1994L0025 — EN — 20.11.2003 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
.B DIRECTIVE 94/25/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 June 1994
on the approximation of the laws, regulations and administrative provisions of the Member States
relating to recreational craft
(OJ L 164, 30.6.1994, p. 15)
Amended by:
Official Journal
No page date
.M1 Directive 2003/44/EC of the European Parliament and of the Council of
16 June 2003
L 214 18 26.8.2003
.M2 Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003
L 284 1 31.10.2003
Corrected by:
.C1 Corrigendum, OJ L 127, 10.6.1995, p. 27 (94/25/EC)
.C2 Corrigendum, OJ L 41, 15.2.2000, p. 20 (94/25/EC)
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DIRECTIVE 94/25/EC OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
of 16 June 1994
on the approximation of the laws, regulations and administrative
provisions of the Member States relating to recreational craft
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Acting in accordance with the procedure laid down in Article 189b of
the Treaty (3),
Whereas the internal market is to comprise an area without internal
frontiers in which the free movement of goods, persons, services and
capital is ensured;
Whereas the laws, regulations and administrative provisions in force in
the various Member States relating to the safety characteristics of
recreational craft differ in scope and content; whereas such disparities
are liable to create barriers to trade and unequal conditions of competition
within the internal market;
Whereas harmonization of national legislation is the only way in which
to remove these barriers to free trade; whereas this objective cannot be
satisfactorily achieved by the individual Member States; whereas this
Directive merely lays down the requirements vital to freedom of movement
for recreational craft;
Whereas this Directive should cover only recreational craft of a
minimum length of 2,5 m and a maximum length of 24 m, derived
from the ISO standards;
Whereas the removal of technical barriers in the field of recreational
craft and their components, to the extent that they cannot be removed
by mutual recognition of equivalence among all the Member States,
should follow the new approach set out in the Council resolution of 7
May 1985 (4) which calls for the definition of essential requirements on
safety and other aspects which are important for the general well-being;
whereas paragraph 3 of Article 100a provides that, in its proposals,
concerning health, safety, environmental protection and consumer
protection, the Commission will take as a base a high level of protection;
whereas the essential requirements constitute the criteria with
which recreational craft, partly completed craft and their components
when separate and when installed must comply;
Whereas, therefore, this Directive sets out essential requirements only;
whereas, in order to facilitate the task of proving compliance with the
essential requirements, harmonized European standards are necessary
for recreational craft and their components as referred to in Annex II;
whereas harmonized European standards are drawn up by private
bodies and must retain their non-mandatory status; whereas, for this
purpose, the European Committee for Standardization (CEN) and the
European Committee for Electrotechnical Standardization (Cenelec)
are recognized as the bodies competent to adopt harmonized standards
which follow the general guidelines for cooperation between the
1994L0025 — EN — 20.11.2003 — 002.001 — 2
(1) OJ No C 123, 15. 5. 1992, p. 7.
(2) OJ No C 313, 30. 11. 1992, p. 38.
(3) Opinion of the European Parliament of 16 November 1992 (OJ No C 337,
21. 12. 1992, p. 17); Council common position of 16 December 1993 (OJ
No C 137, 19. 5. 1994, p. 1); Decision of the European Parliament of 9
March1994 (OJ No C 91, 28. 3. 1994).
(4) OJ No C 136, 4. 6. 1985, p. 1.
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Commission and those two bodies, signed on 13 November 1984;
whereas, for the purposes of this Directive, a harmonized standard is a
technical specification (European Standard or harmonization document)
adopted by one or other of those bodies, or by both, at the prompting
of the Commission pursuant to Council Directive 83/189/EEC of 28
March1983 laying down a procedure for the provision of information
in the field of technical standards and regulations (1) and pursuant to
the general guidelines referred to above;
Whereas, in view of the nature of the risks involved in the use of
recreational craft and their components, it is necessary to establish
procedures applying to the assessment of compliance with the essential
requirements of the Directive; whereas these procedures must be
devised in the light of the level of risk which may be inherent in
recreational craft and their components; whereas, therefore, each category
of conformity must be supplemented by an appropriate procedure
or a choice between several equivalent procedures; whereas the procedures
adopted comply withCouncil Decision 93/465/EEC of 22 July
1993 concerning the modules for the various phases of the conformity
assessment procedures and the rules for the affixing and use of the CE
conformity marking which are intended to be used in the technical
harmonization Directives (2);
Whereas the Council has provided for the affixing of the CE marking
by either the manufacturer or his authorized representative within the
Community; whereas that mark means that the recreational craft and
components comply withall the essential requirements and assessment
procedures provided for by the Community law applying to the
product;
Whereas it is appropriate that the Member States, as provided for by
Article 100a (5) of the Treaty, may take provisional measures to limit
or prohibit the placing on the market and the use of recreational craft
or constituent products thereof in cases where they present a particular
risk to the safety of persons and, where appropriate, domestic animals
or property, provided that the measures are subject to a Community
control procedure;
Whereas the recipients of any decision taken as part of this Directive
must be aware of the reasons behind that decision and the means of
appeal open to them;
Whereas it is necessary to provide for a transitional arrangement
enabling recreational craft and their components manufactured in
compliance with the national regulations in force at the date of adoption
of this Directive to be marketed and placed in service;
Whereas this Directive does not contain any provisions directed
towards limiting the use of the recreational craft after it has been put
into service;
Whereas the construction of recreational craft may have an impact on
the environment to the extent that the craft may discharge polluting
substances; whereas it is therefore necessary to include provisions on
the protection of the environment in the Directive, in so far as those
provisions concern the construction of recreational craft from the point
of view of its direct impact on the environment;
Whereas the provisions of this Directive should not affect Member
States’ entitlement to lay down, in accordance withth e Treaty, such
requirements as they may deem necessary concerning navigation on
certain waters for the purpose of protection of the environment, the
fabric of waterways and ensuring safety on waterways, provided that
this does not mean that the recreational craft is modified in a way not
specified in this Directive,
1994L0025 — EN — 20.11.2003 — 002.001 — 3
(1) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Directive 88/
182/EEC (OJ No L 81, 26. 3. 1988, p. 75).
(2) OJ No L 220, 30. 8. 1993, p. 23.
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HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
Article 1
Scope and definitions
1. This Directive shall apply:
(a) withregard to design and construction, to:
(i) recreational craft and partly completed boats;
(ii) personal watercraft;
(iii) components referred to in Annex II when placed on the
Community market separately and when intended for installation;
(b) with regard to exhaust emissions, to:
(i) propulsion engines which are installed or specifically intended
for installation on or in recreational craft and personal watercraft;
(ii) propulsion engines installed on or in these craft that are subject
to a ‘major engine modification’;
(c) with regard to noise emissions, to:
(i) recreational craft with stern drive engines without integral
exhausts or inboard propulsion engine installations;
(ii) recreational craft with stern drive engines without integral
exhausts or with inboard propulsion installations which are
subject to a major craft conversion and subsequently placed
on the Community market within five years following conversion;
(iii) personal watercraft;
(iv) outboard engines and stern drive engines with integral
exhausts intended for installation on recreational craft;
(d) for products falling under (a)(ii), (b) and (c), the provisions of this
Directive shall only apply from the first placing on the market and/
or putting into service after the date of entry into force of this
Directive.
2. The following shall be excluded from the scope of this Directive:
(a) with regard to paragraph 1(a):
(i) craft intended solely for racing, including rowing racing boats
and training rowing boats, labelled as such by the manufacturer;
(ii) canoes and kayaks, gondolas and pedalos;
(iii) sailing surfboards;
(iv) surfboards, including powered surfboards;
(v) original historical craft and individual replicas thereof
designed before 1950, built predominantly with the original
materials and labelled as such by the manufacturer;
(vi) experimental craft, provided that they are not subsequently
placed on the Community market;
(vii) craft built for own use, provided that they are not subsequently
placed on the Community market during a period of
five years;
1994L0025 — EN — 20.11.2003 — 002.001 — 4
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(viii) craft specifically intended to be crewed and to carry passengers
for commercial purposes, without prejudice to paragraph
3(a), in particular those defined in Council Directive 82/714/
EEC of 4 October 1982 laying down technical requirements
for inland waterway vessels (1), regardless of the number of
passengers;
(ix) submersibles;
(x) air cushion vehicles;
(xi) hydrofoils;
(xii) External combustion steam powered craft, fueled by coal,
coke, wood, oil or gas;
(b) with regard to paragraph 1(b):
(i) propulsion engines installed or specifically intended for installation
on the following:
— craft intended solely for racing and labelled as such by the
manufacturer,
— experimental craft, provided that they are not subsequently
placed on the Community market,
— craft specifically intended to be crewed and to carry
passengers for commercial purposes, without prejudice to
paragraph3(a), in particular those defined in Directive 82/
714/EEC, regardless of the number of passengers,
— submersibles,
— air cushion vehicles,
— hydrofoils;
(ii) original and individual replicas of historical propulsion
engines, which are based on a pre-1950 design, not produced
in series and fitted on craft referred to in paragraph2(a)(v) and
(vii);
(iii) propulsion engines built for own use provided that they are not
subsequently placed on the Community market during a period
of five years;
(c) with regard to paragraph 1(c):
— all craft referred to in point (b) of this paragraph,
— craft built for own use, provided that they are not subsequently
placed on the Community market during a period of five years.
