1996L0098 — EN — 17.02.1997 — 000.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE 96/98/EC
of 20 December 1996
on marine equipment
(OJ L 46, 17.2.1997, p. 25)
Corrected by:
►C1 Corrigendum, OJ L 246, 10.9.1997, p. 7 (96/98)
►C2 Corrigendum, OJ L 241, 29.8.1998, p. 27 (96/98)
1996L0098 — EN — 17.02.1997 — 000.001 — 2
▼B
COUNCIL DIRECTIVE 96/98/EC
of 20 December 1996
on marine equipment
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 84 (2) 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 189c of
the Treaty (3),
(1) Whereas within the framework of the common transport policyfurther measures must be adopted to ensure safety in maritimetransport;
(2) Whereas shipping accidents are a matter of serious concern to theCommunity, in particular those that cause loss of human life andpollution of the Member States’ seas and coastlines;
(3) Whereas the risk of shipping accidents can be effectively reducedby means of common standards that ensure high safety levels inthe performance of the equipment carried on board ships;whereas testing standards and testing methods can have greatinfluence on the future performance of equipment;
(4) Whereas international conventions require flag States to ensurethat the equipment carried on board ships complies with certainsafety requirements and to issue the relevant certificates; whereasto that end testing standards for certain types of marine equip-ment have been developed by the international standardizationbodies and by the International Maritime Organization (IMO);whereas the national testing standards implementing the inter-national standards leave a margin of discretion certificationauthorities, which themselves have different levels of qualifica-tions and experience; whereas that leads to varying levels ofsafety for products which the competent national authorities havecertified as complying with the relevant international safety stan-dards and to great reluctance on the part of Member States toaccept that without further verification ships flying their flagscarry equipment approved by other Member States;
(5) Whereas common rules must be laid down to eliminate differ-ences in the implementation of international standards; whereassuch common rules will result in the elimination of unnecessarycosts and administrative procedures relating to the approval ofequipment, the improvement of operating conditions and of thecompetitive position of Community shipping and the eliminationof technical barriers to trade by means of the mark of conformityaffixed to equipment;
(6) Whereas in its resolution of 8 June 1993 on a common policy onsafe seas (
4) the Council urged the Commission to submit
proposals for harmonizing the implementation of IMO standardsand the procedures for the approval of marine equipment;
(1) OJ No C 218, 23. 8. 1995, p. 9.
(2) OJ No C 101, 3. 4. 1996, p. 3.
(3) European Parliament opinion of 29 November 1995 (OJ No C 339, 18.
12. 1995, p. 21), Council common position of 18 June 1996 (OJ No C248, 26. 8. 1996, p. 10) and European Parliament Decision of 24 October1996 (OJ No C 347, 18. 11. 1996).
(
4) OJ No C 271, 7. 10. 1993, p. 1.
1996L0098 — EN — 17.02.1997 — 000.001 — 3
▼B
(7) Whereas action at Community level is the only possible way of
achieving such harmonization, since Member States acting inde-pendently or through international organizations cannot establishthe same level of safety performance in equipment;
(8) Whereas a Council Directive is the appropriate legal instrumentas it provides a framework for uniform and compulsory applica-tion of the international testing standards by Member States;
(9) Whereas it is appropriate in the first place to address equipmentthe carriage of which on board ship and the approval of which bynational administrations in accordance with safety standards laiddown in international conventions or resolutions is mandatoryunder the main international conventions;
(10) Whereas there are various Directives that ensure the free move-ment of certain products which could be used inter alia ,a s
equipment on board ships but which do not concern the MemberStates’ certification of equipment in accordance with the relevantinternational conventions; whereas equipment to be placed onboard ships must therefore be regulated exclusively by newcommon rules;
(11) Whereas new testing standards must be laid down, preferably atinternational level, for equipment for which such standards do notalready exist or are not sufficiently detailed;
(12) Whereas Member States should ensure that the notified bodiesthat assess the compliance of equipment with testing standardsare independent, efficient and professionally competent to carryout their tasks;
(13) Whereas compliance with international testing standards can bestbe demonstrated by means of conformity-assessment proceduressuch as those laid down in Council Decision 93/465/EEC of 22July 1993 concerning the modules for the various phases of theconformity-assessment procedures and the rules for the affixingand use of the CE conformity marking, which are intended to beused in the technical harmonization Directives (
1);
(14) Whereas nothing in this Directive restricts the right granted to aflag State administration by international conventions to carry outoperational-performance tests on board a ship for which it hasissued a safety certificate, provided such tests do not duplicatethe conformity-assessment procedures;
(15) Whereas equipment covered by this Directive should, as ageneral rule, bear a mark to indicate its compliance with therequirement of this Directive;
(16) Whereas Member States may in certain cases take provisionalmeasures to limit or prohibit the use of equipment bearing themark of conformity;
(17) Whereas the use of equipment not bearing the mark ofconformity may be allowed in exceptional circumstances;
(18) Whereas a simplified procedure involving a regulatory committeemust be followed for the amendment of this Directive,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The purpose of this Directive shall be to enhance safety at sea and the
prevention of marine pollution through the uniform application of therelevant international instruments relating to equipment listed in AnnexA to be placed on board ships for which safety certificates are issued by
(1) OJ No C 220, 30. 8. 1993, p. 23.
1996L0098 — EN — 17.02.1997 — 000.001 — 4
▼B
or on behalf of Member States pursuant to international conventions and
to ensure the free movement of such equipment within the Community.
Article 2
For the purposes of this Directive:
(a) ‘conformity-assessment procedures' shall mean the procedures set
out in Article 10 and Annex B;
(b) ‘equipment' shall mean items listed in Annexes A.1 and A.2 which
must be placed on board a ship for use in order to comply withinternational instruments or are voluntarily placed on board for use,and for which the approval of the flag State administration isrequired according to international instruments;
(c) ‘radiocommunications equipment' shall mean equipment required
by Chapter IV of ►
C2the 1974 Solas Convention, ◄as
amended with regard to the Global Maritime Distress and SafetySystem (GMDSS) in 1988, and two-way VHF radiotelephoneapparatus required by Regulation III/6.2.1 of the same Convention;
(d) ‘international conventions' shall mean:
—►
C2the 1966 International Convention ◄on Load Lines
(LL66),
— the 1972 Convention on the International Regulations for
Preventing Collisions at Sea (Colreg),
— the 1973 International Convention for the Prevention of Pollu-
tion from Ships (Marpol) and
— the 1974 International Convention for the Safety of Life at Sea
(Solas),
together with their Protocols and the amendments thereto in force
on the date of the adoption of this Directive;
(e) ‘international instruments' shall mean the relevant international
conventions, the relevant resolutions and circulars of the Inter-national Maritime Organization (IMO), and the relevant inter-national testing standards;
(f) ‘mark' shall mean the symbol referred to in Article 11 and set out
in Annex D;
(g) ‘notified body' shall mean an organization designated by the
competent national administration of a Member State in accordancewith Article 9;
(h) ‘placed on board' shall mean installed or placed on board a ship;
(i) ‘safety certificates' shall mean the certificates issued by or on
behalf of Member States in accordance with international conven-tions;
(j) ‘ship' shall mean a ship falling within the scope of international
conventions; warships shall not be covered;
(k) ‘Community ship' shall mean a ship for which safety certificates
are issued by or on behalf of Member States under internationalconventions. This definition shall not include a Member Stateadministration’s issuing a certificate for a ship at the request of athird country’s administration;
(l) ‘new ship' shall mean a ship the keel of which is laid or which is
at a similar stage of construction on or after the date of the entryinto force of this Directive. For the purposes of this definition, ‘asimilar stage of construction' shall mean the stage at which:
(i) construction identifiable with a specific ship begins
and
(ii) assembly of that ship has commenced, comprising at least
50 tonnes or 1 % of the estimated mass of all structuralmaterial, whichever is less;
1996L0098 — EN — 17.02.1997 — 000.001 — 5
▼B
(m) ‘existing ship' shall mean a ship which is not a new ship;
(n) ‘testing standards' shall mean the standards set by
— the International Maritime Organization (IMO),
— the International Organization for Standardization (ISO),— the International Electrotechnical Commission (IEC),— the European Committee for Standardization (CEN),— the European Committee for Electrotechnical Standardization
(Cenelec)
and
— the European Telecommunication Standards Institute (ETSI)
in force on the date of the adoption of this Directive, and estab-
lished in accordance with the relevant international conventionsand with the relevant IMO resolutions and circulars to definetesting methods and test results, but only in the form referred to inAnnex A;
(o) ‘type-approval' shall mean the procedures for evaluating equip-
ment produced in accordance with the appropriate testing standardsand the issue of the appropriate certificate.
