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# 52012PC0772

**Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on marine equipment and repealing Directive 96/98/EC /\* COM/2012/0772 final - 2012/0358 (COD) \*/**

  

EXPLANATORY MEMORANDUM

1.           Context of the proposal

1.1.        Background

Marine equipment represents a significant
fraction of the value of a newly built ship, and its quality and good operation
are critical for the safety of the ship and its crew, as well as for the
prevention of maritime accidents and pollution of the marine environment.

The international maritime safety
conventions contain specific requirements for ships to be properly equipped;
furthermore they require flag States to ensure that the equipment carried on
board ships complies with certain safety construction and performance
requirements and to issue the relevant certificates. To that end both the
International Maritime Organization (IMO) and the international and European
standardization bodies produce testing standards for marine equipment. The IMO
develops the convention requirements and the testing standards, and keeps them
up to date, by means of a number of instruments such as Codes, Resolutions and
Circulars.

The international conventions and testing
standards leave certain discretion to the flag administrations. Although in
general IMO instruments containing requirements and testing standards become
mandatory, the IMO tradition to work by consensus may from time to time lead to
the adoption of important safety standards for marine equipment by means of
non-binding instruments; for the same reason, some IMO instruments occasionally
have exceedingly generous deadlines for their implementation or none at all.

In its proposal for a directive on marine
equipment, back in 1995, the Commission clearly identified the problems
encountered in the Internal Market as a result of this state of affairs and in
the absence of EU harmonisation in the marine equipment sector[1]. Member States were reluctant to
mutually accept their respective conformity certificates even in the presence
of comparable requirements – not at least without additional national controls;
the result was multiple approval procedures for the same marine equipment. The
Commission noted how harmonisation would lead to the elimination of important
administrative barriers and open the internal market to marine equipment
certified in the Member States, with significant economies of scale.

Council Directive 96/98/EC of 20 December
1996 on marine equipment[2]
(MED) thus laid down common rules to eliminate differences in the
implementation of international standards by means of a clearly identified set
of requirements and uniform certification procedures. Today, these common rules
continue to be necessary to achieve a smooth operation of the internal market
in the marine equipment sector while ensuring a high level of safety and of
environmental protection.

1.2.        Experience gained in the
implementation of Directive 96/98/EC

The experience gained in the implementation
of the MED has highlighted four areas where the existing Directive does not
fully meet its objectives. These are:

1.2.1.     Identification of
applicable requirements. The periodic amendment of Annex A of the directive

The specific technical requirements and
testing standards applicable to equipment falling under the scope of the MED
are listed in Annex A to the directive. Given the need to keep up with the
legislative production of the IMO and, as appropriate, of the international and
European standardization bodies, Annex A is in need of periodic updates.

IMO instruments and international standards
normally leave a reasonable time between their adoption and their entry into
force, ranging in most cases between twelve and twenty-four months. The system
must be capable of bringing the new requirements into national legislation
within that window, which is currently not the case. Until now, it has never
been possible to fully meet the IMO deadlines, and the delay in the
incorporation of the IMO requirements into the national legal orders of the
Member States has reached peaks of several years.

This generates significant disturbance for
the industry, which must produce to different standards for the European and
international markets and has difficulties in identifying the applicable
requirements. The risk of detention of European ships in foreign ports
increases.

1.2.2.     Quality of the work of the
notified bodies

There is a clearly uneven, where not
insufficient, degree of control of notified bodies by Member States
administrations. The MED requirements on notified bodies currently do not
provide detailed quality benchmarks for the notified bodies themselves or
efficient ways of control for the Member States. Given that correctly
functioning conformity checking procedures are the first and main line of
defence to avoid the entry of non-compliant equipment in the market, concerns
have been raised that these weaknesses may be confronting the industry with
unfair competition from entities taking advantage of this situation.

1.2.3.     Market surveillance

Marine equipment is mostly placed on board
when the ship is built or repaired – anywhere in the world and mostly away from
the EU's borders. Thus the marine equipment that actually enters the physical territory
of the Member States is only a fraction of the equipment covered by the
Directive.

However, the MED only allows market
surveillance to take place on equipment not yet placed on board and contains no
detailed framework – to the point that market surveillance appears as an option
rather than an obligation. Therefore the system in the MED does not adapt to
the reality of the market and in practice makes it very difficult for the
Member States to carry out effective market surveillance.

Market surveillance is therefore unlikely
to provide the national authorities with sufficient information to prevent the
placing of non-compliant products on board EU ships. This has a direct,
negative impact on safety while compliant manufacturers have to face the difficulties
associated with unfair competition and counterfeit.

1.2.4.     Safeguard clause

Experience has highlighted structural
weaknesses in the safeguard clause mechanism as currently laid down in the MED.
There is no incentive for a Member State to carry out an exhaustive procedure
during market surveillance and all the way to the adoption of restrictive
measures, where sample testing is carried out independently and with sufficient
guarantees of reliability. Nothing in the current text obliges the Member States
to have a proper hearing of the manufacturer or put at its disposal any appeal
mechanisms, let alone to seek voluntary correction of any shortcomings in the
first place. This may lead, as in the above mentioned case, to premature
notification to the Commission thus transferring to it the detailed examination
of the substance. This also places on the Commission a burden which is well
beyond its resources and technical capacities, even if the assistance of EMSA
is taken into account.

Moreover, the current safeguard clause
mechanism is burdensome and lengthy, and thus exposes manufacturers to
significant reputational damage for long periods until the case is finally
decided.

1.3.        The new regulatory
framework for the marketing of goods within the EU (NLF)

Regulation 765/2008/EC of the European
Parliament and of the Council setting out the requirements for accreditation
and market surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93[3]
lays down a common EU framework for accreditation and market surveillance. Decision
No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on
a common framework for the marketing of products and repealing Council Decision
93/465/EEC[4]
sets out the common framework of general principles and reference provisions
for the drawing up of EU legislation harmonising the conditions for the
marketing of products (EU harmonisation legislation). According to Article 2, EU
harmonisation legislation shall have recourse to the general principles set out
in this Decision and to the relevant reference provisions of Annexes I, II and
III. However, EU legislation may depart from those general principles and
reference provisions if that is appropriate on account of the specificities of
the sector concerned, especially if comprehensive legal systems are already in
place.

1.4.        Objectives of the proposal

1.4.1.     General objectives

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

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

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

1.4.2.     Specific objectives

This twofold general objective can be
translated into more specific objectives:

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

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

2.           Results of consultation with the
interested parties and impact assessment

Further to regular contacts with
stakeholders since the coming into force of the MED in 1997, stakeholders were
consulted in 2008 when the revision exercise was launched, by means of
questionnaires to the Member States, the industry and the MarED group of
notified bodies. A formal stakeholder consultation meeting was held on 27
November 2008 in Brussels. In April 2012, all stakeholders were contacted again
by the Commission in order to obtain fresher views on the possible amendments
of the directive or new data. The answers received largely confirmed the
problems already examined.

The impact assessment focused on two
alternatives to the baseline (statu quo) scenario, namely maximum
alignment with the NLF and conditional alignment; in this latter case allowing
for a number of MED-specific measures in order to cater for the sector's
particular features. The analysis showed that while on the whole both options
were appropriate, conditional alignment was the most effective and less
burdensome solution and at the same time it had the most positive overall
economic, social and environmental impacts.

The Commission's Impact assessment board
was consulted twice, namely in September 2009 and in August 2012. The remarks
on the initial version led to an in-depth reformulation of the impact
assessment, i.a. refining the problem description, restructuring policy options
and shortening the document. In its second opinion, the Board formulated a
number of additional recommendations which have been incorporated in the final
document.

The complete assessment can be found in the
impact assessment report accompanying this proposal and is also published
online at: http://ec.europa.eu/governance/impact/index\_en.htm
.

3.           Legal elements of the proposal

3.1.        Legal basis

The legal basis for the proposal is Article
100 (2) TFEU.

3.2.        Subsidiarity and
proportionality principles

The principles of subsidiarity and
proportionality are fully respected.

Harmonisation by the EU results in a
clearly identified set of requirements and uniform certification procedures
capable of ensuring a high level of safety and of environmental protection
whilst fostering the smooth functioning of the internal market.

The objectives of the EU in the marine
equipment sector cannot be sufficiently achieved by the action of the Member
States alone; they can be better achieved thanks to EU action.

However, the proposed Directive does not
contain the detailed technical specifications applicable to marine equipment
falling under its scope, but limits itself to mandating compliance with the
requirements and testing standards contained in the international instruments
while providing a mechanism to implement those requirements and standards in a uniform
way. While conformity-checking procedures are harmonised, implementation is
left entirely to the Member States, who remain responsible for ensuring that
marine equipment due to be placed on board EU ships meets the requirements of
the Directive. In case restrictive measures are adopted by a Member State as
regards non-compliant equipment, the Commission is required to intervene only if
objections are raised against these measures within a reasonable time.
Therefore EU action does not go beyond what is strictly necessary to achieve
the objectives spelled out in section 2.3.

3.3.        Choice of instrument

A Directive continues to be the most
appropriate instrument in order to achieve the objectives of the proposal. The
measures envisaged represent a major modification of the provisions contained
in Directive 96/98/EC and therefore, in the interests of clarity, this
Directive should be repealed and replaced by a new Directive.

4.           Budgetary implications

This proposal has no budgetary
implications. The tasks devolved to the Commission, including those for which
the assistance of the European Maritime Safety Agency is foreseen, are not
expected to represent on the whole an increase in workload and will be carried
out with existing resources.

5.           Content of the proposal

Article 1 defines
the objectives of the proposal in line with the relevant objectives laid down
in the Treaties, as referred to in section 1.4 of this memorandum.

The scope of the Directive is defined in Article
3. Marine equipment is installed on board ships wherever they are built,
repaired or supplied. Although marine equipment is of course also traded within
the borders of the EU, the scope of the Directive is defined by reference to
equipment which is a) due to be installed on board a ship flying the flag of a
Member State, and b) for which the approval of the flag State is required by
the international conventions. Similarly, the application of concurrent
Directives is excluded, as only the marine equipment directive can ensure that
marine equipment installed on EU ships complies with the requirements in the
international conventions and instruments.

The requirements for marine equipment are
defined in Article 4 by reference to the international conventions and
instruments. As required by these, demonstration of compliance is confined to
the specific applicable testing standards. Given the need to ensure continued
consistency with the international regulatory framework, these requirements and
standards must apply in their up-to-date version; this automatic update is
consistent with the general policy followed by the EU in the area of maritime
safety. The automatic update does not apply to testing standards as experience
has shown it may lead to disproportionate effects.

Article 5
reflects another distinctive element of the marine equipment sector, namely,
that the flag State has the responsibility to ensure that only equipment which
has been duly approved in accordance with the then applicable requirements of
the international instruments is placed on board ships flying its flag.
Equipment should remain in conformity with those requirements, unless requirements
subsequently adopted by the IMO apply to equipment already placed on board
ships.

Article 6 provides
the basis for the free movement of marine equipment within the EU, based on the
concept of mutual recognition between Member States of equipment complying with
the requirements laid down in the Directive. Article 7 governs the
particular case of the transfer of a ship to a Member State's register based on
the principle of compliance with the Directive requirements, but allowing for
the acceptance of equivalent equipment in order not to place a disproportionate
and unjustified burden on the ship owners or penalise EU flags.

Article 8 reflects
the priority given to the international regulation of maritime safety,
consistent with the global nature of shipping. However, it is necessary to
ensure that failure by the IMO to produce appropriate standards does not impair
the objectives of the Directive, and thus the Commission must be empowered to
lay down appropriate specifications while awaiting the production of the
international standards, by means of delegated acts.