3. For the purposes of this Directive the following definitions shall
apply:
(a) ‘recreational craft’: any boat of any type intended for sports and
leisure purposes of hull length from 2,5 m to 24 m, measured
according to the harmonized standard, regardless of the means of
propulsion; the fact that the same boat could be used for charter
or for recreational boating training shall not prevent it being
covered by this Directive when it is placed on the Community
market for recreational purposes;
(b) ‘personal watercraft’: a vessel less than 4 m in length which uses
an internal combustion engine having a water jet pump as its
primary source of propulsion and designed to be operated by a
person or persons sitting, standing or kneeling on, rather than
within the confines of, a hull;
(c) ‘propulsion engine’: any spark or compression ignition, internal
combustion engine used for propulsion purposes, including two stroke
and four-stroke inboard, stern-drive with or without integral
exhaust and outboard engines;
(d) ‘major engine modification’: the modification of an engine which:
— could potentially cause the engine to exceed the emission limits
set out in Annex I.B. excluding routine replacement of engine
components that do not alter the emission characteristics, or
1994L0025 — EN — 20.11.2003 — 002.001 — 5
(1) OJ L 301, 28.10.1982, p. 1. Directive as amended by the 1994 Act of
Accession.
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— increases the rated power of the engine by more than 15 %;
(e) ‘major craft conversion’: a conversion of a craft which:
— changes the means of propulsion of the craft,
— involves a major engine modification,
— alters the craft to such an extent that it is considered a new
craft;
(f) ‘means of propulsion’: the mechanical method by which the craft is
driven, in particular marine propellers or waterjet mechanical drive
systems;
(g) ‘engine family’: the manufacturer’s grouping of engines which,
through their design, are expected to have similar exhaust emission
characteristics and which comply with the exhaust emissions
requirements of this Directive;
(h) ‘manufacturer’: any natural or legal person who designs and manufactures
a product covered by this Directive or who has such a
product designed and/or manufactured with a view to placing it on
the market on his own behalf;
(i) ‘authorized representative’: any natural or legal person established
in the Community who has received a written mandate from the
manufacturer to act on his behalf with regard to the latter’s obligation
under this Directive.
Article 2
Placing on the market and putting into service
1. Member States shall take all necessary measures to ensure that
the products referred to in Article 1 (1) may be placed on the market
and put into service for use in accordance with their intended purpose
only if they do not endanger the safety and health of persons, property
or the environment when correctly constructed and maintained.
2. The provisions of this Directive shall not prevent Member States
from adopting, in compliance with the Treaty, provisions concerning
navigation on certain waters for the purpose of protection of the environment,
the fabric of waterways, and ensuring safety of waterways,
providing that this does not require modification to craft conforming
to this Directive.
Article 3
Essential requirements
The products referred to in Article 1 (1) shall meet the essential safety,
health, environmental protection and consumer protection requirements
set out in Annex I.
Article 4
Free movement of the products referred to in Article 1(1)
1. Member States shall not prohibit, restrict or impede the placing
on the market and/or putting into service in their territory of products
referred to in Article 1(1) bearing the CE marking referred to in Annex
IV, which indicates their conformity with all the provisions of this
Directive, including the conformity procedures set out in Chapter II.
2. Member States shall not prohibit, restrict or impede the placing
on the market of partly-completed boats where the builder or his
authorized representative established in the Community or the person
responsible for the placing on the market declares, in accordance with
Annex IIIa, that they are intended to be completed by others.
3. Member States shall not prohibit, restrict or impede the placing
on the market and/or putting into service of components referred to in
Annex II and bearing the CE marking referred to in Annex IV which
indicates their conformity with the relevant essential requirements
1994L0025 — EN — 20.11.2003 — 002.001 — 6
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where these components are accompanied by a written declaration of
conformity as provided for in Annex XV and are intended to be incorporated
into recreational craft, in accordance with the declaration,
referred to in Annex IIIb, of the manufacturer, his authorized representative
established in the Community or, in the case of imports from a
third country, of any person who places those components on the
Community market.
4. Member States shall not prohibit, restrict or impede the placing
on the market and/or putting into service of:
— inboard engines and stern drive propulsion engines without integral
exhaust,
— engines type-approved according to Directive 97/68/EC (1) which
are in compliance with stage II provided for in section 4.2.3 of
Annex I to that Directive and of,
— engines type-approved according to Directive 88/77/EEC (2);
where the manufacturer or his authorized representative established in
the Community declares in accordance with Annex XV.3 that the
engine will meet the exhaust emission requirements of this Directive,
when installed in a recreational craft or personal watercraft in accordance
with the manufacturer’s supplied instructions.
5. At trade fairs, exhibitions, demonstrations, etc., Member States
shall not create any obstacles to the showing of the products referred
to in Article 1(1) which do not comply with this Directive, provided
that a visible sign clearly indicates that such products may not be
marketed or put into service until they have been made to comply.
6. Where the products referred to in Article 1(1) are subject to other
Directives covering other aspects and which provide for the affixing of
the CE marking, the latter shall indicate that such products are also
presumed to conform to the provisions of those other Directives. The
CE marking shall indicate conformity with the applicable Directives
or relevant parts thereof. In this case, the particulars of the said Directives
applied by the manufacturer, as published in the Official Journal
of the European Union, must be given in the documents, declaration of
conformity or instructions required by the Directives and accompanying
suchproducts.
Article 5
Member States shall presume compliance with the essential requirements
referred to in Article 3 of products referred to in Article 1 (1)
which meet the relevant national standards adopted pursuant to the
harmonized standards the references of which have been published in
the Official Journal of the European Communities; Member States shall
publish the references of such national standards.
Article 6
1. Where a Member State or the Commission is of the opinion that
the harmonized standards referred to in Article 5 do not fully meet the
essential requirements referred to in Article 3, the Commission or the
Member State shall notify the committee set up under Directive 83/
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(1) Directive 97/68/EC of the European Parliament and of the Council of 16
December 1997 on the approximation of the laws of the Member States
relating to measures against the emission of gaseous and particulate pollutants
from internal combustion engines to be installed in non-road mobile
machinery (OJ L 59, 27.2.1998, p. 1). Directive as amended by Commission
Directive 2001/63/EC (OJ L 227, 23.8.2001, p. 41).
(2) Council Directive 88/77/EEC of 3 December 1987 on the approximation of
the laws of the Member States relating to the measures to be taken against
the emission of gaseous and particulate pollutants from compression ignition
engines for use in vehicles, and the emission of gaseous pollutants from
positive ignition engines fueled with natural gas or liquefied petroleum gas
for use in vehicles (OJ L 36, 9.2.1988, p. 33). Directive as last amended by
Commission Directive 2001/27/EC (OJ L 107, 18.4.2001, p. 10).
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189/CEE, setting out its reasons. The committee shall deliver an urgent
opinion.
In the light of the opinion of the committee, the Commission shall
inform Member States if the standards concerned should be withdrawn
from the publications referred to in Article 5.
2. The Commission may adopt any appropriate measure with a view
to ensuring that this Directive is applied practically in a uniform
manner in pursuance of paragraph3.
3. The Commission shall be assisted by a standing committee (hereinafter
referred to as ‘the Committee’).
Where reference is made to this paragraph, Articles 3 and 7 of Decision
1999/468/EC (1) shall apply, having regard to the provisions of
Article 8 thereof.
The Committee shall adopt its rules of procedure.
4. The Standing Committee may, in addition, examine any question
concerning the application of this Directive and raised by its chairman,
either at the chairman’s initiative or at the request of a Member State.
Article 6a
Committee procedure
1. Amendments which are necessary, in the light of evolution of
technical knowledge and new scientific evidence, to the requirements
of Annex I.B.2 and Annex I.C.1 excluding direct or indirect modifications
to exhaust or noise emission values and to the Froude and P/D
ratio values shall be adopted by the Commission assisted by the
Standing Committee set up pursuant to Article 6(3), acting as a regulatory
committee in accordance with the procedure referred to in
paragraph 2. Issues to be dealt with shall include the reference fuels
and the standards to be used for exhaust and noise emissions testing.
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision 1999/468/EC shall apply, having regard to the provisions of
Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The Committee shall adopt its rules of procedure.
Article 7
Safeguard clause
1. Where a Member State ascertains that products falling within the
scope of Article 1 and bearing the CE marking referred to in Annex IV,
when correctly designed, constructed, installed where appropriate,
maintained and used in accordance with their intended purpose may
endanger the safety and health of persons, property or the environment,
it shall take all appropriate interim measures to withdraw them from
the market or prohibit or restrict their being placed on the market and/
or put into service.
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(1) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).