Article 3
1. This Directive shall apply to equipment for use on board:
(a) a new Community ship whether or not the ship is situated within
the Community at the time of construction;
(b) an existing Community ship
— where such equipment was not previously carried on board
or
— where equipment which was previously carried on board the
ship is replaced, except where international conventions permitotherwise,
whether or not the ship is situated within the Community when the
equipment is placed on board.
2. This Directive shall not apply to equipment which on the date of
the entry into force of this Directive has already been placed on board aship.
3. Notwithstanding the fact that the equipment referred to in para-
graph 1 may fall within the scope of Directives other than this Directivefor the purpose of free movement, and in particular Council Directives89/336/EEC of 3 May 1989 on the approximation of the laws of theMember States relating to electromagnetic compatibility (
1) and 89/
686/EEC of 21 December 1989 on the approximation of the laws of theMember States relating to personal protective equipment (
2), that equip-
ment shall be subject only to this Directive, to the exclusion of allothers for those purposes.
Article 4
Each Member State or the organizations acting on its behalf shall
ensure, when issuing or renewing the relevant safety certificates, thatthe equipment on board Community ships for which it issues safetycertificates complies with the requirements of this Directive.
Article 5
1. Equipment listed in Annex A.1 that is placed on board a
Community ship on or after the date referred to in the second subpara-
(1) OJ No L 139, 23. 5. 1989, p. 19. Directive as last amended by Directive
93/68/EEC (OJ No L 220, 31. 8. 1993, p. 1).
(2) OJ No L 399, 30. 12. 1989, p. 18. Directive as last amended by Directive
93/95/EEC (OJ No L 276, 9. 11. 1993, p. 11).
1996L0098 — EN — 17.02.1997 — 000.001 — 6
▼B
graph of Article 20 (1) shall meet the applicable requirements of the
international instruments referred to in that Annex.
2. The compliance of equipment with the applicable requirements of
the international conventions and of the relevant resolutions and circu-lars of the International Maritime Organization shall be demonstratedsolely in accordance with the relevant testing standards and theconformity-assessment procedures referred to in Annex A.1. For itemslisted in Annex A.1, where both IEC and ETSI testing standards aregiven, those standards shall be alternatives and a manufacturer or hisauthorized representative established within the Community may deter-mine which of them is to be used.
3. Equipment listed in Annex A.1 and manufactured before the date
referred to in paragraph 1 may also be placed on the market and onboard a Community ship the certificates of which were issued by or onbehalf of a Member State in accordance with international conventionsduring the two years following that date if it was manufactured inaccordance with procedures for type-approval already in force withinthe territory of that Member State before the date of the adoption of thisDirective.
Article 6
1. No Member State shall prohibit the placing on the market or the
placing on board a Community ship of equipment referred to in AnnexA.1 which bears the mark or for other reasons complies with thisDirective or refuse to issue or renew the safety certificates relatingthereto.
2. A radio licence shall be issued in accordance with the international
radio regulations by the competent authority before the relevant safetycertificate is issued.
Article 7
1. After the date of the entry into force of this Directive, the
Community shall submit a request to the IMO or to the Europeanstandardization organizations, as appropriate, for the establishment ofstandards, including detailed testing standards, for the equipment listedin Annex A.2.
2. The request referred to in paragraph 1 shall be made:
— by the Presidency of the Council and by the Commission, when it is
submitted to the IMO,
— by the Commission, in accordance with Council Directive 83/
189/EEC of 28 March 1983 laying down a procedure for the provi-sion of information in the field of technical standards and regula-tions (
1), when it is submitted to the European standardization organ-
izations. The mandates issued by the Commission shall aim for thedevelopment of international standards through procedures forcooperation between the European bodies and their counterparts atinternational level.
3. Member States shall do their utmost to ensure that the inter-
national organizations, including the IMO, develop those standardsexpeditiously.
4. The Commission shall monitor the development of the testing
standards on a regular basis.
5. Should the international organizations, including the IMO, fail or
refuse to adopt appropriate testing standards for a specific item ofequipment within a reasonable time, standards based on the work of theEuropean standardization organizations may be adopted in accordancewith the procedure laid down in Article 18.
(1) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by the 1994
Act of Accession.
1996L0098 — EN — 17.02.1997 — 000.001 — 7
▼B
6. When the testing standards referred to in paragraphs 1 or 5 areadopted or enter into force, as appropriate, for a specific item ofequipment, that equipment may be transferred from Annex A.2 toAnnex A.1 in accordance with the procedure laid down in Article 18and, Article 5 shall apply from the date of that transfer.
Article 8
1. In the case of a new ship which, irrespective of its flag, is not
registered in a Member State but is to be transferred to the register of aMember State, such a ship shall, on transfer, be subject to inspection bythe receiving Member State to verify that the actual condition of itsequipment corresponds to its safety certificates and either complies withthis Directive and bears the mark or is equivalent, to the satisfaction ofthat Member State’s administration, to equipment type-approval inaccordance with this Directive.
2. Unless the equipment either bears the mark or that administration
considers it to be equivalent, it shall be replaced.
3. Equipment which is considered equivalent pursuant to this Article
shall be given a certificate by the Member State which shall at all timesbe carried with the equipment and which gives the flag Member State’spermission for the equipment to be placed on board the ship andimposes any restrictions or lays down any provisions relating to the useof the equipment.
4. In the case of radiocommunications equipment, the flag State
administration shall require that such equipment does not unduly affectthe requirements of the radio-frequency spectrum.
Article 9
1. Member States shall notify the Commission and the other Member
States of the bodies which they have designated to carry out the proced-ures for in Article 10 together with the specific tasks which thosenotified bodies have been designated to carry out and the identificationnumbers assigned to them beforehand by the Commission. Each organ-ization shall submit to the Member State which intends to designate itcomplete information concerning, and evidence of compliance with thecriteria laid down in Annex C.
2. At least once every two years each Member State shall cause an
audit of the duties its notified bodies are undertaking on its behalf to becarried out by the administration or by an impartial external organ-ization appointed by the administration. That audit shall ensure thateach notified body continues to comply with the criteria laid down inAnnex C.
3. A Member State which has designated a body shall withdraw its
designation if it finds that that body no longer complies with the criterialaid down in Annex C. It shall immediately inform the Commission andthe other Member States accordingly.
Article 10
1. The conformity-assessment procedure, details of which are listed
in Annex B, shall be:
(i) EC type-examination (module B) and, before equipment is placed
on the market and according to the choice made by the manufac-turer or his authorized representative established within theCommunity from the possibilities indicated in Annex A.1, allequipment shall be subject to:
(a) the EC declaration of conformity to type (module C);
(b) the EC declaration of conformity to type (production-quality
assurance) (module D);
(c) the EC declaration of conformity to type (product-quality assur-
ance) (module E);
1996L0098 — EN — 17.02.1997 — 000.001 — 8
▼B
(d) the EC declaration of conformity to type (product verification)
(module F); or
(ii) EC full-quality assurance (module H).
2. The declaration of conformity to type shall be in written form and
shall give the information specified in Annex B.
3. Where sets of equipment are produced individually or in small
quantities and not in series or in mass, the conformity-assessmentprocedure may be the EC unit verification (module G).
4. The Commission shall keep an up-to-date list of approved equip-
ment and applications withdrawn or refused and shall make it availableto interested parties.
Article 11
1. Equipment referred to in Annex A.1 which complies with the
relevant international instruments and is manufactured in accordancewith the conformity-assessment procedures shall have the mark affixedto it by the manufacturer or his authorized representative establishedwithin the Community.