Articles 9 to 11 deal with the wheel mark. As in the current Directive, a specific
mark is necessary in order to distinguish equipment complying with the
requirements in the international maritime safety conventions, which may be
different from those contained in other EU harmonisation instruments applying
to equipment which is similar in nature but is not for use or installation on
board ships. However, the general principles governing the CE marking, in
particular as laid down in Regulation 765/2008/EC, are applied mutatis
mutandis. In order to facilitate control by the flag and port State
authorities, and to combat counterfeit, Article 11 opens the possibility to use
an electronic tag in addition to or in place of the wheel mark.

Articles 12 to 14 incorporate the reference provisions of Decision 768/2008 as
regards the specific obligations of the economic operators. It must be taken
into account that a) only a fraction of the marine equipment falling under the
scope of the Directive is traded within EU borders, normally by ship yards and
ship repairers, and b) as stated above, a specific mandate is placed on the
Member States to ensure that only compliant equipment is installed on board
ships flying their flags. As a result of this, a) for importers, the act of
affixing the mark triggers the assumption of responsibilities and the
effectiveness of their obligations, which must include granting access to their
premises for national authorities carrying out market surveillance; b) the
appointment of an authorised representative has been made compulsory for
manufacturers located outside the EU; and c) in the case of importers and
distributors, the respective obligations have been limited to those which are
relevant for the sector, namely cooperation with market surveillance and, for
importers, clear identification.

The conformity-checking procedures made
available to manufacturers are listed in Article 15 and further
developed in Annex II. Among the modules foreseen in Decision 768/2008 of
the European Parliament and of the Council on a common framework for the
marketing of products, only those modules which are consistent with the
requirement for specific approval by the flag State as laid down in the
international conventions and instruments have been retained. Slight
adaptations in the text have been made for the same purpose. In order to
facilitate the protection of legitimate intellectual property rights, all
modules contain an obligation for the manufacturer to provide the notified body
with a certified copy of the patent, license or document by which the applicant
purports to have the right to make, use, sell or offer the marine equipment for
sale or use its trademark; this document shall be made available to the competent
courts upon request.

As regards the EU declaration of
conformity, Article 16 aligns the Directive with Decision 768/2008. Like
the affixing of the wheel mark, the act of drawing up of a declaration of
conformity will trigger the manufacturer's responsibilities and obligations
under the Directive. Additional provisions ensure that copies of the
declaration will be deposited with the relevant notified body and can always be
found on board, which will greatly facilitate control by market surveillance
authorities, the flag State and the Port State authorities – at the price of a
negligible additional administrative burden.

Articles 17 to 26 as well as Annexes III
to V incorporate the reference provisions of
Decision 768/2008 as regards notification, notifying authorities, notified
bodies and their respective regimes. This inclusion opens the possibility for
the Member States to have recourse to accreditation – which could help resolve
the chronic paucity of resources in national maritime administrations.
Furthermore, in order to reinforce the control of notified bodies in a context
where the entire process comprising design, testing, certification, production,
delivery and placing on board of marine equipment may entirely happen outside
the EU borders, two additional safeguards have been added to the standard
Member States' monitoring obligations: in the first place, monitoring of
notified bodies should occur at least every two years; secondly, the Commission[5] may participate in the audits
as an observer. As regards notified bodies, the possibility of a manufacturer's
in-house notified body has been discarded, given that it is not appropriate for
the restricted choice of conformity-assessment procedures referred to above.

By virtue of Articles 27 to 31, the
Directive is fully aligned with the general EU market surveillance framework,
including as regards the safeguard procedure. Checks on board may be necessary
and are therefore regulated in Article 27. Article 29 contains two additional specific
elements which appear to be necessary in the marine equipment sector.

·
If the Commission is satisfied that the
technical assessment carried out by the Member State concerned has been fair
and objective, it should not be obliged to repeat this evaluation when
reviewing the restrictive measures adopted by that Member State as regards
non-compliant equipment. The objective is to ensure that the burden placed on
the Commission is commensurate with the means at its disposal and to encourage
the Member States to ensure a fair procedure and take all measures conducive to
an exhaustive and objective evaluation of the risks.

·
It is necessary to cater for the possibility
that shortcomings are identified in the IMO standards. In this case, a
mechanism similar to that described under Article 8 is provided for.

Articles 32 to 34 contain the specific regime in exceptional circumstances, largely
taken from the existing Directive. This concerns exemptions in cases of
technical innovation or for the purpose of testing and evaluation. More
importantly, solutions are provided for the cases where ships cannot obtain
supplies of wheel marked equipment in ports outside the EU in reasonable terms
or where wheelmarked equipment has become unavailable in the market. In all these
cases, the Member States may authorise the placing on board of non-wheelmarked
equipment – subject to the necessary procedural constraints to ensure that
these exemptions do not impair the objectives of the Directive.

Article 35 constitutes
an essential part of the new Directive's architecture, with three distinctive
elements:

·
The requirement for marine equipment to comply
with the specific design, construction and performance requirements laid down
in the international instruments, including the relevant testing standards, as
defined by the Legislator, will be uniformly implemented by empowering the
Commission to identify from these instruments the requirements and standards
corresponding to each item of equipment. This will be done by means of implementing
acts. As shown in the impact assessment, the use of implementing Regulations is
expected to resolve the problems of delay and legal uncertainty described
above, inter alia given that transposition into the Member States' legal
order will no longer be needed.

·
Secondly, the Commission is also empowered to
adopt common criteria and procedures for the application of these requirements
and standards, a necessary measure to ensure that divergent interpretations by
the Member States (e.g. in terms of time, scope or technical implementation)
cannot have an impact on safety or on the smooth functioning of the internal
market. In this respect, the preparatory work carried out by the group of
notified bodies established by the Directive will be taken into account. In
this case, the use of implementing acts has been considered the most
appropriate course of action.

·
Finally, the Commission is charged with the task
of gathering and publishing a significant package of information. This codifies
and expands existing practice and will facilitate the implementation of the
Directive by all actors, as has been suggested during the stakeholder
consultation.

Continued consistency of the new Directive
with the international regulatory framework is ensured by means of the empowerment
given to the Commission in Article 36, so that it can adopt delegated
acts in order to update the list of relevant international conventions and of
standardisation organisations as well as the references to international and
European standards contained in the Directive. Aspecific criterion allowing the
Commission to identify the relevant conventions (namely the requirement of flag
approval of marine equipment) is provided, so that the update of the list by
the Commission cannot constitute an indirect extension of the Directive's scope
as defined in Article 3.

Article 40 provides
for the repeal of Directive 96/98/EC and lays down the necessary transitional
arrangements.

Articles 37(exercise of delegation), 38(committee
procedures), 39 (transposition), 41 (entry into force) and 42 (addressees) contain standard legislative provisions.

2012/0358 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on marine equipment and repealing
Directive 96/98/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 100(2)
thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[6],

Having regard to the opinion of the
Committee of the Regions[7],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       The global dimension of
shipping calls for the Union to apply and support the international regulatory
framework for maritime safety. The international maritime safety conventions
require flag States to ensure that the equipment carried on board ships
complies with certain safety requirements as regards design, construction and
performance, and to issue the relevant certificates. To that end detailed
performance and testing standards for certain types of marine equipment have
been developed by the International Maritime Organization (IMO) and by the
international and European standardization bodies.

(2)       The international
instruments leave a significant margin of discretion to the flag
administrations. In the absence of harmonisation, this leads to varying levels
of safety for products which the competent national authorities have certified
as complying with the said conventions and standards; as a result, the smooth
functioning of the Internal Market is affected as it becomes difficult for the Member
States to accept equipment certified in another Member State to be placed on
board ships flying their flags without further verification.

(3)       Harmonisation by the Union
resolves these problems. Council Directive 96/98/EC of 20 December 1996 on marine
equipment[8]
thus laid down common rules to eliminate differences in the implementation of
international standards by means of a clearly identified set of requirements
and uniform certification procedures.

(4)       There are other various
instruments of Union law which lay down requirements and conditions, inter
alia in order to ensure the free movement of goods within the Internal
Market or for environmental purposes, for certain products which are similar in
nature to equipment used on board ships, but which do not meet the
international standards – which may substantially differ from the internal
legislation of the Union and are in constant evolution. These products cannot
therefore be certified by the Member States in accordance with the relevant
international maritime safety conventions. Equipment to be placed onboard EU
ships in accordance with international safety standards should therefore be
regulated exclusively by this Directive, which should in any event be
considered the lex specialis; furthermore, a specific marking should be
established to indicate that the equipment bearing that mark complies with the
requirements laid down in the relevant international conventions and
instruments.

(5)       Experience in the
implementation of Directive 96/98/EC has shown that it is necessary to take
additional measures in order to enhance the implementation and enforcement
mechanisms of the said Directive and simplify the regulatory environment while
guaranteeing that IMO requirements are applied and implemented in a harmonised
way across the Union.

(6)       Requirements should therefore
be established for marine equipment to meet the safety standards laid down in
the applicable international instruments, including the relevant testing
standards, in order to ensure that equipment which complies with these
requirements can circulate unimpeded within the Internal Market and be placed
on board ships flying the flag of any Member State.

(7)       Decision No 768/2008
of the European Parliament and of the Council on a common framework for the
marketing of products[9]
lays down common principles and reference provisions intended to apply across
sectoral legislation in order to provide a coherent basis for revision or
recasts of that legislation. This Decision constitutes a general framework of a
horizontal nature for future legislation harmonising the conditions for the
marketing of products and a reference text for existing legislation. This
general framework provides appropriate solutions to the problems identified in
the implementation of Directive 96/98/EC. It is therefore necessary to
incorporate the definitions and reference provisions of Decision No 768/2008
into this Directive by making the adaptations which are required by the
specific features of the marine equipment sector.

(8)       Given that marine
equipment is placed on board ships at the time of their construction or repair
all over the world, market surveillance becomes particularly difficult and
cannot be effectively supported by border controls. Therefore it is necessary
to provide market surveillance authorities and port State control officers with
additional, specific means to facilitate their task, such as enabling the use
of electronic tags to replace or supplement the wheelmark.

(9)       Similarly, the
responsibilities of the economic operators should be laid down in a way which
is proportionate and non-discriminatory for those who are established within
the Union, taking into account that a significant fraction of the marine equipment
falling under the scope of this Directive may never be imported and distributed
in the territory of the Member States.

(10)     Compliance with
international testing standards could best be demonstrated by means of
conformity-assessment procedures such as those laid down in Decision No 768/2008.
However, only those conformity-assessment procedures which meet the
requirements of the international instruments should be made available to
manufacturers.

(11)     In order to ensure a fair
and efficient procedure when examining suspected non-compliance, the Member
States should be encouraged to take all measures conducive to an exhaustive and
objective evaluation of the risks; if the Commission is satisfied that this
condition has been met, it should not be obliged to repeat this evaluation when
reviewing the restrictive measures adopted by the Member States as regards
non-compliant equipment.

(12)     The use of marine equipment
not bearing the mark of conformity may be allowed in exceptional circumstances,
especially when it is not possible for a ship to obtain equipment bearing the wheel
mark in a port or installation outside the Union or when equipment bearing the wheel
mark has become unavailable in the market.

(13)     It is necessary to ensure
that the objectives of this Directive are not impaired by shortcomings in the
applicable testing standards or in case the IMO failed to produce appropriate
standards for marine equipment falling under the scope of this Directive. It is
also necessary to adopt appropriate technical criteria so that electronic tags
can be affixed and used in a safe and reliable way. Moreover, it is necessary
to keep up-to-date a number of non-essential elements of this Directive, namely
the list of international conventions laying down safety requirements for
marine equipment contained in Article 2(3) and the references to specific
standards contained in Annex III. The power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should therefore be
delegated to the Commission in respect of the adoption, on an interim basis, of
harmonised technical specifications and testing standards and in order to amend
the said lists and references. It is of particular importance that the
Commission carry out appropriate consultations during its preparatory work,
including at expert level.

