

– 

Avoid duplication of testing and certification by economic operators.

Reduce costs and burdens (administrative, uncertainty, timing etc.), for in particular
to  conformity  assessment
for  small  and  medium-sized  enterprises,  related 
requirements.

Facilitation of access to the US market for EU products.

Increased  regulatory  co-operation  and  co-ordination 
to  setting
international rules for marine equipment. Better alignment of EU and US regulations
to those international rules.

in  relation 

Increased awareness of best regulatory practices.

Reduced regulatory costs in relation to approval of US products.

Increased efficiency in market surveillance and enforcement actions.

The concrete measures to be taken to implement the action

The general actions which will be pursued by the Commission services under the budget lines
will mainly be the following:

– 

– 

– 

Actions  related  to  the  management  of  the  Agreement  and  maintenance  of  the
necessary  degree  of  confidence,  e.g.  participation  in  Joint  Committee  meetings,
taking part in regulatory co-operation projects.

Actions related to the management  and maintenance of Annex  II  of  the  Agreement
which  lists  the  products  that  are  within  the  scope  of  the  Agreement,  e.g.  analysis
work on equivalence of EU and US technical regulations and technical co-operation
work.

Setting  up  of  contact  points  for  the  exchange  of  information  and  establishing  and
managing a two alert system as foreseen in Articles 9 and 16 of the Agreement.

More specifically, the following implementation actions will be needed:

A.         Participation in Joint Committee and co-ordination meetings

The necessary meetings will to a very large extent relate to meetings of the Joint Committee
established  under  Article  7  of  the  Agreement.  With  regard  to  the  frequency  of  Joint
Committee meetings, it is expected that this will be more intense during the first one to two
years of the  Agreement, where up  to  3  meetings per  year could be  required. Thereafter, the
Joint Committee will need to meet on a regular basis (1-2 times per year) although this will
depend  on  how  the  regulatory  programs  of  the  Parties  evolve.  Other  meetings  of  technical
experts  need  to  be  foreseen  as  well,  also  mainly  in  the  initial  phase  of  the  Agreement.  All
these meetings will be attended by Commission officials and given the many times technical
nature of these meetings, experts from  Member  State  authorities  and  the  Notified Bodies or

49

other appropriate experts. The meetings of the Joint Committee would take place alternatively
in  Brussels  and  Washington  DC,  USA.  The  cost  for  reimbursement  of  travel  expenses  for
experts  that  assist  the  Commission  services  in  meetings  would  be  limited  to  travel  and
subsistence expenses.

B.         Analysis of technical regulations

A core element of the mutual recognition obligations of the Agreement is the determination of
equivalence  of  the  respective  EU  and  US  technical  regulations.  These  technical  regulations
will evolve over time to take into account developments within IMO, new technologies, new
risks etc. For products that are included in the Agreement, analysis will have to be carried out
whether applicable new or amended EU and US technical regulations are still equivalent. For
products not yet covered, technical analysis of the technical regulations needs to be carried to
determine whether those products could be brought within the scope of the Agreement. Based
on previous experience, analysis of equivalence contracts are on average within the range of €
20-40.000. An average of 2 analysis per year are expected.

C.         Information dissemination required by the Agreement

This relates, on the one hand, to information dissemination required by the Agreement and, on
the other hand,  information  on and promotion  of the Agreement to industry and  conformity
assessment bodies. With regard to the former, Article 6(4), 9(4) and 10(5) of the Agreement
require the EU and US to make certain information available on the World Wide Web. The
information  required  by  Article  6(4)  is  already  provided  for  within  the  framework  of  the
marine equipment directive 96/98/EC. The other information activities relate to familiarising
and  promoting  the  Agreement  with  industry  and  conformity  assessment  bodies.  This  would
mainly  take  to  form  of  information  publications  and  the  organisation  of  workshops  and
conferences.

D.         Two-way alert system

Article  16  of  the  Agreement  calls  on  the  Parties  to  set  up  a  two-way  alert  system  between
their Regulatory Authorities in order to inform each other of  products  that have been  found
not to comply with applicable technical regulations or can pose an imminent danger to health,
safety or the environment. The practical modalities for such a system will have to be agreed
with  the  US  once  the  Agreement  has  entered  into  force.  However  it  can  very  well  be
envisaged that a system would function on the basis of electronic mail exchanges. Expertise
in  setting  up  such  systems,  including  the  necessary  security  features,  might  need  to  be
contracted and the system maintained.