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The Member State shall immediately inform the Commission of any
such measure, indicating the reasons for its decision, in particular
where non-conformity is the result of:
(a) failure to comply with the essential requirements referred to in
Article 3;
(b) incorrect application of the standards referred to in Article 5, in so
far as it is claimed that those standards have been applied;
(c) shortcomings in the standards referred to in Article 5 themselves.
2. The Commission shall enter into consultation with the parties
concerned as soon as possible. Where, after such consultation, the
Commission finds that:
— the measures are justified, it shall immediately so inform the
Member State which took the initiative and the other Member
States; where the decision referred to in paragraph 1 is attributed
to shortcomings in the standards, the Commission shall, after
consulting the parties concerned, bring the matter before the
Committee referred to in Article 6 (1) within two months, if the
Member State which has taken the decision intends to maintain it,
and shall initiate the procedure referred to in Article 6 (1),
— the measures are unjustified, it shall immediately so inform the
Member State which took the initiative and the manufacturer or
his authorized representative established in the Community.
3. Where a non-complying product referred to in Article 1 bears the
CE marking, the appropriate measures shall be taken by the Member
State which has authority over whomsoever affixed the marking; that
Member State shall inform the Commission and the other Member
States thereof.
4. The Commission shall ensure that the Member States are kept
informed of the progress and outcome of this procedure.
CHAPTER II
Conformity assessment
Article 8
1. Before placing on the market, and/or putting into service,
products referred to in Article 1(1) the manufacturer or his authorized
representative established within the Community shall apply the procedures
referred to in paragraphs 2, 3 and 4 of this Article.
In the case of post-construction assessment for recreational craft, if
neither the manufacturer nor his authorized representative established
within the Community fulfills the responsibilities for the product’s
conformity to this Directive, these can be assumed by any natural or
legal person established within the Community who places the product
on the market, and/or puts it into service, under his own responsibility.
In such a case, the person who places the product on the market or puts
it into service must lodge an application for a post-construction report
with a notified body. The person who places the product on the market
and/or puts it into service must provide the notified body with any
available document and technical file referring to the first placing on
the market of the product in the country of origin. The notified body
shall examine the individual product and carry out calculations and
other assessment to ensure its equivalent conformity with the relevant
requirements of the Directive. In this case, the Builder’s plate described
in Annex I, 2.2 shall include the words (‘Post-construction certificate’).
The notified body shall draw up a report of conformity concerning the
assessment carried out and shall inform the person who places the
product on the market and/or puts it into service of his obligations.
That person shall draw up a declaration of conformity (see Annex
XV) and affix, or cause to be affixed, the CE mark accompanied by
the distinguishing number of the relevant notified body on the product.
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2. With regard to design and construction of products referred to in
Article 1(1)(a), the boat manufacturer or his authorized representative
established in the Community shall apply the following procedures for
boat design categories A, B, C and D as referred to in section 1 of
Annex I.A:
(a) for categories A and B:
(i) for boats from 2,5 m to 12 m hull length: the internal production
control plus tests (module Aa) referred to in Annex VI, or
the EC type-examination (module B) as described in Annex
VII, supplemented by conformity to type (module C) referred
to in Annex VIII, or any of the following modules: B+D, or
B+E, or B+F, or G or H;
(ii) for boats from 12 m to 24 m hull length: the EC type-examination
(module B) referred to in Annex VII supplemented by
conformity to type (module C) referred to in Annex VIII, or
any of the following modules: B+D, or B+E, or B+F, or G or
H;
(b) for category C:
(i) for boats from 2,5 m to 12 m hull length:
— where the harmonized standards relating to Sections 3.2 and
3.3 of Annex I.A are complied with: the internal production
control (module A), referred to in Annex V, or internal
production control plus tests (module Aa) referred to in
Annex VI, or the EC type-examination (module B) as
described in Annex VII, supplemented by conformity to
type (module C) referred to in Annex VIII, or any of the
following modules: B+D, or B+E, or B+F, or G, or H,
— where the harmonized standards relating to Sections 3.2 and
3.3 of Annex I.A are not complied with: the internal
production control plus tests (module Aa) referred to in
Annex VI, or the EC type-examination (module B) as
described in Annex VII, supplemented by conformity to
type (module C) referred to in Annex VIII, or any of the
following modules: B+D, or B+E, or B+F, or G, or H;
(ii) for boats from 12 m to 24 m hull length: the EC type-examination
(module B) referred to in Annex VII followed by
conformity to type (module C) referred to in Annex VIII, or
any of the following modules: B+D, or B+E, or B+F, or G or
H;
(c) for category D:
for boats from 2,5 m to 24 m hull length: the internal production
control (module A) referred to in Annex V, or the internal production
control plus tests (module Aa) referred to in Annex VI, or the
EC type-examination (module B) as described in Annex VII,
supplemented by conformity to type (module C) referred to in
Annex VIII, or any of the following modules: B+D, or B+E, or
B+F or G or H;
(d) for personal watercraft:
the internal production control (module A) referred to in Annex V,
or the internal production control plus tests (module Aa) referred to
in Annex VI, or the EC type-examination (module B) as described
in Annex VII followed by conformity to type (module C) referred
to in Annex VIII, or any of the following modules: B+D, or B+E,
or B+F, or G or H;
(e) for components referred to in Annex II: any of the following
modules: B+C, or B+D, or B+F, or G or H.
3. With regard to exhaust emissions:
for products referred to in Article 1(1)(b), the engine manufacturer or
his authorized representative established in the Community shall apply
the EC type-examination (module B) as described in Annex VII
followed by conformity to type (module C) referred to in Annex VIII,
or any of the following modules: B+D, or B+E, or B+F, or G or H.
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4. With regard to noise emissions:
(a) for products referred to in Article 1(1)(c)(i) and (ii), the boat manufacturer
or his authorized representative established in the
Community shall apply:
(i) where tests are conducted using the harmonized standard (1)
for noise measurement: either internal production control plus
tests (module Aa) referred to in Annex VI, or unit verification
(module G) referred to in Annex XI, or full quality assurance
(module H) referred to in Annex XII;
(ii) where the Froude number and power displacement ratio
method is used for assessment: either the internal production
control (module A) referred to in Annex V, or the internal
production control plus tests (module Aa) referred to in Annex
VI, or unit verification (module G) referred to in Annex XI, or
full quality assurance (module H) referred to in Annex XII;
(iii) where certified reference boat data, established in accordance
with point (i), is used for assessment: either internal production
control (module A) referred to in Annex V, or internal
production control plus supplementary requirements (module
Aa) referred to in Annex VI, or unit verification (module G)
referred to in Annex XI, or full quality assurance (module H)
referred to in Annex XII;
(b) for products referred to in Article 1(1)(c)(iii) and (iv), the personal
watercraft/engine manufacturer or his authorized representative
established in the Community shall apply: internal production
control plus supplementary requirements referred to in Annex VI
(module Aa) or module G or H.
Article 9
Notified bodies
1. Member States shall notify the Commission and other Member
States of the bodies which they have appointed to carry out the tasks
pertaining to the conformity assessment procedures referred to in
Article 8, together with the specific tasks which these bodies have
been appointed to carry out and the identification numbers assigned to
them beforehand by the Commission.
The Commission shall publish a list of the notified bodies, together
with the identification numbers it has allocated to them and the tasks
for which they have been notified, in the Official Journal of the
European Communities. It shall ensure that the list is kept up to date.
2. Member States shall apply the criteria laid down in Annex XIV in
assessing the bodies to be indicated in such notification. Bodies
meeting the assessment criteria laid down in the relevant harmonized
standards shall be presumed to fulfill those criteria.
3. A Member State shall withdraw its approval from such a body if
it is established that the latter no longer satisfies the criteria referred to
in Annex XIV. It shall inform the Commission and the other Member
States of its action forthwith.
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CHAPTER III
CE Marking
Article 10
1. When the following products are placed on the market, they shall
bear the CE marking of conformity:
(a) recreational craft, personal watercraft and components referred to
in Annex II, which are regarded as meeting the corresponding
essential requirements set out in Annex I;
(b) outboard engines which are regarded as meeting the essential
requirements set out in Annex I.B and I.C.;
(c) stern drive engines with integral exhaust which are regarded as
meeting the essential requirements set out in Annex I.B. and I.C.
2. The CE marking of conformity, as shown in Annex IV, must
appear in a visible, legible and indelible form on the craft and the
personal watercraft as in point 2.2 of Annex I.A, on components, as
referred to in Annex II and/or on their packaging, and on outboard
engines and stern drive engines with integral exhaust as in point 1.1
of Annex I.B.
The CE marking shall be accompanied by the identification number of
the body responsible for implementation of the procedures set out in
Annexes IX, X, XI, XII, and XVI.
3. The affixing of markings or inscriptions on products covered by
this Directive which are likely to mislead third parties with regard to
the meaning or the form of the CE marking shall be prohibited. Any
other markings may be affixed to products covered by this Directive
and/or on their packaging provided that the visibility and legibility of
the CE marking is not thereby reduced.
4. Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been
affixed wrongly, the manufacturer or his authorized representative
established in the Community shall be obliged to end the infringement
under conditions laid down by the Member State;
(b) where non-compliance continues, the Member State shall take all
appropriate measures to restrict or prohibit the placing on the
market of the product in question or to ensure that it is withdrawn
from the market, in accordance with the procedure laid down in
Article 7.
CHAPTER IV
Final provisions
Article 11
Detailed grounds shall be given for any decision taken pursuant to this
Directive leading to a restriction on the marketing and putting into
service of products referred to in Article 1 (1). The party concerned
shall be informed of the decision as soon as possible together with the
means of redress available under the laws in force in the Member State
concerned and the periods within which appeals must be lodged.
Article 12
The Commission shall take the necessary measures to ensure that data
affecting all pertinent decisions concerning the management of this
Directive are made available.
Article 13
1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply with this Directive not
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later than 16 December 1995. They shall immediately inform the
Commission thereof.
Member States shall apply these provisions from 16 June 1996.
The Standing Committee referred to in Article 6 (3) may assume its
tasks from the date of the entry into force of this Directive. Member
States may take the measures referred to in Article 9 of such date.
When Member States adopt the provisions referred to in the first
subparagraph, these shall contain a reference to this Directive or shall
be accompanied by such a reference at the time of their official publication.
The procedure for such reference shall be adopted by Member
States.
2. Member States shall communicate to the Commission the text of
the provisions of national law which they adopt in the field governed
by this Directive.
3. Member States shall accept the placing on the market and putting
into service of products referred to in Article 1 (1) which comply with
the rules in force in their territory on the date of adoption of this Directive
during a period of four years from that date.
Article 14
This Directive shall enter into force on the day of its publication in the
Official Journal of the European Communities.
Article 15
This Directive is addressed to the Member States.
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ANNEX I
ESSENTIAL REQUIREMENTS
PRELIMINARY OBSERVATION
For the purposes of this Annex the term ‘craft’ shall cover recreational craft and personal watercraft.
A. Essential safety requirements for the design and construction of craft
1. BOAT DESIGN CATEGORIES
Design category Wind force
(Beaufort scale)
Significant wave height
(H 1/3, metres)
A – ‘Ocean’ exceeding 8 exceeding 4
B – ‘Offshore’ up to, and including, 8 up to, and including, 4
C – ‘Inshore’ up to, and including, 6 up to, and including, 2
D – ‘Sheltered waters’ up to, and including, 4 up to, and including, 0,3
Definitions:
A. OCEAN: Designed for extended voyages where conditions may
exceed wind force 8 (Beaufort scale) and significant wave heights
of 4 m and above but excluding abnormal conditions, and vessels
largely self-sufficient.
B. OFFSHORE: Designed for offshore voyages where conditions up
to, and including, wind force 8 and significant wave heights up to,
and including, 4 m may be experienced.
C. INSHORE: Designed for voyages in coastal waters, large bays,
estuaries, lakes and rivers where conditions up to, and including,
wind force 6 and significant wave heights up to, and including, 2
m may be experienced.
D. SHELTERED WATERS: Designed for voyages on sheltered
coastal waters, small bays, small lakes, rivers and canals when
conditions up to, and including, wind force 4 and significant
wave heights up to, and including, 0,3 m may be experienced,
with occasional waves of 0,5 m maximum height, for example
from passing vessels.
Craft in eachCategory must be designed and constructed to withstand
these parameters in respect of stability, buoyancy, and other relevant
essential requirements listed in Annex I, and to have good handling
characteristics.
2. GENERAL REQUIREMENTS
Products falling under Article 1(1)(a) shall comply with the essential
requirements in so far as they apply to them.
2.1. .M1 Craft identification .
Each craft shall be marked with an identification number including
the following information:
— manufacturer’s code,
— country of manufacture,
— unique serial number,
— year of production,
— model year.
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The relevant harmonized standard gives details of these requirements.
2.2. Builder’s plate
Each craft shall carry a permanently affixed plate mounted separately
from the boat hull identification number, containing the following
information:
— manufacturer’s name,
— CE marking (see Annex IV),
— boat design category according to section 1,
— manufacturer’s maximum recommended load derived from section
3.6 excluding the weight of the contents of the fixed tanks when
full,
— number of persons recommended by the manufacturer for which
the boat was designed to carry when under way.
2.3. Protection from falling overboard and means of reboarding
Depending on the design category, craft shall be designed to minimize
the risks of falling overboard and to facilitate reboarding.
2.4. Visibility from the main steering position
For motor boats, the main steering position shall give the operator,
under normal conditions of use (speed and load), good all-round visibility.
2.5. Owner’s manual
Each craft shall be provided with an owner’s manual in the official
Community language or languages which may be determined by the
Member State in which it is marketed in accordance with the Treaty.
This manual should draw particular attention to risks of fire and
flooding and shall contain the information listed in sections 2.2, 3.6
and 4 as well as the unladen weight of the craft in kilograms.
3. INTEGRITY AND STRUCTURAL REQUIREMENTS
3.1. Structure
The choice and combination of materials and its construction shall
ensure that the craft is strong enough in all respects. Special attention
shall be paid to the design category according to section 1, and the
manufacturer’s maximum recommended load in accordance with
section 3.6.
3.2. Stability and freeboard
The craft shall have sufficient stability and freeboard considering its
design category according to section 1 and the manufacturer’s
maximum recommended load according to section 3.6.
3.3. Buoyancy and flotation
The craft shall be constructed to ensure that it has buoyancy characteristics
appropriate to its design category according to section 1.1,
and the manufacturer’s maximum recommended load according to
section 3.6. All habitable multihull craft shall be so designed as to
have sufficient buoyancy to remain afloat in the inverted position.
Boats of less than six metres in length that are susceptible to
swamping when used in their design category shall be provided with
appropriate means of flotation in the swamped condition.
3.4. Openings in hull, deck and superstructure
Openings in hull, deck(s) and superstructure shall not impair the
structural integrity of the craft or its weathertight integrity when
closed.
Windows, port lights, doors and hatch covers shall withstand the water
pressure likely to be encountered in their specific position, as well as
point loads applied by the weight of persons moving on deck.
Through hull fittings designed to allow water passage into the hull or
out of the hull, below the waterline corresponding to the manufacturer’s
maximum recommended load according to section 3.6, shall
be fitted with shutoff means which shall be readily accessible.
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3.5. Flooding
All craft shall be designed so as to minimize the risk of sinking.
Particular attention should be paid where appropriate to:
— cockpits and wells, which should be self-draining or have other
means of keeping water out of the boat interior,
— ventilation fittings,
— removal of water by pumps or other means.
3.6. Manufacturer’s maximum recommended load
The manufacturer’s maximum recommended load (fuel, water, provisions,
miscellaneous equipment and people (in kilograms)) for which
the boat was designed .M1 . shall be determined
according to the design category (section 1), stability and freeboard
(section 3.2) and buoyancy and flotation (section 3.3).
3.7. Life raft stowage
All craft of categories A and B, and craft of categories C and D
longer than six metres shall be provided with one or more stowage
points for a life raft (life rafts) large enough to hold the number of
persons the boat was designed to carry as recommended by the manufacturer.
This (these) stowage point(s) shall be readily accessible at all
times.
3.8. Escape
All habitable multihull craft over 12 metres long shall be provided
with viable means of escape in the event of inversion.
All habitable craft shall be provided with viable means of escape in
the event of fire.
3.9. Anchoring, mooring and towing
All craft, taking into account their design category and their characteristics
shall be fitted with one or more strong points or other means capable of safely accepting anchoring, mooring and towing loads.
4. HANDLING CHARACTERISTICS
The manufacturer shall ensure that the handling characteristics of the
craft are satisfactory with the most powerful engine for which the
boat is designed and constructed. For all recreational marine engines,
the maximum rated engine power shall be declared in the owner’s
manual in accordance with the harmonized standard.
5. INSTALLATION REQUIREMENTS
5.1. Engines and engine spaces
5.1.1. Inboard engine
All inboard mounted engines shall be placed within an enclosure
separated from living quarters and installed so as to minimize the
risk of fires or spread of fires as well as hazards from toxic fumes,
heat, noise or vibrations in the living quarters.
Engine parts and accessories that require frequent inspection and/or
servicing shall be readily accessible.
The insulating materials inside engine spaces shall be non-combustible.
5.1.2. Ventilation
The engine compartment shall be ventilated. The dangerous ingress of
water into the engine compartment through all inlets must be
prevented.
5.1.3. Exposed parts
Unless the engine is protected by a cover or its own enclosure,
exposed moving or hot parts of the engine that could cause personal
injury shall be effectively shielded.
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5.1.4. Outboard engines starting
All boats with outboard engines shall have a device to prevent starting
the engine in gear, except:
(a) when the engine produces less than 500 newtons (N) of static
thrust;
(b) when the engine has a throttle limiting device to limit thrust to
500 N at the time of starting the engine.
5.1.5. Personal watercraft running without driver
Personal watercraft shall be designed either with an automatic engine
cut-off or with an automatic device to provide reduced speed, circular,
forward movement when the driver dismounts deliberately or falls
overboard.