(14)     The Commission, when
preparing and drawing-up delegated acts, should ensure a simultaneous, timely
and appropriate transmission of relevant documents to the European Parliament
and Council.

(15)     In order to meet the
objectives of this Directive, the international instruments should be uniformly
implemented in the Internal Market. It is therefore necessary, for each item of
marine equipment for which the approval of the flag State is required by the
international conventions, to identify in a clear and timely way the design,
construction and performance requirements as well as the associated testing
standards laid down in the international instruments for that equipment, and to
adopt common criteria and procedures for the implementation of those
requirements and standards by notified bodies, Member State authorities and the
economic operators. Moreover, it is necessary to ensure that only in
exceptional and duly justified cases equipment not bearing the wheel mark is
allowed to be placed on board.

(16)     In order to ensure uniform
conditions for the implementation of this Directive, implementing powers should
be conferred on the Commission. Those powers should be exercised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16
February 2011 laying down the rules and general principles concerning
mechanisms for control by Member States of the Commission’s exercise of
implementing powers.[10]

(17)     The Commission is assisted
by the European Maritime Safety Agency, in accordance with Regulation (EC) […],
in the effective implementation of relevant binding legal acts of the Union and
in the performance of the tasks therein entrusted to the Commission;

(18)     Since the objectives of
this Directive, namely to enhance safety at sea and the prevention of marine
pollution through the uniform application of the relevant international
instruments relating to equipment to be placed on board ships, and to ensure
the free movement of such equipment within the Union, cannot be sufficiently
achieved by the Member States and can therefore, by reason of the scale of the
action, be better achieved at Union level, the Union may adopt measures, in
accordance with the principle of subsidiarity as set out in Article 5 of the
Treaty. In accordance with the principle of proportionality, as set out in that
article, this Directive does not go beyond what is necessary in order to
achieve that objective,

(19)     The measures to be adopted represent
a major modification of the provisions of Directive 96/98/EC and therefore, in
the interests of clarity, that Directive should be repealed and replaced by a
new Directive.

HAVE ADOPTED THIS DIRECTIVE:

Chapter 1

General provisions

Article 1
Objective

The purpose of this Directive is to enhance
safety at sea and to prevent marine pollution through the uniform application
of the relevant international instruments relating to marine equipment to be
placed on board EU ships, and to ensure the free movement of such equipment
within the Union.

Article 2
Definitions

For the purposes of this Directive, the
following definitions apply:

(1)
"Marine equipment" means equipment
falling under the scope of this Directive in accordance with Article 3.

(2)
"EU ship" means a ship, for which
safety certificates are issued by or on behalf of Member States under the
international conventions, with the exception of a ship for which the
administration of a Member State issues a certificate at the request of a third
country's administration;

(3)
"international conventions" means the conventions,
together with their Protocols and Codes of mandatory application, adopted under
the auspices of the International Maritime Organization (IMO) which lay down
specific requirements for the approval by the flag State of equipment to be placed
on board ships. This includes:

–
the 1966 International Convention on Load Lines
(LL66),

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

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

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

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

(4)
"testing standards" means the testing
standards for marine equipment set by

–
the International Maritime Organization (IMO),

–
the International Organization for
Standardization (ISO),

–
the International Electrotechnical Commission
(IEC),

–
the European Committee for Standardization
(CEN),

–
the European Committee for Electrotechnical
Standardization (Cenelec)

–
the International Telecommunication Union (ITU)

–
the European Telecommunication Standards
Institute (ETSI)

–
the Commission, in accordance with this
Directive,

–
the Regulatory Authorities recognised in the
mutual recognition agreements to which the Union is a party.

(5)
"international instruments" means the
international conventions, together with the resolutions and circulars of the
International Maritime Organization giving effect to those conventions, and the
testing standards;

(6)
"wheel mark" means the symbol referred
to in Article 9 and set out in Annex I or, as appropriate, the electronic tag
referred to in Article 11;

(7)
"notified body" means an organisation
designated by the competent national administration of a Member State in
accordance with Article 17;

(8)
"making available on the market" means
any supply of marine equipment on the Union market in the course of a
commercial activity, whether in return for payment or free of charge;

(9)
"placing on the market" means the
first making available of marine equipment on the Union market;

(10)
"manufacturer" means any natural or
legal person who manufactures marine equipment or has marine equipment designed
or manufactured, and markets that equipment under his name or trademark;

(11)
"authorised representative" means any
natural or legal person established within the Union who has received a written
mandate from a manufacturer to act on his behalf in relation to specified
tasks;

(12)
"importer" means any natural or legal
person established within the Union who places marine equipment from a third
country on the EU market;

(13)
"distributor" means any natural or
legal person in the supply chain, other than the manufacturer or the importer, who makes marine
equipment available on the market;

(14)
"economic operators" means the
manufacturer, the authorised representative, the importer and the distributor;

(15)
"accreditation" means accreditation as
defined in Article 2(10) of Regulation (EC) No 765/2008 of the European
Parliament and of the Council [11];

(16)
"national accreditation body" means
national accreditation body as defined in Article 2 (11) of Regulation (EC)
No 765/2008;

(17)
"conformity assessment" means the
process demonstrating whether marine equipment complies with the requirements
laid down in this Directive, in accordance with Article 15;

(18)
"conformity assessment body" means a
body that performs conformity assessment activities including calibration,
testing, certification and inspection;

(19)
"recall" means any measure aimed at
achieving the return of marine equipment that has already been placed on board EU
ships;

(20)
"withdrawal" means any measure aimed
at preventing marine equipment in the supply chain from being made available on
the market;

(21)
"EU declaration of conformity" means a
statement issued by the manufacturer in accordance with article 16;

(22)
"product" means an item of marine
equipment.

Article 3
Scope

1.           This Directive shall apply
to equipment to be placed on board an EU ship and for which the approval of the
flag State administration is required by the international instruments.

2.           Notwithstanding the fact
that the marine equipment referred to in paragraph 1 may also fall within the
scope of instruments of Union law other than this Directive, that marine equipment
shall, for the purpose set out in Article 1, be subject only to this Directive .

Article 4
Requirements for marine equipment

1.           Marine equipment that is
placed on board an EU ship on or after the date referred to in the second
subparagraph of Article 39(1) shall meet the design, construction and
performance requirements of the international instruments as applicable at the
time the said equipment is placed on board.

2.           Compliance of marine equipment
with the requirements referred to in paragraph 1 shall be demonstrated solely
in accordance with the testing standards and by means of the
conformity-assessment procedures referred to in Article 15.

3.           The requirements and
standards referred to in paragraphs 1 and 2 shall be implemented in a uniform
manner, in accordance with Article 35(2) and (3).

4.           The international
instruments, with the exception of testing standards, shall apply in their
up-to-date version, without prejudice to Article 5 of Regulation (EC) No
2099/2002 of the European Parliament and of the Council [12].

Article 5
Application

1.           When issuing, endorsing or
renewing the certificates of the ships flying their flag in accordance with the
international conventions, the Member States shall ensure that the marine equipment
on board those ships complies with the requirements of this Directive.

2.           Member States shall take
the necessary measures to ensure that marine equipment on board ships flying
their flag complies with the requirements in the international instruments
which are applicable to equipment already placed on board. These requirements
shall be implemented in a uniform manner, in accordance with Article 35(4).

Article 6
Functioning of the internal market

Member States shall not prohibit the
placing on the market or the placing on board an EU ship of marine equipment
which complies with this Directive, nor refuse to issue the certificates
relating thereto to the ships flying their flag, or to renew the said
certificates.

Article 7
Transfer of a ship to the register of a Member State

1.           In the case of a ship
which, irrespective of its flag, is not registered in a Member State but is to
be transferred to the register of a Member State, that ship shall, on transfer,
be subject to inspection by the receiving Member State to verify that the
actual condition of its marine equipment corresponds to its safety certificates
and either complies with this Directive and bears the wheel mark or is
equivalent, to the satisfaction of that Member State's administration, to marine
equipment certified in accordance with this Directive.

2.           Unless the equipment
either bears the wheel mark or the administration considers it to be
equivalent, it shall be replaced.

3.           Marine equipment which is
considered equivalent pursuant to this Article shall be given a certificate by
the Member State which shall at all times be carried with the equipment. It
shall give the flag Member State's permission for the equipment to be placed on
board the ship and imposes any restrictions or lays down any provisions
relating to the use of the equipment.

Article 8
Standards for marine equipment

1.           Without prejudice to
Directive 98/34/EC of the European Parliament and the Council[13], the Union shall pursue the
development by the IMO of appropriate international standards, including
detailed technical specifications and testing standards, for marine equipment
whose use or installation on board ships is deemed necessary to enhance
maritime safety and the prevention of marine pollution. The Commission shall
monitor this development on a regular basis.

2.           In the absence of
appropriate international standards developed by the IMO for a specific item of
marine equipment, the Commission shall be empowered to adopt, by means of delegated
acts in accordance with Article 37, harmonised technical specifications and
testing standards for that specific item of marine equipment when it is
necessary in order to remove an unacceptable threat to safety or to the
environment. Those specifications and standards shall apply on an interim basis
and until such time as the IMO has adopted appropriate standards.

Chapter 2

The wheel mark

Article 9
The wheel mark

1.           Marine equipment whose
compliance with the requirements laid down in this Directive has been
demonstrated in accordance with the relevant conformity-assessment procedures
shall have the wheel mark affixed to it.

2.           The wheel mark shall not
be affixed to any other product.

3.           The form of the wheel mark
to be used shall be as set out in Annex I.

4.           Use of the wheel mark
shall be subject to the general principles set out in paragraphs 1 and 3 to 6
of Article 30 of Regulation (EC) No 765/2008, where any reference to the CE
marking shall be construed as a reference to the wheel mark.

Article 10
Rules and conditions for affixing the wheel mark

1.           The wheel mark shall be
affixed visibly, legibly and indelibly to the product or to its data plate.
Where that is not possible or not warranted on account of the nature of the
product, it shall be affixed to the packaging and to the accompanying
documents.

2.           The wheel mark shall be
affixed at the end of the production phase.

3.           The wheel mark shall be
followed by the identification number of the notified body, where that body is
involved in the production control phase, and by the last two digits of the
number of the year in which the mark is affixed.

4.           The identification number
of the notified body shall be affixed by the body itself or, under its
instructions, by the manufacturer or his authorised representative.

5.           Member States shall build
upon existing mechanisms to ensure correct application of the regime governing
the wheel mark and take appropriate action in the event of improper use of the
mark. Member States shall also provide for penalties for infringements, which
may include criminal sanctions for serious infringements. Those penalties shall
be proportionate to the seriousness of the offence and constitute an effective
deterrent against improper use.

Article 11
Electronic tag

1.           The wheel mark may be
supplemented or replaced by an appropriate and reliable form of electronic tag.
In such case, Articles 9 and 10 shall apply, as appropriate, mutatis mutandi.

2.           The Commission shall adopt
delegated acts, in accordance with Article 37, in order to identify the
specific items of marine equipment which can benefit from electronic tagging,
and to lay down appropriate technical criteria as regards the design,
performance, affixing and use of electronic tags.

Chapter 3

Obligations of economic operators

Article 12
Obligations of manufacturers

1.           By affixing the wheel
mark, manufacturers shall take on responsibility for guaranteeing that the marine
equipment to which the mark is affixed has been designed and manufactured in
accordance with the requirements set out in Article 4 and shall undertake the
obligations laid down in paragraphs 2 to 9 of this Article.

2.           Manufacturers shall draw
up the required technical documentation and have the applicable conformity
assessment procedures carried out.

3.           Where compliance of marine
equipment with the applicable requirements has been demonstrated by the
conformity assessment procedure, manufacturers shall draw up an EU declaration
of conformity in accordance with Article 16 and affix the conformity marking in
accordance with Article 9.