– 

The immediate outputs of the action

Once  the  Agreement  enters  into  force  EU  manufacturers  can  reduce  their  costs  related  to
conformity assessment for access to the US market.

– 

The contribution of these outputs to the expected outcomes  in terms  of satisfying
needs or solving problems

The  output  described  above  will  directly  satisfy  the  objective  of  the  Agreement,  i.e.  trade
facilitation.

50

5.3.

Methods of implementation

Under  Article  133  of  the  Treaty  the  Community  has  exclusive  competence  for  commercial
policy and this agreement has been negotiated in accordance with a mandate of the Council of
Ministers and in consultation with the 133 Committee. The Commission will, as proposed, be
responsible for the implementation and management of the Agreement.

In view of ensuring legal certainty to economic operators that their certificates of conformity
will  be  accepted  by  the  other  Party,  a  binding  agreement  is  necessary.  Other  forms  of
agreements, e.g. memorandum of understanding, would not have offered this.

The choice of management method (Joint Committee) has been set out in the Agreement and
constitute a minimum necessary for the proper functioning of the Agreement.

The nature of the Agreement requires close regulatory co-operation between the EU and the
US,  both  bilaterally  and  in  the  different  international  organisations,  the  IMO  in  particular.
However, as a  “spin-off  effect” this co-operation will also  lead  to increased knowledge  and
sharing of experiences and best practices with different regulatory approaches. For example ,
the US has already considered using a part of the marine equipment directive as basis for its
new regulations for navigation equipment.

6.

FINANCIAL IMPACT

6.1.

Total financial impact on Part B - (over the entire programming period)

(The method of calculating the total amounts set out in the table below must be explained by
the breakdown in Table 6.2. )

6.1.1.

Financial intervention

Commitments (in €)

Breakdown

Year

2003

2004

2005

2006

2007

Total

Participation in meetings

21700

21700

10850

10850

10850

75950

Analysis work

120000

80000

80000

80000

80000

440000

Two-way alert system

15000

5000

5000

5000

5000

35000

TOTAL 156700

106700

95850

95850

95850

550950

6.1.2.

Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure
(commitment appropriations)

Year

2003

2004

2005

2006

2007

Total

1) 
administrative assistance

Technical 

and

Technical 

a) 
offices

assistance

51

b)  Other 
administrative assistance:

technical 

and

- intra muros:

- extra muros:

of  which  for  construction
and 
of
maintenance 
computerised  management
systems

Subtotal 1

2) Support expenditure

a) Studies

b) Meetings of experts

c) Information and
publications

Subtotal 2

40000

10000

5000

5000

5000

65000

TOTAL 40000

10000

5000

5000

5000

65000

6.2.

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire
programming period)8

(Where  there  is  more  than  one  action,  give  sufficient  detail  of  the  specific  measures  to  be
taken for each one to allow the volume and costs of the outputs to be estimated)

Breakdown

Commitments (in €)

Type
of outputs
(projects, files )

Number of
outputs

Average unit
cost

(total for years
2003-2007)

Total cost

(total for years
1…n)

1

2

3

4=(2X3)

Action  1:  Participation  external
experts in meetings

- Meetings in Brussels

- Meetings in USA

Action 2: Analysis work

Action 3: Information

Action 4: Two-way alert system

- Setting up of system

- Maintenance of system

TOTAL COST

Meeting

Meeting

Report

Publications

Electronic
messaging
system

7a
7 a

11

5

1

4

2050b
8800 b

40000

13000

15000

5000

14350

61600

440000

65000

15000

20000

615950

Notes:  a)  Two  meetings  the  first  2  years  and  thereafter  one  meeting  per  year;  b)  travel  and
subsistence expenses for 3 experts

8

For further information, see separate explanatory note.

52

                                                
7.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

The  needs  for  human  and  administrative  resources  shall  be  covered  withing  the  allocation
granted to the managing DG in the framework of the annual allocation procedure.

7.1.

Impact on human resources

Types of post

Staff to be assigned to management of the
action using existing and/or additional
resources

Number of
permanent posts

Number of
temporary posts

Officials 
temporary staff

or

A

B

C

Other human resources

Total

1

0,5

1,5

Description of tasks deriving from the
action

If necessary, a fuller description of the
tasks may be annexed.