2. The mark shall be followed by the identification number of the
notified body which has performed the conformity-assessment proce-dure, if that body is involved in the production-control phase, and bythe last two digits of the number of the year in which the mark isaffixed. The identification number of the notified body shall be affixedunder its responsibility either by the body itself or by the manufactureror his authorized representative established within the Community.
3. The form of the mark to be used shall be as set out in Annex D.4. The mark shall be affixed to the equipment or to its data plate so
as to be visible, legible and indelible throughout the anticipated usefullife of the equipment. However, where that is not possible or notwarranted on account of the nature of the piece of equipment, it shall beaffixed to the packaging of the product, to a label or to a leaflet.
5. No marks or inscriptions which are likely to mislead third parties
with regard to the meaning or the graphics of the mark referred to inthis Directive shall be affixed.
6. The mark shall be affixed at the end of the production phase.
Article 12
1. Notwithstanding Article 6, each Member State may take the meas-
ures necessary to ensure that sample checks are carried out on equip-ment bearing the mark which is on its market and which has not yetbeen placed on board, in order to ensure that it complies with thisDirective. Sample checks which are not provided for in the modules forconformity assessment in Annex B shall be carried out at the expense ofthe Member State.
2. Notwithstanding Article 6, after the installation of equipment
which complies with this Directive on board a Community ship, evalu-ation by that ship’s flag State administration of that equipment shall bepermitted when operational on-board performance tests are required byinternational instruments for safety and/or pollution-preventionpurposes, provided that they do not duplicate the conformity-assessmentprocedures already carried out. The flag State administration mayrequire the manufacturer of the equipment, his authorized representativeestablished within the Community or the person responsible formarketing the equipment within the Community to provide the inspec-tion/testing reports.
Article 13
1. Where a Member State ascertains by inspection or otherwise that,
notwithstanding the fact that it bears the mark, a piece of equipmentreferred to in Annex A.1, when correctly installed, maintained and usedfor its intended purpose, may compromise the health and/or safety ofthe crew, the passengers or, where applicable, other persons, or
1996L0098 — EN — 17.02.1997 — 000.001 — 9
▼B
adversely ►C1affect the marine environment, it shall take all appro-
priate interim measures to withdraw that piece of equipment from themarket◄or prohibit or restrict its being placed on the market or being
used on board a ship for which it issues the safety certificates. TheMember State shall immediately inform the other Member States andthe Commission of that measure and indicate the reasons for its decisionand, in particular, whether non-compliance with this Directive is due to:
(a) failure to comply with Article 5 (1) and (2);
(b) incorrect application of the testing standards referred to in Article 5
(1) and (2); or
(c) shortcomings in the testing standards themselves.
2. The Commission shall enter into consultation with the parties
concerned as soon as possible. Where, after such consultation, theCommission finds that:
— the measures are justified, it shall immediately so inform the
Member State which took the initiative and the other MemberStates; where the decision referred to in paragraph 1 is attributed toshortcomings in the testing standards, the Commission shall, afterconsulting the parties concerned, bring the matter before theCommittee referred to in Article 18 within two months if theMember State which has taken the decision intends to maintain itand shall initiate the procedure referred to in Article 18,
— the measures are unjustified, it shall immediately so inform the
Member State which took the initiative and the manufacturer or hisauthorized representative established within the Community.
3. Where a non-complying piece of equipment bears the mark, the
appropriate measures shall be taken by the Member State which hasauthority over whomsoever affixed the mark; that Member State shallinform the Commission and the other Member States of the measures ithas taken.
4. The Commission shall ensure that the Member States are kept
informed of the progress and outcome of this procedure.
Article 14
1. Notwithstanding the provisions of Article 5, in exceptional
circumstances of technical innovation, the flag State administration maypermit equipment which does not comply with the conformity-assess-ment procedures to be placed on board a Community ship if it isestablished by trial or otherwise to the satisfaction of the flag Stateadministration that such equipment is at least as effective as equipmentwhich does comply with the conformity-assessment procedures.
In the case of radiocommunications equipment, the flag State adminis-
tration shall require that such equipment does not unduly affect therequirements of the radio-frequency spectrum.
2. Such trial procedures shall in no way discriminate between equip-
ment produced in the flag Member State and equipment produced inother States.
3. Equipment covered by this Article shall be given a certificate by
the flag Member State which shall at all times be carried with theequipment and which gives the flag Member State’s permission for theequipment to be placed on board the ship and imposes any restrictionsor lays down any provisions relating to the use of the equipment.
4. Where a Member State allows equipment covered by this Article
to be placed on board a Community ship, that Member State shallforthwith communicate the particulars thereof together with the reportsof all relevant trials, assessments and conformity-assessment proceduresto the Commission and the other Member States.
5. Equipment such as is referred to in paragraph 1 shall be added to
Annex A.2 in accordance with the procedure laid down in Article 18.
6. Where a ship with equipment on board which is covered by
paragraph 1 is transferred to another Member State, the receiving flagMember State may undertake the measures necessary, which may
1996L0098 — EN — 17.02.1997 — 000.001 — 10
▼B
include tests and practical demonstrations, to ensure that the equipmentis at least as effective as equipment which does comply with theconformity-assessment procedures.
Article 15
1. Notwithstanding Article 5, a flag State administration may permit
equipment which does not comply with the conformity-assessmentprocedures or is not covered by Article 14 to be placed on board aCommunity ship for reasons of testing or evaluation, but only when thefollowing conditions are complied with:
(a) the equipment must be given a certificate by the flag Member State
which must at all times be carried with the equipment and whichgives the flag Member State permission for the equipment to beplaced on board the Community ship and imposes any restrictionsor lays down any provisions relating to the use of the equipment;
(b) the permission must be limited to a short period of time;
(c) the equipment must not be relied on in place of equipment which
meets the requirements of this Directive and must not replace suchequipment, which must remain on board the Community ship inworking and ready for immediate use.
2. In the case of radiocommunications equipment, the flag State
administration shall require that such equipment does not unduly affectthe requirements of the radio-frequency spectrum.
Article 16
1. Where equipment needs to be replaced in a port outwith the
Community and in exceptional circumstances which shall be duly justi-fied to the flag State administration where it is not practicable in termsof reasonable time, delay and cost to place on board equipment which isEC type-approved, other equipment may be placed on board in accord-ance with the following procedure:
(a) the equipment shall be accompanied by documentation issued by a
recognized organization equivalent to a notified body, where anagreement has been concluded between the Community and thethird country concerned on the mutual recognition of such organ-izations;
(b) should it prove impossible to comply with (a), equipment accompa-
nied by documentation issued by a Member State of the IMO whichis a party to the relevant conventions, certifying compliance withthe relevant IMO requirements, may be placed on board, subject toparagraphs 2 and 3.
2. The flag State administration shall be informed at once of the
nature and characteristics of such other equipment.
3. The flag State administration shall, at the earliest opportunity,
ensure that the equipment referred to in paragraph 1, along with itstesting documentation, complies with the relevant requirements of theinternational instruments and of this Directive.
4. In the case of radiocommunications equipment, the flag State
administration shall require that such equipment does not unduly affectthe requirements of the radio-frequency spectrum.
Article 17
This Directive may be amended in accordance with the procedure laid
down in Article 18, in order:
— to apply subsequent amendments of international instruments for the
purposes of this Directive,
— to update Annex A, both by introducing new equipment and by
transferring equipment from Annex A.2 to Annex A.1 and viceversa,
— to add the possibility of using modules B + C and module H for
equipment listed in Annex A.1,
1996L0098 — EN — 17.02.1997 — 000.001 — 11
▼B
— to include other standardization organizations in the definition of
‘testing standards' in Article 2.
Article 18
1. The Commission shall be assisted by the committee set up by
Article 12 of Council Directive 93/75/EEC of 13 September 1993concerning minimum requirements for vessels bound for or leavingCommunity ports and carrying dangerous or polluting goods (
1)i n
accordance with the procedure laid down in this Article.