5.2. Fuel system
5.2.1. General
The filling, storage, venting and fuel-supply arrangements and installations
shall be designed and installed so as to minimize the risk of
fire and explosion.
5.2.2. Fuel tanks
Fuel tanks, lines and hoses shall be secured and separated or protected
from any source of significant heat. The material the tanks are made
of and their method of construction shall be according to their capacity
and the type of fuel. All tank spaces shall be ventilated.
Petrol fuel shall be kept in tanks which do not form part of the hull
and are:
(a) insulated from the engine compartment and from all other source
of ignition;
(b) separated from living quarters;
Diesel fuel may be kept in tanks that are integral with the hull.
5.3. Electrical system
Electrical systems shall be designed and installed so as to ensure
proper operation of the craft under normal conditions of use and shall
be such as to minimize risk of fire and electric shock.
Attention shall be paid to the provision of overload and short-circuit
protection of all circuits, except engine starting circuits, supplied from
batteries.
Ventilation shall be provided to prevent the accumulation of gases
which might be emitted from batteries. Batteries shall be firmly
secured and protected from ingress of water.
5.4. Steering system
5.4.1. General
Steering systems shall be designed, constructed and installed in order
to allow the transmission of steering loads under foreseeable operating
conditions.
5.4.2. Emergency arrangements
Sailboat and single-engined inboard powered motor boats with
remote-controlled rudder steering systems shall be provided with
emergency means of steering the craft at reduced speed.
5.5. Gas system
Gas systems for domestic use shall be of the vapour-withdrawal type
and shall be designed and installed so as to avoid leaks and the risk of
explosion and be capable of being tested for leaks. Materials and
components shall be suitable for the specific gas used to withstand
the stresses and exposures found in the marine environment.
Each appliance shall be equipped with a flame failure device effective
on all burners. Each gas-consuming appliance must be supplied by a
separate branch of the distribution system, and each appliance must be
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controlled by a separate closing device. Adequate ventilation must be
provided to prevent hazards from leaks and products of combustion.
All craft with a permanently installed gas system shall be fitted with
an enclosure to contain all gas cylinders. The enclosure shall be separated
from the living quarters, accessible only from the outside and
ventilated to the outside so that any escaping gas drains overboard.
Any permanent gas system shall be tested after installation.

5.6. Fire protection
5.6.1. General
The type of equipment installed and the layout of the craft shall take
account of the risk and spread of fire. Special attention shall be paid
to the surroundings of open flame devices, hot areas or engines and
auxiliary machines, oil and fuel overflows, uncovered oil and fuel
pipes and avoiding electrical wiring above hot areas of machines.
5.6.2. Fire-fighting equipment
Craft shall be supplied with fire-fighting equipment appropriate to the
fire hazard, or the position and capacity of fire-fighting equipment
appropriate to the fire hazard shall be indicated. The craft shall not
be put into service until the appropriate fire-fighting equipment is in
place. Petrol engine enclosures shall be protected by a fire extinguishing
system that avoids the need to open the enclosure in the event of fire. Where fitted, portable fire extinguishers shall be readily accessible and one shall be so positioned that it can easily be reached from the main steering position of the craft.
5.7. Navigation lights
Where navigation lights are fitted, they shall comply with the 1972
Colreg or CEVNI regulations, as appropriate.
5.8. Discharge prevention and installations facilitating the delivery
ashore of waste
Craft shall be constructed so as to prevent the accidental discharge of
pollutants (oil, fuel, etc.) overboard.
Craft fitted with toilets shall have either:
(a) holding tanks, or
(b) provision to fit holding tanks.
Craft with permanently installed holding tanks shall be fitted with a
standard discharge connection to enable pipes of reception facilities
to be connected with the craft discharge pipeline. In addition, any through-the-hull pipes for human waste shall be fitted with valves which are capable of being secured in the closed position.
B. Essential requirements for exhaust emissions from propulsion engines
Propulsion engines shall comply with the following essential requirements
for exhaust emissions.
1. ENGINE IDENTIFICATION
1.1. Each engine shall be clearly marked with the following information:
— engine manufacturer’s trademark or trade-name,
— engine type, engine family, if applicable,
— a unique engine identification number,
— CE marking, if required under Article 10.
1.2. These marks must be durable for the normal life of the engine and must
be clearly legible and indelible. If labels or plates are used, they must
be attached in such a manner that the fixing is durable for the normal
life of the engine, and the labels/plates cannot be removed without
destroying or defacing them.
1.3. These marks must be secured to an engine part necessary for normal
engine operation and not normally requiring replacement during the
engine life.
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1.4. These marks must be located so as to be readily visible to the average
person after the engine has been assembled with all the components
necessary for engine operation.
2. EXHAUST EMISSION REQUIREMENTS
Propulsion engines shall be designed, constructed and assembled so that
when correctly installed and in normal use, emissions shall not exceed
the limit values obtained from the following table:
Table 1
(g/kWh)
Type
Carbon monoxide
CO = A + B/PN
n
Hydrocarbons
HC = A + B/PN
n Nitrogen
oxides
NOx
Particulates
PT
A B n A B n
Two-stroke
spark ignition
150,0 600,0 1,0 30,0 100,0 0,75 10,0 Not
applicable
Four-stroke
spark ignition
150,0 600,0 1,0 6,0 50,0 0,75 15,0 Not
applicable
Compression
ignition
5,0 0 0 1,5 2,0 0,5 9,8 1,0
Where A, B and n are constants in accordance with the table, PN is the
rated engine power in kW and the exhaust emissions are measured in
accordance with the harmonised standard (1).
For engines above 130 kW either E3 (IMO) or E5 (recreational marine)
duty cycles may be used.
The reference fuels to be used for the emissions test for engines fuelled
withpetrol and diesel shall be as specified in Directive 98/69/EC
(Annex IX, Tables 1 and 2), and for those engines fuelled with Liquefied
Petroleum Gas as specified in Directive 98/77/EC.
3. DURABILITY
The manufacturer of the engine shall supply engine installation and
maintenance instructions, which if applied should mean that the engine
in normal use will continue to comply with the above limits throughout
the normal life of the engine and under normal conditions of use.
This information shall be obtained by the engine manufacturer by use
of prior endurance testing, based on normal operating cycles, and by
calculation of component fatigue so that the necessary maintenance
instructions may be prepared by the manufacturer and issued with all
new engines when first placed on the market.
The normal life of the engine is considered to mean:
(a) inboard or stern drive engines with or without integral exhaust: 480
hours or 10 years, whichever occurs first;
(b) personal watercraft engines: 350 hours or five years, whichever
occurs first;
(c) outboard engines: 350 hours or 10 years, whichever occurs first.
4. OWNER’S MANUAL
Each engine shall be provided with an owner’s manual in the Community
language or languages, which may be determined by the Member
State in which the engine is to be marketed. This manual shall:
(a) provide instructions for the installation and maintenance needed to
assure the proper functioning of the engine to meet the requirements
of paragraph3, (Durability);
(b) specify the power of the engine when measured in accordance with
the harmonised standard.
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C. Essential requirements for noise emissions
Recreational craft withinboard or stern drive engines without integral
exhaust, personal watercraft and outboard engines and stern drive engines
with integral exhaust shall comply with the following essential requirements
for noise emissions.
1. NOISE EMISSION LEVELS
1.1. Recreational craft withinboard or stern drive engines without integral
exhaust, personal watercraft and outboard engines and stern drive
engines with integral exhaust shall be designed, constructed and
assembled so that noise emissions measured in accordance with tests
defined in the harmonised standard (1) shall not exceed the limit values
in the following table:
Table 2
Single engine power
In kW
Maximum Sound Pressure
Level = LpASmax
In dB
PN = 10 67
10 < PN = 40 72
PN > 40 75
where PN = rated engine power in kW at rated speed and LpASmax =
maximum sound pressure level in dB.
For twin-engine and multiple-engine units of all engine types an allowance
of 3 dB may be applied.
1.2. As an alternative to sound measurement tests, recreational craft with
inboard engine configuration or stern drive engine configuration,
without integral exhaust, shall be deemed to comply with these noise
requirements if they have a Froude number of = 1,1 and a power
displacement ratio of = 40 and where the engine and exhaust system
are installed in accordance withth e engine manufacturer’s specifications.
1.3. ‘Froude number’ shall be calculated by dividing the maximum boat
speed V (m/s) by the square root of the waterline length lwl (m) multiplied
by a given gravitational constant, (g = 9,8 m/s2)
Fn ¼
V
pffiðffigffiffiffi:ffiLffiffiffiwffiffiffilffiffiÞffiffi:
‘Power displacement ratio’ shall be calculated by dividing the engine
power P (kW) by the boat’s displacement D ðtÞ ¼
P
D
1.4. As a further alternative to sound measurement tests, recreational craft
withinboard or stern drive engine configurations without integral
exhaust, shall be deemed to comply with these noise requirements if
their key design parameters are the same as or compatible with those
of a certified reference boat to tolerances specified in the harmonised
standard.