Total

1

0,5

1,5

The  needs  for  human  and  administrative  resources  shall  be  covered  within  the  allocation
granted to the managing DG in the framework of the annual allocation procedure.

7.2.

Overall financial impact of human resources

Type of human resources

Amount (€)

Method of calculation *

Officials

Temporary staff

Other human resources

162000

1,5  staff  (€  108000  per  staff  member
per year)

(specify budget line)

Total

162000

The amounts are total expenditure for twelve months.

7.3.

Other administrative expenditure deriving from the action

Budget line

(number and heading)

Overall allocation (Title A7)

A0701 – Missions staff

- Joint Committee meetings

- Other meetings

Amount €

Method of calculation

18900

7650

Total

26550

2  day  meeting  in  Washington  DC:
travel:  €  2400,  per  diem:  €  2x150,  7
meetings 2003-2007

1  day  meeting  in  Washington  DC:
travel:  €  2400,  per  diem:  €  150,  3
meetings 2003-2007

The amounts are total expenditure for the period 2003-2007.

53

8.

FOLLOW-UP AND EVALUATION

8.1.

Follow-up arrangements

Monitoring and evaluation of the Agreement will be done primarily in relation to the foreseen
results in terms of their effectiveness (how far the results of the Agreement have contributed
to achieving its specific and general objectives; or performance against objectives). However,
issues  such  as  relevance  of  the  Agreement  (to  what  extent  the  Agreement’s  objectives  are
pertinent  in  relation  to  the  evolving  needs  of  the  target  population)  and  the  utility  of  the
Agreement  (how  the  impacts  of  the  Agreement  compare  with  the  needs  of  the  target
population), will also be addressed.

As  an  indicator  for  resources  used,  man-days  spent  by  Commission  officials  dealing  with
issues related to the implementation of the Agreement.

With  regard  to  evaluating  the  effectiveness  of  the  Agreement  (or  performance  against
objectives),  this  can  be  measured  both  in  relation  to  the  trade  facilitation  objective  and  the
regulatory co-operation objective.

With  regard  to  trade  facilitation  and  the  expected  results  described  in  point    5.1.1  and  5.2
above, the following indicators could be used:

– 

– 

– 

Avoiding duplication of testing and certification. Number of certificates delivered to
companies in accordance with the Agreement. This could be put into relation to the
number  of  certificates  delivered  under  the  domestic  systems  before  the  Agreement
entered into force.

Reduction  in  costs.  Savings  (in  EUR)  due  to  avoiding  duplicate  testing  and
certification, estimated as the product of the average cost of testing and certification
and  the  number  of  certificates  issued  in  accordance  with  the  Agreement.  This  is
associated  with  certain  difficulties  due  to  the  large  number  of  products  using
different technologies thus impacting on the price of testing and certification. A case
study approach could however give certain indications.

Increased EU exports. Examine trade data before and after the entry into force of the
Agreement. This indicator will be difficult to use due to, on the one hand, the impact
of  other  variable  (e.g.  exchange  rates,  general  economic  trends)  and,  on  the  other
hand, absence of official trade data for all types of marine equipment. This could also
be included as part of a case study approach to carrying out an evaluation.

With regard to regulatory co-operation and the expected results described in point 9.1 above,
the following indicator could be used:

– 

– 

Regulatory  co-operation.  The  number  of  specific  EU  and  US  technical  regulations
that can be determined as equivalence or alternatively the evolution of the number of
products listed in Annex II of the Agreement.

Enforcement efficiency. Number of alerts passed in the  two way  alert  system. This
could also be put into relation to the enforcement action taken, if any.

The issues of efficiency (how economically various inputs have been converted into outputs)
could also be addressed, but considerable difficulties in assessing costs exist. Furthermore, the
costs  related  to  negotiating  the  Agreement  (e.g.  man-days  spent  by  Commission  staff,

54

consultations with Member States and industry, analysis work  contracted, meetings with the
US etc.) could be seen as a “sunk cost” since those costs would have been incurred whether
an  Agreement  would  have  been  concluded  or  not.  With  regard  to  the  issue  of  efficiency  it
would be more relevant to evaluate this in terms of the management of the Agreement. This
could  be  done  in  relation  to  the  actions,  procedures  and  measures  taken  both  within  the
Community and those taken in relation or together with the US to ensure the well functioning
of the Agreement (see also below).