4.           Manufacturers shall keep
the technical documentation and the EU declaration of conformity referred to in
Article 16 for a period of time commensurate with the level of risk, and in no
case less than the expected lifecycle of the marine equipment, after the wheel
mark has been affixed on the last unit.

5.           Manufacturers shall ensure
that procedures are in place for series production to remain in conformity.
Changes in marine equipment design or characteristics and changes in the
requirements in the international instruments as referred to in Article 4, on the
basis of which conformity of marine equipment is declared shall be adequately
taken into account. When necessary in accordance with Annex II, they shall have
a new conformity assessment carried out.

6.           Manufacturers shall ensure that their products bear a type, batch or
serial number or other element allowing their identification, or, where the
size or nature of the product does not allow it, that the required information
is provided on the packaging or in a document accompanying the product.

7.           Manufacturers shall indicate their name, registered trade name
or registered trade mark and the address at which they can be
contacted on the product or, where that is not possible, on its packaging or in a document accompanying
the product. The address must indicate a single point at which the
manufacturer can be contacted.

8.           Manufacturers shall ensure
that the product is accompanied by instructions and all necessary information
for safe installation on board and safe use of the product, including
limitations of use, if any, in a language which can be easily understood by the
end‑users, together with any other documentation required by the international
instruments or testing standards.

9.           Manufacturers who consider
or have reason to believe that a product which they have placed on the market
or on board EU ships is not in conformity with the applicable requirements in
the international instruments as referred to in Article 4, shall immediately
take the necessary corrective measures to bring that product into conformity,
to withdraw it or recall it, if appropriate. In addition, where the product
presents a risk, manufacturers shall immediately inform the competent national
authorities of the Member States, giving details, in particular, of the
non-compliance and of any corrective measures taken.

10.         Manufacturers shall,
further to a reasoned request from a competent national authority, promptly
provide it with all the information and documentation necessary to demonstrate
the conformity of the product, in a language which can be easily understood by
that authority, and grant to that authority access to their premises for market
surveillance purposes in accordance with Article 19 of Regulation (EC) No
765/2008. They shall cooperate with that authority, at its request, on any
action taken to eliminate the risks posed by products which they have placed on
the market.

Article 13
Authorised representatives

1.           A manufacturer who is not
located in the territory of a Member State shall, by a written mandate, appoint
an authorised representative.

2.           The obligations laid down
in Article 12(1) and the drawing up of technical documentation shall not form
part of the authorised representative's mandate.

3.           An authorised
representative shall perform the tasks specified in the mandate received from
the manufacturer. The mandate shall allow the authorised representative to do
at least the following:

(a)
keep the EU declaration of conformity and the
technical documentation at the disposal of national surveillance authorities
for a period of time commensurate with the level of risk, and in no case less
than the expected lifecycle of the marine equipment, after the wheel mark has
been affixed on the last unit;

(b)
further to a reasoned request from a competent
national authority, provide that authority with all the information and
documentation necessary to demonstrate the conformity of a product;

(c)
cooperate with the competent national
authorities, at their request, on any action taken to eliminate the risks posed
by products covered by their mandate.

Article 14
Other economic operators

1.           Importers shall indicate
their name, registered trade name or registered trade mark and the address at
which they can be contacted on the product or, where that is not possible, on
its packaging or in a document accompanying the product.

2.           Importers and distributors
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of a product in a language which can be easily understood by
that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by products which they have
placed on the market.

3.           An importer or distributor
shall be considered a manufacturer for the purposes of this Directive and he shall
be subject to the obligations of the manufacturer under Article 12, where
he places marine equipment on the market or on board an EU ship under his name
or trademark or modifies marine equipment already placed on the market in such
a way that compliance with the applicable requirements may be affected.

Chapter 4

Conformity assessment and notification
of conformity assessment bodies

Article 15
Conformity assessment procedures

1.           The conformity assessment
procedures shall be as set out in Annex II.

2.           Member States shall ensure
that the manufacturer or his authorized representative carry out the conformity
assessment, for a specific item of marine equipment, by using one of the
options provided by means of implementing acts adopted by the Commission in accordance
with the examination procedure referred to in Article 38(3), from among one of
the following procedures:

(a)
where the EC type-examination (module B) is to
be used, before being placed on the market, all marine equipment shall be
subject to:

–
production-quality assurance (module D);

–
product-quality assurance (module E); or

–
product verification (module F);

(b)
where sets of marine equipment are produced
individually or in small quantities and not in series or in mass, the
conformity- assessment procedure may be the EC unit verification (module G).

3.           The Commission shall keep
an up-to-date list of approved marine equipment and applications withdrawn or
refused and shall make it available to interested parties.

Article 16
EU declaration of conformity

1.           The EU declaration of
conformity shall state that the fulfilment of the requirements laid down in
accordance with Article 4 has been demonstrated.

2.           The EU declaration of
conformity shall follow the model structure set out in Annex III to Decision No 768/2008/EC. It
shall contain the elements specified in the
relevant modules set out in Annex II to this Directive and shall be continuously updated.

3.           By drawing up the EU
declaration of conformity, the manufacturer shall assume the responsibility and
undertake the obligations referred to in Article 12(1).

4.           When marine equipment is placed on board an EU ship, a copy of the EU
declaration of conformity covering the equipment concerned shall be provided to
the ship, and shall be kept on board until the said equipment is removed from
the ship. It shall be translated into the
language or languages required by the flag State.

5.           A copy of the EU declaration
of conformity shall be provided to the notified body or to the bodies having
carried out the relevant conformity-assessment procedures.

Article 17
Notification

1.           Member States shall notify
the Commission and the other Member States of bodies authorised to carry out
third‑party conformity assessment tasks under this Directive.

2.           Notified bodies shall
comply with the requirements laid down in Annex III.

Article 18
Notifying authorities

1.           Member States shall
designate a notifying authority that shall be responsible for setting up and
carrying out the necessary procedures for the assessment and notification of
conformity assessment bodies and the monitoring of notified bodies, including
compliance with the provisions of Article 20.

2.           Notified bodies shall be
monitored at least every two years. The Commission may choose to participate as
an observer in the monitoring exercise.

3.           Member States may decide
that the assessment and monitoring referred to in paragraph 1 shall be
carried out by a national accreditation body.

4.           Where the notifying
authority delegates or otherwise entrusts the assessment, notification or monitoring
referred to in paragraph 1 to a body which is not a governmental entity, that
body shall be a legal entity and shall comply mutatis mutandis with the
requirements laid down in Annex V. In addition it shall have arrangements to
cover liabilities arising out of its activities.

5.           The notifying authority
shall take full responsibility for the tasks performed by the body referred to
in paragraph 4.

6.           The notifying authority
shall comply with the requirements laid down in Annex V.

Article 19
Information obligation on notifying authorities

1.           Member States shall inform
the Commission of their procedures for the assessment and notification of
conformity assessment bodies and the monitoring of such bodies, and of any
changes thereto.

2.           The Commission shall make
that information publicly available.

Article 20
Subsidiaries of and subcontracting by notified bodies

1.           Where a notified body
subcontracts specific tasks connected with conformity assessment or has
recourse to a subsidiary, it shall ensure that the subcontractor or the
subsidiary meets the requirements set out in Annex III and shall inform the
notifying authority accordingly.

2.           Notified bodies shall take
full responsibility for the tasks performed by subcontractors or subsidiaries
wherever these are established.

3.           Activities may be
subcontracted or carried out by a subsidiary only with the agreement of the client.

4.           Notified bodies shall keep
at the disposal of the notifying authority the relevant documents concerning
the assessment of the qualifications of the subcontractor or the subsidiary and
the work carried out by them under this Directive.

Article 21
Changes to notifications

1.           Where a notifying
authority has ascertained or has been informed that a notified body no longer
meets the requirements laid down in Annex III , or that it is failing to fulfil
its obligations, the notifying authority shall restrict, suspend or withdraw
notification as appropriate, depending on the seriousness of the failure to
meet those requirements or fulfil those obligations. It shall immediately
inform the Commission and the other Member States accordingly.

2.           In the event of
restriction, suspension or withdrawal of notification, or where the notified
body has ceased its activity, the notifying Member State shall take appropriate
steps to ensure that the files of that body are either processed by another
notified body or kept available for the responsible notifying and market
surveillance authorities at their request.

Article 22
Challenge of the competence of notified bodies

1.           The Commission shall
investigate all cases where it doubts, based on the information available to it
or brought to its attention, the competence of a notified body or the continued
fulfilment by a notified body of the requirements and responsibilities to which
it is subject.

2.           The notifying Member State
shall provide the Commission, on request, with all information relating to the
basis for the notification or the maintenance of the competence of the body
concerned.

3.           The Commission shall
ensure that all sensitive information obtained in the course of its
investigations is treated confidentially.

4.           Where the Commission
ascertains that a notified body does not meet or no longer meets the
requirements for its notification, it shall inform the notifying Member State
accordingly and request it to take the necessary corrective measures, including
de-notification if necessary.

Article 23
Operational obligations of notified bodies

1.           Notified bodies shall
carry out conformity assessments in accordance with the procedures provided for
in Article 15.

2.           Where a notified body
finds that the requirements laid down in accordance with Article 4 have not
been met by a manufacturer, it shall require that manufacturer to take
appropriate corrective measures and shall not issue a conformity certificate.

3.           Where, in the course of
the monitoring of conformity following the issue of a certificate, a notified
body finds that a product no longer complies, it shall require the manufacturer
to take appropriate corrective measures and shall suspend or withdraw the
certificate if necessary. Where corrective measures are not taken or do not
have the required effect, the notified body shall restrict, suspend or withdraw
any certificates, as appropriate.

Article 24
Information obligation on notified bodies

1.           Notified bodies shall
inform the notifying authority of the following:

(a)
any refusal, restriction, suspension or
withdrawal of a certificate;

(b)
any circumstances affecting the scope of and
conditions for notification;

(c)
any request for information which they have
received from market surveillance authorities regarding conformity assessment
activities;

(d)
on request, conformity assessment activities
performed within the scope of their notification and any other activity performed,
including cross-border activities and subcontracting.

2.           Notified bodies shall
provide the Commission and the Member States, on request, with relevant
information on issues relating to negative and positive conformity assessment
results. Notified bodies shall provide the other notified bodies carrying out
conformity assessment activities covering the same products with information
concerning negative and, on request, positive conformity assessment results.

Article 25
Exchange of experience

The Commission shall provide for the
organisation of exchange of experience between the Member States' national
authorities responsible for notification policy.

Article 26
Coordination of notified bodies

1.           The Commission shall
ensure that appropriate coordination and cooperation between notified bodies
are put in place and properly operated in the form of a sectoral group of
notified bodies.

2.           Member States shall ensure
that the bodies notified by them participate in the work of the sectoral group,
directly or by means of designated representatives.

Chapter 5

Union market surveillance, control of
products, safeguard provisions

Article 27
EU market surveillance framework

1.           As regards marine
equipment, the Member States shall undertake market surveillance in accordance
with the EU market surveillance framework laid down in Chapter III of
Regulation (EC) No 765/2008, subject to the provisions of paragraphs 2 and 3 of
this Article.

2.           National market
surveillance infrastructures and programmes shall take into account the
specific features of the marine equipment sector, and in particular the
responsibilities placed with the flag State administration by the international
conventions.

3.           Market surveillance may
include documentary checks as well as checks of marine equipment which bears
the wheel mark whether or not it has been placed on board ships. Checks of marine
equipment already placed on board shall be limited to such examination as can
be carried out while the equipment concerned remains fully functional on board.
Checks of marine equipment placed on board ships flying the flag of a Member
State other than that carrying out the checks shall be carried out in
accordance with the relevant provisions of Directive 2009/16/EC of the European
Parliament and the Council[14].