1.5. ‘Certified reference boat’ shall mean a specific combination of hull/
inboard engine or stern drive engine without integral exhaust that has
been found to comply with the noise emission requirements, when
measured in accordance withsection 1.1, and for whichall appropriate
key design parameters and sound level measurements have been
included subsequently in the published list of certified reference boats.
2. OWNER’S MANUAL
For recreational craft withinboard engine or stern drive engines withor
without integral exhaust and personal watercraft, the owner’s manual
required under Annex I.A Section 2.5, shall include information necessary
to maintain the craft and exhaust system in a condition that, insofar
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as is practicable, will ensure compliance withth e specified noise limit
values when in normal use.
For outboard engines, the owner’s manual required under Annex I.B.4
shall provide instructions necessary to maintain the outboard engine in
a condition, that insofar as is practicable, will ensure compliance with
the specified noise limit values when in normal use.
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ANNEX II
COMPONENTS
1. Ignition-protected equipment for inboard and stern drive engines.
2. Start-in-gear protection devices for outboard engines.
3. Steering wheels, steering mechanisms and cable assemblies.
4. Fuel tanks intended for fixed installations and fuel hoses.
5. Prefabricated hatches and port lights.
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ANNEX III
DECLARATION BY THE BUILDER OR HIS AUTHORIZED REPRESENTATIVE
ESTABLISHED IN THE COMMUNITY ORTHE PERSON
RESPONSIBLE FOR PLACING ON THE MARKET
(Article 4 (2) and (3))
(a) The declaration by the builder or his authorized representative established in the Community referred to in Article 4 (2) (partly completed craft) shall contain the following:
— the name and address of the builder,
— the name and address of the representative of the builder established in
the Community or, if appropriate, of the person responsible for the placing on the market,
— a description of the partly completed craft,
— a statement that the partly completed craft is intended to be completed
by others and that it complies with the essential requirements that apply
at this stage of construction.
(b) The declaration by the builder, his authorized representative established in the Community or the person responsible for placing on the market referred to in Article 4 (3) (components) shall contain the following:
— the name and address of the builder,
— the name and address of the representative of the builder established in
the Community or, if appropriate, of the person responsible for the placing on the market,
— a description of the component,
— a statement that the component complies with the relevant essential
requirements.
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ANNEX IV
CE MARKING
The CE conformity marking must consist of the initials ‘CE’ taking the
following form:
If the marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.
The various elements of the CE marking must have about the same vertical
dimension, which shall not be less than 5 mm.
The CE marking is followed by the identification number of the notified body if
it intervenes in the control of production.
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ANNEX V
INTERNAL PRODUCTION CONTROL
(module A)
1. The manufacturer or his authorized representative established within the
Community, who carries out the obligations laid down in point 2, ensures
and declares that the products concerned satisfy the requirements of the
Directive that apply to them. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV).
2. The manufacturer shall establish the technical documentation described in paragraph 3 and he or his authorized representative established within the
Community shall keep it for a period ending at least 10 years after the last
product has been manufactured at the disposal of the relevant national authorities for inspection purposes. Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available shall be the responsibility of the person who places the product on the Community market.
3. Technical documentation shall enable the conformity of the products with the requirements of the Directive to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the product (see Annex XIII).
4. The manufacturer or his authorized representative shall keep a copy of the declaration of conformity with the technical documentation.
5. The manufacturer shall take all measures necessary in order that the manufacturing process shall ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the Directive that apply to them.
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ANNEX VI
INTERNAL PRODUCTION CONTROL PLUS TESTS (Module Aa, option
1) This module consists of module A, as referred to in Annex V, plus the following supplementary requirements:
A. Design and construction
On one or several boats representing the production of the manufacturer one or more of the following tests, equivalent calculation or control shall be
carried out by the manufacturer or on his behalf:
(a) test of stability according to section 3.2 of the Essential Requirements
(Annex IA);
(b) test of buoyancy characteristics according to section 3.3 of the Essential
Requirements (Annex IA).
Provisions common to both variations:
These tests or calculations or control shall be carried out under the responsibility of a notified body chosen by the manufacturer.
B. Noise emissions
For recreational craft fitted with inboard or stern drive engines without integral exhaust and for personal watercraft:
On one or several craft representing the production of the craft manufacturer, the sound emission tests defined in Annex I.C shall be carried out by the craft manufacturer, or on his behalf, under the responsibility of a notified body chosen by the manufacturer.
For outboard engines and stern drive engines with integral exhaust:
On one or several engines of each engine family representing the production
of the engine manufacturer, the sound emission tests defined in Annex I.C
shall be carried out by the engine manufacturer, or on his behalf, under the
responsibility of a notified body chosen by the manufacturer.
Where more than one engine of an engine family is tested, the statistical
method described in Annex XVII shall be applied to ensure conformity of
the sample.
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ANNEX VII
EC TYPE-EXAMINATION
(module B)
1. A notified body ascertains and attests that a specimen, representative of the production envisaged, meets the provisions of the Directive that apply to it.
2. The application for the EC type-examination shall be lodged by the manufacturer or his authorized representative established within the Community with a notified body of his choice.
The application shall include:
— the name and address of the manufacturer and, if the application is
lodged by the authorized representative, his name and address in addition,
— a written declaration that the same application has not been lodged with
any other notified body,
— the technical documentation, as described in point 3.
The applicant shall place at the disposal of the notified body a specimen,
representative of the production envisaged and hereinafter called ‘type’ (*).
The notified body may request further specimens if needed for carrying out
the test programme.
3. The technical documentation shall enable the conformity of the product
with the requirements of the Directive to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture and functioning of the product (see Annex XIII).
4. The notified body shall:
4.1. examine the technical documentation, verify that the type has been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the relevant provisions of the standards referred to in Article 5, as well as the components which have been designed without applying the relevant provisions of those standards;
4.2. perform or have performed the appropriate examinations and necessary
tests to check whether, where the standards referred to in Article 5 have
not been applied, the solutions adopted by the manufacturer meet the
Essential Requirements of the Directive;
4.3. perform or have performed the appropriate examinations and necessary
tests to check whether, where the manufacturer has chosen to apply the
relevant standards, these have actually been applied;
4.4. agree with the applicant the location where the examinations and necessary tests shall be carried out.
5. Where the type meets the provisions of the Directive, the notified body
shall issue an EC type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, conclusions of the examination, conditions for its validity and the necessary data for identification of the approved type.
A list of the relevant parts of the technical documentation shall be annexed
to the certificate and a copy kept by the notified body. If the manufacturer is denied a type certification, the notified body shall provide detailed reasons for such denial.
6. The applicant shall inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all
modifications to the approved product which must receive additional
approval where such changes may affect the conformity with the essential
requirements or the prescribed conditions for use of the product. This additional approval is given in the form of an addition to the original EC type examination certificate.
1994L0025 — EN — 20.11.2003 — 002.001 — 27
(*) A type may cover several versions of the product provided that the differences between the versions do not affect the level of safety and the other requirements concerning the performance of the product.
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7. Each notified body shall communicate to the other notified bodies the relevant information concerning the EC type-examination certificates and
additions issued and withdrawn.
8. The other notified bodies may receive copies of the EC type-examination
certificates and/or their additions. The annexes to the certificates shall be
kept at the disposal of the other notified bodies.
9. The manufacturer or his authorized representative shall keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least 10 years after the last product has
been manufactured. Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available shall be the responsibility of the person who places the product on the Community market.
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ANNEX VIII
CONFORMITY TO TYPE
(module C)
1. The manufacturer or his authorized representative established within the
Community ensures and declares that the products concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the Directive that applies to them. The manufacturer shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV).
2. The manufacturer shall take all measures necessary to ensure that the manufacturing process assures compliance of the manufactured products with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them.
3. The manufacturer or his authorized representative shall keep a copy of the declaration of conformity for a period ending at least 10 years after the last product has been manufactured. Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available shall be the responsibility of the person who places the product on the Community market (see Annex XIII).
4. With regard to the assessment of conformity with the exhaust emission
requirements of this Directive and if the manufacturer is not working under
a relevant quality system as described in Annex XII, a notified body chosen
by the manufacturer may carry out or have carried out product checks at
random intervals. When the quality level appears unsatisfactory or when it
seems necessary to verify the validity of the data presented by the manufacturer, the following procedure shall be used:
An engine is taken from the series and subjected to the test described in
Annex I.B. Test engines shall have been run in, partially or completely,
according to the manufacturer’s specifications. If the specific exhaust emissions of the engine taken from the series exceed the limit values according to Annex I.B, the manufacturer may ask for measurements to be done on a sample of engines taken from the series and including the engine originally taken. To ensure the conformity of the sample of engines defined above with the requirements of the Directive, the statistical method described in Annex XVII shall be applied.