8.2.

Arrangements and schedule for the planned evaluation

Article 22(2) of the Agreement calls for that the functioning of the Agreement is reviewed on
a  regular  basis  and  for  the  first  time  no  later  that  2  years  after  its  entry  into  force.  This
evaluation is to be done by the Parties in conjunction and the elements that should be assessed
would have to be agreed mutually. In this respect, the Commission could envisage proposing
the  following  elements  for  assessment:  progress  in  determining  equivalence  (expanding
Annex  II  of  the  Agreement),  functioning  of  Article  10  of  the  Agreement  on  regulatory
changes,  functioning  of  the  two  way  alert  system,  co-operation  between  Conformity
Assessment Bodies and assessing the possibility of establishing a multilateral agreement with
other countries (Article 20(2) of the Agreement). It can very well be envisaged that the review
of the functioning of the Agreement would take place on a biannual basis, however this would
have to be agreed with the US.

The Joint Committee has as one of its functions to constantly evaluate the functioning of the
Agreement. Within the Commission services and in co-operation with Member States in the
133 Committee monitoring and  evaluation  will be carried  out  according  to  the  Commission
staff  working  document  “Guiding  Principles  on  and  a  Vade  mecum  for  the  management  of
agreements on mutual recognition of conformity assessment”.

The  evaluation  of  the  effectiveness  of  the  Agreement,  as  described  above,  would  with
advantage  take  place  in  conjunction  with  the  review  of  the  Agreement  done  by  the  Parties.
This could also take place on a biannual basis. With regard to the evaluation of the relevance
and utility of the Agreement, this would preferably be done four years after its entry into force
when enough experience has been gained.

With regard to specific activities, in particular those requiring financial resources, DG Trade
requires that a project appraisal is made for all financial payments.

9.

ANTI-FRAUD MEASURES

Specific methods of control (submission of interim reports, financial statements, expenditure
statements,  payment  in  instalments  etc.)  will  be  included  in  all  contracts  between  the
Commission and contractors/beneficiaries.

Analysis work, preparation of publications, arrangement of conference will, if not done by the
Commission,  be  done  under  contracts  that  have  been  established  following  tendering
procedures  in  accordance  with  the  Commission’s  financial  regulations.  These  contracts  will
require contractors to produce interim reports showing progress made  and funds used  and a
final report approved by the Commission services before final payment is made. For certain
activities,  e.g.  information  workshops  and  conferences  aimed  at  economic  operators,  grants
can  be  envisaged  after  a  call  for  proposals  and  in  accordance  with  the  Commission’s

55

“Vademecum  on  Grant  Management”.  Where  appropriate,  contracts  also 
contractors/beneficiaries to submit financial accounts certified by their auditors.

require

The  reimbursement  of  travel  expenses  for  experts  assisting  the  Commission  in  the
implementation  of  the  Agreement  will  be  done  on  the  basis  of  invitations  setting  out  the
conditions  for  reimbursement  and  on  the  presentation  of  an  invoice  with  original  receipts.
Commission  staff  will,  as  a  general  rule,  be  present  at  such  meetings  and  if  not  close  co-
operation with the delegations of the Commission will check on the spot to ensure that work
is carried out as required.

DG Trade has a system of internal controls with internal auditors. These controls intervene at
the different stages related to the drafting, establishment, execution and closing of contracts.
Furthermore,  the  new  financial  management  circuits  clearly  describes  and  allocates
responsibilities for all types of financial transactions.

Evaluations of contracts and the management of budget lines by external consultants are also
carried out.

56

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE
TO SMALL AND MEDIUM-SIZED ENTERPRISES( SMEs)

TITLE OF PROPOSAL

Proposal  for  a  Council  Decision  on  the  conclusion  of  an  Agreement  between  the  European
Community  and  the  United  States  of  America  on  the  Mutual  Recognition  of  Certificates  of
Conformity for Marine Equipment

DOCUMENT REFERENCE NUMBER

THE PROPOSAL

1.

Taking  account  of  the  principle  of  subsidiarity,  why  is  Community  legislation
necessary in this area and what are its main aims?