4.           Where the market
surveillance authorities of a Member State intend to carry out sample checks, they
may request the manufacturer to make the necessary samples available at its own
cost in the territory of that Member State.

Article 28
Procedure for dealing with marine equipment presenting a risk at national level

1.           Where the market
surveillance authorities of one Member State have taken action pursuant to
Article 20 of Regulation (EC) No 765/2008, or where they have sufficient
reason to believe that marine equipment covered by this Directive presents a
risk to maritime safety or to the protection of the environment, they shall
carry out an evaluation in relation to the marine equipment concerned covering
all the requirements laid down in this Directive. The relevant economic
operators shall cooperate as necessary with the market surveillance
authorities.

Where, in the course of that evaluation, the
market surveillance authorities find that the marine equipment does not comply
with the requirements laid down in this Directive, they shall without delay
require the relevant economic operator to take all appropriate corrective
actions to bring the marine equipment into compliance with those requirements,
to withdraw the marine equipment from the market, or to recall it within a
reasonable period, commensurate with the nature of the risk, as they may
prescribe.

The market surveillance authorities shall
inform the relevant notified body accordingly.

Article 21 of Regulation (EC) No 765/2008
shall apply to the measures referred to in the second subparagraph of this
paragraph.

2.           Where the market
surveillance authorities consider that non-compliance is not restricted to
their national territory or to ships flying their flag, they shall inform the
Commission and the other Member States of the results of the evaluation and of
the actions which they have required the economic operator to take.

3.           The economic operator
shall ensure that all appropriate corrective action is taken in respect of all
the products concerned that it has made available on the market throughout the Union
or, as necessary, placed or delivered to be placed on board EU ships.

4.           Where the relevant
economic operator does not take adequate corrective action within the period
referred to in the second subparagraph of paragraph 1, or otherwise fails
to meet its obligations under this Directive, the market surveillance
authorities shall take all appropriate provisional measures to prohibit or
restrict the marine equipment being made available on their national market or
placed on board the ships flying their flag, to withdraw the product from that
market or to recall it.

They shall inform the Commission and the other
Member States, without delay, of those measures.

5.           The information referred
to in paragraph 4 shall include all available details, in particular the
data necessary for the identification of the non‑compliant marine equipment,
the origin of the product, the nature of the non‑compliance alleged and the risk involved, the nature and duration of
the national measures taken and the arguments put forward by the relevant
economic operator. In particular, the market surveillance authorities shall
indicate whether the non‑compliance
is due to either:

(a)
failure of the marine equipment to comply with the
applicable design, construction and performance requirements as laid down
pursuant to Article 4;

(b)
non-compliance with the testing standards
referred to in Article 4 during the conformity-assessment procedure;

(c)
shortcomings in the said testing standards.

6.           Member States other than
the Member State initiating the procedure shall without delay inform the
Commission and the other Member States of any measures adopted and of any
additional information at their disposal relating to the non-compliance of the marine
equipment concerned, and, in the event of disagreement with the notified
national measure, of their objections.

7.           Where, within four months
of receipt of the information referred to in paragraph 4, no objection has
been raised by a Member State or by the Commission in respect of a provisional
measure taken by a Member State, that measure shall be deemed justified.

8.           Member States shall ensure
that appropriate restrictive measures are taken in respect of the marine
equipment concerned, such as withdrawal of the product from their market,
without delay.

Article 29
EU safeguard procedure

1.           Where, on completion of
the procedure set out in Article 28(3) and (4), objections are raised
against a measure taken by a Member State, or where the Commission considers that
a national measure may be contrary to Union legislation, the Commission shall
without delay enter into consultation with the Member States and the relevant
economic operator or operators and shall evaluate the national measure. On the
basis of the results of that evaluation, the Commission shall decide whether
the national measure is justified or not.

2.           For the purpose of
paragraph 1, where the Commission is satisfied that the procedure followed in
the adoption of the national measure is appropriate for an exhaustive and
objective evaluation of the risk and complies with the provisions laid down in
Article 21 of Regulation (EC) No 765/2008, it may limit itself to examining the
appropriateness and proportionality of the national measure in relation to the
said risk.

3.           The Commission shall address
its decision to all Member States and shall immediately communicate it to them
and the relevant economic operator or operators.

4.           If the national measure is
considered justified, all Member States shall take the measures necessary to
ensure that the non-compliant marine equipment is withdrawn from their market,
and, where necessary, recalled. They shall inform the Commission accordingly.

5.           If the national measure is
considered unjustified, the Member State concerned shall withdraw the measure.

6.           Where the national measure
is considered justified and the non-compliance of the marine equipment is
attributed to shortcomings in the testing standards referred to in Article 4,
the Commission may confirm, modify or revoke the said measure by means of
implementing acts in accordance with the advisory procedure referred to in
Article 38(2). The Commission shall furthermore be empowered to adopt, by means
of delegated acts in accordance with the procedure referred to in Article 37, interim
harmonised requirements and testing standards for that specific item of marine
equipment in order to remove the threat to safety or to the environment pending
the modification of the testing standard concerned by the relevant international
organisation.

7.           Where the testing standard
concerned is a European Standard, the Commission shall inform the relevant
European standardisation body or bodies and shall bring the matter before the
Committee set up by Article 5 of Directive 98/34/EC. That Committee
shall consult the relevant European standardisation body or bodies and deliver
its opinion without delay.

Article 30
Compliant products which present a risk to maritime safety or to the protection
of the environment

1.           Where, having performed an
evaluation under Article 28(1), a Member State finds that although marine
equipment is in compliance with this Directive, it presents a risk to marine
safety or to the environment, it shall require the relevant economic operator
to take all appropriate measures to ensure that the marine equipment concerned,
when placed on the market, no longer presents that risk, to withdraw the marine
equipment from the market or to recall it within a reasonable period,
commensurate with the nature of the risk, as it may prescribe.

2.           The economic operator
shall ensure that corrective action is taken in respect of all the products
concerned that he has made available on the market throughout the Union or
placed on board EU ships.

3.           The Member State shall
immediately inform the Commission and the other Member States. That information
shall include all available details, in particular the data necessary for the
identification of the marine equipment concerned, the origin and the supply
chain of the marine equipment, the nature of the risk involved and the nature
and duration of the national measures taken.

4.           The Commission shall
without delay enter into consultation with the Member States and the relevant
economic operator or operators and shall evaluate the national measures taken.
On the basis of the results of that evaluation, the Commission shall decide
whether the measure is justified or not, and where necessary, propose
appropriate measures; for this purpose, Article 29(2) shall apply mutatis
mutandis.

5.           The Commission shall
address its decision to all Member States and shall immediately communicate it
to them and the relevant economic operator or operators.

Article 31
Formal non-compliance

1.           Without prejudice to
Article 28, where a Member State makes one of the following findings, it shall
require the relevant economic operator to put an end to the non‑compliance
concerned:

(a)
the wheel mark has been affixed in violation of
Article 9 or of Article 10;

(b)
the wheel mark has not been affixed;

(c)
the EU declaration of conformity has not been
drawn up;

(d)
the EU declaration of conformity has not been
drawn up correctly;

(e)
technical documentation is either not available
or not complete.

2.           Where the non-compliance
referred to in paragraph 1 persists, the Member State concerned shall take all
appropriate measures to restrict or prohibit the marine equipment being made
available on the market or ensure that it is recalled or withdrawn from the
market.

Article 32
Exemptions based on technical innovation

1.           In exceptional circumstances
of technical innovation, the flag State administration may permit marine equipment
which does not comply with the conformity assessment procedures to be placed on
board an EU ship if it is established by trial or otherwise to the satisfaction
of the flag State administration that such equipment is at least as effective
as marine equipment which does comply with the conformity-assessment
procedures.

2.           The trial procedures shall
in no way discriminate between marine equipment produced in the flag Member State
and marine equipment produced in other States.

3.           Marine equipment covered
by this Article shall be given a certificate by the flag Member State which
shall at all times be carried with the equipment and which gives the flag
Member State's permission for the equipment to be placed on board the ship and
imposes any restrictions or lays down any provisions relating to the use of the
equipment.

4.           Where a Member State
allows marine equipment covered by this Article to be placed on board an EU
ship, that Member State shall forthwith communicate the particulars thereof
together with the reports of all relevant trials, assessments and
conformity-assessment procedures to the Commission and the other Member States.

5.           Within twelve months of
receipt of the communication referred to in paragraph 4, the Commission, if it
considers that the conditions laid down in paragraph 1 are not met, may require
the Member State concerned to withdraw the permission granted within a
specified deadline. For this purpose, the Commission shall act by means of
implementing acts. Those implementing acts shall be adopted in accordance with
the advisory procedure referred to in Article 38(2).

6.           Where a ship with marine equipment
on board which is covered by paragraph 1 is transferred to another Member
State, the receiving flag Member State may undertake the necessary measures,
which may include tests and practical demonstrations, to ensure that the
equipment is at least as effective as equipment which does comply with the
conformity-assessment procedures.

Article 33
Exemptions for testing or evaluation

A flag State administration may permit marine
equipment which does not comply with the conformity-assessment procedures or is
not covered by Article 32 to be placed on board an EU ship for reasons of
testing or evaluation, if the following cumulative conditions are complied
with:

(a)
the marine equipment shall be given a
certificate by the flag Member State which shall at all times be carried with
the equipment, state the said Member State's permission for the equipment to be
placed on board the EU ship, impose all necessary restrictions and lay down any
other appropriate provisions as regards the use of the equipment concerned;

(b)
the permission shall be limited to a short
period of time;

(c)
the marine equipment shall not be relied on in
place of equipment which meets the requirements of this Directive and shall not
replace such equipment, which shall remain on board the EU ship in working order
and ready for immediate use.

Article 34
Exemptions in exceptional circumstances

1.           In exceptional
circumstances, which shall be duly justified to the flag State administration,
when marine equipment needs to be replaced in a port outside the Union where it
is not practicable in terms of reasonable time, delay and cost to place on
board equipment which bears the wheel mark, other marine equipment may be
placed on board subject to paragraphs 2 to 4 of this Article.

2.           The marine equipment placed
on board shall be accompanied by documentation issued by a Member State of the
IMO which is a party to the relevant conventions, certifying compliance with
the relevant IMO requirements.

3.           The flag State
administration shall be informed at once of the nature and characteristics of
such other marine equipment.

4.           The flag State
administration shall, at the earliest opportunity, ensure that the marine equipment
referred to in paragraph 1, along with its testing documentation, complies with
the relevant requirements of the international instruments and of this
Directive.

5.           Where it has been
demonstrated that specific marine equipment bearing the wheel mark has become
unavailable on the market, the flag Member State may authorise other marine equipment
to be placed on board subject to the provisions of paragraphs 6 to 8 of this
Article.

6.           The authorised marine equipment
shall comply, as much as possible, with the requirements and testing standards
referred to in Article 4.

7.           The marine equipment
placed on board shall be accompanied by an interim certificate of approval issued
by the flag Member State or by another Member State, stating the following:

(a)
the equipment bearing the wheel mark which the
certified equipment is due to replace;

(b)
the exact circumstances under which the
certificate of approval has been issued, and in particular the unavailability in
the market of equipment bearing the wheel mark;

(c)
the exact design, construction and performance
requirements against which the equipment has been approved by the certifying
Member State;

(d)
the testing standards applied, if any, in the
relevant approval procedures.

8.           The Member State issuing
an interim certificate of approval shall inform the Commission forthwith. If
the Commission considers that the conditions of paragraphs 6 and 7 have not
been met, it may require that Member State to revoke the said certificate or take
other appropriate measures by means of implementing acts. Those implementing
acts shall be adopted in accordance with the advisory procedure referred to in
Article 38(2).