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ANNEX IX
PRODUCTION QUALITY ASSURANCE
(module D)
1. The manufacturer who satisfies the obligations of point 2 ensures and
declares that the products concerned are in conformity with the type as
described in the EC type-examination certificate and satisfy the requirements of the Directive that apply to them. The manufacturer or his
authorized representative established within the Community shall affix the
CE marking to each product and draw up a written declaration of conformity
(see Annex XV). The CE marking shall be accompanied by the
distinguishing number of the notified body responsible for the monitoring
as specified in point 4.
2. The manufacturer shall operate an approved quality system for production, final product inspection and testing as specified in paragraph3 and shall be subject to monitoring as specified in point 4.
3. Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the products concerned.
The application shall include:
— all relevant information for the product category envisaged,
— the documentation concerning the quality system,
— where appropriate, the technical documentation of the approved type
(see Annex XIII) and a copy of the EC type-examination certificate.
3.2. The quality system shall ensure compliance of the products with the type as described in the EC type-examination certificate and with the requirements of the Directive 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 must permit a consistent interpretation of the quality programmes, plan, manuals and records. It shall contain in particular an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the management with regard to product quality,
— the 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 of the personnel concerned, etc.,
— the means to monitor 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. It shall presume conformity with these requirements in respect of quality systems that implement the relevant harmonized standard.
The auditing team shall have at least one member with experience of
evaluation in the product technology concerned. The evaluation procedure
shall include an inspection visit to the manufacturer’s premises.
The decision shall be notified to the manufacturer. The notification shall
contain the conclusions of the examination and the reasoned assessment
decision.
3.4. The manufacturer shall undertake to fulfill the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient. The manufacturer or his authorized representative shall keep the notified body that has approved the quality system informed of any intended updating of the quality system.
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The notified body shall evaluate the modifications proposed and decide
whether the amended quality system will still satisfy the requirements
referred to in paragraph 3.2 or whether a reassessment is required.
It shall notify its decisions to the manufacturer. 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
fulfills the obligations arising out of the approved quality system.
4.2. The manufacturer shall allow the notified body entrance for inspection
purposes to the locations of manufacture, inspection and testing, and
storage 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 of the personnel concerned, etc.
4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.
4.4. Additionally the notified body may pay unexpected visits to the manufacturer.
During such visits the notified body may carry out, or cause to be
carried out, tests to verify that the quality system is functioning correctly,
if necessary. The notified body shall provide the manufacturer with a visit
report and, if a test has taken place, with a test report.
5. The manufacturer shall, for a period ending at least 10 years after the last
product has been manufactured, keep at the disposal of the national authorities:
— the documentation referred to in the second indent of the second
subparagraph of point 3.1,
— the updating referred to in the second subparagraph of point 3.4,
— the decision and reports from the notified body which are referred to in
the final subparagraph of point 3.4, point 4.3 and point 4.4.
6. Each notified body shall give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.
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ANNEX X
PRODUCT VERIFICATION
(module F)
1. This module describes the procedure whereby a manufacturer or his authorized representative established within the Community checks and attests that the products subject to the provisions of point 3 are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the Directive that apply to them.
2. The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the products with the type as
described in the EC type-examination certificate and with the requirements
of the Directive that apply to them. The manufacturer or his authorized
representative established within the Community shall affix the CE
marking to each product and shall draw up a declaration of conformity
(see Annex XV).
3. The notified body shall carry out the appropriate examinations and tests in
order to check the conformity of the product with the requirements of the
Directive either by examination and testing of every product as specified in
point 4 or by examination and testing of products on a statistical basis, as
specified in point 5, at the choice of the manufacturer.
3a. The manufacturer or his authorized representative shall keep a copy of the declaration of conformity for a period ending at least 10 years after the last product has been manufactured.
4. Verification by examination and testing of every product
4.1. All products shall be individually examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5 or equivalent tests shall be carried out in order to verify their conformity with the type as described in the EC type-examination certificate and the requirements of the Directive that apply to them.
4.2. The notified body shall affix, or cause to be affixed, its distinguishing
number to each approved product and draw up a written certificate of
conformity relating to the tests carried out.
4.3. The manufacturer or his authorized representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
5. Statistical verification
5.1. The manufacturer shall present his products in the form of homogeneous lots and shall take all measures necessary in order that the manufacturing process ensures the homogeneity of each lot produced.
5.2. All products shall be available for verification in the form of homogeneous lots. A random sample shall be drawn from each lot. Products in a sample shall be individually examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, shall be carried out to ensure their conformity with the requirements of the Directive which apply to them and to determine whether the lot is accepted or rejected.
5.3. The statistical procedure shall use the following elements:
— the statistical method to be applied,
— the sampling plan with its operational characteristics.
For the assessment of conformity with the exhaust emission requirements,
the procedure defined in Annex XVII shall be applied.
5.4. In the case of accepted lots, the notified body shall affix, or cause to be
affixed, its distinguishing number to each product and shall draw up a
written certificate of conformity relating to the tests carried out. All
products in the lot may be put on the market except those products from
the sample which were found not to be in conformity.
If a lot is rejected, the notified body or the competent authority shall take
appropriate measures to prevent the putting on the market of that lot. In the
event of frequent rejection of lots the notified body may suspend the statistical verification.
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The manufacturer may, under the responsibility of the notified body, affix
the latter’s distinguishing number during the manufacturing process.
5.5. The manufacturer or his authorized representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
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ANNEX XI
UNIT VERIFICATION
(module G)
1. This module describes the procedure whereby the manufacturer ensures and declares that the product concerned, which has been issued with the certificate referred to in point 2, conforms to the requirements of the Directive that apply to it. The manufacturer or his authorized representative established within the Community shall affix the CE marking to the product and draw up a declaration of conformity (see Annex XV).
2. The notified body shall examine the individual product and carry out the
appropriate tests as set out in the relevant standard(s) referred to in Article
5, or equivalent tests, to ensure its conformity withth e relevant requirements of the Directive.
The notified body shall affix, or cause to be affixed, its distinguishing
number on the approved product and shall draw up a certificate of conformity concerning the tests carried out.
3. The aim of the technical documentation is to enable conformity with the
requirements of the Directive to be assessed and the design, manufacture
and operation of the product to be understood (see Annex XIII).
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ANNEX XII
FULL QUALITY ASSURANCE
(module H)
1. This module describes the procedure whereby the manufacturer who satisfies the obligations of paragraph 2 ensures and declares that the products concerned satisfy the requirements of the Directive that apply to them. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a
written declaration of conformity (see Annex XV). The CE marking shall
be accompanied by the distinguishing number of the notified body responsible or the surveillance as specified in point 4.
2. The manufacturer shall operate an approved quality system for design,
manufacture and final product inspection and testing 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 witha notified body.
The application shall include:
— all relevant information for the product cagetory envisaged,
— the quality system’s documentation.
3.2. The quality system shall ensure compliance of the products with the
requirements of the Directive 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. This quality system documentation shall ensure a common understanding of the quality policies and procedures suchas quality programmes, plans, manuals and records.
It shall contain in particular an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the management with regard to design and product
quality,
— the technical design specifications, including standards, that will be
applied and, where the standards referred to in Article 5 will not be
applied in full, the means that will be used to ensure that the essential
requirements of the Directive that apply to the products will be met,
— the design control and design verification techniques, processes and
systematic actions that will be used when designing the products
pertaining to the product category covered,
— 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 of the personnel concerned, etc.,
— the means to monitor the achievement of the required design and
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. It shall presume compliance with these requirements in respect of quality systems that implement the relevant harmonized standard (EN 29001).
The auditing team shall have at least one member experienced as an
assessor in the product technology concerned. The evaluation procedure
shall include an assessment visit to the manufacturer’s premises.
The decision shall be notified to the manufacturer. The notification shall
contain the conclusions of the examination 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 uphold it so that it remains adequate and efficient.
1994L0025 — EN — 20.11.2003 — 002.001 — 35
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The manufacturer or his authorized representative shall keep the notified
body that has approved the quality system informed of any intended
updating of the quality system.
The notified body shall evaluate the modifications proposed and decide
whether the amended quality system will still satisfy the requirements
referred to in paragraph 3.2 or whether a reassessment is required.
It shall notify its decision to the manufacturer. The notification shall
contain the conclusions of the examination and the reasoned assessment
decision.
4. EC surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfills the obligations arising out of the approved quality system.
4.2. The manufacturer shall allow the notified body entrance for inspection
purposes to the locations of design, manufacture, inspection and testing,
and storage, and shall provide it with all necessary information, in particular:
— the quality system documentation,
— the quality records as foreseen by the design part of the quality system,
such as results of analyses, calculations, tests, etc.,
— the quality records as foreseen by the manufacturing part of the quality
system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.
4.4. Additionally the notified body may pay unexpected visits to the manufacturer.
At the time of such visits, the notified body may carry out tests or
have them carried out in order to check the proper functioning of the
quality system where necessary; it shall provide the manufacturer with a
visit report and, if a test has been carried out, with a test report.