2. The Commission representative shall submit to the committee a
draft of the measures to be taken. The committee shall deliver itsopinion on the draft within a time limit which the chairman may laydown according to the urgency of the matter. The opinion shall bedelivered by the majority laid down in Article 148 (2) of the Treaty inthe case of decisions which the Council is required to adopt on aproposal from the Commission. The votes of the representatives of theMember States within the committee shall be weighted in the mannerset out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are
in accordance with the opinion of the committee.
(b) If the measures envisaged are not in accordance with the opinion
of the committee, or if no opinion is delivered, the Commissionshall, without delay, submit to the Council a proposal relating tothe measures to be taken. The Council shall act by a qualifiedmajority.
If the Council has not acted within two months of the date of the
referral to it, the Commission shall adopt the measures proposed.
Article 19
The Member States shall offer each other mutual assistance with a view
to the effective implementation and enforcement of this Directive.
Article 20
1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply with this Directive nolater than 30 June 1998.
They shall apply those measures from 1 January 1999.When Member States adopt the measures referred to in the first
subparagraph, these shall contain references to this Directive or shall beaccompanied by such references on their official publication. Themethods of making such references shall be laid down by the MemberStates.
2. The Member States shall immediately communicate to the
Commission the texts of the provisions of national law which theyadopt in the field governed by this Directive. The Commission shallinform the other Member States thereof.
Article 21
This Directive shall enter into force on the day of its publication in the
Official Journal of the European Communities .
Article 22
This Directive is addressed to the Member States.
(1) OJ No L 247, 5. 10. 1993, p. 19.
1996L0098 — EN — 17.02.1997 — 000.001 — 12
▼B
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dards (1)B+C B+D B+E B+F GHANNEXA
Annex A.1: Equipment for which detailed testing standards already exist in international instru-
ments (1)
IN ADDITION TO THE INTERNATIONAL TESTING STANDARDS SPECIFICALLY
MENTIONED A NUMBER OF PROVISIONS, WHICH MUST BE CHECKED DURINGTYPE-EXAMINATION (TYPE-APPROVAL), ARE TO BE FOUND IN THE RELEVANT
CONVENTION REGULATIONS
1.Life-saving appliances
1Lifebuoys Regulation
III/4 &III,30RegulationIII/7.1,31 IMO Reso-lution A 689(17) × × ×
2Lifebuoysself-ignitinglights RegulationIII/4 &III,30 RegulationIII/7.1,31.2 IMO Reso-lution A 689(17) × × ×
3Lifebuoysself-acti-vatingsmokesignalsRegulationIII/4 &III,30 RegulationIII/7.1,31.3 IMO Reso-lution A 689(17) × × ×
4Lifejackets RegulationIII/4 &III,30 RegulationIII/7.2,32 IMO Reso-lution A 689(17) × × ×
5Immersionsuits RegulationIII/4 &III,30 RegulationIII/7.3,33 IMO Reso-lution A 689(17) × × ×
6Immersionsuits — lifejackets RegulationIII/4 &III,30 RegulationIII/33.1.2 IMO Reso-lution A 689(17) × × ×
7Thermalprotectiveaids RegulationIII/4 &III,30 RegulationIII/34 IMO Reso-lution A 689(17) × × ×
8Rocketparachuteflares (pyro-technics)RegulationIII/4 &III,30 RegulationIII/35 IMO Reso-lution A 689(17) × ×
9Hand flares(pyrotech-nics) RegulationIII/4 &III,30 RegulationIII/36 IMO Reso-lution A 689(17) × ×
10 Buoyantsmokesignals(pyrotech-nics)RegulationIII/4 &III,30 RegulationIII/37 IMO Reso-lution A 689(17) × ×
(1) Where module H appears in column six, module H plus design-examination certifi-
cate is to be understood.
1996L0098 — EN — 17.02.1997 — 000.001 — 13
▼B
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dards (1)B+C B+D B+E B+F GH
11 Line-
throwingappliances(pyrotech-nics)RegulationIII/4 &III,30 RegulationIII/49 IMO Reso-lution A 689(17) × ×
12 Inflatableliferafts RegulationIII/4 &III,30 RegulationIII/38,39 IMO Reso-lution A 689(17) ×
13 Rigid life-rafts RegulationIII/4 &III,30 RegulationIII/38,40 IMO Reso-lution A 689(17) ×
14 Float-freearrange-ments forliferafts;hydrostaticrelease unitsRegulationIII/4 &III,30 RegulationIII/38.6.3 IMO Reso-lution A 689(17) × × ×
15 Lifeboats RegulationIII/4 &III,30 RegulationIII/41 to 46 IMO Reso-lution A 689(17) × ×
16 Rigid rescueboats RegulationIII/4 &III,30 RegulationIII/47.1 & 2 IMO Reso-lution A 689(17) × ×
17 Inflatedrescue boats RegulationIII/4 &III,30 RegulationIII/47 IMO Reso-lution A 689(17) × ×
18 Launchingappliancesusing falland winch(davits)RegulationIII/4 &III,30 RegulationIII/48.1 & 2 IMO Reso-lution A 689(17) × × × ×
19 Float-freelaunchingappliances RegulationIII/4 &III,30 RegulationIII/48.1 & 3 IMO Reso-lution A 689(17) × × ×
20 Free-falllaunchingappliances RegulationIII/4 &III,30 RegulationIII/48.1 & 4 IMO Reso-lution A 689(17) ×
21 Launchingand embar-kation appli-ancesRegulationIII/4 &III,30 RegulationIII/48.1 & 5 IMO Reso-lution A 689(17) × ×
22 Embarka-tion ladders RegulationIII/4 &III,30 RegulationIII/48.7 IMO Reso-lution A 689(17) × × ×
23 Retro-reflectivematerials RegulationIII/4 RegulationIII/30.2.7 IMO Reso-lution A 658(16) × × ×
24 Two-wayVHF radio-telephoneapparatusRegulationIII/4 RegulationIII/6.2.1 IMO Reso-lution A 694(17)
IMO Reso-
lution A 762(18)
I-ETS× × × ×
1996L0098 — EN — 17.02.1997 — 000.001 — 14
▼B
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dards (1)B+C B+D B+E B+F GH
Item Item designa-Regulation
Marpol 73/78
as amendedApplicable
RegulationInternationalModules for conformity assessment
No tion where ‘type-
approval'is
requiredMarpol 73/78
as amendedtesting stan-
dards
B+C B+D B+E B+F GH300.225
IEC 945,
draft
IEC 1097-
12
25 Radar trans-ponderSART RegulationIII/4 RegulationIII/6.2.2 IMO Reso-lution A 530(13)
IMO Reso-
lution A 697(17)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-1
ITU-R 628× × × ×
26 Radar
reflectorRegulationIII/4 RegulationIII/38.5.1.14
Regulation
III/41.8.30IMO Reso-lution A 384(X)
ISO 8729× × × ×
(1) Where IMO Resolutions are cited, these standards are those contained in relevant parts of the Annexes to the
Resolutions and exclude the provisions of the Resolutions themselves.
2.Marine-pollution prevention
27 Oil-filtering
equipment(for an oilcontent ofthe effluentnotexceeding15 p.p.m.)Annex I
Regulation
16(4),(5) &(7)Annex I
Regulation
16 (1) & (2)MEPC 60(33) × × ×
28 Oil/waterinterfacedetectors Annex I
Regulation
15 (3) (b)Annex I
Regulation
15 (3) (b)MEPC 5(XIII) × × ×
29 Oil-contentmeters Annex I
Regulation
16 (5)Annex I
Regulation
16 (2)MEPC 60(33) × × ×
30 Processunitsintended forattachmentto existingoily waterseparatingequipment(for an oilcontent ofthe effluentnotAnnex I
Regulation
16 (5)Annex I
Regulation
16 (5)IMO Reso-lution A 444(XI) × × ×
1996L0098 — EN — 17.02.1997 — 000.001 — 15
▼B
Item Item designa-Regulation
Marpol 73/78
as amendedApplicable
RegulationInternationalModules for conformity assessment
No tion where ‘type-
approval'is
requiredMarpol 73/78
as amendedtesting stan-
dards
B+C B+D B+E B+F GH
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dardsB+C B+D B+E B+F GH
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dardsB+C B+D B+E B+F GHexceeding
15 p.p.m.)