Chapter 6

Final provisions

Article 35
Implementing measures

1.           The Member States shall
notify to the Commission the name and contact details of the authorities in
charge of the implementation of this Directive. The Commission shall draw up,
periodically update and make public a list of these authorities.

2.           For each item of marine
equipment for which the approval of the flag State administration is required
by the international conventions, the Commission shall identify by means of
implementing acts the respective design, construction and performance requirements
and the testing standards provided for in the international instruments.

3.           The Commission may adopt
by means of implementing acts common criteria and detailed procedures for the
application of the requirements and testing standards referred to in paragraph
(2).

4.           The Commission shall, by
means of implementing acts, identify the respective design, construction and
performance requirements newly provided for in the international instruments and
which apply to equipment placed on board before their adoption in order to
ensure that equipment placed on board of EU ships complies with the
international conventions.

5.           The Commission shall set
up and maintain a data base containing at least the following information:

(a)
the list and essential details of the conformity
certificates issued under this Directive;

(b)
the list and essential details of the
declarations of conformity issued under this Directive;

(c)
an up-to-date list of the applicable
international instruments, requirements and testing standards, including any updates
becoming applicable by virtue of Article 4(3);

(d)
the list and full text of the criteria and
procedures referred to in paragraph 3;

(e)
the requirements and conditions for electronic
tagging referred to in Article 11;

(f)
any other useful information with a view to
facilitating correct implementation of this Directive by the Member States, the
notified bodies and the economic operators.

This database shall be made accessible to the
Member States. It shall also be made available, in whole or in part, to the
public for information purposes only.

6.           The implementing acts
referred to in this Article shall be adopted in accordance with the examination
procedure referred to in Article 38(3).

Article 36
Amendments

This Directive may be amended by the
Commission, by means of delegated acts, in order to:

(a)
amend the list of international conventions set
out in Article 2(3), in order to include those conventions which require the
flag State's approval of equipment to be placed on board ships flying its flag;

(b)
update the references to international and
European standards, as referred to in Annex III when new standards become
available.

Those delegated acts shall be adopted in
accordance with the procedure laid down in Article 37.

Article 37
Exercise of the delegation

1.           The power to adopt
delegated acts is conferred on the Commission subject to the conditions laid
down in this Article.

2.           The delegation of power
referred to in Articles 8, 11, 29 and 36 shall be conferred on the Commission
for an indeterminate period of time from the date of entry into force of this
Directive.

3.           The delegation of power
referred to in Articles 8, 11, 29 and 36 may be revoked at any time by the
European Parliament or by the Council. A decision of revocation shall put an end
to the delegation of the power specified in that decision. It shall take effect
the day following the publication of the decision in the Official Journal of
the European Union or at a later date specified therein. It shall not affect
the validity of any delegated acts already in force.

4.           As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.

5.           A delegated act adopted
pursuant to Articles 8, 11, 29 and 36 shall enter into force only if no
objection has been expressed either by the European Parliament or the Council
within a period of 2 months of notification of that act to the European
Parliament and the Council or if, before the expiry of that period, the
European Parliament and the Council have both informed the Commission that they
will not object. That period shall be extended by 2 months at the initiative of
the European Parliament or the Council.

Article 38
Committee

1.           The Commission shall be
assisted by the Committee on Safe Seas and the Prevention of Pollution from
Ships (COSS) established by Regulation (EC) No 2099/2002 of the
European Parliament and of the Council[15].
That committee shall be a committee within the meaning of Regulation (EU) No
182/2011.

2.           Where reference is made to
this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3.           Where reference is made to
this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 39
Transposition

1.           Member States shall adopt
and publish, by [one year after entry into force] at the latest, the
laws, regulations and administrative provisions necessary to comply with this
Directive. They shall forthwith communicate to the Commission the text of those
provisions.

They shall apply those provisions from [one
year after the date of entry into force].

When Member States adopt those provisions, they
shall contain a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

2.           Member States shall
communicate to the Commission the text of the main provisions of national law
which they adopt in the field covered by this Directive.

Article 40
Repeal

1.           Council Directive 96/98/EC
is repealed with effect from [application date].

2.           The requirements and
testing standards for marine equipment applicable on [application date] pursuant
to the provisions of national law adopted by the Member States in order to
comply with Directive 96/98/EC shall continue to apply until the entry into
force of the implementing acts referred to in Article 35(2).

3.           References to the repealed
Directive shall be construed as references to this Directive.

Article 41
Entry into force

This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.

Article 42

This
Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament                       For
the Council

The President                                                 The
President

ANNEX I
Wheel mark

The mark of conformity must take the
following form:

If the wheel mark is reduced or enlarged
the proportions given in the graduated drawing must be respected.

The various components of the wheel mark
must have substantially the same vertical dimension, which may not be less than
5 mm.

That minimum dimension may be waived for
small devices.

ANNEX II
Conformity assessment procedures

I.
Module B: EC-type examination

1.           EC-type examination is the
part of a conformity assessment procedure in which a notified body examines the
technical design of marine equipment and verifies and attests that the
technical design of the marine equipment meets the requirements in the
international instruments.

2.           EC-type examination may be
carried out in either of the following manners:

–
examination of a specimen, representative of the
production envisaged, of the complete product (production type);

–
assessment of the adequacy of the technical
design of the marine equipment through examination of the technical
documentation and supporting evidence referred to in point 3, plus examination
of specimens, representative of the production envisaged, of one or more
critical parts of the product (combination of production type and design type);

3.           The manufacturer shall
lodge an application for EC-type examination with a single notified body of his
choice.

The application shall include:

–
a certified copy of the patent, license or
document by which the applicant purports to have the right to make, use, sell
or offer the marine equipment for sale or use its trademark, which,
notwithstanding point 16 of Annex III, the notified body shall keep at the
disposal of the competent courts;

–
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well;

–
a written declaration that the same application
has not been lodged with any other notified body;

–
the technical documentation. The technical
documentation shall make it possible to assess the conformity of the marine
equipment with the applicable requirements of the international instruments as
referred to in Article 4, and shall include an adequate analysis and assessment
of the risk(s). The technical documentation shall specify the applicable
requirements and cover, as far as relevant for the assessment, the design,
manufacture and operation of the marine equipment. The technical documentation
shall contain, wherever applicable, at least the following elements:

–
a general description of the marine equipment,

–
conceptual design and manufacturing drawings and
schemes of components, sub-assemblies, circuits, etc.,

(a)
descriptions and explanations necessary for the
understanding of those drawings and schemes and the operation of the marine
equipment,

(b)
a list of the requirements and testing standards
which are applicable to the marine equipment concerned in accordance with this
Directive, together with a description of the solutions adopted to meet the
said requirements,

(c)
results of design calculations made,
examinations carried out, etc., and

(d)
test reports;

–
the specimens representative of the production
envisaged. The notified body may request further specimens if needed for
carrying out the test programme;

–
the supporting evidence for the adequacy of the
technical design solution. This supporting evidence shall mention any documents
that have been used. The supporting evidence shall include, where necessary,
the results of tests carried out by the appropriate laboratory of the
manufacturer, or by another testing laboratory on his behalf and under his
responsibility.

4.           The notified body shall:

For the marine equipment:

4.1.        examine
the technical documentation and supporting evidence to assess the adequacy of
the technical design of the marine equipment;

For the specimen(s):

4.2.        verify
that the specimen(s) have been manufactured in conformity with the technical
documentation, and identify the elements which have been designed in accordance
with the applicable provisions of the relevant harmonised standards and/or
technical specifications, as well as the elements which have been designed
without applying the relevant provisions of those standards;

4.3.        carry
out appropriate examinations and tests in accordance with this Directive;

4.4.        agree
with the manufacturer on a location where the examinations and tests will be
carried out.

5.           The notified body shall draw up
an evaluation report that records the activities undertaken in accordance with
point 4 and their outcomes. Without prejudice to its obligations vis-à vis the
notifying authorities, the notified body shall release the content of that
report, in full or in part, only with the agreement of the manufacturer.

6.           Where the type meets the
requirements of the specific international instruments that apply to the marine
equipment concerned, the notified body shall issue an EC-type examination
certificate to the manufacturer. The certificate shall contain the name and
address of the manufacturer, the conclusions of the examination, the conditions
(if any) for its validity and the necessary data for identification of the
approved type. The certificate may have one or more annexes attached.

The certificate and its annexes shall contain
all relevant information to allow the conformity of manufactured products with
the examined type to be evaluated and to allow for in‑service control.

Where the type does not satisfy the applicable
requirements of the international instruments, the notified body shall refuse
to issue an EC‑type examination
certificate and shall inform the applicant accordingly, giving detailed reasons
for its refusal.

7.           The notified body shall keep
itself apprised of any changes in the generally acknowledged state of the art
which indicate that the approved type may no longer comply with the applicable
requirements of the international instruments, and shall determine whether such
changes require further investigation. If so, the notified body shall inform
the manufacturer accordingly.

The manufacturer shall inform the notified body
that holds the technical documentation relating to the EC‑type examination certificate of all
modifications to the approved type that may affect the conformity of the marine
equipment with the requirements of the international instruments or the
conditions for validity of the certificate. Such modifications shall require
additional approval in the form of an addition to the original EC‑type examination certificate.

8.           Each notified body shall inform
its notifying authorities concerning the EC‑type examination certificates and/or any additions thereto which it
has issued or withdrawn, and shall, periodically or upon request, make
available to its notifying authorities the list of certificates and/or any
additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other
notified bodies concerning the EC-type examination certificates and/or any
additions thereto which it has refused, withdrawn, suspended or otherwise
restricted, and, upon request, concerning the certificates and/or additions
thereto which it has issued.

The Commission, the Member States and the other
notified bodies may, on request, obtain a copy of the EC-type examination
certificates and/or additions thereto. On request, the Commission and the
Member States may obtain a copy of the technical documentation and the results
of the examinations carried out by the notified body. The notified body shall
keep a copy of the EC‑type
examination certificate, its annexes and additions, as well as the technical
file including the documentation submitted by the manufacturer, until the
expiry of the validity of the certificate.

9.           The manufacturer shall keep a
copy of the EC‑type examination
certificate, its annexes and additions together with the technical
documentation at the disposal of the national authorities for ten years after
the last product has been manufactured.

10.         The manufacturer's authorised
representative may lodge the application referred to in point 3 and fulfil
the obligations set out in points 7 and 9, provided that they are
specified in the mandate.

II. Module D: Conformity to type based on
quality assurance of the production process

1.           Conformity to type based on
quality assurance of the production process is the part of a conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down
in points 2 and 5, and ensures and declares on his sole
responsibility that the marine equipment concerned is in conformity with the
type described in the EC‑type
examination certificate and satisfy the requirements of the international
instruments that apply to them.

2.           Manufacturing

The manufacturer shall operate an approved
quality system for production, final product inspection and testing of the
products concerned as specified in point 3, and shall be subject to
surveillance as specified in point 4.

3.           Quality system

3.1.        The manufacturer shall lodge an
application for assessment of his quality system with the notified body of his
choice, for the marine equipment concerned.

The application shall include:

–
a certified copy of the patent, license or
document by which the applicant purports to have the right to make, use, sell
or offer the marine equipment for sale or use its trademark, which,
notwithstanding point 16 of Annex III, the notified body shall keep at the
disposal of the competent courts,

–
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well,

–
a written declaration that the same application
has not been lodged with any other notified body,

–
all relevant information for the marine
equipment category envisaged,

–
the documentation concerning the quality system,

–
the technical documentation of the approved type
and a copy of the EC‑type
examination certificate.

3.2.        The quality system shall ensure
that the products are in conformity with the type described in the EC‑type examination certificate and comply
with the requirements of the international instruments that apply to them.