5. The manufacturer shall, for a period ending at least 10 years after the last
product has been manufactured, keep at the disposal of the national authorities:
— the documentation referred to in the second indent of the second
subparagraph of point 3.1,
— the updating referred to in the second subparagraph of point 3.4,
— the decisions and reports from the notified body which are referred to in
the final subparagraph of point 3.4, point 4.3 and point 4.4.
6. Each notified body shall forward to the other notified bodies the relevant
information concerning the quality system approvals issued and withdrawn.
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ANNEX XIII
TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFACTURER
The technical documentation referred to in Annexes V, VII, VIII, IX, XI and
XVI must comprise all relevant data or means used by the manufacturer to
ensure that components or craft comply with the essential requirements relating to them.
The technical documentation shall enable understanding of the design, manufacture and operation of the product, and shall enable assessment of conformity with the requirements of this Directive.
The documentation shall contain so far as relevant for assessment:
(a) a general description of the type,
(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
(c) descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,
(d) a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to fulfill the essential requirements
when the standards referred to in Article 5 have not been applied,
(e) results of design calculations made, examinations carried out, etc.,
(f) test reports, or calculations namely on stability according to section 3.2 of the Essential Requirements and on buoyancy according to section 3.3
thereof (Annex I.A),
(g) exhaust emissions test reports demonstrating compliance with section 2 of the Essential Requirements (Annex I.B),
(h) sound emissions test reports or reference boat data demonstrating compliance with section 1 of the Essential Requirements (Annex I.C).
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ANNEX XIV
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER
STATES FORTHE NOTIFICATION OF BODIES
1. The body, its director and the staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier or installer of the products referred to in Article 1 which they inspect, nor the authorized
representative of any of these parties. They shall not become either involved
directly or as authorized representatives in the design, construction,
marketing or maintenance of the said products. This does not preclude the
possibility of exchanges of technical information between the manufacturer
and the body.
1a. A notified body must be independent and must not be controlled by the
manufacturers or by suppliers.
2. The body and its staff shall carry out the verification tests with the highest
degree of professional integrity and technical competence and shall be free
from all pressures and inducements, particularly financial, which might
influence their judgment or the result of the inspection, especially from
persons or groups of persons with an interest in the result of verifications.
3. The body shall have at its disposal the necessary staff and possess the
necessary facilities to enable it to perform properly the administrative and
technical tasks connected with verification; it shall also have access to the
equipment required for special verification.
4. The staff responsible for inspection shall have:
— sound technical and professional training,
— satisfactory knowledge of the requirements of the tests they carry out
and adequate experience of such tests,
— the ability to draw up the certificates, records and reports required to
authenticate the performance of the tests.
5. The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of tests carried out or on the results of such tests.
6. The body shall take out liability insurance unless its liability is assumed by
the State in accordance with national law, or the Member State itself is
directly responsible for the tests.
7. The staff of the body shall be bound to observe professional secrecy with
regard to all information gained in carrying out its tasks (except vis-à-vis
the competent administrative authorities of the State in which its activities
are carried out) under the Directive or any provision of national law giving
effect to it.
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ANNEX XV
WRITTEN DECLARATION OF CONFORMITY
1. The written declaration of conformity to the provisions of the Directive must always accompany:
(a) the recreational craft and the personal watercraft and must be included
with the owner’s manual (Annex I.A section 2.5),
(b) the components, as referred to in Annex II,
(c) propulsion engines and must be included with the owner’s manual
(Annex I.B.4).
2. The written declaration of conformity shall include the following (1):
(a) name and address of the manufacturer or his authorized representative
established in the Community (2),
(b) description of the product defined in point 1 (3),
(c) references to the relevant harmonized standards used, or references to the specifications in relation to which conformity is declared,
(d) where appropriate, the references of the other Community Directives
applied,
(e) where appropriate, reference to the EC type-examination certificate
issued by a notified body,
(f) where appropriate, the name and address of the notified body,
(g) identification of the person empowered to sign on behalf of the manufacturer or his authorized representative established within the Community.
3. With regard to:
— inboard engines and stern drive propulsion engines without integral
exhaust,
— engines type-approved according to Directive 97/68/EC which are in
compliance with stage II provided for in section 4.2.3 of Annex I of the
latter Directive and,
— engines type-approved according to Directive 88/77/EEC,
the declaration of conformity shall include in addition to the information of
point 2, a statement of the manufacturer that the engine will meet the exhaust emission requirements of this Directive, when installed in a recreational craft, in accordance with the manufacturer’s supplied instructions and that this engine must not be put into service until the recreational craft into which it is to be installed has been declared in conformity, if so required, with the relevant provision of the Directive;
1994L0025 — EN — 20.11.2003 — 002.001 — 39
(1) Must be drawn up in the language(s) as provided for under section 2.5 of Annex I.A.
(2) Business name and full address; the authorized representative must also give the business name and address of the manufacturer.
(3) Description of the product make, type, serial number, where appropriate.
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ANNEX XVI
PRODUCT QUALITY ASSURANCE (MODULE E)
1. This module describes the procedure whereby the manufacturer who satisfies the obligations of point 2 ensures and declares that the products
concerned are in conformity with the type as described in the EC type examination certificate and satisfy the requirements of the directive that
apply to them. The manufacturer or his authorized representative established within the Community must affix the CE mark to each product and draw up a written declaration of conformity. The CE mark must be accompanied by the identification symbol of the notified body responsible for surveillance as specified in point 4.
2. The manufacturer must operate an approved quality system for final
product inspection and testing as specified in point 3 and must be subject
to surveillance as specified in point 4.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system for the products concerned, with a notified body of his choice.
The application must include:
— all relevant information for the product category envisaged,
— the quality system’s documentation,
— if applicable, the technical documentation of the approved type and a
copy of the EC type-examination certificate.
3.2. Under the quality system, each product must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5 or equivalent tests shall be carried out in order to ensure its conformity with the relevant requirements of the directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must ensure a common understanding of the quality programmes, plans, manuals and records.
It must contain in particular an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the management with regard to product quality,
— the examinations and tests that will be carried out after manufacture,
— the means to monitor the effective operation of the quality system,
— quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.
3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
It presumes conformity with these requirements in respect of quality
systems that implement the relevant harmonized standard.
The auditing team must have at least one member experienced as an
assessor in the product technology concerned. The assessment procedure
must include an assessment visit to the manufacturer’s premises.
The decision must be notified to the manufacturer. The notification must
contain the conclusions of the examination and the reasoned assessment
decision.
3.4. The manufacturer must undertake to fulfil the obligations arising from the quality system as approved and to maintain it in an appropriate and efficient manner.
The manufacturer or his authorized representative must keep the notified
body which has approved the quality system informed of any intended
updating of the quality system.
The notified body must evaluate the modifications proposed and decide
whether the modified quality system will still satisfy the requirements
referred to in point 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The notification must
contain the conclusions of the examination and the reasoned assessment
decision.
4. Surveillance under the responsibility of the notified body
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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 must allow the notified body entrance for inspection
purposes to the locations of inspection, testing and storage and shall
provide it withall necessary information, in particular:
— the quality system documentation,
— the technical documentation,
— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.
4.3. The notified body must periodically carry out audits to ensure that the
manufacturer maintains and applies the quality system and must provide
an audit report to the manufacturer.
4.4. Additionally, the notified body may pay unexpected visits to the manufacturer.
At the time of such visits, the notified body may carry out tests or
have them carried out in order to check the proper functioning of the
quality system where necessary; it must provide the manufacturer with a
visit report and, if a test has been carried out, with a test report.
5. The manufacturer must, for a period ending at least 10 years after the last
product has been manufactured, keep at the disposal of the national authorities:
— the documentation referred to in the third indent of the second subparagraphof
point 3.1,
— the updating referred to in the second subparagraph of point 3.4,
— the decisions and reports from the notified body which are referred to in
the final subparagraph of point 3.4, points 4.3 and 4.4.
6. Each notified body must forward to the other notified bodies the relevant
information concerning the quality system approvals issued and withdrawn.
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ANNEX XVII
CONFORMITY OF PRODUCTION ASSESSMENT FOR EXHAUST AND
NOISE EMISSIONS
1. For verifying the conformity of an engine family, a sample of engines is
taken from the series. The manufacturer shall decide the size (n) of the
sample, in agreement withth e notified body.
2. The arithmetical mean X of the results obtained from the sample shall be
calculated for each regulated component of the exhaust and noise emission.
The production of the series shall be deemed to conform to the requirements (pass decision) if the following condition is met:
X + K. S = L
S is standard deviation, where:
S2 = S (x – X)2/(n – 1)
X = the arithmetical mean of the results
x = the individual results of the sample
L = the appropriate limit value
n = the number of engines in the sample
k = statistical factor depending on n (see table)
n 2 3 4 5 6 7 8 9 10
k 0,973 0,613 0,489 0,421 0,376 0,342 0,317 0,296 0,279
n 11 12 13 14 15 16 17 18 19
k 0,265 0,253 0,242 0,233 0,224 0,216 0,210 0,203 0,198
If n = 20 then k = 0,860/vn. k ¼ 0; 860=pffinffiffi
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