31 Oildischargemonitoringand controlsystem foran oil tankerAnnex I
Regulation
15 (3)Annex I
Regulation
15 (3)IMO Reso-lution A 586(14) × × ×
32 Sewagetreatmentplants Annex IV
Regulation
8 (b)Annex IV
Regulation
8 (b)MEPC 2(VI) × × × ×
3.Fire protection
33 Not readily
ignitingmaterials forprimarydeckcoveringRegulationII-2/34.8
Regulation
II-2/49.3RegulationII-2/34.8
Regulation
II-2/49.3IMO Reso-lution A 214(VII)
IMO Reso-
lution A 687(17)
IMO MSC/
Circ. 549×
34 Portable fireextin-guishers RegulationII-2/6.1 RegulationII-2/6 EN 3 × × ×
4.Navigation equipment
35 Magnetic
compassRegulationV/12 (r) RegulationV/12 (b) IMO Reso-lution A 382(X)
IMO Reso-
lution A 394(17)
IEC 945ISO 449,
2269, 10316× × × ×
36 Gyrocompass RegulationV/12 (r) RegulationV/12 (d) IMO Reso-lution A 694(17)
IMO Reso-
lution A 424(XI)
IEC 945ISO 8728× × × ×
1996L0098 — EN — 17.02.1997 — 000.001 — 16
▼B
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dardsB+C B+D B+E B+F GH
37 Radar
equipmentRegulationV/12 (r) RegulationV/12 (g)
Regulation
V/12 (h)IMO Reso-lution A 477(XII)
IMO Reso-
lution A 694(17)
IEC 936 &
945× × × ×
38 ARPA RegulationV/12 (r) RegulationV/12 (j) IMO Reso-lution A 422(XI)
IMO Reso-
lution A 694(17)
IEC 945 &
872× × × ×
39 Echo-soundingequipment RegulationV/12 (r) RegulationV/12 (k) IMO Reso-lution A 224(VII)
IMO Reso-
lution A 694(17)
ISO 9875IEC 945× × × ×
40 Speed- and
distance-measuringequipmentRegulationV/12 (r) RegulationV/12 (l) IMO Reso-lution A 478(XII)
IMO Reso-
lution A 694(17)
IEC 945 &
1023× × × ×
41 Rate-of-turnindicator RegulationV/12 (r) RegulationV/12 (n) IMO Reso-lution A 526(13)
IMO Reso-
lution A 694(17)
IEC 945× × × ×
42 Direction
finderRegulationV/12 (r) RegulationV/12 (p) IMO Reso-lution A 665(16)
IMO Reso-
lution A 694(17)
IEC 945× × × ×
43 Omega
equipmentRegulationV/12 (r) RegulationV/12 (p) IMO Reso-lution A 479(XII)
IMO Reso-
lution A 694(17)
IEC 945 &
1010× × × ×
1996L0098 — EN — 17.02.1997 — 000.001 — 17
▼B
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dardsB+C B+D B+E B+F GH
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dardsB+C B+D B+E B+F GH44 Loran-C
equipmentRegulationV/12 (r) RegulationV/12 (p) IMO Reso-lution A 694(17)
IEC 945 &
1075× × × ×
45 Decca navi-gator equip-ment RegulationV/12 (r) RegulationV/12 (p) IMO Reso-lution A 694(17)
IEC 945 &
1135× × × ×
46 GPS equip-ment RegulationV/12 (r) RegulationV/12 (p) IMO Reso-lution A 694(17)
IEC 945draft IEC
1108-1× × × ×
5.Radio-communication equipment
47 VHF radio
installationcapable oftransmittingandreceivingDSC andradiote-lephonyRegulationIV/14 RegulationIV/7.1.1 IMO Reso-lution A 524(13)
IMO Reso-
lution A 609(15)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-3 &1097-7
ITU-R
493,541
ETS 300
162× × × ×
48 VHF DSCwatchreceiver RegulationIV/14 RegulationIV/7.1.2 IMO Reso-lution A 609(15)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-3 &1097-8
ITU-R
493,541
ETS 300
338
ETS
300.162× × × ×
1996L0098 — EN — 17.02.1997 — 000.001 — 18
▼B
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dardsB+C B+D B+E B+F GH
49 SART radar
transponderRegulationIV/14 RegulationIV/7.1.3 IMO Reso-lution A 530(13)
IMO Reso-
lution A 697(17)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-1
ITU-R 628× × × ×
50 NAVTEX
receiverRegulationIV/14 RegulationIV/7.1.4 IMO Reso-lution A 525(13)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-6
ITU-R 540
& 625
ETS 300
065× × × ×
51 EGCreceiver RegulationIV/14 RegulationIV/7.1.5 IMO Reso-lution A 570(14)
IMO Reso-
lution A 664(16)
IMO Reso-
lution A 694(17)
IEC 945draft IEC
1097-4
ETS 300
460× × × ×
52 HF marinesafety infor-mation(MSI)equipment
(HF NBDP
receiver)RegulationIV/14 RegulationIV/7.1.5 IMO Reso-lution A 700(17)
IMO Reso-
lution A 694(17)
IEC 945 &draft 1097-
11
ITU-R 491,
492, 625,688
ETS 300
067
ETS 300
067/A1× × × ×
53 406 MHzEpirb RegulationIV/14 RegulationIV/7.1.6 IMO Reso-lution A 662(16)
IMO Reso-
lution A 763(18)
IMO Reso-× × × ×
1996L0098 — EN — 17.02.1997 — 000.001 — 19
▼B
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dardsB+C B+D B+E B+F GH
lution A 696
(17)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-2
ETS 300
066
54 L-bandEpirb RegulationIV/14 RegulationIV/7.1.6 IMO Reso-lution A 661(16)
IMO Reso-
lution A 662(16)
IMO Reso-
lution A 694(17)
IEC 945draft IEC
1097-5
ITU-R 632Inmarsat-
system
definition
manual(SDM)
ETS 300
372× × × ×
55 2182 kHzwatchreceiver RegulationIV/14 RegulationIV/7.2 IMO Reso-lution A 383(X)
IMO Reso-
lution A 694(17)
IEC 945IEC 1097-
15
ETS 300
441
UIT-R M
219× × × ×
56 Two-tonealarm signalgenerator RegulationIV/14 RegulationIV/7.3 IMO Reso-lution A 421(XI)
IMO Reso-
lution A 571(14)
IMO Reso-
lution A 694(17)
IEC 945IEC 1097-9ETS 300
373
UIT-R M
219× × × ×
1996L0098 — EN — 17.02.1997 — 000.001 — 20
▼B
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dardsB+C B+D B+E B+F GH
57 MF radio
installationcapable oftransmittingandreceivingDSC andradiote-lephonyRegulationIV/14 RegulationIV/9.1.1
Regulation
IV/10.1.2IMO Reso-lution A 610(15)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-3 &1097-9
ITU-R 493,
541
ETS 300
373
ETS 300
338
UIR-R M
219× × × ×
58 MF radiote-lephoneDSC watchreceiverRegulationIV/14 RegulationIV/9.1.2
Regulation
IV/10.1.3IMO Reso-lution A 610(15)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-3&1097-10
ITU-R
493,541
ETS 300
373
ETS 300
338× × × ×
59 Inmarsat-ASES RegulationIV/14 RegulationIV/10.1.1 IMO Reso-lution A 570(14)
IMO Reso-
lution A 698(17)
IMO Reso-
lution A 694(17)
IEC 945SDM× × × ×
60 Inmarsat-C
SESRegulationIV/14 RegulationIV/10.1.1 IMO Reso-lution A 570(14)
IMO Reso-
lution A 663(16)
IMO Reso-
lution A 664(16)
IMO Reso-
lution A 694(17)
IEC 945SDMdraft IEC
1097-4× × × ×
1996L0098 — EN — 17.02.1997 — 000.001 — 21
▼B
Item Item designa-Regulation
Solas 74 asApplicable
RegulationInternationalModules for conformity assessment
No tionamended where
‘type-approval'
is requiredSolas 74 as
amendedtesting stan-
dardsB+C B+D B+E B+F GH
ETS 300
460
61 MF/HFradio instal-lationcapable oftransmittingandreceivingDSC,NBDP andradiote-lephonyRegulationIV/14 RegulationIV/10.2.1 IMO Reso-lution A 613(15)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-3 &1097-9 &1097-11
ITU-R 493,
541, 476,492, 625
ETS 300
067
ETS 300
373
ETS 300
338× × × ×
62 Radiotele-phone MF/HF DSCwatchreceiverRegulationIV/14 RegulationIV/10.2.2 IMO Reso-lution A 613(15)
IMO Reso-
lution A 694(17)
IEC 945 &
1097-3 &1097-10
ITU-R 493ETS 300
373
ETS 300
338× × × ×
1996L0098 — EN — 17.02.1997 — 000.001 — 22
▼B
Item
NoItem designationRegulation Solas 74 as amended
where ‘type-approval'is requiredInternational testing standards
Item
NoItem designationRegulation Solas 74 as amended
where ‘type-approval'is requiredInternational testing standardsAnnex A.2:
Equipment for which no detailed testing standards exist in international instruments
1.Life-saving appliances
1 Evacuation, slide launching
and embarkationRegulation III/48.5
2 Lifecraft-launching appli-ances Regulation III/4 & III,30 IMO Resolution A 689 (17)
2.Fire protection
3 Materials other than steel
for pipes penetrating ‘A'or‘B'class divisionRegulation II-2/18.2.1 For plastic pipes: IMO Reso-lution A 753 (18)
4 Materials other than steelfor pipes conveying oil orfuel oil Regulation II-2/18.2.2
5 Non-portable and transport-able extinguishers Regulation II-2/6.1
Regulation II-2/7.1.3, 7.2.3
& 7.3.1
6 Fireman’s breathing appa-ratus Regulation II-2/17.1.2