All the elements, requirements and provisions
adopted by the manufacturer shall be documented in a systematic and orderly
manner in the form of written policies, procedures and instructions. The
quality system documentation shall permit a consistent interpretation of the
quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate
description of:

–
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to product
quality,

–
the corresponding manufacturing, quality control
and quality assurance techniques, processes and systematic actions that will be
used,

–
the examinations and tests that will be carried
out before, during and after manufacture, and the frequency with which they
will be carried out,

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc. and

–
the means of monitoring the achievement of the
required product quality and the effective operation of the quality system.

3.3.        The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in point 3.2.

In addition to experience in quality management
systems, the auditing team shall have at least one member with experience of
evaluation in the relevant marine equipment field and marine equipment technology
concerned, and knowledge of the applicable requirements of the international
instruments. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred
to in point 3.1, fifth indent, to verify the manufacturer's ability
to identify the relevant requirements of the international instruments and to
carry out the necessary examinations with a view to ensuring compliance of the product
with those requirements.

The decision shall be notified to the
manufacturer. The notification shall contain the conclusions of the audit and
the reasoned assessment decision.

3.4.        The manufacturer shall undertake
to fulfil the obligations arising out of the quality system as approved and to
maintain it so that it remains adequate and efficient.

3.5.        The manufacturer shall keep the
notified body that has approved the quality system informed of any intended
change to the quality system.

The notified body shall evaluate any proposed
changes and decide whether the modified quality system will continue to satisfy
the requirements referred to in point 3.2 or whether a re-assessment is
necessary.

It shall notify the manufacturer of its
decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.

4.           Surveillance under the
responsibility of the notified body

4.1.        The purpose of surveillance is to
make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

4.2.        The manufacturer shall, for
assessment purposes, allow the notified body access to the manufacture,
inspection, testing and storage sites and shall provide it with all necessary
information, in particular:

–
the quality system documentation;

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc.

4.3.        The notified body shall carry out
periodic audits to make sure that the manufacturer maintains and applies the
quality system and shall provide the manufacturer with an audit report.

4.4.        In addition, the notified body may
pay unexpected visits to the manufacturer. During such visits the notified body
may, if necessary, carry out product tests, or have them carried out, in order
to verify that the quality system is functioning correctly. The notified body
shall provide the manufacturer with a visit report and, if tests have been
carried out, with a test report.

5.           Conformity marking and
declaration of conformity

5.1.        The manufacturer shall affix the
wheel mark set out in Article 9, and, under the responsibility of the notified
body referred to in point 3.1, the latter's identification number to each
individual product that is in conformity with the type described in the EC‑type examination certificate and satisfies
the applicable requirements of the international instruments.

5.2.        The manufacturer shall draw up a
written declaration of conformity for each product model and keep it at the
disposal of the national authorities for ten years after the last product has
been manufactured. The declaration of conformity shall identify the marine
equipment model for which it has been drawn up.

A copy of the declaration of conformity shall
be made available to the relevant authorities upon request.

6.           The manufacturer shall, for a
period ending at least ten years after the last product has been manufactured,
keep at the disposal of the national authorities:

–
the documentation referred to in point 3.1,

–
the change referred to in point 3.5, as
approved,

–
the decisions and reports of the notified body
referred to in points 3.5, 4.3 and 4.4.

7.           Each notified body shall inform
its notifying authorities of quality system approvals issued or withdrawn,
and shall, periodically or upon request, make available to its notifying
authorities the list of quality system approvals refused, suspended or
otherwise restricted.

Each notified body shall inform the other
notified bodies of quality system approvals which it has refused, suspended,
withdrawn or otherwise restricted, and, upon request, of quality system
approvals which it has issued.

8.           Authorised representative

The manufacturer's obligations set out in
points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised
representative, on his behalf and under his responsibility, provided that they
are specified in the mandate.

III.
Module E: Conformity to type based on product quality assurance

1.           Conformity to type based on
product quality assurance is that part of a conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in points 2
and 5, and ensures and declares on his sole responsibility that the marine
equipment concerned is in conformity with the type described in the EC‑type examination certificate and satisfy
the requirements of the international instruments that apply to them.

2.           Manufacturing

The manufacturer shall operate an approved
quality system for final product inspection and testing of the products
concerned as specified in point 3 and shall be subject to surveillance as
specified in point 4.

3.           Quality system

3.1.        The manufacturer shall lodge an
application for assessment of his quality system with the notified body of his
choice, for the marine equipment concerned.

The application shall include:

–
a certified copy of the patent, license or
document by which the applicant purports to have the right to make, use, sell
or offer the marine equipment for sale or use its trademark, which,
notwithstanding point 16 of Annex III, the notified body shall keep at the
disposal of the competent courts,

–
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well,

–
a written declaration that the same application
has not been lodged with any other notified body,

–
all relevant information for the marine
equipment category envisaged,

–
the documentation concerning the quality system,
and

–
the technical documentation of the approved type
and a copy of the EC‑type
examination certificate.

3.2.        The quality system shall ensure
compliance of the products with the type described in the EC‑type examination certificate and with the
applicable requirements of the international instruments.

All the elements, requirements and provisions
adopted by the manufacturer shall be documented in a systematic and orderly
manner in the form of written policies, procedures and instructions. The
quality system documentation shall permit a consistent interpretation of the
quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate
description of:

–
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to product
quality;

–
the examinations and tests that will be carried
out after manufacture;

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc.;

–
the means of monitoring the effective operation
of the quality system.

3.3.        The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in point 3.2.

In addition to experience in quality management
systems, the auditing team shall have at least one member with experience of
evaluation in the relevant marine equipment field and marine equipment technology
concerned, and knowledge of the applicable requirements of the international
instruments. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred
to in point 3.1, fifth indent, in order to verify the manufacturer's ability to
identify the relevant requirements of the international instruments and to
carry out the necessary examinations with a view to ensuring compliance of the
product with those requirements.

The decision shall be notified to the
manufacturer. The notification shall contain the conclusions of the audit and
the reasoned assessment decision.

3.4.        The manufacturer shall undertake
to fulfil the obligations arising out of the quality system as approved and to
maintain it so that it remains adequate and efficient.

3.5.        The manufacturer shall keep the
notified body that has approved the quality system informed of any intended
change to the quality system.

The notified body shall evaluate any proposed
changes and decide whether the modified quality system will continue to satisfy
the requirements referred to in point 3.2 or whether a re-assessment is
necessary.

It shall notify the manufacturer of its
decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.

4.           Surveillance under the
responsibility of the notified body

4.1.        The purpose of surveillance is to
make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

4.2.        The manufacturer shall, for
assessment purposes, allow the notified body access to the manufacture,
inspection, testing and storage sites and shall provide it with all necessary
information, in particular:

–
the quality system documentation;

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc.

4.3.        The notified body shall carry out
periodic audits to make sure that the manufacturer maintains and applies the
quality system and shall provide the manufacturer with an audit report.

4.4.        In addition, the notified body may
pay unexpected visits to the manufacturer. During such visits the notified body
may, if necessary, carry out product tests, or have them carried out, in order
to verify that the quality system is functioning correctly. The notified body
shall provide the manufacturer with a visit report and, if tests have been
carried out, with a test report.

5.           Conformity marking and
declaration of conformity

5.1.        The manufacturer shall affix the
required conformity marking set out in Article 9, and, under the responsibility
of the notified body referred to in point 3.1, the latter's identification
number to each individual product that is in conformity with the type described
in the EC‑type examination
certificate and satisfies the applicable requirements of the international
instruments.

5.2.        The manufacturer shall draw up a
written declaration of conformity for each product model and keep it at the
disposal of the national authorities for ten years after the last product has
been manufactured. The declaration of conformity shall identify the marine
equipment model for which it has been drawn up.

A copy of the declaration of conformity shall
be made available to the relevant authorities upon request.

6.           The manufacturer shall, for a
period ending at least ten years after the last product has been manufactured,
keep at the disposal of the national authorities:

–
the documentation referred to in point 3.1;

–
the change referred to in point 3.5, as
approved;

–
the decisions and reports of the notified body
referred to in points 3.5, 4.3 and 4.4.

7.           Each notified body shall inform
its notifying authorities of quality system approvals issued or withdrawn, and
shall, periodically or upon request, make available to its notifying
authorities the list of quality system approvals refused, suspended or
otherwise restricted.

Each notified body shall inform the other
notified bodies of quality system approvals which it has refused, suspended or
withdrawn, and, upon request, of quality system approvals which it has issued.

8.           Authorised representative

The manufacturer's obligations set out in
points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised
representative, on his behalf and under his responsibility, provided that they
are specified in the mandate.

IV.
Module F: Conformity to type based on product verification

1.           Conformity to type based on
product verification is the part of a conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down in points 2, 5.1
and 6, and ensures and declares on his sole responsibility that the
products concerned, which have been subject to the provisions of point 3,
are in conformity with the type described in the EC‑type examination certificate and satisfy the requirements of the
international instruments that apply to them.

2.           Manufacturing

The manufacturer shall take all measures
necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured products with the approved type described in the
EC‑type examination certificate
and with the requirements of the international instruments that apply to them.

3.           Verification

A notified body chosen by the manufacturer
shall carry out appropriate examinations and tests in order to check the
conformity of the products with the approved type described in the EC‑type examination certificate and with the
appropriate requirements of the international instruments.

The manufacturer shall provide the notified
body with a certified copy of the patent, license or document by which the
applicant purports to have the right to make, use, sell or offer the marine
equipment for sale or use its trademark, which, notwithstanding point 16 of
Annex III, the notified body shall keep at the disposal of the competent
courts.

The examinations and tests to check the
conformity of the products with the appropriate requirements shall be carried
out, at the choice of the manufacturer either by examination and testing of
every product as specified in point 4 or by examination and testing of the
products on a statistical basis as specified in point 5.

4.           Verification of conformity by
examination and testing of every product

4.1         All products shall be individually
examined and tested in accordance with this Directive, in order to verify
conformity with the approved type described in the EC‑type examination certificate and with the appropriate requirements
of the international instruments.

4.2.        The notified body shall issue a
certificate of conformity in respect of the examinations and tests carried out,
and shall affix its identification number to each approved product or have it
affixed under its responsibility.

The manufacturer shall keep the certificates of
conformity available for inspection by the national authorities for ten years
after the last product has been manufactured.

5.           Statistical verification of
conformity

5.1.        The manufacturer shall take all
measures necessary so that the manufacturing process and its monitoring ensure
the homogeneity of each lot produced, and shall present his products for
verification in the form of homogeneous lots.

5.2.        A random sample shall be taken
from each lot. All products in a sample shall be individually examined and
tested in accordance with this Directive, in order to ensure their conformity
with the applicable requirements of the international instruments and to
determine whether the lot is accepted or rejected.

5.3.        If a lot is accepted, all products
of the lot shall be considered approved, except for those products from the
sample that have been found not to satisfy the tests.

The notified body shall issue a certificate of
conformity in respect to the examinations and tests carried out, and shall affix
its identification number to each approved product or have it affixed under its
responsibility.

The manufacturer shall keep the certificates of
conformity at the disposal of the national authorities for ten years after the
last product has been manufactured.

5.4.        If a lot is rejected, the notified
body or the competent authority shall take appropriate measures to prevent that
lot being placed on the market. In the event of the frequent rejection of lots
the notified body may suspend the statistical verification and take appropriate
measures.

6.           Conformity marking and
declaration of conformity

6.1.        The manufacturer shall affix the
required conformity marking set out in Article 9, and, under the responsibility
of the notified body referred to in point 3, the latter's identification
number to each individual product that is in conformity with the approved type
described in the EC‑type
examination certificate and satisfies the applicable requirements of the
international instruments.

6.2.        The manufacturer shall draw up a
written declaration of conformity for each product model and keep it at the
disposal of the national authorities, for ten years after the last product has
been manufactured. The declaration of conformity shall identify the marine
equipment model for which it has been drawn up.