Under  Article  133  of  the  Treaty  the  Community  has  exclusive  competence  for
commercial policy. The legislation is necessary to conclude the Agreement with the
US on the mutual recognition of certificates  for  marine equipment.  The  Agreement
has been negotiated and initialled by the Commission in accordance with negotiating
mandate given by the Council on 9 November 1998.

THE IMPACT ON BUSINESS

2.

Who will be affected by the proposal?

–  which sectors of business

–  which  sizes  of  business  (what  is  the  concentration  of  small  and  medium-sized

firms)

–  are there particular geographical areas of the Community where these businesses

are found

The  business  sectors,  manufacturers  (exporters  and  importers)  and  conformity
assessment  bodies,  affected  are  those  related  to  life  saving  appliances  at  sea,  fire
protection  equipment  used  on  board  ships,  marine  pollution  prevention  and  marine
radio and navigation equipment. Table 1 below gives a picture of the whole maritime
supplies  industry  in  the  Member  States.  It  is  estimated  that  approximately  20%  of
these activities could be related to the products covered by the MRA.

57

The  figures  in  Table  1  indicate  that  companies  in  the  marine  supplies  industry  are
small, with an EU average of 27 employees per company (varying between Member
States  from  5  to  46  employees  per  company)  and  export  oriented,  with  an  EU
average  of  46%  of  production  going  to  export  markets  (varying  between  Member
States from 10% to 80%).

Table 1: Maritime supplies industry in the EU (1999)

Production
Marine
Supplies
(MEURO)
14
108
1 003
869
1 606
5 217
502
1 966
16
10
1 960
87
1 315
721
3 837
19 231

Austria
Belgium
Denmark
Finland
France
Germany
Greece
Italy
Ireland
Luxembourg
The Netherlands
Portugal
Spain
Sweden
United Kingdom
EU

Domestic
Market
(MEURO)

Export Market
(MEURO)

Number of
Employees

Number of
Enterprises
(est.)

3
85
605
574
978
2 248
440
1 238
13
2
1 093
79
1 047
316
1 608
10 329

11
23
398
296
629
2 969
62
728
3
8
867
9
268
406
2 230
8 907

203
1 039
13 098
9 622
18 875
58 739
10 350
23 035
223
33
25 636
2 319
19 198
7 318
47 374
237 062

13
23
381
516
675
1 269
381
960
21
6
836
504
1 665
233
1 382
8 865

Source:  Competitiveness  and  Benchmarking  in  the  Field  of  Marine  Equipment,  study  for  the  European
Commission, DG Enterprise (ETD/98/502029).

3.

What will business have to do to comply with the proposal?

It should be pointed out that the use of the Agreement by businesses is voluntary. For
companies - manufacturers, importers and conformity assessment bodies - that wish
to exploit the opportunities offered by the Agreement will need to make themselves
acquainted  with  it.  The  Commission  intends  to  inform  and  create  awareness  of  the
Agreement through publications (e.g. practical guides), workshops and conferences.

Manufacturers  are  already  now  taking  the  actions  necessary  to  make  use  of  the
Agreement  since  they  must  comply  with  the  EU  marine  equipment  directive
96/98/EC for placing their products on the EU market. The Agreement will result, for
those products covered, in that these actions will also give access to the US market
without any further re-design, testing and certification.

4.

What economic effects is the proposal likely to have?

Based on determining equivalence between specific EU and US technical regulations
for  marine  equipment,  the  Agreement  will  permit  EU  manufacturers  to  test  and
certify their products in the EU to EU requirement for access to the US market. This
will reduce costs directly related to duplicative testing and certification of a product
in  order  to  legally  market  it  in  the  territory  of  the  other  Party.  Since  an  EU
manufacturer can use a conformity assessment body in the EU (instead of the US as
would  be  the  case  without  an  agreement)  will  also  reduce  costs,  burdens  and
uncertainty related to contacting a foreign body. Furthermore, it can be done within a

58

regulatory  framework  and  according  to  technical  regulations  and  standards  EU
manufacturers are already familiar with.

It  can  be  expected  that  the  EU  conformity  assessment  bodies  (the  notified  bodies
under  the  marine  equipment  directive)  can  loose  business  opportunities  since  US
exporters  no  longer  have  to  use  their  services  in  order  to  demonstrate  compliance
with directive 96/98/EC. However, the  Agreement can also provide them  with new
business opportunities in the form of the EU manufacturers which might previously
have  been  deterred  to  exporting  the  US  due  the  costs  and  burdens  related  to
conformity assessment and acquiring the knowledge of a foreign regulatory system.