7 Sprinkler systems (limitedto sprinkler heads and tothe method of automaticsprinkling and signalling)Regulation II-2/12.3, 36.1.2& 36.2
Regulation 41-2 paragraph
5 & 52.2ISO 6182
8 Nozzles for fixed pressurewater-spraying fire-extin-guishing systems formachinery spacesRegulation II-2/10.1
9 Nozzles for fixed pressurewater-spraying fires-extin-guishing systems forspecial category spacesRegulation II-2/37.1.3 IMO Resolution A 123 (V)
10 Cold-weather starting ofgenerator sets (startingdevices) Regulation II-1/44.2
11 Fire hoses Regulation II-2/4.7.1
12 Dual-purpose nozzles Regulation II-2/4.8.4
Regulation II-2/41 — 2
paragraph 1.5
1996L0098 — EN — 17.02.1997 — 000.001 — 23
▼B
Item
NoItem designationRegulation Solas 74 as amended
where ‘type-approval'is requiredInternational testing standards
Item
NoItem designationRegulation Solas 74 as amended
where ‘type-approval'is requiredInternational testing standards13 Electric safety lamp Regulation II-2/17.1.1.4
14 Smoke detectors Regulation II-2/13.3.2
15 Heat detectors Regulation II-2/13.3.3
16 Primary deck covering,
toxic and explosive hazardsRegulation II-2/34.8
Regulation II-2/49.3IMO Resolution A 687 (17)
17 ‘A'and ‘B'class bulkheads
and decks, fire integrityRegulation II-2/3.3.5
Regulation II-2/3.4.4IMO Resolution A 754 (18)
18 Devices to prevent the
passage of flame into thecargo tanks in oil tankersRegulation II-2/59.1.5
Regulation II-2/59.1.9.4 &
59.2IMO MSC/Circ. 373/Rev. 1
IMO MSC/Circ. 450/Rev. 1
19 Non-combustible materials
used in ‘A',‘B'and ‘C'class divisionsRegulation II-2/3.1
Regulation II-2/3.3.4Regulation II-2/3.4.3Regulation II-2/3.5IMO Resolution A 472 (XII)
3.Radio-communication equipment
20 VHF Epirb Regulation IV/14 IMO Resolution A 612 (15)
IMO Resolution A 662IMO Resolution A 694 (17)IEC 945ITU-R 693
1996L0098 — EN — 17.02.1997 — 000.001 — 24
▼B
ANNEXB
Modules for conformity assessment
EC TYPE-EXAMINATION (MODULE B)
1. A notified body must ascertain and attest that a specimen, representative of
the production envisaged, complies with the provisions of the internationalinstruments that apply to it.
2. The application for the EC type-examination must be lodged by the manu-
facturer or his authorized representative established within the Communitywith a notified body of his choice.
The application must include:
— the name and address of the manufacturer and, if the application is
lodged by the authorized representative, his name and address as well,
— a written declaration that the same application has not been lodged
simultaneously with any other notified body,
— the technical documentation as described in point 3.
The applicant must place at the disposal of the notified body a specimen,
representative of the production envisaged and hereinafter called ‘type'(
1).
The notified body may request further specimens if needed for the testprogramme.
3. The technical documentation must make it possible to assess the product’s
compliance with the requirements of the relevant international instruments.It must, as far as is relevant for such assessment, cover the design, thebuilding standard, manufacture, installation and functioning of the productin accordance with the description of technical documentation set down inthe Appendix to this Annex.
4. The notified body must:4.1. examine the technical documentation and verify that the type has been
manufactured in accordance with the technical documentation;
4.2. perform the appropriate examinations and necessary tests or have them
performed to check whether the requirements of the relevant internationalinstruments have actually been met;
4.3. agree with the applicant the location where the examinations and necessary
tests will be carried out.
5. Where the type meets the provisions of the relevant international instru-
ments, the notified body must issue an EC type-examination certificate tothe applicant. The certificate must give the name and address of the manu-facturer, details of the equipment, the conclusions of the examination, theconditions of its validity and the necessary data for identification of theapproved type.
A list of the relevant parts of the technical documentation must be annexed
to the certificate and a copy kept by the notified body.
If a manufacturer is refused a type-certification, the notified body must give
detailed reasons for that refusal.
Where a manufacturer reapplies for type-approval for equipment for which
a type-certificate has been refused, his submission to the notified body mustinclude all relevant documentation, including the original test reports, thedetailed reasons for the previous refusal and details of all modificationsmade to the equipment.
6. The applicant must inform the notified body that holds the technical docu-
mentation concerning the EC type-examination certificate of all modifica-tions to the approved product, which must receive additional approval wheresuch changes may affect compliance with the requirements or the prescribedconditions for use of the product. Such additional approval must be given inthe form of an addition to the original EC type-examination certificate.
7. Each notified body must, on request, provide flag Member State administra-
tions and the other notified bodies with the relevant information concerningthe EC type-examination certificates and additions issued and withdrawn.
(1) A type may cover several versions of the product provided that the differences
between the versions do not affect the level of safety or the other requirementsconcerning the performance of the product.
1996L0098 — EN — 17.02.1997 — 000.001 — 25
▼B
8. The other notified bodies may receive copies of the EC type-examination
certificates and/or their additions. The Annexes to the certificates must bekept at the disposal of the other notified bodies.
9. The manufacturer or his authorized representative established within the
Community must keep with the technical documentation copies of ECtype-examination certificates and their additions for at least 10 years afterthe last product has been manufactured.
CONFORMITY TO TYPE (MODULE C)
1. A manufacturer or his authorized representative established within the
Community must ensure and declare that the products concerned conform totype as described in the EC type-examination certificate and satisfy therequirements of the international instruments that apply to them. The manu-facturer or his authorized representative established within the Communitymust affix the mark to each product and draw up a written declaration ofconformity.
2. The manufacturer must take all measures necessary to ensure that the
manufacturing process ensures that the manufactured products conform totype as described in the EC type-examination certificate and comply withthe requirements of the international instruments that apply to them.
3. The manufacturer or his authorized representative established within the
Community must keep a copy of the declaration of conformity for at least10 years after the last product has been manufactured.
PRODUCTION-QUALITY ASSURANCE (MODULE D)
1. A manufacturer who satisfies the obligations of point 2 must ensure and
declare that the products concerned conform to type as described in the ECtype-examination certificate. The manufacturer or his authorized repres-entative established within the Community must affix the mark to eachproduct and draw up a written declaration of conformity. The mark must beaccompanied by the identification symbol of the notified body responsiblefor surveillance as specified in point 4.