A copy of the declaration of conformity shall
be made available to the relevant authorities upon request.

7.           If the notified body agrees and
under its responsibility, the manufacturer may affix the notified body's
identification number to the products during the manufacturing process.

8.           Authorised representative

The manufacturer's obligations may be fulfilled
by his authorised representative, on his behalf and under his responsibility,
provided that they are specified in the mandate. An authorised representative
may not fulfil the manufacturer's obligations set out in points 2
and 5.1.

V.
Module G: Conformity based on unit verification

1.           Conformity based on unit
verification is the conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in points 2, 3 and 5, and ensures
and declares on his sole responsibility that the product concerned, which has
been subject to the provisions of point 4, is in conformity with the
requirements of the international instruments that apply to it.

2.           Technical documentation

The manufacturer shall establish the technical
documentation and make it available to the notified body referred to in
point 4. The documentation shall make it possible to assess the product's
conformity with the relevant requirements, and shall include an adequate
analysis and assessment of the risk(s). The technical documentation shall
specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the product. The technical
documentation shall, wherever applicable, contain at least the following
elements:

–
a certified copy of the patent, license or
document by which the applicant purports to have the right to make, use, sell
or offer the marine equipment for sale or use its trademark, which,
notwithstanding point 16 of Annex III, the notified body shall keep at the
disposal of the competent courts,

–
a general description of the product,

–
conceptual design and manufacturing drawings and
schemes of components, sub-assemblies, circuits, etc.,

–
descriptions and explanations necessary for the
understanding of those drawings and schemes and the operation of the product,

–
a list of the requirements and testing standards
which are applicable to the marine equipment concerned in accordance with this
Directive, together with a description of the solutions adopted to meet the
said requirements,

–
results of design calculations made,
examinations carried out; and

–
test reports.

The manufacturer shall keep the technical
documentation at the disposal of the relevant national authorities for ten
years after the last product has been manufactured.

3.           Manufacturing

The manufacturer shall take all measures
necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured product with the applicable requirements of the
international instruments.

4.           Verification

A notified body chosen by the manufacturer
shall carry out appropriate examinations and tests in accordance with this
Directive, in order to check the conformity of the product with the applicable
requirements of the international instruments.

The notified body shall issue a certificate of
conformity in respect of the examinations and tests carried out and shall affix
its identification number to the approved product, or have it affixed under its
responsibility.

The manufacturer shall keep the certificates of
conformity at the disposal of the national authorities for ten years after the
last product has been manufactured.

5.           Conformity marking and
declaration of conformity

5.1.        The manufacturer shall affix the
required conformity marking set out in Article 9 and, under the responsibility
of the notified body referred to in point 4, the latter's identification number
to each product that satisfies the applicable requirements of the international
instruments.

5.2.        The manufacturer shall draw up a
written declaration of conformity and keep it at the disposal of the national
authorities for ten years after the last product has been manufactured. The
declaration of conformity shall identify the product for which it has been
drawn up.

A copy of the declaration of conformity shall
be made available to the relevant authorities upon request.

6.           Authorised representative

The manufacturer's obligations set out in
points 2 and 5 may be fulfilled by his authorised representative, on
his behalf and under his responsibility, provided that
they are specified in the mandate.

ANNEX III
Requirements to be met by notified bodies

1.           For the purposes of
notification, a conformity assessment body shall meet the requirements laid
down in points 2 to 11.

2.           A conformity assessment
body shall be established under national law and have legal personality.

3.           A conformity assessment
body shall be a third‑party
body independent of the organisation or the marine equipment it assesses.

4.           A body belonging to a
business association or professional federation representing undertakings
involved in the design, manufacturing, provision, assembly, use or maintenance
of marine equipment which it assesses, may, on condition that its independence
and the absence of any conflict of interest are demonstrated, be considered
such a body.

5.           A conformity assessment
body, its top level management and the personnel responsible for carrying out
the conformity assessment tasks shall not be the designer, manufacturer,
supplier, installer, purchaser, owner, user or maintainer of the marine
equipment which they assess, nor the authorised representative of any of those
parties. This shall not preclude the use of assessed products that are
necessary for the operations of the conformity assessment body or the use of
such products for personal purposes.

6.           A conformity assessment
body, its top level management and the personnel responsible for carrying out
the conformity assessment tasks shall not be directly involved in the design,
manufacture or construction, the marketing, installation, use or maintenance of
that marine equipment, or represent the parties engaged in those activities.
They shall not engage in any activity that may conflict with their independence
of judgement or integrity in relation to conformity assessment activities for
which they are notified. This shall in particular apply to consultancy services.

7.           Conformity assessment
bodies shall ensure that the activities of their subsidiaries or subcontractors
do not affect the confidentiality, objectivity or impartiality of their
conformity assessment activities.

8.           Conformity assessment
bodies and their personnel shall carry out the conformity assessment activities
with the highest degree of professional integrity and the requisite technical
competence in the specific field and shall be free from all pressures and
inducements, particularly financial, which might influence their judgement or
the results of their conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those
activities.

9.           A conformity assessment
body shall be capable of carrying out all the conformity assessment tasks
assigned to it under this Directive and in relation to which it has been
notified, whether those tasks are carried out by the conformity assessment body
itself or on its behalf and under its responsibility.

10.         At all times and for each
conformity assessment procedure and each kind or category of marine equipment in
relation to which it has been notified, a conformity assessment body shall have
at its disposal the necessary:

(a)
personnel with technical knowledge and
sufficient and appropriate experience to perform the conformity assessment
tasks;

(b)
descriptions of procedures in accordance with
which conformity assessment is carried out, ensuring the transparency and the
ability of reproduction of those procedures. It shall have appropriate policies
and procedures in place that distinguish between tasks it carries out as a
notified body and other activities;

(c)
procedures for the performance of activities
which take due account of the size of an undertaking, the sector in which it
operates, its structure, the degree of complexity of the marine equipment technology
in question and the mass or serial nature of the production process.

11.         A conformity assessment
body shall have the means necessary to perform the technical and administrative
tasks connected with the conformity assessment activities in an appropriate
manner and shall have access to all necessary equipment or facilities.

12.         The personnel responsible
for carrying out conformity assessment activities shall have the following:

(a)
sound technical and vocational training covering
all the conformity assessment activities in relation to which the conformity
assessment body has been notified;

(b)
satisfactory knowledge of the requirements of
the assessments they carry out and adequate authority to carry out those
assessments;

(c)
appropriate knowledge and understanding of the
requirements, of the applicable harmonised standards and of the relevant
provisions of EU harmonisation legislation and of its implementing regulations;

(d)
the ability to draw up certificates, records and
reports demonstrating that assessments have been carried out.

13.         The impartiality of the
conformity assessment bodies, their top level management and of the assessment
personnel shall be guaranteed.

14.         The remuneration of the top
level management and assessment personnel of a conformity assessment body shall
not depend on the number of assessments carried out or on the results of those
assessments.

15.         Conformity assessment
bodies shall take out liability insurance unless liability is assumed by the
State in accordance with national law, or the Member State itself is directly
responsible for the conformity assessment.

16.         The personnel of a
conformity assessment body shall observe professional secrecy with regard to
all information obtained in carrying out their tasks under this Directive or
any provision of national law giving effect to it, except in relation to the
competent authorities of the Member State in which its activities are carried
out. Proprietary rights shall be protected.

17.         Conformity assessment
bodies shall participate in, or ensure that their assessment personnel are
informed of, the relevant standardisation activities and the activities of the
notified body coordination group established under the relevant EU harmonisation
legislation and apply as general guidance the administrative decisions and
documents produced as a result of the work of that group.

18.         Conformity assessment
bodies shall meet the requirements of standard EN4011 (ISO guide 65),

19.         Conformity assessment
bodies shall ensure that testing laboratories used for conformity-assessment
purposes meet the requirements of standard EN17025.

ANNEX IV
Notification procedure

1.           Application for
notification

1.1.        A conformity assessment
body shall submit an application for notification to the notifying authority of
the Member State in which it is established.

1.2.        That application shall be
accompanied by a description of the conformity assessment activities, the
conformity assessment module or modules and the marine equipment for which that
body claims to be competent, as well as by an accreditation certificate, where
one exists, issued by a national accreditation body attesting that the
conformity assessment body fulfils the requirements laid down in Annex III of
this Directive.

1.3.        Where the conformity
assessment body concerned cannot provide an accreditation certificate, it shall
provide the notifying authority with all the documentary evidence necessary for
the verification, recognition and regular monitoring of its compliance with the
requirements laid down in Annex III .

2.           Notification procedure

2.1.        Notifying authorities may
notify only conformity assessment bodies which have satisfied the requirements
laid down in Annex III .

2.2.        They shall notify the Commission
and the other Member States using the electronic notification tool developed
and managed by the Commission.

2.3.        The notification shall
include full details of the conformity assessment activities, the conformity
assessment module or modules and marine equipment concerned and the relevant
attestation of competence.

2.4.        Where a notification is not
based on an accreditation certificate as referred to in section 1, the
notifying authority shall provide the Commission and the other Member States
with documentary evidence which attests to the conformity assessment body's
competence and the arrangements in place to ensure that that body will be
monitored regularly and will continue to satisfy the requirements laid down in
Annex III to this Directive.

2.5.        The body concerned may
perform the activities of a notified body only where no objections are raised
by the Commission or the other Member States within two weeks of a notification
where an accreditation certificate is used or within two months of a notification
where accreditation is not used.

2.6.        Only such a body shall be
considered a notified body for the purposes of this Directive.

2.7.        The Commission and the
other Member States shall be notified of any subsequent relevant changes to the
notification.

3.           Identification numbers and
lists of notified bodies

3.1.        The Commission shall assign
an identification number to a notified body.

3.2.        It shall assign a single
such number even where the notified body is recognised as notified under
several EU acts.

3.3.        The Commission shall make
publicly available the list of the bodies notified under this Directive,
including the identification numbers that have been allocated to them and the
activities for which they have been notified.

3.4.        The Commission shall ensure
that that list is kept up to date.

ANNEX V
Requirements to be met by notifying authorities

1.           A notifying authority
shall be established in such a way that no conflict of interest with conformity
assessment bodies occurs.

2.           A notifying authority shall
be organised and operated so as to safeguard the objectivity and impartiality
of its activities.

3.           A notifying authority
shall be organised in such a way that each decision relating to notification of
a conformity assessment body is taken by competent persons different from those
who carried out the assessment.

4.           A notifying authority
shall not offer or provide any activities that conformity assessment bodies
perform or consultancy services on a commercial or competitive basis.

5.           A notifying authority shall
safeguard the confidentiality of the information it obtains.

6.           A notifying authority
shall have a sufficient number of competent personnel at its disposal for the
proper performance of its tasks.

[1]               Cf. COM (1995) 269 final

[2]               OJ L 46, 17.2.1997, p. 25.

[3]               OJ L 218, 13.8.2008, p. 30

[4]               OJ L218, 13.8.2008, p.82

[5]               It must be recalled that, as stated in recital 17,
the European Maritime Safety Agency assists the Commission in the
implementation of the Directive and in carrying out the tasks entrusted to the
former.

[6]               OJ C , , p. .

[7]               OJ C , , p. .

[8]               OJ L 46, 17.2.1997, p. 25.

[9]               OJ L 218, 13.8.2008, p. 82.

[10]               OJ L 55, 28.2.2011, p. 13.

[11]               OJ L 218, 13.8.2008, p. 30.

[12]               OJ L 324, 29.11.2002, p.1.

[13]               OJ L 204, 21.7.1998, p. 37.

[14]               OJ L 131, 28.5.2009, p. 57

[15]             OJ L 324, 29.11.2002, p. 1.

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