Due  to  the  lack  of  verifiable  data,  it  has  been  difficult  to  make  a  clear  economic
assessment  of  the  Agreement.  Indications  from  industry  give  that  testing  and
certification costs for marine equipment are not negligible. The Agreement can help
to reduce these and will thus not only benefit manufacturers of marine equipment but
ship builders as well.

It is thus expected that the Agreement will have an overall positive effect on exports,
employment, investment and competitiveness of EU companies.

5.

Does the proposal contain measures to take account of the specific situation of small
and medium-sized firms (reduced or different requirements etc)?

The  Agreement  does  not  contain  specific  measures  to  take  into  account  of  the
particular  situation  of  small  and  medium-sized  firms,  but  by  its  nature  and  by
reducing certification costs, which are the same for all firms, as well as uncertainty,
the  Agreement  will  potentially  benefit  small  and  medium-sized  enterprises  to  a
greater extent than larger firm.

CONSULTATION

6.

List the organisations which have been consulted about the proposal and outline their
main views.

The  Commission  services  have  on  several  occasions  consulted  with  the  relevant
European  industry  federations:  ILAMA,  EMEC,  ISSETA  CIRM/EURONAV  and
ICOMIA, which have given their support to the Agreement. Representatives of trade
unions (ETUC) and consumers (ANEC) have also been informed. The Commission
services also organised a workshop in May 2000 with the objective of informing and
discussing with all interested parties the issues involved with the marine equipment
mutual  recognition  agreement.  The  workshop  gathered  43  participants  from  10
Member States, as well as from Norway and the US, representing a wide variety of
interests  (public  authorities,  manufacturers,  consumers,  conformity  assessment
bodies). The main conclusions from the discussion were the following:

-

-

The  promotion  of  a  high  level  of  safety  at  sea  and  the  prevention  of  marine
pollution  must  be  a  guiding  principle  towards  a  Mutual  Recognition
Agreement on Marine Equipment.

IMO,  as  well  as  ISO,  IEC  and  ITU,  are  the  fora  in  which  discussion  and
agreement on international rules and standards on marine equipment related to
the safety at sea and the prevention of marine pollution should be made.

59

-

-

-

-

Differences  have  appeared,  for  various  reasons  e.g.  due  to  “gaps”  in  IMO
standards,  in  EU  and  US  marine  equipment  requirements  although  they  are
both based on the existing international instruments of  the  IMO.  Equivalence
between  EU  and  US  requirements  must  therefore  first  be  established  with  a
view to achieve the envisaged MRA+ concept.

The USCG comparative study into EU and  US marine  equipment  conformity
assessment  legislation  and  the  verification  study  commissioned  by  the
Commission  services  and  carried  out  by  Bureau  Veritas  is  a  solid  basis  on
which  to  continue  work  towards  a  MRA  on  marine  equipment,  based  on
equivalence.

Industry  expressed  a  clear  interest  and  benefit  in  the  MRA  concept  based  on
equivalence (MRA+), but showed much less advantage in the “classical MRA”
approach.

Although a MRA is primarily a trade facilitation tool it will also act as a strong
incentive  for  and  promotion  of  regulatory  co-operation  and  international
harmonisation.

The  Transatlantic  Consumer  Dialogue  is  a  forum  of  US  and  EU  consumer
organisations  which  develops  and  agrees  joint  consumer  policy  recommendations  to
the US government and European Union to promote the consumer interest in EU and
US  policy  making.  The  TACD  has  been  quite  critical  of  MRAs  in  general  and  the
concept  of  equivalence  of  technical  regulations.  The  main  objections  raised  by  the
TACD  relates  to  that  MRAs,  as  well  as  equivalence,  could  lead  to:  1)  transfer  of
regulatory  authority  to  foreign  entities  who  may  operate  under  different  conflict  of
interest, transparency and liability rules; 2) privatisation of public functions; 3) loss of
domestic regulatory control; 4) reduced levels of public participation in the regulatory
decision  making  process;  5)  increased  opportunities  for  regulatory  evasion  by
industry; and 6) reduction in levels of health, safety and environmental protection. The
Commission  cannot,  for  the  reasons  explained  in  the  explanatory  memorandum  for
this proposal, agree with the conclusions they draw.

60