2. The manufacturer must operate an approved quality system for production,
final-product inspection and testing as specified in point 3 and must besubject to surveillance as specified in point 4.
3.Quality system
3.1. The manufacturer must lodge an application for assessment of his quality
system with a notified body of his choice for the products concerned.
The application must include:
— all relevant information for the product category envisaged,
— the documentation concerning the quality system,— the technical documentation of the approved type and a copy of the EC
type-examination certificate.
3.2. The quality system must ensure that the products conform to type as
described in the EC type-examination certificate.
All the elements, requirements and provisions adopted by the manufacturer
must be documented in a systematic and orderly manner in the form ofwritten policies, procedures and instructions. The quality-system documen-tation must permit a consistent interpretation of the quality programmes,plan, manuals and records.
It must, in particular, include 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 carriedout,
— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.,
— the means of monitoring the achievement of the required product quality
and the effective operation of the quality system.
3.3. The notified body must assess the quality system to determine whether it
satisfies the requirements laid down in point 3.2. It must presume compli-
1996L0098 — EN — 17.02.1997 — 000.001 — 26
▼B
ance with those requirements in respect of quality systems that implement
the relevant harmonized standard.
The auditing team must have at least one member with experience of
assessment in the product technology concerned. The assessment proceduremust include a visit to the manufacturer’s premises.
The manufacturer must be notified of the decision. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
3.4. The manufacturer must undertake to fulfil the obligations arising out of the
quality system as approved and to uphold it so that it remains adequate andefficient.
The manufacturer or his authorized representative established within the
Community must keep the notified body that has approved the qualitysystem informed of any intended updating of that quality system.
The notified body must assess the modifications proposed and decide
whether the modified quality system will still satisfy the requirements laiddown in point 3.2 or whether a reassessment is required.
The manufacturer must be notified of its decision. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
4.Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection
purposes to the locations of manufacture, inspection and testing and storageand must 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 must periodically carry out audits to make sure that the
manufacturer maintains and applies the quality system and must provide themanufacturer with audit reports.
4.4. In addition, the notified body may pay unannounced visits to the manufac-
turer. During such visits the notified body may carry out tests or cause teststo be carried out to check that the quality system is functioning correctly, ifnecessary. The notified body must provide the manufacturer with a visitreport and, if a test has taken place, with a test report.
5. The manufacturer must, for 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 para-
graph of point 3.1,
— the updating referred to in the second paragraph of point 3.4,— the decision and reports from the notified body referred to in the final
paragraph of point 3.4, point 4.3 and point 4.4.
6. Each notified body must, on request, provide flag Member State administra-
tions and the other notified bodies with the relevant information concerningthe quality-system approvals issued and withdrawn.
PRODUCT-QUALITY ASSURANCE (MODULE E)
1. A manufacturer who satisfies the obligations of point 2 ensures and declares
that the products concerned conform to type as described in the EC type-examination certificate. The manufacturer or his authorized representativeestablished within the Community must affix the mark to each product anddraw up a written declaration of conformity. The mark must be accompa-nied by the identification symbol of the notified body responsible forsurveillance as specified in point 4.
2. The manufacturer must operate an approved quality system for final inspec-
tion and testing as specified in point 3 and must be subject to surveillance asspecified 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.
1996L0098 — EN — 17.02.1997 — 000.001 — 27
▼B
The application must include:
— all relevant information for the product category envisaged,
— documentation concerning the quality system,— 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 must be carried out in order to ensure its compliance with the relevantrequirements of the international instruments. All the elements, require-ments and provisions adopted by the manufacturer must be documented in asystematic and orderly manner in the form of written policies, proceduresand instructions. That quality-system documentation must ensure commonunderstanding of the quality programmes, plans, manuals and records.
It must, in particular, include 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 of monitoring the effective operation of the quality system,— the 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 laid down in point 3.2. It must presume compli-ance with the requirements in respect of quality systems that implement therelevant harmonized standard.
The auditing team must have at least one member with experience as an
assessor in the product technology concerned. The assessment proceduremust include an assessment visit to the manufacturer’s premises.
The manufacturer must be notified of the decision. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
3.4. The manufacturer must undertake to fulfil the obligations arising out of the
quality system as approved and to maintain it in an appropriate and efficientmanner.
The manufacturer or his authorized representative established within the
Community must keep the notified body that has approved the qualitysystem informed of any intended updating of that quality system.
The notified body must evaluate the modifications proposed and decide
whether the modified quality system will still satisfy the requirements laiddown in point 3.2 or whether a reassessment is required.
The manufacturer must be notified of its decisions. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
4.Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection
purposes to the locations of inspection, testing and storage and must provideit with all 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 make sure that the
manufacturer maintains and applies the quality system and must provide themanufacturer with audit reports.
4.4. In addition, the notified body may pay unannounced visits to the manufac-
turer. During such visits the notified body may carry out tests or cause teststo be carried out to check that the quality system is functioning correctly, ifnecessary. The notified body must provide the manufacturer with a visitreport and, if a test has been carried out, with a test report.
5. The manufacturer must, for 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 paragraph
of point 3.1,
1996L0098 — EN — 17.02.1997 — 000.001 — 28
▼B
— the updating referred to in the second paragraph of point 3.4,
— the decision and reports from the notified body referred to in the final
paragraph of point 3.4, point 4.3 and point 4.4.
6. Each notified body must on request provide flag Member State administra-
tions and the other notified bodies with the relevant information concerningthe quality-system approvals issued and withdrawn.
PRODUCT VERIFICATION (MODULE F)
1. A manufacturer or his authorized representative established within the
Community must check and attest that the products subject to point 3conform to the type as described in the EC type-examination certificate.
2. The manufacturer must take all measures necessary to ensure that the
manufacturing process ensures that the products conform to type asdescribed in the EC type-examination certificate. He must affix the mark toeach product and must draw up a declaration of conformity.
3. The notified body must carry out the appropriate examinations and tests in
order to check that the product complies with the requirements of theinternational instruments either by examination and testing of every productas specified in point 4 or by examination and testing of products on astatistical basis, as specified in point 5, at the choice of the manufacturer.
3a. The manufacturer or his authorized representative established within the
Community must keep a copy of the declaration of conformity for at least10 years after the last product has been manufactured.
4.Verification by examination and testing of every product
4.1. All products must be individually examined and appropriate tests must be
carried out in order to verify their conformity to type as described in the ECtype-examination certificate.
4.2. The notified body must affix its identification symbol or cause it to be
affixed to each approved product and draw up a written certificate ofconformity relating to the tests carried out.
4.3. The manufacturer or his authorized representative established within the
Community must ensure that he is able to supply the notified body’scertificate of conformity on request to the flag Member State administration.
5.Statistical verification
5.1. The manufacturer must present his products in the form of homogeneous
lots and must take all measures necessary to ensure that the manufacturingprocess ensures the homogeneity of each lot produced.
5.2. All products must be available for verification in the form of homogeneous
lots. A random sample must be drawn from each lot. Products in a samplemust be individually examined and appropriate tests must be carried out toensure that they comply with the requirements of the international instru-ments which apply to them and to determine whether the lot is to beaccepted or rejected.
5.3. In the case of accepted lots, the notified body must affix its identification
symbol or cause it to be affixed to each product and must draw up a writtencertificate of conformity relating to the tests carried out. All products in thelot may be put on the market except those products from the sample whichare found not to comply.
If a lot is rejected, the notified body or the competent authority must take
appropriate measures to prevent that lot’s being put on the market. In theevent of frequent rejection of lots the notified body may suspend statisticalverification.
The manufacturer may, under the responsibility of the notified body, affix
the latter’s identification symbol during the manufacturing process.
5.4. The manufacturer or his authorized representative established within the
Community must ensure that he is able to supply the notified body’scertificates of conformity on request to the flag Member State administra-tion.
UNIT VERIFICATION (MODULE G)
1. The manufacturer must ensure and declare that the product concerned,
which has been issued with the certificate referred to in point 2, complieswith the requirements of the international instruments that apply to it. Themanufacturer or his authorized representative established within the
1996L0098 — EN — 17.02.1997 — 000.001 — 29
▼B
Community must affix the mark to the product and draw up a declaration of
conformity.
2. The notified body must examine the individual product and carry out
appropriate tests to ensure that it complies with the relevant requirements ofthe international instruments.
The notified body must affix its identification number or cause it to be
affixed to the approved product and must draw up a certificate ofconformity concerning the tests carried out.
3. The aim of the technical documentation is to enable compliance with the
requirements of the international instruments to be assessed and the design,manufacture and operation of the product to be understood.
FULL-QUALITY ASSURANCE (MODULE H)
1. A manufacturer who satisfies the obligations of paragraph 2 must ensure
and declare that the products concerned comply with the requirements of theinternational instruments that apply to them. The manufacturer or hisauthorized representative established within the Community must affix themark to each product and draw up a written declaration of conformity. Themark must be accompanied by the identification symbol of the notified bodyresponsible for surveillance as specified in point 4.
2. The manufacturer must operate an approved quality system for design,
manufacture, final-product inspection and testing as specified in point 3 andmust 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 with a notified body.
The application must include:
— all relevant information for the product category envisaged and
— documentation concerning the quality system.
3.2. The quality system must ensure that the products comply with the require-
ments of the international instruments that apply to them.
All the elements, requirements and provisions adopted by the manufacturer
must be documented in a systematic and orderly manner in the form ofwritten policies, procedures and instructions. The quality-system documen-tation must ensure common understanding of the quality policies andprocedures such as quality programmes, plans, manuals and records.
It must, in particular, include an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the management with regard to product quality,
— the technical design specifications, including standards, that will be
applied and the assurance that the essential requirements of the inter-national instruments that apply to the products will be met,
— the design-control and design-verification techniques, processes and
systematic actions that will be used in the design of the productspertaining 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 carriedout,
— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.,
— the means of monitoring the achievement of the required design and
product quality and the effective operation of the quality system.
3.3. The notified body must assess the quality system to determine whether it
satisfies the requirements laid down in point 3.2. It must presume compli-ance with the requirements in respect of quality systems that implement therelevant harmonized standard.
The auditing team must have at least one member with experience as an
assessor in the product technology concerned. The assessment proceduremust include an assessment visit to the manufacturer’s premises.
The manufacturer must be notified of the decision. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
1996L0098 — EN — 17.02.1997 — 000.001 — 30
▼B
3.4. The manufacturer must undertake to fulfil the obligations arising from the
quality system as approved and to uphold it so that it remains adequate andefficient.
The manufacturer or his authorized representative established within the
Community must keep the notified body that has approved the qualitysystem informed of any intended updating of that quality system.
The notified body must evaluate the modifications proposed and decide
whether the modified quality system will still satisfy the requirements laiddown in point 3.2 or whether a reassessment is required.
The manufacturer must be notified of its decisions. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
4.EC surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection
purposes to the locations of design, manufacture, inspection and testing andstorage and must provide it with all necessary information, in particular:
— the quality-system documentation,
— the quality records as provided for in the design part of the quality
system, such as the results of analyses, calculations, tests, etc.,
— the quality records as provided for in 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 must periodically carry out audits to make sure that the
manufacturer maintains and applies the quality system and must provide themanufacturer with audit reports.
4.4. In addition the notified body may pay unannounced visits to the manufac-
turer. During such visits, the notified body may carry out tests or cause teststo be carried out to check that the quality system is functioning correctly, ifnecessary. The notified body must provide the manufacturer with a visitreport and, if a test has been carried out, with a test report.
5. The manufacturer must, for 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 para-
graph of point 3.1,
— the updating referred to in the second paragraph of point 3.4,— the decision and reports from the notified body referred to in the final
paragraph of point 3.4, point 4.3 and point 4.4.
6. Each notified body must, on request, provide flag Member State administra-
tions and the other notified bodies with the relevant information concerningthe quality-system approvals issued and withdrawn.
7.Design examination
7.1. The manufacturer must lodge an application for examination of the design
with a single notified body.
7.2 The application must make it possible to understand the design, manufacture
and operation of the product and to assess compliance with the requirementsof international instruments.
It must include:
— the technical design specifications, including standards, that have been
applied and
— the necessary supporting evidence for their adequacy, in particular
where the standards specified in Article 5 have not been applied in full.Such supporting evidence must include the results of tests carried out byan appropriate laboratory of the manufacturer’s or on his behalf.
7.3. The notified body must examine the application and where the design
complies with those provisions of the international instruments that apply itmust issue an EC design-examination certificate to the applicant. The certif-icate must include the conclusions of the examination, the conditions of itsvalidity, the data necessary for identification of the approved design and, ifrelevant, a description of the product’s functioning.
7.4. The applicant must keep the notified body that has issued the EC design-
examination certificate informed of any modification to the approveddesign. Modifications to the approved design must receive additionalapproval from the notified body that issued the EC design-examination
1996L0098 — EN — 17.02.1997 — 000.001 — 31
▼B
certificate where such changes may affect compliance with the relevant
requirements of the international instruments or the prescribed conditionsfor use of the product. Such additional approval must be given in the formof an addition to the original EC design-examination certificate.
7.5. The notified bodies must, on request, provide flag Member State administra-
tions and the other notified bodies with the relevant information concerning:
— the EC design-examination certificates and additions issued and
— the EC design-approvals and additional approvals withdrawn.
1996L0098 — EN — 17.02.1997 — 000.001 — 32
▼B
Appendix to Annex B
Technical documentation to be supplied by the manufacturer to the notified
body
The provisions set down in this Appendix apply to all modules of Annex B.The technical documentation referred to in Annex B must comprise all relevant
data and means used by the manufacturer to ensure that equipment complies withthe essential requirements relating to it.
The technical documentation must make it possible to understand the design,
manufacture and operation of the product, and must make it possible to assesscompliance with the requirements of the relevant international instruments.
The documentation must, so far as they are relevant to assessment, include:
— a general description of the type,
— conceptual-design, build standard and manufacturing drawings and schemes
of components, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for the understanding of those draw-
ings and schemes, including the operation of the product,
— the results of design calculations made, impartial examinations carried out,
etc.,
— impartial test reports,— manuals for installation, use and maintenance.
Where appropriate, the design documentation must contain the following:
— attestations relating to the equipment incorporated in the appliance,
— attestations and certificates relating to the methods of manufacture and/or
inspection and/or monitoring of the appliance,
— any other document that makes it possible for the notified body to improve
its assessment.
1996L0098 — EN — 17.02.1997 — 000.001 — 33
▼B
ANNEXC
Minimum criteria to be taken into account by Member States for the
designation of bodies
1. Notified bodies must fulfil the requirements of the relevant EN 45000 series.2. A notified body must be independent and must not be controlled by manufac-
turers or by suppliers.
3. A notified body must be established within the territory of the Community.4. Where type-approvals are issued by a notified body on behalf of a Member
State, the Member State must ensure that the qualifications, technical experi-ence and staffing of the notified body are such as will enable it to issuetype-approvals which comply with the requirements of this Directive and toguarantee a high level of safety.
5. A notified body must be in a position to provide maritime expertise.
A notified body is entitled to perform conformity-assessment procedures for
any economic operator established within or outwith the Community.
A notified body may perform conformity-assessment procedures in any
Member State or State outwith the Community using either its home-basedmeans or the personnel of its branch office abroad.
If a subsidiary of a notified body performs conformity-assessment procedures,
all documents relating to the conformity-assessment procedures must beissued by and in the name of the notified body and not in the name of thesubsidiary.
A subsidiary of a notified body which is established in another Member State
may, however, issue documents relating to conformity-assessment proceduresif it is notified by that Member State.
1996L0098 — EN — 17.02.1997 — 000.001 — 34
▼B
ANNEXD
Mark of conformity
The mark of conformity must take the following form:
If the mark is reduced or enlarged the proportions given in the above graduated
drawing must be respected.
The various components of the mark must have substantially the same vertical
dimension, which may not be less than 5 mm.
That minimum dimension may be waived for small devices.